Fluazifop-P-butyl; Pesticide Tolerances, 25501-25508 [2023-08939]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 88, Number 81 (Thursday, April 27, 2023)]
[Unknown Section]
[Pages 25501-25508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08939]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0310 and EPA-HQ-OPP-2021-0529; FRL-10884-01-OCSPP]


Fluazifop-P-butyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
fluazifop-P-butyl in or on multiple commodities which are identified 
and discussed later in this document. The Interregional Research 
Project Number 4 (IR-4) and Syngenta Crop Protection, LLC requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective April 27, 2023. Objections and 
requests for hearings must be received on or before June 26, 2023 and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The dockets for this action, identified by docket 
identification (ID) numbers EPA-HQ-OPP-2021-0310 and EPA-HQ-OPP-2021-
0529, are available at https://www.regulations.gov or at the Office of 
Pesticide Programs Regulatory Public Docket (OPP Docket) in the 
Environmental Protection Agency Docket Center (EPA/DC), West William 
Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, 
Washington, DC 20460-0001. The Public Reading Room is open from 8:30 
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Public Reading Room and the OPP Docket is 
(202) 566-1744. For the latest status information on EPA/DC services, 
docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration 
Division (7505T), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; email address: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Office of the 
Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID numbers EPA-HQ-OPP-2021-0310 and EPA-HQ-OPP-2021-0529 in the 
subject line on the first page of your submission. All objections and 
requests for a hearing must be in writing and must be received by the 
Hearing Clerk on or before June 26, 2023. Addresses for mail and hand 
delivery of objections and hearing requests are provided in 40 CFR 
178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior

[[Page 25502]]

notice. Submit the non-CBI copy of your objection or hearing request, 
identified by docket ID numbers EPA-HQ-OPP-2021-0310 and EPA-HQ-OPP-
2021-0529, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of August 24, 2021 (86 FR 47275) (FRL-8792-
02-OCSPP), EPA issued a document pursuant to FFDCA section 408(d)(3), 
21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition 
(PP1E8909) by IR-4, North Carolina State University, 1730 Varsity 
Drive, Venture IV, Suite 210, Raleigh, NC 27606. The petition requested 
that 40 CFR 180.411 be amended by establishing tolerances for residues 
of the herbicide fluazifop-P-butyl, butyl(R)-2-[4-[[5-
(trifluoromethyl)-2-pyridinyl]oxy]phenoxy]propanoate, in or on berry, 
low growing, subgroup 13-07G at 3 parts per million (ppm); Brassica, 
leafy greens, subgroup 4-16B at 15 ppm; chive, dried leaves at 40 ppm; 
fruit, citrus, group 10-10 at 0.03 ppm; fruit, stone, group 12-12 at 
0.05 ppm; leaf petiole vegetable subgroup 22B at 3 ppm; onion, green, 
subgroup 3-07B at 4 ppm; papaya at 0.01 ppm; and vegetable, brassica, 
head and stem, group 5-16 at 30 ppm. Upon the establishment of these 
tolerances, IR-4 requested that EPA remove the existing tolerances in 
40 CFR 180.411 for residues of fluazifop-P-butyl in or on fruit, 
citrus, group 10 at 0.03 ppm; fruit, stone at 0.05 ppm; onion, green at 
1.5 ppm; rhubarb at 0.50 ppm; and strawberry at 3.0 ppm. That document 
referenced a summary of the petition prepared by IR-4, the petitioner, 
