[Federal Register Volume 65, Number 138 (Tuesday, July 18, 2000)]
[Rules and Regulations]
[Pages 44447-44453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18100]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301014; FRL-6594-6]

RIN 2070-AB78

Trifloxystrobin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for trifloxystrobin 
regulated as trifloxystrobin and the free form of its acid metabolite 
CGA-321113 in or on almond nutmeat, almond hulls, dried hops cones, 
sugar beet roots, sugar beet tops, sugar beet dried pulp, sugar beet 
molasses, potato tubers, wheat grain, wheat forage, wheat hay, wheat 
straw, wheat bran, and aspirated grain fractions. Novartis Crop 
Protection, Inc. requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act, as amended by the Food Quality Protection Act 
of 1996.

DATES: This regulation is effective July 18, 2000. Objections and 
requests for hearings, identified by docket control number OPP-301014, 
must be received by EPA on or before September 18, 2000.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION section. To ensure proper receipt by EPA, your objections 
and hearing requests must identify docket control number OPP-301014 in 
the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Cynthia Giles-Parker, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460; 
telephone number: (703) 305-7740 and e-mail address: [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
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed in the FOR FURTHER INFORMATION 
CONTACT section.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register--Environmental Documents.'' You can also go directly 
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301014. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of August 17, 1998 (63 FR 43937) (FRL-6018-
2), EPA issued a notice pursuant to section 408 of the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food 
Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing 
the filing of a pesticide petition (PP) 8F4955 for tolerances by 
Novartis Crop Protection, Inc. This notice included a summary of the 
petition prepared by Novartis Crop Protection, Inc., the registrant. An 
amendment to the notice of filing was published in the Federal Register 
of August 26, 1999 (64 FR 46680) (FRL-6099-8) which revised proposed 
tolerance levels and added the metabolite CGA-321113. No comments were 
received in response to the amendment.
    The petition requested that 40 CFR part 180 be amended by 
establishing a tolerance for combined residues of the fungicide 
trifloxystrobin and the free form of its acid metabolite CGA-321113, in 
or on almond nutmeat at 0.04 parts per million (ppm), almond hulls at 
3.0 ppm, dried hops cones at 11.0 ppm, sugar beet roots at 0.1 ppm, 
sugar beet tops at 4.0 ppm, sugar beet dried pulp at 0.4 ppm, sugar 
beet molasses at 0.2 ppm, potato tubers at 0.04 ppm, fruiting 
vegetables at 0.5 ppm, wheat grain at 0.05 ppm, wheat forage at 0.3 
ppm, wheat hay at 0.2, wheat straw at 5.0 ppm, and aspirated grain 
fractions at 5.0 ppm.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and

[[Page 44448]]

