[Federal Register Volume 83, Number 219 (Tuesday, November 13, 2018)]
[Rules and Regulations]
[Pages 56262-56269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24379]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2017-0694; FRL-9985-32]
Cyantraniliprole; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
cyantraniliprole in or on multiple commodities which are identified and
discussed later in this document. The Interregional Research Project
No. 4 (IR-4) and DuPont Crop Protection requested these tolerances
under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective November 13, 2018. Objections and
requests for hearings must be received on or before January 14, 2019,
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-2017-0694, 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. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael Goodis, 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
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP
test guidelines referenced in this document electronically, please go
to https://www.epa.gov/aboutepa/about-office-chemical-safety-and-pollution-prevention-ocspp and select ``Test Methods and Guidelines.''
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-2017-0694 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
January 14, 2019. 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-2017-0694, by one of
the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of March 21, 2018 (83 FR 12311) (FRL-9974-
76), 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
7E8631) by The Interregional Research Project No. 4 (IR-4), Rutgers,
The State University of New Jersey, 500 College Road East, Suite 201 W,
Princeton, NJ 08540. The petition requested that 40 CFR 180.672 be
amended by establishing tolerances for residues of the insecticide,
cyantraniliprole, 3-bromo-1-(3-chloro-2-pyridinyl)-N-[4-cyano-2-methyl-
6-[((methylamino)carbonyl]phenyl]-1H-pyrazole-5-carboxamide, in or on
Berry, low growing, except strawberry, subgroup 13-07H, except
blueberry, lowbush and lingonberry at 0.08 parts per million (ppm)
(proposal to replace an existing tolerance at the same level that is
only for imported Berry, low growing, except strawberry, subgroup 13-
07H, with a tolerance supporting both domestic production and imported
low growing berries, except strawberries); Brassica, leafy greens,
subgroup 4-16B at 30 ppm; Caneberry subgroup 13-07A at 4.0 ppm; Celtuce
at 20 ppm; Coffee, green bean at 0.05 ppm (proposal to replace an
existing tolerance at the same level that is only for imported Coffee,
green bean with a tolerance supporting both domestic production and
imported coffee); Florence fennel at 20 ppm; Kohlrabi at 3.0 ppm; Leafy
greens subgroup 4-16A at 20 ppm; Leaf petiole vegetable subgroup 22B at
20 ppm; and Vegetable,
[[Page 56263]]
Brassica, head and stem, group 5-16 at 3.0 ppm. Upon the establishment
of the above tolerances, IR-4 proposed to remove existing tolerances in
40 CFR part 180.672 in or on the following commodities: Brassica head
and stem, subgroup 5A at 3.0 ppm; Brassica leafy vegetables, subgroup
5B at 30 ppm; and Vegetable, leafy, except Brassica, group 4 at 20 ppm.
In the Federal Register of April 11, 2018 (83 FR 15528) (FRL-9975-
57), 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
7F8622) by DuPont Crop Protection, Stine-Haskell Research Center, P.O.
Box 30, Newark, DE 19714-0030. The petition requested that 40 CFR
180.672 be amended by establishing tolerances for residues of the
insecticide cyantraniliprole, 3-bromo-1-(3-chloro-2-pyridinyl)-N-[4-
cyano-2-methyl-6-[((methylamino)carbonyl]phenyl]-1H-pyrazole-5-
carboxamide, in or on Rice, hulls at 0.05 ppm; Rice, straw at 0.015
ppm; Soybean, forage at 15 ppm; Soybean, hay at 50 ppm; Soybean, hulls
at 1 ppm; Soybean, seed at 0.4 ppm; and Aspirated grain fractions at
200 ppm. Upon the approval of the proposed tolerances in soybean forage
and hay, it is proposed that the existing tolerances for indirect or
inadvertent residues in soybean forage and hay be cancelled. In
addition, DuPont Crop Protection requests to amend the tolerances in 40
CFR 180.672, in or on rice, grain at 0.02 ppm by replacing an existing
tolerance at the same level that is only for imported grain with a
tolerance supporting both domestic production and imported grain.
These documents referenced summaries of the petitions prepared by
DuPont Crop Protection, the registrant, which are available in the
docket, http://www.regulations.gov. Three comments were received on the
notices of filing. EPA's response to these comments is discussed in
Unit IV.C.
