[Federal Register Volume 85, Number 11 (Thursday, January 16, 2020)]
[Rules and Regulations]
[Pages 2654-2659]
[FR Doc No: 2020-00080]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0560; FRL-10002-21]

Fenhexamid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
fenhexamid in or on multiple commodities identified and discussed later
in this document. Interregional Research Project No. 4 (IR-4) requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).

DATES: This regulation is effective January 16, 2020. Objections and
requests for hearings must be received on or before March 16, 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-2018-0560, 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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave, NW, Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the 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-2018-0560 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
March 16, 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-

2018-0560, 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. 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 October 18, 2018 (83 FR 52787) (FRL-
9984-21), 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
8E8689) by Interregional Research Project Number 4 (IR-4) Rutgers, The
State University of New Jersey, 500 College Road East, Suite 201W,
Princeton, NJ 08540. The petition requested that 40 CFR 180.553 be
amended by establishing tolerances for residues of the fungicide
fenhexamid, (N-2,3-dichloro-4-hydroxyphenyl)-1-
methylcyclohexanecarboxamide), in or on arugula at 30.0 parts per
million (ppm); berry, low growing, subgroup 13-07G at 3.0 ppm;
bushberry subgroup 13-07B at 5.0 ppm; caneberry subgroup 13-07A at 20.0
ppm; fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-
07F at 4.0 ppm; fruit, stone, group 12-12, except plum, prune, fresh,
postharvest at 10.0 ppm; garden cress at 30.0 ppm; kiwifruit, fuzzy at
30.0 ppm; leafy greens, subgroup 4-16A, except spinach at 30.0 ppm;
onion, bulb, crop subgroup 3-07A at 2.0 ppm; onion, green, subgroup 3-
07B at 30.0 ppm; upland cress at 30.0 ppm; vegetable, fruiting, group
8-10, except non-bell pepper at 2.0 ppm. Also, the petition requested
to remove existing tolerances in 40 CFR 180.553 for residues of the
fungicide fenhexamid in or on the raw agricultural commodities:
Bushberry subgroup 13B at 5.0 ppm; caneberry subgroup 13A at 20.0 ppm;
cilantro, leaves at 30.0 ppm; fruit, stone, group 12, except plum,
prune, fresh, postharvest at 10.0 ppm; grape at 4.0 ppm; juneberry at
5.0 ppm; kiwifruit, postharvest at 15.0 ppm; leafy greens subgroup 4A,
except spinach at 30.0 ppm; lingonberry at 5.0 ppm; salal at 5.0 ppm;
strawberry at 3.0 ppm; and vegetable, fruiting, group 8, except nonbell
pepper at 2.0 ppm. That document referenced a summary of the petition
prepared by Arysta LifeSciences, the registrant, which is available in
the docket, http://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 is
establishing tolerances at levels that vary from what the petitioner
requested, in accordance with its authority under section
408(d)(4)(A)(i) of the FFDCA. 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 fenhexamid including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with fenhexamid 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.
    Following repeated oral dosing, the most toxicologically relevant
effects were hematological changes (decreased red blood cell (RBC)
counts, hemoglobin, and hematocrit and increased Heinz bodies) in dogs,
and decreased body weights, increased food consumption, and decreased
liver and/or kidney weights in rats and mice. There is no evidence of
immunotoxicity or neurotoxicity in the fenhexamid database. There is no
evidence of qualitative or quantitative susceptibility in the
developmental studies in rats and rabbits. In the reproductive study,
decreased body weights in F1 and F2 pups were observed in the presence
of maternal toxicity. However, there is no concern for increased
susceptibility of offspring because a clear no-observed-adverse-effect-
level (NOAEL) and a well-characterized dose response for offspring
effects was observed in the presence of maternal toxicity. There were
no adverse effects observed in a dermal toxicity study up to the
highest dose tested (1,000 mg/kg/day). Although no subchronic
inhalation study is available for fenhexamid, a 5-day range finding
inhalation study reported lung-specific effects (macroscopic grey
coloration of the lungs and marginal increases in lung weights) at the
highest dose tested. However, concern for these effects is low because
they occurred at a dose more than 7X higher than the selected
inhalation points of departure (POD). In an acute neurotoxicity study
in rats, the only effect observed was a marginally decreased mean body
temperature in male rats following a single high dose of 2,000 mg/kg.
This effect is not considered to be biologically significant.
    Based on the lack of evidence of carcinogenicity in rats and mice
and on the lack of genotoxicity in an acceptable battery of
mutagenicity studies, EPA has classified fenhexamid as ``not likely''
to be a human carcinogen. Specific information on the studies received
and the nature of the adverse effects caused by fenhexamid 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 titled Fenhexamid: ``Human
Health Risk Assessment for Section 3 Registration for New Uses in/on
Onion Bulb Subgroup 3-07A; Onion Green Subgroup 3-07B; Fuzzy Kiwifruit;
Crop Group Conversions/Expansions for Fruit

