Federal Register / Vol. 86, No. 155 / Monday, August 16, 2021 / Rules and Regulations 45651 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2020–0304; FRL–8146–02– 

OCSPP] 

RIN 2070–AB27 

Significant New Use Rules on Certain 

Chemical Substances (20–8.B) 

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 which were the 

subject of premanufacture notices 

(PMNs). This action requires persons to 

notify EPA at least 90 days before 

commencing manufacture (defined by 

statute to include import) or processing 

of any of these chemical substances for 

an activity that is designated as a 

significant new use by this rule. This 

action further requires that persons not 

commence manufacture or processing 

for the significant new use until they 

have submitted a Significant New Use 

Notice (SNUN), EPA has conducted a 

review of the notice, made an 

appropriate determination on the notice, 

and has taken any risk management 

actions as are required as a result of that 

determination. 

DATES: This rule is effective on October 

15, 2021. For purposes of judicial 

review, this rule shall be promulgated at 

1 p.m. (e.s.t.) on August 30, 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 or 

725.920 for the MCAN substance, 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–2020–0304, is 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. 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 finalizing SNURs under TSCA 

section 5(a)(2) for chemical substances 

which were the subject of PMNs P–18– 

399, P–18–400, and P–20–68. These 

SNURs require persons who intend to 

manufacture or process any of these 

chemical substances for an activity that 

is designated as a significant new use to 

notify EPA at least 90 days before 

commencing that activity. 

Previously, in the Federal Register of 

August 25, 2020 (85 FR 52294) (FRL– 

10013–07), EPA proposed SNURs for 

these chemical substances. More 

information on the specific chemical 

substances subject to this final rule can 

be found in the Federal Register 

document proposing the SNURs. The 

docket includes information considered 

by the Agency in developing the 

proposed and final rules, including 

public comments and EPA’s responses 

to the public comments received on the 

proposed rules, as described in Unit IV. 

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 TSCA section 5(a)(2) 

factors listed in Unit III. 

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 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 

same SNUN requirements and EPA 

regulatory procedures as submitters of 

PMNs under TSCA section 5(a)(1)(A). In 

particular, these requirements include 

the information submission 

requirements of TSCA sections 5(b) and 

5(d)(1), the exemptions authorized by 

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

and 5(h)(5) and the regulations at 40 

CFR part 720. Once EPA receives a 

SNUN, EPA must either determine that 

the significant new use is not likely to 

present an unreasonable risk of injury or 

take such regulatory action as is 

associated with an alternative 

determination before 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 


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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 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 the 

substances, in the context of the four 

bulleted TSCA section 5(a)(2) factors 

listed in this unit. During its review of 

these chemicals, EPA identified certain 

conditions of use that are not intended 

by the submitters, but reasonably 

foreseen to occur. EPA is designating 

those reasonably foreseen conditions of 

use as well as certain other 

circumstances of use as significant new 

uses. 

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 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 production 

volume 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 public comments from 

four identifying entities on the proposed 

rule. In addition, EPA received one 

anonymous comment. The Agency’s 

responses are described in a separate 

Response to Public Comments 

document that is available in the public 

docket for this rulemaking. The 

anonymous comment and three of the 

comments from identifying entities were 

broadly supportive of the rule and 

requested no changes to the rule itself; 

therefore, no response is required. EPA 

made no changes to the final rule based 

on these comments. EPA did make one 

change to the reporting requirements for 

two SNURs to make clear that the 

production volume limit in the SNURs 

was confidential. 

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 

SNUR, EPA provided the following 

information for each chemical 

substance: 

• PMN number. 

• Chemical name (generic name, if 

the specific name is claimed as CBI). 

• Chemical Abstracts Service (CAS) 

Registry number (if assigned for nonconfidential chemical identities). 

• Basis for the SNUR. 

• Potentially useful information. 

• CFR citation assigned in the 

regulatory text section of this final rule. 

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. 

VI. Rationale and Objectives of the Rule 

A. Rationale 

During review of the PMNs submitted 

for the chemical substances that are the 

subject of these SNURs and as further 

discussed in Unit IV. of the proposed 

rule, EPA identified certain other 

reasonably foreseen conditions of use in 

addition to those conditions of use 

intended by the submitter. EPA has 

determined that the chemical under the 

intended conditions of use is not likely 

to present an unreasonable risk. 

However, EPA has not assessed risks 

associated with the reasonably foreseen 

conditions of use. EPA is designating 

these conditions of use as well as 

certain other circumstances of use as 

significant new uses. As a result, those 

significant new uses cannot occur 

without going through a separate, 

subsequent EPA review and 

determination process associated with a 

SNUN. 

B. Objectives 

EPA is issuing these SNURs because 

the Agency wants: 

• To 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. 

• To 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 

section 5(a)(3)(C) that the 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 


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significant new use of the chemical 

substance can occur. 

• To be able to complete its review 

and determination on each of the PMN 

substances, while deferring analysis on 

the significant new uses proposed in 

these rules unless and until the Agency 

receives a SNUN. 

Issuance of a SNUR for a chemical 

substance does not signify that the 

chemical substance is listed on the 

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 Rules to Uses 

Occurring Before the Effective Date of 

the Final Rule 

To establish a significant new use, 

EPA must determine that the use is not 

ongoing. The chemical substances 

subject to this rule were undergoing 

premanufacture review at the time of 

signature of the proposed rule and were 

not on the TSCA inventory. 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 the 

chemical substances subject to these 

SNURs, EPA concluded at the time of 

signature of the proposed rule that the 

designated significant new uses were 

not ongoing. 

