Vol. 81 Monday, 

No. 94 May 16, 2016 

Part III 

Environmental Protection Agency 

40 CFR Parts 9 and 721 

Significant New Use Rules on Certain Chemical Substances; Final Rule 


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30452 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2015–0810; FRL–9944–77] 

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 55 chemical substances 

which were the subject of 

premanufacture notices (PMNs). Ten of 

these chemical substances are subject to 

TSCA section 5(e) consent orders issued 

by EPA. This action requires persons 

who intend to manufacture (defined by 

statute to include import) or process any 

of these 55 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 July 15, 

2016. For purposes of judicial review, 

this rule shall be promulgated at 1 p.m. 

(e.s.t.) on May 31, 2016. 

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 June 15, 2016 (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 June 15, 

2016, EPA will withdraw the relevant 

sections of this direct final rule before 

its effective date. 

For additional information on related 

reporting requirement dates, see Units 

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

INFORMATION. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2015–0810, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: Document Control Office 

(7407M), Office of Pollution Prevention 

and Toxics (OPPT), Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

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

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

For technical information contact: 

Kenneth Moss, Chemical Control 

Division (7405M), Office of Pollution 

Prevention and Toxics, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001; 

telephone number: (202) 564–9232; 

email address: Moss.Kenneth@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCA-Hotline@

epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you manufacture (defined 

by statute to include import), process, or 

use the chemical substances contained 

in this rule. The following list of North 

American Industrial Classification 

System (NAICS) codes is not intended 

to be exhaustive, but rather provides a 

guide to help readers determine whether 

this document applies to them. 

Potentially affected entities may 

include: 

• Manufacturers, or processors of one 

or more subject chemical substances 

(NAICS codes 325 and 324110), e.g., 

chemical manufacturing and petroleum 

refineries. 

This action may also affect certain 

entities through pre-existing import 

certification and export notification 

rules under TSCA. Chemical importers 

are subject to the TSCA section 13 (15 

U.S.C. 2612) import certification 

requirements promulgated at 19 CFR 

12.118 through 12.127 and 19 CFR 

127.28. Chemical importers must certify 

that the shipment of the chemical 

substance complies with all applicable 

rules and orders under TSCA. Importers 

of chemicals subject to these SNURs 

must certify their compliance with the 

SNUR requirements. The EPA policy in 

support of import certification appears 

at 40 CFR part 707, subpart B. In 

addition, any persons who export or 

intend to export a chemical substance 

that is the subject of a proposed or final 

rule are subject to the export 

notification provisions of TSCA section 

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

and must comply with the export 

notification requirements in 40 CFR part 

707, subpart D. 

B. What should I consider as I prepare 

my comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

regulations.gov or email. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD–ROM that 

you mail to EPA, mark the outside of the 

disk or CD–ROM as CBI and then 

identify electronically within the disk or 

CD–ROM the specific information that 

is claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When preparing and submitting your 

comments, see the commenting tips at 

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

comments.html. 

II. Background 

A. What action is the Agency taking? 

EPA is promulgating these SNURs 

using direct final procedures. These 

SNURs will require persons to notify 

EPA at least 90 days before commencing 

the manufacture or processing of a 

chemical substance for any activity 

designated by these SNURs as a 

significant new use. Receipt of such 

notices allows EPA to assess risks that 

may be presented by the intended uses 

and, if appropriate, to regulate the 

proposed use before it occurs. 

Additional rationale and background to 

these rules are more fully set out in the 

preamble to EPA’s first direct final 

SNUR published in the Federal Register 

issue of April 24, 1990 (55 FR 17376) 

(FRL–3658–5). Consult that preamble 

for further information on the 

objectives, rationale, and procedures for 

SNURs and on the basis for significant 

new use designations, including 

provisions for developing test data. 

B. What is the Agency’s authority for 

taking this action? 

Section 5(a)(2) of TSCA (15 U.S.C. 

2604(a)(2)) authorizes EPA to determine 


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that a use of a chemical substance is a 

‘‘significant new use.’’ EPA must make 

this determination by rule after 

considering all relevant factors, 

including the four bulleted TSCA 

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

Once EPA determines that a use of a 

chemical substance is a significant new 

use, TSCA section 5(a)(1)(B) requires 

persons to submit a significant new use 

notice (SNUN) to EPA at least 90 days 

before they manufacture or process the 

chemical substance for that use. Persons 

who must report are described in 

§ 721.5. 

C. Applicability of General Provisions 

General provisions for SNURs appear 

in 40 CFR part 721, subpart A. These 

provisions describe persons subject to 

the rule, recordkeeping requirements, 

exemptions to reporting requirements, 

and applicability of the rule to uses 

occurring before the effective date of the 

rule. Provisions relating to user fees 

appear at 40 CFR part 700. According to 

§ 721.1(c), persons subject to these 

SNURs must comply with the same 

SNUN requirements and EPA regulatory 

procedures as submitters of PMNs under 

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

these requirements include the 

information submission requirements of 

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

exemptions authorized by TSCA section 

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

regulations at 40 CFR part 720. Once 

EPA receives a SNUN, EPA may take 

regulatory action under TSCA section 

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

for which it has received the SNUN. If 

EPA does not take action, EPA is 

required under TSCA section 5(g) to 

explain in the Federal Register its 

reasons for not taking action. 

III. Significant New Use Determination 

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

EPA’s determination that a use of a 

chemical substance is a significant new 

use must be made after consideration of 

all relevant factors, including: 

• The projected volume of 

manufacturing and processing of a 

chemical substance. 

• The extent to which a use changes 

the type or form of exposure of human 

beings or the environment to a chemical 

substance. 

• The extent to which a use increases 

the magnitude and duration of exposure 

of human beings or the environment to 

a chemical substance. 

• The reasonably anticipated manner 

and methods of manufacturing, 

processing, distribution in commerce, 

and disposal of a chemical substance. 

In addition to these factors 

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

statute authorized EPA to consider any 

other relevant factors. 

To determine what would constitute a 

significant new use for the 55 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 

55 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 (assigned for nonconfidential chemical identities). 

• Basis for the TSCA section 5(e) 

consent order or the basis for the TSCA 

non-section 5(e) SNURs (i.e., SNURs 

without TSCA section 5(e) consent 

orders). 

• Tests recommended by EPA to 

provide sufficient information to 

evaluate the chemical substance (see 

Unit VIII. for more information). 

• CFR citation assigned in the 

regulatory text section of this rule. 

The regulatory text section of this rule 

specifies the activities designated as 

significant new uses. Certain new uses, 

including production volume limits 

(i.e., limits on manufacture volume) and 

other uses designated in this rule, may 

be claimed as CBI. Unit IX. discusses a 

procedure companies may use to 

ascertain whether a proposed use 

constitutes a significant new use. 

This rule includes 10 PMN substances 

(P–11–150, P–11–484, P–11–543, P–14– 

67, P–15–59, P–15–60, P–15–104, P–15– 

154, P–15–328, and P–15–502) 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 so-called ‘‘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 45 

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, 


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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–11–150 

Chemical name: Alkali transition 

metal oxide (generic). 

CAS number: Claimed confidential. 

Effective date of TSCA section 5(e) 

consent order: April 14, 2015. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the substance 

will be as a battery material. Based on 

test data on the PMN substance and 

structural activity relationship (SAR) 

analysis of test data on analogous 

respirable, poorly soluble particulates, 

subcategory titanium dioxide, EPA 

identified concerns for lung, blood, 

kidney, and adrenal toxicity, 

neurotoxicity, developmental toxicity, 

developmental neurotoxicity, 

cardiovascular and gastrointestinal 

effects, and immunosuppression. The 

Order was issued under TSCA sections 

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

on a finding that the substance may 

present an unreasonable risk of injury to 

human health. To protect against these 

risks, the consent order requires: 

1. Hazard communication. 

Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and the Material Safety 

Data Sheet (MSDS). 

2. Use of personal protective 

equipment including a National 

Institute of Occupational Safety and 

Health (NIOSH)-certified respirator with 

an assigned protection factor (APF) of at 

least 10 or compliance with a New 

Chemicals Exposure Limit (NCEL) of 2.4 

milligrams/cubic meter (mg/m3) as an 8- 

hour time-weighted average, when there 

is potential inhalation exposure. 

3. Submission of certain toxicity 

testing on the PMN substance prior to 

exceeding the confidential production 

volume limit as specified in the consent 

order of the PMN substance. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of a 90-day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465) with special 

attention to histopathology 

(inflammation and cell proliferation) of 

the lung tissues and various parameters 

of the bronchoalveolar lavage fluid 

(BALF) e.g., maker enzyme activities, 

total protein content, total cell count, 

cell differential, and cell viability. It is 

not necessary to look at internal organs. 

EPA recommends that a recovery period 

of 60 days be included to assess the 

progression or regression of any lesions 

would help characterize possible health 

effects of the substance. The submitter 

has agreed to complete this testing by 

the confidential aggregate production 

volume identified in the consent order. 

In addition, EPA has determined that 

the results of a carcinogenicity test 

(OPPTS Test Guideline 870.4200) would 

help characterize the potential human 

health effects of the PMN substance. 

The Order does not require this test at 

any specified time or production 

volume. However, the Order’s 

restrictions on manufacture, processing, 

distribution in commerce, use, and 

disposal of the PMN substances will 

remain in effect until the Order is 

modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citation: 40 CFR 721.10875. 

PMN Numbers P–11–484 and P–11–543 

Chemical names: Perfluoroalkyl 

substituted alkyl sulfonate (generic) (P– 

11–484); and Polyfluorinated alkyl 

quaternary ammonium chloride 

(generic) (P–11–543). 

CAS numbers: Claimed confidential. 

Effective date of TSCA section 5(e) 

consent order: October 30, 2014. 

Basis for TSCA section 5(e) consent 

order: The PMNs state that the generic 

(non-confidential) use of the substances 

will be as surfactants. Based on physical 

chemical properties data, as well as test 

data on analogous perfluorinated 

chemicals and potential perfluorinated 

degradation products including 

perfluorooctanoic acid (PFOA), 

perfluorooctanesulfonate (PFOS), 

perfluorohexane sulfonate (PFHS), and 

1H,1H,2H,2H-perfluorooctanesulfonic 

acid (6–2 FTSA), EPA identified 

concerns for irritation to skin, eyes, 

lungs, mucous membranes, lung 

toxicity, liver toxicity, blood toxicity, 

male reproductive toxicity, 

immunosupression, and oncogenicity. 

EPA has concerns that these degradation 

products will persist in the 

environment, could bioaccumulate or 

biomagnify, and could be toxic (PBT) to 

people, wild mammals, and birds. 

Further, based on test data on P–11–484, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 2,800 and 1 part per billion 

(ppb) respectively for PMN substances 

P–11–484 and P–11–543 respectively in 

surface waters. The Order was issued 

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

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

based on a finding that these substances 

may present an unreasonable risk of 

injury to the environment and human 

health, the substances may be produced 

in substantial quantities and may 

reasonably be anticipated to enter the 

environment in substantial quantities, 

and there may be significant (or 

substantial) human exposure to the 

substances and their potential 

degradation products. To protect against 

these exposures and risks, the consent 

order requires: 

1. Risk notification. If as a result of 

the test data required, the company 

becomes aware that the PMN substances 

may present a risk of injury to human 

health or the environment, the company 

must incorporate this new information, 

and any information on methods for 

protecting against such risk into an 

MSDS, within 90 days. 

2. Submission of certain physical/

chemical property, human health and 

environmental toxicity, and 

environmental fate testing prior to 

exceeding the confidential production 

volume limits specified in the consent 

order. 

3. Recording and reporting of certain 

fluorinated impurities in the starting 

raw material; and manufacture of the 

PMN substances not to exceed the 

maximum established impurity levels of 

certain fluorinated impurities. 

4. Use of the PMN substances only for 

the confidential uses specified in the 

consent order, where use in consumer 

products that could be spray applied are 

prohibited. 

5. Disposal of the PMN substance 

according to the incineration conditions 

specified in the consent order. 

6. Comply with the release to water 

provisions 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 human health 

and environmental toxicity testing 

would help characterize human health 

and environmental effects of the PMN 

substances. The submitter has agreed to 

conduct the testing identified in the 

consent agreement by the confidential 

triggers identified in the consent order. 

Further, EPA has determined that the 

results of an acute inhalation toxicity 

test (OPPTS Test Guideline 870.1300) 

and a 90-day inhalation toxicity test 

(OPPTS Test Guideline 870.3465) with 

a post-exposure observation period of 

up to 3 months and BALF analysis 

would help characterize the human 

health effects from spray application of 

the PMN substances. The Order does 


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not require this testing at any specified 

time or production volume. However, 

the Order’s restrictions on manufacture, 

processing, distribution in commerce, 

use, and disposal of the PMN substances 

will remain in effect until the Order is 

modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citations: 40 CFR 721.10876 (P– 

11–484) and 40 CFR 721.10877 (P–11– 

543). 

PMN Number P–14–67 

Chemical name: 

Polyfluorinatedalkylsulfonyl substituted 

alkane derivative (generic). 

CAS number: Claimed confidential. 

Effective date of TSCA section 5(e) 

consent order: November 4, 2015. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the substance 

will be as a polymer additive. EPA has 

concerns for potential incineration or 

other decomposition products of the 

PMN substance. These fluorinated 

decomposition products may be 

released to the environment from 

incomplete incineration of the PMN 

substance at low temperatures. EPA has 

preliminary evidence, including data on 

some fluorinated polymers which 

suggest that under some conditions, the 

PMN substance could degrade in the 

environment. EPA has concerns that 

these degradation products will persist 

in the environment, could 

bioaccumulate or biomagnify, and could 

be toxic (PBT) to people, wild 

mammals, and birds. These concerns are 

based on data on analogous chemical 

substances, including PFOA and other 

perfluorinated alkyls, including the 

presumed environmental degradant. 

EPA also has concerns that under some 

conditions of use, particularly nonindustrial, commercial, or consumer 

use, the PMN substance could cause 

lung effects, based on limited data on 

some perfluorinated compounds. 

Concerns for the PMN substance are for 

lung toxicity from waterproofing of lung 

membrane, based on PMN properties. 

