[Federal Register Volume 77, Number 153 (Wednesday, August 8, 2012)]
[Rules and Regulations]
[Pages 47296-47302]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-19317]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2010-0875; FRL-9348-8]
Flutriafol; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes and amends tolerances for residues
of Flutriafol [(()-[alpha]-(2-fluorophenyl)-[alpha]-(4-
fluorophenyl)-1H-1,2,4-triazole-1-ethanol], including its metabolites
and degradates in or on multiple commodities which are identified and
discussed later in this document. Cheminova A/S, c/o Cheminova, Inc.
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective August 8, 2012. Objections and
requests for hearings must be received on or before October 9, 2012,
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-2010-0875, is available either
electronically through http://www.regulations.gov or in hard copy at
the OPP Docket in the Environmental Protection Agency Docket Center
(EPA/DC), located in EPA West, 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: Tamue L. Gibson, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-9096; 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.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/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-2010-0875 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
October 9, 2012. 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 that does not contain any 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 a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2010-0875, 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 Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), Mail Code: 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.htm. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.
[[Page 47297]]
II. Summary of Petitioned-for Tolerance
In the Federal Register of December 15, 2010 (75 FR 78240) (FRL-
8853-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
0F7771) by Cheminova A/S, c/o Cheminova, Inc. 1600 Wilson Blvd.,
Arlington, VA 22209. The petition requested that 40 CFR part 180 be
amended by establishing tolerances for residues of the fungicide
flutriafol, including its metabolites and degradates, in or on corn,
field, forage at 4.0 ppm; corn, field, stover at 6.0 ppm; corn, field,
grain at 0.01 ppm; corn, field, flour at 0.03 ppm; corn, field, oil at
0.07 ppm; corn, field, meal at 0.03 ppm; corn, pop, stover at 6.0 ppm;
corn, pop, grain at 0.01 ppm; grape at 1.1 ppm; grape, raisin at 2.5
ppm; peanut at 0.08 ppm; peanut, hay at 18 ppm; fruit, pome (Crop Group
11) at 0.60 ppm; fruit, stone (Crop Group 12) at 0.80 ppm; beet, sugar,
root at 1.5 ppm; beet, sugar, tops at 2.5 ppm; beet, sugar, refined at
0.70 ppm; beet, sugar, molasses at 1.0 ppm; beet, sugar, dried pulp at
1.0 ppm; wheat, forage at 25 ppm; wheat, hay at 9.0 ppm; wheat, straw
at 6.0 ppm; wheat, grain at 0.15 ppm; wheat, grain, bran at 0.20 ppm;
wheat, grain, germ at 0.20 ppm; barley, hay at 9.0 ppm; barley, straw
at 6.0 ppm; barley, grain at 0.15 ppm; barley, grain, bran at 0.20 ppm;
buckwheat, grain at 0.15 ppm; oats, forage at 25 ppm; oats, hay at 9.0
ppm; oats, straw at 6.0 ppm; oats, grain at 0.15 ppm; oats, grain, bran
at 0.20 ppm; rye, forage at 25 ppm; rye, straw at 6.0 ppm; rye, grain
at 0.15 ppm; cattle, liver at 0.12 ppm; goat, liver at 0.12 ppm; horse,
liver at 0.12 ppm; sheep, liver at 0.12 ppm; and milk at 0.02 ppm. The
proposed tolerance for fruit, pome which is based on new field trial
data for pears and previously submitted data for apples, will replace
the current tolerance for apples at 0.20 ppm. That notice referenced a
summary of the petition prepared by Cheminova A/S, c/o Cheminova, Inc,
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, tolerances
for corn, field, forage; corn, field, stover; corn, field, refined oil;
and corn, pop, stover were lowered. Tolerances for corn, field, flour
and corn, field, meal were not required. Established tolerances for
apple; cattle, liver; goat, liver; hog, liver; horse, liver; and sheep,
liver and established rotational crop tolerances for corn, field,
forage; corn, field, stover; corn, field, grain; corn, field, refined
oil; corn, pop; and corn, pop, stover are removed. The proposed
tolerances for wheat, forage; wheat, hay; wheat, straw; wheat, grain;
wheat, grain, bran; wheat, grain, germ; barley, hay; barley, straw;
barley, grain; barley, grain, bran; buckwheat, grain; oat, forage; oat,
hay; oat, straw; oat, grain; oat, grain, bran; rye, forage; rye, straw;
and rye, grain were withdrawn by the petitioner. Tolerances were
previously established on November 9, 2011 for banana, grape, raisin;
pome and stone fruit, sugar beets and for the rotational corn crops--
sweet, field, and popcorn, and cotton. The reasons 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 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. Flutriafol has high oral acute toxicity in the mouse. It has
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.
