UnK«* Stat« 0«o« of P«rttcW« *nd Toxic fcitHMnM* En.tfoniwnfl Protection OHica of talleMo Pro»rmw tTS^6SC) A«»«cy WtaMn^on, DC 20400 540/FS-89-024 oEPA Pesticide Fact Sheet Name of Chemical: Baclllus thuringiensis Reason for Issuance: Registration Standard Date Issued: December 1988 Fact Sheet Number: 93.0 1- DESCRIPTION OF TOE MICROBIAL PESTICIDE Generic Name: Bacillus thurinqiensis Common Name: Bt Trade and Other Names Trade names for Bacillus thurinqiensis subspecies kurstaki include: Dipel, Thuricide, Bactospeine, Leptox, Novabac, Rig Time, Cekubacillina, Attack, Foray, and Javelin. Trade names for Bacillus thurinqiensis subspecies israelensis include: Bactimos, Teknar, and Vectobac. The trade name for Bacillus thurinqiensis subspecies aizawai is Certan. Hie trade name for Bacillus thurinqiensis subspecies san dieqo is M-One. Hie trade name for Bacillus thurinqiensis subspecies tenebrionis is Trident. EPA Shaughnessy Codes (OPP Chemical Codes) Microbial Pesticide Name: Bacillus thurinqiensis (all OPP Chemical Code: 006401 subspecies) Microbial Pesticide Name: Bacillus thurinqiensis subsp. OPP Chemical code: 006401 israelensis ------- Microbial Pesticide Name: Bacillus thurinaiertsis subsp. OPP Chemical Oode: 006402 kurstaki Microbial Pesticide Name: Bacillus thurinaiertsis subsp. OPP Chemical Code: 006403 aizawai Microbial Pesticide Name: Bacillus thuriraiensis subsp. OPP Chemical Oode: 128946 san diego Microbial Pesticide Name: Bacillus thurirwiensis subsp. OPP Chemical Oode: 006405 tenebrionis Year of Initial Registration: 1961 Pesticide Type: Insecticide U.S. and Foreign Produoers: Bacillus thurinaiertsis subsp. israelensis - Abbott Laboratories, Chicago, IL - Duphar B.V., Weesp, Holland - Novo Industri AS, Copenhagen, Denmark - Zoeoon Corporation, A Sandoz Company Dallas, Texas Bacillus thurinaiensis subsp. kurstaki - Abbott laboratories, Chicago, IL - Duphar B.V., Weesp, Holland - Novo Industri AS, Copenhagen, Denmark - Sandoz Crop Protection Corp., Des Plaines, IL - Eoogen, Inc., Langhorne, PA Bacillus thurinaiensis subsp. aizawai - Sandoz Crop Protection Corp., Des Plaines, IL Bacillus thurinqiensis subsp. san dieao - Mycogen Corporation, San Diego, CA Bacillus thuriroiensis subsp. tenebrionis - Sandoz Crop Protection Corp., Des Plaines, IL 02 ------- 2- USE PATTERNS AND FORMULATIONS Target Pests: Bacillus thurinqiensis subsp. israelensis: moscjiito (larvae), fungus gnats (larvae), and black flies (larvae); B.t. subsp. aizawai: Greater wax moth (larvae) ; B.t. subsp. kurstaki: Lepidopterous larvae B.t. subsp. san dieoo: Colorado potato beetle (larvae) and elm leaf beetle (larvae and adults) B.t. subsp. tenebrionis: Colorado potato beetle Registered Uses: B.t. subsp. israelensis: Terrestrial food crop use on pastures; Aquatic food crop use on rice; Aquatic nonfood crop use on brackish water, mangrove swanps, salt marshes, tidal water, drainage systems, irrigation systems, flood water areas, woodland pools, standing water, polluted water, sewage waste lagoons, ponds, lakes, and streams; Greenhouse nonfood crop use on orna- mental plants; Domestic outdoor use on standing water around the dwellings. B.t. subsp. aizawai: Indoor use on enpty honeycombs. B.t. subsp. kurstaki: Terrestrial food crop uses on cotton, corn, soybeans, sorghum (grain crop), small grains, hops, fruits (banana,blueberry, caneberries, cranberry, currant, citrus fruits, grapes, kiwi fruit, pome fruits, stone fruits, small fruits, strawberry, tropical fruits, vegetables (artichoke, asparagus, avocado, beans, beets, carrots, celery, cole crops, cucumber, dandelion, ecpgplant, endive, lentils, lettuoe, melons, okra, onions, parsley, parsnip, peas, pepper, potato, punpkin, radish, rutabaga, safflower, spinach, squash, 03 ------- sugar beets, sugar maple, sunflcwer, sweet potato, Swiss chard, ti, tomato, watercress, watermelon), nuts (nut crops, nut trees, peanut, walnut), flavoring and spioe crops, garlic, horseradish, mint, salisfy, and forage crops, alfalfa, hayage, pastures and rangelands; Terrestrial nonfood crop uses on tobacco, ornamental flowering and herbaoeous plants, ornamental and/or shade trees, and ornamental turf; Aquatic food crop use on rice and wild rice; Greenhouse food crop uses on beans, beets, carrots, celery, cole crops, cucumber, eggplant, endive, flavoring and spioe crops, garlic, lentils, lettuce, melons, onions, parsley, peas, peppers, potato, radish, spinach, squash, sweet potato, strawberry, tcmato. Greenhouse nonfood crop uses on agricultural research crops and ornamental flcwering, herbaoeous and woody plants; Forestry uses on forest trees; Indoor uses on stored birdseed; herbs, spices, and condiments; grain