[Federal Register Volume 85, Number 145 (Tuesday, July 28, 2020)]
[Rules and Regulations]
[Pages 45329-45336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805.
    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: (703) 305-7090; email address: [email protected].

SUPPLEMENTARY INFORMATION:

[[Page 45330]]

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

[[Page 45331]]

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%);

[[Page 45332]]

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

[[Page 45333]]

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.

[[Page 45334]]

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

[[Page 45335]]

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
 

[[Page 45336]]

 
                              * * * * * * *
------------------------------------------------------------------------
\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