The order was issued under TSCA 

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

based on a finding that these substances 

and their potential degradation products 

may present an unreasonable risk of 

injury to the environment and human 

health. 

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. Submission of certain 

environmental fate testing on the PMN 

substance prior to exceeding the 

confidential production volume limit as 

specified in the consent order of the 

PMN substance. 

3. No use of the PMN substance in 

consumer spray products. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of the 

modified aerobic activated sludge 

biodegradation test submitted by the 

company for EPA review would help 

characterize the possible degradation of 

the PMN substance. The submitter has 

agreed to submit the results of this test 

by the confidential production volume 

identified in the consent order. EPA had 

determined that the results of a 

phototransformation of chemicals on 

soil surfaces (Organisation for Economic 

Co-operation and Development (OECD) 

Draft Document January 2002) would 

help characterize the degradation 

potential of the PMN substance. The 

Order does not require this testing at 

any specified time or production 

volume. However, the Order’s 

restrictions on manufacture, processing, 

distribution in commerce, use, and 

disposal of the PMN substances will 

remain in effect until the Order is 

modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citation: 40 CFR 721.10878. 

PMN Number P–14–125 

Chemical name: 1- 

Octadecanaminium, N-(3-chloro-2- 

hydroxypropyl)-N,N-dimethyl-, chloride 

(1:1). 

CAS number: 3001–63–6. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a chemical 

intermediate for surfactant production. 

Based on test data on the PMN 

substance, as well as SAR analysis of 

test data on analogous cationic 

surfactants, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 2 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 

2 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 resulting in surface water 

concentrations exceeding 2 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 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 721.10879. 

PMN Numbers P–14–153, P–14–154, 

P–15–79, and P–15–80 

Chemical names: Fatty acid rxn 

products with aminoalkylamines 

(generic). 

CAS numbers: Claimed confidential. 

Basis for action: The PMN states that 

these substances will be used as 

chemical intermediates, additives for 

flotation products, and as adhesion 

promoters for use in asphalt 

applications. Based on 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 

substances in surface waters. For the 

uses described in the PMN, releases of 

the substances are not expected to result 

in surface water concentrations 

exceeding 1 ppb. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substances may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substances, excluding the 

uses described in the PMNs, result in in 

releases to surface water concentrations 

exceeding 1 ppb may result in 

significant adverse environmental 

effects. Based on this information, the 

PMN substances meet the concern 

criteria at § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

early-life stage toxicity test (OPPTS Test 

Guideline 850.1400); a daphnid chronic 

toxicity test (OPPTS Test Guideline 

850.1300); an algal toxicity test (Office 

of Chemical Safety and Pollution 

Prevention (OCSPP) Test Guideline 

850.4500); log Kow and water solubility 

measurements; as well as either the fish 

acute toxicity mitigated by humic acid 

test (OPPTS Test Guideline 850.1085) or 

the whole sediment acute toxicity 

invertebrates, freshwater test (OPPTS 

Test Guideline 850.1735) would help 

characterize the environmental effects of 

the PMN substances. EPA also 

recommends that the guidance 

document on aquatic toxicity testing of 

difficult substance and mixtures (OECD 

Test Guideline 23) be consulted to 


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facilitate solubility in the test media. 

Testing should be tiered, starting with 

water solubility and log Kow 

measurements before proceeding with 

higher tier toxicity tests. 

CFR citation: 40 CFR 721.10880. 

PMN Numbers P–14–155 and P–14–156 

Chemical names: Fatty acid amides 

(generic). 

CAS numbers: Claimed confidential. 

Basis for action: The PMNs state that 

the substances will be used as chemical 

intermediates, additives for flotation 

products, and adhesion promoters for 

use in asphalt applications. Based on 

SAR analysis of test data on analogous 

amides and aliphatic amines, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

2 and 3 ppb respectively of the PMN 

substances P–14–155 and P–14–156 in 

surface waters. For the uses described in 

the PMNs, releases of the substances are 

not expected to result in surface water 

concentrations that exceed 2 ppb and 3 

ppb of the PMN substances respectively. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substances may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substances, excluding uses 

described in the PMNs, resulting in 

surface water concentrations exceeding 

2 ppb (P–14–155) or 3 ppb (P–14–156) 

of the PMN substances may result in 

significant adverse environmental 

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 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); log Kow and 

water solubility measurements; as well 

as either the fish acute toxicity 

mitigated by humic acid test (OPPTS 

Test Guideline 850.1085) or the whole 

sediment acute toxicity invertebrates, 

freshwater test (OPPTS Test Guideline 

850.1735) would help characterize the 

environmental effects of the PMN 

substances. EPA also recommends that 

the guidance document on aquatic 

toxicity testing of difficult substance 

and mixtures (OECD Test Guideline 23) 

be consulted to facilitate solubility in 

the test media, because of the PMN’s 

low water solubility. Testing should be 

tiered, starting with water solubility and 

log Kow measurements before 

proceeding with higher tier toxicity 

tests. 

CFR citation: 40 CFR 721.10881. 

PMN Number P–14–198 

Chemical name: Trialkylammonium 

borodibenzoate (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a color developer 

for general printing applications. Based 

on test data on the PMN substance and 

SAR analysis of test data on analogous 

aliphatic amines, EPA predicts toxicity 

to aquatic organisms may occur at 

concentrations that exceed 47 ppb of the 

PMN substance in surface waters for 

greater than 20 days per year. This 20- 

day criterion is derived from partial life 

cycle tests (daphnid chronic and fish 

early life stage tests) that typically range 

from 21 to 28 days in duration. EPA 

predicts toxicity to aquatic organisms 

may occur if releases of the substance to 

surface water, from domestic 

manufacture or from uses other than as 

described in the PMN, exceed releases 

from the use described in the PMN. For 

the use described in the PMN, 

environmental releases did not exceed 

47 ppb for more than 20 days per year. 

Therefore, EPA has not determined that 

the proposed manufacturing (defined by 

statute to include import), processing or 

use of the substance may present an 

unreasonable risk. EPA has determined, 

however, that any domestic 

manufacture or use of the substance 

other than as listed in the PMN may 

result in significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at § 721.170(b)(4)(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 721.10882. 

PMN Number P–14–324 

Chemical name: Fatty ester 

derivatives, reaction products with 

alkanolamine, hydroxylated, borated 

(generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the substance will be used as a 

lubricating oil additive. Based on SAR 

analysis of test data on analogous boron 

compounds, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 2 ppb of the 

PMN substance in surface waters for 

greater than 20 days per year. This 20- 

day criterion is derived from partial life 

cycle tests (daphnid chronic and fish 

early life stage tests) that typically range 

from 21 to 28 days in duration. EPA 

predicts toxicity to aquatic organisms 

may occur if releases of the substance to 

surface water, from uses other than as 

described in the PMN, exceed releases 

from the use described in the PMN. For 

the use described in the PMN, 

environmental releases did not exceed 2 

ppb for more than 20 days per year. 

Therefore, EPA has not determined that 

the proposed manufacturing (defined by 

statute to include import), 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 lubricating oil additive 

may result in significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a chronic 

fish early-life stage toxicity test (OPPTS 

Test Guideline 850.1400) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10883. 

PMN Number P–14–397 

Chemical name: Benzenepropanol, 1- 

benzoate. 

CAS number: 60045–26–3. 

Basis for action: The PMN states that 

the substance will be used as a 

plasticizer in adhesives for food-product 

packaging, a diluents-type plasticizer in 

plastisols, a coalescent in architectural 

paints and coatings, and a fragrance 

carrier in fragrances. Based on SAR 

analysis of test data on analogous esters, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 5 ppb of the PMN substance 

in surface waters for greater than 20 

days per year. This 20-day criterion is 

derived from partial life cycle tests 

(daphnid chronic and fish early life 

stage tests) that typically range from 21 

to 28 days in duration. EPA predicts 

toxicity to aquatic organisms may occur 

if releases of the substance to surface 

water, from uses other than as described 

in the PMN, exceed releases from the 

uses described in the PMN. For the uses 

described in the PMN, environmental 

releases did not exceed 5 ppb for more 

than 20 days per year. Therefore, EPA 

has not determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance other than as 

listed in the PMN may result in 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(ii). 


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Recommended testing: EPA has 

determined that the results of a fish 

early-life stage toxicity test (OPPTS Test 

Guideline 850.1400); a daphnid chronic 

toxicity test (OPPTS Test Guideline 

850.1300); and an algal toxicity test 

(OCSPP Test Guideline 850.4500) would 

help characterize the environmental 

effects of the PMN substance. 

CFR citation: 40 CFR 721.10884. 

PMN Number P–14–448 

Chemical name: Alcohols, C12–22, 

distn. residues. 

CAS number: 1476777–83–9. 

Basis for action: The PMN states that 

the use of the substance will be used in 

formulation of defoamers used in the 

production of paper. Based on structureactivity relationship SAR analysis of test 

data on analogous neutral organics, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

7 ppb of the PMN substance in surface 

waters for greater than 20 days per year. 

This 20-day criterion is derived from 

partial life cycle tests (daphnid chronic 

and fish early life stage tests) that 

typically range from 21 to 28 days in 

duration. EPA predicts toxicity to 

aquatic organisms may occur if releases 

of the substance to surface waters 

exceed releases from the use described 

in the PMN. As described in the PMN, 

releases of the substance are not 

expected to result in surface water 

concentrations that exceed 7 ppb for 

more than 20 days per year. Therefore, 

EPA has not determined that the 

proposed manufacturing, processing, or 

use of the substance may present an 

unreasonable risk. EPA has determined, 

however, any use where the cumulative 

molecular weights of the C12 and C14

components exceed 2 percent by weight 

of the overall molecular weight of the 

PMN substance may result in significant 

adverse environmental effects. Based on 

this information, the PMN substance 

meets the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075); an acute invertebrate toxicity 

test, freshwater daphnids (OPPTS Test 

Guideline 850.1010); and an algal 

toxicity test (OCSPP Test Guideline 

850.4500) would help characterize the 

environmental effects of the PMN 

substance. Before conducting these 

aquatic toxicity testing, EPA 

recommends chemical characterization 

of the alkyl range for the alcohol moiety 

and a water solubility test (OECD Test 

Guideline 105) should be conducted. 

CFR citation: 40 CFR 721.10885. 

PMN Number P–14–501 and P–14–502 

Chemical names: Phosphoric acid, 

mixed Bu and decyl and octyl and 2-(2- 

phenoxyethoxy)ethyl and 2- 

phenoxyethyl esters (P–14–501), and 

Phosphoric acid, mixed Bu and decyl 

and octyl and 2-(2-phenoxyethoxy)ethyl 

and 2-phenoxyethyl esters, potassium 

salts (P–14–502). 

CAS numbers: 1502809–48–4 (P–14– 

501) and 1502809–56–4 (P–14–502). 

Basis for action: The PMN states that 

substances will be used as gellants for 

use in oil fracturing. Based on structureactivity relationship (SAR) analysis of 

test data on analogous neutral organics, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 4 ppb of the PMN 

substances in surface waters. As 

described in the PMNs, releases of the 

substances are not expected to result in 

surface water concentrations that exceed 

4 ppb. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substances may present an unreasonable 

risk. EPA has determined, however, that 

any use of substances resulting in 

releases to surface water concentrations 

exceeding 4 ppb may result in 

significant adverse environmental 

effects. Based on this information, the 

PMN substances meet the concern 

criteria at § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test, 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. 

CFR citations: 40 CFR 721.10886 (P– 

14–501) and 40 CFR 721.10887 (P–14– 

502). 

PMN Numbers P–15–59, P–15–60, and 

P–15–104 

Chemical names: Siloxanes and 

Silicones, 3-[(2- 

aminoethyl)amino)propyl Me, di-Me, 

reaction products with cadmium zinc 

selenide sulfide, lauric acid and 

oleylamine (P–15–59); Dodecanoic acid, 

reaction products with cadmium zinc 

selenide sulfide and oleylamine (P–15– 

60); and Phosphonic acid, 

P-tetradecyl-, reaction products with 

cadmium selenide (CdSe) (P–15–104). 

CAS numbers: 1623456–05–2 (P–15– 

59); 1773514–92–3 (P–15–60); and 

1773514–66–1 (P–15–104). 

Effective date of TSCA section 5(e) 

consent order: May 5, 2015. 

Basis for TSCA section 5(e) consent 

order: The PMNs state that the 

substances will be used as a down 

converter for an optical filter for light 

emitting diodes used in displays (P–15– 

59) and as chemical intermediates (P– 

15–60 and P–15–104). Based on SAR 

analysis of test data on analogous 

respirable, poorly soluble particulates 

and the presence of cadmium, EPA 

identified concerns for lung effects, 

kidney effects, and oncogenicity. In 

addition, EPA predicts chronic toxicity 

to aquatic organisms from exposure to 

cadmium. The Order was issued under 

TSCA sections 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 human 

health and the environment. To protect 

against these risks, the consent order 

requires: 

1. Use of impervious gloves to prevent 

dermal exposures, where there is a 

potential for dermal exposures. 

2. Submission of certain material 

characterization data on P–15–59 by the 

time triggers specified in the consent 

order. 

3. Manufacture, process, or use the 

PMN substances only in a liquid 

formulation. 

4. Manufacture, process, and use P– 

15–59 only as a down converter for an 

optical filter for light emitting diodes 

used in displays. 

5. Manufacture, process, and use of P– 

15–60 and P–15–104 only as chemical 

intermediates. 

6. Disposal of the PMN substances 

only by incineration in a permitted 

hazardous waste incinerator. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the development of 

data on certain material characterization 

data specified in the consent order on 

PMN substance P–15–59 would help 

characterize the possible effects of the 

PMN substance. The submitter has 

agreed to submit the results of these 

studies prior to 3 and 18 month time 

triggers identified in the consent order. 

In addition, EPA determined that the 

results of a metabolism and 

pharmacokinetics test (OPPTS Test 

Guideline 870.7485) would help 

characterize the human health and 

environmental effect of the PMN 

substance. The Order does not require 

this testing at any specified time or 

production volume. However, the 

Order’s restrictions on manufacture, 

processing, distribution in commerce, 

use, and disposal of the PMN substances 

will remain in effect until the Order is 


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modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citations: 40 CFR 721.10888 (P– 

15–59), 40 CFR 721.10889 (P–15–60), 

and 40 CFR 721.10890 (P–15–104). 

