1 United States Office of Prevention, Environmental Protection Pesticides and Toxic Agency Substances (7501C)

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# PESTICIDE FACT SHEET
Name of Active Ingredient: Gliocladium catenulatumstrain J1446 Reason for Issuance: New Active Ingredient
Date Issued: June 1998 

### EPA Publication Number: EPA 730-F-98-017

1. DESCRIPTION OF THE MICROBIAL PESTICIDE ! Microbial Pesticide Name: Gliocladium catenulatumstrain J1446 ! Trade Name: PRIMASTOP Biofungicide ! OPP Chemical Code : 021009 ! Basic Manufacturer: Kemira Agro Oy ! US Agent: E. R. Butts 26 Sherman Court P.O. Box 764 Fairfield, CT 06430 The agency has classified PRIMASTOP as a microbial fungicide. PRIMASTOP contains living Gliocladium catenulatumstrain J1446 as the active ingredient. Gliocladium catenulatum is a naturallyoccurring saprophytic fungus, which is widespread in the environment.
2. USE PROFILE Type of Pesticide : Fungicide2 Use Sites : At this time Gliocladium catenulatumis only registered for greenhouse and indoor use. Greenhouse Food artichokes, asparagus, beans, beets, broccoli, brussel sprouts, cabbage, carrots, cauliflower, celery, chicory, chinese cabbage, corn, cucumbers, eggplant, endive, garlic, horseradish, kale, kohlrabi, leeks, lentils, lettuce, melons, New Zealand spinach, onions, parsnips, peas, peppers, potatoes, pumpkins, radishes, rutabagas, spinach, squash, strawberries, tomatoes, turnips, watermelons, aniseed, basil, caraway, chives, dill, fennel, lavender, marjoram, oregano, parsley, rosemary, sage, savory, thyme, watercress Greenhouse Non-Food ornamentals (including flowers, foliage and potted, bedding and seedling plants), tree and shrub seedlings Indoor ornamentals (including flowers, foliage and potted, bedding and seedling plants), tree and shrub seedlings Target Pests for Active Ingredient : to control damping-off, seed rot, root and stem rot, and wilt diseases caused by Rhizoctonia, Pythium, Phytophthora, Fusarium, Didymella, Botrytis, Verticillium, Alternaria, Cladosporium, Helminthosporium, Penicillium , and Plicaria Timing Product may be applied at sowing, potting or transplanting and 2-6 weeks later, after emergence. Cuttings, bulbs, or tubers may be treated before planting or storage. The timing for applying foliar spray is not specified.

