Rule2023-02109
Fluopyram; Pesticide Tolerances
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 1, 2023
Effective
February 1, 2023
Issuing agencies
Environmental Protection Agency
Abstract
This regulation revises the tolerance for residues of fluopyram in or on coffee, green bean and establishes tolerances for residues of fluopyram in or on multiple commodities which are identified and discussed later in this document. The Interregional Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Full Text
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<title>Federal Register, Volume 88 Issue 21 (Wednesday, February 1, 2023)</title>
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[Federal Register Volume 88, Number 21 (Wednesday, February 1, 2023)]
[Rules and Regulations]
[Pages 6636-6643]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-02109]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0449; FRL-10566-01-OCSPP]
Fluopyram; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation revises the tolerance for residues of
fluopyram in or on coffee, green bean and establishes tolerances for
residues of fluopyram in or on multiple commodities which are
identified and discussed later in this document. The Interregional
Project Number 4 (IR-4) requested these tolerances under the Federal
Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective on February 1, 2023. Objections and
requests for hearings must be received
[[Page 6637]]
on or before April 3, 2023, and must be filed in accordance with the
instructions provided in 40 CFR part 178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2021-0449, is available at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or in-person 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Daniel Rosenblatt, 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:
<a href="/cdn-cgi/l/email-protection#27756361756948534e4442546742574609404851"><span class="__cf_email__" data-cfemail="d78593918599b8a3beb4b2a497b2a7b6f9b0b8a1">[email protected]</span></a>.
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:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> 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 <a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2021-0449 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
April 3, 2023. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2021-0449, by one of
the following methods:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
II. Summary of Petitioned-For Tolerance
In the Federal Register of September 22, 2021 (86 FR 52624) (FRL-
8792-03-OCSPP), EPA issued a document pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
petition (PP 1E8932) by the Interregional Research Project Number 4
(IR-4), Project Headquarters, North Carolina University, 1730 Varsity
Drive, Venture IV, Suite 210, Raleigh, NC 27606. The petition requests
to amend 40 CFR 180.661(a)(1) by establishing tolerances for residues
of the fungicide fluopyram, N-[2-[3-chloro-5-(trifluoromethyl)-2-
pyridinyl]ethyl]-2-(trifluoromethyl)benzamide, in or on the following
raw agricultural commodities: Brassica, leafy greens, subgroup 4-16B at
50 parts per million (ppm); celtuce at 20 ppm; coffee, green bean at
0.03 ppm; fennel, Florence, fresh leaves and stalk at 20 ppm; kohlrabi
at 4 ppm; leafy greens subgroup 4-16A at 40 ppm; leaf petiole vegetable
subgroup 22B at 20 ppm; papaya at 1.5 ppm; peppermint, dried leaves at
0.8 ppm; peppermint, fresh leaves at 0.6 ppm; spearmint, dried leaves
at 0.8 ppm; spearmint, fresh leaves at 0.6 ppm; spice group 26 at 70
ppm; vegetable, Brassica, head and stem, group 5-16 at 4 ppm;
individual commodities of proposed crop subgroup 6-XXA; edible podded
bean legume vegetable subgroup at 4 ppm; individual commodities of
proposed crop subgroup 6-XXB edible podded pea legume vegetable
subgroup at 4 ppm; individual commodities of proposed crop subgroup 6-
XXC: succulent shelled bean subgroup at 0.2 ppm; individual commodities
of proposed crop subgroup 6-XXD: succulent shelled pea subgroup at 0.2
ppm; and the individual commodities of proposed crop subgroup 6-XXE:
dried shelled bean, except soybean, subgroup at 0.7 ppm. Due to the
length of the list of commodities, please refer to the document EPA
issued in the Federal Register on September 22, 2021, for a complete
list of the tolerances requested. The petition also requested the
removal of the tolerances for residues of fluopyram in or on bean, dry
at 0.70 ppm; Brassica, head and stem, subgroup 5A at 4.0 ppm; Brassica,
leafy greens, subgroup 5B at 50 ppm; dill, seed at 70 ppm; leafy greens
subgroup 4A at 40 ppm; leafy petioles subgroup 4B at 20 ppm; pea and
bean, succulent shelled, subgroup 6B at 0.20 ppm; and vegetable,
legume, edible podded, subgroup 6A at 4.0 ppm. That document referenced
a summary of the petition prepared by IR-4, the petitioner, which is
available in the docket, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Three comments
were received on the Notice of Filing; however, the comments were not
relevant to the petition for fluopyram tolerances that are the subject
of this action.
