United Stataa
Environmental Protection
AgMicy
Offiovot
Pwtickta and Toxic Subctanea*
Washington DC 20460
540/RS-88-097
PartickJaa
Guidance for the
Reregistration of
Pesticide Products
Containing STREPTOMYCIN
STREPTOMYCIN SULFATE
as the Active Ingredient
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OMB Control No. 2070-0057
Expires 11/89
GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
STREPTOMYCIN
AND
STREPTOMYCIN SULFATE
AS THE ACTIVE INGREDIENT
CASE NUMBER 0169
CAS. NO.: 57-92-1 (3810-74-0)
EPA SHAUGHNESSY CODE: 006306 and 006310
SEPTEMBER 1988
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
Introduction
II. Chemical(s) Covered by this Standard
A. Description of Chemical
B. Use Profile
III. Agency Assessment 6
A. Summary
B. Preliminary Risk Assessment
C. Other Science Findings
D. Tolerance Reassessment
IV. Regulatory Position and Rationale 10
A. Regulatory Positions
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard 15
VI. Requirement for Submission of Generic Data 17
A. What are generic data?
B. Who must submit generic data?
C. What generic data must be submitted?
D. How to comply with DCI requirements
E. Procedures for requesting a change in protocol
F. Procedures for requesting extensions of time
G. Existing stocks provisions upon suspension or
cancellation
H. Procedures for Requesting Extensions of Time
I. Data Format and Reporting Requirements
J. Existing Stocks Provisions upon Suspension or
Cancellation
VII. Requirement for Submission of Product-Specific Data . . 23
VIII. Requirement for Submission of Revised Labeling
IX. Instructions for Submission 24
A. Manufacturing use products (sole active)
B. Manufacturing use products (multiple active)
C. End use products (sole active)
D. End use products Containing the Subject Active
Ingredients as One of Multiple Active Ingredients
E. Intrastate Products
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APPENDICES
I. DATA APPENDICES
Guide to Tables
Table A
Table B
II. LABELING APPENDICES
Summary of label requirements and table
40 CFR 156.10 Labeling Requirements
Physical/Chemical Hazards Labeling Statements
Storage Instructions
Pesticide Disposal Instructions
Container Disposal Instructions
III. BIBLIOGRAPHY APPENDICES
Guide to Bibliography
Bibliography
IV. FORMS APPENDICES
EPA Form 8580-1 FIFRA §3(c)(2)(B) Summary Sheet
EPA Form 8580-3 Generic Data Exemption Statement
EPA Form 8580-4 Product Specific Data Report
EPA Form 8580-6 Certification of Attempt to Enter Into an
Agreement with Other Registrants for Development
of Data
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. Also known as the Reference
Dose or RfD.
a.i. active ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CSF Confidential Statement of Formula
EEC Estimated Environmental Concentration. The estimated
pesticide concentration system in an environment,
such as a terrestrial ecosystem.
EP End Use Product
EPA U.S. Environmental Protection Agency
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
LC50 Median lethal concentration - a statistically derived
concentration of a substance that can be expected to
cause death in 50% of test animals. It is usually
expressed as the weight of substance per weight or
volume of water or feed, e.g., mg/1 or ppm.
LD50 Median lethal dose - a statistically derived single dose
than can be expected to cause death in 50% of the test
animals, when administered by the route indicated
(oral, dermal, inhalation). It is expressed as a
weight of substance per unit weight of animal, e.g.,
mg/kg.
LEL Lowest Effect Level
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of
recording and tracking studies submitted to the Agency.
MP Manufacturing Use Product
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
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OPP Office of Pesticide Programs
OES Office of Endangered Species, U.S. Fish and Wildlife
Service
PADI Provisional Acceptable Daily Intake
PHI Preharvest Interval
ppm parts per million
RfD Reference Dose
TMRC Theoretical Maximal Residue Contribution
IV
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I. INTRODUCTION
EPA has established the Registration Standards program
in order to provide an orderly mechanism by which pesticide
products containing the same active ingredient can be reviewed
and standards set for compliance with FIFRA. The standards
are applicable to reregistration and future applications for
registration of products containing the same active ingredient.
Each registrant of a product containing an active ingredient
subject to this Standard who wishes to continue to sell or
distribute that product must bring his product and labeling
into compliance with FIFRA, as instructed by this Standard.
The Registration Standards program involves a thorough
review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criteria of FIFRA. In its review EPA identifies:
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the pesticide.
2. Additional studies necessary to support continued
registration. The additional studies may not have been
required when the product was initially registered or may be
needed to replace studies that are now considered inadequate.
3. Labeling revisions needed to ensure that the product
is not misbranded and that the labeling is adequate to protect
man and the environment.
