[Federal Register Volume 86, Number 147 (Wednesday, August 4, 2021)]
[Rules and Regulations]
[Pages 41895-41906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16189]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0651; FRL-8623-01-OCSPP]


Zeta-Cypermethrin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of zeta-
cypermethrin in or on multiple commodities that 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 August 4, 2021. Objections and 
requests for hearings must be received on or before October 4, 2021, 
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-2019-0651, is available online at 
http://www.regulations.gov or in-person 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.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, 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: 
RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2019-0651 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 
October 4, 2021. 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-2019-0651, 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.

[[Page 41896]]

II. Summary of Petitioned-For Tolerance

    In the Federal Register of April 15, 2020 (85 FR 20910) (FRL-10006-
54), 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 
9E8790) by IR-4, Rutgers, The State University of New Jersey, 500 
College Road East, Suite 201W, Princeton, NJ 08540. The petition 
requested EPA to establish tolerances in 40 CFR part 180 for residues 
of zeta-cypermethrin (S-cyano(3-phenoxyphenyl) methyl ())(cis-trans 3-(2,2-dichloroethenyl)-2,2 
dimethylcyclopropanecarboxylate), including its metabolites and 
degradates, measuring only total cypermethrin, cyano(3-
phenoxyphenyl)methyl 3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropane 
carboxylate, in or on 116 separate commodities and to remove 52 
established commodities upon establishment of the new commodities. Due 
to the length of the list of commodities, please refer to the Notice of 
Filing referenced above for a complete list of commodities to be 
established and removed. That document referenced a summary of the 
petition prepared by FMC, the registrant, which is available in the 
docket, http://www.regulations.gov. A comment was received on the 
notice of filing. EPA's response to this comment is discussed in Unit 
IV.C.
    Based upon review of the data supporting the petition, EPA is 
establishing some tolerances at different levels than were petitioned 
for and is also modifying some of the commodity definitions to be 
consistent with Agency nomenclature. The reason for these changes is 
explained in Unit IV.D.

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 zeta-cypermethrin including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with zeta-
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.
    Type II pyrethroids, such as the cypermethrins (cypermethrin, zeta-
cypermethrin, and alpha-cypermethrin), contain an alpha-cyano moiety, 
and in rats produce a syndrome that includes pawing, burrowing, 
salivation, hypothermia, and coarse tremors leading to choreoathetosis. 
The adverse outcome pathway (AOP) shared by pyrethroids involves the 
ability to interact with voltage-gated sodium channels (VGSCs) in the 
central and peripheral nervous system, leading to changes in neuron 
firing and, ultimately, neurotoxicity.
    The toxicology database for the cypermethrins is considered 
complete with respect to guideline toxicity studies. While each active 
ingredient does not have its own complete database, studies have been 
bridged across the three chemicals and together are considered adequate 
for human health risk assessment. When evaluated together, the toxicity 
database for the cypermethrins can be used to characterize the overall 
suite of effects associated with cypermethrin exposure, including 
potential developmental and reproductive toxicity, immunotoxicity, and 
neurotoxicity.
    The cypermethrins affect the nervous system, and neurotoxicity is 
the most sensitive effect observed throughout the toxicology database. 
Effects (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 toxic effects 
observed in the database.
    There was no evidence of increased quantitative or qualitative 
susceptibility in the available rat and rabbit developmental toxicity 
studies and rat two-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.
    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 accumulation. 
For the cypermethrins, the points of departure (PODs) for clinical 
signs after single or repeated exposure are comparable across durations 
of exposure. Thus, consistent with this class of compounds, 
neurotoxicity is not considered to progress with repeated 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., RfD) will adequately account for all chronic 
toxicity, including carcinogenicity, that could result from exposure to 
the cypermethrins. While the Agency would typically use a chronic 
population adjusted dose (cPAD) to protect for cancer concerns, use of 
the acute population adjusted dose (aPAD) is considered protective 
because increasing toxicity with increasing

[[Page 41897]]

