[Federal Register Volume 67, Number 99 (Wednesday, May 22, 2002)]
[Rules and Regulations]
[Pages 35915-35924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-12850]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0052; FRL-7178-6]


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 fruit, stone, group; nut, tree, group; pistachio; 
corn, field, grains; corn, field, forage; corn field stover; corn, 
field, refined oil; corn, pop, grain; corn, pop, stover; rice, grain; 
rice, hulls; rice, straw; citrus, dried pulp; citrus oil; fruit, 
citrus, group; egg; poultry, fat; poultry, meat; and poultry, meat by 
products. Bayer, 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 May 22, 2002. Objections and 
requests for hearings, identified by docket control number OPP-2002-
0052, must be received by EPA on or before July 22, 2002.

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-2002-0052 
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:

[[Page 35916]]

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 Potentially
             Categories                 NAICS       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 under the section FOR FURTHER 
INFORMATION CONTACT.

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'', ``Regulations and Proposed Rules'' 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/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr 180--00.html, a beta site 
currently under development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-2002-0052. 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 November 14, 2001 (66 FR 57074) (FRL-
6806-6), 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) 0F6121 for 
tolerances by Bayer Corporation, 8400 Hawthorn Road, P.O. Box 4913, 
Kansas City, MO 64121-0013. This notice included a summary of the 
petition prepared by Bayer Corporation, the registrant. No comments 
were received in response to the amendment.
    The petition requested that 40 CFR 180.555 be amended by 
establishing tolerances for combined residues of the fungicide 
trifloxystrobin and the free form of its acid metabolite CGA-321113, in 
or on fruit, stone, group at 2 parts per million (ppm); nut, tree, 
group at 0.05 ppm; pistachio at 0.05 ppm; corn, field, grains at 0.05 
ppm; corn, field, forage at 0.05 ppm; corn, field, stover at 7 ppm; 
corn, field, refined oil at 0.1 ppm; corn, pop, grain at 0.05 ppm; 
corn, pop, stover at 7 ppm; rice, grain at 3.5 ppm; rice, hulls at 8 
ppm; rice, straw at 7.5 ppm; citrus, dried pulp at 0.8 ppm; citrus, oil 
at 7 ppm; fruit, citrus, group at 0.3 ppm; egg at 0.04 ppm; poultry, 
fat; and poultry, meat; poultry, kidney; poultry, liver; and poultry, 
meat by products at 0.05 ppm. Bayer, Inc. requested these tolerances 
under the Federal Food, Drug, and Cosmetic Act, as amended by the Food 
Quality Protection Act of 1996.
    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 fruit, stone, group at 2 ppm; nut, tree, group at 0.04 
ppm; pistachio at 0.04 ppm; corn, field, grains at 0.05 ppm; corn, 
field, forage at 0.2 ppm; corn, field, stover at 7 ppm; corn, field, 
refined oil at 0.1 ppm; corn, pop, grain at 0.05 ppm; corn, pop, stover 
at 7 ppm; rice, grain at 3.5 ppm; rice, hulls at 8 ppm; rice, straw at 
7.5 ppm; citrus, dried pulp at 0.8 ppm; citrus oil at 30 ppm; fruit, 
citrus, grroup at 0.3 ppm; egg at 0.04 ppm; poultry, fat at 0.04 ppm; 
poultry, meat at 0.04 ppm; poultry, meat by products at 0.04 ppm. In 
examining the data for corn field forage and citrus oil the Agency 
found that the residue data supports a higher tolerance than was 
proposed. 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 nature of the toxic effects caused by trifloxystrobin

[[Page 35917]]

and the free form of its acid metabolite CGA-321113 are discussed below 
as well as the no observed adverse effect level (NOAEL) and the lowest 
observed adverse effect level (LOAEL) from the toxicity studies 
reviewed.
    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 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 dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological level of concern 
(LOC). However, the lowest dose at which adverse effects of concern are 
identified (the LOAEL) is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intra species differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10-6 or one in a 
million). Under certain specific circumstances, MOE calculations will 
be used for the carcinogenic risk assessment. In this non-linear 
approach, a ``point of departure'' is identified below which 
carcinogenic effects are not expected. The point of departure is 
typically a NOAEL based on an endpoint related to cancer effects though 
it may be a different value derived from the dose response curve. To 
estimate risk, a ratio of the point of departure to exposure 
(MOEcancer = point of departure/exposures) is calculated. A 
summary of the toxicological endpoints for trifloxystrobin used for 
human risk assessment is shown in the following Table 1:

