[Federal Register Volume 62, Number 38 (Wednesday, February 26, 1997)]
[Notices]
[Pages 8735-8737]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4630]


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ENVIRONMENTAL PROTECTION AGENCY
[PF-711; FRL-5589-1]


Good Bugs Inc.; Pesticide Tolerance Petition Filing

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of filing.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of a regulation for an exemption 
from the requirement of a tolerance for residues of the microbial 
pesticide Pseudomonas fluorescens PRA-25 in or on peas, snapbeans, 
sweet corn, and supersweet

[[Page 8736]]

corn. The summary of the petition published in this notice was proposed 
by the petitioner Good Bugs Inc.

DATES: Comments, identified by the docket number [PF-711], must be 
received on or before, March 28, 1997.

ADDRESSES: By mail, submit written comments to: Public Response and 
Program Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St. SW., 
Washington, DC 20460. In person, bring comments to Rm. 1132, CM #2, 
1921 Jefferson Davis Highway, Arlington, VA.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: [email protected]. Electronic 
comments must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Comments and data will also be 
accepted on disks in WordPerfect 5.1 file format or ASCII file format. 
All comments and data in electronic form must be identified by docket 
number [PF-711]. Electronic comments on this notice may be filed online 
at many Federal Depository Libraries. Additional information on 
electronic submissions can be found in Unit II. of this document.
    Information submitted as a comment concerning this document may be 
claimed confidential by marking any part or all of that information as 
``Confidential Business Information'' (CBI). CBI should not be 
submitted through e-mail. Information marked as CBI will not be 
disclosed except in accordance with procedures set forth in 40 CFR part 
2. A copy of the comment that does not contain CBI must be submitted 
for inclusion in the public record. Information not marked confidential 
may be disclosed publicly by EPA without prior notice. All written 
comments will be available for public inspection in Rm. 1132 at the 
address given above, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: Teung F. Chin, Regulatory 
Action Leader, Biopesticides and Pollution Prevention Division, Office 
of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location, telephone number, and e-mail 
address: 5th floor CS #1, 2800 Crystal Drive, Arlington, VA, 703-308-
1259, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: EPA has received a pesticide petition (PP 
7G4803) from Good Bugs, Inc., P.O. Box 939, New Glarus, WI 53574, 
proposing pursuant to section 408(d) of the Federal Food, Drug and 
Cosmetic Act, 21 U.S.C. 346a(d), to amend 40 CFR part 180 by 
establishing an exemption from the requirement of a tolerance for 
residues of the microbial pesticide, Pseudomonas fluorescens PRA-25 in 
or on the raw agricultural commodities peas, snap beans, sweet corn and 
supersweet corn.
    Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, Good 
Bugs, Inc. has submitted the following summary of information, data and 
arguments in support of their pesticide petition. This summary was 
prepared by Good Bugs, Inc. and EPA has not fully evaluated the merits 
of the petition. The summary may have been edited by EPA if the 
terminology used was unclear, the summary contained extraneous 
material, or the summary was not clear that it reflected the conclusion 
of the petitioner and not necessarily EPA.

I. Petition Summary

A. Proposed Use Practices

    Seed treatment with Pseudomonas fluorescens PRA-25 will be at the 
rate of 2 oz. per 100 lbs. of seed for snap beans, 3 oz. per 100 lbs of 
seed for peas and snap beans and 4.5 oz. per 100 lbs. of seed for 
supersweet corn. Application is one time only, prior to planting. In 
Wisconsin, 5 acres of peas will be treated in 1997, 50 acres in 1998 
and 200 acres in 1999, 5 acres of snap beans will be treated in 1997, 
50 acres in 1998, and 200 acres in 1999; 5 acres of sweet corn will be 
treated in 1997, 50 in 1998, and 200 in 1999; 5 acres of supersweet 
corn will be treated in 1997, 50 acres in 1998, and 200 acres in 1999. 
In Minnesota, 5 acres of peas will be treated in 1997, 50 acres in 
1998, and 200 acres in 1999; 5 acres of snap beans will be treated in 
1997, 50 acres in 1998, and 200 acres in 1999; 5 acres of sweet corn 
will be treated in 1997, 50 acres in 1998, and 200 acres in 1999; 5 
acres of supersweet corn will be treated in 1997, 50 acres in 1998, and 
200 acres in 1999. In Illinois, 5 acres of peas will be treated in 
1997, 50 acres in 1998, and 200 acres in 1999; 5 acres of sweet corn 
will be treated in 1997, 50 acres in 1998, and 200 acres in 1999; 5 
acres of supersweet corn will be treated in 1997, 50 acres in 1998, and 
200 acres in 1999. In Washington, 5 acres of peas will be treated in 
1997, 50 acres in 1998, and 200 acres in 1999. The product is to be 
applied to the seeds in the planter box immediately before planting.

