[Federal Register Volume 59, Number 71 (Wednesday, April 13, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-8875]


[[Page Unknown]]

[Federal Register: April 13, 1994]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[PP4F4284/R2051; FRL-4771-8]

 

Bacillus Subtilis MBI 600; Proposed Exemption from the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This document proposes establishing an exemption from the 
requirement for a tolerance for residues of the biofungicide Bacillus 
subtilis MBI 600 in or on all raw agricultural commodities when applied 
as a seed treatment for growing agricultural crops in accordance with 
good agricultural practices. This exemption was requested by Gustafson, 
Inc., Dallas, Texas.

DATES: Written comments, identified by the document control number 
[PP4F4284/R2051], must be received on or before May 13, 1994.

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 22202, (703) 305-6900.
    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 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 Virginia address given above from 8 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: Sidney C. Jackson, Acting 
Product Manager (PM) 21, Registration Division (7505C), Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location and telephone number: Rm. 227, CM #2, 1921 Jefferson Davis 
Highway, Arlington, VA 22202, (703) 305-6900.

SUPPLEMENTARY INFORMATION: EPA received from Gustafson, Inc., P.O. Box 
660065, Dallas, Texas 75266-0065, pesticide petition (PP) 4F4284 on 
March 2, 1993, proposing to amend 40 CFR part 180 by establishing a 
regulation pursuant to the Federal Food, Drug and Cosmetics Act, 21 
U.S.C 346a and 371, to exempt from the requirement of a tolerance the 
residues of the biofungicide Bacillus subtilis MBI 600 in or on all raw 
agricultural commodities when applied as a seed treatment for growing 
agricultural crops in accordance with good agricultural practices. The 
notice of application to register Bacillus subtilis MBI 600 as a new 
active ingredient was published in the Federal Register (58 FR 67791) 
on December 22, 1993. No comments were received in response to the FR 
Notice.
    Strain MBI 600 of the bacterium Bacillus subtilis is a naturally 
occurring isolate of the spore-forming genus Bacillus which was first 
isolated from faba bean plants growing at Nottingham University School 
of Agriculture, Sutton Boningham, United Kingdom. Bacillus subtilis is 
a soil saprophyte found world-wide. Strains of this organism are not 
generally regarded as human or animal pathogens. The product is 
intended to be used as a seed treatment. When applied to seeds, the 
bacteria colonize the developing root system, competing with disease 
organisms which attack roots.
    The data submitted in the petition and all other relevant material 
have been evaluated. The toxicological data considered in support of 
the exemption from the requirement of a tolerance include an acute oral 
toxicity/pathogenicity study in the rat, an acute dermal toxicity study 
in the rabbit, an acute pulmonary toxicity/pathogenicity study in the 
rat, an acute intravenous toxicity/pathogenicity study in the rat, a 
primary eye irritation study in the rabbit, and a delayed contact 
hypersensitivity study in the guinea pig. These studies were performed 
on the active ingredient and the end-use product Gus 376 Concentrate 
Biological Fungicide. A review of these studies indicated that the 
biofungicide was not toxic to test animals when administered via the 
oral, dermal, intravenous or pulmonary routes. The active ingredient 
was not infective or pathogenic for test animals when administered via 
the oral, pulmonary or intravenous route. The end-use product produced 
slight ocular irritation which dissipated within 4 days of dosing. An 
overall moderate skin sensitization reaction was noted in the treated 
guinea pigs 24 to 72 hours following treatment. 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 human or domestic health hazards likely to 
arise from the use of the product as a seed treatment.
    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. This is the first exemption from 
the requirement of a tolerance for this biofungicide.
    Bacillus subtilis MBI 600 is considered useful for the purpose for 
which the exemption from the requirement of a tolerance is sought. 
Based on the information considered, the Agency concludes that 
establishment of the exemption will protect the public health. 
Therefore, the regulation is proposed as set forth below.
    Interested persons are invited to submit written comments on the 
proposed rule. Comments must bear a notation indicating the document 
control number [PP4F4284/R2051]. All written comments filed in response 
to this petition will be available in the Public Response and Program 
Resources Branch at the Virginia address given above from 8 a.m to 4 
p.m., Monday through Friday, except legal holidays.
    The Office of Management and Budget has exempted this rule from the 
requirements of section 2 of 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 an 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 procedures, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: April 5, 1994.

Stephen L. Johnson,
Acting Director, Registration Division, Office of Pesticides Programs.

    Therefore, 40 CFR part 180 is 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. By adding new Sec. 180.1128, to read as follows:


Sec. 180.1128  Bacillus subtilis MBI 600; exemption from the 
requirement of a tolerance.

    The biofungicide Bacillus subtilis MBI 600 is exempted from the 
requirement of a tolerance in or on all raw agricultural commodities 
when applied as a seed treatment on seeds used for growing agricultural 
crops in accordance with good agricultural practices.

[FR Doc. 94-8875 Filed 4-12-94; 8:45 am]
BILLING CODE 6560-50-F