**[\<]{.mark}EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY
NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL
REGISTER (1/1/2007)**[\>]{.mark}

**[\<]{.mark}EPA Biopesticides and Pollution Prevention Division
contact: \[Susanne Cerrelli; (703) 308-8077\][\>]{.mark}**

**[\<]{.mark}*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.[\>]{.mark}**

**[\<]{.mark}*SUBMISSION:* E-mail the completed template to:
duggard.mari@epa.gov.[\>]{.mark}**

**[\<]{.mark}*TEMPLATE:*[\>]{.mark}**

**[\<]{.mark}\[Growth Products Ltd.\][\>]{.mark}**

**[\<]{.mark}\[Insert petition number\][\>]{.mark}**

> [\<]{.mark} 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 **\[*Bacillus
> subtilis* GB03\].**[\>]{.mark}

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.

**[\<]{.mark}I. \[Growth Products Ltd.\] Petition Summary[\>]{.mark}**

> [\<]{.mark} **\[Insert petition number\]**[\>]{.mark}

[\<]{.mark}*A. Product Name and Proposed Use Practices*[\>]{.mark}

**[\<]{.mark}** **\[*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).\]**[\>]{.mark}

[\<]{.mark}*B. Product Identity/Chemistry*[\>]{.mark}

**[\<]{.mark}** 1. *Identity of the pesticide and corresponding
residues.* **\[*Bacillus subtilis* GB03.\][\>]{.mark}**

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

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

**[\<]{.mark}***C. Mammalian Toxicological Profile***[\>]{.mark}**

**[\<]{.mark}** **\[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.**[\>]{.mark}

**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.**\]

**[\<]{.mark}***D. Aggregate Exposure***[\>]{.mark}**

**[\<]{.mark}** 1. *Dietary exposure.* **\[**[\>]{.mark}

[\<]{.mark} 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.**\]**\]**[\>]{.mark}

> [\<]{.mark} 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.**\][\>]{.mark}

[\<]{.mark} 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**.**\]**[\>]{.mark}

[\<]{.mark}*E. Cumulative Effects*[\>]{.mark}

[\<]{.mark} **\[It is not expected that, when used as proposed,
*Bacillus subtilis* GB03would result in residues that are of
toxicological concern. The intended use of *Bacillus subtilis* GB03 is
to application to growing plants and crops for the purposes of disease
control and stimulating plant resistance. *Bacillus subtilis* is widely
distributed around the world, including the U.S. Application of
*Bacillus subtilis* GB03 to seeds, foliage or soil will not result in a
substantial increase in concentration in the environment. The level of
*Bacillus subtilis* GB03 in the environment following application will
decrease to levels similar to naturally occurring concentrations. The
results of toxicity testing indicate there is no risk to human health or
the environment from *Bacillus subtilis* GB03. There are no reports of
ecological or human health hazards caused by *Bacillus subtilis* in
general or the strain *Bacillus subtilis* GB03 in specific. It does not
produce recognized toxins, enzymes, or virulence factors normally
associated with mammalian invasiveness or toxicity. The absence of acute
toxicity or pathogenicity in laboratory animals demonstrates the benign
nature of this strain. The limited survival of *Bacillus subtilis* GB03
and the lack of acute toxicity indicate that both the hazard and the
exposure associated with the use of *Bacillus subtilis* GB03 are
low.**\][\>]{.mark}

[\<]{.mark}*F. Safety Determination*[\>]{.mark}

[\<]{.mark} 1. *U.S. population.* **\[Acute toxicity studies have shown
that *Bacillus subtilis* GB03 is not toxic, pathogenic, infective or
significantly to mammals. The intended use of *Bacillus subtilis* GB03
is to application to growing plants and crops for the purposes of
disease control and stimulating plant resistance. The level of *Bacillus
subtilis* GB03 in the environment following application will decrease to
levels similar to naturally occurring concentrations. The results of
toxicity testing indicate there is no risk to human health or the
environment from *Bacillus subtilis* GB03. There are no reports of
ecological or human health hazards caused by *Bacillus subtilis* in
general or the strain *Bacillus subtilis* GB03 in specific. It does not
produce recognized toxins, enzymes, or virulence factors normally
associated with mammalian invasiveness or toxicity. The absence of acute
toxicity or pathogenicity in laboratory animals demonstrates the benign
nature of this strain. The limited survival of *Bacillus subtilis* GB03
and the lack of acute toxicity indicate that both the hazard and the
exposure associated with the use of *Bacillus subtilis* GB03 are low.
There is a reasonable certainty of no harm to the general US population
from exposure to this active ingredient**.**\]**[\>]{.mark}

[\<]{.mark} 2. *Infants and children*. **\[As mentioned above, it is not
expected that, when used as proposed, *Bacillus subtilis* GB03 would
result in residues that are of toxicological concern. There is a
reasonable certainty of no harm for infants and children from exposure
to *Bacillus subtilis* GB03 from the proposed uses.\]**

**[\>]{.mark}**

**[\<]{.mark}***G. Effects on the Immune and Endocrine
Systems***[\>]{.mark}**

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

**[\<]{.mark}***H. Existing Tolerances***[\>]{.mark}**

[\<]{.mark} **\[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. \[57 FR 29033, June 30, 1992).**\][\>]{.mark}

**[\<]{.mark}***I. International Tolerances***[\>]{.mark}**

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