[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
