BIOPESTICIDES REGISTRATION ACTION DOCUMENT



## B eauveria 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, 2015B eauveria bassiana strain ANT

- 03 Biopesticides Registration Action Document Page 2 of 31

TABLE OF CONTENTS

I. EXECUTIVE S UMMARY

................................ ................................ ................................ ................................ ......... 4

II. ACTIVE INGREDIENT OV ERVIEW

................................ ................................ ................................ ................... 6

III. REGULATORY BACKGROUN D

................................ ................................ ................................ ........................... 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 § 158.2 150)

................................ ................................ ......................... 14

V. ENVIRONMENTAL JUS TIC E

................................ ................................ ................................ .............................. 20

VI. RIS K MANAGEMENT DECI S 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. MICROBI AL PES TICIDES DATA REQUIREMENTS

................................ ................................ .. 26

APPENDIX B. PES TICI DE PRODUCTS

................................ ................................ ................................ ........................... 31B eauveria bassiana strain ANT

- 03 Biopesticides Registration Action Document Page 3 of 31

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. P roduct 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 Nes ci ChiefB eauveria bassiana strain ANT

- 03 Biopesticides Registration Action Document Page 4 of 31

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 B eauveria 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 B eauveria
bassiana strain ANT

- 03 at 20.0% concentration (EPA File Symbol 89600

- E) was concurrently
submitted.

B eauveria bassiana strain ANT

- 03 is a naturally occurring bac terium and was originally isolated
in 2000 from Lygus lineolaris found dead in a field in Sherrington, Quebec, Canada. The natural
occurrence of B eauveria 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 pest icide 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 product s under FIFRA section 3(c)(5).

Product Analysis For the purposes of FIFRA sect ion 3(c)(5) registration, the product analysis data req uirements for the manufacturing

- use and e nd

- 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 E PA has determined that a ll applicable mammalian toxicology data requirements for

B eauveria bassiana strain ANT

- 03 are fulfilled. Acceptable Tier I mammalian toxicology data
and other information support the registration of the pesticide product s and the request for an exemption from the requirement of a tolerance for residues of B eauveria bassiana strain ANT

- 03
in or on all food commodities . Tier II and Tier III studies were not requir ed because of the lack of acute toxicity/pathogenicity in the Tier I studies

.

Tolerance Exemption In its application to the EPA in 201 3, Technology Sciences Group, Inc., on behalf of Anatis Bioprotection Inc., provided a petition, data and other informat ion 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, non

occupational exposure is expected. However, r epeated exposures to Beauveria bassiana strain

ANT

- 03 from pesticidal applications will no t exceed the EPA’s level of concern in lig ht of theB eauveria bassiana strain ANT

- 03 Biopesticides Registration Action Document Page 5 of 31

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
G

uideline studies and waiver rationale were submitted to meet data requirements for non

- target organisms f or Beauveria bassiana strain ANT

- 03. These data and waiver rationale are sufficient to fulfill the relevant microbial pesticide data requirements and f or 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, a nd 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 expe c ted 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 p ublic 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 B eauveria 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

B eauveria bassiana strain ANT

- 03 Technical and Bioceres , it is in the best interest of the p ublic
and the environment to issue the se registration s. The basis for this decision can be found in the
risk assessment for B eauveria bassiana strain ANT

- 03, which is characterized throughout this Biopesticides Registration Action Document (BRAD) and the a ssociated referenced documents.B eauveria bassiana strain ANT

- 03 Biopesticides Registration Action Document Page 6 of 31

II

. ACTIVE INGREDIENT OVERVIEW

Biological Name: B eauveria 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 product s containing this active ingredient.