EPA designated August 4, 2020 (the 

date of web posting of the proposed 

rule) as the cutoff date for determining 

whether the new use is ongoing. The 

objective of EPA’s approach is to ensure 

that a person cannot defeat a SNUR by 

initiating a significant new use before 

the effective date of the final rule. 

Persons who began commercial 

manufacture or processing of the 

chemical substances for a significant 

new use identified on or after that date 

will have to cease any such activity 

upon the effective date of the final rule. 

To resume their activities, these persons 

would have to first comply with all 

applicable SNUR notification 

requirements and EPA would have to 

take action under TSCA section 5 

allowing manufacture or processing to 

proceed. 

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, 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 

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 listed here. Descriptions are 

provided for informational purposes. 

The potentially useful information 

identified in Unit IV. of the proposed 

rule will be 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, which may assist with 

EPA’s analysis of the SNUN. For more 

information on alternative test methods 

and strategies to reduce vertebrate 

animal testing, visit https://

www.epa.gov/assessing-and-managingchemicals-under-tsca/alternative-testmethods-and-strategies-reduce. 

EPA strongly encourages persons, 

before performing any testing, to consult 

with the Agency pertaining to protocol 

election. 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). 

The potentially useful information 

described in Unit IV. of the proposed 

rule may not be the only means of 

providing information to evaluate the 

chemical substance associated with the 

significant new uses. However, 

submitting a SNUN without any test 

data 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 which provide detailed 

information on the following: 

• Human exposure and 

environmental release that may result 

from the significant new use of the 

chemical substances. 

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 

analysis is available in the docket for 

this rulemaking. 

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 

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. Paperwork Reduction Act (PRA) 

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

seq., an agency may not conduct or 

sponsor, and a person is not required to 

respond to a collection of information 

that requires OMB approval under PRA, 

unless it has been approved by OMB 

and displays a currently valid OMB 

control number. The OMB control 

numbers for EPA’s regulations in title 40 

of the CFR, after appearing in the 

Federal Register, are listed in 40 CFR 

part 9, and included on the related 

collection instrument or form, if 

applicable. 


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The information collection 

requirements related to this action have 

already been approved by OMB 

pursuant to PRA under OMB control 

number 2070–0012 (EPA ICR No. 574). 

This action does not impose any burden 

requiring additional OMB approval. If 

an entity were to submit a SNUN to the 

Agency, the annual burden is estimated 

to average between 30 and 170 hours 

per response. This burden estimate 

includes the time needed to review 

instructions, search existing data 

sources, gather and maintain the data 

needed, and complete, review, and 

submit the required SNUN. 

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 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 

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 Tribal 

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 

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 a 

significant regulatory action under 

Executive Order 12866. 

I. National Technology Transfer and 

Advancement Act (NTTAA) 

In addition, since this action does not 

involve any technical standards, 

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

note, does not apply to this action. 

J. Executive Order 12898: 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 

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: 


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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 §§ 721.11556 through 

721.11558 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 

* * * * * 

721.11556 ............................. 2070–0012 

721.11557 ............................. 2070–0012 

721.11558 ............................. 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). 

■ 4. Add §§ 721.11556 through 

721.11558 to subpart E to read as 

follows: 

Subpart E Significant New Uses for 

Specific Chemical Substances 

* * * * * 

Sec. 

721.11556 Rosin adduct ester, polymer with 

polyols, compd. with ethanolamine 

(generic). 

721.11557 Rosin adduct ester, polymer with 

polyols, potassium salt (generic). 

721.11558 1,3-Propanediol, 2,2-dimethyl-, 

1,3-diacetate. 

* * * * * 

§ 721. 11556 Rosin adduct ester, polymer 

with polyols, compd. with ethanolamine 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as rosin adduct ester, 

polymer with polyols, compd. with 

ethanolamine (PMN P–18–399) 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 an annual 

production volume greater than the 

confidential production volume 

identified in the PMN. 

(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. 11557 Rosin adduct ester, polymer 

with polyols, potassium salt (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as rosin adduct ester, 

polymer with polyols, potassium salt 

(PMN P–18–400) 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 an annual 

production volume greater than the 

confidential production volume 

identified in the PMN. 

(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. 

§ 721.11558 1,3-Propanediol, 2,2-dimethyl-, 

1,3-diacetate. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1,3-propanediol, 2,2-dimethyl-, 1,3- 

diacetate (PMN P–20–68, CAS No. 

13431–57–7) 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) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (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. 2021–17389 Filed 8–13–21; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 110 

RIN 0906–AB22 

Countermeasures Injury 

Compensation Program: Smallpox 

Countermeasures Injury Table 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Final rule. 

SUMMARY: HHS is establishing the 

Smallpox Countermeasures Injury Table 

(Table) as authorized by the Public 

Readiness and Emergency Preparedness 

Act of 2005 (PREP Act). Through this 

final rule, the Secretary of the U.S. 

Department of Health and Human 

Services (Secretary) adds the Smallpox 

Countermeasures Injury Table to the 

agency’s regulations. The Table includes 

a list of covered smallpox 

countermeasures, required time 


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