47004 Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2018–0567; FRL–9983–14] 

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 28 chemical substances 

which were the subject of 

premanufacture notices (PMNs). The 

chemical substances are subject to 

Orders issued by EPA pursuant to the 

TSCA. This action requires persons who 

intend to manufacture (defined by 

statute to include import) or process any 

of these 28 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 

initiates EPA’s evaluation of the 

intended use within the applicable 

review period. Persons may not 

commence manufacture or processing 

for the significant new use until EPA 

has conducted a review of the notice, 

made an appropriate determination on 

the notice, and has taken such actions 

as are required with that determination. 

DATES: This rule is effective on 

November 16, 2018. For purposes of 

judicial review, this rule shall be 

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

1, 2018. 

Written adverse comments on one or 

more of these SNURs must be received 

on or before October 17, 2018 (see Unit 

VI. of the SUPPLEMENTARY INFORMATION). 

If EPA receives written adverse 

comments, on one or more of these 

SNURs before October 17, 2018, 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–2018–0567, 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, 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 this rule on or after 

October 17, 2018 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 

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? 

1. Direct Final Rule. EPA is 

promulgating these SNURs using direct 

final rule 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 obligates EPA to 

assess risks that may be associated with 

the significant new uses under the 

conditions of use and, if appropriate, to 

regulate the proposed uses before they 

occur. 

2. Proposed Rule. In addition to this 

Direct Final Rule, elsewhere in this 

issue of the Federal Register, EPA is 

issuing a Notice of Proposed 

Rulemaking for this rule. If EPA receives 

no adverse comment, the Agency will 

not take further action on the proposed 

rule and the direct final rule will 

become effective as provided in this 

action. If EPA receives adverse comment 

on one or more of SNURs in this action 

by October 2, 2018 (see Unit VI. of the 

SUPPLEMENTARY INFORMATION), the 

Agency will publish in the Federal 


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Register a timely withdrawal of the 

specific SNURs that the adverse 

comments pertain to, informing the 

public that the actions will not take 

effect. EPA would then address all 

adverse public comments in a response 

to comments document in a subsequent 

final rule, based on the proposed rule. 

B. What is the Agency’s authority for 

taking this action? 

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

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

that a use of a chemical substance is a 

‘‘significant new use.’’ EPA must make 

this determination by rule after 

considering all relevant factors, 

including the four bulleted TSCA 

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

Once EPA determines that a use of a 

chemical substance is a significant new 

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

persons to submit a significant new use 

notice (SNUN) to EPA at least 90 days 

before they manufacture or process the 

chemical substance for that use (15 

U.S.C. 2604(a)(1)(B)(i)). TSCA 

furthermore prohibits such 

manufacturing or processing from 

commencing until EPA has conducted a 

review of the notice, made an 

appropriate determination on the notice, 

and taken such actions as are required 

in association with that determination 

(15 U.S.C. 2604(a)(1)(B)(ii)). As 

described in Unit V., the general SNUR 

provisions are found at 40 CFR part 721, 

subpart A. 

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 must either 

determine that the significant new use 

is not likely to present an unreasonable 

risk of injury or take such regulatory 

action as is associated with an 

alternative determination before the 

manufacture or processing for the 

significant new use can commence. If 

EPA determines that the significant new 

use is not likely to present an 

unreasonable risk, EPA is required 

under TSCA section 5(g) to make public, 

and submit for publication in the 

Federal Register, a statement of EPA’s 

findings. 

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 authorizes EPA to consider any 

other relevant factors. 

To determine what would constitute a 

significant new use for the 28 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 

28 chemical substances in 40 CFR part 

721, subpart E. In this unit, EPA 

provides the following information for 

each chemical substance: 

• PMN number. 

• Chemical name (generic name, if 

the specific name is claimed as CBI). 

• Chemical Abstracts Service (CAS) 

Registry number (if assigned for nonconfidential chemical identities). 

• Basis for the TSCA section 5(e) 

Order. 

• Information identified by EPA that 

would help characterize the potential 

health and/or environmental effects of 

the chemical substance in support of a 

request by the PMN submitter to modify 

the Order, or if a manufacturer or 

processor is considering submitting a 

SNUN for a significant new use 

designated by the SNUR. 

This information may include testing 

required in a TSCA section 5(e) Order 

to be conducted by the PMN submitter, 

as well as testing not required to be 

conducted but which would also help 

characterize the potential health and/or 

environmental effects of the PMN 

substance. Any recommendation for 

information identified by EPA was 

made based on EPA’s consideration of 

available screening-level data, if any, as 

well as other available information on 

appropriate testing for the chemical 

substance. Further, any such testing 

identified by EPA that includes testing 

on vertebrates was made after 

consideration of available toxicity 

information, computational toxicology 

and bioinformatics, and highthroughput screening methods and their 

prediction models. EPA also recognizes 

that whether testing/further information 

is needed will depend on the specific 

exposure and use scenario in the SNUN. 

EPA encourages all SNUN submitters to 

contact EPA to discuss any potential 

future testing. See Unit VIII. for more 

information. 

• CFR citation assigned in the 

regulatory text section of this rule. 

The regulatory text section of these 

rules specifies the activities designated 

as significant new uses. Certain new 

uses, including exceedance of 

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. 

These rules include 28 PMN 

substances that are subject to Orders 

under TSCA section 5(e)(1)(A). Each 

Order is based on one or more of the 

findings in TSCA section 5(a)(3)(B): 

There is insufficient information to 

permit a reasoned evaluation; in the 

absence of sufficient information to 

permit a reasoned evaluation, the 

activities associated with the PMN 

substances may present unreasonable 

risk to human health or the 

environment; the substance is or will be 

produced in substantial quantities, and 

enters or may reasonably be anticipated 

to enter the environment in substantial 

quantities or there is or may be 

significant (substantial) human 

exposure to the substance. Those Orders 

require protective measures to limit 

exposures or otherwise mitigate the 

potential unreasonable risk. The SNURs 

identify as significant new uses any 

manufacturing, processing, use, 

distribution in commerce, or disposal 

that does not conform to the restrictions 

imposed by the underlying Orders, 

consistent with TSCA section 5(f)(4). 

Where EPA determined that the PMN 

substance may present an unreasonable 


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risk of injury to human health via 

inhalation exposure, the underlying 

TSCA section 5(e) Order required, 

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) 

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 that 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) Order 

for the same chemical substance. 

PMN Number: P–14–758 

Chemical name: 2-Propenenitrile, 

polymer with methanamine, 

hydrogenated, 3- 

aminopropylterminated, ethoxylated 

propoxylated. 

CAS number: 2055838–16–7. 

Effective date of TSCA section 5(e) 

Order: September 15, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the generic (nonconfidential) use of the substance will 

be as urethane foam. Based on physical/ 

chemical properties, EPA has identified 

concern for lung toxicity. Based on SAR 

analysis of polycationic polymers, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

416 parts per billion (ppb). The Order 

was issued under TSCA sections 

5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation, the substance may 

present an unreasonable risk of injury to 

human health and the environment. To 

protect against these risks, the Order 

requires: 

1. Refraining from manufacturing the 

PMN substance in the United States (i.e. 

import only); 

2. Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

3. Use of a National Institute of 

Occupational Safety and Health 

(NIOSH)-certified respirator with an 

APF of at least 50 where there is a 

potential for inhalation exposure; 

4. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS; 

5. No application method of the PMN 

substance that results in greater worker 

inhalation exposures to vapor, mist, or 

aerosol than those encountered in roller 

coating application; 

6. Use of the PMN substance only for 

the confidential uses specified in the 

Order; and 

7. No release of the PMN substance 

into the waters of the United States. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Potentially useful information: EPA 

has determined that certain information 

about the physical-chemical properties, 

fate, ecotoxicity and pulmonary effects 

of the PMN substance may be 

potentially useful to characterize the 

effects of the PMN substance in support 

of a request by the PMN submitter to 

modify the Order, or if a manufacturer 

or processor is considering submitting a 

SNUN for a significant new use that 

would be designated by this SNUR. EPA 

has determined that the results of 

physical-chemical property testing, fate, 

acute and chronic aquatic toxicity 

testing, and pulmonary toxicity testing 

would help characterize the potential 

environmental and health effects of the 

PMN substance. Although the Order 

does not require these tests, the Order’s 

restrictions will remain in effect until 

the Order is modified or revoked by 

EPA based on submission of this or 

other information that EPA determines 

is relevant and needed to evaluate a 

modification request. 

CFR citation: 40 CFR 721.11124. 

PMN Number: P–16–493 

Chemical Name: Dicarboxylic acids, 

polymers with alkyl prop-2-enoate, 

alkyl 2- ethylprop-2-enoate, 

alkyl[(alkenyl)alkyl]alkanediol, 

alkanediol, alkanedioic acid, alkyl 2- 

rnethylprop-2-enoate, alkyl prop-2- 

enoic acid, alkylene 

[isocyanatocarbomonocyte] and 

alkanediol, alkanolamine-blocked, 

compds with 2-(alkylamino)alkanol 

(generic). 

CAS Number: Not available. 

Effective date of TSCA section 5(e) 

Order: September 18, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the generic (nonconfidential) use of the substance will 

be as paint. Based on physical/chemical 

properties of the PMN substance and 

test data on analogous diisocyanates, 

EPA identified concerns for dermal 

sensitization, respiratory sensitization, 

lung effects, neurotoxicity, and 

developmental toxicity, as well as skin 

irritation, and a potential for cancer to 

workers due to the possibility of 

isocyanate residuals. The Order was 

issued under TSCA sections 

5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based 

on a finding that in the absence of 

sufficient information to permit a 

reasoned evaluation, the substance may 

present an unreasonable risk of injury to 

human health and the environment. To 

protect against these risks, the Order 

requires: 

1. Refraining from manufacturing or 

processing the PMN substance in the 

United States (i.e., import only); 

2. Import of the PMN substance to 

contain no more than 0.1% residual 

isocyanate by weight; and 

3. Import of the PMN substance to 

contain no more than 1% of a 

confidential component by weight. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Potentially useful information: EPA 

has determined that certain information 

about the health effects of the PMN 

substance may be potentially useful to 

characterize the effects of the PMN 

substance in support of a request by the 

PMN submitter to modify the Order, or 

if a manufacturer or processor is 

considering submitting a SNUN for a 

significant new use that would be 

designated by this SNUR. EPA has 

determined that the results of 

sensitization and pulmonary toxicity 

testing would help characterize the 

potential health effects of the PMN 

substance. Although the Order does not 

require these tests, the Order’s 

restrictions will remain in effect until 

the Order is modified or revoked by 

EPA based on submission of this or 

other information that EPA determines 

is relevant and needed to evaluate a 

modification request. 

CFR citation: 40 CFR 721.11125. 

PMN Number: P–16–514 

Chemical Name: Mixed metal oxide 

(generic). 

CAS Number: Not available. 

Effective date of TSCA section 5(e) 

Order: August 7, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the generic (nonVerDate Sep<11>2014 18:34 Sep 14, 2018 Jkt 244001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 E:\FR\FM\17SER2.SGM 17SER2

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confidential) use of the substance will 

be as a catalyst. Based on SAR analysis 

of test data on analogous mixed metal 

oxides, EPA identified concerns for lung 

effects, systemic effects, eye irritation 

and allergic skin reaction. EPA also 

identified risk to workers for lung 

toxicity based on lung overload for 

respirable, poorly soluble particulates. 

