[Federal Register Volume 85, Number 145 (Tuesday, July 28, 2020)]
[Rules and Regulations]
[Pages 45329-45336]
[FR Doc No: 2020-14419]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0683; FRL-10009-45]

Permethrin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
permethrin in or on multiple commodities which are identified and
discussed later in this document. Interregional Research Project Number
4 (IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective July 28, 2020. Objections and
requests for hearings must be received on or before September 28, 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-2018-0683, 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 note that due to the public health emergency, the EPA Docket
Center (EPA/DC) and Reading Room was closed to public visitors on March
31, 2020. Our EPA/DC staff will continue to provide customer service
via email, phone, and webform. For further information on EPA/DC
services, docket contact information and the current status of the EPA/
DC and Reading Room, please visit https://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
Printing 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-2018-0683 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
September 28, 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-2018-0683, 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 March 18, 2019 (84 FR 9737) (FRL-9989-
71), 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
8E8703) by IR-4, Rutgers, The State University of New Jersey, 500
College Road East, Suite 201W, Princeton, NJ 08540. The petition
requested to establish tolerances in 40 CFR 180.378 for the combined
residues of the insecticide cis- and trans-permethrin isomers [cis-(3-
phenoxyphenyl)methyl 3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropane
carboxylate] and [trans-(3-phenoxyphenyl)methyl 3-(2,2-
dichloroethenyl)-2,2-dimethylcyclopropane carboxylate] in or on the
following agricultural commodities: Celtuce at 5.0 parts per million
(ppm); cherry subgroup 12-12A at 4.0 ppm; fennel, Florence at 5.0 ppm;
leaf petiole vegetable subgroup 22B at 5.0 ppm; peach, subgroup 12-12B
at 2.0 ppm; tea, plucked leaves at 20 ppm; vegetable, tuberous and
corm, subgroup 1C at 0.05 ppm; and a regional tolerance in/on fruit,
small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 2.0
ppm. Additionally, the petition requested, upon approval of the above
tolerances, to remove the existing tolerances in 40 CFR 180.378 in/on
the following agricultural commodities: Cherry, sweet at 4.0 ppm;
cherry, tart at 4.0 ppm; leaf petioles subgroup 4B at 5.0 ppm; peach at
1.0 ppm; and potato at 0.05 ppm. That document referenced a summary of
the petition prepared by FMC, 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 that vary from what was requested. 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 permethrin including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with permethrin 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.
    Behavioral changes and neurotoxic effects, which are characteristic
of Type I pyrethroids, were the primary effects seen in most toxicity
studies. In addition, permethrin has been re-classified from ``Likely
to be Carcinogenic to Humans'' to ``Suggestive Evidence of Carcinogenic
Potential'' based on lung adenomas in female mice. Based on a re-
evaluation of available data, EPA concluded that a non-linear approach
to assessing

carcinogenicity would be appropriate because the selected acute
reference dose would be protective of potential carcinogenicity. A
complete discussion of the toxicological profile for permethrin and the
Agency's cancer conclusion as well as specific information on the
studies received and the nature of the adverse effects caused by
permethrin 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 in the document titled ``Permethrin: Human Health
Risk Assessment for New Use on ``Fruit, Small, Vine Climbing, Except
Fuzzy Kiwifruit, Subgroup 13-07F''; Multiple Crop Group Conversions/
Expansions; and the Establishment of a Tolerance without a U.S.
Registration for Tea, AND the Revised Draft Risk Assessment (DRA) for
Registration Review'' (hereinafter ``Permethrin Human Health Risk
Assessment'') in docket ID number EPA-HQ-OPP-2018-0683 in
Regulations.gov.

