[Federal Register Volume 66, Number 170 (Friday, August 31, 2001)]
[Notices]
[Pages 45988-45993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22025]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1040;FRL-6797-6]


Notice of Filing a Pesticide Petition to Establish a Tolerance 
for a Certain Pesticide Chemical in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of 
certain pesticide chemicals in or on various food commodities.

DATES: Comments, identified by docket control number PF-1040, must be 
received on or before October 1, 2001.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number PF-1040 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, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 305-7704; 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 under FOR FURTHER INFORMATION 
CONTACT.

[[Page 45989]]

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/.
    2. In person. The Agency has established an official record for 
this action under docket control number PF-1040. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, 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 Highway, 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.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number PF-1040 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket control number PF-1040. Electronic comments may 
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI 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. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the person identified under FOR FURTHER INFORMATION 
CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    EPA has received pesticide petitions as follows proposing the 
establishment and/or amendment of regulations for residues of certain 
pesticide chemicals in or on various food commodities under section 408 
of the Federal Food, Drug, and Comestic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that these petitions contain data or information 
regarding the elements set forth in section 408(d)(2); however, EPA has 
not fully evaluated the sufficiency of the submitted data at this time 
or whether the data supports granting of the petition. Additional data 
may be needed before EPA rules on the petition.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.


    Dated: August 16, 2001.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

Summaries of Petitions

    Petitioner summaries of the pesticide petitions are printed below 
as required by section 408(d)(3) of the FFDCA. The summaries of the 
petitions were prepared by the petitioners and represent the views of 
the petitioners. EPA is publishing the petition summaries verbatim 
without editing them in any way. The petition summary announces the 
availability of a description of the analytical methods available to 
EPA for the detection and measurement of the pesticide chemical 
residues or an explanation of why no such method is needed.

Bayer Corporation

0F6121

Summary of Petitions

    EPA has received a pesticide petition (0F6121) from Bayer 
Corporation, 8400 Hawthorne Road, P. O. Box 4913, Kansas City, MO 
64121-0013 proposing, pursuant to section 408(d) of the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part

[[Page 45990]]

180 by establishing a tolerance for residues of trifloxystrobin in or 
on the raw agricultural commodity barley grain at 0.05 parts per 
million (ppm), straw at 0.05 ppm, barley hay at 0.2 ppm, citrus fruits 
group at 0.3 ppm, citrus oil at 7.0 ppm, corn forage at 0.05 ppm, corn 
stover at 7.0 ppm, aspirated grain fractions at 0.1 ppm, popcorn grain 
at 0.05 ppm, popcorn stover at 7.0 ppm, pecans at 0.05 ppm, rice grain 
at 3.5 ppm, rice straw at 7.5 ppm, stone fruits crops group at 2.0 ppm, 
and poultry (fat, kidney, liver, meat by-products, meats at 0.5 ppm). 
EPA has determined that the petition contains data or information 
regarding the elements set forth in section 408(d)(2) of the FFDCA; 
however, EPA has not fully evaluated the sufficiency of the submitted 
data at this time or whether the data supports granting of the 
petition. Additional data may be needed before EPA rules on the 
petition.

A. Residue Chemistry

    1. Residue metabolism. The metabolism of trifloxystrobin in plants 
(cucumbers, apples, wheat, sugar beets and peanuts) is well understood. 
Identified metabolic pathways are substantially similar in plants and 
animals (goat, rat and hen). EPA has determined that trifloxystrobin 
parent and its metabolite CGA-321113 are the residue of concern for 
tolerance setting purposes.
    2. Analytical method. A practical analytical methodology for 
detecting and measuring levels of trifloxystrobin in or on raw 
agricultural commodities has been submitted. The limit of detection 
(LOD) for each analyte of this method is 0.08 ng injected, and the 
limit of quantitation (LOQ) is 0.02 ppm. The method is based on crop 
specific cleanup procedures and determination by gas chromatography 
with nitrogen-phosphorous detection.
    3. Magnitude of residues. Residue trials were performed for 
trifloxystrobin on a full geography of Citrus Fruit Crop Group (with 
oranges, lemons and grapefruit as representative citrus fruit crops), 
field corn, popcorn, and rice as representative crops from the cereal 
grain group, pecans, and Stone Fruits Crop Group (with peaches, plums, 
tart and sweet cherries as representative stone fruit crops). A study 
was conducted on indicator crops to assay for secondary residues in 
rotational crops. A three-level ruminant and poultry study was 
completed to determine the rate of transfer of residues of 
trifloxystrobin from residues in animal feed to ruminant and poultry 
commodities.

