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Number: 2F8103
EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY NOT ICE 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
- 54 12)
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, prop osing 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 mi crobial pesticide Pseudomonas fluorescens s train D7 , in or on growing crops and rang eland

. 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 D owny brome, Japanese brome, M edusahead, and J ointed Goatgrass
. D7 Biopesticide end use product consists entirely of active ingredient. The solid form ulation 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.2

**B. Product Identity/Chemistry 1**  **Identity of the pesticide and corresponding residues.**  D7 contains 95 % w/w Pseudomonas fluorescens strain D7 ( 2 X 1 0 11 CFU/g) as the sole active ingredient. Pseudomonas fluorescens strain D7 is a ubiquitous, naturally occurring, non

pathogenic microorganism. Pseudomonas fluoresc ens 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 o f overwintering and low seed production. The organism is non

- sy stemic. 

### 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. **S tatement 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 fluoresce ns 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, Pse** **udom onas fluorescens**  **strain D7, was determined to be non -**  **toxic to rats when administered by o**  **ral gavage in a single dose of 1.3 x 10 9**  **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 comp letely from the cecum by Day 14.
**2. Acute Pulmo**  **nary 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 sacrifi ces from3

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**  **stra in D7, was determined to be non**  **** **toxic to rats when administered by tracheal injection in a single dose of 4.6 x 10 8**  **CPU/rat. MPCA Clearance Quantification**  of the test microbe was performed on tissues removed at each interim sacrifice to determine the inf ectivity/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, repre sentative 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 10**  **11 organisms** **/ kg body weight .**  **D. Aggregate Exposure** 1. Dietary exposure. i. Food. Pseudom on as fluorescens strain D7 is a naturally occurring organism. At the proposed use rate (2gm/A) , the total population of Pseudom on as fluorescens strain D7 wi ll not increase beyond naturally occurring background levels. Furthermore , the use p attern is application prior to crop emergence. Since the organism is not applied directly to the crop and it is non

- systemic , dietary exposure to Pseudom on as fluorescens strain D7 is expected to be quite low. ii. Drinking water. Pseudom on as fluorescens strain D7 is not likely to increase the natural concentrations of P

seudom on as fluorescens strain D7 in water bodies and is not considered to be a risk to drinking water. iii. 2. Non
- dietary exposure. Migration of Pseudom on as fluorescens strain D7 out of the treated fields is not expected. Therefore, there will be no non

- occup ational, non

- dietary exposure to the ge neral population.4

**E. Cumulative Exposure** There are no other registered products containing Pseudom on as fluorescens strain D7

. **F. Safety Determination U.S. population** 
. Pseudom on as fluorescens strain D7 is a naturally occurring organism. The long

-term population of Pseudom on as 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. Infa nts and children** 
. Pseudom on as fluorescens strain D7 is a naturally occurring organism. At the proposed use rates (2g/A) , the total population of Pseudom on as fluorescens in the soil will not increase beyond the naturally occurring background levels. Final ly , toxicity studies on Pseudom on as 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 Pseudom on as 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 Immu ne and Endocrine Systems**  Pseudom on as fluorescens strain D7 is a naturally occurring, nonpathogenic microorganism. To date there is no evidence to suggest that Pseudom on as 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 Pseudom on as fluorescens strain D7

. **1. International Tolerances** Northwest Agricultural Products is not aware of any international tolerances, exemptions from tolerances or maximum residue levels for Pseudom on as fluorescens strain D7

.