[Federal Register Volume 86, Number 228 (Wednesday, December 1, 2021)]
[Rules and Regulations]
[Pages 68150-68159]
[FR Doc No: 2021-25091]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0352 and EPA-HQ-OPP-2019-0560; FRL-8945-01-OCSPP]

Bifenthrin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
bifenthrin in or on multiple commodities which are identified and
discussed later in this document. The Interregional Project Number 4
(IR-4) and FMC Corporation requested these tolerances under the Federal
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 1, 2021. Objections and
requests for hearings must be received on or before January 31, 2022
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 dockets for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2016-0352 and EPA-HQ-OPP-2019-
0560, are available at http://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 is<PHONE_NUMBER>, and the
telephone number for the OPP Docket is<PHONE_NUMBER>.
    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, Acting Director,
Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number:<PHONE_NUMBER>; 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 numbers EPA-HQ-OPP-2016-0352 and EPA-HQ-OPP-2019-0560 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 January 31, 2022. 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 numbers EPA-HQ-OPP-2016-0352 and EPA-
HQ-OPP-2019-0560, 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 https://www.epa.gov/dockets/where-send-comments-epa-dockets. Additional instructions on commenting or visiting the docket,
along with more information about dockets generally, is available at
http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of October 18, 2016 (81 FR 71668) (FRL-
9952-19), 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
6E8482) by IR-4, Rutgers, the State University of New Jersey, 500
College Road East, Suite 201W, Princeton, NJ 08540. The petition
requested that 40 CFR 180.442 be amended by establishing tolerances for
residues of the insecticide bifenthrin, (2-methyl [1,1'-biphenyl]-3-yl)
methyl-3-(2-chloro-3,3,3,-trifluoro-1-propenyl)-2,2-
dimethylcyclopropanecarboxylate, in or on apple, wet pomace at 1.3
parts per million (ppm); avocado at 0.50 ppm; berry, low growing,
subgroup 13-07G at 3.0 ppm; Brassica, leafy greens, subgroup 4-16B at
15 ppm; caneberry subgroup 13-07A at 1.0 ppm; fruit, citrus, group 10-
10 at 0.05 ppm; fruit, pome, group 11-10, except mayhaw, at 0.70 ppm;
fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F at
0.20 ppm; nut, tree, group 14-12 at 0.05 ppm; peach, subgroup 12-12B at
0.70 ppm; pepper/eggplant subgroup 8-10B at 0.50 ppm; pomegranate at
0.50 ppm; and tomato, subgroup 8-10A at 0.15 ppm. The October 18, 2016,
Federal Register document and the Notice of Filing in docket number
EPA-HQ-OPP-2016-0352 identified the requested tolerance for tomato
subgroup 8-10A as 0.30 ppm. However, IR-4's submitted petition
identified a tolerance of 0.15 ppm for tomato subgroup 8-10A. When
there is a discrepancy between a tolerance in the submitted Notice of
Filing and the submitted petition, EPA uses the tolerance in the
petition as the petitioned-for tolerance, which is 0.15 ppm for tomato
subgroup 8-10A.
    Additionally, the petition requested, upon approval of the above
tolerances, to remove the existing tolerances in 40 CFR 180.442(a) in
or on Brassica, leafy greens, subgroup 5B at 3.5 ppm; caneberry,
subgroup 13A at 1.0 ppm; eggplant 0.05 ppm; fruit, citrus, group 10 at
0.05 ppm; grape at 0.20 ppm; groundcherry at 0.5 ppm; nut, tree, group
14 at 0.05 ppm; okra at 0.50 ppm; pear at 0.5 ppm; pepino at 0.5 ppm;
pepper, bell at 0.5 ppm; pepper, non-bell at 0.5 ppm; pistachio at 0.05
ppm; strawberry at 3.0 ppm; tomato at 0.15

