Document ID: EPA-HQ-OPP-2020-0237-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2020-06-29T04:00Z

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:

Michael Mendelsohn
Branch Chief
Microbial Pesticide Branch
Biopesticides and Pollution Prevention Division
Office of Pesticide Programs
U.S. Environmental Protection Agency
1200 Pennsylvania Ave. N.W.
Washington, D.C. 20460

SUBMISSION: E-mail the completed template to:

TEMPLATE:

J.R. Simplot Company
5369 W. Irving St.
Boise, ID 83706

######

	EPA has received a pesticide petition ###### from J.R. Simplot Company, 5369 W. Irving St., Boise, ID 83706 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 a permanent exemption from the requirement of a tolerance for an plant-incorporated protectant (PIP) inert ingredient, a modified potato acetolactate synthase (StmALS). Pursuant to section 408(d)(2)(A)(i) of FFDCA, as amended, the J.R. Simplot Company has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by the J.R. Simplot Company 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. J.R. Simplot Company Petition Summary
   
   	######

A. Product Name and Proposed Use Practices

	Gen 3 potatoes. The StmALS is 99.7% identical to the native Solanum tuberosum acetolactate synthase (StALS) with only two amino acid changes, which confer herbicide tolerance that will be used as a selectable marker during tissue culture selection. As an inert ingredient, StmALS in potato will be used for screening positive transformation events. Simplot potato events containing StmALS will not be commercialized as herbicide tolerant varieties.

B. Product Identity/Chemistry

	1. Identity of the pesticide and corresponding residues.

	StmALS is an inert ingredient and does not have a pesticidal function or mechanism of action.

 Name: Modified Potato Acetolactate Synthase (StmALS).
 Chemical Identity: The StmAls gene is nucleic acid (including promoter, coding sequence, and terminator) that is transcribed and translated into an amino acid polypeptide with two amino acid substitutions compared to wild type potato ALS.
 Composition: Gen 3 potato events are generated by Agrobacterium-mediated plant transformation. Confirmation of gene insertion is carried out using PCR, Southern blot, and immunoblot methods based on the gene and protein sequences.

	2. Magnitude of residues at the time of harvest and method used to determine the residue.

	Less than 250 ppb in tubers as determined by immunoblot detection. It is estimated that the inert ingredient is less than 0.000025% of potato.

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

	As the protein is expressed in the plant and not applied to the plant through spraying, it is not feasible to remove residues of StmALS from transformed potato events. The safety assessment of StmALS demonstrates that both hazard and exposure associated with the protein is low and that the risk to both humans and the environment is close to zero. Thus, methods for detecting and measuring residues of StmALS are not necessary.

C. Mammalian Toxicological Profile

	The StmALS protein is as safe as the native potato ALS and other ALS proteins with similar amino acid modifications. The StmALS protein is derived from potato ALS and differs from the native protein by two amino acids. The amino acid changes confer herbicide tolerance during tissue culture, enabling selection of transformation events containing a functional insert. StmALS is an inert ingredient for a plant-incorporated protectant and will be used as a selectable marker during potato transformation.

StmALS does not pose a safety risk to human health or the environment based on a weight of evidence that includes:
::	the long history of safe use of potato, the source of the gene from which StmAls was derived,
::	StmALS is 99.7% identical to the native potato ALS,
::	similar amino acid substitutions introduced into StmALS are also found in commonly consumed crops such as maize, wheat, and rice, which are safely consumed by humans,
::	and the lack of similarity between StmALS and known allergens and toxins.

	Proteins are not inherently toxic and are rapidly denatured by the acidic conditions of the stomach and by proteases secreted in the intestinal tract.

	It is expected that there will be negligible exposure of StmALS residues to humans, as well as non-target mammals, birds, fish, or insects, and the environment. StmALS is expressed in all tissues of potato plants and is not applied to plants (i.e., by spraying); therefore, the protein is not present in the environment outside of the plant, and its environmental fate is expected to be the same as for the plant (e.g., when the plant senesces, the protein is degraded).

D. Aggregate Exposure

	1. Dietary exposure.

	The level of StmALS in tubers from any transformed potato event is expected to range from 2-10 ppm (μg/g FW), which equates to an exposure level of 0.0061-0.031 mg/kg bw/d.

	i. Food. 

	The StmALS protein is expressed in potato. Human exposure is expected from eating potato. StmALS is not similar to any known allergens or toxins. The low hazard and low exposure minimizes risk associated with StmALS.

	ii. Drinking water.

	Human exposure is not expected through drinking water.

	2. Non-dietary exposure.

	The StmALS protein is a plant-incorporated protectant inert ingredient. Other uses where human exposure might occur are not intended or expected.

E. Cumulative Effects

	Human exposure to StmALS from diet, food, drinking water, or other occupational or residential use is low and not associated with any known hazard.

F. Safety Determination

	1. U.S. population.

	The following weight of evidence indicates StmALS is not hazardous to humans or the environment:
::	the high percent identity (99.7%) between StmALS and native StALS, which is already present in potato and consumed by humans (and other animals) without negative effects,
::	the ubiquitous presence of acetolactate synthase genes (including those with equivalent amino acid substitutions conferring herbicide tolerance) in edible crops with a history of safe use,
::	and the lack of similarity between StmALS and known allergens or toxins.

	Based on the weight of evidence there is low hazard associated with StmALS and additional hazard characterization, including toxicity testing, is unnecessary. In addition to the low hazard associated with StmALS, the exposure to StmALS from potato consumption is low. Introducing StmALS in potato does not significantly increase levels of ALS above those already present. The low hazard and exposure associated with StmALS indicate that the risks to human safety and the environment are close to zero.

	2. Infants and children.

	The StmALS protein is unlikely to pose risk to infants or children.

G. Effects on the Immune and Endocrine Systems

	The StmALS protein is unlikely to cause effects on the immune and endocrine systems.

H. Existing Tolerances

	None.

I. International Tolerances

	None.