Document ID: EPA-HQ-OPP-2005-0303-0010
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-06-18T04:00Z

<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: >

Susanne Cerrelli, Regulatory Action Leader, Microbial Pesticides Branch

Biopesticides Pollution Prevention Division (7511P), 703-308-8077(w),

Cerrelli.Susanne@epamail.epa.gov

 

<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:>

<Montana Microbial Products>

<8G7320.>

<	EPA has received a pesticide petition 8G7320 from Montana Microbial
Products, 510 East Kent Ave., Missoula MT USA 59801 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.>

<(Options (pick one)>

<	3. to establish an amendment expansion of an existing temporary
tolerance exemption for the>

	

<(Options (pick one)>

	1. the microbial pest control agent  Bacillus mycoides, isolate J when
used as a fungicide on pecans, potatoes, sugar beets, tomatoes, and
peppers.

	

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

	[8G7320]

<A. Product Name and Proposed Use Practices>

<Product Name: Bacillus mycoides isolate J.  End product formulation:
BmJ WP. 

This petition requests a temporary exemption from residue tolerances for
a  three year experimental program of evaluating BmJ WP as a microbial
disease control agent in pecans, potatoes, sugar beets tomatoes and
peppers.

>

<B. Product Identity/Chemistry>

<	1. Identity of the pesticide and corresponding residues. 

>

Name: 

Bacillus mycoides isolate J.  The end product formulation, BmJ WP, is a
wettable powder containing spores as the active ingredient.  Residue
from application will be spores.

The “J” strain of B, mycoides was isolated from sugar beets in
Montana USA and identified as B mycoides by morphology and DNA sequence
analysis. B. Mycoides is a ubiquitous soil organism.  B. mycoides is one
of the six species of bacilli that comprise the B. cereus group; the
others are B. cereus, B. anthracis, B. thuringiensis, B. pseudomycoides,
and B. weihenstephanensis.  DNA sequence matching techniques clearly
differentiate between species in the B. cereus group and clearly
distinguish B. mycoides as a separate species, genetically distinct from
the other species in the group.  The study submitted (MRID 46632905) in
the supporting data for the EUP submission, “Use of RAPD Analysis to
Uniquely Identify Bacillus mycoides isolates”, clearly identifies the
J isolate as B. mycoides and distinguishes the “J” isolate from
other isolates in the B. mycoides species.

<	2. Magnitude of residues at the time of harvest and method used to
determine the residue.  MMP does not expect a significant level
magnitude of BmJ spores to persist in treated foliage.  Persistence
studies of applied BmJ spores show a rapid decline in spore recovery
from treated sugar beet foliage over a two-week period.  Samples taken
immediately after spray application of BmJ showed 106 spores per square
centimeter of sugar beet leaf surface.  Samples taken at 14 days after
application showed spores levels had declined to between 100 and 1000
spores per square centimeter of leaf surface. Given the ubiquitous
natural occurrence of B. mycoides in soil the application of BmJ in the
experimental program would have little effect on the total level of
naturally occurring B. mycoides.

Analytical methods to determine residues of BmJ spores use dilution
plating on selective agar with B. mycoides distinguished by its
distinctive colony morphology. 

>

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

BmJ spores and vegetative growth would not be expected to carry through
to human consumption in shelling of pecans, harvest of potato tubers or
as as residue in refined sugar or in meat or milk from cattle fed BmJ
treated sugar beet tops. Water washing would also remove spores from
tomatoes and peppers

harvested from treated crops. 

>

<C. Mammalian Toxicological Profile>

<An acute pulmonary toxicity pathogenicity study (MRID 44644801) showed
no adverse effects from acute intratracheal exposure to BmJ spores. 
Inhalation of spore containing spray mist represents the most likely
route of human exposure to BmJ spores during the experimental program. 
B. mycoides occurs naturally and ubiquitously in agricultural soils, so
that there has been long term human exposure to B. mycoides and to any
residual B. mycoides cells or spores in food crops.   Studies submitted
and comprehensive searches of research and medical literature did not
identify: any reference to toxicity or pathogenicity of B. mycoides in
mammals; did not identify any known metabolites of toxicological
significance from B. mycoides fermentation; and did not identify
references to B. mycoides as producing toxins in food stuffs or
implicated in food borne toxicity.

