[Federal Register Volume 80, Number 15 (Friday, January 23, 2015)]
[Rules and Regulations]
[Pages 3481-3488]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-01013]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2013-0226; FRL-9914-77]
Flupyradifurone; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
flupyradifurone in or on multiple commodities which 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 January 23, 2015. Objections and
requests for hearings must be received on or before March 24, 2015, 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-2013-0226, 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: Susan Lewis, 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 http://www.epa.gov/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-2013-0226 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
March 24, 2015. 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-2013-0226, 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 June 5, 2013 (78 FR 33785) (FRL-9386-2),
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 2F8101)
by Bayer CropScience LP, 2 T.W. Alexander Dr., P.O. Box 12014, Research
Triangle Park, NC 27709. The petition requested that 40 CFR part 180 be
amended by establishing tolerances for residues of flupyradifurone, 4-
[[(6-chloro-3-pyridinyl)methyl](2,2-difluoroethyl)amino]-2(5H)-
furanone, and its metabolites, difluoro acetic acid (DFA) and 4-[(2,2-
difluoroethyl)amino]furan-2(5H)-one (DFEAF), in or on the following
commodities: Aspirated grains fractions at 40 parts per million (ppm);
root vegetables except sugar beets (crop subgroup 1B) at 1.5 ppm;
tuberous and corm vegetables (crop subgroup 1C) at 0.5 ppm; onion,
bulb, subgroup, (crop subgroup 3-07A) at 0.3 ppm; onion, green,
subgroup, (crop subgroup 3-07B) at 3 ppm; leafy vegetable, except
Brassica vegetables (crop group 4) at 40 ppm; taro leaves at 40 ppm;
head and stem Brassica (crop subgroup 5A) at 6 ppm; leafy Brassica
greens (crop subgroup 5B) at 40 ppm; turnip greens at 40 ppm; edible-
podded legume vegetables (crop subgroup 6A) at 5 ppm; succulent,
shelled pea and bean (crop subgroup 6B) at 4 ppm; dried, shelled pea
and bean (except soybean) (crop subgroups 6C) at 6 ppm; foliage of
legume vegetables, including soybeans (crop group 7), forage, green
vines at 40 ppm; foliage of legume vegetables, including soybeans (crop
group 7), hay at 50 ppm; soybean, seed at 4 ppm;
[[Page 3482]]
fruiting vegetables, except cucurbits (crop group 8-10), fruit at 3
ppm; tomato, paste at 4 ppm; cucurbit vegetables (crop group 9), fruit
at 2 ppm, citrus fruits (crop group 10-10), fruit at 3 ppm; citrus,
pulp, dried at 15 ppm; pome fruits (crop group 11-10), fruit at 1.5
ppm; bushberry subgroup (crop subgroup 13-07B) at 4 ppm; small fruit
vine climbing subgroup, except fuzzy kiwifruit (crop subgroup 13-07F)
at 3 ppm; grapes, raisin at 6 ppm; low growing berry subgroup (crop
subgroup 13-07G) at 1.5 ppm; tree nuts (crop group 14), nutmeat at 0.15
ppm; pistachio at 0.15 ppm; tree nuts (crop group 14), hulls at 15 ppm;
grain, cereal, (crop group 15), except rice; grain at 4 ppm; sweet
corn, kernels plus cobs with husks removed (k+cwhr) at 0.4 ppm; wheat,
bran at 5 ppm; rice, grain (rotational crop) at 4 ppm; grain, cereal,
forage, fodder and straw, group 16, forage at 20 ppm; grain, cereal,
forage, fodder and straw, group 16, hay at 40 ppm; grain, cereal,
forage, fodder and straw, group 16, straw at 30 ppm; grain, cereal,
forage, fodder and straw, group 16, stover at 15 ppm; cotton,
undelinted seed, (crop subgroup 20C) at 0.9 ppm; cotton, gin by-
products at 40 ppm; nongrass animal feeds, forage, (crop group 18) at
20 ppm; nongrass animal feeds, hay, (crop group 18) at 40 ppm; coffee,
bean, green at 2 ppm; coffee, bean, roasted; instant at 3 ppm; hops at
20 ppm; peanut, hay at 30 ppm; peanut, nutmeat at 0.15 ppm; prickly
pear cactus, fruit; at 0.5 ppm; pitaya, fruit at 0.5 ppm; prickly pear
cactus, pads at 0.9 ppm; cattle, goat, hog, horse, sheep fat at 0.5
ppm; cattle, goat, hog, horse, sheep meat at 1 ppm; cattle, goat, hog,
horse, sheep, meat byproducts at 2 ppm; milk at 0.3 ppm, poultry, eggs
at 0.3 ppm, poultry, meat at 0.5 ppm; poultry, meat byproducts at 0.5
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. There were no comments received in response
to the notice of filing.
