Federal Register / Vol. 87, No. 68 / Friday, April 8, 2022 / Rules and Regulations 20719 

EPA-APPROVED ILLINOIS NONREGULATORY AND QUASI-REGULATORY PROVISIONS—Continued 

Name of SIP provision 

Applicable 

geographic or 

nonattainment 

area 

State submittal date EPA approval date Comments 

2008 Lead NAAQS Infrastructure 

Requirements.

Statewide ........ 12/31/2012, 7/5/2017 and 

9/22/2020.

4/8/2022, [Insert Federal Register Citation].All CAA infrastructure elements under 110(a)(2) 

have been approved. 

2008 Ozone NAAQS Infrastructure Requirements.Statewide ........ 12/31/2012, 7/5/2017 and 

9/22/2020.

4/8/2022, [Insert Federal Register Citation].All CAA infrastructure elements under 110(a)(2) 

have been approved except (D)(i)(I) [Prongs 1 

and 2]. A FIP is in place for these elements. 

2010 NO2 NAAQS Infrastructure 

Requirements.

Statewide ........ 12/31/2012, 7/5/2017 and 

9/22/2020.

4/8/2022, [Insert Federal Register Citation].All CAA infrastructure elements under 110(a)(2) 

have been approved. 

2010 SO2 NAAQS Infrastructure 

Requirements.

Statewide ........ 12/31/2012, 7/5/2017 and 

9/22/2020.

4/8/2022, [Insert Federal Register Citation].All CAA infrastructure elements under 110(a)(2) 

have been approved except (D)(i)(I) [Prongs 1 

and 2], which have not yet been submitted. 

2012 PM2.5 NAAQS Infrastructure Requirements.

Statewide ........ 9/29/2017 and 9/22/2020 4/8/2022, [Insert Federal Register Citation].All CAA infrastructure elements under 110(a)(2) 

have been approved except (D)(i)(II) Prong 4. 

2015 Ozone NAAQS Infrastructure Requirements.Statewide ........ 5/16/2019 and 9/22/2020 4/8/2022, [Insert Federal Register Citation].All CAA infrastructure elements under 110(a)(2) 

have been approved except (D)(i)(I) and 

Prong 4 of (D)(i)(II) Prong 4. 

* * * * * * * 

* * * * * 

[FR Doc. 2022–07346 Filed 4–7–22; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2020–0495; FRL–8920–01– 

OCSPP] 

Bacillus Subtilis Strain AFS032321; 

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 Bacillus subtilis 

strain AFS032321 in or on all food 

commodities when used in accordance 

with label directions and good 

agricultural practices. AFS32321 Crop 

Protection, Inc., submitted a petition to 

EPA under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of Bacillus 

subtilis strain AFS032321 under FFDCA 

when used in accordance with this 

exemption. 

DATES: This regulation is effective April 

8, 2022. Objections and requests for 

hearings must be received on or before 

June 7, 2022 and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2020–0495, is 

available at https://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW, Washington, DC 

20460–0001. The Public Reading Room 

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

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. 

Due to the public health concerns 

related to COVID–19, the EPA Docket 

Center (EPA/DC) and Reading Room are 

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: 

Charles Smith, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW, Washington, DC 

20460–0001; main telephone number: 

(703) 305–7090; email address: 

BPPDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

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 Office of the Federal 

Register’s e-CFR site at https://

ecfr.federalregister.gov/current/title-40. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a(g), 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–2020–0495 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 June 

7, 2022. Addresses for mail and hand 

delivery of objections and hearing 

requests are provided in 40 CFR 

178.25(b), although EPA strongly 

encourages those interested in 

submitting objections or a hearing 

request to submit objections and hearing 

requests electronically. See Order 

Urging Electronic Service and Filing 

(April 10, 2020), https://www.epa.gov/ 

sites/production/files/2020-05/ 


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20720 Federal Register / Vol. 87, No. 68 / Friday, April 8, 2022 / Rules and Regulations 

documents/2020-04-10_-_order_urging_

electronic_service_and_filing.pdf. At 

this time, because of the COVID–19 

pandemic, the judges and staff of the 

Office of Administrative Law Judges are 

working remotely and not able to accept 

filings or correspondence by courier, 

personal delivery, or commercial 

delivery, and the ability to receive 

filings or correspondence by U.S. Mail 

is similarly limited. When submitting 

documents to the U.S. EPA Office of 

Administrative Law Judges (OALJ), a 

person should utilize the OALJ e-filing 

system at https://yosemite.epa.gov/OA/ 

EAB/EAB-ALJ_upload.nsf. 

