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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. 
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B. Product Identity/Chemistry

1 Identity of the pesticide and corresponding residues. 

D7 contains 95% w/w Pseudomonas fluorescens strain D7 (2 X 10

11 CFU/g) as the 

sole active ingredient. Pseudomonas fluorescens strain D7 is a ubiquitous, naturally occurring, nonpathogenic 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 noninhibitory 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.

2. 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.

3. 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 
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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 nontoxic 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.

i. 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. 

ii. 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. 

iii. 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.
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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.

G. 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.