The detailed scientific review, which is not contained
in this document, but is available upon request^, focuses on
the pesticide active ingredient. The scientific review
primarily discusses the Agency's evaluation of and conclusions
from available data in its files pertaining to the pesticide
active ingredient. However, during the review of these data
the Agency is also looking for potential hazards that may be
associated with the end use products that contain the active
ingredient. The Agency will apply the provisions of this
Registration Standard to end use products if necessary to
protect man and the environment.
scientific reviews and use index are available from the
National Technical Information Service, 5285 Port Royal Road,
Springfield, Va. 22161 or from the Order Desk (703) 487-4650,
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EPA's reassessment results in the development of a
regulatory position/ contained in this Registration Standard,
on the pesticide and each of its registered uses. See
Section IV - Regulatory Position and Rationale. Based on its
regulatory position/ the Agency may prescribe a variety of
steps to be taken by registrants to maintain their registrations
in compliance with FIFRA. These steps may include:
1. Submission of data in support of product registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the issuance of a Notice of Intent to Cancel or a Notice of
Intent to Suspend (in the case of failure to submit, data).
In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154
to examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the risks of the
pesticide's use outweigh the benefits of use, the Agency
may propose additional regulatory actions, such as cancellation
of uses of the pesticide which have been determined to cause
unreasonable adverse effects on the environment.
EPA has authority under the Data Call-in (DCI) provisions
of FIFRA sec. 3(c)(2)(B) to require that registrants submit
data to answer our questions regarding the chemical, toxicological,
and environmental characteristics and fate of a pesticide.
This Registration Standard lists the data EPA believes are
necessary to resolve our concerns about this pesticide.
These data are listed in the Tables A and B in Appendix I.
Failure to comply with the DCI requirements enumerated in
this Registration Standard may result in issuance by EPA of a
Notice of Intent to Suspend the affected product registrations.
Registrants are reminded that FIFRA sec. 6(a)(2) requires
them to submit factual information concerning possible unreason-
able adverse effects of a pesticide at any time that they
become aware of such information. Registrants must notify
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the Agency of any information, including interim or preliminary
results of studies, if. that information suggests possible
adverse effects on man or the environment. This requirement
is independent of the specific time requirements imposed by
EPA for submission of completed studies called in by the
Agency and continues as long as the products are registered
under FIFRA.
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II. CHEMICAL COVERED BY THIS STANDARD
Description of Chemical
The following pesticide chemical is covered by this
Registration Standard:
Chemical Name: O-2-Deoxy-2- (methylaminoJ-.^L-
glucopyranosyl-( l->2 )-O-5-deoxy-3-C-
formyl-4)-N,N ' -bis
(aminoiminomethyl )-D-streptamine
Common Name: Streptomycin
Trade Names: Agri-Mycin 17®, Agri-Strep® and Plantomycin®
EPA Shaughnessy Numbers: 006306 and 006310 (Streptomycin
Sulfate)
Empirical Formula: C2iH3gN7O12» C42H84N14°36S3 (Streptomycin
Sulfate)
Chemical Abstracts Service (CAS) Number: 57-92-1 and
3810-74-0 (Streptomycin
Physiochemical Characteristics: Sulfate)
Color: pink to tan
Physical State: powder
Odor: burned sugar odor
pH: 4.0 - 7.5
B. Use Profile
Type of Pesticide: Antibiotic bactericide/fungicide
(aminoglycoside antibiotic isolated from
the bacterium Streptomyces griseus)
Pests Controlled (in general): Fungal diseases of selected
fruit, vegetables, seed,
and ornamental crops
Registered uses: Terrestrial food crop use on apple, beans
(seed treatment), celery (to be transplanted),
crabapple, pear, peppers (to be transplanted),
potato (seed piece), and tomato (to be trans-
planted) ;
Terrestrial nonfood crop use on tobacco, (to
be transplanted); ornamental flowers, shrubs,
and trees; and Greenhouse nonfood crop use on
Epcot Display Center.
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Principal Uses:
Ninety-eight percent, of the annual pro-
duction is used on apples, pears, and
tomatoes. Each remaining site accounts
for no more than 1% of the total use of
streptomycin.
Method of Application:
Rates of Application:
Foliar application by ground
equipment such as airblast.
Other methods include aircraft,
duster attachment mounted
over conveyor belt, or hand-held
or motor-driven sprayers, dip treat-
ment, tree injection treatment,
slurry seed/seed piece treatment.
Terrestrial food crop - 25 to 200 ppm
Terrestrial nonfood crop - 50 to 200 ppm
Formulations:
Dust, wettable powder, wettable powder/dust,
emulsifiable concentrate, pelleted/tablets, and
liquid ready-to-use.
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III. AGENCY ASSESSMENT
A. Toxicological Findings
The Agency has reviewed all data in Agency files submitted
to support the registration of streptomycin, data available
in the open literature, and reviews of data conducted by the
Food and Drug Administration (FDA). This section discusses
the Agency's scientific findings and conclusions based on
these data.
Streptomycin has been available for use in humans as an
antibiotic for urinary infections since the late 1940's.
The usual route of administration is through intramuscular
injections since only minor quantities are absorbed through
the gastrointestinal tract. The total daily dose varies from
1 to 2 g or 0.5 to 1 g every 12 hours with treatment usually
lasting 7 to 10 days. In human medicine the use of streptomycin
has been discontinued because of the discovery of more
effective antibiotics that could also be administered orally.