which is available in the docket, https://www.regulations.gov in docket 
ID EPA-HQ-OPP-2021-0310. A comment was received on the notice of 
filing. EPA's response to the comment is discussed in Unit IV.C.
    In the Federal Register of November 17, 2022 (87 FR 68959) (FRL-
9410-07-OCSPP), EPA issued a document pursuant to FFDCA section 
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide 
petition (PP0F8890) by Syngenta Crop Protection, LLC, P.O. Box 18300, 
Greensboro, NC 27419. The petition requested that 40 CFR part 180 be 
amended by establishing tolerances for inadvertent residues of 
fluazifop-P-butyl metabolite 5-(Trifluoromethyl)-2-Pyridone (TFP) in or 
on the raw agricultural commodities corn forage at 0.01 ppm; corn grain 
at 0.01 ppm; and corn stover at 0.015 ppm. That document referenced a 
summary of the petition prepared by Syngenta Crop Protection, LLC, the 
registrant, which is available in the docket, https://www.regulations.gov in docket ID EPA-HQ-OPP-2021-0529. There were no 
comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
modified the levels at which tolerances are being established for some 
commodities and has adjusted the commodity definition for others. The 
reasons for these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for fluazifop-P-butyl including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with fluazifop-P-
butyl follows.
    In an effort to streamline its publications in the Federal 
Register, EPA is not reprinting sections that repeat what has been 
previously published for tolerance rulemaking of the same pesticide 
chemical. Where scientific information concerning a particular chemical 
remains unchanged, the content of those sections would not vary between 
tolerance rulemaking and republishing the same sections is unnecessary. 
EPA considers referral back to those sections as sufficient to provide 
an explanation of the information EPA considered in making its safety 
determination for the new rulemaking.
    EPA has previously published a tolerance rulemaking for fluazifop-
P-butyl in which EPA concluded, based on the available information, 
that there is a reasonable certainty that no harm results from 
aggregate exposure to fluazifop-P-butyl and established tolerances for 
residues of that chemical. EPA is incorporating previously published 
sections from this rulemaking as described further in this rulemaking, 
as they remain unchanged.
    Toxicological profile. For a discussion of the Toxicological 
Profile of fluazifop-P-butyl, see Unit III.A. of the September 27, 
2017, final rulemaking (82 FR 44936) (FRL-9966-67).
    Toxicological points of departure/Levels of concern. For a summary 
of the Toxicological Points of Departure/Levels of Concern for 
fluazifop-P-butyl used for human risk assessment, please reference Unit 
III.B. of the September 27, 2017, final rulemaking. As explained in the 
Food Quality Protection Act (FQPA) safety factor section in this rule, 
the safety factor for inhalation exposure has decreased from 10X to 1X 
so the level of concern for short term inhalation exposures is now 100 
rather than 1,000 like it was in 2017.
    Exposure assessment. Much of the exposure assessment remains the 
same although updates have occurred to accommodate the exposures from 
the petitioned-for tolerances. These updates are discussed in this 
section; for a description of the rest of the EPA approach to and 
assumptions for the exposure assessment, please reference Unit III.C of 
the September 27, 2017, final rulemaking.
    EPA's dietary exposure assessments have been updated to include the

