[Federal Register Volume 75, Number 91 (Wednesday, May 12, 2010)]
[Rules and Regulations]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-11296]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Flutriafol; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes tolerances for residues of
fluorophenyl)-1H-1,2,4-triazole-1-ethanol], including its metabolites
and degradates in or on apple at 0.20 ppm; soybean, seed at 0.35 ppm;
and grain, aspirated fractions at 2.2 ppm; and cattle, goat, hog, horse
and sheep liver at 0.02 ppm. Cheminova A/S, c/o Cheminova, Inc.
requested these tolerances under the Federal Food, Drug, and Cosmetic
DATES: This regulation is effective May 12, 2010. Objections and
requests for hearings must be received on or before July 12, 2010, 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: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0184. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
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; e-mail address: firstname.lastname@example.org.
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
B. How Can I Access Electronic Copies of this Document?
In addition to accessing electronically available documents at
http://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR cite
at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized Test
Guidelines referenced in this document, go directly to the guidelines
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 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-2009-0184 in the subject line on the first
page of your submission. All requests must be in writing, and must be
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178
on or before July 12, 2010.
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 that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2009-0184, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of April 8, 2009 (74 FR 15973) (FRL-8407-
4), 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
7F7197) by Cheminova A/S, c/o Cheminova, Inc., 1600 Wilson Blvd.,
Arlington, VA 22209. The petition requested that 40 CFR 180 be amended
by establishing tolerances for residues of the fungicide flutriafol in
or on the following raw agricultural commodities: Apple at 0.2 parts
per million (ppm); apple, wet pomace at 0.3 ppm; soybean at 0.3 ppm;
soybean, aspirated grain fractions at 0.5 ppm; and liver (cattle, goat,
hog, horse and sheep) at 0.01 ppm. That notice referenced a summary of
the petition prepared by Cheminova A/S, c/o Cheminova Inc., the
registrant, which is available to the public 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 has
determined that tolerances are not needed for apple, juice; wet apple
pomace; soybean meal; soybean hull; and soybean oil. Additionally,
tolerances were increased for soybean seed; aspirated grain fractions;
and cattle, goat, hog, horse and sheep liver. 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 section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, 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 the petitioned-for
tolerances for residues of flutriafol including its metabolites and
degradates in or on apple at 0.20 ppm; soybean, seed at 0.35 ppm;
grain, aspirated fractions at 2.2 ppm; and cattle, goat, hog, horse and
sheep liver at 0.02 ppm. EPA's assessment of exposures and risks
associated with establishing tolerances 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. 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 Apple and Soybean at page 20 in docket
ID number EPA-HQ-OPP-2009-0184.
Flutriafol has low acute oral and inhalation toxicity. A 28-day
dermal toxicity study did not reveal any signs of toxicity at the limit
dose (1,000 mg/kg/day). Thus, flutriafol is not considered to be
acutely toxic via the dermal route. 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.
The pattern of toxicity attributed to flutriafol exposure via the
oral route includes hepatotoxicity, developmental toxicity (manifested
as increased intrauterine death) at the same dose as parental toxicity,
and generalized toxicity (body weight/body weight gains and food
consumption decrements as well as slight anemia).
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 enzymes (alkaline
phosphatase), liver weights, and histopathology findings ranging from
hepatocyte vacuolation to centrilobular hypertrophy and slight
increases in hemosiderin-laden Kupffer cells. With chronic exposures,
there were no indications of progression of liver toxicity in either
species. Neither the chronic/carcinogenicity study in rats nor the
carcinogenicity study in mice revealed treatment-related increases in
Slight indications of effects on red blood cells were sporadically
seen in the database. These effects were manifested in the form of
slight anemia and increased hemosiderin in the liver or spleen of rats
and dogs. Increased platelet, white blood cell, neutrophil, and
lymphocyte counts were also observed in one study in mice. However,
these effects were minimal in severity, were not considered adverse,
and were not observed in any other study or species.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in
sensitivity among members of the human population as well as other
unknowns. Safety is assessed for acute and chronic dietary risks by
comparing aggregate food and water exposure to the pesticide to the
acute population adjusted dose (aPAD) and chronic population adjusted
dose (cPAD). The aPAD and cPAD are calculated by dividing the POD by
all applicable UFs. Aggregate short-, intermediate-, and chronic-term
risks are evaluated by comparing food, water, and residential exposure
to the POD to ensure that the margin of exposure (MOE) called for by
the product of all applicable UFs is not exceeded. This latter value is
referred to as the Level of Concern (LOC).
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
greater than that 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 can be found at http://www.regulations.gov in
document Flutriafol. Human-Health Risk Assessment for Proposed Uses on
Apple and Soybean at page 20 in docket ID number EPA-HQ-OPP-2009-0184.
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 for soybean and apples. Tolerances have been previously
established in 40 CFR 180.629 in or on soybean treated under section 18
of FIFRA. EPA assessed dietary exposures from flutriafol in food as
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.
