Document ID: EPA-HQ-OPP-2022-0672-0003
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Cypermethrin
Posted Date: 2023-10-04T04:00Z

[Federal Register Volume 88, Number 191 (Wednesday, October 4, 2023)]
[Rules and Regulations]
[Pages 68475-68481]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-21821]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2022-0508 and EPA-HQ-OPP-2022-0672; FRL-11407-01-OCSPP]

Cypermethrin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
cypermethrin in or on multiple commodities that are identified and 
discussed later in this document. The Tea Association of the U.S.A. 
Inc. and the American Spice Trade Association requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 4, 2023. Objections and 
requests for hearings must be received on or before December 4, 2023 
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-2022-0508 and EPA-HQ-OPP-2022-
0672, is available at https://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 and the OPP docket is 
(202) 566-1744. For the latest status information on EPA/DC services, 
docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration 
Division (7505T), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; 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).

[[Page 68476]]

     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 Office of the 
Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

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-2022-0508 and EPA-HQ-OPP-2022-0672 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 December 4, 2023. 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-2022-0508 and EPA-
HQ-OPP-2022-0672, by one of the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of July 20, 2022 (87 FR 43231) (FRL-9410-
03-OCSPP) 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 
2E8990) by the Tea Association of the U.S.A. Inc., 362 5th Avenue, 
Suite 1002, New York, NY 10001. The petition requested that 40 CFR part 
180 be amended by establishing tolerances for residues of the 
insecticide cypermethrin, including its metabolites and degradates, in 
or on the raw agricultural commodity tea, dried at 15 parts per million 
(ppm). That document referenced a summary of the petition prepared by 
the Tea Association of the U.S.A. Inc., the petitioner, which is 
available in the docket, https://www.regulations.gov.
    In the Federal Register of September 23, 2022 (87 FR 58047) (FRL-
9410-05-OCSPP), 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 2E9011) by the American Spice Trade Association, 1101 17th 
Street NW, Suite 700, Washington, DC 20036. The petition requested that 
40 CFR part 180 be amended by establishing tolerances for residues of 
the insecticide cypermethrin, including its metabolites and degradates, 
in or on some raw agricultural spice commodities (Allspice; anise 
pepper; Ashwagandha fruit; Batavia-cassia, fruit; Belleric myrobalan; 
caper buds; cardamom, black; cardamom, Ethiopian; cardamom, green; 
cardamom, Nepal; cardamom-amomum; cassia, fruit; cassia, Chinese, 
fruit; Chinese hawthorn; Chinese-pepper; cinnamon, fruit; cinnamon, 
Saigon, fruit; coriander, fruit; cumin, black; Dorrigo pepper, berry; 
Dorrigo pepper, leaf; eucalyptus; gamboge; grains of Selim; juniper, 
berry; miracle fruit; pepper, black; pepper, Indian long; pepper, 
Javanese long; pepper, pink; pepper, Sichuan; pepper, white; 
pepperbush, berry; pepperbush, leaf; peppercorn, green; peppertree; 
peppertree, Peruvian; saunders, red; sumac, fragrant; sumac, smooth, 
leaf; tamarind, seed; Tasmanian, pepper, berry; Tsaoko; Vanilla), at 
0.5 ppm; and on other spice commodities (angelica, seed; Asafoetida; 
calamus-root; chaste tree, Chinese, roots; coptis; coriander, seed; 
fingerroot; jalap; lovage, root; lovage, seed; yellow gentian, roots) 
at 0.2 ppm. That document referenced a summary of the petition prepared 
by the American Spice Trade Association, the petitioner, which is 
available in the docket, https://www.regulations.gov.
    No comments were received on either notice of filing.
    Based upon review of the data supporting the petition, EPA is 
revising the tolerance definition and the tolerance level for tea. The 
reason for these changes is 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 cypermethrin including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with cypermethrin follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    The cypermethrins (cypermethrin, zeta-cypermethrin, and alpha-
cypermethrin) are Type II pyrethroids that contain an alpha-cyano 
moiety. The

