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Trifloxystrobin; Pesticide Tolerance
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: July 18, 2000 (Volume 65, Number 138)]
[Rules and Regulations]
[Page 44447-44453]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18jy00-11]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301014; FRL-6594-6]
RIN 2070-AB78
Trifloxystrobin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for trifloxystrobin
regulated as trifloxystrobin and the free form of its acid metabolite
CGA-321113 in or on almond nutmeat, almond hulls, dried hops cones,
sugar beet roots, sugar beet tops, sugar beet dried pulp, sugar beet
molasses, potato tubers, wheat grain, wheat forage, wheat hay, wheat
straw, wheat bran, and aspirated grain fractions. Novartis Crop
Protection, Inc. requested these tolerances under the Federal Food,
Drug, and Cosmetic Act, as amended by the Food Quality Protection Act
of 1996.
DATES: This regulation is effective July 18, 2000. Objections and
requests for hearings, identified by docket control number OPP-301014,
must be received by EPA on or before September 18, 2000.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION section. To ensure proper receipt by EPA, your objections
and hearing requests must identify docket control number OPP-301014 in
the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Cynthia Giles-Parker,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460;
telephone number: (703) 305-7740 and e-mail address: giles-
parker.cynthia@epa.gov
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS Potentially
Affected Entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed in the FOR FURTHER INFORMATION
CONTACT section.
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations'' and then look up the entry for this document under the
``Federal Register--Environmental Documents.'' You can also go directly
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
2. In person. The Agency has established an official record for
this action under docket control number OPP-301014. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of August 17, 1998 (63 FR 43937) (FRL-6018-
2), EPA issued a notice pursuant to section 408 of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food
Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing
the filing of a pesticide petition (PP) 8F4955 for tolerances by
Novartis Crop Protection, Inc. This notice included a summary of the
petition prepared by Novartis Crop Protection, Inc., the registrant. An
amendment to the notice of filing was published in the Federal Register
of August 26, 1999 (64 FR 46680) (FRL-6099-8) which revised proposed
tolerance levels and added the metabolite CGA-321113. No comments were
received in response to the amendment.
The petition requested that 40 CFR part 180 be amended by
establishing a tolerance for combined residues of the fungicide
trifloxystrobin and the free form of its acid metabolite CGA-321113, in
or on almond nutmeat at 0.04 parts per million (ppm), almond hulls at
3.0 ppm, dried hops cones at 11.0 ppm, sugar beet roots at 0.1 ppm,
sugar beet tops at 4.0 ppm, sugar beet dried pulp at 0.4 ppm, sugar
beet molasses at 0.2 ppm, potato tubers at 0.04 ppm, fruiting
vegetables at 0.5 ppm, wheat grain at 0.05 ppm, wheat forage at 0.3
ppm, wheat hay at 0.2, wheat straw at 5.0 ppm, and aspirated grain
fractions at 5.0 ppm.
Section 408(b)(2)(A)(i) of the 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) 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)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and
[[Page 44448]]
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....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with 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
trifloxystrobin and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a tolerance for combined
residues of trifloxystrobin and the free form of its acid metabolite
CGA-321113 on almond nutmeat at 0.04 ppm, almond hulls at 3.0 ppm,
dried hops cones at 11.0 ppm, sugar beet roots at 0.1 ppm, sugar beet
tops at 4.0 ppm, sugar beet dried pulp at 0.4 ppm, sugar beet molasses
at 0.2 ppm, potato tubers at 0.04 ppm, fruiting vegetables at 0.5 ppm,
wheat grain at 0.05 ppm, wheat forage at 0.3 ppm, wheat hay at 0.2,
wheat bran at 0.15 ppm, and aspirated grain fractions at 5.0 ppm. EPA's
assessment of the dietary exposures and risks associated with
establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The results of toxicity studies for trifloxystrobin are
listed below:
1. Subchronic-Feeding Study-- Rat. The No Observed Adverse Effects
Level (NOAEL) was 500 ppm (30.6-32.8 milligrams/kilogram/day (mg/kg/
day). Decreased body weight, hypertrophy of hepatocytes in males and
pancreatic atrophy were observed at the Lowest Observed Adverse Effects
Level (LOAEL) of 2,000 ppm (127-133 mg/kg/day).