PMN Number P–15–81 

Chemical name: Alkyl silicate, 

polymer with 2-(chloromethyl)oxirane 

and 4,4′0-(1- 

methylethylidene)bis[phenol], 

alkoxylated (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as an ingredient in 

liquid paint coating. Based on SAR 

analysis of test data on analogous 

epoxides, there were health concerns 

regarding skin and lung sensitization, 

mutagenicity, oncogenicity, 

developmental toxicity, male 

reproductive, liver, and kidney toxicity 

based on the epoxide oxidation product 

as well as irritation and lung toxicity 

expected from the ethoxy silane 

hydrolysis product from exposure to the 

PMN substance via dermal exposure. 

Further, based on SAR analysis of test 

data on analogous epoxides, 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, 

occupational exposures are expected to 

be minimal due to use of adequate 

dermal personal protection equipment 

and 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 

without the use of impervious gloves, 

where there is a potential for dermal 

exposure, or any use of the substance 

resulting in surface water 

concentrations exceeding 1 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)(1)(i)(C), (b)(3)(ii) 

and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a 

combined repeated dose toxicity study 

with the reproduction/developmental 

toxicity screening test (OECD Test 

Guideline 422); a Zahn-Wellens/EMPA 

test (OPPTS Test Guideline 835.3200); a 

fish early-life stage toxicity test (OPPTS 

Test Guideline 850.1400); a daphnid 

chronic toxicity test (OPPTS Test 

Guideline 850.1300); and an algal 

toxicity test (OCSPP Test Guideline 

850.4500) would help characterize the 

human health and environmental effects 

of the PMN substance. 

CFR citation: 40 CFR 721.10891. 

PMN Number P–15–109 

Chemical name: Reaction product of a 

mixture of aromatic dianhydrides and 

aliphatic esters with an aromatic 

diamine (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance is as an intermediate. Based 

on SAR analysis of test data on 

analogous anilines, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 11 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 

11 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 

11 ppb may result in significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

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 ready 

biodegradability test (OECD Test 

Guideline 301) would help characterize 

the environmental effects of the PMN 

substance. EPA recommends that the 

fate testing be performed first as the 

results may mitigate the need for further 

toxicity testing or change the testing 

recommendations. 

CFR citation: 40 CFR 721.10892. 

PMN Number P–15–111 

Chemical name: Fatty acids, tall-oil, 

reaction products with an ether and 

triethylenetetramine (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a hardener for 

coating systems. Based on 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 for greater than 20 

days per year. This 20-day criterion is 

derived from partial life cycle tests 

(daphnid chronic and fish early life 

stage tests) that typically range from 21 

to 28 days in duration. EPA predicts 

toxicity to aquatic organisms may occur 

if releases of the substance to surface 

water, from uses other than as described 

in the PMN, exceed releases from the 

use described in the PMN. For the use 

described in the PMN, environmental 

releases did not exceed 1 ppb for more 

than 20 days per year. Therefore, EPA 

has not determined that the proposed 

manufacturing (defined by statute to 

include import), processing, or use of 

the substance may present an 

unreasonable risk. EPA has determined, 

however, that any domestic 

manufacture of the substance, or any 

use of the PMN substance other than as 

described in the PMN may result in 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a 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 ready 

biodegradability test (OECD Test 

Guideline 301) would help characterize 

the environmental effects of the PMN 

substance. EPA recommends that the 

fate testing be performed first as the 

results may mitigate the need for further 

toxicity testing or change the testing 

recommendations. 

CFR citation: 40 CFR 721.10893. 

PMN Number P–15–120 

Chemical name: Substituted benzyl 

acrylate (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a resin for 

industrial coating. Based on SAR 

analysis of test data on analogous 

acrylates, 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 result in significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 


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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 ready 

biodegradability test (OECD Test 

Guideline 301) would help characterize 

the environmental effects of the PMN 

substance. EPA recommends that the 

fate testing be performed first as the 

results may mitigate the need for further 

toxicity testing or change the testing 

recommendations. 

CFR citation: 40 CFR 721.10894. 

PMN Number P–15–154 

Chemical name: Fluoroalkyl acrylate 

copolymer (generic). 

CAS number: Claimed confidential. 

Effective date of TSCA section 5(e) 

consent order: May 14, 2015. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the substance 

will be as a textile treatment. The Order 

was issued under TSCA sections 

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

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

the 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 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. Manufacture of the PMN substance: 

(a) According to the chemical 

composition section of the consent 

order, including analyzing and reporting 

certain starting raw material impurities 

to EPA; and (b) within the maximum 

established limits of certain fluorinated 

impurities of the PMN substance as 

stated in the consent order. 

3. Submission of certain toxicity, 

physical-chemical property, and 

environmental fate testing on the PMN 

substance prior to exceeding the 

confidential production volume limits 

as 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 and environmental fate testing 

would help characterize the PMN 

substance. The submitter has agreed to 

complete the testing identified in the 

testing section of the consent order by 

the confidential limits specified. In 

addition, EPA has determined that the 

results of a 90-day inhalation toxicity 

test in rats (OPPTS Test Guideline 

870.3465/OECD Test Guideline 413) 

with a 60-day holding period, and 

certain physical chemical property and 

environmental fate testing identified in 

the consent order would help 

characterize the human health and fate 

effects of the PMN substance. The Order 

does not require this testing at any 

specified time or production volume. 

However, the Order’s restrictions on 

manufacture, processing, distribution in 

commerce, use, and disposal of the 

PMN substances will remain in effect 

until the Order is modified or revoked 

by EPA based on submission of that or 

other relevant information. 

CFR citation: 40 CFR 721.10895. 

PMN Number P–15–176 

Chemical name: 1-Hexanol, 6- 

mercapto-. 

CAS number: 1633–78–9. 

Basis for action: The PMN states that 

the substance will be used as a chemical 

intermediate to curable monomers. 

Based on SAR analysis of test data on 

analogous thiols, EPA predicts toxicity 

to aquatic organisms may occur at 

concentrations that exceed 8 ppb of the 

PMN substance in surface waters. As 

described in the PMN, releases of the 

substance are not expected to result in 

surface water concentrations that exceed 

8 ppb. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance that results in 

surface water concentrations exceeding 

8 ppb may result in significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075); an aquatic invertebrate acute 

toxicity test, freshwater daphnids 

(OPPTS Test Guideline 850.1010); an 

algal toxicity test (OCSPP Test 

Guideline 850.4500); and a ready 

biodegradability test (OECD Test 

Guideline 301B) would help 

characterize the environmental effects of 

the PMN substance. EPA recommends 

that the fate testing be performed first as 

the results may mitigate the need for 

further toxicity testing or change the 

testing recommendations. 

CFR citation: 40 CFR 721.10896. 

PMN Number P–15–177 

Chemical name: Phenol, 2,2′-[1,2- 

disubstituted-1,2-ethanediyl]

bis(iminomethylene)bis[substituted- 

(generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a catalyst in the 

process to manufacture a crop 

protection chemical. Based on test data 

on the PMN substance, EPA identified 

concerns for blood toxicity to workers 

from dermal exposures to the PMN 

substance. As described in the PMN, 

occupational exposures are expected to 

be minimal due to use of adequate 

dermal personal protection equipment. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance without the use of 

chemical impervious gloves, where 

there is a potential for dermal exposure, 

or any use of the substance other than 

as described in the PMN may cause 

serious health effects. Based on this 

information, the PMN substance meets 

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

Recommended testing: EPA has 

determined that the results of a skin 

absorption, In vitro method (OECD Test 

Guideline 428) would help characterize 

the human health effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10897. 

PMN Number P–15–188 

Chemical name: Carbomonocycles, 

polymer with substituted 

heteromonocycle, succinate, methyl 

acrylate (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the substance will be used as a pigmentwetting resin for Ultra Violet (UV)- 

curable coatings. Based on SAR analysis 

of test data on analogous methacrylates, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 7 ppb of the PMN substance 

in surface waters for greater than 20 

days per year. This 20-day criterion is 

derived from partial life cycle tests 

(daphnid chronic and fish early life 

stage tests) that typically range from 21 

to 28 days in duration. EPA predicts 

toxicity to aquatic organisms may occur 

if releases of the substance to surface 

water, from uses other than as described 

in the PMN, exceed releases from the 

use described in the PMN. For the use 

described in the PMN, environmental 

releases did not exceed 7 ppb for more 

than 20 days per year. Therefore, EPA 

has not determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance other than as 


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listed in the PMN may result in 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a water 

solubility test (OECD Test Guideline 

105); a fish acute toxicity test, 

freshwater and marine (OPPTS Test 

Guideline 850.1075); an acute 

invertebrate toxicity test, freshwater 

daphnids (OPPTS Test Guideline 

850.1010); and an algal toxicity test 

(OCSPP Test Guideline 850.4500) would 

help characterize the environmental 

effects of the PMN substance. The water 

solubility testing should be conducted 

prior to conducting the ecotoxicity 

testing as the results of the water 

solubility may change the recommended 

ecotoxicity testing. 

CFR citation: 40 CFR 721.10898. 

PMN Number P–15–190 

Chemical name: Halogenated alkyl 

trimethylaminium halide (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be for cationization of 

starch. Based on test data on analogous 

alkylating agents, there were health 

concerns regarding mutagenicity, 

oncogenicity, developmental toxicity 

and respiratory sensitization based from 

exposure to the PMN substance via 

inhalation exposure. In addition, based 

on SAR analysis of test data on 

analogous cationic surfactants, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

88 ppb of the PMN substance in surface 

waters. As described in the PMN, 

exposure is expected to be minimal due 

to use of adequate respiratory personal 

protection equipment and releases of 

the substance are not expected to result 

in surface water concentrations that 

exceed 88 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 without the use of NIOSHcertified respirator with an APF of at 

least 10, where there is a potential for 

respiratory exposure, or any use of the 

substance resulting in surface water 

concentrations exceeding 88 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)(1)(i)(C), (b)(3)(ii) 

and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a bacterial 

reverse mutation test, (OPPTS Test 

Guideline 870.5100); a mammalian 

erythrocyte micronucleus test (OPPTS 

Test Guideline 870.5395); an acute oral 

toxicity test (OPPTS Test Guideline 

870.1100); a repeated dose 28-day oral 

toxicity study in rodents (OPPTS Test 

Guideline 870.3050); 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 (OCSPP Test Guideline 

850.4500) would help characterize the 

human health and environmental effects 

of the PMN substance. 

CFR citation: 40 CFR 721.10899. 

PMN Number P–15–252 

Chemical name: Titanium salt, 

reaction products with silica (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a chemical 

intermediate. Based on SAR analysis of 

test data on analogous insoluble metal 

oxides, EPA identified concerns for lung 

toxicity if inhaled based on lung 

overload for respirable, poorly soluble 

particulates. For the use described in 

the PMN, inhalation exposures are 

expected to be minimal as the PMN is 

handled in an enclosed process. 

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 in a 

non-enclosed process, or any use of the 

substance other than listed in the PMN 

may result in significant adverse human 

health effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a 90-day 

inhalation toxicity test (OPPTS Test 

Guideline 870.3465) with 60-day 

holding period and a particle size 

distribution/fiber length and diameter 

distributions (OECD Test Guideline 110) 

would help characterize the human 

health effects of the PMN substance. 

CFR citation: 40 CFR 721.10900. 

PMN Number P–15–272 

Chemical name: Formaldehyde, 

reaction products with aniline and 

aromatic mono- and di-phenol mixture 

(generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a resin. Based on 

SAR analysis of test data on analogous 

phenols, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 1 ppb of the 

PMN substance in surface 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 result in significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075); an acute invertebrate toxicity 

test, freshwater daphnids (OPPTS Test 

Guideline 850.1010); an algal toxicity 

test (OCSPP Test Guideline 850.4500); 

and a ready biodegradability (OECD 

Test Guideline 301) would help 

characterize the environmental effects of 

the PMN substance. EPA recommends 

that the fate testing be performed first as 

the results may mitigate the need for 

further toxicity testing or change the 

testing recommendations. 

CFR citation: 40 CFR 721.10901. 

PMN Number P–15–276 

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 

and skin penetration and toxicity 

induction from inhalation and dermal 

exposure to the PMN substance. 

Further, EPA predicts toxicity to aquatic 

organisms via releases of the PMN 

substance to surface water. Although 

there is potential for dermal exposure, 

EPA does not expect significant 

occupational exposures due to the use 

of impervious gloves, and because the 

PMN is used in a liquid and is not spray 

applied except in a closed system. 

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, and or use of the substance 

may present an unreasonable risk to 

human health or the environment. EPA 

has determined, however, that any use 


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of the substance without the use of 

impervious gloves, where there is 

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 

except in a closed system; or any release 

of the PMN substance into surface 

waters or disposal other than by landfill 

or incineration may cause serious health 

effects or significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

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

and (b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a 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); a 90-day 

inhalation toxicity test (OPPTS 

870.3465) with additional testing 

parameters beyond those noted at CFR 

870.3465, for using the 90-day 

subchronic protocol for nanomaterial 

assessment; a two-year inhalation 

bioassay (OPPTS Test Guideline 

870.4200); and a surface charge by 

electrophoresis (for example, using 

ASTM E2865–12 or NCL Method PCC– 

2—Measuring the Zeta Potential of 

Nanoparticles) would help characterize 

the health and environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10902. 

PMN Number P–15–295 

Chemical name: Acrylated mixed 

metal oxides (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as an intermediate. 

Based on SAR analysis of test data on 

respirable poorly soluble particulates, 

EPA identified potential lung effects 

and dermal toxicity from inhalation and 

dermal exposure to the PMN substance. 

