BIOPESTICIDES REGISTRATION ACTION DOCUMENT

Beauveria bassiana strain ANT-03

Pesticide Chemical (PC) Code: 129990

U.S. Environmental Protection Agency

Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

March 30, 2015
Beauveria bassiana strain ANT-03

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TABLE OF CONTENTS

I. EXECUTIVE S UMMARY .........................................................................................................................................4

II. ACTIVE INGREDIENT OVERVIEW ...................................................................................................................6

III. REGULATORY BACKGROUND...........................................................................................................................6

A. Applications for Pesticide Registration.............................................................................................................6

B. Food Tolerance Exemption...................................................................................................................................6

C. Registration Review................................................................................................................................................6

IV. RIS K ASSESS MENT ...................................................................................................................................................7

A. Product Analysis Assessment (40 CFR § 158.2120).......................................................................................7

B. Human Health Risk Assessment (40 CFR 158.2140).....................................................................................8

C. Environmental Assessment (40 CFR § 158.2150).........................................................................................14

V. ENVIRONMENTAL JUS TICE ..............................................................................................................................20

VI. RIS K MANAGEMENT DECIS ION......................................................................................................................21

VII. ACTIONS REQUIRED OF THE REGIS TRANT.............................................................................................21

A. Final Printed Labeling.........................................................................................................................................21

B. Terms of Registration...........................................................................................................................................22

C. Reporting of Adverse Effects and Hypersensitivity Incidents..................................................................22

VIII. BIBLIOGRAPHY........................................................................................................................................................23

A. Studies Submitted to Support the Registration of Pesticide Manufacturing-Use Product 

Containing Beauveria bassiana strain ANT-03............................................................................................23

B. Studies Submitted to Support the Registration of Pesticide End-Use Product Containing

Beauveria bassiana strain ANT-03. .................................................................................................................24

C. Environmental Protection Agency Risk Assessment Memoranda ..........................................................25

D. Other References...................................................................................................................................................25

APPENDIX A. MICROBIAL PES TICIDES DATA REQUIREMENTS ..................................................................26

APPENDIX B. PES TICIDE PRODUCTS...........................................................................................................................31
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BIOPESTICIDES REGISTRATION ACTION DOCUMENT TEAM

Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

Microbial Pesticides Branch (MPB)

Science Review

Joel V. Gagliardi, Ph.D. Product Analysis and Human Health 

In-soon You, Ph.D. Environmental Effects

Regulatory Review

Shannon Borges Team Leader

ShaRon Carlisle Acting Associate Chief

Denise Greenway Regulatory Action Leader

Kimberly Nesci Chief
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I. EXECUTIVE SUMMARY

Background

In April 2013, Technology Sciences Group, Inc., on behalf of Anatis Bioprotection Inc., 

submitted an application for a new manufacturing-use pesticide product containing the new 

active ingredient Beauveria bassiana strain ANT-03 at 100.0% concentration in powder form

(EPA File Symbol 89600-R) to the United States Environmental Protection Agency (EPA),

under section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). An 

application for a new end-use pesticide product containing the new active ingredient Beauveria 

bassiana strain ANT-03 at 20.0% concentration (EPA File Symbol 89600-E) was concurrently 

submitted.

Beauveria bassiana strain ANT-03 is a naturally occurring bacterium and was originally isolated 

in 2000 from Lygus lineolaris found dead in a field in Sherrington, Quebec, Canada. The natural 

occurrence of Beauveria bassiana strains located in soils and insects is well documented in the 

US and worldwide.

The EPA’s scientists reviewed product analysis, toxicology, and non-target organism data and 

information (40 CFR §§ 158.2120, 158.2140, and 158.2150, respectively) submitted to support 

the registration of the proposed pesticide products. They found that overall, such data and 

information are adequate for risk assessment purposes, fulfill the current microbial pesticide data 

requirements, and support registration of the products under FIFRA section 3(c)(5).

Product Analysis

For the purposes of FIFRA section 3(c)(5) registration, the product analysis data requirements 

for the manufacturing-use and end-use pesticide products were fulfilled by acceptable guideline 

studies. These data requirements include product chemistry and composition, analysis of 

samples, and physical and chemical characteristics.

Toxicology

The EPA has determined that all applicable mammalian toxicology data requirements for 

Beauveria bassiana strain ANT-03 are fulfilled. Acceptable Tier I mammalian toxicology data 

and other information support the registration of the pesticide products and the request for an 

exemption from the requirement of a tolerance for residues of Beauveria bassiana strain ANT-03 

in or on all food commodities. Tier II and Tier III studies were not required because of the lack 

of acute toxicity/pathogenicity in the Tier I studies. 

Tolerance Exemption

In its application to the EPA in 2013, Technology Sciences Group, Inc., on behalf of Anatis 

Bioprotection Inc., provided a petition, data and other information to support an exemption from 

the requirement of a tolerance for residues of Beauveria bassiana strain ANT-03 when used in or 

on all food commodities. No comments were received following publication of this notice. 

Non-Occupational Exposure

Given the home and garden proposed use pattern for Beauveria bassiana strain ANT-03, nonoccupational exposure is expected. However, repeated exposures to Beauveria bassiana strain 

ANT-03 from pesticidal applications will not exceed the EPA’s level of concern in light of the 
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available data that demonstrate Beauveria bassiana strain ANT-03 is not toxic, is non-irritating, 

and is not pathogenic when used as labeled in accordance with good agricultural practices.

Non-target Organisms

Guideline studies and waiver rationale were submitted to meet data requirements for non-target

organisms for Beauveria bassiana strain ANT-03. These data and waiver rationale are sufficient 

to fulfill the relevant microbial pesticide data requirements and for risk assessment purposes. 

Further testing of non-target organisms at higher tier levels (i.e., Tiers II, III, and IV) is not 

required. The EPA’s scientists made a “No Effect” determination for federally listed threatened 

and endangered mammals, birds, and terrestrial and aquatic plants. Effects to listed freshwater 

and marine/estuarine fish and invertebrates and insects could not be precluded, and a 

determination requires additional analysis. Adverse effects to all other non-target organisms are 

not expected to result from the registration of Beauveria bassiana strain ANT-03 when applied 

in accordance with the directions on the label. 

Public Participation

On October 1, 2009, the EPA announced a policy to provide a more meaningful opportunity for 

the public to participate in major registration decisions before they occur. According to this 

policy, the EPA provides a public comment period prior to making a registration decision for, at 

minimum, the following types of applications: new active ingredients; first food uses; first 

outdoor uses; first residential uses; or any other registration actions for which the EPA believes 

there may be significant public interest. 

Consistent with the policy of making registration actions more transparent, the proposed 

pesticide products containing Beauveria bassiana strain ANT-03, a new active ingredient, and 

allowing for this active ingredient’s first food, outdoor, and residential uses were subject to a 15-

day comment period. During this comment period, the EPA received no comments from the 

public.

Registration Decision

The EPA maintains that, based upon the risk assessment and information submitted in support of 

Beauveria bassiana strain ANT-03 Technical and Bioceres, it is in the best interest of the public 

and the environment to issue these registrations. The basis for this decision can be found in the 

risk assessment for Beauveria bassiana strain ANT-03, which is characterized throughout this 

Biopesticides Registration Action Document (BRAD) and the associated referenced documents. 
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II. ACTIVE INGREDIENT OVERVIEW

Biological Name: Beauveria bassiana strain ANT-03 

Culture Collection: Deposited at the Agricultural Research Service Culture Collection 

(NRRL) under NRRL 50797 

OPP Chemical Code: 129990

Type of Pesticide: Microbial Pesticide – Insecticide 

See Appendix B for specific information (i.e., use sites, application 

rates, methods of application, formulation types, and target pests) 

regarding the pesticide products containing this active ingredient.

III. REGULATORY BACKGROUND

A. Applications for Pesticide Registration 

On April 25, 2013, applications for registration were submitted on behalf of Anatis Bioprotection 

Inc., 278, rang Saint-Andre ́, St.-Jacques-le-Mineur, Quebec J0J 1Z0, Canada for the 

manufacturing-use pesticide product, Beauveria bassiana strain ANT-03 Technical (EPA File 

Symbol 89600-R), and the end-use product, Bioceres (EPA File Symbol 89600-E), containing 

the new microbial active ingredient Beauveria bassiana strain ANT-03. In the Federal Register

of December 11, 2013 (78 FR 75343), the EPA announced receipt of these applications for 

registration of a pesticide product containing a new active ingredient for manufacturing-use and 

end-use. No comments were received following the publication of this notice. For more 

information, see the following docket at www.regulations.gov: EPA-HQ-OPP-2013-0718.

B. Food Tolerance Exemption

Concurrent with its registration applications and under the Federal Food, Drug, and Cosmetic 

Act (FFDCA) section 408(d), Anatis Bioprotection Inc. submitted a petition to establish an 

exemption from the requirement of a tolerance for residues of the pesticide active ingredient, 

Beauveria bassiana strain ANT-03 [Pesticide Petition (PP) 3F8176], in or on all food 

commodities. The EPA published a Notice that Anatis Bioprotection Inc. filed a petition to 

establish an exemption of the requirement for a tolerance for residues of Beauveria bassiana

strain ANT-03 in or on all food commodities in the Federal Register of December 30, 2013 (78 

FR 79359) and opened a 30-day comment period. No comments were received following 

publication of this notice. For more information, see the following docket at 

www.regulations.gov: EPA-HQ-OPP-2013-0717.

