Document ID: EPA-HQ-OPP-2007-0159-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-04-13T04:00Z

<EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY NOTICE OF
FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER
(7/1/2006)>

<EPA Biopesticides and Pollution Prevention Division contact: Shanaz
Bacchus: (703) 308-8097>

<Applicant: AgroGreen, Biological Division of Minrav Infrastructures
(1993) Ltd. (“AgroGreen”)>

<6F7111>

<	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.>

<	To establish an exemption from the requirement of a tolerance for>

<	Microbial pesticide Bacillus firmus isolate I-1582>

<	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.>

<I. AgroGreen Petition Summary>

<<6F7111>

>

<A. Product Name and Proposed Use Practices>

Product Name:

<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.

>

<B. Product Identity/Chemistry>

<	1. Identity of the pesticide and corresponding residues. >

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: Chancellor

Scientific Name: Bacillus firmus strain I-1582

Morphology: 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.

<	2. Magnitude of residues at the time of harvest and method used to
determine the residue.>

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.

<	3. A statement of why an analytical method of detecting and measuring
the levels of the pesticide residue are not needed. >

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.

<C. Mammalian Toxicological Profile>

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 (spores – tan
powder [technical]): The acute oral toxicity/pathogenicity for B. firmus
spores is greater than 108 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 (formulated
product): The estimated LD50 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 (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 > 108 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)
(spores – tan powder [technical]): The test substance produced no
toxicity or indications of pathogenicity when administered intravenously
to albino rats at a dose of 107 CFU/animal. There was no mortality
during the study. Clearance of the live organism from all tissues
analyzed was complete by Day 21.

<>

<D. Aggregate Exposure>

<	1. Dietary exposure.>

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.

<	i. Food. >

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.

<	ii. Drinking Water. >

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.

<	2. Non-dietary exposure. >

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.

<E. Cumulative Effects>

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.

<F. Safety Determination>

<	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.

>

<	2. Infants and children. >

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.

<G. Effects on the Immune and Endocrine Systems>

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.

<H. Existing Tolerances>

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.  

<I. International Tolerances>

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.  

AgroGreen submission by RegWest Co. LLC                                 
              EPA Reg. No.82608-R 

EPA-HQ-OPP-2007-0159                Bacillus firmus I-1582   PP 6F7111  
    March 2007

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