United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7511W)
EPA-738-F-98-001
March 1998
R.E.D. FACTS
Pesticide
Reregistration
Use Profile
* Bacillus thuringiensis*
All pesticides sold or distributed in the United States must be
registered by EPA, based on scientific studies showing that they can be used
without posing unreasonable risks to people or the environment. Because of
advances in scientific knowledge, the law requires that pesticides which
were first registered before November 1, 1984, be reregistered to ensure
that they meet today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency develops
any mitigation measures or regulatory controls needed to effectively reduce
each pesticide's risks. EPA then reregisters pesticides that can be used
without posing unreasonable risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA explains the basis
for its decision in a Reregistration Eligibility Decision (RED) document.
This fact sheet summarizes the information in the RED document for
reregistration case 0247, Bacillus thuringiensis.
Bacillus thuringiensis is a group of similar bacteria that act as
insecticides which are used on growing agricultural crops, harvested crops
in storage, ornamentals, bodies of water, and around the home to control
various groups of insects, depending on the particular toxins, known as
delta-endotoxins, produced by the specific isolate of Bacillus thuringiensis.
Formulations include Water Dispersible Granule, Dry Flowable,
Aqueous Suspension, Granule, Technical Powder, Dust, Wettable Powder,
Emulsifiable Suspension, Aqueous Flowable, Bait, and Oil Flowable.
Bacillus thuringiensis is applied by hand sprayer, water treatment by
aerial or ground equipment, soil application by drip or overhead irrigation
systems, foliar application by aerial; conventional ground or hand-held
equipment and center-pivot irrigation systems, and sprayer or sprinkler
cans.
Use practice limitations include Restricted Entry Intervals (REIs) of 4-
48 hours for agricultural uses; direct water application is not to be applied
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directly to treated, finished drinking water reservoirs or drinking water
receptacles; certain terrestrial uses are limited to terrestrial use only due to
potential aquatic hazard.
Regulatory
History
Bacillus thuringiensis was first registered as a pesticide in the U.S. in
. EPA issued a Registration Standard for Bacillus thuringiensis in
December, 1988 (#540/RS-89-023). An associated Data Call-in (DCI)
required additional product analysis, toxicology, and nontarget organism
data.
Currently, approximately 180 Bacillus thuringiensis products are
registered under 15 EPA product code numbers. Two of the product codes
no longer have active products.
Human Health
Assessment
Isolates of Bacillus thuringiensis were originally grouped as
registrations under the following subspecies names, each with an EPA
product code number: Bacillus thuringiensis subspecies kurstaki, Bacillus
thuringiensis subspecies israelensis, Bacillus thuringiensis subspecies
aizawai and Bacillus thuringiensis subspecies tenebrionis, Each isolate is
now assigned its own product code number and, as part of the reregistration
process, the original registrations will be given new product numbers.
Toxicity/Pathogenicity
To date, no known mammalian health effects have been
demonstrated in any infectivity/pathogenicity study. Some strains of
Bacillus thuringiensis have the potential to produce various toxins that may
exhibit toxic symptoms in mammals, however the manufacturing process
includes monitoring to prevent these toxins from appearing in products.
Dietary Exposure
An exemption from the requirements for a tolerance is currently
established for Bacillus thuringiensis in or on beeswax and honey and all
other raw agricultural commodities when it is applied either to growing
crops, or when it is applied after harvest in accordance with good
agricultural practices (40 CFR §180.1011). In addition, there is a tolerance
exemption (40 CFR 180.1001(c)) for Bacillus thuringiensis fermentations
solids and/or solubles. The absence of any toxicological/pathogenicity
concerns for oral mammalian exposures to Bacillus thuringiensis warrants
continuation of these exemptions as long as the proper quality control
procedures are performed.
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Environmental
Assessment
Risk Mitigation
Additional Data
Required
The specific language in the tolerance exemption does not reflect
current taxonomy designations for Bacillus thuringiensis isolates. In
addition, it includes production testing requirements which will now be
required under the product analysis data requirements in 40 CFR 158.740(a)
and will apply to all registered isolates and all uses of Bacillus thuringiensis.
To ensure that the production batch tests requirements do not lapse for any
products, the Agency will repropose the tolerance exemptions following
establishment of the new manufacturing process requirements as described
in the Reregistration Eligibility Document.
Toxicity and infectivity risks due to delta-endotoxin effects to
nontarget avian, freshwater fish, freshwater aquatic invertebrates, estuarine
and marine animals, arthropod predators/parasites, honey bees, annelids and
mammalian wildlife will be minimal to nonexistent at the label use rates of
registered B. thuringiensis active ingredients. However, other toxins which
may be produced by Bacillus thuringiensis can produce adverse direct toxic
effects on nontarget species. Despite the potential for immediate toxic
effects on target, and possibly some nontarget, organisms, there is no
evidence that Bacillus thuringiensis can cause epizooatics in the field.
therefore, the Agency has concluded that there will be no potential for
adverse effects on nontarget organisms for B. thuringiensis-based products if
the the presence of soluble, heat labile exotoxins and beta-exotoxin is
minimized. However, the production process must be closely controlled
and monitored or certified to assure these exotoxins are not present at levels
that can cause significant adverse ecological effects.
To lessen the potential for the production of various undesirable
Bacillus exotoxins, EPA is requiring the following risk mitigation measures.
N Production batch testing is required in order to detect undesirable toxins
and to detect contamination by pathogenic bacteria.
