37702 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2017–0366; FRL–9970–23] 

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 145 chemical substances 

which were the subject of 

premanufacture notices (PMNs). The 

chemical substances are subject to 

consent orders issued by EPA pursuant 

to section 5(e) of TSCA. This action 

requires persons who intend to 

manufacture (defined by statute to 

include import) or process any of these 

145 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 October 

1, 2018. For purposes of judicial review, 

this rule shall be promulgated at 1 p.m. 

(e.s.t.) on August 15, 2018. 

Written adverse comments on one or 

more of these SNURs must be received 

on or before August 31, 2018 (see Unit 

VI. of the SUPPLEMENTARY INFORMATION). 

If EPA receives written adverse 

comments on one or more of these 

SNURs before August 31, 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–2017–0366, 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 

August 31, 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 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD–ROM that 

you mail to EPA, mark the outside of the 

disk or CD–ROM as CBI and then 

identify electronically within the disk or 

CD–ROM the specific information that 

is claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When preparing and submitting your 

comments, see the commenting tips at 

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

comments.html. 

II. Background 

A. What action is the Agency taking? 

1. Direct Final Rule. EPA is 

promulgating these SNURs using direct 

final procedures. These SNURs will 

require persons to notify EPA at least 90 

days before commencing the 

manufacture or processing of a chemical 

substance for any activity designated by 

these SNURs as a significant new use. 

Receipt of such notices 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 August 31, 2018 (see Unit VI. of the 

SUPPLEMENTARY INFORMATION), the 


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Agency will publish in the Federal 

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 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 

145 chemical substances in 40 CFR part 

721, subpart E. In this unit, EPA 

provides the following information for 

each chemical substance: 

• PMN number. 

• Chemical name (generic name, if 

the specific name is claimed as CBI). 

• Chemical Abstracts Service (CAS) 

Registry number (if assigned for nonconfidential chemical identities). 

• Basis for the TSCA section 5(e) 

consent order. 

• 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 each rule 

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 145 PMN 

substances that are subject to Orders 

under TSCA section 5(e)(1)(A)(ii)(I) 

where EPA determined that activities 

associated with the PMN substances 

may present unreasonable risk to human 

health or the environment. Those 

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 

risk of injury to human health via 

inhalation exposure, the underlying 

TSCA section 5(e) Order usually 

requires, among other things, that 

potentially exposed employees wear 

specified respirators unless actual 

measurements of the workplace air 

show that air-borne concentrations of 

the PMN substance are below a New 

Chemical Exposure Limit (NCEL) that is 

established by EPA to provide adequate 

protection to human health. In addition 


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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 Numbers: P–14–472 and P–14–496 

Chemical names: Polyphosphoric 

acids, 2-[alkyl-1-oxo-2-propen-1- 

yl)oxy]ethyl esters, compds. with N- 

(aminoiminomethyl)urea (generic) (P– 

14–472) and Polyphosphoric acids, 2- 

[(2-methyl-1-oxo-2-propen-1- 

yl)oxy]ethyl esters, compds. with alkyl 

amino, polymers with Bu acrylate, N- 

(hydroxymethyl)propenamide and 

styrene (generic) (P–14–496). 

CAS numbers: Not available. 

Effective date of TSCA section 5(e) 

Order: April 26, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the generic (nonconfidential) uses of the PMN 

substances are as a site-controlled 

intermediate (P–14–472) and a paper 

additive (P–14–496). Based on Structure 

Activity Relationship (SAR) analysis of 

test data on acrylates/methacrylates, and 

other structurally similar substances, 

there is potential for irritation and 

sensitization for P–14–472. For P–14– 

496 there is concern for sensitization 

based on the presence of formaldehyde 

and concern for irritation and lung 

effects from the surfactant properties of 

the substance. Further, based on SAR 

analysis of test data on analogous 

phosphates, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 3 parts per 

billion (ppb) of P–14–472 and 4 ppb of 

P–14–496 in surface waters. The Order 

was issued under TSCA sections 

5(a)(3)(B)(i) and 5(e)(1)(A)(i), based on a 

finding that the available information is 

insufficient to permit a reasoned 

evaluation of the human health effects 

of the PMN substances. Further, 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 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 of certain toxicity 

testing on the PMN substances prior to 

exceeding the confidential production 

volume limit as specified in the Order. 

2. Use of personal protective 

equipment to prevent dermal exposure. 

3. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the Safety Data 

Sheet (SDS). 

4. No release of the PMN substances 

resulting in surface water 

concentrations that exceed 3 ppb for P– 

14–472 and 4 ppb for P–14–496. 

5. No modification of the 

manufacturing process that results in 

inhalation exposure and no use 

involving application methods that 

generate a dust, mist, or aerosol. 

6. Use of the PMN substances only as 

a site-limited intermediate (P–14–472) 

and the confidential use specified in the 

Order (P–14–496). 

The SNUR would designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the fate and human health toxicity 

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 will be 

designated by this SNUR. The submitter 

has agreed not to exceed the 

confidential production limit without 

performing a skin sensitization study 

and a biodegradation test on each 

substance. In addition, EPA has 

determined that the results of a 

pulmonary effects testing of the PMN 

substance may be potentially useful in 

characterizing the health effects of the 

PMN substances. Although the Order 

does not require this additional testing, 

the Order’s restrictions on manufacture, 

processing, distribution in commerce, 

and disposal 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 721.11024 (P– 

14–472) and 40 CFR 721.11025 (P–14– 

496). 

PMN Number: P–14–630 

Chemical name: Bismuth bromide 

iodide oxide. 

CAS number: 340181–06–8. 

Effective date of TSCA section 5(e) 

Order: May 10, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the substance will 

be used as a pigment for liquid coatings 

solvent based system; a pigment for 

powder coatings; and a pigment for 

polymer materials. Based on test data 

and physical/chemical properties of the 

PMN substance, as well as SAR analysis 

of analogous respirable, poorly soluble 

particulates, EPA identified concerns for 

lung effects, including fibrosis. The 

Order was issued under TSCA sections 

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

based on insufficient information to 

make a reasoned evaluation and a 

finding that the substance may present 

an unreasonable risk of injury to human 

health. EPA assessed risks based on the 

specific manufacturing, processing, use, 

distribution/transportation, treatment 

and disposal processes, process 

equipment, engineering controls, and 

handling practices (including worker 

activities and cleaning procedures) 

described in the PMN. 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 a National Institute for 

Occupational Safety and Health 

(NIOSH)-certified respirator with an 

Assigned Protection Factor (APF) of at 

least 10 (where there is a potential for 

inhalation exposures) or compliance 

with a New Chemical Exposure Limit 

(NCEL) of 2.4 milligram/meter3 (mg/m3) 

as an 8-hour time-weighted average. 

3. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS. 

4. No use of the substance in a 

consumer product that generates a dust, 

mist, or aerosol. 

The SNUR will designate as a 

‘‘significant new use’’ the absence of 

these protective measures, and any use 

to vary or alter, the manufacturing, 

processing, use, distribution/ 

transportation, treatment and disposal 

processes, process equipment, 

engineering controls, and handling 

practices (including worker activities 

and cleaning procedures) described in 

the PMN in such a way as to change the 

magnitude of inhalation exposure. 


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Potentially useful information: EPA 

has determined that certain information 

about the human health toxicity 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 will be 

designated by this SNUR. The submitter 

has agreed not to exceed the 

confidential production limit without 

performing specific target organ toxicity 

testing. In addition, EPA has determined 

that the results of a chronic toxicity/ 

carcinogenicity test of the PMN 

substance may be potentially useful in 

characterizing the health effects of the 

PMN substance. Although the Order 

does not require this additional testing, 

the Order’s restrictions on manufacture, 

processing, distribution in commerce, 

and disposal 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 721.11026. 

PMN Number: P–15–450 

Chemical name: Aluminum cobalt 

lithium nickel oxide. 

CAS number: 177997–13–6. 

Effective date of TSCA section 5(e) 

Order: March 23, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the substance will 

be used as a mixed metal oxide for 

batteries. Based on test data on the PMN 

substance, EPA identified concerns for 

spleen and kidney toxicity. Based on 

physical/chemical properties of the 

PMN substance, as well as SAR analysis 

of analogous respirable, poorly soluble 

particulates, EPA identified concerns for 

lung effects based on lung overload. 

Based on the crystalline structure of the 

PMN substance, EPA identified concern 

for lung carcinogenicity. The Order was 

issued under TSCA sections 

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

based on insufficient information to 

make a reasoned evaluation and a 

finding that the substance may present 

an unreasonable risk of injury to human 

health. EPA assessed risks based on the 

specific manufacturing, processing, use, 

distribution/transportation, treatment 

and disposal processes, process 

equipment, engineering controls, and 

handling practices (including worker 

activities and cleaning procedures) 

described in the PMN. To protect 

against these risks, the Order requires: 

1. Submission of certain toxicity 

testing on the PMN substance prior to 

exceeding the time limit as specified in 

the Order. 

2. Use of personal protective 

equipment including impervious gloves 

and protective clothing (where there is 

a potential for dermal exposures). 

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 

0.000092 ppm as an 8-hour timeweighted average. 

4. Use of the chemical transfer 

processes and air ventilation processes 

described in the PMN and the exposure 

monitoring requirements described 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. Disposal of the PMN substance by 

landfill only. Air releases are limited by 

processes described in the PMN, 

including filtering through a highefficiency particulate air filter with an 

efficiency rate of 99.99%. 

7. No domestic manufacture of the 

PMN substance. 

The SNUR will designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the human health toxicity 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 will be 

designated by this SNUR. The submitter 

has agreed not to exceed the time limit 

without performing specific target organ 

toxicity testing and carcinogenicity 

testing. In addition, EPA has determined 

that the results of medical monitoring of 

the workers exposed to the substance 

during manufacturing, processing, and 

use may be potentially useful in 

characterizing the health effects of the 

PMN substance. Although the Order 

does not require this medical 

monitoring, the Order’s restrictions on 

manufacture, processing, distribution in 

commerce, and disposal 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 721.11027. 

PMN Number: P–15–705 

Chemical name: Alkylarylamine 

(generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: May 11, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the substance will 

be used as a chemical intermediate and 

as an additive and octane booster in 

aviation fuels. 

Based on test data on the PMN 

substance, EPA has identified concerns 

for dermal irritation, developmental 

toxicity, and blood effects. Based on test 

data on analogous anilines, EPA has 

identified concerns for cardiovascular, 

eye, liver, kidney, and pulmonary 

effects, as well as bladder cancer. The 

Order was issued under TSCA sections 

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

based on insufficient information to 

make a reasoned evaluation and a 

finding that the substance may present 

an unreasonable risk of injury to human 

health. 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 including impervious gloves, 

full body chemical protective clothing 

and chemical goggles or equivalent eye 

protection (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 

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

average. (EPA’s estimates indicate that 

variations of the parameters (including 

batch size, number of processing sites, 

days per year of operation) of the uses 

identified below would not result in 

inhalation exposure that would indicate 

a different respirator.) 

4. No use of the substance in a 

consumer product. 

5. No use other than as a chemical 

intermediate or as an additive and 

octane booster in aviation fuels. 

6. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS. 

7. No release of the PMN substance 

resulting in surface water 

concentrations that exceed 1 ppb. 

The SNUR will designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the human health and aquatic 

toxicity 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 


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SNUN for a significant new use that will 

be designated by this SNUR. The 

submitter has agreed not to exceed the 

confidential production limit without 

performing specific target organ toxicity 

testing and a chronic aquatic toxicity 

test. 

CFR citation: 40 CFR 721.11028. 

PMN Numbers: P–15–706 and P–15–707 

Chemical names: Aliphatic N-alkyl 

urea polymer containing cyclohexyl 

groups and trimethoxy silanes (generic) 

(P–15–706) and Aliphatic N-alkyl urea 

polymer containing aspartic ester 

groups and trimethoxy silanes (generic) 

(P–15–707). 

CAS numbers: Not available. 

Effective date of TSCA section 5(e) 

Order: April 26, 2017. 

Basis for TSCA section 5(e) Order: 

The PMNs state that the generic use of 

the substances will be as ingredients for 

multipurpose exterior coatings. Based 

on SAR analysis on reactive methoxy 

silane moieties, EPA has identified 

concerns for irritation to lungs, eyes, 

and mucus membranes. There are also 

concerns for acute toxicity, 

neurotoxicity, and developmental 

toxicity based on the presence of 

methanol, and for sensitization if there 

are residual isocyanates. The Order was 

issued under TSCA sections 

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

based on insufficient information to 

make a reasoned evaluation and a 

finding that the substances may present 

an unreasonable risk of injury to human 

health. To protect against these risks, 

the Order requires: 

1. Submission of certain toxicity 

testing on the PMN substance prior to 

exceeding the production limit as 

specified in the Order. 

2. Use of personal protective 

equipment including impervious gloves 

(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 a potential for inhalation exposure) or 

compliance with a NCEL of 0.9 mg/m3

as an 8-hour time-weighted average. 

(EPA’s estimates indicate that variations 

of the parameters (including batch size, 

number of processing sites, days per 

year of operation) of the uses identified 

below would not result in inhalation 

exposure that would indicate a different 

respirator.) 

4. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS. 

5. No manufacture beyond an annual 

production volume of 250,000 kilograms 

(kg). 

6. Manufacture of the PMN substances 

to contain no more than 0.1% residual 

isocyanate by weight. 

7. No uses of the substances other 

than allowed in the Order. 

8. No use of the substances in a 

consumer product. 

The SNUR will designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the human health toxicity 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 will be 

designated by this SNUR. The submitter 

has agreed not to exceed the 

confidential production limit without 

performing specific target organ toxicity 

testing for P–15–706. 

CFR citation: 40 CFR 721.11029 (P– 

15–706) and 40 CFR 721.11030 (P–15– 

707). 

PMN Numbers: P–16–273 and P–16–274 

Chemical names: Alkyl 

heteromonocycle, polymer with 

heteromonocycle, carboxyalkyl alkyl 

ethers (generic). 

CAS numbers: Not available. 

Effective date of TSCA section 5(e) 

Order: April 25, 2017. 

Basis for TSCA section 5(e) Order: 

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

be as ingredients in metalworking 

fluids. Based on submitted test data for 

P–16–273 and structurally similar 

surfactants, EPA has identified concerns 

for dermal sensitization and irritation 

and lung effects. Based on submitted 

toxicity data for P–16–273, EPA 

estimates toxicity to aquatic organisms 

may occur for both PMNs at 

concentrations that exceed 10 ppb of the 

PMN substances in surface waters. The 

Order was issued under TSCA sections 

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

based on insufficient information to 

make a reasoned evaluation and a 

finding that the substances may present 

an unreasonable risk of injury to human 

health and the environment. To protect 

against these risks, the Order requires: 

1. No domestic manufacture of the 

PMN substances. 

