United States
Environmental Protection
Agency
Office of Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-92-011
September 1992
R.E.D. FACTS
Pesticide
Reregistration
Nosema locustae
All pesticides sold or used 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 years ago 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 imposes
any regulatory controls that are needed to effectively manage each
pesticide's risks. EPA then reregisters pesticides that can be used without
posing undue hazards to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this and
explains why in a Reregistration Eligibility Document, or RED. This fact
sheet summarizes the information in the RED for Nosema locustae, also
called JV. locustae.
Use Profile
Regulatory
History
Human Health
Assessment
JV. locustae is a microbial insecticide used to control grasshoppers and
crickets in crop fields, lawns and turf, grass way drains, fencerows and
hedgerows. It is made from the spores of the protozoan, JV. locustae
(Canning), which is infectious to certain grasshoppers and crickets. JV.
locustae must be eaten by the target insect to be effective.
The first pesticide product containing JV. locustae as an active
ingredient was registered by EPA on May 9, 1980. Currently, six
registered pesticide products contain JV. locustae. Although it is registered
for use on crop fields, JV. locustae is exempted from the requirement of a
tolerance (or maximum limit) for residues remaining in or on all raw
agricultural commodities. (Please see 40 CFR 180.1041.)
Toxicity
JV. locustae and other, similar microorganisms do not appear to be
hazardous to humans or other mammals. The toxicology studies considered
in support of JV. locustae's reregistration included acute toxicity
studies, a 90-day feeding study in rats, and an abdominal cavity lining
injection study in mice. No adverse effects were noted in any of these
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studies. JV. locustae has been placed in Toxicity Category IV (indicating the
lowest level of toxicity) for all acute effects. JV. locustae spores seem to be
inactivated by passage through the test animal since persistence does not
occur in rats fed the microorganism for 90 days.
Dietary Exposure
Although people possibly could be exposed to residues of N. locustae
through the diet, the amounts involved would likely be very small and
would pose no known health risks. JV. locustae is applied as a bait to cole
crops (such as cabbage and rape) and in orchards. However, most if not all
of the bait is on the soil surface and not on the crop itself, prior to harvest.
Further, JV. locustae is rapidly inactivated by light and warmth
(temperatures over 35 degrees C.), and poses no known hazards to humans.
For these reasons, JV. locustae has been exempted from all tolerance
requirements, as discussed earlier.
Occupational and Residential Exposure
The technical grade, liquid concentrate JV. locustae is formulated onto
a wheat bran bait. This bait is applied by ground equipment to cole crops,
orchards, forests, lawns and gardens for consumption by the target pests,
susceptible grasshoppers and crickets. During ground boom applications to
row crops, people mixing, loading and applying JV. locustae bait may be
exposed to significant amounts of the microorganism on their skin and
through inhalation. However, since JV. locustae poses no human toxicity
concerns, exposure studies are not required at this time.
Human Risk Assessment
The potential risks to humans and other mammals from dietary and
nondietary exposure to JV. locustae are considered negligible. Existing
toxicology studies showed no detectable dose-related effects at any level, as
well as the inability of JV. locustae to replicate in or accumulate in the
tissues of warm blooded animals. EPA requires only that any allergic
reactions following exposure to JV. locustae be reported by the registrants.
Environmental Environmental Fate
AsSGSSITIGnt There are no concerns with the ecological effects of this naturally-
occurring microorganism, so no environmental fate studies are required.
Ecological Effects
EPA received and reviewed a sufficient complement of studies to
perform an ecological hazard assessment of JV. locustae. These studies
show that JV. locustae should not have an adverse effect on avian species,
aquatic invertebrates or honeybees, on an acute basis. It also is not acutely
toxic to and does not cause diseases in freshwater trout. Although some of
these studies were not extended over sufficient time to evaluate fully JV.
locustae's ability to cause infection or disease, the long use history of this
microorganism without reported adverse effects has allowed EPA to waive
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further data requirements. Also, no beneficial non-target insect studies
were submitted. However, such insects would not likely be exposed to JV.
locustae at greater than naturally-occurring levels; thus, the Agency also is
waiving these studies. EPA does not expect JV. locustae to cause any
adverse effects in non-target species.
Environmental and Ecological Risk Assessment
JV. locustae has been tested and studied for 20 years, and has been
used in the field since 1980. No adverse effects have been reported during
the many years of experience with and environmental release of JV. locustae.
Considering this use history along with the studies reviewed, EPA can
foresee no significant adverse effects on nontarget species or the
environment from the registered uses of JV. locustae.
Additional Data EPA has waived all generic data requirements for JV. locustae.
Red UJ r0d Product-specific acute toxicity studies are required to determine appropriate
labeling for reregistration.
Product Labeling
Changes Required
Regulatory
Conclusion
For More
Information
The labels of all registered JV. locustae products must comply with
EPA's current pesticide labeling requirements.
• All registered pesticide products containing the active ingredient JV.
locustae are not likely to cause unreasonable adverse effects in people or the
environment, and are eligible for reregistration. These products will be
reregistered once the required product-specific data and revised labeling are
received and accepted by EPA.
• Registered products containing JV. locustae as well as other active
ingredients will be reregistered once the other active ingredients also are
determined to be eligible for reregistration.
EPA is requesting public comments on the Reregistration Eligibility
Document (RED) for JV. locustae 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 or to submit written comments, please contact the Public
Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs (OPP), US EPA, Washington, DC
20460, telephone 703-305-5805.
In the future, the JV. locustae RED 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 JV. locustae or about EPA's pesticide
reregistration program, please contact the Special Review and Reregistration
Division (7508W), OPP, US EPA, Washington, DC 20460, telephone 703-
308-8000. For information about reregistration of individual JV. locustae
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products, please contact PM Team 18, Registration Division (7505C), OPP,
US EPA, Washington, DC 20460, telephone 703-305-7690.
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, 24 hours a day, seven days a week, or fax your
inquiry to 806-743-3094.
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