Further, EPA predicts toxicity to aquatic 

organisms via releases of the PMN 

substance to surface water. Although 

there is potential for dermal exposure, 

EPA does not expect significant 

occupational exposures due to the use 

of impervious gloves, and because the 

PMN is used in a liquid 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, and or use of the substance 

may present an unreasonable risk to 

human health or the environment. EPA 

has determined, however, that any use 

of the substance without the use of 

impervious gloves, where there is 

potential for dermal exposure; 

manufacturing, processing, or using the 

PMN substance in a form other than as 

a liquid; use of the PMN substance 

involving an application method that 

generates a mist, vapor, or aerosol; any 

release of the PMN substance into 

surface waters; or disposal other than by 

landfill or incineration may cause 

serious health effects or significant 

adverse environmental effects. Based on 

this information, the PMN substance 

meets the concern criteria at 

§ 721.170(b)(3)(ii) and (b))(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; 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 and 

health effects of the PMN substance. 

CFR citation: 40 CFR 721.10903. 

PMN Number P–15–306 

Chemical name: Phenol, 1,1- 

dimethylalkyl derivatives (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a process 

intermediate. Based on SAR analysis of 

test data on analogous phenols, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

13 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 13 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 13 ppb may 

result in significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075); an acute invertebrate toxicity 

test, freshwater daphnids (OPPTS Test 

Guideline 850.1010); an algal toxicity 

test (OCSPP Test Guideline 850.4500); 

and a Zahn-Wellens/EMPA test (OPPTS 

Test Guideline 835.3200) would help 

characterize the environmental effects of 

the PMN substance. EPA recommends 

that the fate testing be performed first as 

the results may mitigate the need for 

further toxicity testing or change the 

testing recommendations. 

CFR citation: 40 CFR 721.10904. 

PMN Number P–15–319 

Chemical name: Butanedioic acid, 2- 

methylene-, dialkyl ester (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as an intermediate for 

production of a lubricant additive. 

Based on SAR analysis of test data on 

analogous acrylates and esters, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

1 ppb of the PMN substance in surface 

waters. As described in the PMN, 

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 that resulting in surface 

water concentrations exceeding 1 ppb 

may result in significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075); an acute invertebrate toxicity 

test, freshwater daphnids (OPPTS Test 

Guideline 850.1010); an algal toxicity 

test (OCSPP Test Guideline 850.4500); 

and a ready biodegradability (OECD 

Test Guideline 301) would help 

characterize the environmental effects of 

the PMN substance. EPA recommends 

that the fate testing be performed first as 

the results may mitigate the need for 

further toxicity testing or change the 

testing recommendations. 

CFR citation: 40 CFR 721.10905. 

PMN Number P–15–324 

Chemical name: Magnesium alkaryl 

sulfonate (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the use of the substance will be as a 

detergent additive in crankcase 

lubricant applications. Based on 

submitted test data on the PMN 

substance, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 1 ppb of the 


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PMN substance in surface waters for 

greater than 20 days per year. This 20- 

day criterion is derived from partial life 

cycle tests (daphnid chronic and fish 

early life stage tests) that typically range 

from 21 to 28 days in duration. EPA 

predicts toxicity to aquatic organisms 

may occur if releases of the substance to 

surface water, from uses other than as 

described in the PMN, exceed releases 

from the use described in the PMN. For 

the use described in the PMN, 

environmental releases did not exceed 1 

ppb for more than 20 days per year. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance other than as listed in the 

PMN may result in significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

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

Recommended testing: EPA has 

determined that the results of a daphnid 

chronic toxicity test (OPPTS Test 

Guideline 850.1300) would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10906. 

PMN Number P–15–326 

Chemical name: 

Polyfluorohydrocarbon (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a specialty gas and 

transfer fluid. Based on test data on the 

PMN substance, EPA identified 

concerns for neurotoxicity and 

uncertain concern for cardiac 

sensitization. Further, based on SAR 

analysis of test data on analogous 

substances, EPA identified concerns for 

developmental toxicity. As described in 

the PMN, EPA does not expect 

significant occupational exposures due 

to use of adequate personal protective 

equipment, and consumer exposures are 

not expected as the PMN substance is 

not used in consumer products. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance other than as listed in the 

PMN or any use in a consumer product 

may result in significant adverse human 

health effects. Based on this 

information, the PMN substance meets 

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

and (b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of 90-day 

inhalation toxicity (OPPTS Test 

Guideline 870.3465) would help 

characterize the health effects of the 

PMN substance. 

CFR citation: 40 CFR 721.10907. 

PMN Number P–15–328 

Chemical name: Aluminum calcium 

oxide salt (generic). 

CAS number: Claimed confidential. 

Effective date of TSCA section 5(e) 

consent order: June 2, 2015. 

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 cement additive. 

Based on SAR analysis of test data on 

analogous respirable, poorly soluble 

particulates, EPA identified concerns for 

lung toxicity based on lung overload. 

The Order was issued under TSCA 

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

based on a finding that the substance 

may present an unreasonable risk of 

injury to human health. To protect 

against these risks, the consent order 

requires: 

1. Hazard communication. 

Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and the MSDS. 

2. Use of personal protective 

equipment including a NIOSH-certified 

respirator with an APF of at least 10 or 

compliance with a NCEL of 5 mg/m3 as 

an 8-hour time-weighted average (when 

there is potential inhalation exposure), 

when there is potential inhalation 

exposure. 

3. Manufacture, processing or use of 

the PMN substance only for the use 

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 a 90-day inhalation 

toxicity test (OPPTS Test Guideline 

870.3465) in rats would help 

characterize possible health effects of 

the substance. The Order does not 

require this testing at any specified time 

or production volume. However, the 

Order’s restrictions on manufacture, 

processing, distribution in commerce, 

use, and disposal of the PMN substances 

will remain in effect until the Order is 

modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citation: 40 CFR 721.10908. 

PMN Number P–15–332 

Chemical name: Polyalkyltrisiloxane 

(generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a site-limited 

intermediate. Based on SAR analysis of 

test data on an analogous substance, 

there were health concerns regarding 

liver and kidney toxicity, thyroid 

effects, and reproductive and 

developmental toxicity from dermal and 

inhalation exposures to the PMN 

substance. Further, based on SAR 

analysis of test data on analogous 

neutral organics, EPA predicts toxicity 

to aquatic organisms may occur at 

concentrations that exceed 4 ppb of the 

PMN substance in surface waters. EPA 

also predicts toxicity to aquatic 

organisms may occur if releases of the 

substance to surface water, from uses 

other than as described in the PMN, 

exceed releases from the use described 

in the PMN. Further, as described in the 

PMN, exposure is expected to be 

minimal due to use of adequate 

respiratory and dermal personal 

protection equipment and releases of 

the substance are not expected to result 

in surface water concentrations 

exceeding 4 ppb. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance that results in 

releases to surface waters exceeding 4 

ppb, any use other than that as a sitelimited intermediate, or any use without 

the use of a NIOSH-certified respirator 

with gas/vapor cartridges and an APF of 

at least 10 and impervious gloves, may 

result in serious human health or 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170 (b)(3)(ii) and 

(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a 

sediment-water lumbriculus toxicity test 

(OECD Test Guideline 225); a combined 

repeated dose toxicity study with the 

reproduction/developmental toxicity 

screening test (OECD Test Guideline 

422); a fish acute toxicity test, 

freshwater and marine (OPPTS Test 

Guideline 850.1075); an aquatic 

invertebrate acute toxicity test, 

freshwater daphnids (OPPTS Test 

Guideline 850.1010); and an algal 

toxicity test (OCSPP Test Guideline 

850.4500) would help characterize the 

human health and environmental effects 

of the PMN substance. All ecotoxicity 

tests should analyze the PMN substance 

as well as the hydrolysis products. 

CFR citation: 40 CFR 721.10909. 

PMN Number P–15–356 

Chemical names: Oxirane, 2,2′-[[1-[4- 

[1-methyl-1-[4-(2- 

oxiranylmethoxy)phenyl]ethyl]phenyl]

ethylidene]bis(4,1- 

phenyleneoxymethylene)]bis- (P–15– 


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356, Chemical A); and 2-Propanol, 1,3- 

bis[4-[1-[4-[1-methyl-1-[4-(2- 

oxiranylmethoxy)phenyl]ethyl]phenyl]- 

1-[4-(2-oxiranylmethoxy)phenyl]ethyl]

phenoxy]- (P–15–356, Chemical B). 

CAS numbers: 115254–47–2 (P–15– 

356, Chemical A) and 180063–56–3 (P– 

15–356, Chemical B). 

Basis for action: The PMN states that 

the substances will be used as additives 

in polymer formulation for electronics. 

Based on test data on the PMN 

substances and on SAR analysis of test 

data on analogous epoxides, EPA 

identified concerns for respiratory 

sensitization and irritation, 

mutagenicity, developmental toxicity, 

male reproduction toxicity, liver and 

kidney toxicity, and oncogenicity. 

Additionally, based on 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 

substances in surface waters. Further, 

EPA has concerns that the PMN 

substances are potentially PBT 

chemicals as described in the New 

Chemical Program’s PBT category (64 

FR 60194; November 4, 1999) (FRL– 

6097–7). EPA estimates that the PMN 

substances will persist in the 

environment more than 2 months and 

estimates a bioaccumulation factor of 

greater than or equal to 1,000. For the 

use described in the PMN, EPA expects 

occupational exposures to be minimal 

and does not expect releases to surface 

waters. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substances may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substances other than as 

additives in polymer formulation for 

electronics or any use of the substances 

resulting in releases to surface waters 

may cause serious human health or 

significant adverse environmental 

effects. Based on this information, the 

PMN substances meet the concern 

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

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

Recommended testing: EPA has 

determined that the results of a 

combined repeated dose toxicity study 

with the reproduction/developmental 

toxicity screening test (OECD Test 

Guideline 422); a sediment-water 

chironomid life-cycle toxicity test 

(OECD Test Guideline 233), using 

spiked water or spiked sediment; a fish 

early-life stage toxicity test (OPPTS Test 

Guideline 850.1400); a daphnid chronic 

toxicity test (OPPTS Test Guideline 

850.1300); and an algal toxicity test 

(OCSPP Test Guideline 850.4500) would 

help characterize the human health and 

environmental effects of the PMN 

substances. 

CFR citations: 40 CFR 721.10910 (P– 

15–356, chemical A) and 40 CFR 

721.10911 (P–15–356, chemical B). 

PMN Number P–15–363 

Chemical name: Aliphatic acrylate 

(generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a monomer. Based 

on SAR analysis of test data on 

analogous acrylates, 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 result in significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075); an acute invertebrate toxicity 

test, freshwater daphnids (OPPTS Test 

Guideline 850.1010); and an algal 

toxicity test (OCSPP Test Guideline 

850.4500) would help characterize the 

environmental effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10912. 

PMN Number P–15–378 

Chemical name: Diisocyanato hexane, 

homopolymer, alkanoic acidpolyalkylene glycol ether with 

substituted alkane (3:1) reaction 

products-blocked (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the substance will be used as a dual 

cure/UV cure adhesion/barrier coating 

for wood substrates. Based on SAR 

analysis of test data on analogous 

diisocyanates, EPA identified concerns 

for respiratory sensitization. As 

described in the PMN, EPA does not 

expect significant occupational dermal 

or inhalation exposure due to use of 

adequate personal protective equipment 

and consumer exposures are not 

expected as the PMN substance is not 

used in consumer products. Therefore, 

EPA has not determined that the 

proposed manufacture, processing, or 

use of the substance may present an 

unreasonable risk. EPA has determined, 

however, that any use of the substance 

without a NIOSH-certified particulate 

respirator with an APF of at least 10 

where there is a potential for inhalation 

exposure, or any use in consumer 

products may cause serious health 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a skin 

sensitization test (OPPTS Test Guideline 

870.2600) and a 90-day inhalation 

toxicity test (OPPTS Test Guideline 

870.3465) would help characterize the 

human health effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10913. 

PMN Number P–15–382 

Chemical name: Polyitaconic acid, 

sodium zinc salt (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the substance will be used as an odor 

neutralization for pet litter and cleaning 

hard surface surfaces, fabrics, skin and 

hair; an odor neutralization for air car; 

and an odor neutralization for waste 

processing and solid waste management 

in paper, oil, gas, mining, agriculture, 

food and municipal industries. Based on 

SAR analysis of test data on analogous 

zinc salts, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 4 ppb of the 

PMN substance in surface waters for 

greater than 20 days per year. This 20- 

day criterion is derived from partial life 

cycle tests (daphnid chronic and fish 

early life stage tests) that typically range 

from 21 to 28 days in duration. EPA 

predicts toxicity to aquatic organisms 

may occur if releases of the substance to 

surface water, from uses other than as 

described in the PMN, exceed releases 

from the use described in the PMN. For 

the use described in the PMN, 

environmental releases did not exceed 4 

ppb for more than 20 days per year. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance other than as listed in the 

PMN may result in significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a 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 


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(OCSPP Test Guideline 850.4500) would 

help characterize the environmental 

effects of the PMN substance. 

CFR citation: 40 CFR 721.10914. 

PMN Number P–15–411 

Chemical name: Fatty acid esters with 

polyols polyalkyl ethers (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as an anti-rust coating 

solution additive. Based on SAR 

analysis of test data on analogous 

nonionic surfactants, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 30 ppb of 

the PMN substance in surface waters. As 

described in the PMN, releases of the 

substance are not expected to result in 

surface water concentrations that exceed 

30 ppb. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance resulting in 

surface water concentrations exceeding 

30 ppb may result in significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

acute toxicity test, freshwater and 

marine (OPPTS Test Guideline 

850.1075); an acute invertebrate toxicity 

test, freshwater daphnids (OPPTS Test 

Guideline 850.1010); and an algal 

toxicity test (OCSPP Test Guideline 

850.4500) would help characterize the 

environmental effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10915. 

PMN Number P–15–435 

Chemical name: 2,7- 

Naphthalenedisulfonic acid, 4-amino-3- 

[substituted]-5-hydroxy-6-[(1E)-2- 

phenyldiazenyl]-, lithium salt (1:3) 

(generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a direct anionic 

dyestuff for the printing industry. Based 

on the results of a 28-day oral study for 

the PMN substance, EPA predicts 

anemia, effects on the adrenals, spleen, 

kidney, lymph nodes and 

immunotoxicity. In addition, based on 

the lithium salt of the PMN, EPA 

identified concerns for developmental 

toxicity and neurotoxicity. Further, 

based on SAR analysis of test data on 

analogous azo reduction products, EPA 

identified concerns for blood effects, 

developmental toxicity, oncogenicity, 

and mutagenicity. As described in the 

PMN, EPA does not expect significant 

risk to workers due to use of adequate 

personal protective equipment. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substance may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substance other than in a liquid 

formulation could result in exposures 

which may cause serious health effects. 