2. Use of the PMN substances only: (i) 

For the confidential uses specified in 

the Order, (ii) at a concentration no 

greater than 3% of the metalworking 

fluid, and (iii) used only in closed 

metalworking systems as specified in 

the PMNs with no modifications in the 

process that would result in worker 

inhalation exposure. 

3. Use of personal protective 

equipment including impervious gloves 

(where there is a potential for dermal 

exposure). 

4. No release of the PMN substances 

resulting in surface water 

concentrations that exceed 10 ppb. 

The SNUR will designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the fate and toxicity of the PMN 

substances may be potentially useful to 

characterize the health and 

environmental 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 will be 

designated by this SNUR. EPA has 

determined that the results of specific 

target organ toxicity testing and a 

biodegradation test of the PMN 

substances may be potentially useful in 

characterizing the health and 

environmental effects of the PMN 

substances. Although the Order does not 

require these tests, the Order’s 

restrictions on manufacture, processing, 

distribution in commerce, and disposal 

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 721.11031. 

PMN Number: P–16–289 

Chemical name: Benzene dicarboxylic 

acid, polymer with alkane dioic acid 

and aliphatic diamine (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: March 24, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states the substance will be 

used as an extrusion compounding 

molding resin. Based on test data on 

analogous high molecular weight 

polymers, EPA has concerns for lung 

effects, which includes lung overload. 

The Order was issued under TSCA 

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

5(e)(1)(A)(ii)(I), based on insufficient 

information to make a reasoned 

evaluation and a finding that the 

substance may present an unreasonable 

risk of injury to human health. To 

protect against these risks, the Order 

requires: 

1. Submission of particle size testing 

on the PMN substance prior to 

exceeding the time limit as specified in 

the Order. 


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2. Manufacture of the PMN substance 

such that the solid particle form has a 

particle size distribution where less 

than 1% of the particles are less than 10 

microns. 

The SNUR will designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the physical/chemical 

characteristics of the PMN substance 

may be potentially useful to characterize 

the health 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 will be 

designated by this SNUR. The submitter 

has agreed not to manufacture beyond a 

certain time period without measuring 

the particle size distribution to 

characterize the fraction of the dry 

particle PMN substance less than 10 

microns. In addition, EPA has 

determined that the results of specific 

target organ toxicity testing of the PMN 

substance may be potentially useful in 

characterizing the health effects of the 

PMN substance. Although the Order 

does not require this additional testing, 

the Order’s restrictions on manufacture, 

processing, distribution in commerce, 

and disposal 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 721.11032. 

PMN Number: P–16–322 

Chemical name: Manganese cyclic 

(tri)amine chloride complex (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: April 25, 2017. 

Basis for TSCA section 5(e) Order: 

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

be as a pulp bleaching catalyst. Based 

on test data on an analog, EPA has 

identified concerns for kidney, blood, 

and thyroid effects, immunotoxicity, 

reproductive and developmental 

toxicity, and neurotoxicity. Based on 

test data on the PMN substance, EPA 

estimates that toxicity to aquatic 

organisms may occur at concentrations 

that exceed 18 ppb of the PMN 

substance in surface waters. The Order 

was issued under TSCA sections 

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

based on insufficient information to 

make a reasoned evaluation and a 

finding that 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 to prevent dermal exposure 

(where there is a potential for dermal 

exposure). 

3. Use of a NIOSH-certified respirator 

with an APF of at least 25 (where there 

is a potential for inhalation exposure) or 

compliance with a NCEL of 1.2 ppm as 

an 8-hour time-weighted average. (EPA’s 

estimates indicate that variations of the 

parameters (including batch size, 

number of processing sites, days per 

year of operation) of the uses identified 

below would not result in inhalation 

exposure that would indicate a different 

respirator.) 

4. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS. 

5. No domestic manufacture of the 

PMN substance. 

6. Process and use of the PMN 

substance only for the confidential uses 

and formulation percentage specified in 

the Order. 

7. No release of the PMN substance 

resulting in surface water 

concentrations that exceed 18 ppb. 

The SNUR will designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the human health and aquatic 

toxicity 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 will 

be designated by this SNUR. The 

submitter has agreed not to exceed the 

confidential production limit without 

performing specific target organ toxicity 

testing, reproductive/developmental 

toxicity testing; and chronic aquatic 

toxicity testing. 

CFR citation: 40 CFR 721.11033. 

PMN Numbers: P–16–338, P–16–339, 

P–16–439, and P–16–440 

Chemical names: Xanthylium, 

(sulfoaryl)-bis [(substituted aryl) 

amino]-, sulfo derivs., inner salts, metal 

salts (generic) (P–16–338); Substituted 

triazinyl metal salt, diazotized, coupled 

with substituted 

pyridobenzimidazolesulfonic acids, 

substituted 

pyridobenzimidazolesulfonic acids, 

diazotized substituted alkanesulfonic 

acid, diazotized substituted aromatic 

sulfonate, diazotized substituted 

aromatic sulfonate, metal salts (generic) 

(P–16–339); Carbon black, (organic 

acidic carbocyclic)-modified, inorganic 

salt (generic) (P–16–439); and Carbon 

black, (organic acidic carbocyclic)- 

modified, metal salt (generic) (P–16– 

440). 

CAS numbers: Not available. 

Effective date of TSCA section 5(e) 

Order: April 11, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the generic (nonconfidential) uses of the PMN 

substances will be as dyestuffs (P–16– 

0338 and P–16–0339) and as coloring 

agents (P–16–0439 and P–16–0440). 

Based on physical/chemical properties 

of the PMN substances and test data on 

analogous poorly respirable particles, 

EPA has identified concerns for 

irritation to the eyes, lungs, and mucous 

membranes, and lung effects. Further, 

based on SAR analysis of test data on 

analogous dyes, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 200 ppb of 

the PMN substances in surface waters. 

The Order was issued under TSCA 

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

5(e)(1)(A)(ii)(I), based on insufficient 

information to make a reasoned 

evaluation and a finding that the 

substances may present an unreasonable 

risk of injury to human health and the 

environment. To protect against these 

risks, the Order requires: 

1. No manufacture of the PMN 

substances beyond the confidential 

annual production volume specified in 

the Order. 

2. No domestic manufacture of the 

PMN substances. 

3. Import the PMN substances only 

according to the terms specified and for 

the confidential uses specified in the 

Order. 

4. No release of the PMN substances 

to surface waters. 

The SNUR will designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the fate, human health toxicity, 

and aquatic toxicity 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 will be 

designated by this SNUR. EPA has 

determined that the results of a 

biodegradation test, specific target organ 

toxicity testing, and acute and chronic 

aquatic toxicity testing of the PMN 


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substances may be potentially useful in 

characterizing the health and 

environmental effects of the PMN 

substances. Although the Order does not 

require these tests, the Order’s 

restrictions on manufacture, processing, 

distribution in commerce, and disposal 

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 721.11034 (P– 

16–338), 40 CFR 721.11035 (P–16–339), 

40 CFR 721.11036 (P–16–439), and 40 

CFR 721.11037 (P–16–440). 

PMN Number: P–16–350 

Chemical name: Polyaralkyl aryl ester 

of methacrylic acid (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: March 31, 2017. 

Basis for TSCA section 5(e) Order: 

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

be as a polymer reactant. Based on test 

data on methacrylate moieties, EPA has 

identified concerns for irritation and 

sensitization based on analogy to 

methacrylates. Based on SAR analysis of 

test data on structurally similar 

respirable surfactants, EPA has 

identified concerns for lung effects. The 

Order was issued under TSCA sections 

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

based on insufficient information to 

make a reasoned evaluation and a 

finding that the substance may present 

an unreasonable risk of injury to human 

health. To protect against these risks, 

the Order requires: 

1. Use of personal protective 

equipment including impervious gloves 

(where there is a potential for dermal 

exposure). 

2. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS. 

3. Manufacture of the PMN substance 

such that it is not less than the 

minimum average molecular weight 

identified in the Order and does not 

contain more than the maximum weight 

percent of low molecular weight species 

below 1,000 Daltons. 

4. Use of the PMN substance only for 

the confidential use specified in the 

Order. 

The SNUR will designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the toxicity of the PMN substance 

may be potentially useful to characterize 

the health 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 will be 

designated by this SNUR. EPA has 

determined that the results of specific 

target organ toxicity testing and a 

sensitization test of the PMN substance 

may be potentially useful in 

characterizing the health effects of the 

PMN substance. Although the Order 

does not require these tests, the Order’s 

restrictions on manufacture, processing, 

distribution in commerce, and disposal 

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 721.11038. 

PMN Number: P–16–352 

Chemical names: Phenol, 2-[[[3- 

(octyloxy)propyl]imino]methyl]- (P–16– 

352, chemical A) and Phenol, 2-[[[3- 

(decyloxy)propyl]imino]methyl]- (P–16– 

352, chemical B). 

CAS numbers: 1858221–49–4 (P–16– 

352, chemical A) and 1858221–50–7 (P– 

16–352, chemical B). 

Effective date of TSCA section 5(e) 

Order: April 21, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the PMN 

substances will be used as co-catalysts 

in the manufacturing of release coatings 

for producing papers and films at a 

concentration of 1% or less. Based on 

SAR analysis of test data on analogous 

phenols, EPA has identified concerns 

for respiratory and dermal irritation and 

developmental toxicity. In addition, 

EPA has identified concerns for liver 

toxicity and reproductive effects based 

on the hydrolysis product ohydroxybenzaldehyde. Further, based 

on SAR analysis of test data on 

analogous phenols, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 1 ppb of 

the PMN substances in surface waters. 

The Order was issued under TSCA 

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

5(e)(1)(A)(ii)(I), based on insufficient 

information to make a reasoned 

evaluation and a finding that 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 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 including impervious gloves 

(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. No domestic manufacture of the 

PMN substances. 

5. No manufacture of the PMN 

substances beyond an annual 

production volume of 250 kg/yr. 

6. No use of the PMN substances in 

application methods that generate a 

dust, mist, or aerosol. 

7. No release of the PMN substance 

resulting in surface water 

concentrations that exceed 1 ppb. 

The SNUR will designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the human health and aquatic 

toxicity 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 will 

be designated by this SNUR. The 

submitter has agreed not to exceed the 

confidential production limit without 

performing specific target organ toxicity, 

reproductive/developmental toxicity, 

and acute aquatic toxicity testing. 

CFR citations: 40 CFR 721.11039 (P– 

16–352, chemical A) and 40 CFR 

721.11040 (P–16–352, chemical B). 

PMN Number: P–16–358 

Chemical name: Alkyl phenol 

(generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: April 24, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the substance will 

be used as a chemical intermediate. 

Based on SAR analysis of test data on 

analogous phenols, EPA has identified 

concerns for developmental toxicity. 

The Order was issued under TSCA 

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

5(e)(1)(A)(ii)(I), based on insufficient 

information to make a reasoned 

evaluation and a finding that the 

substance may present an unreasonable 

risk of injury to human health. 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 including impervious gloves 

(where there is a 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 in the SDS. 

4. Use of the PMN substance only as 

a chemical intermediate. 

5. No manufacture, process, or use of 

the PMN substance in any manner or 

method that generates a dust, mist, or 

aerosol or in a non-enclosed process. 

6. No release of the PMN substance to 

surface waters. 

The SNUR will designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the human health toxicity 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 will be designated 

by this SNUR. The submitter has agreed 

not to exceed the confidential 

production limit without performing 

specific target organ toxicity and 

reproductive/developmental toxicity 

tests. 

CFR citation: 40 CFR 721.11041. 

PMN Number: P–16–364 

Chemical name: Nitrile-butadieneacrylate terpolymers (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: March 31, 2017. 

Basis for TSCA section 5(e) Order: 

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

be as a chemical intermediate. Based on 

SAR analysis of test data on structurally 

similar respirable particles, EPA has 

identified concerns for lung effects, 

including lung overload. The Order was 

issued under TSCA sections 

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

based on insufficient information to 

make a reasoned evaluation and a 

finding that the substance may present 

an unreasonable risk of injury to human 

health. To protect against these risks, 

the Order requires: 

1. Use of the PMN substance only as 

a site-limited chemical intermediate. 

2. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS. 

3. No manufacture, process, or use of 

the PMN substance if it contains more 

than 5% of the particle size distribution 

less than 10 microns. 

The SNUR will designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the toxicity 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 will be 

designated by this SNUR. EPA has 

determined that the results of specific 

target organ toxicity testing of the PMN 

substance may be potentially useful in 

characterizing the health effects of the 

PMN substance. Although the Order 

does not require this test, the Order’s 

restrictions on manufacture, processing, 

distribution in commerce, and disposal 

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 721.11042. 

PMN Number: P–16–399 

Chemical name: Starch, polymer with 

2-propenoic acid, potassium salt, 

oxidized. 

CAS number: 1638117–09–5. 

Effective date of TSCA section 5(e) 

Order: April 6, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the substance will 

be used as an agricultural soil 

amendment for field crops, agricultural 

soil amendment for turf applications 

and direct soil injection with fertilizers, 

and a compound to be used in 

preparation of advanced seed coatings. 

Based on SAR analysis of test data on 

structurally similar respirable particles, 

EPA has identified concerns for lung 

effects, including lung overload. The 

Order was issued under TSCA sections 

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

based on insufficient information to 

make a reasoned evaluation and a 

finding that the substance may present 

an unreasonable risk of injury to human 

health. 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 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 of certain toxicity 

testing on the PMN substance prior to 

exceeding the time limit as specified in 

the Order. 

2. Use of personal protective 

equipment including impervious gloves 

(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. Manufacture of the substance with 

a particulate size greater than 30 

microns. 

The SNUR will designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the toxicity of the PMN substance 

may be potentially useful to characterize 

the health and environmental 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 will 

be designated by this SNUR. The 

submitter has agreed not to manufacture 

beyond a certain time limit without 

performing an acute aquatic toxicity 

test. In addition, EPA has determined 

that the results of specific target organ 

toxicity testing of the PMN substance 

may be potentially useful in 

characterizing the health effects of the 

PMN substance. Although the Order 

does not require this additional testing, 

the Order’s restrictions on manufacture, 

processing, distribution in commerce, 

and disposal 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 721.11043. 

PMN Number: P–16–430 

Chemical name: Pentanedioic acid, 2- 

methyl-. 

CAS number: 617–62–9. 

Effective date of TSCA section 5(e) 

Order: May 17, 2017. 

Basis for TSCA section 5(e) Order: 

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

be as a filler. Based on test data on the 

PMN substance, EPA has identified 

concerns for systemic and reproductive 

toxicity. Based on structural analysis on 

the acid groups and test data, EPA has 

identified concerns for dermal and 

respiratory irritation. Further, based on 

test data on the PMN substance and test 

data on analogous neutral organics, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

14 ppb of the PMN substance in surface 

waters. The Order was issued under 

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

5(e)(1)(A)(ii)(I), based on insufficient 

information to make a reasoned 

evaluation and a finding that the 


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substance may present an unreasonable 

risk of injury to human health and the 

environment. EPA assessed risks based 

on the specific processing, use, 

distribution/transportation, treatment 

and disposal processes, process 

equipment, engineering controls, and 

handling practices (including worker 

activities and cleaning procedures) 

described in the PMN. To protect 

against these risks, the Order requires: 

1. Use of personal protective 

equipment including impervious gloves 

(where there is a potential for dermal 

exposure). 

