Document ID: EPA-HQ-OPP-2013-0717-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2013-12-30T05:00Z

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EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY NOTICE OF
FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER  

EPA Biopesticides and Pollution Prevention Division contact: [Kimberly
Nesci; (703) 308-8059]

INSTRUCTIONS:  Please utilize this outline in preparing the pesticide
petition.  In cases where the outline element does not apply, please
insert “NA-Remove” and maintain the outline. Please do not change
the margins, font, or format in your pesticide petition. Simply replace
the instructions that appear in green, i.e., “[insert company
name],” with the information specific to your action.

SUBMISSION: 

TEMPLATE:

[Anatis Bioprotection Inc.]

[PP 3F8176]

	EPA has received a pesticide petition ([PP 3F8176]) from [Anatis
Bioprotection Inc. (EPA Company No. 89600)], [278, rang Saint-André,
St-Jacques-le-Mineur, Quebec J0J 1Z0, Canada] requesting, pursuant to
section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a(d), to amend 40 CFR part 180 to establish an exemption from
the requirement of a tolerance for microbial pesticide  [Beauveria
bassiana strain ANT-03].

	

Pursuant to section 408(d)(2)(A)(i) of  FFDCA, as amended, [Anatis
Bioprotection Inc.] has submitted the following summary of information,
data, and arguments in support of their pesticide petition. This summary
was prepared by [Anatis Bioprotection Inc.] and EPA has not fully
evaluated the merits of the pesticide petition. The summary may have
been edited by EPA if the terminology used was unclear, the summary
contained extraneous material, or the summary unintentionally made the
reader conclude that the findings reflected EPA’s position and not the
position of the petitioner.

I. [Anatis Bioprotection Inc.] Petition Summary

	[PP 3F8176]

A. Product Name and Proposed Use Practices

	[Beauveria bassiana strain ANT-03 Technical, a Technical Grade Active
Ingredient (TGAI) is proposed for manufacturing use only, for further
formulation into registered end-use products.

	Bioceres is a biological insecticide containing the active ingredient
Beauveria bassiana strain ANT-03 for use on growing crops to control
insect pests. Bioceres acts as a contact biological insecticide for use
in the control or suppression of many foliar-feeding pests, including
aphids, whiteflies, thrips, plant bugs, beetles and weevils infesting
labeled crops or use sites. Bioceres must be mixed with water and
applied as a foliar spray with ground or aerial equipment equipped for
conventional insecticide spraying, or by chemigation, in field,
greenhouse, turf and ornamental or home and garden use sites.]

B. Product Identity/Chemistry

	1. Identity of the pesticide and corresponding residues. [Beauveria
bassiana strain ANT-03 (CAS No. Not applicable).

	

	Information regarding the name, identity and composition has been
submitted to EPA and can be found in MRID Nos. 489472-01 and 489472-02. 

		

	Beauveria bassiana is a ubiquitous entomopathogenic fungus that has
been found in environments around the world.  There is a significant
body of published literature on this microbial pest control agent (MPCA)
with regards to its identification, occurrence, life cycle, pest host
range, mode of action, persistence, efficaciousness, and safety to
mammals and nontarget organisms.  Relevant literature is summarized or
referenced in MRID Nos. 489472-01, 489472-12 and 489472-13.  Beauveria
bassiana strain ANT-03 spores attach to the surface of the target insect
pest, germinate, penetrate the exoskeleton and grow rapidly resulting in
death of the insect host (MRID No. 489472-01).]

	2. Magnitude of residues at the time of harvest and method used to
determine the residue. [An analytical method for residues is not
applicable.  It is expected that, when used as proposed, Beauveria
bassiana strain ANT-03, would not result in residues that are of
toxicological concern.]

	3. A statement of why an analytical method of detecting and measuring
the levels of the pesticide residue are not needed. [NA-Remove]

C. Mammalian Toxicological Profile

	[Studies to evaluate the safety to mammals were conducted on the
technical grade active ingredient (TGAI) and are summarized as follows:

Acute Oral Toxicity/Pathogenicity Study in Rats (OCSPP 885.3050): 
Beauveria bassiana strain ANT-03 Technical (the Microbial Pest Control
Agent or MPCA) was tested in a single high dose exposure in an acute
oral toxicity/pathogenicity study in rats, and there were no signs of
toxicity or infectivity from exposure to test material (MRID No.
489742-03).  There was no mortality during the study and all animals
appeared normal during the duration of the study.  No observable
abnormalities were reported at necropsy.