Small Vine Climbing, except Fuzzy Kiwifruit Subgroup 13-07F; Berry Low
Growing Subgroup 13-07G; Caneberry Subgroup 13-07A; Bushberry Subgroup
13-07B; Fruit Stone Group 12-12, except Plum, Prune Fresh; Leafy Greens
Subgroup 4-16A except Spinach; Vegetable Fruiting Group 8-10 except Non
bell Pepper; and to Establish Individual Tolerances on Arugula; Garden
cress; Upland Cress'' at page 27 in docket ID number EPA-HQ-OPP-2018-
0560.

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-pesticides.
    A summary of the toxicological endpoints for fenhexamid used for
human risk assessment is shown in Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Fenhexamid for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (General population  Not selected. No appropriate toxicological endpoint attributable to a single
 including infants and children).   exposure was identified in the available toxicology studies.
                                  ------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 17 mg/kg/day  Chronic RfD = 0.17   1-year feeding study (dog).
                                   UFA = 10x...........   mg/kg/day.          LOAEL = 124 mg/kg/day based on
                                   UFH = 10x...........  cPAD = 0.17 mg/kg/    decreased RBC counts, hemoglobin,
                                   FQPA SF = 1x........   day.                 and hematocrit and increased
                                                                               Heinz bodies in males and
                                                                               females; increased adrenal
                                                                               weights and intracytoplasmic
                                                                               vacuoles in adrenal cortex in
                                                                               females.
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Cancer (Oral)....................  Classification: ``Not likely to be Carcinogenic to Humans'' based on the
                                    absence of significant tumor increases in two adequate rodent
                                    carcinogenicity studies.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fenhexamid, EPA considered exposure under the petitioned-
for tolerances as well as all existing fenhexamid tolerances in 40 CFR
180.553. EPA assessed dietary exposures from fenhexamid 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 fenhexamid; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the Dietary Exposure Evaluation Model software
with the Food Commodity Intake Database (DEEM-FCID) Version 3.16. This
software uses 2003-2008 food consumption data from the U.S. Department
of Agriculture's (USDA's) National Health and Nutrition Examination
Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in
food, EPA conducted an unrefined chronic dietary exposure assessment
using tolerance-level residues, 100 percent crop treated (100 PCT), and
HED's 2018 default processing factors.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that fenhexamid 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 percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for fenhexamid. Tolerance-level residues and/or 100%
CT were 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 fenhexamid in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fenhexamid. 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.
    Based on the Pesticides in Water Calculator (PWC version 1.52; Feb.
2016) model, the estimated drinking water concentrations (EDWCs) of
fenhexamid for chronic exposures for non-cancer assessments, EDWCs of
fenhexamid are estimated to be 144 ppb for surface water and 1986 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 1986 ppb 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). Fenhexamid is not 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 method of toxicity, EPA has not made a
common mechanism of toxicity finding as to fenhexamid and any other
substances and fenhexamid 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 fenhexamid 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 http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.

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. There is no evidence of
qualitative or quantitative susceptibility in the developmental studies
in rats and rabbits. In the reproductive study, decreased body weights
in F1 and F2 pups were observed in the presence of maternal toxicity.
However, there is no concern for increased susceptibility of offspring
because a clear no-observed-adverse-effect-level (NOAEL) and a well-
characterized dose response for offspring effects was observed in the
presence of maternal toxicity.
    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 fenhexamid is complete.
    ii. There is no indication that fenhexamid is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
    iii. There is no evidence that fenhexamid results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies and no concern for any increased susceptibility
in the young from the 2-generation reproduction study due to the clear
dose-response and NOAEL of that study.
    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 fenhexamid in drinking water. These assessments
will not underestimate the exposure and risks posed by fenhexamid.