2. Use of a NIOSH-certified respirator 

with an APF of at least 10 (where there 

is a potential for inhalation exposure). 

(EPA’s estimates indicate that variations 

of the parameters (including batch size, 

number of processing sites, days per 

year of operation) of the uses identified 

below would not result in inhalation 

exposure that would indicate a different 

respirator.) 

3. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS. 

4. No domestic manufacture of the 

PMN substance. 

5. Import of the PMN substance at or 

below the maximum concentration 

specified in the Order. 

6. No release of the PMN substance 

resulting in surface water 

concentrations that exceed 14 ppb. 

The SNUR will designate as a 

‘‘significant new use’’ the absence of 

these protective measures, and use of 

the chemical substance to vary or alter 

the processing, use, distribution, 

engineering controls, and handling 

practices described in the Order in such 

a way as to change the magnitude of 

inhalation exposure. 

Potentially useful information: EPA 

has determined that certain information 

about the human health toxicity of the 

PMN substance may be potentially 

useful to characterize the effects of the 

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 will be 

designated by this SNUR. EPA has 

determined that the results of specific 

target organ toxicity testing of the PMN 

substance may be potentially useful in 

characterizing the health effects of the 

PMN substance. Although the Order 

does not require this test, the Order’s 

restrictions on manufacture, processing, 

distribution in commerce, and disposal 

will remain in effect until the Order is 

modified or revoked by EPA based on 

submission of this or other information. 

CFR citation: 40 CFR 721.11044. 

PMN Number: P–16–495 

Chemical name: 2-Pentanol, 

4-methyl-, reaction products with 

phosphorus oxide (P2O5), compounds 

with alkylamine (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: April 25, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the generic use 

(non-confidential) of the substance will 

be as a lubricant additive. Based on test 

data on the substance, EPA has 

identified concerns for systemic effects, 

sensitization and irritation to the eyes 

and skin. Based on physical/chemical 

properties, EPA has concerns for lung 

effects, including lung surfactancy. 

Further, based on test data on analogous 

aliphatic amines for the cation and 

neutral organics for the anion as well as 

test data on the PMN substance, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

200 ppb of the PMN substance in 

surface waters. The Order was issued 

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

5(e)(1)(A)(ii)(I), based on insufficient 

information to make a reasoned 

evaluation and a finding that 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. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS. 

4. No manufacture in any manner or 

method that results in inhalation 

exposure. 

5. No use of the PMN substance in an 

application method that generates a 

vapor, mist, or aerosol. 

6. No release of the PMN substance 

resulting in surface water 

concentrations that exceed 200 ppb. 

The SNUR will designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the human health and aquatic 

toxicity of the PMN substance may be 

potentially useful to characterize the 

effects of the PMN substance 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 will 

be designated by this SNUR. The 

submitter has agreed not to exceed the 

confidential production limit without 

performing chronic aquatic toxicity 

tests. In addition, EPA has determined 

that the results of specific target organ 

toxicity testing of the PMN substance 

may be potentially useful in 

characterizing the health effects of the 

PMN substance. Although the Order 

does not require this additional testing, 

the Order’s restrictions on manufacture, 

processing, distribution in commerce, 

and disposal 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 721.11045. 

PMN Number: P–16–513 

Chemical name: Hydroxy 

alkylbiphenyl (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: May 2, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the substance will 

be used as a chemical intermediate. 

Based on test data on an analog, EPA 

has identified concerns for 

developmental toxicity, systemic 

toxicity, blood effects, and corrosion of 

the skin, eyes, and mucous membranes. 

Further, based on SAR analysis of test 

data on analogous amides, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 17 ppb of 

the PMN substances in surface waters. 

The Order was issued under TSCA 

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

5(e)(1)(A)(ii)(I), based on insufficient 

information to make a reasoned 

evaluation and a finding that 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 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. Use of a NIOSH-certified respirator 

with an APF of at least 50 (where there 

is a potential for inhalation exposure). 

(EPA’s estimates indicate that variations 

of the parameters (including batch size, 

number of processing sites, days per 

year of operation) of the uses identified 

below would not result in inhalation 

exposure that would indicate a different 

respirator.) 

4. Use of the PMN substance only as 

a chemical intermediate. 


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5. No release of the PMN substance 

resulting in surface water 

concentrations that exceed 17 ppb. 

The SNUR will designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the human health and aquatic 

toxicity 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 will 

be designated by this SNUR. The 

submitter has agreed not to exceed the 

confidential production limit without 

performing specific target organ toxicity 

and reproductive/developmental 

toxicity testing. In addition, EPA has 

determined that the results of acute 

aquatic toxicity tests may be potentially 

useful in characterizing the 

environmental effects of the PMN 

substance. Although the Order does not 

require these additional tests, the 

Order’s restrictions on manufacture, 

processing, distribution in commerce, 

and disposal 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 721.11046. 

PMN Numbers: P–16–534, P–16–535, 

and P–16–536 

Chemical names: Alkyl alkenoic acid, 

polymer with alkenylcarbomonocycle 

telomer with substituted alkanoic acid 

hydroxyl alkyl substituted alkenyl 

substituted alkyl ester, polyalkylene 

glycol alkyl ether alkyl alkenoate, 

dialkylene glycol diheteromonocyclic 

ether and alkylcarbomonocyclic 

alkenoate, metal salt (generic) (P–16– 

534); Alkyl alkenoic acid, polymer with 

alkenylcarbomonocycle telomer with 

substituted alkanoic acid hydroxyl alkyl 

substituted alkenyl substituted alkyl 

ester, alkanediol diheteromonocyclic 

ether, polyalkylene glycol alkyl ether 

alkyl alkenoate and 

alkylcarbomonocyclic alkenoate, metal 

salt (generic) (P–16–535); and Alkyl 

alkenoic acid, polymer with bis 

heteromonocyclic substituted alkyl 

carbomonocycle, 

alkenylcarbomonocycle telomer with 

substituted alkanoic acid hydroxyl alkyl 

substituted alkenyl substituted alkyl 

ester, polyalkylene glycol alkyl ether 

alkyl alkenoate and 

alkylcarbomonocyclic alkenoate, metal 

salt (generic) (P–16–536). 

CAS numbers: Not available. 

Effective date of TSCA section 5(e) 

Order: April 4, 2017. 

Basis for TSCA section 5(e) Order: 

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

be a component of ink. Based on test 

data on structurally similar respirable 

particles, EPA has identified concerns 

for lung effects if inhaled, based on lung 

overload. In addition, EPA has 

identified ecotoxicity concerns for the 

substances if made with an acid 

component exceeding 20% of the 

molecular weight due potential for 

increased absorption and solubility. The 

Order was issued under TSCA sections 

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

based on insufficient information to 

make a reasoned evaluation and a 

finding that the substances may present 

an unreasonable risk of injury to human 

health and the environment. To protect 

against these risks, the Order requires: 

1. Manufacture of the PMN substances 

such that the minimum average 

molecular weight is 1,800 daltons and 

the carboxylic acid content does not 

exceed 20%. 

2. No domestic manufacture of the 

PMN substances. 

3. Process or use of the PMN 

substances only for the use specified in 

the Order. 

The SNUR will designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the human health and aquatic 

toxicity of the PMN substances may be 

potentially useful to characterize the 

effects of the 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 will 

be designated by this SNUR. EPA has 

determined that the results of specific 

target organ toxicity testing and an acute 

aquatic toxicity test of the PMN 

substances may be potentially useful in 

characterizing the health and 

environmental effects of the PMN 

substances. Although the Order does not 

require these tests, the Order’s 

restrictions on manufacture, processing, 

distribution in commerce, and disposal 

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 721.11047 (P– 

16–534), 40 CFR 721.11048 (P–16–535), 

and 40 CFR 721.11049 (P–16–536). 

PMN Numbers: P–16–549, P–16–550, P– 

16–551, P–16–553, P–16–555, P–16–556, 

P–16–557, P–16–558, P–16–560, P–16– 

561, P–16–562, P–16–563, P–16–564, P– 

16–565, and P–16–567 

Chemical names: Alkaline 

functionalized methacrylate-substituted 

polymer (generic) (P–16–549, P–16–550, 

and P–16–551); Quatenary alkylamine 

functionalized methacrylate-substituted 

polymer (generic) (P–16–553); Neutral 

alcohol functionalized methacrylatesubstituted polymer (generic) (P–16–555 

and P–16–556); Neutral alkyl salt 

functionalized methacrylate-substituted 

polymer (generic) (P–16–557, P–16–558, 

and P–16–560); Acid functionalized 

methacrylate-substituted polymer 

(generic) (P–16–561, P–16–562, P–16– 

563, P–16–564, and P–16–565); and 

Alkylamine functionalized 

methacrylate-substituted polymer 

(generic) (P–16–567). 

CAS numbers: Not available. 

Effective date of TSCA section 5(e) 

Order: May 2, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states the substances will be 

use as crosslinked resins for 

chromatographic separation of 

biomolecules and biocatalysts. Based on 

test data on structurally similar 

respirable particles, EPA has identified 

concerns for lung effects, including lung 

overload. EPA has also identified 

irritation concerns for skin and eyes. 

The Order was issued under TSCA 

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

5(e)(1)(A)(ii)(I), based on insufficient 

information to make a reasoned 

evaluation and a finding that the 

substances may present an unreasonable 

risk of injury to human health. To 

protect against these risks, the Order 

requires: 

1. Use of personal protective 

equipment including impervious gloves 

(where there is a potential for dermal 

exposure). 

2. Manufacture of the PMN substances 

only in the physical form of spherical 

beads and with less than 0.1% below a 

particle size of 10 microns. 

3. No domestic manufacture of the 

PMN substances. 

4. Process or use of the PMN 

substances only for the uses specified in 

the Order. 

The SNUR will designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the human health toxicity of the 

PMN substances may be potentially 

useful to characterize the effects of the 

substances in support of a request by the 

PMN submitter to modify the Order, or 


sradovich on DSK3GMQ082PROD with RULES2
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if a manufacturer or processor is 

considering submitting a SNUN for a 

significant new use that will be 

designated by this SNUR. EPA has 

determined that the results of specific 

target organ toxicity testing of the PMN 

substances may be potentially useful in 

characterizing the health effects of the 

PMN substances. Although the Order 

does not require this testing, the Order’s 

restrictions on manufacture, processing, 

distribution in commerce, and disposal 

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 721.11050. 

PMN Number: P–16–579 

Chemical name: Waste plastics, 

poly(ethylene terephthalate), depolymd. 

with polypropylene glycol ether with 

glycerol (3:1), polymers with alkenoic 

and alkanoic acids (generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: March 13, 2017. 

Basis for TSCA section 5(e) Order: 

The PMN states that the substance will 

be used as an ultraviolet curable coating 

resin. Based on test data on similar 

structural moieties, EPA has identified 

concerns for dermal and respiratory 

sensitization and irritation of mucous 

membranes. In addition, EPA has 

identified human health and 

environmental concerns for the 

substance if made with lower molecular 

weight due potential for increased 

absorption and solubility. The Order 

was issued under TSCA sections 

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

based on insufficient information to 

make a reasoned evaluation and a 

finding that 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 personal protective 

equipment including gloves and 

protective clothing (where there is a 

potential for dermal exposure). 

2. Use of a NIOSH-certified full face 

respirator with an APF of at least 50 

(where there is a potential for inhalation 

exposure). (EPA’s estimates indicate 

that variations of the parameters 

(including batch size, number of 

processing sites, days per year of 

operation) of the uses identified below 

would not result in inhalation exposure 

that would indicate a different 

respirator.) 

3. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS. 

4. No manufacture of the PMN 

substance with an average molecular 

weight less than 1,100 Daltons. 

5. Use of the PMN substance only as 

an ultraviolet curable coating resin. 

The SNUR will designate 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 human health and aquatic toxicity 

of the PMN substance may be 

potentially useful to characterize the 

effects of the 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 will 

be designated by this SNUR. EPA has 

determined that measurement of certain 

physical-chemical properties, the results 

of specific target organ toxicity, 

reproductive/developmental toxicity, 

sensitization, and acute and chronic 

aquatic toxicity testing may be 

potentially useful in characterizing the 

health and environmental effects of the 

PMN substances. Although the Order 

does not require these tests, the Order’s 

restrictions on manufacture, processing, 

distribution in commerce, and disposal 

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 721.11051. 

PMN Number: P–17–32 

Chemical name: 1,3,5- 

Naphthalenetrisulfonic acid. 

CAS number: 6654–64–4. 

Effective date of TSCA section 5(e) 

Order: March 22, 2017. 

Basis for TSCA section 5(e) Order: 

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

monitoring of oil/gas well performance. 

Based on test data on an analog and 

physical/chemical properties of the 

PMN substance, EPA has identified 

concerns for dermal and respiratory 

irritation, developmental toxicity, and 

blood effects. The Order was issued 

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

5(e)(1)(A)(ii)(I), based on insufficient 

information to make a reasoned 

evaluation and a finding that the 

substance may present an unreasonable 

risk of injury to human health. 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 including NIOSH-approved 

respirator (APF 50) and impervious 

gloves (where there is a potential for 

inhalation or dermal exposure). (EPA’s 

estimates indicate that variations of the 

parameters (including batch size, 

number of processing sites, days per 

year of operation) of the uses identified 

below would not result in inhalation 

exposure that would indicate a different 

respirator.) 

3. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS. 

4. No manufacture or processing of 

the PMN substance beyond a 

confidential annual production volume 

specified in the Order. 

5. No manufacture, processing, or use 

using application methods that 

intentionally generate a vapor, mist or 

aerosol. 

The SNUR will designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the human health toxicity 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 will be 

designated by this SNUR. The submitter 

has agreed not to exceed the 

confidential production limit without 

performing specific target organ toxicity 

and developmental toxicity testing. 

CFR citation: 40 CFR 721.11052. 

PMN Numbers: P–17–33, P–17–34, P– 

17–36, P–17–38, P–17–39, P–17–41, P– 

17–42, P–17–43, P–17–45, P–17–47, P– 

17–50, P–17–52, P–17–55, P–17–57, P– 

17–59, P–17–61, P–17–62, P–17–63, P– 

17–64, P–17–66, P–17–67, P–17–69, P– 

17–71, P–17–72, P–17–73, P–17–75, P– 

17–76, P–17–79, P–17–80, P–17–83, P– 

17–85, P–17–87, P–17–90, P–17–91, 

P–17–93 


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CHEMICAL NAMES AND CAS NUMBERS

Chemical name CAS No. 

