Federal Register / Vol. 86, No. 157 / Wednesday, August 18, 2021 / Rules and Regulations 46133 

dialkanolamine, acetates (salts) (PMN 

P–19–27) 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. It is a significant 

new use to manufacture, process, or use 

the PMN substance in any manner that 

results in inhalation exposure to vapor, 

particulate, mist, or aerosols. It is a 

significant new use to manufacture the 

PMN substance beyond an annual 

production volume of 95,600 kg. 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11329 Non-metal tetrakis 

(hydroxyalkyl)-, halide, polymer with amide 

oxidized (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as non-metal tetrakis 

(hydroxyalkyl)-, halide, polymer with 

amide oxidized (PMN P–19–45) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

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

new use to manufacture, process, or use 

the substance in any manner that results 

in inhalation exposure. It is a significant 

new use to manufacture the substance to 

contain greater than 0.1% residual 

unbound formaldehyde by weight. 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitation 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. 

[FR Doc. 2021–17388 Filed 8–17–21; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2018–0627, EPA–HQ– 

OPPT–2018–0777, EPA–HQ–OPPT–2019– 

0359, EPA–HQ–OPPT–2019–0228, EPA–HQ– 

OPPT–2019–0494, and EPA–HQ–OPPT– 

2019–0530; FRL–8000–02–OCSPP] 

RIN 2070–AB27 

Significant New Use Rules on Certain 

Chemical Substances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is issuing significant new 

use rules (SNURs) under the Toxic 

Substances Control Act (TSCA) for 

chemical substances that were the 

subject of premanufacture notices 

(PMNs). The SNURs require persons 

who intend to manufacture (defined by 

statute to include import) or process any 

of these 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 use, 

under the conditions of use for that 

chemical substance, 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 by 

that determination. 

DATES: This rule is effective on October 

18, 2021. For purposes of judicial 

review, this rule shall be promulgated at 

1 p.m. (e.s.t.) on September 1, 2021. 

FOR FURTHER INFORMATION CONTACT: 

For technical information contact: 

William Wysong, New Chemicals 

Division (7405M), Office of Pollution 

Prevention and Toxics, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW, Washington, DC 20460–0001; 

telephone number: (202) 564–4163; 

email address: wysong.william@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 provisions 

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, which would include 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 are subject 

to the export notification provisions of 

TSCA section 12(b) (15 U.S.C. 2611(b)) 

(see 40 CFR 721.20), and must comply 

with the export notification 

requirements in 40 CFR part 707, 

subpart D. 

B. How can I access the dockets? 

The dockets include information 

considered by the Agency in developing 

the proposed and final rules. The 

dockets for this action, identified by 

docket identification (ID) numbers EPA– 

HQ–OPPT–2018–0627, –2018–0777, 

–2019–0359, –2019–0228, –2019–0494, 

and –2019–0530, are available at https:// 

www.regulations.gov and at the Office of 

Pollution Prevention and Toxics Docket 

(OPPT Docket), Environmental 

Protection Agency Docket Center (EPA/ 

DC), West William Jefferson Clinton 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW, Washington, DC. The Public 

Reading Room is open from 8:30 a.m. to 

4:30 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Public Reading Room is 

(202) 566–1744, and the telephone 

number for the OPPT Docket is (202) 

566–0280. 

Due to the public health concerns 

related to COVID–19, the EPA Docket 


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46134 Federal Register / Vol. 86, No. 157 / Wednesday, August 18, 2021 / Rules and Regulations 

Center (EPA/DC) and Reading Room is 

closed to visitors with limited 

exceptions. The staff continues to 

provide remote customer service via 

email, phone, and webform. For the 

latest status information on EPA/DC 

services and docket access, visit https:// 

www.epa.gov/dockets. 

II. Background 

A. What action is the Agency taking? 

EPA is finalizing SNURs under TSCA 

section 5(a)(2) for certain chemical 

substances which were the subject of 

PMNs. EPA will address the other 

proposed SNURs in future Federal 

Register notices. 

Previously, EPA proposed SNURs for 

these chemical substances and 

established the record for these SNURs 

in the following Federal Registers and 

docket ID numbers: 

• October 3, 2018 (83 FR 49903) 

(FRL–9983–81); Docket ID No. EPA– 

HQ–OPPT–2018–0627; 

• July 31, 2019 (84 FR 37199) (FRL– 

9994–62); Docket ID No. EPA–HQ– 

OPPT–2018–0777; 

• August 6, 2019 (84 FR 38158) (FRL– 

9996–62); Docket ID No. EPA–HQ– 

OPPT–2019–0359; 

• October 11, 2019 (84 FR 54816) 

(FRL–9998–64); Docket ID No. EPA– 

HQ–OPPT–2019–0228; 

• November 4, 2019 (84 FR 59335) 

(FRL–10000–54); Docket ID No. EPA– 

HQ–OPPT–2019–0494; and 

• December 6, 2019 (84 FR 66855) 

(FRL–10001–48); Docket ID No. EPA– 

HQ–OPPT–2019–0530. 

The dockets include information 

considered by the Agency in developing 

the proposed and final rules, including 

public comments and EPA’s responses 

to the public comments received. 

B. What is the Agency’s authority for 

taking this action? 

TSCA section 5(a)(2) (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. 

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. Pursuant to 

40 CFR 721.1(c), persons subject to 

these SNURs must comply with the 

significant new use notice (SNUN) 

requirements and EPA regulatory 

procedures as submitters of PMNs under 

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

these requirements include the 

information submission requirements of 

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

exemptions authorized by TSCA 

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

and the regulations at 40 CFR part 720. 

Once EPA receives a SNUN and before 

the manufacture or processing for the 

significant new use can commence, 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. 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 

A. Considerations for Significant New 

Use Determinations 

When the Agency issues an order 

under TSCA section 5(e), section 5(f)(4) 

requires that the Agency consider 

whether to promulgate a SNUR for any 

use not conforming to the restrictions of 

the TSCA Order or publish a statement 

describing the reasons for not initiating 

the rulemaking. TSCA section 5(a)(2) 

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 determining 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, and potential 

human exposures and environmental 

releases that may be associated with 

possible uses of these chemical 

substances, in the context of the four 

bulleted TSCA section 5(a)(2) factors 

listed in this unit. 

B. Procedures for Significant New Uses 

Claimed as CBI 

By this rule, EPA is establishing 

certain significant new uses which have 

been claimed as CBI subject to Agency 

confidentiality regulations at 40 CFR 

part 2 and 40 CFR part 720, subpart E. 

Absent a final determination or other 

disposition of the confidentiality claim 

under 40 CFR part 2 procedures, EPA is 

required to keep this information 

confidential. EPA promulgated a 

procedure to deal with the situation 

where a specific significant new use is 

CBI, at 40 CFR 721.1725(b)(1) and has 

referenced it to apply to other SNURs. 

Under these procedures a 

manufacturer or processor may request 

EPA to determine whether a specific 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 40 CFR 

721.1725(b)(1) with that under 40 CFR 

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. 

IV. Public Comments on Proposed Rule 

and EPA Responses 

EPA received public comments from 

nine identifying entities on the 


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proposed rules. The Agency’s responses 

are presented in the Response to Public 

Comments document that is available in 

each of the dockets for these rules. EPA 

made changes to three of the proposed 

rules as described in the response to 

comments. 

V. Substances Subject to This Rule 

EPA is establishing significant new 

use and recordkeeping requirements for 

chemical substances in 40 CFR part 721, 

subpart E. In Unit IV. of the proposed 

SNURs, EPA provided the following 

information for each chemical 

substance: 

• PMN number. 

• Chemical name (generic name, if 

the specific name is claimed as 

confidential business information 

(CBI)). 

• Chemical Abstracts Service (CAS) 

Registry number (if assigned for nonconfidential chemical identities). 

• Effective date of and basis for the 

TSCA Order. 

• Potentially Useful Information. This 

is information identified by EPA that 

would help characterize the potential 

health and/or environmental effects of 

the chemical substances if a 

manufacturer or processor is 

considering submitting a SNUN for a 

significant new use designated by the 

SNUR. 

• CFR citation assigned in the 

regulatory text section of these rules. 

The regulatory text section of these 

rules specifies the activities designated 

as significant new uses. Certain new 

uses, including production volume 

limits and other uses designated in the 

rules, may be claimed as CBI. 

These final rules include PMN 

substances that are subject to orders 

issued under TSCA section 5(e)(1)(A), as 

required by the determinations made 

under TSCA section 5(a)(3)(B). Those 

TSCA Orders require protective 

measures to limit exposures or 

otherwise mitigate the potential 

unreasonable risk. The final 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 TSCA 

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 Order usually requires 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). The 

comprehensive NCELs provisions in 

TSCA Orders include requirements 

addressing performance criteria for 

sampling and analytical methods, 

periodic monitoring, respiratory 

protection, and recordkeeping. 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 40 CFR 721.63 

respirator requirements may request to 

do so under 40 CFR 721.30. EPA expects 

that persons whose 40 CFR 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 

Order. 

VI. Rationale and Objectives of the Rule 

A. Rationale 

During review of the PMNs submitted 

for the chemical substances that are 

subject to these SNURs and as further 

discussed in Unit IV. of the proposed 

rules, EPA concluded that 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. Based on such 

findings, TSCA Orders requiring the use 

of appropriate exposure controls were 

negotiated with the PMN submitters. As 

a general matter, EPA believes it is 

necessary to follow TSCA Orders with 

a SNUR that identifies the absence of 

those protective measures as significant 

new uses to ensure that all 

manufacturers and processors—not just 

the original submitter—are held to the 

same standard. 

B. Objectives 

EPA is issuing these SNURs because 

the Agency wants to 

• 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. 

• 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; and 

• Be obligated to make a 

determination under TSCA section 

5(a)(3) regarding the use described in 

the SNUN, under the conditions of use. 

The Agency will either determine under 

TSCA section 5(a)(3)(C) that significant 

new use is not likely to present an 

unreasonable risk, including an 

unreasonable risk to a potentially 

exposed or susceptible subpopulation 

identified as relevant by the 

Administrator under the conditions of 

use, or make a determination under 

TSCA section 5(a)(3)(A) or (B) and take 

the required regulatory action associated 

with the determination, before 

manufacture or processing for the 

significant new use of the chemical 

substance can occur. 

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 https://www.epa.gov/tscainventory. 

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 Orders have been issued for all 

the chemical substances that are the 

subject of this rule, and the PMN 

submitters are prohibited by the TSCA 

Orders from undertaking activities 

which will be designated as significant 

new uses. The identities of 50 of the 57 

chemical substances subject to this rule 

have been claimed as confidential (per 

40 CFR 720.85). 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. 

Furthermore, EPA designated the 

publication dates of the proposed rules 

(see Unit II.) as the cutoff dates for 

determining whether the new uses are 

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 final rule. 


