[Federal Register Volume 88, Number 81 (Thursday, April 27, 2023)]
[Rules and Regulations]
[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