[Federal Register Volume 64, Number 186 (Monday, September 27, 1999)]
[Rules and Regulations]
[Pages 51901-51908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-25050]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300922; FRL-6382-5]
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 pome fruit, cucurbit vegetables, grapes, raisins,
peanuts, peanut hay, wet apple pomace, milk, meat, fat and meat by-
products of cattle, goats, hogs, horses and sheep and bananas. 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 September 27, 1999. Objections and
requests for hearings, identified by docket control number OPP-300922,
must be received by EPA on or before November 26, 1999.
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-300922 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-
[email protected]
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
[[Page 51902]]
32532 Pesticide
manufacturing
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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-300922. 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) 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) 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 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 bananas at
0.10 parts per million (ppm), cucurbit vegetables at 0.50 ppm, grapes
at 2.0 ppm, raisins at 5.0 ppm, peanuts at 0.05 ppm, peanut hay at 4.0
ppm, pome fruit at 0.50 ppm, wet apple pomace at 5.0 ppm, milk at 0.02
ppm, and meat, fat and meat by products of cattle, goats, hogs, horses
and sheep at 0.05 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 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 bananas at 0.10 parts per million (ppm), cucurbit
vegetables at 0.50 ppm, grapes at 2.0 ppm, raisins at 5.0 ppm, peanuts
at 0.05 ppm, peanut hay at 4.0 ppm, pome fruit at 0.50 ppm, wet apple
pomace at 5.0 ppm, milk at 0.02 ppm, and meat, fat and meat by products
of cattle, goats, hogs, horses and sheep at 0.05 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 mg/kg/day). Decreased body weight,
hypertrophy of hepatocytes 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
[[Page 51903]]
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 body weights and body weight gain, 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 body weight and weight gain, decreased
food consumption, 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 body weight and body weight gain
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--Developmental Toxicity Study-- Rabbits. The
developmental NOAEL was 250 mg/kg/day. The endpoint was an increase in
fetal incidence of fused sternebrae #3 and #4 at a LOAEL of 500 mg/kg/
day. The uncertainty factor (UF) was 100 based on intra species 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.
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: bananas at 0.10
parts per million (ppm), cucurbit vegetables at 0.50 ppm, grapes at 2.0
ppm, raisins at 5.0 ppm, peanuts at 0.05 ppm, peanut hay at 4.0 ppm,
wet apple pomace at 5.0 ppm, pome fruit at 0.50 ppm, milk at 0.02 ppm,
and meat, fat and meat by products of cattle, goats, hogs, horses and
sheep at 0.05 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 + years old, nursing.
ii. Chronic exposure and risk. In conducting the chronic dietary
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
[[Page 51904]]
were used to calculate the the exposure and risk estimate. The
percentages cPAD utilized were 17% for non-nursing infants, 16% for
children 1-6 years old, 14% for all infants (<1year), and 9% 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 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 and surface water.
Drinking water estimates for the parent, trifloxystrobin, plus the free
form of its acid metabolite CGA-321113, were generated by the SCI-GROW
model. Conservative assumptions were built into the ground water
scenario used by the Screening Concentration in Ground Water (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 (GEENEC) 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 72,600 g/l for females 13+
years (nursing). The DWLOCs for chronic exposure are 1,680 g/l
for the U.S. population, 420 g/l for non-nursing infants and
1,380 g/l for females 13+ years (nursing). The estimated
concentrations of trifloxystrobin in ground water, 4.9 g/l and
surface water, 47.98 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 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 430 to 15 million. 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).
5. Endocrine disrupter effects. EPA is required to develop a
screening program to determine whether certain substances (including
all pesticides and inerts) ``may have an effect in humans that is
similar to an effect produced by a naturally occurring estrogen, or
such other endocrine effect...'' The Agency is currently working with
interested stakeholders, including other government agencies, public
interest groups, industry and research scientists in developing a
screening and testing program and a priority setting scheme to
implement this program.
[[Page 51905]]
D. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. To calculate acute aggregate 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+ years old (nursing). Acute dietary risk
was calculated for females 13+ years old 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), and the values are considered overestimates due to the
conservative assumptions built into the models. 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 7% of the chronic PAD for adult population subgroups (females 13+/
nursing) and no more than 17% of the chronic PAD for infant/children
subgroups (highest subgroup: non-nursing infants). 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, and the values are considered overestimates due
to the conservative assumptions built into the 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
1. Safety factor for infants and children. On June 21, 1999, the
FQPA Safety Factor Committee determined the 10x safety factor for the
protection of infants and children should be removed. The Committee's
rationale for removing the FQPA Safety Factor is as follows:
i. The toxicology database is complete for FQPA assessment.
ii. 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;
iii. It was determined that a developmental neurotoxicity study in
rats is not required.
iv. 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
For plants. EPA determined that the qualitative nature of the
residue in plants is adequately understood for fruits, fruiting
vegetables, cucurbit vegetables and peanuts, based on acceptable
studies conducted on apples, cucumbers, peanuts, and a supplementary
study on wheat. EPA concluded that additional metabolism studies would
be needed to support possible future uses. It was further determined
that the total toxic residues of concern for plants, both for
regulatory and risk assessment purposes, is trifloxystrobin and the
free form of its acid metabolite CGA-321113.
