02-21279. Notice of Filing of Pesticide Petitions to Establish Tolerances for a Certain Pesticide Chemical in or on Food

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces the initial filing of pesticide petitions proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities.

DATES:

Comments, identified by docket ID number OPP-2002,-0172, must be received on or before September 20, 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 ID number OPP-2002-0172 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

By mail: Shaja R. Brothers, 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 particularly 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,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “Federal Register—Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/​fedrgstr/​.

2. In person. The Agency has established an official record for this action under docket ID number OPP-2002-0172. 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 ID number OPP-2002-0172 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 Pesticides 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 ID number OPP-2002-0172. 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 to 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 ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

II. What Action is the Agency Taking?

EPA has received pesticide petitions as follows proposing the establishment and/or amendment of regulations for residues of 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 the petitions 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: August 14, 2002.

Debra Edwards,

Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petitions

The petitioner summary of the pesticide petitions is printed below as required by section 408(d)(3) of the FFDCA. The summary of the petitions were prepared by the Interregional Research Project No. 4 (IR-4) and represents the view the Interregional Research Project No. 4 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.

Interregional Research Project No. 4 (IR-4)

PP 0E6178, 2E6386, 2E6410, and 2E6432

EPA has received pesticide petitions (0E6178, 2E6386, 2E6410, and 2E6432) from the Interregional Research Project No. 4 (IR-4), Rutgers, The State University of New Jersey, Highway No. 1 South, North Brunswick, NJ, 08902-3390 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 180.493 by establishing tolerances for residues of the fungicide dimethomorph [(E,Z)4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propenyl]-morpholine] in or on the following raw agricultural commodities: Dried cone hop at 60 parts per million (ppm) (0E6178); leaf lettuce and head lettuce at 10 ppm (2E6386); cucurbit vegetable group at 0.5 ppm (2E6410); and bulb vegetable group at 2 ppm (2E6432). A related petition (PP 8F4946) for the establishment of a tolerance for residues of dimethomorph in or on imported dried hops cones at 45 ppm has previously been filed by American Cyanamid Company. This notice includes summaries of the petitions prepared by BASF Corporation, Research Triangle Park, NC. 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 support granting of these petitions. Additional data may be needed before EPA rules on these petitions.

A. Residue Chemistry

1. Plant metabolism. The nature of the residues of dimethomorph is adequately understood. No metabolites were identified that require regulation.

2. Analytical method. A reliable method for the determination of dimethomorph residues in dried hops cones, lettuce (head and leaf), cucurbit vegetables (crop group 9), and bulb vegetables (crop group 3) exists; this method is the FDA Multi-Residue Method, Protocol D, as published in the Pesticide Analytical Manual 1.

3. Magnitude of residues. Complete residue data for dimethomorph and the petitioned tolerances have been submitted. The data support the requested tolerances.

B. Toxicological Profile

1. Acute toxicity—i. An acute oral toxicity study was conducted in the Sprague-Dawley rat for dimethomorph technical with a lethal dose (LD)₅₀ of 4,300 milligrams/kilogram body weight (mg/kg bwt) for males and 3,500 mg/kg bwt for females. Based upon EPA toxicity criteria, the acute oral toxicity category for dimethomorph technical is Category III or slightly toxic.

ii. Oral LD₅₀ studies were conducted on the two isomers (E and Z) alone:

a. An acute oral toxicity study in the wistar rat for the E-isomer with a LD₅₀ greater than 5,000 mg/kg bwt for males and approximately 5,000 mg/kg bwt for females.

b. An acute oral toxicity study in the wistar rat for the Z-isomer with a LD₅₀ greater than 5,000 my/kg bwt for both males and females.

iii. An acute dermal toxicity study was conducted in the Wistar rat for dimethomorph technical with a dermal LD₅₀ greater than 5,000 mg/kg bwt for both males and females. Based on the EPA toxicity category criteria, the acute dermal toxicity category for dimethomorph is Category IV or relatively non-toxic.

iv. A 4-hour inhalation study was conducted in wistar rats for dimethomorph technical with a lethal concentration (LC)₅₀ greater than 4.2 mg/L for both males and females. Based on the EPA toxicity category criteria, the acute inhalation toxicity category for dimethomorph technical is Category IV or relatively non-toxic.

