Document ID: EPA-HQ-OPP-2007-1020-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-11-02T04:00Z

<EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY NOTICE OF
FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER 
(1/1/2007)>

<EPA Biopesticides and Pollution Prevention Division contact: [Susanne
Cerrelli; (703) 308-8077]>

 

<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 and brackets, i.e., “[insert
company name],” with the information specific to your action.>

<SUBMISSION: E-mail the completed template to: duggard.mari@epa.gov.>

<TEMPLATE:>

<[Growth Products Ltd.]>

<[Insert petition number]>

<	EPA has received a pesticide petition ([insert petition number]) from
[Growth Products Ltd.], [ PO Box 1259, White Plains, NY 10602]
proposing, 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 amendment/expansion of an existing tolerance exemption for
the microbial pesticide  [Bacillus subtilis GB03].>

		Pursuant to section 408(d)(2)(A)(i) of  FFDCA, as amended, [Growth
Products Ltd.] has submitted the following summary of information, data,
and arguments in support of their pesticide petition. This summary was
prepared by [insert Growth Products Ltd.] 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. [Growth Products Ltd.]  Petition Summary>

<	[Insert petition number]>

<A. Product Name and Proposed Use Practices>

<	[Bacillus subtilis  GB03.  Bacillus subtilis is a naturally occurring
soil saprophyte that is found in soils worldwide.  Strains of this
organism are generally not regarded as human or animal pathogens. 
Bacillus subtilis GB03 was first isolated from plots of cotton grown in
McKinney, Texas, and this strain was subsequently researched, developed
and commercialized by Gustafson, LLC (first registration in 1991). 
Gustafson LLC, now part of Bayer CropScience, maintains registrations of
end-use products containing this strain for application as a seed
treatment of agricultural commodities, and has established a tolerance
exemption specific to that use (40 CFR 180.1111).  Growth Products Ltd.
maintains registrations of end-use products containing this strain for
application as a biofungicide in greenhouses and nurseries.  

Bacillus subtilis GB03 colonizes the developing root system of plants,
and suppresses and controls root diseases by competition.  Bacillus
subtilis GB03 has been shown to increase root mass and plant health on
many agricultural commodities.  The end-use product Companion( Liquid
Biological Fungicide (Growth Products Ltd.) is for the stimulation of
plant growth, the enhancement of plant strength and the prevention of
fungal attack.  Companion( Liquid Biological Fungicide mobilizes plant
defense mechanisms, increasing plant resistance to pathogenic fungal
attack on roots and foliage, increasing rate of growth and increasing
overall crop strength and yield.  Companion( Liquid Biological Fungicide
can be applied as a seed dressing, pre-plant soak, overhead spray or
soil drench, or irrigation application to agricultural crops, ornamental
plants and turf grasses.

The purpose of this petition is the amend the existing tolerance
exemption at 40 CFR 180.1111 to cover use in and on all agricultural
commodities (to remove the specification of use in and on all raw
agricultural commodities when applied as a seed treatment).]>

<B. Product Identity/Chemistry>

<	1. Identity of the pesticide and corresponding residues. [Bacillus
subtilis  GB03.]>

<	2. Magnitude of residues at the time of harvest and method used to
determine the residue. [Not applicable.]>

<	3. A statement of why an analytical method of detecting and measuring
the levels of the pesticide residue are not needed. [An analytical
method for residues is not applicable. Residues of Bacillus subtilis
GB03 are not expected on agricultural commodities.]>

<C. Mammalian Toxicological Profile>

<	[Toxicological data on the active ingredient has been previously
accepted to support the current exemption from the requirement of a
tolerance for residues (for seed treatment of agricultural commodities)
and various registrations by the manufacturer Bayer CropScience
(formerly Gustafson LLC).  Studies on the active ingredient include an
acute oral toxicity/pathogenicity study in the rat, an acute dermal
toxicity study in the rabbit, an acute pulmonary toxicity/pathogenicity
study in the rat, an acute intravenous toxicity/pathogenicity study in
the rat and a primary eye irritation study in the rabbit.  EPA review of
these studies indicated that the active ingredient was not toxic to test
animals when administered via the oral, dermal, intravenous or pulmonary
routes of exposure.  The active ingredient was not infective or
pathogenic to test animals when administered via the oral, pulmonary and
intravenous routes.  No reports of hypersensitivity have been recorded
from personnel working with this organism.>  

Toxicological data on the end-use product Companion( Liquid Biological
Fungicide has been previously accepted to support a registration for
non-food greenhouse use.  An acute oral toxicity study showed no
toxicity at a dose of 5,000 mg/kg  in rats (Toxicity Category IV), a
primary eye irritation study showed mild irritation at a dose of 0.1 mL
in rabbits (Toxicity Category IV), and a primary dermal irritation study
showed moderate dermal irritation at a dose of 0.5 mL in rabbits
(Toxicity Category III).  