2. Subchronic-Feeding Study-- Mouse. The NOAEL was 500 ppm (76.9-
110 mg/kg/day). Increased liver weights and necrosis of hepatocytes
were observed at the LOAEL of 2,000 ppm (315-425 mg/kg/day).
3. Subchronic-Feeding Study-- Dog. The NOAEL was 30 mg/kg/day.
Increased liver weight and hepatocyte hypertrophy in males were
observed at the LOAEL of 150 mg/kg/day.
4. 28-Day Dermal Toxicity Study-- Rat. The NOAEL was 100 mg/kg/day.
Increased liver and kidney weight were observed at the LOAEL of 1,000
mg/kg/day.
5. Developmental Toxicity Study-- Rat. The maternal NOAEL was 10
mg/kg/day. Decreased body weight gain and food consumption were
observed at the maternal LOAEL of 100 mg/kg/day. The developmental
NOAEL was 1,000 mg/kg/day. No developmental effects were observed. The
developmental LOAEL was equal to or greater than 1,000 mg/kg/day.
6. Developmental Toxicity Study-- Rabbit. The maternal NOAEL was 10
mg/kg/day. Decreased mean body weights and decreased mean body weight
gain (compared to control), food consumption and efficiency were
observed at the maternal LOAEL of 50 mg/kg/day. The developmental NOAEL
was 250 mg/kg/day. Skeletal anomolies were observed at the
Developmental LOAEL of 500 mg/kg/day.
7. Reproductive Toxicity Study-- Rat. The parental NOAEL was 50 ppm
(3.8 mg/kg/day). Decreased mean body weight and decreased mean weight
gain (compared to control), decreased food consumption, and increased
incidence of liver, kidney and spleen effects were observed at the
parental LOAEL of 750 ppm (55.3 mg/kg/day). The reproductive NOAEL was
1,500 ppm (110.6 mg/kg/day). The reproductive LOAEL was greater than
1,500 ppm (110.6 mg/kg/day).
8. Chronic-Feeding Study-- Dog. The NOAEL was 5 mg/kg/day.
Increased clinical signs, increased liver weight and hepatocellular
hypertrophy were observed at the LOAEL of 50 mg/kg/day.
9. Carcinogenicity Study-- Mouse. The NOAEL was 300 ppm (39.4 mg/
kg/day). Liver effects were observed at the LOAEL of 1,000 ppm (131.1
mg/kg/day).
10. Chronic Toxicity/Carcinogenicity Study-- Rat. The NOAEL was 250
ppm (9.81-11.37 mg/kg/day). Decreased mean body weight and decreased
mean body weight gain (compared to control) were observed at the LOAEL
of 750 ppm (29.7-34.5 mg/kg/day).
11. Gene Mutation Study-- Salmonella. Negative.
12. Gene Mutation study-- Chinese Hamster Cultured V-79. Positive.
13. Structural Chromosome Aberration-Micronucleus study-- Mouse.
Negative.
14. Structural Chromosome Aberration-Cytogenetics study-- Chinese
Hamster. Negative.
15. DNA Repair study-hepatocytes-- Rat. Negative.
16. Acute Oral Neurotoxicity study-- Rat. The NOAEL and LOAEL could
not be determined.
17. Metabolism study--Rat. The tissue half-lives ranged from 13 to
42 hours. The highest residues were found in liver, kidneys, spleen and
blood. The parent compound was extensively metabolized to approximately
35 metabolites.
B. Toxicological Endpoints
The following endpoints were used in the the risk assessments for
trifloxystrobin.
1. Acute toxicity--Dietary Developmental Toxicity Study-- Rabbits.
The developmental NOAEL was 250 mg/kg/day. The endpoint was an increase
in fetal incidence of fused sternebrae 1#3 and 1#4 at a LOAEL of 500
mg/kg/day. The uncertainty factor (UF) was 100 based on intraspecies
and interspecies variation. The acute reference dose (RfD) was 2.5 mg/
kg/day; the acute population adjusted dose (aPAD) was 2.5 mg/kg/day. In
the study selected, the developmental effects were presumed to occur
after a single exposure. Since this is an in utero effect it is
applicable only to the population subgroup, females 13+ years.