2. Genotoxicty—i. Salmonella reverse gene mutation assays (2 studies) were

negative up to a limit dose of 5,000 grams (g)/plate. Chinese hamster lung V79 cells were negative up to toxic doses in two studies.

ii. Two chinese hamster lung structural chromosomal studies were reportedly positive for chromosomal aberrations at the highest dose tested (HDT) (160 grams milliliter (g/mL)/-S9; 170 g/mL/+S9). Dimethomorph induced only a weak response in increasing chromosome aberrations in this test system. These results were not confirmed in two micronucleus tests under in vivo conditions.

iii. Structural chromosomal aberration studies were weakly positive in human lymphocytic cultures, but only in S9 activated cultures treated at 422 g/mL, the HDT, were strongly cytotoxic. No increase in chromosomal aberrations was observed in the absence of S9 activation at all doses. Furthermore, the positive clastogenic response observed under the in vitro conditions was not conformed in two in vivo micronucleus assays.

iv. Micronucleus assay (2 studies) indicated that dimethomorph was negative for inducing micronuclei in bone marrow cells of mice following intraperitoneal administration of doses up to 200 mg/kg or oral doses up to the limit dose of 5,000 mg/kg. Thus, dimethomorph was found to be negative in these studies for causing cytogenic damage in vivo.

v. Dimethomorph was negative for inducing unscheduled DNA synthesis, in cultured rat liver cells, at doses up to 250 g/mL, a weakly cytotoxic level.

vi. Dimethomorph was negative for transformation in Syrian hamster embryo cells treated, in the presence and absence of activation, up to cytotoxic concentrations (265 g/mL/+S9; 50 g/mL/-S9).

3. Reproductive and developmental toxicity—i. A rat developmental toxicity study was conducted with the lowest observed adverse effect level (LOAEL) for maternal toxicity of 160 mg/kg/day and the no observed adverse effect level (NOAEL) for maternal toxicity of 60 mg/kg/day. The NOAEL for developmental toxicity is 60 mg/kg/day. Dimethomorph is not carcinogenic in the Sprague-Dawley rat.

ii. A rabbit development toxicity study was conducted with a LOAEL for maternal toxicity of 650 mg/kg/day and a NOAEL for maternal toxicity of 300 mg/kg/day. The NOAEL for developmental toxicity is 650 mg/kg/day, the HDT.

iii. A two-generation rat reproduction study was conducted with a LOAEL for parental systemic toxicity of 1,000 ppm, or approximately 80 mg/kg/day, and a NOAEL for parental systemic toxicity of 300 ppm, or approximately 24 mg/kg/day. The NOAEL for fertility and reproductive function was 1,000 ppm, the highest concentration tested (HCT), or approximately 80 mg/kg bwt/day.

4. Subchronic toxicity—i. A 90-day dietary study was conducted in Sprague-Dawley rats with a NOAEL of greater than or equal to 1,000 ppm, the HCT, or approximately 73 mg/kg/day for males and 82 mg/kg/day for females.

ii. A 90-day dog dietary study was conducted with a NOAEL of 450 ppm, or approximately 15 mg/kg/day, and a LOAEL of 1,350 ppm, or approximately 43 mg/kg/day.

