[Federal Register Volume 79, Number 24 (Wednesday, February 5, 2014)]
[Rules and Regulations]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02210]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Cyantraniliprole; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes tolerances for residues of
cyantraniliprole in or on multiple commodities that are identified and
discussed later in this document. E.I. du Pont de Nemours & Company
(DuPont) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective February 5, 2014. Objections and
requests for hearings must be received on or before April 7, 2014, 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-2011-0668, 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), EPA West 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: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-7090; email address: RDFRNotices@epa.gov.
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.
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-2011-0668 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 7, 2014. 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-2011-0668, 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
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 May 23, 2012 (77 FR 30481) (FRL-9347-8),
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 1F7894)
by E.I. du Pont de Nemours & Company (DuPont), 1007 Market St.,
Wilmington, DE 19898. The petition requested that 40 CFR part 180 be
amended by establishing tolerances for residues of the insecticide
its metabolites and degradates, in or on almond hulls at 30 parts per
million (ppm); berries and small fruits, bushberries (subgroup 13-07B)
at 4 ppm; Brassica (cole) leafy vegetables, head and stem Brassica
(subgroup 5A) at 2 ppm; Brassica (cole) leafy vegetables, leafy
Brassica greens (subgroup 5B) at 30 ppm; bulb vegetables, onion, bulb
(subgroup 3-07A) at 0.04 ppm; bulb vegetables, onion, green (subgroup
3-07B) at 8 ppm; cattle, fat at 0.01 ppm; cattle, liver at 0.04 ppm;
cattle, meat at 0.01 ppm; cattle, meat byproducts, except liver at 0.01
ppm; cherries at 6 ppm; citrus fruits (group 10-10) at 0.7 ppm; cotton
gin byproduct at 10 ppm; cucurbit vegetables (group 9) at 0.3 ppm;
fruiting vegetables (group 8-10) at 2 ppm; goat, fat at 0.01 ppm; goat,
liver at 0.04 ppm; goat, meat at 0.01 ppm; goat, meat byproducts,
except liver at 0.01 ppm; hog, fat at 0.01 ppm; hog, liver at 0.04 ppm;
hog, meat at 0.01 ppm; hog, meat byproducts, except liver at 0.01 ppm;
horse, fat at 0.01 ppm; horse, liver at 0.04 ppm; horse, meat at 0.01
ppm; horse, meat byproducts, except liver at 0.01 ppm; leafy vegetables
(except Brassica vegetables) (group 4) at 15 ppm; milk at 0.01 ppm;
milk, fat at 0.04 ppm; oilseeds, except cotton gin byproduct (group 20)
at 1 ppm; pome fruits (group 11-10) at 0.8 ppm; root and tuber
vegetables, tuberous and corm vegetables (subgroup 1C) at 0.15 ppm;
sheep, fat at 0.01 ppm; sheep, liver at 0.04 ppm; sheep, meat at 0.01
ppm; sheep, meat byproducts, except liver at 0.01 ppm; stone fruits,
except cherries (group 12) at 1.5 ppm; tree nuts, except almond hulls
(group 14) at 0.06 ppm; citrus, oil at 6 ppm; citrus, raw peel at 2
ppm; and potato, wet peel at 0.3 ppm.
In addition, DuPont requested to amend 40 CFR part 180 to establish
indirect or inadvertent tolerances for residues of cyantraniliprole, 3-
[(methylamino)carbonyl]phenyl]-1H-pyrazole-5-carboxamide, including its
metabolites and degradates, in or on the following commodities: Foliage
of legume vegetables (group 7), forage at 0.15 ppm; foliage of legume
vegetables (group 7), hay at 0.6 ppm; forage, fodder and straw of
cereal grains (group 16), forage at 0.06 ppm; forage, fodder and straw
of cereal grains (group 16), hay and straw at 0.15 ppm; grass forage,
fodder, and hay (group 17), forage at 0.06 ppm; grass forage, fodder,
and hay (group 17), hay at 0.15 ppm; leaves of root and tuber
vegetables (human food or animal feed) (group 2) at 0.04 ppm; nongrass
animal feeds (forage, fodder, straw, and hay) (group 18), forage at
0.06 ppm; nongrass animal feeds (forage, fodder, straw, and hay) (group
18), hay at 0.15 ppm; peanut hay at 0.03 ppm; root and tuber
vegetables, root vegetables (subgroup 1A) at 0.03 ppm.