   Table 1.--Summary of Toxicological Dose and Endpoints for trifloxystrobin for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
          Exposure Scenario                Dose(mg/kg/day)              Endpoint                  Study
----------------------------------------------------------------------------------------------------------------
Acute Dietary \a\ Females 13-50 only   NOAEL = 250              Increased fetal          Developmental Toxicity
                                       UF = 100...............   skeletal anomalies.       Rabbit
----------------------------------------------------------------------------------------------------------------

[[Page 35918]]

 
 
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\d\ Since an oral NOAEL was selected, inhalation absorption factor of 100% should be used for route-to-route
  extrapolation.

C. Exposure assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established for the combined residues of trifloxystrobin and the free 
form of its acid metabolite CGA-321113 on several commodities; 
including almonds, bananas, sugarbeets, pomefruit, grapes, peanuts, 
potatoes, cucurbit vegetables, fruiting vegetables, and wheat. The 
Agency conducted a new assessment incorporating these commodities and 
the following additional tolerances: fruit, stone, group at 2 ppm; nut, 
tree, group at 0.04 ppm; pistachio at 0.04 ppm; corn, field, grains at 
0.05 ppm; corn, field, forage at 0.2 ppm; corn, field, stover at 7 ppm; 
corn, field, refined oil at 0.1 ppm; corn, pop, grain at 0.05 ppm; 
corn, pop, stover at 7 ppm; rice, grain at 3.5 ppm; rice, hulls at 8 
ppm; rice, straw at 7.5 ppm; citrus, dried pulp at 0.8 ppm; citrus oil 
at 30 ppm; fruit, citrus, group at 0.3 ppm; egg at 0.04 ppm; poultry, 
fat at 0.04 ppm; poultry, meat at 0.04 ppm; poultry, meat by products 
at 0.04 ppm. Risk assessments were conducted by EPA to assess dietary 
exposures from trifloxystrobin in food as follows:
    i. Acute exposure. The acute dietary exposure analysis for 
trifloxystrobin is a Tier 1 assessment because no additional data were 
used to refine the analysis. One hundred percent of proposed and 
registered crops are assumed treated with trifloxystrobin (100% CT) and 
tolerance-level residues were used in the analysis. The acute dietary 
endpoint (increased fetal incidence of fused sternebrae) is only 
applicable to the population subgroup Females 13-50 years old. An acute 
dietary endpoint for the general population including infants and 
children was not identified. The estimated dietary exposure for females 
13-50 years old occupies less than 1 percent of the acute PAD and does 
not exceed EPA's level of concern.

             Table 2.--Results of Acute Dietary Exposure Analysis at the 95th Percentile of Exposure
----------------------------------------------------------------------------------------------------------------
                                                                   aPAD  (mg/kg/  Exposure  (mg/
                       Population Subgroup                             day)           kg/day)         % aPAD
----------------------------------------------------------------------------------------------------------------
Females 13-50 years old                                                      2.5        0.011587            0.46
----------------------------------------------------------------------------------------------------------------

    ii. Chronic exposure. The chronic dietary exposure analysis for 
trifloxystrobin is a Tier 1 assessment because no additional data were 
used to refine the analysis. One hundred percent of proposed and 
registered crops are assumed treated with trifloxystrobin (100% CT) and 
tolerance-level residues were used in the analysis. The chronic dietary 
endpoint applies to all population subgroups including infants and 
children. A listing of the subgroups with the highest exposure are 
reported below in Table 3.
    The results of the chronic dietary analysis show that risk ranges 
from 9% of the cPAD for adult males (20 years and older), to 39% of the 
cPAD for all infants (<1 year). Risk estimates for all population 
subgroups are below EPA's level of concern (100% of the cPAD).

