Federal Register / Vol. 87, No. 87 / Thursday, May 5, 2022 / Rules and Regulations 26687 

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 

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). 

X. 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 ‘‘Trans-anethole (CAS Reg. 

No. 4180–23–8)’’ 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 

*******

Trans-anethole (CAS Reg. No. 4180–23–8) ............................ Not to exceed 3% in pesticide formulations ............................. Fragrance. 

*******

[FR Doc. 2022–09621 Filed 5–4–22; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2018–0204; FRL–9556–01– 

OCSPP] 

Hydrolyzed Vegetable Proteins From 

Soy; 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 hydrolyzed 

vegetable proteins from soy when used 

as an inert ingredient (pH adjusting 

agent, surfactant, or adhesive) in 

pesticide products applied to growing 

crops pre-harvest, limited to 25% in the 

pesticide formulation. SciReg, Inc. on 

behalf of Italpollina USA, Inc. submitted 

a petition to EPA under the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

requesting establishment of an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of 

hydrolyzed vegetable proteins from soy 

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–2018–0204, is 


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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. 

Due to the public health concerns 

related to COVID–19, the EPA Docket 

Center (EPA/DC) and Reading Room is 

open to visitors by 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. 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–2018–0204 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– 

2018–0204, 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 April 19, 

2019 (84 FR 16430) (FRL–9991–14), 

EPA issued a document pursuant to 

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

announcing the filing of a pesticide 

petition (PP IN–11079) by SciReg, Inc. 

(12733 Director’s Loop, Woodbridge, VA 

22192) on behalf of Italpollina USA, Inc. 

(name changed to Hello Nature USA, 

Inc.) (1100 South Tower, 225 Peachtree 

Street NE, Atlanta, GA 30303). The 

petition requested that 40 CFR 180.920 

be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of hydrolyzed 

vegetable proteins when used as an inert 

ingredient (pH adjusting agent, 

surfactant, or adhesive) in pesticide 

products applied to growing crops preharvest under 40 CFR 180.920. That 

document referenced a summary of the 

petition prepared by SciReg, Inc. on 

behalf of Italpollina USA, Inc., the 

petitioner, which is available in the 

docket ID number EPA–HQ–OPP–2018– 

0204, https://www.regulations.gov. 

There were no relevant comments 

received in response to the notice of 

filing. The petitioner subsequently 

requested a limitation of not more than 

25% hydrolyzed vegetable proteins from 

soy in pesticide formulations for use 

under 40 CFR 180.920. 

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 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 tolerance 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. 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 a 

tolerance 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 clearly 


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demonstrated 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. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for hydrolyzed 

vegetable proteins from soy including 

exposure resulting from the exemption 

established by this action. EPA’s 

assessment of exposures and risks 

associated with hydrolyzed vegetable 

proteins from soy follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

validity, completeness, and reliability as 

well as the relationship of the results of 

the studies 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. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by hydrolyzed vegetable proteins from 

soy as well as the no-observed-adverseeffect-level (NOAEL) and the lowestobserved-adverse-effect-level (LOAEL) 

from the toxicity studies can be found 

at http://www.regulations.gov in the 

document titled ‘‘Hydrolyzed Vegetable 

Proteins from Soy; Human Health Risk 

Assessment and Ecological Effects 

Assessment to Support Proposed 

Exemption from the Requirement of a 

Tolerance When Used as an Inert 

Ingredient in Pesticide Formulations’’ in 

docket ID number EPA–HQ–OPP–2018– 

0204. 

Hydrolyzed vegetable proteins (also 

referred to as vegetable hydrolysates) are 

produced through hydrolysis of proteins 

derived from plants such as soybeans, 

peas, corn, alfalfa, potatoes or 

chickpeas. This process breaks the 

protein down to small peptides, reduces 

the molecular weight of the original 

protein and reduces the antigenicity and 

allergenicity of the protein. It is 

expected that systemic toxicity is 

similar for all hydrolyzed vegetable 

proteins regardless the vegetable source. 

Since toxicity data on hydrolyzed 

vegetable proteins from soy are limited, 

toxicity data on hydrolyzed vegetable 

proteins from various sources are used 

to bridge data gaps. Acute and repeated 

dose toxicity studies summarized were 

conducted with a variety of hydrolyzed 

vegetables including soybean, potatoes, 

lupine, avocado, casein and hemp seed 

meal. 

Acute toxicity studies conducted with 

vegetable hydrolysates from various 

vegetables are limited. The acute oral 

toxicity is low in rats treated with soy 

protein hydrolysates (also known as 

hydrolyzed vegetable protein from soy). 

