[Federal Register Volume 81, Number 185 (Friday, September 23, 2016)]
[Rules and Regulations]
[Pages 65552-65557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22976]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0226; FRL-9951-68]


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 LP requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 23, 2016. Objections and 
requests for hearings must be received on or before November 22, 2016, 
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: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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 
November 22, 2016. 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 March 16, 2016 (81 FR 14030) (FRL-9942-
86), 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 
5F8404) by Bayer CropScience LP, 2 T.W. Alexander

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Drive, 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 the insecticide, flupyradifurone, in or on abiu at 0.6 
parts per million (ppm); akee apple at 0.6 ppm; avocado at 0.6 ppm; 
bacury at 0.6 ppm; banana at 0.6 ppm; binjai at 0.6 ppm; caneberry, 
subgroup 13-07A at 5 ppm; canistel at 0.6 ppm; cilantro, fresh leaves 
at 30 ppm; cupuac[uacute] at 0.6 ppm; etambe at 0.6 ppm; jatob[aacute] 
at 0.6 ppm; kava, fresh leaves at 40 ppm; kava, roots at 0.9 ppm; kei 
apple at 0.6 ppm; langstat at 0.6 ppm; lanjut at 0.6 ppm; lucuma at 0.6 
ppm; mabolo at 0.6 ppm; mango at 0.6 ppm; mangosteen at 0.6 ppm; paho 
at 0.6 ppm; papaya at 0.6 ppm; pawpaw, common at 0.6 ppm; pelipisan at 
0.6 ppm; pequi at 0.6 ppm; pequia at 0.6 ppm; persimmon, american at 
0.6 ppm; plantain at 0.6 ppm; pomegranate at 0.6 ppm; poshte at 0.6 
ppm; quandong at 0.6 ppm; quinoa at 3 ppm; sapote at 0.6 ppm; sataw at 
0.6 ppm; screw-pine at 0.6 ppm; star apple at 0.6 ppm; stone fruit, 
stone group 12-12 at 1.5 ppm; tamarind-of-the-Indies at 0.6 ppm; and 
wild loquat at 0.6 ppm. That document referenced a summary of the 
petition prepared by Bayer CropScience LP, the registrant, which is 
available in the docket, http://www.regulations.gov. Comments were 
received on the notice of filing. EPA's response to these comments is 
discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
modified some of the commodity definitions that were proposed. The 
reason for these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue . . 
. .''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for 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.
    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 lowest-observed-adverse-effect-level (LOAEL) 
of 137 mg/kg/day (parental no-observed-adverse-effect-level (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 NOAEL and the 
LOAEL from the toxicity studies can be found at http://www.regulations.gov in the document titled ``Flupyradifurone (122304) 
Human Health Risk Assessment in Support of Proposed Uses on Kava, 
Cilantro, Stone Fruit, Group 12-12, Caneberry, Subgroup 13-07A, Quinoa, 
and Tropical Fruits; Amended Use Requests for Soil Applications to 
Leafy Vegetables, Group 4 and Brassica (Cole) Leafy Vegetables, Group 
5; Use on Greenhouse Grown Tomato, Pepper, Cucumber, and Lettuce; Label 
Amendment to Add Commodities of Tree Nuts, Group 14-12 to label; and 
Label Amendment to Add Use Directions for Clover Grown for Forage, 
Fodder, Seed, Straw, and Hay'' on page 49 in 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 to use in evaluating the risk posed by human

[[Page 65554]]