[[Page 68477]]

adverse outcome pathway (AOP) shared by pyrethroids involves the 
ability to interact with voltage-gated sodium channels (VGSCs) in the 
central and peripheral nervous systems leading to changes in neuron 
firing and, ultimately, neurotoxicity.
    While each active ingredient does not have its own complete 
database, studies have been bridged across the three isomeric mixtures 
and together are considered adequate for human health risk assessment. 
When evaluated together, the toxicity database for cypermethrin, zeta-
cypermethrin, and alpha-cypermethrin can be used to characterize the 
overall suite of effects associated with cypermethrin exposure, 
including potential developmental and reproductive toxicity, 
immunotoxicity, and neurotoxicity. Therefore, the toxicology database 
for the cypermethrins together is considered complete with respect to 
guideline toxicity studies.
    The cypermethrins affect the nervous system, and neurotoxicity is 
the most sensitive effect observed throughout the toxicology database. 
Clinical signs of neurotoxicity were seen for all three compounds 
across species, sexes, and routes of administration. The endpoints and 
points of departure (PODs) selected for risk assessment are based on 
neurotoxicity and are protective of all adverse toxic effects observed 
in the database. EPA determined that the acute toxicity of alpha-
cypermethrin is higher than that of cypermethrin and zeta-cypermethrin. 
To account for this toxicity difference, EPA applied a 5X toxicity 
factor for alpha-cypermethrin. As the current tolerance petitions are 
for cypermethrin, the toxicity PODs for cypermethrin were used for risk 
assessment.
    There was no evidence of increased quantitative or qualitative 
susceptibility in the available rat and rabbit developmental toxicity 
studies and rat 2-generation reproductive studies with the 
cypermethrins. A developmental neurotoxicity (DNT) study with zeta-
cypermethrin indicated increased sensitivity in the offspring, based on 
body weight changes in pups in the absence of treatment-related effects 
in maternal animals at the highest dose tested. However, there is a 
clear no-observed-adverse-effect-level (NOAEL) for effects seen in 
pups, and the doses and endpoints selected for risk assessment are 
protective of the susceptibility.
    For pyrethroid chemicals, the pharmacokinetics indicate that the 
onset of neurotoxicity is rapid, with the time to peak effect for 
neurobehavioral effects occurring within hours. This is followed by 
rapid metabolism and elimination that does not result in 
bioaccumulation. For the cypermethrins, the PODs for clinical signs 
after single or repeated exposure are comparable across durations of 
exposure; thus, neurotoxicity does not seem to progress with increased 
exposure. Therefore, repeated dosing is essentially a series of acute 
exposures. As there is no apparent increase in hazard from repeated/
chronic exposures to cypermethrins, the acute exposure assessment is 
protective of chronic exposures. The totality of the information 
suggests that only single day risk assessments need to be conducted for 
the cypermethrins.
    Cypermethrin is classified as a Group C ``Possible human 
carcinogen,'' based on an increased incidence of benign lung adenomas 
and adenomas plus carcinomas combined in females in a mouse 
carcinogenicity study. No tumors were seen in cypermethrin cancer 
studies in rats or in a cancer study in mice with alpha-cypermethrin. 
The Agency has determined that quantification of cancer risk using a 
non-linear approach (i.e., reference dose or RfD) will adequately 
account for all chronic toxicity, including carcinogenicity, that could 
result from exposure to the cypermethrins.
    Specific information on the studies received and the nature of the 
adverse effects caused by cypermethrin as well as the NOAEL and the 
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies 
can be found at https://www.regulations.gov in document ``Cypermethrin, 
Human Health Risk Assessment for Proposed Tolerances on Tea and 
Commodities of the Codex Crop Subgroups: Spices, Fruit or Berry and 
Spices, Root or Rhizome. The Tolerances are Proposed Without a U.S. 
Registration.'' hereinafter ``Cypermethrin Human Health Risk 
Assessment'' at pages 32-39 in docket ID numbers EPA-HQ-OPP-2022-0508 
and EPA-HQ-OPP-2022-0672.