The Order was issued under TSCA 

sections 5(a)(3)(B)(ii)(I) and 

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

in the absence of sufficient information 

to permit a reasoned evaluation, the 

substance may present an unreasonable 

risk of injury to human health. To 

protect against these risks, the Order 

requires: 

1. Submission to EPA of certain 

toxicity testing before exceeding the 

confidential production volume limit 

specified in the Order; 

2. Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

3. Use of a NIOSH-certified respirator 

with an APF of at least 1,000 where 

there is a potential for inhalation 

exposure or compliance with a NCEL of 

0.04 mg/m3 as an 8-hour time-weighted 

average to prevent inhalation exposure; 

4. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the Safety Data 

Sheet (SDS); 

5. Refraining from manufacturing or 

processing the PMN substance in the 

United States (i.e., import only); 

6. Use of the PMN substance only for 

the confidential use stated in the Order; 

and 

7. Disposal of the PMN substance only 

by recycling as described in the PMN. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Potentially useful information: EPA 

has determined that certain information 

about the health effects of the PMN 

substance may be potentially useful to 

characterize the effects of the PMN 

substance in support of a request by the 

PMN submitter to modify the Order, or 

if a manufacturer or processor is 

considering submitting a SNUN for a 

significant new use that would be 

designated by this SNUR. The submitter 

has agreed not to exceed a certain 

production volume limit without 

performing specific pulmonary and 

internal organ toxicity testing. 

CFR citation: 40 CFR 721.11126. 

PMN Numbers: P–16–576 and P–16–577 

Chemical names: Modified alkyl 

polyamine (generic) (P–16–576) and 

alkyl polyamine (generic) (P–16–577). 

CAS numbers: Not available. 

Effective date of TSCA section 5(e) 

Order: September 18, 2017. 

Basis for TSCA section 5(e) Order: 

The PMNs state that the generic (nonconfidential) use of the substances will 

be as an intermediate (P–16–576) and an 

oil lubricant additive (P–16–577). Based 

on the physical/chemical properties of 

the PMN substances, analogue toxicity 

data, and data on the PMN substances, 

EPA has identified concerns for 

irritation to the skin, eyes, mucous 

membranes, and lungs; effects to the GI 

tract, adrenal glands, and blood; 

immunotoxicity; and reproductive 

toxicity. Based on Structure Activity 

Relationship (SAR) predictions for 

polycationic polymers and aliphatic 

amines, EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 2 parts per billion. The 

Order was issued under TSCA sections 

5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation, the substances may 

present an unreasonable risk of injury to 

human health and the environment. To 

protect against these risks, the Order 

requires: 

1. Use of the PMN substances only for 

the confidential uses stated in the 

Order; 

2. Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

3. Submission to EPA of certain 

toxicity testing for P–16–577 no later 

than 9 months and 12 months from the 

date of the Notice of Commencement 

(NOC) of either substance; 

4. Refraining from manufacture, 

processing or use for consumer use or in 

commercial use where there is use in a 

consumer setting; and 

5. No release of P–16–577 resulting in 

surface water concentrations that exceed 

2 ppb. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Potentially useful information: EPA 

has determined that certain information 

about the environmental and health 

effects of the PMN substances may be 

potentially useful to characterize the 

effects of the PMN substances in 

support of a request by the PMN 

submitter to modify the Order, or if a 

manufacturer or processor is 

considering submitting a SNUN for a 

significant new use that would be 

designated by this SNUR. The submitter 

has agreed not to exceed certain time 

limits without performing specific 

pharmacokinetic and developmental 

toxicity testing. Additionally, EPA has 

determined that the results of chronic 

aquatic toxicity testing on P–16–577 

would help characterize the potential 

environmental effects caused by the 

PMN substances. Although the Order 

does not require this test, the Order’s 

restrictions will remain in effect until 

the Order is modified or revoked by 

EPA based on submission of this or 

other information that EPA determines 

is relevant and needed to evaluate a 

modification request. 

CFR citations: 40 CFR 721.11127 (P– 

16–576) and 40 CFR 721.11128 (P–16– 

577). 

PMN Number: P–16–590 

Chemical Name: Silica gel, reaction 

products with chromium oxide (CrO3) 

and ethoxydiethyl aluminum. 

CAS Number: 932384–12–8. 

Effective date of TSCA section 5(e) 

Order: September 13, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the use of the 

substance will be as a catalyst for 

polyethylene polymerization. Based on 

the reactivity of the PMN substance and 

the presence of chromium VI, EPA 

identified concerns for oncogenicity, 

reproductive toxicity, respiratory 

sensitization, and severe irritation to 

skin, eyes, lung and mucous 

membranes. The Order was issued 

under TSCA sections 5(a)(3)(B)(ii)(I) and 

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

in the absence of sufficient information 

to permit a reasoned evaluation, the 

substance may present an unreasonable 

risk of injury to health. To protect 

against these risks, the Order requires: 

1. Handling the PMN substance under 

an inert atmosphere using containers 

and systems designed not to be exposed 

to the air; 

2. Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

3. Use of a NIOSH-certified respirator 

with an APF of 10 to 1,000 depending 

on monitoring results from the methods 

required in the Order; and 

4. Disposal of all waste streams 

containing the PMN substance and the 

constituent breakdown products of the 

PMN substance in a Resource 

Conservation and Recovery Act (RCRA) 

hazardous waste landfill. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Potentially useful information: EPA 

has determined that certain information 

about the health effects of the PMN 

substance may be potentially useful to 

characterize the effects of the PMN 

substance in support of a request by the 

PMN submitter to modify the Order, or 

if a manufacturer or processor is 

considering submitting a SNUN for a 


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significant new use that would be 

designated by this SNUR. EPA has 

determined that the results of a 

pulmonary toxicity study and a 

carcinogenicity study would help 

characterize the potential health effects 

of the PMN substance. Although the 

Order does not require these tests, the 

Order’s restrictions will remain in effect 

until the Order is modified or revoked 

by EPA based on submission of this or 

other relevant information. 

CFR citation: 40 CFR 721.11129. 

PMN Number: P–16–593 

Chemical Name: Carboxylic acids, C6- 

18 and C5-15-di-, polymers with 

diethyleneglycol, glycerol, sorbitol and 

terephthalic acid. 

CAS Number: 1967778–37–5. 

Effective date of TSCA section 5(e) 

Order: August 7, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the use of the 

substance will be as an aromatic 

polyester polyol for rigid foam. EPA 

identified concerns for lung effects and 

irritation to the eyes and mucous 

membranes based on the physical/ 

chemical properties of the PMN 

substance. The Order was issued under 

TSCA sections 5(a)(3)(B)(ii)(I) and 

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

in the absence of sufficient information 

to permit a reasoned evaluation the 

substance may present an unreasonable 

risk of injury to human health and the 

environment. To protect against these 

risks, the Order requires: 

1. Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

2. Use of the PMN substance only as 

an aromatic polyester polyol for rigid 

foam; 

3. No manufacture, processing, or use 

of the PMN substance to result in 

inhalation exposures to a vapor, mist or 

aerosol; and 

4. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Potentially useful information: EPA 

has determined that certain information 

about the physical-chemical properties 

and health effects of the PMN substance 

may be potentially useful to characterize 

the effects of the PMN substance in 

support of a request by the PMN 

submitter to modify the Order, or if a 

manufacturer or processor is 

considering submitting a SNUN for a 

significant new use that would be 

designated by this SNUR. EPA has 

determined that the results of physicalchemical property testing and 

pulmonary toxicity testing would help 

characterize the potential health effects 

of the PMN substance. Although the 

Order does not require these tests, the 

Order’s restrictions remain in effect 

until the Order is modified or revoked 

by EPA based on submission of this or 

other relevant information. 

CFR citation: 40 CFR 721.11130. 

PMN Number: P–17–5 

Chemical name: 1-tetradecene 

homopolymer hydrogenated. 

CAS number: 1857296–89–9. 

Effective date of TSCA section 5(e) 

Order: August 9, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the use of the 

substance will be as a base fluid/carrier 

fluid for additives in motor oil, 

automatic transmission fluid, and 

industrial lubricants. Based on analysis 

of test data on an analogous chemical 

substance, EPA has identified concerns 

for irritation to mucous membranes and 

hydrocarbon pneumonia. The Order was 

issued under TSCA section 

5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation the substance may 

present an unreasonable risk of injury to 

human health. The Order was also 

issued under TSCA section 

5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), 

based on a finding that the substance is 

or will be produced in substantial 

quantities and that the substance either 

enters or may reasonably be anticipated 

to enter the environment in substantial 

quantities, or there is or may be 

significant (or substantial) human 

exposure to the substance. To protect 

against these risks, the Order requires: 

1. Submission to EPA of certain 

toxicity testing no later than 9 months 

after the NOC; 

2. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS; 

3. No manufacture, processing, or use 

of the PMN substance to result in 

inhalation exposure to a vapor, mist, or 

aerosol; and 

4. Not process the PMN substance for 

use other than as a base fluid/carrier 

fluid for additives in motor oil, 

automatic transmission fluid, and 

industrial lubricants. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Potentially useful information: EPA 

has determined that certain information 

about the health effects of the PMN 

substance may be potentially useful to 

characterize the effects of the PMN 

substance in support of a request by the 

PMN submitter to modify the Order, or 

if a manufacturer or processor is 

considering submitting a SNUN for a 

significant new use that would be 

designated by this SNUR. The submitter 

has agreed not to exceed a certain 

production volume limit without 

performing specific pulmonary toxicity 

testing. 

CFR citation: 40 CFR 721.11131. 

PMN Numbers: P–17–149, P–17–150, P– 

17–151, and P–17–165 

Chemical Name: Fluorocyanophenyl 

alkylbenzoate (generic) 

CAS Numbers: Not available. 

Effective date of TSCA section 5(e) 

Order: August 10, 2017. 

Basis for TSCA section 5(e) Order: 

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

be for electronic device use. Based on 

analysis of test data on analogous 

chemicals, EPA identified concerns for 

reproductive toxicity, developmental 

toxicity, neurotoxicity, and lung and 

skin effects. Based on SAR analysis of 

test data on analogous esters, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

2 ppb for P–17–165 and 4 ppb for the 

other PMN substances. The Order was 

issued under TSCA sections 

5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based 

on a finding that in the absence of 

sufficient information to permit a 

reasoned evaluation the substances may 

present an unreasonable risk of injury to 

human health and the environment. To 

protect against these risks, the Order 

requires: 

1. Submission to EPA of certain 

toxicity testing before exceeding the 

confidential production volume limit 

specified in the Order; 

2. Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

3. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS; 

4. Use of the PMN substances only for 

the confidential use specified in the 

Order; 

5. No modification of the 

manufacture, processing or use of the 

PMN substances to result in inhalation 

exposure to vapor, dust, mist, or aerosol; 

and 

6. No release of the PMN substances 

resulting in surface water 

concentrations that exceed 2 ppb for P– 

17–165 and 4 ppb for the other PMN 

substances. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 


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Potentially useful information: EPA 

has determined that certain information 

about the environmental and health 

effects of the PMN substances may be 

potentially useful to characterize the 

effects of the PMN substances in 

support of a request by the PMN 

submitter to modify the Order, or if a 

manufacturer or processor is 

considering submitting a SNUN for a 

significant new use that would be 

designated by this SNUR. The submitter 

has agreed not to exceed a certain 

production volume limit without 

performing specific reproductive/ 

developmental toxicity testing and acute 

and chronic aquatic toxicity testing. 