to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of 
trifloxystrobin and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for a tolerance for combined 
residues of trifloxystrobin and the free form of its acid metabolite 
CGA-321113 on almond nutmeat at 0.04 ppm, almond hulls at 3.0 ppm, 
dried hops cones at 11.0 ppm, sugar beet roots at 0.1 ppm, sugar beet 
tops at 4.0 ppm, sugar beet dried pulp at 0.4 ppm, sugar beet molasses 
at 0.2 ppm, potato tubers at 0.04 ppm, fruiting vegetables at 0.5 ppm, 
wheat grain at 0.05 ppm, wheat forage at 0.3 ppm, wheat hay at 0.2, 
wheat bran at 0.15 ppm, and aspirated grain fractions at 5.0 ppm. EPA's 
assessment of the dietary exposures and risks associated with 
establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The results of toxicity studies for trifloxystrobin are 
listed below:
    1. Subchronic-Feeding Study-- Rat. The No Observed Adverse Effects 
Level (NOAEL) was 500 ppm (30.6-32.8 milligrams/kilogram/day (mg/kg/
day). Decreased body weight, hypertrophy of hepatocytes in males and 
pancreatic atrophy were observed at the Lowest Observed Adverse Effects 
Level (LOAEL) of 2,000 ppm (127-133 mg/kg/day).
    2. Subchronic-Feeding Study-- Mouse. The NOAEL was 500 ppm (76.9-
110 mg/kg/day). Increased liver weights and necrosis of hepatocytes 
were observed at the LOAEL of 2,000 ppm (315-425 mg/kg/day).
    3. Subchronic-Feeding Study-- Dog. The NOAEL was 30 mg/kg/day. 
Increased liver weight and hepatocyte hypertrophy in males were 
observed at the LOAEL of 150 mg/kg/day.
    4. 28-Day Dermal Toxicity Study-- Rat. The NOAEL was 100 mg/kg/day. 
Increased liver and kidney weight were observed at the LOAEL of 1,000 
mg/kg/day.
    5. Developmental Toxicity Study-- Rat. The maternal NOAEL was 10 
mg/kg/day. Decreased body weight gain and food consumption were 
observed at the maternal LOAEL of 100 mg/kg/day. The developmental 
NOAEL was 1,000 mg/kg/day. No developmental effects were observed. The 
developmental LOAEL was equal to or greater than 1,000 mg/kg/day.
    6. Developmental Toxicity Study-- Rabbit. The maternal NOAEL was 10 
mg/kg/day. Decreased mean body weights and decreased mean body weight 
gain (compared to control), food consumption and efficiency were 
observed at the maternal LOAEL of 50 mg/kg/day. The developmental NOAEL 
was 250 mg/kg/day. Skeletal anomolies were observed at the 
Developmental LOAEL of 500 mg/kg/day.
    7. Reproductive Toxicity Study-- Rat. The parental NOAEL was 50 ppm 
(3.8 mg/kg/day). Decreased mean body weight and decreased mean weight 
gain (compared to control), decreased food consumption, and increased 
incidence of liver, kidney and spleen effects were observed at the 
parental LOAEL of 750 ppm (55.3 mg/kg/day). The reproductive NOAEL was 
1,500 ppm (110.6 mg/kg/day). The reproductive LOAEL was greater than 
1,500 ppm (110.6 mg/kg/day).
    8. Chronic-Feeding Study-- Dog. The NOAEL was 5 mg/kg/day. 
Increased clinical signs, increased liver weight and hepatocellular 
hypertrophy were observed at the LOAEL of 50 mg/kg/day.
    9. Carcinogenicity Study-- Mouse. The NOAEL was 300 ppm (39.4 mg/
kg/day). Liver effects were observed at the LOAEL of 1,000 ppm (131.1 
mg/kg/day).
    10. Chronic Toxicity/Carcinogenicity Study-- Rat. The NOAEL was 250 
ppm (9.81-11.37 mg/kg/day). Decreased mean body weight and decreased 
mean body weight gain (compared to control) were observed at the LOAEL 
of 750 ppm (29.7-34.5 mg/kg/day).
    11. Gene Mutation Study-- Salmonella. Negative.
    12. Gene Mutation study-- Chinese Hamster Cultured V-79. Positive.
    13. Structural Chromosome Aberration-Micronucleus study-- Mouse. 
Negative.
    14. Structural Chromosome Aberration-Cytogenetics study-- Chinese 
Hamster. Negative.
    15. DNA Repair study-hepatocytes-- Rat. Negative.
    16. Acute Oral Neurotoxicity study-- Rat. The NOAEL and LOAEL could 
not be determined.
    17. Metabolism study--Rat. The tissue half-lives ranged from 13 to 
42 hours. The highest residues were found in liver, kidneys, spleen and 
blood. The parent compound was extensively metabolized to approximately 
35 metabolites.

