Document ID: EPA-HQ-OPP-2023-0143-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2023-03-24T04:00Z

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: Jeannine Kausch, 703-347-8920.

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., "[insert company name]," with the information specific to your action.

SUBMISSION: Email the completed template to: Kausch.Jeannine@epa.gov

TEMPLATE:

Marrone Bio Innovations, Inc. 

Petition number XXXXX

	EPA has received a pesticide petition (XXXXX) from Marrone Bio Innovations, Inc, 1540 Drew Ave., Davis, CA 95618 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 the microbial pesticide: 
Inactivated Burkholderia rinojensis strain A396 cells and spent fermentation media 

(Options (pick one)
   
   	1. by establishing a tolerance for residues of  NA-Remove

     	2. to establish an exemption from the requirement of a tolerance for Inactivated Burkholderia rinojensis strain A396 cells and spent fermentation media 

     	3. to establish an amendment/expansion of an existing tolerance exemption for the   NA-Remove

(Options (pick one)
   
   	1. microbial pesticide  Inactivated Burkholderia rinojensis strain A396 cells and spent fermentation media in or on all food commodities when applied as a biological pesticide to crops and non-crop use sites

	2. biochemical pesticide NA-Remove

	3. plant-pesticide NA-Remove in or on NA-Remove.

	
Pursuant to section 408(d)(2)(A)(i) of  FFDCA, as amended, Marrone Bio Innovations, Inc. (MBI) has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by Marrone Bio Innovations, Inc (MBI) 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. Marrone Bio Innovations, Inc. Petition Summary
   
	Petition number XXXXX
   

A. Product Name and Proposed Use Practices

Product Names:
      MBI-306 TGAI (Technical Grade Active Ingredient; for manufacturing use only)
	MBI-306 EP (End-use Product; for agricultural use, including greenhouse, indoor, and forest, food, feed, and nonfood use sites and residential indoor and residential outdoor use sites for  pre and post-harvest uses)
Active Ingredient:
      Burkholderia rinojensis was isolated on April 28, 2008, on Potato Dextrose Agar, by direct plating of soil dilutions. The source soil sample was collected by an MBI Scientist from under an evergreen tree at the Rinnoji Temple in Nikko, Japan on March 30th, 2008. The cumulative evidence obtained from the polyphasic approach that included sequencing of the 16s rRNA gene, FAME profile, antibiotic resistance, phenotype microarrays, among other techniques, has concluded that Burkholderia sp. A396 is a novel member of the Burkholderia genus with pesticidal activity and it lacks the genetic markers commonly associated with members of the B. cepacia complex.
Mode of Action
      The active ingredient, MBI-306 TGAI, is composed of inactivated Burkholderia rinojensis strain A396 cells and spent fermentation media that when formulated into an end-use product (MBI-306 EP) can be used to control or suppress insects, mites, nematodes, and plant pathogens (Pearson, 2021). MBI-306 TGAI has the ability to control soft-bodied insects such as aphids,whiteflies, and mites by interference of the pest life cycle and feeding activity via ingestion. MBI-306 TGAI also demonstrates control and suppression of nematodes by interfering with feeding activity and/or triggering plant defense genes to produce defensive compounds in root tissues. Lastly, MBI-306 TGAI suppresses or controls plant pathogens via disruption of life cycle and/or triggering plant defense genes to produce defensive compounds in treated plant tissue.
Use Pattern
      MBI-306 EP is a biological pesticide for use against soft-bodied insects such as aphids and whiteflies; mites; nematodes; and fungi by interfering with feeding activity and/or life cycle of a pest. MBI-306 EP is a suspension concentrate that can be applied as a foliar spray, as an in-furrow spray at planting, as a transplant water treatment, as a banded soil application at planting, as a soil shank injection at planting, through drip chemigation, as a tree injection, as a foliar spray utilizing an electrostatic sprayer, through a greenhouse (or indoor) fogger, as a foliar application through overhead sprinkler irrigation on certain crops as specified on product label to control listed pests and diseases. This biopesticide can be used in all field application combinations of terrestrial, greenhouse, indoor, and forest, food, feed, and nonfood. residential indoor and residential outdoor use sites.
      

B. Product Identity/Chemistry

	1. Identity of the pesticide and corresponding residues. Not applicable

     	2. Magnitude of residues at the time of harvest and method used to determine the residue. Not applicable. 

     	3. A statement of why an analytical method of detecting and measuring the levels of the pesticide residue are not needed. The results of the acute toxicity studies summarized below demonstrate that the Inactivated Burkholderia rinojensis strain A396 cells and spent fermentation media with insecticide, miticide, nematicide, and fungicide characteristics will not pose a dietary risk.  Residues of "Inactivated Burkholderia rinojensis strain A396 cells and spent fermentation media are not expected on treated food from the proposed new use patterns MBI-306.  The application rate of the TGAI is relatively low and data show that both TGAI and unique marker substance is biodegradable and not expected to persist in the environment. 

