Federal Register / Vol. 87, No. 40 / Tuesday, March 1, 2022 / Rules and Regulations 11315 

TABLE 1 TO 180.920 

Inert ingredients Limits Uses 

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Adipic acid (CAS Reg. No. 124–04–9) ............. ........................................................................... Acidification or buffering agent; pH regulator 

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[FR Doc. 2022–04077 Filed 2–28–22; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2020–0225; FRL–8572–01– 

OCSPP] 

Ipflufenoquin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of ipflufenoquin 

in or on almond, almond, hulls, and 

fruit, pome, group 11–10. Nippon Soda 

Co., Ltd. requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

March 1, 2022. Objections and requests 

for hearings must be received on or 

before May 2, 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–2020–0225, 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, 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, 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–2020–0225 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 May 

2, 2022. Addresses for mail and hand 

delivery of objections and hearing 

requests are provided in 40 CFR 

178.25(b). 

Despite the regulatory instructions to 

submit objections or hearing requests 

via U.S. Mail or hand delivery, EPA 

strongly encourages those interested in 

submitting objections or a hearing 

request, to submit objections and 

hearing requests electronically. See 

Order Urging Electronic Service and 

Filing (April 10, 2020), https://

www.epa.gov/sites/production/files/ 

2020-05/documents/2020-04-10_-_

order_urging_electronic_service_and_

filing.pdf. At this time, because of the 

COVID–19 pandemic, the judges and 

staff of the Office of Administrative Law 

Judges are working remotely and not 

able to accept filings or correspondence 

by courier, personal deliver, or 

commercial delivery, and the ability to 

receive filings or correspondence by 

U.S. Mail is similarly limited. When 

submitting documents to the U.S. EPA 

Office of Administrative Law Judges 

(OALJ), a person should utilize the 

OALJ e-filing system, at https://

yosemite.epa.gov/OA/EAB/EAB-ALJ_

upload.nsf. 

Although EPA’s regulations require 

submission via U.S. Mail or hand 

deliver, EPA intends to treat 

submissions filed via electronic means 

as properly filed submissions during 

this time that the Agency continues to 

maximize telework due to the 

pandemic; therefore, EPA believes the 

preference for submission via electronic 

means will not be prejudicial. If it is 

impossible for a person to submit 

documents electronically or receive 

service electronically, e.g., the person 

does not have any access to a computer, 

the person shall so advise OALJ by 

contacting the Hearing Clerk at (202) 

564–6281. If a person is without access 

to a computer and must file documents 

by U.S. Mail, the person shall notify the 

Hearing Clerk every time it files a 

document in such a manner. The 

address for mailing documents is U.S. 

Environmental Protection Agency, 

Office of Administrative Law Judges, 


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Mail Code 1900R, 1200 Pennsylvania 

Ave. NW, Washington, DC 20460. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2020–0225, 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/contacts.html. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of May 29, 

2020 (85 FR 32338) (FRL–10009–84), 

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 9F8801) by 

Nippon Soda Co., Ltd., Shin-Ohtemachi 

Bldg. 2–1, 2–Chome Ohtemachi 

Chiyoda-ku, Tokyo 100–8165, Japan. 

The petition requested that 40 CFR part 

180 be amended by establishing 

tolerances for residues of the fungicide 

ipflufenoquin, 2-[2-(7,8-difluoro-2- 

methylquinolin-3-yloxy)-6- 

fluorophenyl]propan-2-ol, in or on 

almond at 0.10 ppm; almond hulls at 3.0 

ppm; and pome fruit (Crop Group 11– 

10) at 0.15 ppm; and tolerances for 

residues for ipflufenoquin, QP–1–14, 

QP–1–10, QP–1–11, and QP–1–15 (in 

terms of ipflufenoquin) on cattle, fat at 

0.010 ppm; cattle, meat at 0.01 ppm; 

cattle, meat byproducts at 0.010 ppm; 

dairy cattle milk at 0.01 ppm; goat, fat 

at 0.010 ppm; goat, meat at 0.01 ppm; 

goat, meat byproducts at 0.010 ppm; 

horse, fat at 0.010 ppm; horse, meat at 

0.01 ppm; horse, meat byproducts at 

0.010 ppm; sheep, fat at 0.010 ppm; 

sheep, meat at 0.01 ppm; and sheep, 

meat byproducts at 0.010 ppm. That 

document referenced a summary of the 

petition prepared by Nippon Soda Co., 

Ltd., the registrant, which is available in 

the docket, https://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

concluded that tolerances for residues of 

ipflufenoquin in livestock commodities 

are not needed and is establishing the 

tolerances for almond, almond hulls, 

and pome fruit with several minor 

adjustments. The reasons for these 

changes are explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of 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 in 