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In the unlikely event that a person 

began commercial manufacture or 

processing of the chemical substances 

for a significant new use identified as of 

the abovementioned dates, that person 

will have to cease any such activity 

upon the effective date of the final rule. 

To resume their activities, that person 

would 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 development of any 

particular new information (e.g., 

generating test data) before submission 

of a SNUN. There is an exception: 

If a person is required to submit 

information for a chemical substance 

pursuant to a rule, TSCA Order or 

consent agreement under TSCA section 

4, then TSCA section 5(b)(1)(A) requires 

such information to be submitted to 

EPA at the time of submission of the 

SNUN. 

In the absence of a rule, TSCA Order, 

or consent agreement under TSCA 

section 4 covering the chemical 

substance, persons are required only to 

submit information in their possession 

or control and to describe any other 

information known to them 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. of the proposed rule lists 

potentially useful information for all 

SNURs listed in this document. 

Descriptions are provided for 

informational purposes. The 

information identified in Unit IV. of the 

proposed rule will be potentially useful 

to EPA’s evaluation in the event that 

someone submits a SNUN for the 

significant new use. Companies who are 

considering submitting a SNUN are 

encouraged, but not required, to develop 

the information on the substance. 

EPA strongly encourages persons, 

before performing any testing, to consult 

with the Agency. 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). For more information on 

alternative test methods and strategies 

to reduce vertebrate animal testing, visit 

https://www.epa.gov/assessing-andmanaging-chemicals-under-tsca/ 

alternative-test-methods-and-strategiesreduce. 

In some of the TSCA Orders for the 

chemical substances identified in 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 

potential risks posed by these chemical 

substances. The SNURs contain the 

same production volume limits as the 

TSCA 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 non-exempt 

commercial manufacture or processing. 

Any request by EPA for the triggered 

and pended testing described in the 

TSCA Orders was made based on EPA’s 

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

available information on appropriate 

testing for the PMN substances. Further, 

any such testing request on the part of 

EPA that includes testing on vertebrates 

was made after consideration of 

available toxicity information, 

computational toxicology and 

bioinformatics, and high-throughput 

screening methods and their prediction 

models. 

The potentially useful information 

identified in Unit IV. of the proposed 

rule may not be the only means of 

addressing the potential risks of the 

chemical substance associated with the 

designated significant new uses. 

However, submitting a SNUN without 

any test data or other information may 

increase the likelihood that EPA will 

take action under TSCA sections 5(e) or 

5(f). EPA recommends that potential 

SNUN submitters contact EPA early 

enough so that they will be able to 

conduct the appropriate tests. 

SNUN submitters should be aware 

that EPA will be better able to evaluate 

SNUNs that 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. SNUN Submissions 

According to 40 CFR 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 https://

www.epa.gov/reviewing-new-chemicalsunder-toxic-substances-control-act-tsca. 

X. 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 

analyses are available in each docket 

listed in Unit II. 

XI. Statutory and Executive Order 

Reviews 

Additional information about these 

statutes and Executive Orders can be 

found at https://www.epa.gov/lawsregulations-and-executive-orders. 

A. Executive Order 12866: Regulatory 

Planning and Review and Executive 

Order 13563: Improving Regulations 

and Regulatory Review 

This action establishes SNURs for 

several new chemical substances that 

were the subject of PMNs. The Office of 

Management and Budget (OMB) has 

exempted these types of actions from 

review under Executive Orders 12866 

(58 FR 51735, October 4, 1993) and 

13563 (76 FR 3821, January 21, 2011). 

B. Executive Order 13771: Reducing 

Regulations and Controlling Regulatory 

Costs 

This action is not subject to Executive 

Order 13771 (82 FR 9339, February 3, 

2017), because this action is not a 

significant regulatory action under 

Executive Order 12866. 

C. Paperwork Reduction Act (PRA) 

According to the 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 information 


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collection requirements associated with 

SNURs have already been approved by 

OMB pursuant to the PRA under OMB 

control number 2070–0012 (EPA ICR 

No. 574). This rule does not impose any 

burden requiring additional OMB 

approval. 

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. The Information Collection 

Request (ICR) covering the SNUR 

activities 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. 

If an entity were to submit a SNUN to 

the Agency, the annual burden is 

estimated to average between 30 and 

170 hours per response. This burden 

estimate includes the time needed to 

review instructions, search existing data 

sources, gather and maintain the data 

needed, and complete, review, and 

submit the required SNUN. 

Send any comments about the 

accuracy of the burden estimate, and 

any suggested methods for minimizing 

respondent burden, including through 

the use of automated collection 

techniques, to the Director, Regulatory 

Support Division, Office of Mission 

Support (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. 

D. Regulatory Flexibility Act (RFA) 

Pursuant to the RFA section 605(b) (5 

U.S.C. 601 et seq.), the Agency hereby 

certifies that promulgation of these 

SNURs would not have a significant 

adverse economic impact on a 

substantial number of small entities. 

The requirement to submit a SNUN 

applies to any person (including small 

or large entities) who intends to engage 

in any activity described in the final 

rule as a ‘‘significant new use.’’ Because 

these uses are ‘‘new,’’ based on all 

information currently available to EPA, 

EPA has concluded that no small or 

large entities presently engage in such 

activities. A SNUR requires that any 

person who intends to engage in such 

activity in the future must first notify 

EPA by submitting a SNUN. Although 

some small entities may decide to 

pursue a significant new use in the 

future, EPA cannot presently determine 

how many, if any, there may be. 

However, EPA’s experience to date is 

that, in response to the promulgation of 

SNURs covering over 1,000 chemicals, 

the Agency receives only a small 

number of notices per year. For 

example, EPA received 7 SNUNs in 

Federal fiscal year (FY) 2013, 13 in 

FY2014, 6 in FY2015, 10 in FY2016, 14 

in FY2017, and 11 in FY2018 and only 

a fraction of these were from small 

businesses. In addition, the Agency 

currently offers relief to qualifying small 

businesses by reducing the SNUN 

submission fee from $16,000 to $2,800. 

This lower fee reduces the total 

reporting and recordkeeping of cost of 

submitting a SNUN to about $10,116 for 

qualifying small firms. Therefore, the 

potential economic impacts of 

complying with this SNUR are not 

expected to be significant or adversely 

impact a substantial number of small 

entities. In a SNUR that published in the 

Federal Register of June 2, 1997 (62 FR 

29684) (FRL–5597–1), the Agency 

presented its general determination that 

final SNURs are not expected to have a 

significant economic impact on a 

substantial number of small entities, 

which was provided to the Chief 

Counsel for Advocacy of the Small 

Business Administration. 

E. 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.). 

F. Executive Order 13132: Federalism 

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 (64 FR 43255, 

August 10, 1999). 

G. Executive Order 13175: Consultation 

and Coordination With Indian Tribe 

Governments 

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 

(65 FR 67249, November 9, 2000), do 

not apply to this action. 

H. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks 

This action is not subject to Executive 

Order 13045 (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. 

EPA interprets Executive Order 13045 

as applying only to those regulatory 

actions that concern environmental 

health or safety risks that EPA has 

reason to believe may 

disproportionately affect children, per 

the definition of ‘‘covered regulatory 

action’’ in section 2–202 of the 

Executive Order. 

I. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This action is not subject to Executive 

Order 13211 (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. 

J. National Technology Transfer and 

Advancement Act (NTTAA) 

In addition, since this action does not 

involve any technical standards subject 

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

note). 

K. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

This action does not entail special 

considerations of environmental justice 

related issues as delineated by 


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46138 Federal Register / Vol. 86, No. 157 / Wednesday, August 18, 2021 / Rules and Regulations 

Executive Order 12898 (59 FR 7629, 

February 16, 1994). 

XII. Congressional Review Act 

This action is subject to the CRA (5 

U.S.C. 801 et seq.), and EPA will submit 

a rule report containing this rule and 

other required information to each 

House of the Congress and to the 

Comptroller General of the United 

States. 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: August 9, 2021. 

Tala Henry, 

Deputy Director, Office of Pollution 

Prevention and Toxics. 

Therefore, for the reasons stated in the 

preamble, 40 CFR chapter I is amended 

as follows: 

PART 9—OMB APPROVALS UNDER 

THE PAPERWORK REDUCTION ACT 

■ 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; 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, amend the table by adding 

entries for §§ 721.11150, 721.11267 

through 721.11277, 721.11279 through 

721.11281, 721.11284, 721.11288, 

721.11305, 721.11308, 721.11315 and 

721.11316, 721.11319 through 

721.11321, 721.11346 through 

721.11350, 721.11360 and 721.11361, 

721.11372, 721.11383, 721.11390 

through 721.11393, 721.11422, and 

721.11426 through 721.11443 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 

* * * * * 

721.11150 ............................. 2070–0012 

* * * * * 

721.11267 ............................. 2070–0012 

721.11268 ............................. 2070–0012 

721.11269 ............................. 2070–0012 

721.11270 ............................. 2070–0012 

721.11271 ............................. 2070–0012 

721.11272 ............................. 2070–0012 

721.11273 ............................. 2070–0012 

721.11274 ............................. 2070–0012 

721.11275 ............................. 2070–0012 

721.11276 ............................. 2070–0012 

721.11277 ............................. 2070–0012 

* * * * * 

721.11279 ............................. 2070–0012 

721.11280 ............................. 2070–0012 

721.11281 ............................. 2070–0012 

* * * * * 

721.11284 ............................. 2070–0012 

* * * * * 

721.11288 ............................. 2070–0012 

* * * * * 

721.11305 ............................. 2070–0012 

* * * * * 

721.11308 ............................. 2070–0012 

* * * * * 

721.11315 ............................. 2070–0012 

721.11316 ............................. 2070–0012 

* * * * * 

721.11319 ............................. 2070–0012 

721.11320 ............................. 2070–0012 

721.11321 ............................. 2070–0012 

* * * * * 

721.11346 ............................. 2070–0012 

721.11347 ............................. 2070–0012 

721.11348 ............................. 2070–0012 

721.11349 ............................. 2070–0012 

721.11350 ............................. 2070–0012 

* * * * * 

721.11360 ............................. 2070–0012 

721.11361 ............................. 2070–0012 

* * * * * 

721.11372 ............................. 2070–0012 

* * * * * 

721.11383 ............................. 2070–0012 

* * * * * 

721.11390 ............................. 2070–0012 

721.11391 ............................. 2070–0012 

721.11392 ............................. 2070–0012 

721.11393 ............................. 2070–0012 

* * * * * 

721.11422 ............................. 2070–0012 

40 CFR citation OMB control 

No. 

