[Federal Register Volume 86, Number 35 (Wednesday, February 24, 2021)]
[Rules and Regulations]
[Pages 11133-11139]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03624]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2017-0233; FRL-10005-77]
Tetraniliprole; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
tetraniliprole in or on multiple commodities that are identified and
discussed later in this document. Bayer CropScience requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective February 24, 2021. Objections and
[[Page 11134]]
requests for hearings must be received on or before April 26, 2021, 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-2017-0233, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2017-0233 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 26, 2021. 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-2017-0233, by one of
the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of December 15, 2017 (82 FR 59604) (FRL-
9970-50), 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
7F8558) by Bayer CropScience, 2 T.W. Alexander Drive, Research Triangle
Park, NC 27709. The petition requested that 40 CFR part 180 be amended
by establishing tolerances for residues of the insecticide,
tetraniliprole in or on tuberous and corm vegetables, crop group 1C at
0.015 parts per million (ppm); potato, wet peel at 0.02 ppm; leafy
vegetables, crop group 4-16 at 20 ppm; Brassica head and stem
vegetables, crop group 5-16 at 1.5 ppm; fruiting vegetables, crop group
8-10 at 0.40 ppm; tomato paste at 1.5 ppm; citrus fruit, orange
subgroup 10-10A at 0.50 ppm; citrus fruit, lemon/lime subgroup 10-10B
at 0.80 ppm; citrus fruit, grapefruit subgroup 10-10C at 0.50 ppm;
citrus oil at 4.0 ppm; pome fruit, crop group 11-10 at 0.40 ppm; stone
fruit, crop group 12-12 at 1.0 ppm; plum, dried (prune) at 2.0 ppm;
small fruit, vine climbing subgroup, except fuzzy kiwi, crop subgroup
13-07F at 1.5 ppm; tree nuts, crop group 14-12 at 0.03 ppm; almond
hulls at 4.0 ppm; corn, field, grain at 0.015 ppm; corn, field, forage
at 4.0 ppm; corn, field, stover at 15 ppm; corn, pop, grain at 0.015
ppm; corn, pop, stover at 15 ppm; corn, sweet, kernel plus cobs with
husks removed at 0.01 ppm; corn, sweet, forage at 6.0 ppm; corn, sweet,
stover at 20 ppm; cottonseed, crop group 20C at 0.40 ppm; cotton, gin
byproducts at 30 ppm; soybean seed at 0.20 ppm; soybean hulls at 0.60
ppm; aspirated grain fractions at 45 ppm; soybean forage at 0.07 ppm;
soybean hay at 0.20 ppm; alfalfa, forage and hay at 0.06 ppm; forage,
fodder and straw of cereal grains, crop group 16, except field, pop and
sweet corn at 0.10 ppm; foliage of legume vegetables, crop group 7,
except soybeans at 0.03 ppm; milk at 0.06 ppm; fat of cattle, horses,
sheep and goats at 0.30 ppm; muscle of cattle, horses, sheep and goats
at 0.03 ppm; meat by-products of cattle, horses, sheep and goats at
0.30 ppm. That document referenced a summary of the petition prepared
by Bayer CropScience, the registrant, which is available in the docket,
http://www.regulations.gov. Comments were received on the notice of
filing. EPA's response to these comments is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA has
modified the levels at which tolerances are being established as well
as some of the commodity definitions used. The reasons for these
changes are explained in Unit IV.D.
[[Page 11135]]
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 tetraniliprole including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with tetraniliprole
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 submitted animal toxicity studies on tetraniliprole demonstrate
low toxicity, which is expected based on two factors. Tetraniliprole is
an anthranilimide insecticide that targets the activation of insect
ryanodine receptors, which leads to insect paralysis and death. In
contrast, mammalian ryanodine receptors are substantially less
sensitive (i.e., 350 to >2,500 times less sensitive) to the effects of
anthranilic diamides than insect ryanodine receptors. Moreover,
available data indicate that tetraniliprole has limited absorption at
the higher dose levels (>20 mg/kg), which may contribute to the low
toxicity seen in the animal testing.