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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for cypermethrin used for 
human risk assessment can be found in the Cypermethrin Human Health 
Risk Assessment on pages 18-21.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to cypermethrin, EPA considered exposure under the petitioned-
for tolerances as well as all existing tolerances for the cypermethrins 
in 40 CFR 180.418. EPA assessed dietary exposures from cypermethrin 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 cypermethrin.
    In conducting the acute dietary exposure assessment, EPA used the 
2005-2010 food consumption data from the U.S. Department of 
Agriculture's National Health and Nutrition Examination Survey, What We 
Eat in America (NHANES/WWEIA). The acute dietary exposure assessment is 
a conservative assessment that assumes tolerance level residues for 
most commodities and 100 percent crop treated (PCT) for all 
commodities. The highest field trial values obtained in residue studies 
were used for the commodities that make the most significant 
contribution to dietary risk, specifically apples, peaches, pears, and 
grapes. Empirical and conservative default processing factors were used 
in the assessment. EPA determined that the toxicity of alpha-
cypermethrin is higher than that of cypermethrin and zeta-cypermethrin. 
To account for this

[[Page 68478]]

toxicity difference, HED applied a 5X toxicity factor for alpha-
cypermethrin.
    ii. Chronic exposure. A chronic dietary risk assessment is not 
required for the cypermethrins 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, HED performed a chronic dietary exposure 
assessment in support of the current aggregate human health risk 
assessment. There are residential exposures for the cypermethrins that 
were aggregated with background exposure from dietary sources. The 
chronic assessment is only being used to estimate background dietary 
exposure to all cypermethrins.
    The chronic dietary exposure assessment is a refined assessment 
based on Pesticide Data Program (PDP) monitoring data for most 
commodities. Tolerance level residues were used for a limited number of 
commodities including tea and spices. As with the acute assessment, 
empirical and conservative default processing factors were used for the 
processed commodities for which they were available. EPA made the 
conservative assumption that 100% of all commodities would be treated. 
When monitoring data were used, average residues were calculated by 
incorporating one-half limit of detection (LOD) values for all non-
detects. No zeros were used to calculate the average residues. EPA 
accounted for the 5X toxicity difference by multiplying the average PDP 
values for commodities with alpha-cypermethrin tolerances by a factor 
of 5.
    The cypermethrins have food handling establishment (FHE) uses that 
need to be accounted for in the chronic dietary exposure assessment. 
For chronic dietary assessment, EPA used a residue value of one-half 
the FHE tolerance. EPA estimated the probability that a food item a 
person consumes contains residues as a result of treatment in an FHE at 
some point with any pesticide. This risk assessment paradigm is generic 
for all pesticides. To date, such modelling is not specific to 
cypermethrin. This estimate is 4.65%. In the chronic assessment, this 
value was used for the same commodities as the ones with the FHE 
residue value (0.025 ppm). For all commodities with tolerances, the 
total anticipated residue from the agricultural use exceeded the total 
anticipated residue from the FHE use. For this reason, the FHE residue 
value was only used for commodities that don't have tolerances 
associated with direct application to crops.
    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. 
Cypermethrin is classified as a ``possible human carcinogen.'' The 
Agency has determined that quantification of risk using a non-linear 
approach (i.e., aPAD or aRfD) will adequately account for all chronic 
toxicity, including carcinogenicity, that could result from exposure to 
the cypermethrins.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and 
information on the anticipated 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.
    EPA assumed 100% crop treated for all commodities in the acute and 
chronic dietary exposure assessments. However, as discussed above, in 
the chronic assessment, a percent FHE treatment value of 4.65% was 
incorporated for commodities for which the FHE residue value was used.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for cypermethrin in drinking water. Further information 
regarding EPA drinking water models used in pesticide exposure 
assessment can be found at http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment.
    In both the acute and chronic assessments, EPA used estimated 
drinking water concentrations (EDWCs) generated with the Surface Water 
Concentration Calculator (SWCC), and in both assessments, the EDWC was 
used for both direct and indirect water. For the acute dietary risk 
assessment, EPA used an (EDWC) of 3.5 ppb, and for the chronic exposure 
assessment (used to determine background exposure from food and 
drinking water for the purpose of aggregate risk assessment), EPA used 
an EDWC 0.035 ppb. EPA also determined groundwater EDWCs with a 
different model; however, the Agency used the surface water EDWCs in 
the assessments because the surface water EDWCs were higher than the 
groundwater EDWCs. The use of the surface water values in the dietary 
exposure assessment is protective of potential exposure through 
groundwater sources of drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). The cypermethrins are 
registered for a variety of non-agricultural purposes including 
recreational sites (i.e., golf courses, athletic fields); indoor 
residential/commercial/industrial sites/structural/perimeter and lawn 
uses; gardens and trees; as well as mosquito adulticide, termiticide, 
and pet uses. The current action is for tolerances without a U.S. 
registration for tea and spices, so no residential handler or post-
application exposures are anticipated.
    For assessing aggregate exposure to adults, the Agency used 
exposures from the inhalation handler scenario from applying 
cypermethrin with a sprinkler can to home gardens. For assessing 
aggregate exposure to children, the Agency used exposures to children 1 
to <2 years old (dermal and incidental oral) from post-application 
exposure to pets treated with the pet medallion/tag formulated with 
zeta-cypermethrin.
    The PODs for the oral and dermal routes are based on the same 
effects: therefore, for children, the oral and dermal routes can be 
combined. Since the levels of concern for incidental oral risk and 
inhalation risk are different (100 and 30, respectively), the aggregate 
risk index (ARI) approach was used to calculate aggregate exposure and 
risk for adults. An ARI >=1 is not of concern.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at https://www.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