That document referenced a summary of the petition prepared by
DuPont, the registrant, which is available in the docket, http://www.regulations.gov.
Based upon review of the data supporting the petition, EPA is
establishing several tolerances that vary from levels requested in the
original petition. The reasons for these changes are explained in Unit
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
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. Cyantraniliprole is a 2-generation ryanodine receptor (RyR)
insecticide belonging to the diamide class of chemistry whose
pesticidal mode of action (MOA) is through unregulated activation of
insect RyR channels. This leads to internal calcium store depletion and
impaired regulation of muscle contraction, causing paralysis and
eventual death of the insect. Mammalian RyR are shown to be 350 to
>2,500 times less sensitive than those of insects. In general,
cyantraniliprole administration in mammals 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 90 days
due to enhanced metabolism of the thyroid hormones by the liver.
However, cyantraniliprole does not act directly on the thyroid; the
thyroid effects observed are only as a result of the adverse effects on
the liver. 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. In addition, there are no genotoxicity, mutagenicity,
neurotoxicity, or immunotoxicity concerns. There are also no
developmental or reproductive toxicity concerns. There is no evidence
of an adverse effect attributable to a single dose. 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 the document ``Cyantraniliprole. Aggregate Human
Health Risk Assessment for the Proposed New Uses of the New Active
Insecticide (March 7, 2013)'' at p.16 in docket ID number EPA-HQ-OPP-
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 (LOC) 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 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://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints and points of departure
for cyantraniliprole used for human risk assessment is shown in Table 1
of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Cyantraniliprole for Use in Human Health Risk
POD and uncertainty/ RfD, PAD, LOC for
Exposure/scenario safety factors risk assessment Study and toxicological effects
Acute dietary (general An effect attributed to a single dose was not identified in the toxicology
population, including infants database.
and children and females 13-49
years of age).
Chronic dietary (All populations) NOAEL = 1 mg/kg/day. Chronic RfD = 0.01 Based on 1-year oral study in
UFA = 10x........... mg/kg/day. dogs.
UFH = 10x........... cPAD = 0.01 mg/kg/ LOAEL = 6 mg/kg/day based on
FQPA SF = 1x........ day.. effects indicative of liver
toxicity (increased liver weights
and alkaline phosphatase
activity), and significant
decreases in albumin level.
Incidental oral short-term (1 to NOAEL = 3 mg/kg/day. LOC for MOE = 100.. Based on both 28-day and 90-day
30 days) and incidental oral UFA = 10x........... oral study in dogs.
intermediate-term (1 to 6 UFH = 10x........... 28-Day LOAEL = 35 mg/kg/day
months). FQPA SF = 1x........ (lowest dose tested) based on
decreases in body weight, food
consumption, food efficiency, and
changes in clinical chemistry
(increased alkaline phosphatase,
decreased cholesterol and
90-Day LOAEL = 32 mg/kg/day based
on a collection of treatment-
related effects indicative of
liver toxicity. The effects
included decreases in total
protein, albumin, and cholesterol
in males and females; increases
in alkaline phosphatase in males
and females; increases in alanine
aminotransferase in females; and
increases in liver weights in
males and females.
Dermal short-term (1 to 30 days). A toxicity endpoint was not identified.
Systemic toxicity was not seen in 28-day dermal toxicity in rats at the limit
dose (1,000 mg/kg/day). There are no concerns for developmental or
reproductive toxicity or neurotoxicity.