Based on this information, the PMN 

substance meets the concern criteria at 

§ 721.170(b)(1)(i)(C), (b)(3)(i) and 

(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of an ames 

assay (OPPTS Test Guideline 870.5100) 

with the rival modification; a mouse 

micronucleus assay conducted by the 

oral route (OPPTS Test Guideline 

870.5395); and a combined repeated 

dose and developmental toxicity and 

reproductive toxicity screening test 

(OPPTS Test Guideline 870.3650) would 

help to characterize the health effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10916. 

PMN Number P–15–492 

Chemical name: Polymethylsiloxane, 

distillation residues (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a site-limited 

intermediate. Based on SAR analysis 

test data on analogous silanes, EPA 

identified concerns for mutagenicity, 

liver and kidney toxicity, thyroid 

effects, and reproductive and 

developmental toxicity from dermal and 

inhalation exposures to the PMN 

substance. Further, based on SAR 

analysis of test data on analogous 

neutral organics, EPA predicts toxicity 

to aquatic organisms may occur at 

concentrations that exceed 1 ppb of the 

PMN substance in surface waters. For 

the intermediate use described in the 

PMN, occupational exposures are 

expected to be minimal due to the use 

of adequate respiratory and dermal 

personal protection equipment, and 

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 without the use of a 

NIOSH-certified respirator with gas/

vapor cartridges and an APF of at least 

10, where there is a potential for 

inhalation exposures, any use of the 

substance without the use of impervious 

gloves, where there is a potential for 

dermal exposures; any use of the 

substance other than an intermediate; or 

any use of the substance resulting in 

surface water concentrations exceeding 

1 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 a 

sediment-water lumbriculus toxicity test 

(OECD Test Guideline 225) using spiked 

sediment; a combined repeated dose 

toxicity study with the reproduction/

developmental toxicity screening test 

(OECD Test Guideline 422); a fish earlylife stage toxicity test (OPPTS Test 

Guideline 850.1400); a daphnid chronic 

toxicity test (OPPTS Test Guideline 

850.1300); and an algal toxicity test 

(OCSPP Test Guideline 850.4500) would 

help characterize the human health and 

environmental effects of the PMN 

substance. All ecotoxicity tests should 

analyze for the PMN substance as well 

as the hydrolysis products. 

CFR citation: 40 CFR 721.10917. 

PMN Number P–15–502 

Chemical name: 

Perfluorobutanesulfonamide and 

polyoxyalkylene containing 

polyurethane (generic). 

CAS number: Claimed confidential. 

Effective date of TSCA section 5(e) 

consent order: November 4, 2015. 

Basis for TSCA section 5(e) consent 

order: The PMN states that the generic 

(non-confidential) use of the substance 

will be as a protective treatment. EPA 

has concerns for potential incineration 

or other decomposition products of the 

PMN substance. These fluorinated 

decomposition products may be 

released to the environment from 

incomplete incineration of the PMN 

substance at low temperatures. EPA has 

preliminary evidence, including data on 

some fluorinated polymers which 

suggest that under some conditions, the 

PMN substance could degrade in the 

environment. EPA has concerns that 

these degradation products will persist 

in the environment, could 

bioaccumulate or biomagnify, and could 

be toxic (PBT) to people, wild 

mammals, and birds. These concerns are 

based on data on analogous chemical 

substances, including PFOA and other 

perfluorinated alkyls, including the 

presumed environmental degradant. 

EPA also has concerns that under some 

conditions of use, particularly nonindustrial, commercial, or consumer 

use, the PMN substance could cause 

lung effects, based on limited data on 


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some perfluorinated compounds. 

Concerns for the PMN substance are for 

lung toxicity from waterproofing of lung 

membrane, based on PMN properties. 

The order was issued under TSCA 

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

based on a finding that the substance 

and its potential intermediate and/or 

ultimate degradation products may 

present an unreasonable risk of injury to 

the environment and human health. 

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. Submission of certain 

environmental fate testing on the PMN 

substance prior to exceeding the 

confidential production volume limit as 

specified in the consent order of the 

PMN substance. 

3. No use of the PMN substance in 

consumer spray products. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Recommended testing: EPA has 

determined that the results of an aerobic 

and anaerobic transformation in soil test 

(OECD Test Guideline 307) would help 

characterize the possible degradation of 

the PMN substance. The submitter has 

agreed to submit the results of this test 

by the confidential production volume 

identified in the consent order. EPA had 

determined that the results of a 

phototransformation of chemicals on 

soil surfaces (OECD Draft Document 

January 2002) would help characterize 

the degradation potential of the PMN 

substance. The Order does not require 

this testing at any specified time or 

production volume. However, the 

Order’s restrictions on manufacture, 

processing, distribution in commerce, 

use, and disposal of the PMN substances 

will remain in effect until the Order is 

modified or revoked by EPA based on 

submission of that or other relevant 

information. 

CFR citation: 40 CFR 721.10918. 

PMN Number P–15–542 

Chemical name: Quaternary 

ammonium compounds, (3-chloro-2- 

hydroxypropyl)coco alkyldimethyl, 

chlorides. 

CAS number: 690995–44–9. 

Basis for action: The PMN states that 

the substance will be used as an 

intermediate for surfactant production, 

and as a chemical intermediate for sale 

into commerce. Based on SAR analysis 

of test data on analogous cationic 

(quaternary ammonium) surfactants, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 24 ppb of the PMN 

substance in surface waters. As 

described in the PMN, releases of the 

substance are not expected to result in 

surface water concentrations that exceed 

24 ppb. Therefore, EPA has not 

determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance resulting in 

surface water concentrations exceeding 

24 ppb may result in significant adverse 

environmental effects. Based on this 

information, the PMN substance meets 

the concern criteria at 

§ 721.170(b)(4)(ii). 

Recommended testing: EPA has 

determined that the results of a fish 

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 721.10919. 

PMN Number P–15–559 

Chemical name: Modified 

diphenylmethane diisocyanate 

prepolymer with polyol (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as a raw material for 

flexible foam. Based on SAR analysis of 

analogous diisocyanates, EPA identified 

concerns for potential dermal and 

respiratory sensitization from dermal 

and inhalation exposures, and for 

pulmonary toxicity from inhalation 

exposure, to the PMN substance where 

the average molecular weight is below 

7,500 daltons and any molecular weight 

species is below 1,000 daltons. For the 

molecular weight distribution described 

in the PMN, significant occupational 

exposures are not expected. Therefore, 

EPA has not determined that the 

proposed manufacture of the substance 

may present an unreasonable risk. EPA 

has determined, however, that any 

manufacture of the PMN substance with 

an average molecular weight below 

7,500 daltons, and where any molecular 

weight species is below 1,000 daltons 

may cause serious health effects. Based 

on this information, the PMN substance 

meets the concern criteria at 

§ 721.170(b)(3)(ii). 

Recommended testing: EPA has 

determined that the results of a skin 

sensitization test (OPPTS Test Guideline 

870.2600) and a 90-day inhalation 

toxicity test (OPPTS Test Guideline 

870.3465) would help characterize the 

human health effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10920. 

PMN Number P–15–573 

Chemical name: 

2-Furancarboxyaldehyde, 

5-(chloromethyl)-. 

CAS number: 1623–88–7. 

Basis for action: The PMN states that 

the use of the substance will be as a 

chemical intermediate. Based on SAR 

analysis of test data on analogous 

aldehydes, the EPA identified human 

health concerns for liver toxicity, 

neurotoxicity, sensitization, and cancer 

to workers exposed through dermal and 

inhalation routes. For the chemical 

intermediate use described in the PMN, 

occupational exposures are expected to 

be minimal due to the use of adequate 

personal protective equipment and a 

continuous reaction process such that 

no greater than 50 kilograms of the PMN 

substance is present in the workplace at 

a given time for this use. 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 without the use of a NIOSHcertified respirator with an APF of at 

least 50, where there is a potential for 

inhalation exposures; any use without 

the use of impervious gloves, where 

there is a potential for dermal 

exposures, any use of the substance 

other than as a chemical intermediate; 

or any use beyond the annual 

production volume limit of 15,000 

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

Recommended testing: EPA has 

determined that the results of a skin 

sensitization (OECD Test Guideline 406) 

would help characterize the human 

health effects of the PMN substance; a 

combined repeated dose toxicity test 

with the reproduction/developmental 

toxicity screening test (OECD Test 

Guideline 422) with functional 

observational battery (FOB); a standard 

test method for permeation of liquids 

and gases through protective clothing 

materials under conditions of 

continuous contact (ASTM Test 

Guideline F739) using the format 

specified in the standard guide for 

documenting the results of chemical 

permeation testing of materials used in 

protective clothing materials (ASTM 

Test Guideline F1194–99(2010)); and a 

carcinogenicity test (OECD Test 

Guideline 451) would help characterize 


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the human health effects of the PMN 

substance. 

CFR citation: 40 CFR 721.10921. 

PMN Number P–15–607 

Chemical name: 1,2,4,5,7,8- 

Hexoxonane, 3,6,9-trimethyl-, 3,6,9- 

tris(alkyl) derivs. (generic). 

CAS number: Claimed confidential. 

Basis for action: The PMN states that 

the generic (non-confidential) use of the 

substance will be as an initiator for 

polymerization. Based on data on the 

PMN substance, as well as SAR analysis 

of test data on analogous peroxides, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

56 ppb of the PMN substance in surface 

waters for greater than 20 days per year. 

This 20-day criterion is derived from 

partial life cycle tests (daphnid chronic 

and fish early life stage tests) that 

typically range from 21 to 28 days in 

duration. EPA predicts toxicity to 

aquatic organisms may occur if releases 

of the substance to surface water, from 

uses other than as described in the 

PMN, exceed releases from the use 

described in the PMN. For the use 

described in the PMN, environmental 

releases did not exceed 56 ppb for more 

than 20 days per year. Therefore, EPA 

has not determined that the proposed 

manufacturing, processing, or use of the 

substance may present an unreasonable 

risk. EPA has determined, however, that 

any use of the substance other than as 

listed in the PMN may result in 

significant adverse environmental 

effects. Based on this information, the 

PMN substance meets the concern 

criteria at § 721.170(b)(4)(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) using a solvent 

where the effects of the solvent are 

already known or measured, would help 

characterize the environmental effects of 

the PMN substance. 

CFR citation: 40 CFR 721.10922. 

PMN Number P–15–671 

Chemical name: 9-Octadecen-1- 

amine, hydrochloride (1:1), (9Z)-. 

CAS number: 41130–29–4. 

Basis for action: The PMN states that 

the substance will be used as an 

emulsifying agent used in the 

production of asphalt emulsions for 

chipsealing and other road maintenance 

techniques. Based on test data for the 

PMN substance, as well as SAR analysis 

of test data on analogous aliphatic 

amines, EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 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 

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 721.10923. 

PMN Numbers P–15–689 and P–15–690 

Chemical names: Vegetable fatty acid 

alkyl esters (generic). 

CAS numbers: Claimed confidential. 

Basis for action: The PMNs state that 

the substances will be used as chemical 

intermediates. Based on SAR analysis of 

test data on analogous esters, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

1 ppb of the PMN substances in surface 

waters for greater than 20 days per year. 

This 20-day criterion is derived from 

partial life cycle tests (daphnid chronic 

and fish early-life stage tests) that 

typically range from 21 to 28 days in 

duration. EPA predicts toxicity to 

aquatic organisms may occur if releases 

of the substances to surface water 

exceeds releases from the use described 

in the PMN. For the chemical 

intermediate use described in the PMN, 

environmental releases did not exceed 1 

ppb for more than 20 days per year. 

Therefore, EPA has not determined that 

the proposed manufacturing, 

processing, or use of the substances may 

present an unreasonable risk. EPA has 

determined, however, that any use of 

the substances other than as an 

intermediate 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 

early-life stage toxicity test (OPPTS Test 

Guideline 850.1400); a daphnid chronic 

toxicity test (OPPTS Test Guideline 

850.1300); and an algal toxicity test 

(OCSPP Test Guideline 850.4500) would 

help to characterize the environmental 

effects of the PMN substances. 

Depending on the results of these tests, 

EPA has determined that the results of 

an aerobic and anaerobic metabolism 

test (OECD Test Guideline 308) in 

aquatic sediment systems test; and a 

sediment water chironomid life-cycle 

toxicity test (OECD Test Guideline 233) 

using spiked water or spiked sediment 

would help to further characterize the 

environmental effects of the PMN 

substances. 

CFR citation: 40 CFR 721.10924. 

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 10 of the 55 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 45 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. 


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• 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 July 15, 2016 without 

further notice, unless EPA receives 

written adverse or critical comments, or 

notice of intent to submit adverse or 

critical comments before June 15, 2016. 

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 June 

15, 2016, 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 10 of the 55 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 

41 of the 55 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 May 16, 

2016 as the cutoff date for determining 

whether the new use is ongoing. Persons 

who begin commercial manufacture or 

processing of the chemical substances 

for a significant new use identified as of 

that date would have to cease any such 

activity upon the effective date of the 

final rule. To resume their activities, 

these persons would have to first 

comply with all applicable SNUR 

notification requirements and wait until 

the notice review period, including any 

extensions, expires. If such a person met 

the conditions of advance compliance 

under § 721.45(h), the person would be 

considered exempt from the 

requirements of the SNUR. Consult the 

Federal Register document of April 24, 

1990 for a more detailed discussion of 

the cutoff date for ongoing uses. 

VIII. Test Data and Other Information 

EPA recognizes that TSCA section 5 

does not require developing any 

particular test data before submission of 

a SNUN. The two exceptions are: 

1. Development of test data is 

required where the chemical substance 

subject to the SNUR is also subject to a 

test rule under TSCA section 4 (see 

TSCA section 5(b)(1)). 

