[Federal Register Volume 86, Number 44 (Tuesday, March 9, 2021)]
[Rules and Regulations]
[Pages 13459-13465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04786]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0551; FRL-10019-19]


Fluindapyr; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
fluindapyr in or on multiple commodities which are identified and 
discussed later in this document. FMC Corporation requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 9, 2021. Objections and 
requests for hearings must be received on or before May 10, 2021, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2018-0551, is available at http://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

[[Page 13460]]

telephone number: (703) 305-7090; email address: <a href="/cdn-cgi/l/email-protection#05574143574b6a716c666076456075642b626a73"><span class="__cf_email__" data-cfemail="d5879193879bbaa1bcb6b0a695b0a5b4fbb2baa3">[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 Government 
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2018-0551 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 10, 2021. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2018-0551, by one of 
the following methods:
    <bullet> Federal eRulemaking Portal: http://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 http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of May 9, 2019 (84 FR 20320) (FRL-9992-36), 
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 8F8685) 
by FMC Corporation, 2929 Walnut Street, Philadelphia, PA 19104. The 
petition requested that 40 CFR part 180 be amended by establishing 
tolerances for residues of the fungicide, fluindapyr, 3-
(difluoromethyl)-N-(7-fluoro-2,3-dihydro-1,1,3-trimethyl-1H-inden-4-
yl)-1-methyl-1H-pyrazole-4-carboxamide, in or on almond, hulls at 15 
parts per million (ppm); aspirated grain fractions at 60 ppm; cattle, 
fat at 0.15 ppm; cattle, meat byproducts at 0.6 ppm; field corn, grain 
at 0.01 ppm; field corn, oil at 0.03 ppm; fruit, small vine-climbing 
except fuzzy kiwifruit, crop subgroup 13-07F at 3 ppm; grain, cereal, 
crop group 15, except rice and corn at 0.9 ppm; grain, cereal, forage, 
crop group 16, except rice, forage at 15 ppm; grain, cereal, hay, crop 
group 16 except rice, hay at 8 ppm; grain, cereal, stover, crop group 
16 except rice, stover, and sweet corn stover at 4 ppm; grain, cereal, 
straw, crop group 16, except rice, straw at 20 ppm; poultry, meat 
byproducts at 0.03 ppm; soybean, forage at 15 ppm; soybean, hay at 30 
ppm; soybean, hulls at 0.6 ppm; soybean, seed at 0.2 ppm; sweet corn, 
K+CWHR at 0.01 ppm; sweet corn, stover at 20 ppm; swine, meat 
byproducts at 0.02 ppm; and tree nuts, crop group 14-12 at 0.04 ppm. 
That document referenced a summary of the petition prepared by FMC 
Corporation, the registrant, which is available in the docket, http://www.regulations.gov. One comment was received on the notice of filing. 
EPA's response to this comment is discussed in Unit IV.C.
    Based upon review of the data supporting the petition and in 
accordance with its authority under FFDCA section 408(d)(4)(A)(i) to 
establish tolerances that vary from what was requested, EPA is 
establishing several tolerances at different levels than were 
requested, including additional livestock commodities as necessary. In 
addition, tolerances for fruit, small vine-climbing except fuzzy 
kiwifruit crop group 13-07F and soybeans were removed. 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 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 fluindapyr including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with fluindapyr 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

[[Page 13461]]

