[Federal Register Volume 84, Number 126 (Monday, July 1, 2019)]
[Rules and Regulations]
[Pages 31208-31214]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13523]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0630; FRL-9994-36]


Fluopyram; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
fluopyram in or on cranberry; lentil, dry seed; and pea, dry seed. 
Bayer CropScience requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 1, 2019. Objections and 
requests for hearings must be received on or before August 30, 2019, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2018-0630, 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: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

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

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2018-0630 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 
August 30, 2019. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2018-0630, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of December 21, 2018 (83 FR 65660) (FRL-
9985-67), 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 
7E8638) by Bayer CropScience, 2.T.W. Alexander Drive, Research Triangle 
Park, NC 27709. The petition requested that 40 CFR 180.661 be amended 
by establishing tolerances for residues of the fungicide fluopyram, N-
[2-[3-chloro, -5-(trifluoromethyl)-2-

[[Page 31209]]

pyridinyl] ethyl]-2-(trifluoromethyl) benzamide in or on cranberry at 
2.0 parts per million (ppm); dry peas at 0.70 ppm; and lentils at 0.70 
ppm. That document referenced a summary of the petition prepared by 
Bayer CropScience, the registrant, which is available in the docket, 
http://www.regulations.gov. Comments were received on the notice of 
filing. EPA's response to these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA is 
establishing, in accordance with section 408(d)(4)(a)(i), tolerances 
that vary in some respects from what the petitioner requested. These 
variations and the Agency's underlying rationale for those variations 
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 fluopyram including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with fluopyram 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.
    Decreased body weight and liver effects were the common and 
frequent findings in the fluopyram subchronic and chronic oral toxicity 
studies in rats, mice, and dogs, and they appeared to be the most 
sensitive effects. Liver effects were characterized by increased liver 
weight, hepatocellular hypertrophy, hepatocellular vacuolation, 
increased mitosis and hepatocellular necrosis. Thyroid effects were 
found at dose levels similar to those that produced liver effects in 
rats and mice; these effects consisted of follicular cell hypertrophy, 
increased thyroid weight, and hyperplasia at dose levels greater than 
or equal to 100 milligrams/kilogram/day (mg/kg/day). Changes in thyroid 
hormone levels were also seen in a subchronic toxicity study. In male 
mice, there was an increased incidence of thyroid adenomas.
    Although increased liver tumors were observed in female rats in the 
carcinogenicity study, EPA has concluded that fluopyram is ``Not Likely 
to be Carcinogenic to Humans'' at doses that do not induce cellular 
proliferation in the liver or thyroid glands. This classification was 
based on convincing evidence that non-genotoxic modes of action for 
liver tumors in rats and thyroid tumors in mice have been established 
and that the carcinogenic effects have been demonstrated as a result of 
a mode of action dependent on activation of the CAR/PXR receptors. The 
Agency is using a point of departure for regulating fluopyram (NOAEL of 
1.2 mg/kg/day) that is below the doses that cause cell proliferation in 
the liver (11 mg/kg/day) and subsequent liver tumor formation (89 mg/
kg/day); therefore, the Agency concludes that exposure to fluopyram 
will not be carcinogenic.
    Moreover, fluopyram is not genotoxic or mutagenic. Fluopyram is not 
a developmental toxicant, nor did it adversely affect reproductive 
parameters. No evidence of qualitative or quantitative susceptibility 
was observed in developmental studies in rats and rabbits or in a 
multigeneration study in rats. In an acute neurotoxicity study, 
transient decreased motor activity was seen only on the day of 
treatment, but no other findings demonstrating neurotoxicity were 
observed. In addition, no neurotoxicity was observed in the subchronic 
neurotoxicity study in the presence of other systemic adverse effects. 
Fluopyram did not produce treatment-related effects on the immune 
system.
    Fluopyram has low acute toxicity via the oral, dermal, and 
inhalation routes of exposure. Fluopyram is not a skin or eye irritant 
or sensitizer under the conditions of the murine lymph node assay.
    Specific information on the studies received and the nature of the 
adverse effects caused by fluopyram as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document Fluopyram. Human Health Risk Assessment 
in Support of Tolerances without U.S. Registration on Lentils, Dry 
Peas, and Cranberries at pages 4-6 and page 12 in docket ID number EPA-
HQ-OPP-2018-0630.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are 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 fluopyram used for 
human risk assessment is shown in the Table of this unit.

