[Federal Register Volume 60, Number 55 (Wednesday, March 22, 1995)] [Proposed Rules] [Pages 15109-15111] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 95-6932] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [PP 3E4241/P607; FRL-4941-1] RIN 2070-AC18 Imazethapyr; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: EPA proposes to establish tolerances with regional registration for the sum of the residues of the herbicide imazethapyr, as its ammonium salt, and its metabolite in or on the raw agricultural commodities lettuce and endive. The Interregional Research Project No. 4 (IR-4) requested this proposed regulation. DATES: Comments, identified by the document control number, [PP 3E4241/ P607], must be received on or before April 21, 1995. ADDRESSES: By mail, submit written comments to: Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. In person, bring comments to: Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. Information submitted as a comment concerning this document may be claimed confidential by marking any part or all of that information as ``Confidential Business Information'' (CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the comment that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. All written comments will be available for public inspection in Rm. 1132 at the address given above, from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. FOR FURTHER INFORMATION CONTACT: By mail: Hoyt L. Jamerson, Registration Division (7505W), Office of Pesticide Programs, Environmental Protection [[Page 15110]] Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: Sixth Floor, Crystal Station #1, 2800 Jefferson Davis Hwy., Arlington, VA 22202, (703)-308-8783. SUPPLEMENTARY INFORMATION: 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) 3E4241 to EPA on behalf of the vegetable growers of Florida. The 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 180.447 by establishing tolerances with regional registration for residues of the herbicide imazethapyr, 2- [4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5- ethyl-3-pyridine carboxylic acid, as its ammonium salt, and its metabolite, 2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H- imidazol-2-yl]-5-(1-hydroxyethyl-3-pyridine carboxylic acid), free and conjugated, in or on the raw agricultural commodities lettuce (head and leaf) and endive (escarole) at 0.1 part per million (ppm). The petitioner proposed that use of imazethapyr on lettuce and endive be limited to Florida based on the geographical representation of the residue data submitted. Additional residue data will be required to expand the area of usage. Persons seeking geographically broader registration should contact the Agency's Registration Division at the address provided above. The scientific data submitted in the petition and other relevant material have been evaluated. The toxicological data considered in support of the proposed tolerances include: 1. Several acute toxicology studies placing technical-grade imazethapyr in Toxicity Category III and Toxicity Category IV. 2. A 1-year feeding study with dogs fed diets containing 0, 1,000, 5,000, or 10,000 part per million (ppm) with a systemic no-observed- effect level (NOEL) of 1,000 ppm (25 milligrams (mg)/kilogram (kg)/day) based on decreased packed cell volume, hemoglobin, and erythrocytes in the blood of female dogs at the 5,000-ppm (125 mg/kg/day) dose level. 3. A 78-week carcinogenicity study in mice fed diets containing 0, 1,000, 5,000 or 10,000 ppm (equivalent to 0, 150, 750, or 1,500 mg/kg/ day) with a systemic NOEL of 5,000 ppm based on decreased body weight gain in both sexes at the 10,000-ppm dose level. No carcinogenic effects were observed under the conditions of the study. 4. A 2-year chronic feeding/carcinogenicity study in rats fed diets containing 0, 1,000, 5,000, or 10,000 ppm (equivalent to 0, 50, 250, or 500 mg/kg/day) with no treatment-related systemic or carcinogenic effects observed under the conditions of the study. 5. A multi-generation reproduction study in rats fed diets containing 0, 1,000, 5,000, or 10,000 ppm (equivalent to 0, 50, 250, or 500 mg/kg/day) with no treatment-related systemic or reproductive effects observed under the conditions of the study. 6. Developmental toxicity studies in rats and rabbits with no developmental toxicity observed under the conditions of the studies at dose levels up to and including the highest dose tested (1,125 mg/kg/ day in rats and 1,000 mg/kg/day in rabbits). 7. Mutagenicity studies include gene mutation assays in bacteria cells (negative) and Chinese hamster ovary cells (no dose-response); structural chromosomal aberration assays in vivo in rat bone marrow cells (negative) and in vitro in Chinese hamster ovary cells (positive without activation at levels toxic to cells and negative with activation); and other genotoxic effects (did not induce unscheduled DNA synthesis in rat hepatocytes cultured in vitro). The reference dose (RfD) for imazethapyr is established at 0.25 mg/ kg body weight/day. The RfD is based on a NOEL of 25 mg/kg/day established in the 1-year feeding study in dogs and an uncertainty factor of 100. The theoretical maximum residue contribution (TMRC) from existing uses and the proposed uses on lettuce and endive utilizes less than 1 percent of the RfD for the general population and all 22 subgroup populations for which EPA routinely conducts dietary risk assessments. This is a worst-case estimate of dietary exposure which assumes tolerance level residues and treatment of the total production acreage of the commodities. The dietary risk assessment indicates that there is minimal risk from the establishment of the proposed tolerances for lettuce and endive. The nature of residues in lettuce and endive is adequately understood for the purposes of establishing the proposed tolerances. An adequate analytical method is available for enforcement purposes. The enforcement methodology has been submitted to the Food and Drug Administration for publication in the Pesticide Analytical Manual, Vol. II (PAM II). Because of the long lead time for publication of the method in PAM II, the analytical methodology is being made available in the interim to anyone interested in pesticide enforcement when requested from: Calvin Furlow, Public Response and Program Resources Branch, Field Operations Divisions (7506C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-5937. No secondary residues are expected to occur in meat, milk, poultry, or eggs from this action since lettuce and endive are not considered livestock feed commodities. There are currently no actions pending against the continued registration of this chemical. Based on the information and data considered, the Agency has determined that the tolerances established by amending 40 CFR 180.447 would protect the public health. Therefore, it is proposed that the tolerances 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 document 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 document control number, [PP 3E4241/P607]. All written comments filed in response to this petition will be available in the Public Response and Program Resources Branch, at the address given above from 8 a.m. to 4 p.m., Monday through Friday, except legal holidays. 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 [[Page 15111]] 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 this 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. Pursuant to the requirements of the Regulatory Flexibility Act (Pub. L. 96-354, 94 Stat. 1164, 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 to this effect 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: March 8, 1995. 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. 180.447, by adding new paragraph (d), to read as follows: Sec. 180.447 Imazethapyr, ammonium salt; tolerance for residues. * * * * * (d) Tolerances with regional registration, as defined in Sec. 180.1(n) of this chapter, are established for the sum of residues of the herbicide imazethapyr, 2-[4,5-dihydro-4-methyl-4-(1- methylethyl)-5-oxo-1H-imidazol-2-yl]-5-ethyl-3-pyridine carboxylic acid, as its ammonium salt, and its metabolite, 2-[4,5-dihydro-4- methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-(1-hydroxyethyl)-3- pyridine carboxylic acid, both free and conjugated, in or on the following raw agricultural commodities: ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ Endive (escarole).......................................... 0.1 Lettuce (head and leaf).................................... 0.1 ------------------------------------------------------------------------ [FR Doc. 95-6932 Filed 3-21-95; 8:45 am] BILLING CODE 6560-50-F