On December 24, 2014, the EPA established an exemption from the requirement of a tolerance 

for residues of Beauveria bassiana strain ANT-03 in or on all food commodities, when applied 

as microbial insecticide and used in accordance with label directions and good agricultural 
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practices (40 CFR § 180.1328; 79 FR 77395).

C. Registration Review

In September 2011, the EPA completed a Final Work Plan for Beauveria bassiana strains, 

Registration Review Case 6057. The plan includes a discussion of the Endangered Species 

assessment that will be completed in advance of a Proposed Registration Review Final Decision. 

This active ingredient will now be considered as part of the Beauveria bassiana strains

Registration Review Case 6057. For more information, see the following docket at 

www.regulations.gov: EPA-HQ-OPP-2010-0564.

The end-use product containing Beauveria bassiana strain ANT-03 is proposed for use on 

growing crops as a contact mycoinsecticide to control or suppress foliar-feeding pests and certain 

grubs. Several other strains of Beauveria bassiana, including strains 447, GHA, HF23 and ATCC 

74040, have previously been registered by the EPA and have similar use patterns.

IV. RISK ASSESSMENT

For definitions of scientific terms, please refer to http://www.epa.gov/pesticides/glossary/.

In the Federal Registers of October 26, 2007 (72 FR 60988), and August 30, 2012 (77 FR 

52610), the EPA issued Final Rules on the data requirements to support registration of microbial 

pesticides and updated the definition for microbial pesticides. The data and information 

evaluated for this BRAD were considered in light of these requirements.

The EPA classifies each data submission with an indication of the usefulness for risk assessment 

of the information contained in the documents. A rating of “acceptable” indicates the study is 

scientifically sound and is useful for risk assessment. A “supplemental” rating indicates the data 

provide some information that can be useful for risk assessment. The studies may have certain 

aspects determined not to be scientifically acceptable (“supplemental: upgradable”). If a study is 

rated as “supplemental: upgradable,” the EPA always provides an indication of what is lacking

or what can be provided to change the rating to “acceptable.” If there is simply a “supplemental” 

rating, the reviewer will often state that the study is not required by 40 CFR Part 158. Both 

“acceptable” and “supplemental” studies may be used in the risk assessment process as 

appropriate. An “unacceptable” rating indicates that new data must be submitted.

For the acute toxicity data requirements, Toxicity Categories are assigned based on the hazard(s) 

identified from studies and/or other information submitted to the EPA in support of a pesticide 

registration. The EPA classifies the active ingredients or particular product into Toxicity 

Category I, II, III, or IV, where Toxicity Category I indicates the highest toxicity and Toxicity 

Category IV indicates the lowest toxicity (see section II.B. of U.S. EPA (2014c)).

A. Product Analysis Assessment (40 CFR § 158.2120)

Microbial pesticide product analysis data requirements include product chemistry and 

composition, analysis and certified limits, and physical and chemical characteristics data. 
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Product chemistry and composition data include information about the identity of the active 

ingredient, the manufacturing process, deposition of a sample of the microbial active ingredient

in a nationally recognized culture collection, and discussion of the potential for formation of 

unintentional ingredients. Analysis and certified limits data include information on analysis of 

samples and certification of limits. Physical and chemical characteristics data describe basic 

characteristics of the registered pesticide products, including color, physical state, odor, stability, 

miscibility, pH, corrosion characteristics, viscosity and density.

For the purposes of registration under FIFRA section 3(c)(5), the EPA determined that all 

product analysis data requirements for registration of the Beauveria bassiana strain ANT-03

pesticide products have been fulfilled. The following terms of registration are imposed not due to 

risk concerns, but to clarify and define the quality assurance/quality control measures:

- A method for spore identification must be added to the manufacturing process;

- Batch analysis using viable count calculations must be submitted;

- Specific methods for microbial contamination analyses must be provided; 

- Rejection limits for contaminants must be defined; and

- Unidentified fungi must be explained.

These data must be submitted within ninety days of the registration date, except that 12 months 

are alloted for receipt of the batch analyses.

A new, unique PC Code 129990 has been assigned to Beauveria bassiana strain ANT-03, as it is 

a new active ingredient. A sample of Beauveria bassiana strain ANT-03 is deposited at the

Agricultural Research Service Culture Collection (NRRL) under NRRL 50797.

Refer to Table 1 in Appendix A for a summary of the product analysis data and terms of 

registration. Refer to Table 2 in Appendix A for a summary of the physical and chemical 

properties data.

B. Human Health Risk Assessment (40 CFR 158.2140)

1. Toxicity

The EPA has determined that all applicable mammalian toxicology data requirements for 

Beauveria bassiana strain ANT-03 are fulfilled. Acceptable Tier I mammalian toxicology data 

and information support the registration of the pesticide products and the request for an 

exemption from the requirement of a tolerance for residues of Beauveria bassiana strain ANT-03 

in or on all food commodities. Tier II and Tier III studies were not required because of the lack 

of acute toxicity/pathogenicity in the Tier I studies. 

The toxicity and pathogenicity tests and irritation tests (acute eye and primary dermal irritation) 

that address potential routes of exposure to the active ingredient are all classified in Toxicity 

Category III or IV and revealed little to no toxicity attributed to Beauveria bassiana strain ANT03. 
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The overall conclusions from all toxicological data and information submitted by the applicant 

are briefly described below, in sections IV(B)(1)(a) and (b) and summarized in Table 3 in 

Appendix A.

a. Acute Toxicity/Pathogenicity – Tier I 

Acute Oral Toxicity and Pathogenicity – Rat (Harmonized Guideline 885.3050; MRID No. 

48974203): In an acute oral toxicity and pathogenicity study, groups of ~8-week-old SpragueDawley rats (12/sex) were given a single oral dose of Beauveria bassiana strain ANT-03 (1.2 x 

1011 conidia/g) in sterile phosphate buffer saline (PBS) at a dose of 1.3 x 109 CFU/animal. The 

animals were observed for up to 21 days with interim scheduled sacrifices on Days 3, 7, and 14. 

Five males and five females were treated with inactivated test substance as controls; two males 

and two females were untreated “shelf controls”; and five males and five females were untreated 

controls. There were no treatment-related deaths, clinical signs, necropsy findings, or changes in 

body weight or body weight gain. The test organism was variously recovered from the blood, 

brain, spleen, lungs, liver, kidneys, or cecum contents through Day 7, and cleared by Day 14. 

The test organism cleared from the mesenteric lymph nodes by Day 21. Based on dissemination 

from an oral dose to dispersed internal regions of test animals, this organism may be infectious 

by oral exposure, though not pathogenic or toxic and is unlikely to grow at body temperatures. 

EPA determined this study to be acceptable and concluded that Beauveria bassiana strain ANT03 is not toxic or pathogenic orally at 1.3 x 109 CFU/animal. 

Acute Pulmonary Toxicity and Pathogenicity – Rat (Harmonized Guideline 885.3150; MRID No. 

48974204): In an acute pulmonary toxicity and pathogenicity study, groups of ~7 to 8-week-old 

Sprague-Dawley rats (15/sex) were exposed by the intratracheal route to Beauveria bassiana strain 

ANT-03 (1.2 x 1011 conidia/g) in sterile PBS at a dose of 1.1 x 109 CFU/animal. The animals were 

observed up to 21 days with interim scheduled sacrifices on Days 3, 7, and 14. Five males and five 

females were treated with autoclaved test substance as inactivated controls; four animals/sex were 

untreated “shelf controls”; and five animals/sex were untreated controls. Based on the results of this 

study, Beauveria bassiana strain ANT-03 was not toxic, infective, and/or pathogenic to rats when 

dosed at 1.1 x 109 CFU/animal. There were no test substance-related deaths, clinical signs, or 

necropsy findings. No test organisms were recovered from the blood, liver, kidneys, mesenteric 

lymph nodes, brain, and spleen or cecum contents at any time. Except for the Day 0 sacrifice, the test 

substance was not seen in the lungs at any time. 

EPA determined this study to be acceptable and concluded that Beauveria bassiana strain ANT-03 is 

not toxic, infective, or pathogenic when inhaled at 1.1 x 109 CFU/animal. 

Acute Intraperitoneal Injection Toxicity and Pathogenicity – Rat (Harmonized Guideline 

885.3200; MRID No. 48974205): In an acute intraperitoneal injection toxicity and pathogenicity 

study, fifteen male and fifteen female albino Sprague-Dawley rats were injected with Beauveria 

bassiana strain ANT-03 (1.2 x 1011 conidia/g) in sterile PBS at a dose of 1.4 x 109 CFU/animal. The 

animals were treated on Day 0 and observed for up to 21 days. Three rats/sex treated with the test 

material were sacrificed one hour after dosing and the peritoneal cavity washed with PBS for dose 

verification and enumeration. The remaining animals were sacrificed and necropsied on Day 21. Two 

additional groups of five rats/sex served as untreated and inactivated MPCA controls and were also 
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sacrificed on Day 21. Based on the results of this study, Beauveria bassiana strain ANT-03 does not 

appear to be toxic when administered in a single dose to rats by IP injection at 1.4 x 109 CFU/animal. 

There were no treatment-related deaths, clinical signs, gross necropsy findings, or changes in body 

weight or body weight gain. Mesenteric lymph node weights in treated females were significantly 

lighter than untreated controls.