[[Page 35919]]



         Table 3.--Results of Chronic Dietary Exposure Analysis
------------------------------------------------------------------------
                                                     Exposure
          Population Subgroup            cPAD (mg/   (mg/kg/     % cPAD
                                          kg/day)      day)
------------------------------------------------------------------------
U.S. Population (total)                      0.038    0.00503         13
--------------------------------------------------------------
--------------------------------------------------------------
--------------------------------------------------------------
------------------------------------------------------------------------
------------------------------------------------------------------------
------------------------------------------------------------------------
------------------------------------------------------------------------
------------------------------------------------------------------------

    iii. Cancer. Trifloxystrobin was classified as a ``not likely human 
carcinogen.'' Therefore, a cancer risk assessment was not conducted.
    2. Water exposure. Trifloxystrobin is immobile, degrades and 
transforms rapidly, in soil (half life is about 2 days) and aquatic 
environments (half life is about 15-55 days), mostly to a series of 
isomers and the primary acid metabolite, CGA-321113. The major isomer 
forms at the average rate of 80% of the applied parent, is persistent, 
(half life is about 301 days), and soluble, 30.9 ppm and is also 
mobile. The major degradate minimum Koc is 49, the median Koc is 127 
and is also stable to hydrolysis. The major degradate, CGA-321113 is 
persistent and mobile and has a potential to leach into groundwater. 
CGA-321113 has been found in the soil profile at the 36 inch depth.
    Estimated environmental concentrations (EECs) were calculated for 
total trifloxystrobin residues (parent trifloxystrobin and its major 
degradate, CGA-321113 ) using EPA's FIRST model for surface water and 
the screeninig concentration in ground water (SCI-GROW) model. EPA's 
interim method for drinking water estimates for pesticides used in rice 
paddies was also used to generate EECs. No degradation process of the 
chemical and no dilution with uncontaminated water outside of the paddy 
were taking into account. The rice estimates are ``expected to vastly 
exceed the `true' values found in the environment, especially for 
trifloxystrobin, since available environmental fate data show that this 
compound degrades fairly rapidly in water and soil.''
    EECs were estimated for total trifloxystrobin residues because the 
environmental fate studies indicated that the parent compound forms 
transformation compounds (isomers) which are similar in structure to 
the parent under most conditions. Further, the EPA concluded that both 
trifloxystrobin and the free form of its acid metabolite CGA-321113 are 
of concern for both regulatory and risk assessment purposes for plant 
and livestock commodities.
    The use site with the highest application rate is turfgrass, with a 
maximum label rate of 1.078 pounds active ingredient per acre per year 
(lbs/ai/ac/yr) (three applications at 0.359 lbs/ai/ac/yr). Drinking 
water estimates were also provided for rice paddies that may be treated 
with trifloxystrobin.
    Surface water concentrations of trifloxystrobin and its major 
degradate CGA-321113 are 92 parts per billion (ppb) for the peak value 
(acute) and 50 ppb for the chronic value using the FIRST model. The 
groundwater screening concentration to be used for both acute and 
chronic assessments is 3.4 ppb. These values represent upper-bound 
estimates of the concentrations of total residues of trifloxystrobin 
that might be found in surface water and groundwater from the use of 
trifloxystrobin on turfgrass at the maximum application rate.
    3. Non-dietary exposure. Trifloxystrobin's residential uses include 
turfgrass/ornamental disease control (Compass[reg]). Because the FQPA 
requires consideration of aggregate exposure to all likely non-
occupational uses, this assessment uses non-occupational 
postapplication contact with trifloxystrobin following Compass[reg] use 
on turfgrass as the most common and worst case contributor to such 
exposures. The margin of exposure (MOEs) for applicable residential 
scenarios (i.e., postapplication dermal exposure from pesticide 
residues on lawns, incidental non-dietary ingestion of pesticide 
residues on lawns from hand-to-mouth transfer, incidental non-dietary 
ingestion of residues from pesticide-treated turfgrass from object-to-
mouth activities, and incidental non-dietary ingestion of soil from 
pesticide-treated residential areas) were calculated separately, and 
then combined.
    i. Residential handler. This current petition does not propose 
residential uses for trifloxystrobin. However, the label for the 
trifloxystrobin product, Compass[reg] , includes residential use on 
turfgrass and ornamentals. This product may only be applied by a 
Certified Pest Control Operartor (PCO), not by homeowners directly.
    ii. Postapplication. There is potential for dermal (adults and 
children) and oral exposure (children only) during postapplication 
activities. The following postapplication exposure scenarios resulting 
from lawn treatment were assessed: (1) Dermal exposure from pesticide 
residues on lawns, (2) incidental non-dietary ingestion of pesticide 
residues on lawns from hand-to-mouth transfer, (3) incidental non-
dietary ingestion of residues from object-to-mouth activities 
(pesticide-treated turfgrass), and (4) incidental non-dietary ingestion 
of soil from pesticide-treated residential areas. Postapplication 
exposures from various activities following lawn treatment are 
considered to be the most common and significant in residential 
settings. Exposure via incidental non-dietary ingestion involving other 
plant material may occur but is expected to result in much less 
exposure than the four exposure scenarios listed above.
    The exposure and risk estimates for the four residential exposure 
scenarios are assessed for the day of application (day ``0'') because 
it is assumed that adults and toddlers could contact the lawn 
immediately after application. On