B. Toxicological Endpoints

    The following endpoints were used in the the risk assessments for 
trifloxystrobin.
    1. Acute toxicity--Dietary Developmental Toxicity Study-- Rabbits. 
The developmental NOAEL was 250 mg/kg/day. The endpoint was an increase 
in fetal incidence of fused sternebrae 1#3 and 1#4 at a LOAEL of 500 
mg/kg/day. The uncertainty factor (UF) was 100 based on intraspecies 
and interspecies variation. The acute reference dose (RfD) was 2.5 mg/
kg/day; the acute population adjusted dose (aPAD) was 2.5 mg/kg/day. In 
the study selected, the developmental effects were presumed to occur 
after a single exposure. Since this is an in utero effect it is 
applicable only to the population subgroup, females 13+ years.
    2. Short- and intermediate-term toxicity-- 28-Day Dermal Toxicity 
Study-- Rats. The systemic NOAEL was 100 mg/kg/day. The endpoint was an 
increase in liver and kidney weights at a LOAEL of 1,000 mg/kg/day.
    3. Long-term toxicity. Long-term dermal exposure is not expected 
based on the proposed use pattern. Therefore, a long term dermal risk 
assessment was not performed.
    4. Chronic toxicity--Chronic Toxicity Study-- Dogs. The NOAEL was 5 
mg/kg/day. The endpoint was an increased incidence of clinical signs, 
increased mean liver weight and hepatocellular hypertrophy at a LOAEL 
of 50 mg/kg/day. The UF was 100 for intraspecies and intraspecies 
variation. The chronic RfD was 0.05 mg/kg/day; the chronic PAD was 0.05 
mg/kg/day. The chronic toxicity study in dogs was chosen for the 
chronic dietary risk assessment because the study is chronic and the 
systemic NOAEL is lower than that in the chronic rat study. Also, the 
toxic effects observed were seen in the chronic rat study and the 
multi-generation reproduction study in rats.

[[Page 44449]]

