**[\<]{.mark}EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY
NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL
REGISTER (7/1/2006)[\>]{.mark}**

[\<]{.mark}EPA Biopesticides and Pollution Prevention Division contact:
Shanaz Bacchus: (703) 308-8097[\>]{.mark}

[\<]{.mark}**Applicant: AgroGreen, Biological Division of Minrav
Infrastructures (1993) Ltd. ("AgroGreen")[\>]{.mark}**

**[\<]{.mark}**6F7111[\>]{.mark}

[\<]{.mark} EPA has received a pesticide petition (67F111) from
AgroGreen, 3 Habossem str., P.O. Box 153, Ashdod, 77101 Israel
(submitted by RegWest Company, LLC; 30856 Rocky Road; Greeley, CO
80631-9375) 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.[\>]{.mark}

[\<]{.mark} To establish an exemption from the requirement of a
tolerance for[\>]{.mark}

> [\<]{.mark} Microbial pesticide *Bacillus firmus* isolate
> I-1582[\>]{.mark}

[\<]{.mark} Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as
amended, AgroGreen has submitted the following summary of information,
data, and arguments in support of their pesticide petition. This summary
was prepared by AgroGreen 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}

[\<]{.mark}I. AgroGreen Petition Summary[\>]{.mark}

[\<\<]{.mark}6F7111[\>]{.mark}

> [\>]{.mark}

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

Product Name:

[\<]{.mark}Chancellor.

Proposed Use Practices:

Registration of Chancellor is being proposed as a liquid formulation for
the stimulation and protection of plant roots and the suppression of
plant pathogenic nematodes on fruits, vegetables, field crops, turf and
ornamentals. Chancellor suppresses nematode populations. Chancellor is
applied for soil incorporation by drenching, placement in furrow or by
drip irrigation; it is also suitable for application by foliar spray or
fertigation on turf and may be applied with a pressure or hose-end spray
or drenched when treating home lawns and gardens. Application rates:
soil application: from 1 to 12 pints per acre; turf: 1 oz/gal water;
ornamentals: 1 to 6 ounces per gallon water; seed treatment: 1 to 12 oz
per 100 pounds; soil treatment/compost: 8 to 24 oz per 50 pounds;
residential lawn and garden: ½ to 2 oz per gallon of water applied at
the rate of 1 gallon solution per 10 square feet.

[\>]{.mark}

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

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

The active ingredient in Chancellor is *Bacillus firmus* strain I-1582.
*Bacillus firmus* is a Gram-positive, nonpathogenic and harmless
bacterium. *Bacillus firmus* is ubiquitous in nature and may be isolated
from the air, streams, soils, oil wells, oceans and a variety of plant
root surfaces.

A summary of the *Bacillus firmus* strain I-1582 product identity is as
follows:

[Trade Name:]{.underline} Chancellor

[Scientific Name:]{.underline} *Bacillus firmus* strain I-1582

[Morphology:]{.underline} The isolate has been described as having rods
with a length of 3.2 to 5.0 micrometers and a width of 1.0 to 1.3
micrometers. The spores are ellipsoid and there is no swelling of the
sporangium. The maximum temperature for growth is 40° to 45°C and the
minimum temperature is 5° to 10°C. Pigments have been noted for growth
on certain mediums; growth on CASO appears yellow while growth on FP
appears cream-colored. There is no anaerobic growth.

[\<]{.mark} *2. Magnitude of residues at the time of harvest and method
used to determine the residue.[\>]{.mark}*

No residues of *Bacillus firmus* strain I-1582 are anticipated in
treated crops at harvest. OPPTS Guideline 885.2000 states that "If Tier
I toxicology tests indicate no toxic or other harmful properties, then
no residue data (with the general exception of a monitoring method)
would be indicated and thus a recommendation for an exemption from the
requirements of a tolerance can be made." Studies with *Bacillus firmus*
strain I-1582 demonstrate low mammalian toxicity. No pathogenicity or
infectivity was observed in any of the tests conducted with *Bacillus
firmus* strain I-1582. Because it is naturally occurring, pesticide
residues cannot be distinguished from those that exist in the
environment.

