[Federal Register Volume 85, Number 31 (Friday, February 14, 2020)]
[Rules and Regulations]
[Pages 8461-8468]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02035]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0297; FRL-10004-03]


Flutriafol; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
flutriafol in or on multiple commodities which are identified and 
discussed later in this document. Cheminova A/S on behalf of FMC 
Corporation requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective February 14, 2020. Objections and 
requests for hearings must be received on or before April 14, 2020, 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-2018-0297, 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 
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-2018-0297 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
April 14, 2020. 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

[[Page 8462]]

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-2018-0297, 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 July 24, 2018 (83 FR 34968) (FRL-9980-
31), 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 
8F8661) by Cheminova A/S, on behalf of FMC Corporation, 2929 Walnut 
Street, Philadelphia, PA 19104. The petition requested that 40 CFR 
180.629 be amended by establishing tolerances for residues of the 
fungicide flutriafol, (()-[alpha]-(2-fluorophenyl-[alpha]-
(4-fluorophenyl)-1H-1,2,4-triazole-1-ethanol), in or on alfalfa, forage 
at 15.0 parts per million (ppm); alfalfa, hay at 50 ppm; barley, grain 
at 1.5 ppm; barley, hay at 7.0 ppm; barley, straw at 8.0 ppm; corn, 
sweet, forage at 9.0 ppm; corn, sweet kernels plus cobs with husks 
removed at 0.03 ppm; corn, sweet, stover at 8 ppm; rice, bran at 0.4 
ppm; rice, grain at 0.5 ppm; rice, hulls at 1.5 ppm; rice, straw at 0.9 
ppm. Although the Agency's document did not expressly include the 
following, the petition also requested the removal of the following 
tolerances upon establishment of the petitioned-for tolerances: 
Existing tolerances for inadvertent or indirect residues of flutriafol 
in corn, sweet, forage at 0.09 ppm; corn, sweet, kernels plus cobs with 
husks removed at 0.01 ppm; and corn, sweet, stover at 0.07 ppm. That 
document referenced a summary of the petition prepared by Cheminova A/S 
on behalf of FMC Corporation, 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 is 
issuing some tolerances that vary from what the petitioner requested. 
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 flutriafol including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with flutriafol 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.
    Consistent with the mammalian toxicity profiles of the other 
triazole fungicides, the prevalent adverse effects following oral 
exposure to flutriafol were in the liver. Effects consisted of 
increases in liver enzyme release (alkaline phosphatase), liver 
weights, and histopathology findings (hepatocyte vacuolization to 
centrilobular hypertrophy and slight increases in hemosiderin-laden 
Kupffer cells, minimal to severe fatty changes, and bile duct 
proliferation/cholangiolar fibrosis). Progression of toxicity occurred 
with time as some effects were only observed at chronic durations.
    Slight indications of effects in the hematopoietic system were 
sporadically seen in all species consisting of slight anemia, increased 
platelets, white blood cells, neutrophils, and lymphocytes. The effects 
in the neurotoxicity screening batteries were observed only at higher 
doses and were considered secondary effects (decreased motor activity 
and hindlimb grip strength, ptosis, lost righting reflex, hunched 
posture, and ataxia). Flutriafol showed no evidence of dermal toxicity, 
or immunotoxicity. Flutriafol showed no evidence of carcinogenicity in 
rodents or in vitro.
    There is evidence of increased quantitative and qualitative 
prenatal and postnatal susceptibility for flutriafol in rats and 
rabbits. In the first of two rat developmental toxicity studies, 
developmental effects (delayed ossification or non-ossification of the 
skeleton in the fetuses) were observed at a lower dose than that where 
maternal effects were observed. In the second rat developmental study, 
developmental effects (external, visceral, and skeletal malformations; 
embryo lethality; skeletal variations; a generalized delay in fetal 
development; and fewer live fetuses) were more severe than the 
decreased food consumption and body-weight gains observed in the dams 
at the same dose. For rabbits, intrauterine deaths occurred at a dose 
level that also caused adverse effects in maternal animals. In the 2-
generation reproduction studies, effects in the offspring [decreased 
litter size and percentage of live births (increased pup mortality) and 
liver toxicity] can be attributed to the systemic toxicity of the 
parental animals (decreased body weight and food consumption and liver 
toxicity) observed at the same dose.
    Flutriafol is categorized as having high oral acute toxicity in the 
mouse. It is categorized as having low acute toxicity via the oral, 
dermal and inhalation routes in rats. Flutriafol is minimally 
irritating to the eyes and is not a dermal irritant. Flutriafol was not 
shown to be a skin sensitizer when tested in guinea pigs.
    Specific information on the studies received and the nature of the 
adverse