2. Short- and intermediate-term toxicity-- 28-Day Dermal Toxicity
Study-- Rats. The systemic NOAEL was 100 mg/kg/day. The endpoint was an
increase in liver and kidney weights at a LOAEL of 1,000 mg/kg/day.
3. Long-term toxicity. Long-term dermal exposure is not expected
based on the proposed use pattern. Therefore, a long term dermal risk
assessment was not performed.
4. Chronic toxicity--Chronic Toxicity Study-- Dogs. The NOAEL was 5
mg/kg/day. The endpoint was an increased incidence of clinical signs,
increased mean liver weight and hepatocellular hypertrophy at a LOAEL
of 50 mg/kg/day. The UF was 100 for intraspecies and intraspecies
variation. The chronic RfD was 0.05 mg/kg/day; the chronic PAD was 0.05
mg/kg/day. The chronic toxicity study in dogs was chosen for the
chronic dietary risk assessment because the study is chronic and the
systemic NOAEL is lower than that in the chronic rat study. Also, the
toxic effects observed were seen in the chronic rat study and the
multi-generation reproduction study in rats.
[[Page 44449]]
5. Carcinogenicity. Trifloxystrobin has been classified as a ``not
likely human carcinogen''.
C. Exposures and Risks
1. From food and feed uses. Tolerances are being established for
the combined residues of trifloxystrobin and the free form of its acid
metabolite CGA-321113 on the following commodities: almond nutmeat at
0.04 ppm, almond hulls at 3.0 ppm, dried hops cones at 11.0 ppm, sugar
beet roots at 0.1 ppm, sugar beet tops at 4.0 ppm, sugar beet dried
pulp at 0.4 ppm, sugar beet molasses at 0.2 ppm, potato tubers at 0.04
ppm, fruiting vegetables at 0.5 ppm, wheat grain at 0.05 ppm, wheat
forage at 0.3 ppm, wheat hay at 0.2, wheat straw at 5.0 ppm, wheat bran
0.15 ppm, and aspirated grain fractions at 5.0 ppm. Risk assessments
were conducted by EPA to assess dietary exposures as follows:
i. Acute exposure and risk. Acute dietary 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. The Dietary Exposure Evaluation Model
(DEEM) detailed acute analysis estimates the distribution of single
exposures for the overall U.S. population and certain subgroups. For
this assessment, the only population subgroup of concern for acute
dietary risk is Females 13 years and older. The analysis evaluates
individual food consumption as reported by respondents in the USDA
1989-1992 Continuing Survey of Food Intake by Individuals (CSFII) and
accumulates exposure to the chemical for each commodity. Each analysis
assumes uniform distribution of trifloxystrobin in the commodity
supply. In conducting the acute dietary risk assessment, the Agency
made highly conservative assumptions. One hundred percent of proposed
crops are assumed to be treated with trifloxystrobin, and this is
expected to result in an overestimate of dietary risk. Therefore, this
acute dietary (food only) risk assessment should be viewed as a highly
conservative risk estimate. Further refinement using anticipated
residues or percent of crop treated data in conjunction with a Monte
Carlo analysis would result in a lower dietary exposure estimate. In
the DEEM acute analysis the proposed tolerances for combined residues
of trifloxystrobin and CGA-321113 utilized < 1% of the aPAD for females
13-50 years.
ii. Chronic exposure and risk. In conducting the chronic dietary
(food only) risk assessment, the Agency made highly conservative
assumptions which resulted in an overestimate of human dietary
exposure. One hundred percent of proposed crops are assumed to be
treated with trifloxystrobin, and this is expected to result in an
overestimate of dietary risk. Therefore, this chronic dietary (food
only) risk assessment should be viewed as a highly conservative risk
estimate. Further refinement using anticipated residues or percent of
crop treated data would result in a lower dietary exposure estimate.
