[Federal Register Volume 59, Number 124 (Wednesday, June 29, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-15678]
[[Page Unknown]]
[Federal Register: June 29, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 3F4242/R2066; FRL-4873-2]
RIN No. 2070-AB78
Ampelomyces Quisqualis Isolate M10; 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 of a
tolerance for residues of the biological fungicide Ampelomyces
quisqualis isolate M10 in or on all raw agricultural commodities when
used as a fungicide on agricultural crops in accordance with good
agricultural practices. This exemption was requested by Ecogen, Inc.
EFFECTIVE DATE: This regulation becomes effective June 17, 1994.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 3F4242/R2066], 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
requests 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: Steve Robbins, 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 issued a notice in the Federal Register
of May 11, 1994 (59 FR 24429), announcing that Ecogen, Inc., 2005 Cabot
Blvd., West Langhorne, PA 19047, had submitted pesticide petition (PP)
3F4242 to EPA proposing to amend 40 CFR part 180 by establishing a
regulation under 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 fungicide Ampelomyces quisqualis isolate M10
in or on all raw agricultural commodities when used as a fungicide on
agricultural crops in accordance with good agricultural practices.
No comments were received in response to the notice of filing.
This organism is a naturally occurring strain of Ampelomyces which
was isolated from powdery mildew (Oidium sp.) that was infecting Cynia
plants growing in Israel. Ampelomyces quisqualis is a well known
hyperparasite of the Erysiphaceae family, a pathogenic fungus that
causes powdery mildew diseases on a wide variety of plant species.
Strains of Ampelomyces are not generally regarded as human, animal, or
plant pathogens. The product containing this organism is intended to be
applied as a foliar spray to plants susceptible to infection by powdery
mildew fungi such as apples, cucurbits, grapes, strawberries, and
tomatoes.
The data submitted in the petition and 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, an acute dermal toxicity study, an acute
pulmonary toxicity/pathogenicity study, an acute intraperitoneal
toxicity/pathogenicity study, a primary eye irritation study, and a
primary dermal irritation study.
A review of these studies indicated that the organism was not
toxic, pathogenic, or infective to test animals when administered via
oral or dermal routes of exposure. Mortality to treated rats was
observed in the acute pulmonary test immediately following dosing and
could be related to toxic response or could simply be the result of
dose administration. The results of the pulmonary study are not
directly related to the exemption from tolerance requirements since
consumers of agricultural products would not be exposed to the organism
in this manner. Ampelomyces quisqualis was not pathogenic or infective
to rats in this study or in the acute intraperitoneal toxicity/
pathogenicity study. When rats were dosed intraperitoneally, there was
a failure to gain weight through day 7 of the test, and lesions were
present on the organs in the peritoneum, indicating slight toxicity,
which may be caused by the injection of either the live or killed
microbe. These effects were minimal and reversible and therefore not
considered significant toxic effects. Minimal ocular irritation in
rabbits was noted in the primary eye irritation study, and the product
was found to be nonirritating to rabbits in the primary dermal
irritation study. All of the toxicity studies submitted are considered
acceptable and are sufficient to demonstrate that no foreseeable health
hazards to humans or domestic animals are likely to arise from the use
of this organism as a fungicide on agricultural crops.
Acceptable daily intake (ADI) and maximum permissible intake (MPI)
considerations are not relevant to this petition because the data
submitted demonstrate that this biological control agent is not toxic
to humans by dietary exposure. 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 biological
control agent. Ampelomyces quisqualis isolate M10 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 establishment of a tolerance is not necessary to 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 and/or request for 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 each such issue, 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; the
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.
The Office of Management and Budget has exempted this rule from the
requirements of section 3 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 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 17, 1994.
Daniel M. Barolo,
Director, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is amended as follows:
PART 180--[AMENDED]
a. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
b. In subpart D, by adding new Sec. 180.1131, to read as follows:
Sec. 180.1131 Ampelomyces quisqualis isolate M10; exemption from the
requirement of a tolerance.
The biological fungicide Ampelomyces quisqualis isolate M10 is
exempted from the requirement of a tolerance in or on all raw
agricultural commodities when used as a fungicide on agricultural crops
in accordance with good agricultural practices.
[FR Doc. 94-15678 Filed 6-28-94; 8:45 am]
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