


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: Jeannine Kausch, 703-347-8920

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

Syngenta Crop Protection, LLC

[Insert petition number]

	EPA has received a pesticide petition ([9F8780]) from Syngenta Crop Protection, LLC, 410 Swing Road, Greensboro, NC 27409 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
	
	microbial pesticide  Aspergillus flavus, NRRL 21882 on almond and pistachio.
		
Pursuant to section 408(d)(2)(A)(i) of  FFDCA, as amended, Syngenta Crop Protection, LLC has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by Syngenta Crop Protection, LLC 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. Syngenta Crop Protection, LLC Petition Summary
   
   	[9F8780]

A. Product Name and Proposed Use Practices

	Afla-Guard(R) GR is a biological control agent for agricultural use to displace aflatoxin-producing fungi in the treated crop. Afla-Guard GR is approved for use on peanuts and corn (field and popcorn). For almond and pistachio, the product is applied to the soil at a proposed use rate of 10 pounds of product per acre for the end use product Afla-Guard GR (0.001 pound active ingredient/acre).  The product is applied once during the season, in pistachio from late May through early June and in almond from late May through early July, using a granular applicator.

B. Product Identity/Chemistry

	1. Identity of the pesticide and corresponding residues. The active ingredient in Afla-Guard GR is a naturally occurring, nontoxigenic strain of A. flavus (NRRL 21882). The primary mode of action is by competition of the nontoxigenic strain of A. flavus with the toxigenic strains of A. flavus, which displaces aflatoxin-producing fungi in treated crop.  Syngenta Crop Protection, LLC has submitted a bridging request summarizing the similarities between Aspergillus flavus NRRL 21882 and Aspergillus flavus AF36 to support the bridging of efficacy data for almond and pistachio.  Currently both strains are registered to displace aflatoxin producing fungi on corn.  However, Aspergillus flavus AF36 (EPA Reg. No. 71693-1) is currently registered for use on pistachio, almond and fig on the product label, while the NRRL 21882 strain is not. Given the similarity of toxicity and efficacy data, biochemical expression and gene expression between AF36 and Afla-Guard GR, applying Afla-Guard on almond and pistachio should offer the same reductions in aflatoxin on these crops, as well as have the same human toxicity and environmental effects. Both of these products have the same mode of action, and are extremely similar in their morphology and physical expression. As most metabolites of concern are produced during periods of oxidative stress, biochemical expression being similar is extremely important. Syngenta feels that these two products are similar enough that no risks should be posed to human or environmental health through addition of almond and pistachio to Afla-Guard GR's uses. The bridging justification is based on data that shows that the toxicity and efficacy data and gene expression data are remarkably similar between the two strains of A. flavus.

	2. Magnitude of residues at the time of harvest and method used to determine the residue. The reduction in aflatoxin contamination is a form of biological control that is achieved by competitive exclusion, i.e., the nontoxigenic strain applied to the field exclude native, toxigenic strains from infecting and growing in pistachio and almond.  This benefit is realized without increasing the overall concentration of Aspergillus flavus in the environment in the long term.  Similarly, the total concentration of Aspergillus flavus found in pistachio and almond is not increased above naturally occurring levels when the product is used as directed.

	3. A statement of why an analytical method of detecting and measuring the levels of the pesticide residue are not needed.  A petition for exemption from tolerances is being submitted. Research data from studies on peanuts, cotton, and corn using Aspergillus flavus NRRL 21882 and other A. flavus strains that do not produce aflatoxins (A. flavus NRRL 18543) indicate that residues of naturally occurring A. flavus populations are expected to exist in these crops. The proposed use A. flavus NRRL 21882 on tree nut crops does not increase the potential for higher levels of total A. flavus above naturally occurring levels. A. flavus NRRL 21882 competes with toxigenic strains of A. flavus, resulting in lower levels of aflatoxins, which are potent liver toxins and carcinogens.
Both the U.S. Food and Drug Administration (USFDA) and the U.S. Department of Agriculture (USDA) have set regulatory limits for aflatoxin in food and a regulatory inspection program is already in place that will assure that any tree nuts with visible levels of A. flavus NRRL 21882 will be segregated and subjected to further conditioning, if deemed necessary.
The use of Afla-Guard(TM) on tree nut crops will not increase total Aspergillus flavus levels in food and feed above the background, naturally occurring levels. Therefore, the establishment of tolerance and an analytical method to measure the pesticide residues are not needed. Aspergillus flavus NRRL 21882 is exempted from tolerance on food and feed items of peanuts and corn (Code of Federal Regulations; Title 40, Chapter I, Sub-Chapter E, Part §180.1254). The Agency had also concluded that an analytical method to detect residues of this pesticide on peanuts for enforcement purposes is not needed (EPA BRAD, PC Code 0065002004, March 2004).

C. Mammalian Toxicological Profile

	EPA has classified Aspergillus flavus NRRL 21882 for Afla-Guard as Toxicity Category IV for acute oral toxicity and Category III for pulmonary toxicity effects.  All acute toxicity testing showed little or no pathogenicity and no mortality among the test subjects therefore specific LD50s could not be established. The active ingredient shows no environmental toxicity and has waivers for most environmental toxicity tests since it is naturally occurring and levels of the overall fungal population do not increase with the application of the atoxigenic strain.  The active ingredient is shown to be safe for the environment and for pesticide applicators and has been exempted from the requirement of a tolerance for its labeled uses.

