Document ID: EPA-HQ-OPP-2023-0083-0002
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: Alexandra Boukedes, 202-566-1511

SUBMISSION: Email the completed template to: Boukedes.alexandra@epa.gov.

BioConsortia, Inc.

2F8991

	EPA has received a pesticide petition (2F8991) from BioConsortia, Inc., 279 Cousteau Place, Suite 100, 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 request of a tolerance for the microbial pesticide Bacillus velenzensis strain 11604 in or on all food and feed commodities.
	
Pursuant to section 408(d)(2)(A)(i) of FFDCA, as amended, BioConsortia, Inc. has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by BioConsortia, 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. BioConsortia, Inc. Petition Summary
   
   	2F8991

A. Product Name and Proposed Use Practices

	This notice of filing summarizes the information submitted by BioConsortia, Inc., in support of a request for an exemption from the requirement of a tolerance for Bacillus velenzensis strain 11604 that contains a minimum of 1x10[9] colony forming units (cfu) per gram in Crimson.

Proposed Use Practices: Crimson is an End Use pesticide (EP) that acts by suppressing many fungal and bacterial plant pathogens including powdery mildew, gray mold, downy mildew, Botrytis blight and root rot. Bacillus velenzensis strain 11604 is a microbial pest control agent used by suppressing a number of bacterial and fungal plant pathogens.

The end-use product, Crimson, is a preventative biofungicide that contains Bacillus velenzensis strain 11604. The product is intended for different target markets including end-use products intended for both agricultural and home garden. Crimson is intended for terrestrial, outdoor, aquatic feed and food crop use as a foliar spray and/or soil drench application and is intended for both agricultural and home garden use. The product is proposed for use against multiple foliar and soil phytodiseases including but not limited to powdery mildew, black and gray mold, bacterial leaf blights, spots and specks and root rots, and greenhouse food crop uses.

Crimson, Bacillus velenzensis strain 11604, has three modes of action toward targeted pests. Firstly, it competitively excludes soilborne pathogens by colonizing plant roots to prevent infections. Secondly, Bacillus velenzensis strain 11604 produces metabolites that inhibits or kills foliar and soilborne pathogens. Lastly, the Crimson active ingredient may induce plant resistance to foliar and soilborne pathogens.

B. Product Identity/Chemistry

 Identity of the pesticide and corresponding residues. 
The microbial agent a gram-positive bacterium, designated strain 11604, was isolated from soil collected from a dry, grassy field in Northern California. The strain was identified as Bacillus velenzensis strain 11604 using phylogenetic 16S rDNA sequencing, morphological, biochemical, and physiological data. This strain is able to inhibit germination and growth of numerous plant pathogenic fungi.

	2. Magnitude of residues at the time of harvest and method used to determine the residue. A determination of the magnitude of residues at harvest is not required for
residues that are exempt from tolerances.

	3. A statement of why an analytical method of detecting and measuring the levels of the pesticide residue are not needed. This petition is an exemption from the
requirements of a tolerance without numerical limitation, thus an analytical detection
method should not be required.

C. Mammalian Toxicological Profile

Acute Oral Toxicity (UDP) in Rats
Acute oral toxicity study conducted showed a lack of toxicity to mammals (LD50 > 5000 mg/Kg), and a toxicity category IV.

Acute Dermal Toxicity in Rats
Acute dermal toxicity study conducted showed a lack of toxicity to mammals (LD50 > 5000 mg/Kg), and a toxicity category IV.

Acute Intravenous Toxicity and Pathogenicity Study in Rats
Acute intravenous toxicity and pathogenicity study conducted showed a lack of toxicity to mammals, Bacillus velenzensis strain 11604 showed no toxicity and is not pathogenic in the albino rat. There was no mortality and no clinical signs observed.  The conducted acute injection toxicity and pathogenicity study is classified as acceptable.  This study was conducted in accordance with the guideline recommendations for an acute injection toxicity and pathogenicity study (OCSPP 885.3200; PMRA Data code: M4.3.2; OECD Data Code: IIM 5.3.4) in the Albino rat, showing no significant adverse effects, and demonstrate that the products are non-toxic to mammals.