B. Toxicological Profile

    1. Acute Toxicity. Studies conducted with the technical material of 
trifloxystrobin:
     Rat acute oral toxicity study with a LD50 
>5,000 mg/kg
     Mouse acute oral toxicity study with a LD50 
>5,000 mg/kg
     Rabbit acute dermal toxicity study with a LD50 
>2,000 mg/kg
     Rat acute dermal toxicity study with a LD50 
>2,000 mg/kg
     Rat acute inhalation toxicity study with a LC50 
>4.65 mg/L
     Rabbit eye irritation study showing slight irritation 
(Category III)
     Rabbit dermal irritation study showing slight irritation 
(Category IV)
     Guinea pig dermal sensitization study with Buehler's 
method showing negative findings
     Guinea pig dermal sensitization study with the 
Maximization method showing some positive findings
    2. Genotoxicity. No genotoxic activity is expected of 
trifloxystrobin under in vivo or physiological conditions. The compound 
has been tested for its potential to induce gene mutation and 
chromosomal changes in five different test systems. The only positive 
finding was seen in the in vitro test system (Chinese hamster V79 
cells) as a slight increase in mutant frequency at a very narrow range 
(250 - 278 g/ml) of cytotoxic and precipitating concentrations 
(compound solubility in water was reported to be 0.61 g/ml; 
precipitation was visually noted in culture medium at 150 g/
ml). The chemical was found to be non-mutagenic in the in vivo system 
or all other in vitro systems. Consequently, the limited gene mutation 
activity in the V79 cell line is considered a nonspecific effect under 
non-physiological in vitro conditions and not indicative of a real 
mutagenic hazard.
    3. Reproductive and developmental toxicity. FFDCA section 408 
provides that EPA may apply an additional safety factor for infants and 
children in the case of threshold effects to account for pre- and post-
natal toxicity and the completeness of the database. Based on the 
current toxicological data requirements, the database on 
trifloxystrobin relative to pre- and post-natal effects for children is 
complete.
    In assessing the potential for additional sensitivity of infants 
and children to residues of trifloxystrobin, data were considered from 
teratogenicity studies in the rat and the rabbit and a 2-generation 
reproduction studies in the rat. The teratogenicity studies were 
designed to evaluate adverse effects on the developing embryo as a 
result of chemical exposure during the period of organogenesis. 
Reproduction studies provide information on effects from chemical 
exposure on the reproductive capability of mating animals and systemic 
and developmental toxicity from in-utero exposure.
    In the rat teratology study, reductions in body weight gain and 
food consumption were observed in the dam at 100 mg/kg. No 
teratogenic effects or any other effects were seen on pregnancy or 
fetal parameters except for the increased incidence of enlarged thymus, 
which is a type of variation, at 1,000 mg/kg. The developmental NOAEL 
was 100 mg/kg.
    In the rabbit teratology study, body weight loss and dramatically 
reduced food consumption were observed in the dam at 2,050 
mg/kg. No teratogenic effects or any other effects were seen on 
pregnancy or fetal parameters except for the increase in skeletal 
anomaly of fused sternebrae-3 and -4 at the top dose level of 500 mg/
kg. This finding is regarded as a marginal effect on skeletal 
development that could have resulted from the 40-50% lower food intake 
during treatment at this dose level. The developmental NOAEL was 250 
mg/kg.
    In the 2-generation rate reproduction study, body weight gain and 
food consumption decreased at 750 ppm, especially in females 
during lactation. Consequently, the reduced pup weight gain during 
lactation (750 ppm) and the slight delay in eye opening 
(1,500 ppm) are judged to be a secondary effect of maternal toxicity. 
No other fetal effects or any reproductive changes were noted. The low 
developmental NOAEL, 50 ppm (5 mg/kg), seen in this study was probably 
due to the lack of intermediate dose levels between 50 and 750 ppm. 
Based on an evaluation of the dose-response relationship for pup weight 
at 750 ppm and 1,500 ppm, the NOAEL should have already been nearly 
ten-fold higher if such a dose was available.
    Based on all these teratology and reproduction studies, the lowest 
NOAEL for developmental toxicity is 5 mg/kg while the lowest NOAEL in 
the subchronic and chronic studies is 2.5 mg/kg/day (from the rat 
chronic study). Therefore, no additional sensitivity for infants and 
children to trifloxystrobin is suggested by the database.
    4. Subchronic toxicity. In subchronic studies, several mortality 
related changes were reported for the top dose in dogs (500 mg/kg) and 
rats (800 mg/kg). At these dose levels, excessive toxicity has resulted 
in body weight loss and mortality with the associated and nonspecific 
changes in several organs

