Document ID: EPA-HQ-OPP-2022-0205-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2022-03-22T04:00Z

EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER  

EPA Biopesticides and Pollution Prevention Division contact: [Mike Mendelsohn, (703) 308-8715]

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 format in your pesticide petition. Simply replace the instructions that appear in green, i.e., "[SUNY-College of Environmental Science and Forestry, 1 Forestry Dr., Syracuse, NY 13210]," with the information specific to your action.

SUBMISSION: Email the completed template to: hollis.linda@epa.gov.

TEMPLATE:

[SUNY-College of Environmental Science and Forestry, 1 Forestry Dr., Syracuse, NY 13210]

[Insert petition number]

	EPA has received a pesticide petition ([insert petition number]) from [The IR-4 Project], [500 College Road East, Suite 20 W, Princeton, NJ 08540] on behalf of [SUNY-College of Environmental Science and Forestry, 1 Forestry Dr., Syracuse, NY 13210] requesting, 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 plant-pesticide [Oxalate oxidase gene] in or on [all Castanea spps and their hybrids].

Pursuant to section 408(d)(2)(A)(i) of FFDCA, as amended, [The IR-4 Project], [500 College Road East, Suite 20 W, Princeton, NJ 08540] on behalf of [SUNY-College of Environmental Science and Forestry, 1 Forestry Dr., Syracuse, NY 13210] has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by [SUNY-College of Environmental Science and Forestry] 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. [SUNY-College of Environmental Science and Forestry] Petition Summary
   
   	[Insert petition number]

A. Product Name and Proposed Use Practices

	[Darling 58 American chestnut shows enhanced tolerance to the chestnut blight, caused by the fungus Cryphonectria parasitica, typically showing blight symptoms similar to or less severe than blight-resistant Chinese chestnut.  Darling 58 American chestnut expresses a wheat gene for oxalate oxidase, which degrades oxalic acid produced by the fungus and protects the tree from damage caused by this pathogen.  Darling 58 was developed using Agrobacterium-mediated transformation.  The proposed use practices include distribution programs for both horticultural and ecological restoration purposes, to enhance forest health and genetic diversity.]

B. Product Identity/Chemistry

	1. Identity of the pesticide and corresponding residues. [Oxalate oxidase gene in all Castanea spps and their hybrids.]

	2. Magnitude of residues at the time of harvest and method used to determine the residue. [This section is not applicable as an exemption from the requirement of a tolerance is proposed.]

	3. A statement of why an analytical method of detecting and measuring the levels of the pesticide residue are not needed. [An analytical method for residues is not applicable as an exemption from the requirement of a tolerance is proposed.]

C. Mammalian Toxicological Profile

	[The oxalate oxidase gene and protein are commonly found in the food supply. Darling 58 chestnuts show no evidence of toxicity or allergenicity and there is no substantial difference between the transgenic and wild type American chestnut in regard to its toxicological profile.]

D. Aggregate Exposure

	1. Dietary exposure. [Oxalate oxidase in the Darling 58 American chestnut will be present only as part of a tree. Dietary exposure will be limited to consumption of collected tree nuts.  Experience with other sources of dietary exposure to oxalate oxidase indicates no evidence of toxicity.  Oxalate oxidase and similar enzymes are consumed and handled daily in cereal grains and many other foods including wheat, maize, rice, barley, sorghum, banana, and many dicot crops including strawberry, sunflower, beet, apricot, and peanut without any reports of toxicity, and there is no evidence that it should be considered a toxin.]

	i. Food. [There is a long history of routine exposure to oxalate oxidase in food.  Since the oxalate oxidase enzyme is ubiquitous in food, feed, and many other organisms, there is reasonable certainty that the wheat oxalate oxidase enzyme is not a known or suspected toxin.]

	ii. Drinking water. [The American chestnut is a terrestrial organism and oxalate oxidase will not be applied directly to water and is therefore unlikely to increase any natural concentrations in water bodies and drinking water.  Oxalate oxidase is also not likely to percolate through soil depths or survive municipal treatment of drinking water.]

	2. Non-dietary exposure. [Apart from ingestion in food, skin contact with oxalate oxidase-containing grain and grain products regularly occurs during harvest, processing, and baking. Products with ingredients from oxalate oxidase containing plants such as oats and apricot pits are found in skin care products, again with no reported toxic or allergenic properties.  Turf use and oral exposure from hand-to-mouth and object-to-mouth for toddlers is not relevant to the terrestrial use of Darling 58 American chestnut.]

E. Cumulative Effects

	[There are no other registrations of a similar product and since the oxalate oxidase gene has not been identified as having a common mechanism of toxicity with any other active ingredients, no cumulative effect is expected.]

F. Safety Determination

	1. U.S. population. [There is reasonable certainty that the wheat oxalate oxidase enzyme is not a known or suspected toxin.  The registration of the oxalate oxidase gene will not result in unreasonable risks and there is reasonable certainty that no harm will result from aggregate exposure.]

	2. Infants and children. [There is reasonable certainty that the wheat oxalate oxidase enzyme is not a known or suspected toxin.  The registration of the oxalate oxidase gene will not result in unreasonable risks and there is reasonable certainty that no harm will result to infants or children from aggregate exposure.]

G. Effects on the Immune and Endocrine Systems

	[The oxidase gene occurs naturally in wheat and other crops, is well characterized, is consumed daily by people and livestock and does not function in a manner similar to known hormones and does not act as an endocrine disruptor. Oxalate oxidase is present in many non-allergenic foods, and amino acid sequences do not match any known allergens according to database queries, so novel allergenicity is not a realistic concern.]

H. Existing Tolerances

	[There are no U.S. tolerances for the oxidase gene in or on all Castanea spps and their hybrids.]

I. International Tolerances

	[Codex has not established a MRL for the oxalate oxidase gene in or on all Castanea spps and their hybrids.]