Rule2023-06939
Deltamethrin; Pesticide Tolerances
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 4, 2023
Effective
April 4, 2023
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes tolerances for residues of deltamethrin in or on the raw agricultural commodities, Vegetable, legume, pulse, bean, dried shelled, except soybean, subgroup 6-22E and Vegetable, legume, pulse, pea, dried shelled, subgroup 6-22F. Bayer CropScience requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Full Text
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<title>Federal Register, Volume 88 Issue 64 (Tuesday, April 4, 2023)</title>
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[Federal Register Volume 88, Number 64 (Tuesday, April 4, 2023)]
[Rules and Regulations]
[Pages 19873-19879]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-06939]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2022-0671; FRL-10568-01-OCSPP]
Deltamethrin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
deltamethrin in or on the raw agricultural commodities, Vegetable,
legume, pulse, bean, dried shelled, except soybean, subgroup 6-22E and
Vegetable, legume, pulse, pea, dried shelled, subgroup 6-22F. Bayer
CropScience requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective April 4, 2023. Objections and
requests for hearings must be received on or before June 5, 2023, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2022-0671, is available at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room and the OPP Docket is (202) 566-1744. For the latest
status information on EPA/DC services, docket access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
[[Page 19874]]
FOR FURTHER INFORMATION CONTACT: Daniel Rosenblatt, Acting Director,
Registration Division (7505T), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number: (202) 566-1030; email address:
<a href="/cdn-cgi/l/email-protection#feacbab8acb0918a979d9b8dbe9b8e9fd0999188"><span class="__cf_email__" data-cfemail="67352321352908130e0402142702170649000811">[email protected]</span></a>.
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:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Office of the
Federal Register's e-CFR site at <a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2022-0671 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
June 5, 2023. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2022-0671, by one of
the following methods:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/send-comments-epa-dockets">https://www.epa.gov/dockets/send-comments-epa-dockets</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/">https://www.epa.gov/</a>.
II. Summary of Petitioned-For Tolerance
In the Federal Register of August 30, 2022 (87 FR 52868) (FRL-9410-
04-OCSPP), EPA issued a document pursuant to FFDCA section 408(d)(3),
21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
1E8933) by Bayer CropScience, 800 N Lindbergh Blvd., St. Louis, MO
63141. The petition requested that 40 CFR 180.435 be amended by
establishing tolerances without U.S. Registration for residues of
deltamethrin, (S)-[alpha]-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-
dibromovinyl)-2,2-, in or on the raw agricultural commodity, Crop
Subgroup 6C (Pea and bean, dried, shelled, except soybean) at 0.07
parts per million (ppm). That document referenced a summary of the
petition prepared by Bayer CropScience, the registrant, which is
available in the docket, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. There were no
comments received in response to the notice of filing.
Based upon review of the data supporting the petition and in
accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA
is establishing tolerances for two subgroups in the recently revised
Legume vegetable crop group 6-22 instead of Crop Subgroup 6C (Pea and
bean, dried, shelled, except soybean) as requested by the petitioner.
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 deltamethrin including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with deltamethrin follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The toxicology database for deltamethrin is complete except
for the subchronic inhalation study which the Hazard Science and Policy
Council (HASPOC) recommended to require (TXR 0058335, Z. Staley, 09/30/
2022).
Deltamethrin is a member of the pyrethroid class of insecticides.
Pyrethroids have historically been classified into two groups, Type I
and Type II, based on chemical structure and toxicological effects.
Deltamethrin is a Type II pyrethroid. Type II pyrethroids, which
contain an alpha-cyano moiety, produce a syndrome in rats that includes
pawing, burrowing,
[[Page 19875]]
salivation, hypothermia, and coarse tremors leading to choreoathetosis
(CS-syndrome). The adverse outcome pathway (AOP, identified using a
weight-of-evidence approach based on the Bradford-Hill criteria) shared
by pyrethroids involves the ability to interact with voltage-gated
sodium channels (VGSCs) in the central and peripheral nervous systems,
leading to changes in neuron firing and ultimately, neurotoxicity.