Although EPA’s regulations require 

submission via U.S. Mail or hand 

delivery, EPA intends to treat 

submissions filed via electronic means 

as properly filed submissions during 

this time that the Agency continues to 

maximize telework due to the 

pandemic; therefore, EPA believes the 

preference for submission via electronic 

means will not be prejudicial. If it is 

impossible for a person to submit 

documents electronically or receive 

service electronically, e.g., the person 

does not have any access to a computer, 

the person shall so advise OALJ by 

contacting the Hearing Clerk at (202) 

564–6281. If a person is without access 

to a computer and must file documents 

by U.S. Mail, the person shall notify the 

Hearing Clerk every time it files a 

document in such a manner. The 

address for mailing documents is U.S. 

Environmental Protection Agency, 

Office of Administrative Law Judges, 

Mail Code 1900R, 1200 Pennsylvania 

Ave. NW, Washington, DC 20460. 

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 (excluding 

any Confidential Business Information 

(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 the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2020–0495, by one of the following 

methods: 

• Federal eRulemaking Portal:

https://www.regulations.gov. Follow the 

online instructions for submitting 

comments. Do not submit electronically 

any information you consider to be CBI 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW, Washington, DC 20460–0001. 

• Hand Delivery: To make special

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at https://

www.epa.gov/dockets/where-sendcomments-epa-dockets. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at https:// 

www.epa.gov/dockets. 

II. Background

In the Federal Register of December

21, 2020 (85 FR 82998) (FRL–10016–93), 

EPA issued a document pursuant to 

FFDCA section 408(d)(3), 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide tolerance exemption petition 

(PP 9F8816) by AFS32321 Crop 

Protection, Inc., P.O. Box 14069, 

Research Triangle Park, NC 27709. The 

petition requested that 40 CFR part 180 

be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of the bactericide 

and fungicide Bacillus subtilis strain 

AFS032321 in or on all food 

commodities. That document referenced 

a summary of the petition prepared by 

the petitioner AFS32321 Crop 

Protection, Inc. and available in the 

docket via https://www.regulations.gov. 

No comments were received on the 

notice of filing. 

III. Final Rule

A. EPA’s Safety Determination

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

allows EPA to establish an exemption 

from the requirement of 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 in 

residential settings but does not include 

occupational exposure. Pursuant to 

FFDCA section 408(c)(2)(B), in 

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in FFDCA section 

408(b)(2)(C), which require EPA to give 

special consideration to exposure of 

infants and children to the pesticide 

chemical residue in establishing a 

tolerance or tolerance exemption and to 

‘‘ensure that there is a reasonable 

certainty that no harm will result to 

infants and children from aggregate 

exposure to the pesticide chemical 

residue. . . .’’ Additionally, FFDCA 

section 408(b)(2)(D) requires that EPA 

consider ‘‘available information 

concerning the cumulative effects of [a 

particular pesticide’s] . . . residues and 

other substances that have a common 

mechanism of toxicity.’’ 

EPA evaluated the available 

toxicological and exposure data on 

Bacillus subtilis strain AFS032321 and 

considered their validity, completeness, 

and reliability, as well as the 

relationship of this information to 

human risk. A full explanation of the 

data upon which EPA relied and its risk 

assessment based on those data can be 

found within the document entitled 

‘‘Bacillus subtilis strain AFS032321 (PC 

Code: 006072) Human Health Risk 

Assessment in support of Section 3 

Product Registration under PRIA Action 

Code B590—New active ingredient; food 

use; petition to establish a tolerance 

exemption’’ (Bacillus subtilis strain 

AFS032321 Human Health Risk 

Assessment). This document, as well as 

other relevant information, is available 

in the docket for this action as described 

under ADDRESSES. 

The available data and rationale 

demonstrated that, with regard to 

humans, Bacillus subtilis strain 

AFS032321 is not toxic, pathogenic, or 

infective via the oral route of exposure 

when administered by oral gavage at a 

single dose of 5.4 x 108 colony-forming 

units per test animal; is not anticipated 

to be toxic, pathogenic, or infective via 

the pulmonary route of exposure; is not 

anticipated to be toxic via the dermal 

route of exposure; and is moderately 

irritating via the dermal route of 

exposure. Additionally, the acute oral 

toxicity/pathogenicity study 

demonstrated a pattern of clearance of 

Bacillus subtilis strain AFS032321 from 

the organs and feces of the test animals. 