Short-term, subchronic, and chronic toxicity studies in rats, mice,
and dogs identified the liver as the primary target organ of
flutriafol. Hepatotoxicity was first evident in the subchronic studies
(rats and dogs) in the form of increases in liver enzyme release
(alkaline phosphatase), liver weights, and histopathology findings
ranging from hepatocyte vacuolization to centrilobular hypertrophy and
slight increases in hemosiderin-laden Kupffer cells. It is noteworthy
that with chronic exposures, there are no indications of progression of
liver toxicity in any of the species tested. After over 1 year of
exposure, hepatotoxicity in rats, dogs, and mice took the form of
minimal to severe fatty changes; bile duct proliferation/
cholangiolarfibrosis; hemosiderin accumulation in Kupffer cells;
centrilobular hypertrophy, and increases in alkaline phosphatase
release. Slight indications of effects in the hematopoietic system are
sporadically seen in the database. These effects were manifested in the
form of slight anemia (rats and dogs) and increased platelet, white
blood cell, neutrophil, and lymphocyte counts (mice). These effects,
however, were minimal in severity.
Flutriafol is considered to be ``Not likely to be Carcinogenic to
Humans'' based on the results of the carcinogenicity studies in rats
and mice. The results of the rat chronic toxicity/carcinogenicity study
and the mouse carcinogenicity study are negative for carcinogenicity.
All genotoxicity studies on flutriafol showed no evidence of
clastogenicity or mutagenicity.
Specific information on the studies received and the nature of the
adverse 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 ``Flutriafol: Human Health Risk
Assessment for Proposed Uses on Corn, Grapes, Peanuts, Pome Fruit (Crop
Group 11), Stone Fruit (Crop Group 12), Sugar Beets, Wheat, Barley,
Triticale, Buckwheat, Oats, Rye, Teosinte, and Imported Bananas,'' at
p. 40 in docket ID number EPA-HQ-OPP-2010-0875.
[[Page 47298]]
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://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for flutriafol used for
human risk assessment is shown in the following table.
Table--Summary of Toxicological Doses and Endpoints for Flutriafol for Use in Human Health Risk Assessment
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Point of departure and
Exposure/ Scenario uncertainty/Safety RfD, PAD, LOC for risk Study and toxicological
factors assessment effects
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Acute dietary (Females 13-49 years NOAEL = 7.5 mg/kg/day. Acute RfD = 0.075 mg/ Developmental study-rabbit
of age). UFA = 10x............. kg/day aPAD = 0.075 LOAEL = 15 mg/kg/day based
UFH = 10x............. mg/kg/day. on decreased number of
FQPA SF = 1x.......... live fetuses, complete
litter resorptions and
increased post-
implantation loss.
Acute dietary (General population NOAEL = 250 mg/kg/day. Acute RfD = 2.5 mg/kg/ Neurotoxicity screening
including infants and children). UFA = 10x............. day aPAD = 2.5 mg/kg/ battery-rat
UFH = 10x............. day. LOAEL = 750 mg/kg/day based
FQPA SF = 1x.......... on decreased body weight,
body-weight gain, absolute
and relative food
consumption, and clinical
signs of toxicity in both
sexes: Dehydration, urine-
stained abdominal fur,
ungroomed coat, ptosis,
decreased motor activity,
prostration, limp muscle
tone, muscle flaccidity,
hypothermia, hunched
posture, impaired or lost
righting reflex, scant
feces; in males: Red or
tan perioral substance,
chromodacryorrhea,
chromorhinorrhea and
labored breathing, and in
females: piloerection and
bradypnea.
