Federal Register / Vol. 87, No. 7 / Tuesday, January 11, 2022 / Rules and Regulations 1363 

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 § 180.960, amend the table by 

adding in alphabetical order an entry for 

the polymer ‘‘Acetic acid ethenyl ester, 

polymer with ethene, N- 

(hydroxymethyl)-2-propenamide, and 2- 

propenamide, (AM–E–NMA–VA) 

minimum number average molecular 

weight (in amu), 5500’’ to read as 

follows: 

§ 180.960 Polymers; exemptions from the 

requirement of a tolerance. 

* * * * * 

TABLE 1 TO § 180.960 

Polymer CAS No. 

*******

Acetic acid ethenyl ester, polymer with ethene, N-(hydroxymethyl)-2-propenamide, and 2-propenamide, (AM–E– 

NMA–VA) minimum number average molecular weight (in amu), 5500.

CAS. Reg. No. 49603–78–3. 

* * * * * * * 

[FR Doc. 2022–00312 Filed 1–10–22; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2020–0038; FRL–9086–01– 

OCSPP] 

Trifloxystrobin; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of trifloxystrobin 

in or on multiple commodities which 

are identified and discussed later in this 

document. Bayer CropScience requested 

this tolerance under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

January 11, 2022. Objections and 

requests for hearings must be received 

on or before March 14, 2022, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2020–0038, 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: 

Marietta Echeverria, Acting Director, 

Registration Division (7505P), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW, Washington, DC 20460–0001; 

main telephone number: (703) 305– 

7090; 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 EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Office of the Federal Register’s eCFR 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–2020–0038 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 March 

14, 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– 

2020–0038, 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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1364 Federal Register / Vol. 87, No. 7 / Tuesday, January 11, 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/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. Summary of Petitioned-For 

Tolerances 

In the Federal Register of September 

10, 2020 (85 FR 55810) (FRL–10013–78), 

EPA issued a document pursuant to 

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

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

pesticide petition (PP 9E8792) by Bayer 

CropScience, 800 N Lindbergh Blvd., St. 

Louis, MO 63141. The petition 

requested that 40 CFR 180.555 be 

amended by establishing tolerances for 

residues of the fungicide trifloxystrobin 

in or on the following raw agricultural 

commodities: Caneberry, Crop Subgroup 

13–07A at 3.0 parts per million (ppm); 

Currant, black and red, at 4.0 ppm; 

Edible-Podded Legume Vegetables, Crop 

Subgroup 6A, at 1.5 ppm; Oil, olive, 

refined at 0.5 ppm; Pea, dry, seed at 0.2 

ppm; Succulent shelled pea and bean, 

Crop Subgroup 6B at 0.15 ppm; and 

Tropical and Subtropical, Small fruit, 

edible peel, Crop Subgroup 23A at 0.2 

ppm. That document referenced a 

summary of the petition prepared by 

Bayer CropScience, the petitioner, 

which is available in the docket for this 

action, docket ID number EPA–HQ– 

OPP–2020–0038, at https://

www.regulations.gov. Two comments 

were received on the notice of filing. 

EPA’s response to these comments is 

discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA is 

establishing tolerances for some 

commodities at different levels than 

requested by the petitioner and 

correcting some of the commodity 

definitions. Also, EPA is not 

establishing tolerances for two 

commodities. The reasons for these 

changes are explained in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish 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(b)(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. . . .’’ 

Consistent with FFDCA section 

408(b)(2)(D) and the factors specified 

therein, 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 

trifloxystrobin, including exposure 

resulting from the tolerances established 

by this action. EPA’s assessment of 

exposures and risks associated with 

trifloxystrobin follows. 

In an effort to streamline its 

publications in the Federal Register, 

EPA is not reprinting sections that 

repeat what has been previously 

published for tolerance rulemakings of 

the same pesticide chemical. Where 

scientific information concerning a 

particular chemical remains unchanged, 

the content of those sections would not 

vary between tolerance rulemakings, 

and EPA considers referral back to those 

sections as sufficient to provide an 

explanation of the information EPA 

considered in making its safety 

determination for the new rulemaking. 