Based upon review of the data supporting the petition, EPA has
revised the proposed commodity definitions and altered tolerance levels
for different commodities. EPA has reviewed the available residue data
and has determined the appropriate tolerance levels for residues of
flupyradifurone. The reasons for these changes are explained in Unit
IV.C.
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 flupyradifurone, including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with
flupyradifurone, 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.
Flupyradifurone (BYI 02960) is a new butenolide insecticide. The
most sensitive effects seen in the flupyradifurone database were
skeletal muscle atrophy/degeneration in dogs. With repeated dosing,
reductions in body weight and food consumption were commonly seen in
various studies and in all species of test animals (rats, mice, dogs,
and rabbits). The liver and thyroid were shown to be the common
findings of flupyradifurone toxicity. The database appears to suggest
that dogs are more sensitive to the effects of flupyradifurone;
however, with body weight adjustments (based on a \3/4\ scaling
factor), the dog and rat are almost equally as sensitive in response to
flupyradifurone toxicity. The skeletal muscle atrophy/degeneration seen
in the 90-day and 1-year dog studies formed the basis for chronic
dietary exposure toxicity endpoints.
The developmental toxicity study in rats demonstrated no evidence
of susceptibility in developing animals. In the rabbit developmental
toxicity study, there was an increase in the incidence of fetal death
at 80 milligram/kilogram/day (mg/kg/day) (the highest dose tested), a
dose that did not produce adverse effects in the maternal animals.
Therefore, a quantitative increase in susceptibility was demonstrated
in the rabbit developmental toxicity study. In the 2-generation
reproduction study in rats, decreased parental body weights (>=10%)
were seen at the LOAEL of 137 mg/kg/day (parental NOAEL = 37.8 mg/kg/
day). In contrast, body weight decreases that were considered adverse
were seen in F2 pups at 37.8 mg/kg/day (the parental NOAEL
and the offspring LOAEL; offspring NOAEL = 7.7 mg/kg/day). These
findings suggest quantitative susceptibility for developing young
animals.
The acute neurotoxicity study (dosing by gavage) showed that at the
time of peak-effect, flupyradifurone caused increases in the incidence
of piloerection and dilated pupils at 50 mg/kg. At the next higher dose
level (200 mg/kg) and above, it produced a large host of clinical
signs, which were related to neurotoxicity. The clinical signs included
dilated pupils, lower muscle tone, low arousal, tremors, myoclonic
jerks, chewing, repetitive licking of lips, gait incoordination,
flattened or hunched posture, and impaired righting reflex. In the 90-
day neurotoxicity study, no neurotoxicity or other adverse effects were
seen at dose levels as high as 174 mg/kg/day. The developmental
neurotoxicity study at 102 mg/kg/day yielded an increased incidence of
increased amplitude in startle response.
Flupyradifurone is classified as ``not likely to be carcinogenic to
humans.'' Carcinogenicity studies in rats and mice did not yield a
compound-related increase in tumor incidence, and the genotoxicity
battery did not show flupyradifurone to produce any genotoxicity.
Flupyradifurone did not demonstrate any immunotoxic effects.
Specific information on the studies received and the nature of the
adverse effects caused by flupyradifurone 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 ``Flupyradifurone: Human Health
Risk Assessment for The First Food Use'' in
[[Page 3483]]
docket ID number EPA-HQ-OPP-2013-0226.