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 the NOAEL are the LOAEL are identified.
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 permethrin used for
human risk assessment can be found in the Permethrin Human Health Risk
Assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to permethrin, EPA considered exposure under the petitioned-
for tolerances as well as all existing permethrin tolerances in 40 CFR
180.378. EPA assessed dietary exposures from permethrin 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 permethrin. In estimating acute
dietary exposure, EPA used 2003-2008 food consumption information 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, the acute assessment was refined using
distributions and point estimates derived from pesticide data program
(PDP) monitoring data, field trial data, percent crop treated (PCT)
data, and empirical processing factors.
    ii. Chronic exposure. A chronic dietary endpoint has not been
selected for permethrin because repeated exposure does not result in a
point of departure lower than that resulting from acute exposure;
therefore, the acute dietary risk assessment is protective of chronic
dietary risk. However, since there are residential uses of permethrin,
a highly refined chronic dietary exposure assessment was conducted to
calculate average dietary (food and drinking water) exposure estimates
to support the permethrin aggregate risk assessment. The average
assessment was refined using point estimates derived from PDP
monitoring data, field trial data, PCT data, and empirical processing
factors.
    iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
Cancer risk is quantified using a linear or nonlinear approach. If
sufficient information on the carcinogenic mode of action is available,
a threshold or nonlinear approach is used and a cancer RfD is
calculated based on an earlier noncancer key event. If carcinogenic
mode of action data are not available, or if the mode of action data
determines a mutagenic mode of action, a default linear cancer slope
factor approach is utilized.
    Since the last permethrin risk assessment, the carcinogenic
potential of permethrin was reevaluated in response to new information
submitted. Based on the review of these data, permethrin is now
classified as ``Suggestive Evidence of Carcinogenic Potential'' and
quantification of risk using a non-linear approach (i.e., reference
dose (RfD)) will adequately account for all chronic toxicity, including
carcinogenicity, that could result from exposure to permethrin. A
separate cancer dietary exposure and risk assessment is not required.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of FFDCA authorizes EPA to use available data and information on the
anticipated residue levels of pesticide residues in food and the actual
levels of pesticide residues that have been measured in food. If EPA
relies on such information, EPA must require pursuant to FFDCA section
408(f)(1) that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. For the present action,
EPA will issue such data call-ins as are required by FFDCA section
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be
required to be submitted no later than 5 years from the date of
issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, and the exposure estimate does not
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The acute dietary assessment used the following maximum PCT
estimates: Apples (10%); asparagus (45%); broccoli (15%); cabbage
(30%); cantaloupes (15%); cauliflower (20%); celery (90%); cherries
(15%); corn (2.5%); cucumbers (10%); garlic (50%); hazelnuts (2.5%);
lettuce (65%); onions (25%); peaches (20%); pears (10%);

