EPA BIOPESTICIDES AND POLLUTI ON PREVENTION DIVISION

COMPANY NOTICE OF FILING FOR PE STICIDE PETITIONS PUBLISHED IN

THE FEDERAL REGISTER

EPA Biopesticides and Pollution Prevention Division contact: [Colin Walsh (703) 308-0298]

INSTRUCTIONS: Please utilize this outline in p reparing the pesticide petition. In

cases where the outline element does not apply, please insert “NA-Remove” and

maintain the outline. Please do not chan ge the margins, font, or format in your pesticide petition. Simply replace the instructions that appear in green , i.e., “ [insert company name] ,” with the information specific to your action.

SUBMISSION: E-mail the completed temp late to: hollis.linda@epa.gov.

TEMPLATE:

[AMVAC Chemical Corporation

[Insert petition number]

EPA has received a pesticide petition ([insert petition number]) from [AMVAC Chemical Corporation [4695 MacArthur Court, Ste. 1250, Newport Beach, CA 90660] proposing, pursuant to s ection 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)

2. to establish an exemption from the requirement of a tolerance for

(Options (pick one) 2. biochemical pesticide 3-Decen-2-one

in or on potatoes.

Pursuant to section 408(d)(2)( A)(i) of FFDCA, as amended, AMVAC Chemical Corporation has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by AMVAC Chemical2

Corporation , and EPA has not fully evaluated the merits of the pesticide petition. The summary may have been edited by EPA if the terminology used was unclear, the summary contained extraneous material, or the summary unintentiona lly made the reader conclude that the findings reflected EPA’s position and not the position of the petitioner.

I. AMVAC Chemical Corporation, Petition Summary

[Insert petition number]

A. Product Name and Proposed Use Practices

AMV 1018 Technical, AMV-1018 EP contai n the biochemical, 3-decen-2-one which inhibits potato sprouting.

B. Product Identity/Chemistry

1. Identity of the pestic ide and corresponding residues. 3-Decen-2-one is naturally occurring in yogurt, tuna, porcini mushrooms, Iberico ham, fruits, spices

and other food commodities. 3-Decen-2-one is approved as a direct and indirect food additive per 21 CFR 172.515. From studies, residues of 3-Decen-2-one are not of toxicological concern.

2. Magnitude of residues at the time of har vest and method used to determine the

residue. NA-remove

3. A statement of why an analytical method of detecting and measuring the levels of the pesticide residue are not needed. NA-remove

C. Mammalian Toxicological Profile

Acute toxicity studies conducted with AMV-1018 Technical (98.0% active ingredient) showed no advers e effects by oral, dermal, and inhalation routes of exposure. Rats exposed to structurally similar surrogate co mpounds for 90-days exhibited no adverse effects at the high est doses tested. 3-Decen-2-one is metabolized to innocuous components, and the long history of dietary exposure is not associated with toxicity.

D. Aggregate Exposure

1. Dietary exposure.

i. Food. The acute oral toxicity study conducted with AMV-1018 Technical

resulted in the LD 50 of greater than 5,000 mg/kg of bo dy weight. Structurally similar surrogate compounds administered to rats in the diet for 90-days did not cause adverse effects at the highes t doses tested. These res ult support the perspective

that residues of 3-Decen-2-one are not of toxicological concern following acute or repeated exposure via the diet.3

ii. Drinking water. NA-Remove

2. Non-dietary exposure

. NA-Remove

E. Cumulative Effects

No cumulative effects from the use of 3-Decen-2-one on potatoes are expected due to the low toxicity and residue profiles.

F. Safety Determination

1. U.S. population. There are no safety concerns for using 3-Decen-2-one on potatoes on the U.S. population. The resul ts of toxicity testing and the lack of residues of toxicological concern on treated potatoes show there is minimal risk to

human health from 3-decene-2-one.

2. Infants and children

. There are no safety concerns for using 3-Decen-2-one on potatoes for infants and ch ildren. The results of toxicity testing and the lack of residues of toxicological concern on treated potatoes show there is minimal risk to

infants and children from 3-decene-2-one.

G. Effects on the Immune and Endocrine Systems

There are no reported adverse effects to the immune or endocrine systems

from 3-Decen-2-one

.

H. Existing Tolerances

There are no existing tolerances for 3-Decen-2-one in the United States.

I. International Tolerances

There are no existing international tolerances for 3-Decen-2-one

.