    5. Carcinogenicity. Trifloxystrobin has been classified as a ``not 
likely human carcinogen''.

C. Exposures and Risks

    1. From food and feed uses. Tolerances are being established for 
the combined residues of trifloxystrobin and the free form of its acid 
metabolite CGA-321113 on the following commodities: almond nutmeat at 
0.04 ppm, almond hulls at 3.0 ppm, dried hops cones at 11.0 ppm, sugar 
beet roots at 0.1 ppm, sugar beet tops at 4.0 ppm, sugar beet dried 
pulp at 0.4 ppm, sugar beet molasses at 0.2 ppm, potato tubers at 0.04 
ppm, fruiting vegetables at 0.5 ppm, wheat grain at 0.05 ppm, wheat 
forage at 0.3 ppm, wheat hay at 0.2, wheat straw at 5.0 ppm, wheat bran 
0.15 ppm, and aspirated grain fractions at 5.0 ppm. Risk assessments 
were conducted by EPA to assess dietary exposures as follows:
    i. Acute exposure and risk. Acute dietary risk assessments are 
performed for a food-use pesticide if a toxicological study has 
indicated the possibility of an effect of concern occurring as a result 
of a 1-day or single exposure. The Dietary Exposure Evaluation Model 
(DEEM) detailed acute analysis estimates the distribution of single 
exposures for the overall U.S. population and certain subgroups. For 
this assessment, the only population subgroup of concern for acute 
dietary risk is Females 13 years and older. The analysis evaluates 
individual food consumption as reported by respondents in the USDA 
1989-1992 Continuing Survey of Food Intake by Individuals (CSFII) and 
accumulates exposure to the chemical for each commodity. Each analysis 
assumes uniform distribution of trifloxystrobin in the commodity 
supply. In conducting the acute dietary risk assessment, the Agency 
made highly conservative assumptions. One hundred percent of proposed 
crops are assumed to be treated with trifloxystrobin, and this is 
expected to result in an overestimate of dietary risk. Therefore, this 
acute dietary (food only) risk assessment should be viewed as a highly 
conservative risk estimate. Further refinement using anticipated 
residues or percent of crop treated data in conjunction with a Monte 
Carlo analysis would result in a lower dietary exposure estimate. In 
the DEEM acute analysis the proposed tolerances for combined residues 
of trifloxystrobin and CGA-321113 utilized < 1% of the aPAD for females 
13-50 years.
    ii. Chronic exposure and risk. In conducting the chronic dietary 
(food only) risk assessment, the Agency made highly conservative 
assumptions which resulted in an overestimate of human dietary 
exposure. One hundred percent of proposed crops are assumed to be 
treated with trifloxystrobin, and this is expected to result in an 
overestimate of dietary risk. Therefore, this chronic dietary (food 
only) risk assessment should be viewed as a highly conservative risk 
estimate. Further refinement using anticipated residues or percent of 
crop treated data would result in a lower dietary exposure estimate. 
Thus, in making a safety determination for these tolerances, EPA takes 
into account this highly conservative exposure assessment. The Agency 
is generally concerned with chronic exposures that exceed 100% of the 
chronic PAD (cPAD) or chronic RfD. The proposed trifloxystrobin 
tolerances were used to calculate the the exposure and risk estimate. 
The percentages cPAD utilized were 15% for all infants (< 1 year), 18% 
for children 1-6 years old, and 7.5% or lower for other population 
subgroups.
    iii. Cancer dietary risk from food sources. Trifloxystrobin was 
classified as a ``not likely human carcinogen.'' Therefore, a cancer 
risk assessment was not conducted.
    2. From drinking water. EPA does not have monitoring data available 
to perform a quantitative dietary (drinking water) risk assessment for 
trifloxystrobin and the free form of its acid metabolite. In the 
absence of reliable, available monitoring data, EPA uses models to 
estimate concentrations of pesticides in ground-water and surface 
water. Drinking water estimates for the parent, trifloxystrobin, plus 
the free form of its acid metabolite CGA-321113, were generated by the 
Screening Concentration in Ground Water (SCI-GROW) model. Conservative 
assumptions were built into the ground water scenario used by the SCI-
GROW model, such as assuming shallow ground water, coarse soils and 
high levels of irrigation. The estimate from SCI-GROW represents an 
upper bound on the concentration of trifloxystrobin in ground waters as 
a result of agricultural use.
    The estimate for the parent, trifloxystrobin, using the SCI-GROW 
model is 0.006 part per billion (ppb). For the primary metabolite CGA-
321113, the estimated value is 4.9 ppb. For risk assessment purposes, 
EPA used the estimates for the primary metabolite (and not a sum of 
parent plus metabolite) because the SCI-GROW model assumes 100% 
conversion from parent to CGA-321113.
    Estimates of concentrations of trifloxystrobin and its metabolite 
in surface water were made using the generic expected environmental 
concentration (GENEEC) model. The peak estimate for the parent, 
trifloxystrobin, using the GENEEC model, ranges from 5.29 to 5.56 ppb. 
The 56-day average for the parent ranges from 0.64 to 2.97. For the 
primary metabolite, the peak estimate is 47.98 ppb, and the 56-day 
average estimate is 47.31 ppb. For risk assessment purposes, EPA used 
the estimates for the primary metabolite (and not a sum of parent plus 
metabolite) because the GENEEC model assumes 100% conversion from 
parent to CGA-321113.
    A Drinking Water Level of Comparison (DWLOC) is a theoretical upper 
limit of a pesticide's concentration in drinking water in light of 
total aggregate exposure to that pesticide in food and through 
residential uses. A DWLOC will vary depending on the toxic endpoint, 
consumption and body weight. Different populations will have different 
DWLOCs. EPA uses DWLOCs internally in the risk assessment process as a 
surrogate measure of potential exposure associated with pesticide 
exposure through drinking water. In the absence of monitoring data for 
pesticides, the DWLOC is used as a point of comparison against 
conservative model estimates of potential pesticide concentration in 
water. DWLOC values are not regulatory standards for drinking water. 
EPA has calculated DWLOCs for acute and chronic (non-cancer) exposure 
to trifloxystrobin and the primary metabolite CGA-321113 for the U.S. 
population and selected subgroups.
    The DWLOC for acute risk is 75,000 g/l for females 13-50 
years. The DWLOCs for chronic exposure are 1,600 g/l for the 
U.S. population, 430 g/l for all infants, 1,400 g/l 
for females 13-50 years, and 615 g/l for children 1-6 years. 
The estimated concentrations of trifloxystrobin in ground water, 4.9 
g/l and surface water, 47 g/l, are less than the 
DWLOCs as a contribution to acute and chronic exposure. The estimated 
concentrations of trifloxystrobin and its primary metabolite in ground 
and surface water are considered conservative estimates. Therefore, EPA 
concludes with reasonable certainty that residues of trifloxystrobin in 
food and drinking water would not result in an unacceptable estimate of 
acute or chronic (non-cancer) aggregate human health risk.
    3. From non-dietary exposure. Trifloxystrobin, is proposed for use 
on the following residential non-food sites: turfgrass and ornamentals. 
There are no homeowner uses of trifloxystrobin