FFDCA section 408(b)(2)(D), 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 ipflufenoquin 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with ipflufenoquin follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its 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. 

The primary targets of ipflufenoquin 

in rodents are teeth, the liver, thyroid, 

hematological system, and intestines. 

Tooth effects included discoloration, 

enamel hypoplasia, dysplasia and 

abrasion of the incisors. Liver effects 

included changes in liver weight and 

histopathological changes (increased 

single cell necrosis, bile duct 

hyperplasia, and hepatocellular mitotic 

figures). Thyroid effects were limited to 

follicular cell hypertrophy. Effects in 

the hematological system included 

decrease in red blood cells, hemoglobin 

and hematocrits, and increases in spleen 

weight, prothrombin time and 

erythropoiesis of the spleen. However, 

these hematological effects were 

considered mild and occurred at the 

same or higher doses than the tooth 

effects. Intestinal findings included 

black content, minimal cellular 

infiltration in the lamina propria of the 

colon, minimal hyperplasia epithelium 

and minimal regeneration of the surface 

epithelium in the colon. Intestinal and 

thyroid effects occurred at the same 

doses where tooth effects were observed 

only in the subchronic studies in rats. 

Tooth effects including discoloration, 

enamel hypoplasia, dysplasia and 

abrasion of the incisors were observed 

throughout the ipflufenoquin database 

in rodents only. The toxicology database 

showed no adverse toxicological effects 

were observed in dogs. 

Potential signs of neurotoxicity were 

observed in the acute neurotoxicity 

(ACN) study, but only in one sex at the 

highest doses. No changes in motor 

activity were observed in a 13-week oral 

study in rats. No developmental or 

maternal effects were reported in the 

developmental studies in rats and 

rabbits. No treatment-related 

reproductive effects were reported in 

the reproductive toxicity study in rats. 

Decreased pup body weight was 

observed at the same doses where 

parental toxicity was observed. 

Although no immunotoxicity study is 

available for ipflufenoquin, no evidence 

of immunotoxicity was observed in 

other submitted studies. No systemic 

toxicity was observed in a dermal study 

in rats up to the limit dose. 

Ipflufenoquin is classified as ‘‘Not likely 

to be carcinogenic to humans’’. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by ipflufenoquin as well 

as the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at https:// 

www.regulations.gov in document 

‘‘Ipflufenoquin. Human Health Risk 


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Assessment for Proposed Section 3 

Registration of the New Active 

Ingredient for Uses on Pome Fruit (Crop 

Group 11–10) and Almond.’’ 

(hereinafter ‘‘Ipflufenoquin Human 

Health Risk Assessment’’) at page 37 in 

docket ID number EPA–HQ–OPP–2020– 

0225. 

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 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://

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticide. 

A summary of the toxicological 

endpoints for ipflufenoquin used for 

human risk assessment can be found in 

the Ipflufenoquin Human Health Risk 

Assessment. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to ipflufenoquin, EPA 

considered exposure under the 

petitioned-for tolerances. EPA assessed 

dietary exposures from ipflufenoquin in 

food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. 