[[Page 45991]]

(such as atrophy in the thymus, pancreas, bone morrow, lymph node, and 
spleen) which are not considered specific target organs for the test 
compound. In the dog, specific effects were limited to hepatocellular 
hypertrophy at 150 mg/kg and hyperplasia of the epithelium 
of the gall bladder at 500 mg/kg. Target organ effects in the rat were 
noted as hepatocellular hypertrophy (200 mg/kg) and the 
related liver weight increase (50 mg/kg). In the mouse, 
target organ effects included single cell necrosis (300 mg/
kg) and hypertrophy (1,050 mg/kg) in the liver and extramedullary 
hematopoiesis (300 mg/kg) and hemosiderosis in the spleen 
(1,050 mg/kg).
    In general, definitive target organ toxicity, mostly in the liver, 
was seen at high feeding levels of over 100 mg/kg for an extended 
treatment period. At LOAEL, no serious toxicity was observed other than 
mostly non-specific effects including a reduction in body weight and 
food consumption or liver hypertrophy.
    5. Chronic toxicity. The liver appears to be a major primary target 
organ based on the chronic studies conducted in mice, rats, and dogs. 
It was identified as a target organ in both the mouse and the dog 
studies with trifloxystrobin. However, no liver effect was seen in the 
chronic rat study which produced the lowest NOAEL of 2.5 mg/kg based on 
reduced body weight gain and food consumption seen at higher dose 
levels.
    The compound did not cause any treatment-related increase in 
general tumor incidence, any elevated incidence of rare tumors, or 
shortened time to the development of palpable or rapidly lethal tumors 
in the 18-month mouse and the 24-month rat studies. Dosages in both 
studies were sufficient for identifying a cancer risk. In the absence 
of carcinogenicity, a Reference Dose approach is appropriate for 
quantitation of human risks.
    6. Animal metabolism. Trifloxystrobin is moderately absorbed from 
the gastrointestinal tract of rats and is rapidly distributed. 
Subsequent to a single oral dose, the half life of elimination is about 
2 days and excretion is primarily via bile. Trifloxystrobin is 
extensively metabolized by the rat into about 35 metabolites, but the 
primary actions are on the methyl ester (hydrolysis into an acid), the 
methoxyimino group (O-demethylation), and the methyl side chain 
(oxidation to a primary alcohol). Metabolism is dose dependent as it 
was almost complete at low doses but only about 60% complete at high 
doses.
    In the goat, elimination of orally administered trifloxystrobin is 
primarily via the feces. The major residues were the parent compound 
and the acid metabolite (CGA-321113) plus its conjugates. In the hen, 
trifloxystrobin is found as the major compound in tissues and in the 
excreta, but hydroxylation of the trifluormethyl-phenyl moiety and 
other transformations, including methyl ester hydrolysis and 
demethylation of the methoxyimino group, are also seen. In conclusion, 
the major pathways of metabolism in the rat, goat, and hen are the 
same.
    7. Metabolite toxicology. Metabolism of trifloxystrobin has been 
well characterized in plants, soil, and animals. In plants and soil, 
photolytically induced isomerization results in a few minor metabolites 
not seen in the rat; however, most of the applied materials remained as 
parent compound as shown in the apple and cucumber studies. All 
quantitatively major plant and/or soil metabolites were also seen in 
the rat. The toxicity of the major acid metabolite, CGA-321113 (formed 
by hydrolysis of the methyl ester), has been evaluated in cultured rat 
hepatocytes and found to be 20-times less cytoxic than the parent 
compound. Additional toxicity studies were conducted for several minor 
metabolites seen uniquely in plants and/or soil. The studies indicate 