III

. REGULATORY BACKGROUND

A. Applications for Pesticide Registration

On April 25 , 201 3 , application s for registration were submitted on behalf of Anatis Bioprotection Inc., 278, rang Saint

- Andre ́, St

. - Ja c ques

- le

- Min e u r, Quebec J0 J 1Z 0 , Canada for the manufacturing

- use pesticide product, B eauveria bassiana str ain 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 B eauveria bassiana strain ANT

- 03 . In the Federal Register
of December 1 1 , 201 3 ( 78 FR 75343 ), the EPA announced receipt of th ese application s for registration of a pesticide product containing a new active ingredient for manufacturing

- use and
end

- use. No comme nts were received following the publication of this notice. For more information, see the following docket at www.regulations.gov : EPA

- HQ

- OPP

- 201 3

- 0 71 8

.

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 pestic ide 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 re qui re m e nt for a tol e r a n c e f or r e sidu es of B eauveria 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

- 201 3

- 0 717

.

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 an d good agriculturalB eauveria bassiana strain ANT

- 03 Biopesticides Registration Action Document Page 7 of 31 practices ( 40 CFR § 180.1328 ; 79 FR 77395 ).

C. Registration Review

In September 20 11

, the EPA completed a Final Work Plan for B eauveria bassiana strains

, Registration Review Case 60 57. The plan i ncludes a discussion of the Endangered Species assessment that will be completed in advance of a Proposed Regi stration Review Final Decision. This active ingredient will now be considered as part of the B eauveria bassiana strain s Registration Review Case 6057 . For more informati on, see the following docket at www.regulations.gov : EPA

- HQ

- OPP

- 2010

- 0564

.

The end

- use product containing B eauveria bassiana strain ANT

- 03 is proposed for use on growing crops as a contact mycoinsecticide to control or suppress foliar

- f eeding pests and certain grubs

. Several other strains of Beauveria bassiana , i ncluding strains 447, GHA, HF23 and ATCC

74040

, have pr eviously 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 mic robial 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 o f 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 la cking 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 oth er 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 indica tes the lowest toxicity ( see section II.B. of U.S. EPA (2014 c ) ).

A. Product Analysis Assessment ( 40 CFR § 158.2120 )

Microbial pesticide p roduct analysis data requirements include product chemistry and composition, analysis and certified limits, and physical and chemical characteristics data.B eauveria bassiana strain ANT

- 03 Biopesticides Registration Action Document Page 8 of 31

Product chemistry and composition data inc l ude information about the identit y of the active ingredient , the manufacturing process, de position of a sam ple 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 certificatio n 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 purpo ses of registration under FIFRA section 3(c)(5), the EPA determined that a ll product analysis data requirements for registration of the B eauveria bassiana strain ANT

- 03 pesticide products have been fulfilled . T he 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 add ed to the manufacturing process;

- Batch analysis using viable count calculations must be submitte d;

- S pecific methods for microbial contamination analyses must be provided ;

- Rejection l imits for contaminants must be defined; and

- U nidentified 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 C ode 12999 0 has been assigned to B eauveria bassiana strain ANT

- 03 , as it is a new active ingredient. A sample of B eauveria bassiana strain ANT

- 03 is d eposited at the Agricultural Research Service Culture Collection (NRRL) under NRRL 50797

.

Refer to Table 1 in Appendix A for a summary of t he p rod uct a nalysis data and terms of registration

. Refer to Table 2 in Appendix A f or a summary of the physical and chemical

p roperties data.

B. Human Health Risk Assessment ( 40 CFR 158.2140 )

1. Toxicity

The EPA has determined that a ll applicable mammalian toxicology data requirements for

B eauveria bassiana strain ANT

- 03 are fulfilled. Acceptable Tier I mammalian toxicology data
and information support the registration of the pesticide product s and the request for an exemption from the requirement of a tolerance for residues of B eauveria bassiana strain ANT

- 03
in or on all food commodities . Tier II and Tier III studies were not requi red because of the lack of acute toxicity/pathogenicity in the Tier I studies

.