No such effects were identified in the 

toxicological studies for ipflufenoquin; 

therefore, a quantitative acute dietary 

exposure assessment is unnecessary. An 

acute dietary exposure assessment was 

not required because no endpoint 

attributable to a single dose was 

identified in the ipflufenoquin database. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used the 2003–2008 

food consumption data from the United 

States Department of Agriculture’s 

(USDA) National Health and Nutrition 

Examination Survey, What We Eat in 

America. EPA conducted an unrefined 

chronic dietary exposure assessment 

using tolerance-level residues, 100% 

crop treated assumptions, the Agency’s 

2018 default processing factors, and 

empirical processing factors where 

available. 

iii. Cancer. Based on its review of 

available data, EPA has concluded that 

ipflufenoquin is not likely to be 

carcinogenic. Therefore, a dietary 

exposure assessment for the purpose of 

assessing cancer risk is unnecessary. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue or PCT 

information in the dietary assessment 

for ipflufenoquin. 

2. Dietary exposure from drinking 

water. The Agency used screening-level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for ipflufenoquin in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

ipflufenoquin. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at https://www2.epa.gov/ 

pesticide-science-and-assessingpesticide-risks/about-water-exposuremodels-used-pesticide. 

Based on the Tier II Exposure Model 

Pesticide in Water Calculator (PWC) 

(v1.52, Feb. 23, 2016), the estimated 

drinking water concentrations (EDWCs) 

of ipflufenoquin for acute exposures are 

estimated to be 3.71 parts per billion 

(ppb) for surface water and 53.6 ppb for 

ground water. For chronic exposures for 

non-cancer assessments are estimated to 

be 1.28 ppb for surface water and 49.1 

ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration of value 49.1ppb 

was used to assess the contribution to 

drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Ipflufenoquin is not being registered for 

any specific use patterns that would 

result in residential exposure. 

4. 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.’’ 

Unlike other 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 

ipflufenoquin and any other substances, 

and ipflufenoquin does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

not assumed that ipflufenoquin has a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s website at https:// 

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) 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 on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

Food Quality Protection Act (FQPA) 

Safety Factor (SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

No evidence of increased quantitative or 

qualitative susceptibility was seen in rat 

and rabbit developmental toxicity 

studies. Decreased pup body weight was 

observed in the reproduction study only 

in the presence of parental toxicity. 

Subchronic oral toxicity studies indicate 


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tooth discoloration and enamel 

hypoplasia in rats exposed to 

ipflufenoquin. Children are considered 

the most susceptible population to the 

tooth effects since dental enamel 

development and formation occurs 

during childhood. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

ipflufenoquin is adequate to 

characterize the pre- and postnatal risk 

for infants and children. 

ii. There is evidence of potential 

neurotoxicity (decreased motor activity) 

in the ipflufenoquin database in the 

ACN study. However, concern is low 

because: The observed effects are well 

characterized, with clear NOAELs; they 

occur only at the highest doses tested; 

and the PODs are based on the most 

sensitive effects and are protective of 

any potential neurotoxicity. 

iii. In the 2-generation reproduction 

study in rats, there were no 

reproductive effects observed, and 

offspring toxicity was observed only in 

the presence of parental toxicity. 

Although potential signs of 

neurotoxicity were observed in the ACN 

study, clear NOAELs/LOAELs are 

established, and effects occurred at high 

doses that are not relevant for risk 

assessment purposes. Moreover, 

although children are more susceptible 

to the tooth effects seen in the database, 

the PODs selected for risk assessment 

purposes are protective of the offspring 

and potential effects seen in the 

database. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to ipflufenoquin 

in drinking water. These assessments 

will not underestimate the exposure and 

risks posed by ipflufenoquin. 

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 

chronic PAD (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 risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, ipflufenoquin is not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to ipflufenoquin 

from food and water will utilize less 

than 1% of the cPAD for the general 

U.S. population and all population 

subgroups. There are no residential uses 

for ipflufenoquin. 

3. Short- and intermediate-term risk. 

Short-term aggregate exposure takes into 

account short-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). Short- and 

intermediate-term adverse effects were 

identified; however, ipflufenoquin is 

not being proposed to be registered for 

any use patterns that would result in 

either short- or intermediate-term 

residential exposure. Short- and 

intermediate-term risk is assessed based 

on short- and intermediate-term 

residential exposure plus chronic 

dietary exposure. Because there is no 

short- or intermediate-term residential 

exposure and chronic dietary exposure 

has already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess short-term risk), no further 

assessment of short- or intermediateterm risk is necessary, and EPA relies on 

the chronic dietary risk assessment for 

evaluating short- and intermediate-term 

risk for ipflufenoquin. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

ipflufenoquin is not expected to pose a 

cancer risk to humans. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to 

ipflufenoquin residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

The petitioner has proposed an 

adequate analytical method, Method No. 