subgroups of consumers, including infants and children.
    The target organs of fluindapyr are the liver and thyroid. Liver 
effects include hepatocellular hypertrophy, increased liver weights, 
and bile duct hyperplasia with correlated increases in alkaline 
phosphatase (ALP), alanine aminotransferase (ALT), and gamma glutamyl 
transferase (GGT) at the highest dose tested. Liver effects progress 
with time in treated dogs, while similar effects are not seen in rats 
and mice at high dose levels. Liver effects are seen in the mouse 
carcinogenicity study at a higher dose level than the liver effects 
observed in dogs; the effects consisted of increased incidence of 
hepatocellular alterations (basophilic, eosinophilic, vacuolated), 
necrosis, and pigmented macrophages. Thyroid effects include increased 
instances of follicular hypertrophy/hyperplasia.
    In the acute neurotoxicity study, potential evidence of 
neurotoxicity in the form of decreases in total and ambulatory motor 
activities and in rearing were seen in the rat. However, no additional 
functional observation (FOB) parameters were affected, and no 
neuropathological findings of both central and peripheral nerves were 
observed.
    There is no evidence of increased quantitative or qualitative 
susceptibility in the developmental toxicity studies in rabbits or 
rats; or the reproductive toxicity study in rats. With in-utero 
exposure in the developmental toxicity studies, fluindapyr did not 
produce any adverse effects in either rat or rabbit parental animals or 
fetuses at or approaching the limit dose. In the reproduction study, in 
parental animals (P and F1 males and females), fluindapyr induced an 
increase in thyroid follicular hypertrophy/hyperplasia. It also induced 
adverse effects on a host of reproductive parameters. It also produced 
adverse offspring effects as indicated by decreases in F1 and F2 pup 
body weights in both sexes; thymus and spleen weights were also 
decreased. The parental, reproductive, and offspring effects all 
occurred at the same dose levels. The increased incidence of thyroid 
follicular hypertrophy/hyperplasia raised concerns for the potential of 
thyroid effects on the developing animals. EPA applied a 10X safety 
factor to the appropriate exposure scenarios to account for the 
uncertainties associated with the life stage susceptibility.
    In the chronic toxicity/carcinogenicity studies in rats and mice, 
there was no evidence of carcinogenicity. The mutagenicity battery was 
negative. Fluindapyr 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 fluindapyr 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 http://www.regulations.gov in document ``Fluindapyr: Human Health Risk 
Assessment for Section 3 Registration and Tolerance Requests for a New 
Active Ingredient Proposed for Use on Cereal Grains Crop Group 15 
except Rice; Forage, Fodder and Straw of Cereal Grains Crop Group 16; 
and Soybean'' (hereinafter ``Fluindapyr Human Health Risk Assessment'') 
on pages 14-20 in docket ID number EPA-HQ-OPP-2018-0551.

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 http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticide.
    A summary of the toxicological endpoints for fluindapyr used for 
human risk assessment can be found in the Fluindapyr Human Health Risk 
Assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fluindapyr, EPA considered exposure under the petitioned-
for tolerances. EPA assessed dietary exposures from fluindapyr 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. Such effects were identified 
for fluindapyr. In estimating acute dietary exposure, EPA used 2003-
2008 food consumption information from the United States Department of 
Agriculture (USDA) Nationwide Health and Nutrition Examination Survey, 
What We Eat in America (NHANES/WWEIA). As to residue levels in food, 
the acute analysis assumed 100% crop treated (PCT) for all commodities, 
highest average field trial (HAFT) residue values, empirical and 
default processing factors, and anticipated livestock residues based on 
calculated livestock dietary burden and tissue transfer rates from the 
livestock feeding studies.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used 2003-2008 food consumption data from the USDA's 
NHANES/WWEIA. As to residue levels in food, chronic analysis assumed 
100 PCT for all commodities, field trial mean residue values, empirical 
and default processing factors, and anticipated livestock residues 
based on calculated livestock dietary burden and tissue transfer rates 
from the livestock feeding studies and metabolite ratios from the 
metabolism studies.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that fluindapyr does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue. Section 408(b)(2)(E) of FFDCA authorizes 
EPA to use available data and information on the anticipated residue 
levels of pesticide residues in food and the actual levels of pesticide 
residues that have been measured in food. If EPA relies on such 
information, EPA must require pursuant to FFDCA section 408(f)(1) that 
data be provided 5 years after the tolerance is established, modified, 
or left in effect, demonstrating that the levels in food are not above 
the levels anticipated. For the present action, EPA will issue such 
data call-ins as are required by FFDCA section 408(b)(2)(E)