Thus, in making a safety determination for these tolerances, EPA takes
into account this highly conservative exposure assessment. The Agency
is generally concerned with chronic exposures that exceed 100% of the
chronic PAD (cPAD) or chronic RfD. The proposed trifloxystrobin
tolerances were used to calculate the the exposure and risk estimate.
The percentages cPAD utilized were 15% for all infants (< 1 year), 18%
for children 1-6 years old, and 7.5% or lower for other population
subgroups.
iii. Cancer dietary risk from food sources. Trifloxystrobin was
classified as a ``not likely human carcinogen.'' Therefore, a cancer
risk assessment was not conducted.
2. From drinking water. EPA does not have monitoring data available
to perform a quantitative dietary (drinking water) risk assessment for
trifloxystrobin and the free form of its acid metabolite. In the
absence of reliable, available monitoring data, EPA uses models to
estimate concentrations of pesticides in ground-water and surface
water. Drinking water estimates for the parent, trifloxystrobin, plus
the free form of its acid metabolite CGA-321113, were generated by the
Screening Concentration in Ground Water (SCI-GROW) model. Conservative
assumptions were built into the ground water scenario used by the SCI-
GROW model, such as assuming shallow ground water, coarse soils and
high levels of irrigation. The estimate from SCI-GROW represents an
upper bound on the concentration of trifloxystrobin in ground waters as
a result of agricultural use.
The estimate for the parent, trifloxystrobin, using the SCI-GROW
model is 0.006 part per billion (ppb). For the primary metabolite CGA-
321113, the estimated value is 4.9 ppb. For risk assessment purposes,
EPA used the estimates for the primary metabolite (and not a sum of
parent plus metabolite) because the SCI-GROW model assumes 100%
conversion from parent to CGA-321113.
Estimates of concentrations of trifloxystrobin and its metabolite
in surface water were made using the generic expected environmental
concentration (GENEEC) model. The peak estimate for the parent,
trifloxystrobin, using the GENEEC model, ranges from 5.29 to 5.56 ppb.
The 56-day average for the parent ranges from 0.64 to 2.97. For the
primary metabolite, the peak estimate is 47.98 ppb, and the 56-day
average estimate is 47.31 ppb. For risk assessment purposes, EPA used
the estimates for the primary metabolite (and not a sum of parent plus
metabolite) because the GENEEC model assumes 100% conversion from
parent to CGA-321113.
A Drinking Water Level of Comparison (DWLOC) is a theoretical upper
limit of a pesticide's concentration in drinking water in light of
total aggregate exposure to that pesticide in food and through
residential uses. A DWLOC will vary depending on the toxic endpoint,
consumption and body weight. Different populations will have different
DWLOCs. EPA uses DWLOCs internally in the risk assessment process as a
surrogate measure of potential exposure associated with pesticide
exposure through drinking water. In the absence of monitoring data for
pesticides, the DWLOC is used as a point of comparison against
conservative model estimates of potential pesticide concentration in
water. DWLOC values are not regulatory standards for drinking water.
EPA has calculated DWLOCs for acute and chronic (non-cancer) exposure
to trifloxystrobin and the primary metabolite CGA-321113 for the U.S.
population and selected subgroups.
The DWLOC for acute risk is 75,000 g/l for females 13-50
years. The DWLOCs for chronic exposure are 1,600 g/l for the
U.S. population, 430 g/l for all infants, 1,400 g/l
for females 13-50 years, and 615 g/l for children 1-6 years.
The estimated concentrations of trifloxystrobin in ground water, 4.9
g/l and surface water, 47 g/l, are less than the
DWLOCs as a contribution to acute and chronic exposure. The estimated
concentrations of trifloxystrobin and its primary metabolite in ground
and surface water are considered conservative estimates. Therefore, EPA
concludes with reasonable certainty that residues of trifloxystrobin in
food and drinking water would not result in an unacceptable estimate of
acute or chronic (non-cancer) aggregate human health risk.
3. From non-dietary exposure. Trifloxystrobin, is proposed for use
on the following residential non-food sites: turfgrass and ornamentals.