Benzoic acid, 2-fluoro-, sodium salt (1:1) (P–17–33) ...................................................................................................................... 6654–64–4 

Benzoic acid, 4-fluoro-, sodium salt (1:1) (P–17–34) ...................................................................................................................... 499–90–1 

Benzoic acid, 2,3,4,5-tetrafluoro-, sodium salt (1:1) (P–17–36) ..................................................................................................... 67852–79–3 

Benzoic acid, 2-(trifluoromethyl)-, sodium salt (1:1) (P–17–38) ...................................................................................................... 2966–44–1 

Benzoic acid, 4-(trifluoromethyl)-, sodium salt (1:1) (P–17–39) ...................................................................................................... 25832–58–0 

Benzoic acid, 2,5-difluoro-, sodium salt (1:1) (P–17–41) ................................................................................................................ 522651–42–9 

Benzoic acid, 3-fluoro-, sodium salt (1:1) (P–17–42) ...................................................................................................................... 499–57–0 

Benzoic acid, 2,6-difluoro-, sodium salt (1:1) (P–17–43) ................................................................................................................ 6185–28–0 

Benzoic acid, 3,5-difluoro-, sodium salt (1:1) (P–17–45) ................................................................................................................ 530141–39–0 

Benzoic acid, 2,4-difluoro-, sodium salt (1:1) (P–17–47) ................................................................................................................ 1765–08–8 

Benzoic acid, 3,4-difluoro-, sodium salt (1:1) (P–17–50) ................................................................................................................ 522651–44–1 

Benzoic acid, 3,4,5-trifluoro-, sodium salt (1:1) (P–17–52) ............................................................................................................. 1180493–12–2 

Benzoic acid, 2,3,4-trifluoro-, sodium salt (1:1) (P–17–55) ............................................................................................................. 402955–41–3 

Benzoic acid, 2,4,5-trifluoro-, sodium salt (1:1) (P–17–57) ............................................................................................................. 522651–48–5 

Benzoic acid, 2,3-difluoro-, sodium salt (1:1) (P–17–59) ................................................................................................................ 1604819–08–0 

Benzoic acid, 3-(trifluoromethyl)-, sodium salt (1:1) (P–17–61) ...................................................................................................... 69226–41–1 

Benzoic acid, 2-chloro-, sodium salt (1:1) (P–17–62) ..................................................................................................................... 17264–74–3 

Benzoic acid, 4-chloro-, sodium salt (1:1) (P–17–63) ..................................................................................................................... 3686–66–6 

Benzoic acid, 3-chloro-, sodium salt (1:1) (P–17–64) ..................................................................................................................... 17264–88–9 

Benzoic acid, 2,3-dichloro-, sodium salt (1:1) (P–17–66) ............................................................................................................... 118537–84–1 

Benzoic acid, 2,5-dichloro-, sodium salt (1:1) (P–17–67) ............................................................................................................... 63891–98–5 

Benzoic acid, 3,5-dichloro-, sodium salt (1:1) (P–17–69) ............................................................................................................... 154862–40–5 

Benzoic acid, 2,6-dichloro-, sodium salt (1:1) (P–17–71) ............................................................................................................... 10007–84–8 

Benzoic acid, 3,4-dichloro-, sodium salt (1:1) (P–17–72) ............................................................................................................... 17274–10–1 

Benzoic acid, 2,4-dichloro-, sodium salt (1:1) (P–17–73) ............................................................................................................... 38402–11–8 

Benzoic acid, 2-chloro-4-fluoro-, sodium salt (P–17–75) ................................................................................................................ 855471–43–1 

Benzoic acid, 3-chloro-4-fluoro-, sodium salt (P–17–76) ................................................................................................................ 1421761–18–3 

Benzoic acid, 5-chloro-2-fluoro-, sodium salt (P–17–79) ................................................................................................................ 1382106–78–6 

Benzoic acid, 4-chloro-3-fluoro-, sodium salt (P–17–80) ................................................................................................................ 1421029–88–0 

Benzoic acid, 4-chloro-2-fluoro-, sodium salt (P–17–83) ................................................................................................................ 1382106–64–0 

Benzoic acid, 5-bromo-2-chloro-, sodium salt (P–17–85) ............................................................................................................... 1938142–12–1 

Benzoic acid, 3-bromo-4-fluoro-, sodium salt (P–17–87) ................................................................................................................ 938142–13–2 

Benzoic acid, 2-bromo-5-fluoro-, sodium salt (P–17–90) ................................................................................................................ 1938142–14–3 

Benzoic acid, 4-bromo-2-fluoro-, sodium salt (P–17–91) ................................................................................................................ 1938142–15–4 

Benzoic acid, 4-bromo-3-fluoro-, sodium salt (P–17–93) ................................................................................................................ 1535169–81–3 

Effective date of TSCA section 5(e) 

Order: March 22, 2017. 

Basis for TSCA section 5(e) Order: 

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

for monitoring of oil/gas well 

performance. Based on test data on an 

analog, EPA has identified concerns for 

reproductive, developmental and neurotoxicity, as well as lung toxicity and 

dermal irritation. The Order was issued 

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

5(e)(1)(A)(ii)(I), based on insufficient 

information to make a reasoned 

evaluation and a finding that the 

substances may present an unreasonable 

risk of injury to human health. EPA 

assessed risks based on the specific 

manufacturing, processing, use, process 

equipment, engineering controls, and 

handling practices (including worker 

activities and cleaning procedures) 

described in the PMN. To protect 

against these risks, the Order requires: 

1. Submission of certain toxicity 

testing on the PMN substances prior to 

exceeding the production volume limit 

as specified in the Order. 

2. Use of personal protective 

equipment including impervious gloves 

(where there is a potential for dermal 

exposure). 

3. Use of a NIOSH-certified respirator 

with an APF of at least 50 (where there 

is a potential for inhalation exposure) or 

compliance with a NCEL of 0.0184 ppm 

as an 8-hour time-weighted average. 

4. Use of processes, process 

equipment, engineering controls, and 

handling practices specified in the 

Order for manufacturing and processing. 

5. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS. 

6. No manufacture or process of the 

PMN substances beyond a confidential 

annual production volume specified in 

the Order. 

The SNUR will designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the human health toxicity 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 will be 

designated by this SNUR. The submitter 

has agreed not to exceed the 

confidential production limit without 

performing specific target organ toxicity 

testing on P–17–0091. 

CFR citations: 40 CFR 721.11053. 

PMN Numbers: P–17–35, P–17–37, P– 

17–40, P–17–44, P–17–46, P–17–48, P– 

17–51, P–17–53, P–17–54, P–17–56, P– 

17–58, P–17–60, P–17–65, P–17–68, P– 

17–70, P–17–74, P–17–77, P–17–78, P– 

17–81, P–17–82, P–17–84, P–17–88, P– 

17–89, P–17–92, P–17–97 


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CHEMICAL NAMES AND CAS NUMBERS

Chemical Name CAS No. 

Benzoic acid, 2,3,4,5-tetrafluoro- (P–17–35) ................................................................................................................................... 1201–31–6 

Benzoic acid, 2-(trifluoromethyl)- (P–17–37) ................................................................................................................................... 433–97–6 

Benzoic acid, 2,5-difluoro- (P–17–40) ............................................................................................................................................. 2991–28–8 

Benzoic acid, 2,6-difluoro- (P–17–44) ............................................................................................................................................. 385–00–2 

Benzoic acid, 3,5-difluoro- (P–17–46) ............................................................................................................................................. 455–40–3 

Benzoic acid, 2,4-difluoro- (P–17–48) ............................................................................................................................................. 1583–58–0 

Benzoic acid, 3,4-difluoro- (P–17–51) ............................................................................................................................................. 455–86–7 

Benzoic acid, 3,4,5-trifluoro- (P–17–53) .......................................................................................................................................... 121602–93–5 

Benzoic acid, 2,3,4-trifluoro- (P–17–54) .......................................................................................................................................... 61079–72–9 

Benzoic acid, 2,4,5-trifluoro- (P–17–56) .......................................................................................................................................... 446–17–3 

Benzoic acid, 2,3-difluoro- (P–17–58) ............................................................................................................................................. 4519–39–5 

Benzoic acid, 3-(trifluoromethyl)- (P–17–60) ................................................................................................................................... 454–92–2 

Benzoic acid, 2,3-dichloro- (P–17–65) ............................................................................................................................................ 50–45–3 

Benzoic acid, 3,5-dichloro- (P–17–68) ............................................................................................................................................ 51–36–5 

Benzoic acid, 2,6-dichloro- (P–17–70) ............................................................................................................................................ 50–30–6 

Benzoic acid, 2-chloro-4-fluoro- (P–17–74) ..................................................................................................................................... 2252–51–9 

Benzoic acid, 5-chloro-2-fluoro- (P–17–77) ..................................................................................................................................... 394–30–9 

Benzoic acid, 3-chloro-4-fluoro- (P–17–78) ..................................................................................................................................... 403–16–7 

Benzoic acid, 4-chloro-3-fluoro- (P–17–81) ..................................................................................................................................... 403–17–8 

Benzoic acid, 4-chloro-2-fluoro- (P–17–82) ..................................................................................................................................... 446–30–0 

Benzoic acid, 5-bromo-2-chloro- (P–17–84) ................................................................................................................................... 21739–92–4 

Benzoic acid, 3-bromo-4-fluoro- (P–17–88) .................................................................................................................................... 11007–16–5 

Benzoic acid, 2-bromo-5-fluoro- (P–17–89) .................................................................................................................................... 394–28–5 

Benzoic acid, 4-bromo-3-fluoro- (P–17–92) .................................................................................................................................... 153556–42–4 

Benzoic acid, 4-bromo-2-fluoro- (P–17–97) .................................................................................................................................... 112704–79–7 

Effective date of TSCA section 5(e) 

Order: March 22, 2017. 

Basis for TSCA section 5(e) Order: 

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

for monitoring of oil/gas well 

performance. Based on test data on an 

analog, EPA has identified concerns for 

reproductive, developmental and neurotoxicity, as well as lung toxicity and 

dermal irritation. The Order was issued 

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

5(e)(1)(A)(ii)(I), based on insufficient 

information to make a reasoned 

evaluation and a finding that the 

substances may present an unreasonable 

risk of injury to human health. EPA 

assessed risks based on the specific 

manufacturing, processing, use, process 

equipment, engineering controls, and 

handling practices (including worker 

activities and cleaning procedures) 

described in the PMN. To protect 

against these risks, the Order requires: 

1. Submission of certain toxicity 

testing on the PMN substances prior to 

exceeding the production volume limit 

as specified in the Order. 

2. Use of personal protective 

equipment including impervious gloves 

(where there is a potential for dermal 

exposure). 

3. Use of a NIOSH-certified respirator 

with an APF of at least 50 (where there 

is a potential for inhalation exposure) or 

compliance with a NCEL of 0.0184 ppm 

as an 8-hour time-weighted average to 

prevent inhalation exposure. 

4. Use of processes, process 

equipment, engineering controls, and 

handling practices specified in the 

Order for manufacturing and processing. 

5. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS. 

6. No manufacture or process of the 

PMN substances beyond a confidential 

annual production volume specified in 

the Order. 

The SNUR will designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the human health toxicity 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 will be 

designated by this SNUR. The submitter 

has agreed not to exceed the 

confidential production limit without 

performing specific target organ toxicity 

and reproductive/developmental 

toxicity testing on both P–17–35 and P– 

17–37. 

CFR citations: 40 CFR 721.11054. 

PMN Numbers: P–17–94, P–17–95, P– 

17–96, P–17–98, P–17–99, P–17–100, P– 

17–101, P–17–102, P–17–103, P–17–104, 

P–17–105, P–17–114, P–17–122, P–17– 

123, P–17–124, P–17–125, P–17–126, P– 

17–127, P–17–128, P–17–129, P–17–130, 

P–17–131, P–17–132, P–17–133, P–17– 

134, P–17–135, P–17–136, P–17–137, P– 

17–138, P–17–139, and P–17–140 

CHEMICAL NAMES AND CAS NUMBERS

Chemical name CAS No. 

Benzoic acid, 2,3,4,5-tetrafluoro-, ethyl ester (P–17–94) ................................................................................................................ 122894–73–9 

Benzoic acid, 4-(trifluoromethyl)-, ethyl ester (P–17–95) ................................................................................................................ 583–02–8 

Benzoic acid, 2-(trifluoromethyl)-, ethyl ester (P–17–96) ................................................................................................................ 577–62–8 

Benzoic acid, 2,6-difluoro-, ethyl ester (P–17–98) .......................................................................................................................... 19064–14–3 

Benzoic acid, 2,5-difluoro-, ethyl ester (P–17–99) .......................................................................................................................... 708–25–8 

Benzoic acid, 2,3,4-trifluoro-, ethyl ester (P–17–100) ..................................................................................................................... 351354–50–2 

Benzoic acid, 2-bromo-5-fluoro-, ethyl ester (P–17–101) ............................................................................................................... 351354–50–2 

Benzoic acid, 3,5-difluoro-, ethyl ester (P–17–102) ........................................................................................................................ 350–19–6 


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CHEMICAL NAMES AND CAS NUMBERS—Continued 

Chemical name CAS No. 

Benzoic acid, 5-bromo-2-chloro-, ethyl ester (P–17–103) .............................................................................................................. 76008–73–6 

Benzoic acid, 3-chloro-, ethyl ester (P–17–104 .............................................................................................................................. 1128–76–3 

Benzoic acid, 2-chloro-, ethyl ester (P–17–105) ............................................................................................................................. 7335–25–3 

Benzoic acid, 3-chloro-4-fluoro-, ethyl ester (P–17–114) ................................................................................................................ 137521–81–4 

Benzoic acid, 4-bromo-2-fluoro-, ethyl ester (P–17–122) ............................................................................................................... 474709–71–2 

Benzoic acid, 2-bromo-4,5-difluoro-, ethyl ester (P–17–123) ......................................................................................................... 144267–97–0 

Benzoic acid, 4-bromo-3-fluoro-, ethyl ester (P–17–124) ............................................................................................................... 1130165–74–0 

Benzoic acid, 3-bromo-4-fluoro-, ethyl ester (P–17–125) ............................................................................................................... 23233–33–2 

Benzoic acid, 4-chloro-2-fluoro-, ethyl ester (P–17–126) ................................................................................................................ 4793–20–8 

Benzoic acid, 2,5-dichloro-, ethyl ester (P–17–127) ....................................................................................................................... 35112–27–7 

Benzoic acid, 4-chloro-3-fluoro-, ethyl ester (P–17–128) ................................................................................................................ 203573–08–4 

Benzoic acid, 2-chloro-4-fluoro-, ethyl ester (P–17–129) ................................................................................................................ 167758–87–4 

Benzoic acid, 5-chloro-2-fluoro-, ethyl ester (P–17–130) ................................................................................................................ 773139–56–3 

Benzoic acid, 2,4-difluoro-, ethyl ester (P–17–131) ........................................................................................................................ 108928–00–3 

Benzoic acid, 3,4-difluoro-, ethyl ester (P–17–132) ........................................................................................................................ 144267–96–9 

Benzoic acid, 3,4,5-trifluoro-, ethyl ester (P–17–133) ..................................................................................................................... 495405–09–9 

Benzoic acid, 2,4,5-trifluoro-, ethyl ester (P–17–134) ..................................................................................................................... 351354–41–1 

Benzoic acid, 3-(trifluoromethyl)-, ethyl ester (P–17–135) .............................................................................................................. 76783–59–0 

Benzoic acid, 2,3-difluoro-, ethyl ester (P–17–136) ........................................................................................................................ 773134–65–9 

Benzoic acid, 2,6-dichloro-, ethyl ester (P–17–137) ....................................................................................................................... 81055–73–4 

Benzoic acid, 3,5-dichloro-, ethyl ester (P–17–138) ....................................................................................................................... 91085–56–2 

Benzoic acid, 2,4-dichloro-, ethyl ester (P–17–139) ....................................................................................................................... 56882–52–1 

Benzoic acid, 3,4-dichloro-, ethyl ester (P–17–140) ....................................................................................................................... 28394–58–3 

Effective date of TSCA section 5(e) 

Order: March 22, 2017. 

