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http://www.epa.gov/fedrgstr/EPA-PEST/2001/July/Day-06/p16956.htm
[Federal Register: July 6, 2001 (Volume 66, Number 130)]
[Notices]
[Page 35623-35628]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06jy01-62]
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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:
waller.mary@epa.gov.
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: opp-docket@epa.gov, 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