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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) 308-8059]

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:

TEMPLATE:

[Anatis Bioprotection Inc.]

[PP 3F8176]

EPA has received a pesticide petition ([PP 3F8176]) 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 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. [Anatis Bioprotection Inc.] Petition Summary

[PP 3F8176]

A. Product Name and Proposed Use Practices
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[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 foliarfeeding 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).

Information 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 of 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 resulting 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 analytical 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 Study in Rats (OCSPP 885.3050): Beauveria 

bassiana strain ANT-03 Technical (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 from exposure to 
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test material (MRID No. 489742-03). There was no mortality during the study 

and all animals appeared normal during the duration of the study. No observable 

abnormalities were reported at necropsy.

The MPCA test substance and inactivated MPCA test substance was 

administered to rats by gavage in a single high dose. The animals were observed 

frequently on the day of 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 from the Group IV blood, lungs, liver, kidneys, mesenteric lymph 

nodes and cecum contents by Day 14 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 109 CFU/rat.

2. Acute Pulmonary Toxicity/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 from exposure to test material (MRID No. 489742-04). There was no 

mortality during the study and all animals appeared normal during the duration of 

the study. No observable abnormalities were reported at necropsy.

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 of 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 lymph 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 by tracheal gavage in a single dose of 1.1 x 109 CFU/rat.

3. Acute IP Toxicity/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 injection 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 

necropsy 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 109

CFU/rat.
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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 mL of 

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 weight gain during the study. The gross necropsy conducted at 

termination of the study revealed no observable abnormalities. The estimated 

LD50, as indicated by the data, was determined to be greater than 5050 mg/kg.

5. Hypersensitivity Incidents (OCSPP 885.3400): The registrant has noted that no 

incidents of hypersensitivity 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 eye irritation 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 bassiana 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. 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 

(MRID No. 489742-12). 

The results of toxicity testing indicate there is no risk to human health or the 
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environment from Beauveria bassiana strain ANT-03. Beauveria bassiana strain 

ANT-03 does not produce recognized toxins, enzymes, 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 UVradiation, 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, enzymes, 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.]

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. 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. 

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, enzymes, 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. Non-dietary exposures would not be expected to pose any 

quantifiable risk due to a lack of residues of toxicological concern.]
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E. Cumulative Effects

[It is not expected that, when used as proposed, Beauveria bassiana strain ANT03 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. 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 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, enzymes, 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.]

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. 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 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, enzymes, 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 of 

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 of 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.]
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I. International Tolerances

[A Codex Alimentarium Commission Maximum Residue Level (MRL) is not 

established for Beauveria bassiana strain ANT-03.]