ppm; and turnip, greens at 3.5 ppm. Finally, the petition requested
upon approval of the above tolerances, to remove the existing time-
limited tolerances in 40 CFR 180.442(b) in or on, apple at 0.5 ppm;
nectarine at 0.5 ppm; and peach at 0.5 ppm. That document referenced a
summary of the petition prepared by FMC Corporation and Makhteshim Agan
of North America, Inc. (ADAMA), the registrants, which is available in
the docket, http://www.regulations.gov. There were no comments received
in response to the notice of filing.
    In the Federal Register of February 11, 2020 (85 FR 7708) (FRL-
10005-02), 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
8F8704) by FMC Corporation, 2929 Walnut Street, Philadelphia, PA 19104.
The petition requested that 40 CFR 180.442 be amended by establishing
tolerances for residues of the bifenthrin, (2-methyl [1,1'-biphenyl]-3-
yl) methyl-3-(2-chloro-3,3,3,-trifluoro-1-propenyl)-2,2
dimethylcyclopropanecarboxylate, in or on sunflower (crop subgroup 20B)
at 0.01 ppm. That document referenced a summary of the petition
prepared by FMC Corporation, the registrant, which is available in the
docket, http://www.regulations.gov. There were no comments received in
response to the notice of filing.
    Based upon review of the data supporting the petitions, EPA is
establishing some tolerances that vary from what was requested. The
reasons for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for bifenthrin including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with bifenthrin 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 predominant effects seen in most of the bifenthrin experimental
toxicology studies were behavioral changes characteristic of Type I
pyrethroids, such as muscle tremors, which are consistent with its
mode-of-action (MOA) to activate sodium channels. Additional effects
seen in one or more studies included: muscle twitching, decreased grip
strength, altered landing foot splay, depressed respiration, increased
grooming counts, loss of muscle coordination, staggered gait,
exaggerated hind limb flexion, and convulsions at high doses. Decreased
body weight and food consumption were also noted in repeat-dosing
dietary studies.
    In developmental toxicity studies involving rats and rabbits,
maternal toxicity was observed (neurological effects) while no
developmental effects of biological significance were observed. In the
2-generation reproduction dietary study in the rat, tremors were noted
only in females of both generations, with one parental generation rat
observed to have clonic convulsions, and no observed effects in the
offspring. A developmental neurotoxicity study was also conducted.
Clinical signs of neurotoxicity were observed in both the adults and
offspring at the same dose levels; therefore, there is no indication of
increased qualitative or quantitative susceptibility in the young.
    Bifenthrin is classified as a Group C--``possible human
carcinogen,'' based on an increased incidence of urinary bladder tumors
in mice. However, EPA has determined that quantification of risk using
a non-linear approach (i.e., reference dose (RfD)) will adequately
account for all chronic toxicity, including potential carcinogenicity,
that could result from exposure to bifenthrin for the following
reasons. First, the bladder tumors may not be uncommon in mice and are
not likely to be malignant. Second, these tumors were observed only in
male mice at the highest dose. Third, no evidence of carcinogenicity
was observed in bifenthrin carcinogenicity studies in rats. Finally,
there is a low concern for mutagenicity based on the overall results of
the available mutagenicity tests of bifenthrin.
    A complete discussion of the toxicological profile for bifenthrin
and the Agency's cancer conclusion as well as specific information on
the studies received and the nature of the adverse effects caused by
bifenthrin 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 in the documents titled ``Bifenthrin: Revised
Human Health Risk Assessment for the Requested Section 3 Registration
of Bifenthrin on Pome Fruit Group 11-10 (except Mayhaw), Peach Subgroup
12-12B, Avocado, Pomegranate, Brassica Leafy Greens Subgroup 4-16B; and
Crop Group Conversions/Expansions for Tomato Subgroup 8-10A, Pepper/
Eggplant Subgroup 8-10B, Small Vine Climbing Fruit Subgroup 13-07F, Low
Growing Berry Subgroup 13-07G, Citrus Fruit Group 10 to Citrus Fruit
Group 10-10, Caneberry Subgroup 13A to Caneberry Subgroup 13-07A, and
Tree Nut Group 14 to Tree Nut Group 14-12'' (hereinafter ``Bifenthrin
Multiple Crop Human Health Risk Assessment'') and ``Bifenthrin. Human
Health Risk Assessment for the Proposed New Use on Sunflower Crop
Subgroup 20B'' in docket ID number EPA-HQ-OPP-2016-0352 in
regulations.gov.

