Document ID: EPA-HQ-OPP-2013-0569-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2013-09-12T04:00Z

Number: 2F8103

EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY

NOTICE OF FILING TEMPLATE FOR PESTICIDE PETITIONS PUBLISHED IN THE

FEDERAL REGISTER

(1/1/2004)

EPA Biopesticides and Pollution Prevention Division contact: Leonard
Cole, (703-305-5412)

Northwest Agricultural Products    821 South Chestnut Avenue      
Pasco, WA 99301

EPA Reg. No. 071975

Petition # 2F8103

EPA has received a pesticide petition NAP D7 from Northwest Agricultural
Products, 821 South Chestnut Avenue, Pasco, WA 99301, 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 the microbial pesticide
Pseudomonas fluorescens strain D7, in or on growing crops and rangeland.

Pursuant to section 408(d)(2)(A)(1) of the FFDCA, as amended, Northwest
Agricultural Products has submitted the following summary of
information, data, and arguments in support of their pesticide petition.
This summary was prepared by Northwest Agricultural 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.

Northwest Agricultural Products Petition Summary 2F8103

A. Product name and Proposed Use Practices

Pseudomonas fluorescens is a naturally occurring bacterium isolated from
winter wheat roots in eastern Washington state and evaluated for use in
the control of Downy brome, Japanese brome, Medusahead, and Jointed
Goatgrass.

D7 Biopesticide end use product consists entirely of active ingredient. 
The solid formulation is fast dissolving in water and forms a homogenous
suspension for spraying. The use rate is 2 grams / acre.  The product is
applied pre-emergent as a spray to ground.  

B. Product Identity/Chemistry

1 Identity of the pesticide and corresponding residues. 

D7 contains 95% w/w Pseudomonas fluorescens strain D7 (2 X 1011 CFU/g)
as the sole active ingredient. Pseudomonas fluorescens strain D7 is a
ubiquitous, naturally occurring, non-pathogenic microorganism. 

Pseudomonas fluorescens strain D7  has been found to have herbicidal
properties against various weed species.  Pseudomonas fluorescens strain
D7 is specifically inhibitory to Downy brome (Bromus tectorum
cheatgrass), Japanese brome, Medusahead and Jointed Goatgrass and is
non-inhibitory to grass crops and broad leaf plants.  The product
colonizes plant roots and moves to the weed seed or seedling and
inhibits root elongation and tiller initiation. Visible effects are lack
of germination, stunted plants with few tillers, lack of overwintering
and low seed production.  The organism is non-systemic.

Magnitude of residue at the time of harvest and method used to determine
the residue. This section is not applicable, as Northwest Agricultural
Products is proposing an exemption from the requirement of a tolerance.

Statement of why an analytical method for detecting awl measuring the
levels of the pesticide residue are not needed. An analytical method for
residues is not applicable, as Northwest Agricultural Products is
proposing an exemption from the requirement of a tolerance.

C. Mammalian Toxicological. Profile

1.	Acute oral toxicity/pathogenicity study. 

This study was conducted to evaluate the acute oral toxicity/pathology
of the microbial pest control agent (MPCA) test substance, Pseudomonas
fluorescens strain D7, when administered to rats by gavage in a single
high dose exposure and given an adequate post-exposure observation
period. The MPCA test substance and inactivated MPCA test substance was
administered to rats by gavage in a single high dose. The animals were
observed frequently on the day of dosing (Day 0) for mortality and signs
of pharmacologic and/or toxicologic effects and once daily thereafter
for 21 days. Two control groups (untreated) were conducted concurrently.
There was no mortality during the study. There were no signs of
pharmacologic and/or toxicologic effects observed in any animal during
the study. The gross necropsy conducted at termination of the study
revealed no internal or external observable abnormalities. After two
consecutive interim sacrifices showed no growth of test organism in the
organs plated, no further tissue samples were taken. The test substance,
Pseudomonas fluorescens strain D7, was determined to be non-toxic to
rats when administered by oral gavage in a single dose of 1.3 x 109
CFU/rat.

The test organism had cleared completely from the test group blood,
kidneys, mesenteric lymph nodes, lungs, brain, liver, spleen by Day 7
and had cleared completely from the cecum by Day 14.