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
[[Page 6638]]
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 therein 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 fluopyram including exposure resulting from the
tolerances established by this action. EPA's assessment of exposures
and risks associated with fluopyram follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The toxicological database for fluopyram has been re-
evaluated as part of registration review and relevant studies were
updated in accordance with current practices. The fluopyram database is
considered complete.
Liver effects, thyroid effects, and decreased body weight were the
most common and frequent findings in the subchronic and chronic oral
toxicity studies in rats, mice, and dogs, and appeared to be the most
sensitive effects in the fluopyram toxicological database. Increased
liver tumors were observed in female rats in the carcinogenicity study
at the highest dose tested (89 mg/kg/day). Thyroid effects (increased
thyroid weight along with follicular cell hypertrophy and hyperplasia)
were observed at dose levels similar to those that produced liver
effects in rats and mice. In male mice, there was an increased
incidence of thyroid adenomas at the highest dose tested (105 mg/kg/
day). Fluopyram induces liver enzymes following constitutive androstane
receptor and pregnane X receptor (CAR/PXR) activation, which causes
increased metabolism of thyroid hormones. These changes lead to liver
and thyroid hypertrophy and proliferation, eventually leading to liver
tumors (female rat) and thyroid tumors (male mice). EPA classified
fluopyram as ``Not Likely to be Carcinogenic to Humans'' at doses that
do not induce cellular proliferation in the liver or thyroid glands.
This classification was based on evidence that non-genotoxic modes of
action for liver tumors in rats and thyroid tumors in mice have been
established and that the carcinogenic effects have been demonstrated as
a result of a mode of action dependent on activation of the CAR/PXR
receptors. EPA determined that quantification of risk is not required.
There is sufficient data to ascertain the mode of action of fluopyram.
The chronic Reference Dose (RfD) is derived using the no-observed
adverse-effect level (NOAEL) of 6 mg/kg/day as the POD which is below
the dose of 11 mg/kg/day that caused cell proliferation in the liver (a
key event in tumor formation) and the subsequent liver tumors at a
higher dose (89 mg/kg/day). Additionally, there is no concern for
mutagenicity.
Fluopyram did not elicit developmental or offspring effects, nor
did it adversely affect reproductive parameters. No evidence of
increased qualitative or quantitative susceptibility was observed in
developmental or reproduction toxicity studies. There is no evidence of
neurotoxicity.
Specific information on the studies received and the nature of the
adverse effects caused by fluopyram as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found in the document titled
``Fluopyram. Human Health Risk Assessment for Proposed Uses on Coffee,
Green Bean, Papaya, Peppermint, Spearmint and Crop Group Expansions/
Conversions.'' (hereinafter ``Fluopyram Human Health Risk Assessment'')
on pages 43-52 in docket ID number EPA-HQ-OPP-2021-0449.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the NOAEL and LOAEL. Uncertainty/safety factors are used in
conjunction with the POD to calculate a safe exposure level--generally
referred to as a population-adjusted dose (PAD) or a reference dose
(RfD)--and a safe margin of exposure (MOE). For non-threshold risks,
the Agency assumes that any amount of exposure will lead to some degree
of risk. Thus, the Agency estimates risk in terms of the probability of
an occurrence of the adverse effect expected in a lifetime. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides</a>.
A summary of the toxicological endpoints and PODs for fluopyram
used for human risk assessment can be found in the Fluopyram Human
Health Risk Assessment on pages 25-26.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fluopyram, EPA considered exposure under the petitioned-for
tolerances as well as all existing fluopyram tolerances in 40 CFR
180.661. EPA assessed dietary exposures from fluopyram in food as
follows:
i. Acute and exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. Such effects were identified
for fluopyram.