EPA determined this study to be acceptable and concluded that Beauveria bassiana strain ANT03 is not toxic, infective, or pathogenic intraperitoneally at 1.4 x 109 CFU/animal. 

Acute Dermal Toxicity – Rat (Harmonized Guideline 870.1200; MRID No. 48974206): In an 

acute dermal toxicity study, groups of five male and five female young adult Sprague-Dawley rats 

were dermally exposed to Beauveria bassiana strain ANT-03 (1.2 x 1011 conidia/g) moistened with 

deionized water (1.0 mL/g), applied to clipped application sites of approximately 10% of the body 

surface area for 24 hours at a dose level of 5,050 mg/kg body weight. The animals were treated on 

Day 0 and observed for a period of 14 days. There were no deaths or abnormal gross necropsy 

findings. All of the animals gained weight during both weeks of the study. There were no abnormal 

systemic clinical signs, and signs of dermal irritation were not detected at any time during the study.

EPA determined this study to be acceptable and concluded that Beauveria bassiana strain ANT-03 

has a dermal NOAEL combined of > 5,050 mg/kg bw (EPA Toxicity Category IV). 

Acute Oral Toxicity – Rat (Harmonized Guideline 870.1100)

Acute Dermal Toxicity – Rat (Harmonized Guideline 870.1200)

Acute Inhalation Toxicity – Rat (Harmonized Guideline 870.1300)

Primary Eye Irritation – Rabbit (Harmonized Guideline 870.2400)

Primary Dermal Irritation – Rabbit (Harmonized Guideline 870.2500)

In lieu of toxicology testing of Beauveria bassiana strain ANT-03, the applicant provided 

acceptable scientific justifications/rationales (MRID Nos. 48974213 [TGAI] and 48974302 

[Bioceres EP]) to address the above listed data requirements, summarized below. The EPA 

generally agrees with the rationales provided, and the EPA determined the rationales to be 

acceptable to address the data requirements. (U.S. EPA, 2014a).

Oral gavage administration of the test material did not result in mortality, abnormal clinical 

signs, or gross pathology in rats at a single dose of 1.3 x 109 CFU/animal in an acute oral 

toxicity/pathogenicity study. As calculated by the reviewer, the administered dose of 1.3 x 109

CFU/rat equated to dose levels of approximately 36.7 to 65.7 mg/kg bw. In an acute pulmonary 

infectivity and toxicity study intratracheal administration of the test material (in phosphate 

buffered saline and Tween 20) at a single dose of 1.1 x 109 CFU/animal did not result in 

mortality, abnormal clinical signs, or gross pathology in rats. As calculated by the reviewer, the 

administered dose levels were approximately 31.4 to 56.2 mg/kg bw. TGAIs with Beauveria 

bassiana strains 447, GHA, and HF23 have been tested and classified in US EPA Toxicity 

Category III for primary eye irritation, and an EP formulated with Beauveria bassiana strain 

ATCC 74040 has also been classified in US EPA Toxicity Category III for primary eye irritation. 

In an acute dermal toxicity study, no skin irritation was seen when rats were dermally exposed to 

the test material moistened with deionized water (1.0 mL/g), applied to clipped application sites 

of approximately 10% of the body surface area for 24 hours at a dose level of 5,050 mg/kg bw. 
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There are no inert ingredients added to the TGAI. The inert ingredients added to the EP are 

present in food, recognized as safe, have tolerance exemptions, and are not expected to produce 

any toxic effects. 

b. Acute Toxicology and Subchronic Toxicity/Pathogenicity – Tier II;

Reproductive Fertility Effects, Carcinogenicity, Immunotoxicity, and 

Infectivity/Pathogenicity Analysis – Tier III

Tier II and Tier III studies were not required for Beauveria bassiana strain ANT-03, based on the 

lack of acute toxicity/pathogenicity in the Tier I studies.

 c. Endocrine Disruptors

As required by the Administrator under the Federal Food, Drug, and Cosmetic Act (FFDCA) 

section 408(p), the EPA has developed the Endocrine Disruptor Screening Program (EDSP) and 

has begun to implement the screening program that is to be used to test all pesticides to 

determine whether certain substances (including pesticide active and other ingredients) may have 

an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, 

or other such endocrine effects as the Administrator may designate.” FFDCA section 408(p)(4), 

authorizes the Administrator, by order, to exempt from the requirements of the Endocrine 

Disruptor Screening Program a biologic substance or other substance if a determination is made 

that the substance is anticipated not to produce any effect in humans similar to an effect 

produced by a naturally occurring estrogenic substance. Between October 2009 and February 

2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, which contain 58 

pesticide active ingredients and nine inert ingredients. Beauveria bassiana strain ANT-03 is not 

among the group of 58 pesticide active ingredients on the initial list to be screened under the 

EDSP.

The Agency believes that Beauveria bassiana strain ANT-03 likely is a substance that would not 

produce any effect in humans similar to an effect produced by a naturally occurring estrogenic 

substance. As such, and pursuant to Section 408(p)(4), EPA will determine in the future whether 

it can exempt Beauveria bassiana strain ANT-03 from the requirements of the Section 408(p) 

EDSP. In the event the Agency does determine to exempt this substance from the EDSP, an 

order will be issued. For further information on the status of the EDSP, the policies and 

procedures, the list of 67 chemicals, future lists, the test guidelines and the Tier 1 screening 

battery, please visit our website: http://www.epa.gov/endo/.

2. Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations

Section 408(c)(2)(A)(i) of FFDCA allows the EPA to establish an exemption from the 

requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only 

if the EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines 

“safe” to mean that “there is a reasonable certainty that no harm will result from aggregate 

exposure to the pesticide chemical residue, including all anticipated dietary exposures and all 

other exposures for which there is reliable information.” This includes exposure through drinking 

water and in residential settings, but it does not include occupational exposure. Pursuant to 
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section 408(c)(2)(B) of FFDCA, in establishing or maintaining in effect an exemption from the 

requirement of a tolerance, the EPA must take into account the factors set forth in section 

408(b)(2)(C) of FFDCA, which require the EPA to give special consideration to exposure of 

infants and children to the pesticide chemical residue in establishing a tolerance exemption, and 

to “ensure that there is a reasonable certainty that no harm will result to infants and children from 

aggregate exposure to the pesticide chemical residue....” Additionally, section 408(b)(2)(D) of 

FFDCA requires that the EPA consider “available information concerning the cumulative effects 

of [a particular pesticide's] . . . residues and other substances that have a common mechanism of 

toxicity.”

The EPA performs a number of analyses to determine the risks from aggregate exposure to 

pesticide residues. First, the Agency determines the toxicity of a pesticide. Second, the EPA 

examines exposure to the pesticide through food, drinking water, and through other exposures 

that occur as a result of pesticide use in residential settings. Consistent with section 408(b)(2)(D) 

of FFDCA, the EPA has reviewed the available scientific data and other relevant information, 

and considered its validity, completeness, and reliability and the relationship of this information 

to human risk. The Agency also considered available information concerning the variability of 

the sensitivities of major identifiable subgroups of consumers, including infants and children.

Based on the acute toxicity/pathogenicity data and information discussed previously and 

presented in Table 3 in Appendix A, the data required for a FFDCA risk assessment for 

Beauveria bassiana strain ANT-03 have been fulfilled.

a. Aggregate Exposure

In examining aggregate exposure, section 408 of FFDCA directs EPA to consider 

available information concerning exposures from the pesticide residue in food and all other 

nonoccupational exposures, including drinking water from ground water or surface water and 

exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor 

uses). Due to the biological nature of Beauveria bassiana strain ANT-03, it is not expected to 

persist in the environment or accumulate in any reservoirs; rather it will naturally degrade due to 

consumption by other biological organisms and exposure to heat, cold, sunlight, etc. 

Food Exposure and Risk Characterization: Beauveria bassiana strains are widely found in soils 

and insects worldwide. The EPA found that increased dietary exposure to Beauveria bassiana 

strain ANT-03, a naturally occurring bacterium pathogenic to insects and commonly found in 

agricultural settings and on fresh produce, is anticipated to be negligible. Further, Beauveria 

bassiana is not known to produce any mammalian toxins, and no foodborne disease outbreaks 

associated with Beauveria bassiana or toxin production from Beauveria bassiana have been 

reported. The EPA concluded that the risk posed to adults, infants, and children is likely to be 

minimal because of the low acute oral toxicity/pathogenicity potential of Beauveria bassiana 

strain ANT-03.

Drinking Water Exposure and Risk Characterization: Since Beauveria bassiana is naturally 

present in soils and insects, exposure to Beauveria bassiana from surface water and possibly 

groundwater can be expected. Exposure to residues of Beauveria bassiana strain ANT-03 in 

consumed drinking water may occur as a result of spray drift from aerial and ground applications 
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or runoff of prepared fields and rangelands into surface waters. However, if Beauveria bassiana 

strain ANT-03 were to be transferred to surface water or groundwater intended for eventual 

human consumption (e.g., through spray drift or runoff) and directed to wastewater treatment 

systems or drinking water facilities, water treatment processes would remove any Beauveria 

bassiana present. It likely would not survive the conditions water is subjected to in such systems 

or facilities, including chlorination, pH adjustments, filtration, and/or occasionally high 

temperatures (Centers for Disease Control and Prevention, 2015; U.S. EPA, 2004). In the remote 

likelihood that Beauveria bassiana strain ANT-03 is present in drinking water (e.g., water not 

subject to treatment systems or facilities), its target pest specificity and available toxicity and 

pathogenicity data indicate no toxicity and/or pathogenicity is likely to occur with any drinking 

water exposure to Beauveria bassiana strain ANT-03 that results from pesticide applications 

made in accordance with good agricultural practices (see section IV(B)(1)(a) and Table 3 in 

Appendix A).