The to xicity and pathogenicity tests and irritation tests (acute eye and primary dermal irritation)
that addres s 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 ANT

03.B eauveria bassiana strain ANT

- 03 Biopesticides Registration Action Document Page 9 of 31 The overall conclusions from all toxicological data and information submitted by the applicant are briefly described below, in s ections 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 Sprague

Dawley rats (12/sex) were given a single oral dose of Beauveria bassiana strain ANT

- 03 (1.2 x
10 11 conidia/g) in sterile phosphate buffer saline ( PBS ) at a dose of 1.3 x 10 9 C FU/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, lung s, liver, kidn eys, or cecum contents through D ay 7, and cleared by Day 14. The test organism cleared from the mesenteric lymph nodes by D ay 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 ANT

03 is n ot toxic or pathogenic orally at 1.3 x 10 9 CFU/an imal.

Acute Pulmonary Toxicity and Pathogenicity

– Rat (Harmonized Guideline 885.3 15 0; MRID No.

48 9742 0 4 ) : In an acute pulmonary toxicity and path ogenicity study, groups of ~7 to 8

- week

- old Sprague

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

ANT

- 03 (1.2 x 10 11 conidia/g) in sterile PBS at a dose of 1.1 x 10 9 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 su bstance 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 pathoge nic to rats when
dosed at 1.1 x 10 9 CFU/anima l. 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

no t toxic, infective, o r pathogenic when inhaled at 1 .1 x 10 9 CFU/animal.

Acute Intraperitoneal Injection Toxicity and Pathogenicity

– Rat (Harmonized Guideline

885.3 20 0; MRID No. 48 9742 0 5 ) : 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 10 11 conidia/g) in sterile PBS at a dose of 1.4 x 10 9 CFU/anima l. The
animals were treated on D ay 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 wer e sacrificed and necropsied on D ay 21. Two additional groups of five rats/sex served as untreated and inactivated MPCA controls and were alsoB eauveria bassiana strain ANT

- 03 Biopesticides Registration Action Document Page 10 of 31

sacrificed on D ay 21. Based on the results of this study, Beauveria bassiana strain ANT

- 03 does not appear to be t oxic when administered in a single dose to rats by IP injection at 1.4 x 10 9 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 treate d females were significantly lighter than untreated controls.

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

03 is not toxic, infect ive, or pathogenic intraperitoneally at 1. 4 x 10 9 CFU/animal.

Acute Dermal Toxicity

– Rat ( Harmonized Guideline 8 70

. 120 0; MRID No. 48 9742 0 6 ) : 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 10 11 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 weigh t. The animals were treated on

D ay 0 and observed for a period of 14 days. T here 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 d etermined this study to be acceptable and concluded that Beauveria bassiana strain ANT

- 03

has a d ermal NOAEL combined of > 5

, 050 mg/ k g bw (EPA Toxicity Category IV).

Acute Oral Toxicity

– Rat (Harmon ized 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 B eauveria bassiana strain ANT

- 03 , the applicant provided acceptable scientific justifications/ rationale s ( MRID No s. 48 9742 13 [TGAI] and 48974302 [Bioceres EP]) to address the above listed data requirement s, summarized below. The EPA generally agrees with the rationales provided

, and the EPA determined the rationale s to be acceptable to address the data requirements. (U.S. EPA

, 201 4a).

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 10 9 CFU/animal in an acute oral toxicity/pathogenicity study. As calculated by the reviewer, the administered dose of 1.3 x 10 9 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 10 9 CFU/animal did not result in mortality, abnormal clinical signs, or gross patholo gy in rats. As calculated by the reviewer, the administered dose levels were approximat ely 31.4 to 56.2 mg/kg bw. TGAI s with Beauveria
bassiana strains 447, GHA, and HF23 have been tested and classified in US EPA Toxicity Category III for primary eye irrit ation, 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.B eauveria bassiana strain ANT

- 03 Biopesticides Registration Action Document Page 11 of 31 There are no inert ingredients added to the TGAI. The inert ingredi ents 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 B eauveria 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 ha ve 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 re quirements 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 estrogen ic 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. B eauveria bassiana strain ANT

- 03 is not among the grou p of 58 pesticide active ingredients on the initial list to be screened under the
EDSP.

