


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: [Denise Greenway; (703) 308 8263]


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: E-mail the completed template to: hollis.linda@epa.gov.

TEMPLATE:

[Becker Underwood, Inc.]

[8F7368]

	EPA has received a pesticide petition ([8F7368]) from [Becker Underwood, Inc.], [PO Box 667, Ames, IA 50010] 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 MBI 600]

		Pursuant to section 408(d)(2)(A)(i) of  FFDCA, as amended, [Becker Underwood, Inc.] has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by [Becker Underwood, 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. [Becker Underwood, Inc.]  Petition Summary
   
   	[8F7368]

A. Product Name and Proposed Use Practices

	[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 MBI 600 was first isolated from plots of field beans in Nottingham, UK, and this strain was subsequently researched, developed,  and commercialized by Gustafson, LLC (first registered as EPIC Biological Fungicide in 1994). The registration transferred to MicroBio in 1998 and transferred again to Becker Underwood following their acquisition of MicroBio in 2000. Becker Underwood maintains registrations for use of this strain as a seed and in-furrow treatment of agricultural commodities, and has established a tolerance exemption specific for those uses (40 CFR 180.1128). 
Bacillus subtilis MBI 600 colonizes developing root and shoot systems of plants, suppressing by competition, disease organisms such as Botrytis, Fusarium, Rhizoctonia, and Alternaria as well as those organisms causing powdery mildew and anthracnose. As a result of this biological protection, vigorous root and shoot systems are established by treated plants, which often results in more uniform stands and greater yields. In addition, Bacillus subtilis MBI 600 has been shown to increase the amount of nodulation by nitrogen-fixing bacteria when applied as a seed treatment on many legumes. This improvement in nodulation is a result of a healthier root system allowing more sites for nodules to form from inoculated or naturally occurring soil borne nitrogen-fixing bacteria.

Bacillus subtilis MBI 600 is the active ingredient in Becker Underwood's INTEGRAL(R) Liquid and SUBTILEX(R) (dry) Biological Fungicide products. The products can be incorporated into growing media used in contained environments (e.g. greenhouses); or applied to agricultural crops on pre-planted seeds or by in-furrow irrigation.
      
The purpose of this petition is to expand the scope of the existing exemption from the requirement of a tolerance Bacillus subtilis MBI 600 from:
 
      	"...in and on all raw agricultural commodities when applied as a seed treatment on seeds used to grow agricultural crops in accordance with good agricultural practices." 40 CFR 180.1128
       
       to:
       
        "...use in and on all food commodities when applied/used in accordance with label directions."]

B. Product Identity/Chemistry

	1. Identity of the pesticide and corresponding residues. [Bacillus subtilis MBI 600.]

	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 of Bacillus subtilis MBI 600 is not necessary as this petition requests an exemption from the requirement of a tolerance without numerical limitations.]

C. Mammalian Toxicological Profile

	[Toxicological data on the active ingredient were previously accepted by the EPA to support the current exemption from the requirement of a tolerance for residues of Bacillus subtilis MBI 600 when applied as a seed treatment on agricultural commodities, as well as the various registrations originally held by Gustafson LLC, and now held by Becker Underwood. The exemption met the FQPA 1996 safety standard as presented in the Agency's Tolerance Reassessment Decision dated July 18, 2002.
The acute oral toxicity study demonstrated Bacillus subtilis MBI 600 was not pathogenic, infective or toxic in rats when orally does with 2 x 10[8] CFU per animal (Toxicity Category IV). The acute dermal toxicity study found Bacillus subtilis MBI 600 was not toxic for rabbits when a single 5 x 10[10] CFU/animal (2 ml/kg body weight) dose was administered dermally to rabbits (Toxicity Category IV). An acute pulmonary toxicity/pathogenicity study found Bacillus subtilis MBI 600 to be neither toxic, pathogenic, nor infective to rats dosed intratracheally with 3.4 x 10[8] CFU of the test material (Toxicity Category IV). The acute intravenous toxicity/pathogenicity found Bacillus subtilis MBI 600 was not infective, pathogenic or toxic for rats dosed intravenously with approximately 4 x 10[7] CFU of the test material. The primary eye irritation study produced slight irritation when a single 0.1 g ocular dose was administered to rabbits. Ocular irritation dissipated 4 days post dosing (Toxicity Category IV). Finally, a hypersensitivity study noted an overall moderate skin sensitization reaction in guinea pigs 24 to 72 hours after treatment with Bacillus subtilis MBI 600. No irritation was observed in guinea pigs in a second hypersensitivity study conducted with SUBTILEX(R) Biological Fungicide. The product did not elicit a sensitizing reaction in guinea pigs and did not appear to be a dermal sensitizer. 
In conclusion, Bacillus subtilis MBI 600 is not toxic to test animals when administered via the oral, dermal, intravenous or pulmonary routes of exposure.  Nor is it infective or pathogenic to test animals when administered via the oral, pulmonary and intravenous routes. Furthermore, no reports of hypersensitivity have been recorded from personnel working with this organism. Because of the lack of toxicity, pathogenicity, and infectivity, the EPA concluded the product should not pose a risk to wild mammalian species. 
MBI 600 does not produce recognized toxins, enzymes, or virulence factors normally associated with mammalian invasiveness or toxicity. Non-dietary exposures would not be expected to pose any quantifiable risk due to a lack of residues of toxicological concern. In summary, the risk to human health or the environment from Bacillus subtilis MBI 600 is minimal to none.]