[[Page 13462]]

and authorized under FFDCA section 408(f)(1). Data will be required to 
be submitted no later than 5 years from the date of issuance of these 
tolerances.
    EPA did not use information on the percent of food actually treated 
in the dietary assessment for fluindapyr; 100 PCT was assumed for all 
food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for fluindapyr in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of fluindapyr. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Using the Pesticide Water Calculator (PWC, version 1.52), the 
estimated drinking water concentrations (EDWCs) of fluindapyr were 
determined to be higher in groundwater than in surface water for both 
acute and chronic exposure durations. The following groundwater EDWCs 
were used directly in the dietary exposure model to account for the 
contribution of fluindapyr and relevant transformation products (3-OH-
F9990 and 1-COOH-F9990) residues in drinking water as follows: 254.1 
ppb was used in the acute assessment and 217.8 ppb was used in the 
chronic assessment.
    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).
    Fluindapyr is currently registered for the following use that could 
result in residential exposures: Golf course turf. The currently 
registered use on golf courses will result in short-term (1 to 30 days) 
residential post-application dermal exposures to adult, youth 11 to 
less than 16 years old, and children 6 to less than 11 years old. 
Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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 fluindapyr and any other 
substances and fluindapyr does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this action, 
therefore, EPA has not assumed that fluindapyr has a common mechanism 
of toxicity with other substances.

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 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. In the developmental 
toxicity studies (rat and rabbit), fluindapyr did not produce any 
adverse effects in parental animals or fetuses at or approaching the 
limit dose (1,000 mg/kg/day). In the reproduction study, in parental 
animals (P and F1 males and females), fluindapyr induced an increase in 
thyroid follicular hypertrophy/hyperplasia. It also induced adverse 
effects on a host of reproductive parameters. There is no evidence of 
increased quantitative or qualitative susceptibility in the 
developmental toxicity studies in rabbits or rats or the reproductive 
toxicity study in rats. In the 2-generation reproduction study in rats, 
reproductive effects were observed, and offspring toxicity (decreased 
pup weights in F1 and F2 generation; thymus and spleen weights were 
decreased) was observed in the presence (same dosage) of parental 
toxicity (increase in thyroid follicular hypertrophy/hyperplasia and 
reproductive effects).
    3. Conclusion. Due to the uncertainties concerning the potential 
life stage susceptibility related to adverse thyroid effects seen in 
parental animals of the reproductive study, EPA is retaining the FQPA 
10X SF for exposure scenarios that rely on the reproductive study in 
which such effects were seen. For purposes of this safety assessment, 
those scenarios are the post-application short-term dermal exposures 
and the short-term aggregate risk assessment. For the acute and chronic 
dietary assessments, 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 fluindapyr is complete. Fluindapyr 
caused an increased in the thyroid follicular hypertrophy/hyperplasia 
in the 2-generation reproduction study. The results of these findings 
raised concerns about the potential impact to the developing brain in 
response to changing thyroid levels brought on by thyroid effect in the 
parents. A database uncertainty factor of 10X is placed on fluindapyr 
to address this concern.
    ii. In the acute neurotoxicity study (ACN), decreases in total and 
ambulatory motor activities and in rearing were seen and could be 
considered as potential evidence for neurotoxicity. However, concern 
with fluindapyr is low because (1) no other effects were observed in 
database including in the subchronic neurotoxicity study (SCN); (2) no 
neurohistopathology was found in the ACN, SCN or any toxicity study in 
the fluindapyr database; and (3) the toxicity endpoints and PoD 
selected for risk assessment are protective of the effects seen in the 
ACN.
    iii. There is no evidence that fluindapyr results in increased 
quantitative or qualitative susceptibility in the developmental 
toxicity studies in rabbits or rats or the reproductive toxicity study 
in rats. In the 2-generation reproduction study in rats, reproductive 
effects were observed, and offspring toxicity (decreased pup weights in 
F1 and F2 generation; thymus and spleen weights were decreased) was 
observed in the presence (same dosage) of parental toxicity. Based on 
the effects in the 2-generation reproduction study, there is some 
uncertainty about the potential thyroid-related effects on the 
developing fetus or child. While EPA is retaining the 10X FQPA SF for 
short-term aggregate risk assessment, there is no concern for this 
uncertainty for the acute dietary exposure assessment because 
perturbation of thyroid after a single dose is not anticipated to 
impact the developing fetus or offspring. Nor is there a concern for 
this uncertainty in the chronic dietary assessment because the chronic 
dietary endpoint, based on