[[Page 35920]]

the day of application, it was assumed that 5 percent of the 
application rate is available from the turfgrass as transferrable 
residue (20 percent for object-to-mouth activities). Intermediate-term 
exposure (1 to 6 months) is not expected based on trifloxystrobin's 
short half-life in soil (about 2 days). Chronic or long-term 
(continuous exposure over more than 6 months) exposure is not expected. 
The short-term MOEs for adults and children are above 100, they DO NOT 
exceed EPA's level of concern.
    iii. Recreational. Trifloxystrobin may be used on turf at 
recreational use sites, and, therefore may result in postapplication 
exposure to adults and children involved in recreational activities. 
Exposures to adults and children from the use of trifloxystrobin at 
recreational use sites are assumed to be the same as those assessed for 
residential use sites. Residential turf exposure assessment results in 
what are considered upper bound risk estimates. Therefore, it is not 
expected that the upper bound residential exposure scenario would occur 
on the same day as an upper bound recreational exposure scenario. 
Exposure from these two exposure scenarios are not aggregated. Rather, 
the residential risk estimate should serve as an upper bound for both 
residential and recreational exposure.
    Postapplication exposures from various activities following lawn 
treatment are considered to be the most common and significant in 
residential settings. There is potential for dermal (adults and 
children) and oral exposure (children only) during postapplication 
activities. Four postapplication exposure scenarios resulting from lawn 
treatment were assessed. Postapplication exposure and risk estimates 
for adults and children resulted in MOE's that were above 100 and all 
risks were considered below EPA's level of concern.
    iv. Other exposure sources. Spray drift is always a potential 
source of exposure to residents nearby to spraying operations. This is 
particularly the case with aerial application, but, to a lesser extent, 
could also be a potential source of exposure from the groundboom 
application. The Agency has been working with the Spray Drift Task 
Force, EPA Regional Offices and State Lead Agencies for pesticide 
regulation and other parties to develop the best spray drift management 
practices. The Agency is now requiring interim mitigation measures for 
aerial applications that must be placed on product labels/labeling. The 
Agency has completed its evaluation of the new database submitted by 
the Spray Drift Task Force, a membership of U.S. pesticide registrants, 
and is developing a policy on how to appropriately apply the data and 
the AgDRIFT computer model to its risk assessments for pesticides 
applied by air, orchard airblast and ground hydraulic methods. After 
the policy is in place, the Agency may impose further refinements in 
spray drift management practices to reduce off-target drift and risks 
associated with aerial as well as other application types where 
appropriate.
    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).

D. Safety Factor for Infants and Children

    EPA determined the 10x safety factor for the protection of infants 
and children should be removed for the following reasons:
    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.

