[Federal Register Volume 85, Number 11 (Thursday, January 16, 2020)]
[Rules and Regulations]
[Pages 2654-2659]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. 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: (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 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-

[[Page 2655]]

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

[[Page 2656]]

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

[[Page 2657]]

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.

[[Page 2658]]

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: (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 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

[[Page 2659]]

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