peppers (20%); potatoes (10%); pumpkins (20%); soybeans (2.5%); spinach
(75%); squash (20%); sweet corn (15%); tomatoes (10%); and watermelons
(15%). 100 PCT was used for the remaining commodities.
    The following average PCT estimates were used in the chronic
dietary exposure assessment for the following crops that are currently
registered for permethrin: Apples (5%); artichoke (35%); asparagus
(30%); broccoli (10%); cabbage (15%); cantaloupes (10%); cauliflower
(10%); celery (60%); cherries (10%); corn (1%); cucumbers (5%); garlic
(20%); hazelnuts (2.5%); lettuce (50%); onions (15%); peaches (10%);
pears (2.5%); peppers (10%); potatoes (10%); pumpkins (15%); soybeans
(1%); spinach (55%); squash (10%); sweet corn (10%); tomatoes (5%); and
watermelons (10%). Additionally, a PCT value of 100% from almond was
used for all livestock commodities since almonds have the highest PCT
estimate of the commodities that may be fed to livestock. 100 PCT was
used for the remaining commodities.
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and California Department of
Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the
chemical/crop combination for the most recent 10 years. EPA uses an
average PCT for chronic dietary risk analysis and a maximum PCT for
acute dietary risk analysis. The average PCT figure for each existing
use is derived by combining available public and private market survey
data for that use, averaging across all observations, and rounding to
the nearest 5%, except for those situations in which the average PCT is
less than 1% or less than 2.5%. In those cases, the Agency would use
less than 1% or less than 2.5% as the average PCT value, respectively.
The maximum PCT figure is the highest observed maximum value reported
within the most recent 10 years of available public and private market
survey data for the existing use and rounded up to the nearest multiple
of 5%, except where the maximum PCT is less than 2.5%, in which case,
the Agency uses less than 2.5% as the maximum PCT.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which permethrin may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for permethrin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of permethrin. 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/Exposure Analysis Modeling
System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM
GW) models, EPA calculated the estimated drinking water concentrations
(EDWCs) of permethrin for acute and chronic exposures in surface water.
Residues are not expected to reach groundwater due to permethrin's high
partition coefficient (Kd). EPA used the modeled EDWCs
directly in the dietary exposure model to account for the contribution
of permethrin residues in drinking water as follows: 10.0 ppb was used
in the acute assessment; 1.60 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).
    Permethrin is currently registered for the following uses that
could result in residential exposures: Control of insects in indoor and
outdoor residential sites, including use indoors as a direct spot
treatment (with some residential site restrictions), crack and crevice
application, aerosol space spray, and total release fogger. Outdoor
applications can be made as a direct or spot treatment to buildings/
household perimeters, landscaping, or lawns via aerosol cans, handheld
equipment, and trigger sprays. EPA assessed residential exposure using
the following assumptions: Several permethrin products require personal
protective equipment (PPE) to be worn by applicators. As such, EPA
assumes those products are not used by homeowners, so exposures from
those products have been considered only for residential post-
application exposure assessment. Permethrin product labels with
residential use sites that do not require specific clothing (e.g.,
long-sleeved shirt/long pants) and/or PPE, have been considered in the
residential handler assessment. Residential handler exposure
assessments were performed for adult homeowners applying permethrin
dusts/powders, dips, ready-to-use products, and pump/trigger spray
products to cats and dogs. For spot-on applications to pets, inhalation
exposure is negligible. Since there is no dermal hazard for permethrin,
the residential handler assessment includes only inhalation exposures.
All exposure scenarios are short-term in nature.
    As no dermal hazard has been identified for permethrin, a
quantitative post-application dermal assessment has not been conducted.
Short-term post-application inhalation is expected for adults. The
short-term post-application exposure scenarios for children 1 to less
than 2 years old and 3-6 years old (hand-to-mouth and inhalation
exposures) were combined for each lifestage. This combination should be
considered a protective estimate of children's exposure. In order to
combine these exposures, an aggregate risk index (ARI) was used since
the LOCs for children's hand-to-mouth exposure (100) and inhalation
exposure (30) are different. The target ARI is 1; therefore, ARIs of
less than 1 are risk estimates of concern. The ARIs were calculated as
follows.
    Aggregate Risk Index (ARI) = 1 / [(Incidental Oral LOC / Incidental
Oral MOE) + (Inhalation LOC / Inhalation MOE)].
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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.''
    The Agency has determined that the pyrethroids and pyrethrins share
a common mechanism of toxicity (http://www.regulations.gov; EPA-HQ-OPP-
2011-0746-0045). As explained in that document, the members of this
group share the ability to interact with voltage-gated sodium channels
ultimately leading to neurotoxicity. In 2011, after establishing a
common mechanism grouping for the pyrethroids and pyrethrins, the
Agency conducted a cumulative risk assessment (CRA) which is available
at http://www.regulations.gov; EPA-HQ-OPP-2011-0746-0003. In that
document, the Agency concluded that cumulative exposures to pyrethroids
(based on pesticidal uses registered at the time the assessment was
conducted) did not present risks of concern. For information regarding
EPA's efforts to evaluate the risk of exposure to this class of
chemicals, refer to https://www.epa.gov/ingredients-used-pesticide-products/pyrethrins-and-pyrethroids.
    Since the 2011 CRA, for each new pyrethroid and pyrethrin use, the
Agency has conducted a screen to evaluate any potential impacts on the
CRA prior to registration of that use. A new turf use for the
pyrethroid, tau-fluvalinate, was assessed after completion of the
cumulative, which did impact the worst-case non-dietary risk estimates
identified in the 2011 CRA for the turf scenario. However, the overall
finding (i.e., that the pyrethroid cumulative risk is below the
Agency's level of concern) did not change upon registration of this new
use.
    Prior to a final registration review decision for permethrin, the
Agency will determine whether the 2011 CRA needs to be updated based on
the availability of any new hazard, use, or exposure information that
could potentially change the conclusions of or otherwise impact the
2011 CRA.
    To account for the additional uses requiring tolerances in this
rule, the Agency has conducted an additional screen, taking into
account all previously approved uses and these proposed new uses. The
additional uses will not significantly impact the cumulative assessment
because dietary exposures make a minor contribution to total pyrethroid
exposure relative to residential exposures in the 2011 cumulative risk
assessment. Therefore, the results of the 2011 CRA are still valid and
there are no cumulative risks of concern for the pyrethroids/
pyrethrins.