Chronic dietary (All populations).. NOAEL= 5 mg/kg/day.... Chronic RfD = 0.05 mg/ Chronic toxicity-dog LOAEL
UFA = 10x............. kg/day cPAD = 0.05 mg/ = 20 mg/kg/day based on
UFH = 10x............. kg/day. adverse liver findings
FQPA SF = 1x.......... (increased 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.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation).. Classification: ``Not likely to be Carcinogenic to Humans'' based on the
carcinogenicity studies in rats and mice.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
of the human population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population-
adjusted dose (a = acute, c = chronic). RfD = reference dose. mg/kg/day = milligrams/kilogram/day.
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) 1994-1996 and 1998 Nationwide
[[Page 47299]]
Continuing Surveys of Food Intake by Individuals (CSFII). 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 for risk
assessment, 100 percent crop treated (PCT), and Dietary Exposure
Evaluation Model (DEEMTM) version 7.81 default processing
factors were used.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA made the following
assumptions for the chronic exposure assessment: tolerance-level
residues or tolerance-level residues adjusted to account for the
residues of concern for risk assessment, 100 PCT, and DEEMTM
version 7.81 default processing factors were used.
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. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for flutriafol. Tolerance level residues or tolerance-level residues
adjusted upward to account for the residues of concern for risk
assessment and 100 PCT were assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the flutriafol dietary exposure analysis
and risk assessment. These simulation models take into account data on
the physical, chemical, and fate/transport characteristics of
flutriafol. Further information regarding EPA drinking water models
used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the Food Quality Protection Act (FQPA) Food Index
Reservoir Screening Tool (FIRST), and Pesticide Root Zone Model/Ground
Water (PRZM/GW), the estimated drinking water concentrations (EDWCs) of
flutriafol for acute exposures are estimated to be 48.8 parts per
billion (ppb) for surface water and 310 ppb for ground water.
For chronic exposures for non-cancer assessments the EDWC's are
estimated to be 5.70 ppb for surface water and 202 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 310 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 not
registered for any specific use patterns that would result in
residential exposure.
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.''
Flutriafol is a member of the conazole (triazole) class of
pesticides. Although conazoles act similarly in plants (fungi) by
inhibiting ergosterol biosynthesis, there is not necessarily a
relationship between their pesticidal activity and their mechanism of
toxicity in mammals. Structural similarities do not constitute a common
mechanism of toxicity. Evidence is needed to establish that the
chemicals operate by the same, or essentially the same, sequence of
major biochemical events (EPA, 2002). In conazoles, however, a variable
pattern of toxicological responses is found; some are hepatotoxic and
hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some
induce developmental, reproductive, and neurological effects in
rodents. Furthermore, the conazoles produce a diverse range of
biochemical events including altered cholesterol levels, stress
responses, and altered DNA methylation. It is not clearly understood
whether these biochemical events are directly connected to their
toxicological outcomes. Thus, there is currently no evidence to
indicate that conazoles share common mechanisms of toxicity and EPA is
not following a cumulative risk approach based on a common mechanism of
toxicity for the conazoles. For information regarding EPA's procedures
for cumulating effects from substances found to have a common mechanism
of toxicity, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.
Triazole-derived pesticides can form the metabolite 1,2,4-triazole
(T) and several conjugated triazole metabolites. To support existing
tolerances and to establish new tolerances for triazole-derivative
pesticides, EPA conducted an initial human-health risk assessment for
exposure to T and the conjugated triazole metabolites resulting from
the use of all current and pending uses of any triazole-derived
fungicide as of September 1, 2005. The risk assessment was a highly
conservative, screening-level evaluation in terms of hazards associated
with common metabolites (e.g., use of a maximum combination of
uncertainty factors) and potential dietary and non-dietary exposures
(i.e., high-end estimates of both dietary and non-dietary exposures).