3. SCIENCE ASSESSMENT Toxicology: There is a reasonable certainty that no harm will result from exposure to Gliocladium catenulatumstrain J1446. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. All mammalian toxicology data requirements have been submitted and adequately satisfy data requirements to support registration. The acute oral, acute pulmonary toxicity/pathogenicity, acute dermal irritation and acute eye irritation studies resulted in Toxicity Category IV classifications and indicated that the microbial pesticide is not pathogenic or infective in a single dose. The acute pulmonary toxicity/pathogenicity test resulted in a Toxicity Category III classification based upon the dose level. In the acute intra-peritoneal toxicity/pathogenicity study G. catenulatum strain J1446 demonstrated no signs of toxicity or infectivity. Subchronic and chronic toxicity were not required because survival, replication, infectivity, toxicity, or persistence of the microbial agent was not observed in the test animals treated in the acute oral infectivity test. The Agency has no information to suggest that Gliocladium catenulatum has an effect on the immune and endocrine systems. No specific tests have been conducted with Gliocladium catenulatum strain J1446 to determine such effects. However, as is expected from a non-pathogenic microorganism, the submitted toxicity/pathogenicity studies in rodents indicated that following several routes of exposure, the immune system is still intact and able to process and clear the active ingredient. There are no reports indicating3 that Gliocladium catenulatumstrain J1446 produces any toxins or antibiotics. Therefore, it is unlikely that this organism would have estrogenic or endocrine effects because it is practically non-toxic to mammals. Occupational Exposure and Risk Characterization Occupational exposures and subsequent risks from use of Gliocladium catenulatum J1446 are negligible because the organism has been determined not to be pathogenic to humans and animals. The risks are expected to be minimal based on evaluations of submitted Tier I acute toxicity tests. Based on the application methods listed on the product label, the potential for dermal, eye and inhalation exposures for pesticide handlers exists. Occupational exposure data, although not required, was provided. This data indicates that research with Gliocladium catenulatumJ1446 biofungicide has continued at the Agricultural Research Centre since 1991 and at Kemira Agro Oy Espoo Research Centre since 1993. During these years, an average of 4 persons per year have worked with Gliocladium catenulatumJ1446 biofungicide on a full-time basis, and 9 persons per year on a part-time basis. There has been no evidence that the Gliocladium catenulatumJ1446 biofungicide has caused allergic reactions or other adverse effects to the personnel involved in this work. There may be subpopulations yet to be identified that are prone to allergic reactions from frequent exposure to concentrated levels of G. catenulatum. The required personal protective equipment (PPE) for applicators and handlers is expected to adequately reduce inhalation or dermal exposure to this microbial pesticide. These required PPE are: Long sleeved shirt and long pants. Waterproof gloves. Shoes plus socks. Dust/mist filtering respirator (MSHA/NIOSH approval number prefix TC-21C), or a NIOSH approved respirator with any N, P, R, or HE filter. Food Quality Protection Act Requirements Safety factors from the Food Quality Protection Act (FQPA) were evaluated. These factors included available information concerning the aggregate exposure levels of consumers and users to the pesticide residue and to other related substances. On the basis of G. catenulatum ’s lack of infectivity and toxicity and this product’s limited use pattern, the Agency has determined that there is a reasonable certainty of no harm to the general population, infants, children, and the environment from exposure to this microbial pesticide. Aggregate Exposure from Multiple Routes Including Dermal, Oral, and Inhalation The health risk is expected to be negligible for oral, dermal, and inhalation exposure routes. The potential aggregate exposure, derived from dermal and inhalation exposure via mixing, loading and applying Gliocladium catenulatum Strain 1446, the dietary exposure from drinking water and treated produce containing this organism, should fall well below the currently tested microbial safety levels. In summary, the potential aggregate exposure, derived from non-dietary and non-occupational exposure, should be minimal.
Cumulative Effects Gliocladium catenulatumstrain J1446 is practically non-toxic to mammals. No mechanism of toxicity in mammals has been identified for this organism. Therefore no cumulative effect with other related organisms is anticipated. Ecological Toxicity:4 The intended applications of G. catenulatum to greenhouse food crop, greenhouse non-food crop and indoor use patterns are not expected to pose adverse risks to non-target organisms. Non-target organism testing data are not required for these use patterns of G. catenulatum

. Environmental Fate Environmental fate data were waived because Gliocladium catenulatumstrain J1446 is a naturally occurring saprophytic soil fungus and this genus and species is found throughout the world in a variety of soil types. The ubiquitous nature of the organism suggests that the environmental burden is not likely to increase substantially with the proposed limited indoor and greenhouse use patterns of the microbial pesticide. There were no incidents of pathogenicity or toxicity by G. catenulatum to non-target organisms in the literature searches provided.
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. TOLERANCES FOR FOOD USES AND /OR EXEMPTIONS EPA is issuing a notice establishing an exemption from the requirements of a tolerance for residues of Gliocladium catenulatumstrain J1446 in or on all food commodities.
5. SUMMARY OF DATA GAPS: There are no major data gaps.
6. REGULATORY POSITION: Unconditional Registration

7. CONTACT PERSON AT EPA Office location/telephone number Susanne Cerrelli Room 902 W48, Crystal Mall 2 Regulatory Action Leader 1921 Jefferson Davis Highway Biopesticides and Pollution Arlington, VA 22202 Prevention D ivision (7511C) (703) 308-8077 Office of Pesticide Programs Environmental Protection Agency 410 M Street, S.W. Washington, D.C. 20460
DISCLAIMER: The information in this Pesticide Fact Sheet is a summary only and is not to be used to satisfy data requirements for pesticide registration and reregistration. Contact the Regulatory Action Leader listed above for further information.