30210 Federal Register / Vol. 86, No. 107 / Monday, June 7, 2021 / Rules and Regulations 

[FR Doc. 2021–11840 Filed 6–4–21; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 721 

[EPA–HQ–OPPT–2020–0302; FRL–10022– 

76] 

RIN 2070–AB27 

Modification of Significant New Uses 

of Certain Chemical Substances (20– 

2.M) 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is amending significant 

new use rules (SNURs) issued under the 

Toxic Substances Control Act (TSCA) 

for certain chemical substances 

identified herein, which were the 

subject of premanufacture notices 

(PMNs) and significant new use notices 

(SNUNs). This action would amend the 

SNURs to allow certain new uses 

reported in the SNUNs without 

additional notification requirements and 

modify the significant new use 

notification requirements based on the 

actions and determinations for the 

SNUN submissions. EPA is issuing 

these amendments based on review of 

new and existing data for the chemical 

substances. 

DATES: This rule is effective on August 

6, 2021. For purposes of judicial review, 

this rule shall be promulgated at 1 p.m. 

(e.s.t.) on June 21, 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, which would 

include the SNUR requirements. 

Chemical importers are subject to the 

TSCA section 13 (15 U.S.C. 2612) 

import provisions. The EPA policy in 

support of import certification appears 

at 40 CFR part 707, subpart B. In 

addition, pursuant to 40 CFR 721.20, 

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)), and 

must comply with the export 

notification requirements in 40 CFR part 

707, subpart D. 

B. How can I access the docket? 

The docket includes information 

considered by the Agency in developing 

the proposed and final rules. The docket 

for this action, identified by docket 

identification (ID) number EPA–HQ– 

OPPT–2020–0302, is available at 

https://www.regulations.gov or 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. Please review 

the visitor instructions and additional 

information about the docket available 

at https://www.epa.gov/dockets. 

Due to the public health emergency, 

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. 

II. Background 

A. What action is the Agency taking? 

EPA is issuing amendments to the 

SNURs for certain chemical substances 

in 40 CFR part 721 subpart E. 

Previously, in the Federal Register of 

November 18, 2020 (85 FR 73439) (FRL– 

10013–54), EPA proposed amendments 

to the SNURs for these chemical 

substances and established the record 

for these SNUR amendments in the 

docket under docket ID number EPA– 

HQ–OPPT–2020–0302. That docket 

includes information considered by the 

Agency in developing the proposed and 

final rules, including public comments. 

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 (i.e., a SNUR) 

after considering all relevant factors, 

including those listed in TSCA section 

5(a)(2). EPA may also amend a SNUR 

promulgated under TSCA section 

5(a)(2). Procedures and criteria for 

modifying or revoking SNUR 

requirements appear at 40 CFR 721.185. 

Once EPA determines that a use of a 

chemical substance is a significant new 

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

persons to submit a SNUN to EPA at 

least 90 days before they manufacture, 

import, or process the chemical 

substance for that use. Persons who 

must report are described in 40 CFR 

721.5. 

C. Do the SNUR general provisions 

apply? 

General provisions for SNURs appear 

in 40 CFR part 721, subpart A. These 

provisions describe persons subject to 

the final rule, recordkeeping 

requirements, exemptions to reporting 

requirements, and applicability of the 

rule to uses occurring before the 

effective date of the final rule. 

Provisions relating to user fees appear at 

40 CFR part 700. According to 40 CFR 

721.1(c), persons subject to these SNURs 

must comply with the same notice 

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, EPA must 

either determine that the significant 

new use is not likely to present an 

unreasonable risk of injury or take such 


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regulatory action as is associated with 

an alternative determination before the 

manufacture or processing for the 

significant new use can commence. If 

EPA determines that the significant new 

use is not likely to present an 

unreasonable risk, EPA is required 

under TSCA section 5(g) to make public, 

and submit for publication in the 

Federal Register, a statement of EPA’s 

findings. 

III. Significant New Use Determination 

A. Determination Factors 

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 whether and how to 

modify the significant new uses for the 

chemical substances that are the subject 

of these SNURs, EPA considered 

relevant information about the toxicity 

of the chemical substance, likely human 

exposures and environmental releases 

associated with possible uses, and the 

four TSCA section 5(a)(2) factors listed 

in this unit. 

B. Procedures for Significant New Uses 

Claimed as Confidential Business 

Information (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 proposed 

use would be a significant new use 

under the rule. The manufacturer or 

processor must show that it has a bona 

fide intent to manufacture or process the 

chemical substance and must identify 

the specific use for which it intends to 

manufacture or process the chemical 

substance. If EPA concludes that the 

person has shown a bona fide intent to 

manufacture or process the chemical 

substance, EPA will tell the person 

whether the use identified in the bona 

fide submission would be a significant 

new use under the rule. Since most of 

the chemical identities of the chemical 

substances subject to these SNURs are 

also CBI, manufacturers and processors 

can combine the bona fide submission 

under the procedure in 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 production 

volume limit is not exceeded by the 

amount 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 

EPA received three public comments 

in response to the proposed SNURs. 

