[Federal Register Volume 84, Number 125 (Friday, June 28, 2019)]
[Rules and Regulations]
[Pages 30939-30946]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13520]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0002; FRL-9994-51]


Mefentrifluconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

DATES: This regulation is effective June 28, 2019. Objections and 
requests for hearings must be received on or before August 27, 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-2018-0002, 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-2018-0002 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 27, 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-2018-0002, 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 May 18, 2018 (83 FR 23247) (FRL-9976-
87), 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 
7F8612) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research 
Triangle Park, North Carolina 27709-3528. The petition requested to 
establish tolerances in 40 CFR part 180 for residues of the fungicide 
mefentrifluconazole (BAS 750 F); 2-[4-(4-chlorophenoxy)-2-
(trifluoromethyl)phenyl]-1-(1H-1,2,4-triazole-1-yl)propan-2-ol] in or 
on the following raw agricultural commodities: almond, hulls at 4 parts 
per million (ppm); barley, hay at 15 ppm; barley, straw at 30 ppm; 
cattle, fat at 0.3 ppm;

[[Page 30940]]

cattle, kidney at 0.2 ppm; cattle, liver at 0.5 ppm; cattle, meat at 
0.09 ppm; cattle, muscle at 0.04 ppm; cereal grains crop group 15, 
except wheat and corn at 3 ppm; cherry subgroup 12-12A at 4 ppm; 
citrus, oil at 30 ppm; corn, aspirated grain fractions at 0.3 ppm; 
corn, field, grain at 0.01 ppm; corn, field, stover at 9 ppm; corn, 
sweet, forage at 6 ppm; corn, sweet, grain at 0.02 ppm; corn, sweet, 
stover at 6 ppm; foliage of legume vegetables, except soybean, crop 
subgroup 7A at 20 ppm; forages of cereal grains, crop group 16 at 4 
ppm; goat, fat at 0.3 ppm; goat, kidney at 0.2 ppm; goat, liver at 0.5 
ppm; goat, meat at 0.09 ppm; goat, muscle at 0.04 ppm; grape, raisin at 
4 ppm; grapefruit subgroup 10-10C at 1 ppm; horse, fat at 0.3 ppm; 
horse, kidney at 0.2 ppm; horse, liver at 0.5 ppm; horse, meat at 0.09 
ppm; horse, muscle at 0.04 ppm; legume vegetables (succulent or dried) 
crop group 6, except lentil at 0.1 ppm; lemon/lime subgroup 10-10B at 2 
ppm; lentil, dry at 2 ppm; milk at 0.03 ppm; orange subgroup 10-10A at 
1 ppm; peach subgroup 12-12B at 2 ppm; peanut at 0.01 ppm; peanut, hay 
at 30 ppm; plum prune, fresh at 4 ppm; plum subgroup 12-12C at 2 ppm; 
pome fruit crop group 11-10 at 1.5 ppm; poultry, eggs at 0.01 ppm; 
poultry, fat at 0.01 ppm; poultry, liver at 0.01 ppm; poultry, meat at 
0.01 ppm; poultry, muscle at 0.01 ppm; poultry, skin at 0.01 ppm; 
rapeseed subgroup 20A at 1 ppm; rice, straw at 9 ppm; sheep, fat at 0.3 
ppm; sheep, kidney at 0.2 ppm; sheep, liver at 0.5 ppm; sheep, meat at 
0.09 ppm; sheep, muscle at 0.04 ppm; small fruit vine climbing, except 
fuzzy kiwifruit subgroup 13-07F at 1.5 ppm; sorghum, stover at 9 ppm; 
soybean, aspirated grain fractions at 5 ppm; soybean, forage at 4 ppm; 
soybean, hay at 15 ppm; soybean, seed at 0.3 ppm; sugar beet at 0.6 
ppm; sugar beet, top at 9 ppm; swine, fat at 0.01 ppm; swine, liver at 
0.01 ppm; swine, meat at 0.01 ppm; swine, skin at 0.01 ppm; tree nut 
crop group 14-12 at 0.06 ppm; tuberous and corm vegetables subgroup 1C 
at 0.02 ppm; wheat, aspirated grain fractions at 20 ppm; wheat, grain 
at 0.4 ppm; wheat, hay at 8 ppm; and wheat, straw at 30 ppm. That 