Non-occupational, Residential Risk Characterization: Given the home and garden proposed use 

pattern for Beauveria bassiana strain ANT-03, non-occupational exposure is expected.

However, repeated exposures to Beauveria bassiana strain ANT-03 from pesticidal applications 

will not exceed he EPA’s level of concern in light of the available data that demonstrate 

Beauveria bassiana strain ANT-03 is not toxic (acute dermal toxicity and acute pulmonary 

toxicity/pathogenicity), is non-irritating (primary dermal irritation), and is not pathogenic (acute 

pulmonary toxicity/pathogenicity and acute injection toxicity/pathogenicity) when used as 

labeled in accordance with good agricultural practices (see section IV(B)(1)(a) and Table 3 in 

Appendix A).

b. Cumulative Effects from Substances with a Common Mechanism of Toxicity

Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, 

or revoke a tolerance exemption, the EPA consider “available information concerning the 

cumulative effects of [a particular pesticide’s] . . . residues and other substances that have a 

common mechanism of toxicity.” 

Beauveria bassiana strain ANT-03 is not toxic via the dietary, dermal and pulmonary routes of 

exposure. For the purposes of the tolerance action, therefore, the EPA has concluded that 

Beauveria bassiana strain ANT-03 does not have a common mechanism of toxicity with other 

substances. Thus, section 408(b)(2)(D)(v) of the FFDCA does not apply.

c. Determination of Safety for U.S. Population, Infants and Children 

In considering the establishment of a tolerance or tolerance exemption for a pesticide chemical 

residue, FFDCA section 408 (b)(2)(C) provides that the EPA shall assess the available 

information about consumption patterns among infants and children, special susceptibility of 

infants and children to pesticide chemical residues, and the cumulative effects on infants and 

children of the residues and other substances with a common mechanism of toxicity. In addition, 

FFDCA section 408 (b)(2)(C) provides that the EPA shall apply an additional tenfold (10X) 

margin of exposure (safety) for infants and children in the case of threshold effects to account for 

prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure 

unless the EPA determines that a different margin of exposure (safety) will be safe for infants 
Beauveria bassiana strain ANT-03

Biopesticides Registration Action Document 

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and children. This additional margin of exposure (safety) is commonly referred to as the Food

Quality Protection Act Safety Factor. In applying this provision, the EPA either retains the 

default value of 10X or uses a different additional safety factor when reliable data available to 

the EPA support the choice of a different factor.

Based on the acute toxicity and pathogenicity data/information discussed in section IV(B)(1)(a) 

and Table 3 in Appendix A, the EPA concludes that there are no threshold effects of concern to 

infants, children, or adults when Beauveria bassiana strain ANT-03 is used as labeled in 

accordance with good agricultural practices. As a result, the EPA concludes that no additional 

margin of exposure (safety) is necessary to protect infants and children and that not adding any 

additional margin of exposure (safety) will be safe for infants and children.

Moreover, based on the same data/information and the EPA’s analysis as presented directly 

above, the Agency is able to conclude that there is a reasonable certainty that no harm will result 

to the United States population, including infants and children, from aggregate exposure to the 

residues of Beauveria bassiana strain ANT-03 when it is used—as labeled and in accordance 

with good agricultural practices—as an insecticide. Such exposure includes all anticipated 

dietary exposures and all other exposures for which there is reliable information. The EPA has 

arrived at this conclusion because, considered collectively, the data and information available on 

Beauveria bassiana strain ANT-03 do not demonstrate toxic or pathogenic potential to 

mammals, including infants and children. No toxicological, irritation or pathogenic endpoints 

were noted in mammalian testing of Beauveria bassiana strain ANT-03 and differential effects 

to infants and children are not expected.

3. Occupational Exposure and Risk Characterization

The available data (e.g., lack of toxicity noted for oral, dermal, and inhalation routes of exposure 

to Beauveria bassiana strain ANT-03) do not demonstrate toxic potential to persons 

occupationally exposed to this microbial pest control agent. Standard personal protective 

equipment (PPE) on the label (mixer and handler use of an N-95 equivalent respirator) further 

mitigates unintentional exposures.

4. Human Health Risk Characterization

The EPA considered human exposure to Beauveria bassiana strain ANT-03 in light of the 

standard for registration in FIFRA. A determination has been made that no unreasonable adverse 

effects to the U.S. population in general, and to infants and children in particular, will result 

when the Beauveria bassiana strain ANT-03 manufacturing-use pesticide product is used to 

formulate end-use pesticide products in accordance with EPA-accepted labeling.

C. Environmental Assessment (40 CFR § 158.2150)

Guideline studies and waiver rationale were submitted to meet data requirements for non-target

organisms per 40 CFR § 158.2150 for Beauveria bassiana strain ANT-03. These data and waiver 

rationale are sufficient to fulfill the relevant microbial pesticide data requirements and for risk 

assessment purposes. Further testing of non-target organisms at higher tier levels (i.e., Tiers II, 
Beauveria bassiana strain ANT-03

Biopesticides Registration Action Document 

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III, and IV) is not required. The EPA’s scientists made a “No Effect” determination for federally 

listed threatened and endangered mammals, birds, and terrestrial and aquatic plants. Effects to 

listed freshwater and marine/estuarine fish and invertebrates and insects could not be precluded, 

and a determination requires additional analysis. Adverse effects to all other non-target 

organisms are not expected to result from the registration of Beauveria bassiana strain ANT-03 

when applied in accordance with the directions on the label. 

For a summary of the generic data requirements described in sections IV(C)(1), refer to Table 4 

in Appendix A.

1. Ecological Exposure and Risk Characterization

According to the label for the EP, Beauveria bassiana strain ANT-03 is intended for use on 

agricultural crops, on turf, in ornamental and landscape use sites, and home gardens for the 

control or suppression of many foliar-feeding pests, including aphids, white flies, thrips, plant 

bugs, beetles and weevils infesting labeled crops or use sites. The end-use product, Bioceres, 

containing Beauveria bassiana strain ANT-03 is a wettable powder (Bioceres-WP) or waterdispersible briquette (Bioceres-WB) that is to be mixed in water and applied as a foliar spray 

with ground or aerial equipment fit for conventional insecticide spraying or by chemigation, in 

field or greenhouse use sites at a rate of up to 6 lbs/acre (2.72 x 1013 CFU/acre). When mixed in 

the minimum amount of water suggested on the label (50 gallons), the concentration of the EP 

that is applied to the environment is 0.014 g/mL, resulting in a concentration of the a.i. of 3.8 x 

107 CFU/mL.

The label states that for optimal results, proper timing of the application of Beauveria bassiana 

ANT-03 targeting newly hatched larvae is important. The label also states that thorough 

coverage of infested plant parts is necessary for effective control, and applications can be 

repeated at 5- to 7-day intervals. Single applications to terrestrial environments can lead to 

exposures to non-target organisms in both terrestrial and aquatic environments. Repeated 

applications at the higher label rates may lead to elevated concentrations, which in turn can result 

in a greater potential for non-target exposure in terrestrial and/or nearby aquatic environments. 

Spray drift from foliar applications may result in some exposure to nearby areas, including 

aquatic environments. While Beauveria bassiana ANT-03 is a new strain isolated originally 

from a dead insect in Canada, Beauveria bassiana is known to occur naturally in soil and water 

in various regions of the world (Zimmerman, 2007), so soil- and water-borne non-target

organisms in those regions currently have some exposure to the existing fungal strains.

a. Terrestrial Non-Target Animals

Birds and Mammals

Avian oral toxicity/pathogenicity – Harmonized Guideline 885.4050; MRID No. 48974207

Avian inhalation toxicity – Harmonized Guideline 885.4100; MRID No. 48974213

Wild mammal toxicity/pathogenicity – Harmonized Guideline 885.4150; MRID Nos. 48974203, 

48974204, and 48974205

The guideline study submitted for the avian oral toxicity/pathogenicity testing requirement 
Beauveria bassiana strain ANT-03

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showed no adverse effects in birds tested (Northern bobwhite, Colinus virginianus). However, 

the study is classified as supplemental because the birds were not tested at the maximum hazard 

dose. Nonetheless, Beauveria bassiana strain ANT-03 is not likely to grow at a bird’s high body 

temperatures (see McNab (1966)) and adverse effects to birds exposed via the oral route are 

considered to be unlikely. 

Based on expected lack of adverse effects observed in birds exposed to Beauveria bassiana

strain ANT-03, risk to non-target birds resulting from the registration is not likely significant.

An acute oral toxicity/pathogenicity study with laboratory rats indicated no adverse effects of 

Beauveria bassiana strain ANT-03 when administered at a dose of 1.3 X 109 CFU/animal 

(MRID No. 48974203). An acute pulmonary toxicity/pathogenicity study was also submitted 

(MRID No. 48974204) that indicated Beauveria bassiana was not toxic, infective, or pathogenic 

to rats at a dose of 1.1 x 109 CFU/animal. An acute intraperitoneal (IP) injection toxicity and 

pathogenicity study (MRID No. 48974205) does not appear to show toxicity when administered 

in a single dose to rats by IP injection at 1.4 x 109 CFU/animal (U.S. EPA, 2014a). 