Deltamethrin has been evaluated for a variety of effects in
experimental toxicity studies. Neurotoxicity was observed throughout
the database, and effects were seen across species, sexes, exposure
durations, and routes of administration. Clinical signs characteristic
of Type II pyrethroids, such as increased salivation, altered mobility/
gait, and tremors, were seen in experimental toxicology studies
including neurotoxicity studies (acute and subchronic) in rats,
subchronic and chronic studies in dogs and rats, and developmental and
reproduction studies in rats. In addition to the clinical signs noted
above, increased sensitivity to external stimuli, abnormal
vocalization, and decreased fore- and hind-limb grip strength were
commonly observed in the database.
Deltamethrin did not have any adverse effects on fetuses or
offspring in the prenatal developmental studies in rats and rabbits,
therefore there was no evidence of quantitative or qualitative
susceptibility in these studies. However, qualitative susceptibility
was observed at high doses in the developmental neurotoxicity (DNT) and
2-generation reproduction studies because the effects in the offspring
were more severe than the maternal effects. In the DNT study, an
increased incidence of vocalization when handled was observed during
FOB observations on PND 4 for male pups and decreased pre- and post-
weaning body weight was observed in pups of both sexes. In maternal
animals, only decreased body weight and body weight gain were observed,
and no adverse FOB effects were observed despite having undergone the
same neurological measurements as the pups, including FOB analysis. In
the 2-generation reproduction study, treatment-related effects in the
parental animals at the high dose were limited to lesions on the head,
neck, or forelimbs, and alopecia in the males and ataxia and
hypersensitivity in the females during gestation. At the high dose in
the F1 generation, there were increased pup mortalities (PND 8-14) and
clinical findings observed early in the post-weaning period (i.e.,
impaired righting reflexes, hyperactivity, splayed limbs, vocalization,
and excessive salivation). There was no increase in mortality or
clinical signs in the F2 generation. Decreased body weight was observed
in the adult P and F1 generations, and decreased pup weight was
observed in both the F1 and F2 pups.
In a 21-day dermal toxicity study, no systemic toxicity was
observed up to the limit dose. There was also no toxicity observed
following acute dermal exposure to deltamethrin up to a dose of 2,000
mg/kg/day. The dermal absorption value for deltamethrin is 11.3%.
There was no evidence of immunotoxicity in the available studies
with deltamethrin.
There was no evidence of carcinogenicity in the combined chronic/
carcinogenicity study in rats or the carcinogenicity study in mice. In
a battery of mutagenicity studies, there was no evidence of a mutagenic
effect.
Specific information on the studies received and the nature of the
adverse effects caused by deltamethrin 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> in document ``Deltamethrin Human Health Risk
Assessment for the Proposed Tolerances on Vegetable, Legume, Pulse,
Bean, Dried Shelled, Except Soybean, Subgroup 6-22E and Vegetable,
Legume, Pulse, Pea, Dried Shelled, Subgroup 6-22F, without U.S.
Registration'' (hereinafter ``Deltamethrin Human Health Risk
Assessment'') at 29-34 in docket ID number EPA-HQ-OPP-2022-0671.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (PODs) 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 <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks</a>.
A summary of the toxicological endpoints for deltamethrin used for
human risk assessment can be found on pages 17-18 in the ``Deltamethrin
Human Health Risk Assessment''.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to deltamethrin, EPA considered exposure under the petitioned-
for tolerances as well as all existing deltamethrin tolerances in 40
CFR 180.435. EPA assessed dietary exposures from deltamethrin in food
as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
Such effects were identified for deltamethrin. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture (USDA) 2005-2010 National Health and
Nutrition Examination Survey, What We Eat in American (NHANES/WWEIA).
As to residue levels in food, the acute dietary exposure is partially
refined; the residue inputs were a combination of tolerance-level
residues, Pesticide Data Program (PDP) monitoring data, and mosquito
adulticide residue values. As deltamethrin is registered for use as a
mosquito adulticide, residue estimates for the adulticide use were
included in the dietary exposure assessment. EPA used percent crop
treated (PCT) for some commodities as described below and 100 PCT for
the other commodities.
ii. Chronic exposure. A chronic dietary risk assessment is not
required for deltamethrin 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
deltamethrin that need to be aggregated with background exposure from
dietary
[[Page 19876]]
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
deltamethrin.
In conducting the chronic dietary exposure assessment EPA used the
food consumption data from the USDA 2005-2010 National Health and
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As
to residue levels in food, the chronic dietary exposure is partially
refined; the residue inputs consisted of a combination of tolerance
level residues, PDP monitoring data, mosquito adulticide residue
values, and Food Handling Establishment (FHE) residue values. EPA used
percent crop treated (PCT) estimates for some commodities and 100 PCT
for the other commodities.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that deltamethrin is not likely to be carcinogenic to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
<bullet> 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.