document referenced a summary of the petition prepared by BASF, the 
registrant, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing; 
however, they were not related to mefentrifluconazole.
    Following revisions to that petition, EPA published another notice 
of filing, which supersedes the May 18, 2018 document. That document 
was published in the Federal Register of March 18, 2019 (84 FR 9735) 
(FRL-9989-90). The tolerances requested were the same, except for the 
following: (1) The new petition sought two new tolerances, one for 
residues on corn, pop, grain at 0.01 ppm and one for residues on grain, 
cereal, forage, fodder, and straw, group 16, stover at 9 ppm; and (2) 
the new petition dropped the request for the separate stover tolerances 
for corn, field, stover at 9 ppm; corn, sweet, stover at 6 ppm; and 
sorghum, stover at 9 ppm, as those would be subsumed in the group 16, 
stover tolerance. The amended summary of the petition prepared by BASF, 
the registrant, and referenced in that document, is available in the 
docket, http://www.regulations.gov. Comments were received on the 
notice of filing; however, they were not related to 
mefentrifluconazole.
    Based upon review of the data supporting the petition and under its 
authority in FFDCA section 408(d)(4)(A)(i), EPA is establishing 
tolerances that vary slightly from what the petitioner sought. The 
reason for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for mefentrifluconazole including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with 
mefentrifluconazole follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    The liver was the most consistent target organ across species, with 
mice being the most sensitive species. Following subchronic and chronic 
exposures, increased absolute and relative liver weights, and 
histopathological liver findings (subchronic: hypertrophy, cytoplasmic 
alteration, and necrosis in males; fatty change in females; chronic: 
diffuse and macrovesicular fatty changes) were observed in both sexes. 
Decreased cholesterol was also observed in the mouse subchronic 
toxicity studies (cholesterol was not measured in the mouse 
carcinogenicity study). Following oral exposures to rats, there were 
effects on liver function as evidenced by increased alkaline 
phosphatase (ALP), gamma-glutamyl transferase (GGT), and cholesterol, 
increased absolute and relative liver weights, and histopathological 
findings (hepatocellular hypertrophy (subchronic and chronic), 
multifocal necrosis (females; subchronic)). In dogs, liver effects 
included increased ALP, increased liver weights, and histopathological 
findings in the liver (hepatocellular hypertrophy, eosinophilic change, 
and subcapsular fibrosis). In the 90-day oral toxicity study in dogs, 
males were more sensitive than females; however, in the 1-year toxicity 
study, effects were observed at the same dose for both sexes. The 
toxicity was also shown to progress, with greater increases in ALP 
along with fibrosis being observed in the chronic study. Other effects 
included increased white blood cell (WBC) counts in mice following 
subchronic exposures. In addition, increased adrenal gland weights were 
noted in male rats following subchronic exposures and in female rats, 
dogs, and mice following chronic exposures; however, corresponding 
histopathological findings (eosinophilic cytoplasmic change) were only 
noted in the adrenal glands of female mice in the carcinogenicity 
study. An in vitro human recombinant aromatase assay

[[Page 30941]]