D. Aggregate Exposure

	1. Dietary exposure. Aspergillus flavus NRRL 21882 is neither toxic nor infective as determined by oral exposure studies in rats when dosed by oral gavage at 2.35-3.80 x 108 CFU/animal (EPA BRAD, PC Code 0065002004, March 2004). The potential residues of A. flavus NRRL 21882 on tree nuts are not expected to be any different than those which occur naturally and generally. Tree nuts treated with A. flavus NRRL 21882 are expected to have significantly lower levels of aflatoxins that may be present in nuts from untreated trees. Because the use of Afla-Guard(TM) on tree nuts will not increase total A. flavus levels above background, naturally occurring levels, there is a reasonable certainty that no harm will result from dietary (food only) exposure to residues arising from all currently registered and proposed uses of A. flavus NRRL 21882 on tree nut crops.

	i. Food. Aspergillus flavus NRRL 21882 is a naturally occurring organism that does not produce aflatoxins and thus is safer than toxigenic A. flavus isolates. At the proposed use rate, the total population of A. flavus on the crop is not expected to increase beyond naturally occurring background levels. Total levels of fungus on tree nuts, therefore, may remain unchanged while the amount of aflatoxin is expected to be reduced through the use of Afla-Guard(TM).  The dietary exposure to A. flavus NRRL 21882 is expected to be quite low.
Aspergillus flavus NRRL 21882 strain is not likely to be carcinogenic. In fact, displacement of toxigenic strains of A. flavus by this non-aflatoxin-producing strain may decrease exposure to aflatoxins, which are potent liver toxins and carcinogens.

	ii. Drinking water. Exposure to Aspergillus flavus NRRL 21882 in drinking water is not likely to be greater than current/existing exposures to A. flavus strains. The Afla-Guard(TM) product, if used as labeled, is not likely to accumulate in drinking water. In fact, the displacement of toxigenic strains of A. flavus by this non-aflatoxin-producing strain may decrease exposure to aflatoxins, which are potent liver toxins and carcinogens. Thus, exposure from the proposed use of A. flavus NRRL 21882 is not likely to pose any incremental risk via drinking water to adult humans, infants or children (EPA BRAD, PC Code 0065002004, March 2004).

	2. Non-dietary exposure. Low application rates to the soil by tractor-mounted equipment or similar equipment will not pose undue occupational exposure and risk to workers and pesticide handlers if the pesticide is used as labeled. Appropriate PPE and a 4-hour REI will mitigate occupational exposure and risk. The PPE for mixer/loader, applicator, and other pesticide handlers, and restricted-entry post-application workers include long sleeve shirt, long pants, shoes, socks, waterproof gloves, goggles, and a dust/mist filtering respirator with the NIOSH prefix N - 95, R-95 or P-95.

E. Cumulative Effects

	Based on tests in mammalian systems, Aspergillus flavus NRRL 21882 does not appear to be toxic or pathogenic to humans. The displacement of the aflatoxin-producing strain of A. flavus by A. flavus NRRL 21882 may reduce aflatoxin contamination of peanuts. Based on the low toxicity potential of A. flavus NRRL 21882, the fact that it is non-aflatoxigenic, and the safety net already in place to monitor food/feed commodities for aflatoxins by USDA and US FDA, no cumulative or incremental effect is expected from the use of A. flavus NRRL 21882 on tree nut crops.

F. Safety Determination

	1. U.S. population. Aspergillus flavus NRRL 21882 is a naturally occurring organism. The use of Afla-Guard(TM) on tree nuts will not increase total A. flavus levels above the background or naturally occurring levels in food, drinking water or feed items. Hence, there is a reasonable certainty that no harm will result from the use of this product. In addition, there is the benefit of reduced aflatoxin production.

	2. Infants and children. Aspergillus flavus NRRL 21882 is a naturally occurring organism that does not produce aflatoxins. At the proposed use rate, A. flavus NRRL 21882 is expected to replace the aflatoxin producing natural strains of A. flavus. Therefore, the total population of A. flavus on the crop will not increase beyond naturally occurring background levels. Whereas, the amount of aflatoxin will be reduced through the use of Afla-Guard(TM). Exposure to A. flavus NRRL 21882 in drinking water is not likely to be greater than current/existing exposures to A. flavus strains and may result in lower exposure to aflatoxins. Based on its lack of toxicity and the natural occurrence of A. flavus NRRL 21882, there is a reasonable certainty that no harm will result to infants and children from exposure to potential residues in food or drinking water. The potential reduction in aflatoxin resulting from the use of this product will be a significant benefit to children's health.

G. Effects on the Immune and Endocrine Systems

	Aspergillus flavus NRRL 21882 is a naturally occurring organism which does not produce aflatoxin and is thus safer than Aspergillus flavus isolates producing aflatoxins. There is no evidence to suggest that Aspergillus flavus NRRL 21882 affects the immune or endocrine systems.

H. Existing Tolerances

	Aspergillus flavus NRRL 21882 has been approved for use on peanuts and corn. An exemption from the requirement of a tolerance is established for residues of Aspergillus flavus NRRL 21882 on peanut; peanut, hay; peanut, meal; peanut, refined oil, corn, field, forage; corn, field, grain; corn, field, stover; corn, field, aspirated grain fractions; corn, sweet, kernel plus cob with husk removed; corn, sweet, forage; corn, sweet, stover; corn, pop, grain; and corn, pop, stover.

I. International Tolerances

	Codex Alimentarius Commission has not yet established Maximum Residue Limits (MRLs) for Aspergillus flavus NRRL 21882.