In subchronic toxicity studies (28-day and 90-day) in rats and
mice, no adverse effects were seen at dose levels ranging from
approximately 600 to 1,228 mg/kg/day. In the subchronic studies (28-day
and 90-day) in dogs, an increase in the incidence and frequency of
salivation was found, but this finding did not show a dose related-
response, was a common occurrence in dogs, and was not considered to be
adverse.
No systemic or dermal toxicity was seen in a 28-day dermal toxicity
study at 1,000 mg/kg/day; this finding was consistent with rather low
dermal absorption as the DAF for humans was estimated to be
approximately 9% (upper limit).
No adverse maternal or developmental effects were found at the
limit dose (1,000 mg/kg/day) in the developmental toxicity studies in
rats and rabbits. In the reproduction study, the offspring effect,
slight decrease in pup weight near and above the limit dose, was found
in the absence of any adverse parental effect. Because the potential
increase in susceptibility occurred at the limit dose and on postnatal
days (PND) 14 to 21 at which time the pups were exposed to the test
material through both milk and food resulting in a higher compound
intake, the Agency's concern for the potential risk to infants and
children is low. Tetraniliprole did not cause any effects on
reproductive parameters.
The combined chronic/carcinogenicity study in rats showed a
decrease in body weights, increased incidence of squamous cell
hyperplasia in the cervix and vagina, and corpora lutea depletion in
the ovary at the limit dose. In addition, a slight increase in the
incidence of uterine tumor was observed at a dose slightly above the
limit dose. No genotoxic potential was detected in the battery of
genotoxicity studies. There were no treatment-related tumors seen in
mice and no adverse effects were observed in male rats. The only
adverse effects observed in female rats occurred at the limit dose,
which was the only dose where pre-neoplastic or neoplastic lesions were
observed. Furthermore, there is no concern for mutagenicity and none of
the identified structurally-related compounds induced tumors in rats or
mice. Based on the available data that indicates that the increased
incidence of uterine tumor was seen in only one species (rat), one sex
(female), and is only slightly outside of the historical control range,
EPA has classified tetraniliprole as having ``suggestive evidence of
carcinogenic potential.''
Typically, for chemicals so classified, EPA recommends that a non-
linear or RfD approach be used because the RfD would be protective for
all toxicity, including carcinogenicity. However, in the case of
tetraniliprole, EPA determined that the existing data do not support
establishing toxicity endpoints and that a qualitative assessment is
more appropriate for assessing tetraniliprole. This analysis is
discussed more fully in Unit III.B. below. Similarly, because of the
suggestive nature of the carcinogenicity effects and the fact that the
only tumor effects are seen at doses above the limit dose, EPA has
determined that a qualitative risk assessment would be appropriate in
this case to account for all toxicity including carcinogenicity.
No acute and subchronic neurotoxicity studies were submitted for
tetraniliprole because this requirement was waived. However, no
evidence of neurotoxicity was seen in any of the other studies in the
tetraniliprole database.
Specific information on the studies received and the nature of the
adverse effects caused by tetraniliprole 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 at http://www.regulations.gov in the document titled ``Tetraniliprole: New Active
Ingredient, First Food Use. Human Health Risk Assessment for the
Establishment of Permanent Tolerances on Brassica Head and Stem
Vegetables, Corn (Field, Pop and Sweet), Citrus Fruit, Fruiting
Vegetables, Leafy Vegetables, Pome Fruit, Small Fruit Vine Growing
(except Fuzzy Kiwifruit) including Grape, Soybean, Stone Fruit, Tree
Nuts, and Tuberous and Corm Vegetables, Plus Registration for Seed
Treatment Uses on Corn (Field, Pop and Sweet), Use on Tobacco, and Use
on Golf Course Turf, Sport Fields, and Sod Farms'' on pages 33-69 in
docket ID number EPA-HQ-OPP-2017-0233.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are
[[Page 11136]]
observed (the NOAEL) and the lowest dose at which adverse effects of
concern are identified (the LOAEL). Uncertainty/safety factors are used
in conjunction with the POD to calculate a safe exposure level--
generally referred to as a population-adjusted dose (PAD) or a
reference dose (RfD)--and a safe margin of exposure (MOE). For non-
threshold risks, the Agency assumes that any amount of exposure will
lead to some degree of risk. Thus, the Agency estimates risk in terms
of the probability of an occurrence of the adverse effect expected in a
lifetime. For more information on the general principles EPA uses in
risk characterization and a complete description of the risk assessment
process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
Based on a thorough analysis of the toxicology database of
tetraniliprole, the Agency has determined that a qualitative risk
assessment is more appropriate for tetraniliprole based on the
following reasons:
All the adverse effects (decrease in pup body weights and
non-neoplastic uterine lesions, characterized by prolapsed vagina,
squamous cell hyperplasia in the cervix) in rats were found at or
slightly above the limit dose. Although informative for hazard
characterization for purposes of risk assessment, a toxicity test dose
at or above the limit dose of 1,000 mg/kg/day represents an exposure
that is not expected to occur either daily or over an extended period
of time and therefore is not relevant to exposure levels expected from
the use of tetraniliprole.
