Chlorothalonil; Pesticide Tolerance for Use in or on Asparagus

The Interregional Research Project No. 4 (IR-4), New Jersey Agricultural Experiment Station, P.O. Box 231, Rutgers University, New Brunswick, NJ 08903, has submitted pesticide petition (PP) 2E4042 to EPA on behalf of the Agricultural Experiment Stations of Kentucky, North Carolina, Oklahoma, Virginia, and Washington. This petition requests that the Administrator, pursuant to section 408(e) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e), amend 40 CFR 180.275 by establishing a tolerance for combined residues of the fungicide chlorothalonil [tetrachloroisophthalonitrile] and its metabolite, 4-hydroxy-2,5,6-trichloroisophthalonitrile, in or on the raw agricultural commodity asparagus at 0.1 part per million (ppm). The scientific data submitted in the petition and other relevant material have been evaluated. A discussion of the toxicological data considered in support of the proposed tolerance for asparagus can be found in a proposed rule (PP 0E3889, 2E4113, and 5E4538/P639) published in the Federal Register of January 24, 1996 (61 FR 1884). The Federal Register notice of January 24, 1996, also provides a discussion of the basis for the EPA's classification of chlorothalonil and hexachlorobenzene (HCB), a manufacturing impurity found in chlorothalonil formulations, as probable human carcinogens (Group B2 of EPA's classification system for carcinogens). Dietary risk assessments were conducted using Reference Doses (RfD), the applicable cancer potency factors to assess chronic exposure and risk from chlorothalonil and HCB residues, and the Margin of Exposure (MOE) to assess acute toxicity from chlorothalonil residues. The Reference Dose (RfD) for chlorothalonil is established at 0.018 mg/kg of body weight (bwt)/day, based on a no-observed-effect-level (NOEL) of 1.8 mg/kg/day from the 2-year feeding study in dogs, which demonstrated as effects increased urinary bilirubin levels and kidney vacuolated epithelium, and an uncertainty factor of 100. Available information on anticipated residues and/or percent of crop treated was incorporated into the analysis to estimate the Anticipated Residue Contribution (ARC) from existing uses. The proposed tolerance level of 0.1 ppm and 100 percent crop treated were assumed to estimate dietary exposure to residues of chlorothalonil from the proposed use on asparagus. The ARC from existing uses and the proposed uses utilizes less than 1 percent of the RfD for chlorothalonil for the U.S. population and all population subgroups. EPA generally has no cause for concern for exposures below 100 percent of the RfD. The RfD for HCB is established at 0.0008 mg/kg bwt/day based on a NOEL of 0.08 mg/kg of bwt/day and an uncertainty factor of 100. The NOEL was taken from a 130 week feeding study in rats that showed hepatic centrilobular basophilic chromogenesis. Since there are no published tolerances for HCB, the ARC was generally calculated by multiplying the anticipated residues for chlorothalonil by 0.05 percent, an adjustment based on comparisons of residue data for the two compounds from controlled field trials. The ARC for HCB from existing uses of chlorothalonil and the proposed use on asparagus utilizes less than 1 percent of the RfD for the U.S. population and all population subgroups. The upper bound carcinogenic risks were calculated using the ARC estimates for dietary exposure from existing uses and the proposed use on asparagus, and Q*s (Q stars) of 0.00766 (mg/kg/day)-1 for chlorothalonil and 1.02 (mg/kg/day)-1 for HCB. The upper bound carcinogenic risk from existing and all pending uses of chlorothalonil is estimated at 6.5 x 10-7, with the proposed use for asparagus contributing 1.05 x 10-8 to the cancer risk assessment. The upper bound carcinogenic risk for HCB is estimated at 3.2 x 10-7 from existing and all pending uses, with the proposed use for asparagus contributing 1.2 x 10-7 to the cancer risk assessment. The proposed use on asparagus would contribute negligible increases in the total cancer risks from dietary exposure to residues of chlorothalonil and HCB. The Margin of Exposure (MOE) is a measure of how closely the high- end acute dietary exposure comes to the NOEL from the toxicity endpoint of concern. For chlorothalonil, the MOE was calculated as ratio of the lowest-observed effect level (LOEL) of 175 mg/kg/day from the subchronic study in rats. A NOEL was not established since an effect (renal and gastric lesions) was observed at the single dose tested. An uncertainty factor of 300 was used to calculate the MOE since there was no available NOEL from the study. The acute dietary MOE for chlorothalonil is calculated to be greater than 1,500 for the general population and all population subgroups. Chlorothalonil poses minimal acute dietary risk. The nature of the residue in asparagus is adequately understood. The parent compound and its metabolite (4-hydroxy- 2,5,6- trichloroisophthalonitrile) are the regulated residues. An adequate analytical method, is available for enforcement purposes. The method is listed in the Pesticide Analytical Manual, Volume II (PAM II). There is no reasonable expectation that secondary residues will occur in milk, eggs, or meat, fat, or meat byproducts of livestock or poultry as a result of this action; there are no livestock feed items associated with asparagus. There are presently no actions pending against the continued registration of this chemical. The pesticide is considered useful for the purpose for which the tolerance is sought. Based on the information and data considered, the Agency has determined that the tolerance established by amending 40 CFR part 180 would

