26684 Federal Register / Vol. 87, No. 87 / Thursday, May 5, 2022 / Rules and Regulations 

Commenced Construction On or Before 

December 9, 2004, adopted April 28, 

2009. 

(ii) [Reserved] 

[FR Doc. 2022–09195 Filed 5–4–22; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2018–0090; FRL–9763–01– 

OCSPP] 

Trans-Anethole; 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 trans-anethole 

(CAS No. 4180–23–8) when used as a 

fragrance inert ingredient in pesticide 

formulations at a concentration of 3% of 

the formulation in pre-harvest 

applications to crops. Landis 

International, Inc., on behalf of Morse 

Enterprises Limited, Inc. d/b/a KeyPlex 

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 trans-anethole (CAS No. 

4180–23–8) 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–2018–0090, 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 

closed to visitors with limited 

exceptions. The staff continues to 

provide remote customer service via 

email, phone, and webform. For the 

latest status information on EPA/DC 

services and docket access, visit https:// 

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Marietta Echeverria, Registration 

Division (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 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–2018–0090 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– 

2018–0090, 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 11, 

2018 (83 FR 15528) (FRL–9975–57), 

EPA issued a document pursuant to 

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

announcing the receipt of a pesticide 

petition (PP IN–11093) filed by Landis 

International, Inc., on behalf of Morse 

Enterprises Limited, Inc. d/b/a KeyPlex 

(P.O. Box 2515, Winter Park, FL 32790). 

The petition requested that 40 CFR 

180.920 be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of trans-anethole 

(CAS No. 4180–23–8) when used as a 

fragrance inert ingredient in pesticide 

formulations at a concentration of 3% of 

the formulation when applied preharvest 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 


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Federal Register / Vol. 87, No. 87 / Thursday, May 5, 2022 / Rules and Regulations 26685 

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 

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 trans-anethole, 

including exposure resulting from the 

exemption established by this action. 

EPA’s assessment of exposures and risks 

associated with trans-anethole follows. 

A. Toxicological Profile 

Trans-anethole has low acute toxicity 

via the oral, dermal, and inhalation 

routes, and it is not an eye or dermal 

irritant, nor a skin sensitizer. In 

repeated-dose toxicity studies, the liver 

was the major target organ, with nonspecific effects such as changes in body 

weight and food consumption also 

observed in multiple studies. There is 

no evidence of offspring susceptibility 

in the available developmental toxicity 

study or in the 2-generation 

reproductive toxicity study. The 

offspring effects observed in the 

developmental toxicity study occurred 

at doses higher than those in which 

maternal toxicity was observed. The 

uterine findings described in the 90-day 

oral study occurred only at the highest 

dose tested and have a clear no observed 

adverse effect level (NOAEL). No effects 

on reproductive parameters were 

observed in the 2-generation 

reproductive toxicity study. Concern for 

carcinogenicity is low, based on 

negative results in mutagenicity and 

genotoxicity studies and lack of 

biological significance of the neoplastic 

effects observed in females only at the 

highest dose tested in the chronic/ 

carcinogenicity study. There is no 

evidence of neurotoxicity or 

immunotoxicity in the available studies. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern (LOCs) to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see https://

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

An acute dietary endpoint was not 

selected because no effect attributable to 

a single dose was identified in the 

database. The chronic dietary, 

incidental oral, dermal and inhalation 

endpoints are all selected from the 

developmental toxicity study in rats, 

with a NOAEL of 35 mg/kg/day and a 

LOAEL of 175 mg/kg/day, based on 

decreases in maternal body weight and 

food consumption. 

C. Exposure Assessment 

1. Dietary exposure. Dietary exposure 

(food and drinking water) may occur 

from the existing (non-food) and 

proposed uses of trans-anethole (e.g., 

eating foods treated with pesticide 

formulations containing trans-anethole, 

and drinking water exposures). There is 

also potential for non-pesticide dietary 

exposure since trans-anethole is a 

natural constituent of several food 

commodities (anise, fennel, thyme, 

cinnamon, clove bud, nutmeg, pepper, 

coriander seed, and dill seed) and is 

also used as a food additive (flavoring 

agent). An acute dietary assessment was 

not performed due to the lack of adverse 

effects attributed to a single dietary 

exposure. The chronic dietary exposure 

for food and drinking water utilized 

14.6% of the chronic PAD (cPAD) for 

the U.S. population and 43.4% of the 

cPAD for children 1 to 2 years old, the 

most highly exposed population. 

