[Federal Register Volume 85, Number 166 (Wednesday, August 26, 2020)]
[Rules and Regulations]
[Pages 52483-52488]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18661]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0038; FRL-10011-32]


Inpyrfluxam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

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

DATES: This regulation is effective August 26, 2020. Objections and 
requests for hearings must be received on or before October 26, 2020, 
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-2018-0038, 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 telephone number: (703) 305-7090; email address: 
[email protected].

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

[[Page 52484]]

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-2018-0038 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing and must be received by the Hearing Clerk on or before 
October 26, 2020. 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-2018-0038, by one of 
the following methods:
     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.
     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 http://www.epa.gov/dockets/contacts.html.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of March 18, 2019 (84 FR 9735) (FRL-9989-
90), 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 
7F8634) by Valent U.S.A. LLC, 1600 Riviera Avenue, Suite 200, Walnut 
Creek, CA 94596. The petition requested that 40 CFR part 180 be amended 
by establishing tolerances for residues of the fungicide inpyrfluxam, 
S-2399, in or on apple at 0.01 parts per million (ppm); apple, wet 
pomace at 0.03 ppm; beet, sugar, dried pulp at 0.05 ppm; beet, sugar, 
molasses at 0.03 ppm; beet, sugar, roots at 0.01 ppm; corn, field, 
forage at 0.02 ppm; corn, field, grain at 0.01 ppm; corn, field, stover 
at 0.02 ppm; corn, pop, grain at 0.01 ppm; corn, pop, stover at 0.02 
ppm; corn, sweet, kernel plus cob with husks removed at 0.01 ppm; 
peanut at 0.01 ppm; peanut, hay at 2.0 ppm; rice, grain at 0.01 ppm; 
rice, bran at 0.02 ppm; rice, hulls at 0.05 ppm; and soybean, seed at 
0.01 ppm. That document referenced a summary of the petition prepared 
by Valent U.S.A. LLC, the registrant, which is available in the docket, 
http://www.regulations.gov. There were no comments received in response 
to the notice of filing.
    In the Federal Register of May 8, 2020 (85 FR 27346) (FRL-10008-
38), 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 
7F8634) by Valent U.S.A. LLC, 1600 Riviera Avenue, Suite 200, Walnut 
Creek, CA 94596. The petition requested that 40 CFR part 180 be amended 
by establishing tolerances for residues of the fungicide inpyrfluxam, 
S-2399, in or on corn, sweet, stover at 0.02 ppm; corn, sweet, forage 
at 0.02 ppm; cattle, fat at 0.01 ppm; cattle, meat at 0.01 ppm; cattle, 
meat byproducts at 0.01 ppm; eggs at 0.01 ppm; goat, fat at 0.01 ppm; 
goat, meat at 0.01 ppm; goat, meat byproducts at 0.01 ppm; hog, fat at 
0.01 ppm; hog, meat at 0.01 ppm; hog, meat byproducts at 0.01 ppm; 
horse, fat at 0.01 ppm; horse, meat at 0.01 ppm; horse, meat byproducts 
at 0.01 ppm; milk at 0.01 ppm; poultry, fat at 0.01 ppm; poultry, meat 
at 0.01 ppm; poultry, meat byproducts at 0.01 ppm; sheep, fat at 0.01 
ppm; sheep, meat at 0.01 ppm; and sheep, meat byproducts at 0.01 ppm. 
That document referenced a summary of the petition prepared by Valent 
U.S.A. LLC, the registrant, which is available in the docket, http://www.regulations.gov. A comment was received in response to 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, EPA is 
establishing several tolerances at different levels than were 
requested. 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 inpyrfluxam including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with inpyrfluxam 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 target organs of inpyrfluxam are the liver and thyroid (rats, 
mice, and dogs). Liver effects include increased liver weight, elevated 
liver enzymes, and increased incidences of diffuse hepatocellular 
hypertrophy. Thyroid effects include increased incidences of follicular 
cell hypertrophy.
    Decreased motor activity was seen in the acute neurotoxicity study 
in female rats, but no gross or microscopic morphological changes 
occurred. There was no neurotoxicity observed in the subchronic 
neurotoxicity in rats or in any other studies. No dermal hazard was 
identified in the 28-day dermal toxicity study.
    There was evidence of quantitative sensitivity in the developmental 
toxicity study in rats. In this study, decreased fetal weights were 
observed at a dose