EPA determined that the body weight reduction effects seen
in the 90-day and 1-year oral studies with the dog, (approximately 500
mg/kg/day) were not robust enough to be employed as a toxicity endpoint
for risk assessment, due to the marginal nature of those effects and
the fact that the rat (for which effects were seen at the 1,000 mg/kg/
day, limit dose) was more sensitive, based on a human equivalent dose
analysis.
Available data indicate no potential inhalation risk of
concern.
Available data indicate no adverse systemic effects at the
limit dose (1,000 mg/kg/day) for dermal exposure.
Potential offspring susceptibility was not of concern as
the decrease in pup weight seen in the reproduction study was marginal
and occurred at or above the limit dose (890/1,032 mg/kg/day (males/
females)). In addition, the decrease occurred on postnatal days (PND)
14 to 21, at which time the pups were likely to be exposed to the test
material through both milk and feed resulting in a much higher compound
intake.
Finally, taking into account expected exposures, EPA does
not anticipate dietary exposure levels to occur daily, or over an
extended period of time that would reach levels anywhere near that of
the limit dose (1,000 mg/kg/day). An unrefined chronic dietary (food
only) exposure estimate of tetraniliprole was calculated using
tolerance-level residues for all crops and assuming 100% crop treated,
as well as default processing factors. The screening estimate indicated
that the highest exposure group is children 1 to 2 years old, with an
estimated exposure of 0.027 mg/kg/day. To reach a dose of 1,000 mg/kg/
day, an individual of this subpopulation would need to ingest 37,000
times the estimated dietary exposure. Further, the highest current
application rate is approximately 0.18 lb ai/acre; and in order to
yield residues that would lead to dietary exposures of 1,000 mg/kg/day,
the application rate would have to be greater than 6,000 lb ai/acre.
Consequently, EPA does not believe that an effect at or about the limit
dose is relevant to human health risk assessment for tetraniliprole.
Taking all the foregoing into consideration, EPA has concluded that
a qualitative analysis of tetraniliprole is appropriate.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. There is potential for
exposure to tetraniliprole via food and feed based on the proposed
uses. However, no adverse effects were observed in the submitted
toxicological studies for tetraniliprole regardless of the route of
exposure. Thus, no quantitative dietary exposure assessments are needed
for EPA to conclude with reasonable certainty that dietary exposures to
tetraniliprole do not pose a significant human health risk.
2. Dietary exposure from drinking water. There are no residues of
toxicological concern expected in drinking water from the use of
tetraniliprole. Thus, no drinking water exposure assessments are needed
for the Agency to conclude with reasonable certainty that drinking
water exposures to tetraniliprole do not pose a significant human
health risk.
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).
Based upon the proposed labels, EPA does not anticipate residential
handler exposures. Tetraniliprole is being proposed for registration as
a liquid formulation for use on golf course turf and sports fields that
could result in residential post-application exposures. However, no
adverse effects were observed in the submitted toxicological studies
for tetraniliprole regardless of the route of exposure; therefore, a
quantitative residential post-application exposure assessment was not
conducted. Thus, no residential exposure assessments are needed for the
Agency to conclude with reasonable certainty that residential exposures
to tetraniliprole do not pose a significant human health risk.