[[Page 13463]]

effects in dogs, is protective of potential thyroid-related effects 
observed in developing rats or offspring.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary risk assessments are based on high-end 
assumptions such as 100 PCT assumptions, HAFT and field trial mean 
residue values, empirical and default processing factors, anticipated 
livestock residues based on calculated livestock dietary burden and 
tissue transfer rates from the livestock feeding studies and modeled, 
high-end estimates of residues in drinking water. All of the exposure 
estimates are based on high-end assumptions and are not likely to 
underestimate risk. EPA made conservative (protective) assumptions in 
the ground and surface water modeling used to assess exposure to 
fluindapyr in drinking water. EPA used similarly conservative 
assumptions to assess postapplication exposure of children. These 
assessments will not underestimate the exposure and risks posed by 
fluindapyr.

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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to fluindapyr will occupy 8.9% of the aPAD for all infants (<1 year 
old), the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
fluindapyr from food and water will utilize 33% of the cPAD for infants 
<1 year old, the population group receiving the greatest exposure. 
Based on the explanation in Unit III.C.3., regarding residential use 
patterns, chronic residential exposure to residues of fluindapyr is not 
expected.
    3. Short-term and intermediate-term risk. Short-term and 
intermediate-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-term and 
intermediate-term endpoints and residential exposure estimates are 
identical, and so short-term aggregate exposure is considered 
protective of intermediate-term aggregate exposures. The three 
population subgroups assessed for residential post-application 
exposures are: Adults, youth 11 to <16 years old, and children 6 to <11 
years old. Of the three population subgroups, the children 6 to <11 
years old represent the highest dermal exposure from post-application 
exposures and the highest background dietary exposure. Therefore, this 
population subgroup is considered protective of the other two 
population subgroups.
    For adults, intermediate-term exposure is not expected for the 
residential exposure pathway. Therefore, the intermediate-term 
aggregate risk would be equivalent to the chronic dietary exposure 
estimate. For children, all intermediate-term aggregate risks are 
equivalent to short-term aggregate risks.
    Using the exposure assumptions described in this unit for short-
term and intermediate-term exposures, EPA has concluded the combined 
short- and intermediate term food, water, and residential exposures 
result in aggregate MOEs of 720 for youth (6 to <11 yrs. old) with 
dermal exposure from post-application exposure to residue from treated 
golf course. Because EPA's level of concern for fluindapyr is a MOE of 
100 or below, these MOEs are not of concern.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, fluindapyr 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 fluindapyr residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The petitioner has proposed a liquid chromatography with tandem 
mass spectrometer (LC/MS/MS) for determination of fluindapyr and 
metabolites 3-OH-F9990, F9990-DM-glucoside, 1-OH-Me-F9990, 1-OH-Me-DM-
F9990, and 1-COOH-F9990 in plant commodities. For livestock 
commodities, adequate enforcement methodology using LC/MS/MS is 
available for determination of residues of fluindapyr and its 
metabolites.
    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#235146504a4756464e46574b4c4750634653420d444c55"><span class="__cf_email__" data-cfemail="deacbbadb7baabbbb3bbaab6b1baad9ebbaebff0b9b1a8">[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 Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established an MRL for fluindapyr.

C. Response to Comments

    One comment was received in response to the notice of filing that 
argued against the use fluindapyr on several commodities and the 
overall toxicity of pesticides. In addition, the commenter raised three 
additional concerns: The lack of tests involving the combination of 
fluindapyr and other chemicals; fluindapyr a potential cancer-causing 
agent; and fluindapyr is a fluoride compound. Although the Agency 
recognizes that some individuals believe that pesticides should be 
banned on agricultural crops, the existing legal framework provided by 
section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA) 
authorized EPA to establish tolerances when it determines that the 
tolerance is safe. 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 these 
fluindapyr tolerances are safe. The commenter has provided no 
information supporting a contrary conclusion.
    In its assessment of safety under the FFDCA, EPA considers 
combinations of pesticides by evaluating the cumulative effects of 
pesticides that have a common mechanism of toxicity. At this time, EPA 
has not identified a common