CFR citation: 40 CFR 721.11132. 

PMN Number: P–17–175 

Chemical Name: Fluorinated 

propenoic poly alkyl ether ester 

(generic). 

CAS Number: Not available. 

Effective date of TSCA section 5(e) 

Order: September 1, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the use of the PMN 

substance will be as a leveling agent for 

coatings applied to aluminum printing 

plates. Based on analysis of test data on 

the analogue perfluorohexanoic acid, 

EPA identified concerns for liver 

toxicity, blood toxicity, and male 

reproductive toxicity for the potential 

incomplete incineration product. Based 

on SAR predictions for polyanionic 

polymers for the potential degradation 

product, EPA also identified concern for 

effects of the potential degradation 

products to terrestrial wild animals and 

birds based on test data for analogous 

perfluoro chemicals in mammals. 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. The 

Order was issued under TSCA sections 

5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based 

on a finding that in the absence of 

sufficient information to permit a 

reasoned evaluation the substance may 

present an unreasonable risk of injury to 

human health and the environment. To 

protect against these risks, the Order 

requires: 

1. Refraining from domestic 

manufacture in the United States (i.e., 

import only); 

2. No manufacture (including import) 

beyond a maximum annual production 

volume of 60 kg; and 

3. Use of the PMN substance only as 

a leveling agent for coatings applied to 

aluminum printing plates. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Potentially useful information: EPA 

has determined that certain information 

about the physical-chemical properties 

and fate of the PMN substance may be 

potentially useful to characterize the 

effects of the PMN substance in support 

of a request by the PMN submitter to 

modify the Order, or if a manufacturer 

or processor is considering submitting a 

SNUN for a significant new use that 

would be designated by this SNUR. EPA 

has determined that the results of 

specific physical-chemical properties, 

environmental fate, and 

bioaccumulation testing would help 

characterize the potential health and 

environmental effects of the PMN 

substance. Although the Order does not 

require these tests, the Order’s 

restrictions will remain in effect until 

the Order is modified or revoked by 

EPA based on submission of this or 

other relevant information. 

CFR citation: 40 CFR 721.11133. 

PMN number: P–17–199 

Chemical name: Oxyalkylene 

urethane polyolefin (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: September 14, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the use of the 

substance will be as a binder in sealant. 

Based on the physical/chemical 

properties of the PMN substance, EPA 

identified concerns for oncogenicity, 

male reproductive effects, 

developmental toxicity and 

sensitization if the PMN substance were 

manufactured differently. The Order 

was issued under TSCA sections 

5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation the substance may 

present an unreasonable risk of injury to 

human health. To protect against these 

risks, the Order requires: 

1. Manufacture of the PMN substance 

at no less than the average molecular 

weight specified in the Order; and 

2. Manufacture of the PMN substance 

with no more than 1% of the molecular 

weight content below 1,000 Daltons. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Potentially useful information: EPA 

has determined that certain information 

about the health effects of the PMN 

substance may be potentially useful to 

characterize the effects of the PMN 

substance in support of a request by the 

PMN submitter to modify the Order, or 

if a manufacturer or processor is 

considering submitting a SNUN for a 

significant new use that would be 

designated by this SNUR. EPA has 

determined that the results of specific 

developmental toxicity, internal organ 

toxicity, and sensitization testing would 

help characterize the potential health 

effects of the PMN substance. Although 

the Order does not require these tests, 

the Order’s restrictions remain in effect 

until the Order is modified or revoked 

by EPA based on submission of this or 

other relevant information. 

CFR citation: 40 CFR 721.11134. 

PMN Number: P–17–206 

Chemical Name: Imino alkane amine 

phosphate (generic). 

CAS Number: Not available. 

Effective date of TSCA section 5(e) 

Order: August 9, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the generic (nonconfidential) use of the substance will 

be as a flame retardant for textiles. EPA 

identified concerns for irritation to eyes, 

mucous membranes, and lungs based on 

the pH of the PMN substance being 5. 

Also based on SAR analysis of test data 

on the nearest analogue inorganic 

phosphates EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 2 ppb. The 

Order was issued under TSCA sections 

5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based 

on a finding that in the absence of 

sufficient information to permit a 

reasoned evaluation the substance may 

present an unreasonable risk of injury to 

human health and the environment. To 

protect against these risks, the Order 

requires: 

1. Refraining from domestic 

manufacture in the United States (i.e., 

import only); 

2. Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

3. No modification of the processing 

or use of the PMN substance to result in 

inhalation exposures to vapor, dust, 

mist, or aerosol; 

4. Use of the PMN substance only for 

the confidential use specified in the 

Order; 

5. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS; 

6. No release of the PMN substance 

into the waters of the United States; and 

7. Disposal of the PMN substance and 

waste streams containing the PMN 

substance by incineration. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Potentially useful information: EPA 

has determined that certain information 

about the environmental effects of the 

PMN substance may be potentially 

useful in support of a request by the 


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PMN submitter to modify the Order, or 

if a manufacturer or processor is 

considering submitting a SNUN for a 

significant new use that would be 

designated by this SNUR. EPA has 

determined that the results of specific 

acute aquatic toxicity testing would 

help characterize the potential 

environmental effects of the PMN 

substance. Although the Order does not 

require these tests, the Order’s 

restrictions remain in effect until the 

Order is modified or revoked by EPA 

based on submission of this or other 

relevant information. 

CFR citations: 40 CFR 721.11135 (P– 

17–206). 

PMN Number: P–17–223 

Chemical Name: Fatty acids, tall-oil, 

reaction products with 2-[(2- 

aminoalkyl)amino]alkanol, compds. 

with alkylene oxide-glycidyl o-tolyl 

ether polymer dihydrogenphosphate 

alkyl ether (generic). 

CAS Number: Not available. 

Effective date of TSCA section 5(e) 

Order: September 12, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the generic (nonconfidential) use of the substance will 

be as an additive for open, nondispersive use. EPA identified concerns 

for developmental toxicity based on Nheterocyclic compounds and concerns 

for possible irritation to mucous 

membranes and lung toxicity based on 

potential surfactancy properties. Also 

based on SAR analysis of test data on 

nearest analogue of soluble forms of 

inorganic phosphates, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 15 ppb. 

The Order was issued under TSCA 

sections 5(a)(3)(B)(ii)(I) and 

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

in the absence of sufficient information 

to permit a reasoned evaluation the 

substance may present an unreasonable 

risk of injury to human health and the 

environment. To protect against these 

risks, the Order requires: 

1. Submission to EPA of certain 

toxicity testing before exceeding the 

confidential production volume limit 

specified in the Order; 

2. Refraining from manufacture, 

processing, or use for consumer use or 

in commercial use where there is use in 

a consumer setting; 

3. Refrain from domestic manufacture 

in the United States (i.e., import only); 

4. Use of the PMN substance only for 

the confidential use specified in the 

Order; 

5. Use of the PMN substance in the 

confidential formulation at a 

concentration not greater than 1 percent 

by weight or volume; 

6. Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

7. Refraining from modifying the 

processing if such modification would 

result in inhalation exposures to the 

PMN substance by vapor, dust, mist, or 

aerosol at a concentration of greater than 

1 percent by weight or volume; 

8. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS; and 

9. No release of the PMN substance 

resulting in surface water 

concentrations that exceed 15 ppb. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Potentially useful information: EPA 

has determined that certain information 

about the physical-chemical properties, 

environmental effects, and health effects 

of the PMN substance may be 

potentially useful in support of a 

request by the PMN submitter to modify 

the Order, or if a manufacturer or 

processor is considering submitting a 

SNUN for a significant new use that 

would be designated by this SNUR. The 

submitter has agreed not to exceed a 

certain production volume limit without 

performing specific reproductive/ 

developmental toxicity testing and acute 

aquatic toxicity testing. EPA has also 

determined that the results of specific 

physical-chemical property and 

pulmonary toxicity testing would help 

characterize the potential human and 

environmental effects of the PMN 

substance. Although the Order does not 

require these tests, the Order’s 

restrictions remain in effect until the 

Order is modified or revoked by EPA 

based on submission of this or other 

relevant information. 

CFR citation: 40 CFR 721.11136. 

PMN Number: P–17–230 

Chemical Name: Oxirane, 2-alkyl-, 

polymer with oxirane, mono[N-[3- 

(carboxyamino)-4(or 6)- 

alkylphenyl]carbamate], alkyl ether, 

ester with 2,2′,2′′-nitrilotris-[alkanol] 

(generic). 

CAS Number: Not available. 

Effective date of TSCA section 5(e) 

Order: September 12, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the generic (nonconfidential) use of the substance will 

be as an additive for open, nondispersive use. Based on the potential 

surfactant properties, cationic binding 

to lung tissues, EPA identified concerns 

for lung toxicity and skin irritation. 

Based SAR analysis of test data on 

analogous polycationic polymers, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

65 parts per billion. The Order was 

issued under TSCA sections 

5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based 

on a finding that in the absence of 

sufficient information to permit a 

reasoned evaluation the substance may 

present an unreasonable risk of injury to 

human health and the environment. To 

protect against these risks, the Order 

requires: 

1. Submission to EPA of certain 

toxicity testing before exceeding the 

confidential production volume limit 

specified in the Order; 

2. Refraining from manufacture, 

processing, or use for consumer use or 

in commercial use where there is use in 

a consumer setting; 

3. Refraining from domestic 

manufacture in the United States (i.e., 

import only); 

4. Use of the PMN substance only for 

the confidential use specified in the 

Order; 

5. Use of the PMN substance in the 

confidential formulation at a 

concentration not greater than 1 percent 

by weight or volume; 

6. Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

7. Refraining from modifying the 

processing method if such modification 

would result in inhalation exposures to 

the PMN substance by vapor, dust, mist, 

or aerosol, at a concentration of greater 

than 1 percent by weight or volume; 

8. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS; and 

9. No release of the PMN substance 

resulting in surface water 

concentrations that exceed 65 ppb. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Potentially useful information: EPA 

has determined that certain information 

about the physical-chemical properties, 

environmental effects, and health effects 

of the PMN substance may be 

potentially useful in support of a 

request by the PMN submitter to modify 

the Order, or if a manufacturer or 

processor is considering submitting a 

SNUN for a significant new use that 

would be designated by this SNUR. The 

submitter has agreed not to exceed a 

certain production volume limit without 

performing specific acute aquatic and 

sediment toxicity testing. EPA has also 

determined that the results of specific 

physical-chemical property and 

pulmonary toxicity testing would help 

characterize the potential health effects 

of the PMN substance. Although the 


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Order does not require these tests, the 

Order’s restrictions will remain in effect 

until the Order is modified or revoked 

by EPA based on submission of this or 

other relevant information. 

CFR citation: 40 CFR 721.11137. 

PMN Number: P–17–236 

Chemical Name: Formaldehyde, 

polymer with (chloromethyl) oxirane 

and substituted aromatic compounds 

(generic). 

CAS Number: Not available. 