Streptomycin is still extensively used in veterinary medicine
as a prophylactic treatment of animals (fowl, calves, and swine)
raised for food production.
A variety of allergic reactions has been observed in
sensitive patients treated with streptomycin. These reactions
include: erythema, rashes, uticaria, purpura, drop in blood
pressure, headache, nausea and vomiting. The following has
been observed after prolonged therapy for tuberculosis:
vertigo and tinnitus, diplopia after rapid movement of the
head, and deafness. These effects do not occur following a
briefer use for periods of 5 to 10 days in acute infections.
Subchronic and chronic toxicity tests in laboratory
animals were conducted for the FDA. These tests are summarized
below.
1. A 2-year rat study was conducted employing doses of
0, 1, 5, and 10 mg/kg/day. The only adverse effect noted was
reduced weight gain in the 10 mg/kg/day male rats. The NOEL
for this study is 5 mg/kg/day based on reduced weight gain.
2. In a rabbit teratology study, the animals were dosed
with 5 and 10 mg/kg from days 6-19 of gestation. The FDA
reviewer noted that there were no teratogenic effects at
either dose. The NOEL for teratogenic effects in the rabbit
is 10 mg/kg/day.
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3. In a 90-day cat study, animals were dosed orally
with 40 mg/kg/day and also injected intramuscularly with 75-200
mg/kg/day. The cats that were receiving streptomycin intramuscularly
lost the righting reflex in three weeks whereas those orally
treated and the control animals did not. Gross pathology and
histopathology were unremarkable and FDA concluded that the
NOEL was 40 mg/kg/day.
4. In a 90-day guinea pig study it was further concluded
that 40 mg/kg/day administered orally produced no hearing loss.
Based on these older and unconventional studies, it can be
concluded that 5 mg/kg/day is a conservative NOEL for oral
exposure to streptomycin. A provisional ADI or RfD of 0.05
mg/kg/day can be established using an uncertainty factor of 100.
Another study which was conducted for the FDA, addresses
the concern that streptomcyin resistant microorganisms will
develop due to increased background levels. In this study
beagle dogs were fed a diet containing 0, 2, or 10 ug of
streptomycin per gram of feed. The 2-ug/g level was selected to
represent a residue level of the antibiotic. In both treatment
groups, medicated feed resulted in a shift from a predominantly
streptomycin-susceptible coliform fecal population to resistant
population. An increase in the prevalence of streptomycin-
resistance was observed after 15 days of streptomycin-supplemented
feeding and persisted during the posttreatment phase of the study.
B. Other Science Findings
There are no available environmental fate and exposure
data for review. Also, no ecological effects data are available.
C. Tolerance Reassessment
Tolerances for residues of streptomycin in or on food/feed
items are currently set at 0.25 ppm and are expressed in
terms of streptomycin (40 CFR 180.245). The available data
indicate that the registered use of streptomycin on apples,
celery, pears, peppers, potatoes, and tomatoes will not
result in tolerance-exceeding residues.
Based on the registered uses of streptomycin on tomatoes
and peppers (uses are identical for both representative
commodities), the available data are sufficient to permit
a crop group tolerance being established for residues in or
on fruiting vegetables, if registrants are so interested.
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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. The available data
indicate that a tolerance at the detection limit of the method
(0.25 ppm) would be appropriate. In the case of bean vines and
hay, the registrant may instead elect to amend the appropriate
product labels to include a livestock feeding restriction.
Use of streptomycin as a drug in food animals is
regulated by the Food and Drug Administration according to
21 CFR 556.610; tolerances of zero ppm are established for
residues of streptomycin in the uncooked edible tissues of
chickens, turkeys, and swine, and in eggs. The U.S. Department
of Agriculture, Food Safety Inspection Service (FSIS), in
conjunction with FDA, has established administrative tolerances
for streptomycin at 2 ppm in the kidney of cattle, poultry and
swine.
Data were not submitted regarding the nature of the
residue of streptomycin in animals. Data on metabolism of
streptomycin in food animals are not needed because the
exposure of livestock to residues of streptomycin from pesticidal
uses in feed items involves only apple and tomato pomace and,
possibly, bean vines and hay at the present time. Streptomycin
residues, if any, from this exposure route are expected to
be insignificant in relation to use of streptomycin as a
livestock antibiotic (via feed or injection). Available
USDA, FSIS monitoring data reveal up to 3.3% of cattle
and swine kidney samples have residues in excess of tolerances.
Codex maximum residue limits (MRL) have not been established
or proposed for residues of streptomycin in or on any food/feed
commodity; therefore, no questions regarding compatibility
between U.S. tolerances and Codex MRL exist.
The dietary exposure to streptomycin, if any, is expected
to be very low because residues are very low due to the
seed/seedling treatment use and a long post harvest interval
(PHI) on the crop uses. Moreover, exposure, if any, from the
pesticidal uses is expected to be significantly lower than
exposure via use as a livestock antibiotic. Thus, the contri-
bution to the risk of pesticidal uses of streptomycin is
insignificant.