The results of toxicity testing indicate there is no risk to human
health or the environment from Bacillus subtilis GB03. There are no
reports of ecological or human health hazards caused by Bacillus
subtilis in general or the strain Bacillus subtilis GB03 in specific. It
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. The limited survival of
Bacillus subtilis GB03 and the lack of acute toxicity indicate that both
the hazard and the exposure associated with the use of Bacillus subtilis
GB03 are low.  Non-dietary exposures would not be expected to pose any
quantifiable risk due to a lack of residues of toxicological concern.]

<D. Aggregate Exposure>

<	1. Dietary exposure. [>

<	i. Food. [Dietary exposure from use of Bacillus subtilis GB03, as
proposed, is minimal.  The intended use of Bacillus subtilis GB03 is to
application to growing plants and crops for the purposes of disease
control and stimulating plant resistance.  Bacillus subtilis is widely
distributed around the world, including the U.S.  Application of
Bacillus subtilis GB03 to seeds, foliage or soil will not result in a
substantial increase in concentration in the environment.  

	The results of toxicity testing indicate there is no risk to human
health or the environment from Bacillus subtilis GB03. There are no
reports of ecological or human health hazards caused by Bacillus
subtilis in general or the strain Bacillus subtilis GB03 in specific. It
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
Bacillus subtilis GB03in consumed drinking water would be unlikely. 
Bacillus subtilis is not known to grow or thrive in aquatic
environments.  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 Bacillus subtilis GB03 is to
treatment of growing plants and crops for the purposes of disease
control.  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 Bacillus subtilis GB03. There are no
reports of ecological or human health hazards caused by Bacillus
subtilis in general or the strain Bacillus subtilis GB03 in specific. It
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 application to growing plants or crops.  

	The results of toxicity testing indicate there is no risk to human
health or the environment from Bacillus subtilis GB03. There are no
reports of ecological or human health hazards caused by Bacillus
subtilis in general or the strain Bacillus subtilis GB03in specific. It
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. The limited survival of
Bacillus subtilis GB03and the lack of acute toxicity indicate that both
the hazard and the exposure associated with the use of Bacillus subtilis
GB03 are low.  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, Bacillus subtilis
GB03would result in residues that are of toxicological concern. The
intended use of Bacillus subtilis GB03 is to application to growing
plants and crops for the purposes of disease control and stimulating
plant resistance.  Bacillus subtilis is widely distributed around the
world, including the U.S.  Application of Bacillus subtilis GB03 to
seeds, foliage or soil will not result in a substantial increase in
concentration in the environment.  The level of Bacillus subtilis GB03
in the environment following application will decrease to levels similar
to naturally occurring concentrations.  The results of toxicity testing
indicate there is no risk to human health or the environment from
Bacillus subtilis GB03. There are no reports of ecological or human
health hazards caused by Bacillus subtilis  in general or the strain
Bacillus subtilis GB03 in specific. It 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. The limited survival of Bacillus subtilis GB03 and the lack
of acute toxicity indicate that both the hazard and the exposure
associated with the use of Bacillus subtilis GB03 are low.]>

<F. Safety Determination>

<	1. U.S. population. [Acute toxicity studies have shown that Bacillus
subtilis GB03 is not toxic, pathogenic, infective or significantly to
mammals.  The intended use of Bacillus subtilis GB03 is to application
to growing plants and crops for the purposes of disease control and
stimulating plant resistance.  The level of Bacillus subtilis GB03 in
the environment following application will decrease to levels similar to
naturally occurring concentrations.  The results of toxicity testing
indicate there is no risk to human health or the environment from
Bacillus subtilis GB03. There are no reports of ecological or human
health hazards caused by Bacillus subtilis in general or the strain
Bacillus subtilis GB03 in specific. It 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. The limited survival of Bacillus subtilis GB03 and the lack
of acute toxicity indicate that both the hazard and the exposure
associated with the use of Bacillus subtilis GB03 are low.  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, Bacillus subtilis GB03 would result in residues
that are of toxicological concern. There is a reasonable certainty of no
harm for infants and children from exposure to Bacillus subtilis GB03
from the proposed uses.]

>

<G. Effects on the Immune and Endocrine Systems>

<	[To date there is no evidence to suggest that Bacillus subtilis GB03
functions in a manner similar to any known hormone, or that it acts as
an endocrine disrupter.]>

<H. Existing Tolerances>

<	[40 CFR 180.1111.  Bacillus subtilis GB03; exemption from the
requirement of a  tolerance.  The biofungicide Bacillus subtilis GB03 is
exempted from the requirement of a tolerance in or on all raw
agricultural commodities when applied as a seed treatment for growing
agricultural crops in accordance with good agricultural practice.  [57
FR 29033, June 30, 1992).]>

<I. International Tolerances>

<	[A Codex Alimentarium Commission Maximum Residue Level (MRL) is not
required for Bacillus subtilis GB03.]>

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