duration of exposure is not demonstrated for the cypermethrins. The 
NOAEL in the mouse cancer study is 57 mg/kg/day and tumors were seen at 
229 mg/kg/day. The acute point of departure (POD) of 7.16 mg/kg/day 
selected for risk assessment is 32-fold lower than the dose that 
induced lung tumors in mice. Only the mouse study with cypermethrin 
resulted in tumor formation: No evidence of carcinogenicity was 
observed in cancer studies in rats with cypermethrin or mice with 
alpha-cypermethrin.
    Specific information on the studies received and the nature of the 
adverse effects caused by zeta-cypermethrin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled ``Zeta-Cypermethrin, Human 
Health Risk Assessment for a Proposed Use on Basil and Various Crop 
Group Expansions and Conversions'' (hereinafter ``Zeta-Cypermethrin 
Human Health Risk Assessment'') on pages 45-51 in docket ID number EPA-
HQ-OPP-2019-0651.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticide.
    A summary of the toxicological endpoints for zeta-cypermethrin used 
for human risk assessment can be found in the Zeta-Cypermethrin Human 
Health Risk Assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to zeta-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 
zeta-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.
    In conducting the acute dietary exposure assessment, EPA used the 
2003-2008 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 refined probabilistic assessment based on tolerance level residues 
for most commodities and Pesticide Data Program (PDP) monitoring data 
for the commodities that make the most significant contribution to 
dietary risk. Estimates of the maximum percent crop treated were used 
for the same commodities for which PDP data were used and for one 
commodity for which the tolerance was used. Additional information on 
the assumptions used in the acute assessment can be found on pages 35-
36 in the Zeta-Cypermethrin Human Health Risk Assessment.
    ii. Chronic exposure. A chronic dietary risk assessment is not 
required for zeta-cypermethrin because repeated 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. However, EPA performed a chronic dietary exposure 
assessment for use in the aggregate assessment, since there are 
residential exposures for zeta-cypermethrin that need to be aggregated 
with background exposure from dietary sources. In the aggregate human 
health risk assessment, the average or chronic exposure estimates are 
combined with the appropriate residential exposure estimates and 
compared to the POD for zeta-cypermethrin.
    The chronic dietary exposure assessment is a highly refined 
assessment based on Pesticide Data Program (PDP) monitoring data for 
most commodities. Tolerance level residues were used for a small number 
of commodities including fresh and dried basil; however, these 
commodities are not highly consumed and, therefore, they make a 
negligible contribution to the dietary risk. Refining the residue 
estimates for these commodities would have an insignificant effect on 
exposure estimates. As with the acute assessment, conservative default 
processing factors were generally used for the processed commodities 
for which they were available. The Agency made the conservative 
assumption that 100% of all commodities would be treated. When 
monitoring data were used, average residues were calculated by 
incorporating \1/2\ limit of detection (LOD) values for all non-
detects. No zeros were used to calculate the average residues. The 
cypermethrins have food handling establishment (FHE) uses that need to 
be accounted for in the chronic dietary exposure assessment. For these 
uses, EPA used a residue value of one-half the tolerance. BEAD provided 
an estimate of 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. It is not specific to the cypermethrins. 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). In 
cases where the total anticipated residue from the FHE use exceeded the 
total anticipated residue from the agricultural use, the FHE 
anticipated residue was used.
    iii. Cancer. 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 on cypermethrin. 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 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

[[Page 41898]]

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.
    For the acute assessment, the following PCT assumptions were made:
Cypermethrin
    The following maximum percent crop treated estimates were used in 
the acute dietary risk assessment for the following crops that are 
currently registered for cypermethrin: Lettuce, head: 5%; lettuce, 
leaf: 5%; broccoli: 10%; cabbage: 10%; cauliflower: 10%.
Zeta-Cypermethrin
    The following maximum percent crop treated estimates were used in 
the acute dietary risk assessment for the following crops that are 
currently registered for zeta-cypermethrin: Lettuce, head: 75%; 
lettuce, leaf: 75%; spinach: 55%; celery: 60%; broccoli: 30%; cabbage: 
45%; cauliflower: 25%; bean, green: 20%; tomato, puree: 20%; orange, 
juice: 55%; grapefruit, juice: 65%; peach: 10%; grape: 5%; rice: 15%; 
sugarcane: 2.5%.
Alpha-Cypermethrin
    The following maximum percent crop treated estimates were used in 
the acute dietary risk assessment for the following crops that are 
currently registered for cypermethrin: Lettuce, head: 20%; lettuce, 
leaf: 20%; spinach: 2.5%; celery: 2.5%; broccoli: 2.5%; cabbage: 2.5%; 
cauliflower: 2.5%; bean, green: 2.5%; tomato, puree: 2.5%; orange, 
juice: 2.5%; grapefruit, juice: 2.5%; rice: 85%.
    In the chronic assessment, the Agency made the conservative 
assumption of 100% crop treated for all commodities with established 
tolerances. However, PCT was effectively incorporated into the 
assessment through the use of monitoring data for some commodities, 
which reflect the PCT for commodities in commerce. For the FHE uses, 
EPA incorporated an estimate of 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 estimate is 4.65%, which is not 
specific to the cypermethrins. In the chronic assessment, EPA used this 
value for all commodities that do not have established tolerances. EPA 
also used this value when the total anticipated residue for a commodity 
was higher for the FHE use than it was for the agricultural use.
    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 zeta-cypermethrin 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 zeta-cypermethrin in drinking water. Further information 
regarding EPA drinking water models used in pesticide exposure 
assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Surface Water Concentration Calculator (SWCC) and the 
Pesticide Root Zone Model for Groundwater (PRZM-GW), for the acute 
dietary risk assessment, EPA used an estimated drinking water 
concentration (EDWC) of 3.5 ppb in the DEEM-FCID Model. For the chronic 
exposure assessment (used to determine background exposure from food 
and drinking water for the purpose of aggregate risk assessment), EPA 
used a value of 0.035 ppb for both direct and indirect water. The 
groundwater estimate of 0.0036 ppb was much lower than surface water 
residues; therefore, the Agency used the surface water EDWCs in the 
assessments. 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 does not add any new uses with 
residential exposures.
    For assessing aggregate exposure to adults, the Agency used 
exposures from

[[Page 41899]]