Based upon review of the data supporting the petition, EPA modified
some of the tolerance levels to conform to EPA's rounding classes and
revised the commodity terminology for two tolerances. 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 cyantraniliprole including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with
cyantraniliprole 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.
In general, cyantraniliprole administration in mammalian test
species produces both adverse and adaptive changes in the liver,
thyroid gland, and adrenal cortex. With repeated dosing, consistent
findings of mild to moderate increases in liver weights across multiple
species (rats, mice and dogs) are observed. Dogs appear to be more
sensitive than rats and mice; cyantraniliprole produces adverse liver
effects (increases in alkaline phosphatase, decreases in cholesterol,
and decreases in albumin) in dogs at lower dose levels than in rats. In
addition, the liver effects in the dog show progressive severity with
increased duration of exposure. The available data also show thyroid
hormone homeostasis is altered in rats following exposure to
cyantraniliprole after 28 or 90 days; however, cyantraniliprole is not
a direct thyroid toxicant.
Cyantraniliprole is classified as ``not likely to be carcinogenic
to humans'' based on the absence of increased tumor incidence in
acceptable/guideline carcinogenicity studies in rats and mice, and
there are no mutagenicity concerns. There are also no developmental or
reproductive toxicity concerns and no offspring susceptibility
concerns. Cyantraniliprole does not produce developmental toxicity in
either rats or rabbits. The 2-generation reproduction study in rats
shows that cyantraniliprole has no adverse effect on any reproductive
parameters.
Acute and subchronic neurotoxicity studies reveal no evidence of
neurotoxicity. Similarly, cyantraniliprole does not adversely impact
the immune system in rats and mice. Based on the results of a 28-day
dermal study in rats (as well as the dermal LD50 study),
cyantraniliprole does not demonstrate any appreciable toxicity via
dermal exposure. The 28-day inhalation toxicity study in rats does not
show any adverse systemic or portal of entry effect at the highest
concentration tested (100 mg/m\3\, equivalent to 18 mg/kg/day).
Cyantraniliprole has no significant acute toxicity via the oral,
dermal, and inhalation routes of exposure. Cyantraniliprole is not an
eye or skin irritant and does not cause skin sensitization.
Specific information on the studies received and the nature of the
adverse effects caused by cyantraniliprole 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 document ``Cyantraniliprole. Human Health Risk
Assessment for Proposed Uses and Tolerance Requests on Coffee;
Caneberry Subgroup 13-07A; Low Growing Berry Subgroup 13-07H, Except
Strawberry, Lowbush Blueberry and Lingonberry; Brassica Leafy Greens
Subgroup 4-16A; Leafy Greens Subgroup 4-16B; Brassica Head and Stem
Vegetable Group 5-16; Leaf Petiole Vegetable Subgroup 22B; Celtuce;
Florence Fennel; Kohlrabi; Rice; Soybean; and Aspirated Grain
Fractions'' on pages 36-45 in docket ID number EPA-HQ-OPP-2017-0694.
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
[[Page 56264]]
is no appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks.
A summary of the toxicological endpoints for cyantraniliprole used
for human risk assessment is discussed in Unit III.B of the final rule
published in the Federal Register of February 5, 2014 (79 FR 6826)
(FRL-9388-7).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to cyantraniliprole, EPA considered exposure under the
petitioned-for tolerances as well as all existing cyantraniliprole
tolerances in 40 CFR 180.672. EPA assessed dietary exposures from
cyantraniliprole in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for cyantraniliprole;
therefore, a quantitative acute dietary exposure assessment is
unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the 2003-2008 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 refined chronic (food and drinking
water) dietary assessment was conducted assuming average field trial
residues for all crops (except crop subgroup 1A, for which tolerance
level residues were assumed); percent crop treated (PCT) data;
empirical processing factors; and default processing factors were used
as appropriate.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that cyantraniliprole 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 percent crop treated (PCT) information.
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: If data are available on pesticide use and
food consumption in a particular area, the exposure estimate does not
understate exposure for the population in such areas.