2. Development of test data may be 

necessary where the chemical substance 

has been listed under TSCA section 

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

In the absence of a TSCA section 4 

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

listing covering the chemical substance, 

persons are required only to submit test 

data in their possession or control and 

to describe any other data known to or 

reasonably ascertainable by them (see 40 

CFR 720.50). However, upon review of 

PMNs and SNUNs, the Agency has the 

authority to require appropriate testing. 

In cases where EPA issued a TSCA 

section 5(e) consent order that requires 

or recommends certain testing, Unit IV. 

lists those tests. Unit IV. also lists 

recommended testing for non-5(e) 

SNURs. Descriptions of tests are 

provided for informational purposes. 

EPA strongly encourages persons, before 

performing any testing, to consult with 

the Agency pertaining to protocol 

selection. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http://

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ The 

Organisation for Economic Co-operation 

and Development (OECD) test 

guidelines are available from the OECD 

Bookshop at http://

www.oecdbookshop.org or SourceOECD 

at http://www.sourceoecd.org. 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 


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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 

under the rule. The manufacturer or 

processor must show that it has a bona 

fide intent to manufacture or process the 

chemical substance and must identify 

the specific use for which it intends to 

manufacture or process the chemical 

substance. If EPA concludes that the 

person has shown a bona fide intent to 

manufacture or process the chemical 

substance, EPA will tell the person 

whether the use identified in the bona 

fide submission would be a significant 

new use under the rule. Since most of 

the chemical identities of the chemical 

substances subject to these SNURs are 

also CBI, manufacturers and processors 

can combine the bona fide submission 

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

with that under § 721.11 into a single 

step. 

If EPA determines that the use 

identified in the bona fide submission 

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

the use does not meet the criteria 

specified in the rule for a significant 

new use, that person can manufacture or 

process the chemical substance so long 

as the significant new use trigger is not 

met. In the case of a production volume 

trigger, this means that the aggregate 

annual production volume does not 

exceed that identified in the bona fide 

submission to EPA. Because of 

confidentiality concerns, EPA does not 

typically disclose the actual production 

volume that constitutes the use trigger. 

Thus, if the person later intends to 

exceed that volume, a new bona fide 

submission would be necessary to 

determine whether that higher volume 

would be a significant new use. 

X. SNUN Submissions 

According to § 721.1(c), persons 

submitting a SNUN must comply with 

the same notification requirements and 

EPA regulatory procedures as persons 

submitting a PMN, including 

submission of test data on health and 

environmental effects as described in 40 

CFR 720.50. SNUNs must be submitted 

on EPA Form No. 7710–25, generated 

using e-PMN software, and submitted to 

the Agency in accordance with the 

procedures set forth in 40 CFR 720.40 

and § 721.25. E–PMN software is 

available electronically at http://

www.epa.gov/opptintr/newchems. 

XI. Economic Analysis 

EPA has evaluated the potential costs 

of establishing SNUN requirements for 

potential manufacturers and processors 

of the chemical substances subject to 

this rule. EPA’s complete economic 

analysis is available in the docket under 

docket ID number EPA–HQ–OPPT– 

2015–0810. 

XII. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

This action establishes SNURs for 

several new chemical substances that 

were the subject of PMNs, or TSCA 

section 5(e) consent orders. The Office 

of Management and Budget (OMB) has 

exempted these types of actions from 

review under Executive Order 12866, 

entitled ‘‘Regulatory Planning and 

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

B. Paperwork Reduction Act (PRA) 

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

seq.), an agency may not conduct or 

sponsor, and a person is not required to 

respond to a collection of information 

that requires OMB approval under PRA, 

unless it has been approved by OMB 

and displays a currently valid OMB 

control number. The OMB control 

numbers for EPA’s regulations in title 40 

of the CFR, after appearing in the 

Federal Register, are listed in 40 CFR 

part 9, and included on the related 

collection instrument or form, if 

applicable. EPA is amending the table in 

40 CFR part 9 to list the OMB approval 

number for the information collection 

requirements contained in this action. 

This listing of the OMB control numbers 

and their subsequent codification in the 

CFR satisfies the display requirements 

of PRA and OMB’s implementing 

regulations at 5 CFR part 1320. This 

Information Collection Request (ICR) 

was previously subject to public notice 

and comment prior to OMB approval, 

and given the technical nature of the 

table, EPA finds that further notice and 

comment to amend it is unnecessary. As 

a result, EPA finds that there is ‘‘good 

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

Administrative Procedure Act (5 U.S.C. 

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

without further notice and comment. 

The information collection 

requirements related to this action have 

already been approved by OMB 

pursuant to PRA under OMB control 

number 2070–0012 (EPA ICR No. 574). 

This action does not impose any burden 

requiring additional OMB approval. If 

an entity were to submit a SNUN to the 

Agency, the annual burden is estimated 

to average between 30 and 170 hours 

per response. This burden estimate 

includes the time needed to review 

instructions, search existing data 

sources, gather and maintain the data 

needed, and complete, review, and 

submit the required SNUN. 

Send any comments about the 

accuracy of the burden estimate, and 

any suggested methods for minimizing 

respondent burden, including through 

the use of automated collection 

techniques, to the Director, Collection 

Strategies Division, Office of 

Environmental Information (2822T), 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001. Please remember to 

include the OMB control number in any 

correspondence, but do not submit any 

completed forms to this address. 

C. Regulatory Flexibility Act (RFA) 

On February 18, 2012, EPA certified 

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

601 et seq.), that promulgation of a 

SNUR does not have a significant 

economic impact on a substantial 

number of small entities where the 

following are true: 

1. A significant number of SNUNs 

would not be submitted by small 

entities in response to the SNUR. 

2. The SNUR submitted by any small 

entity would not cost significantly more 

than $8,300. 

A copy of that certification is available 

in the docket for this action. 

This action is within the scope of the 

February 18, 2012 certification. Based 

on the Economic Analysis discussed in 

Unit XI. and EPA’s experience 

promulgating SNURs (discussed in the 

certification), EPA believes that the 

following are true: 

• A significant number of SNUNs 

would not be submitted by small 

entities in response to the SNUR. 

• Submission of the SNUN would not 

cost any small entity significantly more 

than $8,300. 


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Therefore, the promulgation of the 

SNUR would not have a significant 

economic impact on a substantial 

number of small entities. 

D. Unfunded Mandates Reform Act 

(UMRA) 

Based on EPA’s experience with 

proposing and finalizing SNURs, State, 

local, and Tribal governments have not 

been impacted by these rulemakings, 

and EPA does not have any reasons to 

believe that any State, local, or Tribal 

government will be impacted by this 

action. As such, EPA has determined 

that this action does not impose any 

enforceable duty, contain any unfunded 

mandate, or otherwise have any effect 

on small governments subject to the 

requirements of UMRA sections 202, 

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

E. Executive Order 13132 

This action will not have a substantial 

direct effect on States, on the 

relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

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

1999). 

F. Executive Order 13175 

This action does not have Tribal 

implications because it is not expected 

to have substantial direct effects on 

Indian Tribes. This action does not 

significantly nor uniquely affect the 

communities of Indian Tribal 

governments, nor does it involve or 

impose any requirements that affect 

Indian Tribes. Accordingly, the 

requirements of Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000), do not apply 

to this action. 

G. Executive Order 13045 

This action is not subject to Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997), because this is not an 

economically significant regulatory 

action as defined by Executive Order 

12866, and this action does not address 

environmental health or safety risks 

disproportionately affecting children. 

H. Executive Order 13211 

This action is not subject to Executive 

Order 13211, entitled ‘‘Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

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

22, 2001), because this action is not 

expected to affect energy supply, 

distribution, or use and because this 

action is not a significant regulatory 

action under Executive Order 12866. 

I. National Technology Transfer and 

Advancement Act (NTTAA) 

In addition, since this action does not 

involve any technical standards, 

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

note), does not apply to this action. 

J. Executive Order 12898 

This action does not entail special 

considerations of environmental justice 

related issues as delineated by 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

XIII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects 

40 CFR Part 9 

Environmental protection, Reporting 

and recordkeeping requirements. 

40 CFR Part 721 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: May 3, 2016. 

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 

* * * * * 

721.10875 ....................... 2070–0012 

721.10876 ....................... 2070–0012 

721.10877 ....................... 2070–0012 

721.10878 ....................... 2070–0012 

721.10879 ....................... 2070–0012 

721.10880 ....................... 2070–0012 

721.10881 ....................... 2070–0012 

721.10882 ....................... 2070–0012 

721.10883 ....................... 2070–0012 

721.10884 ....................... 2070–0012 

721.10885 ....................... 2070–0012 

721.10886 ....................... 2070–0012 

721.10887 ....................... 2070–0012 

721.10888 ....................... 2070–0012 

721.10889 ....................... 2070–0012 

721.10890 ....................... 2070–0012 

721.10891 ....................... 2070–0012 

721.10892 ....................... 2070–0012 

721.10893 ....................... 2070–0012 

721.10894 ....................... 2070–0012 

721.10895 ....................... 2070–0012 

721.10896 ....................... 2070–0012 

721.10897 ....................... 2070–0012 

721.10898 ....................... 2070–0012 

721.10899 ....................... 2070–0012 

721.10900 ....................... 2070–0012 

721.10901 ....................... 2070–0012 

721.10902 ....................... 2070–0012 

721.10903 ....................... 2070–0012 

721.10904 ....................... 2070–0012 

721.10905 ....................... 2070–0012 

721.10906 ....................... 2070–0012 

721.10907 ....................... 2070–0012 

721.10908 ....................... 2070–0012 

721.10909 ....................... 2070–0012 

721.10910 ....................... 2070–0012 

721.10911 ....................... 2070–0012 

721.10912 ....................... 2070–0012 

721.10913 ....................... 2070–0012 

721.10914 ....................... 2070–0012 

721.10915 ....................... 2070–0012 

721.10916 ....................... 2070–0012 

721.10917 ....................... 2070–0012 

721.10918 ....................... 2070–0012 

721.10919 ....................... 2070–0012 

721.10920 ....................... 2070–0012 

721.10921 ....................... 2070–0012 

721.10922 ....................... 2070–0012 

721.10923 ....................... 2070–0012 

721.10924 ....................... 2070–0012 

721.10925 ....................... 2070–0012 

* * * * * 

* * * * * 


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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 § 721.10875 to subpart E to 

read as follows: 

§ 721.10875 Alkali transition metal oxide 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkali transition metal 

oxide (PMN P–11–150) is subject to 

reporting under this section for the 

significant new uses described in 

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

requirements of this rule do not apply 

to quantities of the PMN substance after 

it has been completely reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. (A) 

Requirements as specified in 

§ 721.63(a)(4), (a)(6)(ii), (a)(6)(v), 

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

percent), and (c). When determining 

which persons are reasonably likely to 

be exposed as required for 

§ 721.63(a)(4), engineering control 

measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an Assigned Protection 

Factor (APF) of at least 10 meet the 

requirements of § 721.63(a)(4): 

(1) Any NIOSH-certified air-purifying 

elastomeric half-mask respirator 

equipped with N100 (if oil aerosols 

absent), R100, or P100 filters. 

(2) Any appropriate NIOSH-certified 

N100 (if oil aerosols absent), R100, or 

P100 filtering facepiece respirator. 

(3) Any NIOSH-certified air-purifying 

full facepiece respirator equipped with 

N100 (if oil aerosols absent), R100, or 

P100 filters. 

(4) Any NIOSH-certified negative 

pressure (demand) supplied air 

respirator equipped with a half-mask. 

(5) Any NIOSH-certified negative 

pressure (demand) self-contained 

breathing apparatus (SCBA) equipped 

with a half-mask. 

(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 TSCA section 

5(e) consent order for this substance. 

The NCEL is 2.4 mg/m3 as an 8-hour 

time weighted average (TWA) verified 

by actual monitoring data. 

(ii) Hazard communication program. 

Requirements as specified in § 721.72(a) 

through (e)(concentration set at 0.1 

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

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

(g)(2)(iii), (g)(2)(iv)(use respiratory 

protection, or maintain workplace 

airborne concentrations at or below an 

8-hour time-weighted average of 2.4 mg/ 

m3), and (g)(5). 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(q). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (d) and (f) through 

(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)(iii) of this section. 

■ 5. Add § 721.10876 to subpart E to 

read as follows: 

§ 721.10876 Perfluoroalkyl substituted 

alkyl sulfonate (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as perfluoroalkyl substituted 

alkyl sulfonate (PMN P–11–484) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (k)(analysis and 

reporting and limitations of maximum 

impurity levels of certain fluorinated 

impurities; and use other described in 

the consent order), (o)(use in a 

consumer product that could be spray 

applied), and (q). 

(ii) Disposal. Requirements as 

specified in § 721.85. Incineration of 

wastes in an incinerator operating at the 

temperature of at least 1,000 degrees 

Celsius and a residence time of 

minimum of 2 seconds. Any tank or 

vessel washings, residues from transport 

vessels or tanks, and similar materials 

that are captured and retained in the 

normal course of manufacturing and 

processing for re-use in manufacturing 

of the PMN substance or products made 

from the PMN substance are exempt 

from this method of disposal. 

(iii) Release to water. Requirements as 

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

(c)(1) apply to the PMN substance 

except under the terms specified in the 

consent order. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 6. Add § 721.10877 to subpart E to 

read as follows: 

§ 721.10877 Polyfluorinated alkyl 

quaternary ammonium chloride (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polyfluorinated alkyl 

quaternary ammonium chloride (PMN 

P–11–543) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k)(analysis and 

reporting and limitations of maximum 

impurity levels of certain fluorinated 

impurities; and use other described in 

the consent order), (o)(use in a 

consumer product that could be spray 

applied), and (q). 

(ii) Disposal. Requirements as 

specified in § 721.85. Incineration of 

wastes in an incinerator operating at the 

temperature of at least 1,000 degrees 

Celsius and a residence time of 

minimum of 2 seconds. Any tank or 

vessel washings, residues from transport 

vessels or tanks, and similar materials 

that are captured and retained in the 

normal course of manufacturing and 

processing for re-use in manufacturing 

of the PMN substance or products made 

from the PMN substance are exempt 

from this method of disposal. 

