02-6156. 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-1071, must be received on or before April 15, 2002.

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-1071 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

By mail: Mary L. Waller, Fungicide Branch, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: [phone]; e-mail address: [e-mail].

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:

Categories	NAICS codes	Examples of 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”, 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-1071. 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 [phone].

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-1071 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 [phone].

3. Electronically. You may submit your comments electronically by e-mail to: [e-mail], 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-1071. 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 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: February 28, 2002.

Peter Caulkins,

Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

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 Aventis CropScience, 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.

Aventis CropScience

PP 9F6051

EPA has received a pesticide petition (9F6051) from Aventis CropScience, 2 TW Alexander Drive, Research Triangle Park, NC 27709 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 combined residues of the fungicide triticonazole 5-[(4- chlorophenyl)methylene]-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol), and its metabolites, 5-[(4-chlorophenyl)methylene]-2-hydroxymethyl-2-methyl-1-(1H-1,2,4-triazol- 1ylmethyl)cyclopentanol (RPA 404886) and 5-[(4-chlorophenyl)methylene]-2,2-dimethyl-1-(1H- 1,2,4-triazol-1ylmethyl)cyclopentan-1,3-trans-diol (RPA 406341)] in or on the raw agricultural commodities wheat grain at 0.05 parts per million (ppm), wheat forage at 0.05 ppm, wheat hay at 0.05 ppm, wheat straw at 0.05 ppm, barley grain at 0.05 ppm, barley forage at 0.05 ppm, barley hay at 0.05 ppm, and barley straw at 0.05 ppm. EPA has determined that the petition contains data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism. Metabolism studies in wheat and barley were conducted using both phenyl-ring and triazole-ring labeled material in order to fully define the metabolic fate of triticonazole. Treatment regimes were chosen to simulate a commercial seed treatment application. The results from both crops were similar. Hydroxylation is the primary route of metabolism with the carbons of the cyclopentane ring and the methyl groups being the sites susceptible to oxidative degradation.

2. Analytical method. The plant metabolism studies indicated that analysis for the parent compound, triticonazole, and the metabolites RPA 404886 and RPA 406341 was sufficient to enable the assessment of the relevant residues in wheat and barley. Following extraction of the crop matrix and sample cleanup, the analytical enforcement method relies on the use of Turbo Ionspray, liquid chromatography/mass spectroscopy (LC/MS) for determination of the residue level. This method allows detection and measurement of residues in or on agricultural commodities at or above the proposed tolerance level. Analysis using Electrospray, liquid chromatography/ mass spectroscopy/mass spectroscopy (LC/MS/MS) is more sensitive, and allows quantitation of analytes down to 0.005 ppm.

3. Magnitude of residues. Field residue trials were conducted across the major regions of small-grain cereal production in the United States. The treatment regime was selected to represent the use pattern that is the most likely to result in the highest residues.

Trials to define the magnitude of the residues in wheat raw agricultural commodity, were conducted at 22 trial sites of which 13 used spring wheat varieties and 9 used fall wheat varieties. The wheat seeds were treated with a triticonazole formulation at a rate of approximately 10 g active ingredient (a.i.)/100 kg wheat seed, a rate twice that anticipated under commercial use practice. Generally, the level of triticonazole residues observed in the samples were very low. For wheat forage, the residue of triticonazole found in or on the samples did not exceed 0.02 ppm; whereas, the residues for wheat hay did not exceed 0.008 ppm and the residues for wheat straw did not exceed 0.007 ppm. Triticonazole was not detected (method detection limit (MDL) = 0.002 ppm) in or on the wheat grain samples, except in one of the two replicate samples from one trial site where the residue level was determined to be 0.0055 ppm. Residues of the metabolites were not detected (MDL = 0.002 ppm) in any forage, hay grain or straw samples, except at one site where residues of RPA 406341 in the straw were just above the MDL but less than the limit of quantification (LOQ) of the method.

Trials to define the magnitude of the residues in the raw agricultural commodity barley were conducted at 14 trial sites of which 12 used spring wheat varieties and 2 used fall wheat varieties. The barley seeds were treated as described above for wheat. No residues of triticonazole or metabolites were detected (MDL = 0.002 ppm) in or on the barley grain samples. In the barley hay samples, no residues of triticonazole or metabolites were detected above the LOQ of the method (0.005 ppm), except at one site where the mean level of triticonazole in the duplicate samples was 0.0058 ppm. Similarly, in the straw, no residues of triticonazole or metabolites were detected above the LOQ of the method except in one replicate at one site where triticonazole was found at 0.0067 ppm.