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 for flupyradifurone used
for human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Flupyradifurone, for Use in Human Health Risk
Assessment
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Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
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Acute dietary (All populations).. NOAEL = 35 mg/kg/day Acute RfD = .35 mg/ Acute neurotoxicity study--rat.
UFA = 10x........... kg/day. LOAEL = 50 mg/kg/day based on
UFH = 10x........... increased incidences of
FQPA SF = 1x........ piloerection in both sexes and
pupil dilation in females on day
1. At the next higher dose level
(200 mg/kg) or above, lower
muscle tone, rapid respiration,
low arousal, tremors, myoclonic
jerks, chewing, repetitive
licking of lips, gait
incoordination, flattened or
hunched posture, dilated pupils,
impaired (uncoordinated or slow)
righting reflex, impaired flexor
and tail pinch responses, and
reduced rectal temperature.
Automated measures of motor
activity were also reduced in
both sexes, compared to controls.
Chronic dietary (All populations) NOAEL = 7.8 mg/kg/ Chronic RfD = .078 1-year oral toxicity study--dog.
day. mg/kg/day. LOAEL = 28 mg/kg/day based on
UFA = 10x........... cPAD = .078 mg/kg/ minimal to slight, focal to
UFH = 10x........... day.. multifocal areas of skeletal
FQPA SF = 1x........ muscle degeneration in
grastrocnemius and/or biceps
femoris muscle.
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Cancer (Oral, dermal, inhalation) Flupyradifurone is classified as ``not likely to be carcinogenic to humans''
based on data showing no treatment related increase in tumor incidence in
rat and mouse carcinogenicity studies.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population
adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation
from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human
population (intraspecies).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to flupyradifurone, EPA considered exposure under the
petitioned-for tolerances. EPA assessed dietary exposures from
flupyradifurone, 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. Such effects were identified
for flupyradifurone. Exposure and risk assessments were conducted using
the Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCID). This software uses 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 assumed that
flupyradifurone residues were present at recommended tolerance levels
in all commodities and that 100% of these crops were treated with
flupyradifurone. DEEM default processing factors were used for
cranberry juice, dried apple, dried beef, and dried pear; empirical
processing factors were used for processed commodities of apple (sauce
and juice), citrus oil, coffee, corn (bran, flour, meal, starch, oil),
cotton (oil), grape (wine, juice), grapefruit (juice), hops (dried
cones), lemons (juice), limes (juice), oranges (juice and peel), peanut
(butter, oil), pears (juice), potatoes (chips, flakes, cooked),
soybeans (oil, milk, flour), tomatoes (juice, puree, paste), and wheat
(bran, germ, flour).
ii. Chronic exposure. Exposure and risk assessments were conducted
using the DEEM-FCID. This software uses 2003-2008 food consumption data
from the USDA's NHANES/WWEIA. EPA assumed that flupyradifurone residues
were present at recommended tolerance levels in all commodities and
that 100% of these crops were treated with flupyradifurone. DEEM
default processing factors were used for cranberry juice, dried apple,
dried beef, and dried pear; empirical processing factors were used for
processed commodities of apple (sauce and juice), citrus oil, coffee,
corn (bran, flour, meal, starch, oil), cotton (oil), grape (wine,
juice), grapefruit (juice), hops (dried cones), lemons (juice), limes
(juice), oranges (juice and peel), peanut (butter,
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oil), pears (juice), potatoes (chips, flakes, cooked), soybeans (oil,
milk, flour), tomatoes (juice, puree, paste), and wheat (bran, germ,
flour).
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that flupyradifurone 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.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for flupyradifurone. Tolerance-level residues and/or
100 PCT were assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for flupyradifurone, in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of flupyradifurone. 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 Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) the estimated drinking water concentrations (EDWCs)
of flupyradifurone for acute exposures is estimated to be 52.5 parts
per billion (ppb) for surface water. Based on the Pesticide Root Zone
Model Ground Water (PRZM GW), the EDWCs of flupyradifurone for acute
exposures are estimated to 352 ppb for ground water.
