[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
------------------------------------------------------------------------

    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