Some wild mammals may be exposed to Beauveria bassiana strain ANT-03 in treated areas. 

Since adverse effects were not observed in the mammalian studies, risk to wild mammals is 

expected to be low from the registration of the new active ingredient.

Non-target Insect and Honey Bee Testing

Non-target insect testing – Harmonized Guideline 885.4340; MRID Nos. 48974210, 48974211,

and 48974213

Honey bee testing – Harmonized Guideline 885.4380; MRID No. 48974213

The guideline study submitted to meet the requirement for non-target insect testing showed no 

toxicity to ladybird beetles (Hippodamia convergens) upon a 10-day dietary exposure to corn 

earworm (Helicoverpa zea) sprayed with Beauveria bassiana ANT-03 at 1 x 106 CFU/mL.

However, reduced food consumption was observed with the test substance group during Days 7-

11 when compared to the untreated control group. It is not possible to determine potential 

toxicity or pathogenicity in this study, since reduced food consumption could be the result of 

toxicity/pathogenicity, or could have resulted in reduced exposure during the study. Therefore, 

these results are inconclusive. 

The results with green lacewing larvae indicated no significant differences in mortality among 

different test groups when exposed to Beauveria bassiana ANT-03 at 1 x 106 CFU/mL in a 25-

day dietary toxicity/pathogenicity study. However, the mean number of eggs consumed per day 

during Days 0-7 in the untreated control group, inactivated test substance group, and test 

substance group was 19.3, 14.5, and 16.3, respectively. The inactivated test substance group and 

the test substance group consumed significantly fewer eggs during Days 0-7 than did the 

untreated control group (p<0.0001). (The presence or absence of the surfactant in the various test 

groups was not clear. Upon request for clarification, the applicant submitted additional 

information that stated that only test substance and inactive test substance groups included the

surfactant (MRID No. 49453101) but not the untreated control. Surfactants can cause adverse 

effects in some insects.) The reduced egg consumption observed might be due to the surfactant, 
Beauveria bassiana strain ANT-03

Biopesticides Registration Action Document 

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but this cannot be confirmed without having a control group treated with the surfactant alone. 

Without this control, results are inconclusive.

The third guideline insect study was not submitted, but a data waiver was requested. The 

rationale to support the request for no additional testing was not sufficient to conclude that 

adverse effects to non-target insects is unlikely. 

In light of the observation of reduced food consumption in adult ladybird beetles tested and the 

fact that Beauveria bassiana is an entomopathogen known to have a wide host range, the EPA 

cannot conclude that adverse effects to non-target insects will not occur. It should be best to 

exercise caution with the uses of the new active ingredient: e.g., to avoid the use of the new 

active ingredient on or around the crops that are pollinated by insects. The language in the Use 

Directions on the label under the heading “SENSITIVE AREAS” states, “[t]he pesticide should 

only be applied when the potential for drift to adjacent sensitive areas (e.g., residential areas, 

bodies of water, known habitat for threatened or endangered species, non-target crops) is 

minimal (e.g., when wind is blowing away from the sensitive areas),” which may serve to reduce 

exposure. Additional language will be required to alert users to the potential for adverse effects 

to insects, including beneficial species.

 

A study with honey bees was not provided to support the honey bee data requirement for the 

proposed FIFRA section 3 registration of Beauveria bassiana strain ANT-03. A data waiver was 

requested with rationale that included a reference (Al-mazra’awi, 2006) that involved honey bees 

as a vector for the dispersal of another strain of Beauveria bassiana for control of tarnished plant 

bug on canola, without observable impact on honey bees. Given that Beauveria bassiana species 

is a known insect pathogen and honey bee is a major pollinating insect that plays an important 

role agriculturally as well as environmentally, the absence of the required Tier 1 Honey Bee 

study is likely to increase concerns about the effects of Beauveria bassiana ANT-03 on honey 

bees. In addition, the existing data may not be sufficient to predict the effects of Beauveria

bassiana strain ANT-03, a unique strain, on other beneficial non-target insects. A vector 

technology has been developed to use honey bees to disseminate conidia of Beauveria bassiana

to control target pests such as whiteflies and thrips (Shipp, 2009), but studies like this generally 

are not intended to study the direct effects of Beauveria bassiana on honey bees or the bee hives, 

but to evaluate the effectiveness of honey bee as a vector to transfer the microbial pest control 

agent. One study (Al Mazra’awi et al., 2007) did examine the effects of another strain of 

Beauveria bassiana on honey bees. In this study, mortality was low and not significantly 

different from that of the controls; however, mycosis in bee cadavers from Beauveria bassiana

treated hives indicated the potential for Beauveria bassiana to cause mortality in honey bees. 

Based on the above information, the rationale provided by the applicant is not sufficient to 

determine conclusively that Beauveria bassiana strain ANT-03 will not adversely affect honey 

bees or that applications to insect pollinated crops will not cause bee mortality. Thus, a statement 

is required to be added to caution users about the potential effects on bees and other pollinators, 

and specifically restrict users from applying the end-use product when bees are visiting crops and 

surrounding areas. This language is likely to reduce exposure, but may not eliminate it 

completely.
Beauveria bassiana strain ANT-03

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b. Aquatic Non-Target Animals

Freshwater Fish and Invertebrate Testing

Freshwater Fish Toxicity/Pathogenicity – Harmonized Guideline 885.4200; MRID No. 

48974208

Freshwater Invertebrate Toxicity/Pathogenicity – Harmonized Guideline 885.4240; MRID No.

48974209

A guideline study submitted for the non-target freshwater fish testing requirements indicated no 

toxicity/pathogenicity of Beauveria bassiana ANT-03 to Oncorhynchus mykiss(rainbow trout) 

when tested at 1 x 106 CFU/mL. However, one of the three replicates of the test substance group 

(10 of the 30 fish in that group) was not included in the mortality calculations. The study 

author’s explanation for the mortality was that this was likely due to a temporary lack of 

aeration/drop in dissolved oxygen in the test containers, but no other details (e.g., analysis of the 

dead fish for the MPCA and/or necropsy) were provided. 

A guideline study for the non-target freshwater invertebrate testing showed toxicity to Daphnia 

magna at 1 x 106 CFU/mL. Mortality reached 100% in the 1 x 106 test substance group 

(Beauveria bassiana strain ANT-03) by Day 8 and 20% in the 1 x 103 test substance group in 21 

days. The study is classified as supplemental for the following reasons: The study indicates that 

Beauveria bassiana strain ANT-03 is toxic to Daphnia when tested at 1 x 106 conidia/mL. The 

study describes the EC50 values for survival, reproduction and biomass. However, the 

significance of these EC50 values are uncertain, because the study was not designed properly to 

calculate a definitive EC50. In the daphnia study, two concentrations were tested at 103 and 106

CFU/mL. Since 100% mortality was observed at the high rate and 20% mortality was observed 

at the low rate, it can be concluded that the LC50 is >103 CFU/mL. More testing at concentrations 

lower than 106 CFU/mL but higher than 103 CFU/mL is needed to support the EC50 values 

presented in the Daphnia study.

The EPA Standard Wetland, which is a wetland of 1 acre in size and 15 cm in depth, can be used 

to determine a worst-case scenario estimate for estimated environmental concentration (EEC) in 

water. The EEC for water is calculated to be 4.49 x 105 CFU/mL ([6 lbs (product/acre) X (454 

g/lb) X (1 X 1010 CFU/g product) X (1 acre/40,468,564 cm2)] ÷ 15 cm. Using the EPA Standard 

Pond, which is a pond of 1 acre in size and 6 ft (182.88 cm) deep, the EEC would be 3.7 x103

CFU/mL. To gain a more realistic EEC based on the potential for spray drift, the Tier I aerial 

agricultural application scenario in the AgDRIFT spray drift model can be applied to these 

numbers. Under that scenario assuming fine to medium droplet size, a maximum of 12.5% of the 

amount applied is expected to reach aquatic areas at the water’s edge. Therefore, the EEC for the 

wetland and pond can be refined to 5.6 x 104 CFU/mL and 4.62 x 102 CFU/mL. Since the 

potential for exposure falls above 103 CFU/mL from the Daphnia study described above, adverse 

effects to aquatic invertebrates in some aquatic systems cannot be ruled out, especially since 

repeated applications may increase exposure. 

To address this, the EPA will be requiring a spray drift buffer of 50 ft from the water’s edge. 

This buffer will reduce exposure to 3.1 x 104 CFU/mL in the standard wetland and 2.59 x 102

CFU/mL in the standard pond. While it cannot be assured that such a spray buffer would 
Beauveria bassiana strain ANT-03

Biopesticides Registration Action Document 

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eliminate the potential for adverse effects in all cases, the EPA feels confident that this buffer 

would provide sufficient protection for aquatic organisms to address any risk concerns. 

Estuarine/Marine Fish and Invertebrate Testing

Estuarine/Marine Fish and Invertebrate Testing – Harmonized Guideline 885.4280; MRID No. 

