EPA

BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER EPA Biopesticides and Pollution Prevention TEMPLATE Natural Industries, Inc. Petition Number : 9F7587 EPA has re ceived a pesticide petition ( 9F7587 ) from Natural Industries, Inc., 6223 Theall Rd., Houston, TX 77066 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 to establish an exemption from the requirement of a tolerance for the microbial pesticide Paecilomyces fumosoroseus strain FE 9901 in or on vegetable and herb crops. Pursuant to section 408(d)(2)(A)(i) of FFDCA, as amended, Natural Industries, Inc. has submitted the foll owing summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by Natural Industries, Inc. 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 unintentionally made the reader conclude that the findings reflected EPA’s position and not the position of the petitioner.

I. Natural Industries, Inc. Petition Summary ( 9F7587 ) A. Product Name and Proposed Use Practices : NoFlyTM W P a mycoinsecticide to control whiteflies on agricultural food crops grown in greenhouses. B. Product Identity/Chemistry : Identity of the pesticide and corresponding residues. Paecilomyces fumosoroseus strain FE 9901 is a naturally occurring fungus occurring in various soil types. Residues of Paecilomyces fumosoroseus strain FE 9901 are not expected to occur since the organism degrades rapidly in sunlight and high temperatures. Any remaining residues are removed from post harvest washing and treatments.2

C. Mammalian Toxicological Profile : Acute toxicity/pathogenicity studies conducted with NoFlyTM Technical (60.0% active ingredient) showed no adverse effects by any route of exposure. Paecilomyces fumosoroseus strain FE 9901 can’t grow and develop at human and other mammal body temperatures (35  ̊C or above). Additionally, acute pulmonary and acute injection toxicity studies showed that Paecilomyces fumosoroseus strain FE 9901 is not pathogenic, not infectious and showed minimal persistence in rats. D. Aggregate Exposure

. Dietary exposure : food. Residues of Paecilomyces fumosoroseus strain FE 9901 are not expected to occur since it degrades rapidly in sun light and in high temperatures, which are common in greenhouses. Any remaining residues will wash off during the processing of the fo od. E. Cumulative Effects : No cumulative effects from the use of Paecilomyces fumosoroseus strain FE 9901 on food crops since the organism can’t grow or persist at temperature above 35  ̊C or above. F

. Safety Determination 1. U.S. population . There are no safety concerns for using Paecilomyces fumosoroseus strain FE 9901 on food crops on the U.S. population. The organism can’t grow or infect huma ns and does not persist in temperatures above 35  ̊ C. The organism also rapidly degrades in sunlight. Any remaining microorganisms will be washed off with common food processing procedures. 2. Infants and children . There are no safety concerns for us ing Paecilomyces fumosoroseus strain FE 9901 on food crops for infants and children. The organism can’t grow or infect humans and does not persist in temperatures above 35  ̊ C. The organism also rapidly degrades in sunlight. Any remaining microorganisms wil l be washed off with common food processing procedures. G. Effects on the Immune and Endocrine Systems : There are no reported adverse effects to the immune or endocrine systems from Paecilomyces fumosoroseus strain FE 9901. H. Existing Tolerances : There are no existing tolerances for Paecilomyces fumosoroseus strain FE 9901 in the United States. I. International Tolerances : There are no existing international tolerances for Paecilomyces fumosoroseus strain FE 9901.