Effective date of TSCA section 5(e) 

Order: September 11, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the generic (nonconfidential) use of the substance will 

be as matrix resin for composite 

materials and binder resin for electronic 

materials. Based on analysis of test data 

on the PMN substance, analysis of data 

on analogous chemicals, and on the 

epoxide chemical category of concern, 

EPA identified concerns for skin and 

lung sensitization, oncogenicity, 

developmental toxicity, and male 

reproductive toxicity. The Order was 

issued under TSCA sections 

5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based 

on a finding that in the absence of 

sufficient information to permit a 

reasoned evaluation the substance may 

present an unreasonable risk of injury to 

health. To protect against these risks, 

the Order requires: 

1. Submission to EPA of certain 

toxicity testing before exceeding the 

confidential production volume limit 

specified in the Order; 

2. Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

3. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS; 

4. Refraining from domestic 

manufacture in the United States (i.e., 

import only); 

5. Use of the PMN substance only as 

described in the PMN; and 

6. No manufacture, processing, or use 

that results in inhalation exposure to 

vapor, dust, mist, or aerosol. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Potentially useful information: EPA 

has determined that certain information 

about the health effects of the PMN 

substance may be potentially useful in 

support of a request by the PMN 

submitter to modify the Order, or if a 

manufacturer or processor is 

considering submitting a SNUN for a 

significant new use that would be 

designated by this SNUR. The submitter 

has agreed not to exceed a certain 

production volume limit without 

performing sensitization testing. EPA 

has also determined that the results of 

specific internal organ toxicity and 

carcinogenicity testing would help 

characterize the potential health effects 

of the PMN substance. Although the 

Order does not require these tests, the 

Order’s restrictions will remain in effect 

until the Order is modified or revoked 

by EPA based on submission of this or 

other relevant information. 

CFR citation: 40 CFR 721.11138. 

PMN numbers: P–17–241, P–17–242, P– 

17–243, P–17–244 

Chemical names: Acid, reaction 

products with cadmium selenide 

(CdSe), trioctylphosphine and 

trioctylphosphine oxide (generic) (P– 

17–241), Acid, reaction products with 

cadmium selenide sulfide, acid, 

trioctylphosphine and 

trioctylphosphine oxide (generic) (P– 

17–242), Acid, reaction products with 

cadmium metal selenide sulfide, 

trioctylphosphine and 

trioctylphosphine oxide (generic) (P– 

17–243), Metal oxide reaction products 

with cadmium metal selenide sulfide, 

and amine (generic) (P–17–244). 

CAS numbers: Not available. 

Effective date of TSCA section 5(e) 

Order: September 20, 2017. 

Basis for TSCA section 5(e) Order: 

The PMNs state that the generic (nonconfidential) use of P–17–241, P–17– 

242, and P–17–243 will be as chemical 

intermediates, and the specific use of P– 

17–244 will be as a down converting 

phosphor particle for use in conjunction 

with optoelectronic components. Based 

on analogy to respirable poor soluble 

particulates and the presence of 

cadmium, EPA identified concerns for 

lung effects, kidney effects, and 

oncogenicity for the PMN substances. 

EPA also identified concerns for 

neurotoxicity, developmental toxicity, 

and kidney toxicity for PMN P–17–244 

based on the presence of other 

chemicals. Based on analysis of test data 

for cadmium and selenium core 

components, there is high hazard for 

acute and chronic environmental 

toxicity for PMNs P–17–241, P–17–242, 

and P–17–243. There is potential 

chronic environmental toxicity for PMN 

P–17–244 based on the presence of 

cadmium. The Order was issued under 

TSCA sections 5(a)(3)(B)(ii)(I) and 

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

in the absence of sufficient information 

to permit a reasoned evaluation the 

substances may present an unreasonable 

risk of injury to health and the 

environment. To protect against these 

risks, the Order requires: 

1. Submission to EPA of certain 

testing for P–17–244 before exceeding 

the confidential production volume 

limit specified in the Order; 

2. Use of personal protective 

equipment where there is potential for 

dermal exposure; 

3. Manufacture, processing, and use 

P–17–241, P–17–242, and P–17–243 

only as chemical intermediates as 

required in the Order; 

4. Manufacture, processing, and use 

P–17–241, P–17–242, and P–17–243 

only in liquid formulations; 

5. No use of P–17–241, P–17–242, and 

P–17–243 in applications that generate 

a dust, mist, or aerosol; 

6. Manufacture, processing and use of 

P–17–244, only as a down-converter for 

use in conjunction with optoelectronic 

components; 

7. For workers potentially exposed to 

the solid form of P–17–244, use of a 

laminar-flow fume hood or glove box to 

reduce or eliminate inhalation exposure, 

and workers who may still be exposed 

by inhalation will use a NIOSH-certified 

full-faced respirator with an APF of at 

least 50; and 

8. 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. 

Potentially useful information: EPA 

has determined that certain information 

about the fate and health effects of the 

PMN substances may be potentially 

useful in support of a request by the 

PMN submitter to modify the Order, or 

if a manufacturer or processor is 

considering submitting a SNUN for a 

significant new use that would be 

designated by this SNUR. The submitter 

has agreed not to exceed a certain 

production volume limit without 

performing certain fate and internal 

organ toxicity testing on P–17–244. EPA 

has also determined that the results of 

specific fate testing would help 

characterize the potential health and 

environmental effects of the PMN 

substances. Although the Order does not 

require these tests, the Order’s 

restrictions will remain in effect until 

the Order is modified or revoked by 

EPA based on submission of this or 

other relevant information. 

CFR citations: 40 CFR.11139 (P–17– 

241), 40 CFR.11140 (P–17–242), 40 

CFR.11141 (P–17–243), and 40 

CFR.11142 (P–17–244). 

PMN number: P–17–265 

Chemical name: Alkanoic acid, 2- 

alkyl-, substituted alkyl ester, polymer 

with alkyl alkenoate, substituted 

carbomonocycle, substituted alkyl 


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alkenoate and alkyl substituted 

alkenoate, substituted alkanenitrileinitiated (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: August 16, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the use of the 

substance will be as a coating resin 

intermediate. Based on physical/ 

chemical properties EPA identified 

concerns for lung toxicity, systemic 

toxicity, reproductive toxicity, 

corrosion, and irritation for the PMN 

substance when it has an acid 

concentration greater than 20% or an 

amine concentration greater than 5%. 

Based on SAR analysis for anionic 

polymers and physical/chemical 

properties, EPA has identified concern 

for environmental effects when it has an 

acid concentration greater than 20%. 

The Order was issued under TSCA 

sections 5(a)(3)(B)(ii)(I) and 

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

in the absence of sufficient information 

to permit a reasoned evaluation the 

substance may present an unreasonable 

risk of injury to health and the 

environment. To protect against these 

risks, the Order requires: 

1. Refraining from manufacturing the 

PMN substance with an acid 

concentration greater than 20%; and 

2. Refraining from manufacturing the 

PMN substance with an amine 

concentration greater than 5%. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Potentially useful information: EPA 

has determined that certain information 

about the health and environmental 

effects of the PMN substance may be 

potentially useful in support of a 

request by the PMN submitter to modify 

the Order, or if a manufacturer or 

processor is considering submitting a 

SNUN for a significant new use that 

would be designated by this SNUR. EPA 

has determined that the results of 

specific physical-chemical property 

testing, pulmonary toxicity testing, 

irritation testing, and acute and chronic 

aquatic toxicity testing would help 

characterize the potential health and 

environmental effects of the PMN 

substance. Although the Order does not 

require these tests, the Order’s 

restrictions will remain in effect until 

the Order is modified or revoked by 

EPA based on submission of this or 

other relevant information. 

CFR citation: 40 CFR 721.11143. 

PMN number: P–17–301 

Chemical name: Manganese 

heterocyclic-amine carboxylate 

complexes (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: September 22, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the generic use of 

the PMN substance will be as a surface 

drier in clear and pigmented coatings 

systems. Based on the physical/ 

chemical properties of the PMN 

substance and analysis of analogue test 

data, EPA identified concerns for 

neurotoxicity, developmental toxicity, 

and eye and skin irritation. The Order 

was issued under TSCA sections 

5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation the substance may 

present an unreasonable risk of injury to 

health and the environment. The Order 

was also issued under TSCA sections 

5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), 

based on a finding that the substance is 

or will be produced in substantial 

quantities and that the substance either 

enters or may reasonably be anticipated 

to enter the environment in substantial 

quantities. To protect against these 

risks, the Order requires: 

1. Submission to EPA of certain 

testing before exceeding an aggregate 

total production of 430,000 kilograms of 

the PMN substance; 

2. Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

3. Use of a NIOSH-certified respirator 

with an APF of at least 10 where there 

is potential for inhalation exposure; 

4. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS; and 

5. No use of the PMN substance other 

than as a surface drier in clear and 

pigmented coatings systems. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Potentially useful information: EPA 

has determined that certain information 

about the health effects of the PMN 

substance may be potentially useful in 

support of a request by the PMN 

submitter to modify the Order, or if a 

manufacturer or processor is 

considering submitting a SNUN for a 

significant new use that would be 

designated by this SNUR. The submitter 

has agreed not to exceed the production 

limit without performing specific 

reproductive/developmental toxicity 

testing. 

CFR citation: 40 CFR 721.11144. 

PMN number: P–17–318 

Chemical name: Sulfuric acid mixed 

salt (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: September 25, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the generic (nonconfidential) use of the substance will 

be as a component in nutrient solutions. 

Based on analogue data and information 

provided in the SDS, EPA has identified 

concerns for skin, eye, respiratory, and 

GI tract irritation, corrosion and acute 

toxicity. Also, based on SAR predictions 

for analogue inorganic salts, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

760 ppb. The Order was issued under 

TSCA sections 5(a)(3)(B)(ii)(I) and 

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

in the absence of sufficient information 

to permit a reasoned evaluation the 

substance may present an unreasonable 

risk of injury to human health and the 

environment. The Order was also issued 

under TSCA sections 5(a)(3)(B)(ii)(II) 

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

that the substance is or will be produced 

in substantial quantities and that the 

substance either enters or may 

reasonably be anticipated to enter the 

environment in substantial quantities. 

To protect against these risks, the Order 

requires: 

1. Submission of certain toxicity 

testing on the PMN substance prior to 

exceeding the confidential production 

volume limit specified in the Order. 

2. Use of personal protective 

equipment where there is a potential for 

dermal exposure. 

3. Use of the PMN substance only for 

the confidential use specified in the 

Order. 

4. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS. 

5. Manufacture of the PMN substance 

to contain no more than 1% free 

ammonia. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Potentially useful information: EPA 

has determined that certain information 

about the health and environmental 

effects of the PMN substance may be 

potentially useful in support of a 

request by the PMN submitter to modify 

the Order, or if a manufacturer or 

processor is considering submitting a 

SNUN for a significant new use that 

would be designated by this SNUR. The 

submitter has agreed not to exceed the 

production limit without performing 

specific acute aquatic toxicity testing. 

EPA has also determined that the results 

of specific reproductive/developmental 

toxicity testing would help characterize 

the potential health and environmental 


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effects of the PMN substance. Although 

the Order does not require these tests, 

the Order’s restrictions will remain in 

effect until the Order is modified or 

revoked by EPA based on submission of 

this or other relevant information. 

CFR citation: 40 CFR 721.11145. 