<bullet> Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
<bullet> 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 dietary assessment, the following PCT assumptions were
made:
The maximum PCT estimates used in the acute dietary risk assessment
for the following crops that are currently registered for deltamethrin
were: apples, 2.5%; carrots, 5%; cucumbers, 5%; soybeans, 2.5%; and
watermelons, 10%. In addition, EPA used a value of 9% as an estimate of
the percentage of the orange crop that might be imported. EPA assumed
100 PCT for all other commodities included in the acute assessment.
The average PCT estimates used in the chronic dietary risk
assessment for the following crops that are currently registered for
deltamethrin were: apples, 1%; globe artichokes, 5%; carrots, 1%;
cotton, 1%; cucumbers, 1%; leeks, 1%; onions, 1%; potatoes, 1%;
pumpkins, 2.5%; rapeseed, 2.5%; shallot, 1%; squash, 1%; sunflowers,
5%; and watermelons, 1%. EPA assumed 100 PCT for all other commodities
included in the chronic assessment.
In the chronic assessment, for the commodities that are only
covered by the FHE tolerance, the assumption was made that there was a
4.65% chance that a food item consumed by a person contained
deltamethrin residues as a result of treatment at some point in an FHE.
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%, respectively. The maximum PCT figure is
the highest observed maximum value reported within the 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 deltamethrin 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 deltamethrin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of deltamethrin. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at <a href="https://www.epa.gov/science-and-assessing-pesticide-risks/pesticide-risk-assessment">https://www.epa.gov/science-and-assessing-pesticide-risks/pesticide-risk-assessment</a>.
The deltamethrin limit of solubility is 0.20 ppb. EPA used 0.20 ppb
as the estimated drinking water concentration (EDWC) for both the acute
and chronic dietary assessments because the concentration of
deltamethrin in water cannot exceed the limit of solubility.
Although a chronic dietary endpoint was not identified for
deltamethrin, a chronic dietary exposure assessment was performed to
provide background exposure for the aggregation with short-term
residual exposure.
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).
[[Page 19877]]
There are no proposed residential uses associated with the proposed
use on imported peas and beans. However, deltamethrin is currently
registered for the following uses that could result in residential
exposures: Indoor (spot, crack and crevice) and outdoor (turf, garden
and trees) environments, pet collars, paint preservative, impregnated
mosquito net, and wide area mosquito and fly control.
In the previous risk assessment, all residential handler scenarios
(adults only) resulted in inhalation risk estimates greater than the
LOC (i.e., MOEs >= 1,000), with MOEs ranging from 1,200 to 850,000,
which are not of concern. No risk estimates of concern were identified
for residential post-application exposure scenarios (children's
incidental oral). The MOEs ranged from 290 to 1,500,000 and were
greater than the LOC of 100.
Although there are no residential uses associated with the proposed
tolerances, the aggregate human health risk assessment was updated to
include the additional dietary exposure expected from residues in peas
and beans. EPA selected only the most conservative, or worst- case,
residential adult and child scenarios to be included in the aggregate
estimates, based on the lowest overall MOE (i.e., highest exposure and
risk estimates). The adult worst-case residential handler exposure
estimate resulted from adults fastening (applying) pet collars treated
with deltamethrin to large dogs. The children's (1 to <2 years old)
worst-case residential exposure estimate resulted from hand-to-mouth
(post-application) exposure to residues from perimeter/spot treatments
on carpeting.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/operating-procedures-residential-pesticide">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/operating-procedures-residential-pesticide</a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>; 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>; 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 <a href="https://www.epa.gov/used-pesticide-products/registration-review-pyrethrins-and-pyrethroids">https://www.epa.gov/used-pesticide-products/registration-review-pyrethrins-and-pyrethroids</a>.
Deltamethrin is included in the pyrethroids/pyrethrins cumulative
risk assessment. No dietary, residential, or aggregate risk estimates
of concern have been identified in the single chemical assessment. In
the cumulative assessment, residential exposure was the greatest
contributor to the total exposure. Dietary exposures make a minor
contribution to the total pyrethroid exposure. The dietary exposure
assessment performed in support of the pyrethroid cumulative was much
more highly refined than that performed for deltamethrin. The minor
increase in dietary exposure to deltamethrin residues, as a result of
the proposed tolerance, would make an insignificant contribution to
cumulative exposure.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act (FQPA) Safety Factor (SF). In applying this provision,
EPA either retains the default value of 10X, or uses a different
additional safety factor when reliable data available to EPA support
the choice of a different factor.