Inhalation short-term (1 to 30 Inhalation study LOC for MOE = 30... Based on 28-day inhalation
days). NOAEL = 0.1 mg/kg/ toxicity study in rats.
day. A LOAEL was not established
UFA = 3x.\a\........ because the highest concentration
UFH = 10x........... tested (0.1 mg/L) did not
FQPA SF = 1x........ demonstrate any adverse portal of
HEC = 0.05 mg/L..... entry or systemic effects.
HED = 7.2 mg/kg/day.
Cancer (oral, dermal, inhalation) Classification: ``Not likely to be Carcinogenic to Humans'' based on data
showing lack of treatment-related increase in tumor incidence in the rat and
mouse carcinogenicity studies. Mutagenic concern was not reported in the
FQPA SF = Food Quality Protection Act Safety Factor. HEC = human equivalent concentration. HED = human
equivalent dose. LOAEL = lowest observed adverse effect level. LOC = level of concern. mg/kg/day = milligram/
mg/L = milligram/Liter. MOE = margin of exposure. NOAEL = no observed adverse effect level. PAD = population-
adjusted dose. POD = point of departure. RfD = reference dose. UF = uncertainty factor. UFA = extrapolation
from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human
\a\ The magnitude of the UFs applied is dependent on the methodology used to calculate risk. The reference
concentration (RfC) methodology takes into consideration the pharmacokinetic (PK) differences, but not the
pharmacodynamic (PD) differences. Consequently, the UF for interspecies extrapolation may be reduced to 3x (to
account for the PD differences).
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. 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
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the 2003-2008 food
consumption data from the U.S. 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, EPA conducted a
somewhat refined chronic (food and drinking water) dietary assessment
assuming average field trial residues for all crops (except crop
subgroup 1A which used tolerance levels). Tolerance-level residues were
used to cover residues in all livestock commodities except liver and
meat byproducts for which higher anticipated residue calculations were
used. For processed commodities, input values included combined average
residues of parent and the metabolite with relevant processing factors.
It was assumed that 100% crop treated (PCT) for all crops.
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 information. Section 408(b)(2)(E) of FFDCA
authorizes EPA to use available data and information on the anticipated
residue levels of pesticide residues in food and the actual levels of
pesticide residues that have been measured in food. If EPA relies on
such information, EPA must require pursuant to FFDCA section 408(f)(1)
that data be provided 5 years after the tolerance is established,
modified, or left in effect, demonstrating that the levels in food are
not above the levels anticipated. For the present action, EPA will
issue such data call-ins as are required by FFDCA section 408(b)(2)(E)
and authorized under FFDCA section 408(f)(1). Data will be required to
be submitted no later than 5 years from the date of issuance of these
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 http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of cyantraniliprole for
acute exposures are estimated to be 43.14 parts per billion (ppb) for
surface water and 6.33 ppb for ground water. For chronic exposures for
non-cancer assessments EDWCs are also estimated to be 24.45 ppb for
surface water and 6.33 for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. An acute dietary risk
assessment was not conducted since no acute toxicological effects were
found. For chronic dietary risk assessment, the water concentration of
value 24.45 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
proposed for use on the following sites that could result in
residential exposures: indoor crack/crevice application, turfgrass,
golf courses, and ornamentals including both outdoors and in interior
plantscapes. EPA assessed residential exposure using the following
assumptions: Residential exposure 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 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 http://www.epa.gov/opp00001/science/residential-exposure-sop.html.
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 Web site at http://www.epa.gov/pesticides/cumulative.
