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**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:**  **[ Kimberly Nesci;**  **(703) 308 -**  **80 59**  **] 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 chang e the margins, font, or format**  **in your pesticid**  **e petition . Simply replace the instructions that appear in**  **green , i.e., “**  **[ insert**  **company name ]**  **,” with the information specific to your action. SUBMISSION:**  **TEMPLATE:** [Anatis Bioprotection Inc. ] [ PP 3F8176 ] EPA has received a pesticide petition ( [ PP 3 F8176 ] ) from [ Anatis Bioprotection Inc. (EPA Company No. 89600) ] , [ 278, rang Saint-André, St- Jacques - le - Mineur, Quebec J0J 1Z0, Canada] 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 [Beauveria bassiana strain ANT - 03 ] . Pursuant to section 408(d)(2)(A)(i) of FFDCA, as amended, [ Anatis Bioprotection Inc. ] has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by [Anatis Bioprotection Inc. ] and EPA has not fully

evaluated the merits of the pesticide petition. The summary may have been edited b y EPA if th e 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. [Anatis Bioprotection Inc. ] Petition Summary [ PP 3F8176 ] A. Product Name and Proposed Use Practices2 [ Beauveria bassiana strain ANT - 03 Technical, a Technical Grade Active Ingredient (TGAI) is proposed for manufacturing use only, for further formulation into registered end-use products. Bioceres is a biological insecticide containing the active ingredient Beauveria bassiana strain ANT - 03 for use on growing crops to control insect pests. Bioceres acts as a contact biological insecticide for use in the control or suppression of many f oliarfeeding pests, including aphids, whiteflies, thrips, plant bugs, beetles and weevils infesting labeled crops or use sites. Bioceres must be mixed with water and applied as a foliar spray

with ground or aerial equipment equipped for conventional insecticide spraying, or by

chemigation, in field, greenhouse, turf and ornamental or home and garden use sites. ] B. Product Identity/Chemistry 1. Identity of the pesticide and corresponding residues . [Beauveria bassiana strain ANT - 03 (CAS No. Not applicable). In formation regarding the name, identity and composition has been submitted to EPA and can be found in MRID Nos. 489472 - 01 and 489472 - 02. Beauveria bassiana is a ubiquitous entomopathogenic fungus that has been found in environments around the world. There is a significant body o f published literature on this microbial pest control agent (MPCA) with regards to its identification, occurrence, life cycle, pest host range, mode of action, persistence, efficaciousness, and safety to mammals and nontarget organisms. Relevant literature is summarized or referenced in MRID Nos. 489472 - 01, 489472 - 12 and 489472 - 13. Beauveria bassiana strain ANT - 03 spores attach to the surface of the target insect pest, germinate, penetrate the exoskeleton and grow rapidly

re sulting in death of the insect host (MRID No. 489472 - 01). ] 2. Magnitude of residues at the time of harvest and method used to determine the residue. [An analy

tical method for residues is not applicable. It is expected that, when used as proposed, Beauveria bassiana strain ANT - 03, would not result in residues that are of toxicological concern. ] 3. A statement of why an analytical method of detecting and measuring the levels of the pesticide residue are not needed. [NA- Remove ] C. Mammalian Toxicological Profile [ Studies to evaluate the safety to mammals were conducted on the technical grade active ingredient (TGAI) and are summarized as follows: 1. Acute Oral Toxicity

/Pathogenicity

S tudy in Rats (OCSPP 885.3050) : Beauveria bassiana strain ANT - 03 Technic al (the Microbial Pest Control Agent or MPCA) was tested in a single high dose exposure in an acute oral toxicity /pathogenicity study in rats, and there were no signs of toxicity or infectivity

f rom exposure to3 test material (MRID No. 489742 - 03). There wa s no mortality d uring the study and all animals appeared normal during the duration of the study . No observable abnormalities were reported at necrops y. The MPCA test substance and inactivated MPCA test substance was administered to rats by

g avage in a single high dose. The animals were observed frequently on the day

o f dosing (Day

0 ) for mortality

and signs of pharmacologic and/or toxicologic effects and once daily thereafter for 21 days. A control group (untreated) was conducted concurrently. The test organism had cleared completely

f rom the Group IV blood, lungs, liver, kidneys, mesenteric ly mph nodes and cecum contents by D ay 1 4 and had cleared completely from the brain and spleen by

Day 21. After two consecutive interim sacrifices showed no growth of test organism in the organs plated, no further tissue samples were taken. The test substance was determined to be non -toxic to rats when administered by oral gavage in a single dose of 1.3 x 10 9 CFU/rat. 2. Acute Pulmonary