E. Aggregate Risks and Determination of Safety

    Acute and chronic aggregate risk estimates were calculated in this 
risk assessment. Acute aggregate risk was calculated by comparing acute 
drinking water levels of concern (DWLOCs) to potential drinking water 
exposure to trifloxystrobin. Similarly, chronic aggregate risk was 
calculated by comparing chronic DWLOCs to potential drinking water 
exposure.
    Short-term aggregate risk estimates were also calculated. Short-
term risk is based on exposures occurring over 1 to 30 days. Short-term 
aggregate risk was calculated by combining risk estimates for high-end 
residential oral and/or dermal exposures with chronic food and drinking 
water risks. Intermediate-term risk is based on 30 to 180 days of 
exposure (1 to 6 months). Intermediate-term exposure is not expected to 
occur based on the short soil half-life (about 2 days). Chronic non-
dietary aggregate risk was not calculated as chronic dermal and oral 
exposures (from residential treatment) are not expected. Cancer 
aggregate risk was not calculated because trifloxystrobin is classified 
as ``not likely human carcinogen.''
    1. Acute risk (food + drinking water). The acute aggregate risk 
assessment takes into account exposure estimates from dietary 
consumption of trifloxystrobin from food and drinking water sources. 
The acute risk estimate for Females 13-50 years, resulting from 
aggregate exposure to trifloxystrobin in food and drinking water is 
below EPA's level of concern. Acute aggregate risk was not calculated 
for the U.S. population including infants and

[[Page 35921]]

children or other population subgroups as EPA did not identify an 
endpoint for risk assessment for those groups.
    The surface and groundwater EECs were used to compare against back-
calculated DWLOCs for aggregate risk assessments. To calculate the 
DWLOC for acute exposure relative to an acute toxicity endpoint, the 
acute dietary food exposure (from DEEM[reg]) was subtracted from the 
aPAD to obtain the acceptable acute exposure to trifloxystrobin in 
drinking water. The acute DWLOCs are listed in the following Table 4:

                                             Table 4.--DWLOCs for Acute Dietary Exposure to Trifloxystrobin
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                 Max. Water      Rice Surface      Ground
                 Population Subgroup\1\                   Acute PAD (mg/  Food Exposure (mg/  Exposure (mg/kg/  Water (g/L)\3\   Water  (g/   DWLOC (g/
                                                              kg/day)          kg/day)            day)\2\                          L)\3\        L)\4\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females (13-50 years)                                                2.5              0.012                2.5              48          3.4       75,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Within each of these subgroups, the subpopulation with the highest (acute) food exposure having an adequately representative number of samples was
  selected EPA default body weight is 60 kg for females (13+ years old).
\2\ Maximum Water Exposure (mg/kg/day) = Acute PAD (mg/kg/day) - Acute Food Exposure.
\3\ Estimate for the highest use rate was chosen.
\4\ DWLOC (g/L) = [Maximum water Exposure (mg/kg/day) x body wt (kg)] / [(10-3 mg/g) x water consumed daily (L/day)]. g/L = parts per billion. EPA
  default daily drinking rate is 2 L/day for adults.