that these metabolites, including CGA-357261, CGA-373466, and NOA-
414412, are not mutagenic to bacteria and are of low acute toxicity 
(LD50 >2,000 mg/kg). In conclusion, the metabolism and 
toxicity profiles support the use of an analytical enforcement method 
that accounts for parent trifloxystrobin.
    8. Endocrine disruption. CGA-279202 does not belong to a class of 
chemicals known for having adverse effects on the endocrine system. 
Developmental toxicity studies in rats and rabbits and reproduction 
study in rats gave no indication that CGA-279202 might have any effects 
on endocrine function related to development and reproduction. The 
subchronic and chronic studies also showed no evidence of a long-term 
effect related to the endocrine system.
    i. Dietary exposure-- a. Food. Acute and chronic dietary exposure 
assessments were performed on the crops that are the subject of this 
petition using field trial residue values on the citrus and stone fruit 
crop groups, corn, rice, barley, and pecans. In addition, established 
uses on sugar beets, almonds, fruiting vegetable (crop group), pome 
fruit (crop group), cucurbits (crop group), bananas, grapes, peanuts, 
potatoes, hops, and wheat were included in the assessment. All residues 
were generated from field trials conducted with a minimum pre-harvest 
interval and maximum application rate. In addition, if market share 
data were available, residues were adjusted for the percent crop 
treated. The residues in processed potatoes, sugar beets (molasses), 
tomatoes, oranges (juice), apples (juice), corn, rice, wheat fractions, 
peanuts, and grapes (juice) were adjusted using experimentally 
determined processing factors generated from processing studies. For 
all other processed fractions, USDA default processing factors were 
utilized. Residues in animal commodities were calculated from 
theoretical dietary burden calculations and transfers factors obtained 
from livestock and poultry feeding studies. Assessments were conducted 
utilizing the Dietary Exposure Evaluation Model (DEEM) from 
Novigen Sciences and the 1994-96 Continuing Survey of Food Intake by 
Individuals (CSFII). Acute exposure for the U.S. population and all 
population subgroups were compared to an acute reference dose (aRfD) of 
2.5 mg/kg/day based on a developmental no-observable adverse effect 
level (NOAEL) in rabbits and a 100-fold uncertainty factor. Although 
this endpoint is applicable to females only in the strictest sense, the 
developmental NOAEL was used for all populations due to the lack of a 
suitable toxicological endpoint. Chronic exposure was compared to a 
chronic RfD of 0.05 mg/kg/day based on a chronic study in dogs and a 
100-fold uncertainty factor. Both acute and chronic toxicological 
endpoints were taken from the final pesticide tolerance rule for 
trifloxystrobin published in the Federal Register of September 27, 1999 
(OPP-300922; FRL-6382-5).
    Both acute and chronic exposure was minimal in all population 
subgroups. The acute results were obtained from a probabilistic, 1,000-
iteration Monte Carlo assessment. Acute exposure was expressed at the 
99.9th percentile of exposure and ranged from 0.17% to 0.08% of the 
aRfD with non-nursing infants (less than 1 year old) as the most 
sensitive population subgroup (0.80% of the RfD). The chronic exposure 
assessment was conducted by taking the mean field trial residue values 
and comparing to average daily consumption values. Chronic exposure 
ranged from 0.2% to 1.2% of the chronic RfD and the most sensitive 
population was non-nursing infants (less than 1 year old).
    b. Drinking water--Estimated surface water concentration. The 
generic expected environmental concentration (GENEEC) estimated surface 
water