5. Chronic toxicity—i. A 2-year chronic toxicity study was conducted in Sprague-Dawley rats with a NOAEL of 200 ppm or approximately 9 mg/kg/day for males and 12 mg/kg/day for females. The LOAEL for systemic toxicity is 750 ppm, or approximately 36 mg/kg/day for males and 58 mg/kg/day for females.

ii. A 1-year chronic toxicity study was conducted in dogs with a NOAEL of 450 ppm, or approximately 14.7 mg/kg/day and a LOAEL of 1,350, or approximately 44.6 mg/kg/day.

iii. A 2-year carcinogenicity study was conducted in Sprague-Dawley rats with a NOAEL for systemic toxicity of 200 ppm, or approximately 9 mg/kg/day for males and 11 mg/kg/day for females. The LOAEL for systemic toxicity was 750 ppm, or approximately 34 mg/kg/day for males and 46 mg/kg/day for females. There was no evidence of increased incidence of neoplastic lesions in treated animals. The NOAEL for carcinogenicity is 2,000 ppm, the HCT, or approximately 95 mg/kg/day for males and 132 mg/kg/day for females.

iv. A 2-year carcinogenicity study was conducted in mice with a NOAEL for systemic toxicity of 100 mg/kg/day and a LOAEL of 1,000 mg/kg/day. There was no evidence of increased incidence of neoplastic lesions in treated animals. The NOAEL for carcinogenicity is 1,000 mg/kg/day, the HDT.

6. Animal metabolism. Results from the livestock and rat metabolism studies show that orally administered dimethomorph was rapidly excreted by the animals. The principal route of elimination is the feces.

7. Metabolite toxicology. There were no metabolites identified in plant or animal commodities which require regulation.

8. Endocrine disruption. Collective organ weights and histopathological findings from the two-generation reproduction study in rats, as well as from the subchronic and chronic toxicity studies in two or more animal species, demonstrate no apparent estrogenic effects or effects on the endocrine system. There is no information available which suggests that dimethomorph technical would be associated with endocrine effects.

C. Aggregate Exposure

1. Dietary exposure. Tolerances have been established (40 CFR 180.493) for the residues of dimethomorph in or on potatoes at 0.05 ppm, potatoes, wet peel at 0.15 ppm, tomato at 0.5 ppm, tomato paste at 1.0 ppm, hop, dried cones at 60 ppm (import tolerance) and time-limited tolerances have been established for cantaloupe, cucumber, squash and watermelon at 1 ppm and on the cereal grains group: fodder at 0.15 ppm, forage and grain at 0.05 ppm, hay at 0.10 ppm, and straw at 0.15 ppm.

i. Food—a. Acute dietary exposure. An acute dietary risk assessment is not required because no acute toxicological endpoints were identified by EPA for dimethomorph.

b. Chronic dietary exposure. To assess the potential chronic dietary exposure to dimethomorph residues for all tolerances in effect early in 1999, EPA used the Dietary Exposure Evaluation Model (DEEM ®) to conduct a chronic dietary (food only) exposure analysis. In conducting this analysis, EPA made very conservative assumptions: That all commodities having dimethomorph tolerances contain residues of dimethomorph and that those residues are at the level of the tolerance. These assumptions result in an overestimate of human dietary exposure. All section 18 tolerances (cantaloupe, watermelon, cucumber, squash, and tomato) were included in this assessment along with tolerances for cereal grain crops and potato.

ii. Drinking water. The Generic Estimated Environmental Concentration (GENEEC) was 24 parts per billion (ppb) for 56 days. This model was used to determine surface water residues. Dimethomorph residues in ground water were also estimated using the Screening Concentration in Ground Water (SCI-GROW) model, but these estimates were significantly lower than those obtained from the GENEEC model. Given the low levels of dimethomorph residues as estimated by the GENEEC model, the additional use of dimethomorph on hops, lettuce, cucurbit vegetables, and bulb vegetables is not expected to reach a level of concern for residues in drinking water.

2. Non-dietary exposure. Currently, there are no registered residential uses for dimethomorph in the United States. Thus, an assessment of non-dietary exposure is not relevant to this petition.

D. Cumulative Effects

There is no information to indicate that any toxic effects produced by dimethomorph would be cumulative with those of any other chemical. The fungicidal mode of action of dimethomorph is unique; dimethomorph inhibits cell wall formation only in Oomycete fungi. The result is lysis of the cell wall that kills growing cells and inhibits spore formation in mature hyphae. This unique mode of action and limited pest spectrum suggest that there is little or no potential for cumulative toxic effects in mammals. In addition, the toxicity studies submitted to support this petition do not indicate that dimethomorph is a particularly toxic compound. No toxic end-points of potential concern were identified.