Based on the PRZM/EXAMS the EDWCs of flupyradifurone for chronic
exposures for non-cancer assessments are estimated to be 22.3 ppb for
surface water and based on the PRZM GW the EDWCs are estimated to be
307 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 352 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 307 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).
Flupyradifurone is not registered for any specific use patterns
that would result in residential exposure.
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 flupyradifurone to share a common mechanism of
toxicity with any other substances, and flupyradifurone does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
flupyradifurone 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
different factor.
2. Prenatal and postnatal sensitivity. The developmental toxicity
study in rats demonstrated no evidence of susceptibility in developing
animals. In the rabbit developmental toxicity study, there was an
increase in the incidence of fetal death at 80 mg/kg/day, a dose that
did not produce adverse effects in the maternal animals. Therefore, a
quantitative increase in susceptibility was demonstrated in the rabbit
developmental toxicity study; however, the deaths occurred only at the
highest tested dose. In the 2-generation reproduction study in rats,
decreased parental body weights (>=10%) were seen at the LOAEL of 137
mg/kg/day (parental NOAEL = 37.8 mg/kg/day). In contrast, body weight
decreases that were considered adverse were seen in F2 pups
at 37.8 mg/kg/day (the parental NOAEL and the offspring LOAEL;
offspring NOAEL = 7.7 mg/kg/day). These findings suggest quantitative
susceptibility for developing young animals. However, the effects seen
in the rabbit developmental study and in the rat reproductive study
occurred at doses higher than the toxicity POD for risk assessment,
which was selected from the 1-year dog study (28 mg/kg/day, LOAEL) with
a NOAEL of 7.8 mg/kg/day. The NOAEL (7.8 mg/kg/day) selected as the POD
for chronic dietary risk assessment is protective of the effects seen
in the rat F2 pups and the increased incidence of fetal
death in the developmental rabbit study. Therefore, there are no
concerns for the observed increased susceptibility.
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 flupyradifurone is complete.
ii. Although there is evidence that flupyradifurone has neurotoxic
effects, EPA has a complete set of neurotoxicity studies (acute,
subchronic, and developmental). The effects of those studies are well-
characterized and indicate neurotoxic effects that occur at levels
above the chronic POD that was selected for risk assessment. The NOAEL
for the acute neurotoxicity study is being used for the acute POD.
Therefore, there is no need to retain the 10X FQPA SF to account for
any uncertainty concerning these effects.
iii. There is no evidence that flupyradifurone 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. There is quantitative susceptibility in rabbit developmental
study and in the pup of the reproduction study, but the PODs are
protective of this increased susceptibility.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to flupyradifurone in drinking water. These
assessments will not underestimate the exposure and risks posed by
flupyradifurone.
[[Page 3485]]
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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to flupyradifurone will occupy 38% of the aPAD for children 1-2 years
old, the population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
flupyradifurone from food and water will utilize 84% of the cPAD for
children 1-2 years old the population group receiving the greatest
exposure.
3. Short-term and Intermediate-term risk. Short-term and
Intermediate-term aggregate exposure takes into account short-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). A short-term/
intermediate-term adverse effect was identified; however,
flupyradifurone is not registered for any use patterns that would
result in short-term or intermediate-term residential exposure. Because
there is no short-term or intermediate-term residential exposure and
chronic dietary exposure has already been assessed under the
appropriately protective cPAD (which is at least as protective as the
POD used to assess short-term risk), no further assessment of short-
term risk is necessary, and EPA relies on the chronic dietary risk
assessment for evaluating short-term risk for flupyradifurone.
4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, flupyradifurone is not expected to pose a cancer risk to
humans.
5. 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 flupyradifurone residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (high performance liquid
chromatography with tandem mass spectrometry (HPLC/MS-MS)) is available
to enforce the tolerance expression. The validated limit of
quantification (LOQ) is 0.01 mg/kg for flupyradifurone in most
commodities.