[[Page 52485]]

lower than the presence of maternal toxicity. No quantitative 
susceptibility was observed in the developmental toxicity study in 
rabbits and the 2-generation reproduction study in rats. In the 2-
generation reproduction study in rats, no reproductive effects were 
observed, and offspring toxicity (decreased pup weights in F1 and F2 
generations) was observed in the presence (same dosage) of parental 
toxicity (thyroid weight changes and histopathology in P and F1 
generations).
    In the chronic toxicity/carcinogenicity studies in rats and mice, 
there was no evidence of carcinogenicity. The mutagenicity battery was 
negative. Inpyrfluxam 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 inpyrfluxam 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 the document titled ``Inpyrfluxam. Human Health 
Risk Assessment for the Section 3 Registration Action of the New Active 
Ingredient, Inpyrfluxam, for Foliar Application on Apple, Peanut, Rice, 
Soybean, and Sugar Beet; Soil Application on Corn; and Seed Treatment 
Uses on Canola, Cereal Grains, Legume Vegetables, and Sugar Beet'' 
(hereinafter ``Inpyrfluxam Human Health Risk Assessment'') on pages 42-
46 in docket ID number EPA-HQ-OPP-2018-0038.

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 inpyrfluxam used for 
human risk assessment can be found in the Inpyrfluxam Human Health Risk 
Assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to inpyrfluxam, EPA considered exposure under the petitioned-
for tolerances. EPA assessed dietary exposures from inpyrfluxam 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 inpyrfluxam. In estimating acute 
dietary exposure, EPA used 2003-2008 food consumption information from 
the United States Department of Agriculture's (USDA) National Health 
and Nutrition Examination Survey, What We Eat in America, (NHANES/
WWEIA). As to residue levels in food, the acute analysis assumed 
tolerance-level residues or higher by combining residues of the parent 
and residues of the applicable metabolites of concern, adjusting for 
molecular weight. In addition, the assessment used 100 percent crop 
treated (PCT) estimates and default processing factors.
    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, the chronic analysis 
assumed tolerance-level residues or higher by combining residues of the 
parent and residues of the applicable metabolites of concern, adjusting 
for molecular weight. In addition, the assessment used 100 PCT 
estimates and default processing factors.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that inpyrfluxam 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 and PCT information. EPA did not use 
anticipated residue or PCT information for assessing the inpyrfluxam 
exposures.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk 
assessment for inpyrfluxam in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of inpyrfluxam. 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 Root Zone Model-Variable Volume Water Model 
(PRZM-VVWM) and Pesticide Root Zone Model-Groundwater (PRZM-GW) models, 
EPA calculated the estimated drinking water concentrations (EDWCs) of 
inpyrfluxam for acute and chronic exposures in surface and ground 
water. EPA used the modeled EDWCs directly in the dietary exposure 
model to account for the contribution of inpyrfluxam residues in 
drinking water as follows: 104.5 ppm was used in the acute assessment 
and 69.5 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).
    Inpyrfluxam is not being proposed to be 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 inpyrfluxam and any other 
substances, and inpyrfluxam 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 inpyrfluxam has a 
common mechanism of toxicity with other substances. For information 
regarding EPA's efforts to determine which chemicals have a common

