United States
Environmental Protection
Agency
Office of Pesticides and Toxic Substances
Office of Pesticide Programs (TS-766C)
Washington, DC 20460 54 0/FS~ 91 ~H 9
PB # 91-110536
• vvEPA Pesticide
Fact Sheet
Name of Chemical:
Reason for Issuance:
Date Issued:
Fact Sheet Number:
Trichoderma harzianum Rifai Strain KRL-AG2
Registration of New Biological
November 1990
218
Descr ipt ion
i
Generic Name:
Trade Names:
EPA Shaughnessy Code:
Year of Initial
Registration:
Pesticide Type:
U.S. and Foreign
Producers:
Trichoderma harzianum Rifai Strain KRL-AG2
F-Stop Biological Fungicide Concentrate and
F-Stop Biological Fungicide Seed Protectant
128903
1990
Biofungicide
Eastman Kodak Company /
343 State Street
Rochester, New York 14650
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 and seed rot diseases
caused by Pythium species on beans (green and dry), cabbage, corn
(field and sweet), cotton, cucumbers, peanuts, potatoes,
sorghum, soybeans, sugar beets, and tomatoes.
Types of formulations: Both products are identical and are
powdered formulations containing 98% of the active ingredient.
The active ingredient is a genetically modified strain of
Trichoderma harzianum derived by protoplast fusion of two
auxotrophic mutants of Trichoderma.
Types and methods of application: The EP is a seed treatment
applied as a water-based slurry or in combination with diluents,
carriers and/or adjuvants approved for coating seed through
standard slurry or mist type commercial seed treating equipment.
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Application rate: The EP is applied at the rate of 5 ounces of
product per 100 pounds of seed.
3. Science Findings
Summary Science Statement;
The toxicological data which were submitted for this active
ingredient included reports of an acute oral toxicity/patho-
genicity 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 indicated
that the biofungicide is not toxic to, infective in, or
pathogenic to rats by oral, pulmonary or intravenous routes of
exposure.
A request that acute dermal toxicity testing be waived for
this biofungicide was made based on the fact that the parent
organism is wide spread and innocuous in nature. To support the
waiver, additional information on worker exposure was requested.
Information on the history of the production process, a summary
of sources of operator exposure and the number of exposure hours
for a typical employee were submitted. The major potential
source of worker exposure occurred during the fermentation
process. No workers have shown evidence of dermal sensitivity
to the organism and at other steps in the manufacturing process
no indication of adverse effects were shown. Based on this
information and the results of the acute studies, the acute
dermal toxicity testing was waived because there is little
likelyhood of acute effects from dermal exposure.
A primary eye irritation study was conducted on rabbits. The
Trichoderma harzianum strain initially caused slight irritation
to the eyes but no irritation was noted at 7 days after treatment
No incidents of hypersensitivity in humans have occurred during
the development of the products.
The company was also requested to identify any sources of
bacterial contamination and the steps in the manufacturing
process where contamination might occur to ensure the absence of
pathogenic microorganisms and/or toxins. No human or animal
pathogens were detected in any of the production batches of the
products.
To support the lack of adverse effects on wildlife, an avian
oral pathogenicity/toxicity study on bob white quail was
' submitted which indicated that the test organism is practically
nontoxic to terrestrial avian species by ingestion. The
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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/c'u ft.
packed - 43.6 Ibs/cu ft.
pH 6.17
Storage stability 184 days at 20°C
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 be 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
9
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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Environmental Protection Agencv
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