The Agency believes that B eauveria bassiana strain ANT

- 03 likely is a substance that would not produce any effect in humans similar to an effect produced by a naturall y occurring estrogenic substance. As such, and pursuant to Section 408(p)(4), EPA will determine in the future whether it can exempt B eauveria bassiana strain ANT

- 03 from the requirements of the Section 408(p) EDSP. In the event the Agency does determine t o 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 w ebsite: 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 toB eauveria bassiana strain ANT

- 03 Biopesticides Registration Action Document Page 12 of 31 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 ch ildren 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 subgroup s 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 , t he data required for a FFDCA risk assessment for

B eauveria 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 d ietary 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

re ported. 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

c onsumed drinking water may occur as a result of spray drift from aerial and ground applicationsB eauveria bassiana strain ANT

- 03 Biopesticides Registration Action Document Page 13 of 31 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 groundw ater 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 oc cur 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, r epeated exposures to Beauveria bassiana strain ANT

- 03 from pesticidal applications
will no t 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 (pri mary dermal irritation), and is not pathogenic (acute

p ulmonary 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 “ava ilable 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 ap ply.

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 commo n 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 toxi city 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 infantsB eauveria bassiana strain ANT

- 03 Biopesticides Registration Action Document Page 14 of 31 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 bassi ana 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 U nited 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 demonstra te 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 e xpected.

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

m

itigates unintentional ex posures

.

4

. Human Health Risk Characterization

The EPA considered human exposure to B eauveria 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. popu lation in general, and to infants and children in particular, will result
when the B eauveria bassiana strain ANT

- 03 manufacturing

- use pesticide product i s used to formulate end

- use pesticide products in accordance with EPA

- a ccept ed labeling.

C. Environmental Assessment ( 40 CFR § 158.2150 )

Guideline studies and waiver rationale were submitted to mee t 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,B eauveria bassiana strain ANT

- 03 Biopesticides Registration Action Document Page 15 of 31 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. Ef fects 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 expec ted 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 crop s , on turf, in ornamental and landscape use sites, and home gardens fo r 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 water

dispersible 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 10 13 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
10 7 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 c an 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 concen trations, 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 Bea uveria 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 requirementB eauveria bassiana strain ANT

- 03 Biopesticides Registration Action Document Page 16 of 31 showed no adverse effects in birds tested (Northern bobwhite, Colinus virginianus ). However,

t he study is classified as supplemental because the birds were not test ed 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 expec ted lack of adverse effects observed in birds exposed to Beauveria bassiana
strain ANT

- 03, risk to non

- target bi rds resulting from the registration is not likely significant.

An acute oral toxicity/pathogenicity study with laboratory rats indicated no adv erse effects of
Beauveria bassiana strain ANT

- 03 when administered at a dose of 1.3 X 10 9 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 pat hogenic
to rats at a dose of 1.1 x 10 9 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 10 9 CFU /animal (U

. S

. EPA, 2014 a ).

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 f rom the registration of the new active ingredient

.

Non

- target Insect and Honey Bee Testing

Non

- target insect testing

– Harmonized Guideline 885.4340; MRID No s

. 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 A NT

- 03 at 1 x 10 6 CFU /m L

. 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 re duced 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 10 6 CFU /m L in a 25

- day dietary toxicity/pathogenicity study. However, t he mean number of eggs consumed per day during Days 0

- 7 in the untreated control group, inactivat ed 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 submit ted additional
information that stated that only test substance and inactive test substance groups included the
surfacta nt (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,B eauveria bassiana strain ANT

- 03 Biopesticides Registration Action Document Page 17 of 31 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

exe rcise 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 he ading “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 ad dition, 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 t hat 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 s ufficient 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 r equired 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 m ay not eliminate it completely.B eauveria bassiana strain ANT

- 03 Biopesticides Registration Action Document Page 18 of 31

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 10 6 CFU /m L

. 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 la ck 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 D aphnia

magna at 1 x 10 6 CFU /m L . Mortality reached 100% in the 1 x 10 6 test substance group ( Beauveria bassiana strain ANT