    For the acute aggregate risk scenario, food and drinking water 
exposures were taken into account. DWLOCs were calculated for females 
(13-50 years old) the only subgroup to which the acute dietary endpoint 
applies. The DWLOC was 75,000 ppb for females. This value is well above 
the EECs for drinking water, and therefore, acute aggregate risk is 
below EPA's level of concern.
    2. Short-term risk (food + drinking water + residential). The 
short-term aggregate risk assessment estimates risks likely to result 
from 1- to 30-day exposure to trifloxystrobin residues are from food, 
drinking water, and residential pesticide uses. High-end estimates of 
residential exposure are used in the short-term assessment, while 
average values are used for food and drinking water exposure (i.e. 
chronic exposures).
    A short-term risk assessment is required for adults because there 
is a residential exposure scenario (postapplication only). In addition, 
a short-term risk assessment is required for infants and children 
because there are residential post-application dermal and oral exposure 
scenarios. Toddlers' incidental oral exposure is assumed to include 
hand-to-mouth exposure, object-to-mouth exposure and exposure through 
incidental ingestion of soil.
    Different endpoints were identified by EPA for short-term 
incidental oral and dermal risk assessment. The basis for the oral 
endpoint is reduced pup body weights and the dermal endpoint is based 
on increases in liver and kidney weights. Therefore, it is not possible 
to combine the exposure from both dietary/oral exposure with that from 
dermal exposure.
    For the short-term aggregate risk scenario, food, drinking water 
and residential exposures are taken into account. DWLOCs were 
calculated for the U.S. population, males (13-19 years old), all 
infants (less than 1 year old) and females (13-50 years old). DWLOCs 
ranged from 170 ppb for all infants to 1,200 pbb for the U.S. 
population and males (13-19 years old). These values are above the EECs 
for drinking water and therefore, short-term aggregate risk is below 
EPA's level of concern.
    3. Intermediate-term risk. The intermediate-term aggregate risk 
assessment estimates risks likely to result from 1 to 6 months of 
exposure (30 to 180 days) to trifloxystrobin residues from food, 
drinking water, and residential pesticide uses. High-end estimates of 
residential exposure are used in the short-term assessment, while 
average values are used for food and drinking water exposure (i.e. 
chronic exposures).
    Intermediate-term exposure is not expected to occur based on the 
short soil half-life (about 2 days). Therefore, an intermediate-term 
aggregate risk assessment was not performed.
    4. Chronic risks. The chronic aggregate risk assessment takes into 
account exposure estimates from dietary consumption of trifloxystrobin 
from food and drinking water sources. Chronic risk estimates resulting 
from aggregate exposure to trifloxystrobin in food and drinking water 
are below EPA's level of concern from all population subgroups.
    The surface and groundwater EECs were used to compare against back-
calculated DWLOCs for aggregate risk assessments. To calculate DWLOCs 
for chronic exposure relative to a chronic toxicity endpoint, the 
chronic dietary food exposure (from DEEM[reg]) was subtracted from the 
cPAD to obtain the acceptable chronic exposure to trifloxystrobin in 
drinking water. The chronic DWLOCs are listed in the following Table 5:

                                            Table 5.--DWLOCs for Chronic Dietary Exposure to Trifloxystrobin.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                            Max. Water     Rice Surface
                 Population Subgroup\1\                     Chronic PAD    Food Exposure  Exposure  (mg/  Water (g/L)\3\   Ground Water     DWLOC  (g/
                                                            (mg/kg/day)     (mg/kg/day)     kg/day)\2\                       (g/L)\3\          L)\4\
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. Population                                                    0.038         0.00503           0.033             140             3.4           1,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
-----------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Within each of these subgroups, the subpopulation with the highest food exposure having an adequately representative number of samples was selected
  EPA default body weights are: General U.S. Population, 70 kg; Females (13+ years old), 60 kg; and, All Infants/Children, 10 kg.
\2\ Maximum Water Exposure (mg/kg/day) = Chronic PAD (mg/kg/day) - Chronic Food Exposure.
\3\ Estimate for the highest use rate was chosen.

[[Page 35922]]

 
\4\ DWLOC (g/L) = [Maximum water Exposure (mg/kg/day) x body wt (kg)] / [(10-3 mg/g) x water consumed daily (L/day)]. g/L = parts per billion. EPA
  default daily drinking rates are 2 L/day for Adults and 1 L/day for Infants/Children.

    Chronic DWLOCs for all population subgroups are above the estimated 
concentrations of trifloxystrobin and its metabolites in drinking 
water, and are therefore not of concern.
    5. Aggregate cancer risk. Not applicable. There is no evidence of 
carcinogenicity.
    6. Determination of safety. EPA concludes with reasonable certainty 
that aggregate exposure from trifloxystrobin will not result in harm to 
the adult U.S. population or infants and children.

IV. Other Considerations

A. Metabolism in Plants and Animals

    1. For plants. The qualitative nature of the residue in plants is 
adequately understood for fruits, fruiting vegetables, cucurbit 
vegetables and peanuts, based on acceptable metabolism studies 
conducted on apples, cucumbers, peanuts, and a supplementary study on 
wheat. For the current petition, Bayer submitted two sugar beet 
trifloxystrobin metabolism studies. As result of these studies the 
nature of trifloxystrobin in/on sugar beets is adequately understood. 
The sugar beet metabolism studies, however, do not fulfill the wheat 
metabolism data requirement because the two crops are too dissimilar.
    2. For animals. No livestock data were submitted. The qualitative 
nature of the residue in livestock is adequately understood based on 
acceptable studies conducted on goats and laying hens. The EPA has 
determined that the total toxic residues for livestock, both for 
regulatory and risk assessment purposes, is trifloxystrobin and the 
free form of its acid metabolite CGA-321113. Additionally, metabolite 
L7a (taurine conjugate of trifloxystrobin) in the liver should be 
included in the risk assessment.