Using the Tolerance Assessment System (TAS) based on
a NOEL of 5 mg/kg/day and an uncertainty factor of 100,
1.8% of the ADI is utilized. Thus, no appreciable health
risk should result from these pesticidal uses of streptomycin.
Unless FDA reduces the allowable levels of streptomycin in
meat, additional residue determinations in the food commodities
covered by FDA tolerances are not needed.
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D. Data Requirements
The Agency has identified the data it believes are
necessary to fully evaluate the environmental and ecological
effects associated with the use of streptomycin. These data
must be submitted in order to maintain registration of products
or to register new products containing streptomycin.
ENVIRONMENTAL FATE
Hydrolysis
Photodegradation
Aerobic and Anaerobic Soil Metabolism
Soil Dissipation
Fish Accumulation
Adsorption/Desorption
ECOLOGICAL EFFECTS
Avian Acute Oral
Avian Subacute Dietary
Honey Bee Acute Contact LD5Q
PRODUCT CHEMISTRY
(Must beresubmitted)
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IV. REGULATORY POSITION AND RATIONALE
A. REGULATORY POSITIONS AND RATIONALES
(1) The Agency is waiving the requirements for submission
of further toxicology testing on streptomycin.
Rationale; In support of the use of streptomycin as a
human drug, several studies were conducted and submitted to
the Food and Drug Administration for review. The Agency is
not requiring any further toxicological testing on streptomycin
based on the following reasons:
(a) FDA conducted a two-year rat study in which the only
adverse effect was reduced weight gain in the group of rats
with the highest dose (10 mg/kg/day). They also conducted
a rabbit teratology study using doses of 5 and 10 mg/kg/day
which showed no teratogenic effects at either dose. The
NOEL's for these studies are 5 mg/kg/day and 10 mg/kg/day,
respectively.
(b) Streptomycin is applied to seed/seedlings/seed pieces
of celery, peppers, potatoes, and tomatoes prior to (trans-)
planting. Residues in these commodities are far below the
limits of detection. Exposure as a result of consumption of
these treated commodities is extremely low. The only dietary
exposure to streptomycin, if any, would be as a result of
its use on apples and pears. Residues on apples and pears are
nondetectable due to the long PHI (50 days for apples and 30
days for pears). The potential exposure to any residues
that may occur on apples and pears is expected to be significantly
lower than that to meat and eggs resulting from the use of
streptomycin as a livestock drug in food animals.
(c) The main route of exposure to streptomycin as a
result of its pesticidal uses to the U.S. population is
orally through dietary- consumption of crops treated with
streptomycin. Oral exposure is insignificant because only
minor quantities are absorbed through the human gastrointestinal
tract.
(d) Streptomycin has been available since the 1940's for
use as an antibiotic for urinary infections. Streptomycin has
generally been replaced by more effective antibiotics.
There is a history of administration to humans at substantially
higher doses than the levels to whio.i numans are exposed to
as a result of the pesticidal uses. Because of the documented
effects on humans as a result of streptomycin's use as a
drug, further toxicological testing in laboratory animals
will not produce any additional inf or ,:Mt ion regarding the
public health risk from the continuei pesticidal uses of
streptomycin.
m
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(2) None of the risk criteria listed in 40 CFR 154.7
prescribing a Special Review have been met. Therefore,
streptomycin is not being placed in Special Review at this time.
Rationale; After consideration of available toxicology
information and past use of streptomycin as a human drug,
the Agency has determined that no reason exists for
placement of streptomycin in Special Review at this time.
(3) Potential for development of streptomycin resistant
microorganisms due to increased background levels from pesticidal
uses is minimal.
Rationale; Beagle dogs were administered 2 ppm of
streptomycin in the diet. Streptomycin was shown to induce
drug resistance in the enteric (intestinal) microorganisms.
However, antibiotic/resistance is not a concern when using
streptomycin as a pesticide because dietary exposure from
pesticidal uses is negligible. Since the only significant
dietary exposure results from the use as a veterinary
drug, the Agency concludes that the overall drug pressure on
microorganisms is not affected by the pesticidal uses.
Should FDA in the future disallow the use of streptomycin in
food animals, the Agency will reevaluate the impact of potential
streptomycin residues on crops.
(4) The Agency is requiring a label statement on possible
hypersensitivity reactions to streptomycin.
Rationale; A variety of allergic reactions have been
observed in streptomycin sensitive patients including: erythema,
rashes, uticaria, purpura, decrease in blood pressure, headache,
nausea and vomiting.
(5) While data gaps are being filled, currently
registered manufacturing-use products (MP's) and end-use
products (EP's) containing streptomycin as the sole active
ingredient may be sold, distributed, formulated, and used,
subject to the terms and conditions specified in this Standard.
Registrants must provide or agree to develop additional data,
as specified in the Data Appendices, in order to maintain
existing registrations.