* * * * * 

721.11426 ............................. 2070–0012 

721.11427 ............................. 2070–0012 

721.11428 ............................. 2070–0012 

721.11429 ............................. 2070–0012 

721.11430 ............................. 2070–0012 

721.11431 ............................. 2070–0012 

721.11432 ............................. 2070–0012 

721.11433 ............................. 2070–0012 

721.11434 ............................. 2070–0012 

721.11435 ............................. 2070–0012 

721.11436 ............................. 2070–0012 

721.11437 ............................. 2070–0012 

721.11438 ............................. 2070–0012 

721.11439 ............................. 2070–0012 

721.11440 ............................. 2070–0012 

721.11441 ............................. 2070–0012 

721.11442 ............................. 2070–0012 

721.11443 ............................. 2070–0012 

* * * * * 

* * * * * 

PART 721—SIGNIFICANT NEW USES 

OF CHEMICAL SUBSTANCES 

■ 3. The authority citation for part 721 

continues to read as follows: 

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

2625(c). 

Subpart E—Significant New Uses for 

Specific Chemical Substances 

■ 4. Add § 721.11150 to read as follows: 

§ 721.11150 2-Pyrrolidinone, 1-butyl-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

2-pyrrolidinone, 1-butyl- (PMN P–14– 

627, CAS No. 3470–98–2) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

(b), and (c). When determining which 

persons are reasonably likely to be 

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

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. For 

purposes of § 721.63(a)(2)(i), butyl or 

Silver Shield gloves may be used. For 

purposes of § 721.63(b), the 

concentration is set at 1.0%. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), (g)(1)(i) and (ix), (g)(2)(i) 

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


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Federal Register / Vol. 86, No. 157 / Wednesday, August 18, 2021 / Rules and Regulations 46139 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. For purposes of § 721.72(e), the 

concentration is set at 1.0%. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

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

new use to import the substance in 

containers of less than 55 gallons when 

the concentration of the confidential 

component identified in the TSCA 

Order is greater than 5% by weight for 

any product either intended for sale or 

distribution for consumer use, including 

for use in consumer products, or both 

intended for commercial use and made 

available to consumers for retail 

purchase of any kind. It is a significant 

new use to use or sell the PMN 

substance in handheld spray 

applications that generate a vapor, mist 

or aerosol. 

(iv) Significant new use to import. It 

is a significant new use to import the 

PMN substance other than to be 

processed or sold for: 

(A) Dispersions for industrial coatings 

(e.g., polyurethane, acrylic, epoxy); 

(B) Coating for consumer and 

professional use; 

(C) Adhesives and sealants; 

(D) Solvent-borne industrial coatings; 

(E) Silicon wafer cleaning in 

microelectronics in clean rooms; 

(F) Photoresist stripping in 

microelectronics in clean rooms; 

(G) Coatings for microelectronics (e.g., 

casting of polymer films) in clean 

rooms; 

(H) Reaction medium for 

polymerization, polymer coatings for 

industrial and professional applications 

(e.g., wire enamel, non-stick and friction 

reduction coating) membranes; 

(I) Solvent for chemical synthesis 

reactions (e.g., pharmaceuticals); 

(J) Formulation of inks; 

(K) Industrial cleaner (e.g., cleaner for 

wind turbine, oil rigs, large engines); 

(L) Solvent for cleaning industrial 

reactors; 

(M) Wax inhibitors (in hydrocarbon 

lines); 

(N) Petrochemical extraction 

processes; 

(O) Paint stripper; 

(P) Solvents for production and 

formulation of fertilizer; 

(Q) Solvent for production and 

formulation of active ingredients for 

agriculture; 

(R) Solvent for formulation of active 

ingredients for agriculture-end use 

pesticide product). 

(v) Significant new use to use or sell. 

It is a significant new use to use or sell 

the PMN substance for: 

(A) Dispersions for industrial coatings 

(e.g., polyurethane, acrylic, epoxy) in a 

concentration greater than 18% in 

formulated products; 

(B) Adhesives and sealants in 

concentrations greater than 18% in 

formulated products; 

(C) Solvent-borne industrial coatings 

in concentrations greater than 30% in 

formulated products; 

(D) Coatings for microelectronics (e.g., 

casting of polymer films) in clean rooms 

in concentrations greater than 20% in 

formulated products; 

(E) Reaction medium for 

polymerization, polymer coatings for 

industrial and professional applications 

(e.g., wire enamel, non-stick and friction 

reduction coating) membranes in 

concentrations greater than 40% in 

formulated products; 

(F) Inks in concentrations greater than 

15% in formulated products; 

(G) Solvent for chemical synthesis 

reactions (e.g., pharmaceuticals) in 

concentrations greater than 40% in 

formulated products; 

(H) Industrial cleaner (e.g., cleaner for 

wind turbine, oil rigs, large engines) in 

concentrations greater than 20% in 

formulated products; 

(I) Wax inhibitors (in hydrocarbon 

lines) in concentrations greater than 

20% in formulated products; 

(J) Petrochemical extraction processes 

in concentrations greater than 60% in 

formulated products; 

(K) Paint stripper only for industrial 

use in concentrations greater than 20% 

in formulated products; 

(L) Solvent for formulation of active 

ingredients for agriculture-end use 

pesticide product) in concentrations 

greater than 70% in formulated 

products; 

(M) Paint removers in concentrations 

greater than 5% in formulated products 

intended for sale or distribution for 

‘‘consumer’’ use, including ‘‘commercial 

use’’ when the ‘‘saleable good or 

service’’ could introduce PMN material 

into a ‘‘consumer’’ setting; 

(N) Coatings in concentrations greater 

than 1% in formulated products 

intended for sale or distribution for 

‘‘consumer’’ use, including ‘‘commercial 

use’’ when the ‘‘sealable good or 

service’’ could introduce PMN material 

into a ‘‘consumer’’ setting. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

manufacturers and processors of this 

substance. 

(2) Limitation 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 §§ 721.11267 through 

721.11277 to read as follows: 

Sec. 

* * * * * 

721.11267 Silane amine carbonate (generic). 

721.11268 Hydrochlorofluoroolefin 

(generic). 

721.11269 Fatty acid modified aromatic 

polyester polyol (generic). 

721.11270 Dodecanedioic acid and 1,6- 

hexanediol polymer with 3-hydroxy-2,2- 

dimethylpropyl-2,2- 

dimethylhydracrylate, neopentylglycol, 

1,2-ethanediol, adipic acid, isophthalic 

acid, terephthalic acid, 2-Oxooxopane, 

BayFlex 2002H and 1,1′- 

methylenebis(isocyanatobenzene) 

(generic). 

721.11271 Ethanone, 1-[4-(4- 

chlorophenoxy)-2- 

(trifluoromethyl)phenyl]-. 

721.11272 Vegetable oil, polymer with 

alkanedioic acid, alkali lignin, 

diethylene glycol- and polyol-depolymd. 

poly(ethylene terephthalate) waste 

plastics and arylcarboxylic acid 

anhydride (generic). 

721.11273 Vegetable oil, polymer with 

alkanedioic acid, alkali lignin, 

diethylene glycol- and polyol-depolymd. 

poly(ethylene terephthalate) waste 

plastics (generic). 

721.11274 Waste plastics, poly(ethylene 

terephthalate), depolymd. with 

diethylene glycol, polymers with 

alkanedioic acid, alkali lignin and 

arylcarboxylic acid anhydride (generic). 

721.11275 Waste plastics, poly(ethylene 

terephthalate), depolymd. with 

diethylene glycol and polyol, polymers 

with alkanedioic acid, alkali lignin and 

arylcarboxylic acid anhydride (generic). 

721.11276 Vegetable oil, polymer with 

alkanedioic acid, alkali lignin, 

diethylene glycol- and polyol-depolymd. 

poly(ethylene terephthalate) waste 

plastics and arylcarboxylic acid 

anhydride (generic). 

721.11277 Vegetable oil, polymer with 

alkanedioic acid, alkali lignin, 

diethylene glycol-depolymd. 

poly(ethylene terephthalate) waste 

plastics and arylcarboxylic acid 

anhydride (generic). 

* * * * * 

§ 721.11267 Silane amine carbonate 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as silane amine carbonate 

(PMN P–17–157) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 


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46140 Federal Register / Vol. 86, No. 157 / Wednesday, August 18, 2021 / Rules and Regulations 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(3) through (5), (a)(6)(v) 

and (vi), and (b). 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. For 

purposes of § 721.63(a)(5), respirators 

must provide a National Institute for 

Occupational Safety and Health 

(NIOSH) assigned protection factor 

(APF) of at least 1,000. For purposes of 

§ 721.63(b), the concentration is set at 

1.0%. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

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

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

hazard and warning statements that 

meet the criteria of the Globally 

Harmonized System and OSHA Hazard 

Communication Standard may be used. 

For purposes of § 721.72(e), the 

concentration is set at 1.0%. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

to manufacturers and processors of this 

substance. 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11268 Hydrochlorofluoroolefin 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as hydrochlorofluoroolefin 

(PMN P–17–295) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(3) through (5), (a)(6)(v) 

and (vi), and (b). 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. For 

purposes of § 721.63(a)(5), respirators 

must provide a National Institute for 

Occupational Safety and Health 

(NIOSH) assigned protection factor 

(APF) of at least 10. For purposes of 

§ 721.63(b), the concentration is set at 

1.0%. 

(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 Order for this substance. 

The NCEL is 23.6 mg/m3 (3.9 ppm) 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 Order. 

(B) [Reserved] 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f) and (g)(1) and (2). For 

purposes of § 721.72(e), the 

concentration is set at 1.0%. For 

purposes of § 721.72(g)(1), this 

substance may cause: Internal organ 

effects; reproductive effects; fatality. For 

purposes of § 721.72(g)(2), when using 

this substance: Avoid skin contact; 

avoid breathing substance; avoid 

ingestion; use respiratory protection or 

maintain workplace airborne 

concentrations at or below an 8-hour 

time-weighted average of 23.6 mg/m3

(3.9 ppm); use skin protection. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f), (k), and (o). For 

purposes of § 721.80(k), the use is as a 

refrigerant used in closed systems for 

chillers (commercial comfort air 

conditioners) and industrial process 

refrigeration. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

manufacturers and processors of this 

substance. 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11269 Fatty acid modified aromatic 

polyester polyol (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substances identified 

generically as fatty acid modified 

aromatic polyester polyol (PMN P–17– 

306 and PMN P–17–307) 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) and (iii), (a)(3), 

(b), and (c). When determining which 

persons are reasonably likely to be 

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

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. For 

purposes of § 721.63(b), the 

concentration is set at 1.0%. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

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

(g)(5). For purposes of § 721.72(e), the 

concentration is set at 1.0%. For 

purposes of § 721.72(g)(1), this 

substance may cause: Internal organ 

effects; ocular effects. 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. It is a significant 

new use to use an application method 

that generates a vapor, mist, aerosol, or 

dust containing the substance resulting 

in inhalation exposures. 

