[Federal Register Volume 66, Number 130 (Friday, July 6, 2001)]
[Notices]
[Pages 35623-35628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-16956]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1031; FRL-6790-1]


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 a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket control number PF-1031, must be 
received on or before September 4, 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-1031 in the subject line on the first page of your 
response.

[[Page 35624]]


FOR FURTHER INFORMATION CONTACT: By mail: Mary L. Waller, Registration 
Support Branch, Registration Division (7505W), Office of Pesticide 
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-9354; 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 codes         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.

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'' ``Regulation 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-1031. 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-1031 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-1031. 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 a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set

[[Page 35625]]

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 
support 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: June 20, 2001.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petitions

    The petitioner summary of the pesticide petition is printed below 
as required by section 408(d)(3) of the FFDCA. The summary of the 
petition was prepared by the petitioner and represents the view of the 
petitioners. EPA is publishing the petition summary verbatim without 
editing it 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.

Uniroyal Chemical Company

PP 1F6297, 0F6077, and 8F4938

    EPA has received pesticide petitions (1F6297, 0F6077, and 8F4938) 
from Uniroyal Chemical Company, 74 Amity Rd., Bethany, CT 06525 
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 180 by 
establishing tolerances for residues of [[1-1-((4-chloro-2-
(trifluoromethyl) phenyl)imino)-2-propoxyethyl -1H-Imidazole]] in or on 
the raw agricultural commodities strawberries at 2.0 parts per million 
(ppm) [1F6297], the cucurbit crop group at 0.5 ppm [0F6077] and 
cherries at 2.0 ppm [8F4938]. EPA has determined that the petitions 
contain 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 petitions. Additional data may be needed 
before EPA rules on the petitions.

A. Residue Chemistry

    1. Plant metabolism. In crops, the metabolism of 14C-
Phenyl] triflumizole was investigated in cucumber, pears, grapes and 
apples. The major metabolites were: N-(4-chloro-2-
trifluoromethylphenyl)-n-propoxyacetamidine (FM-6-1), N-(4-chloro-2-
trifluoromethyphenyl)-n- propoxyacetanilide (FD-1-1) and the free or 
conjugated products of N-(4-chloro-2-trifluoromethylphenyl)-
hydroxyacetamidine (the O-dealkylation product of FM-6-1), N-(4-chloro-
2-trifluoromethylphenyl)-hydroxyacetanilide (FD-2-1) and the 
triflumizole aniline (FA-1-1).
    2. Analytical method. The analytical method is suitable for 
analyzing crops for residues of triflumizole and its aniline containing 
metabolites at the proposed tolerance levels. The analytical method has 
been independently validated. Residue levels of triflumizole are 
converted to FA-1-1 by acidic and alkaline reflux, followed by 
distillation. Residues are then extracted and subjected to SPE 
purification. Detection and quantitation are conducted by a gas 
chromatography equipped with nitrogen phosphorus detector, electron 
capture detector or mass spectrometry detection. The limit of 
quantitation of the method has been determined at 0.05 parts per 
million (ppm) for cucurbits and cherries, and 0.02 ppm for 
strawberries. The enforcement methodology has been submitted to the 
Food & Drug Administration (FDA) for publication in the Pesticide 
Analytical Manual, Vol. II (PAM II).
    3. Magnitude of residues. Eight field trials in strawberries were 
conducted in commercial growing areas of the United States. The 
analytical data show that the mean measured residue in/on strawberries 
was 0.859 ppm. The highest residue data was 2.0 ppm. Crop field trial 
residue data from 0 -day pre-harvest interval studies were conducted on 
cucumbers, muskmelon, and squash (cucurbits). In these trials, residues 
ranged from 0.06 to 0.39 ppm. Field trials were carried out on cherries 
in five states. In these trials the residues of triflumizole and it's 
aniline containing metabolites ranged from 0.4 to 1.5 ppm. These data 
support the proposed tolerances for triflumizole. There are no 
processed commodities or feed commodities associated with these crops.