[[Page 25503]]

additional exposure from the proposed new uses and indirect/inadvertent 
residues of fluazifop-P-butyl on the commodities identified in this 
action and were conducted using the Dietary Exposure Evaluation Model 
software using the Food Commodity Intake Database (DEEM-FCID) Version 
4.02, which uses the 2005-2010 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). 
The acute dietary exposure assessment assumed tolerance-level residues 
for plant commodities, anticipated residues for livestock commodities, 
100 percent crop treated (PCT) and default processing factors. The 
chronic dietary exposure assessment was based on mean residue levels 
from crop field trials, average PCT estimates for registered uses of 
fluazifop-P-butyl, projected PCT estimates for proposed new uses on 
broccoli and cauliflower, and experimentally determined processing 
factors where available. For both the acute and chronic exposure 
assessments, the residues were adjusted to account for additional 
metabolites of concern.
    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 Agency estimated the PCT for existing uses as follows:
    For the acute dietary analysis, 100% crop treated was assumed for 
all crops. The average percent crop treated estimates were used in the 
chronic dietary risk assessments for the following crops that are 
currently registered for fluazifop-P-butyl: apricots 1%; asparagus 1%; 
carrots 25%; cherries 1%; cotton 1%; dry beans/peas 1%; garlic 5%; 
grapefruit 5%; grapes 1%; lemons 1%; onions 10%; oranges 1%; peaches 
2.5%; peanuts 1%; plums/prunes 1%; potatoes 1%, soybeans 2.5%; 
strawberries 1%; sugar beets 1%.
    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 1% 
or 2.5% as the average PCT value, respectively. The maximum PCT figure 
is the highest observed maximum value reported within the recent 10 
years of available public and private market survey data for the 
existing use and rounded up to the nearest multiple of 5%, except where 
the maximum PCT is less than 2.5%, in which case, the Agency uses 2.5% 
as the maximum PCT.
    In addition, projected PCT was used for the proposed uses on 
broccoli (30% PCT) and cauliflower (45% PCT); 100 PCT was assumed for 
the other proposed uses. EPA assumes the percent crop treated for a new 
use (PCTn) is unlikely to exceed that of the PCT of the dominant 
pesticide (i.e., the one with the greatest PCT) used on that crop over 
the three most recent years of available data, which spans from 2016--
2020. Comparisons are only made among pesticides of the same pesticide 
types (e.g., the dominant insecticide on the crop is selected for 
comparison with a new insecticide). The PCTs included in the analysis 
may be for the same pesticide or for different pesticides since the 
same or different pesticides may dominate each year. Typically, EPA 
uses USDA/NASS as the source for raw PCT data because it is publicly 
available and does not have to be calculated from available data 
sources. When USDA/NASS does not survey a specific use site, EPA uses 
other appropriate public data or private market research to calculate 
the PCTn.
    The average PCT of the market leader(s) is appropriate for use in 
the chronic dietary risk assessment because it represents exposure over 
time. This method of estimating a PCT for a new use of a registered 
pesticide or a new pesticide produces a high-end estimate that is 
unlikely, in most cases, to be exceeded during the initial five years 
of actual use. The predominant factors that bear on whether the 
estimated PCTn could be exceeded are (1) the extent of pest pressure on 
the crops in question; (2) the pest spectrum of the new pesticide in 
comparison with the market; and (3) resistance concerns with the market 
leaders. EPA has examined the relevant data and concludes that it is 
unlikely that the actual PCT with fluazifop-P-butyl on broccoli and 
cauliflower will exceed the PCTn within the next 5 years.
    The Agency believes that the three conditions discussed in this 
section have been met. With respect to Condition a, PCT estimates are 
derived from Federal and private market survey data, which are reliable 
and have a valid basis. The Agency is reasonably certain that the 
percentage of the food treated is not likely to be an underestimation. 
As to Conditions b and c, regional consumption information and 
consumption information for significant subpopulations is taken into 
account through EPA's computer-based model for evaluating the exposure 
of significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
reliable information on the regional consumption of food to

[[Page 25504]]