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    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 = 0.35 mg/ Acute neurotoxicity study--rat
                                   UFA = 10 x..........   kg/day.             LOAEL = 50 mg/kg/day based on
                                   UFH = 10 x..........  aPAD = 0.35 mg/kg/    increased incidences of
                                   FQPA SF = 1 x.......   day.                 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/day  Chronic RfD = 0.078  Oral toxicity study--dog (1-year)
                                   UFA = 10 x..........   mg/kg/day.          LOAEL = 28 mg/kg/day based on
                                   UFH = 10 x..........  cPAD = 0.078 mg/kg/   minimal to slight, focal to
                                   FQPA SF = 1 x.......   day.                 multifocal areas of skeletal
                                                                               muscle degeneration in
                                                                               gastrocnemius and/or biceps
                                                                               femoris muscle.
Dermal short-term (1 to 30 days).  Dermal (or oral)      LOC for MOE = 100..  Oral toxicity study--dog (90-day)
                                    study NOAEL = 12 mg/                      LOAEL = 33 mg/kg/day based
                                    kg/day (dermal                             skeletal muscle atrophy/
                                    absorption rate =                          degeneration.
                                    7.42%.                                    2-Generation reproduction study--
                                   UFA = 10 x..........                        rat (co-critical study)
                                   UFH = 10 x..........                       NOAEL = 7.7 mg/kg/day.
                                   FQPA SF = 1 x.......                       Offspring LOAEL = 38.7 mg/kg/day
                                                                               based on pup body weight
                                                                               decrease.
Inhalation short-term (1 to 30     Oral study NOAEL =    LOC for MOE = 100..  Oral toxicity study--dog (90-day)
 days).                             12 mg/kg/day                              LOAEL = 33 mg/kg/day based on
                                    (inhalation                                skeletal muscle atrophy/
                                    absorption rate =                          degeneration.
                                    100%).                                    2-Generation reproduction study--
                                   UFA = 10 x..........                        rat (co-critical study)
                                   UFH = 10 x..........                       NOAEL = 7.7 mg/kg/day.
                                   FQPA SF = 1 x.......                       Offspring LOAEL = 38.7 mg/kg/day
                                                                               based on pup body weight
                                                                               decrease.
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Cancer (Oral, dermal, inhalation)  Classification: Not likely to be carcinogenic to humans--based on data
                                    showing no treatment-related increase in tumors incidence in rat and mouse
                                    carcinogenicity studies. No mutagenic concern was reported in the
                                    genotoxicity 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. MOE = margin of exposure. 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 as well as all existing flupyradifurone 
tolerances in 40 CFR 180.679. 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. In estimating 
acute dietary exposure, EPA used food consumption data from the United 
States Department of Agriculture's (USDA's) National Health and 
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA; 
2003-2008). As to residue levels in food, EPA assumed 100% crop treated 
(PCT), tolerance level residues and Dietary Exposure Evaluation Model 
(DEEM) (ver. 7.81) default processing factors.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment

[[Page 65555]]

EPA used the food consumption data from the USDA's NHANES/WWEIA; 2003-
2008. As to residue levels in food, EPA assumed 100 PCT, tolerance 
level residues and DEEM (ver. 7.81) default processing factors.
    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 PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
flupyradifurone. Tolerance level residues and 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS), Tier 1 Rice Model and Pesticide Root Zone Model 
Ground Water (PRZM GW) model, the estimated drinking water 
concentrations (EDWCs) of flupyradifurone for acute exposures are 
estimated to be 112 parts per billion (ppb) for surface water and 352 
ppb for ground water, and for chronic exposures are estimated to be 112 
ppb for surface water and 307 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the acute dietary risk 
assessment, the water concentration value of 352 ppb was used to assess 
the contribution to drinking water. For the 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).
    Currently there are no registered uses for flupyradifurone that 
could result in residential exposures. However, there is a proposal to 
register uses that could result in residential exposures for 
application to ornamental plants (gardens, trees, shrubs, flowers). 
Therefore, the EPA considered the proposed residential uses and 
assessed residential exposure using the following assumptions: For 
residential handlers, short-term dermal and inhalation exposures were 
assessed for adults mixing, loading and applying liquids and ready to 
use formulations to gardens and trees using a variety of application 
equipment. For post-application exposure, short-term dermal exposures 
to adults and children (6 to <11 years old) to gardens, trees, and 
retail plants and indoor plants was evaluated. Only short-term 
residential exposures are expected. Further information regarding EPA 
standard assumptions and generic inputs for residential exposures may 
be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There is no evidence that 
flupyradifurone produces increased susceptibility in in the rat 
developmental study. There is quantitative increase in susceptibility 
in the rabbit developmental and rat reproduction studies. In the rabbit 
developmental study, no maternal effect was seen at the highest tested 
dose (80 mg/kg/day), while there was an increase in fetal death and 
decrease fetal body weight at the same dose level. In the rat 
reproduction study, maternal effect, decrease in body weight, was seen 
at 137 mg/kg/day, whereas decreases in pup body weight was seen at the 
next lower dose, 38.7 mg/kg/day or above. However, the PODs selected 
for risk assessment are protective of the quantitative susceptibility 
seen in the rabbit fetuses and rat pups.
    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. There is quantitative increase in 
susceptibility in the rabbit developmental and rat reproduction 
studies. However, the PODs selected for risk assessment are protective 
of the quantitative susceptibility seen in the rabbit fetuses and rat 
pups.
    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

[[Page 65556]]

flupyradifurone in drinking water. EPA used similarly conservative 
assumptions to assess the proposed residential post-application 
exposure of children. These assessments will not underestimate the 
exposure and risks posed by flupyradifurone.