In addition, the Agency retained the additional 10X FQPA SF for the
protection of infants and children. The assessment included evaluations
of risks for various subgroups, including those comprised of infants
and children. The Agency's complete risk assessment can be found in the
propiconazole reregistration docket at http://www.regulations.gov,
Docket Identification (ID) Number EPA-HQ-OPP-2005-0497 and an updated
assessment may be found in docket ID EPA-HQ-OPP-2011-0120 in the
document entitled ``Common Triazole Metabolites: Updated Dietary (Food
+ Water) Exposure and Risk Assessment to Address the Amended
metconazole Section 3 Registration to Add uses on Tuberous and Corm
Vegetables (Group 1C) and Bushberry Subgroup 13-07B.'' The Agency has
determined that the proposed application to field and popcorn will not
result in residues of 1,2,4-triazole (T), triazolylalanine (TA), and
triazolylacetic acid (TAA) greater than the estimates incorporated in
the most recent assessment. Therefore, a revised triazole metabolite
assessment is not needed.
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.
[[Page 47300]]
2. Prenatal and postnatal sensitivity. The potential impact of in
utero and perinatal flutriafol exposure was investigated in three
developmental toxicity studies (two in rats, one in rabbits) and two
multigenerational reproduction toxicity studies in rats. In the first
of two rat developmental toxicity studies, a quantitative
susceptibility was observed (delayed ossification or non-ossification
of the skeleton in the fetuses) at a lower dose than maternal effects.
In the second rat developmental study, a qualitative susceptibility was
noted. Although developmental toxicity occurred at the same dose level
that elicited maternal toxicity, the 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. For rabbits, intrauterine deaths
occurred at a dose level that also caused adverse effects in maternal
animals. In the 2-generation reproduction studies, a qualitative
susceptibility was also seen. 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).
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 concern for neurotoxicity with flutriafol. Signs of
neurotoxicity were reported in the acute and subchronic neurotoxicity
studies at the highest dose only; however, 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 studies in rats, mice, and
dogs, or in the long-term toxicity studies in rats, mice, and dogs. A
developmental neurotoxicity study (DNT) is not required given these
results.
iii. There are no residual uncertainties for pre- and/or post-natal
toxicity. Though there is evidence for increased susceptibility in the
prenatal studies in rats and rabbits and the 2-generation reproduction
study in rats, there are no concerns for the offspring toxicity
observed in the developmental and reproductive toxicity studies for the
following reasons:
a. Clear NOAELs and LOAELs were established in the fetuses/
offspring;
b. The dose-response for these effects are well defined and
characterized;
c. Developmental endpoints are used for assessing acute dietary
risks to the most sensitive population (females 13-49) as well as all
other short- and intermediate-term exposure scenarios; and
d. The chronic reference dose is greater than 300-fold lower than
the dose 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 performed based
on 100 PCT and tolerance-level (or higher) residues. 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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to flutriafol will occupy 24% 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 42% of the cPAD for all
infants less than 1 year old the population group receiving the
greatest exposure. There are no residential uses for flutriafol. 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
not registered for any use patterns that would result in short-term
residential exposure. Therefore, the short-term aggregate risk is the
sum of the risk from exposure to flutriafol through food and water and
will not be greater than the chronic aggregate risk.
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). Flutriafol is not registered for any use patterns that would
result in intermediate-term residential exposure. Therefore, the
intermediate-term aggregate risk is the sum of the risk from exposure
to flutriafol through food and water, which has already been addressed,
and will not be greater than the chronic aggregate risk.
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 (Gas Chromatography/Nitrogen/
Phosphorus detector (GS/NPD) method for proposed tolerances and method
ICIA AM00306 for ruminant liver) are available to enforce the tolerance
expression. The method may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number: (410) 305-2905; email address:
[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
[[Page 47301]]
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 a
MRLs for flutriafol; therefore, harmonization is not an issue.