There are no homeowner uses of trifloxystrobin
[[Page 44450]]
proposed, but residential lawns are listed on the label as sites which
may be treated by a professional pesticide applicator. Therefore, risk
assessments (dermal and oral) were conducted for adults and children
who may be exposed to trifloxystrobin after application by a
professional pesticide applicator. Short and intermediate-term post-
application residential risk estimates do not exceed EPA's level of
concern, Margins Of Exposure (MOE) range from 760 to 300,000. Acute and
chronic aggregate risk (food plus water) estimates do not exceed EPA's
level of concern. Short- and intermediate-term aggregate risk estimates
also do not exceed EPA's level of concern.
4. Cumulative exposure to substances with common mechanism of
toxicity. Section 408(b)(2)(D)(v) 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.'' Trifloxystrobin belongs to a new class
of fungicides, the MAEs (beta-methoxyacryl esters), which are synthetic
analogs of strobilurin A, an antifungal secondary metabolite of the
fungus Strobilurus tenacellus. Trifloxystrobin works by interfering
with respiration in plant pathogenic fungi. The site of action of
strobilurin compounds is located in the mitochondrial respiration
pathway between cytochromes b and c1 at the level of the hydroquinone
binding site. As a result of this mode of action, trifloxystrobin is a
potent inhibitor of fungal spore germination and mycelial growth.
Trifloxystrobin can be referred to more specifically as an
oximinoacetate.
EPA does not have, at this time, available data to determine
whether trifloxystrobin has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
trifloxystrobin does not appear to produce a toxic metabolite produced
by other substances. For the purposes of this tolerance action,
therefore, EPA has not assumed that trifloxystrobin has a common
mechanism of toxicity with other substances. For information regarding
EPA efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961,
November 26, 1997) (FRL. start
D. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. To calculate acute aggregate dietary risk, high-end
exposures from food and drinking water sources are compared to the
acute PAD. Exposure to trifloxystrobin residues and the free form of
its acid metabolite, CGA-321113 in food will occupy no more than < 1%
of the acute PAD for females 13-50 years. Acute dietary risk from food
was calculated for females 13-50 years because the endpoint upon which
the acute PAD is based is on developmental effects. Residue levels used
for food-source dietary risk assessments were very conservative:
proposed tolerance levels were used, and 100% crop treated was assumed,
with no refinements. Acute dietary exposure estimates were calculated
for the 95th percentile. Estimated drinking water levels were
calculated using drinking water models (SCI-GROW and GENEEC)).
Estimated concentrations of trifloxystrobin residues in surface and
ground water are lower than EPA's DWLOCs. Therefore, EPA does not
expect acute aggregate risk to trifloxystrobin residues from acute food
and drinking water sources to exceed EPA's level of concern for acute
aggregate risk.
2. Chronic risk. Exposure to trifloxystrobin and the free form of
its acid metabolite, CGA-321113 residues in food will occupy no more
than 3.5% of the chronic PAD for adult population subgroups (females
13-50 years) and no more than 18% of the chronic PAD for infant/
children subgroups (highest subgroup: children 1-6 years). Residue
levels used for food-source dietary risk assessments were not refined
and did not incorporate percent of crop treated. Estimated
concentrations of trifloxystrobin residues in surface and ground water
are lower than EPA's DWLOCs. Estimated drinking water levels were
calculated using drinking water models. Chronic residential exposure of
trifloxystrobin is not expected. EPA does not expect chronic aggregate
risk to trifloxystrobin residues from food, water and residential
sources to exceed EPA's level of concern for chronic aggregate risk.
3. Short-term risk. To calculate short-term aggregate risk, high-
end residential risk (oral) is combined with chronic food and drinking
water risks. Since trifloxystrobin causes the same toxic effects but
different NOAELs were found across different routes, risks for food,
drinking water and residential exposure paths are combined to estimate
short-term risk. Based on EPA's short-term aggregate risk calculation,
EPA does not expect short-term aggregate risk to trifloxystrobin
residues from food, water and residential sources to exceed EPA's level
of concern for short-term aggregate risk.