48974213 

The applicant did not submit a guideline study to meet the requirement for non-target

marine/estuarine fish and invertebrate testing, but submitted rationale in lieu of testing. This 

testing is conditionally required if significant exposure of non-target marine/estuarine fish and 

invertebrates to Beauveria bassiana strain ANT-03 is expected. The rationale submitted by the 

applicant is supplemental as it relied mainly on the freshwater fish and invertebrate

toxicity/pathogenicity testing results. The EPA generally does not rely on results of testing with 

freshwater species to support risk conclusions on marine/estuarine species. Also, as described 

above, the rainbow trout study results were inconclusive, and the Daphnia study indicated 

adverse effects were possible, though at an unknown level of exposure.

The condition for requiring estuarine/marine fish and invertebrate studies would depend on 

whether there would be significant exposure of aquatic organisms to Beauveria bassiana ANT03, which in turn would depend on both the type/amount of application (singular or multiple; 

foliar or soil surface) and the proximity of the treated areas to aquatic environments. 

Given the potential toxicity of Beauveria bassiana ANT-03 to rainbow trout and Daphnia and 

also potential exposure, as described above for freshwater environments, especially when applied 

repeatedly, adverse effects on other non-target aquatic organisms (both in freshwater and in 

marine/estuarine waters) are expected to occur. 

To address this risk, EPA will be requiring a spray drift buffer of 50 ft from the water’s edge, as 

described above. While it cannot be assured that such a spray buffer would eliminate the 

potential for adverse effects in all cases, the EPA feels confident that this buffer would provide 

sufficient protection for aquatic organisms to address any risk concerns. 

c. Non-Target Plants

Terrestrial and Aquatic Plants

Non-target Plant Testing – Harmonized Guideline 885.4300; MRID No. 48974213

A guideline study for Non-target Plant Testing, Tier 1 was not submitted, but a data waiver was 

requested. Scientific rationale submitted for a waiver of the requirement for Non-target Plant 

Testing consists of the following: Beauveria bassiana ANT-03 is a naturally occurring soil 

fungus whose level in the environment would not significantly increase with the registration of 

the new active ingredient, and the uses of the new a.i. on agricultural crop, turf, ornamental and 

landscape, and home and garden use sites is not expected to result in increased exposure to nontarget plants. 

Beauveria bassiana ANT-03 is a newly isolated strain from a dead insect in Canada, with new 
Beauveria bassiana strain ANT-03

Biopesticides Registration Action Document 

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uses (e.g., for terrestrial and food). This strain was stated to be not phytotoxic to certain crops in 

research and development, but data were not provided to support the claim of no phytotoxicity. 

Scientific rationale based solely on the published information on existing strains is not sufficient 

for the waiver request for the new a.i. However, while Beauveria bassiana is a known 

entomopathogen, it is generally not known as a plant pathogen. Therefore, the proposed uses of 

Beauveria bassiana ANT-03 do not exceed the EPA’s level of concern. 

2. Environmental Fate Assessment Data

As the data and information provided are sufficient to fulfill the Tier I non-target organism data 

requirements and mitigation language will address any identified non-target organism risks and 

uncertainties associated with Beauveria bassiana ANT-03, further testing at higher levels (Tiers 

II, III, and IV) is not required. 

3. Threatened and Endangered Species Assessment

The EPA has determined that no adverse effects are anticipated for most non-target species 

exposed to Beauveria bassiana strain ANT-03 as a result of the labeled applications, including 

mammals, birds, terrestrial and aquatic plants. Therefore, a “No Effect” determination is made 

for direct and indirect effects to federally listed endangered and threatened (“listed”) mammals, 

birds, terrestrial and aquatic plants and for their designated critical habitat. 

Adverse effects to freshwater and marine/estuarine fish and invertebrates and non-target insects 

cannot be ruled out. Therefore, direct effects to individuals of listed insect species cannot be 

precluded, nor can indirect effects to listed species that depend on these organisms or effects on 

Critical Habitat related to these organisms. Additional analysis of the potential effects is 

necessary to make a determination for these species. 

V. ENVIRONMENTAL JUSTICE

EPA seeks to achieve environmental justice—the fair treatment and meaningful involvement of 

all people regardless of race, color, national origin, or income—with respect to the development, 

implementation, and enforcement of environmental laws, regulations, and policies. Fair 

treatment means that no group of people, including racial, ethnic, or socioeconomic groups, 

should bear a disproportionate share of the negative environmental consequences resulting from 

industrial, municipal, and commercial operations or the execution of federal, state, local, and 

tribal environmental programs and policies. Meaningful involvement means that (1) potentially 

affected community residents have an appropriate opportunity to participate in decisions about a 

proposed activity that will affect their environment and/or health; (2) the public’s contribution 

can influence the regulatory agency’s decision; (3) the concerns of all participants involved will 

be considered in the decision-making process; and (4) the decision-makers seek out and facilitate 

the involvement of those potentially affected. EPA has this goal for all communities and persons 

across the U.S. 

To help address potential environmental justice issues, during the 15-day public participation 

comment period, the EPA sought information on any groups or segments of the population who, 
Beauveria bassiana strain ANT-03

Biopesticides Registration Action Document 

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as a result their location, cultural practices, or other factors, may have atypical, unusually high 

exposure to Beauveria bassiana strain ANT-03, compared to the general population. The EPA 

received no public comments on this particular matter.

For additional information regarding environmental justice issues, please visit EPA’s web site at 

http://www.epa.gov/compliance/environmentaljustice/index.html.

VI. RISK MANAGEMENT DECISION

Section 3(c)(5) of FIFRA provides for the registration of a pesticide provided that all the 

following determinations are made: 

(1) its composition is such as to warrant the claims for it; 

(2) its labeling and other materials required to be submitted comply with the 

requirements of FIFRA; 

(3) it will perform its intended function without unreasonable adverse effects on the 

environment; and 

(4) when used in accordance with widespread and commonly recognized practice, it will 

not generally cause unreasonable adverse effects on the environment. 

To satisfy criterion one (1), the Beauveria bassiana strain ANT-03 pesticide products have wellknown properties. The EPA has no knowledge that would contradict the claims made on the 

label for the manufacturing-use pesticide product, Beauveria bassiana strain ANT-03 Technical,

and the end-use pesticide product is not expected to cause unreasonable adverse effects on the 

environment when used according to the label instructions. Criterion two (2) is satisfied by the 

current product labels, as well as the data and information presented in this document. The EPA 

believes that the Beauveria bassiana strain ANT-03, will not cause any unreasonable adverse 

effects on the environment, and the end-use product is likely to control pests, satisfying criterion 

three (3). Criterion four (4) is satisfied in that the Beauveria bassiana strain ANT-03 is not 

expected to cause unreasonable adverse effects when used according to label instructions. 

Therefore, Beauveria bassiana strain ANT-03 Technical and Bioceres, the end-use pesticide 

product, are eligible for registration under FIFRA section 3(c)(5) for the labeled uses.

VII. ACTIONS REQUIRED OF THE REGISTRANT

A. Final Printed Labeling 

Before releasing the pesticide products containing Beauveria bassiana strain ANT-03 for 

shipment, the registrant is required to provide appropriate final printed labeling to the EPA.
Beauveria bassiana strain ANT-03

Biopesticides Registration Action Document 

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B. Terms of Registration

As terms of the registration, the applicant must provide the following: 

1) a manufacturing process amended to describe a method for identifying spores as 

Beauveria bassiana strain ANT-03; 

2) batch analyses using viable count calculations; 

3) specific methods for microbial contamination analyses; 

4) defined rejection limits for contaminants; and

5) an explanation of unidentified fungi.

Data and information to address these five terms are required not due to risk concerns, but to 

clarify and define the quality assurance/quality control measures. Receipt by the EPA is required 

within 90 days of the technical product’s registration issuance date, except that 12 months are 

allowed for the submission addressing the batch analyses requirement (term two).

The end-use product label must include the following hazard statement under the Environmental 

Hazards section to address ecological risk concerns and uncertainties:

“This product may harm beneficial insects and honey bees. Do not apply around bee 

hives. Do not apply while bees and other pollinating insects are actively foraging. This 

product may be harmful to aquatic organisms. Drift and runoff may be hazardous to aquatic 

organisms in water adjacent to treated areas. Do not apply within 50 feet of aquatic habitats 

(such as, but not limited to, lakes, reservoirs, rivers, streams, marshes, ponds, estuaries, and 

commercial fish ponds).”

C. Reporting of Adverse Effects and Hypersensitivity Incidents

Notwithstanding the information stated in the previous sections, it should be clearly understood 

that certain specific data are required to be reported to the EPA as a requirement for maintaining 

the federal registration for a pesticide product. Reports of all incidents of adverse effects to the 

environment must be submitted to the EPA under the provisions stated in FIFRA section 6(a)(2). 

Additionally, all incidents of hypersensitivity (including both suspected and confirmed incidents) 

must be reported to the EPA under the provisions of 40 CFR § 158.2140(d).
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Biopesticides Registration Action Document 

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VIII. BIBLIOGRAPHY

For definitions of scientific terms, please refer to http://www.epa.gov/pesticides/glossary/.

A. Studies Submitted to Support the Registration of Pesticide Manufacturing-Use 

Product Containing Beauveria bassiana strain ANT-03

MRID Citation Receipt 

Date

48974200

Anatis Bioprotection, Inc. (2013) Submission of Product Chemistry, 

Toxicity and Efficacy Data in Support of the Application for 

Registration of Beauveria bassiana Strain ANT-03 Technical. 