B. Toxicological Profile

    1. Acute toxicity. The database includes the following studies: a 
rat acute oral study with a LD50 of 1.42 g/kg; a rabbit 
acute dermal study with a LD50 >5 g/kg; a rat acute 
inhalation study with a LC50 >3.2 mg/l; a rabbit primary 
ocular irritation study which showed mild irritation; a rabbit primary 
dermal irritation study which showed no irritation; a guinea pig dermal 
sensitization study which showed slight dermal sensitization potential.
    2. Genotoxicity. Triflumizole was negative in all genotoxicity 
assays including: Ames assay in S. typhimurium, gene conversion assay 
in yeast strain D4, REC assay in B. subtilis, unscheduled DNA synthesis 
(UDS) assay in cultured rat hepatocytes, chromosome aberration assay in 
cultured Chinese hampster ovary (CHO) cells and a mouse micronucleus 
assay.
    3. Reproductive and developmental toxicity. In a developmental 
toxicity study, triflumizole was administered by oral gavage to 
pregnant female Sprague Dawley rats at dosage levels of 0, 10, 35 or 
120 mg/kg/day. Maternal toxicity, as evidenced by a substantial 
reduction in body weight (bwt) gain, was seen at 35 and 120 mg/kg/day. 
At these dosage levels there was a decrease in fetal viability in the 
form of late resorptions. There were no teratogenic effects. The no 
observed adverse effect level (NOAEL) for maternal and developmental 
toxicity was 10 mg/kg/day. Triflumizole was also administered by oral 
gavage to pregnant female New Zealand White rabbits at dosage levels of 
0, 5, 25, or 50 mg/kg/day. At a dose level of 50 mg/kg/day there was a 
reduction in bwt gain in kits. There were no developmental or 
teratogenic effects. The NOAEL for maternal toxicity was 25 mg/kg/day 
and the NOAEL for developmental toxicity was greater than 50 mg/kg/day.
    The reproduction toxicity of triflumizole was evaluated in a rat 
reproduction study, conducted on three generations, at dietary 
concentrations of 0, 30, 70 and 170 ppm. Fertility was not affected by 
treatment. There was an increase in placental weight in the F1b, F2b 
and F3b litters and a statistically significant increase in gestation 
length in the high dose group at the F1a and F3a mating intervals. The 
NOAEL for systemic parental toxicity was greater than 170 ppm and the 
NOAEL for developmental effects was 70 ppm based upon effects seen in 
litters of both studies at the high dose level, including increased 
incidences of hydroureter and space between the body wall and organs. 
The NOAEL for reproductive effects was 70 ppm (3.5 mg/kg/day) based on 
increased gestation length observed at the high dose level at 2 of 6 
mating intervals.
    4. Subchronic toxicity. To assess sub-acute dermal toxicity, 
triflumizole was applied to the backs of male and female Sprague Dawley 
rats for three weeks. High dose female rats exposed to 1,000 mg/kg/day 
exhibited mild fatty vacuolation in the liver, which was

[[Page 35626]]