conducted with mefentrifluconazole indicates that it has the potential 
to interact with the aromatase enzyme.
    There was no evidence of increased quantitative or qualitative 
fetal susceptibility in the developmental toxicity studies in rats and 
rabbits or offspring susceptibility in the two-generation reproduction 
toxicity studies in rats. In the developmental toxicity study in rats, 
fetal effects (increased placental weight, decreased fetal weight, 
increased incidence of dilated renal pelvis) occurred at the same dose 
as maternal effects (increased placental weight). In the developmental 
toxicity study in rabbits, no maternal or developmental effects were 
seen up to the highest dose tested (25 mg/kg/day); 50 mg/kg/day was 
established as the maximum tolerable dose (MTD) for non-pregnant female 
rabbits in the range-finding studies. In the two-generation 
reproduction study in rats; offspring effects (decreased pup body 
weight, increased total litter loss and litters containing pup death 
during post-natal day (PND) 1-4, and increased incidence of dilated 
renal pelvis) occurred at the same dose as those eliciting parental 
toxicity (changes in clinical chemistry parameters (increased ALP, GGT, 
triglycerides, cholesterol), increased relative liver weights, 
histopathological findings in the liver, and increased total litter 
loss and litters containing pup death during PND 1-4). Reproductive 
toxicity (decreased implantation sites per dam in the F1 generation 
maternal animals) was observed at the same dose causing parental and 
offspring effects.
    In the acute neurotoxicity study in rats, unsteady gait, increased 
foot splay, and decreased motor activity were observed at 2,000 mg/kg 
(no-observed-adverse-effect-level (NOAEL) = 600 mg/kg) for both sexes. 
However, there is no other evidence of neurotoxicity in the database. 
In addition, there were no treatment-related histopathological findings 
in the central or peripheral nervous system in the toxicological 
database.
    Mefentrifluconazole was categorized as having low acute toxicity 
via the oral, dermal, and inhalation routes (Toxicity Categories III-
IV). It is a not an eye or skin irritant (Toxicity Category IV), but it 
is a dermal sensitizer.
    M750F022 is a metabolite that was identified as a residue of 
concern in the livestock metabolism studies and has a hydroxyl group 
instead of the triazole ring as a result of cleavage. In the available 
rat metabolism data, M750F022 was not found at significant amounts; 
however, it is a proposed intermediate for several metabolites that 
were observed in the study. Additional toxicological studies were 
performed, which demonstrated that M750F022 was of low acute toxicity 
by the oral route in rats. There was no genotoxic concern identified in 
three in vitro genotoxicity assays. In a 28-day oral toxicity study in 
mice, the liver was identified as the target organ. M750F022 showed 
considerably lower potential for aromatase inhibition than the parent, 
mefentrifluconazole, in an in vitro aromatase inhibition assay. Based 
on these studies, M750F022 is not considered to be a greater 
toxicological concern than mefentrifluconazole.
    Specific information on the studies received and the nature of the 
adverse effects caused by mefentrifluconazole as well as the NOAEL and 
the lowest-observed-adverse-effect-level (LOAEL) from the toxicity 
studies can be found at http://www.regulations.gov in the document 
titled ``Mefentrifluconazole. Human Health Risk Assessment for the 
Section 3 Registration Action of the New Active Ingredient on Non-
Residential Turf, Sod Farms, Ornamentals, Commercial and On-Farm Seed 
Treatment; and Pome Fruit, Crop Group 11-10; Stone Fruit, Crop Group 
12-12; Tree Nuts, Crop Group 14-12; Cereal Grains, Crop Group 15; 
Legume Vegetables, Crop Group 6; Foliage of Legume Vegetables, Crop 
Group 7; Citrus Fruit, Crop Group 10-10; Small Fruit Vine Climbing, 
Except Fuzzy Kiwifruit Subgroup 13-07F; Soybeans; Peanuts; Sugar Beet; 
Rapeseed Subgroup 20A; and Tuberous and Corm Vegetables Subgroup 1C'' 
on pages 50-57 in docket ID number EPA-HQ-OPP-2018-0002.

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 mefentrifluconazole 
used for human risk assessment is shown in the Table of this unit.

    Table--Summary of Toxicological Doses and Endpoints for Mefentrifluconazole for Use in Human Health Risk
                                                   Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-50       NOAEL = 73 mg/kg/day  Acute RfD = 0.73 mg/ Two-Generation Reproduction
 years of age).                    UFA = 10X...........   kg/day.              Toxicity Study.
                                   UFH = 10X...........  aPAD = 0.73 mg/kg/   LOAEL = 194 mg/kg/day based on
                                   FQPA SF = 1X........   day.                 decreased implantations per dam.
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Acute dietary (General population  No appropriate toxicological effect attributable to a single dose was
 including infants and children).   observed. Therefore, a dose and endpoint were not identified for this risk
                                    assessment.
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr

[[Page 30942]]