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
The GC/NPD method AG-659A is proposed for tolerance enforcement
purposes for residues of trifloxystrobin and the free form of its acid
metabolite CGA-321113 in plant and animal matrices. Method validation
recoveries indicate that this method adequately recovers residues of
trifloxystrobin and CGA-321113, usually with a limit of quantitation
(LOQ) of 0.02 ppm. A variant (AG-659) of the method has been
independently validated. A method validation trial of AG-659A has been
requested of EPA for trifloxystrobin and the free form of its acid
metabolite, CGA-321113. In the interim, based on its pre-trial review,
EPA has provisionally concluded that method 659A appears to be suitable
for tolerance enforcement.
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. Bananas. EPA recommended for a 0.1 ppm tolerance for whole
bananas.
ii. Cucurbit vegetables. EPA recommended for a 0.5 ppm tolerance.
iii. Grapes. EPA recommended for a 2.0 ppm tolerance.
[[Page 51906]]
iv. Peanuts. EPA recommended for a tolerance of 0.05 ppm (based on
LOQs) for peanuts and 4.0 ppm for peanut hay.
v. Pome fruits. EPA recommended for a 0.5 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. Grape processed commodities. No concentration of residues
occurred in grape juice; no tolerance is required. Residues
concentrated in raisins in one of two studies; based on the positive
study, EPA recommended a 5.0 ppm tolerance.
ii. Peanut processed commodities. Residues did not concentrate in
meal or refined oil; no tolerances are required.
iii. Apple processed commodities. Residues did not concentrate in
juice; no tolerance is required. Residues concentrated in wet pomace;
based on the highest average field trial (HAFT) value and the average
concentration factor, EPA recommended a tolerance of 5.0 ppm.
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 recommended for 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. Proposed
plantback restrictions for the FlintTM 50WDG label
(immediate plantback of any crop listed on the label; 30-day plantback
of all other crops) and the Stratego twin-pack label (immediate
plantback of peanuts; 30-105 day plantback of other crops, to
accommodate the propiconazole co-active ingredient in the product) are
adequate for trifloxystrobin uses. No rotational crop tolerances must
be proposed at this time.
V. Conclusion
Therefore, tolerances are established EPA for combined residues of
trifloxystrobin and the free form of its acid metabolite CGA-321113 in/
on bananas at 0.10 ppm, cucurbit vegetables at 0.50 ppm, grapes at 2.0
ppm, raisins at 5.0 ppm, peanuts at 0.05 ppm, peanut hay at 4.0 ppm,
pome fruit at 0.50 ppm, wet apple pomace at 5.0 ppm, milk at 0.02 ppm,
and meat, fat and meat by products of cattle, goats, hogs, horses and
sheep at 0.05 ppm. There are no U.S. registrations for trifloxystrobin
on bananas.
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-300922 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 November
26, 1999.
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 be 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
[[Page 51907]]
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 [email protected], 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-300922, 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-
[email protected]. 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 section 408(d) of the
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). 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 unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require prior consultation with State, local, and tribal
government officials as specified by Executive Order 12875, entitled
Enhancing the Intergovernmental Partnership (58 FR 58093, October 28,
1993) and Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19,1998), or special
consideration of environmental justice related issues under 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 in accordance with Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). 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 12612,
entitled Federalism (52 FR 41685, October 30, 1987). This action
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 the Federal Food, Drug, and Cosmetic Act,
21 U.S.C. 346a(b)(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). In addition, since
tolerances and exemptions that are establised by EPA on the basis of a
petition under FFDCA section 408(d), such as the tolerances in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
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: September 20, 1999.
Susan B. Hazen,
Acting Director, 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 added to read as follows:
Sec. 180.555 Trifloxystrobin; tolerances for residues.
(a) General. Tolerances are established for combined residues of
trifloxystrobin (Benzeneacetic acid, (E,E)--(methoxyimino)-2-
[[[[1-[3-(trifluoromethyl) phenyl]ethylidene]amino]oxy]methyl]-, methyl
ester) and the free form of its acid metabolite CGA-321113 ((E,E)-
methoxyimino-[2-[1-(3-trifluoromethyl-phenyl)-
ethylideneaminooxymethyl]-phenyl]acetic acid in or on the following
commodities.
[[Page 51908]]
------------------------------------------------------------------------
Parts
Commodity per
million
------------------------------------------------------------------------
Apple pomace (wet)............................................. 5.0
Bananas\1\..................................................... 0.10
Cattle, fat.................................................... 0.05
Cattle, meat................................................... 0.05
Cattle, meat by product........................................ 0.05
Cucurbit vegetables............................................ 0.50
Goats, fat..................................................... 0.05
Goats, meat.................................................... 0.05
Goats, meat by product......................................... 0.05
Grapes......................................................... 2.0
Hogs, fat...................................................... 0.05
Hogs, meat,.................................................... 0.05
Hogs, meat by product.......................................... 0.05
Horses, fat.................................................... 0.05
Horses, meat................................................... 0.05
Horses, meat by product........................................ 0.05
Milk........................................................... 0.02
Peanut hay..................................................... 4.0
Peanuts........................................................ 0.05
Pome fruit..................................................... 0.5
Raisins........................................................ 5.0
Sheep, fat..................................................... 0.05
Sheep, meat.................................................... 0.05
Sheep, meat by product......................................... 0.05
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of September 27, 1999 for use on
bananas.
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 99-25050 Filed 9-24-99; 8:45 am]
BILLING CODE 6560-50-F