- 03) by Day 8 and 20% in the 1 x 10 3 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 D aphnia when tested at 1 x 10 6 conidia/mL

. The study describes the EC 50 values for sur vival, reproduction and biomass. However, the significance of these EC 50 values are uncertain, because the study was not designed properly to
calculate a definitive EC 50

. In the daphnia study, two concentrations were tested at 10 3 and 10 6

CFU /m L . Since 100 % mortalit y was observed at the high rate and 20% mortality was observed at the low rate, i t can be concluded that the LC 50 is >10 3 CFU /m L . More testing at concentrations
lower than 10 6 CFU/mL but higher than 10 3 CFU/mL is needed to support the EC 50 values presented in the D aphnia 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 environ mental c oncentration ( EEC ) in
water. T he EEC for water is calculated to be 4.49 x 10 5 CFU /m L ([6 lbs (product/acre) X (454 g/lb) X (1 X 10 10 CFU /g product) X (1 acre/40,468,564 cm 2 )] ÷ 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 x10 3

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 maxi mum 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 10 4 CFU /mL and 4.62 x 10 2 CFU /mL. Since the potential for exposure falls above 10 3 CFU /mL from th e 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 10 4 CFU /mL in the standard wetland and 2.59 x 10 2

CFU /mL in the standard pond. While it cannot be assured that such a spray buffer wouldB eauveria bassiana strain ANT

- 03 Biopesticides Registration Action Document Page 19 of 31 eliminate the potential for adverse effects in all cas es, 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 conditiona lly 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 ANT

03, 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 buffe r 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 i ncrease with the registration of
the new acti ve ingredient, and the uses of the new a.i. on agricultural crop, turf, ornamental and
lands cape, and home and garden use sites is not expected to result in increased exposure to non

target plants.

Beauveria bassiana ANT

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

- 03 Biopesticides Registration Action Document Page 20 of 31 uses (e.g., for terrestrial and food). This strain was s tated 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 waiv er 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 ef fects 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

cann ot 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 orig in, 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

a ffected 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 concer ns 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,B eauveria bassiana strain ANT

- 03 Biopesticides Registration Action Document Page 21 of 31 as a result their location, cultural practices, or other factors, may have atypical, unusually high exposure to B eauveria bassiana strain ANT

- 03 , compared to the general population. The EPA

rece ived 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/complianc e/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 recog nized practice, it will not generally cause unreasonable adverse effects on the environment.

To satisfy criterion one (1), the Beauveria bassiana strain ANT

- 03 pesticide product s have well

known 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 label s , as well as the data and information presented in this document. The EPA
believes that the Beauveria bassiana strain ANT

- 03 , will not ca use 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 REQ UIRED OF THE REGISTRANT

A. Final Printed Labeling

Before releasing the pesticide products containing B eauveria bassiana strain ANT

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

- 03 Biopesticides Registration Action Document Page 22 of 31

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 submiss ion addressing the batch analyse s 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. T his product may be harmful to aquatic organisms . Drift and runoff may be hazardous to aquatic organisms in water adjacent to treated areas. Do no t 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 t he EPA under the provisions of 40 CFR § 158.2140(d).B eauveria bassiana strain ANT

- 03 Biopesticides Registration Action Document Page 23 of 31

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

- May

2013

48974201 Roberts, A. (2013) Product Chemistry for Beauveria bassiana Strain

ANT

- 03 Technical: (Group B). Unp ublished study prepared by Technology Sciences Group, Inc. 228p. 03

- May

2013

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

- May

2013

48974203 Monds, K. (2011) Bioterra (Beauveria bassiana): Acute Oral Toxicity/Pathogenicity Study in Rats: Final Report. Project Number: 14817/11/OCR. Unpublished study p repared by Stillmeadow, Inc. 31p. 03