2. Prenatal and postnatal sensitivity. Deltamethrin did not have
any adverse effects on fetuses or offspring in the prenatal
developmental studies in rats and rabbits. However, qualitative
susceptibility was observed at high doses in the developmental
neurotoxicity (DNT) and 2-generation reproduction study. In the DNT
study, an increased incidence of vocalization when handled was observed
during FOB observations on PND 4 for male pups and decreased pre- and
post-weaning body weight was observed in pups of both sexes. In
maternal animals, only decreased body weight and body weight gain were
observed despite undergoing the same neurological measurements as the
pups, including FOB analysis. In the 2-generation reproduction study,
treatment-related effects in the parental animals at the high dose were
limited to lesions on the head, neck, or forelimbs, and alopecia in the
males and ataxia and hypersensitivity in the females during gestation.
At the high dose in the F1 generation, there were increased pup
mortalities (PND 8-14) and clinical findings observed early in the
post-weaning period (i.e., impaired righting reflexes, hyperactivity,
splayed limbs, vocalization, and excessive salivation). There was no
increase in mortality or clinical signs in the F2 generation. Decreased
body weight was observed in the adult P and F1 generations, and
decreased pup weight was observed in both the F1 and F2 pups.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced from 10X to 1X with the exception of inhalation
exposure scenarios, for which the 10X FQPA Safety Factor was retained
as a database uncertainty factor. That decision is based on the
following findings:
i. The toxicity database for deltamethrin is complete, except for a
subchronic inhalation study that HASPOC recommended not to waive (TXR
0058335, Z. Staley, 09/30/2022). Studies that are available to inform
the FQPA SF include developmental toxicity studies in rats and rabbits,
a reproduction study in rats, an acute neurotoxicity (ACN) study, a
subchronic neurotoxicity (SCN) study, and developmental neurotoxicity
(DNT) studies.
ii. There is evidence of neurotoxicity in the deltamethrin
toxicology database. As with other pyrethroids, deltamethrin causes
neurotoxicity from interaction with sodium channels leading to clinical
signs of neurotoxicity. These effects are well characterized and
adequately assessed by the body of data available to the Agency,
therefore, there is no residual uncertainty regarding neurotoxicity.
iii. There were no indications of fetal toxicity in any of the
guideline studies, including developmental studies in the
[[Page 19878]]
rat and rabbit, a developmental neurotoxicity study in rats, and a 2-
generation reproduction study in rats. There was evidence of increased
juvenile qualitative susceptibility at high doses observed in both the
DNT and 2-generation reproduction studies. In the DNT study, increased
vocalization was observed during FOB handling of pups on PND 4 at the
same dose where decreased body weight and body weight gain were
observed in maternal animals (16.1 mg/kg/day). No findings were
observed in the maternal animals during FOB handling in the DNT. In the
2-generation reproduction study, the P generation showed limited
clinical signs of neurotoxicity and decreased body weights at the
highest dose tested (21.2/23.5 mg/kg/day, M/F). Effects observed in the
F1 generation at the same dose included decreased pup weight, increased
pup mortality between PND 8-14, increased pup mortality within the
first 8 days post-weaning, and additional clinical signs of
neurotoxicity not observed in the parental generation. The increased
mortality and additional clinical signs were considered evidence of
qualitative sensitivity in juveniles.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary exposure assessments are based on a combination
of robust monitoring data and field trial residue levels that account
for parent and metabolites of concern, processing factors, and percent
crop treated assumptions. 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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to deltamethrin will occupy 26% of the aPAD for children 3 to 5 years
old, the population group receiving the greatest exposure.
Acute aggregate risk of exposure to deltamethrin results from
exposure to residues in food and drinking water alone. Therefore, acute
aggregate risk estimates are equivalent to the acute dietary risk
estimates, which are below the level of concern of 100% of the aPAD.
Acute aggregate risk estimates are not of concern for the general U.S.
population or any population subgroup.
