Document ID: EPA-HQ-OPP-2006-0481-0014
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-02-04T05:00Z

SEQ CHAPTER \h \r 1 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

	

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-hydrox
ybenzamide (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.

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.

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   HYPERLINK
"http://www.regulations.gov/"  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-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.  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

	

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.