[[Page 68479]]

common mechanism of toxicity (https://www.regulations.gov; EPA-HQ-OPP-
2008-0489-0006). 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 https://www.regulations.gov; EPA-HQ-OPP-2011-0746. 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/registration-review-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 those uses being granted. A new turf use for the 
pyrethroid, tau-fluvalinate, was assessed after completion of the 
cumulative. The new use did impact the worst-case non-dietary risk 
estimates identified in the 2011 CRA for the turf scenario. However, 
the overall risk finding (i.e., pyrethroid cumulative risk is above the 
Agency's level of concern (LOC) and therefore not of concern) did not 
change upon registration of this new use.
    For the requested tolerances for tea and spices, the Agency has 
conducted an additional screen, taking into account all previously 
approved uses and these proposed tolerances. The petitioned-for 
tolerances 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; furthermore, the petitioned-for tolerances are not 
associated with any increase in residential or non-occupational 
exposure. 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 Food Quality 
Protection Act (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 quantitative or qualitative susceptibility in the available 
rat and rabbit developmental toxicity studies and rat 2-generation 
reproductive studies with the cypermethrins. A developmental 
neurotoxicity (DNT) study with zeta-cypermethrin indicated increased 
sensitivity in the offspring, based on body weight changes in pups in 
the absence of treatment-related effects in maternal animals at the 
highest dose tested. However, there is a clear NOAEL for effects seen 
in pups, and the doses and endpoints selected for risk assessment are 
protective of the susceptibility.
    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 from 10X to 1X. That decision is based on the 
following findings:
    i. The toxicity database for the cypermethrins is considered 
complete. When evaluated together, the toxicity database for 
cypermethrin, zeta-cypermethrin, and alpha-cypermethrin can be used to 
characterize the overall suite of effects associated with cypermethrin 
exposure, including potential developmental and reproductive toxicity, 
immunotoxicity, and neurotoxicity. Acceptable developmental toxicity 
studies in rats and rabbits, reproduction studies in rats, 
neurotoxicity studies (acute, subchronic, and developmental 
neurotoxicity) in rats, and immunotoxicity studies in rats are 
available.
    ii. Like other pyrethroids, the cypermethrins cause neurotoxicity 
by interacting with sodium channels, leading to clinical signs of 
neurotoxicity. These effects are well characterized and adequately 
assessed by the available guideline and non-guideline studies. There 
are no residual uncertainties with regard to evidence of neurotoxicity 
for the cypermethrins.
    iii. No evidence of increased qualitative or quantitative 
susceptibility was noted in the developmental toxicity or reproduction 
studies for the cypermethrins. However, quantitative susceptibility was 
seen in the rat DNT study with zeta-cypermethrin with an increased 
sensitivity in the offspring based on body weight changes in pups in 
the absence of adverse, treatment-related effects in maternal animals. 
The results from the DNT study are very similar to results observed in 
the reproduction studies where body weight changes (decreased body 
weight gain) were seen in maternal and offspring animals at doses 