[[Page 52486]]

mechanism of toxicity and to evaluate the cumulative effects of such 
chemicals, see EPA's website at http://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 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 study in rats, decreased fetal weights were observed at a dose 
lower than the presence of maternal toxicity. No quantitative 
susceptibility was observed in the developmental toxicity study in 
rabbits and the 2-generation reproduction study in rats. In the 2-
generation reproduction study in rats, no reproductive effects were 
observed, and offspring toxicity (decreased pup weights in F1 and F2 
generations) was observed in the presence (same dosage) of parental 
toxicity (thyroid weight changes and histopathology in P and F1 
generations).
    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 inpyrfluxam is complete.
    ii. Decreased motor activity was observed in females in the acute 
neurotoxicity study; however, no neurotoxicity was observed in the 
subchronic neurotoxicity or in any other studies in the inpyrfluxam 
database; therefore, a developmental neurotoxicity study was not needed 
with the absence of neuropathology.
    iii. In the 2-generation reproduction study in rats, no 
reproductive effects were observed, and offspring toxicity (decreased 
pup weights in F1 and F2 generations) was observed in the presence of 
parental toxicity (thyroid weight changes and histopathology in P and 
F1 generations). Although there were developmental effects (decreased 
fetal weights) in the developmental study in rats in the absence of 
maternal toxicity, a clear NOAEL and LOAEL were identified, and the 
PODs selected for risk assessment purposes are protective of the 
developmental 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 anticipated residues to account for the metabolites of 
concern. EPA made conservative (protective) assumptions in the ground 
and surface water modeling used to assess exposure to inpyrfluxam in 
drinking water. These assessments will not underestimate the exposure 
and risks posed by inpyrfluxam.

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 inpyrfluxam will occupy 6.4% of the aPAD for all infants less than 
one 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 
inpyrfluxam from food and water will utilize 1.7% of the cPAD for 
children 1 to 2 years old, the population group receiving the greatest 
exposure. There are no residential uses for inpyrfluxam.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account short- and intermediate-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, inpyrfluxam 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 inpyrfluxam.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, inpyrfluxam 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 inpyrfluxam residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The petitioner has proposed a multi-residue method (quick, easy, 
cheap, effective, rugged and safe; QuEChERS; Method No. VP-393940) for 
the determination of inpyrfluxam in plant commodities. For livestock 
commodities, adequate enforcement methodology using the high 
performance liquid chromatography with tandem mass detection (HPLC-MS/
MS, or LC-MS/MS) is available for determination of residues of 
inpyrfluxam 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: 
[email protected].

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

[[Page 52487]]

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 any MRLs for inpyrfluxam.

C. Response to Comments

    One comment was received to the notice of filing that stated in 
part ``ban use of valent impyrfluxam [sic] on corn cattle meat and 
other sites.''
    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) authorizes 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 inpyrfluxam tolerances are safe. The commenter has provided 
no information supporting a contrary conclusion.

D. Revisions to Petitioned-For Tolerances

    Some of the proposed commodity definitions for the tolerances being 
established are different than requested to be consistent with Agency 
nomenclature. EPA is not establishing a tolerance for residues in/on 
rice hulls as requested; it is not necessary as rice hulls are no 
longer considered a significant livestock feedstuff. Also, residues 
were less than the LOQ in the processed commodities at exaggerated 
rates; therefore, a tolerance for rice bran is not required. No 
separate tolerance is needed for apple, wet pomace since the residues 
on pomace will be adequately covered by the tolerance on ``apple'' due 
to a lack of concentration during processing. Similarly, no separate 
tolerances are needed for sugar beet molasses or sugar beet dried pulp 
since residues on those commodities will be adequately covered under 
``beet, sugar, roots.'' Finally, EPA revised the tolerance value for 
``peanut, hay'' from 2.0 ppm (as requested) to 2 ppm, to be consistent 
with OECD's rounding class practices.