which fluazifop-P-butyl may be applied in a particular area.
    Dietary exposure from drinking water. The recommended estimated 
drinking water concentrations in the September 27, 2017, final 
rulemaking remain valid and are considered protective of potential 
drinking water residue levels anticipated from the proposed new uses.
    Non-occupational 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).
    There are no new proposed residential uses. Fluazifop-P-butyl is 
currently registered for use on lawns/turf (including home lawns and 
golf courses) and ornamentals in residential settings that could result 
in residential exposures. For these currently registered uses of 
fluazifop-P-butyl, there are no residential (handler and post-
application) risk estimates of concern. The residential exposure 
scenarios recommended for aggregate risk assessment of fluazifop-P-
butyl are dermal and inhalation handler exposure from applications to 
gardens/trees using a backpack sprayer for adults and combined dermal 
plus hand-to-mouth post-application exposure from high-contact 
activities on treated turf for children 1 to less than 2 years old.
    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.'' Unlike other pesticides for 
which EPA has followed a cumulative risk approach based on a common 
mechanism of toxicity, EPA has not made a common mechanism of toxicity 
finding as to fluazifop-P-butyl and any other substances, and 
fluazifop-P-butyl does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this tolerance 
action, therefore, EPA has not assumed that fluazifop-P-butyl has a 
common mechanism of toxicity with other substances.
    Safety factor for infants and children. Section 408(b)(2)(C) of 
FFDCA provides that EPA shall apply an additional tenfold (10X) margin 
of safety for infants and children in the case of threshold effects to 
account for prenatal and postnatal toxicity and the completeness of the 
database on toxicity and exposure unless EPA determines based on 
reliable data that a different margin of safety will be safe for 
infants and children. This additional margin of safety is commonly 
referred to as the Food Quality Protection Act Safety Factor (FQPA 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.
    Prenatal and postnatal sensitivity. Increased quantitative 
sensitivity of the fetus was observed in the rat developmental studies 
in which no maternal toxicity was observed. Developmental toxicity in 
the rat was generally related to incomplete and/or delayed 
ossification. At higher doses, decreased fetal body weight and an 
increased incidence of diaphragmatic hernia were observed. In the 
rabbit, maternal and developmental toxicity were observed at the same 
dose. Maternal toxicity included abortions, weight loss, and death, 
while fetal toxicity included abortions, skeletal effects, and fetuses 
that were small and/or had cloudy eyes. In the rat reproduction and 
fertility study, maternal toxicity (increased liver weight, bile duct 
hyperplasia, and geriatric nephropathy) and offspring toxicity 
(decreased pup viability, decreased pup body weight, and 
hydronephrosis) were observed at the same dose level, and decreased 
female fertility was observed at the highest dose.
    Conclusion. The FQPA Safety Factor is being retained at 10X for the 
acute dietary assessment, as an uncertainty factor for lowest observed 
adverse effect level (LOAEL) to no observed adverse effect level 
(NOAEL) extrapolation (UFL) due to lack of a NOAEL in the 
acute neurotoxicity study from which the risk assessment endpoint was 
chosen. For the remaining applicable exposure scenarios, 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:
     The toxicity database is adequate for characterizing pre- 
and postnatal risk for infants and children. The database includes five 
rat developmental toxicity studies, two rabbit developmental toxicity 
studies, a rat reproduction study, acute and subchronic neurotoxicity 
studies, a delayed neurotoxicity study, and an immunotoxicity study. 
EPA previously retained the 10X FQPA SF when assessing short-term 
inhalation exposures due to a lack of a subchronic inhalation study; 
however, EPA has determined that the subchronic inhalation study is no 
longer necessary to assess risk to infants and children because of the 
low potential for volatilization, the low acute inhalation toxicity of 
fluazifop, the fact that the respiratory system is not a target organ, 
and the fact that the use of the oral point of departure (POD) results 
in margins of exposure (MOEs) greater than 1,000 for all residential 
handler scenarios. Thus, the available data is sufficient to ensure 
that the 1X will be protective.
     The endpoints selected are protective of any potential 
neurotoxic effects.
     There was no indication of increased fetal or offspring 
susceptibility compared to maternal toxicity in the rabbit 
developmental or rat reproduction studies. Quantitative susceptibility 
of the fetus was noted in the rat developmental studies. However, the 
selected PODs are protective for these effects. Therefore, the degree 
of concern is low.
     There is no residual uncertainty in the exposure database 
for fluazifop-P-butyl with respect to dietary (food and water) and 
residential (turf and ornamental use) exposure. The dietary food 
exposure assessments include assumptions that result in high-end 
estimates of dietary food exposure. Also included in the assessments 
are modeled drinking water estimates that are designed to be protective 
of the highest potential residue levels in drinking water from among a 
range of exposure scenarios. In addition, the residential exposure 
assessment was conducted based on the conservative assumptions for 
assessing post-application exposure of children found in the 
Residential Standard Operating Procedures and chemical-specific data 
such that residential exposure and risk will not be underestimated.
    Aggregate risks and determination of safety. EPA determines whether 
acute and chronic dietary pesticide exposures are safe by comparing 
dietary exposure estimates to the acute population adjusted dose (aPAD) 
and the chronic population adjusted dose (cPAD). Short-, intermediate-, 
and chronic term aggregate risks are evaluated by comparing the 
estimated total food, water, and residential exposure to the 
appropriate points of departure to ensure that an adequate MOE exists.
    Acute dietary risks are below the Agency's level of concern of 100% 
of the aPAD; they are 38% of the aPAD for children 1 to 2 years old, 
the group with the highest exposure. Chronic dietary risks are below 
the Agency's level of concern of 100% of the cPAD; they are 66% of the 
cPAD for children 1 to 2