The lethal dose, LD50 is >5,000 

milligrams per kilogram bodyweight 

(mg/kg). Vegetable hydrolysates from 

soy and lupine proteins do not cause 

skin irritation in rabbits. In vitro studies 

with human skin show no irritation 

with vegetable hydrolysates from 

potatoes. No eye irritation is observed in 

rabbits treated with vegetable 

hydrolysates from soy, nor in in vitro 

studies with human cornea treated with 

vegetable hydrolysates from potatoes. 

Slight eye irritation is observed in 

rabbits treated with vegetable 

hydrolysates from lupine. Vegetable 

hydrolysates from avocado and lupine 

proteins are not dermal sensitizers in 

the mouse local lymph node assay 

(LLNA) or the guinea pig maximization 

test, respectively. 

An 8-week oral toxicity study in rats 

treated with hydrolysates from hemp 

seed meal show no adverse effects up to 

1,000 milligrams/kilogram/day (mg/kg/ 

day), the limit dose. Also, no toxicity is 

seen in rats treated with approximately 

20,000 mg/kg/day of hydrolysates from 

Lupinus albus and L. luteus for 112 days 

via the diet. 

No developmental, reproduction or 

carcinogen toxicity studies are available 

for review. However, as stated above, no 

toxicity is seen in repeated dose studies 

with hydrolysates of vegetable proteins 

in rats up to 20,000 mg/kg/day. No 

evidence of neurotoxicity or 

immunotoxicity is seen in the available 

studies. 

Mutagenicity studies are available 

with hydrolyzed vegetable protein from 

potato, lupine and pea proteins. Ames 

tests conducted with these hydrolyzed 

vegetable proteins were negative. 

Therefore, hydrolyzed vegetable 

proteins are not expected to be 

mutagenic. 

To assess the immunologic response 

against hydrolyzed vegetable proteins 

from soy, dogs were sensitized to nonhydrolyzed soy protein over a 90-day 

period then were exposed to either nonhydrolyzed or hydrolyzed soy 

intradermally (30 days after 

sensitization) and orally (8 months after 

sensitization). Dogs intradermally 

exposed to hydrolyzed soy protein 

experienced an inflammatory response 

that was half the response detected after 

injection of non-hydrolyzed soy protein. 

Dogs orally exposed to hydrolyzed soy 

protein up to 17.75 grams over the 

course of 150 minutes did not 

experience clinical signs or reactions. 

While hydrolyzed vegetable proteins 

from soy are not toxic, there is a 

potential for allergenicity from soy 

proteins. The concern is low for the 

potential for allergenicity from 

hydrolyzed vegetable proteins from soy 

due to dietary exposure because the 

hydrolysis process breaks down the 

protein structure to reduce allergenicity 

to hydrolyzed vegetable proteins from 

soy. Enzymatic hydrolysis of soybean 

proteins is a common process used by 

industry to improve functional 

properties and has been used to reduce 

allergenicity in making hypoallergenic 

soybean products. Soybean products are 

well known products that have been 

used as food for a very long time. The 

methods for elimination of allergenicity 

are always the same: Denaturation by 

heat or pH change and hydrolysis by 

any means that degrade the protein 

structures. In the current petition, the 

proprietary method used to hydrolyze 

soybean proteins is such that no 

allergenic protein is expected to remain 

intact in the finished product. Although, 

the hydrolysis process is partial, any 

non-hydrolyzed soy proteins, which are 

those presenting a residual risk of 

allergenicity, are removed by 

centrifugation from the solution. 

To further demonstrate that the 

enzymatic hydrolysis of soy proteins is 

effective in reducing antigenicity and 

allergenicity, a Soy ELISA (enzymelinked immunosorbent assay) was 

conducted with hydrolyzed soy proteins 

extracted from soybean oil cake. The 

Soy ELISA test is a highly sensitive 

detection system used to detect soy 

residues in foodstuffs and has a level of 

quantification of 1.7 mg/kg soy. 

Through the detection of reactive robust 

indicator proteins called soy trypsin 

inhibitors, soy content and allergenic 

potential can be evaluated in test 

samples. The concentration of soy 

trypsin inhibitor proteins is directly 

proportional to the concentration of soy 


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in a test sample. No soy trypsin 

inhibitors were found in any samples of 

vegetable hydrolysates from soy, 

indicating a negative result for the 

presence of residual soy allergenic 

proteins in hydrolyzed vegetable 

proteins from soy within the LOQ of the 

ELISA assay. Although the LOQ for the 

ELISA test is 1.7 mg/kg of soy, the soy 

protein hydrolysates contain only 

hydrolyzed protein, which has been 

shown to have low allergenic potential 

as explained above. Therefore, there is 

low concern for allergenicity from soy 

protein hydrolysates at levels below the 

LOQ. 