PMN number: P–17–323 

Chemical name: 2-Propenoic acid, 

branched alkyl ester (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: September 26, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the use of the 

substance will be as a reactive monomer 

for use in producing polymers. Based on 

the physical/chemical properties of the 

PMN substance (as described in the 

New Chemical Program’s PBT category 

at 64 FR 60194; November 4, 1999) and 

test data on structurally similar 

substances, the PMN substance is a 

potentially persistent, bioaccumulative, 

and toxic (PBT) chemical. EPA 

estimates that the PMN substance will 

persist in the environment more than 2 

months and estimates a 

bioaccumulation factor of greater than 

or equal to 1,000. Based on SAR 

analysis of test data on analogous 

acrylates and from the branched acid 

that may be formed after ester 

hydrolysis, EPA has identified concerns 

for eye and skin irritation, oncogenicity, 

developmental toxicity, liver toxicity, 

kidney toxicity, and sensitization. The 

Order was issued under TSCA sections 

5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation the substance may 

present an unreasonable risk of injury to 

human health and the environment. To 

protect against these risks, the Order 

requires: 

1. Submission of certain toxicity 

testing on the PMN substance prior to 

exceeding the confidential production 

volume limit as specified in the Order; 

2. Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

3. No use of the PMN substance other 

than as a reactive monomer for use in 

producing polymers; 

4. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS; 

5. Refraining from domestic 

manufacture in the United States (i.e., 

import only); and 

6. No release of the PMN substance to 

the waters of the United States. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Potentially useful information: EPA 

has determined that certain information 

about the health effects of the PMN 

substance may be potentially useful in 

support of a request by the PMN 

submitter to modify the Order, or if a 

manufacturer or processor is 

considering submitting a SNUN for a 

significant new use that would be 

designated by this SNUR. The submitter 

has agreed not to exceed the production 

limit without performing specific 

developmental/reproductive toxicity 

and sensitization testing. EPA has also 

determined that the results of specific 

fate testing would help characterize the 

potential health effects of the PMN 

substance. Although the Order does not 

require these tests, the Order’s 

restrictions will remain in effect until 

the Order is modified or revoked by 

EPA based on submission of this or 

other relevant information. 

CFR citation: 40 CFR 721.11146. 

PMN number: P–17–326 

Chemical name: 

Allyloxymethylacrylate (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: September 5, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the generic (nonconfidential) use of the substance will 

be as an ultraviolet curable monomer. 

Based on analysis of test data on the 

PMN substance and the physical/ 

chemical properties of the PMN 

substance, EPA identified concerns for 

oncogenicity, developmental and 

reproductive effects, liver and kidney 

toxicity, sensitization, and irritation. 

Additionally, the SDS indicates 

concerns for severe skin and eye damage 

and allergic skin reaction. Based on 

analysis of acute aquatic toxicity data, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 26 ppb. The Order was 

issued under TSCA sections 

5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation the PMN substance 

may present an unreasonable risk of 

injury to health and the environment. 

To protect against these risk, the Order 

requires: 

1. Submission of certain toxicity 

testing on the PMN substance prior to 

exceeding the confidential production 

volume limit as specified in the Order; 

2. Use of personal protective 

equipment where there is potential for 

dermal exposure; 

3. Use of NIOSH certified respirators 

with an APF of 10 to prevent inhalation 

exposure where there is potential for 

inhalation exposure; 

4. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS; 

5. Refraining from domestic 

manufacture in the United States (i.e., 

import only); 

6. Use of the PMN substance only as 

specified in the Order; and 

7. No release of the PMN substance 

into the waters of the United States. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Potentially useful information: EPA 

has determined that certain information 

about the health and environmental 

effects of the PMN substance may be 

potentially useful in support of a 

request by the PMN submitter to modify 

the Order, or if a manufacturer or 

processor is considering submitting a 

SNUN for a significant new use that 

would be designated by this SNUR. The 

submitter has agreed not to exceed the 

production limit without performing 

specific developmental/reproductive 

toxicity and sensitization testing. EPA 

has also determined that the results of 

specific chronic aquatic toxicity testing 

would help characterize the potential 

environmental effects of the PMN 

substance. Although the Order does not 

require these tests, the Order’s 

restrictions will remain in effect until 

the Order is modified or revoked by 

EPA based on submission of this or 

other relevant information. 

CFR citation: 40 CFR 721.11147. 

PMN number: P–17–345 

Chemical name: Polyurethane, 

methacrylate blocked (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: September 6, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the generic (nonconfidential) use of the substance will 

be as a resin intermediate. Based on 

physical/chemical properties of the 

PMN substance, EPA identified 

concerns for irritation to skin, eye, lung, 

mucous membranes, and potential 

neurotoxicity. The Order was issued 

under TSCA sections 5(a)(3)(B)(ii)(I) and 

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

in the absence of sufficient information 

to permit a reasoned evaluation the 

substance may present an unreasonable 

risk of injury to health and the 

environment. To protect against these 

risks, the Order requires: 

1. Submission of certain toxicity 

testing within six months from the date 

of the NOC; 

2. Use of personal protective 

equipment where there is potential for 

dermal exposure; 


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3. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and SDS; 

4. No manufacturing, processing, or 

use of the PMN substance in a manner 

that would result in inhalation exposure 

to vapor, mist, aerosol, or dust; and 

5. Use the PMN substance only as 

specified in the Order. 

The SNUR designates as a ‘‘significant 

new use’’ the absence of these protective 

measures. 

Potentially useful information: EPA 

has determined that certain information 

about the health effects of the PMN 

substance may be potentially useful in 

support of a request by the PMN 

submitter to modify the Order, or if a 

manufacturer or processor is 

considering submitting a SNUN for a 

significant new use that would be 

designated by this SNUR. The submitter 

has agreed not to exceed the production 

limit without performing specific eye 

irritation testing. 

CFR citation: 40 CFR 721.11148. 

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 all 28 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) Orders 

requiring the use of appropriate 

exposure controls were negotiated with 

the PMN submitters. 

The SNURs identify as significant 

new uses any manufacturing, 

processing, use, distribution in 

commerce, or disposal that does not 

conform to the restrictions imposed by 

the underlying Orders, consistent with 

TSCA section 5(f)(4). 

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 either determine 

that the prospective manufacture or 

processing is not likely to present an 

unreasonable risk, or to take necessary 

regulatory action associated with any 

other determination, before the 

described significant new use of the 

chemical substance occurs. 

• EPA will identify as significant new 

uses any manufacturing, processing, 

use, distribution in commerce, use, or 

disposal that does not conform to the 

restrictions imposed by the underlying 

Orders, consistent with TSCA section 

5(f)(4). 

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. The effective date of 

this rule is November 16, 2018 without 

further notice, unless EPA receives 

written adverse comments before 

October 17, 2018. 

If EPA receives written adverse 

comments on one or more of these 

SNURs before October 17, 2018, EPA 

will withdraw the relevant sections of 

this direct final rule before its effective 

date. 

This rule establishes SNURs for a 

number of chemical substances. Any 

person who submits adverse 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 an 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) Orders have been 

issued for all of the chemical 

substances, and the PMN submitters are 

prohibited by the TSCA section 5(e) 

Orders from undertaking activities 

which will be designated as significant 

new uses. The identities of 24 of the 28 

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) for a chemical substance 

covered by this action. 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 September 

17, 2018 as the cutoff date for 

determining whether the new use is 

ongoing. The objective of EPA’s 

approach has been to ensure that a 

person could not defeat a SNUR by 

initiating a significant new use before 

the effective date of the direct final rule. 

Persons who begin commercial 

manufacture or processing of the 

chemical substances for a significant 

new use identified as of that date will 

have to cease any such activity upon the 

effective date of the final rule. To 

resume their activities, these persons 

will have to first comply with all 

applicable SNUR notification 

requirements and wait until EPA has 

conducted a review of the notice, made 

an appropriate determination on the 

notice, and has taken such actions as are 

required with that determination. 

VIII. Development and Submission of 

Information 

EPA recognizes that TSCA section 5 

does not require developing any 

particular new information (e.g., 

generating test data) before submission 

of a SNUN. There is an exception: 

development of test data is required 

where the chemical substance subject to 

the SNUR is also subject to a rule, order 

or consent agreement under TSCA 

section 4 (see TSCA section 5(b)(1)). 

In the absence of a TSCA section 4 

test rule covering the chemical 

substance, persons are required only to 

submit information in their possession 

or control and to describe any other 

information 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. 

Unit IV. lists required or recommended 


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testing for all of the listed 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. 

Furthermore, pursuant to TSCA section 

4(h), which pertains to reduction of 

testing in vertebrate animals, EPA 

encourages consultation with the 

Agency on the use of alternative test 

methods and strategies (also called New 

Approach Methodologies, or NAMs), if 

available, to generate the recommended 

test data. EPA encourages dialog with 

Agency representatives to help 

determine how best the submitter can 

meet both the data needs and the 

objective of TSCA section 4(h). To 

access the OCSPP test guidelines 

referenced in this document 

electronically, please go to http://

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ The 

Organisation for Economic Co-operation 

and Development (OECD) test 

guidelines are available from the OECD 

Bookshop at http://www.oecdbookshop.

org or SourceOECD at http://

www.sourceoecd.org. 

In certain of the TSCA section 5(e) 

Orders for 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. Listings of the 

tests specified in the TSCA section 5(e) 

Orders are included in Unit IV. The 

SNURs contain the same production 

volume limits as the TSCA section 5(e) 

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. 

Any request by EPA for the triggered 

and pended testing described in the 

Orders was made based on EPA’s 

consideration of available screeninglevel data, if any, as well as other 

available information on appropriate 

testing for the PMN substances. Further, 

any such testing request on the part of 

EPA that includes testing on vertebrates 

was made after consideration of 

available toxicity information, 

computational toxicology and 

bioinformatics, and high-throughput 

screening methods and their prediction 

models. 

Potentially useful information 

identified in Unit IV. may not be the 

only means of addressing the potential 

risks of the chemical substance. 

However, submitting a SNUN without 

any test data may increase the 

likelihood that EPA will take action 

under TSCA section 5(e), particularly if 

satisfactory test results have not been 

obtained from a prior PMN or SNUN 

submitter. EPA recommends that 

potential SNUN submitters contact EPA 

early enough so that they will be able 

to conduct the appropriate tests. 

SNUN submitters should be aware 

that EPA will be better able to evaluate 

SNUNs which provide detailed 

information on the following: 

• Human exposure and 

environmental release that may result 

from the significant new use of the 

chemical substances. 

• Information on risks posed by the 

chemical substances compared to risks 

posed by potential substitutes. 

IX. Procedural Determinations 

By this rule, EPA is establishing 

certain significant new uses which have 

been claimed as CBI subject to Agency 

confidentiality regulations at 40 CFR 

part 2 and 40 CFR part 720, subpart E. 

Absent a final determination or other 

disposition of the confidentiality claim 

under 40 CFR part 2 procedures, EPA is 

required to keep this information 

confidential. EPA promulgated a 

procedure to deal with the situation 

where a specific significant new use is 

CBI, at § 721.1725(b)(1). 

Under these procedures a 

manufacturer or processor may request 

EPA to determine whether a proposed 

use would be a significant new use 

under the rule. The manufacturer or 

processor must show that it has a bona 

fide intent to manufacture or process the 

chemical substance and must identify 

the specific use for which it intends to 

manufacture or process the chemical 

substance. If EPA concludes that the 

person has shown a bona fide intent to 

manufacture or process the chemical 

substance, EPA will tell the person 

whether the use identified in the bona 

fide submission would be a significant 

new use under the rule. Since most of 

the chemical identities of the chemical 

substances subject to these SNURs are 

also CBI, manufacturers and processors 

can combine the bona fide submission 

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

with that under § 721.11 into a single 

step. 