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), 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 http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    The Agency has determined that the pyrethroids and pyrethrins share 
a common mechanism of toxicity http://www.regulations.gov; EPA-HQ-OPP-
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 http://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/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. The most recent screen, which 
takes into account the previous uses and the new use on basil, 
demonstrates that the new uses will not significantly impact the 
cumulative assessment because dietary exposures comprise only a minor 
contribution to the total pyrethroid exposure. Therefore, there are no 
cumulative risks of concern for the pyrethroids and 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. 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 developmental 
neurotoxicity (DNT) study with zeta-cypermethrin with an increased 
sensitivity in the offspring based on body weight changes in pups (5-
10%) 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 (BW) changes 
(decreased BW 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 and a clear developmental NOAEL and LOAEL 
were identified.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for the cypermethrins is complete.
    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 developmental neurotoxicity (DNT) study, but for the 
reasons discussed in Unit III.D.2, there is no residual concern for 
effects observed in the study and a clear developmental NOAEL and LOAEL 
were identified.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary exposure assessments account for parent and 
metabolites of concern. The assessments include percent crop treated 
assumptions and conservative, default processing factors. 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 aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. Using the exposure assumptions described in this unit 
for acute exposure, EPA has concluded that acute exposure to zeta-
cypermethrin from food and water will utilize 35% of the aPAD for 
adults 20 to 49 years old, the population group receiving the greatest 
exposure.
    2. Chronic risk. A chronic dietary risk assessment is not required 
for zeta-cypermethrin because repeated 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

[[Page 41900]]

short-term residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Zeta-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 zeta-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 140 for 
children and an ARI of 4.7 for adults. Because EPA's level of concern 
for zeta-cypermethrin is an MOE of 100 or below, or an ARI of 1 or 
below, 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 
zeta-cypermethrin as a ``possible human carcinogen'' and determined 
that a non-linear approach 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 zeta-cypermethrin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate tolerance-enforcement methods are available in PAM 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). 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). 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.
    There is no Codex MRL for cypermethrin or the enriched forms, 
alpha- and zeta-cypermethrin, in/on basil. There are, however, Codex 
MRLs for numerous commodities contained in the crop groups and 
subgroups for which tolerances are being established in this 
rulemaking. EPA is harmonizing the tolerances with Codex MRLs for teff, 
grain; tomato; the commodities in the fruit, stone group 12-12, fruit, 
citrus subgroups 10-10A, 10-10B, and 10-10C, and the nut, tree, group 
14-12; edible podded beans and peas; and dried beans and peas.
    EPA is not harmonizing several U.S. tolerances with corresponding 
Codex MRLs because the Codex MRLs are lower than the U.S. tolerances. 
The available residue data indicate that use under registered U.S. 
pesticide products would exceed the Codex MRLs and thus harmonizing 
could result in food being adulterated when following approved label 
instructions. EPA does not consider the lack of harmonization in these 
instances to provide a trade barrier to imports since commodities that 
comply with the Codex MRL could be imported into the United States. The 
U.S. tolerances that are not being harmonized for this reason are 
onion, bulb, subgroup 3-07A; onion, green, subgroup 3-07B; fruit, 
small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F; 
rapeseed, subgroup 20A; sunflower, subgroup 20B; cottonseed, subgroup 
20C; quinoa, grain; leafy greens subgroup 4-16A; Brassica, leafy 
greens, subgroup 4-16B; vegetable, Brassica, head and stem, group 5-16; 
fruit, pome, group 11-10; and kohlrabi.
    In addition, EPA is establishing tolerances for the fruiting 
vegetable crop group 8-10, which includes tomato, bell pepper, nonbell 
pepper, eggplant, and okra, at 0.2 ppm because the available 
representative commodity data support establishing the crop group at 
0.2 ppm. While this action harmonizes with the Codex MRL for tomato, it 
results in tolerance levels for the other commodities in the crop group 
being different from the Codex MRLs for other commodities in that group 
since Codex has established different levels for the different 
commodities. EPA has determined it is appropriate to maintain the crop 
group based on the representative commodity data supporting the group 
tolerance. Finally, EPA is not harmonizing tolerances for succulent 
shelled beans and peas commodities with the Codex MRLs for such 
commodities because the magnitude of the difference is too great. The 
current tolerance for the subgroup is 0.1 ppm, versus the Codex MRL of 
0.7 ppm. In addition, the U.S. tolerance is currently harmonized with 
the Canadian MRL of 0.1 ppm for succulent shelled peas.

C. Response to Comments

    One comment was received in response to the Notice of Filing. The 
comment stated in part that the Agency should ``deny ir4 rutgers 
chemical profiteering college from getting a permit.'' Although the 
Agency recognizes that some individuals believe that pesticides should 
be banned on agricultural crops, the existing legal framework provided 
by section 408 of the FFDCA authorizes EPA to establish tolerances when 
it determines that the tolerance is safe. Upon consideration of the 
validity, completeness, and reliability of the available data as well 
as other factors the FFDCA requires EPA to consider, EPA has determined 
that the zeta-cypermethrin tolerances are safe. The commenter has 
provided no information indicating that a safety determination cannot 
be supported.

D. Revisions to Petitioned-For Tolerances

    Commodity definitions have been corrected to be consistent with 
Agency nomenclature. Also, EPA is not establishing a tolerance for 
edible podded pea as requested because the commodity is being removed 
from the proposed crop group 6-19. Edible podded pea is being removed 
from proposed crop group 6-19 because it is not referring to any 
specific pea.

