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CFR Citation: 40 CFR Part 180

RIN ID: RIN 2070-AB78

OPP ID: [OPP-300994; FRL-6555-5]

NOTICE: RULES

ACTION: Pesticides; tolerances in food, animal feeds, and raw agricultural commodities:

DOCUMENT ACTION: Final rule.

SUBJECT CATEGORY: Myclobutanil; Pesticide Tolerances

DATES: This regulation is effective May 10, 2000. Objections and requests for hearings, identified by docket control number OPP300994, must be received by EPA on or before July 10, 2000.

DOCUMENT SUMMARY: This regulation establishes tolerances for combined residues of myclobutanil in or on a variety of food commodities. Rohm and Haas Company and the Interregional Research Project #4 (IR4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act of 1996.

SUMMARY: Myclobutanil,

SUPPLEMENTAL INFORMATION

A. Does this Action Apply to Me?

You may be affected by this action if you sell, distribute, manufacture, or use pesticides for agricultural applications, process food, distribute or sell food, or implement governmental pesticide regulations. Potentially affected categories and entities may include, but are not limited to:
Examples of Categories NAICS 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.
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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 RegisterEnvironmental 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 OPP300994. The official record consists of the documents specifically referenced in this action, 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 Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 3055805. II. Background and Statutory Findings

In the Federal Register of September 2, 1999 (64 FR 48165) (FRL 60495), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104170) announcing the filing of pesticide petitions (PP) for tolerances by Rohm and Haas Company and IR4. This notice included a summary of the petitions prepared by Rohm and Haas Company, the registrant. There were no comments received in response to the notice of filing.

The petitions requested that 40 CFR 180.443 be amended by establishing tolerances for combined residues of the fungicide myclobutanil alphabutylalpha(4chlorophenyl)1H1,2,4triazole1 propanenitrile and its alcohol metabolite (alpha(3hydroxybutyl) alpha(4chlorophenyl)1H1,2,4triazole1propanenitrile (free and bound), in or on the following commodities:

1. PP 7E4862. IR4 proposes the establishment of a tolerance for asparagus at 0.02 parts per million (ppm).

2.PP 7E4866. IR4 proposes the establishment of a tolerance for the caneberry subgroup at 1.0 ppm. The petition was subsequently amended to propose the establishment of a tolerance for the caneberry subgroup at 2.0 ppm.

3. PP 8E4939. IR4 proposes the establishment of tolerances for currant at 3.0 ppm and gooseberry at 2.0 ppm.

4. PP 7E4877. IR4 proposes the establishment of a tolerance for mint at 3.0 ppm. The petition was revised to specify peppermint and spearmint tops at 3.0 ppm.

5. PP 7E4861. IR4 proposes the establishment of a tolerance for snap beans at 1.0 ppm. The petition was amended to proposed a tolerance for succulent snap bean at 1.0 ppm.

6. PP 4E4302. IR4 proposes the establishment of a tolerance for strawberry at 0.5 ppm.

7. PP 1F4030. Rohm and Haas Company proposes the establishment of tolerances for tomato at 0.3 ppm, tomato puree at 0.6 ppm and tomato paste at 1.2 ppm. The petition was subsequently amended to propose tolerances for tomato at 0.3 ppm, tomato puree at 0.5 ppm and tomato paste at 1.0 ppm.

8. PP 9F3812. Rohm and Haas Company proposes the establishment of a tolerance for the pome fruit group at 0.5 ppm. The petition was amended to propose a tolerance for mayhaw at 0.7 ppm and apple wet pomace at 1.3 ppm.

9. PP 2F4155. Rohm and Haas Company proposes the establishment of tolerances for the cucurbit vegetables group at 0.5 ppm. The petition was amended to propose a tolerance for the cucurbit vegetables group at 0.2 ppm. The petition was also amended to propose tolerances for indirect and inadvertent residues of myclobutanil (parent compound only) at 0.03 ppm for the following rotational crop groups: root and tuber vegetables group; leaves of root and tuber vegetables group; leafy vegetables (except Brassica vegetables) group; Brassica leafy vegetables group; legume vegetables group; foliage of legume vegetables group; fruiting vegetables group; cereal grains group; forage, fodder and straw of cereal grains group; and the nongrass animal feeds group.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through food and drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....''

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL57547).

III. Aggregate Risk Assessment and Determination of Safety

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2), for tolerances for residues of myclobutanil on the named commodities. EPA's assessment of exposures and risks associated with establishing the tolerances follows.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by myclobutanil are discussed in this unit as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.
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Table 1. Toxicity Profile of Myclobutanil Technical Guideline/Study Results 821(a) Subchronic Feeding in Rats (13 NOAEL: 1000 ppm
weeks). LOAEL: 3000 ppm based on increased liver, kidney weights; hypertrophy, necrosis in liver; pigmentation in convoluted kidney tubules; vacuolated adrenal cortex. 821(a) Subchronic Feeding in Mice (13 NOAEL: 45 mg/kg/day( 300 ppm) weeks). LOAEL: 150 mg/kg/day (1000 ppm) based on hepatocytic hypertrophy, swollen vacuolated centrilobular hepatocytes, single large hepatocyte vacuoles, centrilobular individual cell hepatocyte necrosis and centrilobular necrotic hepatitis; cytoplasmic eosinophilia and/or hypertrophy of the zona fasculata cells of the adrenal glands of males.
821(b) Subchronic Feeding in Dogs (13 NOAEL: 5 mg/kg/day (200 ppm) Weeks). LOAEL: 20 mg/kg/day (800 ppm) based on liver changes including increased alkaline phosphatase, relative and absolute liver weight and hepatocellular hypertrophy. 822 28day Dermal Toxicity in Rats.... NOAEL for systemic effects: greater than 100 mg a.i./kg/ day (the highest dose in both studies)

FOR FURTHER INFORMATION CONTACT By mail: Hoyt Jamerson, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 3089368; and email address: jamerson.hoyt@epa.gov.