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-pesticides.
    A summary of the toxicological endpoints for bifenthrin used for
human risk assessment can be found in the Bifenthrin Multiple Crop
Human Health Risk Assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to bifenthrin, EPA considered exposure under the petitioned-
for tolerances as well as all existing bifenthrin tolerances in 40 CFR
180.442. EPA assessed dietary exposures from bifenthrin 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 bifenthrin. In estimating acute
dietary exposure, EPA used 2003-2008 food consumption data from the
United States Department of Agriculture's (USDA's) National Health and
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As
to residue levels in food, the acute assessment was refined using
distributions and point estimates derived from pesticide data program
(PDP) monitoring data, field trial data, percent crop treated (PCT)
data, and empirical processing factors.
    ii. Chronic exposure. A chronic dietary endpoint has not been
selected for bifenthrin 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,
since there are residential uses of bifenthrin, a refined chronic
dietary exposure assessment was conducted to calculate average (food
and drinking water) exposure estimates representing background dietary
exposure to support the bifenthrin aggregate risk assessment. The
assessment was refined using point estimates derived from PDP
monitoring data, field trial data, PCT data, and empirical processing
factors.
    iii. Cancer. As discussed in Unit III.A., EPA has determined that
the acute reference dose (RfD) will adequately account for all repeated
exposure/chronic toxicity, including potential carcinogenicity, which
could result from exposure to bifenthrin. A separate cancer exposure
assessment was not conducted.
    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.
    The acute dietary assessment used the following maximum PCT
estimates: Almonds: 40%, artichoke: 65%, green beans (fresh &
succulent): 60%, blueberries (all bushberries): 35%, broccoli: 25%,
Brussel sprouts: 5%, cabbage: 50%, caneberries: 55%, canola: 25%,
cantaloupes: 55%, carrots: 5%, cauliflower: 2.5%, celery: 45%, citrus
(all others): 2.5%, corn: 10%, cotton: 20%, cucumbers: 35%, dry beans/
peas: 5%, eggplant: 45%, grapefruit: 2.5%, grapes, juice: 10%, grapes,
table: 2.5%, grapes, wine: 5%, hazelnuts: 5%, honeydews: 90%, kumquat:
2.5%, lemons: 2.5%, lettuce; 15%, lima beans: 40%, lime: 2.5%, okra:
45%, onions: 5%, oranges, 10%, peanuts: 20%, pears: 2.5%, green peas
(fresh & succulent): 50%, pecans: 20%, peppers (all); 30%, pistachios:
55%, potatoes: 15%, pummelo: 2.5%, pumpkins: 25%, soybeans: 10%,
spinach: 15%, squash: 25%, strawberries: 70%, sweet corn: 50%,
tangerines: 2.5%, tomatoes: 45%, walnuts: 25%, and watermelons: 20%.
The acute dietary assessment also used the following maximum PCT
estimates for some of the new uses: apples: 55%, avocados: 50%,
nectarines: 65%, peaches: 35%, and pomegranates: 60%.
    The following average PCT estimates for bifenthrin were used to
refine the chronic dietary risk assessment for the following crops:
Almonds: 25%, artichoke: 30%, green beans (fresh & succulent): 55%,
blueberries (all bushberries): 10%, broccoli: 15%, Brussel sprouts: 1%,
cabbage: 30%, caneberries: 45%, canola: 10%, cantaloupes: 50%, carrots:
2.5%, cauliflower: 1%, celery: 10%, citrus (all others): 1%, corn: 5%,
cotton: 15%, cucumbers: 20%, dry beans/peas: 2.5%, eggplant: 25%,
grapefruit: 1%, grapes, juice: 2.5%, grapes, table: 1%, grapes, wine:
2.5%, hazelnuts: 1%, honeydews: 25%, kumquat: 1%, lemons: 1%, lettuce;
10%, lima beans: 20%, lime: 1%, okra: 25%, onions: 2.5%, oranges, 1%,
peanuts: 10%, pears: 1%, green peas (fresh & succulent): 30%, pecans:
10%, peppers (all); 20%, pistachios: 35%, potatoes: 10%, pummelo: 1%,
pumpkins: 15%, soybeans: 5%, spinach: 2.5%, squash: 20%, strawberries:
55%, sweet corn: 40%, tangerines: 1%, tomatoes: 25%, walnuts: 15%, and
watermelons: 15%. The chronic dietary assessment also used the
following maximum PCT estimates for some of the new uses: apples: 50%,
avocados: 50%, nectarines: 65%, peaches: 35%, and pomegranates: 60%.
    A default of 100% CT was used for all livestock and game
commodities, freshwater finfish, and all other registered uses where no
maximum/average PCT estimates were available. All other commodities
included for depicting food handling establishment (FHE) uses were
refined with the upper bound estimate of 4.65% for non-fumigant
treatments made in FHEs.
    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
are taken into account through EPA's computer-based model for
evaluating the exposure of significant subpopulations including several