B. Analytical Method for Plants and Livestock

    EPA has completed a method validation trial 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 livestock commodities. The enforcement method has been 
submitted to the Food and Drug Administration for publication in the 
Pesticides Assessment Manual II.
    The analytical methods, AG-659A or AG-659A/REM 177.04, are adequate 
for collecting data for residues of trifloxystrobin and its acid 
metabolite CGA-321113 in/on all crops associated with this petition.

C. 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.

V. Conclusion

    Therefore, tolerances are established for combined residues of 
trifloxystrobin and the free form of its acid metabolite CGA-321113 in/
on fruit, stone, group at 2 ppm; nut, tree, group at 0.04 ppm; 
pistachio at 0.04 ppm; corn, field, grains at 0.05 ppm; corn, field, 
forage at 0.2 ppm; corn, field, stover at 7 ppm; corn, field, refined 
oil at 0.1 ppm; corn, pop, grain at 0.05 ppm; corn, pop, stover at 7 
ppm; rice, grain at 3.5 ppm; rice, hulls at 8 ppm; rice, straw at 7.5 
ppm; citrus, dried pulp at 0.8 ppm; citrus oil at 30 ppm; fruit, 
citrus, grroup at 0.3 ppm; egg at 0.04 ppm; poultry, fat at 0.04 ppm; 
poultry, meat at 0.04 ppm; poultry, meat by products at 0.04 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-2002-0052 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 July 22, 
2002.
    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 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

[[Page 35923]]

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-2002-0052, 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 6.1/8.1 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 a tolerance 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). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). 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 any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or 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). For these same reasons, the 
Agency has determined that this rule does not have any ''tribal 
implications'' as described in Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 6, 2000). Executive Order 13175, requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by tribal officials in the development of regulatory policies that have 
tribal implications.'' ''Policies that have tribal implications'' is 
defined in the Executive order to include regulations that have 
``substantial direct effects on one or more Indian tribes, on the 
relationship between the Federal Government and the Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
Government and Indian tribes.'' This rule will not have substantial 
direct effects on tribal governments, on the relationship between the 
Federal Government and Indian tribes, or on the distribution of power 
and responsibilities between the Federal Government and Indian tribes, 
as specified in Executive Order 13175. Thus, Executive Order 13175 does 
not apply to this rule.

VIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq.,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 final rule in the Federal Register. This final 
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.


[[Page 35924]]


    Dated: May 13, 2002.
Debra Edwards,
Acting 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), 346(a), and 374.

    2. Section 180.555 is amended by alphabetically adding commodities 
to the table in paragraph (a) to read as follows:


 180.555  Trifloxystrobin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Citrus, dried pulp...........................................        0.8
Citrus, oil..................................................         30
Corn, field, forage..........................................        0.2
Corn, field, grain...........................................       0.05
Corn, field, stover..........................................          7
Corn, field, refined oil.....................................        0.1
Corn, pop, grain.............................................       0.05
Corn, pop, stover............................................          7
                                * * * * *
Egg..........................................................       0.04
Fruit, citrus, group.........................................        0.3
Fruit, stone, group..........................................          2
                                * * * * *
 
Nut, tree, group.............................................       0.04
                                * * * * *
Pistachio....................................................       0.04
                                * * * * *
 
Poultry, fat.................................................       0.04
Poultry, meat................................................       0.04
Poultry, meat byproducts.....................................       0.04
                                * * * * *
 
Rice, grain..................................................        3.5
Rice, hulls..................................................          8
Rice, straw..................................................        7.5
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 02-12850 Filed 5-21-99; 8:45 am]
BILLING CODE 6560-50-S