If EPA determines that the use 

identified in the bona fide submission 

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

the use does not meet the criteria 

specified in the rule for a significant 

new use, that person can manufacture or 

process the chemical substance so long 

as the significant new use trigger is not 

met. In the case of a production volume 

trigger, this means that the aggregate 

annual production volume does not 

exceed that identified in the bona fide 

submission to EPA. Because of 

confidentiality concerns, EPA does not 

typically disclose the actual production 

volume that constitutes the use trigger. 

Thus, if the person later intends to 

exceed that volume, a new bona fide 

submission would be necessary to 

determine whether that higher volume 

would be a significant new use. 

X. SNUN Submissions 

According to § 721.1(c), persons 

submitting a SNUN must comply with 

the same notification requirements and 

EPA regulatory procedures as persons 

submitting a PMN, including 

submission of test data on health and 

environmental effects as described in 40 

CFR 720.50. SNUNs must be submitted 

on EPA Form No. 7710–25, generated 

using e-PMN software, and submitted to 

the Agency in accordance with the 

procedures set forth in 40 CFR 720.40 

and § 721.25. E–PMN software is 

available electronically at http://

www.epa.gov/opptintr/newchems. 

XI. Economic Analysis 

EPA has evaluated the potential costs 

of establishing SNUN requirements for 

potential manufacturers and processors 

of the chemical substances subject to 

this rule. EPA’s complete economic 

analysis is available in the docket under 

docket ID number EPA–HQ–OPPT– 

2018–0567. 

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) 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 


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of the CFR, after appearing in the 

Federal Register, are listed in 40 CFR 

part 9, and included on the related 

collection instrument or form, if 

applicable. EPA is amending the table in 

40 CFR part 9 to list the OMB approval 

number for the information collection 

requirements contained in this action. 

This listing of the OMB control numbers 

and their subsequent codification in the 

CFR satisfies the display requirements 

of PRA and OMB’s implementing 

regulations at 5 CFR part 1320. This 

Information Collection Request (ICR) 

was previously subject to public notice 

and comment prior to OMB approval, 

and given the technical nature of the 

table, EPA finds that further notice and 

comment to amend it is unnecessary. As 

a result, EPA finds that there is ‘‘good 

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

Administrative Procedure Act (5 U.S.C. 

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

without further notice and comment. 

The information collection 

requirements related to this action have 

already been approved by OMB 

pursuant to PRA under OMB control 

number 2070–0012 (EPA ICR No. 574). 

This action does not impose any burden 

requiring additional OMB approval. If 

an entity were to submit a SNUN to the 

Agency, the annual burden is estimated 

to average between 30 and 170 hours 

per response. This burden estimate 

includes the time needed to review 

instructions, search existing data 

sources, gather and maintain the data 

needed, and complete, review, and 

submit the required SNUN. 

Send any comments about the 

accuracy of the burden estimate, and 

any suggested methods for minimizing 

respondent burden, including through 

the use of automated collection 

techniques, to the Director, Collection 

Strategies Division, Office of 

Environmental Information (2822T), 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW, Washington, DC 

20460–0001. Please remember to 

include the OMB control number in any 

correspondence, but do not submit any 

completed forms to this address. 

C. Regulatory Flexibility Act (RFA) 

On February 18, 2012, EPA certified 

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

601 et seq.), that promulgation of a 

SNUR does not have a significant 

economic impact on a substantial 

number of small entities where the 

following are true: 

1. A significant number of SNUNs 

would not be submitted by small 

entities in response to the SNUR. 

2. The SNUR submitted by any small 

entity would not cost significantly more 

than $8,300. 

A copy of that certification is 

available in the docket for this action. 

This action is within the scope of the 

February 18, 2012 certification. Based 

on the Economic Analysis discussed in 

Unit XI. and EPA’s experience 

promulgating SNURs (discussed in the 

certification), EPA believes that the 

following are true: 

• A significant number of SNUNs 

would not be submitted by small 

entities in response to the SNUR. 

• Submission of the SNUN would not 

cost any small entity significantly more 

than $8,300. 

Therefore, the promulgation of the 

SNUR would not have a significant 

economic impact on a substantial 

number of small entities. 

D. Unfunded Mandates Reform Act 

(UMRA) 

Based on EPA’s experience with 

proposing and finalizing SNURs, State, 

local, and Tribal governments have not 

been impacted by these rulemakings, 

and EPA does not have any reasons to 

believe that any State, local, or Tribal 

government will be impacted by this 

action. As such, EPA has determined 

that this action does not impose any 

enforceable duty, contain any unfunded 

mandate, or otherwise have any effect 

on small governments subject to the 

requirements of UMRA sections 202, 

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

E. Executive Order 13132 

This action will not have a substantial 

direct effect on States, on the 

relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

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

1999). 

F. Executive Order 13175 

This action does not have Tribal 

implications because it is not expected 

to have substantial direct effects on 

Indian Tribes. This action does not 

significantly nor uniquely affect the 

communities of Indian Tribal 

governments, nor does it involve or 

impose any requirements that affect 

Indian Tribes. Accordingly, the 

requirements of Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000), do not apply 

to this action. 

G. Executive Order 13045 

This action is not subject to Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997), because this is not an 

economically significant regulatory 

action as defined by Executive Order 

12866, and this action does not address 

environmental health or safety risks 

disproportionately affecting children. 

H. Executive Order 13211 

This action is not subject to Executive 

Order 13211, entitled ‘‘Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

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

22, 2001), because this action is not 

expected to affect energy supply, 

distribution, or use and because this 

action is not a significant regulatory 

action under Executive Order 12866. 

I. National Technology Transfer and 

Advancement Act (NTTAA) 

In addition, since this action does not 

involve any technical standards, 

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

note), does not apply to this action. 

J. Executive Order 12898 

This action does not entail special 

considerations of environmental justice 

related issues as delineated by 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

XIII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects 

40 CFR Part 9 

Environmental protection, Reporting 

and recordkeeping requirements. 

40 CFR Part 721 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: September 5, 2018. 

Jeffery T. Morris, 

Director, Office of Pollution Prevention and 

Toxics. 

Therefore, 40 CFR parts 9 and 721 are 

amended as follows: 


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Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations 47017 

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 § 14;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 

* * * * * 

721.11124 ............................. 2070–0012 

721.11125 ............................. 2070–0012 

721.11126 ............................. 2070–0012 

721.11127 ............................. 2070–0012 

721.11128 ............................. 2070–0012 

721.11129 ............................. 2070–0012 

721.11130 ............................. 2070–0012 

721.11131 ............................. 2070–0012 

721.11132 ............................. 2070–0012 

721.11133 ............................. 2070–0012 

721.11134 ............................. 2070–0012 

721.11135 ............................. 2070–0012 

721.11136 ............................. 2070–0012 

721.11137 ............................. 2070–0012 

721.11138 ............................. 2070–0012 

721.11139 ............................. 2070–0012 

721.11140 ............................. 2070–0012 

721.11141 ............................. 2070–0012 

721.11142 ............................. 2070–0012 

721.11143 ............................. 2070–0012 

721.11144 ............................. 2070–0012 

721.11145 ............................. 2070–0012 

721.11146 ............................. 2070–0012 

721.11147 ............................. 2070–0012 

721.11148 ............................. 2070–0012 

* * * * * 

* * * * * 

PART 721—[AMENDED] 

■ 3. The authority citation for part 721 

continues to read as follows: 

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

2625(c). 

■ 4. Add § 14;721.11124 to subpart E to 

read as follows: 

§ 721.11124 2-Propenenitrile, polymer with 

methanamine, hydrogenated, 3- 

aminopropylterminated, ethoxylated 

propoxylated. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

2-Propenenitrile, polymer with 

methanamine, hydrogenated, 3- 

aminopropylterminated, ethoxylated 

propoxylated (PMN P–14–758; CAS No. 

2055838–16–7) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. The requirements of this 

section do not apply to quantities of the 

PMN substance after they have been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), (a)(3) through (5) 

(respirators must provide a National 

Institute for Occupational Safety and 

Health assigned protection factor of at 

least 50), and (a)(6)(v), (particulate), 

(when determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g. 

enclosure or confinement of 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), 

§ 721.63(b) (concentration set at 1.0%), 

and § 721.63(c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (d), (e) (concentration set at 

1.0%), (f), (g)(1)(ii), (g)(2)(ii), (g)(4)(iii), 

and (g)(5). Alternative hazard and 

warning statements that meet the 

criteria of the Globally Harmonized 

System and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f) and (k). A 

significant new use is any spray 

application method that results in 

greater worker inhalation exposures to 

vapor, mist, or aerosol than the roller 

coating application. 

(iv) Release to water. Requirements as 

specified in § 721.90(b)(1), and (c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 5. Add § 14;721.11125 to subpart E to 

read as follows: 

§ 721.11125 Dicarboxylic acids, polymers 

with alkyl prop-2-enoate, alkyl 2-ethylprop2-enoate, alkyl[(alkenyl)alkyl]alkanediol, 

alkanediol, alkanedioic acid, alkyl 2- 

rnethylprop-2-enoate, alkyl prop-2-enoic 

acid, alkylene [isocyanatocarbomonocyte] 

and alkanediol, alkanolamine-blocked, 

compds with 2-(alkylamino)alkanol 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as dicarboxylic acids, 

polymers with alkyl prop-2-enoate, 

alkyl 2-ethylprop-2-enoate, 

alkyl[(alkenyl)alkyl]alkanediol, 

alkanediol, alkanedioic acid, alkyl 2- 

methylprop-2-enoate, alkyl prop-2-enoic 

acid, alkylene 

[isocyanatocarbomonocyte] and 

alkanediol, alkanolamine-blocked, 

compds with 2-(alkylamino)alkanol (P– 

16–493) 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 

substance after they have been reacted 

(cured). 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f). It is a significant 

new use to import the PMN substance 

to contain more than 0.1% residual 

isocyanate by weight. It is a significant 

new use to import the PMN substance 

to contain more than 1% of a 

confidential component by weight. 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 6. Add § 721.11126 to subpart E to 

read as follows: 


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47018 Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations 

§ 721.11126 Mixed metal oxide (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as a mixed metal oxide 

(P–16–514) 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)(3) through (5) 

(respirators must provide a National 

Institute for Occupational Safety and 

Health assigned protection factor of at 

least 1,000), and (a)(6) (particulate), 

(when determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of 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), 

§ 721.63(b) (concentration set at 1.0%), 

and § 721.63(c). 

(A) As an alternative to the respirator 

requirements in paragraph (a)(2)(i) of 

this section, a manufacturer or processor 

may choose to follow the new chemical 

exposure limit (NCEL) provision listed 

in the TSCA section 5(e) Order for this 

substance. The NCEL is 0.04 mg/m3 as 

an 8-hour time weighted average. 

Persons who wish to pursue NCELs as 

an alternative to § 721.63 respirator 

requirements may request to do so 

under § 721.30. Persons whose § 721.30 

requests to use the NCELs approach are 

approved by EPA will be required to 

follow NCELs provisions comparable to 

those contained in the corresponding 

TSCA section 5(e) Order. 