In estimating acute dietary exposure, EPA used 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). As to residue levels in food, a partially
refined acute dietary exposure assessment was conducted, incorporating
field trial residues for coffee and the commodities of crop group 15
and crop subgroup 20A, and tolerance-level residues for all other crop
commodities. One hundred percent crop treated (PCT) was assumed.
ii. Chronic exposure. In conducting the chronic dietary exposure
[[Page 6639]]
assessment, EPA used the food consumption data from the USDA's 2005-
2010 NHANES/WWEIA and DEEM-FCID; version 4.02. As to residue levels in
food, the chronic dietary exposure assumed tolerance-level residues for
mint and papaya and used mean field trial data and empirical processing
factors for all other commodities. Average PCT estimates were used for
some crops.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that fluopyram does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
iv. Anticipated residue and 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 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 the following conditions are met:
<bullet> 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.
<bullet> Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
<bullet> 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: almonds,
20%; apples, 25%; apricots, 5%; artichoke, 15%; broccoli, 2.5%;
cabbage, 2.5%; carrots, 1%; cauliflower, 1%; cherries, 25%; cotton, 1%;
dry beans and peas, 1%; grapefruit, 10%; grapes, raisins, 1%; table
grapes, 5%; wine grapes; 20%; lemons, 1%; lettuce, 1%; onions, 1%;
oranges, 15%; peaches, 1%; peanuts, 2.5%; pears, 5%; peppers, 5%;
pistachios, 15%; potatoes, 20%; strawberries, 10%; tomatoes, 1%;
walnuts, 10%; and watermelons, 15%. EPA assumed 100 PCT for all other
commodities included in the chronic assessment.
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and California Department of
Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the
chemical/crop combination for the most recent 10 years. EPA uses an
average PCT for chronic dietary risk analysis and a maximum PCT for
acute dietary risk analysis. The average PCT figure for each existing
use is derived by combining available public and private market survey
data for that use, averaging across all observations, and rounding to
the nearest 5%, except for those situations in which the average PCT is
less than 1% or less than 2.5%. In those cases, the Agency would use
less than 1% or less than 2.5% as the average PCT value, respectively.
The maximum PCT figure is the highest observed maximum value reported
within the most recent 10 years of available public and private market
survey data for the existing use and rounded up to the nearest multiple
of 5%, except where the maximum PCT is less than 2.5%, in which case,
the Agency uses less than 2.5% as the maximum PCT.
The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which fluopyram may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for fluopyram in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fluopyram. Further information regarding EPA
drinking water models used in pesticide exposure assessments can be
found at <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-risk-assessment">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-risk-assessment</a>.
Based on the Surface Water Concentration Calculator (SWCC) and
Pesticide Root Zone Model--Ground Water (PRZM-GW) model, the estimated
drinking water concentrations (EDWCs) of fluopyram for acute exposures
are estimated to be 50.6 parts per billion (ppb) for surface water and
97.6 ppb for ground water. For chronic exposures for non-cancer
assessments, the EDWCs of fluopyram are estimated to be 17.3 ppb for
surface water and 90.5 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 97.6 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of 90.5 ppb was used to assess the
contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
There are no residential exposures associated with the proposed
uses of fluopyram on coffee, mint, and papaya in this action; however,
residential post-application exposures are anticipated from other
registered uses of fluopyram on golf course turf, residential lawns,
fruit trees, nut trees, ornamentals, and gardens. From the reevaluation
of the toxicity database, the endpoints selected for residential
exposures include incidental oral and short- and intermediate-term
inhalation endpoints, but a dermal endpoint is no longer selected. A
dermal endpoint was not selected as there were no adverse effects
observed in the route-specific dermal
[[Page 6640]]
toxicity study, which included evaluation of fluopyram target organs,
up to the limit dose of 1,000 mg/kg/day. Additionally, there was no
evidence of increased quantitative susceptibility in the fluopyram
database.
EPA assessed residential exposure using the following assumptions.
Residential handler exposures and risk are not assessed in this
document because the existing registered uses for residential sites are
from end-use products that require handlers to wear specific clothing
and personal protective equipment (PPE). Thus, EPA has assumed that
those products are not for homeowner use and a quantitative residential
handler assessment is not warranted at this time. There are residential
post-application exposures from existing turf uses that have been
previously assessed. The residential exposure for use in the children 1
to less than 2 years old aggregate assessment reflects incidental oral
hand-to-mouth post-application exposure to treated lawns. The MOE is
5,400, which is greater than the level of concern of 100 and therefore
is not of concern. Further information regarding EPA standard
assumptions and generic inputs for residential exposures may be found
at <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/operating-procedures-residential-pesticide">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/operating-procedures-residential-pesticide</a>.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
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 fluopyram and any other
substances, and fluopyram does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this action,
therefore, EPA has not assumed that fluopyram has a common mechanism of
toxicity with other substances.