C. Revisions to Petitioned-for Tolerances
Based on the analysis of the residue trial data and Organization
for Economic Cooperation and Development (OECD) tolerance calculation
procedures, tolerances for corn, field, forage; corn, pop, stover; and
corn, field, stover were lowered. Established rotational crop
tolerances for corn, field forage; corn, field, stover; corn, field,
grain; corn, field, refined oil; corn, pop; and corn, pop, stover are
removed as they are superseded by tolerances for direct application to
the growing crop. The established tolerance for apple is removed and
superseded by the previously established higher tolerance for fruit,
pome, group 11-09. The established tolerances for cattle; liver; goat,
liver; hog, liver; horse, liver; and sheep, liver are replaced by
tolerances for meat byproducts of cattle, goat, hog, horse, and sheep.
Based on the results from the field corn processing study, tolerances
for corn, field, flour and corn, field, meal are not needed. Tolerances
for wheat, forage; wheat, hay; wheat, straw; wheat, grain; wheat, bran;
wheat, germ; barley, hay; barley, straw; barley, grain; barley, grain,
bran; buckwheat, grain; oat, forage; oat, hay; oat, straw; oat, grain;
oat, grain, bran; rye, forage; rye, straw; rye, grain were withdrawn by
the petitioner. Tolerances were previously established on November 9,
2011 for banana; grape; grape, raisin; pome and stone fruit; sugar
beets and for the rotational crops, field and popcorn, and cotton.
V. Conclusion
Therefore, tolerances are established for residues of flutriafol,
[(()-[alpha]-(2-fluorophenyl)-[alpha]-(4-fluorophenyl)-1H-
1,2,4-triazole-1-ethanol], including its metabolites and degradates, in
or on corn, field, forage at 0.75 ppm; corn, field, stover at 1.5 ppm;
corn, field, grain at 0.01 ppm; corn, field, refined oil at 0.02 ppm;
corn, pop at 0.01 ppm; corn, pop, stover at 1.5 ppm; cattle, meat
byproducts at 0.07 ppm; goat, meat byproducts at 0.07 ppm; hog, meat
byproducts at 0.02 ppm; horse, meat byproducts at 0.07 ppm and sheep,
meat byproducts at 0.07 ppm. This final rule deletes established
tolerances for apple; cattle; liver; goat, liver; hog, liver; horse,
liver; and sheep, liver. This final rule also deletes established
rotational crop tolerances for corn, field, forage; corn, field,
stover; corn, field, grain; corn, field, refined oil; corn, pop; and
corn, pop, stover.
VI. Statutory and Executive Order Reviews
This final rule 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 final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule 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 final rule 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 final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
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 of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. 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 this final rule in the Federal
Register. This final rule 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: July 27, 2012.
Lois Rossi,
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. Section 180.629 is amended as follows:
0
i. Remove the entries for ``Apple''; ``Cattle, liver''; ``Goat,
liver''; ``Hog, liver''; ``Horse, liver''; and ``Sheep, liver'' from
the table to paragraph (a).
0
ii. Add alphabetically the entries for ``Cattle, meat byproducts'';
``Corn, field, forage''; ``Corn, field, grain''; ``Corn, field, refined
oil''; ``Corn, field, stover'';
[[Page 47302]]
``Corn, pop''; ``Corn, pop, stover''; ``Goat meat byproducts''; ``Hog,
meat byproducts''; ``Horse meat byproducts''; and ``Sheep meat
byproducts'' to the table in paragraph (a).
0
iii. Remove the entries for ``Corn, field, forage''; ``Corn, field,
grain''; ``Corn, field, refined oil''; ``Corn, field, stover''; ``Corn,
pop''; and ``Corn, pop, stover'' from the table in paragraph (d).
The added entries read as follows:
Sec. 180.629 Flutriafol; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Cattle, meat byproducts................................. 0.07
Corn, field, forage..................................... 0.75
Corn, field, grain...................................... 0.01
Corn, field, refined oil................................ 0.02
Corn, field, stover..................................... 1.5
Corn, pop............................................... 0.01
Corn, pop, stover....................................... 1.5
* * * * *
Goat, meat byproducts................................... 0.07
* * * * *
Hog, meat byproducts.................................... 0.02
Horse, meat byproducts.................................. 0.07
* * * * *
Sheep, meat byproducts.................................. 0.07
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2012-19317 Filed 8-7-12; 8:45 am]
BILLING CODE 6560-50-P