within the range of normal biological variation. Therefore, the NOAEL 
for sub-acute dermal toxicity in rats was greater than 1,000 mg/kg/day.
    Triflumizole was fed to male and female Sprague Dawley rats for 
thirteen weeks at dietary concentrations of 0, 20, 200 and 2,000 ppm to 
assess sub-chronic toxicity. At a dosage level of 2,000 ppm there was a 
reduction in body weight gain, an increase in liver and kidney weights, 
lipid droplets in liver and a decrease in serum alkaline phosphatase in 
males and females. High dose females exhibited a reduction in red blood 
cell (RBC) and hemoglobin in blood. The NOAEL for sub-chronic toxicity 
in rats was 200 ppm (10 mg/kg/day).
    5. Chronic toxicity. Triflumizole was fed to male and female Beagle 
dogs for one year at dietary concentrations of 0, 100, 300 and 1,000 
ppm to assess chronic toxicity. At a dosage level of 1,000 ppm there 
was an increase in serum liver enzymes and a decrease in RBC 
concentration. The NOAEL for chronic toxicity in dogs was 300 ppm 
(7.5mg/kg/day).
    Triflumizole was fed to male and female Sprague Dawley rats for two 
years at dietary concentrations of 0, 100, 400 and 1,600 ppm to assess 
chronic toxicity At the high dose level there was a substantial 
reduction in body weight gain in males and females. At the mid and high 
dose levels there was an increase in liver weight. Ovary weight was 
increased in high dose female rats, and kidney weights were elevated in 
high dose animals. Alanine amino-transferase and lactose dehydrogenase 
was elevated in high dose males and females, respectively. High dose 
females had an increased incidence of ovarian follicular cysts, while 
high dose males exhibited pancreatic acinar cell atrophy. Fatty 
vacuolization of the liver was seen at all dose levels and hepatocytic 
hypertrophy was seen in high and mid-dose males and females. Female 
rats given 400 or 1,600 ppm had an increased incidence of basophilic 
foci/areas of hepatocytic alteration. Effects at 100 ppm were confined 
to hepatocytic fatty vacuolation and hypertrophy in females. These 
changes were less severe than those seen in rats given 400 or 1,600 ppm 
and were considered by the laboratory to be indicative of adaptive 
metabolic change. The dietary level of 100 ppm (5 mg/kg/day) is 
considered to be a NOAEL.
    6. Animal metabolism. Triflumizole, [14C-Phenyl] 1-(1-((4-chloro-2-
trifluoromethylphenyl)imino)-2-propoxyethyl)-1H-imidazole, was found to 
be rapidly absorbed and excreted in rats. Two days after oral dosing, 
78% was found to be excreted in the urine and 20% in the feces. No sex 
difference was noted. It appears that the loss of the imidazole ring 
was the basic step in the metabolic pathway of this fungicide in 
mammals. The elimination of the imidazole ring yielded initially N-(4-
chloro-2-trifluoromethylphenyl)-n-propoxyacetamidine (FM-6-1 and N-(4-
chloro-2-trifluoromethylphenyl)-n-propoxyacetanilide (FD-1-1). Other 
hydroxylated metabolites identified (free, or as sulfate/glucuronide 
conjugates) included, among others, N-(4-chloro-2-
trifluoromethylphenyl)-hydroxyacetamidine (FM-8-1); 4-chloro-2-
trifluoromethyl-hydroxyacetanilide (FD-2-1); and 4-chloro-2- 
trifluoromethyl-6-hydroxyaniline (FA-1-5).
    7. Metabolite toxicology. Both plant and animals produce the same 
metabolites that were identified in the metabolism studies; therefore, 
the toxicity of the metabolites has essentially been evaluated in the 
rat toxicology studies.
    8. Endocrine disruption. In the rat reproduction study there was an 
increase in placental weight in females at the high dose level of 170 
ppm. There was also a biologically significant increase in gestation 
length in high dose F0 and F2 females (F1a and F3a intervals). The 
NOAEL for endocrine effects is 70 ppm (3.5 mg/kg/day).

C. Aggregate Exposure

    1. Dietary exposure-- i. Food. Tolerances have been established (40 
CFR 180.476) for the combined residues of triflumizole, and its 
metabolites containing the 4-chloro-2-trifluoromethylaniline moiety, 
calculated as the parent compound, in or on apples, pears and grapes. 
Tolerances have also been established for the combined residues of 
triflumizole and the metabolite 4-chloro-2-hydroxy-6- 
trifluoromethylaniline sulfate and other metabolites containing the 4-
chloro-2-trifluoromethylaniline moiety, calculated as the parent 
compound in or on eggs, milk, meat, fat, and meat by-products of 
cattle, goats, hogs, horses, poultry and sheep.
    Field trial residue values from the currently labeled raw 
agricultural commodities (apples, pears, grapes) and from the proposed 
cucurbit, cherry, filbert and strawberry uses were used to estimate 
dietary exposure (Dietary Exposure Evaluation Model 
(DEEM)TM, Novigen Sciences, Inc.). Tissue to feed ratios 
were used to calculate secondary residues for meat, milk, and egg 
products. Processing factors and percent of crop treated were also 
factored into the estimates.
    ii. Drinking water. Exposure to triflumizole or its degradates in 
drinking water is not anticipated, and is unlikely to occur. 
Triflumizole is not expected to contaminate ground water. Laboratory 
and field data have demonstrated that it degrades rapidly and that 
triflumizole and its metabolites do not leach, even in sandy soil. A 
Maximum Contaminant Level (MCL) for triflumizole has not been 
established by EPA. Ornamental and proposed residential uses are not 
expected to result in drinking water concerns. Most commercial uses on 
outdoor-grown plants would typically be only a spot treatment or on 
very limited acreage. Containerized ornamentals would mimic greenhouse 
production, as these plants are generally elevated off the ground, with 
some type of ground covering underneath. For residential areas, 
triflumizole would be used only by commercial applicators, and only as 
a spot treatment.
    Tier I screen models generic expected environmental concentration 
(GENEEC) (surface water) and screening concentration in ground water 
(SCI-GRO) (ground water) were used to predict the estimated 
environmental concentration (EEC) of triflumizole from current and 
proposed food uses. For surface water, the theoretical acute EEC was 18 
parts per billion (ppb) (peak concentration) and the chronic EEC 
(divided by 3 to account for the large overestimates inherent in the 
model) was 3 ppb. Theoretical acute and chronic ground water 
concentrations from the SCI-GRO modeling were 0.1 ppb.
    2. Non-dietary exposure. The only source of non-dietary exposure to 
triflumizole for consideration under FQPA is in the proposed use of 
Terraguard 50W on institutional, recreational, and homeowner landscapes 
and other outdoor ornamentals. This registration could result in 
intermittent, low-level residential post-application exposures. 
Terraguard 50W is not available for application by homeowners and is 
not registered for use on turf. Only professional handlers would apply 
Terraguard 50W to any existing or proposed use sites. Treatment would 
be made to individual plants or specific sub-sections within labeled 
use sites, and only as needed for disease. The above use sites amount 
to minimal acreage in comparison with turf and other sources of 
residential exposure, and activities therein are of low duration and 
intensity.
    Dislodgeable foliar residues (DFRs) can be estimated from existing 
data. A