EPA has previously published a 

number of tolerance rulemakings for 

trifloxystrobin, in which EPA 

concluded, based on the available 

information, that there is a reasonable 

certainty that no harm would result 

from aggregate exposure to 

trifloxystrobin and established 

tolerances for residues of that chemical. 

EPA is incorporating previously 

published sections of those rulemakings 

that remain unchanged, as described 

further in this rulemaking. Specific 

information on the risk assessment 

conducted in support of this action, 

including on the studies received and 

the nature of the adverse effects caused 

by trifloxystrobin, can be found in the 

document titled ‘‘Trifloxystrobin. 

Human Health Aggregate Risk 

Assessment for Use on Currant, Black 

and Red; Edible-Podded Legume 

Vegetables, Subgroup 6A; Succulent 

Shelled Pea and Bean, Subgroup 6B; 

Dried Shelled Pea; Caneberry, Subgroup 

13–07A; Tropical and Subtropical, 

Small Fruit, Edible Peel, Subgroup 23A 

without U.S. Registration.’’ dated 

September 29, 2021, which is available 

in the docket for this action at https:// 

www.regulations.gov. 

Toxicological profile. For a discussion 

of the Toxicological Profile of 

trifloxystrobin, see Unit III.A. of the 

trifloxystrobin tolerance rulemaking 

published in the Federal Register of 

February 15, 2019 (84 FR 4340) (FRL– 

9985–23) (Docket number EPA–HQ– 

OPP–2017–0530–0008). 

Toxicological points of departure/ 

Levels of concern. For a summary of the 

Toxicological Points of Departure/ 

Levels of Concern used for the safety 

assessment, see Unit III.B. of the 

February 15, 2019 rulemaking. 

Exposure assessment. Much of the 

exposure assessment remains the same 

since the February 15, 2019 rulemaking, 

although the new exposure assessment 

incorporates additional dietary 

exposures from the petitioned-for 

tolerances and reevaluates residential 

exposures based on approved label 

amendments. These updates are 

discussed in this section; for a 

description of the rest of EPA’s 

approach to and assumptions for the 

exposure assessment, including with 

respect to residue data, percent crop 

treated (PCT), processing factors, 

estimated drinking water 

concentrations, and the Agency’s 

conclusions about cumulative effects, 

see Unit III.C. of the February 15, 2019 

rulemaking. 

EPA’s acute and chronic dietary (food 

and drinking water) exposure 

assessments have been updated to 

include the additional exposure from 

residues of trifloxystrobin on the 

commodities identified in this action. 

The acute dietary assessment used the 

same assumptions described in the 

February 15, 2019 rulemaking 

concerning tolerance-level residues, 

100% CT and default processing factors. 

As described in the February 15, 2019 

rulemaking, the assumptions for the 

chronic dietary assessment included 

average field trial residues for selected 

crops, tolerance-level residues for all 

other crop commodities, default and 

empirical processing factors, and PCT 

data when available. Tolerance-level 

residues were used for the commodities 

identified in this action. 

In the new chronic dietary exposure 

assessment, EPA assumed average field 

trial residues for apples, rice and 

commodities in subgroups 4A, 4B, 5A, 

5B and 19A. The following average PCT 

estimates were used in the chronic 

dietary risk assessment for the crops for 

which trifloxystrobin is currently 

registered: Apples: 25%, apricots: 10%, 

cantaloupes 5%, carrots 2.5%, cotton: 


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10%, cherries: 25%, pop, sweet, and 

field corn: <2.5%, cucumbers: <2.5%, 

dry beans/peas: <1%, grapefruit: 30%, 

grapes: 25%; hazelnuts: 65%, oranges: 

5%, peaches: <2.5%, peanuts: 5%, 

pears: 10%, pecans: 15%, peppers: 5%, 

plums/prunes: <2.5%, potatoes: <1%, 

pumpkins: 5%, rice: 15%, soybeans: 

5%, squash: <2.5%, strawberries: 5%, 

sugar beets: 5%, sweet corn: <2.5%, 

tangerines: 5%, tomatoes: <2.5%, 

watermelons: 5%, and wheat: <2.5%. 