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 average PCT for existing uses as follows:
Citrus: oranges 62%, grapefruit 87%, and lemons 46%; pome fruit: apples
61% and pears 76%; stone fruits: apricots 53%, cherries 48%, peaches
41%, and plums/prunes 59%; tree nuts: almonds 72%, hazelnuts 65%,
pecans 22%, pistachios 49%, and walnuts 53%; bushberries (subgroup 13-
07B): blueberries 45%; fruiting vegetables: peppers 45% and tomatoes
54%; cucurbits: cantaloupes 50%, cucumbers 23%, pumpkins 18%, squash
24%, and watermelons 29%; leafy vegetables: celery 70%, lettuce 78%,
and spinach 53%; Brassica (cole) leafy vegetables: broccoli 81%,
cabbage 50%, and cauliflower 83%; onion 58%; potato 50%; oilseeds:
canola 15% and sunflower 35%; corn 56%, cotton 41%; peanuts 41%;
carrots 23%; soybeans 21%; strawberries 59%; vegetable crop group 7:
dry beans/peas 6%, soybeans 21%, beans (snap, bush, etc.) 49%, and peas
fresh/green/sweet) 38%; vegetable crop group 2: sugar beets 40%;
vegetable crop group 6A: soybeans 21%, beans (snap, bush, etc., string)
49%; peas fresh/green/sweet) 38%; and vegetable crop group 6C: dried
bean and peas 6%. 100 PCT was assumed for all other crops, including
all proposed new use crops. For imported grapes (wine grapes), a 50%
import estimate was used in the chronic dietary risk 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 (CDPR) 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 figures for each existing
use are derived by combining available public and private market survey
data for that use, averaging across all observations, and rounding up
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
[[Page 56265]]
which cyantraniliprole 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 cyantraniliprole in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of cyantraniliprole. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
Based on the Pesticides in Water Calculator (PWC; version 1.52) and
Pesticide Root Zone Model Ground Water (PRZM GW) for ground water and
FQPA Index Reservoir Screening Tool (FIRST) for surface water, the
estimated drinking water concentrations (EDWCs) of cyantraniliprole for
chronic exposures for non-cancer assessments are estimated to be 24 ppb
for surface water and 64 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration value of 64 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).
Cyantraniliprole is currently registered for the following uses
that could result in residential exposures: Turf grass (including
residential, recreational, and golf course turf), ornamentals, and
structural buildings (including indoor crack/crevice and outdoor
broadcast). EPA assessed residential exposure using the following
assumptions: EPA determined that residential exposures may occur by the
dermal, oral, and inhalation routes of exposures. However, since dermal
hazard has not been identified for cyantraniliprole, the only exposures
of concern are handler inhalation (for adults), and post-application
incidental oral (for children). Residential handler exposure is
expected to be short-term in duration. The turf and ornamental labels
indicate that a maximum of two applications are allowed per season.
Thus, intermediate-term handler exposures are not likely because of the
intermittent nature of applications by homeowners. Post-application
incidental oral exposures for children may occur for short- and
intermediate-term durations due to the persistence of cyantraniliprole.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.'' EPA has not found
cyantraniliprole to share a common mechanism of toxicity with any other
substances, and cyantraniliprole does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that cyantraniliprole 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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. There is no evidence of
susceptibility in developmental toxicity studies in rats and rabbits.
The developmental toxicity study in rats is tested up to the limit dose
(1,000 mg/kg/day). In the rabbit developmental toxicity study,
decreases in fetal body weight are seen at a dose higher than that
resulting in maternal effects. In the reproductive toxicity study,
increased incidence of thyroid follicular epithelium hypertrophy/
hyperplasia occurs in F1 parental animals at a dose lower
than that for the parental (P) generation. A clear NOAEL (1.4 mg/kg/
day) is established for F1 parental animals, and the PODs
selected for risk assessment from the dog studies (1 or 3 mg/kg/day)
are protective of the effect (thyroid effect) seen in the F1
parental animals. In addition, the submitted data support the
conclusion that the effects on the thyroid are secondary to effects on
the liver. As such, a comparative thyroid study is not required at this
time.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for cyantraniliprole is complete.
ii. There is no indication that cyantraniliprole is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. There is no evidence that cyantraniliprole results in
increased susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases. The exposure databases are complete or are estimated based
on data that reasonably account for potential exposures. The chronic
dietary food exposure assessment was a refined assessment which assumed
average field trial residues for all crops (except crop subgroup 1A);
PCT when available; empirical processing factors, if available, or
default processing factors, as appropriate. The 2012 Residential
standard operating procedures (SOPs) were previously used to assess
post-application exposure to children including incidental oral
exposure, and the residential post-application assessment assumed that
maximum application rates are applied and that hand-to-mouth activities
occur on the day of application. All of the exposure estimates are
based on conservative, health-protective assumptions and are not likely
to underestimate risk. EPA made conservative (protective) assumptions
in the ground and surface water modeling used to assess exposure to
cyantraniliprole in drinking water. EPA used similarly conservative
assumptions to assess post application exposure of children as well as
[[Page 56266]]
incidental oral exposure of toddlers. These assessments will not
underestimate the exposure and risks posed by cyantraniliprole.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
cyantraniliprole is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
cyantraniliprole from food and water will utilize 99% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
cyantraniliprole is not expected.