Although there may be some dietary and 

non-occupational exposures to residues 

of Bacillus subtilis strain AFS032321 

when used in accordance with label 

directions and good agricultural 

practices, there is not a concern due to 

the lack of potential for adverse effects. 

For example, no significant adverse 

effects have been associated with 

dietary exposure to Bacillus subtilis 

group strains, of which this active 

ingredient is a part, and these organisms 

are often present in agricultural settings 

(i.e., water, soil, and plant roots) and are 

commonly found on various types of 

fresh produce. Because there are no 

threshold levels of concern with the 

toxicity, pathogenicity, or infectivity of 

Bacillus subtilis strain AFS032321, EPA 

determined that no additional margin of 

safety is necessary to protect infants and 

children as part of the qualitative 

assessment conducted. Based upon its 


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Federal Register / Vol. 87, No. 68 / Friday, April 8, 2022 / Rules and Regulations 20721 

evaluation in the Bacillus subtilis strain 

AFS032321 Human Health Risk 

Assessment, which concludes that there 

are no risks of concern from aggregate 

exposure to Bacillus subtilis strain 

AFS032321, EPA concludes that there is 

a reasonable certainty that no harm will 

result to the U.S. population, including 

infants and children, from aggregate 

exposure to residues of Bacillus subtilis 

strain AFS032321. 

B. Analytical Enforcement Methodology 

An analytical method is not required 

for Bacillus subtilis strain AFS032321 

because EPA is establishing an 

exemption from the requirement of a 

tolerance without any numerical 

limitation. 

C. Conclusion 

Therefore, an exemption from the 

requirement of a tolerance is established 

for residues of Bacillus subtilis strain 

AFS032321 in or on all food 

commodities when used in accordance 

with label directions and good 

agricultural practices. 

IV. Statutory and Executive Order 

Reviews 

This action establishes a tolerance 

exemption under FFDCA section 408(d) 

in response to a petition submitted to 

EPA. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001), or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act, 44 U.S.C. 

3501 et seq., nor does it 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). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance exemption in this action, 

do not require the issuance of a 

proposed rule, the requirements of the 

Regulatory Flexibility Act (5 U.S.C. 601 

et seq.) do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or Tribes. As a 

result, this action does not alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

EPA 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. Thus, EPA 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 action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (2 U.S.C. 1501 et 

seq.). 

This action does not involve any 

technical standards that would require 

EPA’s consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act (15 

U.S.C. 272 note). 

V. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: April 1, 2022. 

Edward Messina, 

Director, 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. Add § 180.1386 to subpart D to read 

as follows: 

§ 180.1386 Bacillus subtilis strain 

AFS032321; exemption from the 

requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of Bacillus subtilis strain AFS032321 in 

or on all food commodities when used 

in accordance with label directions and 

good agricultural practices. 

[FR Doc. 2022–07561 Filed 4–7–22; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 302 

[EPA–HQ–OLEM–2022–0299; FRL–9335– 

01–OLEM] 

Addition of 1-Bromopropane to the List 

of CERCLA Hazardous Substances; 

List of Hazardous Substances; 

Technical Corrections 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The U.S. Environmental 

Protection Agency (EPA or the Agency) 

is issuing a technical amendment to 

modify the Comprehensive 

Environmental Response, 

Compensation, and Liability Act 

(CERCLA) list of hazardous substances, 

to be consistent with the statutory 

provisions that currently comprise this 

list. These modifications include adding 

the Clean Air Act (CAA) HAP 1- 

Bromopropane and removing the 

Resource Conservation and Recovery 

Act (RCRA) vacated K-Code Wastes: 

K064, K065, K066, K090, and K091. The 

Agency is also adding clarifying 

language, correcting a Chemical 

Abstract Service Registry Number 

(CASRN), and modifying the formatting 

of hazardous substance isomers and 

homologs that are listed with parent 

substances. 

DATES: This final rule is effective on 

April 8, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Barre, U.S. Environmental 

Protection Agency, Office of Emergency 

Management, (MC: 5104A), 1200 

Pennsylvania Avenue NW, Washington, 


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