None of the comments pertained to the 

proposed SNURs or the basis for these 

SNURs. As a result, EPA is finalizing 

the rules as proposed and is not 

responding to the comments. 

V. Rationale of the Final Rule 

These amendments are based on 

EPA’s determination under 40 CFR 

721.85(a)(3) that significant new use 

notices for some of the activities 

designated as significant new uses of the 

relevant chemical substances were 

submitted to EPA and after reviewing 

the notices, EPA concluded that there is 

no need to require additional notice 

from persons who propose to engage in 

identical or similar activities. In those 

instances where EPA expanded the 

scope of the significant new use, the 

Agency identified concerns, as 

discussed in Unit IV. of the proposed 

rule, associated with certain potential 

new uses. In addition to considering the 

factors discussed in Unit IV. of the 

proposed rule, EPA determined that 

those uses could result in changes in the 

type or form of exposure to the chemical 

substance, increased exposures to the 

chemical substance, and/or changes in 

the reasonably anticipated manner and 

methods of manufacturing, processing, 

distribution in commerce, and disposal 

of the chemical substance. 

VI. Applicability of Rules to Uses 

Occurring Before Effective Date of the 

Final Rule 

To establish a significant new use, 

EPA must determine that the use is not 

ongoing. EPA solicited comments on the 

proposed rule, providing an opportunity 

for members of the public to indicate 

whether any of the uses which are not 

significant new uses under the current 

rules, but which would be regulated as 

‘‘significant new uses’’ if the proposed 

rule is finalized, are ongoing. EPA 

received no comments that these uses 

were ongoing. Therefore, EPA concludes 

that the uses are not ongoing. 

EPA designated November 18, 2020 

(the date of publication of the proposed 

rule) as the cutoff date for determining 

whether the new use is ongoing. The 

objective of EPA’s approach has been to 

ensure that a person could not defeat a 

SNUR by initiating a significant new use 

before the effective date of the final rule. 

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 cutoff date, 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. 

VII. Development and Submission of 

Information 

EPA recognizes that TSCA section 5 

generally 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, 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, 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 


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information known to or reasonably 

ascertainable by them (see 40 CFR 

720.50). However, upon review of PMNs 

and SNUNs, the Agency has the 

authority to require appropriate testing. 

Unit IV. of the proposed rule lists 

potentially useful information for all 

SNURs addressed in this final rule. 

Descriptions are provided for 

informational purposes. The 

information identified in Unit IV. of the 

proposed rule will be potentially useful 

to EPA’s evaluation of a chemical 

substance in the event that someone 

submits a SNUN for a significant new 

use pursuant to the SNURs addressed in 

this final rule. Companies who are 

considering submitting a SNUN are 

encouraged, but are not required, to 

develop the potentially useful 

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 on 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 dialogue 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. 

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. 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; and 

VIII. 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 under 40 CFR part 

720, 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 721.25 and 720.40. E– 

PMN software is available electronically 

at https://www.epa.gov/reviewing-newchemicals-under-toxic-substancescontrol-act-tsca. 

IX. Economic Analysis 

EPA has evaluated the potential costs 

of establishing SNUN requirements for 

potential manufacturers and processors 

of the chemical substances subject to 

this rule. EPA’s complete economic 

analysis is available in the docket for 

this rulemaking. 

X. 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 modifies SNURs for 

several new chemical substances that 

were the subject of PMNs and SNUNs. 

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. 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 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. 

The information collection activities 

associated with these SNURs have 

already been approved by OMB 

pursuant to the PRA under OMB control 

number 2070–0012 (EPA ICR No. 574). 

This action does not impose any burden 

requiring additional OMB approval. If 

an entity were to submit a SNUN to the 

Agency, the annual burden is estimated 

to average between 30 and 170 hours 

per response. This burden estimate 

includes the time needed to review 

instructions, search existing data 

sources, gather and maintain the data 

needed, and complete, review, and 

submit the required SNUN. 

The listing of the OMB control 

numbers of the collection instruments 

and their subsequent codification in the 

table in 40 CFR 9.1 satisfies the display 

requirements of the PRA and OMB’s 

implementing regulations at 5 CFR part 

1320. Since this ICR was previously 

subject to public notice and comment 

prior to OMB approval, and given the 

technical nature of the table in 40 CFR 

part 9, 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 in 40 

CFR 9.1 without further notice and 

comment. 