[[Page 45992]]

concentrations for trifloxystrobin uses contributed little to the over 
exposure. These estimated concentrations were not adjusted for the 
estimated market share of percentage of use area. The highest day-56 
expected environmental concentration (EEC) value was 0.27 parts per 
billion (ppb) provided by the established trifloxystrobin turf use. 
According to the EPA ``OPP's Interim Approach for Addressing Drinking 
Water Exposure,'' the average day-56 value is divided by three when 
correcting for overestimation of the GENEEC model. The EPA has accepted 
that the average day-56 EEC value is divided by six in the case when 
the product is applied to turf and accounts for the effects of grass/
turf in decreasing runoff (EPA, 1998. EPA-730-F97-2, PB97-137806, page 
15). This division by six was used to calculate the potential exposure 
via surface water from the trifloxystrobin turf application, 0.27 ppb/
6=0.045 ppb.
    Estimated ground water concentrations. The SCI-GROW estimated 
ground water concentrations for trifloxystrobin uses also contributed 
little to the overall exposure. The estimated concentrations were not 
adjusted for the estimated market share or percentage of use area. In 
each use scenario, the concentration of trifloxystrobin in ground water 
was predicted to be below 1 part per trillion. The highest estimated 
concentration of trifloxystrobin in the ground water was 0.000859 ppb 
provided by the trifloxystrobin turf use.
    c. Drinking water levels of concern--Acute exposure. Based on the 
EPA's ``Interim Guidance for Conducting Drinking Water Exposure and 
Risk Assessments'' document (drafted 12/2/97), acute drinking water 
levels of comparison (DWLOCacute) were calculated for 
trifloxystrobin. The lowest acceptable Margin of Exposure (MOE) for any 
pesticide is 100. This value was used in the DWLOC calculations. Based 
on this analysis, the maximum estimated trifloxystrobin surface water 
at Peak Day-0 (2.54 ppb) and ground water (0.000859 ppb) 
concentrations, human drinking water exposures do not exceed the 
calculated acute DWLOC values (g/L:24,8000 to 87,325). 
Therefore, acute human drinking water exposures to trifloxystrobin from 
the existing and newly proposed uses would not exceed the exposure 
allowable by the risk cup. From the acute dietary exposure analysis 
provided for the trifloxystrobin dietary assessment, the acute drinking 
water levels of comparison (DWLOCacute) were calculated for 
CGA-32113. Based on this analysis, the maximum estimated CGA-32114 in 
surface water at Peak Day-0 (38.73 ppb) and in ground water (4.944316 
ppb) concentrations, human drinking water exposures do not exceed the 
calculated acute DWLOC values (g/L:24800 to 87150). Therefore, 
acute human drinking water exposures to CGA-32114 from the existing and 
newly proposed trifloxystrobin uses would not exceed the exposure 
allowable by the risk cup.
    Chronic exposure. The chronic drinking water levels of comparison 
(DWLOCchronic) were calculated for trifloxystrobin. The 
maximum estimated trifloxystrobin surface water (0.09 ppb) and ground 
water (0.000859 ppb) concentrations do not exceed the calculated 
chronic DWLOC values (g/L:494 to 1747). Therefore, chronic 
human drinking water exposures to the existing and newly proposed 
trifloxystrobin uses would not exceed the exposure allowable by the 
risk cup. From the chronic dietary exposure analysis provided for the 
trifloxystrobin dietary assessment, the chronic drinking water levels 
of comparison (DWLOCchronic) were calculated for CGA-32113. 
Based on this analysis, the maximum estimated CGA-32113 in surface 
water at Day 56/3 (12.24 ppb) and in ground water (0.989 ppb) 
concentrations, human drinking water exposures do not exceed the 
calculated chronic DWLOC values (g/L:494 to 1,745). Therefore, 
chronic human drinking water exposures to the existing and newly 
proposed trifloxystrobin uses would not exceed the exposure allowable 
by the risk cup.
    ii. Non-dietary exposure. Non-dietary exposure to trifloxystrobin 
is considered negligible as the chemical is intended primarily for 
commercial and agricultural use. Post-application re-entry exposure to 
homeowners from professional use on residential ornamentals is 
considered negligible. For workers handling this chemical, acceptable 
margins of exposure (in the range of thousands) have been obtained for 
both acute and chronic scenarios.