 
Chronic dietary (All populations)  NOAEL= 3.5 mg/kg/day  Chronic RfD = 0.035  Mouse Carcinogenicity Study.
                                   UFA = 10X...........   mg/kg/day.          LOAEL = 9.1 mg/kg/day based on
                                   UFH = 10X...........  cPAD = 0.035 mg/kg/   increased liver weights and
                                   FQPA SF = 1X........   day.                 histopathological findings in the
                                                                               liver (both sexes).
Incidental/Adult oral short-term   NOAEL = 11 mg/kg/day  LOC for MOE = 100..  Subchronic Toxicity--Mouse.
 (1-30 days).                      UFA = 10X...........                       LOAEL = 58 mg/kg/day increased
                                   UFH = 10X...........                        total white blood cell (WBC)
                                   FQPA SF = 1X........                        counts, decreased cholesterol
                                                                               levels, increased absolute and
                                                                               relative liver weights, and
                                                                               histopathological liver findings.
Dermal short-term (1 to 30 days)   Oral study NOAEL =    LOC for MOE = 100..  Subchronic Toxicity--Mouse.
 and intermediate-term (1-6         11 mg/kg/day                              LOAEL = 58 mg/kg/day increased
 months).                           (dermal absorption                         total WBC counts, decreased
                                    factor = 15.6%).                           cholesterol levels, and
                                   UFA = 10X...........                        histopathological liver findings.
                                   UFH = 10X...........
                                   FQPA SF = 1X........
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Cancer (Oral, dermal, inhalation)  Classification: ``Not likely to be Carcinogenic to Humans'' based on the
                                    absence of treatment-related tumors in two adequate rodent carcinogenicity
                                    studies.
----------------------------------------------------------------------------------------------------------------
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 mefentrifluconazole, EPA considered exposure under the 
petitioned-for tolerances. EPA assessed dietary exposures from 
mefentrifluconazole in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for 
the general population for mefentrifluconazole; therefore, a 
quantitative acute dietary exposure assessment for the general 
population is unnecessary.
    However, such effects were identified for mefentrifluconazole for 
females 13 to 49 years old. In estimating acute dietary exposure, EPA 
used 2003-2008 food consumption information from the U.S. Department of 
Agriculture's National Health and Nutrition Examination Survey, What We 
Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA 
conducted an unrefined acute dietary exposure and risk assessment 
assuming 100 percent crop treated (PCT), default processing factors, 
and tolerance-level residues for all food commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used 2003-2008 food consumption data from the USDA's 
NHANES/WWEIA. As to residue levels in food, EPA conducted a partially 
refined chronic dietary exposure and risk assessment assuming 100 PCT, 
empirical processing factors (when available), and average field-trial 
residues for some commodities.
    iii. Cancer. A cancer dietary exposure and risk assessment was not 
conducted for mefentrifluconazole as it was classified as ``Not likely 
to be Carcinogenic to Humans'' based on the absence of treatment-
related tumors in two adequate rodent carcinogenicity studies.
    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.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for mefentrifluconazole in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of mefentrifluconazole. Further information 
regarding EPA drinking water models used in pesticide exposure 
assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide in Water Calculator (PWC), the estimated 
drinking water concentrations (EDWCs) of mefentrifluconazole for acute 
exposures are estimated to be 42.3 parts per billion (ppb) for surface 
water and 30.3 ppb for ground water, and for chronic exposures are 
estimated to be 18.4 ppb for surface water and 5.1 ppb for ground 
water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the acute dietary risk 
assessment, the water concentration value of 42.3 ppb was used to 
assess the contribution to drinking water and for the chronic dietary 
risk assessment, the water concentration of value 18.4 ppb was used to 
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in

[[Page 30943]]