Studies were conducted to determine if triticonazole residues concentrated upon processing wheat or barley grain. The wheat or barley seeds used for these studies were treated at a nominal rate of 50 g a.i./100kg wheat seed, a rate 10 times that anticipated under commercial use practice. Grain samples were collected at normal commercial maturity. Using procedures that simulate commercial practices, wheat grain was processed into bran, flour, middlings, shorts, and germ; whereas barley grain was processed into bran, flour, or pearled barley. Using LC/MS/MS, the LOQ and MDL for triticonazole and metabolites were 0.005 ppm and 0.002 ppm, respectively, for all matrices. Triticonazole-related residues were below the MDL for all grain and processed fraction samples. Based on these results, residues of triticonazole and metabolites do not concentrate in wheat or barley processed fractions following a triticonazole seed treatment application.

B. Toxicological Profile

1. Acute toxicity. Triticonazole is of low acute toxicity placing the active ingredient in Toxicity Category III and IV. Triticonazole is non-irritating to the eyes and skin and is not a skin sensitizer.

2. Genotoxicty. The genetic toxicity of triticonazole has been evaluated through a full battery of mutagenicity assays. Triticonazole was not mutagenic or genotoxic in any assay in either the presence or absence of metabolic activation.

3. Reproductive and developmental toxicity. Triticonazole is not a reproductive or developmental toxicant.

a. Teratology - rat. Groups of at least 23 pregnant rats received daily oral doses of 0, 40, 200 or 1,000 mg/kg/day of triticonazole from day 6 to day 15 of gestation inclusive. The mean weight gain and the food intake of females receiving 1,000 mg/kg/day was marginally lower than that of the controls. Litter size, survival in utero and mean fetal and placental weights were unaffected by treatment. There were no major abnormalities or visceral abnormalities at any dosage used. The mean weight gain and the food intake of females receiving 1,000 mg/kg/day was marginally lower than that of the controls. Females at 40 and 200 mg/kg/day were unaffected.

There was an apparent increase in the incidence of fetuses with an additional 14th rib or pair of ribs at 1,000 mg/kg/day. The incidences at 40 and 200 mg/kg/day were within the historical control range. Because the increased incidence of supernumerary (14th) ribs is not toxicologically significant, the NOAEL for maternal and developmental toxicity was 1,000 mg/kg/day.

b. Teratology - rabbit. Triticonazole was administered by gavage to 4 groups of at least 18 pregnant New Zealand white rabbits at dosages of 5, 25, 50 or 75 mg/kg/day, from Day 6 to Day 19 of gestation inclusive. Administration of 25 mg/kg/day was associated with body weight reduction and reduced food intake. At 50 and 75 mg/kg/day more marked body weight loss, reduced food intake and deaths were observed. Slightly increased pre-implantation and post-implantation losses and increased incidences of skeletal anomalies were observed at 75 mg/kg, secondary to severe maternal toxicity (6 animals died out of 20). The NOAEL for maternal toxicity was 25 milligrams/kilogram of body weight/day (mg/kg bwt/day) based on reduced body weight gains and food consumption at 50 mg/kg bwt/day. The NOAEL for fetal development was 50 mg/kg bwt/day, based on skeletal abnormalities noted in the presence of severe maternal toxicity at 75 mg/kg bwt/day.

c. Two-generation reproduction - rat. Groups of 28 males and 28 females Crl:CD BR/VAF/Plus rats (F0) were offered diets containing 0, 5, 25, 750 and 5,000 ppm of triticonazole for 10 weeks before mating and throughout gestation, lactation and weaning of the pups. A second generation of selected pups (F1) was provided diets at the same concentrations as their parents from weaning for at least 10 weeks before mating and throughout mating, gestation and lactation. The NOAEL for systemic toxicity is 750 ppm, based on mortality, decreased body weight gain, and food consumption seen in the high dose animals in both generations. The NOAEL for reproductive performance and fetal effects is also 750 ppm, based on a reduction in mating and fertility indices, number of live births, pup viability and pup body weights at 5,000 ppm.

4. Subchronic toxicity—i. 28-day dietary - rat. Groups of five male and five female F-344 rats received triticonazole continuously, via the diet, at concentrations of 0, 500, 1,500, 5,000, 15,000 or 50,000 ppm (0, 50, 150, 500, 1,500, and 5,000 mg/kg/day, respectively for 4-weeks. At 5,000 ppm (500 mg/kg/day) growth performance, food consumption and efficiency of food utilization of males were inferior to control values throughout the treatment period. Hematological investigations revealed low platelet counts in males. Blood chemistry investigations revealed minimally low glucose concentrations. High liver weights and low prostate and uterus weights were noted at necropsy. The NOAEL for systemic toxicity was 1,500 ppm (150 mg/kg/day).

ii. 90-day dietary - rat. Four groups of 10 male and 10 female CD rats received triticonazole via the diet at concentrations of 25, 250, 12,500 or 25,000 ppm (2.5, 25, 1,250, or 2,500 mg/kg/day) for 13 weeks. The NOAEL for this study was 12,500 ppm (1,250 mg/kg/day) based on reduced body weight gain, food consumption, and histopathological changes in the liver and adrenals.

c. Dermal toxicity evaluation. No adverse effects were noted in rats at the limit dose of 1,000 mg/kg bwt/day.