T oxicity

/Pathogenicity Study

in Rats (OCSPP 885.3150) : Beauveria bassiana strain ANT - 03 Technical (the Microbial Pest Control Agent or MPCA) was tested in a single high dose exposure in an acute pulmonary toxicity /pathogenicity study

in rats, and there were no signs of toxicity or infectivity

f rom exposure to test material (MRID No. 489742 - 04). There was no mortality d uring the study

and all animals appeared normal during the duration of the study . No observable abnormalities were reported at necrops y. The MPCA test substance and inactivated MPCA test substance was administered to rats by

tracheal gavage in a single high dose. The animals were observed frequently on the day

o f dosing (Day

0 ) for mortality

and signs of pharmacologic and/or toxicologic effects and once daily thereafter for 21 days. A control group (untreated) was conducted concurrently. The test organism was not seen at any time from the Group IV - MPCA blood, kidneys, mesenteric ly mph nodes, brain, liver, spleen and cecum contents. Except for the Day 0 sacrifice, the test substance was not seen in the lungs at any time. After two consecutive interim sacrifices showed no growth of the test substance in the organs plated, no further tissue samples were taken. The test substance was determined to be non-toxic to rats when administered b y tracheal gavage in a single dose of 1.1 x 10 9 CFU/rat. 3. Acute IPToxicity

/Pathogenicity

Study in Rats (OCSPP 885.320) : In the IP study, the MPCA test substance and inactivated MPCA test substance were administered to rats by intraperitonial in

jection in a single high dose (MRID No. 489742 - 05). The animals were observed frequently on day of dosing for mortality

and signs of pharmacologic and/or toxicologic effects and once daily thereafter for 21 days. Control groups (untreated and inactive) were conducted concurrently. A gross necrops y of all animals was performed and recorded. There were no mortalities and no abnormal general health findings. The test substance was determined to be non-toxic to rats when administered by IP injection at a single dose of 1.4 x 10 9 CFU/rat.4

4. Acute Dermal Toxicity ( OCSPP 870.1200) : Beauveria bassiana strain ANT - 03 Technical (the Microbial Pest Control Agent or MPCA) was tested in a single high dose exposure in an acute dermal toxicity study in rats, and there were no signs of toxicity

or dermal irritation from exposure to test material (MRID No. 489742 - 06). The MPCA test substance was evaluated for its dermal toxicity potential and relative skin irritancy when a single dose moistened with 1.0 mLo f deionized (DI) water/g test substance, at a level of 5050 mg/kg, was applied to the intact skin of albino rats. No mortality occurred. There were no clinical signs of toxicity or signs of dermal irritation at any time throughout the study . Animals exhibited weekly

w eight gain during the study . The gross necrops y conducted at termination of the study revealed no observable abnormalities. The estimated LD50, as indicated b y the data, was determined to be greater than 5050 mg/kg. 5. Hy

persensitivity

Incidents (OCSPP 885.3400 ) : The registrant has noted that no incidents of hy

persensitivity

or any other adverse effects have occurred through the research, development or testing of the active ingredient and its related enduse product. Should any

incidents occur, they

will be reported per FIFRA Section 6(a)(2). Rationales for no further testing have been submitted for acute oral toxicity (limit), acute inhalation toxicity

(limit), primary

eyeirritation and primary dermal irritation data requirements on Beauveria bassiana strain ANT - 03 Technical (MRID No. 489742 - 13). Rationales are based on discussions of existing data and, in the case of the primary eye irritation requirement, mitigating label language. Data has been generated and submitted to demonstrate that Beauveria bass iana strain ANT - 03 does not produce unintentional ingredients such as toxic metabolites (beauvericin) or microbial contaminants (MRID Nos. 489742 - 01 and 489742 - 02). In conclusion, the results of toxicity testing show there is no risk to human health from the active ingredient. Beauveria bassiana strain ANT - 03 is not toxic, pathogenic, infective or irritating to mammals. ] D. Aggregate Exposure 1. Dietary exposure. i. Food. [ Dietary

exposure from use of Beauveria bassiana strain ANT - 03, as proposed, is minimal. The intended use of Beauveria bassiana strain ANT - 03 is as a biological insecticide to growing plants in agricultural, greenhouse, turf and ornamental and home and garden use sites. D ata in published literature demonstrate that Beauveria bass iana does not persist in the environment following application. Environmental conditions such as UV -radiation, air temperature and rainfall are factors that lead to a short life in field conditions (MRID No. 489742 - 12). The results of toxicity

testing indicate there is no risk to human health or the5 environment from Beauveria bassiana strain ANT - 03. Beauveria bassiana strain ANT - 03 does not produce recognized toxins, enzy mes, or virulence factors normally associated with mammalian invasiveness or toxicity . The absence of acute toxicity

