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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