For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides</a>.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act (FQPA) Safety Factor (SF). In applying this provision,
EPA either retains the default value of 10X, or uses a different
additional safety factor when reliable data available to EPA support
the choice of a different factor.
2. Prenatal and postnatal sensitivity. There is no evidence of
increased susceptibility following in utero and/or postnatal exposure
in the developmental toxicity studies in rats or rabbits, or in the 2-
generation rat reproduction study. There is no evidence of
neurotoxicity, and there are no residual uncertainties in the exposure
database. While thyroid effects are observed throughout the database,
EPA determined that the comparative thyroid assay (CTA) be waived based
on a weight-of-evidence approach.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced from 10X to 1X. That decision is based on the
following findings:
i. The toxicology database for fluopyram is complete and adequate
for risk assessment. EPA waived the subchronic inhalation toxicity
study requirement and the previously required CTA for fluopyram for the
following reasons: (1) the margins of exposure are low using the
current endpoints; (2) thyroid effects are well-characterized and
protected for using the current endpoints; and (3) acute inhalation
toxicity is low and the compound is unlikely to volatilize. The
toxicology database includes acceptable developmental toxicity studies
in the rat and rabbit and an acceptable reproductive toxicity study in
the rat, as well as acute and subchronic neurotoxicity studies.
ii. Potential signs of neurotoxicity were observed in the rat acute
neurotoxicity study (decreased motor activity) and in the rat chronic/
carcinogenicity study (reduced use of hind-limbs and limited motor
activity). However, these effects are not specific to neurotoxicity,
occur in the presence of other effects, and can also be attributed to
systemic toxicity. There is a low degree of concern for potential
neurotoxic effects since (1) clear NOAELs were identified for these
effects, (2) no other neurotoxic effects were identified in the
database, (3) potentially neurotoxic effects are not the most sensitive
effect in the toxicity database, and (4) the endpoints chosen for risk
assessment are protective of these potentially neurotoxic effects.
iii. The available developmental toxicity studies in rats and
rabbits and the multi-generation reproduction in rats demonstrate no
evidence of increased susceptibility in the developing or young animals
which were exposed during pre- or post-natal periods. No developmental
or offspring effects were noted in these studies.
iv. There are no residual uncertainties in the exposure database.
The acute dietary exposure assessment was performed using conservative
exposure inputs, including field trial residue levels or tolerance
level residues for all crops; and average field-trial residue levels
were assumed for all crops in the chronic dietary exposure assessment.
The acute dietary assessment assumed 100 PCT, whereas the chronic
dietary assessment utilized average PCT numbers for some crops. Both
acute and chronic dietary assessments incorporated empirical or default
processing factors. EPA made conservative (protective) assumptions in
the ground and surface water modeling used to assess exposure to
fluopyram in drinking water. EPA used similarly conservative
assumptions to assess post application exposure of children as well as
incidental oral exposure of toddlers. These assessments will not
underestimate the exposure and risks posed by fluopyram.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute population adjusted dose (aPAD) and chronic population adjusted
dose (cPAD). For linear cancer risks, EPA calculates the lifetime
probability of acquiring cancer given the estimated aggregate exposure.
Short-, intermediate-, and chronic-term risks are evaluated by
comparing the estimated aggregate food, water, and residential exposure
to the appropriate PODs to ensure that an adequate MOE exists.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary
[[Page 6641]]
exposure from food and water to fluopyram will occupy 25% of the aPAD
for children 1 to 2 years old, the population group receiving the
greatest exposure. The aggregate acute risk estimate includes only
exposure to residues of fluopyram in food and drinking water, which is
below the Agency's level of concern of 100% of the aPAD and is not of
concern.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
fluopyram from food and water will utilize 16% of the cPAD for all
infants less than 1 year old, the population group receiving the
greatest exposure. Chronic residential exposure to residues of
fluopyram is not expected. Therefore, the chronic aggregate exposure is
equivalent to the chronic dietary exposure, which is below the Agency's
level of concern of 100% of the cPAD and is not of concern.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Fluopyram is
currently registered for uses that could result in short-term
residential post-application exposure, and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with short-term residential exposures to fluopyram. Using the
exposure assumptions described in this unit for short-term exposures,
EPA has concluded the combined short-term food, water, and residential
exposures result in aggregate MOEs of 2,100 for children (1 to less
than 2 years old). Because EPA's level of concern for fluopyram is an
MOE of 100 or below, the short-term aggregate risk is not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
The short-and intermediate-term PODs are the same and the
intermediate-term exposures are smaller than the short-term exposures,
thus, the short-term aggregate exposure assessment is protective of any
intermediate-term exposures.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, fluopyram is not expected to pose a cancer risk to humans.