An HPLC/MS-MS method, Method RV-004-A11-05 (latest revision of the
data collection method RV-004-A11-04), is adequate as the enforcement
method for determination of residues of flupyradifurone in livestock
commodities. The validated LOQ for flupyradifurone is 0.01 mg/kg in all
matrices.
The Food and Drug Administration (FDA) multi-residue methods (MRMs)
are suitable for flupyradifurone only in non-fatty matrices. The
methods are not suitable for fatty matrices or matrices that require
further clean-up. 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. The Codex has not
established a MRLs for flupyradifurone.
C. Revisions to Petitioned-For Tolerances
The Petitioner requested a definition for enforcement of tolerance
as the sum of flupyradifurone and DFA and DFEAF, expressed as
flupyradifurone, which significantly inflated the field trial residue
values and resulted in higher tolerance values. EPA, consistent with
its global review partners, has selected parent flupyradifurone only as
the residue definition for tolerance enforcement. Flupyradifurone is
the major portion of the residue in plant commodities and in some
livestock commodities. In other livestock commodities, it is present at
the same approximate concentration as some metabolites. Moreover, the
significant metabolite DFA is not suitable for enforcement purposes, as
its concentration is erratic with time. The harmonized enforcement
definition, flupyradifurone only, will facilitate trade and is
predicted to be the residue definition adopted by Codex in the future
based on application of their policy. Therefore, EPA is reducing the
tolerance values for the petitioned-for tolerances for the following
commodity groups/subgroups or commodities: Cattle, goat, hog, horse,
and sheep meat and meat byproducts; hog fat; milk; poultry eggs; root
vegetables subgroup 1B; tuberous and corm vegetables subgroup 1C; bulb
onion subgroup 3-07A; leafy vegetable group 4; legume vegetables
subgroups 6A, 6B, 6C; soybean; foliage of legume vegetables group 7;
fruiting vegetables group 8-10; cucurbit vegetables group 9; citrus
pulp; pome fruits group 11-10; grape raisins; bushberry subgroup 13B
except cranberry; tree nut group 14; cereal grain group 15 except rice
and except corn; sweet corn, cereal grain forage, fodder, and straw
group 16; nongrass animal feeds crop group 18; cotton undelinted seed;
coffee bean; hops; peanut hay; peanut; prickly pear cactus fruit and
pad.
The petition requested a tolerance for root vegetables, except
sugar beets subgroup 1B at 1.5 ppm. The ratio of highest average field
trials (HAFTs) of the representative commodities (carrot/radish, 0.603/
0.046 ppm) was 13, but the ratio of the median residue value was 1.8.
The small median ratio indicates that the central tendency of both
carrot and radish residue values are similar and that a single
tolerance would be appropriate for the subgroup, represented by carrot
and radish. The higher tolerance estimate from carrot (0.90 ppm) will
cover all members of the subgroup.
The petition requested a tolerance for the leafy vegetable, except
Brassica vegetables, group 4 at 40 ppm. Based on the available residue
data, EPA is establishing separate tolerances for each of the subgroups
of group 4, instead of a single tolerance for the whole group. For
subgroup 4A (leafy greens), EPA is
[[Page 3486]]
establishing a tolerance at 30 ppm, based on the highest residues,
which were found on the representative crop spinach. For subgroup 4B
(leafy petioles), EPA is establishing a separate tolerance at 9.0 ppm
based on the celery residues. The leafy greens subgroup tolerance was
translated to cover taro leaves; therefore, EPA is establishing a
tolerance for taro leaves at 30 ppm, rather than the 40 ppm requested.
The petitioned-for tolerance for the shelled pea and bean subgroup
6B at 4 ppm was not possible because the residues on the garden pea and
lima bean were substantially different. Residues differ by more than 5X
between succulent peas and succulent beans. In accordance with 40 CFR
180.40(g), a subgroup tolerance is not normally appropriate; rather,
EPA may establish individual crop tolerances. Therefore, EPA is
establishing individual tolerances for succulent peas and succulent
beans.