In conducting the acute dietary exposure assessment, EPA used the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCID\TM\, version 2.03) which incorporates food
consumption data as reported by respondents in the United States
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). The following
assumptions were made for the acute exposure assessment: Tolerance-
level residues, 100% crop treated (CT), and DEEM\TM\ version 7.81
default processing factors were used.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the DEEM\TM\ software with DEEM-FCID\TM\, version
2.03 which incorporates food consumption data as reported by
respondents in the USDA 1994-1996 and 1998 Nationwide CSFII. The
following assumptions were made for the chronic exposure assessment:
Tolerance-level residues, 100% CT, and DEEM\TM\ version 7.81 default
processing factors were used.
iii. Cancer. The Agency classified flutriafol as ``Not Likely to be
Carcinogenic to Humans'' based on the results of the carcinogenicity
studies in rats and mice. All genotoxicity studies on flutriafol showed
no evidence of clastogenicity or mutagenicity. Flutriafol is a member
of a class of pesticides known as triazoles. Although several triazoles
are carcinogenic, many are not and flutriafol has been adequately
tested and found not to be carcinogenic in long-term studies in rats
and mice. Structure-activity-relationship analysis indicates that
flutriafol may have the potential to produce thyroid and/or liver
tumors in rodents. However, in the rat and mouse carcinogenicity
studies, there were no treatment-related increases in tumor incidence
when comparing treated animals to controls.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for flutriafol. Tolerance level residues and 100% CT
were assumed for all food commodities.
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. 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 First Index Reservoir Screening Tool (FIRST), and
Screening Concentration in Ground Water (SCI-GROW) models, 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 4.8 ppb for ground water. For chronic exposures for non-
cancer assessments are estimated to be 5.7 ppb for surface water and
4.8 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 48.8 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 5.7 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 triazole-containing 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
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. 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 website at http://www.epa.gov/pesticides/cumulative.
Triazole-derived pesticides can form the metabolite 1,2,4-triazole
(T) and two triazole conjugates triazolylalanine (TA) and
triazolylacetic acid (TAA). 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,
TA, and TAA 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-
The Agency completed an updated dietary risk assessment considering
exposure to T, TA, and TAA based on established and proposed uses of
triazole fungicides; however, this risk assessment did not include
flutriafol uses. The resulting acute and chronic exposure to T, TA, and
TAA were less than the Agency's level of concern (T: <=36% aPAD and
<=54% cPAD; TA/TAA: 34% aPAD and <=40% cPAD). The Agency concludes that
revised T and TA/TAA dietary risk assessments are unnecessary for the
following reasons: (1) Incorporation of the flutriafol uses resulted in
negligible changes to the T and TA/TAA residue estimates incorporated
into the previous dietary analyses and (2) the T and TA/TAA drinking
water estimates incorporated into the previous dietary analyses assumed
an annual fungicide application rate of 10.38 pound active ingredient/
acre (lb ai/acre) for nonagricultural uses and 2.0 lb ai/acre for
agricultural uses and the formation of T and/or TA/TAA at 30.7% of the
applied rate. Since the annual application rate for flutriafol is
<=0.63 lb ai/acre and since all environmental degradates were
identified at <10% total radioactive residue (TRR), a revised drinking
water assessment was unnecessary.
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 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. The potential impact of in
utero and perinatal flutriafol exposure was investigated in three
developmental toxicity studies (two in rats, one in rabbits) and a
multigeneration reproduction toxicity study in rats. Only one of the
rat developmental toxicity studies was acceptable. Qualitative
susceptibility was noted in the acceptable rat developmental study and
in the two-generation reproduction study.
In the acceptable rat developmental study, developmental toxicity
(late resorptions, skeletal malformations and variations, decrease in
fetal weights) occurred at the same dose level that elicited maternal
toxicity (late resorptions, decreased food consumption, body weight
gains). In rabbits, a decreased number of live fetuses were observed at
the same dose that also caused adverse effects in maternal animals
(complete litter resorptions, increased post-implantation loss,
decreased body weight gain and food consumption).
In the two-generation reproduction study, effects in the offspring
(decreased litter size and percentage of live births and liver
toxicity) were observed at the same dose as parental toxicity
(decreased body weight and food consumption and liver toxicity) and may
be related to the systemic toxicity of the parents. There is no concern
for the offspring toxicity observed in the developmental and
reproductive toxicity studies for the following reasons: (1) the
effects were seen in the presence of maternal/parental/systemic
toxicity; (2) clear NOAELs and LOAELs were established in the fetuses/
offspring; (3) the dose-response for these effects are well defined and
characterized; and (4) 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.
3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. That decision is based on the following findings.