[[Page 13464]]

mechanism of toxicity between fluindapyr and other pesticides and thus 
there are no combinations of pesticides to consider at this time.
    EPA has evaluated available data concerning carcinogenicity and 
determined that fluindapyr is not likely to be carcinogenic to humans. 
This conclusion is based on a lack of treatment-related tumors seen in 
male or female rats or mice and no concern for mutagenicity. The 
commenter has provided no additional information about potential 
carcinogenicity.
    Fluindapyr contains a difluoromethyl group and a fluorine-
substituted phenyl group. The difluoromethyl group remains intact on 
the compounds identified in crop (primary and rotational), livestock, 
and environmental fate studies, including the compounds identified as 
the residues of concern for tolerance enforcement and risk assessment 
purposes for crop and livestock commodities. While the metabolism 
studies show the phenyl group does degrade, it is extremely unlikely 
for the fluorine to form a free fluorine because the stability of the 
bond between the fluorine and carbon atom. Therefore, applications of 
fluindapyr are not expected to result in dietary exposure to fluoride.

D. Revisions to Petitioned-For Tolerances

    Based on EPA's review of the data supporting the petition, EPA is 
establishing tolerances that vary from what the petitioner requested 
under its authority in FFDCA section 408(d)(4)(A)(i). Some commodity 
terms are altered to be consistent with Agency nomenclature. EPA is not 
establishing tolerances for corn oil since EPA determined that residues 
on this commodity will be adequately covered under corn, field, grain 
due to the lack of concentration during processing. EPA is also not 
establishing tolerances for fruit, small vine-climbing except fuzzy 
kiwifruit, crop subgroup 13-07F and the soybean commodities as 
initially requested since they are not necessary at this time, due to 
the withdrawal of the proposed uses by the petitioner.
    EPA is establishing tolerance levels lower than what the petitioner 
requested for grain, aspirated fractions; grain, cereal, group 15, 
except rice and corn from 0.9 ppm; and cattle, fat based on the 
submitted field trial data for those commodities using the OEDC MRL 
(Maximum Residue Limit) calculator.
    Because of potential increase of fluindapyr (including metabolites 
and degradates) in livestock diet, largely due to cereal grain crop 
group 15 and 16 use, and based on updated maximum reasonably balanced 
diet (MRBD) calculations for livestock, the Agency has determined that 
finite residues will be incurred in poultry (egg, fat, meat, and meat 
byproducts), ruminants (fat, milk, meat, and meat byproducts), hog 
(fat, meat, and meat byproducts), and horse (fat, meat, and meat 
byproducts); therefore, under 40 CFR 180.6, EPA is establishing 
tolerances for those commodities.

V. Conclusion

    Therefore, tolerances are established for residues of fluindapyr, 
3-(difluoromethyl)-N-(7-fluoro-2,3-dihydro-1,1,3-trimethyl-1H-inden-4-
yl)-1-methyl-1H-pyrazole-4-carboxamide, in or on almond, hulls at 15 
ppm ; corn, field, grain at 0.01 ppm; corn, sweet, kernel plus cob with 
husks removed at 0.01 ppm; corn, sweet, stover at 20 ppm; grain, 
aspirated fractions at 20 ppm; grain, cereal, forage, fodder, and 
straw, group 16 forage, except rice at 15 ppm; grain, cereal, forage, 
fodder, and straw, group 16, hay, except rice at 8 ppm; grain, cereal, 
forage, fodder, and straw, group 16, stover, except rice at 4 ppm; 
grain, cereal, forage, fodder, and straw, group 16, straw, except rice 
at 20 ppm; grain, cereal, group 15, except rice and corn at 0.8 ppm; 
nut, tree, group 14-12 at 0.04 ppm; egg at 0.01 ppm; milk at 0.01 ppm; 
cattle, fat at 0.03 ppm; cattle, meat at 0.01; goat, fat at 0.03 ppm; 
goat, meat at 0.01 ppm; hog, fat at 0.01 ppm; hog, meat at 0.01 ppm; 
horse, fat at 0.03 ppm; horse, meat at 0.01 ppm; poultry, fat at 0.01 
ppm; poultry, meat at 0.01 ppm; sheep, fat at 0.03 ppm; and sheep, meat 
at 0.01 ppm. In addition, tolerances are established for residues of 
fluindapyr, 3-(difluoromethyl)-N-(7-fluoro-1,1,3-trimethyl-2,3-dihydro-
1H-inden-4-yl)-1-methyl-1H-pyrazole-4-carboxamide, and 3-
(difluoromethyl)-N-(7-fluoro-1-hydroxymethyl-1,3-dimethyl-2,3-dihydro-
lH-inden-4-yl)-1-methyl-lH-pyrazole-4-carboxamide, in or on cattle, 
meat byproducts at 0.3 ppm; goat, meat byproducts at 0.3 ppm; horse, 
meat byproducts at 0.3 ppm; hog, meat byproducts at 0.01 ppm; poultry, 
meat byproducts at 0.01 ppm; and sheep, meat byproducts at 0.3 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 tolerance 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).

