Federal Register / Vol. 87, No. 22 / Wednesday, February 2, 2022 / Rules and Regulations 5709 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2021–0139; FRL–9253–01– 

OCSPP] 

Saccharomyces cerevisiae Strain 

LAS02; 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 Saccharomyces 

cerevisiae strain LAS02 in or on all food 

commodities when used in accordance 

with label directions and good 

agricultural practices. Lesaffre Yeast 

Corporation (c/o Wagner Regulatory 

Associates, 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 

Saccharomyces cerevisiae strain LAS02 

under FFDCA when used in accordance 

with this exemption. 

DATES: This regulation is effective 

February 2, 2022. Objections and 

requests for hearings must be received 

on or before April 4, 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–2021–0139, 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 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: 

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://

www.ecfr.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–2021–0139 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 April 

4, 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/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– 

2021–0139 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. 


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5710 Federal Register / Vol. 87, No. 22 / Wednesday, February 2, 2022 / Rules and Regulations 

• 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/where-sendcomments-epa-dockets. 

II. Background 

In the Federal Register of September 

22, 2021 (86 FR 52624) (FRL–8792–03), 

EPA issued a notice pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

tolerance exemption petition (PP 

0F8841) by Lesaffre Yeast Corporation 

(c/o Wagner Regulatory Associates, 

Inc.,) P.O. Box 640, 7217 Lancaster Pike, 

Suite A, Hockessin, DE 19707. 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 Saccharomyces cerevisiae 

strain LAS02 in or on all food 

commodities. That notice referenced a 

summary of the petition prepared by the 

petitioner Lesaffre Yeast Corporation 

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 

Saccharomyces cerevisiae strain LAS02 

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 

‘‘Human Health Risk Assessment of the 

New Active Ingredient Saccharomyces 

cerevisiae strain LAS02 in the Proposed 

End-use Product EPA File Symbol 

91810–G with an Associated Tolerance 

Exemption Petition’’ (Saccharomyces 

cerevisiae strain LAS02 Human Health 

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 

supported by existing scientific 

literature on Saccharomyces cerevisiae 

strain LAS02 and related 

Saccharomyces cerevisiae species 

demonstrate that, with regard to 

humans, Saccharomyces cerevisiae 

strain LAS02 is not toxic, pathogenic, or 

infective via any reasonably foreseeable 

route of exposure. Humans, including 

infants and children, are naturally 

exposed to Saccharomyces cerevisiae as 

this microorganism is commonly found 

in many habitats including soil, water, 

and plant surfaces. Furthermore, 

humans, including infants and children, 

have a long history of safe dietary 

exposure to strains of Saccharomyces 

cerevisiae through their use in food 

production, nutritional supplements, 

and bio-therapeutics. Saccharomyces 

cerevisiae strain LAS02 is expected to 

be non-toxic, non-pathogenic, and noninfective based on its genetic similarity 

to other food-use Saccharomyces 

cerevisiae strains and its lack of genetic 

modification. 

Although there may be some dietary 

and non-occupational exposures to 

pesticide residues of Saccharomyces 

cerevisiae strain LAS02 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. Humans have a long 

history of dietary exposure of 

Saccharomyces cerevisiae through its 

use in food and supplement products 

and natural exposure through its 

presence in the environment with no 

reported significant adverse effects 

attributable to dietary or nonoccupational exposure based on the 

proposed pesticide uses. Because there 

are no threshold levels of concern with 

the toxicity, pathogenicity, or infectivity 

of Saccharomyces cerevisiae strain 

LAS02, 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 evaluation in the 

Saccharomyces cerevisiae strain LAS02 

Human Health Assessment, which 

concludes that there are no risks of 

concern from aggregate exposure to 

Saccharomyces cerevisiae strain LAS02, 

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 Saccharomyces cerevisiae 

strain LAS02. 

