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Burkholderia (Pseudomonas) Cepacia Type Wisconsin; Tolerance Exemption
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: June 7, 1995 (Volume 60, Number 109)]
[Proposed Rules]
[Page 30048-30050]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07jn95-36]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 0F3885/R2142; FRL-4958-9]
RIN 2070-AC18
Burkholderia (Pseudomonas) Cepacia Type Wisconsin; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes that an exemption from the requirement
of a tolerance be established for residues of the biological pesticide
Burkholderia (Pseudomonas) cepacia type Wisconsin in or on all raw
agricultural commodities, resulting from use on plant roots or seedling
roots. EPA is proposing this regulation on its own initiative. The
proposal would amend the existing tolerance exemption for this
organism, which is limited to the seed treatment use.
DATES: Comments identified by the docket number, [PP 0F3885/R2142],
must be received on or before July 7, 1995.
ADDRESSES: Submit written comments by mail 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: Public Docket, Rm.
1132, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202.
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). Information so marked will
not be disclosed except in accordance with procedures as 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 will be included in the public docket by EPA without prior
notice. The public docket is available for public inspection in Rm.
1132 at the above address, from 8 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays.
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
the docket number [PP 0F3885/R2142]. No Confidential Business
Information (CBI) should be submitted through e-mail. Electronic
comments on this proposed rule may be filed online at many Federal
Depository Libraries. Additional information on electronic submissions
can be found below in this document.
FOR FURTHER INFORMATION CONTACT: By mail: Denise Greenway,
Biopesticides and Pollution Prevention Division (7501W), Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location and telephone number: Rm. CS51L6, Crystal Station #1, 2800
Crystal Drive, Arlington, VA 22202, (703)-308-8263; e-mail:
greenway.denise@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of April 3, 1991 (56
FR 13642), EPA issued a notice that Stine Microbial Products, 4722
Pflaum Rd., Madison, WI 53704, had submitted pesticide petition (PP)
0F3885 to EPA proposing to amend 40 CFR part 180 by establishing a
regulation pursuant to the Federal Food, Drug and Cosmetic Act (21
U.S.C. 346a and 371), to exempt from the requirement of a tolerance the
residues of the biological pesticide Pseudomonas cepacia type Wisconsin
in or on all raw agricultural commodities when applied as a seed
treatment for growing agricultural crops in accordance with good
agricultural practices. There were no comments received in response to
the notice.
In the Federal Register of December 23, 1992 (57 FR 61003), an
exemption from the requirement of a tolerance was established for
residues of the biological pesticide Pseudomonas cepacia type Wisconsin
in or on all raw agricultural commodities when applied as a seed
treatment for growing agricultural crops in accordance with good
agricultural practices.
Stine Microbial Products has subsequently proposed a new use site,
plant roots or seedling roots. Like the seed treatment use for which an
exemption from the requirement of a tolerance now exists (40 CFR
180.1115), Pseudomonas cepacia type Wisconsin applied to plant roots or
seedling roots will colonize the developing root system, and by
producing antibiotics, protect the seedling or plant from a range of
plant pathogenic fungi and nematodes. The Agency has determined that
this presents no new hazard issues and that the following originally
submitted data can support the registration for use as a soil, seed, or
seedling treatment:
The organism is a naturally occurring biotype of the bacterial
species Pseudomonas cepacia which is found world wide. The original
isolates of Pseudomonas cepacia type Wisconsin were identified as
colonizers of the roots and rhizospheres of maize. Further testing
indicated that this biotype will colonize roots of many crop plants.
Pseudomonas cepacia type Wisconsin has been shown to produce
antibiotics which are effective against a diverse range of plant
pathogenic fungi. Pseudomonas cepacia type Wisconsin is not generally
regarded as a human or animal pathogen. Products containing this
organism are intended to be used for formulating other end-use products
or as a seed treatment (and the proposed plant root and seedling root
use). When applied to seeds (or plant or seedling roots), the bacteria
colonize the developing root system, and by producing antibiotics,
protect the seedling from a range of plant pathogenic fungi and
nematodes.