2. Chronic risk. Based on the data summarized in Unit III.A., there
is no increase in hazard with increasing dosing duration. As a result,
there is no increase in toxicity with repeated/chronic dietary
exposures; therefore, the acute aggregate assessment is protective of
potential chronic aggregate exposures.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Deltamethrin
is currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to deltamethrin.
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 MOEs of 260 for
children 1 to 2 years old. Because this MOE is greater than the LOC of
100 for dietary and children's hand-to-mouth exposure, the short-term
aggregate risk estimate for children 1 to 2 years old is not of
concern. The combined short-term food, water and residential exposures
for adults results in an aggregate risk index (ARI) of 1.2, which is
greater than EPA's level of concern of an ARI of 1, so these risks are
also not of concern. EPA used an ARI approach for the adult short-term
risk because the level of concern for dietary exposure (100) is
different than the level of concern for inhalation exposure (1,000).
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Because toxicity does not increase with repeated dosing,
intermediate-term risk is covered by the assessments for short-term
exposures.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, deltamethrin is not expected to pose a cancer risk to humans.
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 deltamethrin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatography with electron
capture detection (GC/ECD) method) is available in PAM Volume II
(Section 180.422) is available to enforce the tolerance expression. Two
other GC/ECD methods are also available for enforcing deltamethrin
tolerances in plant commodities.
The methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
<a href="/cdn-cgi/l/email-protection#cebcabbda7aabbaba3abbaa6a1aabd8eabbeafe0a9a1b8"><span class="__cf_email__" data-cfemail="21534452484554444c4455494e4552614451400f464e57">[email protected]</span></a>.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has established MRLs for deltamethrin in or on the raw or
processed agricultural commodities, Pulses (group) at 1 ppm. The Codex
MRL is much higher and is based on a post-harvest use. EPA cannot
harmonize the tolerance of 0.07 ppm because of the large difference in
the values which would limit its usefulness as an enforcement tool.
However, EPA will be harmonizing with the Canadian MRL of 0.07 ppm for
the equivalent subgroups.
[[Page 19879]]
C. Revisions to Petitioned-For Tolerances
FFDCA section 408(d)(4)(A)(i) permits the Agency to finalize a
tolerance that varies from that sought by the petition. EPA is
establishing tolerances for two subgroups in the recently revised
Legume vegetable crop group 6-22 instead of Crop Subgroup 6C (Pea and
bean, dried, shelled, except soybean) (See Pesticides; Expansion of
Crop Grouping Program VI, (87 FR 57627) (September 21, 2022) (FRL-5031-
13-OCSPP). The revised subgroups ``Vegetable, legume, pulse, bean,
dried shelled, except soybean, subgroup 6-22E'' and ``Vegetable,
legume, pulse, pea, dried shelled, subgroup 6-22F'' include all
commodities in the original crop subgroup 6C while also aligning with
the updated crop groups.
V. Conclusion
Therefore, tolerances are established for residues of deltamethrin,
(S)-[alpha]-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dibromovinyl)-2,2-, in
or on the raw or processed agricultural commodities, Vegetable, legume,
pulse, bean, dried shelled, except soybean, subgroup 6-22E and
Vegetable, legume, pulse, pea, dried shelled, subgroup 6-22F at 0.07
ppm. As a housecleaning activity, EPA is removing the first footnote to
the table in paragraph (a)(1) because it is unnecessary and included in
the second footnote.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: March 29, 2023.
Daniel Rosenblatt,
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:
PART 180--TOLERANCE 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. 180.435, amend paragraph (a)(1) by:
0
a. Adding a heading to the table;
0
b. Adding in alphabetical order to the table entries for ``Vegetable,
legume, pulse, bean, dried shelled, except soybean, subgroup 6-22E
\1\'' and ``Vegetable, legume, pulse, pea, dried shelled, subgroup 6-
22F \1\'';
0
c. Revising the table footnotes.
The additions and revision read as follows:
Sec. 180.435 Deltamethrin; tolerances for residues.
(a) * * *
(1) * * *
Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Vegetable, legume, pulse, bean, dried shelled, except 0.07
soybean, subgroup 6-22E \1\................................
Vegetable, legume, pulse, pea, dried shelled, subgroup 6-22F 0.07
\1\........................................................
* * * * *
------------------------------------------------------------------------
* There are no U.S. registrations.
\1\ There are no U.S. registrations as of April 4, 2023.
* * * * *
[FR Doc. 2023-06939 Filed 4-3-23; 8:45 am]
BILLING CODE 6560-50-P
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