regional groups. Use of 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 bifenthrin 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 bifenthrin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of bifenthrin. 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.
    EPA used the limit of solubility as the drinking water input, i.e.,
the maximum possible residues that could occur in drinking water based
on the chemical properties of the compound. EPA used the modeled EDWCs
directly in the dietary exposure model to account for the contribution
of bifenthrin residues in drinking water as follows: 0.014 ppb was used
in the acute assessment and 0.014 ppb was used in the chronic
assessment.
    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). Bifenthrin is
currently registered for the following uses that could result in
residential exposures: Lawns/turf, indoor environments, gardens/trees,
pets (dog shampoo), termiticide and indoor/outdoor surface treatment
for various residential and commercial premises.
    EPA assessed residential exposure using the following assumptions.
There is the potential for residential handler and post-application
exposures from the use of bifenthrin. These exposures were assessed
using the 2012 Residential SOPs and submitted chemical-specific residue
data [bifenthrin-specific turf transferable residue (TTR; liquid and
granular) and dislodgeable foliar residue (DFR; liquid) data are
available]. EPA did not quantitatively assess the outdoor residential
handler uses in/around home foundations, outdoor impervious surfaces,
wood piles/structures and fence posts. Residential handler exposure
assessments were performed for adult homeowners applying bifenthrin
ready-to-use products (aerosol, hose-end sprayers and dog shampoos);
mixing/loading/applying liquid concentrates; loading/applying granular
formulations and applying dust formulations. The application rates for
these uses that were quantitatively assessed are equal to or higher
than those outdoor uses and thus are protective of the outdoor uses.
Dermal and inhalation risk estimates were combined in this assessment
because the toxicological effects for these exposure routes were the
same. A total aggregate risk index (ARI) was used because the levels of
concern (LOCs) for dermal exposure (100) and inhalation exposure (30)
are different. ARIs of less than 1 are risk estimates of concern. The
ARIs were calculated as follows. Aggregate Risk Index (ARI) = 1/
[(Dermal LOC / Dermal MOE) + (Inhalation LOC / Inhalation MOE)]. All
exposures are short-term in nature. There are no dermal or inhalation
risk estimates of concern for residential handlers for the registered
uses of bifenthrin.
    Post-application exposure was assessed for broadcast applications
to turf, gardens/trees, indoor environments (carpets and hard floor)
and treated pets. Residential post-application exposures are expected
to be short-, intermediate- or long-term in duration. Because the
single dose and repeat dosing bifenthrin 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 acute/single
day residential post-application assessments are protective of expected
longer-term exposures. Dermal and incidental oral risk estimates were
combined because the toxicological effects for these exposure routes
were similar [combined Margin of Exposure (MOE) approach used since
LOCs are the same].
    There were some residential post-application risk estimates of
concern identified previously in Registration Review. Specifically,
dermal post-application risks were identified for a liquid formulation
product with a maximum application rate of 2.3 lb ai/A, and risks were
identified for episodic ingestion of granules at application rates
greater than 0.34 lb ai/A. As a result, during Registration Review,
some bifenthrin labels were amended or canceled to address these risk
concerns. The product label for the liquid formulation with the high
application rate of 2.3 lb ai/A, which was canceled as of July 2021
(EPA Reg. #279-3152), was never commercialized. Because that product
was never sold or distributed, there are no exposures from that product
for consideration in the aggregate risk assessment. In addition, 25
granular products were either canceled or amended to require watering
in of the product after application when application rates were greater
than 0.34 lb ai/A. Although these label changes reduce the risks from
ingestion of granules, that use is not included in the aggregate
assessment because it is considered an episodic event and not a routine
behavior.
    The following residential exposure scenarios were selected for
aggregation and represent the worst-case risk estimates: Adults
contacting treated gardens (dermal exposure); children 1 to