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 was no evidence of
increased qualitative or quantitative susceptibility in guideline
developmental toxicity studies in the rat and rabbit and a three-
generation reproductive toxicity study in the rat. Maternal toxicity
included neurological effects such as tremors in the rat and decreased
body weights in the rat and rabbit. Increased post-implantation loss,
decreased offspring size, and decreased ossification were observed in
the studies, but all effects occurred at maternally toxic doses or
above.
    3. Conclusion. The Agency considers the FQPA SF as having two
components, with 3x assigned to pharmacokinetic (PK) and 3x to
pharmacodynamic (PD) differences. Previously, the Agency retained a 3x
FQPA SF (1x for PD and 3x for PK differences) for children less than 6
years old based on concerns for PK differences between adults and
children. EPA has re-evaluated the need for an FQPA SF for human health
risk assessments for pyrethroid pesticides based on a review of the
available guideline and literature studies as well as data from the
Council for the Advancement of Pyrethroid Human Risk Assessment
(CAPHRA) program. Because no new information of suitable quality was
available on the age-related PD properties of the pyrethroids, the PD
contribution to the FQPA safety factor remains at 1x. Regarding PK,
recent data including human physiologically based pharmacokinetic
(PBPK) models as well as in vivo and in vitro data on protein binding,
enzyme ontogeny, and metabolic clearance, support the conclusion that
the PK contribution to the FQPA SF can be reduced to 1x for all
populations. For further information about the Agency's determination
to reduce this FQPA safety factor, please see Re-Evaluation of the FQPA
Safety Factor for Pyrethroids: Updated Literature and CAPHRA Program
Data Review, which can be found at https://www.epa.gov/ingredients-used-pesticide-products/2019-evaluation-fqpa-safety-factor-pyrethroids.
Therefore, the Agency concludes that the default 10x FQPA SF can be
reduced to 1x for all populations for the pyrethroid pesticides.

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 permethrin will occupy 12% of the aPAD for all infants less than 1
year old, the population group receiving the greatest exposure.
    2. Chronic risk. A chronic dietary endpoint has not been selected
for permethrin because repeated exposure does not result in a point of
departure lower than that resulting from acute exposure; therefore, the
acute dietary risk assessment is protective of chronic dietary risk.
    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).
    Permethrin is currently registered for uses that could result in
short-term residential exposure, and the Agency has determined that it
is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to permethrin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate ARIs of 80 for adults and
2.9 for children 1 to less than 2 years old.

Because EPA's level of concern for permethrin is an ARI of 1 or below,
these ARIs are not of concern.
    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). Because no intermediate-term adverse effect was identified,
permethrin is not expected to pose an intermediate-term risk.
    5. Aggregate cancer risk for U.S. population. As stated in Unit
III.A., EPA has concluded that the acute reference dose (RfD) will
adequately account for all repeated exposure/chronic toxicity,
including carcinogenicity, which could result from exposure to
permethrin. Based on the lack of acute risk at regulated levels of
exposure, EPA concludes that exposure to permethrin will not pose an
aggregate cancer risk.
    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 permethrin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate gas chromatography (GC) electron capture detection (GC/
ECD) methods are available for enforcing tolerances of permethrin per
se and are listed in PAM Vol. II (Section 180.378). Method I is a GC/
ECD method for determining permethrin in plant matrices and has a limit
of quantitation (LOQ) of 0.05 ppm for each isomer. Method II is a GC/
ECD method for determining permethrin in animal matrices that has a LOQ
of 0.01 ppm for each isomer. In addition, permethrin is completely
recovered using FDA Multiresidue Methods (PAM Vol. I Sections 302 and
304).

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established any MRLs for permethrin in or on
celtuce, Swiss chard or Florence fennel. Therefore, harmonization is
not an issue for these commodities.
    The Codex has established MRLs for permethrin in or on tea, green,
black (black, fermented and dried) at 20 ppm; potato at 0.05 ppm; and
gooseberry and grapes at 2 ppm which are the same as the U.S.
tolerances being established by this document and are therefore
harmonized.
    The Codex has established MRLs for permethrin in or on stone fruit
at 2 ppm. The U.S. tolerance for peach subgroup 12-12B is harmonized
with the Codex MRL. Harmonization of the U.S. tolerance for cherry
subgroup 12-12A at 4 ppm is not possible because the U.S. tolerance is
higher. Reducing the U.S. tolerance could cause U.S. growers to have
violative residues despite legal use of permethrin.
    The Codex has established MRLs for permethrin in or on celery at 2
ppm. This MRL is lower than the tolerance of 5 ppm being established
for permethrin in or on leaf petiole vegetable subgroup 22B in the
United States. Harmonization is not feasible because the tolerance is
based on field trial data that resulted in residues that necessitated
the higher limit.

C. Revisions to Petitioned-For Tolerances

    All trailing zeroes have been removed from the proposed tolerances
to be consistent with Organization for Economic Cooperation and
Development (OECD) Rounding Class Practice.
    A tolerance is currently established for residues of permethrin in/
on the leaf petioles subgroup 4B at 5.0 ppm, which includes Swiss
chard. Crop subgroup 4B is being converted to the leaf petiole
vegetable subgroup 22B, which does not include Swiss chard. Therefore,
the Agency is establishing an individual tolerance of 5 ppm for Swiss
chard based on the currently established tolerance for this commodity
as part of crop subgroup 4B.
    The commodity definition for Florence fennel has been revised to
read fennel, Florence, fresh leaves and stalks.