Therefore, chronic dietary risks are not 

of concern, because they are less than 

100% of the cPAD. 

2. Residential exposure. The proposed 

pre-harvest use of trans-anethole in 

crops is not anticipated to result in 

residential exposure. Residential 

exposure to trans-anethole may occur 

from existing non-food pesticide uses as 


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26686 Federal Register / Vol. 87, No. 87 / Thursday, May 5, 2022 / Rules and Regulations 

well as from non-pesticide products that 

may be used in and around the home, 

such as toiletries. For residential 

handler short-term exposure scenarios, 

MOEs ranged from 540 to 4,900,000, 

which are greater than the LOC of 100 

and therefore are not of concern. 

Residential handler intermediate-term 

and long-term exposures are not 

expected because applications are not 

expected to occur daily or for more than 

30 days. For residential post-application 

exposure scenarios (short- and 

intermediate-term), MOEs ranged from 

1,100 to 16,000,000, which are greater 

than the LOC of 100 and therefore are 

not of concern. 

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 

trans-anethole and any other 

substances, and trans-anethole does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this action, therefore, EPA 

has assumed that trans-anethole does 

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. Based on the evaluation of 

available toxicity studies, there is low 

concern for pre- and postnatal 

susceptibility for infants and children 

from exposure to trans-anethole. The 

FQPA safety factor has been reduced to 

1X because: (1) The toxicity database is 

adequate to characterize potential preand postnatal risk for infants and 

children; (2) no effects on reproductive 

organs or reproductive parameters were 

observed in the available reproduction 

toxicity study; (3) the developmental 

effects observed occurred at doses above 

which maternal effects were seen, with 

clear NOAELs; (4) no evidence of 

neurotoxicity was observed in the 

database; and (5) the assumptions for 

the exposure assessment are unlikely to 

underestimate risk. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

cPAD. For linear cancer risks, EPA 

calculates the lifetime probability of 

acquiring cancer given the estimated 

aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute aggregate risk. An acute 

aggregate risk assessment takes into 

account exposure estimates from acute 

dietary consumption of food and 

drinking water. However, there was no 

hazard attributable to a single exposure 

seen in the toxicity database for transanethole. Therefore, trans-anethole is 

not expected to pose an acute aggregate 

risk. 

2. Short-term aggregate risk. Shortterm aggregate exposure takes into 

account short-term residential (dermal 

and inhalation) exposure plus chronic 

dietary exposure (food and drinking 

water). The short-term aggregate MOE is 

490 for adults and 190 for children, 

which are greater than the LOC of 100 

and therefore are not of concern. 

3. Intermediate-term aggregate risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential (dermal and inhalation) 

exposure plus chronic dietary exposure 

(food and drinking water). The 

intermediate-term aggregate MOE is 710 

for adults and 190 for children, which 

are greater than the LOC of 100 and 

therefore are not of concern. 

4. Chronic aggregate risk. A chronic 

aggregate risk assessment takes into 

account exposure estimates from 

chronic dietary consumption of food 

and drinking water. The chronic 

aggregate risk is equal to the chronic 

dietary risk and is not of concern. 

5. Aggregate cancer risk for U.S. 

population. EPA has not identified any 

concerns for carcinogenicity relating to 

trans-anethole. Therefore, a cancer 

aggregate assessment was not 

conducted. 

6. Determination of safety. Taking 

into consideration all available 

information on trans-anethole, 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 transanethole residues. Therefore, the 

establishment of an exemption from the 

requirement of a tolerance under 40 CFR 

180.920 for residues of trans-anethole 

when used as a fragrance inert 

ingredient in pesticide formulations 

applied pre-harvest to crops at a 

concentration of 3% of the formulation 

can be considered assessed as safe 

under section 408 of the FFDCA. 

VII. 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 trans-anethole 

in or on any food commodities. EPA is 

establishing a limitation on the amount 

of trans-anethole that may be used in 

pesticide formulations applied preharvest. 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 pesticide formulation 

for food use that exceeds 3% transanethole in the final pesticide 

formulation. 

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 trans-anethole. 

VIII. Conclusion 

Taking into consideration all available 

information on trans-anethole, 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 transanethole residues. Therefore, an 

exemption from the requirement of a 

tolerance is established under 40 CFR 

180.920 for trans-anethole when used as 

an inert ingredient at no more than 3% 

of the total pesticide formulation. 

IX. Statutory and Executive Order 

Reviews 

This action establishes an exemption 

from the requirement of a tolerance 


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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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