[\<]{.mark} *3. A statement of why an analytical method of detecting and
measuring the levels of the pesticide residue are not needed.
[\>]{.mark}*

OPPTS Guideline 885.2000 states that "If Tier I toxicology tests
indicate no toxic or other harmful properties, then no residue data
(with the general exception of a monitoring method) would be indicated
and thus a recommendation for an exemption from the requirements of a
tolerance can be made." Studies with *Bacillus firmus* strain I-1582
demonstrate low mammalian toxicity. No pathogenicity or infectivity was
observed in any of the tests conducted with *Bacillus firmus* strain
I-1582. Further, *Bacillus firmus* strain I-1582 is a
naturally-occurring microorganism and *Bacillus firmus* is widespread in
the environment. Also, because of the low toxicity potential and its
natural occurrence, even if residues occur on treated agricultural
food/feed items, they would not harm U.S. human adult, children and
infant populations.

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

AgroGreen conducted the required toxicology studies to support its
petition for an exemption from the requirement of a tolerance and
associated registration. The studies conducted show low mammalian
toxicity for *Bacillus firmus* strain I-1582. No pathogenicity or
infectivity was observed in any of the tests conducted with *Bacillus
firmus* strain I-1582. *Bacillus firmus* strain I-1582 does not produce
toxins.

Toxicology data in support of the exemption from the requirement of a
tolerance for *Bacillus firmus* strain I-1582 included studies with the
cell mass (technical) and with the formulated product as follows:

Acute Toxicity and/or Pathogenicity

*[Guideline 885.3050: Acute oral toxicity/pathogenicity]{.underline}*
(spores -- tan powder \[technical\]): The acute oral
toxicity/pathogenicity for *B. firmus* spores is greater than 10^8^
CFU/animal (rat). There was no mortality during the study. Total
clearance of the live organism from the blood occurred by Day 7 and
clearance from the remaining test organs occurred by Day 14.

*[Guideline 885.3100: Acute dermal toxicity/pathogenicity]{.underline}*
(formulated product): The estimated LD~50~ was determined to be \> 5050
mg/kg (rabbit). No mortality occurred during the study. There were no
clinical signs of toxicity at any time throughout the study. The gross
necropsy conducted at termination of the study revealed no observable
abnormalities.

*[Guideline 885.3150: Acute pulmonary
toxicology/pathogenicity]{.underline}* (spores -- tan powder
\[technical\]): The test substance produced no toxicity or indications
of pathogenicity when administered by pulmonary instillation to albino
rats at a dose of \> 10^8^ CFU/animal. There was no mortality during the
study. Clearance of the live organism from all tissues analyzed was
complete by Day 14.

*[Guideline 885.3200: Acute injection toxicology/pathogenicity
(I.V)]{.underline}* (spores -- tan powder \[technical\]): The test
substance produced no toxicity or indications of pathogenicity when
administered intravenously to albino rats at a dose of 10^7^ CFU/animal.
There was no mortality during the study. Clearance of the live organism
from all tissues analyzed was complete by Day 21.

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

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

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

*Bacillus firmus* is naturally-occurring and widespread in the
environment. The low toxicity and nonpathogenicity/infectivity of
*Bacillus firmus* strain I-1582 is demonstrated by the data summarized
above. The product will be applied by incorporation into soil and/or by
drenching.

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

It is not anticipated that residues of *Bacillus firmus* strain I-1582
will occur in treated raw agricultural commodities. Also, because of the
low toxicity potential and its natural occurrence, even if residues
occur on treated agricultural food/feed items, they would not harm U.S.
human adult, children and infant populations. The product will be
applied by incorporation into soil and/or by drenching. Because
*Bacillus firmus* strain I-1582 is naturally occurring, pesticide
residues cannot be distinguished from those that exist in the
environment.