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.''
EPA has not found tetraniliprole to share a common mechanism of
toxicity with any other substances, and tetraniliprole does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
tetraniliprole does not have 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 http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
D. Safety Factor for Infants and Children
Section 408(b)(2)(C) requires the application of an additional
tenfold margin of safety to account for potential risks to infants and
children, in the case of threshold effects. For tetraniliprole, EPA has
not identified any toxicological endpoints of concern associated with
any threshold effects and is conducting a qualitative assessment. That
qualitative assessment does not use safety factors for assessing risk,
and no additional safety factor is needed for assessing risk to infants
and children. EPA has also evaluated the available data and concluded
that there are no residual uncertainties concerning the
[[Page 11137]]
potential risks to infants and children that would impact its
conclusions about threshold effects.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
No adverse effects were observed in the submitted toxicological
studies at doses relevant to human health pesticide risk assessment for
tetraniliprole regardless of the route of exposure. Effects observed in
the data base (e.g., decreased body weight) were both marginal, and
only seen at doses not expected to occur daily or over an extended
period. Based on a lack of toxicity at exposure levels expected from
approved application rates and an expectation that aggregate exposures
to residues of tetraniliprole will not reach the levels required to
cause any adverse effects, 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 tetraniliprole
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate analytical method (01414) which uses high-performance
liquid chromatography with tandem mass spectrometry (HPLC/MS/MS) to
quantitate residues of tetraniliprole in various crops is available for
enforcement. An adequate HPLC/MS/MS method, Method FV-002-A16-01, is
proposed as the enforcement method for determination of residues of
tetraniliprole in livestock matrices. The methods may be requested
from: Chief, Analytical Chemistry Branch, Environmental Science Center,
701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-
2905; email address: [email protected].
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The Codex has not
established any MRLs for tetraniliprole.
C. Response to Comments
Five comments were received to the notice of filing. Four of the
comments were not related specifically to tetraniliprole or pesticides
in general, dealing instead with ``anti-environmental morons'',
electric cars, and wind farms and their impact on birds and bats. The
fifth comment was submitted on behalf of the Center for Biological
Diversity that was primarily concerned about EPA's consideration of the
impacts of tetraniliprole on the environment, pollinators, and
endangered species. None of these comments are relevant to the Agency's
evaluation of safety of the tetraniliprole tolerances under section 408
of the FFDCA, which requires the Agency to evaluate the potential harms
to human health, not effects on the environment.
D. Revisions to Petitioned-For Tolerances
The Agency is establishing tolerances based on the Organization for
Economic Cooperation and Development (OECD) rounding class practice and
to reflect the preferred commodity definitions currently used by the
Agency, which results in some variations between established tolerances
and the tolerances the petitioner requested.
For field corn and popcorn, the available data support a tolerance
of 0.01 ppm, slightly lower than the petitioned-for tolerance (0.015
ppm).
The petitioner requested tolerances on dried fruit (prune) and
potato wet peel. The available data indicates that residues on those
commodities do not concentrate so the new tolerances on stone fruit
group 12-12 (1.0 ppm) and vegetable, tuberous and corm, subgroup 1C
(0.015 ppm), respectively, are adequate to cover residues in these
commodities.
For citrus fruits (subgroups 10-10A, 10B, and 10C), the Agency used
the OECD statistical calculation procedures to determine the
appropriate tolerance value based on the available field trial residue
data, which resulted in a higher tolerance value for each of these
subgroups than what the petitioner requested.
Based on the highest average field trial (HAFT) (0.767 ppm) for
lime and using a processing factor of 8.6, the Agency calculated that a
tolerance of 7 ppm is necessary to cover residues in citrus oil.
Similarly, based on the HAFT (0.136 ppm) for soybean seed and using a
processing factor of 2.6, the Agency determined that a tolerance of 0.4
ppm is appropriate for soybean hulls.