The data submitted in the petition and other relevant material have
been [[Page 30049]] evaluated. The toxicological data considered in
support of the exemption from the requirement of a tolerance include an
acute oral toxicity/pathogenicity study, an acute dermal toxicity
study, an acute pulmonary toxicity/pathogenicity study, and an acute
intravenous toxicity/pathogenicity study. All studies were conducted
with the rat as the test animal. A review of these studies indicated
that the organism was not acutely toxic to test animals when
administered via dermal and intravenous routes. The active ingredient
was not infective or pathogenic to test animals when administered via
the oral, pulmonary, or intravenous route. No reports of
hypersensitivity have been recorded from personnel working with this
organism. All of the toxicity studies submitted are considered
acceptable. The toxicity data provided are sufficient to show that
there are no foreseeable health hazards to humans or domestic animals
likely to arise from the use of this organism as a seed (or seedling
root or plant root) treatment.
Residue chemistry data were not required; such data are necessary
only if the submitted toxicity studies indicate that additional Tier II
or Tier III toxicology data are needed. These additional data were not
needed. Therefore, no residue data are required to establish an
exemption from the requirement of a tolerance for the biological
pesticide Pseudomonas cepacia type Wisconsin in or on all raw
agricultural commodities when applied to plant roots and seedling roots
or used as a seed treatment for growing agricultural crops in
accordance with good agricultural practices.
Acceptable daily intake (ADI) and maximum permissible intake (MPI)
considerations are not relevant to this petition because the data
submitted demonstrated that this biological control agent is not toxic
to humans. No enforcement actions are expected. Therefore, the
requirement for an analytical method for enforcement purposes is not
applicable to this exemption request.
The Agency hereby takes the initiative to amend the current
tolerance exemption (40 CFR 180.1115) by expanding it to include the
proposed use on plant roots and seedling roots. The Agency also
proposes that the exemption from the requirement of a tolerance be
further amended to update the organism name. There has been a recent
change in the bacterial taxonomy affecting the generic affiliation of
the RNA group II pseudomonads and moving them from the genus
Pseudomonas to the newly described genus Burkholderia. To reduce
confusion by completely changing the organism name, it is proposed that
the former genus name be inserted parenthetically after the new one,
Burkholderia (Pseudomonas) cepacia.
Burkholderia (Pseudomonas) cepacia type Wisconsin is considered
useful for the purposes for which the exemption from the requirement of
a tolerance is sought. Based on the information considered, the Agency
concludes that the establishment of a tolerance is not necessary to
protect the public health. Therefore, EPA proposes that an exemption
from the requirement of a tolerance be established as set forth below.
Any person who has registered or submitted an application for
registration of a pesticide under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) as amended, which contains the ingredient
listed herein, may request within 30 days after the publication of this
document in the Federal Register that this rulemaking proposal be
referred to an Advisory Committee in accordance with section 408(e) of
the Federal Food, Drug, and Cosmetic Act (FFDCA).
Interested persons are invited to submit written comments on the
proposed regulation. Comments must bear a notation indicating the
document control number, [PP 0F3885/R2142]. All written comments filed
in response to this petition will be available in the Public Response
and Program Resources Branch at the above address from 8 a.m. to 4:30
p.m., Monday through Friday, except legal holidays.
A record has been established for this rulemaking under docket
number [PP 0F3885/R2142] (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 a.m. to 4:30 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 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.
The Office of Management and Budget has exempted this document from
the requirement of review pursuant to Executive Order 12866.
Pursuant to the requirements of the Regulatory Flexibility Act
(Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator
has determined that regulations establishing new tolerances or raising
tolerance levels or establishing exemptions from tolerance requirements
do not have a significant economic impact on a substantial number of
small entities. A certification statement to this effect was published
in the Federal Register of May 4, 1981 (46 FR 24950).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 1, 1995.
Janet L. Andersen,
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR part 180 be amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 346a and 371.
2. Section 180.1115 is revised to read as follows:
Sec. 180.1115 Burkholderia (Pseudomonas) cepacia type Wisconsin;
exemption from the requirement of a tolerance.
The biological pesticide Burkholderia (Pseudomonas) cepacia type
Wisconsin is exempted from the requirement of a tolerance in or on all
raw agricultural commodities when applied to plant roots and seedling
roots, or as a seed treatment for growing agricultural crops
[[Page 30050]] in accordance with good agricultural practices.
[FR Doc. 95-13961 Filed 6-6-95; 8:45 am]
BILLING CODE 6560-50-F