(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 

these substances. 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11270 Dodecanedioic acid and 1,6- 

hexanediol polymer with 3-hydroxy-2,2- 

dimethylpropyl-2,2-dimethylhydracrylate, 

neopentylglycol, 1,2-ethanediol, adipic acid, 

isophthalic acid, terephthalic acid, 2- 

Oxooxopane, BayFlex 2002H and 1,1′- 

methylenebis(isocyanatobenzene) 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 


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(1) The chemical substance identified 

generically as dodecanedioic acid and 

1,6-hexanediol polymer with 3-hydroxy2,2-dimethylpropyl-2,2- 

dimethylhydracrylate, neopentylglycol, 

1,2-ethanediol, adipic acid, isophthalic 

acid, terephthalic acid, 2-Oxooxopane, 

BayFlex 2002H and 1,1′- 

methylenebis(isocyanatobenzene) (PMN 

P–17–320) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(3) through (5), (a)(6)(v) 

and (vi), and (c). When determining 

which persons are reasonably likely to 

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

and (4), engineering control measures 

(e.g., enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. For 

purposes of § 721.63(a)(5), respirators 

must provide a National Institute for 

Occupational Safety and Health 

(NIOSH) assigned protection factor 

(APF) of at least 50. For purposes of 

§ 721.63(6), the airborne form(s) of the 

substance include particulate (including 

solids or liquid droplets). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (d), (f), (g)(1), (g)(2)(i), (ii), (iv), 

and (v), and (g)(5). For purposes of 

§ 721.72(g)(1), this substance may cause: 

Skin irritation; respiratory 

complications; mutagenicity. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o), (y)(1), and 

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

manufacture the substance containing 

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 (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

manufacturers and processors of this 

substance. 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11271 Ethanone, 1-[4-(4- 

chlorophenoxy)-2-(trifluoromethyl)phenyl]-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

ethanone, 1-[4-(4-chlorophenoxy)-2- 

(trifluoromethyl)phenyl]- (PMN P–17– 

329, CAS No. 1417782–28–5) 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), (a)(2)(i) through (iv), 

(a)(3) through (5), (a)(6)(v) and (vi), and 

(c). When determining which persons 

are reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4) 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. For 

purposes of § 721.63(a)(5), respirators 

must provide a National Institute for 

Occupational Safety and Health 

(NIOSH) assigned protection factor 

(APF) of at least 50. For purposes of 

§ 721.63(a)(6), the airborne form(s) of 

the substance include particulate 

(including solids or liquid droplets). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (d), (f), (g)(1), (g)(2)(i), (ii), (iv), 

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

(5). For purposes of § 721.72(g)(1), this 

substance may cause: Respiratory 

complications, internal organ effects, 

reproductive effects; sensitization. For 

purposes of § 721.72(g)(4), notice to 

users: Do not release to water at 

concentrations that exceed 7 parts per 

billion. 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). 

(iv) Release to water. Requirements as 

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

(c)(4) where N=7. 

(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) Limitation 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. 

§ 721.11272 Vegetable oil, polymer with 

alkanedioic acid, alkali lignin, diethylene 

glycol- and polyol-depolymd. poly(ethylene 

terephthalate) waste plastics and 

arylcarboxylic acid anhydride (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as vegetable oil, polymer 

with alkanedioic acid, alkali lignin, 

diethylene glycol- and polyoldepolymd. poly(ethylene terephthalate) 

waste plastics and arylcarboxylic acid 

anhydride (PMN P–17–367) 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. It is a significant 

new use to manufacture, process, or use 

the substance with greater than the 

confidential percentages of low 

molecular weight components specified 

in the Order or less than the 

confidential average molecular weight 

specified in the Order. 

(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) Limitation 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. 

§ 721.11273 Vegetable oil, polymer with 

alkanedioic acid, alkali lignin, diethylene 

glycol- and polyol-depolymd. poly(ethylene 

terephthalate) waste plastics (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as vegetable oil, polymer 

with alkanedioic acid, alkali lignin, 

diethylene glycol- and polyoldepolymd. poly(ethylene terephthalate) 

waste plastics (PMN P–17–368) 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. It is a significant 

new use to manufacture, process, or use 


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the substance with greater than the 

confidential percentages of low 

molecular weight components and less 

than the confidential average molecular 

weight specified in the Order. 

(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) Limitation 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. 

§ 721.11274 Waste plastics, poly(ethylene 

terephthalate), depolymd. with diethylene 

glycol, polymers with alkanedioic acid, 

alkali lignin and arylcarboxylic acid 

anhydride (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 diethylene glycol, polymers with 

alkanedioic acid, alkali lignin and 

arylcarboxylic acid anhydride (PMN P– 

17–369) 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. It is a significant 

new use to manufacture, process, or use 

the substance with greater than the 

confidential percentages of low 

molecular weight components and less 

than the confidential average molecular 

weight specified in the Order. 

(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) Limitation 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. 

§ 721.11275 Waste plastics, poly(ethylene 

terephthalate), depolymd. with diethylene 

glycol and polyol, polymers with 

alkanedioic acid, alkali lignin and 

arylcarboxylic acid anhydride (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 diethylene glycol and polyol, 

polymers with alkanedioic acid, alkali 

lignin and arylcarboxylic acid 

anhydride (PMN P–17–370) 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. It is a significant 

new use to manufacture, process, or use 

the substance with greater than the 

confidential percentages of low 

molecular weight components specified 

in the Order or less than the 

confidential average molecular weight 

specified in the Order. 

(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) Limitation 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. 

§ 721.11276 Vegetable oil, polymer with 

alkanedioic acid, alkali lignin, diethylene 

glycol- and polyol-depolymd. poly(ethylene 

terephthalate) waste plastics and 

arylcarboxylic acid anhydride (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as vegetable oil, polymer 

with alkanedioic acid, alkali lignin, 

diethylene glycol- and polyoldepolymd. poly(ethylene terephthalate) 

waste plastics and arylcarboxylic acid 

anhydride (PMN P–17–371) 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. It is a significant 

new use to manufacture, process, or use 

the substance with greater than the 

confidential percentages of low 

molecular weight components and less 

than the confidential average molecular 

weight specified in the Order. 

(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) Limitation 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. 

§ 721.11277 Vegetable oil, polymer with 

alkanedioic acid, alkali lignin, diethylene 

glycol-depolymd. poly(ethylene 

terephthalate) waste plastics and 

arylcarboxylic acid anhydride (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as vegetable oil, polymer 

with alkanedioic acid, alkali lignin, 

diethylene glycol-depolymd. 

poly(ethylene terephthalate) waste 

plastics and arylcarboxylic acid 

anhydride (PMN P–17–372) 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. It is a significant 

new use to manufacture, process, or use 

the substance with greater than the 

confidential percentages of low 

molecular weight components specified 

in the Order or less than the 

confidential average molecular weight 

specified in the Order. 

(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) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 6. Add §§ 721.11279 through 

721.11281 to read as follows: 

* * * * * 


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Sec. 

721.11279 Substituted propanoic acid, 

polymer with alkylisocyanatesubstituted carbomonocycle, dialkyl 

carbonate, hydroxyl alkyl substituted 

alkanediol, alkanediol, isocyanato 

substituted carbomonocycle, alkanol 

substituted amines-blocked, compds. 

with (alkylamino)alkanol (generic). 

721.11280 Propanediol phosphate (generic). 

721.11281 Substituted cashew, nutshell 

liquid, polymer with epichlorohydrin, 

phosphate (generic). 

* * * * * 

§ 721.11279 Substituted propanoic acid, 

polymer with alkylisocyanate-substituted 

carbomonocycle, dialkyl carbonate, 

hydroxyl alkyl substituted alkanediol, 

alkanediol, isocyanato substituted 

carbomonocycle, alkanol substituted 

amines-blocked, compds. with 

(alkylamino)alkanol (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as substituted propanoic 

acid, polymer with alkylisocyanatesubstituted carbomonocycle, dialkyl 

carbonate, hydroxyl alkyl substituted 

alkanediol, alkanediol, isocyanato 

substituted carbomonocycle, alkanol 

substituted amines-blocked, compds. 

with (alkylamino)alkanol (PMN P–17– 

394) 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). It is a significant 

new use to use the substance for any use 

other than as a coating to improve 

chemical resistance. It is a significant 

new use to import the substance with 

average molecular weight greater than 

1,000 daltons, containing greater than 

0.1% residual isocyanate by weight, or 

with greater than 4% of the confidential 

chemical component specified in the 

Order. 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitation 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. 

§ 721.11280 Propanediol phosphate 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as propanediol phosphate 

(PMN P–18–23) 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 fully 

reacted (cured). 

(2) The significant new uses are: 

(i) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (d), (f), (g)(1) and (2), (g)(3)(i) 

and (ii), (g)(4)(iii), and (g)(5). For 

purposes of § 721.72(g)(1), this 

substance may cause: Skin irritation; 

respiratory complications; internal 

organ effects; eye irritation. For 

purposes of § 721.72(g)(2), when using 

this substance: Avoid skin contact; 

avoid breathing substance; use skin 

protection; use eye protection; avoid eye 

contact. Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o). It is a 

significant new use to manufacture, 

process, or use the substance in any 

manner that generates a vapor, spray, 

mist, or aerosol. 

(iii) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c), (f) through (i), 

and (k) are applicable to manufacturers 

and processors of this substance. 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11281 Substituted cashew, nutshell 

liquid, polymer with epichlorohydrin, 

phosphate (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as substituted cashew, 

nutshell liquid, polymer with 

epichlorohydrin, phosphate (PMN P– 

18–24) 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 fully 

reacted (cured). 

(2) The significant new uses are: 

(i) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (d), (f), (g)(1) and (2), (g)(3)(i) 

and (ii), (g)(4)(iii), and (g)(5). For 

purposes of § 721.72(g)(1), this 

substance may cause: Skin irritation; 

respiratory complications; eye irritation. 

For purposes of § 721.72(g)(2), when 

using this substance: Avoid skin 

contact; avoid breathing substance; use 

skin protection; use eye protection; 

avoid eye contact. Alternative hazard 

and warning statements that meet the 

criteria of the Globally Harmonized 

System and OSHA Hazard 

Communication Standard may be used. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o). It is a 

significant new use to manufacture, 

process, or use the substance in any 

manner that generates a vapor, spray, 

mist, or aerosol. 

(iii) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c), (f) through (i), 

and (k) are applicable to manufacturers 

and processors of this substance. 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 7. Add § 721.11284 to read as follows: 

§ 721.11284 Di(substituted-1,3- 

trialkylammonium) dialkylammonium salt 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as di(substituted-1,3- 

trialkylammonium) dialkylammonium 

salt (PMN P–18–88) 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 fully reacted (cured). 