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 Safety Factor (FQPA SF). In applying this provision, EPA
either retains the default value of 10x, or uses a different additional
SF when reliable data available to EPA support the choice of a
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 decrease
in fetal body weight is 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 (offspring of P0
generation) at 14 mg/kg/day which is lower than that for the parental
(P0) generation (110 mg/kg/day). 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
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 1. That decision is based on the following
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. As discussed in Unit III.D.2., there is no evidence that
cyantraniliprole results in increased susceptibility in in utero rats
or rabbits in the prenatal developmental studies.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and average field trial residues. The field trial data were
validated against the appropriate guideline criteria and found
acceptable. The field trial data reflect the maximum residues that are
likely to occur on food commodities when cyantraniliprole is used
according to label directions at the maximum allowed application rate
and minimum allowed interval from treatment to harvest. These are farm
gate residues and do not reflect decreases in residues that may occur
during transport and storage prior to consumption. No corrections were
made for the percentage of crops treated, that is, it was assumed that
100% of all crops for which there is a cyantraniliprole tolerance will
be treated. Therefore, the data are considered unlikely to
underestimate actual dietary exposure to cyantraniliprole. EPA made
conservative (protective) assumptions in the ground and surface water
modeling used to assess exposure to cyantraniliprole in drinking water.
In addition, the residential exposure assessment is based on the
updated 2012 Residential Standard Operating Procedures (SOPs) employing
surrogate study data, including conservative exposure assumptions based
on day 0 dermal/oral contact to turf and surfaces treated at the
maximum application rate. These data are reliable and are not expected
to underestimate risks to adults or children. The Residential SOPs are
based upon reasonable ``worst-case'' assumptions are not expected to
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 50% of the cPAD for
children 1-2 years old (the population group receiving the greatest
exposure) and 22% of the general U.S. population.
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 proposed 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. Residential
exposure estimates of all possible scenarios are not of concern. Short-
term inhalation MOEs range from 22,000 to 220,000,000. Furthermore,
these calculated risk estimates are highly conservative because the
inhalation exposure POD is based on an exposure duration of 24 hours
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 290 for children
1-2 years old (the population group receiving the greatest exposure)
and 22,000 for adults. Because EPA's LOC for cyantraniliprole is a MOE
of 100 or below, these MOEs are 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). For adults, intermediate-term exposure is not expected for the
residential exposure pathway. Therefore, the intermediate-term
aggregate risk would be equivalent to the chronic dietary exposure
estimate. For children 1 to <2 years old, the short-term aggregate risk
is protective of the intermediate-term duration.
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
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 residue analytical method data have been submitted.
Validation data have been provided for the proposed enforcement
methods. Methods for measuring cyantraniliprole include the European
Union (EU) multi-residue method DFG S19 (LC/MS/MS module, Dupont-21328)
and the North American Free Trade Association (NAFTA) LC/MS/MS 1187 and
1552 methods. These methods utilize two mass ion transitions so
confirmatory methods are not required. EU Method DFG S19 has been
independently validated with a limit of quantification (LOQ) of 0.01
ppm for parent cyantraniliprole in cereals and dry products, matrices
with high water content, acidic matrices, and fatty products. NAFTA
method 1187 has been independently validated with an LOQ of 0.01 ppm
for parent cyantraniliprole in almonds, onions, tomato paste, and sun
dried tomatoes. NAFTA method 1552 has been independently validated with
an LOQ of 0.01 ppm for parent cyantraniliprole in milk, muscle, and
kidney. Note that cyantraniliprole is not recovered using the Food and
Drug Administration (FDA) multi-residue methods.
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. Currently there are no
Codex MRLs for cyantraniliprole.
C. Response to Comments
The Agency did not receive any public comments on the May 23, 2012
Federal Register Notice of Filing.
D. Revisions to Petitioned-For Tolerances
Based on the residue data provided and using the Organization of
Economic Cooperation and Development (OECD) statistical calculation
procedures, EPA is revising the tolerance levels for the following
plant commodities: Almond hulls; Brassica head and stem vegetables
(subgroup 5A); fruit, pome (group 11-10); fruit, stone; nut, tree
(group 14-12); oilseed (group 20); vegetable, cucurbit (group 9); and
vegetable, leafy (except Brassica) (group 4).