Acute Inhalation Toxicity in Rats
Acute inhalation toxicity study conducted showed a lack of toxicity to mammals (LC50 = > 2 mg/L). Toxicity based on lack of deaths at the limit dose = EPA Toxicity Category IV. The acute inhalation study conducted satisfies the guideline requirement for an acute inhalation study (OCSPP 870.1300) in the rat, showing no significant adverse effects, and demonstrate that the products are non-toxic to mammals.

Primary Dermal Irritation in Rabbits
The primary dermal irritation study conducted showed Bacillus velenzensis strain 11604 is not a dermal irritant and is EPA Toxicity Category IV, showing no significant adverse effects.

Primary Eye Irritation in Rabbits
The primary eye irritation study conducted showed Bacillus velenzensis strain 11604 is practically non-irritating to the eye and a Toxicity Category IV, showing no significant adverse effects.

D. Aggregate Exposure

	1. Dietary exposure. Bacillus velenzensis strain 11604 is a soil born microbe. Dietary exposure to this microbial pesticide may occur, but the complete absence of any acute oral toxicity, infectivity, and/or pathogenicity effects, as discussed in Unit C, supports the conclusion that this active ingredient is not toxic at high exposure levels, and, therefore, establishment of a tolerance exemption for residues of Bacillus velenzensis strain 11604 is appropriate.

	i. Food. Based on the results from the toxicity studies presented in Unit C, no toxicity, infectivity, pathogenicity or other adverse effects from dietary exposure to Bacillus velenzensis strain 11604 from the proposed pesticidal uses of Bacillus Bacillus velenzensis strain 11604 are expected. Bacillus species, Bacillus velenzensis strain 11604, are commonly found in agricultural settings, and occur naturally on fresh produce with no known adverse effects. Bacillus velenzensis strain 11604 is not known to produce mammalian toxins, and no foodborne illnesses associated with Bacillus velenzensis strain 11604 have been reported.

	ii. Drinking water. Drinking water exposure. Bacillus velenzensis strain 11604 is naturally present in soils; therefore, Bacillus velenzensis strain 11604 may occur in surface water and possibly groundwater. According to the World Health Organization, Bacillus species are often detected in drinking water even after going through acceptable water treatment processes, largely because the spores are resistant to these disinfection processes (reference provided at the end of the petition exemption document via this submission). Should this microbial pesticide be present, no adverse effects are expected from exposure to Bacillus velenzensis strain 11604 through drinking water, based on the results of toxicity studies described in Unit C.

	2. Non-dietary exposure. The proposed used site is limited to agricultural sites and greenhouse.  Migration of the Bacillus velenzensis strain 11604 out of the treated fields is not expected. Therefore, there will be no nonoccupational, non-dietary exposure to the general population. 

E. Cumulative Effects

	There is no other registered product containing Bacillus velenzensis strain 11604. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ``available information'' concerning the cumulative effects of a particular pesticide's residues and ``other substances that have a common mechanism of toxicity.''

Bacillus velenzensis strain 11604 variant soil does not operate via a toxic mode of action and thus does not share a common mechanism of toxicity with any other substances. Therefore, section 408(b)(2)(D)(v) does not apply.

F. Safety Determination

	1. U.S. population. There are no existing U.S. population information for Bacillus velenzensis strain 11604.  

	2. Infants and children. There are no existing infants and children information for Bacillus velenzensis strain 11604. Based on the results from the toxicity studies presented in Unit C, no toxicity, infectivity, pathogenicity or other adverse effects from dietary exposure to Bacillus velenzensis strain 11604 from the proposed pesticidal uses of Bacillus velenzensis strain 11604 are expected.

G. Effects on the Immune and Endocrine Systems

	There is no information available to suggest that Bacillus velenzensis strain 11604 has an effect on immune and endocrine system. Bacillus velenzensis strain 11604 is a ubiquitous organism in the environment and there have been no reports of the organism affecting immune and endocrine systems. Therefore, it is unlikely that this organism would have estrogenic or endocrine effects because it is practically non-toxic to mammals.

H. Existing Tolerances

	There are no existing tolerances for Bacillus velenzensis strain 11604.

I. International Tolerances

	No Codex maximum residue levels exist for Bacillus velenzensis strain 11604.