(iii) Release to water. Requirements as 

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

(c)(1) apply to the PMN substance 

except under the terms specified in the 

consent order. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 


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(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 7. Add § 721.10878 to subpart E to 

read as follows: 

§ 721.10878 Polyfluorinatedalkylsulfonyl 

substituted alkane derivative (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 

polyfluorinatedalkylsulfonyl substituted 

alkane derivative (PMN P–14–67) is 

subject to reporting under this section 

for the significant new uses described in 

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

requirements of this rule do not apply 

to quantities of the PMN substance after 

it has been completely reacted (cured). 

(2) The significant new uses are: 

(i) Hazard communication program. 

Requirements as specified in § 721.72. A 

significant new use of the substance is 

any manner or method of manufacture 

or processing associated with any use of 

the substance without providing risk 

notification as follows: 

(A) If as a result of the test data 

required under TSCA section 5(e) 

consent order for the substance, the 

employer becomes aware that the 

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 the substance is not 

being manufactured, processed, or used 

in the employer’s workplace, the 

employer must add the new information 

to a MSDS before the substance is 

reintroduced into the workplace. 

(B) The employer must ensure that 

persons who will receive the PMN 

substance from the employer, or who 

have received the PMN substance from 

the employer within 5 years from the 

date the employer becomes aware of the 

new information described in paragraph 

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

an MSDS containing the information 

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

this section within 90 days from the 

time the employer becomes aware of the 

new information. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (k) and (o)(use in 

a consumer product that could be spray 

applied), and (q). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 8. Add § 721.10879 to subpart E to 

read as follows: 

§ 721.10879 1-Octadecanaminium, N-(3- 

chloro-2-hydroxypropyl)-N,N-dimethyl-, 

chloride (1:1). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1-octadecanaminium, N-(3-chloro-2- 

hydroxypropyl)-N,N-dimethyl-, chloride 

(1:1) (PMN P–14–125; CAS No. 3001– 

63–6) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

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

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 9. Add § 721.10880 to subpart E to 

read as follows: 

§ 721.10880 Fatty acid rxn products with 

aminoalkylamines (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as fatty acid rxn products 

with aminoalkylamines (PMNs P–14– 

153, P–14–154, P–15–79, and P–15–80) 

are subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80. A significant new 

use of the substances is any use other 

than as chemical intermediates, 

additives for flotation products, or 

adhesion promoters for use in asphalt 

applications where the surface water 

concentrations described under 

paragraph (a)(3)(i) of this section are 

exceeded. 

(ii) [Reserved]. 

(3) The significant new uses for any 

use other than as chemical 

intermediated, additives for flotation 

products, or adhesion promoters for use 

in asphalt applications are: 

(i) Release to water. Requirements as 

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

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

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), (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. 

■ 10. Add § 721.10881 to subpart E to 

read as follows: 

§ 721.10881 Fatty acid amides (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as fatty acid amides (PMNs 

P–14–155 and P–14–156) are subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80. A significant new 

use of the substances is any use other 

than as chemical intermediates, 

additives for flotation products, or 

adhesion promoters for use in asphalt 

applications where the surface water 

concentrations described under 

paragraph (a)(3)(i) of this section are 

exceeded. 

(ii) [Reserved]. 

(3) The significant new uses for any 

use other than as chemical 

intermediated, additives for flotation 

products, or adhesion promoters for use 

in asphalt applications are: 

(i) Release to water. Requirements as 

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


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(c)(4) (N=2 for P–14–155 and N=3 for P– 

14–156). 

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 11. Add § 721.10882 to subpart E to 

read as follows: 

§ 721.10882 Trialkylammonium 

borodibenzoate (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as trialkylammonium 

borodibenzoate (PMN P–14–198) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f) and (j). 

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 12. Add § 721.10883 to subpart E to 

read as follows: 

§ 721.10883 Fatty ester derivatives, 

reaction products with alkanolamine, 

hydroxylated, borated (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as fatty ester derivatives, 

reaction products with alkanolamine, 

hydroxylated, borated (PMN P–14–324) 

is subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial commercial, and 

consumer activities. Requirements as 

specified in § 721.80. A significant new 

use of the substance is a use other than 

as a lubricating oil additive. 

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 13. Add § 721.10884 to subpart E to 

read as follows: 

§ 721.10884 Benzenepropanol, 1-benzoate. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

benzenepropanol, 1-benzoate (PMN P– 

14–397; CAS No. 60045–26–3) is subject 

to reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial commercial, and 

consumer activities. Requirements as 

specified in § 721.80. A significant new 

use of the substance is use other than as 

a plasticizer in adhesives for foodproduct packaging; a diluents-type 

plasticizer in plastisol; a coalescent in 

architectural paints and coating; and a 

fragrance carrier in fragrances. 

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 14. Add § 721.10885 to subpart E to 

read as follows: 

§ 721.10885 Alcohols, C12–22, distn. 

residues. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

alcohols, C12–22, distn. residues (PMN P– 

14–448; CAS No. 1476777–83–9) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial commercial, and 

consumer activities. Requirements as 

specified in § 721.80. A significant new 

use of the substance is any use where 

the cumulative molecular weights of the 

C12 and C14 components exceed 2 

percent by weight of the overall 

molecular weight of the PMN substance. 

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 15. Add § 721.10886 to subpart E to 

read as follows: 

§ 721.10886 Phosphoric acid, mixed Bu 

and decyl and octyl and 2-(2- 

phenoxyethoxy)ethyl and 2-phenoxyethyl 

esters. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

phosphoric acid, mixed Bu and decyl 

and octyl and 2-(2-phenoxyethoxy)ethyl 

and 2-phenoxyethyl esters (PMN P–14– 

501; CAS No. 1502809–48–4) is subject 

to reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

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

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 16. Add § 721.10887 to subpart E to 

read as follows: 

§ 721.10887 Phosphoric acid, mixed Bu 

and decyl and octyl and 2-(2- 

phenoxyethoxy)ethyl and 2-phenoxyethyl 

esters, potassium salts. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

phosphoric acid, mixed Bu and decyl 

and octyl and 2-(2-phenoxyethoxy)ethyl 

and 2-phenoxyethyl esters, potassium 

salts (PMN P–14–502; CAS No. 


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1502809–56–4) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

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

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 17. Add § 721.10888 to subpart E to 

read as follows: 

§ 721.10888 Siloxanes and Silicones, 

3-[(2-aminoethyl)amino)propyl Me, di-Me, 

reaction products with cadmium zinc 

selenide sulfide, lauric acid and oleylamine. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

siloxanes and silicones, 3-[(2- 

aminoethyl)amino)propyl Me, di-Me, 

reaction products with cadmium zinc 

selenide sulfide, lauric acid and 

oleylamine (PMN P–15–59; CAS No. 

1623456–05–2) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

consumer activities. Requirements as 

specified in § 721.80(p) (three months 

and eighteen months). A significant new 

use of the substance is manufacture, 

process, or use the chemical substance 

other than as a down converter for an 

optical filter for light emitting diodes 

used in displays, or other than in a 

liquid formulation. 

(iii) Disposal. Requirements as 

specified in § 721.85. It is a significant 

new use to dispose of the chemical 

substance other than by incineration in 

a permitted hazardous waste 

incinerator. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (e), (i), and (j) 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 § 721.10889 to subpart E to 

read as follows: 

§ 721.10889 Dodecanoic acid, reaction 

products with cadmium zinc selenide 

sulfide and oleylamine. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

dodecanoic acid, reaction products with 

cadmium zinc selenide sulfide and 

oleylamine (PMN P–15–60; CAS No. 

1773514–92–3) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(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) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80. It is a significant 

new use to manufacture, process, or use 

the chemical substance other than as a 

chemical intermediate or other than in 

a liquid formulation. 

(iii) Disposal. Requirements as 

specified in § 721.85. It is a significant 

new use to dispose of the chemical 

substance other than by incineration in 

a permitted hazardous waste 

incinerator. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (e), (i) and (j) 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 § 721.10890 to subpart E to 

read as follows: 

§ 721.10890 Phosphonic acid, Ptetradecyl-, reaction products with cadmium 

selenide (CdSe). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

phosphonic acid, P-tetradecyl-, reaction 

products with cadmium selenide (CdSe) 

(PMN P–15–104; CAS No. 1773514–66– 

1) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

consumer activities. Requirements as 

specified in § 721.80. It is a significant 

new use to manufacture, process, or use 

the chemical substance other than as a 

chemical intermediate or other than in 

a liquid formulation. 

(iii) Disposal. Requirements as 

specified in § 721.85 It is a significant 

new use to dispose of the chemical 

substance other than by incineration in 

a permitted hazardous waste 

incinerator. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (e), (i), and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 20. Add § 721.10891 to subpart E to 

read as follows: 

§ 721.10891 Alkyl silicate, polymer with 2- 

(chloromethyl)oxirane and 4,4′-(1- 

methylethylidene)bis[phenol], alkoxylated 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkyl silicate, polymer 


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with 2-(chloromethyl)oxirane and 4,4′- 

(1-methylethylidene)bis[phenol], 

alkoxylated (PMN P–15–81) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 40 CFR 

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

(concentration set at 0.1 percent), and 

(c). 

(ii) Release to water. Requirements as 

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

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

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 21. Add § 721.108992 to subpart E to 

read as follows: 

§ 721.10892 Reaction product of a mixture 

of aromatic dianhydrides and aliphatic 

esters with an aromatic diamine (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as reaction product of a 

mixture of aromatic dianhydrides and 

aliphatic esters with an aromatic 

diamine (PMN P–15–109) 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=11). 

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 22. Add § 721.10893 to subpart E to 

read as follows: 

§ 721.10893 Fatty acids, tall-oil, reaction 

products with an ether and 

triethylenetetramine (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as fatty acids, tall-oil, 

reaction products with an ether and 

triethylenetetramine (PMN P–15–111) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f) and (j). 

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i), are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 23. Add § 721.10894 to subpart E to 

read as follows: 

§ 721.10894 Substituted benzyl acrylate 

(generic) 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as substituted benzyl 

acrylate (PMN P–15–120) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

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

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 24. Add § 721.10895 to subpart E to 

read as follows: 

§ 721.10895 Fluoroalkyl acrylate 

copolymer (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

fluoroalkyl acrylate copolymer (PMN 

P–15–154) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Hazard communication program. 

Requirements as specified in § 721.72. A 

significant new use of the substance is 

any manner or method of manufacture 

or processing associated with any use of 

the substance without providing risk 

notification as follows: 

(A) If as a result of the test data 

required under TSCA section 5(e) 

consent order for the substance, the 

employer becomes aware that the 

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 the substance is not 

being manufactured, processed, or used 

in the employer’s workplace, the 

employer must add the new information 

to a MSDS before the substance is 

reintroduced into the workplace. 

(B) The employer must ensure that 

persons who will receive the PMN 

substance from the employer, or who 

have received the PMN substance from 

the employer within 5 years from the 

date the employer becomes aware of the 

new information described in paragraph 

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

an MSDS containing the information 

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

this section within 90 days from the 

time the employer becomes aware of the 

new information. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (analysis and 

reporting and limitations of maximum 

impurity levels of certain fluorinated 

impurities), and (q). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (e) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 25. Add § 721.10896 to subpart E to 

read as follows: 


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§ 721.10896 1-Hexanol, 6-mercapto-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1-hexanol, 6-mercapto-. (PMN P–15– 

176; CAS No.1633–78–9) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

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

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 26. Add § 721.10897 to subpart E to 

read as follows: 

§ 721.10897 Phenol, 2,2′-[1,2-disubstituted1,2-ethanediyl]

bis(iminomethylene)bis[substituted- 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified generically as phenol, 2,2′-

[1,2-disubstituted-1,2-ethanediyl]

bis(iminomethylene)bis[substituted- 

(PMN P–15–177) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

(a)(3). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 27. Add § 721.10898 to subpart E to 

read as follows: 

§ 721.10898 Carbomonocycles, polymer 

with substituted heteromonocycle, 

succinate, methyl acrylate (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as carbomonocycles, 

polymer with substituted 

heteromonocycle, succinate, methyl 

acrylate (PMN P–15–188) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80. A significant new 

use of the substance is any use other 

than as a pigment-wetting resin for UVcurable coatings. 

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (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. 

■ 28. Add § 721.10899 to subpart E to 

read as follows: 

§ 721.10899 Halogenated alkyl 

trimethylaminium halide (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as halogenated alkyl 

trimethylaminium halide (PMN P–15– 

190) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(4), (a)(6)(i), (b)(concentration 

set at 0.1 percent) and (c). When 

determining which persons are 

reasonably likely to be exposed as 

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

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 721.63(a)(4): 

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

helmet and with appropriate gas/vapor 

(acid gas, organic vapor, or substance 

specific) cartridges in combination with 

HEPA filters. 

(B) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting facepiece, hood, or helmet. 

(C) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full facepiece. 

(ii) Release to water. Requirements as 

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

(c)(4) (N=88). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 29. Add § 721.10900 to subpart E to 

read as follows: 

§ 721.10900 Titanium salt, reaction 

products with silica (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as titanium salt, reaction 

products with silica (PMN P–15–252) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

When determining which persons are 

reasonably likely to be exposed as 

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

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 721.63(a)(4): 

(A) NIOSH-certified air-purifying 

elastomeric half-mask respirator 

equipped with N100 (if oil aerosols 

absent), R100, or P100 filters. 

(B) NIOSH-certified N100 (if oil 

aerosols absent), R100, or P100 filtering 

facepiece respirator. 


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(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(g). 

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (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. 

■ 30. Add § 721.10901 to subpart E to 

read as follows: 

§ 721.10901 Formaldehyde, reaction 

products with aniline and aromatic monoand di-phenol mixture (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as formaldehyde, reaction 

products with aniline and aromatic 

mono- and di-phenol mixture (PMN 

P–15–272) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

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

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 31. Add § 721.10902 to subpart E to 

read as follows: 

§ 721.10902 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–15–276) is subject to 

reporting under this section for the 

significant new uses described in 

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

requirements of this rule do not apply 

to quantities of the PMN substance after 

it has been completely reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), and (a)(3). 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. A significant new 

use is manufacture, process, or use of 

the PMN substance other than in a 

liquid formulation. A significant new 

use is use other than as a thin film for 

electronic device applications or any 

use involving an application method 

that generates a vapor, mist, or aerosol 

unless such application method occurs 

in an enclosed process. An enclosed 

process is defined as an operation that 

is designed and operated so that there 

is no release associated with normal or 

routine production processes into the 

environment of any substance present in 

the operation. An operation with 

inadvertent or emergency pressure relief 

releases remains an enclosed process so 

long as measures are taken to prevent 

worker exposure to and environmental 

contamination from the releases. 