[[Page 8463]]

effects caused by flutriafol 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 ``Human Health Risk Assessment in Support of a Section 3 
Registration for Application to Alfalfa, Barley, Sweet Corn, Rice (as a 
Rotated Crop), Turf, and Ornamentals at 18'' in docket ID number EPA-
HQ-OPP-2018-0297.

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 flutriafol used for 
human risk assessment is shown in Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Flutriafol 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 (Females 13 to 49    NOAEL = 7.5 mg/kg/    Acute RfD = 0.075    Developmental study--rabbit.
 years of age).                     day                   mg/kg/day           LOAEL = 15 mg/kg/day based on
                                   UFA = 10X...........  aPAD = 0.075 mg/kg/   decreased number of live fetuses,
                                   UFH = 10X...........   day.                 complete litter resorptions and
                                   FQPA SF = 1X........                        increased post-implantation loss.
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population  NOAEL = 250 mg/kg/    Acute RfD = 2,5 mg/  Neurotoxicity screening battery--
 including infants and children).   day                   kg/day               rat.
                                   UFA = 10X...........  aPAD = 2.5 mg/kg/    LOAEL = 750 mg/kg/day based on
                                   UFH = 10X...........   day.                 decreased body weight, body-
                                   FQPA SF = 1X........                        weight gain, absolute and
                                                                               relative food consumption, and
                                                                               clinical signs of toxicity in
                                                                               both sexes: Dehydration, urine-
                                                                               stained abdominal fur, ungroomed
                                                                               coat, ptosis, decreased motor
                                                                               activity, prostration, limp
                                                                               muscle tone, muscle flaccidity,
                                                                               hypothermia, hunched posture,
                                                                               impaired or lost righting reflex,
                                                                               scant feces; in males: Red or tan
                                                                               perioral substance,
                                                                               chromodacryorrhea,
                                                                               chromorhinorrhea and labored
                                                                               breathing, and in females:
                                                                               Piloerection and bradypnea.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 5 mg/kg/day   Chronic RfD = 0.05   Chronic toxicity--dog.
                                   UFA = 10X...........   mg/kg/day           LOAEL = 20 mg/kg/day based on
                                   UFH = 10X...........  cPAD = 0.05 mg/kg/    adverse liver findings (increased
                                   FQPA SF = 1X........   day.                 liver weights, increased
                                                                               centrilobular hepatocyte lipid in
                                                                               the liver, and increases in
                                                                               alkaline phosphatase, albumin,
                                                                               and triglycerides), increased
                                                                               adrenal cortical vacuolation of
                                                                               the zona fasciculata, and marked
                                                                               hemosiderin pigmentation in the
                                                                               liver and spleen in both sexes;
                                                                               mild anemia (characterized by
                                                                               decreased hemoglobin, hematocrit,
                                                                               and red blood cell count) in the
                                                                               males; and initial body weight
                                                                               losses, decreased cumulative body-
                                                                               weight gains, and increased
                                                                               adrenal weights in the females.
----------------------------------------------------------------------------------------------------------------
Dermal short-term (1 to 30 days).  Dermal (or oral)      LOC for MOE = <100   Developmental toxicity--rabbit.
                                    study NOAEL = 7.5                         LOAEL = 15 mg/kg/day based on
                                    mg/kg/day (dermal                          decreased number of live fetuses,
                                    absorption factor =                        complete litter resorptions and
                                    15%                                        increased post-implantation loss.
                                   UFA = 10X...........
                                   UFH = 10X...........
                                   FQPA SF = 1X........
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhala-               Classification: ``Not likely to be Carcinogenic to Humans''
 tion).                                        based on the carcinogenicity studies in rats and mice.
----------------------------------------------------------------------------------------------------------------
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).