<2 years old contacting treated turf (dermal and incidental oral
exposure at the 0.23 lb ai/A rate); children 6 to <11 years old
contacting treated gardens (dermal exposure); and children 11 to 16
years old golfing on treated turf (dermal exposure).
    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 registration of that use. A new turf use for the
pyrethroid, tau-fluvalinate, was assessed after completion of the
cumulative, which did impact the worst-case non-dietary risk estimates
identified in the 2011 CRA for the turf scenario (Memo, DeLeon, H.,
D450820, 12/16/2019). However, the overall finding (i.e., that the
pyrethroid cumulative risk is below the Agency's level of concern) did
not change upon registration of this new use.
    To account for the additional uses requiring tolerances in this
rule, the Agency has conducted an additional screen, taking into
account all previously approved uses and these proposed new uses. The
additional uses will not significantly impact the cumulative assessment
because dietary exposures make a minor contribution to total pyrethroid
exposure relative to residential exposures in the 2011 cumulative risk
assessment. Therefore, the results of the 2011 CRA are still valid and
there are no cumulative risks of concern for the pyrethroids/
pyrethrins.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the 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. Bifenthrin has been
evaluated for potential developmental effects in the rat (following
gavage and dietary administration) and in the rabbit (gavage
administration). Maternal toxicity included neurological effects
(tremors in rats and rabbits; head and forelimb twitching in rabbits).
There were no developmental effects of biological significance in
either species. The registrant submitted a Developmental Neurotoxicity
(DNT) study, which establishes a clear NOAEL for the adult and
offspring toxicity. The NOAEL in adults and offspring is similar in
magnitude, and the LOAELs are based on the clinical signs of
neurotoxicity (dams had tremors and convulsions, offspring had
increased grooming counts). Based on targeted testing in the DNT study
for common endpoints for bifenthrin, there was no increase in
sensitivity in rat pups. However, the Agency has reviewed existing
pyrethroid data and concludes that the DNT is not a particularly
sensitive study for comparing the sensitivity of young and adult
animals to pyrethroids. Some literature studies indicated
susceptibility for other pyrethroids, but in context, these studies
were conducted at relatively high doses, which may not reflect
environmental exposures. The reproductive toxicity of bifenthrin was
examined in a 2-generation reproduction dietary study in the rat.
Tremors were noted only in females of both generations, with one
parental generation rat observed to have clonic convulsions, and no
observed effects in the offspring. Overall, there is no indication of
increased juvenile sensitivity specifically to bifenthrin.
    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 bifenthrin is complete.
    ii. Like other pyrethroids, bifenthrin causes clinical signs of
neurotoxicity from interaction with sodium channels. These effects are
adequately assessed by the available guideline and non-guideline
studies. Bifenthrin is a Type I pyrethroid, and neurotoxic effects
characteristic of Type I pyrethroids were observed in adults in most of
the bifenthrin toxicity database. Specifically, muscle tremors and
decreased motor activity were observed in adults in guideline studies
throughout the bifenthrin toxicology database, and hind-limb flexion
was observed in adults the dermal study. For these reasons, the tremors
seen in juveniles in the 2-generation reproduction study are not
considered age-dependent effects.
    iii. There was no evidence that bifenthrin resulted in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study. Previously, however, EPA retained a FQPA safety factor of 3X to
account for concerns about pharmacokinetic (PK) differences between
adults and children. The Agency has re-evaluated the need for an FQPA
Safety Factor for human health risk assessments for pyrethroid
pesticides based on a review of the available guideline and literature
studies as well as data from the Council for the Advancement of
Pyrethroid Human Risk Assessment (CAPHRA) program. That recent data,
including human physiologically based pharmacokinetic (PBPK) models as
well as in vivo and in vitro data on protein binding, enzyme ontogeny,
and metabolic clearance, support the conclusion that the PK
contribution to the FQPA safety factor can be reduced to 1X for all
populations.
    iv. There are no residual uncertainties identified in the exposure
databases.