[[Page 44450]]

proposed, but residential lawns are listed on the label as sites which 
may be treated by a professional pesticide applicator. Therefore, risk 
assessments (dermal and oral) were conducted for adults and children 
who may be exposed to trifloxystrobin after application by a 
professional pesticide applicator. Short and intermediate-term post-
application residential risk estimates do not exceed EPA's level of 
concern, Margins Of Exposure (MOE) range from 760 to 300,000. Acute and 
chronic aggregate risk (food plus water) estimates do not exceed EPA's 
level of concern. Short- and intermediate-term aggregate risk estimates 
also do not exceed EPA's level of concern.
    4. Cumulative exposure to substances with common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.'' Trifloxystrobin belongs to a new class 
of fungicides, the MAEs (beta-methoxyacryl esters), which are synthetic 
analogs of strobilurin A, an antifungal secondary metabolite of the 
fungus Strobilurus tenacellus. Trifloxystrobin works by interfering 
with respiration in plant pathogenic fungi. The site of action of 
strobilurin compounds is located in the mitochondrial respiration 
pathway between cytochromes b and c1 at the level of the hydroquinone 
binding site. As a result of this mode of action, trifloxystrobin is a 
potent inhibitor of fungal spore germination and mycelial growth. 
Trifloxystrobin can be referred to more specifically as an 
oximinoacetate.
    EPA does not have, at this time, available data to determine 
whether trifloxystrobin has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
trifloxystrobin does not appear to produce a toxic metabolite produced 
by other substances. For the purposes of this tolerance action, 
therefore, EPA has not assumed that trifloxystrobin has a common 
mechanism of toxicity with other substances. For information regarding 
EPA efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, 
November 26, 1997) (FRL. start

D. Aggregate Risks and Determination of Safety for U.S. Population

    1. Acute risk. To calculate acute aggregate dietary risk, high-end 
exposures from food and drinking water sources are compared to the 
acute PAD. Exposure to trifloxystrobin residues and the free form of 
its acid metabolite, CGA-321113 in food will occupy no more than < 1% 
of the acute PAD for females 13-50 years. Acute dietary risk from food 
was calculated for females 13-50 years because the endpoint upon which 
the acute PAD is based is on developmental effects. Residue levels used 
for food-source dietary risk assessments were very conservative: 
proposed tolerance levels were used, and 100% crop treated was assumed, 
with no refinements. Acute dietary exposure estimates were calculated 
for the 95th percentile. Estimated drinking water levels were 
calculated using drinking water models (SCI-GROW and GENEEC)). 
Estimated concentrations of trifloxystrobin residues in surface and 
ground water are lower than EPA's DWLOCs. Therefore, EPA does not 
expect acute aggregate risk to trifloxystrobin residues from acute food 
and drinking water sources to exceed EPA's level of concern for acute 
aggregate risk.
    2. Chronic risk. Exposure to trifloxystrobin and the free form of 
its acid metabolite, CGA-321113 residues in food will occupy no more 
than 3.5% of the chronic PAD for adult population subgroups (females 
13-50 years) and no more than 18% of the chronic PAD for infant/
children subgroups (highest subgroup: children 1-6 years). Residue 
levels used for food-source dietary risk assessments were not refined 
and did not incorporate percent of crop treated. Estimated 
concentrations of trifloxystrobin residues in surface and ground water 
are lower than EPA's DWLOCs. Estimated drinking water levels were 
calculated using drinking water models. Chronic residential exposure of 
trifloxystrobin is not expected. EPA does not expect chronic aggregate 
risk to trifloxystrobin residues from food, water and residential 
sources to exceed EPA's level of concern for chronic aggregate risk.
    3. Short-term risk. To calculate short-term aggregate risk, high-
end residential risk (oral) is combined with chronic food and drinking 
water risks. Since trifloxystrobin causes the same toxic effects but 
different NOAELs were found across different routes, risks for food, 
drinking water and residential exposure paths are combined to estimate 
short-term risk. Based on EPA's short-term aggregate risk calculation, 
EPA does not expect short-term aggregate risk to trifloxystrobin 
residues from food, water and residential sources to exceed EPA's level 
of concern for short-term aggregate risk.
    4. Intermediate-term risk. To calculate intermediate-term aggregate 
risk, high-end residential risk (oral) are combined with chronic food 
and drinking water risks. Since trifloxystrobin causes the same toxic 
effects but different NOAELs were found across different routes, risks 
for food, drinking water and residential exposure paths are combined to 
estimate intermediate-term risk. Based on EPA's intermediate term 
aggregate risk calculation, EPA does not expect intermediate-term 
aggregate risk to trifloxystrobin residues from food, water and 
residential sources to exceed the EPA's level of concern for 
intermediate-term aggregate risk.
    5. Aggregate cancer risk for U.S. population. Not applicable. There 
is no evidence of carcinogenicity.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
from aggregate exposure to residues.