similar to those in the DNT study, with no indication of increased 
susceptibility. Therefore, there is no residual concern for effects 
observed in the study since a clear developmental NOAEL and LOAEL were 
identified for which the selected PODs for risk assessment are 
protective.
    iv. There are no residual uncertainties with regard to exposure. 
The dietary exposure assessments account for parent and metabolites of 
concern. In addition, they are refined, but could be more highly 
refined. The assessments include 100 percent crop treated assumptions, 
tolerance level residues for most commodities in the acute dietary 
exposure assessment, and default processing factors for many of the 
processed commodities. Furthermore, conservative, upper-bound 
assumptions were used to determine exposure through drinking water and 
residential sources, such that these exposures have not been 
underestimated.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing dietary exposure estimates to the acute 
PAD (aPAD) and chronic PAD (cPAD). Short-, intermediate-, and chronic-
term aggregate risks are evaluated by comparing the estimated total 
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. Using the exposure assumptions described in this unit 
for acute exposure, EPA has concluded that acute exposure to 
cypermethrin from food and water will utilize 71% of the aPAD for 
children 1 to 2 years old, the population group receiving the greatest 
exposure. Acute aggregate risk estimates are not of concern for the 
general U.S. population or any population subgroup.
    2. Chronic risk. A chronic dietary risk assessment is not required 
for cypermethrin because repeated

[[Page 68480]]

exposure does not result in a POD 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). Cypermethrin 
is 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 cypermethrin.
    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 an aggregate MOE of 130 for 
children and an ARI of 4.5 for adults. Because EPA's level of concern 
for cypermethrin is an MOE below 100, or an ARI below 1, these MOEs/
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). While there is potential intermediate-term residential 
exposure, because the single dose and repeat dosing cypermethrin 
studies show that repeat exposures do not result in lower points of 
departure, the residential assessments are conducted as a series of 
acute exposures and the same endpoint is used regardless of duration. 
Therefore, the short-term aggregate assessment is considered protective 
of any intermediate-term exposures.
    5. Aggregate cancer risk for U.S. population. EPA has classified 
cypermethrin as a ``possible human carcinogen'' and determined that a 
non-linear approach relying on the acute regulatory endpoints should be 
used for cancer assessment. As the acute dietary exposure estimates are 
not of concern, cancer risk is not of concern.
    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 cypermethrin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate tolerance-enforcement methods are available in PAM 
(Pesticide Analytical Manual) Volume II for determining residues of 
zeta-cypermethrin in plant (Method I) and livestock (Method II) 
commodities. Both methods are gas chromatographic methods with 
electron-capture detection (GC/ECD) and have undergone successful 
Agency petition method validations (PMVs). These methods are not 
stereospecific; therefore, no distinction is made between residues of 
cypermethrin (all 8 stereoisomers), zeta-cypermethrin (enriched in 4 
isomers) and alpha-cypermethrin (enriched in 2 isomers).