Basis for TSCA section 5(e) Order: 

The PMNs state that the substances are 

for monitoring oil/gas well performance. 

Based on test data on an analog, EPA 

has identified concerns for 

reproductive, developmental and neurotoxicity, as well as lung toxicity and 

dermal irritation. Further, based on SAR 

analysis of test data on analogous 

neutral organics, EPA predicts toxicity 

to aquatic organisms may occur at 

concentrations that exceed 15 ppb of the 

PMN substances in surface waters. The 

Order was issued under TSCA sections 

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

based on insufficient information to 

make a reasoned evaluation and a 

finding that the substances may present 

an unreasonable risk of injury to human 

health and the environment. EPA 

assessed risks based on the specific 

manufacturing, processing, use, process 

equipment, engineering controls, and 

handling practices (including worker 

activities and cleaning procedures) 

described in the PMNs. To protect 

against these risks, the Order requires: 

1. Submission of certain toxicity 

testing on the PMN substances prior to 

exceeding the production volume limit 

as specified in the Order. 

2. Use of personal protective 

equipment including impervious gloves 

(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 

0.0184 ppm as an 8-hour time-weighted 

average. 

4. Use of processes, process 

equipment, engineering controls, and 

handling practices specified in the 

Order for manufacturing and processing. 

5. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS. 

6. No manufacture or process of the 

PMN substances beyond a confidential 

annual production volume specified in 

the Order. 

7. No release of the PMN substances 

resulting in surface water 

concentrations that exceed 15 ppb. 

The SNUR will designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the human health and aquatic 

toxicity 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 will be 

designated by this SNUR. The submitter 

has agreed not to exceed the 

confidential production limit without 

performing specific target organ toxicity 

and reproductive/developmental 

toxicity testing on P–17–127; specific 

target organ toxicity testing on P–17– 

101; and acute aquatic toxicity testing 

on both P–17–101 and P–17–127. 

CFR citations: 40 CFR 721.11055. 

PMN Number: P–17–198 

Chemical name: Neodymium 

aluminium alkyl polymer complexes 

(generic). 

CAS number: Not available. 

Effective date of TSCA section 5(e) 

Order: April 27, 2017. 

Basis for TSCA section 5(e) Order: 

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

be as a catalyst in a closed process. 

Based on physical/chemical properties 

of the substance and test data on the 

PMN substance, EPA has identified 

concerns for dermal and respiratory 

irritation, corrosion, developmental 

toxicity, and lung effects. The Order was 

issued under TSCA sections 

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

based on insufficient information to 

make a reasoned evaluation and a 

finding that the substance may present 

an unreasonable risk of injury to human 

health. To protect against these risks, 

the Order requires: 

1. Submission of glove permeation 

testing on the PMN substance prior to 

exceeding the production volume limit 

as specified in the Order. 

2. Use of personal protective 

equipment including impervious gloves 

(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. No domestic manufacture of the 

PMN substance. 

5. No use in any manner or method 

where there is potential for inhalation 

exposure. 


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6. Use of the PMN substance in a 

closed system as specified in the PMN. 

The SNUR will designate as a 

‘‘significant new use’’ the absence of 

these protective measure. 

Potentially useful information: EPA 

has determined that the results of glove 

permeability testing will help 

characterize the effectiveness of 

protective measures to mitigate human 

health risk 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 will be 

designated by this SNUR. The submitter 

has agreed not to manufacture beyond a 

certain time period without performing 

glove permeability testing. 

CFR citation: 40 CFR 721.11056. 

PMN Numbers: P–17–272, P–17–273, P– 

17–274, P–17–275, P–17–276 and P–17– 

277 

Chemical name: Fatty acid amide 

alkyl amine salts (generic). 

CAS numbers: Not available. 

Effective date of TSCA section 5(e) 

Order: August 4, 2017. 

Basis for TSCA section 5(e) Order: 

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

be as a component in asphalt emulsion. 

Based on SAR analysis of test data on 

analogous substances, EPA has 

identified concerns for dermal and 

respiratory irritation, corrosion, 

developmental toxicity, systemic effect, 

sensitization and lung effects. The Order 

was issued under TSCA sections 

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

based on insufficient information to 

make a reasoned evaluation and a 

finding that the substances may present 

an unreasonable risk of injury to human 

health and environment. To protect 

against these risks, the Order requires: 

1. Use of the PMN substances only for 

the use specified in the Order. 

2. Use of personal protective 

equipment for workers exposed 

dermally to the PMN substances 

(including impervious gloves, chemical 

goggles or equivalent eye protection and 

clothing which covers any other 

exposed areas of the arms and torso). 

3. No modification of the 

manufacture, process or use of the PMN 

substances if it results in inhalation 

exposure to vapor, dust, mist or aerosol. 

4. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS. 

5. No release of the PMN substances 

into the waters of the United States. 

The SNUR will designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the human health and aquatic 

toxicity 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 will be 

designated by this SNUR. EPA has 

determined that the results of specific 

target organ toxicity testing of the PMN 

substances, and acute and chronic 

aquatic toxicity testing of the PMN 

substances may be potentially useful in 

characterizing the health and 

environmental effects of the PMN 

substances. Although the Order does not 

require these tests, the Order’s 

restrictions on manufacture, processing 

and distribution in commerce, 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 721.11057. 

PMN Numbers: P–17–278, P–17–279 and 

P–17–280 

Chemical name: Fatty acid amide 

alkyl amine salts (generic). 

CAS numbers: Not available. 

Effective date of TSCA section 5(e) 

Order: August 4, 2017. 

Basis for TSCA section 5(e) Order: 

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

be as a component in asphalt emulsion. 

Based on SAR analysis of test data on 

analogous substances, EPA has 

identified concerns for irritation, 

corrosion, developmental toxicity, 

systemic effect, sensitization and lung 

effects. The Order was issued under 

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

5(e)(1)(A)(ii)(I), based on insufficient 

information to make a reasoned 

evaluation and a finding that the 

substances may present an unreasonable 

risk of injury to human health and 

environment. To protect against these 

risks, the Order requires: 

1. Use of the PMN substances only for 

the use specified in the Order. 

2. Use of personal protective 

equipment for workers exposed 

dermally to the PMN substances 

(including impervious gloves, chemical 

goggles or equivalent eye protection and 

clothing which covers any other 

exposed areas of the arms and torso). 

3. No modification of the 

manufacture, process or use of the PMN 

substances if it results in inhalation 

exposure to vapor, dust, mist or aerosol. 

4. Establishment and use of a hazard 

communication program, including 

human health precautionary statements 

on each label and in the SDS. 

5. No release of the PMN substances 

into the waters of the United States. 

The SNUR will designate as a 

‘‘significant new use’’ the absence of 

these protective measures. 

Potentially useful information: EPA 

has determined that certain information 

about the human health and aquatic 

toxicity 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 will be 

designated by this SNUR. EPA has 

determined that the results of specific 

target organ toxicity testing and acute 

and chronic aquatic toxicity testing of 

the PMN substances may be potentially 

useful in characterizing the health and 

environmental effects of the PMN 

substances. Although the Order does not 

require these tests, the Order’s 

restrictions on manufacture, processing 

and distribution in commerce 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 721.11058. 

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 145 chemical substances 

regulation was warranted under TSCA 

section 5(e), pending the development 

of information sufficient to make 

reasoned evaluations of the health or 

environmental effects of the chemical 

substances. The basis for such findings 

is outlined in Unit IV. Based on these 

findings, TSCA section 5(e) consent 

orders requiring the use of appropriate 

exposure controls were negotiated with 

the PMN submitters. 

The 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). 


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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, 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 October 1, 2018 without 

further notice, unless EPA receives 

written adverse comments before 

August 31, 2018. 

If EPA receives written adverse 

comments on one or more of these 

SNURs before August 31, 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 a notice of 

commencement (NOC) and the chemical 

substance has not been added to the 

TSCA Inventory, no person may 

commence such activities without first 

submitting a PMN. Therefore, for 

chemical substances for which an NOC 

has not been submitted EPA concludes 

that the designated significant new uses 

are not ongoing. 

When chemical substances identified 

in this rule are added to the TSCA 

Inventory, EPA recognizes that, before 

the rule is effective, other persons might 

engage in a use that has been identified 

as a significant new use. However, 

TSCA section 5(e) consent orders have 

been issued for all of the chemical 

substances, and the PMN submitters are 

prohibited by the TSCA section 5(e) 

consent orders from undertaking 

activities which will be designated as 

significant new uses. The identities of 

38 of the 145 chemical substances 

subject to this rule have been claimed as 

confidential and EPA has received one 

post-PMN bona fide submission (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 August 1, 

2018 (the date of public release of this 

rule) 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. In developing this rule, EPA 

has recognized that, given EPA’s 

practice of on occasion posting rules on 

its website a week or more in advance 

of Federal Register publication, this 

objective could be thwarted even before 

that publication. 

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 potentially useful 

information for all of the listed SNURs. 

Descriptions of this information is 

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) 

consent 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 specified tests that would 

permit a reasoned evaluation of the 


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potential risks posed by these chemical 

substances. Under recent TSCA section 

5(e) consent orders, each PMN submitter 

is required to submit each study at least 

14 weeks (earlier TSCA section 5(e) 

consent orders required submissions at 

least 12 weeks) before reaching the 

specified production limit. The SNURs 

contain the same production volume 

limits as the TSCA section 5(e) consent 

orders. Exceeding these production 

limits is defined as a significant new 

use. Persons who intend to exceed the 

production limit must notify the Agency 

by submitting a SNUN at least 90 days 

in advance of commencement of nonexempt commercial manufacture or 

processing. 

Any request by EPA for the triggered 

and pended testing described in the 

Consent Orders 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 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 highthroughput screening methods and their 

prediction models. 

The 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 or other information 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 generate useful 

information. 

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– 

2017–0366. 

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 and TSCA 

section 5(e) consent orders. The Office 

of Management and Budget (OMB) has 

exempted these types of actions from 

review under Executive Order 12866, 

entitled ‘‘Regulatory Planning and 

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

B. Paperwork Reduction Act (PRA) 

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

seq.), an agency may not conduct or 

sponsor, and a person is not required to 

respond to a collection of information 

that requires OMB approval under PRA, 

unless it has been approved by OMB 

and displays a currently valid OMB 

control number. The OMB control 

numbers for EPA’s regulations in title 40 

of the CFR, after appearing in the 

Federal Register, are listed in 40 CFR 

part 9, and included on the related 

collection instrument or form, if 

applicable. EPA is amending the table in 

40 CFR part 9 to list the OMB approval 

number for the information collection 

requirements contained in this action. 

This listing of the OMB control numbers 

and their subsequent codification in the 

CFR satisfies the display requirements 

of PRA and OMB’s implementing 

regulations at 5 CFR part 1320. This 

Information Collection Request (ICR) 

was previously subject to public notice 

and comment prior to OMB approval, 

and given the technical nature of the 

table, EPA finds that further notice and 

comment to amend it is unnecessary. As 

a result, EPA finds that there is ‘‘good 

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

Administrative Procedure Act (5 U.S.C. 

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

without further notice and comment. 

The information collection 

requirements related to this action have 

already been approved by OMB 

pursuant to PRA under OMB control 

number 2070–0012 (EPA ICR No. 574). 

This action does not impose any burden 

requiring additional OMB approval. If 

an entity were to submit a SNUN to the 

Agency, the annual burden is estimated 

to average between 30 and 170 hours 

per response. This burden estimate 


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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: July 19, 2018. 

Jeffery T. Morris, 

Director, Office of Pollution Prevention and 

Toxics. 

Therefore, 40 CFR parts 9 and 721 are 

amended as follows: 

PART 9—[AMENDED] 

■ 1. The authority citation for part 9 

continues to read as follows: 

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

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

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

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

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

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

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

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

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

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

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

11023, 11048. 

■ 2. In § 9.1, add the following sections 

in numerical order under the 

undesignated center heading 

‘‘Significant New Uses of Chemical 

Substances’’ to read as follows: 

§ 9.1 OMB approvals under the Paperwork 

Reduction Act. 

* * * * * 

40 CFR citation OMB 

control No. 

* * * * * 

Significant New Uses of Chemical 

Substances 

* * * * * 

721.11024 ............................. 2070–0012 


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40 CFR citation OMB 

control No. 

721.11025 ............................. 2070–0012 

721.11026 ............................. 2070–0012 

721.11027 ............................. 2070–0012 

721.11028 ............................. 2070–0012 

721.11029 ............................. 2070–0012 

721.11030 ............................. 2070–0012 

721.11031 ............................. 2070–0012 

721.11032 ............................. 2070–0012 

721.11033 ............................. 2070–0012 

721.11034 ............................. 2070–0012 

721.11035 ............................. 2070–0012 

721.11036 ............................. 2070–0012 

721.11037 ............................. 2070–0012 

721.11038 ............................. 2070–0012 

721.11039 ............................. 2070–0012 

721.11040 ............................. 2070–0012 

721.11041 ............................. 2070–0012 

721.11042 ............................. 2070–0012 

721.11043 ............................. 2070–0012 

721.11044 ............................. 2070–0012 

721.11045 ............................. 2070–0012 

721.11046 ............................. 2070–0012 

721.11047 ............................. 2070–0012 

721.11048 ............................. 2070–0012 

721.11049 ............................. 2070–0012 

721.11050 ............................. 2070–0012 

721.11051 ............................. 2070–0012 

721.11052 ............................. 2070–0012 

721.11053 ............................. 2070–0012 

721.11054 ............................. 2070–0012 

721.11055 ............................. 2070–0012 

721.11056 ............................. 2070–0012 

721.11057 ............................. 2070–0012 

721.11058 ............................. 2070–0012 

* * * * * 

* * * * * 

PART 721—[AMENDED] 

■ 3. The authority citation for part 721 

continues to read as follows: 

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

2625(c). 