(iii) Disposal. Requirements as 

specified in § 721.85(a)(1), (a)(2), (b)(1), 

(b)(2), (c)(1), and (c)(2). 

(iv) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (e), (i), (j), and (k) 

are applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 32. Add § 721.10903 to subpart E to 

read as follows: 

§ 721.10903 Acrylated mixed metal oxides 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as acrylated mixed metal 

oxides (PMN P–15–295) 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). 

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

(w)(2), (x)(1), (x)(2), and (y)(1). 

(iii) Disposal. Requirements as 

specified in § 721.85(a)(1), (a)(2), (b)(1), 

(b)(2), (c)(1), and (c)(2). 

(iv) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (e), (i), (j), and (k) 

are applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 33. Add § 721.10904 to subpart E to 

read as follows: 

§ 721.10904 Phenol, 1,1-dimethylalkyl 

derivatives (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically phenol, 1,1-dimethylalkyl 

derivatives (PMN P–15–306) 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=13). 

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 


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■ 34. Add § 721.10905 to subpart E to 

read as follows: 

§ 721.10905 Butanedioic acid, 2- 

methylene-, dialkyl ester (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as butanedioic acid, 2- 

methylene-, dialkyl ester (PMN P–15– 

319) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

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

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 35. Add § 721.10906 to subpart E to 

read as follows: 

§ 721.10906 Magnesium alkaryl sulfonate 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as magnesium alkaryl 

sulfonate (PMN P–15–324) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial commercial, and 

consumer activities. Requirements as 

specified in § 721.80. A significant new 

use of the substance is any use other 

than as a detergent additive in crankcase 

lubricant applications. 

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 36. Add § 721.10907 to subpart E to 

read as follows: 

§ 721.10907 Polyfluorohydrocarbon 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polyfluorohydrocarbon 

(PMN P–15–326) 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) and (o). 

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 37. Add § 721.10908 to subpart E to 

read as follows: 

§ 721.10908 Aluminum calcium oxide salt 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as aluminum calcium oxide 

salt (PMN P–15–328) 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). 

(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), 

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

which persons are reasonably likely to 

be exposed as required for § 721.63 

(a)(4), engineering control measures 

(e.g., enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. The 

following National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirators with an 

Assigned Protection Factor (APF) of at 

least 10 meet the requirements of 

§ 721.63(a)(4): 

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

helmet and with appropriate gas/vapor 

(acid gas, organic vapor, or substance 

specific) cartridges in combination with 

HEPA filters. 

(B) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting face piece, hood, or helmet. 

(C) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full face piece. 

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 TSCA section 

5(e) consent order for this substance. 

The NCEL is 5 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) 

trhough (f)(concentration set at 1.0 

percent), (g)(1)(ii), (g)(2)(When using 

this substance avoid breathing the 

substance, and use respiratory 

protection, or maintain workplace 

airborne concentrations at or below an 

8-hour time-weighted average of 5 mg/ 

m3.) and (g)(5). 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (d) and (f) through 

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)(iii) of this section. 

■ 38. Add § 721.10909 to subpart E to 

read as follows: 

§ 721.10909 Polyalkyltrisiloxane (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polyalkyltrisiloxane 

(PMN P–15–332) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

(a)(6)(i), (b)(concentration set at 1.0 

percent), and (c). When determining 


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which persons are reasonably likely to 

be exposed as required for 

§ 721.63(a)(4), engineering control 

measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 721.63(a)(4): 

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

helmet and with appropriate gas/vapor 

(acid gas, organic vapor, or substance 

specific) cartridges in combination with 

HEPA filters. 

(B) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting facepiece, hood, or helmet. 

(C) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full facepiece. 

(ii) Industrial commercial, and 

consumer activities. Requirements as 

specified in § 721.80(h). 

(iii) Release to water. Requirements as 

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

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

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) 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. 

■ 39. Add § 721.10910 to subpart E to 

read as follows: 

§ 721.10910 Oxirane, 2,2′-[[1-[4-[1-methyl1-[4-(2-oxiranylmethoxy)phenyl]

ethyl]phenyl]ethylidene]bis(4,1- 

phenyleneoxymethylene)]bis- (P–15–356, 

Chemical A). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

oxirane, 2,2′-[[1-[4-[1-methyl-1-[4-(2- 

oxiranylmethoxy)phenyl]ethyl]phenyl]

ethylidene]bis(4,1- 

phenyleneoxymethylene)]bis- (PMN 

P–15–356, Chemical A; CAS No. 

115254–47–2) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial and 

consumer activities. Requirements as 

specified in § 721.80. A significant new 

use of the substance is any use other 

than as an additive in polymer 

formulation for electronics. 

(ii) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 40. Add § 721.10911 to subpart E to 

read as follows: 

§ 721.10911 2-Propanol, 1,3-bis[4-[1-[4-[1- 

methyl-1-[4-(2- 

oxiranylmethoxy)phenyl]ethyl]phenyl]-1-[4- 

(2-oxiranylmethoxy)phenyl]ethyl]phenoxy]- 

(P–15–356, Chemical B). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

2-propanol, 1,3-bis[4-[1-[4-[1-methyl-1- 

[4-(2- 

oxiranylmethoxy)phenyl]ethyl]phenyl]- 

1-[4-(2-oxiranylmethoxy)phenyl]

ethyl]phenoxy]- (PMN P–15–356, 

Chemical B; CAS No. 180063–56–3) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial and 

consumer activities. Requirements as 

specified in § 721.80. A significant new 

use of the substance is any use other 

than as an additive in polymer 

formulation for electronics. 

(ii) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 41. Add § 721.10912 to subpart E to 

read as follows: 

§ 721.10912 Aliphatic acrylate (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as aliphatic acrylate (PMN 

P–15–363) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

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

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 42. Add § 721.10913 to subpart E to 

read as follows: 

§ 721.10913 Diisocyanato hexane, 

homopolymer, alkanoic acid-polyalkylene 

glycol ether with substituted alkane (3:1) 

reaction products-blocked (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as diisocyanato hexane, 

homopolymer, alkanoic acidpolyalkylene glycol ether with 

substituted alkane (3:1) reaction 

products-blocked (PMN P–15–378) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

determining which persons are 

reasonably likely to be exposed as 

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

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 10 meet the 

requirements of § 721.63(a)(4): 

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

helmet and with appropriate gas/vapor 

(acid gas, organic vapor, or substance 

specific) cartridges in combination with 

HEPA filters. 

(B) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

loose fitting facepiece, hood, or helmet. 


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Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations 30479 

(C) NIOSH-certified negative pressure 

(demand) supplied-air respirator with a 

full facepiece. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (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. 

■ 43. Add § 721.10914 to subpart E to 

read as follows: 

§ 721.10914 Polyitaconic acid, sodium zinc 

salt (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polyitaconic acid, sodium 

zinc salt (PMN P–15–382) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial commercial, and 

consumer activities. Requirements as 

specified in § 721.80. A significant new 

use of the substance is any use other 

than as an odor neutralization for pet 

litter and cleaning hard surface surfaces, 

fabrics, skin and hair; an odor 

neutralization for air car; and an odor 

neutralization for waste processing and 

solid waste management in paper, oil, 

gas, mining, agriculture, food and 

municipal industries. 

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 44. Add § 721.10915 to subpart E to 

read as follows: 

§ 721.10915 Fatty acid esters with polyols 

polyalkyl ethers (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as fatty acid esters with 

polyols polyalkyl ethers (PMN P–15– 

411) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

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

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 45. Add § 721.10916 to subpart E to 

read as follows: 

§ 721.10916 2,7-Naphthalenedisulfonic 

acid, 4-amino-3-[substituted]-5-hydroxy-6- 

[(1E)-2-phenyldiazenyl]-, lithium salt (1:3) 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 2,7-naphthalenedisulfonic 

acid, 4-amino-3-[substituted]-5-hydroxy6-[(1E)-2-phenyldiazenyl]-, lithium salt 

(1:3) (PMN P–15–435) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80. A significant new 

use of the substance is any use other 

that in a liquid formulation. 

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers and 

processors of these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 46. Add § 721.10917 to subpart E to 

read as follows: 

§ 721.10917 Polymethylsiloxane, 

distillation residues (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polymethylsiloxane, 

distillation residues (PMN P–15–492) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

(a)(6)(ii), (a)(6)(v), (a)(6)(vi), 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 operations, general 

and local ventilation) or administrative 

control measure (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 

respirator with an assigned protection 

factor (APF) of at least 10 meets the 

minimum requirements for 

§ 721.63(a)(4): NIOSH-certified powered 

air-purifying respirator with a hood or 

helmet and with appropriate gas-vapor 

(acid gas, organic vapor, or substance 

specific) cartridges. 

(ii) Industrial commercial, and 

consumer activities. Requirements as 

specified in § 721.80(g). 

(iii) Release to water. Requirements as 

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

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

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (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. 

■ 47. Add § 721.10918 to subpart E to 

read as follows: 

§ 721.10918 Perfluorobutanesulfonamide 

and polyoxyalkylene containing 

polyurethane (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 

perfluorobutanesulfonamide and 

polyoxyalkylene containing 

polyurethane (PMN P–15–502) is 

subject to reporting under this section 

for the significant new uses described in 

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

requirements of this rule do not apply 

to quantities of the PMN substance after 

it has been completely reacted (cured). 

(2) The significant new uses are: 

(i) Hazard communication program. A 

significant new use of the substance is 


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30480 Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations 

any manner or method of manufacture 

or processing associated with any use of 

the substance without providing risk 

notification as follows: 

(A) If as a result of the test data 

required under TSCA section 5(e) 

consent order for the substance, the 

employer becomes aware that the 

substances may present a risk of injury 

to human health or the environment, the 

employer must incorporate this new 

information, and any information on 

methods for protecting against such risk, 

into a MSDS as described in § 721.72(c) 

within 90 days from the time the 

employer becomes aware of the new 

information. If the substance is not 

being manufactured, processed, or used 

in the employer’s workplace, the 

employer must add the new information 

to a MSDS before the substance is 

reintroduced into the workplace. 

(B) The employer must ensure that 

persons who will receive the PMN 

substance from the employer, or who 

have received the PMN substance from 

the employer within 5 years from the 

date the employer becomes aware of the 

new information described in paragraph 

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

an MSDS containing the information 

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

this section within 90 days from the 

time the employer becomes aware of the 

new information. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific 

use is subject to this section. The 

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

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

■ 48. Add § 721.10919 to subpart E to 

read as follows: 

§ 721.10919 Quaternary ammonium 

compounds, (3-chloro-2- 

hydroxypropyl)coco alkyldimethyl, 

chlorides. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

quaternary ammonium compounds, 

(3-chloro-2-hydroxypropyl)coco 

alkyldimethyl, chlorides (PMN P–15– 

542; CAS No. 690995–44–9) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

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

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 49. Add § 721.10920 to subpart E to 

read as follows: 

§ 721.10920 Modified diphenylmethane 

diisocyanate prepolymer with polyol 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as modified 

diphenylmethane diisocyanate 

prepolymer with polyol (PMN P–15– 

559) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80. A significant new 

use of the substance is manufacture of 

the substance where the average 

molecular weight is below 7,500 

daltons, and where any molecular 

weight species is below 1,000 daltons. 

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 50. Add § 721.10921 to subpart E to 

read as follows: 

§ 721.10921 2-Furancarboxyaldehyde, 

5-(chloromethyl)-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

2-furancarboxyaldehyde, 5- 

(chloromethyl)- (PMN P–15–573; CAS 

No. 1623–88–7) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

(a)(6)(v), and (c). When determining 

which persons are reasonably likely to 

be exposed as required for 

§ 721.63(a)(4), engineering control 

measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. The following 

National Institute for Occupational 

Safety and Health (NIOSH)-certified 

respirators with an assigned protection 

factor (APF) of at least 50 meet the 

requirements of § 721.63(a)(4): 

(A) NIOSH-certified powered airpurifying respirator with a tight-fitting 

half mask and HEPA filters. 

(B) NIOSH-certified continuous flow 

supplied-air respirator equipped with a 

tight-fitting half mask. 

(C) NIOSH-certified negative pressure 

(demand) supplied-air respirator 

equipped with a full facepiece. 

(ii) Industrial commercial, and 

consumer activities. Requirements as 

specified in § 721.80(g) (chemical 

intermediate use in a continuous 

reaction process such that no greater 

than 50 kilograms is present in the 

workplace at a given time) and 

(s)(15,000 kilograms). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (e) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 51. Add § 721.10922 to subpart E to 

read as follows: 

§ 721.10922 1,2,4,5,7,8-Hexoxonane, 3,6,9- 

trimethyl-, 3,6,9-tris(alkyl) derivs. (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 11,2,4,5,7,8-hexoxonane, 

3,6,9-trimethyl-, 3,6,9-tris(alkyl) derivs. 

(PMN P–15–607) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 


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Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations 30481 

(2) The significant new uses are: 

(i) Industrial commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j). 

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 52. Add § 721.10923 to subpart E to 

read as follows: 

§ 721.10923 9-Octadecen-1-amine, 

hydrochloride (1:1), (9Z)-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

9-octadecen-1-amine, hydrochloride 

(1:1), (9Z)- (PMN P–15–671; CAS No. 

41130–29–4) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

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

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

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 53. Add § 721.10924 to subpart E to 

read as follows: 

§ 721.10924 Vegetable fatty acid alkyl 

esters (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as vegetable fatty acid alkyl 

esters (PMNs P–15–689 and P–15–690) 

are subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(g). 

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i) are 

applicable to manufacturers and 

processors of these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

[FR Doc. 2016–11121 Filed 5–13–16; 8:45 am] 

BILLING CODE 6560–50–P 


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