United States
                              Environmental Protection
                              Agency
             Office of Pesticides and Toxic Substances
             Office of Pesticide Programs (TS-766C)
             Washington. DC 20460   54Q/FS~91-118
              	PR  # 91-110528
       4>EPA       Pesticide
                              Fact Sheet
                              Name of Chemical:  Giiociadium virens 01-21
                              Reason for Issuance: Registration of New Biological
                                                 Pesticide
                              Date Issued:
                              Fact Sheet Number:
            November 1990

             217
         1.  Description

             Generic Name:

             Trade Names:

             EPA Shaughnessy Code:

             Year of Initial
              Registration:

             Pesticide Type:

             U.S. and Foreign  '
              Producers:
Giiociadium virens GL-21

WRC-GL-21 and WRC-AP-1

128900-8


1990

Biofungicide
W.R.  Grace & Co.
7379  Route 32
Columbia, MD  21044
         2.  Use Patterns and Formulations

             Application sites:  The manufacturing use product (MP)  is
              for use only in the formulation of fungicides.  The end-use
              product (EP) is for use in the control of damping-off
              diseases, particularly those caused by Pythium and
              Rhizoctonia, of greenhouse ornamental and food crops.

             Types of formulations:  A liquid MP containing 20% active
              ingredient and a granular EP containing 12% active ingredient.

             Types and methods of application:  The EP is blended with soil
              or soilless plant growing media at least 3 days prior  to
              planting or incorporated into the media surface in plant beds
              prior to or at planting.
                                                                         Printed on Recycled Paper

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    Application rate:   The EP is applied  at  the  rate of
     1-1 1/4 ounces/cubic foot of media when blended or at the
     rate of 3/4 - 1 ounce/square foot of bed surface.


3.   Science Findings

    Summary Science statement:

    The toxicological data which were submitted  for this active
    ingredient included reports of an acute  oral toxicity/
    pathogenicity study,  an acute pulmonary  toxicity/pathogenicity
    study and an acute intravenous toxicity/pathogenicity study.
    The studies were performed using rats.   All  studies were
    classified as acceptable.  The review of these studies
    indicates that the biofungicide is not toxic to, infective in,
    or pathogenic to rats by oral or pulmonary routes of exposure
    and not infective or  pathogenic to rats  by intravenous
    injection.  Mycelium  of the fungus was used  for the injections
    and was found to be acutely toxic and lethal to test animals
    due to mechanical clogging of capillaries, however, these
    mortalities were not  considered to be relevant in this case
    since injection is not a normal route of exposure and the
    product consists of chlamydospores rather than mycelium.

    Acute dermal toxicity testing was not required for this
    biofungicide based on the facts that  the end-use product
    consists of large pellets, the label  will require that gloves be
    worn when handling the product and application will be by soil
    incorporation.  A primary eye irritation study was not required
    since protective eye  covering must be worn.   The inert materials
    in the product have been exempted from the requirement for a
    tolerance in 180.1001 and no indications of toxicity were
    reported  in workers following 1-2 years of working with the
    organism.

    Although Gliocladium strains are known to produce certain
    toxins, data were submitted which showed that only one of the
    known toxins  (gliotoxin) was produced in detectable amounts.
    Since gliotoxin is sensitive to oxidation, the levels that may
    exist in  the product are not considered to be of toxicological
    significance since the toxin will be rapidly degraded. This
    conclusion  is supported by the demonstrated lack of toxicity
    in the oral and pulmonary studies conducted on rats.

    Data requirements for evaluating adverse effects on birds,
    wild mammals, freshwater fish, freshwater aquatic

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requirement for tests on aquatic birds was waived because it is
not expected that the fungus will enter the aquatic environment
since its only use is as a seed treatment.  Data requirements
for evaluating adverse effects on freshwater fish and
invertebrates, estuarine and marine organisms, nontarget
plants and insects and honey bees were waived.  The seed
treatment use pattern makes it unlikely that Trichoderma would
enter aquatic environments, contact nontarget plant species or
that honey bees or other insects would be exposed to the organism.

Because only minimal exposure, if any, to nontarget organisms may
occur from the use of this biofungicide as a seed treatment, there
is not expected to be a "may effect" situation with regard to
endangered species.

Data for environmental fate (Tier II) are not required for this
biofungicide because no more than negligible environmental
exposure associated with the seed treatment use is likely and the
initial (Tier I) tests were waived or not required.

Chemical Characteristics:
Property                    MP and EP

Color                       yellow-green
Physical state              powder
Odor                        vinegar
Density/bulk density        fluffed - 28.8 Ibs/cu ft.
                            packed  - 43.6 Ibs/cu ft.
pH                          6.17
Storage stability           184 days at 20C
Viscosity                   N/A
Miscibility                 N/A
Corrosion characteristics   N/A

Toxicological Characteristics:

Acute effects:  Data were submitted for acute toxicity/
pathogenicity as determined in oral, pulmonary and intravenous
tests.  Data were classified acceptable.  The tests indicated
that the product was not toxic to, infective in or pathogenic
to rats.

Other toxicity information:  Information was submitted which
demonstrated that no human or animal pathogens were detected
during the manufacturing process.  Information was included
on the history of the production process,  a summary of sources
of operator exposure and number of exposure hours for a typical

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    employee.   No hypersensitivity or other toxicological effects
    attributable to working with the organism were reported.

    Ecological Effects;

    Data on the ecological effects of the biofungicide were
    included only for an avian oral pathogenicity/toxicity study
    on bob white quail.   The test organism was practically nontoxic
    to terrestrial avian species by ingestion.   Data requirements
    for all other ecological effects testing were waived based on
    the nature of the fungus and the facts that it is unlikely that
    the organism will enter aquatic environments and minimal
    exposure would be likely due to the seed treatment use pattern.

4.  Benefits

    The use of the end-use product will be beneficial in the  control
    of damping-off and seed rot diseases of seedling plants which
    may be a source of economic loss by reducing the stand of plants
    in the field.  The availability of a biological fungicide would
    provide a less toxic alternative to the currently registered
    chemical seed treatments.

5.  Tolerance Assessment

    An exemption from the requirement for a tolerance for residues
    of Trichoderma harzianum Rifai Strain KRL-AG2 on beans, (green
    and dry),  cabbage, corn (field and sweet),  cotton, cucumbers,
    peanuts, potatoes, sorghum, soybeans, sugar beets, and tomatoes
    when used as a seed treatment in accordance with good
    agricultural practices was requested.  Since testing of the
    biofungicide showed not evidence of effects which would be of
    toxicological concern, an exemption will t>e granted.

6.  Summary of Major Data Gaps

    No data gaps exist for this active ingredient.

    Contact Person at EPA

    Susan T. Lewis
    Product Manager (21)
    Fungicide-Herbicide Branch
    Registration Division (H-7505C)
    Environmental Protection Agency
    401 M St.", SW.
    Washington, DC  20460

DISCLAIMER:  The information presented in this Pesticide Fact Sheet
is for informational purposes only and may not be used to fulfill
data requirements for pesticide registration and reregistration..

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