■ 4. Add § 721.11024 to subpart E to 

read as follows: 

§ 721.11024 Polyphosphoric acids, 2- 

[alkyl-1-oxo-2-propen-1-yl)oxy]ethyl esters, 

compds. with N-(aminoiminomethyl)urea 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polyphosphoric acids, 2- 

[alkyl-1-oxo-2-propen-1-yl)oxy]ethyl 

esters, compds. with N- 

(aminoiminomethyl)urea (PMN P–14– 

472) 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), (3), and (c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), (g)(1)(i), (ii), (sensitization), 

(g)(2)(i), (v), (g)(3)(i), (ii), (g)(4)(i), and 

(g)(5). Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System (GHS) and 

OSHA Hazard Communication Standard 

may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(h), (q), and (y)(1). 

It is a significant new use to have 

manufacturing activities that result in 

inhalation exposure. 

(iv) Release to water. Requirements as 

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

(c)(4) where N = 3. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) 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 § 721.11025 to subpart E to 

read as follows: 

§ 721.11025 Polyphosphoric acids, 2-[(2- 

methyl-1-oxo-2-propen-1-yl)oxy]ethyl 

esters, compds. with alkyl amino, polymers 

with Bu acrylate, N- 

(hydroxymethyl)propenamide and styrene 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polyphosphoric acids, 2- 

[(2-methyl-1-oxo-2-propen-1- 

yl)oxy]ethyl esters, compds. with alkyl 

amino, polymers with Bu acrylate, N- 

(hydroxymethyl)propenamide and 

styrene (PMN P–14–496) 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), (3), and (c). 

(ii) Hazard communication. 

Requirements as specified in 

§ 721.72(a), through (f), (g)(1)(i), (ii), 

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

and (g)(5). Alternative hazard and 

warning statements that meet the 

criteria of the Globally Harmonized 

System (GHS) and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k), (q) and (y)(1). It 

is a significant new use to have 

manufacturing activities that result in 

inhalation exposure. 

(iv) Release to water. Requirements as 

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

(c)(4) where N = 4. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (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. 

■ 6. Add § 721.11026 to subpart E to 

read as follows: 

§ 721.11026 Bismuth bromide iodide 

oxide. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

bismuth bromide iodide oxide (PMN P– 

14–630, CAS No. 340181–06–8) 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)(4), when determining which 

persons are reasonably likely to be 

exposed as required for § 721.63(a)(4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible, 

(a)(5)(respirators must provide a 

National Institute for Occupational 

Safety and Health (NIOSH) assigned 

protection factor (APF) of at least 10), 

(a)(6)(i) (particulate), (b) (concentration 

set at 1.0%), and (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 2.4 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 


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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)(ii), (g)(2)(ii), (use respiratory 

protection or maintain workplace 

airborne concentrations at or below an 

8-hour time-weighted average of 2.4 mg/ 

m3), and (g)(5). Alternative hazard and 

warning statements that meet the 

criteria of the Globally Harmonized 

System (GHS) and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(q). It is a 

significant new use to vary or alter, the 

manufacturing, processing, and use, 

distribution/transportation, treatment 

and disposal processes, process 

equipment, engineering controls, and 

handling practices (including worker 

activities and cleaning procedures) 

described in the PMN in such a way as 

to change the magnitude of inhalation 

exposure. It is a significant new use to 

use the substance for a consumer 

product that generates a dust, 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 (d), and (f) through 

(i) are applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 7. Add § 721.11027 to subpart E to 

read as follows: 

§ 721.11027 Aluminum cobalt lithium 

nickel oxide. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

aluminum cobalt lithium nickel oxide 

(PMN P–15–450, CAS No. 177997–13–6) 

is subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (3), (4), when 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible, (a)(5) 

(respirators must provide a National 

Institute for Occupational Safety and 

Health (NIOSH) assigned protection 

factor (APF) of at least 1,000), (a)(6) 

(particulate) (b) (concentration set at 

0.1%), and (c). It is a significant new use 

to manufacture or process the substance 

without the chemical transfer processes 

and air ventilation processes described 

in the PMN and the exposure 

monitoring requirements described in 

the Order. 

(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 0.000092 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 0.1%), (f), 

(g)(1)(ii), (This substance may cause 

damage to the lung, kidney, and spleen), 

(g)(1)(vii), (g)(2)(i), (ii), (iii), (When 

using this substance wear protective 

gloves/protective clothing/eye 

protection/face protection), the 

following human health precautionary 

statement must appear on the SDS as 

specified in paragraph (a)(2)(ii): (When 

using this substance use respiratory 

protection or maintain workplace 

airborne concentrations at or below an 

8-hour time-weighted average of 

0.000092 mg/m3), (g)(2)(v), and (g)(5). 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System (GHS) and 

OSHA Hazard Communication Standard 

may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(p) (24 months and 

6 years). 

(iv) Disposal. Requirements as 

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

(c)(2). It is a significant new use to 

release this chemical substance to air 

unless using the chemical transfer and 

air ventilation processes described in P– 

15–0450 including filtering through a 

high-efficiency particular air filter with 

an efficiency rate of 99.99% before 

release to air. 

(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 (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 

is subject to this section. The provisions 

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

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

■ 8. Add § 721.11028 to subpart E to 

read as follows: 

§ 721.11028 Alkylarylamine (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkylarylamine (PMN P– 

15–705) 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), (ii), (iii), (a)(3), 

and (4), when determining which 

persons are reasonably likely to be 

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

and (4), engineering control measures 

(e.g., enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible, (a)(5) 

(respirators must provide a National 

Institute for Occupational Safety and 

Health (NIOSH) assigned protection 

factor (APF) of at least 1,000), 

(a)(6)(particulate), (a)(6)(v), (vi), (b) 

(concentration set at 0.1%), and (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 0.48 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 


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37722 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations 

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 0.1%), 

(f), (g)(1)(i), (ii), (iv), (vi), (vii), (ix), 

(g)(2)(i), (ii), (iii), (use respiratory 

protection or maintain workplace 

airborne concentrations at or below an 

8-hour time-weighted average of 0.48 

mg/m3), (g)(2)(v), (g)(3)(ii), (g)(4)(i), and 

(g)(5). Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System (GHS) and 

OSHA Hazard Communication Standard 

may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

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

significant new use to use the substance 

other than as a chemical intermediate or 

as an additive and octane booster in 

aviation fuels. 

(iv) Release to water. Requirements as 

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

(c)(4) where N = 1. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (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. 

■ 9. Add § 721.11029 to subpart E to 

read as follows: 

§ 721.11029 Aliphatic N-alkyl urea polymer 

containing cyclohexyl groups and 

trimethoxy silanes (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as aliphatic N-alkyl urea 

polymer containing cyclohexyl groups 

and trimethoxy silanes (PMN P–15–706) 

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), (iv), (a)(3) 

and (4), when determining which 

persons are reasonably likely to be 

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

and (4), engineering control measures 

(e.g., enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible, (a)(5) 

(respirators must provide a National 

Institute for Occupational Safety and 

Health (NIOSH) assigned protection 

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

(particulate), (a)(6)(v), (vi), (b) 

(concentration set at 1.0%), and (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 0.9 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)(ii), (ix), (g)(2)(i), (ii), (iii), (use 

respiratory protection or maintain 

workplace airborne concentrations at or 

below an 8-hour time-weighted average 

of 0.9 mg/m3), (g)(2)(v), and (g)(5). 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System (GHS) and 

OSHA Hazard Communication Standard 

may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k), (o), (p) (594,000 

kilograms, P–15–706 and P–15–707 

combined), and (t)(250,000 kilograms, 

P–15–706 and P–15–707 combined). A 

significant new use is any manufacture, 

processing, or use of the PMN substance 

with more than 0.1% residual 

isocyanate by weight. 

(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 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. 

■ 10. Add § 721.11030 to subpart E to 

read as follows: 

§ 721.11030 Aliphatic N-alkyl urea polymer 

containing aspartic ester groups and 

trimethoxy silanes (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as aliphatic N-alkyl urea 

polymer containing aspartic ester 

groups and trimethoxy silanes (PMN P– 

15–707) 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), (iv), (a)(3), 

(4), when determining which persons 

are reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible, (a)(5) 

(respirators must provide a National 

Institute for Occupational Safety and 

Health (NIOSH) assigned protection 

factor (APF) of at least 10), (a)(6)(i), (v), 

(vi), (b) (concentration set at 1.0%), and 

(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 0.9 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)(ii), (g)(1)(ix), (g)(2)(i), (ii), (iii), 

(use respiratory protection or maintain 

workplace airborne concentrations at or 

below an 8-hour time-weighted average 

of 0.9 mg/m3), (g)(2)(v), and (g)(5). 


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Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System (GHS) and 

OSHA Hazard Communication Standard 

may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k), (o), (p) (594,000 

kilograms, P–15–706 and P–15–707 

combined), and (t) (250,000 kilograms, 

P–15–706 and P–15–707 combined). A 

significant new use is any manufacture, 

processing, or use of the PMN substance 

with more than 1% residual isocyanate 

by weight. 

(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 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. 

■ 11. Add § 721.11031 to subpart E to 

read as follows: 

§ 721.11031 Alkyl heteromonocycle, 

polymer with heteromonocycle, 

carboxyalkyl alkyl ether (generic). 

(a) Chemical substances and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as alkyl heteromonocycle, 

polymer with heteromonocycle, 

carboxyalkyl alkyl ether (PMNs P–16– 

273 and P–16–0274) are subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

(concentration set at 1.0%), and (c). 

When determining which persons are 

reasonably likely to be exposed as 

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

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

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

(f), (g)(1)(i), (ii), (dermal sensitization), 

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

(g)(4)(iii), and (g)(5). Alternative hazard 

and warning statements that meet the 

criteria of the Globally Harmonized 

System (GHS) and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

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

new use to use the substances for the 

uses specified in the Order, at a 

concentration greater than 3% of the 

metal working fluid, and use other than 

the closed metal working systems as 

specified in the PMNs with no 

modifications in the process that would 

result in worker inhalation exposure. 

(iv) Release to water. Requirements as 

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

(c)(4) where N = 10. 

(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), 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. 

■ 12. Add § 721.11032 to subpart E to 

read as follows: 

§ 721.11032 Benzene dicarboxylic acid, 

polymer with alkane dioic acid and aliphatic 

diamine (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

generically as benzene dicarboxylic 

acid, polymer with alkane dioic acid 

and aliphatic diamine (PMN P–16–289) 

is subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k)(Manufacture 

only in a form with a particle size 

distribution where less than 1.0 percent 

of the particles are less than 10 microns) 

and (p) (six months). 

(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. 

■ 13. Add § 721.11033 to subpart E to 

read as follows: 

§ 721.11033 Manganese cyclic (tri)amine 

chloride complex (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as manganese cyclic 

(tri)amine chloride complex (PMN P– 

16–322) 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), (3), (4), when 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible, (a)(5) 

(respirators must provide a National 

Institute for Occupational Safety and 

Health (NIOSH) assigned protection 

factor (APF) of at least 25), (a)(6)(i), 

(particulate), (b) (concentration set at 

1.0%), and (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 1.2 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), (vi), (viii), (ix), (g)(2)(i), (ii), 

(iii), (use respiratory protection or 

maintain workplace airborne 

concentrations at or below an 8-hour 

time-weighted average of 1.2 mg/m3), 

(v), (g)(3) (This substance may be toxic 

to algae. This substance may be harmful 

to invertebrates), (g)(4)(i), (ii), (do not 

release to water to yield surface water 


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concentrations above 18 ppb.), and 

(g)(5). Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System (GHS) 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)(4), (b)(4), and 

(c)(4) where N = 18. 

(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), 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. 

■ 14. Add § 721.11034 to subpart E to 

read as follows: 

§ 721.11034 Xanthylium, (sulfoaryl)-bis 

[(substituted aryl) amino]-, sulfo derivs., 

inner salts, metal salts (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as xanthylium, (sulfoaryl)- 

bis [(substituted aryl) amino]-, sulfo 

derivs., inner salts, metal salts (PMN 

P–16–338) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

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

(ii) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(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 § 721.11035 to subpart E to 

read as follows: 

§ 721.11035 Substituted triazinyl metal 

salt, diazotized, coupled with substituted 

pyridobenzimidazolesulfonic acids, 

substituted pyridobenzimidazolesulfonic 

acids, diazotized substituted alkanesulfonic 

acid, diazotized substituted aromatic 

sulfonate, diazotized substituted aromatic 

sulfonate, metal salts (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as substituted triazinyl metal 

salt, diazotized, coupled with 

substituted 

pyridobenzimidazolesulfonic acids, 

substituted 

pyridobenzimidazolesulfonic acids, 

diazotized substituted alkanesulfonic 

acid, diazotized substituted aromatic 

sulfonate, diazotized substituted 

aromatic sulfonate, metal salts (PMN P– 

16–339) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

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

(ii) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(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. 

■ 16. Add § 721.11036 to subpart E to 

read as follows: 

§ 721.11036 Carbon black, (organic acidic 

carbocyclic)-modified, inorganic salt 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as carbon black, (organic 

acidic carbocyclic)-modified, inorganic 

salt (PMN P–16–439) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

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

(ii) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 17. Add § 721.11037 to subpart E to 

read as follows: 

§ 721.11037 Carbon black, (organic acidic 

carbocyclic)-modified, metal salt (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as carbon black, (organic 

acidic carbocyclic)-modified, metal salt 

(PMN P–16–440) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

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

(ii) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 18. Add § 721.11038 to subpart E to 

read as follows: 

§ 721.11038 Polyaralkyl aryl ester of 

methacrylic acid (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 


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Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations 37725 

generically as polyaralkyl aryl ester of 

methacrylic acid (PMN P–16–350) 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), 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 (c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (d), (f), (g)(1)(i), (ii), 

(sensitization), (mutagenicity); (g)(2)(i), 

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

hazard and warning statements that 

meet the criteria of the Globally 

Harmonized System (GHS) 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 

substance lower than the minimum 

average molecular weight identified in 

the Order and to contain more than the 

maximum weight percent of low 

molecular weight species below 1,000 

daltons identified in the Order. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) 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. 

■ 19. Add § 721.11039 to subpart E to 

read as follows: 

§ 721.11039 Phenol, 2-[[[3- 

(octyloxy)propyl]imino]methyl]-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

phenol, 2-[[[3- 

(octyloxy)propyl]imino]methyl]- (PMN 

P–16–352, chemical A; CAS No. 

1858221–49–4) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

(vi), (particulate), (b) (concentration set 

at 1.0%), and (c). When determining 

which persons are reasonably likely to 

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

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. 

(ii) Hazard communication. 

Requirements as specified in § 721.72 

(a) through (e) (concentration set at 

1.0%), (f), (g)(1)(i), (iv), (vi), (ix), 

(g)(2)(i), (v), (g)(3)(i), (ii), and (g)(5). 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System (GHS) and 

OSHA Hazard Communication Standard 

may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f), (p) (10,500 and 

13,000 kilograms, respectively, for the 

total of this substance and the substance 

subject to 721.11039), (t) (250 kilograms 

for the total of this substance and the 

substance subject to 721.11039), and 

(y)(1). 