[[Page 41901]]

    The petitioner requested a tolerance of 0.7 ppm for the individual 
commodities in the proposed revisions to crop subgroup 6B, succulent 
shelled pea and bean subgroup. EPA is not revising the level of the 
individual tolerances because the magnitude of the difference is too 
great. The current tolerance for the subgroup is 0.1 ppm. In addition, 
the U.S. tolerance is currently harmonized with the Canadian MRL of 0.1 
ppm for succulent shelled peas.
    The petitioner requested a tolerance of 0.35 ppm for fruit, citrus, 
group 10-10. Codex has established MRLs of 0.3 ppm for citrus except 
pummelo and shaddock, and 0.5 ppm for the pummelo and grapefruits 
subgroup (including shaddock-like hybrids among other grapefruits). The 
0.3 ppm Codex MRL is based on U.S. residue data. As a result, the 
Agency is establishing a tolerance of 0.3 ppm for the orange subgroup 
10-10A and the lemon/lime subgroup 10-10B. The Agency is also 
establishing a tolerance of 0.5 ppm for the grapefruit subgroup 10-10C 
to harmonize with the Codex MRL of 0.5 ppm for the pummelo and 
grapefruits subgroup.
    The petitioner requested a tolerance of 0.2 ppm for teff, grain. 
There is a Codex MRL of 0.3 ppm for Cereal grains except rice, barley, 
oats, rye, and wheat. The Codex cereal grains crop group includes teff. 
As a result, EPA is setting the tolerance on teff, grain at 0.3 ppm to 
harmonize with Codex.

E. International Trade Considerations

    In this rule, EPA is establishing a lower tolerance for zeta-
cypermethrin residues in or on the orange subgroup 10-10-A and the 
lemon/lime subgroup 10-10B than the current tolerance. The current 
tolerance for the fruit, citrus, group 10 is 0.35 ppm. For the reasons 
explained in Unit IV.D of this document (i.e., to harmonize with the 
Codex MRLs), the Agency believes these revised, lower tolerances are 
appropriate.
    In accordance with the World Trade Organization's (WTO) Sanitary 
and Phytosanitary Measures (SPS) Agreement, EPA intends to notify the 
WTO of the changes to these tolerances in order to satisfy its 
obligations under the Agreement. In addition, the SPS Agreement 
requires that Members provide a ``reasonable interval'' between the 
publication of a regulation subject to the Agreement and its entry into 
force to allow time for producers in exporting Member countries to 
adapt to the new requirement. Accordingly, EPA is establishing an 
expiration date for the existing tolerance to allow this tolerance to 
remain in effect for a period of six months after the effective date of 
this final rule. After the 6-month period expires, this tolerance will 
be reduced or revoked, as indicated in the regulatory text, and 
allowable residues on fruit, citrus, group 10 must conform to the 
tolerance for subgroups 10-10A and 10-10B.
    This reduction in tolerance level is not discriminatory; the same 
food safety standard contained in the FFDCA applies equally to 
domestically produced and imported foods. The new tolerance level is 
supported by available residue data.