Although the petitioner did not expressly identify certain
tolerances as intended to cover indirect or inadvertent residues in
rotational crops, because certain crops are only approved as crops that
may be rotated into treated fields on the label, EPA is establishing
tolerances for indirect or inadvertent residues for those commodities:
alfalfa, forage at 0.015 ppm; alfalfa, hay at 0.06 ppm; cottonseed
subgroup 20C at 0.4 ppm; cotton, gin byproducts at 30 ppm; grain,
cereal, forage, fodder, and straw, group 16, except field corn,
popcorn, and sweet corn at 0.1 ppm; and vegetable, foliage of legume,
except soybean, subgroup 7A.
All the proposed tolerances for livestock commodities were revised
based on calculation of the dietary burden.
V. Conclusion
Therefore, tolerances are established for residues of
tetraniliprole, including its metabolites and degradates. Compliance
with the tolerance levels is to be determined by measuring only
tetraniliprole 1-(3-chloro-2-pyridinyl)-N-[4-cyano-2-methyl-6-
[(methylamino)carbonyl]phenyl]-3-[[5-(trifluoromethyl)-2H-tetrazol-2-
yl]methyl]-1H-pyrazole-5-carboxamide, in or on almond, hulls at 4 ppm;
cattle, fat at 0.04 ppm; cattle, meat at 0.02 ppm; cattle, meat
byproducts at 0.3 ppm; corn, field, forage at 4 ppm; corn, field, grain
at 0.01 ppm; corn, field, stover at 15 ppm; corn, pop, grain at 0.01
ppm; corn, pop, stover at 15 ppm; corn, sweet, forage at 6 ppm; corn,
sweet, kernel plus cob with husks removed at 0.01 ppm; corn, sweet,
stover at 20 ppm; fruit, citrus, group 10-10, oil at 7 ppm; fruit,
pome, group 11-10 at 0.5 ppm; fruit, small vine climbing, except fuzzy
kiwifruit, subgroup 13-07F at 1.5 ppm; fruit, stone, group 12-12 at 1
ppm; goat, fat at 0.04 ppm; goat, meat at 0.02 ppm; goat, meat
byproducts at 0.3 ppm; grain, aspirated fractions at 50 ppm; grapefruit
[[Page 11138]]
subgroup 10-10C at 0.9 ppm; horse, fat at 0.04 ppm; horse, meat at 0.02
ppm; horse, meat byproducts at 0.3 ppm; lemon/lime subgroup 10-10B at
1.5 ppm; milk at 0.05 ppm; nut, tree, group 14-12 at 0.03 ppm; orange
subgroup 10-10A at 1 ppm; sheep, fat at 0.04 ppm; sheep, meat at 0.02
ppm; sheep, meat byproducts at 0.3 ppm; soybean, forage 0.07 ppm;
soybean, hay at 0.2 ppm; soybean, hulls at 0.4 ppm; soybean, seed at
0.2 ppm; tomato, paste at 1.5 ppm; vegetable, brassica, head and stem,
group 5-16 at 1.5 ppm; vegetable, fruiting, group 8-10 at 0.4 ppm;
vegetable, leafy, group 4-16 at 20 ppm; and vegetable, tuberous and
corm, subgroup 1C at 0.015 ppm.
Additionally, tolerances are established for inadvertent residues
of tetraniliprole, including its metabolites and degradates. Compliance
with the tolerance levels is to be determined by measuring only
tetraniliprole 1-(3-chloro-2-pyridinyl)-N-[4-cyano-2-methyl-6-
[(methylamino)carbonyl]phenyl]-3-[[5-(trifluoromethyl)-2H-tetrazol-2-
yl]methyl]-1H-pyrazole-5-carboxamide in or on alfalfa, forage at 0.015
ppm; alfalfa, hay at 0.06 ppm; cotton, gin byproducts at 30 ppm;
cottonseed subgroup 20C at 0.4 ppm; grain, cereal, forage, fodder and
straw, group 16, except field corn, popcorn, and sweet corn at 0.1 ppm;
and vegetable, foliage of legume, except soybean, subgroup 7A at 0.03
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 Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). This action does not contain any information collections subject
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
et seq.), nor does it require any special considerations under
Executive Order 12898, entitled ``Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance 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 19, 2021.