(2) The significant new uses are: 

(i) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), (g)(1)(ii) through (iv), 

(g)(2)(i) through (iii) and (v), and (g)(5). 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 


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be used. For purposes of § 721.72(e), the 

concentration is set at 1.0%. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k). It is a 

significant new use to manufacture, 

process, or use the substance in any 

manner that generates a vapor, mist, 

particulate, or aerosol. 

(iii) Release to water. Requirements as 

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

(c)(4) where N=1000. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c), (f) through (i), 

and (k) are applicable to manufacturers 

and processors of this substance. 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 8. Add § 721.11288 to read as follows: 

§ 721.11288 Benzene, 1-(chloromethyl)-3- 

methyl-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

benzene, 1-(chloromethyl)-3-methyl- 

(PMN P–18–134; CAS No. 620–19–9) 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) and (iii), (a)(3) 

through (5), (a)(6)(v) and (vi), (b), and 

(c). When determining which persons 

are reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. For 

purposes of § 721.63(a)(5), respirators 

must provide a National Institute for 

Occupational Safety and Health 

(NIOSH) assigned protection factor 

(APF) of at least 1,000. For purposes of 

§ 721.63(a)(6), the airborne form(s) of 

the substance include particulate and 

combination gas/vapor and particulate. 

For purposes of § 721.63(b), the 

concentration is set at 0.1%. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), (g)(1), (g)(2)(i) through (v), 

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

purposes of § 721.72(e), the 

concentration is set at 0.1%. For 

purposes of § 721.72(g)(1), this 

substance may cause: Respiratory 

irritation; severe skin burns and eye 

damage; sensitization (respiratory and 

dermal); serious eye irritation; 

respiratory complications; central 

nervous system effects; reproductive 

effects; cancer; developmental effects. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial, Commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k). It is a 

significant new use to vary the process 

or use methods described in the PMN 

such that occupational exposure is 

increased. 

(iv) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (i) and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitation 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 § 721.11305 to read as follows: 

§ 721.11305 Unsaturated polycyclic 

hydrocarbon (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as unsaturated polycyclic 

hydrocarbon (PMN P–17–419) is subject 

to reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

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

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. For 

purposes of 721.63(a)(5), respirators 

must provide a National Institute for 

Occupational Safety and Health 

(NIOSH) assigned protection factor 

(APF) of at least 50. For purposes of 

721.63(b), the concentration is set at 

1.0%. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), (g)(1), (g)(2)(i), (ii), (iv) and 

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

For purposes of § 721.72(e), the 

concentration is set at 1.0%. For 

purposes of § 721.72(g)(1), this 

substance may cause: Skin sensitization; 

specific target organ toxicity; skin 

irritation; respiratory complications; 

reproductive effects; developmental 

effects. Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

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

significant new use to manufacture the 

substance for more than 9 months. 

(iv) Release to water. Requirements as 

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

(c)(1). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (i) and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitation 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 § 721.11308 to read as 

follows: 

§ 721.11308 Mixed metal oxide (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance generically 

identified as mixed metal oxide (PMN 

P–18–55) 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) through (6), (b), and 

(c). When determining which persons 

are reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 


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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. For 

purposes of § 721.63(a)(5), respirators 

must provide a National Institute for 

Occupational Safety and Health 

(NIOSH) assigned protection factor 

(APF) of at least 1,000. For purposes of 

§ 721.63(a)(6), the airborne form(s) of 

the substance include particulate. For 

purposes of § 721.63(b), the 

concentration is set at 0.1%. 

(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 Order for this substance. 

The NCEL is 0.04 mg/m3 as an 8-hour 

time weighted average. Persons who 

wish to pursue NCELs as an alternative 

to § 721.63 respirator requirements may 

request to do so under § 721.30. Persons 

whose § 721.30 requests to use the 

NCELs approach are approved by the 

EPA will be required to follow NCELs 

provisions comparable to those 

contained in the corresponding TSCA 

Order. 

(B) [Reserved] 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f) and (g)(1), (2), and (5). For 

purposes of § 721.72(e), the 

concentration is set at 0.1%. For 

purposes of § 721.72(g)(1), this 

substance may cause: Allergic skin 

reaction; respiratory sensitization; germ 

cell mutagenicity; respiratory 

complications; cancer. For purposes of 

§ 721.72(g)(2), when using this 

substance: Avoid skin contact; avoid 

breathing substance; avoid ingestion; 

use skin protection; use respiratory 

protection or maintain workplace 

airborne concentrations at or below an 

8-hour time-weighted average of 0.04 

mg/m3. Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k). 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

manufacturers and processors of this 

substance. 

(2) Limitation 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 § 721.11315 to read as 

follows: 

§ 721.11315 Lithium nickel hydride oxide. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

lithium nickel hydride oxide (PMN P– 

18–123; CAS No. 2081933–92–6) 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) through (6), and (c). 

When determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. For 

purposes of § 721.63(a)(5), respirators 

must provide a National Institute for 

Occupational Safety and Health 

(NIOSH) assigned protection factor 

(APF) of at least 50. For purposes of 

§ 721.63(a)(6), the airborne form(s) of 

the substance include particulate. 

(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 Order for this substance. 

The NCEL is 0.05 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 

Order. 

(B) [Reserved] 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

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

and (vii) through (ix), (g)(2), (g)(3)(ii), 

(g)(4)(i), and (g)(5). For purposes of 

§ 721.72(g)(2), when using this 

substance: Avoid skin contact; avoid 

breathing substance; avoid ingestion; 

use skin protection; use respiratory 

protection or maintain workplace 

airborne concentrations at or below an 

8-hour time-weighted average of 0.05 

mg/m3. Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial, commercial, and 

consumer activities. It is a significant 

new use to manufacture the substance 

for more than four years. 

(iv) Release to water. Requirements as 

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

(c)(4) where N=32. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (i) and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 12. Add § 721,11316 to read as 

follows: 

§ 721.11316 Lithium nickel potassium 

oxide. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

lithium nickel potassium oxide (PMN 

P–18–124, CAS No. 210352–95–7) 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), (3) through (6), and (c). 

When determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. For 

purposes of § 721.63(a)(5), respirators 

must provide a National Institute for 

Occupational Safety and Health 

(NIOSH) assigned protection factor 

(APF) of at least 50. For purposes of 

§ 721.63(a)(6), the airborne form(s) of 

the substance include particulate. 

(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 Order for this substance. 

The NCEL is 0.05 mg/m3 as an 8-hour 

time weighted average. Persons who 

wish to pursue NCELs as an alternative 

to § 721.63 respirator requirements may 


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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 

Order. 

(B) [Reserved] 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

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

and (vii) through (ix), (g)(2), (g)(3)(ii), 

(g)(4)(i), and (g)(5). For purposes of 

§ 721.72(g)(2), when using this 

substance: Avoid skin contact; avoid 

breathing substance; avoid ingestion; 

use skin protection; use respiratory 

protection or maintain workplace 

airborne concentrations at or below an 

8-hour time-weighted average of 0.05 

mg/m3. Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial, commercial, and 

consumer activities. It is a significant 

new use to manufacture the substance 

for more than four years. 

(iv) Release to water. Requirements as 

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

(c)(4) where N=32. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (i) and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 13. Add §§ 721.11319 through 

721.11321 to read as follows: 

Sec. 

* * * * * 

721.11319 Waste plastics, poly(ethylene 

terephthalate), polymers with diethylene 

glycol, glycerol, polyerythritol, 

triethylene glycol, trimethylolalkane and 

polypropylene glycol (generic). 

721.11320 Waste plastics, poly(ethylene 

terephthalate), polymers with diethylene 

glycol, glycerol, polyerythritol, phthalic 

anhydride, triethylene glycol, 

trimethylolalkane and polypropylene 

glycol (generic). 

721.11321 Naphtha oils (generic). 

* * * * * 

§ 721.11319 Waste plastics, poly(ethylene 

terephthalate), polymers with diethylene 

glycol, glycerol, polyerythritol, triethylene 

glycol, trimethylolalkane and polypropylene 

glycol (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as waste plastics, 

poly(ethylene terephthalate), polymers 

with diethylene glycol, glycerol, 

polyerythritol, triethylene glycol, 

trimethylolalkane and polypropylene 

glycol (PMN P–18–200) 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) through (6), (b), and 

(c). When determining which persons 

are reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. For 

purposes of § 721.63(a)(5), respirators 

must provide a National Institute for 

Occupational Safety and Health 

(NIOSH) assigned protection factor 

(APF) of at least 10. For purposes of 

§ 721.63(a)(6), the airborne form(s) of 

the substance include particulate. For 

purposes of § 721.63(b), the 

concentration is set at 1.0%. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), (g)(1)(iv), (g)(2), (g)(3)(i) and 

(ii), and (g)(4) and (5). For purposes of 

§ 721.72(e), the concentration is set at 

1.0%. For purposes of § 721.72(g)(2), 

when using this substance: Avoid skin 

contact; avoid eye contact; use skin 

protection; use respiratory protection; 

use eye protection. For purposes of 

§ 721.72(g)(4), notice to users: Water 

release restrictions apply. 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). 

(iv) Release to water. Requirements as 

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

(c)(4) where N=280. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (i) and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11320 Waste plastics, poly(ethylene 

terephthalate), polymers with diethylene 

glycol, glycerol, polyerythritol, phthalic 

anhydride, triethylene glycol, 

trimethylolalkane and polypropylene glycol 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as waste plastics, 

poly(ethylene terephthalate), polymers 

with diethylene glycol, glycerol, 

polyerythritol, phthalic anhydride, 

triethylene glycol, trimethylolalkane 

and polypropylene glycol (PMN P–18– 

201) 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) through (6), (b), and 

(c). When determining which persons 

are reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. For 

purposes of § 721.63(a)(5), respirators 

must provide a National Institute for 

Occupational Safety and Health 

(NIOSH) assigned protection factor 

(APF) of at least 10. For purposes of 

§ 721.63(a)(6), the airborne form(s) of 

the substance include particulate. For 

purposes of § 721.63(b), the 

concentration is set at 1.0%. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), (g)(1)(iv), (g)(2), (g)(3)(i) and 

(ii), and (g)(4) and (5). For purposes of 

§ 721.72(e), the concentration is set at 

1.0%. For purposes of § 721.72(g)(2), 

when using this substance: Avoid skin 

contact; avoid eye contact; use skin 

protection; use respiratory protection; 

use eye protection. For purposes of 

§ 721.72(g)(4), notice to users: Water 

release restrictions apply. 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). 

(iv) Release to water. Requirements as 

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

(c)(4) where N=280. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 


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(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (i) and (k) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11321 Naphtha oils (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as naphtha oils (PMN P–18– 

235) 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 incorporated into a gasoline 

or transportation fuel formulation below 

the maximum confidential 

concentration specified in the Order for 

the substance. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f) and (k). 

