[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
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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
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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]
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