[[Page 8464]]

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to flutriafol, EPA considered exposure under the petitioned-
for tolerances as well as all existing flutriafol tolerances in 40 CFR 
180.629. EPA assessed dietary exposures from flutriafol 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 flutriafol. In estimating acute 
dietary exposure, EPA used food consumption information from the United 
States Department of Agriculture (USDA) National Health and Nutrition 
Examination Survey, What We Eat in America, (NHANES/WWEIA) conducted 
from 2003-2008. As to residue levels in food, EPA made the following 
assumptions for the acute exposure assessment: Tolerance-level residues 
or tolerance-level residues adjusted to account for the residues of 
concern (ROC) for risk assessment, and 100 percent crop treated (PCT). 
Since adequate processing studies have been submitted that indicate 
that residues do not concentrate as a result of processing at levels 
which would require a tolerance in or on apple juice (translated to 
pear juice), grape juice, dried prunes, and tomato puree, the Agency's 
2018 default processing factors for these commodities were reduced to 
1. In addition, the Agency used a processing factor of 1 for raisin and 
tomato paste since those existing tolerances already account for the 
concentration of residues during the processing of the RACs, i.e., 
grape and tomato, into those processed commodities. The default 
processing factors were retained for the remaining relevant 
commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA conducted from 2003-2008. As to residue levels in food, for the 
chronic analysis EPA assumed the same residue estimates as that used in 
the acute assessment excluding wheat, apple, and grape, where average 
field-trial residues were assumed and apple and grape where screening-
level usage analysis (SLUA) percent crop treated estimates were assumed 
(100 PCT assumed for the remaining crops). The chronic analysis also 
incorporated refinements to the livestock residue estimates through 
incorporation of median residues for selected commodities in 
calculation of the dietary burden estimates (100 PCT assumed) and 
through the incorporation of average residues from the feeding study. 
The Agency used the same processing factors for the chronic dietary 
assessment as it used for the acute assessment.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that flutriafol 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. Section 408 (b)(2)(E) 
of FFDCA authorizes EPA to use available data and information on the 
anticipated residue levels of pesticide residues in food and the actual 
levels of pesticide residues that have been measured in food. If EPA 
relies on such information, EPA must require pursuant to FFDCA section 
408(f)(1) that data be provided 5 years after the tolerance is 
established, modified, or left in effect, demonstrating that the levels 
in food are not above the levels anticipated. For the present action, 
EPA will issue such data call-ins as are required by FFDCA section 
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be 
required to be submitted no later than 5 years from the date of 
issuance of these 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 evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The acute analysis assumed 100 PCT for all commodities. For the 
chronic analysis, the Agency used PCT for the following uses: Apple 
15%; grape 5%; and raisin 1%.
    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 figure for each existing 
use is derived by combining available public and private market survey 
data for that use, averaging across all observations, and rounding up 
to the nearest 5%, except for those situations in which the average PCT 
is less than 1% or less than 2.5%. In those cases, the Agency would use 
less than 1% or less than 2.5% as the average PCT value, respectively. 
The maximum PCT figure is the highest observed maximum value reported 
within the most recent 10 years of available public and private market 
survey data for the existing use and rounded up to the nearest multiple 
of 5%, except where the maximum PCT is less than 2.5%, in which case, 
the Agency uses less than 2.5% as the maximum PCT.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which flutriafol may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for flutriafol in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of flutriafol.

