[Federal Register Volume 60, Number 182 (Wednesday, September 20, 1995)]
[Rules and Regulations]
[Pages 48657-48659]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23318]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 4F4368/R2166; FRL-4974-1]
RIN 2070-AB78
Fliocladium Virens Isolate GL-21; 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 microbial pesticide Gliocladium virens
GL-21 in or on terrestrial food crops grown outdoors. W.R. Grace & Co.
requested this tolerance exemption pursuant to the Federal Food, Drug
and Cosmetic Act (FFDCA).
EFFECTIVE DATE: This regulation becomes effective September 20,1995.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 4F4368/R2166], 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 a 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.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect in 5.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket number [PP
4F4368/R2166]. No Confidential Business Information (CBI) should be
submitted through e-mail. Electronic copies of objections and hearing
requests on this rule may be filed online at many Federal Depository
Libraries. Additional information on electronic submissions can be
found below in this document.
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; e-mail:
greenway.denise@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the
Federal Register of September 28, 1994 (59 FR 49397), which announced
that W.R. Grace & Co., 7379 Route 32, Columbia, MD 21044, had submitted
pesticide petition (PP) 4F4368 to EPA requesting that the
Administrator, pursuant to section 408(d) of the Federal Food, Drug,
and Cosmetic Act (FFDCA), 21 U.S.C 346a(d), establish an exemption from
the requirement of a tolerance for residues of Gliocladium
[[Page 48658]]
virens GL-21 on terrestrial food crops grown outdoors. An error in the
September 24, 1994 notice of filing is corrected to specify that the
area of title 40 of the Code of Federal Regulations (CFR) to be amended
is 40 CFR 180.1100, not 40 CFR 180.1001.
There were no comments received in response to the notice of
filing.
In the Federal Register of December 6, 1990 (55 FR 50325), EPA
established an exemption from the requirement of a tolerance for
residues of the biofungicide Gliocladium virens GL-21 in or on all raw
agricultural commodities when used as a fungicide for inoculation of
plant growth media in greenhouses in accordance with good agricultural
practices.
W.R. Grace & Co. has subsequently proposed to include use of
Gliocladium virens GL-21 on terrestrial food crops grown outdoors. Like
the greenhouse treatment use for which an exemption from tolerance now
exists (40 CFR 180.1100), Gliocladium virens GL-21 blended with the
soil will control damping-off diseases, particularly those caused by
Pythium and Rhizoctonia on terrestrial food crops grown outdoors. The
Agency has determined that this use presents no new hazard issues and
that the following submitted data can support the registration for use
on terrestrial food crops grown outdoors:
Gliocladium virens GL-21 is a naturally occurring, ubiquitous soil
fungus found throughout the United States in various soil types.
Gliocladium virens GL-21 is demonstrated to be nonpathogenic and
noninfective to mammalian species as determined by the toxicological
data below. Inoculation of soil with spores of Gliocladium virens GL-21
at the dosage levels provides a sufficiently high population to control
plant pathogenic fungi of economic importance. The organism is not
persistent at the inoculated high concentrations and falls off to
background levels over a period of a few weeks. No indications of
toxicity have been reported in workers following 1 to 2 years of
working with the organism.
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 tolerance include an acute oral
toxicity/pathogenicity study, an acute pulmonary toxicity/pathogencity
study, and an acute intravenous toxicity/pathogenicity study. All
studies were conducted with the rat as the test animal. A review of
these studies indicated that the organism was not acutely toxic,
infective, or pathogenic to test animals when administered via the
oral, pulmonary, or intravenous route. Primary eye irritation and acute
dermal toxicity studies were also considered in support of the
exemption from the requirement of a tolerance. A review of the acute
dermal study indicated that the organism was not toxic to rabbits. No
reports of hypersensitivity have been recorded from personnel working
with this organism. The toxicity data provided are sufficient to show
that there are no foreseeable health hazards to humans or domestic
animals likely to arise from the use of this organism on terrestrial
food crops grown outdoors.
Residue chemistry data were not required; such data are necessary
only if the submitted toxicity studies indicate that additional Tier II
or Tier III toxicology data are needed. These additional data were not
needed. Therefore, no residue data are required in order to establish
an exemption from the requirement of a tolerance for the biological
pesticide Gliocladium virens GL-21 in or on terrestrial food crops
grown outdoors.
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
because of the low toxicity. Therefore, the requirement for an
analytical method for enforcement purposes is not applicable to this
exemption request.
The Agency hereby amends the current tolerance exemption (40 CFR
180.1100) by expanding it to include the proposed use on terrestrial
food crops grown outdoors.
Gliocladium virens GL-21 is considered useful for the purposes for
which the exemption from the requirement of tolerance is sought. Based
on the information considered, the Agency concludes 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 and the relief sought (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 possiblity 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).
A record has been established for this rulemaking under docket
number [PP 4F4368/R2166] (including objections and hearing requests
submitted electronically as described below). A public version of this
record, including printed, paper versions of electronic comments, which
does not include any information claimed as CBI, is available for
inspection from 8 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The public record is located in Room 1132 of the Public
Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Written objections and hearing requests, identified by the document
control number [PP 4F4368/R2166], may be submitted to the Hearing Clerk
(1900), Environmental Protection Agency, Rm. 3708, 401 M St., SW.,
Washington, DC 20460.
A copy of electronic objections and hearing requests filed with the
Hearing Clerk can be sent directly to EPA at:
opp-Docket@epamail.epa.gov
A copy of electronic objections and hearing requests filed with the
Hearing Clerk must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any objections and hearing requests received
electronically into printed, paper form as they are received and will
place the paper copies in the official rulemaking record which will
also include all objections and hearing
[[Page 48659]]
requests submitted directly in writing. The official rulemaking record
is the paper record maintained at the address in ADDRESSES at the
beginning of this document.
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 of 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 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: August 23, 1995.
Daniel M. Barolo,
Director, Office of Pesticide Programs.
Therefore, 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. Section 180.1100 is revised to read as follows:
Sec. 180.1100 Gliocladium virens GL-21; exemption from the
requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of the biofungicide Gliocladium virens GL-21 in or on all raw
agricultural commodities when used either as a fungicide for
inoculation of plant growth media in greenhouses or on terrestrial food
crops grown outdoors in accordance with good agricultural practices.
[FR Doc. 95-23318 Filed 9-19-95; 8:45 am]
BILLING CODE 6560-50-F