V. Conclusion

    Therefore, tolerances are established for residues of permethrin in
or on celtuce at 5 ppm; cherry subgroup 12-12A at 4 ppm; fennel,
Florence, fresh leaves and stalks at 5 ppm; leaf petiole vegetable
subgroup 22B at 5 ppm; peach subgroup 12-12B at 2 ppm; Swiss chard at 5
ppm; tea, plucked leaves at 20 ppm; vegetable, tuberous and corm,
subgroup 1C at 0.05 ppm; and a tolerance for regional registration for
fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F at
2 ppm.
    Additionally, the following tolerances are removed as unnecessary
due to the establishment of the above tolerances: Cherry, sweet at 4.0
ppm; cherry, tart at 4.0 ppm; leaf petioles subgroup 4B at 5.0 ppm;
peach at 1.0 ppm; potato at 0.05 ppm.
    Lastly, EPA has revised the tolerance expression in paragraphs (a)
and (c) to clarify (1) that, as provided in FFDCA section 408(a)(3),
the tolerance covers metabolites and degradates of permethrin not
specifically mentioned; and (2) that compliance with the specified
tolerance levels is to be determined by measuring only the specific
compounds mentioned in the tolerance expression.
    The revised tolerance expression makes clear that the tolerances
cover residues of permethrin and its metabolites and degradates, but
that compliance with the tolerance levels will be determined by
measuring only permethrin [(3-phenoxyphenyl)methyl 3-(2,2-
dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate], as the sum of
its cis- and trans- isomers in or on the commodity. EPA has determined
that it is reasonable to make this change final without prior proposal
and opportunity for comment, because public comment is not necessary,
in that the change has no substantive effect on the tolerance, but
rather is merely intended to clarify the existing tolerance expression.

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: June 12, 2020.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, the EPA amends
40 CFR part 180 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.  180.378:
0
a. Amend paragraph (a) by:
0
i. Revising the introductory text;
0
ii. In the table, adding, in alphabetical order, the commodities
``celtuce; cherry subgroup 12-12A'', ``fennel, Florence, fresh leaves
and stalks'', ``leaf petiole vegetable subgroup 22B'', ``peach subgroup
12-12B'', ``Swiss chard'', ``tea, plucked leaves; and vegetable,
tuberous and corm, subgroup 1C''; and
0
iii. In the table, removing the commodities ``cherry, sweet'',
``cherry, tart'', ``leaf petioles subgroup 4B'', ``peach'', and
``potato''.
0
b. Amend paragraph (c) by:
0
i. Revising the introductory text; and
0
ii. In the table, adding, in alphabetical order, the commodity ``fruit,
small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F''.
    The revisions and additions read as follows:

Sec.  180.378  Permethrin; tolerances for residues.

    (a) General. Tolerances are established for residues of permethrin,
including its metabolites and degradates, in or on the commodities in
the table below. Compliance with the tolerance levels specified below
is to be determined by measuring only permethrin [(3-
phenoxyphenyl)methyl 3-(2,2-dichloroethenyl)-2,2-
dimethylcyclopropanecarboxylate], as the sum of its cis- and trans-
isomers in or on the commodity.

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

                              * * * * * * *
Celtuce.................................................               5
Cherry subgroup 12-12A..................................               4

                              * * * * * * *
Fennel, Florence, fresh leaves and stalks...............               5

                              * * * * * * *
Leaf petiole vegetable subgroup 22B.....................               5

                              * * * * * * *
Peach subgroup 12-12B...................................               2

                              * * * * * * *
Swiss chard.............................................               5
Tea, plucked leaves \1\.................................              20

                              * * * * * * *
Vegetable, tuberous and corm, subgroup 1C...............            0.05

                              * * * * * * *
------------------------------------------------------------------------
\1\ There are no United States registrations for use of permethrin on
  tea, plucked leaves as of July 28, 2020.

* * * * *
    (c) Tolerances with regional registrations. Tolerances with
regional registrations, as defined in Sec.  180.1(l), are established
for residues of permethrin, including its metabolites and degradates,
in or on the commodities in the table below. Compliance with the
tolerance levels specified below is to be determined by measuring only
permethrin [(3-phenoxyphenyl)methyl 3-(2,2-dichloroethenyl)-2,2-
dimethylcyclopropanecarboxylate], as the sum of its cis- and trans-
isomers in or on the commodity.

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

                              * * * * * * *
Fruit, small, vine climbing, except fuzzy kiwifruit,                   2
 subgroup 13-07F........................................

                              * * * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2020-14419 Filed 7-27-20; 8:45 am]
BILLING CODE 6560-50-P