(ii) [Reserved]. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 14. Add §§ 721.11346 through 

721.11350 to read as follows: 

* * * * * 

Sec. 

721.11346 Perfluoropolyether halide 

(generic). 

721.11347 Perfluoropolyether aryl (generic). 

721.11348 Substituted aryl 

perfluoropolyether (generic). 

721.11349 Sulfonated perfluoropolyether 

aromatic transition metal salt (generic). 

721.11350 Sulfonated perfluoropolyether 

aryl alkali metal salt (generic). 

* * * * * 

§ 721.11346 Perfluoropolyether halide 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as perfluoropolyether halide 

(PMN P–16–151) 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 (f), (g)(3)(i) and (ii), (g)(4)(i) and 

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

warning statements that meet the 

criteria of the Globally Harmonized 

System and OSHA Hazard 

Communication Standard may be used. 

For purposes of § 721.72(e), the 

concentration is set at 1.0%. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

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

significant new use to manufacture the 

substance for more than one year. 

(iii) Disposal. Requirements as 

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

(c)(1). Incineration must be hazardous 

waste high temperature incineration 

where the treatment efficiency is no less 

than 99.99%. 

(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 (c) and (f) through 

(k) are applicable to manufacturers and 

processors of this substance. 

(2) Limitation 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. 

§ 721.11347 Perfluoropolyether aryl 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as perfluoropolyether aryl 

(PMN P–16–152) 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 (f), (g)(3)(i) and (ii), (g)(4)(i) and 

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

warning statements that meet the 

criteria of the Globally Harmonized 

System and OSHA Hazard 

Communication Standard may be used. 

For purposes of § 721.72(e), the 

concentration is set at 1.0%. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) and (t). 

(iii) Disposal. Requirements as 

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

(c)(1). Incineration must be hazardous 

waste high temperature incineration 

where the treatment efficiency is no less 

than 99.99%. 

(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 (c) and (f) through 

(k) are applicable to manufacturers and 

processors of this substance. 

(2) Limitation 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. 

§ 721.11348 Substituted aryl 

perfluoropolyether (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as substituted aryl 

perfluoropolyether (PMN P–16–153) 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 (f), (g)(3)(i) and (ii), (g)(4)(i) and 

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

warning statements that meet the 

criteria of the Globally Harmonized 

System and OSHA Hazard 

Communication Standard may be used. 

For purposes of § 721.72(e), the 

concentration is set at 1.0%. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) and (t). 

(iii) Disposal. Requirements as 

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

(c)(1). Incineration must be hazardous 

waste high temperature incineration 

where the treatment efficiency is no less 

than 99.99%. 

(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 (c) and (f) through 

(k) are applicable to manufacturers and 

processors of this substance. 


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(2) Limitation 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. 

§ 721.11349 Sulfonated perfluoropolyether 

aromatic transition metal salt (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as sulfonated 

perfluoropolyether aromatic transition 

metal salt (PMN P–16–154) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), (g)(3)(i) and (ii), (g)(4)(i) and 

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

warning statements that meet the 

criteria of the Globally Harmonized 

System and OSHA Hazard 

Communication Standard may be used. 

For purposes of § 721.72(e), the 

concentration is set at 1.0%. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) and (t). 

(iii) Disposal. Requirements as 

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

(c)(1). Incineration must be hazardous 

waste high temperature incineration 

where the treatment efficiency is no less 

than 99.99%. 

(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 (c) and (f) through 

(k) are applicable to manufacturers and 

processors of this substance. 

(2) Limitation 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. 

§ 721.11350 Sulfonated perfluoropolyether 

aryl alkali metal salt (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as sulfonated 

perfluoropolyether aryl alkali metal salt 

(PMN P–16–155) 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 (f), (g)(3)(i) and (ii), (g)(4)(i) and 

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

warning statements that meet the 

criteria of the Globally Harmonized 

System and OSHA Hazard 

Communication Standard may be used. 

For purposes of § 721.72(e), the 

concentration is set at 1.0%. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k) and (t). 

(iii) Disposal. Requirements as 

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

(c)(1). Incineration must be hazardous 

waste high temperature incineration 

where the treatment efficiency is no less 

than 99.99%. 

(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 (c) and (f) through 

(k) are applicable to manufacturers and 

processors of this substance. 

(2) Limitation 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. 

■ 15. Add § 721.11360 to read as 

follows: 

§ 721.11360 Benzenepropanal, 

.alpha.,.alpha.,3-trimethyl-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

benzenepropanal, .alpha.,.alpha.,3- 

trimethyl- (PMN P–18–129; CAS No. 

107737–97–3) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(t). 

(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) Limitation 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 § 721.11361 to read as 

follows: 

§ 721.11361 Multiwalled carbon nanotubes 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as multiwalled carbon 

nanotubes (PMN P–18–182) 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 that 

have been: 

(i) Embedded or incorporated into a 

polymer matrix that itself has been 

reacted (cured); 

(ii) Embedded in a permanent solid/ 

polymer form that is not intended to 

undergo further processing, except 

mechanical processing; or 

(iii) Incorporated into an article as 

defined at 40 CFR 720.3(c). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (3) through (6), and (c). 

When determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. For 

purposes of § 721.63(a)(5), respirators 

must provide a National Institute for 

Occupational Safety and Health 

(NIOSH) assigned protection factor 

(APF) of at least 50. For purposes of 

§ 721.63(a)(6), the airborne form(s) of 

the substance include particulate. 

(ii) Industrial, commercial, and 

consumer activities. It is a significant 

new use to use an application method 

that generates a dust, mist, or aerosol, 

unless such application method occurs 

in an enclosed process. It is a significant 

new use to use the substance other than 

for heat transfer, heat storage, thermal 

emission, and general temperature 

management in heat-generating systems 

such as electronics, to improve 

mechanical properties or electrical 

conductivities of other materials or 


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products, and for light absorption 

properties. 

(iii) Disposal. Requirements as 

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

and (2), and (c)(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 (k) are applicable 

to manufacturers and processors of this 

substance. 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 17. Add § 721.11372 to read as 

follows: 

§ 721.11372 Phenol-formaldehyde epoxy, 

polymer with an alkyl polyether polysulfide 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as phenol-formaldehyde 

epoxy, polymer with an alkyl polyether 

polysulfide (PMN P–19–5) 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) and (3). 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (d), (f), (g)(1), (g)(2)(i), (ii), and 

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

For purposes of § 721.72(g)(1), this 

substance may cause: Internal organ 

effects; reproductive effects; cancer; skin 

and respiratory sensitization; germ cell 

mutagenicity. For purposes of 

§ 721.72(g)(4), notice to users: Water 

release restrictions apply. Alternative 

hazard and warning statements that 

meet the criteria of the Globally 

Harmonized System and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, commercial, and 

consumer activities. It is a significant 

new use to manufacture, process, or use 

the substance in any manner that results 

in inhalation exposure. 

(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 (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c), (f) through (i), 

and (k) are applicable to manufacturers 

and processors of this substance. 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 18. Add § 721.11383 to read as 

follows: 

§ 721.11383 Triarylsulfonium salt 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as triarylsulfonium salt 

(PMN P–16–548) 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). It is 

a significant new use to process or use 

the substance in a manner that generates 

a vapor, mist, or aerosol. 

(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 (b). 

(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) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

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

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

■ 19. Add §§ 721.11390 through 

721.11393 to read as follows: 

* * * * * 

Sec. 

721.11390 Branched cyclic and linear 

hydrocarbons from plastic 

depolymerization (generic). 

721.11391 Alkane, alkene, styrenic 

compounds derived from plastic 

depolymerization (generic). 

721.11392 Carbon compound derived from 

plastic depolymerization (generic). 

721.11393 Branched cyclic and linear 

hydrocarbons from plastic 

depolymerization (generic). 

* * * * * 

§ 721.11390 Branched cyclic and linear 

hydrocarbons from plastic 

depolymerization (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as branched cyclic and 

linear hydrocarbons from plastic 

depolymerization (PMN P–17–398) 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 that 

have been refined or blended into other 

chemical or fuel formulations. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k). For purposes of 

§ 721.80(k), the use is as a refinery 

feedstock or a fuel blending additive. 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11391 Alkane, alkene, styrenic 

compounds derived from plastic 

depolymerization (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkane, alkene, styrenic 

compounds derived from plastic 

depolymerization (PMN P–17–399) 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 that 

have been refined or blended into other 

chemical or fuel formulations. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k). For purposes of 

§ 721.80(k), the use is as a refinery 

feedstock or a fuel blending additive. 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 


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§ 721.11392 Carbon compound derived 

from plastic depolymerization (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as carbon compound derived 

from plastic depolymerization (PMN P– 

18–1) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. It is a significant 

new use to manufacture the substance 

containing more than 1% of the 

particles less than 75 microns. It is a 

significant new use to manufacture the 

substance other than by the enclosed 

process described in the premanufacture 

notice. 

(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) Limitation 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. 

§ 721.11393 Branched cyclic and linear 

hydrocarbons from plastic 

depolymerization (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as branched cyclic and 

linear hydrocarbons from plastic 

depolymerization (PMN P–18–28) 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 that 

have been refined or blended into other 

chemical or fuel formulations. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k). For purposes of 

§ 721.80(k), the use is as a refinery 

feedstock or a fuel blending additive. 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 20. Add § 721.11422 to read as 

follows: 

§ 721.11422 Alkanediamine, dialkyl-, 

polymer with .alpha.-hydro-.omega.-[(1-oxo2-propen-1-yl)oxy]poly(oxy-1,2-ethanediyl) 

ether with substituted alkyl-substituted 

alkanediol, reaction products with alkylalkanamine (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkanediamine, dialkyl-, 

polymer with .alpha.-hydro-.omega.-[(1- 

oxo-2-propen-1-yl)oxy]poly(oxy-1,2- 

ethanediyl) ether with substituted alkylsubstituted alkanediol, reaction 

products with alkyl-alkanamine (PMN 

P–17–393) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. The requirements of this section 

do not apply to quantities of the PMN 

substance after they have been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(4) through (6) and (c). When 

determining which persons are 

reasonably likely to be exposed as 

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

control measures (e.g., enclosure or 

confinement of the operation, general, 

and local ventilation) or administrative 

control measures (e.g., workplace 

policies and procedures) shall be 

considered and implemented to prevent 

exposure, where feasible. For purposes 

of § 721.63(a)(5), respirators must 

provide a National Institute for 

Occupational Safety and Health 

(NIOSH) assigned protection factor 

(APF) of at least 1,000. For purposes of 

§ 721.63(a)(6), the airborne form(s) of 

the substance include particulate. 

(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 Order for this substance. 

