[Federal Register Volume 87, Number 40 (Tuesday, March 1, 2022)]
[Rules and Regulations]
[Pages 11315-11319]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04264]


-----------------------------------------------------------------------

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: 
<a href="/cdn-cgi/l/email-protection#2e7c6a687c60415a474d4b5d6e4b5e4f00494158"><span class="__cf_email__" data-cfemail="75273133273b1a011c161006351005145b121a03">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> 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 e-CFR site at https://www.ecfr.gov/current/title-40.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, 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,

[[Page 11316]]

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:
    <bullet> 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.
    <bullet> Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
    <bullet> 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-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in document ``Ipflufenoquin. Human Health Risk

[[Page 11317]]

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-and-assessing-pesticide-risks/assessing-human-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-assessing-pesticide-risks/about-water-exposure-models-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 non-occupational, 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-and-assessing-pesticide-risks/cumulative-assessment-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

[[Page 11318]]

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 intermediate-term 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 multi-residue 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 multi-residue 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: 
<a href="/cdn-cgi/l/email-protection#493b2c3a202d3c2c242c3d21262d3a092c3928672e263f"><span class="__cf_email__" data-cfemail="245641574d4051414941504c4b4057644154450a434b52">[email protected]</span></a>.

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-

[[Page 11319]]

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

0
1. The authority citation for part 180 continues to read as follows:

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


0
2. Add Sec.  180.719 to subpart C to read as follows:


Sec.  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-[alpha],[alpha]-dimethylbenzenemethanol, in or on the 
commodities.

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             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


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>