Rationale; Under FIFRA, the Agency may elect not to cancel
or withhold registration even though data are missing or are
inadequate (see FIFRA section 3(c)(2)(B) and 3(c)(7)). Issuance
of this Standard provides a mechanism for identifying data needs.
These data will determine if additional regulatory actions are
necessary. The Agency will consider registration of any sig-
nificant new use on a case-by-case basis while data gaps are
being filled and data evaluated.
1 1
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B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard,
products must contain streptomycin as the sole active
ingredient, bear required labeling, and conform to the pro-
duct composition, acute toxicity limits, and use pattern
requirements listed in this section.
C. ACCEPTABLE RANGES AND LIMITS
Product Composition Standard - To be registered or reregistered
under this Standard,MP' s must contain streptomycin as the sole
active ingredient. Each MP formulation proposed for reregistration
must be fully described with an appropriate certification of
limits, stating maximum and minimum amounts of the active
ingredient and inert ingredients which are present Ln products,
as well as impurities found at greater than 0.1 percent.
Acute Toxicity Limits - The Agency will consider registration
of technical grade, and end-use products containing streptomycin
provided that the product labeling bears appropriate precautionary
statements for the acute toxicity category in which each
product is placed.
Use Patterns - To be registered under this Standard, MP's must
be labeled for formulation into other MP's or into EP's bearing
federally-registered uses. The Use Index ("EPA Compendium
of Acceptable Uses (for availability, see page 1) lists all
federally-registered uses of streptomycin, as well as approved
maximum application rates and frequencies.
The use patterns currently registered are terrestrial food
crop, terrestrial nonfood crop, and greenhouse nonfood crop.
D. REQUIRED LABELING
All streptomycin products must bear appropriate labeling
as specified in 40 CFR 156.10. Appendix II contains additional
information on label specifications.
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 this document
unless the product bears an amended label which complies with
the specifications of the Standard.
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In order to remain in compliance with FIFRA, no pesticide
product containing streptomycin as an active ingredient may
be distributed, sold, offered for sale, held for sale, shipped,
delivered for shipment, or received and (having so received)
delivered or offered to be delivered by any person after 24
months from receipt of this document unless the product bears
an amended label which complies with the specifications of
this Standard.
In addition to the above, in order to remain in compliance
with FIFRA, the following information must appear on the
labeling:
1. All MP's and EP's must bear the following statements;
A. Ingredient Statement. The ingredient statement
for MP's and EP's must list the active ingredient
as:
Streptomycin (% ai )
Streptomycin Sulf ate (% ai )
(80.2% streptomycin)
2. Manufacturing-Use Products
A. Use Pattern Statement. All manufacturing-use
products must state that they are intended for formu-
lation into end-use products and acceptable use patterns
However, no use may be included on the label where
the registrant fails to agree to comply with the data
requirements in Table A for that use pattern.
B. Disposal Statements. Because streptomycin has not
been designated as an acute or toxic hazardous
waste under the Resource Conservation and Recovery
Act (RCRA), the following is the appropriate pesticide
disposal statement which must appear on the labeling
for streptomycin products:
"Wastes resulting from the use of this product
may be disposed of on site or at an approved waste
disposal facility."
The labels of all products must bear the appropriate
container disposal statement (See Appendix III).
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C. All MP's must bear the following statement:
"Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans, or
public waters unless this product is specifically
identified and addressed in an NPDES permit. Do not
discharge effluent containing this product to sewer
systems without previously notifying the sewage
treatment plant authority. For guidance contact
your State Water Board or Regional Office of the
EPA. "
3. End-Use Products. All End-Use products are to bear
the following statements on the label:
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,
Decontamination
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.
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A."are subject to certain requirements
for data submittal or changes in composition, labeling or
packaging of the product. The applicable requirements depend
on whether the product is a manufacturing or end use product
and whether the pesticide is the sole active ingredient or
one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and B2
3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms, Confiden-
tial statement of Formula, data compensation provisions)
associated with reregistration.
2 Data requirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to
Tables in that Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registra-
tion standard. Table B lists product-specific data applicable
to manufacturing use products. The data in Tables A and B
need not be submitted by an end use producer who is eligible
for the generic data exemption for that active ingredient.
Table C lists product-specific data applicable to end use
products. The Agency has decided that, in most cases, it
will not require the submittal of product-specific data for
end use products at this time. Therefore most Registration
Standards do not contain a Table C.
*i
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B. Manufacturing use products containing this pesticide
as one of multiple active ingredients are subject to:
1. The data requirements listed in Table A.
2. The labeling requirements specified for manufacturing
use products in Section IV.
C. End use products containing this pesticide as the
sole active ingredient are subject to:
1. The restrictions (if any) upon use/ composition, or
packaging listed in Section IV if they pertain to the
end use product.
2. If eligible for the generic data exemption3, the
data requirements listed in Table C.
3. If not eligible for the generic data exemption, the
data requirements listed in Table A and the data require-
ments listed in Table C.
4. The labeling requirements specified for end use
products in Section IV.
D. End use products containing this pesticide as one of
multiple active ingredients are subject to:
1. If not eligible for the generic data exemption,
the data requirements listed in Tables A and C.