4. Intermediate-term risk. To calculate intermediate-term aggregate
risk, high-end residential risk (oral) are combined with chronic food
and drinking water risks. Since trifloxystrobin causes the same toxic
effects but different NOAELs were found across different routes, risks
for food, drinking water and residential exposure paths are combined to
estimate intermediate-term risk. Based on EPA's intermediate term
aggregate risk calculation, EPA does not expect intermediate-term
aggregate risk to trifloxystrobin residues from food, water and
residential sources to exceed the EPA's level of concern for
intermediate-term aggregate risk.
5. Aggregate cancer risk for U.S. population. Not applicable. There
is no evidence of carcinogenicity.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
from aggregate exposure to residues.
E. Aggregate Risks and Determination of Safety for Infants and Children
EPA determined the 10x safety factor for the protection of infants
and children should be removed. Based on the following:
1. The toxicology database is complete for FQPA assessment.
2. There is no indication of increased susceptibility of rat or
rabbits to trifloxystrobin. In the developmental and reproductive
toxicity studies, effects in the fetuses/offspring were observed only
at or above treatment levels which resulted in evidence of parental
toxicity.
3. It was determined that a developmental neurotoxicity study in
rats is not required.
4. The exposure assessments will not underestimate the potential
dietary (food and drinking water) or nondietary exposures for infants
and children from the use of trifloxystrobin.
IV. Other Considerations
A. Metabolism in Plants and Animals
1. For plants. EPA determined that the qualitative nature of the
residue in plants is adequately understood for almonds, hops, fruiting
vegetables, tuberous and corm vegetables, and sugar beets based on
acceptable studies conducted on apples, cucumbers, peanuts and a
supplementary study on
[[Page 44451]]
wheat and that these plant commodities are of concern for both
regulatory and risk assessment purposes. EPA concluded that additional
metabolism studies would be needed to support registration of
trifloxystrobin and the free form of its acid metabolite CGA-321113 on
wheat.
2. For animals. The EPA determined that the qualitative nature of
the residue in animals is adequately understood based on acceptable
studies conducted in goats and laying hens. It was determined that the
total toxic residues for animals, both for regulatory and risk
assessment purposes, is trifloxystrobin and the free form of its acid
metabolite CGA-321113. Additionally, the liver contribution for
metabolite L7a (taurine conjugate of trifloxystrobin) is to be included
for risk assessment purposes, assuming equal toxicity as
trifloxystrobin.
B. Analytical Enforcement Methodology
EPA has completed a method validation of AG-659A on apples, wet
apple pomace, grapes, summer squash, peanut hay, peanuts, cow liver,
cow milk and raisins, and concluded that AG-659A is suitable for
enforcement of trifloxystrobin and the free form of its acid metabolite
in plant and animal commodities. Method AG-659A is the proposed
analytical method for the enforcement of trifloxystrobin in plant and
animal commodities. It supersedes Method AG-659. Compared to AG-659,
AG-659A also includes extractability and accountability of
14C-CGA-279202 in animal matrices, minor changes, and
suggestions resulting from the independent laboratory validation (ILV)
to improve the ruggedness of the method. Method AG-659A has been
validated by the petitioner for both trifloxystrobin and its acid
metabolite CGA-321113. This method adequately recovers residues of
trifloxystrobin and CGA-321113, usually with a limit of quantitation
(LOQ) of 0.02 ppm.
C. Magnitude of Residue
1. Crop field trials. The field trials were adequate in number,
geographically representative, and reasonably reflected the proposed
use patterns. In all cases, the tolerances EPA recommended were for
combined residues of trifloxystrobin and the free form of its acid
metabolite CGA-321113.
i. Almond. EPA recommended for a 0.04 ppm tolerance in/on almond
nutmeats and 3.0 ppm in/on almond hulls.
ii. Fruiting vegetables. Additional residue data would be needed to
support future registrations for fruiting vegetables. In the interim,
EPA recommended for a 0.5 ppm tolerance.
iii. Hops. EPA recommended for a 11.0 ppm tolerance in/on hops,
dried cones.
iv. Potato. EPA recommended for a tolerance of 0.04 ppm (based on
LOQs).
v. Sugar beet. EPA recommended for a 0.1 ppm tolerance on sugar
beet roots and 4.0 ppm on sugar beet tops.
vi. Wheat. EPA recommended at 0.05 ppm on wheat grain, 0.3 ppm on
wheat forage, 0.2 ppm on wheat hay, 5.0 ppm on wheat straw.
vii. Aspirated grain fractions. EPA recommended for a 5.0 ppm
tolerance.