Except for an immunotoxicity study, the toxicological
database is complete. In accordance with the revised part 158 an
immunotoxicity study is required. In the case of flutriafol, there was
no evidence of toxicity to the immune organs in any study in the
database. Increased hemosiderin in the spleen was observed in rats or
dogs. However, this was considered due to the storage of iron following
the clearance of damaged erythrocytes from the blood and not to an
immunotoxic effect. Increased platelet, white blood cell, neutrophil,
and lymphocyte counts were also observed in one study in mice. However,
these effects were minimal in severity, were not considered adverse,
and were not observed in any other study or species. Therefore, they
are not considered immunotoxic effects.
In addition, flutriafol does not belong to a class of chemicals
(e.g., the organotins, heavy metals, or halogenated aromatic
hydrocarbons) that would be expected to be immunotoxic. Based on the
above considerations, the Agency does not believe that conducting a
special series OPPTS Harmonized Guideline 870.7800 immunotoxicity study
will result in a point of departure lower than that used for overall
risk assessment. Therefore an additional UFDB does not need to be
There are no concerns or residual uncertainties for pre-
and/or post-natal toxicity. There is no evidence of quantitative
susceptibility following in utero exposures to rats or rabbits and
following pre- and post-natal exposures to rats for two generations.
There is no concern for the offspring toxicity observed in the
developmental and reproductive toxicity studies for the following
reasons: (1) The effects were seen in the presence of maternal/parental
systemic toxicity; (2) clear NOAELs and LOAELs were established in the
fetuses/offspring; (3) the dose-response for these effects are well
defined and characterized; and (4) 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
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 is not required.
The dietary exposure assessment is conservative in nature
(utilized tolerance level residues and 100% CT were utilized).
Conservative (protective) assumptions were used in the
ground water and surface water modeling to assess exposure to
flutriafol in drinking water.
There are no proposed residential uses.
Based on summaries of confined/field rotational crop
studies submitted by the petitioner, the Agency determined that
rotation of only soybean to a treated field was acceptable. The Agency
is requesting that the petitioner submit a detailed version of these
studies and views this requirement as confirmatory and, therefore, not
requiring the application of additional uncertainty factors.
Storage stability data for flutriafol and/or its
metabolites in/on livestock and soybean commodities have been
requested. Based on the available storage stability data, which did not
result in the degradation of flutriafol or its metabolites in a variety
of matrices, the Agency views these data as confirmatory and,
therefore, not requiring the application of additional uncertainty
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases 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 POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
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 3.7% 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 will utilize 4.6% of the cPAD for (children 1 to 2
years old) the population group receiving the greatest exposure. There
are no proposed or existing residential uses of flutriafol. Therefore,
chronic dietary exposure to flutriafol is not a concern to the Agency.
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 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
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. For flutriafol there
were no treatment-related increases in tumor incidence when comparing
treated animals to controls in the rat and mouse carcinogenicity
studies. Therefore, the human cancer risk from flutriafol is
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 methodologies (multiresidue method (MRM)
Protocol D for apples; GC/Nitrogen/Phosphorus detector (NPD) method for
soybean seed and method ICIA AM00306 for ruminant liver) are available
to enforce the tolerance expression. The methods may be requested from:
Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905;
e-mail address: email@example.com.
B. International Residue Limits
There are no currently established Codex, Canadian, or Mexican
maximum residue limits for flutriafol on apples and soybeans.
C. Revisions to Petitioned-For Tolerances
Based on the processing data, the Agency determined that apple
juice, wet apple pomace, soybean meal, soybean hull, and soybean oil
tolerances are unnecessary. However, a tolerance for grain, aspirated
fractions at 2.2 is required. Based on the crop field trial data,
livestock feeding study, and/or the tolerance calculator, EPA is
recommending for higher tolerances than that proposed by the petitioner
for soybean, seed; aspirated grain fractions, and liver (cattle, goat,
hog, horse, and sheep).
Therefore, tolerances are established for residues of flutriafol
including its metabolites and degradates in or on apple at 0.20 ppm;
soybean, seed at 0.35 ppm; grain, aspirated fractions at 2.2 ppm;
cattle, goat, hog, horse and sheep liver at 0.02 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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) (Public Law 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
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
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: April 28, 2010.
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Revise Sec. 180.629 to read as follows:
180.629 Flutriafol; tolerances for residues.
(a) General. Tolerances are established for the residues of
fluorophenyl)-1H-1,2,4-triazole-1-ethanol], including its metabolites
and degradates in or on the following commodities. Compliance with the
following tolerances is to be determined by measuring flutriafol only.
Commodity Parts per million
Cattle, liver........................................ 0.02
Goat, liver.......................................... 0.02
Grain, aspirated fractions........................... 2.2
Hog, liver........................................... 0.02
Horse, liver......................................... 0.02
Sheep, liver......................................... 0.02
Soybean, seed........................................ 0.35
(b) Section 18 tolerance [Reserved].
(c) Tolerances with regional registrations [Reserved].
(d) Indirect or inadvertent residues [Reserved].
[FR Doc. 2010-11296 Filed 5-11-10; 8:45 am]
BILLING CODE 6560-50-S