[[Page 8465]]

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 First Index Reservoir Screening Tool (FIRST), 
Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM5-
VVWM) and Pesticide Root Zone Model Ground Water (PRZM GW), the 
estimated drinking water concentrations (EDWCs) of flutriafol for acute 
exposures are estimated to be 29.5 parts per billion (ppb) for surface 
water and 630 ppb for ground water. For chronic exposure assessments, 
the EDWCs are estimated to be 5.8 ppb for surface water and 540 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 630 ppb was used to assess 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 540 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).
    Flutriafol is currently registered for the following uses that 
could result in residential exposures: Golf course turf. EPA assessed 
residential exposure using the following assumptions: Residential 
handler exposure is not expected as result of the golf course use. 
There is the potential for post-application exposure for individuals 
exposed as a result of being in an environment that has been previously 
treated with flutriafol (i.e. golf courses). The quantitative exposure/
risk assessment for residential post-application exposures is based on 
the following scenario:
     Dermal exposures for children (6 to <11 years old), 
children (11 to <16 years old), and adults contacting residues 
deposited on turf resulting from broadcast golf course applications.
    These lifestages are not the only lifestages that could be 
potentially exposed for these post-application scenarios; however, the 
assessment of these lifestages are considered health protective for the 
exposures and risks for any other potentially exposed lifestages.
    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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to flutriafol and any other 
substances. Although the conazole fungicides (triazoles) produce 1,2,4 
triazole and its acid-conjugated metabolites (triazolylalanine and 
triazolylacetic acid), 1,2,4 triazole and its acid-conjugated 
metabolites do not contribute to the toxicity of the parent conazole 
fungicides (triazoles). The Agency has assessed the aggregate risks 
from the 1,2,4 triazole and its acid-conjugated metabolites 
(triazolylalanine and triazolylacetic acid) separately. The new uses of 
flutriafol are not expected to quantitatively alter the dietary 
exposure estimates used in the most recent aggregate risk assessment 
for the common triazole metabolites. The most recent triazole aggregate 
risk assessment (Common Triazole Metabolites: Updated Aggregate Human 
Health Risk Assessment to Address New Section 3 Registrations For Use 
of Difenoconazole and Mefentrifluconazole; DP451447, dated May 15, 
2019) can be found at https://www.regulations.gov at docket ID number 
EPA-HQ-OPP-2018-0002. Flutriafol does not appear to produce any other 
toxic metabolite produced by other substances. For the purposes of this 
action, therefore, EPA has not assumed that flutriafol has a common 
mechanism of toxicity with other substances.

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 evidence of 
increased quantitative and qualitative prenatal and postnatal 
susceptibility for flutriafol in rats. In the first of two rat 
developmental toxicity studies, developmental effects (delayed 
ossification or non-ossification of the skeleton in the fetuses) were 
observed at a lower dose than that where maternal effects were 
observed. In the second rat developmental study, developmental effects 
(external, visceral, and skeletal malformations; embryo lethality; 
skeletal variations; a generalized delay in fetal development; and 
fewer live fetuses) were more severe than the decreased food 
consumption and body-weight gains observed in the dams at the same 
dose. For rabbits, decreased number of live fetuses, complete litter 
resorptions and increased post-implantation loss were observed. Under 
current practices, these effects are considered both maternal and 
developmental effects, and it is unknown whether the effects occurred 
from toxicity to maternal animals or the fetuses. In the two-generation 
reproduction studies, effects in the offspring [decreased litter size 
and percentage of live births (increased pup mortality) and liver 
toxicity] was observed at the same dose as systemic toxicity in the 
parental animals (decreased body weight and food consumption and liver 
toxicity).
    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 flutriafol is complete.
    ii. There is no indication that flutriafol is a neurotoxic 
chemical, and there is no need for a developmental neurotoxicity study 
or additional uncertainty factors (UFs) to account for neurotoxicity. 
Signs of neurotoxicity were reported in the acute and subchronic 
neurotoxicity studies at the highest dose tested only. In the acute 
neurotoxicity study, these effects were primarily seen in animals that 
were agonal (at the point of death) and, thus, are not indicative of 
neurotoxicity. In addition, there was no evidence of neurotoxicity in 
any additional short-term or long-term toxicity studies in rats, mice, 
and dogs.
    iii. There are no concerns or residual uncertainties for prenatal 
and/or