The NCEL is 0.039 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 

Order. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (d), (f), and (g)(1) through (3) 

and (5). For purposes of § 721.72(g)(1), 

this substance may cause: Skin 

irritation; respiratory complications; eye 

irritation; skin sensitization. For 

purposes of § 721.72(g)(2), when using 

this substance: Avoid skin contact; 

avoid breathing substance; avoid 

ingestion; use skin protection; use 

respiratory protection or maintain 

workplace airborne concentrations at or 

below an 8-hour time-weighted average 

of 0.039 mg/m3. For purposes of 

§ 721.72(g)(3), this substance may be: 

Toxic to aquatic organisms; hazardous 

to the aquatic environment. Alternative 

hazard and warning statements that 

meet the criteria of the Globally 

Harmonized System and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k). It is a 

significant new use to manufacture the 

substance with an average molecular 

weight less than 1,000 daltons and with 

more than 10% less than 500 daltons. 

(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 (d), (f) through (i), 

and (k) are applicable to manufacturers 

and processors of this substance. 

(2) Limitation 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. 

■ 21. Add §§ 721.11426 through 

721.11443 to read as follows: 

* * * * * 

Sec. 

721.11426 Halogenated sodium benzene 

alkylcarboxylate (generic) (P–19–86). 

721.11427 Halogenated sodium benzene 

alkylcarboxylate (generic) (P–19–87). 

721.11428 Halogenated sodium benzene 

alkylcarboxylate (generic) (P–19–89). 

721.11429 Halogenated sodium benzoate 

(generic) (P–19–90). 

721.11430 Halogenated benzene 

alkylcarboxylic acid (generic) (P–19–91). 

721.11431 Halogenated benzene 

alkylcarboxylic acid (generic) (P–19–92). 

721.11432 Halogenated benzoic acid 

(generic) (P–19–93). 


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721.11433 Halogenated alkylbenzoic acid, 

ethyl ester (generic) (P–19–97). 

721.11434 Halogenated alkylbenzoic acid, 

ethyl ester (generic) (P–19–100). 

721.11435 Halogenated alkylbenzoic acid, 

ethyl ester (generic) (P–19–101). 

721.11436 Halogenated alkylbenzoic acid, 

ethyl ester (generic) (P–19–102). 

721.11437 Halogenated benzoic acid, ethyl 

ester (generic) (P–19–103). 

721.11438 Halogenated alkylbenzoic acid, 

ethyl ester (generic) (P–19–104). 

721.11439 Halogenated benzoic acid, ethyl 

ester (generic) (P–19–105). 

721.11440 Halogenated alkylbenzoic acid, 

ethyl ester (generic) (P–19–106). 

721.11441 Halogenated alkylbenzoic acid, 

ethyl ester (generic) (P–19–107). 

721.11442 Halogenated alkylbenzoic acid, 

ethyl ester (generic) (P–19–108). 

721.11443 Halogenated benzoic acid, ethyl 

ester (generic) (P–19–110). 

* * * * * 

§ 721.11426 Halogenated sodium benzene 

alkylcarboxylate (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as halogenated sodium 

benzene alkylcarboxylate (PMN P–19– 

86) 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 (f), (g)(1), (g)(2)(i) through (iii), 

and (g)(5). For purposes of § 721.72(e), 

the concentration is set at 1.0%. For 

purposes of § 721.72(g)(1), this 

substance may cause: Skin irritation; 

respiratory complications; central 

nervous system effects; internal organ 

effects; reproductive effects; 

developmental effects; eye irritation. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

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

significant new use to manufacture, 

process, or use the substance other than 

in a liquid formulation. It is a significant 

new use to manufacture or process the 

substance without including the 

engineering controls/processes 

described in the premanufacture notice. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

(i) are applicable to manufacturers and 

processors of this substance. 

(2) Limitation 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. 

§ 721.11427 Halogenated sodium benzene 

alkylcarboxylate (generic) (P–19–87). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as halogenated sodium 

benzene alkylcarboxylate (PMN P–19– 

87) 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 (f), (g)(1), (g)(2)(i) through (iii), 

and (g)(5). For purposes of § 721.72(e), 

the concentration is set at 1.0%. For 

purposes of § 721.72(g)(1), this 

substance may cause: Skin irritation; 

respiratory complications; central 

nervous system effects; internal organ 

effects; reproductive effects; 

developmental effects; eye irritation. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

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

significant new use to manufacture, 

process, or use the substance other than 

in a liquid formulation. It is a significant 

new use to manufacture or process the 

substance without including the 

engineering controls/processes 

described in the premanufacture notice. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

(i) are applicable to manufacturers and 

processors of this substance. 

(2) Limitation 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. 

§ 721.11428 Halogenated sodium benzene 

alkylcarboxylate (generic) (P–19–89). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as halogenated sodium 

benzene alkylcarboxylate (PMN P–19– 

89) 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 (f), (g)(1), (g)(2)(i) through (iii), 

and (g)(5). For purposes of § 721.72(e), 

the concentration is set at 1.0%. For 

purposes of § 721.72(g)(1), this 

substance may cause: Skin irritation; 

respiratory complications; central 

nervous system effects; internal organ 

effects; reproductive effects; 

developmental effects; eye irritation. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

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

significant new use to manufacture, 

process, or use the substance other than 

in a liquid formulation. It is a significant 

new use to manufacture or process the 

substance without including the 

engineering controls/processes 

described in the premanufacture notice. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

(i) are applicable to manufacturers and 

processors of this substance. 

(2) Limitation 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. 

§ 721.11429 Halogenated sodium benzoate 

(generic) (P–19–90). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as halogenated sodium 

benzoate (PMN P–19–90) 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 (f), (g)(1), (g)(2)(i) through (iii), 

and (g)(5). For purposes of § 721.72(e), 

the concentration is set at 1.0%. For 

purposes of § 721.72(g)(1), this 


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46152 Federal Register / Vol. 86, No. 157 / Wednesday, August 18, 2021 / Rules and Regulations 

substance may cause: Skin irritation; 

respiratory complications; central 

nervous system effects; internal organ 

effects; reproductive effects; 

developmental effects; eye irritation. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

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

significant new use to manufacture, 

process, or use the substance other than 

in a liquid formulation. It is a significant 

new use to manufacture or process the 

substance without including the 

engineering controls/processes 

described in the premanufacture notice. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

(i) are applicable to manufacturers and 

processors of this substance. 

(2) Limitation 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. 

§ 721.11430 Halogenated benzene 

alkylcarboxylic acid (generic) (P–19–91). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as halogenated benzene 

alkylcarboxylic acid (PMN P–19–91) 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), and (iv), 

(a)(3) through (6), (b), and (c). When 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. For 

purposes of § 721.63(a)(5), respirators 

must provide a National Institute for 

Occupational Safety and Health 

(NIOSH) assigned protection factor 

(APF) as described in the TSCA Order 

for this substance. For purposes of 

§ 721.63(a)(6), the airborne form(s) of 

the substance include particulate, gas/ 

vapor, and combination gas/vapor and 

particulate. For purposes of § 721.63(b), 

the concentration is set at 1.0%. 

(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 Order for this substance. 

The NCEL is 0.0273 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 

Order. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f) and (g)(1), (2), and (5). For 

purposes of § 721.72(e) concentration 

set at 1.0%. For purposes of 

§ 721.72(g)(1), this substance may cause: 

Skin irritation; respiratory 

complications; central nervous system 

effects; internal organ effects; 

reproductive effects; developmental 

effects; eye irritation. For purposes of 

§ 721.72(g)(2), when using this 

substance: Avoid skin contact; avoid 

breathing substance; avoid ingestion; 

use skin protection; use respiratory 

protection or maintain workplace 

airborne concentrations at or below an 

8-hour time-weighted average of 0.0273 

mg/m3. Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

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

a significant new use to manufacture or 

process the substance without including 

the engineering controls/processes 

described in the premanufacture notice. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

manufacturers and processors of this 

substance. 

(2) Limitation 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. 

§ 721.11431 Halogenated benzene 

alkylcarboxylic acid (generic) (P–19–92). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as halogenated benzene 

alkylcarboxylic acid (PMN P–19–92) 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), and (iv), 

(a)(3) through (6), (b), and (c). When 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. For 

purposes of § 721.63(a)(5), respirators 

must provide a National Institute for 

Occupational Safety and Health 

(NIOSH) assigned protection factor 

(APF) as described in the TSCA Order 

for this substance. For purposes of 

§ 721.63(a)(6), the airborne form(s) of 

the substance include particulate, gas/ 

vapor, and combination gas/vapor and 

particulate. For purposes of § 721.63(b), 

the concentration is set at 1.0%. 

(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 Order for this substance. 

The NCEL is 0.0273 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 

Order. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f) and (g)(1), (2), and (5). For 

purposes of § 721.72(e), the 

concentration is set at 1.0%. For 

purposes of § 721.72(g)(1), this 

substance may cause: Skin irritation; 

respiratory complications; central 

nervous system effects; internal organ 

effects; reproductive effects; 

developmental effects; eye irritation. For 

purposes of § 721.72(g)(2), when using 

this substance: Avoid skin contact; 

avoid breathing substance; avoid 

ingestion; use skin protection; use 

respiratory protection or maintain 


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Federal Register / Vol. 86, No. 157 / Wednesday, August 18, 2021 / Rules and Regulations 46153 

workplace airborne concentrations at or 

below an 8-hour time-weighted average 

of 0.0273 mg/m3. Alternative hazard 

and warning statements that meet the 

criteria of the Globally Harmonized 

System and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

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

a significant new use to manufacture or 

process the substance without including 

the engineering controls/processes 

described in the premanufacture notice. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

manufacturers and processors of this 

substance. 

(2) Limitation 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. 

§ 721.11432 Halogenated benzoic acid 

(generic) (P–19–93). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as halogenated benzoic acid 

(PMN P–19–93) 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), and (iv), 

(a)(3) through (6), (b), and (c). When 

determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent exposure, where feasible. For 

purposes of § 721.63(a)(5), respirators 

must provide a National Institute for 

Occupational Safety and Health 

(NIOSH) assigned protection factor 

(APF) as described in the TSCA Order 

for the substance. For purposes of 

§ 721.63(a)(6), the airborne form(s) of 

the substance include particulate, gas/ 

vapor, and combination gas/vapor and 

particulate. 

(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 Order for this substance. 

The NCEL is 0.0273 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 

Order. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f) and (g)(1), (2), and (5). For 

purposes of § 721.72(e), the 

concentration is set at 1.0%. For 

purposes of § 721.72(g)(1), this 

substance may cause: Skin irritation; 

respiratory complications; central 

nervous system effects; internal organ 

effects; reproductive effects; 

developmental effects; eye irritation. For 

purposes of § 721.72(g)(2), when using 

this substance: Avoid skin contact; 

avoid breathing substance; avoid 

ingestion; use skin protection; use 

respiratory protection or maintain 

workplace airborne concentrations at or 

below an 8-hour time-weighted average 

of 0.0273 mg/m3. Alternative hazard 

and warning statements that meet the 

criteria of the Globally Harmonized 

System and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

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

a significant new use to manufacture or 

process the substance without including 

the engineering controls/processes 

described in the premanufacture notice. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

manufacturers and processors of this 

substance. 

