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gliocladium virens GL-21 (WRC-GL-21) Tolerance Requirement Exemption 8/95

[Federal Register: September 20, 1995 (Volume 60, Number 182)]
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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 
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 
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.