[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
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Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
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Acute dietary (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.
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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.
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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.
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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