United States
Environmental Protection
Agency
Office of Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-92-009
September 1992
R.E.D. FACTS
Pesticide
Reregistration
Use Profile
Regulatory
History
Streptomycin and
Streptomycin Sulfate
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 streptomycin and
streptomycin sulfate, referred to as streptomycin.
Streptomycin is a human antibiotic drug which also is used as a
pesticide, to control bacteria, fungi and algae. Streptomycin controls
bacterial and fungal diseases of certain fruit, vegetables, seed, and
ornamental crops, and controls algae in ornamental ponds and aquaria. The
use of streptomycin to control fireblight on apples and pears accounts for
58% of its total use. Other significant uses are on nursery stock and in
landscape maintenance (17% of use), and on tobacco (7% of use).
Streptomycin has been used in the United States as a drug to treat
bacterial infections in humans since the 1940s. It was first registered as a
pesticide in 1955, for use in controlling bacterial and fungal diseases of
certain agricultural and non-agricultural crops. EPA issued a Registration
Standard for streptomycin in September 1988. Currently, sixteen end-use
pesticide products containing streptomycin are registered.
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Human Health EPA has waived all generic toxicology data requirements for
Assessment streptomycin because extensive information is available from studies
conducted on animals in support of its use as a human drug.
Toxicity
Streptomycin is of low toxicity when taken orally, and has been placed
in Toxicity Category IV (indicating the lowest level of acute toxicity) for
this effect. A subchronic toxicity study showed that cats receiving
intramuscular injections of streptomycin lost the righting reflex in three
weeks, while those receiving oral doses did not. A chronic feeding study in
rats indicated that streptomycin does not have the potential to cause cancer.
An antibiotic resistance study using beagle dogs showed an increase in the
resistance of coliform fecal bacteria to streptomycin. The same potential
may exist for the development of chemical resistance in the respiratory
flora.
Streptomycin is used as an antibiotic in humans to treat urinary tract
infections, usually through intramuscular injections given for seven to 10
days. A variety of allergic reactions have been observed in sensitive
patients treated, including redness of the skin, rashes, hives, drop in blood
pressure, headache, nausea and vomiting.
Dietary Exposure
Tolerances or maximum residue limits of 0.25 parts per million (ppm)
are established in 40 CFR 180.245 for residues of streptomycin in or on
celery, peppers, tomatoes, potatoes and pome fruits (apples, pears,
crabapples and quinces). EPA finds that these tolerances are acceptable.
However, a tolerance also must be established for streptomycin in or on
succulent and dried beans.
A state Special Local Need registration for foliar treatment of sugar
beets grown for seed is considered a non-food use, so no tolerance is
required. Other tolerances have been established by the Food and Drug
Administration and the U.S. Department of Agriculture to regulate
streptomycin residues resulting from its use as a veterinary medicine.
No international Codex or Canadian tolerances are established for
streptomycin. Mexican tolerances are harmonized with the U.S. tolerances.
Occupational Exposures
EPA is not requiring occupational or residential exposure monitoring
data for streptomycin since considerable information is available as a result
of its use for many years as an antibiotic drug. However, since
streptomycin has produced allergic reactions in some human patients,
pesticide products containing streptomycin must bear label statements that
restrict reentry into treated fields and require the use of certain protective
clothing and equipment while handling and applying these products.
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Environmental
Assessment
Human Risk Assessment
Streptomycin has been used as a beneficial human and animal drug for
many years. Using its Dietary Risk Evaluation System, EPA finds that the
dietary risk from pesticide products containing streptomycin appears
minimal. Regarding the problem of drug resistance, EPA has no data
indicating that streptomycin pesticide residues remaining in the food supply
have a significant or even a measurable potential for increasing human
resistance to that drug.
Workers may be exposed to streptomycin while applying products that
contain this pesticide, or while working in fields where crops have been
treated. If they are among those people who are sensitive to streptomycin,
workers may have an allergic response. The potential also may exist for the
development of chemical resistance in the respiratory flora. To lessen this
risk, EPA is requiring through product labeling several exposure and risk
reduction measures including the use of protective clothing during
application, and the observation of a 12-hour reentry interval after
application.
Environmental Fate
Since there are no ecological or health effects concerns with the
naturally-occurring antibiotic streptomycin, EPA has waived all
environmental fate data requirements except for a hydrolysis study, which is
being required as confirmatory data.
Ecological Effects
EPA has reviewed the available information for streptomycin and has
determined that all ecological effects data requirements are satisfied except
for an aquatic invertebrate toxicity study, which is being required as
confirmatory data. Streptomycin is practically non-toxic to birds,
freshwater invertebrates and honey bees, and is slightly toxic to cold water
and warm water species of fish. Streptomycin is toxic to algae, so
precautionary labeling for all non-aquatic uses is required.
Environmental Risk Assessment
Streptomycin products, when labeled and used as described in the
RED, should not pose unreasonable risks or adverse effects on non-target
species or the environment. They also should not pose a significant risk to
threatened or endangered species.
Additional Data Additional generic (active ingredient-specific) data required for
Required confirmatory purposes include product chemistry data on technical grade
streptomycin sulfate, a hydrolysis study and an aquatic invertebrate toxicity
study.
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Product-specific data, including a product chemistry study for each
registration and acute toxicology studies, also are required for
reregistration.
Product Labeling The labels of all streptomycin pesticide products must comply with
Changes Required EPA's current pesticide labeling requirements. Current label precautions
still are applicable and required. The following new or revised label
statements also are required:
• Products registered for commercial use on agricultural crops and
ornamentals must include in the human hazards section the restricted
entry statement, "Entry into treated fields is prohibited for 12 hours
following application."
• Products registered for commercial use on agricultural crops and
ornamentals must include in the human hazards section the protective
clothing statement, "Prolonged or frequently repeated skin contact
may cause allergic reactions in some individuals. Do not breathe dust
or spray mist. Wear a MSHA/NIOSH approved TC-21C dust/mist
filtering respirator, long sleeved shirt, pants, shoes, and chemical-
resistant gloves while handling or applying this product. Wash
thoroughly after handling or applying."
• All products except those used as algicides in ornamental aquaria
and ponds must include in the environmental hazards section the
statement, "This product may be hazardous to aquatic plants. Do not
apply directly to water, areas where surface water is present, or to
intertidal areas below the mean high water mark. Do not contaminate
water by cleaning of equipment or disposal of wastes."
Regulatory
Conclusion
• All currently registered pesticide products containing streptomycin
or streptomycin sulfate as the active ingredient are not likely to cause
unreasonable adverse effects in people or the environment, and are eligible
for reregistration.
• These products will be reregistered once certain product-specific
data, revised Confidential Statements of Formula and revised labeling are
received and accepted by EPA. Although the reregistration of all products
will proceed in the absence of the confirmatory data, the Agency does not
anticipate any changes in its regulatory position based on these confirmatory
data. If the product chemistry, hydrolysis and invertebrate toxicity data
identify a risk that requires modification of the RED, EPA will publish its
rationale in the Federal Register and notify affected registrants of its
decision.
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For More EPA is requesting public comments on the Reregistration Eligibility
Information Document (RED) for streptomycin and streptomycin sulfate 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 streptomycin and streptomycin sulfate 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 streptomycin and streptomycin sulfate 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 streptomycin and streptomycin sulfate products, please contact
the Registration Division (7505C), OPP, US EPA, Washington, DC 20460,
telephone 703-305-7382.
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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