(2) Limitation 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. 

§ 721.11433 Halogenated alkylbenzoic 

acid, ethyl ester (generic) (P–19–97). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as halogenated alkylbenzoic 

acid, ethyl ester (PMN P–19–97) 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 (f), (g)(1), (g)(2)(i) through (iii), 

(g)(3)(i) and (ii), and (g)(5). For purposes 

of § 721.72(e), the concentration is set at 

1.0%. For purposes of § 721.72(g)(1), 

this substance may cause: Skin 

irritation; respiratory complications; 

central nervous system effects; internal 

organ effects; reproductive effects; 

developmental effects; eye irritation. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

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

significant new use to manufacture or 

process the substance without including 

the engineering controls/processes 

described in the premanufacture notice. 

(iii) 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 (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c), (f) through (i), 

and (k) are applicable to manufacturers 

and processors of this substance. 

(2) Limitation 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. 

§ 721.11434 Halogenated alkylbenzoic 

acid, ethyl ester (generic) (P–19–100). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as halogenated alkylbenzoic 

acid, ethyl ester (PMN P–19–100) 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 (f), (g)(1), (g)(2)(i) through (iii), 

(g)(3)(i) and (ii), and (g)(5). For purposes 

of § 721.72(e), the concentration is set at 

1.0%. For purposes of § 721.72(g)(1), 

this substance may cause: Skin 

irritation; respiratory complications; 

central nervous system effects; internal 


jbell on DSKJLSW7X2PROD with RULES
46154 Federal Register / Vol. 86, No. 157 / Wednesday, August 18, 2021 / Rules and Regulations 

organ effects; reproductive effects; 

developmental effects; eye irritation. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

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

significant new use to manufacture or 

process the substance without including 

the engineering controls/processes 

described in the premanufacture notice. 

(iii) 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 (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c), (f) through (i), 

and (k) are applicable to manufacturers 

and processors of this substance. 

(2) Limitation 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. 

§ 721.11435 Halogenated alkylbenzoic 

acid, ethyl ester (generic) (P–19–101). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as halogenated alkylbenzoic 

acid, ethyl ester (PMN P–19–101) 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 (f), (g)(1), (g)(2)(i) through (iii), 

(g)(3)(i) and (ii), and (g)(5). For purposes 

of § 721.72(e), the concentration is set at 

1.0%. For purposes of § 721.72(g)(1), 

this substance may cause: Skin 

irritation; respiratory complications; 

central nervous system effects; internal 

organ effects; reproductive effects; 

developmental effects; eye irritation. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

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

significant new use to manufacture or 

process the substance without including 

the engineering controls/processes 

described in the premanufacture notice. 

(iii) 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 (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c), (f) through (i), 

and (k) are applicable to manufacturers 

and processors of this substance. 

(2) Limitation 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. 

§ 721.11436 Halogenated alkylbenzoic 

acid, ethyl ester (generic) (P–19–102). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as halogenated alkylbenzoic 

acid, ethyl ester (PMN P–19–102) 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 (f), (g)(1), (g)(2)(i) through (iii), 

(g)(3)(i) and (ii), and (g)(5). For purposes 

of § 721.72(e), the concentration is set at 

1.0%. For purposes of § 721.72(g)(1), 

this substance may cause: Skin 

irritation; respiratory complications; 

central nervous system effects; internal 

organ effects; reproductive effects; 

developmental effects; eye irritation. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

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

significant new use to manufacture or 

process the substance without including 

the engineering controls/processes 

described in the premanufacture notice. 

(iii) 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 (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c), (f) through (i), 

and (k) are applicable to manufacturers 

and processors of this substance. 

(2) Limitation 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. 

§ 721.11437 Halogenated benzoic acid, 

ethyl ester (generic) (P–19–103). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as halogenated benzoic acid, 

ethyl ester (PMN P–19–103) 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 (f), (g)(1), (g)(2)(i) through (iii), 

(g)(3)(i) and (ii), and (g)(5). For purposes 

of § 721.72(e) concentration set at 1.0%. 

For purposes of § 721.72(g)(1), this 

substance may cause: Skin irritation; 

respiratory complications; central 

nervous system effects; internal organ 

effects; reproductive effects; 

developmental effects; eye irritation. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

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

significant new use to manufacture or 

process the substance without including 

the engineering controls/processes 

described in the premanufacture notice. 

(iii) 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 (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c), (f) through (i), 

and (k) are applicable to manufacturers 

and processors of this substance. 

(2) Limitation 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. 

§ 721.11438 Halogenated alkylbenzoic 

acid, ethyl ester (generic) (P–19–104). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as halogenated alkylbenzoic 

acid, ethyl ester (PMN P–19–104) is 


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Federal Register / Vol. 86, No. 157 / Wednesday, August 18, 2021 / Rules and Regulations 46155 

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 (f), (g)(1), (g)(2)(i) through (iii), 

(g)(3)(i) and (ii), and (g)(5). For purposes 

of § 721.72(e), the concentration is set at 

1.0%. For purposes of § 721.72(g)(1), 

this substance may cause: Skin 

irritation; respiratory complications; 

central nervous system effects; internal 

organ effects; reproductive effects; 

developmental effects; eye irritation. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

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

significant new use to manufacture or 

process the substance without including 

the engineering controls/processes 

described in the premanufacture notice. 

(iii) 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 (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c), (f) through (i), 

and (k) are applicable to manufacturers 

and processors of this substance. 

(2) Limitation 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. 

§ 721.11439 Halogenated benzoic acid, 

ethyl ester (generic) (P–19–105). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as halogenated benzoic acid, 

ethyl ester (PMN P–19–105) 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 (f), (g)(1), (g)(2)(i) through (iii), 

(g)(3)(i) and (ii), and (g)(5). For purposes 

of § 721.72(e), the concentration is set at 

1.0%. For purposes of § 721.72(g)(1), 

this substance may cause: Skin 

irritation; respiratory complications; 

central nervous system effects; internal 

organ effects; reproductive effects; 

developmental effects; eye irritation. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

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

significant new use to manufacture or 

process the substance without including 

the engineering controls/processes 

described in the premanufacture notice. 

(iii) 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 (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c), (f) through (i), 

and (k) are applicable to manufacturers 

and processors of this substance. 

(2) Limitation 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. 

§ 721.11440 Halogenated alkylbenzoic 

acid, ethyl ester (generic) (P–19–106). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as halogenated alkylbenzoic 

acid, ethyl ester (PMN P–19–106) 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 (f), (g)(1), (g)(2)(i), (ii), and (iii), 

(g)(3)(i) and (ii), and (g)(5). For purposes 

of § 721.72(e), the concentration is set at 

1.0%. For purposes of § 721.72(g)(1), 

this substance may cause: Skin 

irritation; respiratory complications; 

central nervous system effects; internal 

organ effects; reproductive effects; 

developmental effects; eye irritation. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

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

significant new use to manufacture or 

process the substance without including 

the engineering controls/processes 

described in the premanufacture notice. 

(iii) 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 (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c), (f) through (i), 

and (k) are applicable to manufacturers 

and processors of this substance. 

(2) Limitation 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. 

§ 721.11441 Halogenated alkylbenzoic 

acid, ethyl ester (generic) (P–19–107). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as halogenated alkylbenzoic 

acid, ethyl ester (PMN P–19–107) 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 (f), (g)(1), (g)(2)(i) through (iii), 

(g)(3)(i) and (ii), and (g)(5). For purposes 

of § 721.72(e), the concentration is set at 

1.0%. For purposes of § 721.72(g)(1), 

this substance may cause: Skin 

irritation; respiratory complications; 

central nervous system effects; internal 

organ effects; reproductive effects; 

developmental effects; eye irritation. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

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

significant new use to manufacture or 

process the substance without including 

the engineering controls/processes 

described in the premanufacture notice. 

(iii) 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 (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c), (f) through (i), 

and (k) are applicable to manufacturers 

and processors of this substance. 

(2) Limitation or revocation of certain 

notification requirements. The 


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46156 Federal Register / Vol. 86, No. 157 / Wednesday, August 18, 2021 / Rules and Regulations 

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. 

§ 721.11442 Halogenated alkylbenzoic 

acid, ethyl ester (generic) (P–19–108). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as halogenated alkylbenzoic 

acid, ethyl ester (PMN P–19–108) 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 (f), (g)(1), (g)(2)(i) through (iii), 

(g)(3)(i) and (ii), and (g)(5). For purposes 

of § 721.72(e), the concentration is set at 

1.0%. For purposes of § 721.72(g)(1), 

this substance may cause: Skin 

irritation; respiratory complications; 

central nervous system effects; internal 

organ effects; reproductive effects; 

developmental effects; eye irritation. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

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

significant new use to manufacture or 

process the substance without including 

the engineering controls/processes 

described in the premanufacture notice. 

(iii) 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 (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c), (f) through (i), 

and (k) are applicable to manufacturers 

and processors of this substance. 

(2) Limitation 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. 

§ 721.11443 Halogenated benzoic acid, 

ethyl ester (generic) (P–19–110). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as halogenated benzoic acid, 

ethyl ester (PMN P–19–110) 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 (f), (g)(1), (g)(2)(i) through (iii), 

(g)(3)(i) and (ii), and (g)(5). For purposes 

of § 721.72(e), the concentration is set at 

1.0%. For purposes of § 721.72(g)(1), 

this substance may cause: Skin 

irritation; respiratory complications; 

central nervous system effects; internal 

organ effects; reproductive effects; 

developmental effects; eye irritation. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

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

significant new use to manufacture or 

process the substance without including 

the engineering controls/processes 

described in the premanufacture notice. 

(iii) 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 (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c), (f) through (i), 

and (k) are applicable to manufacturers 

and processors of this substance. 

(2) Limitation 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. 

[FR Doc. 2021–17392 Filed 8–17–21; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2020–0118; FRL–8653–01– 

OCSPP] 

Fluensulfone; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerance for residues of fluensulfone in 

or on soybean, seed. Makhteshim Agan 

of North America (d/b/a ADAMA) 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

August 18, 2021. Objections and 

requests for hearings must be received 

on or before October 18, 2021, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2020–0118, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW, Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. 

Due to the public health concerns 

related to COVID–19, the EPA Docket 

Center (EPA/DC) and Reading Room is 

closed to visitors with limited 

exceptions. The staff continues to 

provide remote customer service via 

email, phone, and webform. For the 

latest status information on EPA/DC 

services and docket access, visit https:// 

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Marietta Echeverria, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW, 

Washington, DC 20460–0001; main 

telephone number: (703) 305–7090; 

email address: RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. 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: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 


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