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,
fenhexamid 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
fenhexamid from food and water will utilize 79% of the cPAD for all
infants (<1 year old), the population subgroup receiving the greatest
exposure. There are no residential uses for fenhexamid. Based on the
explanation in Unit III.C.3., regarding residential use patterns,
chronic residential exposure to residues of fenhexamid is not expected.
    3. Short-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).
    A short-term adverse effect was identified; however, fenhexamid is
not registered for any use patterns that would result in short-term
residential exposure. Short-term risk is assessed based on short-term
residential exposure plus chronic dietary exposure. Because there is no
short-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-term risk is necessary, and EPA relies on
the chronic dietary risk assessment for evaluating short-term risk for
fenhexamid.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    An intermediate-term adverse effect was identified; however,
fenhexamid is not registered for any use patterns that would result in
intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no 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 intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for
fenhexamid.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, fenhexamid is not expected to pose a cancer risk to humans.
    6. 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 fenhexamid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology Bayer AG Method 00362, a high-
performance liquid chromatography (HPLC) method with electrochemical
detection (ECD) is available to enforce the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
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.
    Codex MRLs for head and leaf lettuce; eggplant, tomato, and bell
pepper; and apricot, nectarine, and peach are harmonized with the U.S.
tolerances for fenhexamid on leafy greens subgroup 4-16A, except
spinach; vegetable, fruiting, group 8-10, except non bell pepper; and
fruit, stone, group 12-12, except plum, prune, dried, respectively. The
Codex MRLs for other stone fruits in crop group 12-12 are lower than
the crop group tolerance; harmonizing with them could result in over-
tolerance residues in the U.S. despite legal use of the pesticide
according to the label.
    The established U.S. tolerances for fenhexamid in or on caneberry
subgroup 13-07A and kiwifruit, fuzzy are 20 ppm and 30 ppm
respectively. These values are higher than the Codex MRL values of 15
ppm for individual commodities in caneberry subgroup 13-07A and
kiwifruit, fuzzy. The U.S. tolerance values for fenhexamid on caneberry
subgroup 13-07A and kiwifruit, fuzzy were determined based on expected
residues resulting from U.S. use pattern; harmonizing with Codex MRL
values may result in over tolerance residues. The established U.S.
tolerances for residues of fenhexamid in grape and strawberry are
currently harmonized with Canada but are lower than the established
Codex MRLs. These U.S. tolerances were established as part of a joint
review with the Health Canada Pest Management Regulatory Agency (PMRA);
therefore, EPA is not raising these tolerances to harmonize with Codex.

C. Revisions to Petitioned-For Tolerances

    EPA has revised the proposed tolerances for residues of fenhexamid
on onion bulb subgroup 3-07A; onion green subgroup 3-07B; fuzzy
kiwifruit; fruit small vine climbing, except fuzzy kiwifruit subgroup
13-07F; berry low growing subgroup 13-07G; caneberry subgroup 13-07A;
bushberry subgroup 13-07B; fruit stone group 12-12, except plum prune
fresh; leafy greens subgroup 4-16A except spinach; vegetable fruiting
group 8-10 except nonbell pepper; arugula; garden cress and upland
cress based on current OECD rounding classes. In addition, EPA
corrected the commodity definition for fruit, stone, group 12-12,
except plum, prune, fresh and plum, prune, dried.