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).
Cyantraniliprole 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 cyantraniliprole.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in an aggregate MOE of 149 for
children 1 to 2 years old. For adults, the oral and inhalation routes
of exposure are not appropriate to be aggregated since the endpoints of
concern are not common. Because EPA's level of concern for
cyantraniliprole is a MOE of 100 or below, this MOE 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). Cyantraniliprole is currently registered for uses that could
result in intermediate-term residential exposure, however, the short-
term aggregate risk estimate described above is protective of potential
intermediate-term exposures and risks in children.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, cyantraniliprole is not expected to pose a cancer risk to
humans.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to cyantraniliprole residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (liquid chromatography with tandem
mass spectroscopy (LC/MS/MS)) is available to enforce the tolerance
expression.
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
[email protected].
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
There are no established Codex MRLs on the caneberry subgroup 13-
07A, soybean, aspirated grain fractions, celtuce, Florence fennel and
rice. The U.S. tolerances being established for coffee and Brassica,
leafy greens subgroup 4-16A are harmonized with Codex. The U.S.
tolerances being established for the low growing berry subgroup 13-07H;
leaf petiole vegetable subgroup 22B; Brassica head and stem vegetable
group 5-16; leafy greens subgroup 4-16B; and kohlrabi are not
harmonized with Codex MRLs. The Codex MRLs established for residues of
cyantraniliprole on these commodities are lower than the recommended
U.S. tolerances. The U.S. tolerances cannot be harmonized because
following the label use directions could result in residues above the
established Codex MRLs.
C. Response to Comments
EPA received three comments in response to the Notices of Filing.
The first comment indicated IR-4 and Rutgers University are
profiteering by registering pesticides. The content of this comment is
not material to the safety of the tolerances that are the subject of
this action; pesticide registration occurs under the provisions of the
Federal Insecticide, Fungicide, and Rodenticide Act. The FFDCA allows
any person to file a petition proposing the establishment of a
tolerance, and financial benefit from associated registration of
pesticides is not a factor EPA considers when determining whether a
tolerance is safe.
The second comment stated, in part, that no residues should be
allowed. The Agency recognizes that some individuals believe that
pesticides should be banned on agricultural crops. However, the
existing legal framework provided by section 408 of the Federal Food,
Drug and Cosmetic Act (FFDCA) states that tolerances may be set when
persons seeking such tolerances or exemptions have demonstrated that
the pesticide meets the safety standard imposed by that statute. This
citizen's comment appears to be directed at the underlying statute and
not EPA's implementation of it; the citizen has made no contention that
EPA has acted in violation of the statutory framework.
The last comment expressed concern about pollutant loadings and
relatively high costs of regulations. The commenter also mentioned the
Shelby Amendment, the Freedom of Information Act and the
Intergovernmental Panel on Climate Change. The comment did not raise
any issue related to the Agency's safety determination for
cyantraniliprole tolerances. The receipt of this comment
[[Page 56267]]
is acknowledged; however, this comment is not relevant to this action.
D. Revisions to Petitioned-For Tolerances
EPA modified the proposed tolerance levels for soybean, hulls and
soybean, seed to conform to the Agency's rounding classes. The Agency
also revised the commodity terminology to use the correct commodity
definitions for Florence fennel (Fennel, Florence, fresh leaves and
stalk) and Aspirated grain fractions (Grain, aspirated grain
fractions).