- May

2013

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

- May

2013

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

- May

2013

489742 06 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

- May

2013

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

- May

2013

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

- May

2013B eauveria bassiana strain ANT

- 03 Biopesticides Registration Action Document Page 24 of 31

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

- May

2013

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

- May

2013

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

- May

2013

48974212 Roberts, A. (2013) Summary of Data on Beauveria bassiana conidia
Field Persistence. Unpublished study prepared by Anatis Bioprotection, Inc. 48p. 03

- May

2013

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

- May

2013

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

- Aug

2014

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

- Aug

2014

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

- May

2013

48974301 Roberts, A. (2013) Product Chemistry for Bioceres. Unpublished study prepared by Technology Sciences Group, Inc. 69p. 03

- May

2013B eauveria 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

- May

2013

C

. Environmental Protection Agency Risk Assessment Memoranda

U.S. EPA. 201 4a. 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 , 201 4

.

U.S. EPA. 201 4b . 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), conta ining the active ingredient Beauveria bassiana strain ANT

03 . Memorandum from I. You to D

. Greenway dated September 19 , 201 4

.

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 (Hemipte ra: Miridae) on canola. Environmental Entomology 35:1569

– 1577.

Centers for Dise ase Control and Prevention. 2015 . Drinking Water

- Water Treatment. Available
from http://w ww.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 Agri

Food Canada.

U.S. EPA. 201 4c . 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 ht tp://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.B eauveria 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 r equirement 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 expla ined.

Beauveria bassiana strain ANT

- 03 Technical contains 100.0% by weigh t Beauveria bassiana strain ANT

- 03, containing not less than 2.2 x 10 10 CFU/g

Bioceres is an end

- use product cont a ining 20% w/w Beauveria bassiana
strain ANT

- 03 and not less than 1 x 10 10 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
A gricultural Research Service Culture Collection (NRRL) under NRRL
50797

885.1500 Certification of Limits Limits are adequate/acceptable.B eauveria 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

. Exp ected 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 a pplicable, 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 a pplicable, per 40 CFR § 158.2120(d ) (4)

830.7300 Density/Relative Density/Bulk Density 0.280 g/cm 3 0.286 g/cm 3B eauveria 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 10 9 CFU/animal 48974203

885.3150 Acute Pulmonary Toxicity/ Pathogenicity

- Rat Not toxic, infective or pathogenic when inhaled at 1. 1 x 10 9 CFU/animal 48974204

885.3200 Acute Intraperitoneal Injection Toxicity/ Pathogenicity

- Rat Not toxic, infective or pathogenic intraperitoneally at 1.4 x 10 9 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 p roduct, 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 48 974213 (TGAI) 48974302 (EP)

870.1200 Acute Dermal Toxicity Dermal NOAEL combined > 5050 mg/Kg bw TOXICITY CATEGORY IV 48974213 (TGAI)

48 974206 (TGAI and EP) 48974302 (EP)

870.1300 Acute Inhalation Toxicity Waived
TOXICITY CATEGORY I II 48 974213 (TGAI) 48974302 (EP)

870.2400 Primary Eye Irritation Waived
TOXICITY CATEGORY III 48 974213 (TGAI) 48974302 (EP)

870.2500 Primary Dermal Irritation Waived
TOXICITY CATEGORY III 48 974213 (TGAI) 48974302 (EP)B eauveria 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 1 0 8 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/pathogenici ty 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 10 6

CFU /m

L . 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 LC 50 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 10 3 CFU /m

L of test medium. 100% mortality was shown when tested at 1 x 10 6 CFU /m

L . An EC 50 could not be determined, but is estimated to be between 10 3 and 10 6 CFU /mL.
Class ification: Supplemental 48974209B eauveria 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 ( Helicove rpa 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 Ins ect 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 wi th 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 test ing 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 10 6 CFU /m

L . Repeated applications over large areas may lead to some exposure of B. bassiana ANT

- 03 in nearby aqua tic

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 48974213B eauveria bassiana strain ANT

- 03 Biopesticides Registration Action Document Page 31 of 31

APPENDIX B. PESTICIDE PRODUCT S

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

89 6 00

- 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