5. Chronic toxicity - dog. a. Four groups of 4 male and 4 female beagle dogs received triticonazole in gelatin capsules at dosages 2.5, 25 and 150 mg/kg/day. A similar control group received only empty gelatin capsules. The NOAEL for this study was 25 mg/kg bwt/day based on clinical signs of toxicity, lower for body weight gains; organ weight changes and histopathological changes of the liver and adrenals were seen at the LOAEL of 150 mg/kg/day.

b. Combined chronic toxicity/oncogenicity - rat. Four groups of 50 males and 50 females CD rats were administered triticonazole via the diet at concentrations of 5, 25, 750 and 5,000 ppm for 2-years. Observed adverse effects were only at the highest dose of 5,000 ppm with decreased body weight gain in females and histopathological changes in the adrenals. The NOAEL for this study was 750 ppm that is equivalent to 29.4 and 38.3 mg/kg/day respectively for males and females.

c. Oncogenicity - mouse. Triticonazole was administered via the diet to four groups of 52 male and 52 female CD mice at concentrations of 0, 15, 150 and 1,500 ppm for 78 weeks. The NOAEL was 150 ppm (17.4 and 20.1 mg/kg for males and females respectively) based on reductions in body weight gain, increased relative and absolute liver weights and histopathological changes in the liver at 1,500 ppm. There were no treatment-related neoplasms in this study.

6. Neurotoxicity—a. Acute neurotoxicity. Groups of 10 male and 10 female rats were dosed once by oral gavage at dose levels of 0, 80, 400, or 2,000 mg/kg of triticonazole in a methyl cellulose suspension. There were no differences observed in body weight, in any of the functional observation battery (FOB), or in motor activity. Microscopy revealed no changes related to the administration of triticonazole. Therefore, the NOAEL for acute neurotoxicity exceeds 2,000 mg/kg.

b. Subchronic neurotoxicity. Groups of 10 male and 10 female rats received basal diet containing triticonazole at inclusion levels of 0, 500, 2,500 or 10,000 ppm (0, 33, 170 and 695 mg/kg/day in the males, and 0, 39, 199 and 820 mg/kg/day in the females). There were no differences observed in bodyweight, in any of the FOB, or in motor activity. Microscopy revealed no changes related to the administration of triticonazole. Therefore, the NOAEL for sub-acute neurotoxicity exceeds 10,000 ppm (exceeds 695 mg/kg/day) in the rat.

7. Animal metabolism. Studies conducted in cows and hens using¹⁴ C-triticonazole indicate the majority of the radioactivity is rapidly excreted with almost a negligible amount transferred to tissues, milk or eggs. Hyrdoxylation represented the primary metabolic pathway with the carbon atoms on the cyclopentane and those of the methyl groups being the sites of attack. Principal metabolites included RPA 406341 and RPA 404886 and a metabolite in which the hydroxymethyl group of RPA 404886 was further oxidized to a carboxylic acid function.

8. Endocrine disruption. No studies have been conducted to investigate the potential of triticonazole to induce estrogenic or other endocrine effects. The EPA has not yet developed the criteria it will use for characterizing endocrine disrupting substances. Therefore, an evaluation of the potential of triticonazole to induce estrogenic or other endocrine effects cannot be conducted at this time.

C. Aggregate Exposure

1. Dietary exposure. Tolerances are proposed under 40 CFR part 180 for the combined residues of triticonazole and metabolites in or on wheat grain, forage, straw, and hay, and in or on barley grain, forage, straw, and hay. The registration of triticonazole for control of fungal diseases in turf (non-food use) is pending at EPA. The turf use is for application by professional applicators, and does not include use on residential turf. Therefore, potential non-occupational (residential) exposure would include exposures resulting from consumption of potential residues in food and water only.

i. Food. Potential dietary exposures from food were estimated using the DEEM software system (Novigen Sciences, Inc.) and the 1994-96 USDA consumption data. Residue data from field trial studies in which grain grown from triticonazole treated barley and wheat seed was used to estimate chronic and acute dietary exposure. Percent crop treated values include the total amount of barley and wheat treated with any seed treatment pesticide, and thus, are conservative. Metabolism studies show that triticonazole residues are not expected in livestock tissues from animals fed at levels found in treated seed feed items. Tier 3 chronic exposure for the overall U.S. population was estimated to be 0.000002 mg/kg/bwt/day, representing less than 0.1% of the chronic reference dose. Chronic exposure for the most highly exposed population subgroup, children 1-6 years of age, was calculated to be 0.000004 mg/kg/bwt/day, also less than 0.1% of the chronic reference dose.

