Federal Register / Vol. 87, No. 87 / Thursday, May 5, 2022 / Rules and Regulations 26691 

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 (PRA) (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 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 action 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 FFDCA 

section 408(n)(4). 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. 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 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 (UMRA) (2 U.S.C. 1501 et 

seq.). 

This action does not 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 

(NTTAA) (15 U.S.C. 272 note). 

VIII. 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 29, 2022. 

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 § 180.920, amend table 1 to 

180.920, by adding in alphabetical order 

‘‘Hydrolyzed vegetable proteins from 

soy’’ to read as follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

TABLE 1 TO 180.920 

Inert ingredients Limits Uses 

*******

Hydrolyzed vegetable proteins from soy .......... Not to exceed 25% of pesticide formulation .... pH adjusting agent, surfactant, adhesive. 

* * * * * * * 

[FR Doc. 2022–09655 Filed 5–4–22; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2018–0545; FRL–9761–01– 

OCSPP] 

Cell Walls of Saccharomyces 

Cerevisiae; Tolerance Exemption 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of cell walls of 

Saccharomyces cerevisiae (also known 

as yeast cell walls or YCWs) when used 

as a carrier inert ingredient in pesticide 

formulations in pre-harvest applications 

to crops. SciReg, Inc., on behalf of Eden 

Research, 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 cell 

walls of Saccharomyces cerevisiae on 

food or feed commodities when used in 

accordance with this exemption. 

DATES: This regulation is effective May 

5, 2022. Objections and requests for 

hearings must be received on or before 

July 5, 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–2018–0545, 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 and OPP Docket 

is (202) 566–1744. Due to the public 

health concerns related to COVID–19, 

the EPA Docket Center (EPA/DC) and 

Reading Room is open to visitors by 


lotter on DSK11XQN23PROD with RULES1
26692 Federal Register / Vol. 87, No. 87 / Thursday, May 5, 2022 / Rules and Regulations 

appointment only. For the latest status 

information on EPA/DC services and 

access, visit https://www.epa.gov/ 

dockets. 

FOR FURTHER INFORMATION CONTACT: 

Marietta Echeverria, Registration 

Division (7505T), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW, 

Washington, DC 20460–0001; main 

telephone number: (202) 566–1030; 

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. 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. 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–2018–0545 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 July 

5, 2022. 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 (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– 

2018–0545, 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/contacts.html. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at https:// 

www.epa.gov/dockets. 

II. Petition for Exemption 

In the Federal Register of October 18, 

2018 (83 FR 52787), EPA issued a 

document pursuant to FFDCA section 

408, 21 U.S.C. 346a, announcing the 

receipt of a pesticide petition (PP IN– 

11175) filed by SciReg, Inc. (12733 

Director’s Loop, Woodbridge, VA 

22192), on behalf of Eden Research. The 

petition requested that 40 CFR 180.920 

be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of cell walls of 

Saccharomyces cerevisiae (also known 

as yeast cell walls or YCWs) when used 

as a carrier inert ingredient in pesticide 

formulations applied pre-harvest to 

crops. That document included a 

summary of the petition prepared by the 

petitioner and solicited comments on 

the petitioner’s request. The Agency did 

not receive any public comments. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

hydrocarbons; surfactants such as 

polyoxyethylene polymers and fatty 

acids; carriers such as clay and 

diatomaceous earth; thickeners such as 

carrageenan and modified cellulose; 

wetting, spreading, and dispersing 

agents; propellants in aerosol 

dispensers; microencapsulating agents; 

and emulsifiers. The term ‘‘inert’’ is not 

intended to imply nontoxicity; the 

ingredient may or may not be 

chemically active. Generally, EPA has 

exempted inert ingredients from the 

requirement of a tolerance based on the 

low toxicity of the individual inert 

ingredients. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

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

defines ‘‘safe’’ to mean that EPA has 

determined 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 it 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 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.’’ 

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 harm 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 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(c)(2)(A), and the factors specified in 

FFDCA section 408(c)(2)(B), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action and considered its 


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Federal Register / Vol. 87, No. 87 / Thursday, May 5, 2022 / Rules and Regulations 26693 

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. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure to YCWs, including 

exposure resulting from the exemption 

established by this action. EPA’s 

assessment of exposures and risks 

associated with YCWs follows. 

A. Toxicological Profile 

YCWs are obtained by hydrolyzing 

intact yeast (Saccharomyces cerevisiae) 

cells. Given the long history of safe 

dietary exposure to strains of S. 

cerevisiae through their use in food, 

beverages, and nutritional supplements, 

YCWs are expected to be non-toxic. 

Although no toxicity information is 

available for YCWs, data from the major 

chemical components of YCWs (bglucan and mannan) are used to assess 

the safety of YCWs. 