[[Page 13465]]

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.

Edward Messina,
Acting Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended 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.  180.716 to subpart C to read as follows:


Sec.  180.716  Fluindapyr; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
fungicide fluindapyr, including its metabolites and degradates, in or 
on the commodities in Table 1 of this section. Compliance with the 
tolerance levels specified in Table 1 is to be determined by measuring 
only fluindapyr, 3-(difluoromethyl)-N-(7-fluoro-1,1,3-trimethyl-2,3-
dihydro-1H-inden-4-yl)-1-methyl-1H-pyrazole-4-carboxamide, in or on the 
commodity.

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                              million
------------------------------------------------------------------------
Almond, hulls................................................         15
Cattle, fat..................................................       0.03
Cattle, meat.................................................       0.01
Corn, field, grain...........................................       0.01
Corn, sweet, kernel plus cob with husks removed..............       0.01
Corn, sweet, stover..........................................         20
Egg..........................................................       0.01
Goat, fat....................................................       0.03
Goat, meat...................................................       0.01
Grain, aspirated fractions...................................         20
Grain, cereal, forage, fodder, and straw, group 16, forage,           15
 except rice.................................................
Grain, cereal, forage, fodder, and straw, group 16, hay,               8
 except rice.................................................
Grain, cereal, forage, fodder, and straw, group 16, stover,            4
 except rice.................................................
Grain, cereal forage, fodder, and straw, group 16, straw,             20
 except rice.................................................
Grain, cereal group 15, except rice and corn.................        0.8
Hog, fat.....................................................       0.01
Hog, meat....................................................       0.01
Horse, fat...................................................       0.03
Horse, meat..................................................       0.01
Milk.........................................................       0.01
Nut, tree, group 14-12.......................................       0.04
Poultry, fat.................................................       0.01
Poultry, meat................................................       0.01
Sheep, fat...................................................       0.03
Sheep, meat..................................................       0.01
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the fungicide 
fluindapyr, including its metabolites and degradates, in or on the 
commodities in Table 2 of this section. Compliance with the tolerance 
levels specified in Table 2 is to be determined by measuring the sum of 
fluindapyr, 3-(difluoromethyl)-N-(7-fluoro-1,1,3-trimethyl-2,3-dihydro-
1H-inden-4-yl)-1-methyl-1H-pyrazole-4-carboxamide, and 3-
(difluoromethyl)-N-(7-fluoro-1-hydroxymethyl-1,3-dimethyl-2,3-dihydro-
lH-inden-4-yl)-1-methyl-lH-pyrazole-4-carboxamide, calculated as the 
stoichiometric equivalent of fluindapyr, in or on the commodity.

                       Table 2 to Paragraph (a)(2)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                              million
------------------------------------------------------------------------
Cattle, meat byproducts......................................        0.3
Goat, meat byproducts........................................        0.3
Horse, meat byproducts.......................................        0.3
Hog, meat byproducts.........................................       0.01
Poultry, meat byproducts.....................................       0.01
Sheep, meat byproducts.......................................        0.3
------------------------------------------------------------------------

    (b)-(d) [Reserved]

[FR Doc. 2021-04786 Filed 3-8-21; 8:45 am]
BILLING CODE 6560-50-P


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