UnK* Stat	0o of PrttcW *nd Toxic fcitHMnM*
En.tfoniwnfl Protection	OHica of talleMo Prormw tTS^6SC)
Acy	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

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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
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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,
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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
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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.
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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.
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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
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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.
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