Transmittal of 13 Studies.

03-May2013

48974201

Roberts, A. (2013) Product Chemistry for Beauveria bassiana Strain 

ANT-03 Technical: (Group B). Unpublished study prepared by 

Technology Sciences Group, Inc. 228p.

03-May2013

48974202

Mayrand-Provencher, L. (2013) Analysis of Beauvericin in the Fungus 

(Species) Beauveria bassiana (Bals.) Vuill Strain: ANT-03 Stage: Aerial 

conidia. Project Number: 230/2013/01/OCR. Unpublished study 

prepared by Eliapharma Services, Inc. 32p.

03-May2013

48974203

Monds, K. (2011) Bioterra (Beauveria bassiana): Acute Oral 

Toxicity/Pathogenicity Study in Rats: Final Report. Project Number: 

14817/11/OCR. Unpublished study prepared by Stillmeadow, Inc. 31p.

03-May2013

48974204

Monds, K. (2011) Bioterra (Beauveria bassiana): Acute Pulmonary 

Toxicity/Pathogenicity Study in Rats: Final Report. Project Number: 

15020/11/OCR. Unpublished study prepared by Stillmeadow, Inc. 28p.

03-May2013

48974205

Monds, K. (2011) Bioterra (Beauveria bassiana): Acute Intraperitoneal 

Injection Toxicity/Pathogenicity Study in Rats: Final Report. Project 

Number: 14818/11/OCR. Unpublished study prepared by Stillmeadow, 

Inc. 22p.

03-May2013

48974206

Kuhn, J. (2011) Bioterra (Beauveria bassiana): Acute Dermal Toxicity 

Study in Rats: Final Report. Project Number: 15014/11/OCR. 

Unpublished study prepared by Stillmeadow, Inc. 12p.

03-May2013

48974207

Younger, C. (2011) Bioterra (Beauveria bassiana): Acute MPCA Oral 

Toxicity Study in Bobwhite Quail: Final Report. Project Number: 

14819/11/OCR. Unpublished study prepared by Stillmeadow, Inc. 18p.

03-May2013

48974208

Hartwell, T. (2011) Bioterra (Beauveria bassiana): Microbial Pest 

Control Agent (MPCA) Freshwater Fish Test with Oncorhynchus 

mykiss (Rainbow Trout): Final Report. Project Number: 

14820/11/OCR. Unpublished study prepared by Stillmeadow, Inc. 20p.

03-May2013
Beauveria bassiana strain ANT-03

Biopesticides Registration Action Document 

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MRID Citation Receipt 

Date

48974209

Hartwell, T. (2011) Bioterra (Beauveria bassiana): Microbial Pest 

Control Agent (MPCA) Freshwater Aquatic Invertebrate Test with 

Daphnia magna: Final Report. Project Number: 15016/11/OCR. 

Unpublished study prepared by Stillmeadow, Inc. 33p.

03-May2013

48974210

Younger, C. (2011) Bioterra (Beauveria bassiana): Ladybird Beetle 

Non-Target Insect Microbial Testing: Final Report. Project Number: 

15017/11/OCR. Unpublished study prepared by Stillmeadow, Inc. 14p.

03-May2013

48974211

Younger, C. (2011) Bioterra (Beauveria bassiana): Green Lacewing 

Microbial Testing: Final Report. Project Number: 15018/11/OCR. 

Unpublished study prepared by Stillmeadow, Inc. 18p.

03-May2013

48974212

Roberts, A. (2013) Summary of Data on Beauveria bassiana conidia 

Field Persistence. Unpublished study prepared by Anatis Bioprotection, 

Inc. 48p.

03-May2013

48974213

Roberts, A. (2013) Response to Tier 1 Microbial Pesticide Data 

Requirements for Beauveria bassiana strain ANT-03 Technical. 

Unpublished study prepared by Technology Sciences Group, Inc. 136p.

03-May2013

49453100

Anatis Bioprotection, Inc. (2014) Submission of Toxicity Data in 

Support of the Registration of Beauveria bassiana strain ANT-03 

Technical. Transmittal of 1 Study. 

22-Aug2014

49453101

Roberts, A. (2014) Response to EPA Questions for Beauveria bassiana 

Strain ANT-03 Technical Testing. Project Number: 15017/11, 

10018/11. Unpublished study prepared by Technology Science Group, 

Inc. 110p.

22-Aug2014

B. Studies Submitted to Support the Registration of Pesticide End-Use Product

Containing Beauveria bassiana strain ANT-03

MRID Citation Receipt 

Date

48974300

Anatis Bioprotection, Inc. (2013) Submission of Product Chemistry 

and Toxicity Data in Support of the Application for Registration of 

Bioceres. Transmittal of 2 Studies.

03-May2013

48974301 Roberts, A. (2013) Product Chemistry for Bioceres. Unpublished study 

prepared by Technology Sciences Group, Inc. 69p.

03-May2013
Beauveria bassiana strain ANT-03

Biopesticides Registration Action Document 

Page 25 of 31

MRID Citation Receipt 

Date

48974302

Roberts, A. (2013) Response to Tier 1 Microbial Pesticide Data 

Requirements for Bioceres. Unpublished study prepared by 

Technology Sciences Group Inc. 41p.

03-May2013

C. Environmental Protection Agency Risk Assessment Memoranda

U.S. EPA. 2014a. Beauveria bassiana strain ANT-03 (review submitted studies for FIFRA 

Section 3 registration of an MUP (TGAI) and EP with a food tolerance exemption petition. 

Memorandum from J. Gagliardi to D. Greenway dated September 17, 2014.

U.S. EPA. 2014b. Environmental risk assessment for the FIFRA Section 3 registration of the 

TGAI, Beauveria bassiana strain ANT-03 (EPA Reg. No. 89600-R) and the EP, Bioceres 

(EPA Reg. No. 89600-E), containing the active ingredient Beauveria bassiana strain ANT03. Memorandum from I. You to D. Greenway dated September 19, 2014.

D. Other References

Al-mazra’awi MS. 2007. Impact of the entomopathogen fungus Beauveria bassiana on the 

honey bees. Apis mellifera (Hymenoptera: Apidae). World Journal of Agricultural Sciences

3(1):7–11.

Al-mazra’awi MS, Shipp JL, Broadbent AB, Kevan PG. 2006. Dissemination of Beauveria 

bassiana by honey bees (Hymenoptera: Apidae) for control of tarnished plant bug 

(Hemiptera: Miridae) on canola. Environmental Entomology 35:1569–1577.

Centers for Disease Control and Prevention. 2015. Drinking Water - Water Treatment. Available 

from http://www.cdc.gov/healthywater/drinking/public/water_treatment.html.

McNab BK. 1966. An analysis of the body temperature of birds. The Condor 68:47–55.

Shipp L. 2009. Hand-Off Method for Application of Microbial Agents. Agriculture and AgriFood Canada. 

U.S. EPA. 2014c. Chapter 7 of the Label Review Manual (Precautionary Statements) (Revised 

July 2014). Available from http://www2.epa.gov/sites/production/files/2014-

07/documents/chapter7_revised_final_0714.pdf.

U.S. EPA. 2004. Primer for Municipal Wastewater Treatment Systems. EPA 832-R-04-001. 

Available from http://www.epa.gov/npdes/pubs/primer.pdf.

Zimmerman G. 2007. Review on safety of the entomopathogenic fungi Beauveria bassiana and 

Beauveria brongniartii. Biocontrol Science and Technology 17(6):553–596.
Beauveria bassiana strain ANT-03

Biopesticides Registration Action Document 

Page 26 of 31

APPENDIX A. MICROBIAL PESTICIDES DATA REQUIREMENTS (40 CFR PART 158 – SUBPART V)

TABLE 1. Product Analysis Data Requirements for the TGAI Beauveria bassiana strain ANT-03 and the End-Use Pesticide Product (EP), Bioceres (40 CFR § 

158.2120)

Harmonized 

Guideline 

Number

Data Requirement Results Summary MRID No. (TGAI) MRID No. (Bioceres)

885.1100 Product Identity

Submitted data fulfill the requirement for product identity, manufacturing 

process, and discussion of formation of unintentional ingredients. The EPA 

is requiring as a term of registration of the TGAI the following:

- That a method for spore identification be added to the 

manufacturing process;

- That specific methods for microbial contamination analyses be 

provided;

- That rejection limits for contaminants be defined; and

- That unidentified fungi be explained.

Beauveria bassiana strain ANT-03 Technical contains 100.0% by weight 

Beauveria bassiana strain ANT-03, containing not less than 2.2 x 1010

CFU/g

Bioceres is an end-use product containing 20% w/w Beauveria bassiana 

strain ANT-03 and not less than 1 x 1010 CFU ai/g.

48974201

48974202

49453101

48974301

885.1200 Manufacturing Process

885.1300

Discussion of Formation 

of Unintentional 

Ingredients

885.1400 Analysis of Samples

Submitted data fulfill the requirement. For the TGAI, the EPA is requiring 

submission of batch analyses using viable count calculations with the 

TGAI.