2. Processed commodities. In all cases, the tolerances EPA
recommended were for combined residues of trifloxystrobin and the free
form of its acid metabolite CGA-321113.
i. Sugar beet. No concentration of residues occurred in refined
sugar; no tolerance is required. EPA recommended a 0.2 ppm in molasses
and 0.4 ppm in dried beet pulp.
ii. Potato. No concentration of residues occured in flakes and
chips, and no tolerances are required. Residues for wet peel were lower
than the tolerance level recommended for potato, hence, no tolerance
for wet peel is required.
iii. Tomato. No concentration of residues occurred in puree; no
tolerance is required. No tolerance on tomato paste is required,
pending residue data reflecting the maximum application rate.
iv. Wheat. No concentration of residues occurred in germ,
middlings, shorts, and flour. EPA recommended tolerance of 0.15 ppm on
bran and 5.0 ppm on aspirated grain fractions.
3. Residues in poultry and eggs. Based on the poultry metabolism
study, EPA concluded that finite residues of trifloxystrobin are not
expected in poultry commodities. Thus, poultry feeding data and
tolerances for poultry commodities are not required at this time.
4. Residues in meat and milk. A dairy cattle feeding study was
conducted at levels equivalent to 2, 6, and 20 ppm in the diet (mg/kg
diet on a dry weight basis). Because the highest feeding level was only
3-4x the calculated maximum theoretical dietary burden (6.2 ppm, beef
cattle; 4.9 ppm, dairy cattle) and because residues of trifloxystrobin
and the acid metabolite CGA-321113 were detected in fat at this feeding
level, EPA concluded that animal commodity tolerances were needed.
Based on LOQs each for parent and CGA-321113 of 0.01 ppm for milk and
0.02 ppm for other animal commodities, EPA has established a 0.02 ppm
LOQ tolerance for combined residues of trifloxystrobin and the free
form of its acid metabolite CGA-321113 in milk and a 0.05 ppm combined
residue tolerance for the meat, fat and meat byproducts of cattle,
goats, hogs, horses and sheep. For risk assessment purposes only, 0.1
ppm trifloxystrobin-equivalent residue is used for liver. This value is
based on the sum of the liver contribution of metabolite L7a (estimated
at ca 0.05 ppm trifloxystrobin equivalent, adjusted to a 1x feeding
level from the goat metabolism study, TFMP-14C label) plus
that of the recommended 0.05 ppm tolerance for the combined residues of
trifloxystrobin and CGA-321113 in meat byproducts.
D. International Residue Limits
There are no Codex, Canadian, or Mexican maximum residue limits
(MRLs) established for trifloxystrobin. Harmonization is thus not an
issue at this time.
E. Rotational Crop Restrictions
An acceptable confined rotational crop study was submitted. The
predominant metabolite, trifluoroacetic acid, is not of concern at the
( 0.2 ppm) levels reported. Quantifiable residues
( 0.02 ppm) of trifloxystrobin and CGA-321113 are not
expected in/on crops rotated at a 30-day plantback interval.