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).
    Mefentrifluconazole is proposed to be registered for the following 
uses that could result in residential exposures: non-residential turf 
(i.e., golf courses). EPA assessed residential exposure using the 
following assumptions: Residential handler exposures are not 
anticipated based on the proposed use sites and therefore have not been 
quantitatively assessed. 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 mefentrifluconazole. Short-term 
dermal exposures were assessed for adults, youth 11 to less than 16 
years old, and children 6 to less than 11 years old.
    The residential exposure scenario used in both the adult aggregate 
assessment and the children 6 to <11 years old aggregate assessment is 
from post-application dermal exposure after applications to golf 
courses from golfing activities. These scenarios for aggregation, 
adults and children (6 to <11 years old), represent the worst-case risk 
estimates and are protective of all other lifestages and exposure 
scenarios.
    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 mefentrifluconazole and 
any other substances; the Agency's previous statements regarding the 
potential for a common mechanism among the conazoles noted that the 
underlying data available at the time were inconclusive. 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 supporting risk assessment concludes that aggregate 
risks are below the Agency's level of concern and can be found at 
http://www.regulations.gov in the document titled ``Common Triazole 
Metabolites: Updated Aggregate Human Health Risk Assessment to Address 
New Section 3 Registrations For Use of Difenoconazole and 
Mefentrifluconazole'' in docket ID number EPA-HQ-OPP-2018-0002. 
Mefentrifluconazole 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 mefentrifluconazole 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 was no evidence of 
increased quantitative or qualitative fetal susceptibility in the 
developmental toxicity studies in rats and rabbits or offspring 
susceptibility in the two-generation reproduction toxicity studies in 
rats.
    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 existing toxicological database for mefentrifluconazole is 
adequate for FQPA evaluation. Developmental toxicity studies in rats 
and rabbits as well as a two-generation reproduction study in rats are 
available for FQPA consideration. The Agency has determined, using a 
weight-of-evidence approach, that the subchronic neurotoxicity, 
subchronic inhalation toxicity, and immunotoxicity studies are not 
required at this time.
    ii. In the acute neurotoxicity study in rats, unsteady gait, 
increased foot splay, and decreased motor activity were considered 
adverse at 2,000 mg/kg (NOAEL = 600 mg/kg). However, concern is low 
since the effects are characterized by clear NOAEL and LOAEL values, 
there is no other evidence of neurotoxicity in the database, there were 
no corroborating histopathological findings in the central or 
peripheral nervous system, and the effects were seen at a dose that is 
not considered relevant for human health risk assessment.
    iii. There is no evidence that mefentrifluconazole results in 
increased susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the two-generation 
reproduction study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary assessment is based on high-end assumptions, 
assuming 100 PCT, and average field trial residues. EPA made 
conservative (protective) assumptions in the ground and surface water 
modeling used to assess exposure to mefentrifluconazole in drinking 
water. EPA used similarly conservative assumptions to assess post-
application exposure of children. These assessments will not 
underestimate the exposure and risks posed by mefentrifluconazole.

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 mefentrifluconazole will occupy 2.2% of the aPAD for females 13 to 
49 years old, the only population group of concern.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
mefentrifluconazole from food and water will utilize 19% of the cPAD 
for

[[Page 30944]]

children 1 to 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 
mefentrifluconazole 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).
    Mefentrifluconazole 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 
mefentrifluconazole.
    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 2,600 for adults 
and 1,900 for children 6 to less than 11 years old. Because EPA's level 
of concern for mefentrifluconazole 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, 
mefentrifluconazole 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 mefentrifluconazole.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, mefentrifluconazole 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 mefentrifluconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The registrant, BASF, has proposed a Quick Easy Cheap Effective 
Rugged and Safe (QuEChERS) multi-residue method (BASF method L0295/01) 
for the determination of mefentrifluconazole residues in plant 
matrices. BASF Analytical Method No. L0272/01 is proposed as the 
enforcement method for the determination of residues of 
mefentrifluconazole in livestock commodities by liquid chromatography 
coupled with tandem mass spectrometry (LC-MS/MS).
    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 may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established any MRLs for mefentrifluconazole.