Edward Messina,
Acting Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
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. Add Sec. 180.709 to read as follows:
Sec. 180.709 Tetraniliprole; tolerances for residues.
(a) General. Tolerances are established for residues of
tetraniliprole, including its metabolites and degradates, in or on the
commodities in table 1 in this paragraph (a). Compliance with the
tolerance levels specified in table 1 in this paragraph (a) is to be
determined by measuring only tetraniliprole 1-(3-chloro-2-pyridinyl)-N-
[4-cyano-2-methyl-6-[(methylamino)carbonyl]phenyl]-3-[[5-
(trifluoromethyl)-2H-tetrazol-2-yl]methyl]-1H-pyrazole-5-carboxamide.
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Almond, hulls........................................... 4
Cattle, fat............................................. 0.04
Cattle, meat............................................ 0.02
Cattle, meat byproducts................................. 0.3
Corn, field, forage..................................... 4
Corn, field, grain...................................... 0.01
Corn, field, stover..................................... 15
[[Page 11139]]
Corn, pop, grain........................................ 0.01
Corn, pop, stover....................................... 15
Corn, sweet, forage..................................... 6
Corn, sweet, kernel plus cob with husks removed......... 0.01
Corn, sweet, stover..................................... 20
Fruit, citrus, group 10-10, oil......................... 7
Fruit, pome, group 11-10................................ 0.5
Fruit, small vine climbing, except fuzzy kiwifruit, 1.5
subgroup 13-07F........................................
Fruit, stone, group 12-12............................... 1
Goat, fat............................................... 0.04
Goat, meat.............................................. 0.02
Goat, meat byproducts................................... 0.3
Grain, aspirated fractions.............................. 50
Grapefruit subgroup 10-10C.............................. 0.9
Horse, fat.............................................. 0.04
Horse, meat............................................. 0.02
Horse, meat byproducts.................................. 0.3
Lemon/lime subgroup 10-10B.............................. 1.5
Milk.................................................... 0.05
Nut, tree, group 14-12.................................. 0.03
Orange subgroup 10-10A.................................. 1
Sheep, fat.............................................. 0.04
Sheep, meat............................................. 0.02
Sheep, meat byproducts.................................. 0.3
Soybean, forage......................................... 0.07
Soybean, hay............................................ 0.2
Soybean, hulls.......................................... 0.4
Soybean, seed........................................... 0.2
Tomato, paste........................................... 1.5
Vegetable, brassica, head and stem, group 5-16.......... 1.5
Vegetable, fruiting, group 8-10......................... 0.4
Vegetable, leafy, group 4-16............................ 20
Vegetable, tuberous and corm, subgroup 1C............... 0.015
------------------------------------------------------------------------
(b)-(c) [Reserved]
(d) Indirect or inadvertent residues. Tolerances are established
for indirect or inadvertent residues of tetraniliprole, including its
metabolites and degradates, in or on the commodities in table 2 in this
paragraph (d). Compliance with the tolerance levels specified in table
2 in this paragraph (d) is to be determined by measuring only
tetraniliprole 1-(3-chloro-2-pyridinyl)-N-[4-cyano-2-methyl-6-
[(methylamino)carbonyl]phenyl]-3-[[5-(trifluoromethyl)-2H-tetrazol-2-
yl]methyl]-1H-pyrazole-5-carboxamide.
Table 2 to Paragraph (d)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Alfalfa, forage......................................... 0.015
Alfalfa, hay............................................ 0.06
Cotton, gin byproducts.................................. 30
Cottonseed subgroup 20C................................. 0.4
Grain, cereal, forage, fodder and straw, group 16, 0.1
except field corn, popcorn and sweet corn..............
Vegetable, foliage of legume, except soybean, subgroup 0.03
7A.....................................................
------------------------------------------------------------------------
[FR Doc. 2021-03624 Filed 2-23-21; 8:45 am]
BILLING CODE 6560-50-P