30206 Federal Register / Vol. 86, No. 107 / Monday, June 7, 2021 / Rules and Regulations 

PART 81—DESIGNATION OF AREAS 

FOR AIR QUALITY PLANNING 

PURPOSES 

■ 1. The authority citation for part 81 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart C—Section 107 Attainment 

Status Designations 

■ 2. In § 81.305, the table entitled 

‘‘California—2008 8-Hour Ozone 

NAAQS [Primary and Secondary]’’ is 

amended by revising the entry for ‘‘Kern 

County (Eastern Kern), CA’’ to read as 

follows: 

§ 81.305 California. 

* * * * * 

CALIFORNIA–2008 8-HOUR OZONE NAAQS 

[Primary and secondary] 

Designated area 

Designation Classification 

Date 1 Type Date 1 Type 

* * * * * * * 

Kern County (Eastern Kern), CA: 2 ........................... Nonattainment .. July 7, 2021 ...... Severe-15. 

Kern County (part): 

That portion of Kern County (with the exception of that portion in Hydrologic Unit Number 18090205—the Indian 

Wells Valley) east and south of a line described as follows: Beginning at the Kern-Los Angeles County boundary and running north and east along the northwest 

boundary of the Rancho La Liebre Land Grant to the 

point of intersection with the range line common to 

Range 16 West and Range 17 West, San Bernardino 

Base and Meridian; north along the range line to the 

point of intersection with the Rancho El Tejon Land Grant 

boundary; then southeast, northeast, and northwest along 

the boundary of the Rancho El Tejon Grant to the northwest corner of Section 3, Township 11 North, Range 17 

West; then west 1.2 miles; then north to the Rancho El 

Tejon Land Grant boundary; then northwest along the 

Rancho El Tejon line to the southeast corner of Section 

34, Township 32 South, Range 30 East, Mount Diablo 

Base and Meridian; then north to the northwest corner of 

Section 35, Township 31 South, Range 30 East; then 

northeast along the boundary of the Rancho El Tejon 

Land Grant to the southwest corner of Section 18, Township 31 South, Range 31 East; then east to the southeast 

corner of Section 13, Township 31 South, Range 31 

East; then north along the range line common to Range 

31 East and Range 32 East, Mount Diablo Base and Meridian, to the northwest corner of Section 6, Township 29 

South, Range 32 East; then east to the southwest corner 

of Section 31, Township 28 South, Range 32 East; then 

north along the range line common to Range 31 East and 

Range 32 East to the northwest corner of Section 6, 

Township 28 South, Range 32 East, then west to the 

southeast corner of Section 36, Township 27 South, 

Range 31 East, then north along the range line common 

to Range 31 East and Range 32 East to the Kern-Tulare 

County boundary. 

* * * * * * * * 

1This date is July 20, 2012, unless otherwise noted. 

2Excludes Indian country located in each area, unless otherwise noted. 

[FR Doc. 2021–11704 Filed 6–4–21; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2021–0138; FRL–10023–34] 

Cellulose, Ethyl Ether; Exemption 

From the Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of cellulose, ethyl 

ether; number average molecular weight 

13,000 Daltons when used as an inert 

ingredient in a pesticide chemical 

formulation. Exponent, Inc. on behalf of 

Nutrition & Biosciences USA 1, LLC, 

formerly DDP Specialty Electronic 

Materials US, Inc. submitted a petition 

to EPA under the Federal Food, Drug, 

and Cosmetic Act (FFDCA), requesting 

an exemption from the requirement of a 


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tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of 

cellulose, ethyl ether on food or feed 

commodities. 

DATES: This regulation is effective June 

7, 2021. Objections and requests for 

hearings must be received on or before 

August 6, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2021–0138. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. 

S–4400, One Potomac Yard (South 

Bldg.), 2777 S Crystal Dr., Arlington, 

VA. The Docket Facility is open from 

8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays. The 

Docket Facility telephone number 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; 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. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Publishing 

Office’s e-CFR site at http://

ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. 

C. Can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2021–0138 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing and must be received 

by the Hearing Clerk on or before 

August 6, 2021. Addresses for mail and 

hand delivery of objections and hearing 

requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2021–0138, by one of 

the following methods. 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW, Washington, DC 

20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Background and Statutory Findings 

In the Federal Register of March 22, 

2021 (86 FR 15162) (FRL–10021–44), 

EPA issued a notification pursuant to 

section 408 of FFDCA, 21 U.S.C. 346a, 

announcing the receipt of a pesticide 

petition (PP IN–11484) filed by 

Exponent, Inc., 1150 Connecticut Ave. 