	The MPCA test substance and inactivated MPCA test substance was
administered to rats by gavage in a single high dose. The animals were
observed frequently on the day of dosing (Day 0) for mortality and signs
of pharmacologic and/or toxicologic effects and once daily thereafter
for 21 days. A control group (untreated) was conducted concurrently. The
test organism had cleared completely from the Group IV blood, lungs,
liver, kidneys, mesenteric lymph nodes and cecum contents by Day 14 and
had cleared completely from the brain and spleen by Day 21. After two
consecutive interim sacrifices showed no growth of test organism in the
organs plated, no further tissue samples were taken. The test substance
was determined to be non-toxic to rats when administered by oral gavage
in a single dose of 1.3 x 109 CFU/rat.

Acute Pulmonary Toxicity/Pathogenicity Study in Rats (OCSPP 885.3150): 
Beauveria bassiana strain ANT-03 Technical (the Microbial Pest Control
Agent or MPCA) was tested in a single high dose exposure in an acute
pulmonary toxicity/pathogenicity study in rats, and there were no signs
of toxicity or infectivity from exposure to test material (MRID No.
489742-04).  There was no mortality during the study and all animals
appeared normal during the duration of the study.  No observable
abnormalities were reported at necropsy.

The MPCA test substance and inactivated MPCA test substance was
administered to rats by tracheal gavage in a single high dose. The
animals were observed frequently on the day of dosing (Day 0) for
mortality and signs of pharmacologic and/or toxicologic effects and once
daily thereafter for 21 days. A control group (untreated) was conducted
concurrently. The test organism was not seen at any time from the Group
IV - MPCA blood, kidneys, mesenteric lymph nodes, brain, liver, spleen
and cecum contents. Except for the Day 0 sacrifice, the test substance
was not seen in the lungs at any time. After two consecutive interim
sacrifices showed no growth of the test substance in the organs plated,
no further tissue samples were taken. The test substance was determined
to be non-toxic to rats when administered by tracheal gavage in a single
dose of 1.1 x 109 CFU/rat.

Acute IP Toxicity/Pathogenicity Study in Rats (OCSPP 885.320):  In the
IP study, the MPCA test substance and inactivated MPCA test substance
were administered to rats by intraperitonial injection in a single high
dose (MRID No. 489742-05).  The animals were observed frequently on day
of dosing for mortality and signs of pharmacologic and/or toxicologic
effects and once daily thereafter for 21 days. Control groups (untreated
and inactive) were conducted concurrently. A gross necropsy of all
animals was performed and recorded. There were no mortalities and no
abnormal general health findings. The test substance  was determined to
be non-toxic to rats when administered by IP injection at a single dose
of 1.4 x 109 CFU/rat.

Acute Dermal Toxicity (OCSPP 870.1200): Beauveria bassiana strain ANT-03
Technical (the Microbial Pest Control Agent or MPCA) was tested in a
single high dose exposure in an acute dermal toxicity study in rats, and
there were no signs of toxicity or dermal irritation from exposure to
test material (MRID No. 489742-06).  The MPCA test substance was
evaluated for its dermal toxicity potential and relative skin irritancy
when a single dose moistened with 1.0 mL of deionized (DI) water/g test
substance, at a level of 5050 mg/kg, was applied to the intact skin of
albino rats. No mortality occurred. There were no clinical signs of
toxicity or signs of dermal irritation at any time throughout the study.
Animals exhibited weekly weight gain during the study. The gross
necropsy conducted at termination of the study revealed no observable
abnormalities. The estimated LD50, as indicated by the data, was
determined to be greater than 5050 mg/kg.

5.	Hypersensitivity Incidents (OCSPP 885.3400):   The registrant has
noted that no incidents of hypersensitivity or any other adverse effects
have occurred through the research, development or testing of the active
ingredient and its related end-use product.  Should any incidents occur,
they will be reported per FIFRA Section 6(a)(2).

Rationales for no further testing have been submitted for acute oral
toxicity (limit), acute inhalation toxicity (limit), primary eye
irritation and primary dermal irritation data requirements on Beauveria
bassiana strain ANT-03 Technical (MRID No. 489742-13).  Rationales are
based on discussions of existing data and, in the case of the primary
eye irritation requirement, mitigating label language.