[[Page 8466]]

postnatal toxicity. There is evidence of increased quantitative and 
qualitative susceptibility in developmental and reproduction toxicity 
studies; however, there concern is low based on the following:
     Clear NOAELs and LOAELs were established for effects in 
the fetuses/offspring.
     The dose-response for these effects are well defined and 
characterized.
     Developmental endpoints are used for assessing acute 
dietary risks to the most sensitive population (females 13 to 49) as 
well as all other short-term and intermediate-term exposure scenarios.
     The acute reference dose for females 13 to 49 is 1,000-
fold lower than the dose at which quantitative susceptibility in the 
first developmental rat study was observed.
     The chronic reference dose is greater than 300-fold lower 
than the doses at which the offspring effects were observed in the 2-
generation reproduction studies.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were somewhat refined 
in that the chronic analysis used some average field trial residue data 
as well as some percent crop treated information. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to flutriafol in drinking water. These assessments 
will not underestimate the exposure and risks posed by flutriafol.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. Using the exposure assumptions discussed in this unit 
for acute exposure, the acute dietary exposure from food and water to 
flutriafol will occupy 69% of the aPAD for females 13-49 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 
flutriafol from food and water will utilize 75% of the cPAD for all 
infants <1 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 
flutriafol 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). Flutriafol 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 flutriafol.
    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 380 for adults, 
500 for youth ages 11 to <16 years old, and 160 for children ages 6 to 
<11 years old. Because EPA's level of concern for flutriafol is an 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, 
flutriafol 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 
flutriafol.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, flutriafol 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 flutriafol residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology based on validation data were 
provided as part of the magnitude residues studies. In addition, the 
QuECHERS method has been shown to support and enforce the tolerance 
expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    There are no Codex MRLs established for residues of flutriafol in/
on the proposed commodities.

C. Revisions to Petitioned-For Tolerances

    Based on the analysis of available field trial data and the 
Organization for Economic Co-operation and Development (OECD) tolerance 
calculation procedure, EPA is establishing higher tolerance levels for 
residues in/on alfalfa forage and hay than what the petitioner proposed 
as it appears the petitioner averaged the residues from the two 
cuttings for both commodities. EPA used the higher residues of the two 
cuttings as this represents a worst-case scenario. Based on the 
increased dietary burden from new additional feed commodities (i.e., 
alfalfa forage and hay), EPA calculates that the established tolerances 
for residues of flutriafol in/on fat, liver, and meat byproducts, 
except liver of cattle,

[[Page 8467]]

goat, horse, and sheep; eggs; and fat and meat byproducts of poultry 
need to be increased to avoid adulteration of those commodities. In 
accordance with 40 CFR 180.6, EPA is increasing those tolerances in 
this rulemaking.
    EPA is not recommending tolerances for rice hulls or rice straw as 
these commodities are no longer considered to be significant feed items 
or for rice bran as it is lower than the rice, grain (RAC) tolerance. 
Finally, EPA is expressing tolerance values to be consistent with 
OECD's rounding class practice.