2.	Acute Pulmonary Toxicity/ Pathogenicity

This study was conducted to evaluate the pulmonary toxicity, infectivity
and pathogenicity of a microbial pest control agent (MPCA) at a single
high dose exposure and an adequate post-exposure observation period. The
animals were observed frequently on day of dosing for mortality and
signs of pharmacologic and/or toxicologic effects and once daily
thereafter for 21 days. Two control groups (untreated) were conducted
concurrently. Tissue and blood samples taken at interim sacrifices from
the group receiving the active test substance and the shelf control
group were cultured to provide quantitative measurements of the test
microbe's clearance pattern. There were no abnormal general health
observations. A gross necropsy of all animals was performed and
recorded. There were no observed abnormalities during necropsy. The test
substance appeared to clear from test animals by Day 3, as
quantification results from plated tissue and fluids yielded counts that
were below clearance threshold. With the counts below clearance
threshold and no observed abnormalities during general health
observations or at necropsy, there is no evidence for toxic or
pathogenic effects caused by the test substance. The test substance,
Pseudomonas fluorescens strain D7, was determined to be non-toxic to
rats when administered by tracheal injection in a single dose of 4.6 x
108  CPU/rat.

MPCA Clearance Quantification of the test microbe was performed on
tissues removed at each interim sacrifice to determine the
infectivity/pathogenicity and estimate clearance of MPCA after dosing.
At the Day 0 sacrifice, the lungs were the only tissue quantified. At
other time points, tissues/fluid removed from each animal included:
kidneys, brain, liver, lungs, spleen, blood, representative lymph nodes,
cecum contents, and where appropriate, from any lesion.

3.	Acute Dermal Toxicity/Irritation. 

The test substance, Pseudomonas fluorescens strain D7, was evaluated for
its dermal toxicity potential and relative skin irritancy when a single
dose moistened with 2.0 mL of DI water/g test substance, at a level of
2000 mg/kg, was applied to the intact skin of albino rabbits. No
mortality occurred during the study. Observations for evidence of dermal
irritation were made at approximately 60 minutes after removal of
wrappings, and on Days 4, 7, 11 and 14. There were no clinical signs of
toxicity at any time throughout the study. The only sign of dermal
irritation was erythema on Day 1. All animals showed full clearance of
any dermal irritation after 24 hours.  Animals exhibited weekly weight
gain during the study, with the exception of one female that lost weight
between Days 7 and 14. The gross necropsy conducted at termination of
the study revealed no observable abnormalities. The estimated LD50, as
indicated by the data, was determined to be greater than 2000 mg/kg.
This is equivalent to exposure to over 4 x 1011 organisms/ kg body
weight.

D. Aggregate Exposure

1. Dietary exposure.

Food. Pseudomonas fluorescens strain D7 is a naturally occurring
organism. At the proposed use rate (2gm/A), the total population of
Pseudomonas fluorescens strain D7 will not increase beyond naturally
occurring background levels. Furthermore, the use pattern is application
prior to crop emergence.  Since the organism is not applied directly to
the crop and it is non-systemic, dietary exposure to Pseudomonas
fluorescens strain D7 is expected to be quite low. 

Drinking water. Pseudomonas fluorescens strain D7 is not likely to
increase the natural concentrations of Pseudomonas fluorescens strain D7
in water bodies and is not considered to be a risk to drinking water. 

2. Non-dietary exposure. Migration of Pseudomonas fluorescens strain D7
out of the treated fields is not expected. Therefore, there will be no
non-occupational, non-dietary exposure to the general population.

E. Cumulative Exposure

There are no other registered products containing Pseudomonas
fluorescens strain D7.

F. Safety Determination

U.S. population. Pseudomonas fluorescens strain D7 is a naturally
occurring organism. The long-term population of Pseudomonas fluorescens
strain D7 in the environment is not increased either in the environment
or in the crops. Thus, there is reasonable certainty that no harm will
result from use of this product.

2. Infants and children. Pseudomonas fluorescens strain D7  is a
naturally occurring organism. At the proposed use rates (2g/A), the
total population of Pseudomonas fluorescens in the soil will not
increase beyond the naturally occurring  background levels. Finally,
toxicity studies on Pseudomonas fluorescens strain D7 do not raise risk
concerns. Based on its lack of toxicity by all likely routes of exposure
and the natural occurrence of Pseudomonas fluorescens strain D7, there
is a reasonable certainty that no harm will result to infants and
children from exposures to potential residues.

Effects on the Immune and Endocrine Systems

Pseudomonas fluorescens strain D7 is a naturally occurring,
nonpathogenic microorganism. To date there is no evidence to suggest
that Pseudomonas fluorescens strain D7 functions in a manner similar to
any known hormone, or that it acts as an endocrine disruptor.

Existing Tolerances

There are no U.S. EPA tolerances for Pseudomonas fluorescens strain D7.

1. International Tolerances

Northwest Agricultural Products is not aware of any international
tolerances, exemptions from tolerances or maximum residue levels for
Pseudomonas fluorescens strain D7.

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