One hundred percent (100%) CT was 

assumed for the remaining 

commodities. Due to uncertainty in PCT 

data from California, PCT for almonds, 

walnuts, pistachio, celery, artichokes, 

and nectarine were set to 100%. 

Anticipated residue and percent crop 

treated information. Section 408(b)(2)(F) 

of FFDCA states that the Agency may 

use data on the actual percent of food 

treated for assessing chronic dietary risk 

only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, and the exposure 

estimate does not understate exposure 

for the population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

required by FFDCA section 408(b)(2)(F), 

EPA may require registrants to submit 

data on PCT. 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6 to 7 years. EPA uses an average 

PCT for chronic dietary risk analysis. 

The average PCT figure for each existing 

use is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

one. In those cases, 1% is used as the 

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a 100 PCT for 

acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency believes that Conditions 

a, b, and c discussed above have been 

met. With respect to Condition a, PCT 

estimates are derived from Federal and 

private market survey data, which are 

reliable and have a valid basis. The 

Agency is reasonably certain that the 

percentage of the food treated is not 

likely to be an underestimation. As to 

Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which trifloxystrobin may be applied in 

a particular area. 

Estimated drinking water 

concentrations have not changed since 

the February 15, 2019 rulemaking, 

because there will be no U.S. 

registrations for use of trifloxystrobin on 

the commodities identified in this 

action. The non-dietary (i.e., residential) 

exposure assessment reevaluated 

residential exposures and risk based on 

approved label amendments reflecting a 

lower representative single maximum 

application rate of 0.34 lb ai/A for 

products with residential turf use sites. 

There was no adverse systemic hazard 

via the dermal route of exposure. The 

updated residential post-application 

risk estimates for children 1 to less than 

2 years old were not of concern. 

Safety factor for infants and children. 

EPA continues to conclude that there is 

reliable data showing that the safety of 

infants and children is adequately 

protected if the Food Quality Protection 

Act (FQPA) safety factor is reduced from 

10X to 1X for all routes of exposure 

other than inhalation. The FQPA safety 

factor of 10X has been retained for 

inhalation endpoints only to account for 

the lack of the subchronic inhalation 

toxicity study for trifloxystrobin at this 

time. The reasons for this determination 

are articulated in Unit III.D. of the 

February 15, 2019 rulemaking. 

Assessment of aggregate risks. EPA 

determines whether acute and chronic 

dietary pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the acute population adjusted dose 

(aPAD) and chronic population adjusted 

dose (cPAD). Short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing the estimated aggregate food, 

water, and residential exposure to the 

appropriate points of departure (PODs) 

to ensure that an adequate margin of 

exposure (MOE) exists. For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. 

Acute dietary (food and drinking 

water) risks are below the Agency’s 

level of concern of 100% of the aPAD: 

They are 3.4% of the aPAD at the 95th 

percentile of exposure for females 13 to 

49 years old, which is the population 

subgroup with the highest exposure 

estimate. No other subpopulations were 

evaluated. Chronic dietary (food and 

drinking water) risks are below the 

Agency’s level of concern of 100% of 

the cPAD: They are 58% of the cPAD for 

infants less than 1 year old, which is the 

population subgroup with the highest 

exposure estimate. Moreover, the shortterm aggregate risk for the population 

subgroup with the highest total 

exposure (children 1 to less than 2 years 

old) is represented by an aggregate MOE 

of 120, which is not a risk of concern 

because EPA considers MOEs of 100 or 

less to be of concern; short-term 

aggregate risk calculations are protective 

of the intermediate-term duration of 

exposure. Chronic aggregate risk is 

equivalent to chronic dietary (food and 

drinking water) risk estimates, which 

are not of concern. Trifloxystrobin is 

classified as ‘‘not likely to be 

carcinogenic to humans’’ based on the 

absence of significant tumor increases in 

two adequate rodent carcinogenicity 

studies; therefore, cancer exposure and 

risk assessments were not conducted at 

this time. 