D. Aggregate Exposure

	1. Dietary exposure. []

	i. Food. [The proposed use pattern may result in dietary exposure with possible residues in or on agricultural commodities. However, little to no risk is expected  for the general population, including infants and children, or animals because of the lack of demonstrated toxicity/pathogenicity of Bacillus subtilis MBI 600. Furthermore, Bacillus subtilis is used in the production of fermented foods and commonly consumed by humans with no adverse health effects. Additionally, Bacillus subtilis is commonly used on a large, industrial scale basis to produce food grade products.
	Acute dietary assessments were conducted on October 10, 1993 in a Science Advisory Board (SAB) review for the registration of a Bacillus subtilis MBI 600 concentrate product. No toxicological end points of concern were identified. There are no dietary risks that exceed the Agency's Level of Concern (LOC).]

      	ii. Drinking water. [The potential for transfer of Bacillus subtilis MBI 600 to surface or ground water during run-off associated with intended use applications is considered minimal to non-existent, due to its percolation through, and resulting capture in soil. Accordingly, the use of this microbial pest control agent on terrestrial plants is not anticipated to negatively impact the quality of drinking water.]

2. Non-dietary exposure. [The potential for dermal exposure to pesticide residues of Bacillus subtilis MBI 600 for the general population, including infants and children, is unlikely as the use sites are limited to agricultural and horticultural applications. In addition, as the microbe is a ubiquitous, naturally occurring soil bacterium, it is likely many individuals have had prior exposure. Accordingly, any potential increase in dermal exposure due to pesticidal use of Bacillus subtilis MBI 600 would be inconsequential. Furthermore, as summarized previously, MBI 600 is of low dermal toxicity - Toxicity Category IV. 

Similarly, the inhalation exposure to pesticide residues of Bacillus subtilis MBI 600 for the general population, including infants and children is unlikely because potential use sites are agricultural and horticultural. Also, as stated before, the microbe is a ubiquitous, naturally occurring soil bacterium, and it is likely many individuals have had prior exposure. The acute pulmonary toxicity/pathogenicity testing of Bacillus subtilis MBI 600 demonstrated it is neither toxic, pathogenic nor infective - Toxicity Category IV Therefore, any potential increase in inhalation exposure due to pesticidal use of Bacillus subtilis MBI 600 would be inconsequential. 
The results of toxicity testing indicate there is no risk to human health or the environment from Bacillus subtilis MBI 600. It is not toxic to test animals when administered via the oral, dermal, intravenous or pulmonary routes of exposure.  Nor is it infective or pathogenic to test animals when administered via the oral, pulmonary and intravenous routes.  In addition, no reports of hypersensitivity have been recorded from personnel working with this organism. 
MBI 600 does not produce recognized toxins, enzymes, or virulence factors normally associated with mammalian invasiveness or toxicity.  The limited survival of MBI 600 and the lack of acute toxicity indicate that both the hazard and the exposure associated with the use of MBI 600 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

	[Bacillus subtilis MBI 600 is non-toxic to mammals. Because no mechanism of pathogenicity or toxicity in mammals has been identified for this organism, no cumulative effects from the interaction of residues of this product with other related microbial pesticides are anticipated when this product is used as directed on the label and in accordance with good agricultural/horticultural practices.
It is not expected that, when used as directed, Bacillus subtilis MBI 600 would result in residues that are of toxicological concern. The intended use of Bacillus subtilis MBI 600 is to apply it to growing media, seeds, and growing plants and crops for the purposes of disease control.  Bacillus subtilis is widely distributed in the US and around the world.  Application of Bacillus subtilis MBI 600 to seeds, foliage or soil will not result in any significant increases in overall concentrations of Bacillus subtilis in the environment.  
The results of toxicity testing indicate there is no risk to human health or the environment from Bacillus subtilis MBI 600. There are no reports of ecological or human health hazards caused by Bacillus subtilis in general or the strain Bacillus subtilis MBI 600 in specific. MBI 600 does not produce significant quantities of extracellular enzymes or possess other virulence factors that would predispose it to cause infection. The absence of acute toxicity or pathogenicity in laboratory animals demonstrates the benign nature of this strain.]

F. Safety Determination

	1. U.S. population. [There is reasonable certainty that no harm to the US population, including infants and children, will result from aggregate exposure to residues of Bacillus subtilis MBI 600 from its use as a microbial pest control agent. The results of toxicity testing indicate there is no risk to human health or the environment from Bacillus subtilis MBI 600. It is not toxic to test animals when administered via the oral, dermal, intravenous or pulmonary routes of exposure.  Nor is it infective or pathogenic to test animals when administered via the oral, pulmonary and intravenous routes. Bacillus subtilis MBI 600 does not produce recognized toxins, enzymes, or virulence factors normally associated with mammalian invasiveness or toxicity. In addition, no reports of hypersensitivity have been recorded from personnel working with this organism.]

	2. Infants and children. [For the same reasons stated previously, there is reasonable certainty that no harm to infants and children will result from aggregate exposure to residues of Bacillus subtilis MBI 600 from its use as a microbial pest control agent.]

G. Effects on the Immune and Endocrine Systems

	[There is no evidence to date suggesting Bacillus subtilis MBI 600 functions in a manner similar to any known hormone, or that it acts as an endocrine disrupter.]

H. Existing Tolerances

      [40 CFR 180.1128 Bacillus subtilis MBI 600; exemption from the requirement of a tolerance. 

The biofungicide, Bacillus subtilis  MBI 600 is exempted from the requirement of a tolerance in and on all raw agricultural commodities when applied as a seed treatment on seeds used to grow agricultural crops in accordance with good agricultural practices."]

I. International Tolerances

	[A Codex Alimentarium Commission Maximum Residue Level (MRL) is not required for Bacillus subtilis MBI 600.]