(B) [Reserved] 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e) (concentration set at 1.0%), 

(f), (g)(1)(iv), (lung toxicity if inhaled), 

(eye irritation), (allergic skin reaction), 

(g)(2)(i) through (iii) and (v) (use 

respiratory protection or maintain 

workplace airborne concentrations at or 

below an 8-hour time-weighted average 

of 0.04 mg/m3), (g)(4)(i), and (g)(5). 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial, Commercial, and 

consumer activities. Requirements as 

specified in § 721.80(e), (f), (k), and (q). 

(iv) Disposal. Requirements as 

specified in § 721.85. It is a significant 

new use to dispose of the PMN 

substance other than by recycling as 

described in the Order. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (j) are applicable to 

manufacturers, importers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 7. Add § 721.11127 to subpart E to 

read as follows: 

§ 721.11127 Modified alkyl polyamine 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as modified alkyl polyamine 

(PMN P–16–576) 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) and (iii), (a)(3), 

and (a)(6) (particulate), (vapor), (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), § 721.63(b) 

(concentration set at 1.0%), and 

§ 721.63(c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e) (concentration set at 1.0%), 

(f), (g)(1)(i), (ii), (vi), (viii), (g)(2)(i) 

through (iii) and (v), (g)(3)(i) and (ii), 

and (g)(5). Alternative hazard and 

warning statements that meet the 

criteria of the Globally Harmonized 

System and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k). It is a 

significant new use to manufacture the 

chemical substance more than 9 

months. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (i), are applicable 

to 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. 

■ 8. Add § 721.11128 to subpart E to 

read as follows: 

§ 721.11128 Alkyl polyamine (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as alkyl polyamine (PMN 

P–16–577) 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)(iii), (a)(3), 

(a)(6)(v), (a)(6) (particulate), (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), § 721.63(b) 

(concentration set at 1.0%), and 

§ 721.63(c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e) (concentration set at 1.0%), 

(f), (g)(1)(i), (ii), (vi), (viii), (g)(2)(i) 

through (iii) and (v), (g)(3)(i) and (ii), 

and (g)(5). Alternative hazard and 

warning statements that meet the 

criteria of the Globally Harmonized 

System and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k). It is a 

significant new use to manufacture the 

chemical substance more than 9 

months. 

(iv) Release to water. Requirements as 

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

(c)(4) where N = 2. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (i) and (k) are 


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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. 

■ 9. Add § 721.11129 to subpart E to 

read as follows: 

§ 721.11129 Silica gel, reaction products 

with chromium oxide (CrO3) and 

ethoxydiethyl aluminum. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

silica gel, reaction products with 

chromium oxide (CrO3) and 

ethoxydiethyl aluminum is (P–16–590, 

CAS No. 932384–12–8) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1) and (a)(3) through (5) 

(respirators must provide a National 

Institute for Occupational Safety and 

Health assigned protection factor of 10 

to 1,000 depending on the results of the 

exposure monitoring as described in the 

Order for P16–590 and required by this 

section (a)(2)(i), (a)(6) (particulate), and 

(a)(6) (vapor), (when determining which 

persons are reasonably likely to be 

exposed as required for § 721.63(a)(1) 

and (4) engineering control measures 

(e.g. enclosure or confinement of 

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), 

§ 721.63(b) (concentration set at 0.1%), 

and § 721.63(c). It is a significant new 

use to not conduct the exposure 

monitoring required in the Order for 

P16–590 when workers are reasonably 

likely to be exposed by inhalation. 

(ii) Industrial, Commercial, and 

consumer activities. Requirements as 

specified in § 721.80. It is a significant 

new use to manufacture, process, or use 

the PMN substance other than in a 

system where the PMN substance is 

handled in an inert atmosphere and is 

not designed to be exposed to air. 

(iii) Disposal. Requirements as 

specified in § 721.85. It is a significant 

new use to dispose of all waste streams 

containing the PMN substance and the 

constituent breakdown products of the 

PMN substance other than in a Resource 

Conservation and Recovery Act 

hazardous waste landfill. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 10. Add § 14;721.11130 to subpart E to 

read as follows: 

§ 721.11130 Carboxylic acids, C6–18 and 

C5–15-di-, polymers with diethylene glycol, 

glycerol, sorbitol and terephthalic acid. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

carboxylic acids, C6–18 and C5–15-di-, 

polymers with diethylene glycol, 

glycerol, sorbitol and terephthalic acid 

(P–16–593, CAS No. 1967778–37–5) is 

subject to reporting under this section 

for the significant new uses described in 

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

requirements of this section do not 

apply to quantities of the substance after 

they have been 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 (iii), 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 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), 

§ 721.63(b) (concentration set at 1.0%), 

and § 721.63(c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e) (concentration set at 1.0%), 

(f), (g)(1)(ii), (irritation), (g)(2)(i) through 

(iii) and (v), and (g)(5). Alternative 

hazard and warning statements that 

meet the criteria of the Globally 

Harmonized System and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, Commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k)(aromatic 

polyester polyol for rigid foam). It is a 

significant new use to manufacture, 

process, or use the PMN substance to 

result in inhalation exposure to a vapor, 

mist or aerosol. 

(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 (i) are applicable to 

manufacturers, importers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 11. Add § 14;721.11131 to subpart E to 

read as follows: 

§ 721.11131 1-tetradecene homopolymer 

hydrogenated. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1-tetradecene homopolymer 

hydrogenated (PMN P–17–5, CAS No. 

1857296–89–9) 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) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e)(concentration set at 1.0%), 

(f), (g)(1)(ii), (g)(2)(ii), and (g)(5). 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k)(base fluid/ 

carrier fluid for additives in motor oil, 

automatic transmission fluid, and 

industrial lubricants). It is a significant 

new use to manufacture the chemical 

substance more than 9 months. It is a 

significant new use to manufacture, 

process, or use the PMN substance to 

resuls in inhalation exposure to a vapor, 

mist or aerosol. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) 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. 

■ 12. Add § 14;721.11132 to subpart E to 

read as follows: 

§ 721.11132 Fluorocyanophenyl 

alkylbenzoate (generic) 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances generically 

identified as fluorocyanophenyl 

alkylbenzoate (P–17–149), (P–17–150), 

(P–17–151), and (P–17–165) are subject 


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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), (iii), and (iv), 

(a)(3), and (a)(6)(v), (particulate), (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 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), § 721.63(b) 

(concentration set at 1.0%) and 

§ 721.63(c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e)(concentration set at 1.0%), 

(f), (g)(1)(i) through (iii), (iv), (vi), and 

(ix), (g)(2)(i), (ii), (iii), and (v), (g)(3)(i) 

and (ii), and (g)(5). Alternative hazard 

and warning statements that meet the 

criteria of the Globally Harmonized 

System and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, Commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) and (q). It is a 

significant new use to manufacture, 

process, or use the PMN substance to 

result in inhalation exposures to vapor, 

dust, mist, or aerosols to the substance. 

(iv) Release to water. Requirements as 

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

(c)(4) where N = 2 for P–17–165 and N 

= 4 for P–17–149, P–17–150, and P–17– 

151. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (i) and (k) are 

applicable to manufacturers, importers, 

and processors of these substances. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 13. Add § 14;721.11133 to subpart E to 

read as follows: 

§ 721.11133 Fluorinated propenoic poly 

alkyl ether ester (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as fluorinated propenoic poly 

alkyl ether ester (P–17–175) 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 substance after 

they have been reacted (cured). 

(2) The significant new uses are: 

(i) Industrial, Commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f) and (t)(60 

kilograms). It is a significant new use to 

use the substance other than as a 

leveling agent for coatings applied to 

aluminum printing plates. 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (i) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

significant new use rule. 

■ 14. Add § 14;721.11134 to subpart E to 

read as follows: 

§ 721.11134 Oxyalkylene urethane 

polyolefin (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as oxyalkylene urethane 

polyolefin (PMN P–17–199) 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. It is a new use the 

manufacture (including import) the 

PMN substance with an average 

molecular weight greater than specified 

in the Order or with more than 1% of 

the molecular weight content 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) through (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. 

■ 15. Add § 14;721.11135 to subpart E to 

read as follows: 

§ 721.11135 Imino alkane amine phosphate 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as imino alkane amine 

phosphate (P–17–206) 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 substance after 

they have been 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 (iii), (a)(3), 

and (a)(6)(v), (particulate), (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 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), § 721.63(b) 

(concentration set at 1.0%) and 

§ 721.63(c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e)(concentration set at 1.0%), 

(f), (g)(1)(i), (g)(2)(i) and (v), (g)(3)(i) and 

(ii), (g)(4)(iii), and (g)(5), Alternative 

hazard and warning statements that 

meet the criteria of the Globally 

Harmonized System and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, Commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f) and (k). It is a 

significant new use to modify 

processing or use if it results in 

inhalation exposure to vapor, dust, mist, 

or aerosols to the substance. 

(iv) Disposal. Requirements as 

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

(c)(1). 

(v) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (k) are applicable 

to manufacturers, importers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 


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(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. 

■ 16. Add § 14;721.11136 to subpart E to 

read as follows: 

§ 721.11136 Fatty acids, tall-oil, reaction 

products with 2-[(2- 

aminoalkyl)amino]alkanol, compds. with 

alkylene oxide-glycidyl o-tolyl ether 

polymer dihydrogen phosphate alkyl ether 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as fatty acids, tall-oil, reaction 

products with 2-[(2- 

aminoalkyl)amino]alkanol, compds. 

with alkylene oxide-glycidyl o-tolyl 

ether polymer dihydrogen phosphate 

alkyl ether (P–17–223) 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 substance after 

they have been reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

(a)(6)(v), (particulate), (when 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and, 

engineering control measures (e.g. 

enclosure or confinement of 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), 

§ 721.63(b) (concentration set at 1.0%) 

and § 721.63(c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e)(concentration set at 1.0%), 

(f), (g)(1)(i) and (ii), (g)(2)(i), (ii), and (v), 

(g)(3)(i) and (ii), and (g)(5), Alternative 

hazard and warning statements that 

meet the criteria of the Globally 

Harmonized System and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, Commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f), (k), and (q). It is 

a significant new use to modify any 

processing if such modification would 

result in inhalation exposures to the 

PMN substance by vapor, dust, mist, or 

aerosol, at a concentration of greater 

than 1 percent by weight or volume. It 

is a significant new use to use the PMN 

substance in the confidential 

formulation identified in the Order at 

concentration greater than 1 percent by 

weight or volume. It is a significant new 

use to manufacture, process, or use the 

substance for consumer use or for 

commercial uses that could introduce 

the substance into a consumer setting. 