or pathogenicity

in laboratory

animals demonstrates the benign nature of this strain. ] ii. Drinking water. [ Similarly, exposure to humans from residues of Beauveria bassiana strain ANT - 03 in consumed drinking water would be unlikely. Potential exposure to surface water would be negligible and exposure to drinking water (well or ground water) would be impossible to measure. The intended use of Beauveria bassiana strain ANT - 03 is as a biological insecticide to growing plants in agricultural, greenhouse, turf and ornamental and home and garden use sites. Data in published literature demonstrate that Beauveria bassiana does not persist in the environment following application. Environmental conditions such as UV radiation, air temperature and rainfall are factors that lead to a short life in field conditions. The risk of the microorganism passing through the soil to ground water is minimal to unlikely. Additionally the fungus would not tolerate the conditions water is subjected to in a drinking-water facility (including: chlorination, pH adjustments, high temperatures and/or anaerobic conditions). The results of toxicity

testing indicate there is no risk to human health or the environment from Beauveria bassiana strain ANT - 03. Beauveria bassiana strain ANT - 03 does not produce recognized toxins, enzy mes, or virulence factors normally associated with mammalian invasiveness or toxicity . The absence of acute toxicity

or pathogenicity

in laboratory

animals demonstrate s the benign nature of this strain. ] 2. Non -dietary exposure . [ The potential for non- dietary exposure to the general population, including infants and children, is unlikely as the proposed use sites are agricultural. The intended use of Beauveria bassiana strain ANT - 03 is as a biological insecticide to growing plants in agricultural, greenhouse, turf and ornamental and home and garden use sites. D ata in published literature demonstrate that Beauveria bassiana does not persist in the environment following application. Environmental conditions such as UV -radiation, air temperature and rainfall are factors that lead to a short life in field conditions. Personal Protective Equipment (PPE) mitigates the potential for exposure to applicators and handlers of the proposed products, when used in agricultural settings. The results of toxicity

testing indicate there is no risk to human health or the environment from Beauveria bassiana strain ANT - 03. Beauveria bassiana strain ANT - 03 does not produce recognized toxins, enzy mes, or virulence factors normally associated with mammalian invasiveness or toxicity . The absence of acute toxicity

or pathogenicity

in laboratory

animals demonstrates the benign nature of this strain. N on- dietary exposures would not be expected to pose any quantifiable risk due to a lack of residues of toxicological concern. ]6

E. Cumulative Effects [ Iti s not expected that, when used as proposed, Beauveria bassiana strain ANT 03 would result in residues that are of toxicological concern. The intended use of Beauveria bassiana strain ANT - 03 is as a biological insecticide to growing plants in agricultural, greenhouse, turf and ornamental and home and garden use sites. D ata in published literature demonstrate that Beauveria bassiana does not persist in the environment following application. Environmental conditions such as UV -radiation, air temperature and rainfall are factors that lead to a short life in field conditions. The results of toxicity

testing indicate there is no risk to human health or the environment from Beauveria bassiana strain ANT - 03. Beauveria bassiana strain ANT - 03 does not produce recognized toxins, enzy

mes, or virulence factors normally associated with mammalian invasiveness or toxicity. The absence of acute toxicity or p athogenicity in laboratory animals demonstrates the benign nature of this strain. ] F . Safety Determination 1. U.S. population. [ Acute toxicity studies have shown that Beauveria bassiana strain ANT - 03 is not toxic, pathogenic, infective or irritating to mammals. The intended use of Beauveria bassiana strain ANT - 03 is as a biological insecticide to growing plants in agricultural, greenhouse, turf and ornamental and home and garden use sites. D ata in published literature demonstrate that Beauveria bassian a does not persist in the environment following application. Environmental conditions such as UV -radiation, air temperature and rainfall are factors that lead to a short life in field conditions. The results of toxicity

testing indicate there is no risk to human health or the environment from Beauveria bassiana strain ANT - 03. Beauveria bassiana strain ANT - 03 does not produce recognized toxins, enzy

mes, or virulence factors normally associated with mammalian invasiveness or toxicity. The absence of acute toxicity or pathogenicity in laboratory animals demonstrates the benign nature of this strain. There is a reasonable certainty o f no harm to the general US population from exposure to this active ingredient. ] 2. Infants and children . [As mentioned above , it is not expected that, when used as proposed, Beauveria bassiana strain ANT - 03 would result in residues that are of toxicological concern. There is a reasonable certainty o f no harm for infants and children from exposure to Beauveria bassiana strain ANT - 03 from the proposed uses. ] G. Effects on the Immune and Endocrine Systems [ To date there is no evidence to suggest that Beauveria bassiana strain ANT - 03 functions in a manner similar to any known hormone, or that it acts as an endocrine disrupter. ] H. Existing Tolerances [ There is no US EPA tolerance or tolerance exemption for Beauveria bassiana strain ANT - 03. ]7

I . International Tolerances [A Codex Alimentarium Commission Maximum Residue Level (MRL) is not established for Beauveria bassiana strain ANT - 03. ]