Although the acute dietary exposure estimates are refined, the exposure
estimates will not underestimate risk for the established and proposed
uses of bifenthrin since the residue levels used are based on either
monitoring data reflecting actual residues found in the food supply, or
on high-end residues from field trials which reflect the use patterns
which would result in highest residues in foods. Furthermore,
processing factors used were either those measured in processing
studies, or default high-end factors representing the maximum
concentration of residue into a processed commodity. EPA made
conservative (protective) assumptions to assess exposure to bifenthrin
in drinking water. EPA used similarly conservative assumptions to
assess post-application exposure of children as well as incidental oral
exposure of toddlers. These assessments will not underestimate the
exposure and risks posed by bifenthrin.

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 bifenthrin will occupy 15% of the aPAD for infants (<1 year old),
the population group receiving the greatest exposure. The acute
aggregate risk assessment combines exposures to bifenthrin in food and
drinking water only and is equivalent to the acute dietary assessment.
There are no acute aggregate risks estimates of concern.
    2. Chronic risk. The chronic (food and drinking water) exposure
assessment for bifenthrin was conducted solely for the purpose of
obtaining an average dietary exposure estimate for use in the aggregate
assessment. The population subgroup with the highest average dietary
exposure estimate is children 1 to 2 years old (0.000189 mg/kg/day).
    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). Bifenthrin 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 bifenthrin.
    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 520 for adults
(treated gardens). The short-term aggregate assessment for children 1
to less than 2 years old resulted in an MOE of 170 (treated turf at
0.23 lb ai/A). The short-term aggregate assessment for children 6 to
less than 11 years old and children 11 to 16 years old resulted in MOEs
of 1,600 (treated gardens) and 7,600 (golfing), respectively. Because
EPA's level of concern for bifenthrin is an MOE of 100 or lower, these
MOEs 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 bifenthrin 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 concluded
that the acute reference dose (RfD) will adequately account for all
repeated exposures, including carcinogenicity, which could result from
exposure to bifenthrin.
    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 bifenthrin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with an
electron capture detector (GC/ECD) analyses for determining bifenthrin
residues in both plant and livestock commodities) is available to
enforce the tolerance expression. The method may be requested from:
Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>;
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 not established any MRLs for bifenthrin in or on
apple, wet pomace; avocado; fruit, pome, group 11-10; peach, or
pomegranate. The following U.S. tolerances being established are
harmonized with the Codex MRLs, which are identified in parentheses:
Caneberry subgroup 13-07A at 1 ppm (blackberry, dewberries and
raspberries); fruit, citrus, group 10-10 at 0.05 ppm (citrus fruit);
and nut, tree, group 14-12 at 0.05 ppm (tree nuts). The U.S. tolerance
for pepper/eggplant subgroup 8-10B at 0.5 ppm is harmonized with the
Codex MRL on pepper. It is not possible to harmonize with the Codex
MRLs of all commodities in the subgroup, including eggplant at 0.3 ppm
and dried chili peppers at 5 ppm.
    The Codex has established an MRL for bifenthrin in or on grape at
0.3 ppm. The Agency is establishing the tolerance in or on fruit,
small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 0.3
ppm (rather than at 0.2 ppm, the existing U.S. tolerance on grape) to
harmonize with the Codex MRL on grape.
    The Canadian MRL for bifenthrin in or on pear is 0.9 ppm and there
are no Codex MRLs for the commodities in the pome fruit crop group. EPA
is establishing the U.S. tolerance for fruit, pome, group 11-10, except
mayhaw at 0.9 ppm (rather than at the request level of 0.70 ppm based
on submitted residue data and the existing U.S. tolerance for

pear) to harmonize with the Canadian MRL.
    EPA is establishing the tolerance for tomato subgroup 8-10A at 0.3
ppm (rather than at 0.15 ppm, the existing U.S. tolerance on tomato) to
harmonize with the Codex MRL of 0.3 ppm in/on tomato. Additionally, EPA
is establishing the tolerance for Brassica, leafy greens, subgroup 4-
16B at 4 ppm (rather than at 3.5 ppm, the existing U.S. tolerance on
Brassica, leafy greens, subgroup 5B) to harmonize with the Codex MRL of
4 ppm in/on mustard greens.
    It is not possible to harmonize the U.S. tolerance for Berry, low
growing, subgroup 13-07G at 3 ppm with the Codex MRL for strawberry at
1 ppm. Reducing the U.S. tolerance would put U.S. growers at risk of
having violative residues despite legal use of the pesticide according
to the label.