Determination of safety. Therefore, 

based on the risk assessments and 

information described above, EPA 

concludes there is a reasonable certainty 

that no harm will result to the general 

population, or to infants and children, 

from aggregate exposure to 

trifloxystrobin residues. More detailed 

information on the subject action to 

establish tolerances in or on Caneberry, 

subgroup 13–07A; Currant; Vegetable, 

legume, edible podded, subgroup 6A; 

Pea and bean, succulent shelled, 

subgroup 6B; and Tropical and 

subtropical, small fruit, edible peel, 

subgroup 23A can be found in the 

document entitled, ‘‘Trifloxystrobin. 

Human Health Aggregate Risk 

Assessment for Use on Currant, Black 

and Red; Edible-Podded Legume 


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Vegetables, Subgroup 6A; Succulent 

Shelled Pea and Bean, Subgroup 6B; 

Dried Shelled Pea; Caneberry, Subgroup 

13–07A; Tropical and Subtropical, 

Small Fruit, Edible Peel, Subgroup 23A 

without U.S. Registration.’’ dated 

September 29, 2021 at 

www.regulations.gov, under docket ID 

number EPA–HQ–OPP–2020–0038. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

For a discussion of the available 

analytical enforcement method, see Unit 

IV.A. of the February 15, 2019 

rulemaking. 

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 tolerances for trifloxystrobin are 

not harmonized with Codex for every 

commodity identified in this action. No 

Codex MRLs have been established for 

residues of trifloxystrobin in or on 

Caneberry, subgroup 13–07A and 

Currant. The U.S. tolerance level for 

Vegetable, legume, edible-podded, 

subgroup 6A (1.5 ppm), calculated using 

the Organisation for Economic Cooperation and Development (OECD) 

MRL procedure, is much higher than the 

Codex MRL (0.01 ppm), and thus 

harmonization is not possible. 

Similarly, the U.S. tolerance level for 

Pea and bean, succulent shelled, 

subgroup 6B (0.2 ppm) is much higher 

than the Codex MRL (0.01 ppm for lima 

beans only), and thus harmonization is 

not possible. The U.S. tolerance level for 

Tropical and subtropical, small fruit, 

edible peel, subgroup 23A, is 

harmonized with the Codex MRL 

established in or on olives, a member of 

subgroup 23A, at 0.3 ppm. 

C. Response to Comments 

We received two comments regarding 

this import tolerance. A comment was 

received on September 10, 2020 

regarding the absence of an analytical 

method and obtaining additional data. 

Analytical enforcement methodology is 

available for trifloxystrobin and is 

described in Unit IV.A. of the February 

15, 2019 rulemaking (84 FR 4340) (FRL– 

9985–23). A risk assessment was 

conducted by EPA based on the wellcharacterized toxicology database for 

this active ingredient, and no risks of 

concern were identified. Tolerances are 

being set based on residue data and 

calculations using the OECD MRL 

calculation procedures. 

An anonymous comment was 

received October 13, 2020, supporting 

the pesticide regulation. Upon 

consideration of the validity, 

completeness, and reliability of the 

available data as well as other factors 

the FFDCA requires EPA to consider, 

EPA has determined that the 

trifloxystrobin tolerances are safe. 

D. Revisions to Petitioned-For 

Tolerances 

The Agency is setting a tolerance for 

residues of trifloxystrobin in or on 

Caneberry, subgroup 13–07A at 2 ppm 

rather than the requested 3.0 ppm; in or 

on Currant at 3 ppm instead of the 

requested 4.0 ppm; and in or on Pea and 

bean, succulent shelled, subgroup 6B at 

0.2 ppm rather than the requested 0.15 

ppm based on values determined in 

accordance with the OECD MRL 

calculation procedures. A tolerance in 

or on Currant is being set rather than the 

petitioned-for ‘‘Currant, black and red’’ 

based on standard commodity 

definitions. Based on crop group 

revisions, the terminology Pea and bean, 

succulent shelled, subgroup 6B is used 

instead of the petitioned-for ‘‘Succulent 

shelled pea and bean, subgroup 6B’’ and 

Vegetable, legume, edible podded, 

subgroup 6A is used instead of the 

petitioned-for ‘‘Edible-podded legume 

vegetables, subgroup 6A.’’ The 

petitioned-for tolerance on ‘‘Pea, dry 

seed’’ is not being set because this 

commodity is covered by a tolerance 

that is already established for Pea and 

bean, dried shelled, except soybean, 

subgroup 6C. The tolerance in or on 

Tropical and subtropical, small fruit, 

edible peel, subgroup 23A tolerance is 

being set at 0.3 ppm rather than the 

petitioned-for 0.2 ppm to harmonize 

with the Codex MRL. The petitioned-for 

tolerance in or on Olive, oil is not being 

established because this commodity is 

covered by the tolerance established in 

this action for subgroup 23A. 