E. Safety Determination

1. U.S. population. The cPAD is 0.1 mg/kg bwt/day, based on a NOAEL of approximately 10 mg/kg bwt/day (200 ppm) from a 2-year dietary toxicity study in rats that demonstrated decreased body weight and liver foci in females at 750 ppm. The cPAD is calculated using an uncertainty factor of 100. The theoretical maximum residue contribution (TMRC) for lettuce, cucurbit and bulb vegetable is estimated at 0.003 mg/kg bwt/day for the general population. This represents a dietary exposure to the general population of the United States that is 3.0% of the cPAD. The TMRC for dried hops cones is estimated at 0.0000515 mg/kg bwt/day for the general population. This represents a dietary exposure to the general population of the United States which is 0.05% of the cPAD. The combined TMRC for all current and pending dimethomorph tolerances in potato, tomato, grape, hop, cereal grain commodities, lettuce (head and leaf), endive (escarole), radicchio, cucurbit vegetable (crop group 9), and bulb vegetable (crop group 3) will utilize less than 10% of the cPAD for the general U.S. population. Since EPA generally has no concern for exposures below 100% of the cPAD, there is a reasonable certainty that no harm will result from aggregate exposure to dimethomorph residues in or on commodities of the cited crops.

Drinking Water

i. Lettuce, cucurbit and bulb vegetables. Currently, the only federally registered food/feed uses of dimethomorph in the United States are on potato and tomato crops. For these uses, the Drinking Water Level of Concern (DWLOC) from chronic exposure to dimethomorph was estimated by BASF to be 2,800 ppb for the U.S. population and for males 13 years and older, and 910 ppb for children 1-6 years of age. Given the low levels of dimethomorph residues as estimated by the GENEEC model, the large margin of exposure (38x-116x), and the similar use patterns of dimethomorph on commodities of the cited crops, the additional proposed uses of dimethomorph are not expected to reach a level of concern for residues in drinking water.

ii. Hops. For this use, the DWLOC from chronic exposure to dimethomorph was estimated by EPA to be 3,400 ppb for the U.S. population and for males 13 years and older, 2,900 ppb for females 13 years and older, and 960 ppb for children (1-6 years of age). Given the low levels of dimethomorph residues as estimated by the GENEEC model and the large margin of exposure (40x-142x), the additional use of dimethomorph on hops is not expected to reach a level of concern for residues in drinking water.

2. Infants and children. The TMRC for all commodities covered in this petition is minimal. The consumption of residues of dimethomorph on lettuce (head and leaf), cucurbit vegetables (crop group 9), and bulb vegetables (crop group 3) will use approximately 7.0% of the cPAD for children ages 1-6. The TMRC for residues of dimethomorph in hops as consumed by infants, non-nursing infants, children ages 1-6, and children ages 7-12 are each estimated to be 0.00% of the cPAD. Moreover, the combined TMRC values for all current and pending dimethomorph tolerances will utilize less than 10% of the cPAD for each of the subgroups.

The results of the studies submitted to support this package provide no evidence that dimethomorph caused reproductive, developmental or reproductive effects. No such effects were noted at dose levels that were not maternally toxic. The NOAELs observed in the developmental and reproductive studies were 6 to 65 times higher than the NOAEL used to establish the cPAD. There is no evidence to indicate that children or infants would be more sensitive than adults to toxic effects caused by exposure to dimethomorph.

Therefore, the registrant believes that the results of the toxicology and metabolism studies support both the safety of dimethomorph to humans based on the intended use as a fungicide on domestically produced hops, lettuce (head and leaf), cucurbit vegetables (crop group 9), and bulb vegetables (crop group 3) and the granting of the requested tolerances.

F. International Tolerances

There are no Canadian, Mexican, or codex MRLs established for dimethomorph for the commodities associated with this request; consequently, a discussion of international harmonization is not relevant.