[[Page 31210]]



   Table --Summary of Toxicological Doses and Endpoints for Fluopyram for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General             NOAEL = 50 mg/kg/day  Acute RfD = 0.50 mg/ Acute Neurotoxicity--Rat.
 population, including all         UFA = 10x...........   kg/day.             LOAEL = 100 mg/kg/day based on
 subpopulations).                  UFH = 10x...........  aPAD = 0.50 mg/kg/    decreased motor and locomotor
                                   FQPA SF = 1x........   day.                 activity in females. The LOAEL in
                                                                               males was 125 mg/kg/day.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 1.2 mg/kg/    Chronic RfD = 0.012  Combined Chronic Toxicity/
                                    day.                  mg/kg/day.           Carcinogenicity--Rat.
                                   UFA = 10x...........  cPAD = 0.012 mg/kg/  LOAEL = 6.0 mg/kg/day based on
                                   UFH = 10x...........   day.                 follicular cell hypertrophy in
                                   FQPA SF = 1x........                        the thyroid, and increased liver
                                                                               weight with gross pathological
                                                                               and histopathological findings.
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1-30   NOAEL = 14.5 mg/kg/   Residential LOC for  2-generation reproduction study--
 days) & Intermediate-term (1-6     day.                  MOE = 100.           Rats.
 months).                          UFA = 10x...........                       LOAEL = 82.8 mg/kg/day based on
                                   UFH= 10x............                        clinical chemistry changes and
                                   FQPA SF = 1x........                        increased kidney weight in
                                                                               parents, and decreased body
                                                                               weight and body weight gain with
                                                                               decreases in spleen and thymus
                                                                               weights in offspring.
----------------------------------------------------------------------------------------------------------------
Dermal short-term (1-30 days) &    NOAEL = 300 mg/kg/    Residential LOC for  28-day dermal study--Rat.
 Intermediate-term (1-6 months).    day.                  MOE = 100.          LOAEL = 1000 mg/kg/day based on
                                   UFA= 10x............                        increased cholesterol (females),
                                   UFH= 10x............                        and increased prothrombin time
                                   FQPA SF = 1x........                        (males).
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1-30 days)  NOAEL = 14.5 mg/kg/   Residential LOC for  2-generation reproduction study--
 & Intermediate-term (1-6 months).  day.                  MOE = 100.           Rats.
                                   UFA = 10x...........                       LOAEL = 82.8 mg/kg/day based on
                                   UFH = 10x...........                        clinical chemistry changes and
                                   FQPA SF = 1x........                        increased kidney weight in
                                                                               parents, and decreased body
                                                                               weight and body weight gain with
                                                                               decreases in spleen and thymus
                                                                               weights in offspring.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Fluopyram is classified as ``not likely to be carcinogenic to humans''.
----------------------------------------------------------------------------------------------------------------
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 fluopyram, EPA considered exposure under the petitioned-for 
tolerances as well as all existing fluopyram tolerances in 40 CFR 
180.180.661. EPA assessed dietary exposures from fluopyram 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 fluopyram. In estimating acute 
dietary exposure, EPA used food consumption information from the United 
States Department of Agriculture (USDA) Nationwide Health and Nutrition 
Examination Survey, What We Eat in America (NHANES/WWEIA) conducted 
from 2003-2008. As to residue levels in food, the acute dietary 
analysis was obtained from the Dietary Exposure Evaluation Model using 
the Food Commodity Intake Database (DEEM-FCID; version 3.16). The 
assessment is based on 100 percent crop treated (PCT) and tolerance-
level residues for all commodities. Default and empirical processing 
factors were used in the assessment. Additionally, certain correction 
factors for metabolites were also incorporated.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA Nationwide 
Health and Nutrition Examination Survey, What We Eat in America 
(NHANES/WWEIA) conducted from 2003-2008. As to residue levels in food, 
the chronic dietary analysis was obtained from the Dietary Exposure 
Evaluation Model using the Food Commodity Intake Database (DEEM-FCID; 
version 3.16). In the assessment, average field trial residues and 
average PCT were used. Empirical processing factors were included for 
processed commodities where available. Otherwise, DEEM 2018 default 
processing factors were used.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that fluopyram does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E)