The acute oral toxicity of b-glucan is 

low, with an LD50 >2,000 mg/kg. The 

repeated-dose toxicity for the major 

components of YCWs is low. No adverse 

effects were observed in subchronic 

studies in mice or rats or in a screening 

reproductive toxicity study in rats with 

b-glucan. 

No oral chronic or carcinogenicity 

studies are available for YCWs or its 

components. However, there is low 

concern for genotoxicity or 

mutagenicity, based on negative results 

in mammalian and bacterial 

genotoxicity tests with b-glucan and 

mannan. No evidence of neurotoxicity 

or immunotoxicity is seen in the 

available studies. 

B. Toxicological Points of Departure/ 

Levels of Concern 

No toxicological endpoint of concern 

for YCWs has been identified in the 

database. 

C. Exposure Assessment 

1. Dietary exposure. Dietary exposure 

(food and drinking water) may occur 

from the current pesticidal uses of cell 

walls of Saccharomyces cerevisiae 

strain LAS117 as well as the proposed 

pre-harvest use of YCWs in crops (e.g., 

eating foods treated with pesticide 

formulations containing YCWs, and 

drinking water exposures). Dietary 

exposure may also occur from nonpesticidal exposure (e.g. YCW dietary 

supplements). However, no endpoint of 

concern was identified. Therefore, a 

quantitative acute or chronic dietary 

exposure assessment is not necessary for 

YCWs. 

2. Residential exposure. The current 

pesticidal uses of cell walls of 

Saccharomyces cerevisiae strain 

LAS117 as well as the proposed preharvest use of YCWs in crops are not 

anticipated to result in residential 

exposure. Residential exposure may 

occur from non-pesticidal uses (e.g., 

skin care products). However, no 

toxicological endpoint of concern was 

identified. Therefore, a quantitative 

assessment for residential exposure was 

not performed. 

3. Cumulative effects from substances 

with a common mechanism of toxicity. 

Unlike pesticides for which EPA has 

followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

YCWs and any other substances, and 

YCWs do not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

action, therefore, EPA has assumed that 

YCWs do not have a common 

mechanism of toxicity with other 

substances. 

D. Safety Factor for 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 database unless 

EPA concludes that a different margin of 

safety will be safe for infants and 

children. As part of its qualitative 

assessment, the Agency did not use 

safety factors for assessing risk to YCWs, 

and no additional safety factor is needed 

for assessing risk to infants and 

children. Based on the low toxicity in 

the available studies, EPA has 

concluded that there are no 

toxicological endpoints of concern for 

the U.S. population, including infants 

and children. 

E. Aggregate Risks and Determination of 

Safety 

Taking into consideration all available 

information on YCWs, EPA has 

determined that there is a reasonable 

certainty that no harm to the general 

population or any population subgroup, 

including infants and children, will 

result from aggregate exposure to YCW 

residues. Therefore, the establishment of 

an exemption from the requirement of a 

tolerance under 40 CFR 180.920 for 

residues of YCWs when used as a carrier 

inert ingredient in pesticide 

formulations in pre-harvest applications 

to crops is safe under FFDCA section 

408. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is not establishing a numerical 

tolerance for residues of YCWs in or on 

any food commodities. 

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 

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

Codex is a joint United Nations Food 

and Agriculture Organization/World 

Health Organization food standards 

program, and it is recognized as an 

international food safety standardssetting 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 YCWs. 

VI. Conclusion 

Taking into consideration all available 

information on YCWs, EPA has 

determined that there is a reasonable 

certainty that no harm to the general 

population or any population subgroup, 

including infants and children, will 

result from aggregate exposure to YCW 

residues. Therefore, an exemption from 

the requirement of a tolerance is 

established under 40 CFR 180.920 for 

YCWs when used as an inert ingredient 

(carrier) in pesticide formulations. 

VII. Statutory and Executive Order 

Reviews 

This action establishes an exemption 

from the requirement of a tolerance 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. 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 


lotter on DSK11XQN23PROD with RULES1
26694 Federal Register / Vol. 87, No. 87 / Thursday, May 5, 2022 / Rules and Regulations 

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 (PRA) (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 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 action 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 FFDCA 

section 408(n)(4). 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. 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 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 (UMRA) (2 U.S.C. 1501 et 

seq.). 

This action does not 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 

(NTTAA) (15 U.S.C. 272 note). 

VIII. 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 29, 2022. 

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 § 180.920, amend Table 1 to 

180.920 by adding in alphabetical order 

an entry for ‘‘Cell Walls of 

Saccharomyces cerevisiae’’ to read as 

follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

TABLE 1 TO 180.920 

Inert ingredients Limits Uses 

* * * * * 

Cell Walls of Saccharomyces cerevisiae................. Carrier. 

* * * * * 

[FR Doc. 2022–09622 Filed 5–4–22; 8:45 am] 

BILLING CODE 6560–50–P 


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