Pesticide, food, and feed additive petitions: Uniroyal Chemical Co.,

[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]

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.

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:

1. General Information

   1. 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.

   2. 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.

   3. 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 filedonline at many Federal Depository Libraries.

   4. 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.

   5. 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.

2. 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.

   1. 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.

   2. Toxicological Profile

      1. Acute toxicity. The database includes the following studies: a rat acute oral study with a LD50of 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).

   3. 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.

   4. 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.

   5. 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.

   6. International Tolerances

      There are no Codex, Canadian or Mexican maximum residue limits established for triflumizole on strawberries, cucurbits or cherries.

      [FR Doc. 01-16956Filed7-5-01; 8:45 am]

      BILLING CODE 6560-50-S