3 If you purchase from another producer and use as the
source of your active ingredient only EPA-registered products,
you are eligible for the generic data exemption for generic
data concerning that active ingredient (Table A) and product-
specific data for the registered manufacturing use product
you purchase (Table B).
Two circumstances nullify this exemption:
1) if you change sources of active ingredient, to an
unregistered product, formulate your own active ingredient,
or acquire your active ingredient from a firm with ownership
in common with yours, you individually lose the exemption
and become subject to the data requirements in Table A.
2) If no producer subject to the generic data requirements
in Table A agrees to submit the required data, all end use
producers lose the exemption, and become subject to the data
requirements in Table A.
16
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2. If eligible for the generic data exemption, the
data requirements listed in Table c.
3. The labeling requirements specified for end use
products in Section IV.
VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of FIFRA sec. 3(c)(2)(B). It
refers to the data listed in Table A, which are required to
be submitted by registrants to maintain in effect the regis-
tration of products containing this active ingredient.4
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation11
of a product. "Typical formulation" testing is often required
for ecological effects studies and applies to all products
having that formulation type. These are classed as generic
data, and are contained in Table A.
B. who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and S 152.85) to submit
generic data in response to a DCI notice if the registrant
who supplies the active ingredient in his product is complying
with the data request.
If you are granted a generic data exemption, you rely on
the efforts of other persons to provide the Agency with the
required data. If the registrants who have committed to
generate and submit the required data fail to take appropriate
steps to meet the requirements or are no longer in compliance
with this data requirements notice, the Agency will consider
4 Registrations granted after issuance of this Standard will
be conditioned upon submittal or citation of the data listed
in this Registration Standard.
17
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that both they and you are not in compliance and will normally
initiate proceedings to suspend the registrations of both
your product(s) and their product(s) unless you commit to submit
and submit the required data in the specified timeframe. In
such cases, the Agency generally will not grant a time extension
for submitting the data.
If you are not now eligible for a generic data exemption,
you may qualify for one if you change your source of supply
to a registered source that does not share ownership in
common with your firm. if you choose to change sources of
supply, the Confidential statement of Formula must identify
the new source(s) and you must submit a Generic Data Exemption
Statement.
If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standard, you will be required to submit or cite generic data
relevant to the uses of your product if, at the time the
application is submitted, the data have been submitted to the
Agency by current registrants. If the required data have not
yet been submitted, any new registration will be conditioned
upon the new registrant's submittal or citation of the
required data not later than the date upon which current
registrants of similar products are required to provide such
data. See FIFRA sec. 3(c)(7)(A). If you thereafter fail to
comply with the condition of that registration to provide
data, the registration may be cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current uses of all products containing this
active ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the
Agency.
D. How to comply with PCI requirements.
within 90 days of your receipt of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comply with the DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself, if you use this method, you must state who will
-------
submit the data on which you will rely. You must also provide
EPA with documentary evidence that an agreement has been
formed which allows you to rely upon the data to be submitted.
Such evidence may be: (1) your letter offering to join in
an agreement and the other registrant's acceptance of your
offer, (2) a written statement by the parties that an agreement
exists, or (3) a written statement by the person who will be
submitting the data that you may rely upon its submittal.
The Agency will also require adequate assurance that the
person whom you state will provide the data is taking appropriate
steps to secure it. The agreement to produce the data need
not specify all of the terms of the final arrangement between
the parties or a mechanism to resolve the terms.
If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data
Submitter Number, as part of your 90-day response. The
request must include the following information:
a. A list of the members of the consortium;
b. The name and address of the designated representative
of the consortium, with whom EPA will correspond
concerning the data;
c. Identity of the Registration Standard containing
the data requirement;
d. A list of the products affected (from all members
of the consortium); and
e. Identification of the specific data that the con-
sortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submittals by the consortium.
3. YOU have attempted to enter into an agreement to
jointly develop data, but no other registrant has accepted
your offer. You request that EPA not suspend your registration
for non-compliance with the PCI. EPA has determined that,
as a general policy, it will not suspend the registration of
a product when the registrant has in good faith sought and
continues to seek to enter into a data development/cost
sharing program, but the other registrants developing the
data have refused to accept its offer. [If your offer is
accepted, you may qualify for option 2 above by entering
into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for Develop-
ment of Data" (EPA Form 8580-6, enclosed).
19
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2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must,
at a minimum, contain the following language or its equivalent:
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terms to be agreed or failing agreement
to be bound by binding arbitration as provided by FIFRA
section 3(c)(2)(B)(iii).
The remainder of your offer may not in any way attempt to
limit this commitment. If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI Summary sheet that he will
develop and submit the data required under the DCI, then you
may qualify for this option. In order for you to avoid
suspension under this method, you may not later withdraw or
limit your offer to share in the burden of developing the
data.