protect the public health. Therefore, it is proposed that the tolerance be established as set forth below. Any person who has registered or submitted an application for registration of a pesticide, under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) as amended, which contains any of the ingredients listed herein, may request within 30 days after publication of this notice in the Federal Register that this rulemaking proposal be referred to an Advisory Committee in accordance with section 408(e) of the FFDCA. Interested persons are invited to submit written comments on the proposed regulation. Comments must bear a notation indicating the docket number [PP 2E4042/P661]. A record has been established for this rulemaking under docket number [PP 2E4042/P661] (including comments and data submitted electronically as described below). A public version of this record, including printed, paper versions of electronic comments, which does not include any information claimed as CBI, is available for inspection from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The public record is located in Room 1132 of the Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. The official record for this rulemaking, as well as the public version, as described above will be kept in paper form. Accordingly, EPA will transfer all comments received electronically into printed, paper form as they are received and will place the paper copies in the official rulemaking record which will also include all comments submitted directly in writing. The official rulemaking record is the paper record maintained at the Virginia address in ``ADDRESSES'' at the beginning of this document. Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency must determine whether the regulatory action is ``significant'' and therefore subject to all the requirements of the Executive Order (i.e., Regulatory Impact Analysis, review by the Office of Management and Budget (OMB)). Under section 3(f), the order defines ``significant'' as those actions likely to lead to a rule (1) having an annual effect on the economy of $100 million or more, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities (also known as ``economically significant''); (2) creating serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement, grants, user fees, or loan programs; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in t his Executive Order. Pursuant to the terms of this Executive Order, EPA has determined that this rule is not ``significant'' and is therefore not subject to OMB review. This action does not impose any enforceable duty, or contain any ``unfunded mandates'' as described in Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), or require prior consultation as specified by Executive Order 12875 (58 FR 58093, October 28, 1993), entitled Enhancing the Intergovernmental Partnership, or special consideration as required by Executive Order 12898 (59 FR 7629, February 16, 1994). Pursuant to the requirements of the Regulatory Flexibility Act (5 U.S.C. 601-612), the Administrator has determined that regulations establishing new tolerances or raising tolerance levels or establishing exemptions from tolerance requirements do not have a significant economic impact on a substantial number of small entities. A certification statement explaing the factual basis for this determination was published in the Federal Register of May 4, 1981 (46 FR 24950).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: June 4, 1996.

Stephen L. Johnson, Director, Registration Division, Office of Pesticide Programs. Therefore, it is proposed that 40 CFR part 180 be amended as follows:

PART 180--[AMENDED]

1. The authority citation for part 180 continues to read as follows:

Authority: 21 U.S.C. 346a and 371. 2. In Sec. 180.275, the table in paragraph (a) is amended by adding alphabetically the raw agricultural commodity asparagus, to read as follows:

Sec. 180.275 Chlorothalonil; tolerances for residues.

(a) * * *

------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ * * * * * Asparagus.................................................. 0.10 * * * * * ------------------------------------------------------------------------

* * * * *

[FR Doc. 96-15478 Filed 6-18-96; 8:45 am] BILLING CODE 6560-50-F