The petition requested a tolerance for cereal grains, grain, group
15 except rice at 4 ppm. The residues on sweet corn and field corn
grain were much lower than those on sorghum, wheat, and barley grains;
therefore, EPA is excluding corn (field corn, popcorn, and sweet corn)
grain from that group 15 tolerance, as well as rice. Based on available
residue data, EPA is establishing separate tolerances for popcorn,
grain, field corn, grain, and sweet corn (kernels plus cobs with husks
removed) at 0.05 ppm. Under 180.40(h), EPA may exclude some commodities
from a group tolerance where the residue levels are significantly
higher or lower than the other commodities in the group. Corn, unlike
the other cereal grains, has a protective husk and this difference is
often reflected in lower residues for late season foliar applications.
Therefore, EPA is excluding corn grain and rice from the crop group 15
tolerance and establishing separate tolerances for corn. The remaining
cereal grains, represented by grain sorghum, barley, and wheat, are
quite similar.
The petition requested a tolerance on nongrass animal feeds group
18, forage at 20 ppm and hay at 40 ppm. EPA is unable to establish
group 18 tolerances at this time for forage and hay because data from
only four field trials on clover (one of the representative crops) was
available. Based on the available data, EPA is establishing tolerances
for alfafa and regional tolerances for clover (since use on clover is
restricted to Washington, Oregon, and Idaho, the area where the field
trials were conducted). A group tolerance could be considered if
additional field trials for clover from diverse areas of the U.S. were
supplied.
The petition requested a tolerance for rice grain at 4 ppm as a
rotational crop. EPA cannot establish this tolerance at this time
because no data were provided to support this request. Rice field trial
data are required to establish a tolerance.
The proposed wheat bran tolerance of 5 ppm is not necessary. The
cereal grain group tolerance covers wheat bran. The highest average
field trial (HAFT) residue for wheat grain was 0.73 ppm and the
experimentally determined processing factor for the conversion of grain
to bran was 2.4. Therefore, the tolerance estimate for wheat bran is
1.8 ppm (0.73 x 2.4). As 1.8 ppm is less than the 3 ppm cereal group
tolerance, a separate tolerance for wheat bran is not needed.
EPA was petitioned for tolerances on tree nut group 14 and
pistachio. In the Federal Register of August 22, 2012 (77 FR 50617)
(FRL-9354-3), EPA issued a final rule that revised the crop grouping
regulations. As part of this action, EPA expanded and revised the
existing tree nut group 14. Changes to crop group 14 included adding
the specialty commodities African nut tree, Brazilian pine, bunya, bur
oak, cajou nut, candlenut, coconut, coquito nut, dika nut, ginkgo,
guiana chestnut, heartnut, Japanese horse-chestnut, mongongo nut,
monkey-pot, monkey puzzle nut, okari nut, pachira nut, peach palm nut,
pequi, pili nut, pine nut, pistachio, tropical almond and yellowhorn
including cultivars, varieties, and/or hybrids of these; and naming the
new crop group tree nut group 14-12. 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 petitions for which a Notice of Filing had been published, the
Agency would attempt to conform these petitions to the final rule.
Therefore, consistent with this final rule, EPA has assessed exposure
to the, insecticide flupyradifurone, assuming use under the revised
tree nut group 14-12. Because revising the requested crop group to the
updated crop group did not result in a risk of concern, EPA is
establishing tolerances for flupyradifurone residues on tree nut group
14-12.
Cranberry was removed from subgroups 13-07B and 13-07G at the
request of the petitioner as a modification to the original request.
Tolerances are not needed for the processed commodities instant
coffee, roasted coffee, and tomato paste. The recommended tolerances
for the raw agricultural commodities, tomato and green coffee bean
cover the respective processed commodities. The highest average field
trial (HAFT) result for coffee was 0.55 ppm, and the processing factors
for instant coffee and roasted coffee were 0.59 and 1.9, respectively.
Tolerance estimate (HAFT x processing factor; 0.55 x 0.59 = 0.32 ppm
roasted bean; 0.55 x 1.9 = 1.0 ppm instant coffee) are less than the
recommended green coffee bean tolerance (1.5 ppm). The HAFT for the
tomato field trials was 0.57 ppm and the processing factor for
conversion to paste was 2.0, and the product (0.57 x 2.0) is less than
the recommended fruiting vegetable group tolerance (1.5 ppm).