C. Regulatory Flexibility Act (RFA) 

Pursuant to the RFA section 605(b), 5 

U.S.C. 601 et seq., I hereby certify that 

promulgation of this SNUR 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, it appears 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, the number of SNUNs 

received was seven in Federal fiscal 

year (FY) 2013, 13 in FY2014, six in 

FY2015, 12 in FY2016, 13 in FY2017, 

and 11 in FY2018. 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 


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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. 

D. Unfunded Mandates Reform Act 

(UMRA) 

Based on EPA’s experience with 

proposing and finalizing SNURs, State, 

local, and Tribal governments have not 

been impacted by these rulemakings, 

and EPA does not have any reasons to 

believe that any State, local, or Tribal 

government will be impacted by this 

action. As such, EPA has determined 

that this action does not impose any 

enforceable duty, contain any unfunded 

mandate, or otherwise have any effect 

on small governments subject to the 

requirements of UMRA sections 202, 

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

E. Executive Order 13132: Federalism 

This action will not have federalism 

implications because it is not expected 

to 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). 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribe 

Governments 

This action will not have Tribal 

implications because it is not expected 

to have substantial direct effects on 

Indian Tribes, significantly or uniquely 

affect the communities of Indian Tribal 

governments, and does not 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. 

G. 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. 

H. 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. 

I. National Technology Transfer and 

Advancement Act (NTTAA) 

Since this action does not involve any 

technical standards, NTTAA section 

12(d) (15 U.S.C. 272 note), does not 

apply to this action. 

J. Executive Order 12898: 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 

Executive Order 12898 (59 FR 7629, 

February 16, 1994). 

K. Congressional Review Act (CRA) 

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 in 40 CFR Part 721 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: May 25, 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 721—SIGNIFICANT NEW USES 

OF CHEMICAL SUBSTANCES 

■ 1. The authority citation for part 721 

continues to read as follows: 

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

2625(c). 

■ 2. Amend § 721.983 by revising 

paragraphs (a)(1) and (a)(2)(ii) to read as 

follows: 

§ 721.983 Sulfonyl azide intermediate 

(generic). 

(a) * * * (1) The chemical substance 

identified generically as sulfonyl azide 

intermediate (PMN P–99–1202 and 

SNUN S–15–6) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) * * * 

(ii) Industrial, commercial, and 

consumer activities. Requirements as 

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

new use to import, process, or use this 

chemical substance as a powder unless 

less than 1% of particles by weight are 

less than 200 microns. 

* * * * * 

■ 3. Amend § 721.9675 by revising 

paragraphs (a)(1), (a)(2)(i), (a)(2)(ii) and 

(b)(1) to read as follows: 

§ 721.9675 Titanate [Ti6O13 (2-)], 

dipotassium. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

titanate [Ti6O13 (2-)], dipotassium 

(PMN P–90–226; SNUNs P–96–1408, S– 

08–6, S–09–4, S–13–49, S–16–5, and S– 

17–6; CAS No. 12056–51–8) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) * * * 

(i) Protection in the workplace. For 

manufacturing, processing, and use of 

SN–17–6: Requirements as specified in 

§ 721.63(a)(4), (5), (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 

assigned protection factor of at least 10. 

For purposes of § 721.63(a)(6), the 

airborne form(s) of the substance 

include particulate (including solid or 

liquid droplets). 

(A) As an alternative to the respirator 

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

this section, a manufacturer or processor 

may choose to follow the new chemical 

exposure limit (NCEL) provision listed 

in the TSCA section 5(e) consent order 

for this substance. The NCEL is 0.8 mg/ 

m3 as an 8-hour time weighted average. 

Persons who wish to pursue NCELs as 

an alternative to § 721.63 respirator 

requirements may request to do so 

under § 721.30. Persons whose § 721.30 

requests to use the NCELs approach are 

approved by EPA will be required to 

follow NCELs provisions comparable to 

those contained in the corresponding 

TSCA section 5(e) consent order. 

(B) [Reserved] 


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(ii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(f) and (l). In 

addition, a significant new use of the 

substance is importation of the chemical 

substance if: 

(A) Manufactured by other than the 

method described in premanufacture 

notice P–90–226 and significant new 

use notices P–96–1408, S–08–6, S–09–4, 

S–13–49, S–16–5, and S–17–6. 

(B) Manufactured producing 

respirable, acicular fibers with an 

average aspect ratio of greater than 5. 

The average aspect ratio is defined as 

the ratio of average length to average 

diameter. For manufacture of S–17–6: 

Manufacture with a particle size 

distribution containing greater than 

30% of particles less than 10 microns. 

(b) * * * 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (d) and (i) are 

applicable to manufacturers and 

processors of this substance. 

