Dow AgroSciences & IR-4. Pesticide Tolerance Petition. Petitions: PP 1E6326, PP 2E6360 and PP 2E6466 for the raw agricultural commodities:

• The summary of the petition was prepared by Interregional Research Project Number 4 (IR-4). IR-4 submitted the petitions on behalf of the registrant, Dow AgroSciences LLC, who prepared this notice of filing.
• Genotoxicty. Ethalfluralin was weakly mutagenic in activated strains TA1535 and TA100 of salmonella typhimurium, but not in strains TA1537, TA1538, and TA98 in an Ames assay... In Chinese hamster ovary cells, ethalfluralin was negative without S9 activation, but it was clastogenic with activation.
• Reproductive and developmental toxicity. The developmental NOAEL in rats was 1,000 mg/kg/day, the highest dose. In rabbits the NOAELs for maternal and developmental toxicity were 75 mg/kg/day. The maternal LOAEL at 150 mg/kg/day was based on abortions and decreased food consumption. These effects as well as decreased weight gain, enlarged liver, and orange urine were found at 300 mg/kg/day. In this study developmental toxicity was observed. The developmental LOAEL in rabbits was 150 mg/kg/day, based on slightly increased resorptions, abnormal cranial development, and increased sternal variants. In a three-generation rat reproduction study, the parental NOAEL was 12.5 mg/kg/day. The parental LOAEL was 37.5 mg/kg/day, based on depressed mean body weight gains in males in all generations. No treatment-related effects were noted on reproductive parameters and the NOAEL was 37.5 mg/kg/day or greater. A 7-month multigeneration bridging study was conducted with doses equivalent to 0, 8, 20, or 61 mg/kg/day in the
diet of Fischer 344 rats. The parental NOAEL was 20 mg/kg/day. The parental LOAEL was 61 mg/kg/day based on increased liver weights.
• Chronic toxicity. Ethalfluralin was administered to Fisher 344 rats in the diet for 2 years in combined chronic toxicity and carcinogenicity replicate studies. The doses were equivalent to 0, 4.2, 10.7, or 32.3 mg/kg/day. The NOAEL for systemic effects was 32.3 mg/kg/day. Mammary gland fibroadenomas were found in dosed female rats at statistically significant incidences in the mid and high doses. EPA's Office of Pesticide Program's Carcinogenicity Peer Review Committee concluded that, ethalfluralin should be classified as Group C, a possible human carcinogen, based on increased mammary gland fibroadenomas and adenomas/fibroadenomas combined in female rats. The tumor incidences were statistically significant at both the mid and high dose, and exceeded the upper range of historical controls. Based on a low dose extrapolation, the Q1* of 8.9 x 10-2 (mg/kg/day)-1 has been calculated. Based on both registered and proposed product uses, exposure to ethalfluralin from food is estimated to not exceed a lifetime cancer risk of 8.47 x 10-7. Cancer risks of less than 1 x 10-6 are generally considered to be negligible.
• Beagle dogs were given 0, 4, 20, or 80 mg/kg/day orally, by capsule, for 1 year. The NOAEL was 4 mg/kg/day. The LOAEL was 20 mg/kg/day, based on increased urinary bilirubin, variations in erythrocyte morphology, increased thrombocyte count, and increased erythroid series of the bone marrow. Elevated alkaline phosphatase levels were found at the two higher doses and siderosis of the liver at the high dose.

Proposed Revocation of Tolerances. "When EPA establishes tolerances for residues in or on raw agricultural commodities, consideration must be given to the possible residues of those pesticides in meat, milk, poultry, and/or eggs produced by animals that are fed agricultural products (for example, grain or hay) containing pesticide residues (40 CFR 180.6). When considering this possibility, EPA can conclude that: (1) Finite residues will exist in meat, milk, poultry, and/or eggs; (2) there is a reasonable expectation that finite residues will exist; or (3) there is a reasonable expectation that finite residues will not exist. In 1994, the ethalfluralin RED recommended revocation for egg, milk, fat, meat, and meat byproduct tolerances based on animal metabolism data (submitted since the time that the tolerances were originally established) from which EPA concluded that there is no reasonable expectation of finite residues for meat, fat, and meat byproduct commodities and the associated tolerances are not required according to 40 CFR 180.6(a)(3). Those feeding studies used exaggerated amounts of the pesticide and did not show measurable residues in animal tissues. Since the ethalfluralin RED, completed prior to the implementation of the FQPA, the Agency has reviewed the regulatory conclusions in the RED and determined in a memorandum January 3, 2002, that for egg, milk, fat, meat, and meat byproduct commodities there is no reasonable expectation of finite residues and the egg, milk, fat, meat, and meat byproduct tolerances for ethalfluralin are no longer needed and are not required according to 40 CFR 180.6(a)(3). Therefore, the Agency is proposing to revoke the tolerances in 40 CFR 180.416 for residues of ethalfluralin in or on goats, fat; goats, meat; and goats, mbyp. A copy of the Agency's January 3, 2002 memorandum will be placed in the docket."

IR-4 * - Pesticide Tolerance of 0.05 ppm in or on Canola and Safflower seed.- FINAL RULE.
Prenatal / developmental non-rodent studies: Abnormal cranial development, increase in sternal variants.
Chronic Toxicity in Dogs: increased urinary bilirubin, variations in erythrocyte morphology, increased thrombocyte count, and increased erythroid series of the bone marrow.
Combined Chronic/Carcinogenicity rat studies: Mammary gland fibroadenomas were found in dosed female rats at statistically significant incidences in mid and high doses.
Combined Chronic / Carcinogenicity mice studies: focal hepatocellular hyperplasia in both sexes and increased liver, kidney, and heart weights in females.
Bacterial reverse mutation test: weakly mutagenic.
In vitro mammalian chromosome aberration test: clastogenic with S9 activation.
2-year chronic carcinogenicity rat study: increased incidence of mammary gland fibroadenomas and combined adenomas/ fibroadenomas in female rats.

IR-4 * - Three pesticide petitions to establish tolerances for residues in or on Canola, Safflower and Dill at 0.05 ppm.

PLATTE CHEMICAL - Request to Voluntarily Cancel 2 Pesticide Registrations for Clean Crop Curbit EC Herbicide. EPA Reg. Nos. 034704 NH-94-0001 and 034704 OH-91-0004.

* Interregional Research Project Number 4 (IR-4) 681 U.S. Highway # 1, South, North Brunswick, NJ 08902- 3390