In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice in a timely manner. If the other registrant fails to
develop the data or for some other reason would be subject to
suspension, your registration as well as that of the other
registrant will normally be subject to initiation of suspension
proceedings, unless you commit to submit and submit the required
data in the specified timeframe. In such cases, the Agency
generally will not grant a time extension for submitting the data.
4. You request a waiver of the data requirement. If
you believe that a data requirement does not (or should not)
apply to your product or its uses, you must provide EPA with
a statement of the reasons why you believe this is so. Your
statement must address the specific composition or use factors
that lead you to believe that a requirement does not apply.
Since the Agency has carefully considered the composition and
uses of pesticide products in determining that a data require-
ment applies, EPA does not anticipate that many waivers will
be granted. A request for waiver does not extend the time-
frames for developing required data, and if your waiver
request is denied, your registration may be suspended if you
fail to submit the data. The Agency will respond in writing
to your request for a waiver.
5. You request that EPA amend your registration by deleting
the uses for which the data are needed. YOU are not required
to submit data for uses which are no longer on your label.
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6. You request voluntary cancellation of the registration
of your product(s) for which the data are needed.
E. Registrant Requests Regarding Data Requirements and Agency
Responses
All requests for modification of data requirements
(inapplicability, waiver), approval of protocols or protocol
changes, or time extensions must be submitted in writing.
The original requirement remains in effect unless the Agency
has notified you in writing that it has agreed to a change in
the requirement. While being considered by the Agency, such
requests for changes in the requirements do not alter the
original requirements or extend the time allowed for meeting
the requirement.
F. Test Protocols and standards
All studies required under this Notice must be conducted
in accordance with test standards outlined in the Pesticide
Assessment Guidelines, unless other protocol or standards are
approved for use by the Agency in writing. All testing must
be conducted in accordance with applicable Good Laboratory
Practices regulations in 40 CFR Part 160.
The Pesticide Assessment Guidelines, which are referenced
in the Data Tables, are available from the National Technical
Information service (NTIS), Attn: Order Desk, 5285 Port Royal
Road, Springfield, VA 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if
the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (Part 158.70),
Please note, however, that certain OECD standards (such as
test duration, selection of test species, and degradate
identification which are environmental fate requirements) are
less restrictive than those in the EPA Assessment Guidelines
listed above. When using the OECD protocols, they should be
be modified as appropriate so that the data generated by the
study will satisfy the requirements of Part 158. Normally,
the Agency will not extend deadlines for complying with data
requirements when the studies were not conducted in accord
with acceptable standards. The OECD protocols are available
from OECD, 1750 Pennsylvania Avenue, N.W., Washington, D.C.
20006.
21
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G. Procedures for requesting a change in test protocol.
If you will generate the required data and plan to use
test procedures which deviate from EPA's Pesticide Assessment
Guidelines or the Reports of Expert Groups to the Chemicals
Group, Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must submit for EPA
approval the protocols you propose to use.
You should submit your protocols before beginning testing,
because the Agency will not ordinarily accept as sufficient
studies using unapproved protocols. A request for protocol
approval will not extend the timeframe for submittal of the
data, nor will extensions generally be given to conduct
studies due to submittal of inappropriate protocols. The
Agency will respond in writing to your request for protocol
approval or change.
H. Procedures for requesting extensions of time.
If you think that you will need more time to generate
the data than is allowed by EPA's schedule, you may submit a
request for an extension of time.
EPA will view failure to request an extension before
the data submittal response deadline as a waiver of any
future claim that there was insufficient time to submit the
data. While EPA considers your request, you must strive to
meet the deadline for submitting the data.
The extension request should state the reasons why you
believe that an extension is necessary and the steps you
have taken to meet the testing deadline. Time extensions
normally will not be granted due to problems with laboratory
capacity or adequacy of funding, since the Agency believes
that with proper planning these can be overcome. The Agency
will respond in writing to any requests for extension of time.
I. Data Format and Reporting Requirements
All data submitted in response to this Notice must comply
with EPA requirements regarding the reporting of data,
including the manner of reporting, the completeness of results,
and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or
included in this Notice or contained in PR Notice 86-5 (issued
July 29, 1986). All studies must be submitted in the form of
a final report; a preliminary report will not be considered
to fulfill the submittal requirement.
22
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j. Existing stocks provision upon suspension or cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under
FIFRA sec. 3(c)(2)(B), an existing stocks provision for the
registrant is not consistent with the Act. Accordingly, the
Agency does not anticipate granting permission to sell or
distribute existing stocks of suspended product except in
rare circumstances. If you believe that your product will be
suspended or cancelled and that an existing stocks provision
should be granted, you have the burden of clearly demonstrating
to EPA that granting such permission would be consistent with
the Act. The following information must be included in any
request for an existing stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of
existing stocks and your estimate of the time required
for their sale or distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing
using a specific formulated product, and, unlike generic
data, generally support only the registration of that product.
All such data must be submitted by the dates specified in
this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed in Table C. As noted earlier, the Agency has
decided that it will not routinely require product-specific
data for end use products at this time. Therefore, Table C
may not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section VI.D through J. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options VI.D.I. (submit data)
or VI.D.6.(cancellation of registration).
