United States Office of Pesticides and Toxic Substances • ''' '
Environmental Protection Office of Pesticide Programs (TS-766C)
Agency Washington. DC 20460 ~
540/FS-88-096'/. .
Pesticide
Fact Sheet
Name of Chemical: STREPTOMYCIN
Reason for issuance: Registration Standard
Date Issued: September 1988
Fact Sheet Number: 135
1. DESCRIPTION OF CHEMICAL
Chemical Name: 0-2-Decxy-2-(methylamirx>)^-L-glucopyranosyl-(l->2)-0-5-
deoxy-3-C-formy 1—V-L-lyxof uranosyl- (l->4) -N, N' -bis
(ajninoiminomethyl)-D-streptanine
ANSI Common Name: Streptomycin
Other Coounon Names: streptamine
Principal Trade Names: Agri-Mycin 17*, Agri-Step®, Plantomycin*
EPA (Shaughnessy) Code: 006306, 006310 (streptomycin sulfate)
Chemical Abstracts Service (CAS) Number: 57-92-1, 3810-74-0 (streptomycin
sulfate)
Year of Initial Registration: 1958
Pesticide Type(s): Fungicide
Chemical Family: Aminoglycoside antibiotic isolated from the bacterium
U.S. and Foreign Producers: U.S. Merck & Co., Inc. and Pfizer, Inc.
2. USE PATTERNS AND FORMULATIONS
Registered uses: Terrestrial food crop uses on fruit and vegetables,
terrestrial nonfood crop uses on tobacco and ornamentals,
and greenhouse nonfood crop use on ornamentals
Uses: Ninety-eight percent of annual production is used on apples, pears,
and tomatoes
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Pests controlled (in general): Fungal diseases of selected fruit,
vegetables, seed, and ornamental crops
Types of Formulations: Dust, wettable powder, wettable powder/dust,
emulsifiable concentrate, pelleted/tablets, and
liquid ready-to-use
Types and Method of Application: Foliar application by ground equipment,
such as airblast. Other methods include:
aircraft, duster attachment mounted over
conveyor belt, hand-held or motor driven
sprayers, dip treatment, tree injection
treatment, slurry seed treatment.
Application Rates: Terrestrial food crop - 25 to 200 ppm
Terrestrial nonfood crop - 50 to 200 ppm
3. SCIENCE FINDINGS
Chemical Characteristics:
Physical state: powder
Color: pink to tan
Odor: burned sugar
Molecular Weight: 581.58; 1457.40 (streptomycin sulfate)
Empirical Formula: C21H39N7°12? C42H84N14°36S3 (Streptomycin sulfate)
Toxicology Characteristics
Streptomycin has been used since the late 1940's to treat bacterial
infections in humans. As a result of this use as a human drug, there
is an extensive body of toxicological data available on streptomycin.
Thus, all toxicological data requirements have been waived.
Physiological and Biochemical Characteristics
Metabolism and Persistence in Plants and Animals: The Agency
has determined that plant and animal metabolism data were not
needed for the following reasons:
- metabolism of streptomycin in mammals has already been traced in
connection with its use in humans;
- residues are non-detectable (< 0.5 ppm) in or on crops when
treated according to label use rates and directions;
- large amounts of toxicological data exist;
- most crops are treated at or before transplanting (celery, peppers,
pototoes and tomatoes) and pome fruits are treated foliarly but with
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a 30-day PHI for pears and a 50-day PHI for apples and crabapples
- potential daily exposure to streptomycin as a pesticide is < 0.01%
of the daily clinical dosage (1-4 grams/day)
4. TOLERANCE ASSESSMENT
Tolerances have been established for residues of streptomycin in
a variety of raw agricultural commodities at 0.25 ppm (40 CFR 180.245).
These tolerances are supported by the available data. Tolerances must
be proposed for residues of streptomycin in or on beans (succulent and
dried), bean vines and bean hay to reflect the registered use on beans.
5. SUIWARY OF REGUIATORY POSITIONS
- At this time, none of the risk criteria prescribing a Special
Review have been met.
- While dati gaps are being filled, currently registered manufacturing-
use products and end-use products containing streptomycin as the sole
active ingredient may be sold, distributed, formulated, and used,
subject to the conditions of this Standard. In order to maintain
existing registrations, registrants must provide or agree to
develop additional data specified in the Data Appendices.
- No significant human dietary exposure is anticipated due to the lack
of detectable residues and the long PHIs.
- Because of the large amount of existing human data, all toxicology
requirements have been waived by the Agency for this Standard.
- The Agency is deferring to the Food and Drug Administration on
the issue of development of streptomycin resistant microorganisms.
6. LABELING REQUIREMENTS
All streptomycin products must bear appropriate labeling as specified
in 40 CFR 156.10. Appendix II of the Standard contains information on label
requirements.
In order to remain in compliance with FIFRA, no pesticide product
containing streptomycin may be released for shipment by the registrant
after 12 months from receipt of the Guidance Document, unless the
product bears amended labeling which complies with the specifications in
the Standard.
In order to remain in compliance with FIFRA, no pesticide product
containing streptomycin may be distributed, sold, offered for sale, held
for sale, shipped, delivered for shipment, or received and (having been so
received) delivered or offered to be delivered by any person after 24
months from receipt of the Guidance Document, unless the product bears
amended labeling which complies with the specifications of the Standard.
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Under the Precautionary Statements section of the label, the
following statements nust appear:
May cause allergic skin reactions. Do not breathe dust or spray mist.
Wear dust mask and rubber gloves. Wash thoroughly after handling.
This material is not to be used for medical, veterinary, or human
purposes.
Do not apply this product in a way that will contact unprotected
workers, either directly or through drift. Only protected handlers
may be in the area during application. Do not enter or allow entry
into treated areas until (sprays have dried/dusts have settled/
vapors have dispersed, as applicable) to perform hand labor tasks.
Decontaiuinat ion
If the pesticide comes in contact with skin, wash off with soap and
water. Always wash hands, face, and arms with soap and water before
smoking, eating, drinking or toileting. Before removing gloves,
wash them with soap and water.
7. SUMMARY OF DATA GAPS
Product Chemistry
(must be resubmitted)
Environmental Fate
Hydrolysis
Photodegradat ion
Aerobic and Anaerobic Metabolism
Soil Dissipation
Fish Accumulation
Adsorpt ion/Desorpt ion
Ecological Effects
Avian Acute Oral
Avian Subacute Dietary
Honey Bee Acute LD5Q
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8. CONTACT PERSON AT EPA
Lois A. Rossi
Product manager (21)
Fungicides-Herbicides Branch
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
Office location and phone number:
Room 227, Crystal Mall #2
1921 Jefferson Davis Highway
Arlington, VA
(703) 557-1900
9. DISCLAIMER; The information in this Pesticide Fact Sheet is a summary
only and may not be used to satisfy data requirements for pesticide regis-
tration and reregistration. The complete Registration Standard for the
pesticide may be obtained from the National Technical Information Service.
Contact the Product Manager listed above for further information.
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vvEPA
U.S. Environmental Protection Agency
Office of Pesticide Program (TS-757C)
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Washington, D.C. 20460
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