C. Revisions to Petitioned-For Tolerances

    Under FFDCA section 408(d)(4)(A)(i), EPA may establish tolerances 
that vary from those sought by the petition. For consistency in 
nomenclature, EPA has used the Agency's preferred commodity terms for 
the commodities for which tolerances were requested. In addition, the 
levels at which several tolerances are being established vary from the 
original petition due to differences in how tolerance values were 
calculated. Finally, EPA is establishing tolerances for processed 
commodities where residues concentrate in commodities for which 
tolerances are being established. A summary and rationale behind these 
modifications can be found at http://www.regulations.gov in the 
document titled ``Mefentrifluconazole. Human Health Risk Assessment for 
the Section 3 Registration Action of the New Active Ingredient on Non-
Residential Turf, Sod Farms, Ornamentals, Commercial and On-Farm Seed 
Treatment; and Pome Fruit, Crop Group 11-10; Stone Fruit, Crop Group 
12-12; Tree Nuts, Crop Group 14-12; Cereal Grains, Crop Group 15; 
Legume Vegetables, Crop Group 6; Foliage of Legume Vegetables, Crop 
Group 7; Citrus Fruit, Crop Group 10-10; Small Fruit Vine Climbing, 
Except Fuzzy Kiwifruit Subgroup 13-07F; Soybeans; Peanuts; Sugar Beet; 
Rapeseed Subgroup 20A; and Tuberous and Corm Vegetables Subgroup 1C'' 
on pages 10-13 in docket ID number EPA-HQ-OPP-2018-0002.

V. Conclusion

    Therefore, tolerances are established for residues of 
mefentrifluconazole, including its metabolites and degradates, in or on 
Almond, hulls at 4 ppm; Beet, sugar, dried pulp at 2 ppm; Beet, sugar, 
leaves at 9 ppm; Beet, sugar, roots at 0.6 ppm; Cattle, fat at 0.2 ppm; 
Cattle, meat at 0.03 ppm; Cattle, meat byproducts at 0.3 ppm; Cherry 
subgroup 12-12A at 4 ppm; Corn, field, grain at 0.01 ppm; Corn, milled 
byproducts at 0.03 ppm; Corn, pop, grain at 0.01 ppm; Corn, sweet, 
kernel plus cob with husks removed at 0.03 ppm; Egg at 0.01 ppm; Fruit, 
citrus, group 10-10, dried pulp at 2 ppm; Fruit, citrus, group 10-10, 
oil at 15 ppm; Fruit, pome, group 11-10 at 1.5 ppm; Fruit, small, vine 
climbing, except fuzzy kiwifruit, subgroup 13-07F at 1.5 ppm; Goat, fat 
at 0.2 ppm; Goat, meat at 0.03 ppm; Goat, meat byproducts at 0.3 ppm; 
Grain, aspirated grain fractions at 6 ppm; Grain, cereal, forage, 
fodder, and straw, group 16, forage at 6 ppm; Grain, cereal, forage, 
fodder, and straw, group 16, hay at 15 ppm; Grain, cereal, forage, 
fodder, and straw, group 16, stover at 9 ppm; Grain, cereal, forage, 
fodder, and straw, group 16, straw at 30 ppm; Grain, cereal, group 15, 
except wheat and corn at 4 ppm; Grape, raisin at 4 ppm; Grapefruit 
subgroup 10-10C at 0.5 ppm; Hog, fat at 0.015 ppm; Hog, meat at 0.01 
ppm; Hog, meat byproducts at 0.03 ppm; Horse, fat at 0.2 ppm; Horse, 
meat at 0.03 ppm; Horse, meat byproducts at 0.3 ppm; Lemon/lime 
subgroup 10-10B at 1 ppm; Lentil, dry, seed at 2 ppm; Milk at 0.03 ppm; 
Milk, fat at 0.8 ppm; Nut, tree, group 14-12 at 0.06 ppm; Orange 
subgroup 10-10A at 0.6 ppm; Peach subgroup 12-12B at 1.5 ppm; Peanut at 
0.01 ppm; Peanut, hay at 30 ppm; Plum prune, dried at 4 ppm; Plum 
subgroup 12-12C at 2 ppm; Poultry, fat at 0.015 ppm; Poultry, meat at 
0.01