885.1250

Deposition of a Sample 

in a Nationally 

Recognized Culture 

Collection

A sample of Beauveria bassiana strain ANT-03 is on deposit with the 

Agricultural Research Service Culture Collection (NRRL) under NRRL 

50797

885.1500 Certification of Limits Limits are adequate/acceptable.
Beauveria bassiana strain ANT-03

Biopesticides Registration Action Document 

Page 27 of 31

TABLE 2. Physical and Chemical Characteristics for Beauveria bassiana strain ANT-03 and the End-Use Pesticide Product (EP), Bioceres 

(40 CFR § 158.2120)

Guideline Reference No./Property

Description of Results - Beauveria bassiana strain 

ANT-03 TGAI

MRID No. 48974201

Description of Results – Bioceres

MRID No. 48974301

830.6302 Color Cream-white

Not applicable, per 40 CFR § 158.2120(c)

830.6303 Physical State Powder

830.6304 Odor Odorless

830.6313 Stability Stable refrigerated 1 year, stable 6 months at room temp. 

Expected with metals

830.6317 Storage Stability Stable under refrigerated conditions (4± 2o C) for 1 year Stable 1 year 4+/-2 degrees C; 6 months 21 degrees C in 

vacuum-sealed bags; 3 months in non-vacuum-sealed bags. 

830.6319 Miscibility Not applicable, not an emulsifiable liquid or diluted with 

petroleum solvents Not applicable, per 40 CFR § 158.2120(d)(2)

830.6320 Corrosion Characteristics No observed corrosion or packaging degradation during 1-

year storage stability test

No observations of corrosion or packaging degradation 

during 1-year storage stability study.

830.7000 pH Not applicable, the TGAI/MUP is a powder Not applicable, EP is a powder

830.7100 Viscosity Not applicable, per 40 CFR § 158.2120(d)(4) - TGAI/MUP is 

not a liquid Not applicable, per 40 CFR § 158.2120(d)(4)

830.7300 Density/Relative Density/Bulk Density 0.280 g/cm3 0.286 g/cm3
Beauveria bassiana strain ANT-03

Biopesticides Registration Action Document 

Page 28 of 31

TABLE 3. Tier I Toxicology Data Requirements for Beauveria bassiana strain ANT-03 TGAI and Bioceres EP(40 CFR § 158.2140)

Harmonized 

Guideline 

Number

Data Requirement Results Summary and Classification MRID No.

885.3050 Acute Oral Toxicity/

Pathogenicity - Rat Not toxic or pathogenic orally at 1.3 x 109 CFU/animal 48974203

885.3150 Acute Pulmonary Toxicity/

Pathogenicity - Rat Not toxic, infective or pathogenic when inhaled at 1.1 x 109 CFU/animal 48974204

885.3200

Acute Intraperitoneal 

Injection Toxicity/

Pathogenicity - Rat

Not toxic, infective or pathogenic intraperitoneally at 1.4 x 109 CFU/animal 48974205

885.3400 Hypersensitivity Incidents

The EPA regulations require that hypersensitivity incidents, including 

immediate-type and delayed-type reactions of humans and domestic animals, 

that occur during the testing or production of the technical grade of the active 

ingredient, or manufacturing-use product, or end-use product, or are otherwise 

known to the applicant, be reported if they occur (refer to test note #3 of 40 CFR 

§ 158.2140(d)). 

885.3500 Cell Culture Not required because Beauveria bassiana strain ANT-03 is not a virus (refer to 

test note #4 of 40 CFR § 158.2140(d)). n/a

870.1100 Acute Oral Toxicity Waived

TOXICITY CATEGORY III 

48974213 (TGAI)

48974302 (EP)

870.1200 Acute Dermal Toxicity Dermal NOAEL combined > 5050 mg/Kg bw TOXICITY CATEGORY IV

48974213 (TGAI)

48974206 (TGAI and 

EP)

48974302 (EP)

870.1300 Acute Inhalation Toxicity Waived

TOXICITY CATEGORY III

48974213 (TGAI)

48974302 (EP)

870.2400 Primary Eye Irritation Waived

TOXICITY CATEGORY III

48974213 (TGAI)

48974302 (EP)

870.2500 Primary Dermal Irritation Waived

TOXICITY CATEGORY III

48974213 (TGAI)

48974302 (EP)
Beauveria bassiana strain ANT-03

Biopesticides Registration Action Document 

Page 29 of 31

TABLE 4. Non-Target Organism Toxicology Data Requirements for Beauveria bassiana strain ANT-03 TGAI and Bioceres EP (40 CFR 158.2150)

Data Requirement

Harmonized

Guideline 

Number.

Results Summary and Classification MRID No.

Avian oral

toxicity/pathogenicity

885.4050 An avian oral test indicated that B. bassiana strain ANT-03 is not toxic or 

pathogenic to Northern bobwhite (Colinus virginianus) dosed at a 5X field 

application rate (2.4 x 108 CFU/mL), but the birds were not tested at a maximum 

hazard dose. 

Classification: Supplemental

48974207

Avian Inhalation Test 885.4100 Avian inhalation test was not conducted, but a waiver was submitted. The 

rationale provided is not sufficient, but other information indicates that there is not 

likely hazard that will result for the proposed uses.

Classification: Supplemental

48974213

Wild mammals 885.4150 Wild mammal testing was not conducted, but a data waiver was requested. Studies 

conducted with B. bassiana strain ANT-03 on laboratory animals are appropriate 

for use in risk assessment. Studies with laboratory rats indicated no concerns for 

toxicity/pathogenicity in mammals.

Classification: Acceptable

48974213

Freshwater fish

toxicity/pathogenicity

885.4200 A freshwater fish test with B. bassiana strain ANT-03 showed no toxic or 

pathogenic effect on Rainbow trout (Oncorhynchus mykiss) dosed at 1 x 106

CFU/mL. However, mortality in one of the three test substance replicates was high 

and the replicate was discarded. Because of the above high mortality data, the 30 

day LC50 could not be determined conclusively. 

Classification: Supplemental

48974208

Freshwater invertebrate

toxicity/pathogenicity

885.4240 A freshwater invertebrate study with B. bassiana strain ANT-03 showed 20% 

mortality of Daphnia magna at exposure to 1 x 103 CFU/mL of test medium. 

100% mortality was shown when tested at 1 x 106 CFU/mL. An EC50 could not be 

determined, but is estimated to be between 103 and 106 CFU/mL.

Classification: Supplemental

48974209
Beauveria bassiana strain ANT-03

Biopesticides Registration Action Document 

Page 30 of 31

TABLE 4. Non-Target Organism Toxicology Data Requirements for Beauveria bassiana strain ANT-03 TGAI and Bioceres EP (40 CFR 158.2150)

Data Requirement

Harmonized

Guideline 

Number.

Results Summary and Classification MRID No.

Non-target insect

testing

885.4340 A laboratory bioassay with adult ladybird beetles (Hippodamia convergens) at 

10X the field application rate showed no mortality of B. bassiana strain ANT-03 

to the test organism (Helicoverpa zea) within 8 days of testing. However, reduced 

food consumption was observed with the test substance group during Days 7-11 

when compared to the untreated control group.

Classification: Supplemental

A laboratory bioassay with green lacewing larvae (Chrysoperla rufilabris) at 10X 

the field application rate showed no adverse effects of B. bassiana strain ANT-03 

to the test organism (Helicoverpa zea) within 25 days of testing. 

Classification: Acceptable 

A waiver from the requirement of Non-target Insect Testing for a third species was 

requested, but scientific rationale provided for a waiver was not sufficient.

Classification: Supplemental

48974210

48974211

48974213

Honey bee testing 885.4380 Because B. bassiana is a known entomopathogenic fungus with a broad host 

range, scientific rationale provided was not sufficient to conclude that no adverse 

effects of B. bassiana strain ANT-03 on honey bees are likely to occur. 

Classification: Supplemental 

48974213

Estuarine/marine fish and 

invertebrate testing

885.4280 A waiver from the requirement for the Estuarine/Marine Fish and Invertebrate 

Testing was requested. Scientific rationale provided was insufficient to conclude 

that no adverse effects are expected on non-target fish and invertebrates for all 

applications. B. bassiana strain ANT-03 was shown to be toxic to the aquatic 

invertebrate Daphnia magna at 1 x 106 CFU/mL. Repeated applications over large 

areas may lead to some exposure of B. bassiana ANT-03 in nearby aquatic 

environments. 

Classification: Supplemental

48974213

Non-target plant 

Testing

885.4300 A data waiver from Non-target Plant Testing of B. bassiana strain ANT-03 was 

requested. Scientific rationale largely based on existing B. bassiana strains 

submitted was not sufficient to support no adverse effects to all plants. 

Classification: Supplemental

48974213
Beauveria bassiana strain ANT-03

Biopesticides Registration Action Document 

Page 31 of 31

APPENDIX B. PESTICIDE PRODUCTS

EPA 

Registration 

Number

Product Name

Percentage 

Active 

Ingredient

Formulation Type Use Site(s) Method(s) of 

Application

Application 

Rate Target Pest(s)

89600-1

Beauveria 

bassiana strain 

ANT-03 

Technical

100% Manufacturing-Use 

Product (powder)

For 

manufacturing 

use only

N/A N/A N/A

89600-2 Bioceres 20.0%

End-Use Product 

(wettable powder or

water dispersible

briquettes) 

Agricultural and 

ornamental crops, 

turf, residential

Ground, 

aerial, 

chemigation 

Up to 6 

lbs/acre

Foliar pests (whiteflies, 

aphids, thrips, plant 

bugs, certain drosophila, 

beetles and borers) and 

certain grubs