COMPANY FEDERAL REGI STER DOCUMENT SUBMI SSION TEMPLATE (1/1/2005) EPA Registration Division contact: [ Janet Whitehurst, 703 - 305 - 6129 ] Valent U.S.A. Company EPA has received a pesticide petition ([ 9F7568 ]) from Valent U.S.A. Company, 1600 Riviera Ave., Walnut Creek, CA 94596 - 8025 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 part 180 by

e stablishing a tolerance for residues of 2,6 - Dichlorobenzamide (BAM) in or on the following raw agricultural commodities: Cattle, fat; Cattle, meat by products; Goat, fat; Goat meat by

products; Horse, fat ; Horse meat by products; Sheep, fat ; and Sheep, meat by pro ducts at 0.05 ppm, Cattle, meat; Goat, meat ; Horse, meat; Sheep , meat at 0.02 ppm, and Milk at 0.01 ppm. EPA has determined that the petition contains 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 supports granting of the petition. Additional data may be needed before EPA rules on the petition. A. Residue Chemistry 1. Plant Metabolism . BAM is a metabolite and/or environmental degradate of the pesticidal active ingredients fluopicolide and dichlobenil. BAM is included in the tolerance expression for dichlobenil because it is a major metabolite/degradate of dichlobenil in primary

crops. BAM is a minor metabolite of fluopicolide and is included in the tolerance expres sion for fluopicolide in primary crops. The Fluopicolide Risk Assessment Team has concluded that tolerance expression in livestock should include the metabolite, 2,6 - dichlorobenzamide (BAM) only. The metabolism of BAM in both plants and animals is adequately understood for the purposes of granting the proposed tolerance. Fluopicolide is metabolized slowly to 2,6 - dichlorobenzamide (BAM; AE C653711) and 3 - chloro - 5 - trifluoromethylpy

ridine - 2 - carboxyl ic acid (PCA; AE C657188), via cleavage of the bond between the carbon attached to the py ridine ring and the amide nitrogen of the parent compound, and to 2,6 - dichloro -N - [(3 - chloro - 5 - trifluoromethylpy

ridin- 2 - yl )methyl ] - 3 -hydroxybenzamide (AE C643890) via hydroxyl ation of the phenyl ring in the parent compound. Based on the results of the soil drench applications in lettuce, fluopicolide is metabolized in soil to BAM, which is then taken up by the plant. 2. Analytical Method.A practical analy tical method utilizing liquid chromatography and mass spectrometry

detection that is validated for detecting and measuring levels of fluopicolide and BAM in animal matrices has been submitted. A confirmation method for milk, with a limit of quantitation of 0.002 ppm, has also been developed and is being submitted as part of this petition. 3. Magnitude of Residues . Residue data has been submitted which adequately support the requested tolerances. B. Toxicological Profile The EPA has assessed the BAM toxicological profile as well as the no - observed- adverse effect- level (NOAEL) and the lowest- observed- adverse - effect - level (LOAEL) from the toxicity studies in the following assessment which can be found at http://www.regulations.gov : 2,6 -Dichlorobenzamide (BAM); 2,6 - Dichlorobenzamide (BAM) as a Metabolite/Degradate of Fluopicolide and Dichlobenil. Human Health Risk Assessment for Proposed Uses of Rhubarb, Dichlobenil on Caneberries (Subgroup 13 - 07A), and Bushberries (Subgroup 13 - 07B), Docket ID Number EPA- HQ - OPP - 2007 - 0604. C. Aggregate Exposure The aggregate exposure to BAM following treatment with dichlobenil and/or fluopicolide in all currently registered food/feed uses has previously b een assessed by

the EPA (see FR Vol. 73, No. 167, Wednesday, August 27, 2008, p. 50563 or docket ID EPA- HQ OPP - 2007 - 0604 for the most current assessment). The previous risk assessments on BAM, however, did not include the potential dietary (food) contribution of BAM residues in potato, rotated wheat, or in animal tissue commodities (i.e. meat/milk). Therefore, the incremental additional dietary risk from these potential food residues was assessed using the Cumulative and Aggregate Risk Evaluation System (CARES). The assessment was conducted using BAM toxicology endpoints previously

identified by the EPA. F or acute exposure scenarios involving the general population or subpopulations except females age 13 - 49, an endpoint (NOAEL) of 100 mg/kg was utilized. Acute exposure scenarios for females (ages 13 - 49) utilized an endpoint (NOAEL) of 30 mg/kg/day. Chronic exposure scenarios for all population subgroups utilized a toxicology

endpoint of 4.5 mg/kg/day . An additional 10X FQPA safety f actor was incorporated for all scenarios.Exposure to BAM via non- food sources (i.e. water, residential) was not assessed as these

routes have already been included in previous assessments and are not expected to change from the current tolerance setting action. Dietary exposure estimates were based on proposed tolerance values, default or experimentally

determined processing factors, and 100% crop treated. The proposed tolerance values for the commodities assessed are as follows: Potato: 0.01 ppm Wheat flour/grain: 0.02 ppm Wheat bran/germ: 0.04 ppm Meat: 0.02 ppm Meat/fat: 0.05 ppm Milk: 0.01 ppm The resulting highly conservative exposure estimates were compared against the applicable BAM endpoints discussed above. F or acute exposure scenarios, the analys is shows that the MOE’s for the general population and for all subgroups, all greatly exc eed the Agency ’s level of concern of 1000. S imilarly, chronic exposure to the general population and all subgroups exceed the Agency ’s level of concern of 1000. D. Cumulative Effects Section 408(b)(2)(D)(v) requires that, when considering whether to e stablish, modify, or revoke a tolerance, the Agency c onsider “available information” concerning the cumulative effects of a particular pesticide’s residues and “other substances that have a common mechanism of toxicity”. EPA does not have, at this time, available data to determine whether BAM has a common mechanism of toxicity with other substances or how to include this compound in a cumulative risk assessment. F or the purposes of this tolerance action, EPA has not assumed that BAM has a common mechanism of toxicity with other substances. E. Safety Determination 1. U.S. population. Valent USA concludes that there is a reasonable certainty that no harm will result to the general population (or any subpopulation) by

including the incremental additional exp osure resulting from the proposed new BAM tolerances. 2. Infants and children . Valent USA concludes that there is a reasonable certainty that no harm will result to the general population (or any subpopulation) by including the incremental additional exp osure resulting from the proposed new BAM tolerances. F. International TolerancesThere are no CODEX tolerances for residues of BAM.