E. Aggregate Risks and Determination of Safety for Infants and Children

    EPA determined the 10x safety factor for the protection of infants 
and children should be removed. Based on the following:
    1. The toxicology database is complete for FQPA assessment.
    2. There is no indication of increased susceptibility of rat or 
rabbits to trifloxystrobin. In the developmental and reproductive 
toxicity studies, effects in the fetuses/offspring were observed only 
at or above treatment levels which resulted in evidence of parental 
toxicity.
    3. It was determined that a developmental neurotoxicity study in 
rats is not required.
    4. The exposure assessments will not underestimate the potential 
dietary (food and drinking water) or nondietary exposures for infants 
and children from the use of trifloxystrobin.

IV. Other Considerations

A. Metabolism in Plants and Animals

    1. For plants. EPA determined that the qualitative nature of the 
residue in plants is adequately understood for almonds, hops, fruiting 
vegetables, tuberous and corm vegetables, and sugar beets based on 
acceptable studies conducted on apples, cucumbers, peanuts and a 
supplementary study on

[[Page 44451]]

wheat and that these plant commodities are of concern for both 
regulatory and risk assessment purposes. EPA concluded that additional 
metabolism studies would be needed to support registration of 
trifloxystrobin and the free form of its acid metabolite CGA-321113 on 
wheat.
    2. For animals. The EPA determined that the qualitative nature of 
the residue in animals is adequately understood based on acceptable 
studies conducted in goats and laying hens. It was determined that the 
total toxic residues for animals, both for regulatory and risk 
assessment purposes, is trifloxystrobin and the free form of its acid 
metabolite CGA-321113. Additionally, the liver contribution for 
metabolite L7a (taurine conjugate of trifloxystrobin) is to be included 
for risk assessment purposes, assuming equal toxicity as 
trifloxystrobin.

B. Analytical Enforcement Methodology

    EPA has completed a method validation of AG-659A on apples, wet 
apple pomace, grapes, summer squash, peanut hay, peanuts, cow liver, 
cow milk and raisins, and concluded that AG-659A is suitable for 
enforcement of trifloxystrobin and the free form of its acid metabolite 
in plant and animal commodities. Method AG-659A is the proposed 
analytical method for the enforcement of trifloxystrobin in plant and 
animal commodities. It supersedes Method AG-659. Compared to AG-659, 
AG-659A also includes extractability and accountability of 
14C-CGA-279202 in animal matrices, minor changes, and 
suggestions resulting from the independent laboratory validation (ILV) 
to improve the ruggedness of the method. Method AG-659A has been 
validated by the petitioner for both trifloxystrobin and its acid 
metabolite CGA-321113. This method adequately recovers residues of 
trifloxystrobin and CGA-321113, usually with a limit of quantitation 
(LOQ) of 0.02 ppm.