V. Conclusion

    Therefore, tolerances are established for residues of zeta-
cypermethrin in or on the following commodities: Basil, dried leaves at 
40 ppm; Basil, fresh leaves at 7 ppm; Bean, adzuki, dry seed at 0.05 
ppm; Bean, American potato, dry seed at 0.05 ppm; Bean, asparagus, dry 
seed at 0.05 ppm; Bean, asparagus, edible podded at 0.7 ppm; Bean, 
black, dry seed at 0.05 ppm; Bean, broad, dry seed at 0.05 ppm; Bean, 
broad, succulent shelled at 0.1 ppm; Bean, catjang, edible podded at 
0.7 ppm; Bean, catjang, dry seed at 0.05 ppm; Bean, catjang, succulent 
shelled at 0.1 ppm; Bean, cranberry, dry seed at 0.05 ppm; Bean, dry, 
dry seed at 0.05 ppm; Bean, field, dry seed at 0.05 ppm; Bean, French, 
dry seed at 0.05 ppm; Bean, French, edible podded at 0.7 ppm; Bean, 
garden, dry seed at 0.05 ppm; Bean, garden, edible podded at 0.7 ppm; 
Bean, goa, dry seed at 0.05 ppm; Bean, goa, edible podded at 0.7 ppm; 
Bean, goa, succulent shelled at 0.1 ppm; Bean, great northern, dry seed 
at 0.05 ppm; Bean, green, dry seed at 0.05 ppm; Bean, green, edible 
podded at 0.7 ppm; Bean, guar, dry seed at 0.05 ppm; Bean, guar, edible 
podded at 0.7 ppm; Bean, kidney, dry seed at 0.05 ppm; Bean, kidney, 
edible podded at 0.7 ppm; Bean, lablab, dry seed 0.05 ppm; Bean, 
lablab, edible podded 0.7 ppm; Bean, lablab, succulent shelled at 0.1 
ppm; Bean, lima, dry seed at 0.05 ppm; Bean, lima, succulent shelled at 
0.1 ppm; Bean, morama, dry seed at 0.05 ppm; Bean, moth, dry seed at 
0.05 ppm; Bean, moth, edible podded at 0.7 ppm; Bean, moth, succulent 
shelled at 0.1 ppm; Bean, mung, dry seed at 0.05 ppm; Bean, mung, 
edible podded at 0.7 ppm; Bean, navy, dry seed at 0.05 ppm; Bean, navy, 
edible podded at 0.7 ppm; Bean, pink, dry seed at 0.05 ppm; Bean, 
pinto, dry seed at 0.05 ppm; Bean, red, dry seed at 0.05 ppm; Bean, 
rice, dry seed at 0.05 ppm; Bean, rice, edible podded at 0.7 ppm; Bean, 
scarlet runner, dry seed at 0.05 ppm; Bean, scarlet runner, edible 
podded at 0.7 ppm; Bean, scarlet runner, succulent shelled at 0.1 ppm; 
Bean, snap, edible podded at 0.7 ppm; Bean, sword, dry seed at 0.05 
ppm; Bean, sword, edible podded at 0.7 ppm; Bean, tepary, dry seed at 
0.05 ppm; Bean, urd, dry seed at 0.05 ppm; Bean, urd, edible podded at 
0.7 ppm; Bean, wax, edible podded at 0.7 ppm; Bean, wax, succulent 
shelled at 0.1 ppm; Bean, yardlong, dry seed at 0.05 ppm; Bean, 
yardlong, edible podded at 0.7 ppm; Bean, yellow, dry seed at 0.05 ppm; 
Brassica, leafy greens, subgroup 4-16B at 14 ppm; Bushberry subgroup 
13-07B at 0.8 ppm; Caneberry subgroup 13-07A at 0.8 ppm; Celtuce at 10 
ppm; Chickpea, dry seed at 0.05 ppm; Chickpea, edible podded at 0.7 
ppm; Chickpea, succulent shelled at 0.1 ppm; Cottonseed subgroup 20C at 
0.5 ppm; Cowpea, dry seed at 0.05 ppm; Cowpea, edible podded at 0.7 
ppm; Cowpea, succulent shelled at 0.1 ppm; Fennel, Florence, fresh 
leaves and stalk at 10 ppm; Fruit, pome, group 11-10 at 2 ppm; Fruit, 
small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 2 ppm; 
Fruit, stone, group 12-12 at 2 ppm; Gram, horse, dry seed at 0.05 ppm; 
Grapefruit subgroup 10-10C at 0.5 ppm; Grass pea, dry seed at 0.05 ppm; 
Grass pea, edible podded at 0.7 ppm; Jackbean, dry seed at 0.05 ppm; 
Jackbean, edible podded at 0.7 ppm; Jackbean, succulent shelled at 0.1 
ppm; Kohlrabi at 2 ppm; Leaf petiole vegetable subgroup 22B at 10 ppm; 
Leafy greens subgroup 4-16A at 10 ppm; Lemon/Lime subgroup 10-10B at 
0.3 ppm; Lentil, dry seed at 0.05 ppm; Lentil, edible podded at 0.7 
ppm; Lentil, succulent shelled at 0.1 ppm; Longbean, Chinese, dry seed 
at 0.05 ppm; Longbean, Chinese, edible podded at 0.7 ppm; Lupin, 
Andean, dry seed at 0.05 ppm; Lupin, Andean, succulent shelled at 0.1 
ppm; Lupin, blue, dry seed at 0.05 ppm; Lupin, blue, succulent shelled 
at 0.1 ppm; Lupin, grain, dry seed at 0.05 ppm; Lupin, grain, succulent 
shelled at 0.1 ppm; Lupin, sweet white, dry seed at 0.05 ppm; Lupin, 
sweet white, succulent shelled at 0.1 ppm; Lupin, sweet, dry seed at 
0.05 ppm; Lupin, sweet, succulent shelled at 0.1 ppm; Lupin, white, dry 
seed at 0.05 ppm; Lupin, white, succulent shelled at 0.1 ppm; Lupin, 
yellow, dry seed at 0.05 ppm; Lupin, yellow, succulent shelled at 0.1 
ppm; Nut, tree, group 14-12 at 0.05 ppm; Onion, bulb, subgroup 3-07A at 
0.1 ppm; Onion, green, subgroup 3-07B at 3 ppm; Orange subgroup 10-10A 
at 0.3 ppm; Pea, blackeyed, dry seed at 0.05 ppm; Pea, blackeyed, 
succulent shelled at 0.1 ppm; Pea, crowder, dry seed at 0.05 ppm; Pea, 
crowder, succulent shelled at 0.1 ppm; Pea, dry,

[[Page 41902]]