[\<]{.mark} *ii. Drinking Water. [\>]{.mark}*

It is not anticipated that residues of *Bacillus firmus* strain I-1582
will occur in drinking water. *Bacillus firmus* strain I-1582 is
ubiquitous in nature and may be isolated from the air, water (seas,
streams, oceans, rivers), soils and a variety of plant root surfaces.
Because *Bacillus firmus* strain I-1582 is naturally occurring in the
environment, pesticide residues in drinking water cannot be
distinguished from those that exist in the environment.

[\<]{.mark} *2. Non-dietary exposure. [\>]{.mark}*

The potential for non-occupational, non-dietary exposure to the general
population is not expected to be significant. *Bacillus firmus* strain
I-1582 is ubiquitous in nature and may be isolated from the air, water
(seas, streams, oceans, rivers), soils and a variety of plant root
surfaces. Because *Bacillus firmus* strain I-1582 is naturally occurring
in the environment, pesticide residues cannot be distinguished from
those that exist in the environment.

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

There is no anticipated potential for cumulative effects of *Bacillus
firmus* strain I-1582 and other substances that have a common mechanism
of toxicity. In the rat acute oral study, total clearance of the live
organism from the blood occurred by Day 7 and clearance from the
remaining test organs by Day 14. The rat acute pulmonary study showed
total clearance of the live organisms from the blood, kidneys and liver
by Day 7 and clearance from the remaining test organs by Day 14. The
acute injection study showed clearance of the live organism from the
cecum contents and liver by Day 14 and clearance from the remaining test
organs by Day 21. Toxic effects produced by *Bacillus firmus* strain
I-1582 should not be cumulative with those of any other chemical
compounds.

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

[\<]{.mark} *1. U.S. population.*

*Bacillus firmus* is a naturally-occurring microorganism which is
widespread and ubiquitous in the environment. The low toxicity of
*Bacillus firmus* strain I-1582 is demonstrated by the data summarized
above. Based on this information, the aggregate exposure to *Bacillus
firmus* strain I-1582 over a lifetime should not pose appreciable risks
to human health. There is a reasonable certainty that no harm will
result from aggregate exposure to *Bacillus firmus* strain I-1582
residues. Exempting *Bacillus firmus* strain I-1582 from the requirement
of a tolerance should be considered safe and pose insignificant risk.

[\>]{.mark}

[\<]{.mark} *2. Infants and children. [\>]{.mark}*

The toxicity and exposure data are sufficiently complete to adequately
address the potential for additional sensitivity of infants and children
to residues of *Bacillus firmus* strain I-1582. There is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to *Bacillus firmus* strain I-1582 residues.

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

No specific tests have been conducted with *Bacillus firmus* strain
I-1582 to determine whether it may have an effect in humans that is
similar to an effect produced by a naturally-occurring estrogen or other
endocrine effects. However, it is not likely that *Bacillus firmus*
strain I-1582 would have estrogen or endocrine effects because:

-   It is a naturally-occurring microorganism which is widespread and
    ubiquitous in the environment.

-   It has demonstrated low mammalian toxicity

-   No pathogenicity, infectivity or systemic effects were observed in
    any of the tests conducted with *Bacillus firmus* strain I-1582
    (except very slight to slight erythema on Day 1 of the acute dermal
    study):

    -   When administered orally to rats the total clearance of the live
        organism from the blood occurred by Day 7 and clearance from the
        remaining test organs occurred by Day 14.

    -   When administered by pulmonary instillation to rats, clearance
        of the live organism from all tissues analyzed was complete by
        Day 14.

    -   When administered intravenously to rats clearance of the live
        organism from all tissues analyzed was complete by Day 21.

-   An exhaustive literature search of the AGRICOLA, TOXLINE, BIOLOGICAL
    ABSTRACTS, Life Sciences 1990-1998, PubMed (indexed for MEDLINE) and
    OCLC databases for all years of available publications was
    conducted. There were no reports of pathogenic or systemic effects.

-   *Bacillus firmus* strain I-1582 does not secrete any toxins or
    antibiotics.

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

The applicant is not aware of any tolerances or exemptions from the
requirement of a tolerance that may have been established or applied for
domestically, other than this petition.

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

The applicant is not aware of any tolerances or exemptions from the
requirement of a tolerance that may have been established or applied for
internationally, other than this petition.