Tolerances are not required for poultry meat and poultry meat
byproducts, as the projected diet for poultry and the results of the
poultry feeding study indicate that residues are not likely in poultry
meat and poultry meat byproducts.
V. Conclusion
Therefore, tolerances are established for residues of
flupyradifurone, 4-[[(6-chloro-3-pyridinyl)methyl](2,2-
difluoroethyl)amino]- 2(5H)-furanone, are: Alfalfa, forage at 9.0 ppm;
alfalfa, hay at 20 ppm; almond, hulls at 15 ppm; bean, succulent at 0.2
ppm; berry, low growing, subgroup 13-07G, except cranberry at 1.5 ppm;
Brassica, head and stem, subgroup 5A at 6.0 ppm; Brassica, leafy
greens, subgroup 5B at 40 ppm; bushberry subgroup 13-07B, except
cranberry at 4.0 ppm; cactus, fruit at 0.30 ppm; cactus, pads at 0.70
ppm; cattle, fat at 0.20 ppm; cattle, meat at 0.30 ppm; cattle, meat
byproducts at 1.0 ppm; clover, forage at 20 ppm; clover, hay at 30 ppm;
coffee, green bean at 1.5 ppm; corn, field, grain at 0.05 ppm; corn,
pop, grain at 0.05 ppm; corn, sweet, kernels plus cobs with husks
removed at 0.05 ppm; cotton, gin byproducts at 40 ppm; cottonseed
subgroup 20C at 0.80 ppm; egg at 0.01 ppm; fruit, citrus, group 10-10
at 3.0 ppm; fruit, citrus, dried pulp, at 10 ppm; fruit, pome, group
11-10 at 0.70 ppm; fruit, small vine climbing, except fuzzy kiwifruit,
subgroup 13-07F at 3.0 ppm; goat, fat at 0.20 ppm; goat, meat at 0.30
ppm; goat, meat byproducts at 1.0 ppm; grain, aspirated grains
fractions at 40 ppm; grain, cereal, except rice and corn, group 15 at
3.0 ppm; grain, cereal, forage, fodder and straw, group 16 at 30 ppm;
grape, raisin at 5.0 ppm; hog, fat at 0.01 ppm; hog, meat at 0.01 ppm;
hog, meat byproducts at 0.04 ppm; hops, dried cones 10 ppm; horse, fat
at 0.20 ppm; horse, meat at 0.30 ppm; horse, meat byproducts at 1.0
ppm; leaf petioles, subgroup 4B at 9.0
[[Page 3487]]
ppm; leafy greens, subgroup 4A at 30 ppm; milk at 0.15 ppm; nut, tree,
group 14-12 at 0.02 ppm; onion, bulb, subgroup 3-07A at 0.09 ppm;
onion, green, subgroup 3-07B at 3.0 ppm; pea and bean, dried, shelled
except soybean, subgroup 6C at 3.0 ppm; pea, succulent at 2.0 ppm;
peanut at 0.04 ppm; peanut, hay at 20 ppm; pitaya at 0.30 ppm; sheep,
fat at 0.2 ppm; sheep, meat at 0.30 ppm; sheep, meat byproducts at 1.0
ppm; soybean, seed at 1.5 ppm; taro leaves at 30 ppm; turnip greens at
40 ppm; vegetable, cucurbit, group 9 at 0.40 ppm; vegetable, fruiting,
group 8-10 at 1.5 ppm; vegetable, legume, edible podded, subgroup 6A at
3.0 ppm; vegetable, root, except sugar beet, subgroup 1B at 0.9 ppm;
vegetable, tuberous and corm, subgroup 1C at 0.05 ppm; vegetable,
foliage of legume, group 7, at 30 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
recordkeeping requirements.
Dated: January 14, 2015.
Jack E. Housenger,
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. 180.679 to read as follows:
Sec. 180.679 Flupyradifurone; tolerances for residues.
