[Federal Register Volume 59, Number 109 (Wednesday, June 8, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-13675]


[[Page Unknown]]

[Federal Register: June 8, 1994]


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DEPARTMENT OF EDUCATION
 

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[PP 4F4284/R2063; FRL-4865-8]
RIN 2070-AB78

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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This rule establishes 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.

EFFECTIVE DATE: Effective on May 25, 1994.

ADDRESSES: Written objections, identified by the document control 
number [PP 4F4284/R2063], may be submitted to the: Hearing Clerk 
(1900), Environmental Protection Agency, Rm. M-3708, 401 M St., SW., 
Washington, DC 20460.

FOR FURTHER INFORMATION CONTACT: Steve Robbins, 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 Hwy., Arlington, 
VA 22202, (703)- 305-6900.

SUPPLEMENTARY INFORMATION: EPA received from Gustafson, Inc., P.O. Box 
660065, Dallas, TX 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 of December 22, 
1993 (58 FR 67791). A rule proposing to establish an exemption from the 
requirement for a tolerance for this organism was published in the 
Federal Register of April 13, 1994 (59 FR 17509). No comments were 
received in response to the Federal Register documents.
    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 established as set forth below.
    Any person adversely affected by this regulation may, within 30 
days after publication of this document in the Federal Register, file 
written objections with the Hearing Clerk, at the address given above. 
40 CFR 178.20. The objections submitted must specify the provisions of 
the regulation deemed objectionable and the grounds for the objections. 
40 CFR 178.25. Each objection must be accompanied by the fee prescribed 
in 40 CFR 178.27. A request for a hearing will be granted if the 
Administrator determines that the material submitted shows the 
following: There is a genuine and substantial issue of fact; there is a 
reasonable possibility that available evidence identified by the 
requestor would, if established, resolve one or more of such issues in 
favor of the requestor, taking into account uncontested claims to the 
contrary; and resolution of factual issue(s) in the manner sought by 
the requestor would be adequate to justify the action requested. 40 CFR 
178.32.
    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: May 25, 1994.

Daniel M. Barolo,
Acting Director, Office of Pesticide 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. 94-13675 Filed 6-7-94; 8:45 am]
BILLING CODE 6560-50-F