V. Conclusion

    Therefore, tolerances are established for residues of inpyrfluxam, 
including its metabolites and degradates, in or on the following plant 
commodities: Apple at 0.01 ppm; beet, sugar, roots at 0.01 ppm; corn, 
field, forage at 0.02 ppm; corn, field, grain at 0.01 ppm; corn, field, 
stover at 0.02 ppm; corn, pop, grain at 0.01 ppm; corn, pop, stover at 
0.02 ppm; corn, sweet, kernel plus cob with husks removed at 0.01 ppm; 
corn, sweet, forage at 0.02 ppm; corn, sweet, stover at 0.02 ppm; 
peanut at 0.01 ppm; peanut, hay at 2 ppm; rice, grain at 0.01 ppm; and 
soybean, seed at 0.01 ppm.
    Also, tolerances are established for residues of inpyrfluxam, 
including its metabolites and degradates, in or on the following 
livestock commodities: Cattle, fat at 0.01 ppm; cattle meat at 0.01 
ppm; cattle, meat byproducts at 0.01 ppm; egg at 0.01 ppm; goat, fat at 
0.01 ppm; goat, meat at 0.01 ppm; goat, meat byproducts at 0.01 ppm; 
hog, fat at 0.01 ppm; hog, meat at 0.01 ppm; hog, meat byproducts at 
0.01 ppm; horse, fat at 0.01 ppm; horse, meat at 0.01 ppm; horse meat 
byproducts at 0.01 ppm; milk at 0.01 ppm; poultry, fat at 0.01 ppm; 
poultry, meat at 0.01 ppm; poultry, meat byproducts at 0.01 ppm; sheep, 
fat at 0.01 ppm; sheep, meat at 0.01 ppm; and sheep meat byproducts at 
0.01 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), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). 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: August 11, 2020.
Edward Messina,
Acting Director, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

[[Page 52488]]

PART 180--[AMENDED]

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.  180.712 to subpart C to read as follows:


Sec.  180.712  Inpyrfluxam; tolerances for residues.

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

                        Table 1 to Sec.   180.712
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Apple.......................................................        0.01
Beet, sugar, roots..........................................        0.01
Corn, field, forage.........................................        0.02
Corn, field, grain..........................................        0.01
Corn, field, stover.........................................        0.02
Corn, pop, grain............................................        0.01
Corn, pop, stover...........................................        0.02
Corn, sweet, kernel plus cob with husks removed.............        0.01
Corn, sweet, forage.........................................        0.02
Corn, sweet, stover.........................................        0.02
Peanut......................................................        0.01
Peanut, hay.................................................           2
Rice, grain.................................................        0.01
Soybean, seed...............................................        0.01
------------------------------------------------------------------------

    (2) Tolerances are established for residues of inpyrfluxam, 
including its metabolites and degradates, in or on the commodities in 
Table 2 to this section. Compliance with the tolerance levels specified 
in Table 2 to this section is to be determined by measuring the free 
and conjugated forms of the sum of inpyrfluxam (3-(difluoromethyl)-N-
[(3R)-2,3-dihydro-1,1,3-trimethyl-1H-inden-4-yl]-1-methyl-1H-pyrazole-
4-carboxamide, and its metabolites 3-(difluoromethyl)-N-[1'-
(hydroxymethyl)-(1'S,3'R)-1',3'-dimethyl-2',3'-dihydro-1'H-inden-4'-
yl]-1-methyl-1H-pyrazole-4-carboxamide and 3-(difluoromethyl)-N-[1'-
(hydroxymethyl)-(1'R,3'S)-1',3'-dimethyl-2',3'-dihydro-1'H-inden-4'-
yl]-1-methyl-1H-pyrazole-4-carboxamid, calculated as the stoichiometric 
equivalent of inpyrfluxam, in or on the commodity:

                        Table 2 to Sec.   180.712
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.01
Cattle, meat................................................        0.01
Cattle, meat byproducts.....................................        0.01
Egg.........................................................        0.01
Goat, fat...................................................        0.01
Goat, meat..................................................        0.01
Goat, meat byproducts.......................................        0.01
Hog, fat....................................................        0.01
Hog, meat...................................................        0.01
Hog, meat byproducts........................................        0.01
Horse, fat..................................................        0.01
Horse, meat.................................................        0.01
Horse, meat byproducts......................................        0.01
Milk........................................................        0.01
Poultry, fat................................................        0.01
Poultry, meat...............................................        0.01
Poultry, meat byproducts....................................        0.01
Sheep, fat..................................................        0.01
Sheep, meat.................................................        0.01
Sheep, meat byproducts......................................        0.01
------------------------------------------------------------------------

    (b)-(d) [Reserved]

[FR Doc. 2020-18661 Filed 8-25-20; 8:45 am]
BILLING CODE 6560-50-P