D. Cumulative Effects

    Consideration of a common mechanism of toxicity is not appropriate 
at this time since there is no information to indicate that toxic 
effects produced by trifloxystrobin would be cumulative with those of 
any other types of chemicals. Furthermore, the oximinoacetate is a new 
type of fungicide and no compound in this general chemical class 
currently has a significant market share. Consequently, aggregate risk 
is the only potential exposure to trifloxystrobin.

E. Safety Determination

    1. U.S. population. To calculate acute aggregate risk, high-end 
exposures from food and drinking water sources are compared to the 
acute population adjusted dose (aPAD). Exposure to trifloxystrobin 
residues and the free form of its acid metabolite, CGA-321113 in food 
will occupy <1% of the aPAD for females 13+ years old (nursing). Acute 
dietary risk was calculated for females 13+ years old because the 
endpoint upon which the aPAD is based is on developmental effects. 
Estimated drinking water levels were calculated using drinking water 
models (SCI-GROW and GENEEC), and the values are considered 
overestimates due to the conservative assumptions built into the 
models. Estimated concentrations of trifloxystrobin residues in surface 
and ground water are lower than EPA's DWLOCs. Therefore, it is not 
expected that acute aggregate risk to trifloxystrobin residues from 
acute food and drinking water sources will exceed EPA's level of 
concern for acute aggregate risk.
    Chronic exposure to residues of trifloxystrobin and the free form 
of its acid metabolite, CGA-321113, in food will occupy less than 0.5% 
of the chronic population adjusted dose (cPAD) for adult population 
subgroups (females 13+/nursing) and no more than 2.0% of the cPAD for 
infant/children subgroups (highest subgroup: non-nursing infants). 
Estimated concentrations of trifloxystrobin residues in surface and 
ground water are lower than EPA's DWLOCS. Estimated drinking water 
levels were calculated using drinking water models, and the values are 
considered overestimates due to the conservative assumptions built into 
the models. EPA has previously determined chronic residential exposure 
of trifloxystrobin is not expected. The established and pending uses of 
trifloxystrobin when combined in a chronic aggregate risk assessment 
for food, water and residential sources will not exceed EPA's level of 
concern for chronic aggregate risk.
    Bayer concludes that there is a reasonable certainty that no harm 
will result from aggregate exposure to trifloxystrobin residue.
    2. Infants and children. On June 21, 1999, the EPA FQPA Safety 
Factor Committee determined the 10x safety factor for the protection of 
infants and children should be removed for trifloxystrobin. The 
Committee's rationale for removing the FQPA Safety Factor is as 
follows:

[[Page 45993]]

    i. The trifloxystrobin toxicology database is complete for FQPA 
assessment.
    ii. There is no indication of increased susceptibility of rat or 
rabbits to trifloxystrobin.
    In the developmental and reproductive toxicity studies, effects in 
the fetuses/offspring were observed only at or above treatment levels 
which resulted in evidence of parental toxicity.
    Using the same exposure assumptions as employed for the 
determination in the general population, it has been calculated that 
the percent of the RfD that will be utilized by aggregate exposure to 
residues of trifloxystrobin is <2.0% for non-nursing infants (<1 year 
old)(the most impacted sub-population). Therefore, based on the 
completeness and reliability of the toxicity data base and the 
conservative exposure assessment, Bayer concludes that there is a 
reasonable certainty that no harm will result to infants and children 
from aggregate exposure to trifloxystrobin residues.

F. International Tolerances

    No Codex MRLs have been established for residues of 
trifloxystrobin.

[FR Doc. 01-22025 Filed 8-30-01; 8:45 am]
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