[Federal Register Volume 60, Number 109 (Wednesday, June 7, 1995)]
[Proposed Rules]
[Pages 30048-30050]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-13961]



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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: [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 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: 
[email protected].

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-D[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.
    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