B. Product Identity/Chemistry

    1. Pseudomonas fluorescens PRA-25 was originally isolated from the 
rhizosphere of a pea plant in Wisconsin. Strain PRA-25 is a gram 
negative, rod shaped, aerobic, non spore forming bacterium. A 
fluorescent pigment (pyroverdin) is produced on King's Medium B. The 
strain was identified as a member of the Pseudomonas fluorescens/putida 
group using gas chromatography fatty acid (GC-FAME) analysis. GC-FAME 
and Biolog analysis was used to identify strain PRA-25 as Pseudomonas 
fluorescens (Trevisan)Migula Biotype B (=biovar II). Biovar II includes 
Pseudomonas marginalis pathogens as well as saprophytes (Bergey's 
Manual), so a potato rot assay was conducted. The known soft-rot 
pathogen Erwinia carotovora was included as a check treatment. Strain 
PRA-25 did not rot potatoes. Good Bugs, Inc. concludes that Pseudomonas 
fluorescens PRA-25 is a saprophytic member of Pseudomonas fluorescens 
biovar II.
    2. Pseudomonas fluorescens PRA-25 will be used as a seed treatment 
and does not grow systemically in the plant. Good Bugs does not 
anticipate residues at the time of harvest. Good Bugs, Inc., therefore, 
believes a method to determine residues is not necessary.
    3. An analytical method for detecting and measuring the levels of 
Pseudomonas fluorescens PRA-25 is not needed because the use as a seed 
treatment will not leave residues on the harvested crop. Pseudomonas 
fluorescens is a common contaminant of raw and refrigerated milk, meat, 
fish, and cheese. All biovars of Pseudomonas fluorescens appear to be 
readily isolated from foodstuff.

C. Mammalian Toxicological Profile

    Good Bugs, Inc. states that the Acute Oral Limit Toxicity Testing 
of Pseudomonas fluorescens PRA-25 showed no evidence of toxicity or 
pathogenicity in rats dosed once by oral gavage with strain PRA-25. 
Normal weight gains were observed in all test animals during the 
observation period. No lesions were observed in any test animal.
    Waivers for genotoxicity, reproductive and developmental toxicity, 
subchronic toxicity and chronic toxicity are requested. This testing is 
not generally required for microbial pesticides and Good Bugs, Inc. 
believes that the lack of toxicity along with the lack of exposure does 
not warrant such testing.

D. Aggregate Exposure

    1. Dietary exposure. Pseudomonas fluorescens is a ubiquitous 
bacterium that is commonly associated with soil, water, plant roots and 
leaves, meat, fish, and dairy products. Good Bugs, Inc. believes that 
no additional exposure to

[[Page 8737]]

food or drinking water is anticipated by using Pseudomonas fluorescens 
PRA-25 as a seed treatment.
    2. Non-dietary exposure such as lawn care, topical insect 
repellents, etc. is not anticipated since this microbial pesticide does 
not have these uses.
    3. Occupational exposure will be mitigated through the use of 
proper personal protective equipment.

E. Cumulative Exposure

    Biological control agents of this type generally work by out 
competing disease organisms, thus, not having a toxic mode of action 
that can be shared. Other exposure can occur since other strains of 
Pseudomonas fluorescens are registered as microbial pesticides. Good 
Bugs, Inc. believes that human exposure from use of Pseudomonas 
fluorescens PRA-25 as a seed treatment is expected to be negligible.

F. Safety Determination

    Good Bugs, Inc. believes that the safety of the U.S. population and 
that of infants and children will not be adversely affected by the use 
of Pseudomonas cepacia PRA-25 as a vegetable seed treatment. Strain 
PRA-25 is a naturally occurring strain originally isolated from the 
rhizosphere of a pea.

G. Existing Tolerances

    1. Tolerance exemptions have been granted for other strains of 
Pseudomonas fluorescens.
    2. International tolerance exemptions have been granted for other 
strains of Pseudomonas fluorescens.

II. Public Record

    Interested persons are invited to submit comments on the notice of 
filing. Comments must bear a notation indicating the document control 
number, [PF-711].
    A record has been established for this notice under docket number 
[PF-711] including comments and data submitted electronically as 
described below). A public version of this record, including printed, 
paper versions of electronic comments, which does not include any 
information claimed as CBI, is available for inspection from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The public 
record is located in Room 1132 of the Public Response and Program 
Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, Crystal Mall #2, 
1921 Jefferson Davis Highway, Arlington, VA.
    Electronic comments can be sent directly to EPA at:
    [email protected]
    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will transfer all comments received electronically into printed, 
paper form as they are received and will place the paper copies in the 
official rulemaking record which will also include all comments 
submitted directly in writing. The official rulemaking record is the 
paper record maintained at the address in ``ADDRESSES'' at the 
beginning of this document.

List of subjects

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: February 11, 1997.

Janet L. Andersen,

Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

[FR Doc. 97-4630 Filed 2-25-97; 8:45 am]
BILLING CODE 6560-50-F