Nonetheless, the petitioner did submit new data on field accumulation
in rotational crops. Trifloxystrobin (as CGA-279202 50 WG) was applied
to squash or cucumbers as a post-foliar spray four times at 7-day
intervals at 0.25 lb active ingredient/acre (ai/A/) application for a
maximum rate of 1.0 lb ai/A/season. The last application occurred on
the day of primary crop harvest. Rotational crops were planted 30-31,
and 120 days after the last application. The following rotational crops
were planted: leaf lettuce, turnips, and wheat. Crops were grown under
normal agricultural conditions. Samples of the appropriate RACs were
collected at normal harvest maturity, frozen, and maintained frozen
(approximately -20 deg. C) until analysis using method AG-659A. The LOQ
for both analytes were 0.02 ppm. Residues of trifloxystrobin and its
acid metabolite CGA-321113 were all less than the LOQ in all crops
planted at 30-31 days after the last application. The revised draft
Flint label (EPA Reg. 100-919) proposes a 30-day plantback
restriction for crops not listed on the label and would permit treated
areas to be replanted immediately following harvest with any crop
listed on the label (pome fruits, grapes, cucurbit vegetables, almonds,
fruiting vegetables, hops, potatoes, sugar
[[Page 44452]]
beets, and wheat). For the Stratego labels, celery, cereals,
corn, pineapple, and sugarcane may be replanted 30 days after the last
application; for all other crops, a 105-day plantback interval must be
observed. The proposed plantback restrictions for Flint and
Stratego are adequate and no rotational crop tolerances need
to be proposed, provided that rotational crop restrictions of the
Stratego labels are compatible with those of the
propiconazole labels.
V. Conclusion
Therefore, tolerances are established for combined residues of
trifloxystrobin and the free form of its acid metabolite CGA-321113 in/
on almond nutmeat at 0.04 ppm, almond hulls at 3.0 ppm, dried hops
cones at 11.0 ppm, sugar beet roots at 0.1 ppm, sugar beet tops at 4.0
ppm, sugar beet dried pulp at 0.4 ppm, sugar beet molasses at 0.2 ppm,
potato tubers at 0.04 ppm, fruiting vegetables at 0.5 ppm, wheat grain
at 0.05 ppm, wheat forage at 0.3 ppm, wheat hay at 0.2, wheat straw at
5.0 ppm, wheat bran 0.15 ppm, and aspirated grain fractions at 5.0 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-301014 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 on or before September
18, 2000.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
You may also deliver your request to the Office of the Hearing Clerk in
Room M3708, Waterside Mall, 401 M St., SW., Washington, DC 20460. The
Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Office of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A. of
this preamble, you should also send a copy of your request to the PIRB
for its inclusion in the official record that is described in Unit
I.B.2. of this preamble. Mail your copies, identified by docket number
OPP-301014, to: Public Information and Records Integrity Branch,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. In person or by courier, bring a copy to the
location of the PRIB described in Unit I.B.2. of this preamble. You may
also send an electronic copy of your request via e-mail to: opp-
docket@epa.gov. Please use an ASCII file format and avoid the use of
special characters and any form of encryption. Copies of electronic
objections and hearing requests will also be accepted on disks in
WordPerfect 5.1/6.1 file format or ASCII file format. Do not include
any CBI in your electronic copy. You may also submit an electronic copy
of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established EPA, resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. Regulatory Assessment Requirements
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). 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., or impose any enforceable
duty or contain any
[[Page 44453]]
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any
prior consultation as specified by Executive Order 13084, entitled
Consultation and Coordination with Indian Tribal Governments (63 FR
27655, May 19, 1998); special considerations as required by Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or require OMB review or any Agency action under
Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997). 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). 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. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4).
VIII. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
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 rule in the Federal Register. This 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: June 29, 2000.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), (346a), and 371.
2. Section 180.555 is amended by alphabetically adding the
following entries to the table in paragraph (a) to read as follows:
Sec. 180.555 Trifloxystrobin; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Almond, hulls................................................ 3.0
Almond, nutmeat.............................................. 0.04
* * * * *
Aspirated grain fractions.................................... 5.0
* * * * *
Fruiting vegetables.......................................... 0.5
* * * * *
Hops, dried cones............................................ 11.0
* * * * *
Potato, tubers............................................... 0.04
* * * * *
Sugar beet, dried pulp....................................... 0.4
Sugar beet, molasses......................................... 0.2
Sugar beet, roots............................................ 0.1
Sugar beet, tops............................................. 4.0
Wheat, bran.................................................. 0.15
Wheat, forage................................................ 0.3
Wheat, grain................................................. 0.05
Wheat, hay................................................... 0.2
Wheat, straw................................................. 5.0
------------------------------------------------------------------------
* * * * *
[FR Doc. 00-18100 Filed 7-17-00; 8:45 am]
BILLING CODE 6560-50-F