(iv) Release to water. Requirements as 

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

(c)(4) where N = 1. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 20. Add § 721.11040 to subpart E to 

read as follows: 

§ 721.11040 Phenol, 2-[[[3- 

(decyloxy)propyl]imino]methyl]-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

phenol, 2-[[[3- 

(decyloxy)propyl]imino]methyl]- (PMN 

P–16–352, chemical B; CAS No. 

1858221–50–7) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

(vi), (particulate), (b) (concentration set 

at 1.0%), and (c). When determining 

which persons are reasonably likely to 

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

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

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

(f), (g)(1)(i), (iv), (vi), (ix), (g)(2)(i), (v), 

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

hazard and warning statements that 

meet the criteria of the Globally 

Harmonized System (GHS) and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f), (p) (10,500 and 

13,000 kilograms respectively for the 

total of this substance and the substance 

subject to § 721.9998), (t) (250 kilograms 

for the total of this substance and the 

substance subject to § 721.9998), and 

(y)(1). 

(iv) Release to water. Requirements as 

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

(c)(4) where N = 1. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 21. Add § 721.11041 to subpart E to 

read as follows: 

§ 721.11041 Alkyl phenol (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkyl phenol (PMN P–16– 

358) 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), (iv), (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 


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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, (b) 

(concentration set at 1.0%), and (c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

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

(f), (g)(1)(ix), (g)(2)(i), (ii), (iii), (v), 

(g)(4)(iii), and (g)(5). Alternative hazard 

and warning statements that meet the 

criteria of the Globally Harmonized 

System (GHS) and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(a) through (c), (g), 

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

(iv) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (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. 

■ 22. Add § 721.11042 to subpart E to 

read as follows: 

§ 721.11042 Nitrile-butadiene-acrylate 

terpolymers (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as nitrile-butadiene-acrylate 

terpolymers PMN P–16–364) 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 (GHS) and 

OSHA Hazard Communication Standard 

may be used. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(h), (k) 

(Manufacture of the substance with a 

particle size distribution where greater 

than 5.0 percent of the particles are less 

than 10 microns). 

(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 (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. 

■ 23. Add § 721.11043 to subpart E to 

read as follows: 

§ 721.11043 Starch, polymer with 2- 

propenoic acid, potassium salt, oxidized. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

starch, polymer with 2-propenoic acid, 

potassium salt, oxidized (PMN P–16– 

399, CAS No. 1638117–09–5) is subject 

to reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (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, (b) 

(concentration set at 1.0%), and (c). 

(ii) Hazard communication. 

Requirements as specified in 

§ 721.72(a), (b), (c), (d), (e) 

(concentration set 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 (GHS) and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (Manufacture of 

the substance with a particulate size less 

than 30 microns) and (p) (12 months). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

(i) are applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 24. Add § 721.11044 to subpart E to 

read as follows: 

§ 721.11044 Pentanedioic acid, 2-methyl-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

pentanedioic acid, 2-methyl- (PMN P– 

16–430, CAS No. 617–62–9) 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) Protection in the workplace. 

Requirements as specified in § 721.63 

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

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible, (a)(5) 

(respirators must provide a National 

Institute for Occupational Safety and 

Health (NIOSH) assigned protection 

factor (APF) of at least 10), (a)(6)(i), (v), 

(vi), (b) (concentration set at 1.0%), and 

(c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

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

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

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

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System (GHS) and 

OSHA Hazard Communication Standard 

may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f) and (k) (import 

of the substance at or below the 

maximum concentration specified in the 

Order). 

(iv) Release to water. Requirements as 

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

(c)(4) where N = 14. 

(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), 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 


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

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

■ 25. Add § 721.11045 to subpart E to 

read as follows: 

§ 721.11045 2-Pentanol, 4-methyl-, reaction 

products with phosphorus oxide (P2O5), 

compounds with alkylamine (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

generically as 2-pentanol, 4-methyl-, 

reaction products with phosphorus 

oxide (P2O5), compounds with 

alkylamine (PMN P–16–495) is subject 

to reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (3), when determining 

which persons are reasonably likely to 

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

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible, (a)(6) 

(particulate), (b) (concentration set at 

1.0%), and (c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

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

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

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

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System (GHS) and 

OSHA Hazard Communication Standard 

may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(q) and (y)(1). A 

significant new use is any manner or 

method of manufacturing that results in 

inhalation exposure. 

(iv) Release to water. Requirements as 

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

(c)(4) where N = 200. 

(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), 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. 

■ 26. Add § 721.11046 to subpart E to 

read as follows: 

§ 721.11046 Hydroxy alkylbiphenyl 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as hydroxy alkylbiphenyl 

(PMN P–16–513) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (3), (4), when 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible, (a)(5) 

(respirators must provide a National 

Institute for Occupational Safety and 

Health (NIOSH) assigned protection 

factor (APF) of at least 50), (a)(6)(i), (v), 

(vi), (b) (concentration set at 1.0%), and 

(c). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(g) and (q). 

(iii) Release to water. Requirements as 

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

(c)(4) where N = 17. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 27. Add § 721.11047 to subpart E to 

read as follows: 

§ 721.11047 Alkyl alkenoic acid, polymer 

with alkenylcarbomonocycle telomer with 

substituted alkanoic acid hydroxyl alkyl 

substituted alkenyl substituted alkyl ester, 

polyalkylene glycol alkyl ether alkyl 

alkenoate, dialkylene glycol 

diheteromonocyclic ether and 

alkylcarbomonocyclic alkenoate, metal salt 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkyl alkenoic acid, 

polymer with alkenylcarbomonocycle 

telomer with substituted alkanoic acid 

hydroxyl alkyl substituted alkenyl 

substituted alkyl ester, polyalkylene 

glycol alkyl ether alkyl alkenoate, 

dialkylene glycol diheteromonocyclic 

ether and alkylcarbomonocyclic 

alkenoate, metal salt (PMN P–16–534) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

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

significant new use to manufacture the 

substance such that the lowest number 

average molecular weight is less than 

1,800 daltons and the carboxylic acid 

content exceeds 20 percent). 

(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)(iii) of this section. 

■ 28. Add § 721.11048 to subpart E to 

read as follows: 

§ 721.11048 Alkyl alkenoic acid, polymer 

with alkenylcarbomonocycle telomer with 

substituted alkanoic acid hydroxyl alkyl 

substituted alkenyl substituted alkyl ester, 

alkanediol diheteromonocyclic ether, 

polyalkylene glycol alkyl ether alkyl 

alkenoate and alkylcarbomonocyclic 

alkenoate, metal salt (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkyl alkenoic acid, 

polymer with alkenylcarbomonocycle 

telomer with substituted alkanoic acid 

hydroxyl alkyl substituted alkenyl 

substituted alkyl ester, alkanediol 

diheteromonocyclic ether, polyalkylene 

glycol alkyl ether alkyl alkenoate and 

alkylcarbomonocyclic alkenoate, metal 

salt (PMN P–16–535) 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 


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

significant new use to manufacture the 

substance such that the lowest number 

average molecular weight is less than 

1,800 daltons and the carboxylic acid 

content exceeds 20 percent). 

(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)(iii) of this section. 

■ 29. Add § 721.11049 to subpart E to 

read as follows: 

§ 721.11049 Alkyl alkenoic acid, polymer 

with bis heteromonocyclic substituted alkyl 

carbomonocycle, alkenylcarbomonocycle 

telomer with substituted alkanoic acid 

hydroxyl alkyl substituted alkenyl 

substituted alkyl ester, polyalkylene glycol 

alkyl ether alkyl alkenoate and 

alkylcarbomonocyclic alkenoate, metal salt 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkyl alkenoic acid, 

polymer with bis heteromonocyclic 

substituted alkyl carbomonocycle, 

alkenylcarbomonocycle telomer with 

substituted alkanoic acid hydroxyl alkyl 

substituted alkenyl substituted alkyl 

ester, polyalkylene glycol alkyl ether 

alkyl alkenoate and 

alkylcarbomonocyclic alkenoate, metal 

salt (PMN P–16–536) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

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

significant new use to manufacture the 

substance such that the lowest number 

average molecular weight is less than 

1,800 daltons, and the carboxylic acid 

content exceeds 20 percent). 

(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)(iii) of this section. 

■ 30. Add § 721.11050 to subpart E to 

read as follows: 

§ 721.11050 Certain functionalized 

methacrylate-substituted polymers. 

(a)(1) The chemical substances listed 

in the Table of this section 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 substances 

after they have been reacted (cured). 

TABLE—FUNCTIONALIZED METHACRYLATE-SUBSTITUTED POLYMERS

PMN No. Chemical name 

P–16–549 ........................................................................... Alkaline functionalized methacrylate-substituted polymer (generic). 

P–16–550 ........................................................................... Alkaline functionalized methacrylate-substituted polymer (generic). 

P–16–551 ........................................................................... Alkaline functionalized methacrylate-substituted polymer (generic). 

P–16–553 ........................................................................... Quatenary alkylamine functionalized methacrylate-substituted polymer (generic). 

P–16–555 ........................................................................... Neutral alcohol functionalized methacrylate-substituted polymer (generic). 

P–16–556 ........................................................................... Neutral alcohol functionalized methacrylate-substituted polymer (generic). 

P–16–557 ........................................................................... Neutral alkyl salt functionalized methacrylate-substituted polymer (generic). 

P–16–558 ........................................................................... Neutral alkyl salt functionalized methacrylate-substituted polymer (generic). 

P–16–560 ........................................................................... Neutral alkyl salt functionalized methacrylate-substituted polymer (generic). 

P–16–561 ........................................................................... Acid functionalized methacrylate-substituted polymer (generic). 

P–16–562 ........................................................................... Acid functionalized methacrylate-substituted polymer (generic). 

P–16–563 ........................................................................... Acid functionalized methacrylate-substituted polymer (generic). 

P–16–564 ........................................................................... Acid functionalized methacrylate-substituted polymer (generic). 

P–16–565 ........................................................................... Acid functionalized methacrylate-substituted polymer (generic). 

P–16–567 ........................................................................... Alkylamine functionalized methacrylate-substituted polymer (generic). 

(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), 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, (a)(6) 

(particulate), (b) (concentration set at 

1.0%), and (c). 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f) and (k) 

(crosslinked resin used for 

chromatographic separation of 

biomolecules and biocatalysts). It is a 

significant new use to import the 

substance in any form other than 

spherical beads with 0.1 percent less 

than 10 microns 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 31. Add § 721.11051 to subpart E to 

read as follows: 


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§ 721.11051 Waste plastics, poly(ethylene 

terephthalate), depolymd. with 

polypropylene glycol ether with glycerol 

(3:1), polymers with alkenoic and alkanoic 

acids (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as waste plastics, 

poly(ethylene terephthalate), depolymd. 

with polypropylene glycol ether with 

glycerol (3:1), polymers with alkenoic 

and alkanoic acids (PMN P–16–579) 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), (4),when 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible, (a)(5) 

(respirators must provide a National 

Institute for Occupational Safety and 

Health (NIOSH) assigned protection 

factor (APF) of at least 50), (a)(6) 

(particulate), (b) (concentration set 

1.0%), and (c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

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

(f), (g)(1) (This substance may cause 

respiratory and dermal irritation). (This 

substance may cause irritation of the 

mucous membranes). (This substance 

may cause respiratory and dermal 

sensitization). (This substance may 

cause mutagenicity), (g)(2)(i), (ii), (iii), 

(iv), (v), (g)(5). Alternative hazard and 

warning statements that meet the 

criteria of the Globally Harmonized 

System (GHS) and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) (an ultraviolet 

curable coating resin). It is a significant 

new use to manufacture the substance 

with an average molecular weight less 

than 1,100 Daltons. 

(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 and processors of this 

substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 32. Add § 721.11052 to subpart E to 

read as follows: 

§ 721.11052 1,3,5-Naphthalenetrisulfonic 

acid. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1,3,5-naphthalenetrisulfonic acid (PMN 

P–17–32, CAS No. 6654–64–4) is subject 

to reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

when determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible, (a)(5) 

(respirators must provide a National 

Institute for Occupational Safety and 

Health (NIOSH) assigned protection 

factor of at least 50, (a)(6)(v), (vi), 

(particulate), (b) (concentration set at 

1.0%), and (c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

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

(f), (g)(1)(i), (ii), (iv), (ix), (g)(2)(i), (ii), 

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

and warning statements that meet the 

criteria of the Globally Harmonized 

System (GHS) and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(q) and (t). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) 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. 

■ 33. Add § 721.11053 to subpart E to 

read as follows: 

§ 721.11053 Certain halogenated sodium 

benzoate salts. 

(a)(1) The chemical substances listed 

in the Table of this section is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

TABLE—HALOGENATED SODIUM BENZOATE SALTS

PMN No. CAS No. Chemical name 

P–17–33 .............................................................................. 6654–64–4 Benzoic acid, 2-fluoro-, sodium salt (1:1). 

P–17–34 .............................................................................. 499–90–1 Benzoic acid, 4-fluoro-, sodium salt (1:1). 

P–17–36 .............................................................................. 67852–79–3 Benzoic acid, 2,3,4,5-tetrafluoro-, sodium salt (1:1). 

P–17–38 .............................................................................. 2966–44–1 Benzoic acid, 2-(trifluoromethyl)-, sodium salt (1:1). 

P–17–39 .............................................................................. 25832–58–0 Benzoic acid, 4-(trifluoromethyl)-, sodium salt (1:1). 

P–17–41 .............................................................................. 522651–42–9 Benzoic acid, 2,5-difluoro-, sodium salt (1:1). 

P–17–42 .............................................................................. 499–57–0 Benzoic acid, 3-fluoro-, sodium salt (1:1). 

P–17–43 .............................................................................. 6185–28–0 Benzoic acid, 2,6-difluoro-, sodium salt (1:1). 

P–17–45 .............................................................................. 530141–39–0 Benzoic acid, 3,5-difluoro-, sodium salt (1:1). 

P–17–47 .............................................................................. 1765–08–8 Benzoic acid, 2,4-difluoro-, sodium salt (1:1). 

P–17–50 .............................................................................. 522651–44–1 Benzoic acid, 3,4-difluoro-, sodium salt (1:1). 

P–17–52 .............................................................................. 1180493–12–2 Benzoic acid, 3,4,5-trifluoro-, sodium salt (1:1). 

P–17–55 .............................................................................. 402955–41–3 Benzoic acid, 2,3,4-trifluoro-, sodium salt (1:1). 

P–17–57 .............................................................................. 522651–48–5 Benzoic acid, 2,4,5-trifluoro-, sodium salt (1:1). 

P–17–59 .............................................................................. 1604819–08–0 Benzoic acid, 2,3-difluoro-, sodium salt (1:1). 

