[Federal Register Volume 62, Number 34 (Thursday, February 20, 1997)]
[Notices]
[Pages 7780-7782]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4115]


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ENVIRONMENTAL PROTECTION AGENCY
[PF-709; FRL-5588-5]


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 temporary exemption from the 
requirement of the tolerance for residues of Burkholderia (pseudomonas) 
cepacia strain AMMD in or on American ginseng, carrots, peas, potatoes, 
snap beans, supersweet and sweet corn, tomatoes, and turf in 
California, Florida, Illinois, Minnesota, Missouri, Ohio, Washington, 
and Wisconsin for the 1997-1999 growing seasons. The summary of the 
petition was prepared by the petitioner, Good Bugs, Inc.

DATES: Comments, identified by the docket control number [PF-709], must 
be received on or before March 24, 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: Crystal Mall #2, 
Room

[[Page 7781]]

1132, 1921 Jefferson Davis Highway, Arlington, VA. Comments and data 
may also be submitted electronically by sending electronic mail (e-
mail) to: <a href="/cdn-cgi/l/email-protection#99f6e9e9b4fdf6faf2fcedd9fce9f8f4f8f0f5b7fce9f8b7fef6ef"><span class="__cf_email__" data-cfemail="b1dec1c19cd5ded2dad4c5f1d4c1d0dcd0d8dd9fd4c1d09fd6dec7">[email protected]</span></a>. 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 in 5.1 file format or ASCII file format. All 
comments and data in electronic form must be identified by docket 
control number [PF-709]. 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 notice 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 Room 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 c/o (PM 90), 
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, Crystal Station #1, 
2800 Crystal Drive, Arlington, VA, 703-308-1259, e-mail: 
<a href="/cdn-cgi/l/email-protection#2f4c474641015b4a5a41486f4a5f4e424e4643014a5f4e01484059"><span class="__cf_email__" data-cfemail="d1b2b9b8bfffa5b4a4bfb691b4a1b0bcb0b8bdffb4a1b0ffb6bea7">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: EPA has received a pesticide petition [PP-
7G4796] 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 a temporary exemption from the requirement of a tolerance 
for residues of the microbial pesticide, Burkholderia (pseudomonas) 
cepacia strain AMMD in or on the raw agricultural commodities American 
ginseng, carrots, peas, potatoes, snap beans, supersweet and sweet 
corn, tomatoes, and turf. 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

    1. Foliar applications of Burkholderia (pseudomonas) cepacia strain 
AMMD for potatoes, carrots, tomatoes, and turf will be at the rate of 4 
oz/acre/application, 20 applications per acre per year. In Wisconsin, 
20 acres of potatoes will be treated in 1997, 100 acres in 1998, and 
500 acres in 1999; 5 acres of carrots will be treated in 1997, 10 acres 
in 1998, and 10 acres in 1999; 10 acres of turf will be treated in 
1997, 100 acres in 1998, and 100 acres in 1999. In Minnesota, 20 acres 
of turf will be treated in 1997, 100 acres in 1998, and 100 acres in 
1999. In California, 10 acres of carrots will be treated in 1998 and 10 
acres in 1999; 100 acres of potatoes will be treated in 1998 and 100 
acres in 1999; 100 acres of tomatoes will be treated in 1998 and 100 
acres in 1999. In Ohio, 5 acres of tomatoes will be treated in 1997, 20 
acres in 1998, and 20 acres in 1999; 5 acres of turf will be treated in 
1997, 100 acres in 1998, and 100 acres in 1999. In Florida, 10 acres of 
potato will be treated in 1997, 100 acres in 1998, and 100 in 199; 5 
acres of tomatoes will be treated in 1997, 100 acres in 1998, and 100 
in 1999; 5 acres of turf will be treated in 1997, 100 acres in 1998, 
and 100 acres in 1999. In Missouri, 5 acres of turf will be treated in 
1997, 100 acres in 1998, and 500 acres in 1999. For foliar applications 
on American ginseng, 4 oz/acre/application, 12 applications/acre/year 
will be applied in Wisconsin on 4,000 acres in 1997, 1998, and 1999.
    2. For seed treatment of peas and sweet corn, the rate of 
application is 3 oz. per 100 lbs of seed, for snap beans 2 oz. per 100 
lbs of seed and for supersweet corn, 4.5 oz. per 100 lbs of seed. 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 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 Minnesota, 5 acres of peas will be treated in 1997, 
50 in 1998, and 200 in 1999; 5 acres of snap beans will be treated in 
1997, 50 acres in 1998, and 200 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 199 9; 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.

B. Product Identity/Chemistry

    1. Burkholderia (pseudomonas) cepacia strain AMMD was originally 
isolated from the rhizosphere of a pea plant. The cells of this strain 
are gram negative, aerobic, rod shaped and produce poly-beta-
hydroxybutyrate granules intracellularly. Colonies are convex and 
white, but eventually become crenulated on nutrient broth yeast extract 
agar plates. Two colony morphologies, smooth and rough are present. 
Fluorescent pigments are not produced on King's Medium B. The species 
Burkholderia (pseudomonas) cepacia was first identified using gas 
chromatography fatty acid (GC-FAME) analysis.
    2. Burkholderia (pseudomonas) cepacia strain AMMD residues are not 
anticipated at the time of harvest by Good Bugs, Inc. Treatment of 
aerial plant parts and seeds are the only uses for this proposed 
microbial pesticide. Residues from seed treatments are not expected as 
the bacteria does not grow systemically in the plant. The above ground 
parts of potatoes, American ginseng, and carrots are not eaten. Based 
on conducted studies, Good Bugs, Inc. believes that strain AMMD does 
not survive well in the phyllosphere. Populations were no longer 
detectable 4 days after spray application to snap bean leaves and 
flowers. An enforcement method for residues is not needed to protect 
human health.
    3. Good Bugs, Inc. believes that an analytical method for detecting 
and measuring the levels of this microbial pesticide residue is not 
needed to protect human health due to lack of signficant exposure.