Tier 3 acute exposure at the 99.9^th percentile for the overall U.S. population was estimated to be 0.000017 mg/kg/bwt/day, less than 0.1% of the acute reference dose. Acute exposure for the most highly exposed population subgroup, again children 1-6 years old, was estimated to be 0.00002 mg/kg/bwt/day, less than 0.1% of the acute reference dose. These analyses represent worst case estimates of potential dietary exposure to wheat and barley. Any exposure from residues of triticonazole in the diet are likely to be negligible to non-existent in real world situations.

ii. Drinking water. EPA's standard operating procedure (SOP) for drinking water exposure and risk assessments was used to perform the drinking water assessment. This SOP uses a variety of tools to conduct drinking water assessment. These tools include water models such as screening concentration in ground water (SCI-GROW), generic expected environmental concentration (GENEEC), pesticide root zone management system/exposure analysis modeling system (PRZMS/EXAMS), and monitoring data. If monitoring data are not available, then the models are used to predict potential residues in surface and ground water, and the highest residue is assumed to be the drinking water residue. In the case of triticonazole, monitoring data do not exist; therefore, GENEEC was used to estimate the concentration of triticonazole that might occur in water. The GENEEC values represent very conservative assumptions and worst case scenarios. The calculated drinking water levels of comparison (DWLOC), for chronic and acute exposures for all adults and children exceed the drinking water estimated concentrations (DWECs) from the models by many orders of magnitude. The acute DWLOC for children is 2,500 parts per billion (ppb). The acute DWEC is 0.098 ppb. The chronic DWLOC for adults is 5,950 ppb. The chronic DWLOC for children/toddlers is 1,700 ppb. The DWEC for the worst case chronic scenario is 0.024 ppb. The drinking water levels of comparison are based on highly conservative dietary (food) exposures and are expected to be even higher in real world situations. Any exposure from triticonazole in drinking water would be negligible based on these highly conservative analyses.

2. Non-dietary exposure. The pending CHIPCO brand TRITON registration for triticonazole is for commercial turf grass, golf courses and sod farms. It is not intended for home use. As such, there would be no exposure in residential homes from this use, and is not included in the aggregate risk assessment.

D. Cumulative Effects

Section 408(b)(2)(D)(v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information”, concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” There is no reliable data at this time to determine whether triticonazole has a common mechanism of toxicity with other substances, or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, triticonazole does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance petition, therefore, it has not been assumed that triticonazole has a common mechanism of toxicity with other substances.

E. Safety Determination

1. U.S. population. Using the conservative assumptions described above, based on the completeness and reliability of the toxicity data, it is concluded that chronic dietary exposure to the proposed uses of triticonazole will utilize less than 0.1% of the chronic reference dose for the U.S. population. The actual exposure is likely to be much less as more realistic data and models are developed. EPA generally has no concern for exposures below 100% of the RfD because the RfD represents the level at or, below which daily aggregate exposure over a lifetime will not pose appreciable risk to human health. Acute exposure estimates for the U.S. population utilizes less than 0.1% of the acute RfD. This is a conservative assessment and actual exposure is likely to be far less. Drinking water levels of comparison based on the dietary exposure are much greater than highly conservative estimated levels, and would be expected to be well below the 100% level of the RfD, if they occur at all. Therefore, there is a reasonable certainty that no harm will occur to the U.S. population from aggregate exposure (food and drinking water) residues of triticonazole.

2. Infants and children. FFDCA Section 408 provides that the Agency may apply an additional safety factor for infants and children to account for pre-natal and post-natal toxicity or incompleteness of the data base. The toxicology data base for triticonazole regarding potential pre-natal and post-natal effects in children is complete according to existing Agency data requirements and does not indicate any particular developmental or reproductive concerns. The developmental toxicity studies clearly demonstrate that triticonazole is not teratogenic and the reproductive toxicity study did not indicate any increased sensitivity to the effects of triticonazole in developing, or young animals. Therefore, an extra safety factor is not warranted.

Using the conservative assumptions described in the exposure section above, exposure to residues of triticonazole in food for children 1-6 years old, (the most highly exposed sub group) is less than 0.1% of the acute and chronic reference doses. As in the adult situation, drinking water levels of comparison are much higher than the worst case drinking water estimated concentrations, and are expected to use well below 100% of the reference dose, if they occur at all. Therefore, there is a reasonable certainty that no harm will occur to infants and children from aggregate exposure to residues of triticonazole.

F. International Tolerances

Maximum residue limits codex MRLs for triticonazole and metabolites in or on wheat and barley commodities have not been established by the Codex Alimentarius Commission.