Moreover, residues of hydrolyzed 

vegetable proteins from soy used in 

pesticide formulations in accordance 

with the tolerance exemption 

established in this action will be 

exposed to the effects of weather and 

microbial degradation before the treated 

crop enters the food chain. Therefore, 

based on the hydrolysis process, the 

negative ELISA assay and the expected 

effects of weather and microbial 

degradation, the concern is low for the 

potential allergenicity of hydrolyzed 

vegetable proteins from soy. 

B. Toxicological Points of Departure/ 

Levels of Concern 

The available toxicity studies indicate 

that vegetable hydrolysates from soy 

have very low overall toxicity. Since no 

toxicity is observed in the available 

studies, an endpoint of concern for risk 

assessment purposes was not identified. 

Therefore, a qualitative risk assessment 

was conducted for acute and chronic 

dietary exposures and short- and 

intermediate-term incidental oral, 

dermal and inhalation exposures. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to hydrolyzed vegetable 

proteins from soy, EPA considered 

exposure under the proposed exemption 

from the requirement of a tolerance and 

from existing uses. EPA assessed dietary 

exposures from hydrolyzed vegetable 

proteins from soy in food as follows. 

Dietary exposure (food and drinking 

water) to hydrolyzed vegetable proteins 

from soy may occur following ingestion 

of foods with residues from their use in 

accordance with this exemption. Dietary 

exposure may also occur after ingestion 

of food residues from their use in 

fertilizer products, dietary treatment for 

specific health conditions and use as a 

food additive (plant protein products) 

according to the U.S. Food and Drug 

Administration (FDA) under 21 CFR 

170.3(n)(33). However, a quantitative 

dietary exposure assessment was not 

conducted since a toxicological 

endpoint for risk assessment was not 

identified. 

2. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., textiles (clothing and diapers), 

carpets, swimming pools, and hard 

surface disinfection on walls, floors, 

tables). 

Hydrolyzed vegetable proteins from 

soy may be used in pesticide products 

and non-pesticide products that may be 

used in and around the home (e.g., for 

lawn and garden pest control, indoor 

pest control, cosmetics and personal 

care products). A quantitative 

residential exposure assessment was not 

conducted since a toxicological 

endpoint for risk assessment was not 

identified. 

3. 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.’’ 

Based on the lack of toxicity in the 

available data, hydrolyzed vegetable 

proteins from soy and its metabolites are 

not expected to share a common 

mechanism of toxicity with other 

chemicals; therefore, section 

408(b)(2)(D)(v) does not apply. 

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. Based on the lack of threshold 

effects, EPA has not identified any 

toxicological endpoints of concern and 

is conducting a qualitative assessment 

of hydrolyzed vegetable proteins from 

soy. The qualitative assessment does not 

use safety factors for assessing risk, and 

no additional safety factor is needed for 

assessing risk to infants and children. 

Based on an assessment of hydrolyzed 

vegetable proteins from soy, 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 hydrolyzed vegetable 

proteins from soy, EPA has determined 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children, 

from aggregate exposure to hydrolyzed 

vegetable proteins from soy residues. 

Therefore, the establishment of an 

exemption from the requirement of a 

tolerance under 40 CFR 180.920 for 

residues of hydrolyzed vegetable 

proteins from soy when used as an inert 

ingredient in pesticide formulations 

applied to growing crops pre-harvest 

limited to 25% in the final formulation, 

is safe under FFDCA section 408. 

V. Other Considerations 

Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is not establishing a numerical 

tolerance for residues of hydrolyzed 

vegetable proteins from soy in or on any 

food commodities. EPA is establishing a 

limitation on the amount of hydrolyzed 

vegetable proteins from soy that may be 

used in pesticide formulations applied 

to growing crops pre-harvest. This 

limitation will be enforced through the 

pesticide registration process under the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (‘‘FIFRA’’), 7 U.S.C. 

136 et seq. EPA will not register any 

such pesticide formulation that exceeds 

25% of hydrolyzed vegetable proteins 

from soy. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.920 for hydrolyzed 

vegetable proteins from soy when used 

as an inert ingredient (pH adjusting 

agent, surfactant, or adhesive) in 

pesticide formulations applied to 

growing crops pre-harvest limited to 

25% in the formulation. 

VII. Statutory and Executive Order 

Reviews 

This action establishes a tolerance 

exemption 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 


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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