C. Mammalian Toxicological Profile

    Good Bugs, Inc. believes that acute oral limit toxicity testing of 
Burkholderia (pseudomonas) cepacia strain AMMD showed no evidence of 
toxicity or pathogenicity in rats dosed

[[Page 7782]]

once by oral gavage with strain AMMD. Normal weight gains were observed 
in all test animals during the observation period. No lesions were 
observed in any test animal. A waiver for genotoxicity, reproductive 
and developmental toxicity, subchronic toxicity, and chronic toxicity 
is requested. This testing is not generally required for microbial 
pesticides and the lack of toxicity along with the lack of exposure 
does not warrant such testing.

D. Aggregate Exposure

    1. Dietary exposure. The species Burkholderia (pseudomonas) cepacia 
is a common inhabitant of soils, plant surfaces, and fresh water. Good 
Bugs, Inc. believes that use of this microbial pesticide as outlined is 
not expected to increase dietary exposure via food or water 
consumption. Transfer of the microbial pesticide to drinking water is 
unlikely due to the low survivability of the organism in the 
environment. Any low levels of oral exposure that may occur would not 
be harmful due to the lack of mammalian toxicity.
    2. Non-dietary exposure of Burkholderia (pseudomonas) cepacia 
strain AMMD. Good Bugs, Inc. believes that treatment of turf as 
outlined in the experimental plan will be on limited acreage and, due 
to the low survivability of the organism, exposure will be minimal.
    3. Worker exposure via dermal exposure or inhalation. Good Bugs, 
Inc. believes that worker exposure will be minimized by the label 
requirements of long-sleeved shirt, long pants, gloves, and the wearing 
of a respirator.

E. Cumulative Exposure

    Biological control agents of this type generally work by 
outcompeting the disease organisms, therefore, not having a toxic mode 
of action that can be shared. However, other exposure can occur since 
another strain of Burkholderia (pseudomonas) cepacia is already 
registered with the Agency. Good Bugs, Inc. believes that since the 
Agency has registered this other strain and granted an exemption from 
tolerance, this added exposure does not present a hazard to human 
health in and of itself and thus does not add to cumulative exposure.

F. Safety Determination

    1. Good Bugs, Inc. believes the safety of the U.S. population and 
that of infants and children will not be adversely affected by the use 
of Burkholderia (pseudomonas) cepacia strain AMMD. Strain AMMD was 
originally isolated from the rhizosphere of a pea and strains of 
Burkholderia (pseudomonas) cepacia are widely distributed in nature and 
are readily isolated from soil, fresh water, and plant roots and 
leaves. Strain AMMD does not survive well in the phyllosphere and 
cannot be detected after 4 days.
    2. Some strains of Burkholderia (pseudomonas) cepacia are 
infectious to individuals with cystic fibrosis or compromised immune 
systems. Some strains of Burkholderia (pseudomonas) cepacia can also 
cause skin infection of feet known as swamp rot. In addition, this 
bacterium has been isolated from nosocomial sources such as 
contaminated indwelling medical devices and antiseptic solutions. Good 
Bugs, Inc. believes that because of the importance of these clinical 
strains, it is critical that Burkholderia (pseudomonas) cepacia strain 
AMMD is distinguished from other strains. Two recent studies have 
determined that plant associated strains are distinct from clinical 
isolates. Molecular phyllogenetic studies based on deoxyribonucleic 
acid (DNA)-DNA and DNA-ribosomal ribonucleic acid (RNA) hybridization 
of 150 isolates have identified 4 genomovars of Burkholderia 
(pseudomonas) cepacia. All cystic fibrosis isolates cluster in 
genomovar III; while environmental isolates (including phytopathogenic 
type strain) belong to genomovar I.

G. Existing Tolerances

    1. A tolerance exemption for Burkholderia (pseudomonas) cepacia, 
Wisconsin isolate/strain M36 (a.k.a. Blue Circle Inoculant), was 
granted in 1992 by EPA.
    2. It is not known if any international tolerance exemptions exist.

II. Public Record

    Interested persons are invited to submit comments on the this 
notice of filing. Comments must bear a notation indicating the docket 
control number, [PF-709].
    A record has been established for this notice under docket control 
number [PF-709] 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:

    <a href="/cdn-cgi/l/email-protection#a3ccd3d38ec7ccc0c8c6d7e3c6d3c2cec2cacf8dc6d3c28dc4ccd5"><span class="__cf_email__" data-cfemail="cea1bebee3aaa1ada5abba8eabbeafa3afa7a2e0abbeafe0a9a1b8">[email protected]</span></a>


    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 notice, 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 
record which will also include all comments submitted directly in 
writing. The official record is the paper record maintained at the 
address in ``ADDRESSES'' at the beginning of this notice.

List of Subjects

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

    Dated: February 6, 1997.

Janet L. Andersen,

Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.
[FR Doc. 97-4115 Filed 2-19-97; 8:45 am]
BILLING CODE 6560-50-F


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