NW, Suite 1100, Washington, DC 20036 

on behalf of Nutrition & Biosciences 

USA 1, LLC, 3490 Winton Place, 

Rochester, NY 14623 formerly DDP 

Specialty Electronic Materials US, Inc., 

400 Arcola Road, Collegeville, PA 

19426. The petition requested that 40 

CFR 180.960 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of cellulose, ethyl ether; CAS Reg. No. 

9004–57–3. That notification included a 

summary of the petition prepared by the 

petitioner and solicited comments on 

the petitioner’s request. The Agency did 

not receive any comments. 

Section 408(c)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the exemption is ‘‘safe.’’ 

Section 408(c)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and 

use in residential settings but does not 

include occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing an 

exemption from the requirement of a 

tolerance and to ‘‘ensure that there is a 


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reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue . . .’’ and specifies 

factors EPA is to consider in 

establishing an exemption. 

III. Risk Assessment and Statutory 

Findings 

EPA establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be shown that the 

risks from aggregate exposure to 

pesticide chemical residues under 

reasonably foreseeable circumstances 

will pose no appreciable risks to human 

health. In order to determine the risks 

from aggregate exposure to pesticide 

inert ingredients, the Agency considers 

the toxicity of the inert in conjunction 

with possible exposure to residues of 

the inert ingredient through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. If 

EPA is able to determine that a finite 

tolerance is not necessary to ensure that 

there is a reasonable certainty that no 

harm will result from aggregate 

exposure to the inert ingredient, an 

exemption from the requirement of a 

tolerance may be established. 

Consistent with FFDCA section 

408(b)(2)(D), EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action and considered its validity, 

completeness and reliability and the 

relationship of this information to 

human risk. EPA has also considered 

available information concerning the 

variability of the sensitivities of major 

identifiable subgroups of consumers, 

including infants and children. In the 

case of certain chemical substances that 

are defined as polymers, the Agency has 

established a set of criteria to identify 

categories of polymers expected to 

present minimal or no risk. The 

definition of a polymer is given in 40 

CFR 723.250(b) and the exclusion 

criteria for identifying these low-risk 

polymers are described in 40 CFR 

723.250(d). cellulose, ethyl ether 

conforms to the definition of a polymer 

given in 40 CFR 723.250(b) and meets 

the following criteria that are used to 

identify low-risk polymers. 

1. The polymer is not a cationic 

polymer nor is it reasonably anticipated 

to become a cationic polymer in a 

natural aquatic environment. 

2. The polymer does contain as an 

integral part of its composition at least 

two of the atomic elements carbon, 

hydrogen, nitrogen, oxygen, silicon, and 

sulfur. 

3. The polymer does not contain as an 

integral part of its composition, except 

as impurities, any element other than 

those listed in 40 CFR 723.250(d)(2)(ii). 

4. The polymer is neither designed 

nor can it be reasonably anticipated to 

substantially degrade, decompose, or 

depolymerize. 

5. The polymer is manufactured or 

imported from monomers and/or 

reactants that are already included on 

the Toxic Substances Control Act 

(TSCA) Chemical Substance Inventory 

or manufactured under an applicable 

TSCA section 5 exemption. 

6. The polymer is not a water 

absorbing polymer with a number 

average molecular weight (MW) greater 

than or equal to 10,000 daltons. 

Additionally, the polymer also meets 

as required the following exemption 

criteria specified in 40 CFR 723.250(e). 

7. The polymer does not contain 

certain perfluoroalkyl moieties 

consisting of a CF3- or longer chain 

length as listed in 40 CFR 723.250(d)(6). 

Additionally, the polymer also meets 

as required the following exemption 

criteria: Specified in 40 CFR 723.250(e): 

The polymer’s number average MW is 

greater than or equal to 10,000 daltons. 

The polymer contains less than 2% 

oligomeric material below MW 500 and 

less than 5% oligomeric material below 

MW 1,000. 

Thus, cellulose, ethyl ether meets the 

criteria for a polymer to be considered 

low risk under 40 CFR 723.250. Based 

on its conformance to the criteria in this 

unit, no mammalian toxicity is 

anticipated from dietary, inhalation, or 

dermal exposure to cellulose, ethyl 

ether. 

IV. Aggregate Exposures 

For the purposes of assessing 

potential exposure under this 

exemption, EPA considered that 

cellulose, ethyl ether could be present 

in all raw and processed agricultural 

commodities and drinking water, and 

that non-occupational non-dietary 

exposure was possible. The number 

average MW of cellulose, ethyl ether is 

13,000 daltons. Generally, a polymer of 

this size would be poorly absorbed 

through the intact gastrointestinal tract 

or through intact human skin. Since 

cellulose, ethyl ether conform to the 

criteria that identify a low-risk polymer, 

there are no concerns for risks 

associated with any potential exposure 

scenarios that are reasonably 

foreseeable. The Agency has determined 

that a tolerance is not necessary to 

protect the public health. 

