EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE

PETITIONS PUBLISHED IN TH E FEDERAL REGISTER

EPA Registration Division contact: [P.V Shah; 703-308-1846]

INSTRUCTIONS: Please utilize this outline in preparing the pesticide petition. In cases where the outline element does not apply, please insert “NA-Remove” and maintain the outline. Please do not change the margins, font, or forma t in your pesticide petition. Simp ly replace the instructions that appear in green , i.e., “ [insert company name] ,” with the information specific to your action.

TEMPLATE:

[West Agro, Inc.]

[Insert petition number]

EPA has received a pesticide petition ( ) from [West Agro, Inc.], [11100 N. CONGRESS AVE. KANSAS CITY MO 64153] 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.

(Options (pick one)

to establish an exemption from the requirement of a tolerance for concentrations of up to and including 1200 ppm of acetic acid as an inert ingredient used as an active ingredient promoter in a sanitizing end use product for use on dairy processing equipment and food-processing equipment and utensils under 40 CFR 180.940(b) and 180.940(c).] EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of FDDCA; 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 [This information is not available, no r required for the establishment of a tolerance exemption.]

1. Plant metabolism. [NA-Remove]

2. Analytical method. [NA-Remove]

3. Magnitude of residues. [NA-Remove]

B. Toxicological Profile

1. Acute toxicity. [ The acute oral LD50 was greater than 3310 mg/kg in rats and greater than 4960 mg/kg in mice. The dermal LD 50 was 1,060 mg/kg in rats. The acute inhalation LC50 was greater than 11.4 mg/kg in rats. Co rneal damage was seen in acute ey e irritation studies that did not reverse in seven days. An acute dermal/skin sensit ization study found that a high concentration (60%) of acetic acid was corrosive to the skin.]

2. Genotoxicity. [A reverse mutation assay of acetic acid was negative with and without metabolic activation. An in vitro Chinese hamster ovary assay was negative for genotoxicity.2

Acetic acid is not considered to be genotoxic .]

3. Reproductive and developmental toxicity. [ There was no suggestion of reproductive toxicity in the 90-day rat oral study of acetic acid. Developmental toxicity studies in the mouse, rat and rabbit found that acetic acid did not induce developmental toxicity at the highest dose level of 1,600 mg/kg/day.]

4. Subchronic toxicity. [ A subchronic study in the rat by the drinking water route of administration, also summarized in the EPA Final Work plan, found that the only toxicity was found at the highest dose level (390 mg /kg/day) in the form of decreased body weight gain. The NOAEL was 195.mg/kg/day. ]

5. Chronic toxicity. [Chronic studies are not available for acetic acid]

6. Animal metabolism. [ Acetic acid, in the form of acetate, is known to combine with Coenzyme A. Three molecules of of acetyl-CoA fo rm mevalonic acid. Mevalonic acid may also be formed by the reaction of acetyl-CoA with acetoacetyl-ACP to form β -hydroxy- β -methylglutaryl-A

Carrier Protein. Mevalonic acid is then converted to squalene and ultimately to cholesterol. AcetylCoA also provides the carbon source in fatty acid synthesis .]

7. Metabolite toxicology

. [No metabolites of toxicological concern have been identified.]



### 8. Endocrine disruption

. [ Toxicity related to endocrine di sruption was not observed in the currently available database. ]

C. Aggregate Exposure

1. Dietary exposure. [Concentrations will be less than 1200 ppm in disinfectant formulations containing acetic acid. As a result, humans may be exposed to very low residue levels through the

diet from food. ]

i. Food. [The potential dietary exposure for acetic acid was calculated using method described by the FDA in the 1993 document “Sanit izing Solutions: Chemist ry Guidance for Food Additive Petitions”. Assuming that the total surface contacting food is 2000 cm 2 , that the residue of acetic acid is 1 mg/cm 2 , and that the maximum concentrat ion of 1,200 ppm is present in antimicrobial formulation, the Estimated Daily Inta ke would be 2.4 mg person or 0.04 mg/kg bw/day for a 60 kg individual. This is much less than th e RfD of 1.95 mg/kg/day that would result from the application of a 100-fold uncertainty factor to the NOAEL of 195 mg/kg/day in the subchronic study .]

ii. Drinking water. [Exposure via drinking water is not expected to be significant ]

2. Non-dietary exposure

. [Workers may experience dermal ex posure during application of pesticide products if personal protective clothing is not worn. Concentrations of acetic acid are less than 1.0% and this concentration is not expected to be associated with irri tation or other toxicity. Thus, a safety finding for acetic acid can be made for non-dietary exposures. ]

D. Cumulative Effects

[There are no available data or other reliable information that suggests that any toxic effects produced by acetic acid would be cumulative with those of any other chemical compounds. Acetic acid does not appear to produce toxic metabolites in common with other substances. It is assumed

that acetic acid does not share a common mechanis m of toxicity with oth er pesticidal substances. ]

E. Safety Determination

1. U.S. population. [There is a reasonable certainty that no harm to huma ns will result from3

the use of acetic acid as an inert ingredient in pesticide products.]

2. Infants and children

. [ There was no suggestion of reproductive toxicity in the 90-day rat oral study of acetic acid. Developmental toxicity studies in the mouse, rat and rabbit found that acetic acid did not induce developmental toxicity at the highest dose level of 1,600 mg/kg/day. ]

F. International Tolerances

[NA-Remove]