C. Magnitude of Residue

    1. Crop field trials. The field trials were adequate in number, 
geographically representative, and reasonably reflected the proposed 
use patterns. In all cases, the tolerances EPA recommended were for 
combined residues of trifloxystrobin and the free form of its acid 
metabolite CGA-321113.
    i. Almond. EPA recommended for a 0.04 ppm tolerance in/on almond 
nutmeats and 3.0 ppm in/on almond hulls.
    ii. Fruiting vegetables. Additional residue data would be needed to 
support future registrations for fruiting vegetables. In the interim, 
EPA recommended for a 0.5 ppm tolerance.
    iii. Hops. EPA recommended for a 11.0 ppm tolerance in/on hops, 
dried cones.
    iv. Potato. EPA recommended for a tolerance of 0.04 ppm (based on 
LOQs).
    v. Sugar beet. EPA recommended for a 0.1 ppm tolerance on sugar 
beet roots and 4.0 ppm on sugar beet tops.
    vi. Wheat. EPA recommended at 0.05 ppm on wheat grain, 0.3 ppm on 
wheat forage, 0.2 ppm on wheat hay, 5.0 ppm on wheat straw.
    vii. Aspirated grain fractions. EPA recommended for a 5.0 ppm 
tolerance.
    2. Processed commodities. In all cases, the tolerances EPA 
recommended were for combined residues of trifloxystrobin and the free 
form of its acid metabolite CGA-321113.
    i. Sugar beet. No concentration of residues occurred in refined 
sugar; no tolerance is required. EPA recommended a 0.2 ppm in molasses 
and 0.4 ppm in dried beet pulp.
    ii. Potato. No concentration of residues occured in flakes and 
chips, and no tolerances are required. Residues for wet peel were lower 
than the tolerance level recommended for potato, hence, no tolerance 
for wet peel is required.
    iii. Tomato. No concentration of residues occurred in puree; no 
tolerance is required. No tolerance on tomato paste is required, 
pending residue data reflecting the maximum application rate.
    iv. Wheat. No concentration of residues occurred in germ, 
middlings, shorts, and flour. EPA recommended tolerance of 0.15 ppm on 
bran and 5.0 ppm on aspirated grain fractions.
    3. Residues in poultry and eggs. Based on the poultry metabolism 
study, EPA concluded that finite residues of trifloxystrobin are not 
expected in poultry commodities. Thus, poultry feeding data and 
tolerances for poultry commodities are not required at this time.
    4. Residues in meat and milk. A dairy cattle feeding study was 
conducted at levels equivalent to 2, 6, and 20 ppm in the diet (mg/kg 
diet on a dry weight basis). Because the highest feeding level was only 
3-4x the calculated maximum theoretical dietary burden (6.2 ppm, beef 
cattle; 4.9 ppm, dairy cattle) and because residues of trifloxystrobin 
and the acid metabolite CGA-321113 were detected in fat at this feeding 
level, EPA concluded that animal commodity tolerances were needed. 
Based on LOQs each for parent and CGA-321113 of 0.01 ppm for milk and 
0.02 ppm for other animal commodities, EPA has established a 0.02 ppm 
LOQ tolerance for combined residues of trifloxystrobin and the free 
form of its acid metabolite CGA-321113 in milk and a 0.05 ppm combined 
residue tolerance for the meat, fat and meat byproducts of cattle, 
goats, hogs, horses and sheep. For risk assessment purposes only, 0.1 
ppm trifloxystrobin-equivalent residue is used for liver. This value is 
based on the sum of the liver contribution of metabolite L7a (estimated 
at ca 0.05 ppm trifloxystrobin equivalent, adjusted to a 1x feeding 
level from the goat metabolism study, TFMP-14C label) plus 
that of the recommended 0.05 ppm tolerance for the combined residues of 
trifloxystrobin and CGA-321113 in meat byproducts.

D. International Residue Limits

    There are no Codex, Canadian, or Mexican maximum residue limits 
(MRLs) established for trifloxystrobin. Harmonization is thus not an 
issue at this time.

E. Rotational Crop Restrictions

    An acceptable confined rotational crop study was submitted. The 
predominant metabolite, trifluoroacetic acid, is not of concern at the 
( 0.2 ppm) levels reported. Quantifiable residues 
( 0.02 ppm) of trifloxystrobin and CGA-321113 are not 
expected in/on crops rotated at a 30-day plantback interval. 
Nonetheless, the petitioner did submit new data on field accumulation 
in rotational crops. Trifloxystrobin (as CGA-279202 50 WG) was applied 
to squash or cucumbers as a post-foliar spray four times at 7-day 
intervals at 0.25 lb active ingredient/acre (ai/A/) application for a 
maximum rate of 1.0 lb ai/A/season. The last application occurred on 
the day of primary crop harvest. Rotational crops were planted 30-31, 
and 120 days after the last application. The following rotational crops 
were planted: leaf lettuce, turnips, and wheat. Crops were grown under 
normal agricultural conditions. Samples of the appropriate RACs were 
collected at normal harvest maturity, frozen, and maintained frozen 
(approximately -20 deg. C) until analysis using method AG-659A. The LOQ 
for both analytes were 0.02 ppm. Residues of trifloxystrobin and its 
acid metabolite CGA-321113 were all less than the LOQ in all crops 
planted at 30-31 days after the last application. The revised draft 
Flint label (EPA Reg. 100-919) proposes a 30-day plantback 
restriction for crops not listed on the label and would permit treated 
areas to be replanted immediately following harvest with any crop 
listed on the label (pome fruits, grapes, cucurbit vegetables, almonds, 
fruiting vegetables, hops, potatoes, sugar