Data has been generated and submitted to demonstrate that Beauveria
bassiana strain ANT-03 does not produce unintentional ingredients such
as toxic metabolites (beauvericin) or microbial contaminants (MRID Nos.
489742-01 and 489742-02). 

In conclusion, the results of toxicity testing show there is no risk to
human health from the active ingredient.  Beauveria bassiana strain
ANT-03 is not toxic, pathogenic, infective or irritating to mammals.]

D. Aggregate Exposure

	1. Dietary exposure. 

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

	The results of toxicity testing indicate there is no risk to human
health or the environment from Beauveria bassiana strain ANT-03.
Beauveria bassiana strain ANT-03 does not produce recognized toxins,
enzymes, or virulence factors normally associated with mammalian
invasiveness or toxicity.  The absence of acute toxicity or
pathogenicity in laboratory animals demonstrates the benign nature of
this strain.]

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

	

	The results of toxicity testing indicate there is no risk to human
health or the environment from Beauveria bassiana strain ANT-03.
Beauveria bassiana strain ANT-03 does not produce recognized toxins,
enzymes, or virulence factors normally associated with mammalian
invasiveness or toxicity.  The absence of acute toxicity or
pathogenicity in laboratory animals demonstrates the benign nature of
this strain.]

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

	The results of toxicity testing indicate there is no risk to human
health or the environment from Beauveria bassiana strain ANT-03.
Beauveria bassiana strain ANT-03 does not produce recognized toxins,
enzymes, or virulence factors normally associated with mammalian
invasiveness or toxicity.  The absence of acute toxicity or
pathogenicity in laboratory animals demonstrates the benign nature of
this strain.  Non-dietary exposures would not be expected to pose any
quantifiable risk due to a lack of residues of toxicological concern.]

E. Cumulative Effects

	[It is not expected that, when used as proposed, Beauveria bassiana
strain ANT-03 would result in residues that are of toxicological
concern. The intended use of Beauveria bassiana strain ANT-03 is as a
biological insecticide to growing plants in agricultural, greenhouse,
turf and ornamental and home and garden use sites.  Data in published
literature demonstrate that Beauveria bassiana does not persist in the
environment following application.  Environmental conditions such as
UV-radiation, air temperature and rainfall are factors that lead to a
short life in field conditions.  The results of toxicity testing
indicate there is no risk to human health or the environment from
Beauveria bassiana strain ANT-03. Beauveria bassiana strain ANT-03 does
not produce recognized toxins, enzymes, or virulence factors normally
associated with mammalian invasiveness or toxicity.  The absence of
acute toxicity or pathogenicity in laboratory animals demonstrates the
benign nature of this strain.]

F. Safety Determination

	1. U.S. population. [Acute toxicity studies have shown that Beauveria
bassiana strain ANT-03 is not toxic, pathogenic, infective or irritating
to mammals.  The intended use of Beauveria bassiana strain ANT-03 is as
a biological insecticide to growing plants in agricultural, greenhouse,
turf and ornamental and home and garden use sites.  Data in published
literature demonstrate that Beauveria bassiana does not persist in the
environment following application.  Environmental conditions such as
UV-radiation, air temperature and rainfall are factors that lead to a
short life in field conditions.  The results of toxicity testing
indicate there is no risk to human health or the environment from
Beauveria bassiana strain ANT-03. Beauveria bassiana strain ANT-03 does
not produce recognized toxins, enzymes, or virulence factors normally
associated with mammalian invasiveness or toxicity.  The absence of
acute toxicity or pathogenicity in laboratory animals demonstrates the
benign nature of this strain.  There is a reasonable certainty of no
harm to the general US population from exposure to this active
ingredient.]

	2. Infants and children. [As mentioned above, it is not expected that,
when used as proposed, Beauveria bassiana strain ANT-03 would result in
residues that are of toxicological concern. There is a reasonable
certainty of no harm for infants and children from exposure to Beauveria
bassiana strain ANT-03 from the proposed uses.]

G. Effects on the Immune and Endocrine Systems

	[To date there is no evidence to suggest that Beauveria bassiana strain
ANT-03 functions in a manner similar to any known hormone, or that it
acts as an endocrine disrupter.]

H. Existing Tolerances

	[There is no US EPA tolerance or tolerance exemption for Beauveria
bassiana strain ANT-03.]

I. International Tolerances

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

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