6. Determination of safety. Based on these risk assessments and
information described above, EPA concludes that there is a reasonable
certainty that no harm will result to the general population, or to
infants and children from aggregate exposure to fluopyram residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology DFG Method S19 using GC/MSD (gas
chromatography with mass-selective detection) is available to enforce
the tolerance expression.
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
<a href="/cdn-cgi/l/email-protection#621007110b0617070f07160a0d0611220712034c050d14"><span class="__cf_email__" data-cfemail="c1b3a4b2a8a5b4a4aca4b5a9aea5b281a4b1a0efa6aeb7">[email protected]</span></a>.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
There are no established Codex MRLs for Brassica, leafy greens,
subgroup 4-16B; celtuce; coffee, green bean; fennel, Florence, fresh
leaves and stalk; kohlrabi; leaf petiole vegetable subgroup 22B; mint;
papaya; or edible podded peas. The U.S. tolerance for spice group 26 is
harmonized with the Codex MRL of 70 ppm in/on dill seed, which is the
representative crop for spice group 26. The U.S. tolerances for the
succulent shelled bean subgroup 6-22C and succulent shelled pea
subgroup 6-22D are harmonized with the Codex MRL of 0.2 ppm for the
commodities in those subgroups.
For the remaining commodities (leafy greens subgroup 4-16A;
vegetable, Brassica, head and stem, group 5-16; edible podded bean
subgroup 6-22A; and dried shelled bean, except soybean, subgroup 6-
22E), the established Codex MRLs are lower than the U.S. tolerances.
Harmonization is not possible because decreasing the U.S. tolerances
would put U.S. growers at risk of having violative residues despite
legal use of fluopyram according to the label.
C. Revisions to Petitioned-For Tolerances
Because the final Phase VI crop group rule has been published, EPA
is establishing tolerances for new subgroups in legume vegetable crop
group 6-22 rather than for each individual commodity in those subgroups
as requested by the petitioner. The Phase VI crop group rule allows the
commodities to be covered as part of the new group or subgroups instead
of needing to be listed separately. The Phase VI crop group was
published on September 21, 2022, and was effective on November 21, 2022
(87 FR 57627) (FRL-5031-13-OCSPP).
V. Conclusion
Therefore, tolerances are established for residues of fluopyram, N-
[2-[3-chloro-5-(trifluoromethyl)-2-pyridinyl]ethyl]-2-
(trifluoromethyl)benzamide, in or on Brassica, leafy greens, subgroup
4-16B at 50 ppm; celtuce at 20 ppm; fennel, Florence, fresh leaves and
stalk at 20 ppm; kohlrabi at 4 ppm; leaf petiole vegetable subgroup 22B
at 20 ppm; leafy greens subgroup 4-16A at 40 ppm; papaya at 1.5 ppm;
peppermint, dried leaves at 0.8 ppm; peppermint, fresh leaves at 0.6
ppm; spearmint, dried leaves at 0.8 ppm; spearmint, fresh leaves at 0.6
ppm; spice group 26 at 70 ppm; vegetable, Brassica, head and stem,
group 5-16 at 4 ppm; vegetable, legume, bean, edible podded, subgroup
6-22A at 4 ppm; vegetable, legume, pea, edible podded, subgroup 6-22B
at 4 ppm; vegetable, legume, bean, succulent shelled, subgroup 6-22C at
0.2 ppm; vegetable, legume, pea, succulent shelled, subgroup 6-22D at
0.2 ppm; and vegetable, legume, pulse, bean, dried shelled, except
soybean, subgroup 6-22E at 0.7 ppm. The tolerance for coffee, green
beans at 0.03 ppm is revised to remove the footnote. The following
tolerances are removed: bean, dry at 0.70 ppm; Brassica, head and stem,
subgroup 5A at 4.0 ppm; Brassica, leafy greens, subgroup 5B at 50 ppm;
dill, seed at 70 ppm; leafy greens subgroup 4A at 40 ppm; leafy
petioles subgroup 4B at 20 ppm; pea and bean, succulent shelled,
subgroup 6B; and vegetable, legume, edible podded, subgroup 6A.