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).
    Codex has established an MRL of 15 ppm for residues of cypermethrin 
in or on tea. The U.S. tolerance for residues of cypermethrin in or on 
Tea, dried is harmonized with the Codex MRL.
    Codex has established an MRL of 0.5 ppm for residues of 
cypermethrin on the crop subgroup Spices, Fruits and Berries and an MRL 
of 0.2 ppm for residues on the crop subgroup Spices, Roots and 
Rhizomes. The U.S. tolerances for residues of cypermethrin in or on the 
individual spice commodities are harmonized with the relevant Codex 
MRL.

C. Revisions to Petitioned-For Tolerances

    The Tea Association requested a tolerance of 15.0 ppm for Tea. The 
United States conforms to OECD rounding classes when setting tolerances 
and is establishing the tolerance level at 15 ppm rather than 15.0 ppm 
for Tea, dried.

V. Conclusion

    Therefore, tolerances are established for residues of cypermethrin, 
including its metabolites and degradates, in or on Allspice at 0.5 ppm; 
Angelica, seed at 0.2 ppm; Anise pepper at 0.5 ppm; Asafoetida at 0.2 
ppm; Ashwagandha fruit at 0.5 ppm; Batavia-cassia, fruit at 0.5 ppm; 
Belleric myrobalan at 0.5 ppm; Calamus-root at 0.2 ppm; Caper buds at 
0.5 ppm; Cardamom, black at 0.5 ppm; Cardamom, Ethiopian at 0.5 ppm; 
Cardamom, green at 0.5 ppm; Cardamom, Nepal at 0.5 ppm; Cardamom-amomum 
at 0.5 ppm; Cassia, fruit at 0.5 ppm; Cassia, Chinese, fruit at 0.5 
ppm; Chaste tree, Chinese, roots at 0.2 ppm; Chinese hawthorne at 0.5 
ppm; Chinese-pepper at 0.5 ppm; Cinnamon, fruit at 0.5 ppm; Cinnamon, 
Saigon, fruit at 0.5 ppm; Coptis at 0.2 ppm; Coriander, fruit at 0.5 
ppm; Coriander, seed at 0.2 ppm; Cumin, black at 0.5 ppm; Dorrigo 
pepper, berry at 0.5 ppm; Dorrigo pepper, leaf at 0.5 ppm; Eucalyptus 
at 0.5 ppm; Fingerroot at 0.2 ppm; Gamboge at 0.5 ppm; Grains of Selim 
at 0.5 ppm; Jalap at 0.2 ppm; Juniper, berry at 0.5 ppm; Lovage, root 
at 0.2 ppm; Lovage, seed at 0.2 ppm; Miracle fruit at 0.5 ppm; Pepper, 
black at 0.5 ppm; Pepper, Indian long at 0.5 ppm; Pepper, Javanese, 
long at 0.5 ppm; Pepper, pink at 0.5 ppm; Pepper, Sichuan at 0.5 ppm; 
Pepper, white at 0.5 ppm; Pepperbush, berry at 0.5 ppm; Pepperbush, 
leaf at 0.5 ppm; Peppercorn, green at 0.5 ppm; Peppertree at 0.5 ppm; 
Peppertree, Peruvian at 0.5 ppm; Saunders, red at 0.5 ppm; Sumac, 
fragrant at 0.5 ppm; Sumac, smooth, leaf at 0.5 ppm; Tamarind, seed at 
0.5 ppm; Tasmanian, pepper, berry at 0.5 ppm; Tea, dried at 15 ppm; 
Tsaoko at 0.5 ppm; Vanilla at 0.5 ppm; and Yellow gentian, roots at 0.2 
ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). 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,

[[Page 68481]]

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: September 24, 2023.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

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.  180.418, revise paragraph (a)(1) to read as follows:

Sec.  180.418  Cypermethrin and isomers alpha-cypermethrin and zeta-
cypermethrin; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide cypermethrin ()alpha cyano-(3-
phenoxyphenyl)methyl ()cis,trans-3(2,2-dichloroethenyl-2,2-
dimethylcyclopropanecarboxylate in or on the commodities in table 1 to 
paragraph (a)(1).