The proposed tolerance for citrus oil was lowered from 4 ppm to 2.4
ppm, consistent with the results from application of the median
processing factor to the highest average field trials (HAFT) for
oranges. EPA is not establishing tolerances for the processed
commodities citrus raw peel and potato wet peel. The processing studies
do not show a concentration of residue in these commodities relative to
the raw agricultural commodities (RAC); therefore, the tolerances on
RAC are sufficient to cover residues in these processed commodities.
EPA is not establishing separate tolerances for liver of cattle,
goat, horse, and sheep; hog fat, liver, meat, and meat byproducts; and
milk fat. The livestock commodity tolerances are derived from
consideration of the maximum reasonably balanced livestock diets and
the livestock feeding studies. A tolerance value of 0.01 ppm is
appropriate for liver (of cattle, goat, horse, and sheep), which is
covered by the meat byproducts tolerance. The dietary exposures of hogs
and poultry do not indicate a need for tolerances (residues are not
anticipated), and there is no indication of significant
concentration of cyantraniliprole in milk fat relative to milk.
With the exception of the proposed tolerance for leaves of root and
tuber vegetables, EPA is revising all of the proposed tolerances for
inadvertent residues (with a plantback interval (PBI) of 30 days) based
on available residue data and use of the OECD statistical calculation
procedures. For some crop groups, more than one tolerance was proposed
for various components of the group (e.g., crop group 16 which includes
forage, fodder, and straw of cereal grains); however, only one
tolerance is possible per group, and the tolerance is based on the
member commodity with the highest residue levels.
EPA issued a final rule in the Federal Register of August 22, 2012
(77 FR 50617) (FRL-9354-3) that revised some crop grouping regulations.
As part of that action, EPA expanded and revised the previously
existing tree nut crop group 14. Changes to crop group 14 included
adding pistachios plus a number of other nuts, revising the taxonomic
names for several commodities, and naming the new crop group tree nut
group 14-12. The representative commodities remain the same as previous
almond and pecan. That final rule became effective on October 22, 2012.
EPA indicated in the August 22, 2012 final rule as well as the earlier
proposed rule published in the Federal Register of November 9, 2011 (76
FR 69693) (FRL-8887-8) that, for existing petitions for which a Notice
of Filing had been published, the Agency would attempt to conform these
petitions to the rule. Therefore, consistent with this rule, EPA has
assessed and is establishing a tolerance for cyantraniliprole on tree
nuts crop group 14-12.
Therefore, tolerances are established for residues of
its metabolites and degradates, in or on almond, hulls at 8.0 ppm;
Brassica head and stem (subgroup 5A) at 3.0 ppm; Brassica leafy
vegetables (subgroup 5B) at 30 ppm; bushberry (subgroup 13-07B) at 4.0
ppm; cattle, fat at 0.01 ppm; cattle, meat at 0.01 ppm; cattle, meat
byproducts at 0.01 ppm; cherry (subgroup 12-12A) at 6.0 ppm; citrus,
oil at 2.4 ppm; cotton, gin byproducts at 10 ppm; fruit, citrus (group
10-10) at 0.70 ppm; fruit, pome (group 11-10) at 1.5 ppm; goat, fat at
0.01 ppm; goat, meat at 0.01 ppm; goat, meat byproducts at 0.01 ppm;
horse, fat at 0.01 ppm; horse, meat at 0.01 ppm; horse, meat byproducts
at 0.01 ppm; milk at 0.01 ppm; nut, tree (group 14-12) at 0.04 ppm;
oilseed (group 20) at 1.5 ppm; onion, bulb (subgroup 3-07A) at 0.04
ppm; onion, green (subgroup 3-07B) at 8.0 ppm; peach (subgroup 12-12B)
at 1.5 ppm; plum (subgroup 12-12C) at 0.50 ppm; sheep, fat at 0.01 ppm;
sheep, meat at 0.01 ppm; sheep, meat byproducts at 0.01 ppm; vegetable,
cucurbit (group 9) at 0.40 ppm; vegetable, fruiting (group 8-10) at 2.0
ppm; vegetable, leafy (except Brassica) (group 4) at 20 ppm; vegetable,
tuberous and corm (subgroup 1C) at 0.15 ppm. In addition, indirect or
inadvertent tolerances for cyantraniliprole, 3-bromo-1-(3-chloro-2-
pyrazole-5-carboxamide), including its metabolites and degradates, in
or on the following commodities: Animal feed, nongrass (group 18) at
0.20 ppm; grain, cereal, forage, fodder and straw (group 16) at 0.50
ppm; grass forage, fodder and hay (group 17) at 0.50 ppm; peanut, hay
at 0.01 ppm; vegetable, foliage of legume (group 7) at 0.70 ppm;
vegetable, leaves of root and tuber vegetables (group 2) at 0.04 ppm;
vegetable, root (subgroup 1A) at 0.02 ppm.
