[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:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-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