[[Page 35627]]

recent study on Terraguard 50W DFRs on Spathiphyllum foliage showed 
significantly lower levels of triflumizole than would be predicted by 
current Agency SOP defaults, and an approximately complete dissipation 
within the minimum treatment interval of 30 days. From that study, 
potential residue levels were calculated based on the geometric means 
of regressed values that were adjusted to represent the maximum 
application rate of 1.0 lb ai/acre, and averaged over the duration of 
potential post-application exposure.
    The DFR transfer coefficients, representing reentry into treated 
gardens, are EPA default assumptions (draft OPP/HED SOP for Residential 
Exposure Assessment). Such defaults are considered by EPA to be very 
conservative and are considered to be screening-level assumptions. In 
addition, work by the Agricultural Reentry Task Force and others has 
shown far lower transfer coefficients for many relatively high-exposure 
activities, such as pruning, that may occur on residential landscapes. 
Contact with residential landscape foliage is assumed to occur 
incidentally or for short durations since typical Terraguard 
applications will be spot-treatments within small areas.
    The toxicological assumptions in this assessment are also 
conservative, including (a) a default value of 100% dermal absorption; 
(b) the acute endpoint of 3.5 mg/kg/day (see above) for short-term 
assessment; and (c) the sub-chronic endpoint of 3.5 mg/kg/day (see 
above) for intermediate-term assessment. Chronic assessment is not 
required since a yearly maximum of 3 applications, from which 
triflumizole is expected to dissipate within 30-days, should result in 
less than 90-days of potential exposure per year. The factors used in 
the assessment and resulting estimates of absorbed daily dose and 
margins of exposure (MOEs) are provided in the following table:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Short-Term Assessment:                         Intermediate Term Assessment:
                                                     ---------------------------------------------------------------------------------------------------
                                                           Females 13-50           Infants/Children          Females 13-50           Infants/Children
--------------------------------------------------------------------------------------------------------------------------------------------------------
Duration of Assessment (days)                                          7 days                   7 days                  90-days                  90-days
DFR (~g/cm2)                                                            0.345                    0.345                   0.0092                   0.0092
Transfer Coefficient (cm2/hr)                                          1,0000                    5,000                   1,0000                    5,000
Duration (hr/day)                                                       0.083                    0.033                    0.083                    0.033
bwt (kg)                                                                   60                       10                       60                       10
Absorbed Daily Dose (mg/kg/day)                                       0.00477                  0.00569                  0.00013                  0.00015
NOAEL (mg/kg/day)                                                         3.5                      3.5                      3.5                      3.5
Margin of Exposure (MOE):                                                 733                      615                    27501                    23057
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The above calculations are based on appropriate DFR data from an 
ornamental crop, a complete toxicological profile, transfer 
coefficients understood to be conservative, and a very conservative 
assumption of 100% dermal absorption. The resulting MOEs, which are 
still well over 100, therefore indicate clearly that residential 
exposure following Terraguard 50W use on institutional, recreational, 
and homeowner landscapes, and other outdoor ornamentals, would pose a 
low potential risk and a reasonable certainty of no harm.