N If the organism is capable of producing beta-exotoxin, the registrant
must ensure that none is present in the TGAI and that the product is not put
in a medium, including formulated end use products that allows germination
and/or growth at any time prior to use.
N Each manufacturing process must be standardized and certified by a
Daphnia magna test using a 10 day exposure period.
EPA is requiring the submission of a new manufacturing process as an
additional generic study for Bacillus thuringiensis to confirm its regulatory
assessments and conclusions.
The Agency also is requiring product-specific data including product
chemistry and acute toxicity studies, a storage stability study, efficacy
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studies for public health uses, revised Confidential Statements of Formula
(CSFs), and revised labeling for reregistration.
Product LabGlinQ All Bacillus thuringiensis end-use products must comply with EPA's
Changes Required current pesticide product labeling requirements and with the following. For
a comprehensive list of labeling requirements, please see the Bacillus
thuringiensis RED document.
Percent Active Ingredient: The percent active ingredient by weight for
Bacillus thuringiensis-based products is required in lieu of potency
determinations and a statement must be included "There is no direct
relationship between intended activity (potency) and the Percent Active
Ingredient by Weight."
Active Ingredients: The label must identify the active ingredient as Bacillus
thuringiensis and all toxins and/or chemical substances that are present at
levels that are known to contribute to the efficacy of the product against the
target pest(s) must be listed on the label.
Personal Protective Equipment Requirements: A respiratory protection
statement must appear on the label for different uses as follows:
Agricultural Use Products - The personal protective equipment (PPE)
section must include the statement: "As a general precaution when exposed
to potentially high concentrations of living microbial products such as this,
all mixer/loaders and applicators must wear a dust/mist filtering respirator
meeting NIOSH standards of at least N-95, R-95, or P-95."
Registrants may add the following engineering control statements to the PPE
section if they so choose: "When handlers use closed systems, enclosed
cabs, or aircraft in a manner that meets the requirements listed in the
Worker Protection Standard (WPS) for agricultural pesticides [40 CFR
170.240(d) (4-6)], the handler PPE requirements may be reduced or
modified as specified in the WPS."
PPE for early entry in the Agricultural Use Requirements box remains
unaffected.
Non-Agricultural Use Products not Used Around the Home - Either the
PPE section or the precautionary statements of the Hazards to Humans and
Domestic Animals section must include the statement: "As a general
precaution when exposed to potentially high concentrations of living
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microbial products such as this, all mixer/loaders and applicators not in
enclosed cabs or aircraft must wear a dust/mist filtering respirator meeting
NIOSH standards of at least N-95, R-95, or P-95."
Domestic (Home) Use Products - Either the PPE section or the
precautionary statements of the Hazards to Humans and Domestic Animals
section must include the statement: "As a general precaution when exposed
to potentially high concentrations of living microbial products such as this,
wear a dust particle mask when mixing or applying this product."
Environmental Hazard Statement: All commercially applied products with
directions for outdoor terrestrial uses must have the following statements in
the Environmental Hazards section: "Do not apply directly to water, or to
areas where surface water is present or to intertidal areas below the mean
high water mark. Do not contaminate water when cleaning equipment or
disposing of equipment washwaters." This statement should be preceded by
"For terrestrial uses," if the product has aquatic sites in addition to
terrestrial, forestry (except aerial application) and/or domestic outdoor uses.
This revised statement would then not apply to other general use patterns --
aquatic (e.g., mosquito larvicides or adulticides, aquatic herbicides,
piscicides, slimicides, etc.), greenhouse and indoor uses. The "For
terrestrial uses," qualifier is not allowed on products which allow aerial
application to forests but which have no approved aquatic use sites.
For residential consumer products, the required statement is: "Do not
apply directly to water. Do not contaminate water when disposing of
equipment washwaters or rinsate."
For direct water application uses, the required statement is: "Do not
apply directly to treated, finished drinking water reservoirs or drinking
water receptacles."
Spray Drift Labeling: The following language must be placed on each
product label that can be applied aerially: "Avoiding spray drift at the
application site is the responsibility of the applicator. The interaction of
many equipment-and-weather-related factors determine the potential for
spray drift. The applicator and the grower are responsible for considering
all these factors when making decisions."
Regulatory The use of currently registered products containing Bacillus
Conclusion thuringiensis in accordance with approved labeling will not pose
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unreasonable risks or adverse effects to humans or the environment.
Therefore, all uses of these products are eligible for reregistration.
Bacillus thuringiensis products will be reregistered once the required
confirmatory generic data, product-specific data, revised Confidential
Statements of Formula, and revised labeling are received and accepted by
EPA.
For More EPA is requesting public comments on the Reregistration Eligibility
Information Decision (RED) document for Bacillus thuringiensis during a 60-day time
period, as announced in a Notice of Availability published in the Federal
Register. To obtain a copy of the RED document or to submit written
comments, please contact the Pesticide Docket, Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone
703-305-5805.
Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregistration Information System at
703-308-7224. They also are available on the Internet on EPA's web site at
www.epa.gov .
Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone
513-489-8190, fax 513-489-8695.
Following the comment period, the Bacillus thuringiensis RED
document also will be available from the National Technical Information
Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161, telephone
703-487-4650.
For more information about EPA's pesticide reregistration program,
the Bacillus thuringiensis RED, or reregistration of individual products
containing Bacillus thuringiensis, please contact the Biopesticides and
Pollution Prevention Division (7511W), OPP, US EPA, Washington, DC
20460, telephone 703-308-8712.
For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN). Call toll-
free 1-800-858-7378, between 9:30 am and 7:30 pm Eastern Standard Time,
Monday through Friday.
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