C. Mammalian Toxicological Profile

	Acute Oral Toxicity (OCSPP 870.1100):  MBI-306 TGAI was low in toxicity in an acute oral toxicity test in albino rats following the up-and-down procedure. Female albino rats received a gavage dose of 5,000 mg/kg of the test article.   Three of the 5 animals dosed at 5,000 mg/kg survived during the 14-day observation period.    The LD50 for MBI-306 TGAI was determined to be >5000 mg/kg body weight, classifying it as a Category IV substance for acute oral toxicity.
	Acute Dermal Toxicity (OCSPP 870.1200): MBI 306 TGAI was not toxic in an acute dermal study conducted on albino rats.  Single undiluted doses of 5000 mg/kg body weight of the test article were applied to the intact skin of 10 albino rats and exposure was maintained for 24 hours. There was no mortality observed in the study.  The LD50 for dermal exposure to MBI-306 TGAI is greater than 5,000 mg/kg, classifying it as a Category IV substance for acute dermal toxicity.
	Acute Inhalation Toxicity (OCSPP 870.1300): MBI 306 TGAI was low in toxicity to albino rats exposed to the test substance by inhalation.  Following inhalation of undiluted MBI-306 TGAI the test substance was not toxic in rats, with an LD50 > 5 mg/L. An acute inhalation study in rats exposed to the undiluted end use product, MBI-306 WDG, resulted in an LD50 in male and female rats > 5 mg/L, classifying it as a Category IV substance for acute inhalation toxicity.
	Primary Eye Irritation (OCSPP 870.2400):  A primary eye irritation study conducted on MBI 306 TGAI indicated that MBI-306 TGAI is a minimal eye irritant, Toxicity Category IV. 
	Primary Dermal Irritation (OCSPP 870.2500: The results from an acute dermal irritation study demonstrate that MBI-306 TGAI is slightly irritating to the skin, Classified as a Toxicity Category IV.  
      90-day Repeated Oral Toxicity Study (OCSPP 870.3100: The results from a, repeated oral exposure study in rats demonstrated that MBI-306 TGAI does not produce adverse toxicological effects. The chronic toxicity study determined an NOAEL of 900 mg/kg/day.  
	A rationale was provided in place of the Toxicity / Pathogenicity study data requirements based on the fact that the microbial preparation is inactivated during the manufacturing process.

D. Aggregate Exposure

     	i. Dietary exposure. Dietary exposure from use of Inactivated Burkholderia rinojensis strain A396 cells and spent fermentation media, as proposed, is minimal.  The characteristics of the active ingredient, end product, and marker compound, plus the very low application rate, suggest that no residues will remain on crops or food commodities from the existing and proposed uses. The results of toxicity testing following acute and chronic oral exposure indicate that Inactivated Burkholderia rinojensis strain A396 cells and spent fermentation media is low in acute toxicity. There are no reports of adverse human health effects related to oral exposure to Burkholderia rinojensis strain A396 cells. The absence of adverse toxicity in laboratory animals following repeated oral exposure to high doses of the product supports the benign nature of Burkholderia rinojensis strain A396.

     	ii. Food. Residues of Inactivated Burkholderia rinojensis Strain A396 cells and spent fermentation media are not expected to occur on treated food commodities based on the proposed use patterns of the insecticide, miticide, nematicide, and fungicide end use products containing MBI-306 TGAI.

     	iii. Drinking water. Similarly, exposure of humans to residues of Inactivated Burkholderia rinojensis strain A396 cells and spent fermentation media in drinking water would be minimal based on the degradation rate of the TGAI and marker substance in the biopesticide product and the low proposed application rates and methods.

     	iv. Non-dietary exposure. The potential for non-dietary exposure to the general population, including infants and children, is low as the proposed use sites are generally agricultural.  That said, residential uses are proposed for the MBI-306 EP. Given the label instructions for direct application, its low home and garden use rates, and the rapid biodegradation of the active ingredient, the potential for child exposure to the active ingredient after application is low.

E. Cumulative Effects

	To our knowledge there are no available data or other reliable information that suggests any toxic effects produced by Inactivated Burkholderia rinojensis strain A396 cells and spent fermentation media would be cumulative with those of any other chemical compounds.  Cumulative effects from use of the insecticide, miticide, nematicide, and fungicide products conataining Inactivated Burkholderia rinojensis strain A396 cells and spent fermentation media are not expected due to the very low residues of each.  

F. Safety Determination

     	1. U.S. population. The available information presented in this petition supports, the precedent uses of the microbe, and EPA's decision in the FFDCA position that there is reasonable certainty that no harm to humans will result from the use of Inactivated Burkholderia rinojensis strain A396 cells and spent fermentation media as an active ingredient in biological insecticide, miticide, nematicide and fungicide products.

     	2. Infants and children.  It is not expected that Burkholderia rinojensis strain A396, when used as currently approved and as proposed, would result in residues that are of toxicological concern. There is a reasonable certainty of no harm for infants and children from exposure to Burkholderia rinojensis strain A396 from the proposed uses.

G. Effects on the Immune and Endocrine Systems

	To date, there is no evidence to suggest that Burkholderia rinojensis strain A396, functions in a manner similar to any known hormone, or can act as an endocrine disrupter.

H. Existing Tolerances

	There is currently an exemption from the requirement of a tolerance for "Heat-killed Burkholderia spp. strain A396 cells and spent fermentation media in or on all food commodities when applied as a biological insecticide to agricultural crops ..."  40 CFR 180.1325. As this substance, inactivated Burkholderia rinojensis strain A396 cells and spent fermentation media is manufactured differently, it has been evaluated separately and is petitioning for a separate exemption from the requirement of a tolerance. 

I. International Tolerances

	There are no International tolerance exemptions in place for Burkholderia rinojensis strain A396.