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 37% 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 86% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
flupyradifurone is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). For 
flupyradifurone there are uses pending which the Agency has included in 
this action 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 flupyradifurone.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and proposed residential exposures result in aggregate MOEs of 170 for 
adults and 190 for children (6 to <11 years old). Because EPA's level 
of concern for flupyradifurone 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).
    An intermediate-term adverse effect was identified; however, 
flupyradifurone is not registered for any use patterns that would 
result in intermediate-term residential exposure. Intermediate-term 
risk is assessed based on intermediate-term residential exposure plus 
chronic dietary exposure. Because there is no 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 intermediate-term risk), no 
further assessment of intermediate-term risk is necessary, and EPA 
relies on the chronic dietary risk assessment for evaluating 
intermediate-term risk for flupyradifurone.
    5. 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.
    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 flupyradifurone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate analytical method (Method RV-001-P10-03) which uses 
high-performance liquid chromatography with tandem mass spectrometry 
(HPLC/MS/MS) to quantitate residues of flupyradifurone and 
difluoroacetic acid (DFA) in various crops is available for 
enforcement.
    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 any MRLs for flupyradifurone.

C. Response to Comments

    EPA received two comments to the Notice of Filing. The first 
stated, in part, that EPA should deny this petition because it is a 
harmful and toxic chemical. The Agency understands the commenter's 
concerns and recognizes that some individuals believe that pesticides 
should be banned on agricultural crops. However, the existing legal 
framework provided by section 408 of the Federal Food, Drug and 
Cosmetic Act (FFDCA) states that tolerances may be set when persons 
seeking such tolerances or exemptions have demonstrated that the 
pesticide meets the safety standard imposed by that statute. EPA has 
assessed the effects of this chemical on human health and determined 
that aggregate exposure to it will be safe. This citizen's comment 
appears to be directed at the underlying statute and not EPA's 
implementation of it; the citizen has made no contention that EPA has 
acted in violation of the statutory framework.
    The second comment was from Interregional Research Project Number 4 
(IR-4) and was in support of the petition.

D. Revisions to Petitioned-For Tolerances

    Bayer CropScience LP petitioned for tolerances on abiu, akee apple, 
avocado, bacury, banana, binjai, canistel, cupuac[uacute], etambe, 
jatob[aacute], kei apple, langstat, lanjut, lucuma, mabolo, mango, 
mangosteen, paho, papaya, common pawpaw, pelipisan, pequi, pequia, 
American persimmon, plantain, pomegranate, poshte, quandong, sapote, 
sataw, screw-pine, star apple, tamarind-of-the-Indies, and wild loquat. 
These commodities are all listed in the newly established crop subgroup 
24B for tropical and subtropical, medium to large fruit, with a smooth, 
inedible peel. Subgroup 24B further breaks out the different types of 
avocado (to include Guatemalan, Mexican, and West Indian avocado), 
mango (to include horse and Saipan mango), and sapote (to include

[[Page 65557]]

black, green, and white sapote). Although the petitioner did not 
specify any particular kind of avocado, mango, and sapote, the Agency 
considers the request for avocado, mango, and sapote to be general in 
nature and include all varieties of those commodities. As a result, the 
requested commodities align with the commodities contained in the new 
subgroup 24B.
    In the Federal Register of May 3, 2016 (81 FR 26471) (FRL-9944-87) 
establishing that crop group, EPA indicated 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 is establishing tolerances on crop 
subgroup 24B, the tropical and subtropical, medium to large fruit, 
smooth, inedible peel subgroup, rather than all the commodities 
individually. EPA's dietary and aggregate risk assessments are based on 
data from the required representative commodities and account for 
flupyradifurone exposure from all of the subgroup 24B commodities.

V. Conclusion

    Therefore, tolerances are established for residues of 
flupyradifurone, including its metabolites and degradates, in or on 
caneberry subgroup 13-07A at 5.0 ppm; cilantro, fresh leaves at 30 ppm; 
fruit, stone, group 12-12 at 1.5 ppm; kava, fresh leaves at 40 ppm; 
kava, roots at 0.90 ppm; quinoa, grain at 3.0 ppm; and the tropical and 
subtropical, medium to large fruit, smooth, inedible peel subgroup 24B 
at 0.60 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: September 14, 2016.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.


0
2. In Sec.  180.679, add alphabetically the commodities ``Caneberry 
subgroup 13-07A''; ``Cilantro, fresh leaves''; ``Fruit, stone, group 
12-12''; ``Kava, fresh leaves''; ``Kava, roots''; ``Quinoa, grain''; 
and ``Tropical and subtropical, medium to large fruit, smooth, inedible 
peel subgroup 24B'' to the table in paragraph (a) to read as follows:


Sec.  180.679  Flupyradifurone; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Caneberry subgroup 13-07A...............................             5.0
 
                                * * * * *
Cilantro, fresh leaves..................................              30
 
                                * * * * *
Fruit, stone, group 12-12...............................             1.5
 
                                * * * * *
Kava, fresh leaves......................................              40
Kava, roots.............................................            0.90
 
                                * * * * *
Quinoa, grain...........................................             3.0
 
                                * * * * *
Tropical and subtropical, medium to large fruit, smooth,            0.60
 inedible peel subgroup 24B.............................
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-22976 Filed 9-22-16; 8:45 am]
 BILLING CODE 6560-50-P