V. Conclusion
Therefore, tolerances are established for residues of
cyantraniliprole, 3-bromo-1-(3-chloro-2-pyridinyl)-N-[4-cyano-2-methyl-
6-[((methylamino)carbonyl]phenyl]-1H-pyrazole-5-carboxamide, in or on
Berry, low growing, except strawberry, subgroup 13-07H, except
blueberry, lowbush and lingonberry at 0.08 parts per million (ppm);
Brassica, leafy greens, subgroup 4-16B at 30 ppm; Caneberry subgroup
13-07A at 4.0 ppm; Celtuce at 20 ppm; Fennel, Florence, fresh leaves
and stalk at 20 ppm; Grain, aspirated grain fractions at 200 ppm;
Kohlrabi at 3.0 ppm; Leaf petiole vegetable subgroup 22B at 20 ppm;
Leafy greens subgroup 4-16A at 20 ppm; Rice hulls at 0.05 ppm; Rice,
straw at 0.015 ppm; Soybean, forage at 15 ppm; Soybean, hay at 50 ppm;
Soybean, hulls at 1.0 ppm; Soybean, seed at 0.40 ppm; and Vegetable,
Brassica, head and stem, group 5-16 at 3.0 ppm. In addition, EPA is
removing the following tolerances as they are superseded by the new
tolerances being established in this rulemaking: from paragraph (a)
(Berry, low growing, except strawberry, subgroup 13-07H at 0.08 ppm;
Brassica head and stem, subgroup 5A at 3.0 ppm; Brassica leafy
vegetables, subgroup 5B at 30 ppm; and Vegetable, leafy, except
Brassica, group 4 at 20 ppm) and from paragraph (d) (soybean, forage at
0.70 ppm and soybean, hay at 0.70 ppm). Finally, EPA is removing the
footnote noting the lack of US registrations for the tolerances for
coffee, green bean and rice, grain.
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 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: October 24, 2018.
Michael Goodis,
Director, Registration Division, 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. In Sec. 180.672:
0
a. In the table to paragraph (a):
0
i. Remove the entry ``Berry, low growing, except strawberry, subgroup
13-07H\1\''.
0
ii. Add alphabetically the entry ``Berry, low growing, except
strawberry, subgroup 13-07H, except blueberry, lowbush and
lingonberry''.
0
iii. Remove the entry ``Brassica head and stem, subgroup 5A''.
0
iv. Add alphabetically the entry ``Brassica, leafy greens, subgroup 4-
16B.
0
v. Remove the entry ``Brassica leafy vegetables, subgroup 5B''.
0
vi. Add alphabetically the entries: ``Caneberry subgroup 13-07A'' and
``Celtuce''.
0
vii. Revise the entry ``Coffee, green bean''.
0
viii. Add alphabetically the entries: ``Fennel, Florence, fresh leaves
and stalk''; ``Grain, aspirated grain fractions''; ``Kohlrabi''; ``Leaf
petiole vegetable subgroup 22B''; ``Leafy greens subgroup 4-16A'';
0
ix. Revise the entry ``Rice, grain''.
0
x. Add alphabetically the entries: ``Rice hulls''; ``Rice, straw'';
``Soybean, forage''; ``Soybean, hay''; ``Soybean, hulls''; ``Soybean,
seed''; and ``Vegetable, Brassica, head and stem, group 5-16''.
0
xi. Remove the entry ``Vegetable, leafy, except Brassica, group 4''.
[[Page 56268]]
0
b. Remove from the table in paragraph (d) the entries: ``Soybean,
forage''; and ``Soybean, hay''.
The additions and revisions read as follows:
Sec. 180.672 Cyantraniliprole; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
Berry, low growing, except strawberry, subgroup 13-07H, 0.08
except blueberry, lowbush and lingonberry..............
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
Brassica, leafy greens, subgroup 4-16B.................. 30
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
Caneberry subgroup 13-07A............................... 4.0
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
Celtuce................................................. 20
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
Coffee, green bean...................................... 0.05
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
Fennel, Florence, fresh leaves and stalk................ 20
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
Grain, aspirated grain fractions........................ 200
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
Kohlrabi................................................ 3.0
------------------------------------------------------------------------
Leaf petiole vegetable subgroup 22B..................... 20
Leafy greens subgroup 4-16A............................. 20
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
Rice, grain............................................. 0.02
------------------------------------------------------------------------
Rice, hulls............................................. 0.05
Rice, straw............................................. 0.015
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
Soybean, forage......................................... 15
Soybean, hay............................................ 50
Soybean, hulls.......................................... 1.0
Soybean, seed........................................... 0.40
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
Vegetable, Brassica, head and stem, group 5-16.......... 3.0
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
[[Page 56269]]
* * * * *
[FR Doc. 2018-24379 Filed 11-9-18; 8:45 am]
BILLING CODE 6560-50-P