[[Page 25505]]

years old, the most highly exposed group. Fluazifop-P-butyl 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 fluazifop-P-butyl. The short-term 
aggregate MOE for adults is 200 and for children 1 to <2 years old is 
480. These are greater than the level of concern of 100 and are not of 
concern. All residential exposures are anticipated to be short-term in 
duration; thus, an intermediate-term aggregate risk assessment is not 
required.
    Fluazifop-P-butyl is classified as ``Not Likely to be Carcinogenic 
to Humans''; therefore, EPA does not expect fluazifop-P-butyl exposures 
to pose an aggregate cancer risk.
    Therefore, based on the risk assessments and information described 
above, EPA concludes there is a reasonable certainty that no harm will 
result to the general population, or to infants and children, from 
aggregate exposure to fluazifop-P-butyl residues. More detailed 
information on this action can be found in the document ``Fluazifop-P-
butyl. Human Health Risk Assessment for Proposed Uses and/or Tolerances 
on Brassica, leafy greens (subgroup 4-16B), Vegetable, Brassica, head 
and stem (group 5-16), Leaf petiole vegetable (subgroup 22B), Chive, 
dried leaves, and Papaya; Crop group expansions to Onion, green, 
subgroup 3-07B and Berry, low growing, subgroup 13-07G; Crop group 
conversions to Fruit, citrus, group 10-10 and Fruit, stone, group 12-
12; and Rotational Field Corn'' in docket ID EPA-HQ-OPP-2021-0310 and 
EPA-HQ-OPP-2021-0529.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (High Performance Liquid 
Chromatography/Ultra-Violet Spectrometry (HPLC/UV)) is available to 
enforce the tolerance expression for crops. In addition, method 
GRM044.09A, a liquid chromatography and tandem mass spectroscopy (LC/
MS/MS) method, is available for the enforcement of 5-(Trifluoromethyl)-
2-Pyridone (TFP) residues in/on rotational crops.
    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 tolerances for fruit, citrus, group 10-10 and 
fruit, stone, group 12-12 are being harmonized with the respective 
Codex MRLs at 0.01 ppm. No Codex MRLs have been established for 
residues of fluazifop-P-butyl in or on the other commodities in this 
rulemaking.

C. Response to Comments

    One comment was received on the notice of filing, which opposed EPA 
establishing the requested tolerances and objected to the use of 
pesticides on crops. Although the Agency recognizes that some 
individuals believe that pesticides should be banned on agricultural 
crops, the existing legal framework provided by section 408 of the 
FFDCA authorizes EPA to establish tolerances when it determines that 
the tolerances are safe. Upon consideration of the validity, 
completeness, and reliability of the available data as well as other 
factors the FFDCA requires EPA to consider, EPA has determined that the 
fluazifop-P-butyl tolerances are safe. The commenter has provided no 
information indicating that a safety determination cannot be supported.

D. Revisions to Petitioned-For Tolerances

    The tolerance levels for fruit, citrus, group 10-10 and fruit, 
stone, group 12-12 are being set at the method limit of quantitation 
(LOQ) of the analytical method, 0.01 ppm, to harmonize with the Codex 
MRLs for these crop groups. The Codex MRL for citrus and stone fruit is 
established at 0.01 ppm, reflecting the LOQ of the enforcement method 
and no detects in the field trial data. The established U.S. tolerances 
of 0.03 ppm for fruit, citrus, group 10 and 0.05 ppm for fruit, stone 
reflect the highest LOQ reported in the respective field trials. As 
sprays are directed to weeds at the base of the trees or vines, residue 
translocation into tree/vine fruit is not expected, and suitably 
sensitive analytical enforcement methods are available. Therefore, a 
tolerance of 0.01 ppm for groups 10-10 and 12-12 is not expected to 
lead to violative residues.
    IR-4 requested a tolerance of 4 ppm for onion, green, subgroup 3-
07B based partly on the established tolerance of 1.5 ppm for onion, 
green and field trial residue data on chives, fresh leaves that 
supports a tolerance of 4 ppm. Because green onion is the 
representative commodity for onion, green, subgroup 3-07B, EPA is 
establishing the tolerance for subgroup 3-07B at 1.5 ppm and is 
establishing a tolerance for chives, fresh leaves at 4 ppm based on the 
chives field trial residue data. In addition, EPA corrected the 
commodity definitions for the field corn commodities to reflect 
standard Agency terminology.

E. International Trade Considerations

    In this rule, EPA is establishing tolerances for fluazifop-P-butyl 
residues in or on fruit, citrus, group 10-10 and fruit, stone, group 
12-12 at 0.01 ppm that are lower than the current tolerances of 0.03 
ppm for fruit, citrus, group 10 and 0.05 ppm for fruit, stone. For the 
reasons explained in Unit IV.D, the Agency believes these revised, 
lower tolerances are appropriate based on available residue data and 
analytical methods.
    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 retaining the 
existing tolerances for citrus group 10 and stone fruit by establishing 
an expiration date for these at the existing tolerance levels of 0.03 
ppm and 0.05 ppm, respectively, to allow these tolerances to remain in 
effect for a period of 6 months after the effective date of this final 
rule. After the 6-month period expires, the allowable residues on 
members of the citrus fruit group 10-10 and the stone fruit group 12-12 
must conform to the new lower tolerance level of 0.01 ppm. 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 levels are supported by 
available residue data.