* * * * * 

■ 4. Amend § 721.10288 by revising 

paragraphs (a)(1) and (a)(2)(i) to read as 

follows: 

§ 721.10288 Cyclohexane, oxidized, byproducts from, distn. residues. 

(a) * * * (1) The chemical substance 

identified as cyclohexane, oxidized, byproducts from, distn. residues (PMN P– 

11–316; CAS No. 1014979–92–0) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) * * * 

(i) Release to water. Requirements as 

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

(c)(4), where N=470. 

* * * * * 

■ 5. Amend § 721.10432 by: 

■ a. Revising paragraphs (a)(1), (a)(2)(i) 

and (a)(2)(ii); 

■ b. Adding paragraphs (a)(2)(iii) and 

(iv); and 

■ c. Revising paragraph (b)(1). 

The revisions and additions read as 

follows: 

§ 721.10432 1,2,4,5,7,8-Hexoxonane, 3,6,9- 

triethyl-3,6,9-trimethyl-. 

(a) * * * (1) The chemical substance 

identified as 1,2,4,5,7,8-hexoxonane, 

3,6,9-triethyl-3,6,9-trimethyl- (PMN P– 

98–1028 and SNUNs S–14–9, S–17–12, 

and S–17–15; CAS No. 24748–23–0) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) * * * 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(3) through (5), 

(a)(6)(v), (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 

assigned protection factor 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) through (3), (g)(4)(i), 

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

the concentration is set at 1.0%. For 

purposes of § 721.72(g)(1), the required 

human health hazard statements 

include: Internal organ effects; 

reproductive effects; allergic skin 

reaction. For purposes of § 721.72(g)(2), 

the required human health 

precautionary statements include: Use 

skin protection; where engineering 

controls are not determined to be 

adequate, use respiratory protection. For 

purposes of § 721.72(g)(3), the required 

environmental hazard statements 

include: This substance may cause long 

lasting harmful effects to aquatic life. 

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 process or use the substance 

with an application method that 

generates a mist, vapor, or aerosol. 

(iv) Release to water. Requirements as 

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

(c)(4), where N=56. 

(b) * * * 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers and 

processors of this substance. 

* * * * * 

■ 6. Amend § 721.10907 by revising 

paragraphs (a)(1) and (a)(2)(i) to read as 

follows: 

§ 721.10907 Polyfluorohydrocarbon 

(generic). 

(a) * * * (1) The chemical substance 

identified generically as 

polyfluorohydrocarbon (PMN P–15–326 

and SNUN S–17–11) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) * * * 

(i) Industrial commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o). It is a 

significant new use to use the substance 

other than for the confidential uses 

described in PMN P–15–326 and SNUN 

S–17–11. 

* * * * * 

■ 7. Amend § 721.10922 by: 

■ a. Revising paragraphs (a)(1), (a)(2)(i) 

and (a)(2)(ii); 

■ b. Adding paragraphs (a)(2)(iii) and 

(iv); 

■ c. Revising paragraph (b)(1); and 

■ d. Removing paragraph (b)(3). 

The revisions and additions read as 

follows: 

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

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

(a) * * * (1) The chemical substance 

identified generically as 1,2,4,5,7,8- 

hexoxonane, 3,6,9-trimethyl-, 3,6,9- 

tris(alkyl) derivs. (PMN P–15–607 and 

SNUN S–17–13) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) * * * 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(3) through (5), 

(a)(6)(v), (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 

assigned protection factor 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) through (3), (g)(4)(i), 

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

the concentration is set at 1.0%. For 

purposes of § 721.72(g)(1), the required 

human health hazard statements 

include: Internal organ effects; 

reproductive effects; allergic skin 

reaction. For purposes of § 721.72(g)(2), 

the required human health 

precautionary statements include: Use 

skin protection; where engineering 

controls are not determined to be 

adequate, use respiratory protection. For 

purposes of § 721.72(g)(3), the required 

environmental hazard statements 

include: This substance may cause long 

lasting harmful effects to aquatic life. 

Alternative hazard and warning 

statements that meet the criteria of the 


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Federal Register / Vol. 86, No. 107 / Monday, June 7, 2021 / Rules and Regulations 30215 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial commercial, and 

consumer activities. It is a significant 

new use to process or use the substance 

with an application method that 

generates a mist, vapor, or aerosol. 

(iv) Release to water. Requirements as 

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

(c)(4), where N=56. 

(b) * * * 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (i) and (k) are 

applicable to manufacturers and 

processors of this substance. 

* * * * * 

[FR Doc. 2021–11768 Filed 6–4–21; 8:45 am] 

BILLING CODE 6560–50–P 


khammond on DSKJM1Z7X2PROD with RULES