V. Cumulative Effects From Substances 

With a Common Mechanism of Toxicity 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ EPA has not 

found cellulose, ethyl ether to share a 

common mechanism of toxicity with 

any other substances, and cellulose, 

ethyl ether does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that cellulose, ethyl ether does 

not have a common mechanism of 

toxicity with other substances. For 

information regarding EPA’s efforts to 

determine which chemicals have a 

common mechanism of toxicity and to 

evaluate the cumulative effects of such 

chemicals, see EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

VI. Additional Safety Factor for the 

Protection of Infants and Children 

Section 408(b)(2)(C) of FFDCA 

provides that EPA shall apply an 

additional tenfold margin of safety for 

infants and children in the case of 

threshold effects to account for prenatal 

and postnatal toxicity and the 

completeness of the data base unless 

EPA concludes that a different margin of 

safety will be safe for infants and 

children. Due to the expected low 

toxicity of cellulose, ethyl ether, EPA 

has not used a safety factor analysis to 

assess the risk. For the same reasons the 

additional tenfold safety factor is 

unnecessary. 

VII. Determination of Safety 

Based on the conformance to the 

criteria used to identify a low-risk 

polymer, EPA concludes that there is a 

reasonable certainty of no harm to the 

U.S. population, including infants and 

children, from aggregate exposure to 

residues of cellulose, ethyl ether. 

VIII. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 


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Federal Register / Vol. 86, No. 107 / Monday, June 7, 2021 / Rules and Regulations 30209 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

The Codex has not established a MRL 

for cellulose, ethyl ether. 

IX. Conclusion 

Accordingly, EPA finds that 

exempting residues of cellulose, ethyl 

ether from the requirement of a 

tolerance will be safe. 

X. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these rules 

from review under Executive Order 

12866, entitled Regulatory Planning and 

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

Because this final rule has been 

exempted from review under Executive 

Order 12866, this final rule is not 

subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it involve any technical 

standards that would require Agency 

consideration of voluntary consensus 

standards pursuant to section 12(d) of 

the National Technology Transfer and 

Advancement Act of 1995 (NTTAA), 

Public Law 104–113, section 12(d) (15 

U.S.C. 272 note). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or Tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or Tribal Governments, 

on the relationship between the 

National Government and the States or 

Tribal Governments, or on the 

distribution of power and 

responsibilities among the various 

levels of government or between the 

Federal Government and Indian Tribes, 

or otherwise have any unique impacts 

on local governments. Thus, the Agency 

has determined that Executive Order 

13132, entitled Federalism (64 FR 

43255, August 10, 1999) and Executive 

Order 13175, entitled Consultation and 

Coordination with Indian Tribal 

Governments (65 FR 67249, November 

9, 2000) do not apply to this final rule. 

In addition, this final rule does not 

impose any enforceable duty or contain 

any unfunded mandate as described 

under Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Pub. L. 

104–4). 

Although this action does not require 

any special considerations under 

Executive Order 12898, entitled Federal 

Actions to Address Environmental 

Justice in Minority Populations and 

Low-Income Populations (59 FR 7629, 

February 16, 1994), EPA seeks to 

achieve environmental justice, the fair 

treatment and meaningful involvement 

of any group, including minority and/or 

low-income populations, in the 

development, implementation, and 

enforcement of environmental laws, 

regulations, and policies. As such, to the 

extent that information is publicly 

available or was submitted in comments 

to EPA, the Agency considered whether 

groups or segments of the population, as 

a result of their location, cultural 

practices, or other factors, may have 

atypical or disproportionately high and 

adverse human health impacts or 

environmental effects from exposure to 

the pesticide discussed in this 

document, compared to the general 

population. 

XI. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this rule in the Federal 

Register. This rule is not a ‘‘major rule’’ 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: May 28, 2021. 

Marietta Echeverria, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, for the reasons stated in the 

preamble, EPA is amending 40 CFR 

chapter I as follows: 

PART 180—TOLERANCES AND 

EXEMPTIONS FOR PESTICIDE 

CHEMICAL RESIDUES IN FOOD 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.960, amend the table by 

adding in alphabetical order the 

polymer ‘‘Cellulose, ethyl ether, 

minimum number average molecular 

weight (in amu), insert 13,000 Daltons’’ 

to read as follows: 

§ 180.960 Polymers; exemptions from the 

requirement of a tolerance. 

* * * * * 

Polymer CAS No. 

*******

Cellulose, ethyl ether, minimum number average molecular weight (in amu), insert 13,000 Daltons ................................................................................. 9004–57–3 

*******


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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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