[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 [www.gpo.gov]
[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 
https://www.regulations.gov or at the Office of Pesticide Programs 
Regulatory Public Docket (OPP Docket) in the Environmental Protection 
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., 
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The 
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room and the OPP Docket is (202) 566-1744. For the latest 
status information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2022-0671 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/.

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, https://www.regulations.gov. 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 https://www.regulations.gov 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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks.
    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:
     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 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 https://www.epa.gov/science-and-assessing-pesticide-risks/pesticide-risk-assessment.
    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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/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 https://www.regulations.gov; EPA-HQ-OPP-
2008-0489-0006. As explained in that document, the members of this 
group share the ability to interact with voltage-gated sodium channels 
ultimately leading to neurotoxicity. In 2011, after establishing a 
common mechanism grouping for the pyrethroids and pyrethrins, the 
Agency conducted a cumulative risk assessment (CRA) which is available 
at https://www.regulations.gov; EPA-HQ-OPP-2011-0746. In that document, 
the Agency concluded that cumulative exposures to pyrethroids (based on 
pesticidal uses registered at the time the assessment was conducted) 
did not present risks of concern. For information regarding EPA's 
efforts to evaluate the risk of exposure to this class of chemicals, 
refer to https://www.epa.gov/used-pesticide-products/registration-review-pyrethrins-and-pyrethroids.
    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: 
[email protected].

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