(a) General. Tolerances are established for residues of the
insecticide flupyradifurone, including its metabolites and degradates,
in or on the commodities in the following table. Compliance with the
tolerance levels specified in the following table is to be determined
by measuring only flupyradifurone, 4-[[(6-chloro-3-
pyridinyl)methyl](2,2-difluoroethyl)amino]- 2(5H)-furanone.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Alfalfa, forage............................................ 9.0
Alfalfa, hay............................................... 20
Almond, hulls.............................................. 15
Bean, succulent............................................ 0.20
Berry, low growing, except cranberry subgroup 13-07G....... 1.5
Brassica, head and stem subgroup 5A........................ 6.0
Brassica, leafy greens subgroup 5B......................... 40
Bushberry, except cranberry subgroup 13-07B................ 4.0
Cactus, fruit.............................................. 0.30
Cactus, pads............................................... 0.70
Cattle, fat................................................ 0.20
Cattle, meat............................................... 0.30
Cattle, meat byproducts.................................... 1.0
Coffee, green bean \1\..................................... 1.5
Corn, field, grain......................................... 0.05
Corn, pop, grain........................................... 0.05
Corn, sweet, kernels plus cobs with husks removed.......... 0.05
Cotton, gin byproducts..................................... 40
Cottonseed, subgroup 20C................................... 0.80
Egg........................................................ 0.01
Fruit, citrus, dried pulp.................................. 10
Fruit, citrus, group 10-10................................. 3.0
Fruit, pome, group 11-10................................... 0.70
Fruit, small vine climbing, except fuzzy kiwifruit, 3.0
subgroup 13-07F...........................................
Goat, fat.................................................. 0.20
Goat, meat................................................. 0.30
Goat, meat byproducts...................................... 1.0
Grain, aspirated grain fractions........................... 40
Grain, cereal, forage, fodder and straw, group 16.......... 30
Grain, cereal, group 15, except rice and corn.............. 3.0
Grape, raisin.............................................. 5.0
Hog, fat................................................... 0.01
Hog, meat.................................................. 0.01
Hog, meat byproducts....................................... 0.04
Hops, dried cones.......................................... 10
Horse, fat................................................. 0.20
Horse, meat................................................ 0.30
Horse, meat byproducts..................................... 1.0
Leaf petioles, subgroup 4B................................. 9.0
Leafy greens, subgroup 4A.................................. 30
Milk....................................................... 0.15
Nut, tree, group 14-12..................................... 0.02
Onion, bulb, subgroup 3-07A................................ 0.09
Onion, green, subgroup 3-07B............................... 3.0
Pea and bean, dried, shelled except soybean, subgroup 6C... 3.0
Pea, succulent............................................. 2.0
Peanut..................................................... 0.04
[[Page 3488]]
Peanut, hay................................................ 20
Pitaya..................................................... 0.30
Sheep, fat................................................. 0.20
Sheep, meat................................................ 0.30
Sheep, meat byproducts..................................... 1.0
Soybean, seed.............................................. 1.5
Taro leaves................................................ 30
Turnip greens.............................................. 40
Vegetable, cucurbit, group 9............................... 0.40
Vegetable, foliage of legume, group 7...................... 30
Vegetable, fruiting, group 8-10............................ 1.5
Vegetable, legume, edible podded, subgroup 6A.............. 3.0
Vegetable, root, except sugar beet, subgroup 1B............ 0.90
Vegetable, tuberous and corm, subgroup 1C.................. 0.05
------------------------------------------------------------------------
\1\ No U.S. registration.
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional restrictions. Tolerances are
established for residues of the insecticide flupyradifurone, including
its metabolites and degradates, in or on the commodities in the
following table. Compliance with the tolerance levels specified in the
following table is to be determined by measuring only flupyradifurone,
4-[[(6-chloro-3-pyridinyl)methyl](2,2-difluoroethyl)amino]- 2(5H)-
furanone.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Clover, forage............................................. 20
Clover, hay................................................ 30
------------------------------------------------------------------------
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 2015-01013 Filed 1-22-15; 8:45 am]
BILLING CODE 6560-50-P