P 3996 G, adapted from the multiresidue method (quick, easy, cheap, 

effective, rugged and safe; QuEChERS; 

Method No. EN 15662:2009–02) for the 

determination of ipflufenoquin in plant 

commodities. For livestock 

commodities, adequate enforcement 

methodology, Method No. NCAS 18– 

290 (adapted from QuEChERS multiresidue enforcement method EN 15662), 

using high-performance liquid 

chromatography with tandem mass 

detection (HPLC/MS–MS) is available 

for determination of residues of 

ipflufenoquin. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

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). 

The Codex has not established any 

MRLs for ipflufenoquin. 

C. Revisions To Petitioned-For 

Tolerances 

Based on the feeding study and the 

dietary burden estimates, EPA 

concludes that there is no reasonable 

expectation of finite residues in 

livestock commodities as a result of 

eating treated feedstuff (40 CFR 

180.6(a)(3)). Therefore, tolerances for 

residues of ipflufenoquin in livestock 

commodities are not needed. 

Additionally, EPA corrected the pome 

fruit crop group commodity definition 

and is establishing the tolerance level 

for ‘‘almond, hulls’’ at 3 ppm instead of 

3.0 ppm to be consistent with OECD’s 

rounding class practices. 

Although the summary of the petition 

cited in Unit II of this preamble 

indicated a request for a tolerance on 

almond at 0.10 ppm (and EPA’s notice 

of filing published in the Federal 

Register indicated the request for a 

tolerance at 0.10 ppm), the actual 

petition sought a tolerance at 0.01 ppm. 

Based on its review of the underlying 

residue data, EPA has determined that 

it is appropriate to set the tolerance for 

almond at 0.01 ppm. 

V. Conclusion 

Therefore, tolerances are established 

for residues of ipflufenoquin, 2-[2-(7,8- 

difluoro-2-methylquinolin-3-yloxy)-6- 


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fluorophenyl]propan-2-ol, in or on 

almond at 0.01 ppm; almond, hulls at 3 

ppm; and fruit, pome, group 11–10 at 

0.15 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) 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 tolerances 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). 

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: February 23, 2022. 

Edward Messina, 

Director, Office of Pesticide Programs. 

Therefore, for the reasons stated in the 

preamble, EPA is amending 40 CFR 

chapter I as follows: 

PART 180—TOLERANCES AND 

EXEMPTIONS FOR PESTICIDE 

CHEMICAL RESIDUES IN FOOD 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Add § 180.719 to subpart C to read 

as follows: 

§ 180.719 Ipflufenoquin; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the fungicide 

ipflufenoquin, including its metabolites 

and degradates, in or on the 

commodities to Table 1 of this section. 

Compliance with the tolerance levels 

specified in Table 1 is to be determined 

by measuring only ipflufenoquin, 2- 

[(7,8-difluoro-2-methyl-3- 

quinolinyl)oxy]-6-fluoro-a,adimethylbenzenemethanol, in or on the 

commodities. 

TABLE 1 TO PARAGRAPH (a) 

Commodity Parts per 

million 

Almond .................................. 0.01 

Almond, hulls ........................ 3 

Fruit, pome, group 11–10 ..... 0.15 

(b)–(d) [Reserved] 

[FR Doc. 2022–04264 Filed 2–28–22; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2020–0349; FRL–9550–01– 

OCSPP] 

Potassium Acetate; 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 potassium 

acetate (CAS Reg. No. 127–08–2) when 

used as an inert ingredient (nutrient) in 

pesticide formulations applied to 

growing crops only. Valagro S.p.A. 

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 for potassium acetate. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of potassium acetate when 

used in accordance with this exemption. 

DATES: This regulation is effective 

March 1, 2022. Objections and requests 

for hearings must be received on or 

before May 2, 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–2020–0349, 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. 


jspears on DSK121TN23PROD with RULES1