B. Analytical Enforcement Methodology 

An analytical method is not required 

for Saccharomyces cerevisiae strain 

LAS02 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 Saccharomyces 

cerevisiae strain LAS02 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 


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Federal Register / Vol. 87, No. 22 / Wednesday, February 2, 2022 / Rules and Regulations 5711 

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: January 14, 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 § 180.1391 to subpart D to read 

as follows: 

§ 180.1391 Saccharomyces cerevisiae 

strain LAS02; exemption from the 

requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of Saccharomyces cerevisiae strain 

LAS02 in or on all food commodities 

when used in accordance with label 

directions and good agricultural 

practices. 

[FR Doc. 2022–02099 Filed 2–1–22; 8:45 am] 

BILLING CODE 6560–50–P 

GENERAL SERVICES 

ADMINISTRATION 

41 CFR Part 102–77 

[FMR Case 2021–02; Docket No. GSA–FMR– 

2021–0024, Sequence No. 1] 

RIN 3090–AK47 

Federal Management Regulation; Art in 

Architecture 

AGENCIES: Office of Government-wide 

Policy (OGP), General Services 

Administration (GSA). 

ACTION: Final rule with 60-day comment 

period. 

SUMMARY: GSA is issuing a final rule 

amending the Federal Management 

Regulation (FMR) to update certain 

provisions of the Art in Architecture 

program. These revisions clarify the 

policies to collect, manage, fund, and 

commission visual art in Federal 

buildings. The rule updates policies 

consistent with the requirements of the 

Executive Order (E.O.) issued May 14, 

2021, titled ‘‘Revocation of Certain 

Presidential Actions and Technical 

Amendment.’’ The rule also supports 

the goals of the E.O. issued January 20, 

2021, titled ‘‘Advancing Racial Equity 

and Support for Underserved 

Communities Through the Federal 

Government.’’ 

DATES: 

Effective date: January 31, 2022. 

Comments due date: Please submit 

comments by the method listed in the 

ADDRESSES section by April 4, 2022 for 

consideration in future rulemaking. 

ADDRESSES: Submit comments in 

response to FMR Case 2021–02 to: 

Regulations.gov: https://

www.regulations.gov. Submit comments 

via the Federal eRulemaking portal by 

searching for ‘‘FMR Case 2021–02.’’ 

Select the link ‘‘Comment Now’’ that 

corresponds with FMR Case 2021–02. 

Follow the instructions provided at the 

‘‘Comment Now’’ screen. Please include 

your name, company name (if any), and 

‘‘FMR Case 2021–02’’ on your attached 

document. If your comment cannot be 

submitted using https://

www.regulations.gov, call or email the 

points of contact in the FOR FURTHER

INFORMATION CONTACT section of this 

document for alternative instructions. 

Instructions: Please submit comments 

only and cite FMR Case 2021–02 in all 

correspondence related to this case. 

Comments received generally will be 

posted without change to https://

www.regulations.gov, including any 

personal or business confidential 

information, or both, provided. To 

confirm receipt of your comment(s), 

please check www.regulations.gov 

approximately two to three days after 

submission to verify posting. 

FOR FURTHER INFORMATION CONTACT: For 

clarification of content, contact Mr. 

Chris Coneeney, Director, Real Property 

Policy Division, Office of Governmentwide Policy, at 202–208–2956 or 

chris.coneeney@gsa.gov. For 

information pertaining to status or 

publication schedules, contact the 

Regulatory Secretariat Division at 202– 

501–4755 or GSARegSec@gsa.gov. 

Please cite FMR Case 2021–02. 

SUPPLEMENTARY INFORMATION: 

I. History of the Program 

Art in U.S. public buildings has a long 

history, beginning in the 1850s in the 

U.S. Custom House in New Orleans and 

continuing at the U.S. Capitol and 

through the Beaux-Arts era when 

courthouses and custom houses 

throughout the Nation were embellished 

with works of art. In the 1930s, the 

Great Depression saw the creation of 

relief programs of the New Deal, 

including four art programs: The Public 

Works of Art, which employed artists to 

create artworks; the Section of Fine Arts 

(the Section), a Treasury Department 

effort that awarded commissions to 

artists through competitions to secure 

the best quality artwork for installation 

in public buildings, including Federal 

buildings, courthouses and post offices; 


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