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Allspice \1\................................................         0.5
Angelica, seed \1\..........................................         0.2
Anise pepper \1\............................................         0.5
Asafoetida \1\..............................................         0.2
Ashwagandha fruit \1\.......................................         0.5
Batavia-cassia, fruit \1\...................................         0.5
Belleric myrobalan \1\......................................         0.5
Brassica, head and stem, subgroup 5A........................         2.0
Brassica, leafy greens, subgroup 5B.........................        14.0
Calamus-root \1\............................................         0.2
Caper buds \1\..............................................         0.5
Cardamom, black \1\.........................................         0.5
Cardamom, Ethiopian \1\.....................................         0.5
Cardamom, green \1\.........................................         0.5
Cardamom, Nepal \1\.........................................         0.5
Cardamom-amomum \1\.........................................         0.5
Cassia, fruit \1\...........................................         0.5
Cassia, Chinese, fruit \1\..................................         0.5
Cattle, fat.................................................         1.0
Cattle, meat................................................         0.2
Cattle, meat byproducts.....................................        0.05
Chaste tree, Chinese, roots \1\.............................         0.2
Chinese hawthorne \1\.......................................         0.5
Chinese-pepper \1\..........................................         0.5
Cinnamon, fruit \1\.........................................         0.5
Cinnamon, Saigon, fruit \1\.................................         0.5
Coptis \1\..................................................         0.2
Coriander, fruit \1\........................................         0.5
Coriander, seed \1\.........................................         0.2
Cotton, gin byproducts......................................        11.0
Cotton, undelinted seed.....................................         0.5
Cumin, black \1\............................................         0.5
Dorrigo pepper, berry \1\...................................         0.5
Dorrigo pepper, leaf \1\....................................         0.5
Egg.........................................................        0.05
Eucalyptus \1\..............................................         0.5
Fingerroot \1\..............................................         0.2
Gamboge \1\.................................................         0.5
Grains of Selim \1\.........................................         0.5
Goat, fat...................................................         1.0
Goat, meat..................................................         0.2
Goat, meat byproducts.......................................        0.05
Hog, fat....................................................         0.1
Hog, meat...................................................        0.05
Horse, fat..................................................         1.0
Horse, meat.................................................         0.2
Horse, meat byproducts......................................        0.05
Jalap \1\...................................................         0.2
Juniper, berry \1\..........................................         0.5
Lettuce, head...............................................         4.0
Lovage, root \1\............................................         0.2
Lovage, seed \1\............................................         0.2
Milk, fat (reflecting 0.10 in whole milk)...................         2.5
Miracle fruit \1\...........................................         0.5
Onion, bulb.................................................         0.1
Onion, green................................................         6.0
Pecan.......................................................        0.05
Pepper, black \1\...........................................         0.5
Pepper, Indian long \1\.....................................         0.5
Pepper, Javanese, long \1\..................................         0.5
Pepper, pink \1\............................................         0.5
Pepper, Sichuan \1\.........................................         0.5
Pepper, white \1\...........................................         0.5
Pepperbush, berry \1\.......................................         0.5
Pepperbush, leaf \1\........................................         0.5
Peppercorn, green \1\.......................................         0.5
Peppertree \1\..............................................         0.5
Peppertree, Peruvian \1\....................................         0.5
Poultry, fat................................................        0.05
Poultry, meat...............................................        0.05
Saunders, red \1\...........................................         0.5
Sheep, fat..................................................         1.0
Sheep, meat.................................................         0.2
Sheep, meat byproducts......................................        0.05
Sumac, fragrant \1\.........................................         0.5
Sumac, smooth, leaf \1\.....................................         0.5
Tamarind, seed \1\..........................................         0.5
Tasmanian, pepper, berry \1\................................         0.5
Tea, dried \1\..............................................          15
Tsaoko \1\..................................................         0.5
Vanilla \1\.................................................         0.5
Yellow gentian, roots \1\...................................         0.2
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of October 4, 2023.

* * * * *
[FR Doc. 2023-21821 Filed 10-3-23; 8:45 am]
BILLING CODE 6560-50-P