crops; peanuts; agricultural and oil seeds; soybeans, sunflower, and tobaooo (including flue-cured). B.t. subsp. san diego: Terrestrial food crop uses on egg- plant, potato and tomato; Terrestrial nonfood crop uses on elm trees. B.t. subsp. tenebrionis: Terrestrial food crop use chi potatoes. Methods of Application: Hand sprayer; water treatment by aerial or ground equipment; soil application by drip or overhead irrigation systems; foliar application by aerial, conventional ground or 04 ------- harid-held equipment and center-pivot irrigation systems; sprayer or sprinkler cans. Formulations: Technicals, formulation intermediate, dusts, granular, pelletecy tablet, lettable pcwder, enulsifiable conoentrate, flowable concentrate, ready-to-use, and pressurized liquid. 3. SCIENCE FINDINGS The Agency reviewed arid evaluated available data, including both data submitted to the Agency in support of registration of B. thurimiensis as an active ingredient and data from the published literature. This information served as the basis for issuance of a draft Registration Standard in 1986. On October 10, 1986, the Agency informed the public regarding the availability of the draft Registration Standard for comment in the FEDERAL REGISTER, 51 FR 37488. In the ocranent period of two months, five ceranenters responded to the Agency. All comments have been taken into consideration in the issuanoe of this final Registration Standard. The specific conments, as well as the Agency's responses, are present in the public docket assigned to this Registration Standard. In the 1986 draft Registration Standard, the Agency concluded that adequate data were available to assess the toxicological and other biological effects of B. thurinaiensis on manuals, that no data gaps existed in the toxicology data base, and that there were no substantial human or environmental safety conoems except for certain endangered lepidopteran insect species. Although substantial gaps were found to exist in the ecological effects data base, there were no substantive concerns regarding unreasonable adverse effects of B. thurimiensis for the registered products. Therefore, the Agency concluded that the use of B. thurimiensis products could be continued, and that products could be used as registered, with only minor precautionary labeling changes and additional nontarget organism data being required. Since the issuanoe of the 1986 draft Registration Standard, the Agency has revised the Pesticide Assessment Guidelines Subdivision M, reassessed hazard to endangered species, and has reviewed additional data on B. thurimiensis. The Agency has also more keenly focused cm product identity; i.e., strain-to-strain variability within subspecies designations. Current methods applicable to strain identification have advanced considerably since the initial B. thurimiensis registration (1961). As with conventional chemical products, it is essential to knew product identity so that the applicability of test results, i.e. toxicity testing and host range, can be related to specific products. A major focus of this Registration Standard is to obtain state-of-the-art identification data on B. thurimiensis strains. Each registered strain must be placed in a recognized culture collection and is subject to the data requirements of this Standard. 05 ------- Although the data submitted to the Agency since 1986 shew rodent and nontaiget organism effects, these data do not change the assessment of the draft 1986 Registration Standard that there is no evidence of any substantial human or environmental safety concerns related to current uses of B. thuringiensis. Furthermore, there is no evidence that B. thuringiensis poses a health risk via the oral route of exposure. Hie ncntarget organism effects include acute toxicity in birds (178 pprn LD50 and 1 pprn NOEL) and suggest adverse effects in freshwater fish, plants, aquatic invertebrates, and rare beneficial insects. The contribution of inert ingredients to toxicity as well as the relevance to environmental risk of routes of exposure and dose levels used in testing have yet to be determined. Therefore, whether these results show hazard to the environment cannot be determined until additional data are submitted. Endangered Species Risk to federally listed endangered species cannot be fully determined at this time. Hcwever, the U.S. Fish and Wildlife Service (FWS) has determined (198?) that certain uses of the subspecies kurstaki jeopardize the continued existence of the Kern primrose sphinx moth, Lange's metalmark butterfly, Smith's blue butterfly, El Segundo blue butterfly, Oregon silverspot butterfly, San Bruno elfin butterfly, Lot is blue butterfly, and the Schaus