(iv) Release to water. Requirements as 

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

(c)(4) where N = 15. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (i) and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 17. Add § 14;721.11137 to subpart E to 

read as follows: 

§ 721.11137 Oxirane, 2-alkyl-, polymer with 

oxirane, mono[N-[3-(carboxyamino)-4(or 6)- 

alkylphenyl]carbamate], alkyl ether, ester 

with 2,2′,2′′-nitrilotris-[alkanol] (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as oxirane, 2-alkyl-, polymer 

with oxirane, mono[N-[3- 

(carboxyamino)-4(or 6)- 

alkylphenyl]carbamate], alkyl ether, 

ester with 2,2′,2′′-nitrilotris-[alkanol] (P– 

17–230) 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 

substance after they have been 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 (iii), (a)(3), 

and (a)(6)(v), (particulate), (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 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), § 721.63(b) 

(concentration set at 1.0%) and 

§ 721.63(c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e)(concentration set at 1.0%), 

(f), (g)(1)(i) and (ii), (eye irritation), 

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

and (g)(5). Alternative hazard and 

warning statements that meet the 

criteria of the Globally Harmonized 

System and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, Commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f), (k), and (q). It is 

a significant new use to modify 

processing methods if such modification 

would result in inhalation exposures to 

the PMN substance by vapor, dust, mist, 

or aerosol, at a concentration of greater 

than 1 percent by weight or volume. It 

is a significant new use to use the PMN 

substance in the confidential 

formulation at a concentration greater 

than 1 percent by weight or volume. It 

is a significant new use to manufacture, 

process, or use the substance for 

consumer use or for commercial uses 

that could introduce the substance into 

a consumer setting. 

(iv) Release to water. Requirements as 

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

(c)(4) where N = 65. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (i) and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 18. Add § 14;721.11138 to subpart E to 

read as follows: 

§ 721.11138 Formaldehyde, polymer with 

(chloromethyl) oxirane and substituted 

aromatic compounds (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as formaldehyde, polymer 

with (chloromethyl) oxirane and 

substituted aromatic compounds (P–17– 

236) 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 the PMN substance after 

it has been incorporated into the 

confidential forms identified in the 

Order. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

(a)(3), and (a)(6) (particulate), (when 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1), engineering 


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control measures (e.g. enclosure or 

confinement of 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), § 721.63(b) 

(concentration set at 1.0%), and 

§ 721.63(c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e)(concentration set at 1.0%), 

(f), (g)(1)(ii), (vi), (vii), and (ix), (skin 

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

and (g)(5). Alternative hazard and 

warning statements that meet the 

criteria of the Globally Harmonized 

System and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, Commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f), (k), and (q). It is 

a significant new use to modify 

manufacture, processing, or use if it 

results in inhalation exposure to vapor, 

dust, mist, or aerosols to the substance. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (i) are applicable to 

manufacturers, importers, and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

(a)(1) and (a)(2)(iii) of this section. 

■ 19. Add § 14;721.11139 to subpart E to 

read as follows: 

§ 721.11139 Acid, reaction products with 

cadmium selenide (CdSe), 

trioctylphosphine and trioctylphosphine 

oxide (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as acid, reaction products 

with cadmium selenide (CdSe), 

trioctylphosphine and 

trioctylphosphine oxide (PMN P–17– 

241) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), and (a)(3) and (6) 

(particulate), (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), and 

§ 721.63(c). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(g) and (y)(1). It is 

a significant new use to manufacture, 

process, or use the substance other than 

in a liquid formulation. 

(iii) Disposal. Requirements as 

specified in § 721.85. It is a significant 

new use to dispose of the substance and 

any waste stream containing the 

substance other than 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 (b). 

(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. 

■ 20. Add § 14;721.11140 to subpart E to 

read as follows: 

§ 721.11140 Acid, reaction products with 

cadmium selenide sulfide, acid, 

trioctylphosphine and trioctylphosphine 

oxide (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as acid, reaction products 

with cadmium selenide sulfide, acid, 

trioctylphosphine and 

trioctylphosphine oxide (PMN P–17– 

242), is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(2)(i), and (a)(3) and (6) 

(particulate), (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), and 

§ 721.63(c). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(g) and (y)(1). It is 

a significant new use to manufacture, 

process, or use the substance other than 

in a liquid formulation. 

(iii) Disposal. Requirements as 

specified in § 721.85. It is a significant 

new use to dispose of the substance and 

any waste stream containing the 

substance other than 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 (b). 

(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. 

■ 21. Add § 721.11141 to subpart E to 

read as follows: 

§ 721.11141 Acid, reaction products with 

cadmium metal selenide sulfide, 

trioctylphosphine and trioctylphosphine 

oxide (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as acid, reaction products 

with cadmium metal selenide sulfide, 

trioctylphosphine and 

trioctylphosphine oxide (PMN P–17– 

243), 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), and (a)(3) and (6) 

(particulate), (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), and 

§ 721.63(c). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(g) and (y)(1). It is 

a significant new use to manufacture, 

process, or use the substance other than 

in a liquid formulation. 

(iii) Disposal. Requirements as 

specified in § 721.85. It is a significant 

new use to dispose of the substance and 

any waste stream containing the 

substance other than in a permitted 

hazardous waste incinerator. 

(b) Specific requirements. The 

provisions of subpart A of this part 


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apply to this section except as modified 

by this paragraph (b). 

(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. 

■ 22. Add § 721.11142 to subpart E to 

read as follows: 

§ 721.11142 Metal oxide reaction products 

with cadmium metal selenide sulfide, and 

amine (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as metal oxide reaction 

products with cadmium metal selenide 

sulfide, and amine (PMN P–17–244) 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) through (5) 

(respirators must provide a National 

Institute for Occupational Safety and 

Health assigned protection factor (APF) 

of at least 50), and (a)(6)(particulate), 

(when determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible), and 

§ 721.63(c). It is a significant new use to 

handle the solid form of the substance 

without use of a fume hood or glove 

box. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(q), (k) (down 

converting phosphor particle for use in 

conjunction with optoelectronic 

components), and (y)(1) and (2). 

(iii) Disposal. Requirements as 

specified in § 721.85. It is a significant 

new use to dispose of the substance and 

any waste stream containing the 

substance other than 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 (b). 

(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. 

(3) Determining whether a specific use 

us subject to this section. The provisions 

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

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

■ 23. Add § 721.11143 to subpart E to 

read as follows: 

§ 721.11143 Alkanoic acid, 2-alkyl-, 

substituted alkyl ester, polymer with alkyl 

alkenoate, substituted carbomonocycle, 

substituted alkyl alkenoate and alkyl 

substituted alkenoate, substituted 

alkanenitrile-initiated (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as alkanoic acid, 2-alkyl-, 

substituted alkyl ester, polymer with 

alkyl alkenoate, substituted 

carbomonocycle, substituted alkyl 

alkenoate and alkyl substituted 

alkenoate, substituted alkanenitrileinitiated (PMN P–17–265) 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 substance after 

they have been completely reacted or 

cured. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80. It is a significant 

new use to manufacture the PMN 

substance with an acid concentration 

greater than 20%. It is a significant new 

use to manufacture the PMN substance 

with an amine concentration greater 

than 5%. 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a), (b), (c), and (i). 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 24. Add § 721.11144 to subpart E to 

read as follows: 

§ 721.11144 Manganese heterocyclicamine carboxylate complexes (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as manganese heterocyclicamine carboxylate complexes (PMN P– 

17–301) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. The requirements of this Order 

do not apply to quantities of the PMN 

substance after they have been entrained 

in cured coating or ink. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(3) through (5) 

(respirators must provide a National 

Institute for Occupational Safety and 

Health (NIOSH) assigned protection 

factor (APF) of at least 10), and (a)(6) 

(particulate), (when determining which 

persons are reasonably likely to be 

exposed as required for § 721.63(a)(1) 

and (4), engineering control measures 

(e.g. enclosure or confinement of 

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), 

§ 721.63(b) (concentration set at 1.0%), 

and § 721.63(c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e)(concentration set at 1.0%), 

(f), (g)(1)(i) through (iii) and (ix), (eye 

irritation), (g)(2)(ii) through (iv), (avoid 

skin and eye contact), (use skin and eye 

protection), and (g)(5). Alternative 

hazard and warning statements that 

meet the criteria of the Globally 

Harmonized System and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (surface drier in 

clear and pigmented coatings systems) 

and (p) (430,000 kilograms). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (i). 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 25. Add § 721.11145 to subpart E to 

read as follows: 

§ 721.11145 Sulfuric acid mixed salt 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as sulfuric acid mixed salt 

(PMN P–17–318) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

(a)(6)(v), (particulate), (when 


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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 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), § 721.63(b) 

(concentration set at 1.0%), and 

§ 721.63(c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e)(concentration set at 1.0%), 

(f), (g)(1)(i), (irritation to eye, 

respiratory, and GI tract), (corrosion), 

(acute toxicity), (g)(2)(i) and (iii), and 

(g)(5). Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) and (q). It is a 

significant new use to manufacture of 

the PMN substance with more than 1% 

free ammonia content. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (i). 

(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. 

■ 26. Add § 721.11146 to subpart E to 

read as follows: 

§ 721.11146 2-Propenoic acid, branched 

alkyl ester (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 2-propenoic acid, 

branched alkyl ester (PMN P–17–323) 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 substance after 

they have been reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

(a)(3), and (a)(6)(v), (particulate), (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 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), § 721.63(b) 

(concentration set at 1.0%), and 

§ 721.63(c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e) (concentration set at 1.0%), 

(f), and (g)(1)(iv) and (ix), (skin and eye 

irritation), (oncogenicity), 

(sensitization), (g)(2)(i), (iii), and (v), 

(use eye protection), (g)(4)(iii), and 

(g)(5). Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f), (k) (reactive 

monomer for use in producing 

polymers), and (q). 

(iv) Release to water. Release to water 

requirements as specified in 

§ 721.90(a)(1), (b)(1), and (c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (i) and (k). 

(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. 

■ 27. Add § 721.11147 to subpart E to 

read as follows: 

§ 721.11147 Allyloxymethylacrylate 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as allyloxymethylacrylate 

(PMN P–17–326) is subject to reporting 

under this section for the significant 

new uses as described in paragraph 

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

of this section do not apply to quantities 

of the substance after they have been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

(a)(3) through (5) (respirators must 

provide a National Institute for 

Occupational Safety and Health 

assigned protection factor of at least 10), 

and (a)(6)(v), (particulate), (when 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measure (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible), 

§ 721.63(b) (concentration set at 1.0%), 

and § 721.63(c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e) (concentration set at 1.0%), 

(f), (g)(1)(i), (iv), (vi), and (ix), 

(sensitization), (g)(2)(i) through (v), 

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

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f), (k), and (q). 

(iv) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Requirements as 

specified in § 721.125(a) through (i), and 

(k) are applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(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. 

■ 28. Add § 721.11148 to subpart E to 

read as follows: 

§ 721.11148 Polyurethane, methacrylate 

blocked (generic). 

(a) Chemical substance and 

significant new sues subject to reporting. 

(1) The chemical substance generically 

identified as polyurethane, methacrylate 

blocked (PMN P–17–345) 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 substance after 

they have been completely reacted 

(cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

(a)(6)(v), (particulate), (when 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1), engineering 


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Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations 47025 

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measure (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible), § 721.63(b) 

(concentration set at 1.0%), and 

§ 721.63(c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (e)(concentration set at 1.0%), 

(f), (g)(1)(irritation to skin, eyes, lungs, 

and mucous membranes), (g)(2)(i) 

through (iii) and (v), and (g)(5). 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k). It is a 

significant new use to manufacture the 

chemical substance more than 6 

months. It is a significant new use to 

modify manufacture, processing, or use 

if it results in inhalation exposure to 

vapor, dust, mist, or aerosols to the 

substance. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except ss modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) 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. 

[FR Doc. 2018–19950 Filed 9–14–18; 8:45 am] 

BILLING CODE 6560–50–P 


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