D. Cumulative Effects

    The potential for cumulative effects of triflumizole, an imidazole, 
and other substances that have a common mechanism of toxicity was 
considered. The mammalian toxicity of triflumizole is well defined. No 
reliable information exists to indicate that toxic effects produced by 
triflumizole would be cumulative with those of any other chemical 
compounds. Therefore, consideration of a common mechanism of toxicity 
with other compounds is not appropriate. Thus, only the potential risks 
of triflumizole are considered in the aggregate exposure assessment.

E. Safety Determination

    1. U.S. population-- i. Short-term risk. Based on the toxicology 
database, the NOAEL of 3.5 mg/kg/day from the reproduction toxicity 
study, and available information on anticipated residues and percent 
crop treated, the acute dietary exposure was determined to be within 
the acceptable MOE of 100. Exposure to potential triflumizole residues 
in drinking water is not expected to significantly contribute to the 
overall exposure of females 13-50 years old and infants and children, 
as DWLOC's are substantially higher than modeled EEC's. Residential 
post application exposure would occur within an acceptable margin of 
safety. Based on these assessments, Uniroyal concludes that there is 
reasonable certainty of no harm to females (13-50 years old), infants, 
and children from short-term aggregate exposure to triflumizole 
residues.
    ii. Intermediate-term risk. Based on the toxicology database, the 
RfD of 0.035 mg/kg/day from the reproduction study, and available 
information on anticipated residues and percent crop treated, the 
chronic dietary exposure was determined as 0.1% of the RfD for females 
(13-50 years old), and 0.4% for infants and children. These exposures 
do not exceed EPA's level of concern of >100% of the RfD. Exposure to 
potential triflumizole residues in drinking water is not expected to 
significantly contribute to the overall exposure of females 13-50 years 
old and infants and children, as DWLOC's are substantially higher than 
modeled EEC's. Residential post application exposure would occur within 
an acceptable margin of safety. Based on these assessments, Uniroyal 
concludes that there is reasonable certainty of no harm to females (13-
50 years old), infants, and children from intermediate-term aggregate 
exposure to triflumizole residues.
    iii. Chronic risk. Based on the toxicology database, the reference 
dose (RfD) of 0.035 mg/kg/day from the reproduction study, and 
available information on anticipated residues and percent crop treated, 
the chronic dietary exposure was determined as 0.1% of the RfD for the 
U.S. population, and 0.4% for infants and children. These exposures do 
not exceed EPA's level of concern of >100% of the RfD. Exposure to 
potential triflumizole residues in drinking water is not expected to 
significantly contribute to the overall exposure of the U.S. 
population, infants, and children, as DWLOC's are substantially higher 
than modeled EEC's. Based on these assessments, Uniroyal concludes that 
there is reasonable certainty of no harm to the U.S. population, 
infants, and children from chronic aggregate exposure to triflumizole 
residues.
    2. Infants and children. Triflumizole was evaluated in rat and 
rabbit developmental toxicity studies and a three generation rat 
reproduction study to assess the potential for additional

[[Page 35628]]

sensitivity to infants and children. No developmental toxicity was seen 
in the rabbit teratology study at doses up to 50 mg/kg/day. Maternal 
toxicity was seen at this dosage level. In the rat teratology study, 
there was an increase in late resorptions at doses of 35 and 120 mg/kg/
day which was accompanied by maternal toxicity in the form of a 
substantial reduction in bwt. The NOAEL for maternal and developmental 
toxicity was 10 mg/kg/day. In the rat reproduction study, there was an 
increase in gestation length and an increased incidence of hydroureter 
and space between the body wall and organs at the high dose level of 
170 ppm. The NOAEL for reproductive and developmental effects was 3.5 
mg/kg/day. No additional safety factor is necessary as the data package 
is complete and the sensitivity to infants and children is adequately 
characterized.

F. International Tolerances

    There are no Codex, Canadian or Mexican maximum residue limits 
established for triflumizole on strawberries, cucurbits or cherries.
[FR Doc. 01-16956 Filed 7-5-01; 8:45 am]
BILLING CODE 6560-50-S