[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: opp-docket@epamail.epa.gov. 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:
chin.teung@epamail.epa.gov.
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:
opp-docket@epamail.epa.gov
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