V. Conclusion

    Therefore, tolerances are established for residues of fluazifop-P-
butyl in or on berry, low growing, subgroup 13-07G at 3 ppm; Brassica, 
leafy greens, subgroup 4-16B at 15 ppm; chives, dried leaves at 40 ppm; 
chives, fresh leaves at 4 ppm;

[[Page 25506]]

fruit, citrus, group 10-10 at 0.01 ppm; fruit, stone, group 12-12 at 
0.01 ppm; leaf petiole vegetable subgroup 22B at 3 ppm; onion, green, 
subgroup 3-07B at 1.5 ppm; papaya at 0.01 ppm; and vegetable, Brassica, 
head and stem, group 5-16 at 30 ppm. The established tolerances for 
fruit, citrus, group 10 at 0.03 ppm and fruit, stone at 0.05 ppm are 
designated to expire 6 months from the publication of this document. 
EPA is removing the established tolerances for onion, green at 1.5 ppm; 
rhubarb at 0.50 ppm; and strawberry at 3.0 ppm as unnecessary upon the 
establishment of the new tolerances. In addition, EPA is revising the 
residue definition for fluazifop-P-butyl in both 40 CFR 180.411(a) and 
(c) to be consistent with Agency practice and to read as follows:
    ``Tolerances are established for residues of the herbicide 
fluazifop-P-butyl, butyl (2R)-2-[4-[[5-(trifluoromethyl)-2-
pyridinyl]oxy]phenoxy]propanoate, including its metabolites and 
degradates, in or on the commodities listed below. Compliance with the 
tolerance levels specified below is to be determined by measuring only 
those fluazifop-P-butyl residues convertible to fluazifop, 2-[4-[[5-
(trifluoromethyl)-2-pyridinyl]oxy]phenoxy]propanoic acid, expressed as 
fluazifop, in or on the commodity''.
    Additionally, tolerances are established for indirect or 
inadvertent residues of the fluazifop-P-butyl metabolite, 5-
trifluoromethyl-2-pyridinone (TFP) in or on corn, field, forage at 0.01 
ppm; corn, field, grain at 0.01 ppm; and corn, field, stover at 0.015 
ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001), or to Executive Order 13045, 
entitled ``Protection of Children from Environmental Health Risks and 
Safety Risks'' (62 FR 19885, April 23, 1997). This action does not 
contain any information collections subject to OMB approval under the 
Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it 
require any special considerations under Executive Order 12898, 
entitled ``Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations'' (59 FR 7629, February 16, 
1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or Tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
Tribal Governments, on the relationship between the National Government 
and the States or Tribal Governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian Tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999), and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    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: April 24, 2023.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter 1 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. Revise Sec.  180.411 to read as follows:


Sec.  180.411  Fluazifop-P-butyl; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide fluazifop-P-butyl, butyl (2R)-2-[4-[[5-(trifluoromethyl)-2-
pyridinyl]oxy]phenoxy]propanoate, including its metabolites and 
degradates, in or on the commodities in table 1 to this paragraph (a). 
Compliance with the tolerance levels specified in table 1 is to be 
determined by measuring only those fluazifop-P-butyl residues 
convertible to fluazifop, 2-[4-[[5-(trifluoromethyl)-2-
pyridinyl]oxy]phenoxy]propanoic acid, expressed as fluazifop, in or on 
the commodity''.