[[Page 30945]]

ppm; Poultry, meat byproducts at 0.01 ppm; Rapeseed subgroup 20A at 1 
ppm; Sheep, fat at 0.2 ppm; Sheep, meat at 0.03 ppm; Sheep, meat 
byproducts at 0.3 ppm; Soybean, seed at 0.4 ppm; Vegetable, foliage of 
legume, group 7 at 20 ppm; Vegetable, legume, group 6, except lentil 
and soybean seed at 0.15 ppm; Vegetable, tuberous and corm, subgroup 1C 
at 0.04 ppm; and Wheat, grain at 0.3 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997), 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 19, 2019.
Richard Keigwin,
Director, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Add Sec.  180.705 to subpart C to read as follows:


Sec.  180.705   Mefentrifluconazole; tolerances for residues.

    (a) General. Tolerances are established for residues of 
mefentrifluconazole, including its metabolites and degradates, in or on 
the commodities in the table below. Compliance with the tolerance 
levels specified below is to be determined by measuring only 
mefentrifluconazole, [alpha]-[4-(4-chlorophenoxy)-2-
(trifluoromethyl)phenyl]-[alpha]-methyl-1H-1,2,4-triazole-1-ethanol, in 
or on the commodity.

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................           4
Beet, sugar, dried pulp.....................................           2
Beet, sugar, leaves.........................................           9
Beet, sugar, roots..........................................         0.6
Cattle, fat.................................................         0.2
Cattle, meat................................................        0.03
Cattle, meat byproducts.....................................         0.3
Cherry subgroup 12-12A......................................           4
Corn, field, grain..........................................        0.01
Corn, milled byproducts.....................................        0.03
Corn, pop, grain............................................        0.01
Corn, sweet, kernel plus cob with husks removed.............        0.03
Egg.........................................................        0.01
Fruit, citrus, group 10-10, dried pulp......................           2
Fruit, citrus, group 10-10, oil.............................          15
Fruit, pome, group 11-10....................................         1.5
Fruit, small, vine climbing, except fuzzy kiwifruit,                 1.5
 subgroup 13-07F............................................
Goat, fat...................................................         0.2
Goat, meat..................................................        0.03
Goat, meat byproducts.......................................         0.3
Grain, aspirated grain fractions............................           6
Grain, cereal, forage, fodder, and straw, group 16, forage..           6
Grain, cereal, forage, fodder, and straw, group 16, hay.....          15
Grain, cereal, forage, fodder, and straw, group 16, stover..           9
Grain, cereal, forage, fodder, and straw, group 16, straw...          30
Grain, cereal, group 15, except wheat and corn..............           4
Grape, raisin...............................................           4
Grapefruit subgroup 10-10C..................................         0.5
Hog, fat....................................................       0.015
Hog, meat...................................................        0.01
Hog, meat byproducts........................................        0.03
Horse, fat..................................................         0.2
Horse, meat.................................................        0.03
Horse, meat byproducts......................................         0.3
Lemon/lime subgroup 10-10B..................................           1
Lentil, dry, seed...........................................           2
Milk........................................................        0.03
Milk, fat...................................................         0.8
Nut, tree, group 14-12......................................        0.06
Orange subgroup 10-10A......................................         0.6
Peach subgroup 12-12B.......................................         1.5
Peanut......................................................        0.01
Peanut, hay.................................................          30
Plum prune, dried...........................................           4
Plum subgroup 12-12C........................................           2
Poultry, fat................................................       0.015
Poultry, meat...............................................        0.01
Poultry, meat byproducts....................................        0.01
Rapeseed subgroup 20A.......................................           1
Sheep, fat..................................................         0.2
Sheep, meat.................................................        0.03
Sheep, meat byproducts......................................         0.3
Soybean, seed...............................................         0.4
Vegetable, foliage of legume, group 7.......................          20
Vegetable, legume, group 6, except lentil and soybean seed..        0.15

[[Page 30946]]

 
Vegetable, tuberous and corm, subgroup 1C...................        0.04
Wheat, grain................................................         0.3
------------------------------------------------------------------------

    (b) [Reserved]
    (c) [Reserved]
    (d) [Reserved]

[FR Doc. 2019-13520 Filed 6-27-19; 8:45 am]
 BILLING CODE 6560-50-P