[[Page 44452]]

beets, and wheat). For the Stratego labels, celery, cereals, 
corn, pineapple, and sugarcane may be replanted 30 days after the last 
application; for all other crops, a 105-day plantback interval must be 
observed. The proposed plantback restrictions for Flint and 
Stratego are adequate and no rotational crop tolerances need 
to be proposed, provided that rotational crop restrictions of the 
Stratego labels are compatible with those of the 
propiconazole labels.

V. Conclusion

    Therefore, tolerances are established for combined residues of 
trifloxystrobin and the free form of its acid metabolite CGA-321113 in/
on almond nutmeat at 0.04 ppm, almond hulls at 3.0 ppm, dried hops 
cones at 11.0 ppm, sugar beet roots at 0.1 ppm, sugar beet tops at 4.0 
ppm, sugar beet dried pulp at 0.4 ppm, sugar beet molasses at 0.2 ppm, 
potato tubers at 0.04 ppm, fruiting vegetables at 0.5 ppm, wheat grain 
at 0.05 ppm, wheat forage at 0.3 ppm, wheat hay at 0.2, wheat straw at 
5.0 ppm, wheat bran 0.15 ppm, and aspirated grain fractions at 5.0 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301014 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before September 
18, 2000.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
You may also deliver your request to the Office of the Hearing Clerk in 
Room M3708, Waterside Mall, 401 M St., SW., Washington, DC 20460. The 
Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The telephone number for the 
Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [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-301014, to: Public Information and Records Integrity Branch, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. In person or by courier, bring a copy to the 
location of the PRIB described in Unit I.B.2. of this preamble. You may 
also send an electronic copy of your request via e-mail to: [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 FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable 
duty or contain any

[[Page 44453]]

unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any 
prior consultation as specified by Executive Order 13084, entitled 
Consultation and Coordination with Indian Tribal Governments (63 FR 
27655, May 19, 1998); special considerations as required by Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or require OMB review or any Agency action under 
Executive Order 13045, entitled Protection of Children from 
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 
1997). This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note). Since tolerances and exemptions that are established on the 
basis of a petition under FFDCA section 408(d), such as the tolerance 
in this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4).

VIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this rule in the Federal Register. This rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: June 29, 2000.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), (346a), and 371.
    2. Section 180.555 is amended by alphabetically adding the 
following entries to the table in paragraph (a) to read as follows:


Sec. 180.555  Trifloxystrobin; tolerances for residues.

    (a) *  *  *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls................................................        3.0
Almond, nutmeat..............................................       0.04
 
                      *      *      *      *      *
Aspirated grain fractions....................................        5.0
 
                      *      *      *      *      *
Fruiting vegetables..........................................        0.5
 
                      *      *      *      *      *
Hops, dried cones............................................       11.0
 
                      *      *      *      *      *
Potato, tubers...............................................       0.04
 
                      *      *      *      *      *
Sugar beet, dried pulp.......................................        0.4
Sugar beet, molasses.........................................        0.2
Sugar beet, roots............................................        0.1
Sugar beet, tops.............................................        4.0
Wheat, bran..................................................       0.15
Wheat, forage................................................        0.3
Wheat, grain.................................................       0.05
Wheat, hay...................................................        0.2
Wheat, straw.................................................        5.0
------------------------------------------------------------------------

    *      *      *      *      *
[FR Doc. 00-18100 Filed 7-17-00; 8:45 am]
BILLING CODE 6560-50-F