V. Conclusion

    Therefore, tolerances are established for residues of flutriafol, 
()[hyphen][alpha][hyphen](2[hyphen]fluorophenyl[hyphen][alpha][hyph
en](4[hyphen]fluorophenyl)[hyphen]1H[hyphen]1,2,4[hyphen]triazole[hyphen
]1[hyphen]ethanol), in or on alfalfa, forage at 20 parts per million 
(ppm); alfalfa, hay at 70 ppm; barley, grain at 1.5 ppm; barley, hay at 
7 ppm; barley, straw at 8 ppm; corn, sweet, forage at 9 ppm; corn, 
sweet kernels plus cobs with husks removed at 0.03 ppm; corn, sweet, 
stover at 8 ppm; rice, grain at 0.5 ppm. Based on the increased dietary 
burden from the new additional feed commodities, that agency is 
revising the following established tolerances of flutriafol in or on 
cattle, fat at 0.2 parts per million (ppm); cattle, liver at 1.5 ppm; 
cattle, meat byproducts, except liver at 0.08 ppm; egg at 0.02 ppm; 
goat, fat at 0.2 ppm; goat, liver at 1.5 ppm; goat, meat byproducts, 
except liver at 0.08 ppm; horse, fat at 0.2 ppm; horse, liver at 1.5 
ppm; horse, meat byproducts, except liver at 0.08 ppm; poultry, fat at 
0.02 ppm; poultry, meat byproducts at 0.02 ppm; sheep, fat at 0.2 ppm; 
sheep, liver at 1.5 ppm; sheep, meat byproducts, except liver at 0.08 
ppm. Also, this regulation removes established tolerances for 
inadvertent or indirect residues of flutriafol in corn, sweet, forage 
at 0.09 ppm; corn, sweet, kernels plus cobs with husks removed at 0.01 
ppm; and corn, sweet, stover at 0.07 ppm the entries for the tolerances 
contained in paragraph (d) of Sec.  180.629. These tolerances are 
superseded and no longer necessary with the establishment of the new 
tolerances for sweet corn commodities.

VI. Statutory and Executive Order Reviews

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

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: January 23, 2020.
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.  180.629:
0
a. In the table in paragraph (a):
0
i. Add alphabetically the entries for ``Alfalfa, forage''; ``Alfalfa, 
hay''; ``Barley, grain''; ``Barley, hay''; and ``Barley, straw'';
0
ii. Revise the entries for ``Cattle, fat''; ``Cattle, liver''; and 
``Cattle, meat byproducts, except liver'';
0
iii. Add alphabetically the entries for ``Corn, sweet, forage''; 
``Corn, sweet, kernel plus cob with husk removed''; and ``Corn, sweet, 
stover''; and
0
iv. Revise the entries for ``Egg''; ``Goat, fat''; ``Goat, liver''; 
``Goat, meat byproducts, except liver''; ``Horse, fat''; ``Horse, 
liver''; ``Horse, meat byproducts, except liver''; ``Poultry, fat''; 
``Poultry, meat byproducts''; ``Sheep, fat''; ``Sheep, liver''; and 
``Sheep, meat byproducts, except liver''; and
0
b. In paragraph (d):
0
i. In the introductory text, remove ``table below'' and ``specified 
below'' and add in their places ``table 2 to this paragraph (d)'' and 
``specified in table 2 to this paragraph (d),'' respectively; and
0
ii. Revise the table.
    The revisions and additions read as follows:

[[Page 8468]]

Sec.  180.629  Flutriafol; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Alfalfa, forage.............................................          20
Alfalfa, hay................................................          70
 
                                * * * * *
Barley, grain...............................................         1.5
Barley, hay.................................................           7
Barley, straw...............................................           8
 
                                * * * * *
Cattle, fat.................................................         0.2
Cattle, liver...............................................         1.5
Cattle, meat byproducts, except liver.......................        0.08
 
                                * * * * *
Corn, sweet, forage.........................................           9
Corn, sweet, kernel plus cob with husk removed..............        0.03
Corn, sweet, stover.........................................           8
 
                                * * * * *
Egg.........................................................        0.02
 
                                * * * * *
Goat, fat...................................................         0.2
Goat, liver.................................................         1.5
Goat, meat byproducts, except liver.........................        0.08
 
                                * * * * *
Horse, fat..................................................         0.2
Horse, liver................................................         1.5
Horse, meat byproducts, except liver........................        0.08
 
                                * * * * *
Poultry, fat................................................        0.02
Poultry, meat byproducts....................................        0.02
 
                                * * * * *
Sheep, fat..................................................         0.2
Sheep, liver................................................         1.5
Sheep, meat byproducts, except liver........................        0.08
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (d) * * *

                        Table 2 to Paragraph (d)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Rice, grain.................................................         0.5
------------------------------------------------------------------------

[FR Doc. 2020-02035 Filed 2-13-20; 8:45 am]
 BILLING CODE 6560-50-P