C. Revisions to Petitioned-For Tolerances

    EPA is establishing the tolerance at different levels than
requested for: Apple, wet pomace; avocado; berry, low growing, subgroup
13-07G; Brassica, leafy greens, subgroup 4-16B; caneberry subgroup 13-
07A; fruit, pome, group 11-10, except mayhaw; fruit, small, vine
climbing, except fuzzy kiwifruit, subgroup 13-07F; peach subgroup 12-
12B; pepper/eggplant subgroup 8-10B; pomegranate; sunflower (crop
subgroup 20B) and tomato subgroup 8-10A.
    All trailing zeroes have been removed from the proposed tolerances
to be consistent with Organization for Economic Cooperation and
Development (OECD) Rounding Class Practice. In addition, the proposed
apple, wet pomace tolerance of 1.3 ppm has been established at 1.5 ppm
because the value determined is rounded following the OECD rounding
class practice.
    To harmonize with the applicable international MRLs, the tolerances
for fruit, pome, group 11-10, except mayhaw; fruit, small, vine
climbing, except fuzzy kiwifruit, subgroup 13-07F; and tomato subgroup
8-10A were established at higher limits than what was proposed.
    The petitioner withdrew the change to the use pattern that would
have necessitated the change to the tolerance for Brassica, leafy
greens, subgroup 4-16B from 3.5 ppm to 15 ppm. EPA is establishing the
tolerance for Brassica, leafy greens, subgroup 4-16B at 4 ppm, based on
the crop group conversion of the established tolerance on Brassica,
leafy greens, subgroup 5B and adjusting it to harmonize with the Codex
MRL for mustard greens.
    The commodity definition for sunflower (crop subgroup 20B) has been
revised to sunflower subgroup 20B and the proposed tolerance at 0.01
has been established at 0.05 based on the current enforcement method
limit of quantitation (LOQ).

D. International Trade Considerations

    In this rule, EPA is establishing a lower tolerance for bifenthrin
residues in or on groundcherry than the current tolerance. The current
tolerance for groundcherry is 0.5 ppm, but groundcherry is a commodity
in the proposed crop group expansion from tomato to tomato subgroup 8-
10A, for which EPA is establishing a new tolerance in this rulemaking
at 0.3 ppm. As a result, EPA intends for the allowable residues on
groundcherry to be reduced. As discussed in EPA's crop grouping
rulemaking, EPA has determined that groundcherry is similar to tomatoes
and appropriately categorized in subgroup 8-10A. See 72 FR 69150 (Dec.
7, 2007). Based on residue data supporting the 0.3 ppm tolerance for
subgroup 8-10A and the similarity of groundcherry to tomatoes, EPA
concludes that it is appropriate to reduce the tolerance on
groundcherry as well.
    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 six-month period expires, this tolerance
will be reduced or revoked, as indicated in the regulatory text, and
allowable residues on groundcherry must conform to the tolerance for
subgroup 8-10A.
    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

    Tolerances are established for residues of bifenthrin, (2-methyl
[1,1'-biphenyl]-3-yl) methyl-3-(2-chloro-3,3,3,-trifluoro-1-propenyl)-
2,2-dimethylcyclopropanecarboxylate, in or on apple, wet pomace at 1.5
ppm; avocado at 0.5 ppm; berry, low growing, subgroup 13-07G at 3 ppm;
Brassica, leafy greens, subgroup 4-16B at 4 ppm; caneberry subgroup 13-
07A at 1 ppm; fruit, citrus, group 10-10 at 0.05 ppm; fruit, pome;
group 11-10, except mayhaw at 0.9 ppm; fruit, small, vine climbing,
except fuzzy kiwifruit, subgroup 13-07F at 0.3 ppm; nut, tree, group
14-12 at 0.05 ppm; peach subgroup 12-12B at 0.7 ppm; pepper/eggplant
subgroup 8-10B at 0.5 ppm; pomegranate at 0.5 ppm; sunflower subgroup
20B at 0.05 ppm; and tomato subgroup 8-10A at 0.3 ppm.
    The following tolerances are removed as unnecessary due to the
establishment of the above tolerances: Brassica, leafy greens, subgroup
5B at 3.5 ppm; caneberry subgroup 13A at 1.0 ppm; eggplant at 0.05 ppm;
fruit, citrus, group 10 at 0.05 ppm; grape at 0.2 ppm; nut, tree, group
14 at 0.05 ppm; okra at 0.50 ppm; pear at 0.5 ppm; pepino at 0.5 ppm;
pepper, bell at 0.5 ppm; pepper, nonbell at 0.5 ppm; pistachio at 0.05
ppm; strawberry at 3.0 ppm; tomato at 0.15 ppm; and turnip, greens at
3.5 ppm.
    Additionally, the following Section 18 time-limited tolerances are
removed as unnecessary due to the establishment of the above permanent
tolerances: Apple at 0.5 ppm; avocado at 0.50 ppm; nectarine at 0.5
ppm; peach at 0.5 ppm; and pomegranate at 0.50 ppm.
    Finally, EPA is setting a six-month expiration date for the current
groundcherry tolerance at 0.5 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to petitions 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), nor is it considered a regulatory action under
Executive Order 13771, entitled ``Reducing Regulations and Controlling
Regulatory Costs'' (82 FR 9339, February 3, 2017). 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