[[Page 6642]]
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the 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: January 26, 2023.
Daniel Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:
PART 180--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. In Sec. 180.661, table 1 to paragraph (a)(1) is amended by:
0
a. Removing the entries for ``Bean, dry'' and ``Brassica, head and
stem, subgroup 5A'';
0
b. Adding in alphabetical order the entry ``Brassica, leafy greens,
subgroup 4-16B'';
0
c. Removing the entry for ``Brassica, leafy greens, subgroup 5B'';
0
d. Adding in alphabetical order the entry ``Celtuce'';
0
e. Revising the entry for ``Coffee, green beans'' by removing the
footnote;
0
f. Removing the entry for ``Dill, seed'';
0
g. Adding in alphabetical order the entries ``Fennel, Florence, fresh
leaves and stalk'', ``Kohlrabi'', ``Leaf petiole vegetable subgroup
22B'' and ``Leafy greens subgroup 4-16A'';
0
h. Removing the entries for ``Leafy greens subgroup 4A'' and ``Leafy
petioles subgroup 4B'';
0
i. Adding in alphabetical order the entry ``Papaya'';
0
j. Removing the entry ``Pea and bean, succulent shelled, subgroup 6B'';
0
k. Adding in alphabetical order the entries ``Peppermint, dried
leaves'', ``Peppermint, fresh leaves'', ``Spearmint, dried leaves'',
``Spearmint, fresh leaves'', ``Spice group 26'', ``Vegetable, Brassica,
head and stem, group 5-16'', ``Vegetable, legume, bean, edible podded,
subgroup 6-22A'', and ``Vegetable, legume, bean, succulent shelled,
subgroup 6-22C'';
0
l. Removing the entry ``Vegetable, legume, edible podded, subgroup
6A'';
0
m. Adding in alphabetical order the entries ``Vegetable, legume, pea,
edible podded, subgroup 6-22B'', ``Vegetable, legume, pea, succulent
shelled, subgroup 6-22D''and ``Vegetable, legume, pulse, bean, dried
shelled, except soybean, subgroup 6-22E''; and
0
n. Removing footnote 2.
The additions and revisions read as follows:
Sec. 180.661 Fluopyram; tolerances for residues.
(a) * * *
(1) * * *
Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * * * *
Brassica, leafy greens, subgroup 4-16B............... 50
* * * * * * *
Celtuce.............................................. 20
[[Page 6643]]
* * * * * * *
Coffee, green beans.................................. 0.03
* * * * * * *
Fennel, Florence, fresh leaves and stalk............. 20
* * * * * * *
Kohlrabi............................................. 4
Leaf petiole vegetable subgroup 22B.................. 20
Leafy greens subgroup 4-16A.......................... 40
* * * * * * *
Papaya............................................... 1.5
* * * * * * *
Peppermint, dried leaves............................. 0.8
Peppermint, fresh leaves............................. 0.6
* * * * * * *
Spearmint, dried leaves.............................. 0.8
Spearmint, fresh leaves.............................. 0.6
Spice group 26....................................... 70
* * * * * * *
Vegetable, Brassica, head and stem, group 5-16....... 4
* * * * * * *
Vegetable, legume, bean, edible podded, subgroup 6- 4
22A.................................................
Vegetable, legume, bean, succulent shelled, subgroup 0.2
6-22C...............................................
Vegetable, legume, pea, edible podded, subgroup 6-22B 4
Vegetable, legume, pea, succulent shelled, subgroup 6- 0.2
22D.................................................
Vegetable, legume, pulse, bean, dried shelled, except 0.7
soybean, subgroup 6-22E.............................
* * * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations.
* * * * *
[FR Doc. 2023-02109 Filed 1-31-23; 8:45 am]
BILLING CODE 6560-50-P
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