swallowtail butterfly. An earlier consultation (1984) with FVJS addressing rangeland/pastureland pesticide use found that B. thuringiensis (subspecies not specified) jeopardize the existence of the Kern Primrose Sphinx moth, Delta Green Ground Beetle, and the Valley Elderberry longhom Beetle. As sane B. thuringiensis products have activity against dipterans, these products could effect arty endangered dipterans that may be listed in the future. Tolerances Hie 40 CFR 180.1011 tolerance exemption for B. thuringiensis is currently being reevaluated by the Agency. This reevaluation will continue as data submitted in response to the Registration Standard are reviewed. Areas which the Agency wishes to address in this reevaluation include the soope of the exenption (e.g. whether asporogenic strains should be included), quality assurance measures, limits or restriction on the presence of beta-exotoxin and whether or not the mouse subcutaneous test should be replaced with a mouse intraperitoneal test. The 40 CFR 180.1001(c) inert tolerance exenption for B. thuringiensis fermentation solids and/or solubles is also currently being reevaluated by the Agency as product analysis data are submitted in response to the Registration Standard. 06 ------- 4. SUMMARY OF TOE REGULATORY POSITIONS a. The Agency is requiring special tests designed to more accurately characterize strains of Bacillus thurinaiensis. Hiese data will be used to reclassify registered strains into groups of strains with similar characteristics. b. Registrants and applicants must identify the number of B. thurinaiensis strains present in their products; each strain is subject to all the data requirements applicable to the use pattern(s) of that strain. c. Upon review of the data submitted in response to the Registration Standard, the Agency will reevaluate the current tolerance exenption for B. thurinaiensis (40 CFR 180.1011) and the inert toleranoe exenption for B. thurinaiensis fermentation solids and/or solubles (40 CFR 180.1001 (c)). d. Testing requirements set forth for food use products (CFR 40 180.1011) will be required for nonfood uses of thurinaiensis as well. Analysis for production batch contaminating microorganisms and their metabolites is not currently required of nonfood use products, such as those used in forestry programs. In order to assure public and applicator safety, the Agency believes such testing requirements need to be imposed on all B. thurinaiensis products. e. Hie Agency is not requiring data on ground water. f. The Agency is not requiring Endangered Species labeling at this time. g. Hie Agency is not initiating a Special Review of B. thurinaiensis at this time. h. B, thurinaiensis does not meet the criteria for Restricted Use at this time. i. The Agency is not requiring a reentry interval for B. thurimiensis. j. Protective clothing is not required for users of any B. thurimiensis products at this time. k. Each registered strain is to be deposited in a recognized culture collection. 6- SUMMARY OF MAJOR DATA GAPS Due to the current Agency grouping of B. thurinaiensis active ingredients by subspecies and the variability of strains within a subspecies, data supporting one strain within a subspecies may not be adequate to support another strain in the same subspecies. Each distinct strain, including each strain within a subspecies (active ingredient), is subject to all the data requirements applicable to the use pattern(s) of that strain. In order to utilize data submitted to the Agency prior to the issuance of the Registration Standard, registrants must show that the strain used in testing is substantially similar to the strain present in the product currently. Data gaps exist for all 07 ------- requirements listed in the data tables of the Registration Standard. Hcwever, same of these gaps may be filled if the registrant shews that the strain used in testing is substantially similar to the strain present in the product currently. 7. CONTACT PERSON AT EPA Fhillip 0. Hutton Product Manager (17) Insecticide Rodenticide Branch Registration Division (TS-767C) Offioe of Pesticide Programs Environmental Protection Agency 401 M Street, S. w. Washington, D. C. 20460 Offioe location and telephone number: Room 207, Crystal Mall #2 1921 Jefferson Davis Highway Arlington, VA 22202 (703) 557-2690 DISCLAIMER: The information in this Pesticide Fact Sheet is a suttmary only and is not to be used to satisfy data requirements for pesticide registration and reregistration. The oanplete Registration Standard for the pesticide may be obtained from the National Technical Information Servioe. Oorrtact the Product Manager listed above for further information. Oo ------- |