V. Conclusion

    Therefore, tolerances are established for residues of fenhexamid,
in or on arugula at 30 ppm; berry, low growing, subgroup 13-07G at 3
ppm; bushberry subgroup 13-07B at 5 ppm; caneberry subgroup 13-07A at
20 ppm; cress, garden at 30 ppm; cress, upland at 30 ppm; fruit, small,
vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 4 ppm; fruit,
stone, group 12-12, except plum, prune at 10 ppm; kiwifruit, fuzzy at
30 ppm; leafy greens, subgroup 4-16A, except spinach at 30 ppm; onion,
bulb, subgroup 3-07A at 2 ppm; onion, green, subgroup 3-07B at 30 ppm;
and vegetable, fruiting, group 8-10, except nonbell pepper at 2 ppm.
    Additionally, the existing tolerances on the following commodities
are removed as unnecessary due to the establishment of the above
tolerances: bushberry subgroup 13B; caneberry subgroup 13A; cilantro,
leaves; fruit, stone, group 12, except plum, prune, fresh, postharvest;
grape; juneberry; kiwifruit, postharvest; leafy greens subgroup 4A,
except spinach; lingonberry; salal; strawberry; and vegetable,
fruiting, group 8, except nonbell pepper. Finally, EPA is revising the
tolerance expression to be consistent with Agency policy.

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: December 6, 2019.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

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. In Sec.  180.553, amend paragraph (a) as follows:
0
 a. Revise the introductory text;
0
 b. Add alphabetically the entries for ``Arugula'' and ``Berry, low
growing, subgroup 13-07G'';
0
 c. Remove the entry for ``Bushberry subgroup 13B'';
0
 d. Add alphabetically the entry for ``Bushberry subgroup 13-07B'';
0
 e. Remove the entry for ``Caneberry subgroup 13A'';
0
f. Add alphabetically the entry for ``Caneberry subgroup 13-07A'';
0
g. Remove the entry for ``Cilantro, leaves'';
0
 h. Add alphabetically the entries for ``Cress, garden''; ``Cress,
upland''; ``Fruit, small, vine climbing, except fuzzy kiwifruit,
subgroup 13-07F''; and ``Fruit, stone, group 12-12, except plum,
prune'';
0
i. Remove the entries for ``Fruit, stone, group 12, except plum, prune,
fresh, postharvest''; ``Grape''; and ``Juneberry'';
0
j. Add alphabetically the entry for ``Kiwifruit, fuzzy'';
0
 k. Remove the entries for ``Kiwifruit, postharvest'' and ``Leafy
greens subgroup 4A, except spinach'';
0
 l. Add alphabetically the entry for ``Leafy greens, subgroup 4-16A,
except spinach'';
0
 m. Remove the entry for ``Lingonberry'';
0
n. Add alphabetically the entries for ``Onion, bulb, subgroup 3-07A''
and ``Onion, green, subgroup 3-07B'';
0
o. Remove the entries for ``Salal''; ``Strawberry''; and ``Vegetable,
fruiting, group 8, except nonbell pepper''; and
0
p. Add alphabetically the entry for ``Vegetable, fruiting, group 8-10,
except non bell pepper''.
    The revisions and additions read as follows:

Sec.  180.553  Fenhexamid; tolerances for residues.

    (a) General. Tolerances are established for residues of fenhexamid,
including its metabolites and degradate, in or on the commodities in
the table in this paragraph (a). Compliance with the tolerance levels
specified in this paragraph (a) is to be determined by measuring only
fenhexamid (N-2,3-dichloro-4-hydroxyphenyl)-1-
methylcyclohexanecarboxamide).

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------

                              * * * * * * *
Arugula.................................................              30

                              * * * * * * *
Berry, low growing, subgroup 13-07G.....................               3
Bushberry subgroup 13-07B...............................               5
Caneberry subgroup 13-07A...............................              20
Cress, garden...........................................              30
Cress, upland...........................................              30

                              * * * * * * *
Fruit, small, vine climbing, except fuzzy kiwifruit,                   4
 subgroup 13-07F........................................
Fruit, stone, group 12-12, except plum, prune...........              10

                              * * * * * * *
Kiwifruit, fuzzy........................................              30
Leafy greens, subgroup 4-16A, except spinach............              30
Onion, bulb, subgroup 3-07A.............................               2
Onion, green, subgroup 3-07B............................              30

                              * * * * * * *
Vegetable, fruiting, group 8-10, except nonbell pepper..               2
------------------------------------------------------------------------

* * * * *
[FR Doc. 2020-00080 Filed 1-15-20; 8:45 am]
 BILLING CODE 6560-50-P