[[Page 25507]]



                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Banana..................................................            0.01
Beans, dry, seed........................................              50
Beet, sugar, dried pulp.................................             1.0
Beet, sugar, molasses...................................             3.5
Beet, sugar, roots......................................            0.25
Berry, low growing, subgroup 13-07G.....................               3
Brassica, leafy greens, subgroup 4-16B..................              15
Bushberry subgroup 13-07B...............................            0.30
Caneberry subgroup 13-07A...............................            0.08
Carrot, roots...........................................             2.0
Cattle, fat.............................................            0.05
Cattle, meat............................................            0.05
Cattle, meat byproducts.................................            0.05
Chives, dried leaves....................................              40
Chives, fresh leaves....................................               4
Citrus, dried pulp......................................            0.40
Citrus, juice...........................................            0.06
Citrus, oil.............................................            30.0
Cotton, gin byproducts..................................             1.5
Cotton, refined oil.....................................             1.3
Cotton, undelinted seed.................................             1.0
Egg.....................................................            0.05
Endive..................................................             6.0
Fruit, citrus, group 10 \2\.............................            0.03
Fruit, citrus, group 10-10..............................            0.01
Fruit, small vine climbing, except fuzzy kiwifruit,                 0.03
 subgroup 13-07F........................................
Fruit, stone \2\........................................            0.05
Fruit, stone, group 12-12...............................            0.01
Goat, fat...............................................            0.05
Goat, meat..............................................            0.05
Goat, meat byproducts...................................            0.05
Hog, fat................................................            0.05
Hog, meat...............................................            0.05
Hog, meat byproducts....................................            0.05
Horse, fat..............................................            0.05
Horse, meat.............................................            0.05
Horse, meat byproducts..................................            0.05
Leaf petiole vegetable subgroup 22B.....................               3
Lettuce, head...........................................             3.0
Lettuce, leaf...........................................             5.0
Milk....................................................            0.05
Nut, macadamia..........................................             0.1
Onion, bulb, subgroup 3-07A.............................            0.50
Onion, green, subgroup 3-07B............................             1.5
Papaya..................................................            0.01
Peanut..................................................             1.5
Peanut, meal............................................             2.2
Pecans..................................................            0.05
Poultry, fat............................................            0.05
Poultry, meat...........................................            0.05
Poultry, meat byproducts................................            0.05
Potato \1\..............................................             1.0
Potato, chips \1\.......................................             2.0
Potato, granules/flakes \1\.............................             4.0
Sheep, fat..............................................            0.05
Sheep, meat.............................................            0.05
Sheep, meat byproducts..................................            0.05
Soybean, seed...........................................             2.5
Vegetable, Brassica, head and stem, group 5-16..........              30
Vegetable, tuberous and corm, except potato, subgroup 1D             1.5
------------------------------------------------------------------------
\1\ No U.S. registrations.
\2\ This tolerance expires on June 26, 2023.

    (b) [Reserved]
    (c) Tolerances with regional registrations. Tolerances are 
established for residues of the herbicide fluazifop-P-butyl, butyl 
(2R)-2-[4-[[5-(trifluoromethyl)-2-pyridinyl]oxy]phenoxy]propanoate, 
including its metabolites and degradates, in or on the commodities in 
table 2 to this paragraph (c). Compliance with the tolerance levels 
specified in table 2 is to be determined by measuring only those 
fluazifop-P-butyl residues convertible to fluazifop, 2-[4-[[5-
(trifluoromethyl)-2-

[[Page 25508]]

pyridinyl]oxy]phenoxy]propanoic acid, expressed as fluazifop, in or on 
the commodity''.

                        Table 2 to Paragraph (c)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Asparagus...............................................             3.0
Coffee, bean............................................             0.1
Fescue, forage..........................................             4.0
Fescue, hay.............................................              15
Pepper, tabasco.........................................             1.0
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. Tolerances are established 
for residues of the herbicide fluazifop-P-butyl, butyl (2R)-2-[4-[[5-
(trifluoromethyl)-2-pyridinyl]oxy]phenoxy]propanoate, including its 
metabolites and degradates, in or on the commodities in table 3 to this 
paragraph (d). Compliance with the tolerance levels specified in table 
3 is to be determined by measuring only those fluazifop-P-butyl 
residues convertible to 5-trifluoromethyl-2-pyridinone (TFP), expressed 
as TFP, in or on the commodity.

                        Table 3 to Paragraph (d)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Corn, field, forage.....................................            0.01
Corn, field, grain......................................            0.01
Corn, field, stover.....................................           0.015
------------------------------------------------------------------------

[FR Doc. 2023-08939 Filed 4-26-23; 8:45 am]
BILLING CODE 6560-50-P