dry seed at 0.05 ppm; Pea, dwarf, edible podded at 0.7 ppm; Pea, 
English, succulent shelled at 0.1 ppm; Pea, field, dry seed at 0.05 
ppm; Pea, garden, dry seed at 0.05 ppm; Pea, garden, succulent shelled 
at 0.1 ppm; Pea, green, dry seed at 0.05 ppm; Pea, green, edible podded 
at 0.7 ppm; Pea, green, succulent shelled at 0.1 ppm; Pea, pigeon, dry 
seed at 0.05 ppm; Pea, pigeon, edible podded at 0.7 ppm; Pea, pigeon, 
succulent shelled at 0.1 ppm; Pea, snap, edible podded at 0.7 ppm; Pea, 
snow, edible podded at 0.7 ppm; Pea, southern, dry seed at 0.05 ppm; 
Pea, southern, succulent shelled at 0.1 ppm; Pea, sugar snap, edible 
podded at 0.7 ppm; Pea, winged, dry seed at 0.05 ppm; Pea, winged, 
edible podded at 0.7 ppm; Quinoa, grain at 3 ppm; Quinoa, hay at 6 ppm; 
Quinoa, straw at 20 ppm; Rapeseed subgroup 20A at 0.2 ppm; Soybean, 
vegetable, dry seed at 0.05 ppm; Soybean, vegetable, edible podded at 
0.7 ppm; Soybean, vegetable, succulent shelled at 0.1 ppm; Sunflower 
subgroup 20B at 0.2 ppm; Teff, forage 3 ppm; Teff, grain at 0.3 ppm; 
Teff, hay at 6 ppm; Teff, straw at 7 ppm; Vegetable, brassica, head and 
stem, group 5-16 at 2 ppm; Vegetable, fruiting, group 8-10 at 0.2 ppm; 
Velvetbean, dry seed at 0.05 ppm; Velvetbean, edible podded at 0.7 ppm; 
Velvetbean, succulent shelled at 0.1 ppm; and Yam bean, African, dry 
seed at 0.05 ppm.
    Tolerances are also removed for the following commodities due to 
establishment of tolerances for the above commodities: Berry group 13 
at 0.8 ppm; Borage, seed at 0.2 ppm; Brassica, head and stem, subgroup 
5A at 2.00 ppm; Brassica, leafy greens, subgroup 5B at 14.00 ppm; 
Cabbage at 2.00 ppm; Castor oil plant, seed at 0.2 ppm; Chinese 
tallowtree, seed at 0.2 ppm; Cilantro, leaves at 10 ppm; Cotton, 
undelinted seed at 0.5 ppm; Crambe, seed at 0.2 ppm; Cuphea, seed at 
0.2 ppm; Echium, seed at 0.2 ppm; Euphorbia, seed at 0.2 ppm; Evening 
primrose, seed at 0.2 ppm; Flax, seed at 0.2 ppm; Fruit, citrus, group 
10 at 0.35 ppm; Fruit, pome, group 11 at 2 ppm; Fruit, stone, group 12 
at 1 ppm; Gold of pleasure, seed at 0.2 ppm; Grape at 2 ppm; Hare's-ear 
mustard, seed at 0.2 ppm; Jojoba, seed at 0.2 ppm; Lesquerella, seed at 
0.2 ppm; Lunaria, seed at 0.2 ppm; Meadowfoam, seed at 0.2 ppm; 
Milkweed, seed at 0.2 ppm; Mustard, seed at 0.2 ppm; Niger seed, seed 
at 0.2 ppm; Nut, tree, group 14 at 0.05 ppm; Oil radish, seed at 0.2 
ppm; Okra at 0.2 ppm; Onion, bulb at 0.10 ppm; Onion, green at 3.00 
ppm; Pea and bean, dried shelled, except soybean subgroup 6C at 0.05 
ppm; Pea and bean, succulent shelled, subgroup 6B at 0.1 ppm; Pecan at 
0.05 ppm; Pistachio at 0.05 ppm; Poppy, seed at 0.2 ppm; Rapeseed at 
0.2 ppm; Rose hip, seed at 0.2 ppm; Safflower, seed at 0.2 ppm; Sesame, 
seed at 0.2 ppm; Stokes aster, seed at 0.2 ppm; Sunflower, seed at 0.2 
ppm; Sweet rocket, seed at 0.2 ppm; Tallowwood, seed at 0.2 ppm; Tea 
oil plant, seed at 0.2 ppm; Turnip, greens at 14 ppm; Vegetable, 
fruiting, group 8 at 0.2 ppm; Vegetable, leafy, except brassica, group 
4 at 10.00 ppm; Vegetable, legume, edible podded, subgroup 6A at 0.5 
ppm; and Vernonia, seed at 0.2 ppm.
    In addition, EPA is removing language from paragraph (a)(3) for 
tolerances that have expired. The tolerances for residues of alpha-
cypermethrin on ``Fruit, citrus, group 10-10'' at 10 ppm and ``Hog, 
fat'' at 1.0 ppm expired on December 5, 2018, as indicated by the 
footnote associated with those entries in the table in paragraph 
(a)(3). EPA is removing those expired tolerances as part of this rule 
as a housekeeping measure.

VI. Statutory and Executive Order Reviews

    This action establishes and modifies 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, 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 (CRA)

    Pursuant to the CRA (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: July 22, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

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

[[Page 41903]]

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:
0
a. Amend paragraph (a)(2) by revising the table; and
0
b. Amend the table in paragraph (a)(3) by:
0
i. Adding the heading ``Table 3 to Paragraph (a)(3)'';
0
ii. Removing the entries ``Fruit, citrus, group 10-10 \1\'' and ``Hog, 
fat \1\''; and
0
iii. Removing the corresponding footnote 1.
    The additions and revisions read as follows:


