Document ID: EPA-HQ-OPP-2016-0352-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Bifenthrin
Posted Date: 2021-12-01T05:00Z

[Federal Register Volume 86, Number 228 (Wednesday, December 1, 2021)]
[Rules and Regulations]
[Pages 68150-68159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 (202) 566-1744, and the 
telephone number for the OPP Docket is (703) 305-5805.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting Director, 
Registration Division (7505P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; main telephone number: (703) 305-7090; email address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

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

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

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

[[Page 68152]]

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/

[[Page 68153]]

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),

[[Page 68154]]

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

[[Page 68155]]

<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.

[[Page 68156]]

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: (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 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

[[Page 68157]]

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

[[Page 68158]]

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

[[Page 68159]]

 
 
                              * * * * * * *
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