[[Page 31211]]

and authorized under FFDCA section 408(f)(1). Data will be required to 
be submitted no later than 5 years from the date of issuance of these 
tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic reevaluation of 
any estimates used. To provide for the periodic evaluation of the 
estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may 
require registrants to submit data on PCT.
    The Agency estimated the average PCT for existing uses as follows: 
Almonds, 20%; apples, 25%; apricots, 5%; artichoke, 15%; broccoli, 
2.5%; cabbage, 2.5%; carrots, 1%; cauliflower, 1%; cherries, 25%; 
cotton, 1%; dry beans and peas, 1%; grapefruit, 10%; grapes, raisins, 
1%; table grapes, 5%; wine grapes; 20%; lemons, 1%; lettuce, 1%; 
onions, 1%; oranges, 15%; peaches, 1%; peanuts, 2.5%; pears, 5%; 
peppers, 5%; pistachios, 15%; potatoes, 20%; strawberries, 10%; 
tomatoes, 1%; walnuts, 10%; and watermelons, 15%.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and California Department of 
Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the 
chemical/crop combination for the most recent 10 years. EPA uses an 
average PCT for chronic dietary risk analysis and a maximum PCT for 
acute dietary risk analysis. The average PCT figures for each existing 
use are derived by combining available public and private market survey 
data for that use, averaging across all observations, and rounding up 
to the nearest 5%, except for those situations in which the average PCT 
is less than 1% or less than 2.5%. In those cases, the Agency would use 
less than 1% or less than 2.5% as the average PCT value, respectively. 
The maximum PCT figure is the highest observed maximum value reported 
within the most recent 10 years of available public and private market 
survey data for the existing use and rounded up to the nearest multiple 
of 5%, except where the maximum PCT is less than 2.5%, in which case, 
the Agency uses less than 2.5% as the maximum PCT.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for fluopyram in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of fluopyram. 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 Surface Water Concentration Calculator (SWCC) and 
Pesticide Root Zone Model Ground Water (PRZM GW), the estimated 
drinking water concentrations (EDWCs) of fluopyram for acute exposures 
are estimated to be 50.6 parts per billion (ppb) for surface water and 
97.6 ppb for ground water. For chronic exposures for non-cancer 
assessments, the EDWCs of fluopyram are estimated to be 17.3 ppb for 
surface water and 90.5 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 97.6 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 90.5 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).
    Fluopyram is currently registered for use on golf course turf, 
residential lawns, fruit trees, nut trees, ornamentals and gardens that 
could result in residential exposures. EPA assessed residential 
exposure using the following assumptions. For residential handler 
exposure, EPA assessed short-term dermal and inhalation handler 
exposure (derived from treating lawns by hose-end sprayers in adults). 
For residential post-application exposures, EPA assessed dermal 
exposure scenarios (for adults and children (1 to <2 years old) dermal 
exposure to treated turf during high contact lawn activities; for 
adults and youths (11 to <16 yr old) dermal exposure to treated turf 
during mowing and golfing activities; for children (6 to <11 years old) 
dermal exposure to treated turf during golfing activities; and for 
adults and children (6 to <11 years old) dermal exposure to treated 
gardens) and oral exposure (for children (1 to <2 years old) incidental 
oral exposure as a result of contacting treated turf). The Agency used 
the most conservative residential risk estimates (from the adult 
inhalation handler exposures from treating lawns with hose-end sprayer 
and from the child (1 to <2 years old) incidental oral hand-to-mouth 
post-application exposures to treated lawns) in the fluopyram aggregate 
assessment. Further information regarding EPA standard assumptions and 
generic inputs for residential exposures may be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found fluopyram to share a common mechanism of toxicity 
with any other substances, and fluopyram does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that fluopyram does not 
have a common mechanism of toxicity with other substances. For 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see EPA's website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    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

[[Page 31212]]