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

* * * * *
    (a)(2) * * *

                       Table 2 to Paragraph (a)(2)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.........................................              15
Alfalfa, hay............................................              30
Alfalfa, seed...........................................            0.50
Almond, hulls...........................................               6
Animal feed, nongrass, group 18, forage.................               8
Animal feed, nongrass, group 18, hay....................              40
Artichoke, globe........................................            0.60
Avocado.................................................            0.50
Barley, grain...........................................             3.0
Barley, hay.............................................             6.0
Barley, straw...........................................            20.0
Basil, dried leaves.....................................              40
Basil, fresh leaves.....................................               7
Bean, adzuki, dry seed..................................            0.05
Bean, American potato, dry seed.........................            0.05
Bean, asparagus, dry seed...............................            0.05
Bean, asparagus, edible podded..........................             0.7
Bean, black, dry seed...................................            0.05
Bean, broad, dry seed...................................            0.05
Bean, broad, succulent shelled..........................             0.1
Bean, catjang, dry seed.................................            0.05
Bean, catjang, edible podded............................             0.7
Bean, catjang, succulent shelled........................             0.1
Bean, cranberry, dry seed...............................            0.05
Bean, dry, dry seed.....................................            0.05
Bean, field, dry seed...................................            0.05
Bean, French, dry seed..................................            0.05
Bean, French, edible podded.............................             0.7
Bean, garden, dry seed..................................            0.05
Bean, garden, edible podded.............................             0.7
Bean, goa, dry seed.....................................            0.05
Bean, goa, edible podded................................             0.7
Bean, goa, succulent shelled............................             0.1
Bean, great northern, dry seed..........................            0.05
Bean, green, dry seed...................................            0.05
Bean, green, edible podded..............................             0.7
Bean, guar, dry seed....................................            0.05
Bean, guar, edible podded...............................             0.7
Bean, kidney, dry seed..................................            0.05
Bean, kidney, edible podded.............................             0.7
Bean, lablab, dry seed..................................            0.05
Bean, lablab, edible podded.............................             0.7
Bean, lablab, succulent shelled.........................             0.1
Bean, lima, dry seed....................................            0.05
Bean, lima, succulent shelled...........................             0.1
Bean, morama, dry seed..................................            0.05
Bean, moth, dry seed....................................            0.05
Bean, moth, edible podded...............................             0.7
Bean, moth, succulent shelled...........................             0.1
Bean, mung, dry seed....................................            0.05
Bean, mung, edible podded...............................             0.7
Bean, navy, dry seed....................................            0.05
Bean, navy, edible podded...............................             0.7
Bean, pink, dry seed....................................            0.05
Bean, pinto, dry seed...................................            0.05
Bean, red, dry seed.....................................            0.05
Bean, rice, dry seed....................................            0.05
Bean, rice, edible podded...............................             0.7
Bean, scarlet runner, dry seed..........................            0.05
Bean, scarlet runner, edible podded.....................             0.7

[[Page 41904]]

 
Bean, scarlet runner, succulent shelled.................             0.1
Bean, snap, edible podded...............................             0.7
Bean, sword, dry seed...................................            0.05
Bean, sword, edible podded..............................             0.7
Bean, tepary, dry seed..................................            0.05
Bean, urd, dry seed.....................................            0.05
Bean, urd, edible podded................................             0.7
Bean, wax, edible podded................................             0.7
Bean, wax, succulent shelled............................             0.1
Bean, yardlong, dry seed................................            0.05
Bean, yardlong, edible podded...........................             0.7
Bean, yellow, dry seed..................................            0.05
Beet, sugar, roots......................................            0.05
Beet, sugar, tops.......................................            0.20
Brassica, leafy greens, subgroup 4-16B..................              14
Buckwheat, grain........................................             3.0
Buckwheat, hay..........................................             6.0
Buckwheat, straw........................................            20.0
Bushberry subgroup 13-07B...............................             0.8
Caneberry subgroup 13-07A...............................             0.8
Canistel................................................            0.50
Castor oil plant, refined oil...........................             0.4
Cattle, fat.............................................            1.00
Cattle, meat............................................             0.2
Cattle, meat byproducts.................................            0.05
Celtuce.................................................              10
Chickpea, dry seed......................................            0.05
Chickpea, edible podded.................................             0.7
Chickpea, succulent shelled.............................             0.1
Chinese tallowtree, refined oil.........................             0.4
Citrus, dried pulp......................................             1.8
Citrus, oil.............................................             4.0
Corn, field, forage.....................................             9.0
Corn, field, grain......................................            0.05
Corn, field, stover.....................................              30
Corn, pop, grain........................................            0.05
Corn, pop, stover.......................................              30
Corn, sweet, forage.....................................           15.00
Corn, sweet, kernel plus cob with husks removed.........            0.05
Corn, sweet, stover.....................................           15.00
Cottonseed subgroup 20C.................................             0.5
Cowpea, dry seed........................................            0.05
Cowpea, edible podded...................................             0.7
Cowpea, succulent shelled...............................             0.1
Egg.....................................................            0.05
Euphorbia, refined oil..................................             0.4
Evening primrose, refined oil...........................             0.4
Fennel, Florence, fresh leaves and stalk................              10
Food commodities/feed commodities (other than those                 0.05
 covered by a higher tolerance as a result of use on
 growing crops) in food/feed handling establishments....
Fruit, citrus, group 10 \1\.............................            0.35
Fruit, pome, group 11-10................................               2
Fruit, small, vine climbing, except fuzzy kiwifruit,                   2
 subgroup 13-07F........................................
Fruit, stone, group 12-12...............................               2
Goat, fat...............................................            1.00
Goat, meat..............................................             0.2
Goat, meat byproducts...................................            0.05
Grain, aspirated fractions..............................            10.0
Gram, horse, dry seed...................................            0.05
Grapefruit subgroup 10-10C..............................             0.5
Grass, forage, fodder, and hay, group 17, forage........              10
Grass, forage, fodder and hay, group 17, hay............              35
Grass pea, dry seed.....................................            0.05
Grass pea, edible podded................................             0.7
Hog, fat................................................             0.1
Hog, meat...............................................            0.05
Horse, fat..............................................            1.00
Horse, meat.............................................             0.2
Horse, meat byproducts..................................            0.05
Jackbean, dry seed......................................            0.05
Jackbean, edible podded.................................             0.7

[[Page 41905]]