P–17–61 .............................................................................. 69226–41–1 Benzoic acid, 3-(trifluoromethyl)-, sodium salt (1:1). 

P–17–62 .............................................................................. 17264–74–3 Benzoic acid, 2-chloro-, sodium salt (1:1). 

P–17–63 .............................................................................. 3686–66–6 Benzoic acid, 4-chloro-, sodium salt (1:1). 


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TABLE—HALOGENATED SODIUM BENZOATE SALTS—Continued 

PMN No. CAS No. Chemical name 

P–17–64 .............................................................................. 17264–88–9 Benzoic acid, 3-chloro-, sodium salt (1:1). 

P–17–66 .............................................................................. 118537–84–1 Benzoic acid, 2,3-dichloro-, sodium salt (1:1). 

P–17–67 .............................................................................. 63891–98–5 Benzoic acid, 2,5-dichloro-, sodium salt (1:1). 

P–17–69 .............................................................................. 154862–40–5 Benzoic acid, 3,5-dichloro-, sodium salt (1:1). 

P–17–71 .............................................................................. 10007–84–8 Benzoic acid, 2,6-dichloro-, sodium salt (1:1). 

P–17–72 .............................................................................. 17274–10–1 Benzoic acid, 3,4-dichloro-, sodium salt (1:1). 

P–17–73 .............................................................................. 38402–11–8 Benzoic acid, 2,4-dichloro-, sodium salt (1:1). 

P–17–75 .............................................................................. 855471–43–1 Benzoic acid, 2-chloro-4-fluoro-, sodium salt. 

P–17–76 .............................................................................. 1421761–18–3 Benzoic acid, 3-chloro-4-fluoro-, sodium salt. 

P–17–79 .............................................................................. 1382106–78–6 Benzoic acid, 5-chloro-2-fluoro-, sodium salt. 

P–17–80 .............................................................................. 1421029–88–0 Benzoic acid, 4-chloro-3-fluoro-, sodium salt. 

P–17–83 .............................................................................. 1382106–64–0 Benzoic acid, 4-chloro-2-fluoro-, sodium salt. 

P–17–85 .............................................................................. 1938142–12–1 Benzoic acid, 5-bromo-2-chloro-, sodium salt. 

P–17–87 .............................................................................. 938142–13–2 Benzoic acid, 3-bromo-4-fluoro-, sodium salt. 

P–17–90 .............................................................................. 1938142–14–3 Benzoic acid, 2-bromo-5-fluoro-, sodium salt. 

P–17–91 .............................................................................. 1938142–15–4 Benzoic acid, 4-bromo-2-fluoro-, sodium salt. 

P–17–93 .............................................................................. 1535169–81–3 Benzoic acid, 4-bromo-3-fluoro-, sodium salt. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (2)(i), (iv), (a)(3), when 

determining which persons are 

reasonably likely to be exposed as 

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

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible, (a)(5) 

(respirators must provide a National 

Institute for Occupational Safety and 

Health (NIOSH) assigned protection 

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

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

1.0%), and (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 0.0184 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)(i), (ii), (iii), (iv), (vi), (ix), 

(g)(2)(i), (ii), (iii), (use respiratory 

protection or maintain workplace 

airborne concentrations at or below an 

8-hour time-weighted average of 0.0184 

mg/m3), (g)(2)(v), and (g)(5). Alternative 

hazard and warning statements that 

meet the criteria of the Globally 

Harmonized System (GHS) and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

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

a significant new use to manufacture or 

process the substances other than for the 

processes 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. 

(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. 

■ 34. Add § 721.11054 to subpart E to 

read as follows: 

§ 721.11054 Certain halogenated benzoic 

acids 

(a) The chemical substances listed in 

the Table of this section is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

TABLE—HALOGENATED BENZOIC ACIDS

PMN No. CAS No. Chemical name 

P–17–35 .............................................................................. 1201–31–6 Benzoic acid, 2,3,4,5-tetrafluoro-. 

P–17–37 .............................................................................. 433–97–6 Benzoic acid, 2-(trifluoromethyl)-. 

P–17–40 .............................................................................. 2991–28–8 Benzoic acid, 2,5-difluoro-. 

P–17–44 .............................................................................. 385–00–2 Benzoic acid, 2,6-difluoro-. 

P–17–46 .............................................................................. 455–40–3 Benzoic acid, 3,5-difluoro-. 

P–17–48 .............................................................................. 1583–58–0 Benzoic acid, 2,4-difluoro-. 

P–17–51 .............................................................................. 455–86–7 Benzoic acid, 3,4-difluoro-. 

P–17–53 .............................................................................. 121602–93–5 Benzoic acid, 3,4,5-trifluoro-. 

P–17–54 .............................................................................. 61079–72–9 Benzoic acid, 2,3,4-trifluoro-.

P–17–56 .............................................................................. 446–17–3 Benzoic acid, 2,4,5-trifluoro-. 

P–17–58 .............................................................................. 4519–39–5 Benzoic acid, 2,3-difluoro-. 

P–17–60 .............................................................................. 454–92–2 Benzoic acid, 3-(trifluoromethyl)-. 

P–17–65 .............................................................................. 50–45–3 Benzoic acid, 2,3-dichloro-. 

P–17–68 .............................................................................. 51–36–5 Benzoic acid, 3,5-dichloro-. 

P–17–70 .............................................................................. 50–30–6 Benzoic acid, 2,6-dichloro-. 


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TABLE—HALOGENATED BENZOIC ACIDS—Continued 

PMN No. CAS No. Chemical name 

P–17–74 .............................................................................. 2252–51–9 Benzoic acid, 2-chloro-4-fluoro-. 

P–17–77 .............................................................................. 394–30–9 Benzoic acid, 5-chloro-2-fluoro-.

P–17–78 .............................................................................. 403–16–7 Benzoic acid, 3-chloro-4-fluoro-.

P–17–81 .............................................................................. 403–17–8 Benzoic acid, 4-chloro-3-fluoro-.

P–17–82 .............................................................................. 446–30–0 Benzoic acid, 4-chloro-2-fluoro-.

P–17–84 .............................................................................. 21739–92–4 Benzoic acid, 5-bromo-2-chloro-. 

P–17–88 .............................................................................. 11007–16–5 Benzoic acid, 3-bromo-4-fluoro-. 

P–17–89 .............................................................................. 394–28–5 Benzoic acid, 2-bromo-5-fluoro-. 

P–17–92 .............................................................................. 153556–42–4 Benzoic acid, 4-bromo-3-fluoro-. 

P–17–97 .............................................................................. 112704–79–7 Benzoic acid, 4-bromo-2-fluoro-. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

when determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible, (a)(5) 

(respirators must provide a National 

Institute for Occupational Safety and 

Health (NIOSH) assigned protection 

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

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

1.0%), and (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 0.0184 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)(i), (ii), (iii), (iv), (vi), (ix), 

(g)(2)(i), (ii), (iii), (use respiratory 

protection or maintain workplace 

airborne concentrations at or below an 

8-hour time-weighted average of 0.0184 

mg/m3), (g)(2)(v), and (g)(5). Alternative 

hazard and warning statements that 

meet the criteria of the Globally 

Harmonized System (GHS) and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

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

significant new use to manufacture or 

process the substances other than for the 

processes 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. 

(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. 

■ 35. Add § 721.11055 to subpart E to 

read as follows: 

§ 721.11055 Certain halogenated benzoic 

acids ethyl esters. 

(a) The chemical substances listed in 

the Table of this section is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

TABLE—HALOGENATED BENZOIC ACID ETHYL ESTERS

PMN No. CAS No. Chemical name 

P–17–94 .............................................................................. 122894–73–9 Benzoic acid, 2,3,4,5-tetrafluoro-, ethyl ester. 

P–17–95 .............................................................................. 583–02–8 Benzoic acid, 4-(trifluoromethyl)-, ethyl ester. 

P–17–96 .............................................................................. 577–62–8 Benzoic acid, 2-(trifluoromethyl)-, ethyl ester. 

P–17–98 .............................................................................. 19064–14–3 Benzoic acid, 2,6-difluoro-, ethyl ester. 

P–17–99 .............................................................................. 708–25–8 Benzoic acid, 2,5-difluoro-, ethyl ester. 

P–17–100 ............................................................................ 351354–50–2 Benzoic acid, 2,3,4-trifluoro-, ethyl ester. 

P–17–101 ............................................................................ 351354–50–2 Benzoic acid, 2-bromo-5-fluoro-, ethyl ester. 

P–17–102 ............................................................................ 350–19–6 Benzoic acid, 3,5-difluoro-, ethyl ester. 

P–17–103 ............................................................................ 76008–73–6 Benzoic acid, 5-bromo-2-chloro-, ethyl ester. 

P–17–104 ............................................................................ 1128–76–3 Benzoic acid, 3-chloro-, ethyl ester. 

P–17–105 ............................................................................ 7335–25–3 Benzoic acid, 2-chloro-, ethyl ester. 

P–17–114 ............................................................................ 137521–81–4 Benzoic acid, 3-chloro-4-fluoro-, ethyl ester. 

P–17–122 ............................................................................ 474709–71–2 Benzoic acid, 4-bromo-2-fluoro-, ethyl ester. 

P–17–123 ............................................................................ 144267–97–0 Benzoic acid, 2-bromo-4,5-difluoro-, ethyl ester. 

P–17–124 ............................................................................ 1130165–74–0 Benzoic acid, 4-bromo-3-fluoro-, ethyl ester. 

P–17–125 ............................................................................ 23233–33–2 Benzoic acid, 3-bromo-4-fluoro-, ethyl ester. 

P–17–126 ............................................................................ 4793–20–8 Benzoic acid, 4-chloro-2-fluoro-, ethyl ester. 

P–17–127 ............................................................................ 35112–27–7 Benzoic acid, 2,5-dichloro-, ethyl ester. 

P–17–128 ............................................................................ 203573–08–4 Benzoic acid, 4-chloro-3-fluoro-, ethyl ester. 

P–17–129 ............................................................................ 167758–87–4 Benzoic acid, 2-chloro-4-fluoro-, ethyl ester. 

P–17–130 ............................................................................ 773139–56–3 Benzoic acid, 5-chloro-2-fluoro-, ethyl ester. 

P–17–131 ............................................................................ 108928–00–3 Benzoic acid, 2,4-difluoro-, ethyl ester. 


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TABLE—HALOGENATED BENZOIC ACID ETHYL ESTERS—Continued 

PMN No. CAS No. Chemical name 

P–17–132 ............................................................................ 144267–96–9 Benzoic acid, 3,4-difluoro-, ethyl ester. 

P–17–133 ............................................................................ 495405–09–9 Benzoic acid, 3,4,5-trifluoro-, ethyl ester. 

P–17–134 ............................................................................ 351354–41–1 Benzoic acid, 2,4,5-trifluoro-, ethyl ester. 

P–17–135 ............................................................................ 76783–59–0 Benzoic acid, 3-(trifluoromethyl)-, ethyl ester. 

P–17–136 ............................................................................ 773134–65–9 Benzoic acid, 2,3-difluoro-, ethyl ester. 

P–17–137 ............................................................................ 81055–73–4 Benzoic acid, 2,6-dichloro-, ethyl ester. 

P–17–138 ............................................................................ 91085–56–2 Benzoic acid, 3,5-dichloro-, ethyl ester. 

P–17–139 ............................................................................ 56882–52–1 Benzoic acid, 2,4-dichloro-, ethyl ester. 

P–17–140 ............................................................................ 28394–58–3 Benzoic acid, 3,4-dichloro-, ethyl ester. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

when determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible, (a)(5) 

(respirators must provide a National 

Institute for Occupational Safety and 

Health (NIOSH) assigned protection 

factor of at least 1000), (a)(6) 

(particulate), (a)(6)(v), (vi), (b) 

(concentration set at 1.0%), and (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 0.0184 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)(i), (ii), (iii), (iv), (vi), (ix), 

(g)(2)(i), (ii), (iii), (use respiratory 

protection or maintain workplace 

airborne concentrations at or below an 

8-hour time-weighted average of 0.0184 

mg/m3), (g)(2)(v), (g)(3)(i), (ii), (g)(4)(i), 

and (g)(5). Alternative hazard and 

warning statements that meet the 

criteria of the Globally Harmonized 

System (GHS) and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

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

significant new use to manufacture or 

process the substances other than for 

processes described in the Order. 

(iv) Release to water. Requirements as 

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

(c)(4) where N = 15 ppb. 

(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) 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. 

■ 36. Add § 721.11056 to subpart E to 

read as follows: 

§ 721.11056 Neodymium aluminium alkyl 

polymer complexes (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as neodymium aluminium 

alkyl polymer complexes (PMN P–17– 

198) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

when determining which persons are 

reasonably likely to be exposed as 

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

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible, (b) 

(concentration set 1.0%), and (c). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

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

(g)(1)(ix), (The substance may react 

violently with water, (This substance 

may cause skin irritation and corrosion), 

(This substance may cause respiratory 

complications, irritation, and corrosion), 

(g)(2)(i), (ii), (iii), (When using this 

substance use in closed system to 

prevent any inhalation exposure), 

(When using this substance use skin and 

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

hazard and warning statements that 

meet the criteria of the Globally 

Harmonized System (GHS) and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(c) (It is a 

significant new use to process the 

substance in manner that results in 

inhalation exposure.), (f), and (p) (8 

months). 

(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 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. 

■ 37. Add § 721.11057 to subpart E to 

read as follows: 

§ 721.11057 Fatty acid amide alkyl amine 

salts (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as fatty acid amide alkyl 

amine salts (PMN P–17–272, P–17–273, 

P–17–274, P–17–275, P–17–276 and P– 

17–277) are subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. The requirements of this section 


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Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations 37733 

do not apply to quantities of the 

substances 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), (iv), (a)(3). 

When determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) engineering 

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

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

(f), (g)(1) (skin irritation), (respiratory 

complication), (internal organ effect), 

(systemic effect), (sensitization), 

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

(g)(4)(i), (iii), and (g)(5). Alternative 

hazard and warning statements that 

meet the criteria of the Globally 

Harmonized System (GHS) and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k), and (y)(1). 

(iv) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (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. 

■ 38. Add § 721.11058 to subpart E to 

read as follows: 

§ 721.11058 Fatty acid amide alkyl amine 

salts (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as fatty acid amide alkyl 

amine salts (PMN P–17–278, P–17–279 

and P–17–280) are 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 

substances 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), (iv), (a)(3). 

When determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) engineering 

control measures (e.g., enclosure or 

confinement of the operation, general 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

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

(f), (g)(1) (skin irritation), (respiratory 

complication), (internal organ effect), 

(systemic effect), (sensitization), 

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

(g)(4)(i), (iii), and (g)(5). Alternative 

hazard and warning statements that 

meet the criteria of the Globally 

Harmonized System (GHS) and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k), and (y)(1). 

(iv) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (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. 

[FR Doc. 2018–15995 Filed 7–31–18; 8:45 am] 

BILLING CODE 6560–50–P 


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