VI. Statutory and Executive Order Reviews
This final rule 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 final rule has
been exempted from review under Executive Order 12866, this final rule
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 final rule 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 final rule 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 final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (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 of 1995 (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
Dated: January 24, 2014.
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Add new Sec. 180.672 to subpart C to read as follows:
Sec. 180.672 Cyantraniliprole; tolerances for residues.
(a) General. Tolerances are established for the combined residues
of the insecticide cyantraniliprole, 3-bromo-1-(3-chloro-2-pyridinyl)-
carboxamide, including its metabolites and degradates, in or on
commodities in the following table. Compliance with the tolerance
levels specified in the following table is to be determined by
measuring only cyantraniliprole in or on the commodity.
Almond, hulls.............................................. 8.0
Brassica head and stem (subgroup 5A)....................... 3.0
Brassica leafy vegetables (subgroup 5B).................... 30
Bushberry (subgroup 13-07B)................................ 4.0
Cattle, fat................................................ 0.01
Cattle, meat............................................... 0.01
Cattle, meat byproducts.................................... 0.01
Cherry (subgroup 12-12A)................................... 6.0
Citrus, oil................................................ 2.4
Cotton, gin byproducts..................................... 10
Fruit, citrus (group 10-10)................................ 0.70
Fruit, pome (group 11-10).................................. 1.5
Goat, fat.................................................. 0.01
Goat, meat................................................. 0.01
Goat, meat byproducts...................................... 0.01
Horse, fat................................................. 0.01
Horse, meat................................................ 0.01
Horse, meat byproducts..................................... 0.01
Nut, tree (group 14-12).................................... 0.04
Oilseed (group 20)......................................... 1.5
Onion, bulb (subgroup 3-07A)............................... 0.04
Onion, green (subgroup 3-07B).............................. 8.0
Peach (subgroup 12-12B).................................... 1.5
Plum (subgroup 12-12C)..................................... 0.50
Sheep, fat................................................. 0.01
Sheep, meat................................................ 0.01
Sheep, meat byproducts..................................... 0.01
Vegetable, cucurbit (group 9).............................. 0.40
Vegetable, fruiting (group 8-10)........................... 2.0
Vegetable, leafy (except Brassica) (group 4)............... 20
Vegetable, tuberous and corm (subgroup 1C)................. 0.15
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. Tolerances are established
for indirect or inadvertent tolerances for residues of
its metabolites and degradates, in or on commodities in the following
table. Compliance with the tolerance levels specified in the following
table is to be determined by measuring only cyantraniliprole in or on
Animal feed, nongrass (group 18)........................... 0.20
Grain, cereal, forage, fodder and straw (group 16)......... 0.50
Grass forage, fodder and hay (group 17).................... 0.50
Peanut, hay................................................ 0.01
Vegetable, foliage of legume (group 7)..................... 0.70
Vegetable, leaves of root and tuber vegetables (group 2)... 0.04
Vegetable, root (subgroup 1A).............................. 0.02
[FR Doc. 2014-02210 Filed 2-4-14; 8:45 am]
BILLING CODE 6560-50-P