    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: November 10, 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:

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. Amend Sec.  180.442 by:
0
a. In the table in paragraph (a)(1)
0
i. Adding in alphabetical order the commodities: ``Apple, wet pomace'';
``Avocado''; ``Berry, low growing, subgroup 13-07G''; ``Brassica, leafy
greens, subgroup 4-16B'';
0
ii Removing the commodities: ``Brassica, leafy greens, subgroup 5B'';
``Caneberry subgroup 13A'';
0
iii. Adding in alphabetical order the commodity ``Caneberry subgroup
13-07A'';
0
iv. Removing the commodities ``Eggplant''; ``Fruit, citrus, group 10'';
0
v. Adding in alphabetical order the commodities ``Fruit, citrus, group
10-10''; ``Fruit, pome, group 11-10, except mayhaw''; ``Fruit, small,
vine climbing, except fuzzy kiwifruit, subgroup 13-07F'';
0
vi. Removing the commodity ``Grape'';
0
vii. Revising the entry for ``Groundcherry''
0
viii. Removing the commodity ``Nut, tree, group 14'';
0
ix. Adding in alphabetical order the commodity ``Nut, tree, group 14-
12'';
0
x. Removing the commodity ``Okra'';
0
xi. Adding in alphabetical order the commodity ``Peach subgroup 12-
12B''
0
xii. Removing the commodities ``Pear''; ``Pepino''; ``Pepper, bell'';
``Pepper, nonbell'';
0
xiii. Adding in alphabetical order the commodity ``Pepper/eggplant
subgroup 8-10B'';
0
xiv. Removing the commodity ``Pistachio''
0
xv, Adding in alphabetical order the commodity ``Pomegranate'';
0
xvi. Removing the commodity ``Strawberry'';
0
xvii. Adding in alphabetical order the commodity ``Sunflower subgroup
20B'';
0
xviii. Removing the commodity ``Tomato'';
0
xix. Adding in alphabetical order the commodity ``Tomato subgroup 8-
10A''; and
0
xx. Removing the commodity ``Turnip, greens''.
0
b. Remove and reserve paragraph (b).
    The additions and revisions read as follows.

Sec.  180.442   Bifenthrin; tolerances for residues.

    (a)(1) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------

                              * * * * * * *
Apple, wet pomace.......................................             1.5

                              * * * * * * *
Avocado.................................................             0.5

                              * * * * * * *
Berry, low growing, subgroup 13-07G.....................               3

                              * * * * * * *
Brassica, leafy greens, subgroup 4-16B..................               4

                              * * * * * * *
Caneberry subgroup 13-07A...............................               1

                              * * * * * * *
Fruit, citrus, group 10-10..............................            0.05
Fruit, pome, group 11-10, except mayhaw.................             0.9
Fruit, small, vine climbing, except fuzzy kiwifruit,                 0.3
 subgroup 13-07F........................................

                              * * * * * * *
Groundcherry \2\........................................             0.5

                              * * * * * * *
Nut, tree, group 14-12..................................            0.05

                              * * * * * * *
Peach subgroup 12-12B...................................             0.7

                              * * * * * * *
Pepper/eggplant subgroup 8-10B..........................             0.5
Pomegranate.............................................             0.5

                              * * * * * * *
Sunflower subgroup 20B..................................            0.05

                              * * * * * * *
Tomato subgroup 8-10A...................................             0.3

                              * * * * * * *
------------------------------------------------------------------------
\1\There are no U.S. registrations.
\2\ This tolerance expires on June 1, 2022.

* * * * *
[FR Doc. 2021-25091 Filed 11-30-21; 8:45 am]
BILLING CODE 6560-50-P