 
Jackbean, succulent shelled.............................             0.1
Jojoba, refined oil.....................................             0.4
Kohlrabi................................................               2
Leaf petiole vegetable subgroup 22B.....................              10
Leafy greens subgroup 4-16A.............................              10
Lemon/Lime subgroup 10-10B..............................             0.3
Lentil, dry seed........................................            0.05
Lentil, edible podded...................................             0.7
Lentil, succulent shelled...............................             0.1
Longbean, Chinese, dry seed.............................            0.05
Longbean, Chinese, edible podded........................             0.7
Lupin, Andean, dry seed.................................            0.05
Lupin, Andean, succulent shelled........................             0.1
Lupin, blue, dry seed...................................            0.05
Lupin, blue, succulent shelled..........................             0.1
Lupin, grain, dry seed..................................            0.05
Lupin, grain, succulent shelled.........................             0.1
Lupin, sweet white, dry seed............................            0.05
Lupin, sweet white, succulent shelled...................             0.1
Lupin, sweet, dry seed..................................            0.05
Lupin, sweet, succulent shelled.........................             0.1
Lupin, white, dry seed..................................            0.05
Lupin, white, succulent shelled.........................             0.1
Lupin, yellow, dry seed.................................            0.05
Lupin, yellow, succulent shelled........................             0.1
Mango...................................................            0.70
Milk, fat (reflecting 0.10 in whole milk)...............            2.50
Niger seed, refined oil.................................             0.4
Nut, tree, group 14-12..................................            0.05
Oat, grain..............................................             3.0
Oat, hay................................................             6.0
Oat, straw..............................................            20.0
Onion, bulb, subgroup 3-07A.............................             0.1
Onion, green, subgroup 3-07B............................               3
Orange subgroup 10-10A..................................             0.3
Papaya..................................................            0.50
Pea, blackeyed, dry seed................................            0.05
Pea, blackeyed, succulent shelled.......................             0.1
Pea, crowder, dry seed..................................            0.05
Pea, crowder, succulent shelled.........................             0.1
Pea, dry, dry seed......................................            0.05
Pea, dwarf, edible podded...............................             0.7
Pea, English, succulent shelled.........................             0.1
Pea, field, dry seed....................................            0.05
Pea, garden, dry seed...................................            0.05
Pea, garden, succulent shelled..........................             0.1
Pea, green, dry seed....................................            0.05
Pea, green, edible podded...............................             0.7
Pea, green, succulent shelled...........................             0.1
Pea, pigeon, dry seed...................................            0.05
Pea, pigeon, edible podded..............................             0.7
Pea, pigeon, succulent shelled..........................             0.1
Pea, snap, edible podded................................             0.7
Pea, snow, edible podded................................             0.7
Pea, southern, dry seed.................................            0.05
Pea, southern, succulent shelled........................             0.1
Pea, sugar snap, edible podded..........................             0.7
Pea, winged, dry seed...................................            0.05
Pea, winged, edible podded..............................             0.7
Peanut..................................................            0.05
Poultry, fat............................................            0.05
Poultry, meat...........................................            0.05
Quinoa, grain...........................................               3
Quinoa, hay.............................................               6
Quinoa, straw...........................................              20
Rapeseed subgroup 20A...................................             0.2
Rice, grain.............................................            1.50
Rice, hulls.............................................            6.00
Rice, wild, grain.......................................             1.5
Rose hip, refined oil...................................             0.4
Rye, grain..............................................             3.0

[[Page 41906]]

 
Rye, hay................................................             6.0
Rye, straw..............................................            20.0
Sapodilla...............................................            0.50
Sapote, black...........................................            0.50
Sapote, mamey...........................................            0.50
Sheep, fat..............................................            1.00
Sheep, meat.............................................             0.2
Sheep, meat byproducts..................................            0.05
Sorghum, grain, forage..................................             0.1
Sorghum, grain, grain...................................             0.5
Sorghum, grain, stover..................................             5.0
Soybean, seed...........................................            0.05
Soybean, vegetable, dry seed............................            0.05
Soybean, vegetable, edible podded.......................             0.7
Soybean, vegetable, succulent shelled...................             0.1
Star apple..............................................            0.50
Stokes aster, refined oil...............................             0.4
Sugarcane, cane.........................................            0.60
Sunflower subgroup 20B..................................             0.2
Sunflower, refined oil..................................             0.5
Tallowwood, refined oil.................................             0.4
Tea oil plant, refined oil..............................             0.4
Teff, forage............................................               3
Teff, grain.............................................             0.3
Teff, hay...............................................               6
Teff, straw.............................................               7
Vegetable, brassica, head and stem, group 5-16..........               2
Vegetable, cucurbit, group 9............................             0.2
Vegetable, fruiting, group 8-10.........................             0.2
Vegetable, root and tuber, group 1, except sugar beet...             0.1
Velvetbean, dry seed....................................            0.05
Velvetbean, edible podded...............................             0.7
Velvetbean, succulent shelled...........................             0.1
Vernonia, refined oil...................................             0.4
Wheat, forage...........................................             3.0
Wheat, grain............................................             0.2
Wheat, hay..............................................             6.0
Wheat, straw............................................             7.0
Yam bean, African, dry seed.............................            0.05
------------------------------------------------------------------------
\1\ This tolerance expires on February 4, 2022.

    (a)(3) * * *

Table 3 to Paragraph (a)(3)

* * * * *
[FR Doc. 2021-16189 Filed 8-3-21; 8:45 am]
BILLING CODE 6560-50-P


