[Federal Register Volume 60, Number 40 (Wednesday, March 1, 1995)]
[Rules and Regulations]
[Pages 11032-11033]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-4599]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[PP 4F4351/R2108; FRL-4938-1]
RIN 2070-AB78


Candida Oleophila Isolate I-182; Exemption From the Requirement 
of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This document establishes an exemption from the requirement of 
a tolerance for residues of the post-harvest biological fungicide 
Candida oleophila isolate I-182. Ecogen, Inc., requested this tolerance 
exemption.

EFFECTIVE DATE: This regulation becomes effective on March 1, 1995.

ADDRESSES: Written objections and hearing requests, identified by the 
document control number, [PP 4F4351/R2108], may be submitted to: 
Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M 
St., SW., Washington, DC 20460. A copy of any objections and hearing 
requests filed with the Hearing Clerk should be identified by the 
document control number and submitted 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 copy of objections and hearing 
request to: Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 
22202. Fees accompanying objections shall be labeled ``Tolerance 
Petition Fees'' and forwarded to: EPA Headquarters Accounting 
Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh, 
PA 15251.

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: CS51L6, CS #1, 2800 Crystal Drive, 
Arlington, VA 22202, (703)-308-8263.

SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the 
Federal Register of September 28, 1994 (59 FR 49396), which announced 
that Ecogen, Inc., 2005 Cabot Blvd. West, Langhorne, PA 19047, had 
submitted pesticide petition (PP) 4F4351 to EPA requesting that the 
Administrator, pursuant to section 408(d) of the Federal Food, Drug, 
and Cosemtic Act (FFDCA), 21 U.S.C. 346a(d), establish an exemption 
from the requirement of a tolerance for residues of Candida oleophila 
isolate I-182 in or on all raw agricultural commodities. Errors in the 
September 28, 1994 notice of filing were corrected in the Federal 
Register of November 2, 1994 (59 FR 54911), to specify that C. 
oleophila isolate I-182 is a biological fungicide, not an insecticide, 
and that the area of title 40 of the Code of Federal Regulations (CFR) 
to be amended is 40 CFR part 180, not 40 CFR 180.1001(c) and (d).
    There were no comments received in response to these notices of 
filing. 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 are 
summarized as follows:
    Rats have been challenged with high doses of the pure preparations 
of C. oleophila by the oral, pulmonary, and interperitoneal routes of 
exposure. In each of these tests, the test animals survived to the end 
of the study without visible signs of toxicity or pathogenicity from 
the presence of C. oleophila. The test microbe was not isolated from 
any organs or tissues on day 3 in the oral and pulmonary studies and on 
day 7 in the interperitoneal injection study. These findings indicate 
that the test microbe was recognized by the immune system and cleared 
from the rats by the normal routes. In addition, the end-product 
formulation of C. oleophila was tested for dermal toxicity/irritation, 
eye irritation, and acute oral toxicity and showed no mortality or 
significant signs of toxicity.
    Candida oleophila isolate I-182 is a microbial pesticide as defined 
by 40 CFR 158.65. The toxicity studies provided are sufficient to show 
that there are no foreseeable human or domestic health hazards likely 
to arise from the use of the product to control post-harvest decay in 
citrus and pome fruit.
    Acceptable daily intake (ADI) and maximum permissible intake (MPI) 
considerations are not relevant to this petition. Enforcement actions 
based on the level of residue found in a commodity are not expected. 
Therefore, the requirement for an analytical method for enforcement 
purposes is not applicable to this exemption request. Candida oleophila 
isolate I-182 is considered useful for the purposes for which the 
exemption from tolerance is sought. Based on the information and data 
considered, the Agency concludes [[Page 11033]] that the establishment 
of a tolerance is not necessary to protect the public health. 
Therefore, the exemption from requirement of a tolerance 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 and/or request a hearing with the Hearing Clerk, at 
the address given above (40 CFR 178.20). A copy of the objections and/
or hearing requests filed with the Hearing Clerk should be submitted to 
the OPP docket for this rulemaking. 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 by 40 CFR 180.33(i). If a hearing is 
requested, the objections must include a statement of the factual 
issue(s) on which a hearing is requested, the requestor's contentions 
on such issues, and a summary of any evidence relied upon by the 
objector (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 or facts 
to the contrary; and resolution of the factual issue(s) in the manner 
sought by the requestor would be adequate to justify the action 
requested (40 CFR 178.32).
    Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency 
must determine whether the regulatory action is ``significant'' and 
therefore subject to review by the Office of Management and Budget 
(OMB) and the requirements of the Executive Order. Under section 3(f), 
the order defines a ``significant regulatory action'' as an action that 
is likely to result in a rule (1) having an annual effect on the 
economy of $100 million or more, or adversely and materially affecting 
a sector of the economy, productivity, competition, jobs, the 
environment, public health or safety, or State, local, or tribal 
governments or communities (also referred to as ``economically 
significant''); (2) creating serious inconsistency or otherwise 
interfering with an action taken or planned by another agency; (3) 
materially altering the budgetary impacts of entitlement, grants, user 
fees, or loan programs or the rights and obligations or recipients 
thereof; or (4) raising novel legal or policy issues arising out of 
legal mandates, the President's priorities, or the principles set forth 
in this Executive Order.
    Pursuant to the terms of the Executive Order, EPA has determined 
that this rule is not ``significant'' and is therefore not subject to 
OMB review.
    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: February 14, 1995.

Daniel M. Barolo,
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. In subpart D, by adding new Sec. 180.1144, to read as follows:


Sec. 180.1144   Candida oleophila isolate I-182; exemption from the 
requirement of a tolerance.

    Candida oleophila isolate I-182, when used as a post-harvest 
biological fungicide, is exempted from the requirement of a tolerance 
in or on all raw agricultural commodities.

[FR Doc. 95-4599 Filed 2-28-95; 8:45 am]
BILLING CODE 6560-50-F