additional safety factor when reliable data available to EPA support 
the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased susceptibility in the developing or young animals which were 
exposed during pre- or post-natal periods.
    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 fluopyram is complete.
    ii. There is no indication that fluopyram is a neurotoxic chemical. 
Although transient decreases in motor and locomotor activities in the 
acute neurotoxicity study were seen on the day of treatment and limited 
use of hind-limbs and reduced motor activity was seen in the rat 
chronic/carcinogenicity study, there were no other associated 
neurobehavioral or histopathology changes found in other studies in the 
fluopyram toxicity database. The effects seen in the chronic/
carcinogenicity study were in the presence of increased mortality and 
morbidity such as general pallor and emaciated appearance. Therefore, 
the reduced motor activity and limited use of hind-limbs seen in these 
two studies were judged to be the consequence of the systemic effects 
and not direct neurotoxicity. Additionally, there is no need for a 
developmental neurotoxicity study or additional UFs to account for 
neurotoxicity.
    iii. There is no evidence that fluopyram results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The acute dietary exposure assessment was performed using 
conservative exposure inputs, including tolerance-level residues for 
all crops, whereas the chronic dietary assessment included average 
field-trial residue levels for all crops. The acute dietary assessment 
assumed 100 PCT, whereas the chronic dietary assessment utilized 
average PCT numbers for several crops. Both acute and chronic dietary 
assessments incorporated empirical or default processing factors. EPA 
made conservative (protective) assumptions in the ground and surface 
water modeling used to assess exposure to fluopyram in drinking water. 
EPA used similarly conservative assumptions to assess post-application 
exposure of children as well as incidental oral exposure of toddlers. 
These assessments will not underestimate the exposure and risks posed 
by fluopyram.

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 fluopyram will occupy 30% 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 
fluopyram from food and water will utilize 84% 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 fluopyram 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).
    Fluopyram is currently registered for uses that could result in 
short-term residential exposure, and the Agency has determined that it 
is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to fluopyram. Using the exposure 
assumptions described in this unit for short-term exposures, EPA has 
concluded the combined short-term food, water, and residential 
exposures result in aggregate MOEs of 1500 for adults and 1400 for 
children (1 to <2 years old). Because EPA's level of concern for 
fluopyram 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, 
fluopyram 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 
fluopyram.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, fluopyram 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 fluopyram residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (German multiresidue method DFG 
Method S19 and GC/MSD (gas chromatography with mass-selective 
detection)) is available to enforce the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

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

[[Page 31213]]

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 established MRLs for fluopyram in or on dry pea and 
lentil (0.7 ppm); the US tolerances being established in this rule for 
those commodities are harmonized with the Codex MRLs. Codex has not 
established an MRL for residues of fluopyram on cranberry.

C. Response to Comments

    Two comments were received in response to the notice of filing. 
Although it is difficult to decipher the real meaning, one comment 
appeared to suggest that EPA focus on enforcing proper use of the 
pesticide by farmers and workers rather than revising tolerance 
regulations. The Agency directs the commenter to the Federal 
Insecticide, Fungicide, and Rodenticide Act, which is the existing law 
that provides for enforcing appropriate use of the pesticide. This 
tolerance rulemaking is being undertaken under the Federal Food, Drug, 
and Cosmetic Act, which directs EPA to establish tolerances for 
residues of pesticides in or on food that it determines are safe. The 
Agency has assessed the safety of these tolerances and made that 
determination, as indicated in this rulemaking and supporting 
documents. The second comment to the notice of filing is not germane to 
this action.

D. Revisions to Petitioned-For Tolerances

    The Agency is revising the commodity definition on lentils and dry 
peas to reflect the common commodity vocabulary currently used by the 
Agency. The commodity definition was revised from lentils to lentil, 
dry seed and dry peas to pea, dry seed. Moreover, tolerances are being 
established without the requested trailing zeros in accordance with the 
Agency's current rounding class practice.

V. Conclusion

    Therefore, tolerances are established for residues of fluopyram, in 
or on cranberry at 2 ppm; lentil, dry seed at 0.7 ppm; and pea, dry 
seed at 0.7 ppm. There are currently no U.S. registrations for use of 
fluopyram on these commodities; these tolerances are being established 
to cover residues in or on these commodities that are imported into the 
United States.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). This action does not contain any information collections subject 
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 
et seq.), nor does it require any special considerations under 
Executive Order 12898, entitled ``Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: June 18, 2019.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


0
2. In Sec.  180.661, add alphabetically the entries for ``Cranberry''; 
``Lentil, dry seed''; and ``Pea, dry seed'' to read as follows:


Sec.  180.661  Fluopyram; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Cranberry \1\...............................................           2
 
                                * * * * *
Lentil, dry seed \1\........................................         0.7
 
                                * * * * *
Pea, dry seed \1\...........................................         0.7
 
                                * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations.


[[Page 31214]]

* * * * *
[FR Doc. 2019-13523 Filed 6-28-19; 8:45 am]
BILLING CODE 6560-50-P