V. Conclusion 

Therefore, tolerances are established 

for residues of trifloxystrobin including 

its metabolites and degradates in or on 

Caneberry, subgroup 13–07A at 2 parts 

per million (ppm); Currant at 3 ppm; 

Pea and bean, succulent shelled, 

subgroup 6B at 0.2 ppm; Tropical and 

subtropical, small fruit, edible peel, 

subgroup 23A at 0.3 ppm; and 

Vegetable, legume, edible podded, 

subgroup 6A at 1.5 ppm. 

VI. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

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). 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 tolerances for residues 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 


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Federal Register / Vol. 87, No. 7 / Tuesday, January 11, 2022 / Rules and Regulations 1367 

1 42 U.S.C. 1320a–7d. 

2Section 1128B of the Act; 42 U.S.C. 1320a–7b(b). 

3The safe harbor regulations are set forth at 42 

CFR 1001.952. 

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). 

VII. 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 5, 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 § 180.555, amend the table in 

paragraph (a) by: 

■ a. Adding in alphabetical order the 

entries for ‘‘Caneberry, subgroup 13– 

07A’’; ‘‘Currant’’; ‘‘Pea and bean, 

succulent shelled, subgroup 6B’’; 

‘‘Tropical and subtropical, small fruit, 

edible peel, subgroup 23A’’; and 

‘‘Vegetable, legume, edible podded, 

subgroup 6A’’. 

■ b. Add footnote 4. 

The additions read as follows: 

§ 180.555 Trifloxystrobin; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

*******

Caneberry, subgroup 13–07A4 ........................................................................................................................................................... 2 

*******

Currant 4 ............................................................................................................................................................................................... 3 

*******

Pea and bean, succulent shelled, subgroup 6B4 ............................................................................................................................... 0.2 

* * * * * * * 

Tropical and subtropical, small fruit, edible peel, subgroup 23A4 ...................................................................................................... 0.3 

*******

Vegetable, legume, edible podded, subgroup 6A4 ............................................................................................................................. 1.5 

*******

3 ******* 4There are no U.S. registrations on this commodity as of January 11, 2022. 

* * * * * 

[FR Doc. 2022–00311 Filed 1–10–22; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of Inspector General 

42 CFR Part 1008 

Medicare and State Health Care 

Programs: Fraud and Abuse; 

Procedures Regarding the Submission 

of Advisory Opinion Requests to, and 

the Issuance of Advisory Opinions by, 

OIG 

AGENCY: Office of Inspector General 

(OIG), Department of Health and Human 

Services (HHS). 

ACTION: Final rule. 

SUMMARY: OIG is amending the 

regulations governing the procedures for 

the submission of advisory opinion 

requests to, and the issuance of advisory 

opinions by, OIG. 

DATES: This final rule is effective 

February 10, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Christina Hinkle, Office of Counsel to 

the Inspector General, (202) 465–6245. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Pursuant to section 1128D of the 

Social Security Act (the Act),1 HHS, 

through OIG, publishes advisory 

opinions regarding the application of 

the Federal anti-kickback statute 2 and 

the safe harbor provisions, as well as 

OIG’s administrative sanction 

authorities, to parties’ proposed or 

existing arrangements. More 

specifically, in consultation with the 

Department of Justice (DOJ) OIG issues 

written advisory opinions to requesting 

parties with regard to: (1) What 

constitutes prohibited remuneration 

under the Federal anti-kickback statute; 

(2) whether an arrangement or proposed 

arrangement satisfies the criteria in 

section 1128B(b)(3) of the Act, or 

established by regulation (i.e., safe 

harbors),3 for activities that do not result 

in prohibited remuneration; (3) what 

constitutes an inducement to reduce or 


khammond on DSKJM1Z7X2PROD with RULES