  >

<D. Aggregate Exposure>

<	1. Dietary exposure. MMP does not expect human dietary exposure to BmJ
spores to result from the experimental program. 

 >

<	i. Food. The experimental program will include five crops, pecans,
potatoes, sugar beets, tomatoes and peppers.  MMP does not see dietary
exposure resulting from application of BmJ in the experimental program. 

In pecans spores applied as foliage spray will also contact nut shell,
however spores would be removed when shells are removed prior to any
human consumption.

In potatoes, spore applied to foliage will not directly contact tubers. 
Tubers are exposed to natural soil concentrations of Bacillus that
exceed the quantity of BmJ spores applied to potato foliage.  MMP would
not expect applied BmJ to create a significant residue in potatoes. 
Washing pealing and or cooking will remove or destroy any residual
spores.

 

MMP would not expect any residue of BmJ applied to sugar beet foliage to
carry through sugar beet processing to create a residue in refined sugar
for human consumption.  BmJ application will create minimal residues on
sugar beet foliage.  Cattle fed sugar beet tops treated with BmJ may
have an exposure to a low level of BmJ spores.  Given the natural
occurrence of B. mycoides, MMP does not expect that exposure to applied
BmJ on sugar beet tops would represent a significant increase in natural
exposure of cattle to B. mycoides.  MMP would also not expect any human
exposure to BmJ spores in meat or milk as a result of feeding sugar beet
tops with BmJ residue to cattle.

In tomatoes and peppers, spores applied as foliage sprays may leave a
BmJ spore residue on the tomatoes or peppers.  From persistence studies,
MMP expects BmJ residue to decline by more than 1000 fold over a two
week period.  Washing harvested fruit will also further reduce or
eliminate any BmJ residue. >

<	ii. Drinking water.  The experimental program will not affect drinking
water.  Program design and experimental label prohibit application of
BmJ WP within 100 meters of surface water.  In any inadvertent water
contamination, BmJ spores would be diluted to levels insignificant
compared to natural background levels of B. mycoides. >

<	2. Non-dietary exposure. Non-dietary exposure to BmJ as a result of
the experimental program will be limited to personnel involved in
application and monitoring of the experimental program.    Applicators
following label directions will wear personnel protective clothing
including respiratory protection, limiting non-dietary exposure.   The
experimental program will not apply BmJ near human habitation and MMP
will restrict public access to test sites where BmJ has been applied. 
MMP does not expect any non-dietary exposure to the general public. >

<E. Cumulative Effects>

< The experimental program and temporary tolerance exemption is for a
two year period with trials conducted in different crops in widely
separated regions of the country limiting cumulative effects.>

<F. Safety Determination>

<	1. U.S. population. There will be no increased exposure of the US
population as a result of the limited experimental program.  The
available data submitted and published literature do not identify
pathogenicity or toxicity of B. mycoides to mammals.  Application of BmJ
in the experimental program poses minimal safety risk to the US
population.>

<	2. Infants and children. Based on the limited use pattern in the
experimental program and absence of residues in food, MMP does not
expect any exposure infants and children to B. mycoides.  Based on the
toxicity profile, BmJ poses minimal safety risk to infants and children>

<G. Effects on the Immune and Endocrine Systems>

<Exhaustive literature searches did not identify any recorded effect of
B. mycoides on the human immune or endocrine system.  The pulmonary
toxicity, pathogenicity study did not show any adverse immune system
effects.>

<H. Existing Tolerances>

<A temporary exemption from the requirement for tolerances for BmJ had
been previously approved in connection with and Experimental Use Permit,
82761-EUP-1for an experimental program in sugar beets conducted in 2006,
No other tolerances have been established for BmJ.>

<I. International Tolerances>

<No international tolerances have been established for BmJ. >

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