COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION 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 establishing a tolerance for residues of 2,6-Dichlorobenzamide (BAM) in or 

on the following raw agricultural commodities: Cattle, fat; Cattle, meat byproducts; Goat, 

fat; Goat meat byproducts; Horse, fat; Horse meat byproducts; Sheep, fat; and Sheep, 

meat byproducts 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 expression 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-

trifluoromethylpyridine-2-carboxylic acid (PCA; AE C657188), via cleavage of 

the bond between the carbon attached to the pyridine ring and the amide nitrogen 

of the parent compound, and to 2,6-dichloro-N-[(3-chloro-5-

trifluoromethylpyridin-2-yl)methyl]-3-hydroxybenzamide (AE C643890) via

hydroxylation 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 analytical 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 been assessed by the EPA (see 

FR Vol. 73, No. 167, Wednesday, August 27, 2008, p. 50563 or docket ID EPA-HQOPP-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. For 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 factor 

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. For acute exposure scenarios, the analysis 

shows that the MOE’s for the general population and for all subgroups, all greatly exceed 

the Agency’s level of concern of 1000. Similarly, 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 establish, modify, or 

revoke a tolerance, the Agency consider “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. For 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 exposure 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 exposure resulting from the proposed new 

BAM tolerances.

F. International Tolerances
There are no CODEX tolerances for residues of BAM.