Failure to comply with the product-specific data require-
ments for your products will result in suspension of the
product's registration.
F
23
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VIII. REQUIREMENT FOR SUBMITTAL OF REVISED LABELING
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supporting the product
and its uses. General labeling requirements are set out in
40 CFR 156.10 (see Appendix II - LABELING and SUMMARY). In
addition, labeling language specific to products containing
this pesticide is specified in Section IV.D of this Registra-
tion Standard. Responses to this Registration Standard must
include draft labeling for Agency review.
Labeling must be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for storage
in 8-1/2 x 11 files. Draft labeling must indicate the intended
colors of the final label, clear indication of the front
panel of the label, and the intended type sizes of the text.
If you fail to submit revised labeling as required,
which complies with 40 CFR 156.10 and the specific instructions
in Section IV.D., EPA may seek to cancel the registration of
your product under FIFRA sec. 6.
IX. INSTRUCTIONS FOR SUBMITTAL
All submittals in response to this Registration Standard
must be sent to the following address:
Office of Pesticide Programs
OPP Mailroom (TS-767C)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
Attn: [Name of chemical] Registration standard
All submittals in response to this Registration standard
are non-fee items, including 90-day responses, protocols and
waiver requests, data, and revised labeling. Submittals must
be clearly identified as being in response to the Registration
Standard. Under no circumstances may Registration standard
responses be combined with other types of filings for which
fees are required.
A. Manufacturing Use Products (MUPs) containing the subject
pesticide as sole active ingredient.
1. within 90 days from receipt of this document, you
must submit for each product subject to this Registration
Standard:
24
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a. Generic Data Exemption Statement (EPA Form 8580-3),
if applicable, or the "FIFRA Section 3(c)(2)(B) Summary
Sheet" (EPA Form 8580-1), with appropriate attachments.
b. Confidential statement of Formula (EPA Form 8570-4).
c. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR
152.80-152.99.
2. Within 9 months from receipt of this document you
must submit:
a. Application for Pesticide Registration (EPA
Form 8570-1).
b. Two copies of any required product-specific data
(See Table B).
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
d. Product specific Data Report (EPA Form 8580-4).
3. Within the times set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is delayed
or aborted so that the schedule cannot be met, immediately
notify the Agency of the problem, the reasons for the problem,
and your proposed course of action.
B. Manufacturing Use Products containing the subject pesticide
in combination with other active ingredients.
1. within 90 days from receipt of this document, you
must submit:
a. Generic Data Exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA sec. 3(c)(2)(B) Summary
Sheet, with appropriate attachments (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
2. Within 9 months of receipt of this document, you must
submit:
Three copies of draft labeling, including the container
label and any associated supplemental labeling.
3. Within the time frames set forth in Table A, you must
submit all generic data, unless you ace eligible for the
generic data exemption. If for any reason any test is delayed
or aborted so that the schedule cannot be met, immediately
25
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notify the Agency of the problem, the reasons for the problem,
and your proposed course of action.
C. End Use Products containing the subject pesticide as sole
active ingredient.
1. Within 90 days from receipt of this document, you
must submit:
a. Generic data exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA Section 3(c)(2)(B) Summary
Sheet, with appropriate attachments (EPA Form 8580-1).
b. confidential statement of Formula (EPA Form 8570-4).
2. Within 9 months from receipt of this document you
must submit:
a. Two copies of any product-specific data, if required
by Table C.
b. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
3. Within the times set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is delayed
or aborted so that the schedule cannot be met, immediately
notify the Agency of the problem, the reasons for the problem,
and your proposed course of action.
D. End use Products containing the subject active ingredient
as one of multiple active ingredients
1. within 90 days from receipt of this document, you
must submit:
a. Generic data exemption Statement (EPA Form 8580-3),
if applicable, o_r the FIFRA section 3(c)(2)(B) summary
Sheet, with appropriate attachments (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
2. Within 9 months from the receipt of this document, you
must submit:
Three copies of draft labeling, including the container
label and any associated supplemental labeling.
26
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3. Within the times set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is delayed
or aborted so that the schedule cannot be met, immediately
notify the Agency of the problem, the reasons for the problem,
and your proposed course of action.
E. Intrastate Products
Applications for full Federal registration of intrastate
products were required to be submitted no later than July 31,
1988. Unless an application for registration was submitted
by that date, no product may be released for shipment by the
producer after July 31, 1988.
27
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TGUIDE-1
GUIDE TO TABLES
Tables A and B contain listings of data requirements
for the pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158.
The reference numbers accompanying each test refer to the
test protocols set out in the Pesticide Assessment Guidelines,
which are available from the National Technical Information •
Service, 5285 Port Royal Road, Springfield, VA 22161.
2. Test Substance (Column 2). This column lists the composition
of the test substance required to be used for the test, as
follows:
TGAI = Technical grade of the active ingredient
PAI « Pure active ingredient
PAIRA = Pure active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
EP = End use product
Any other test substances, such as metabolites, "will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CFR Part 158. The following
letter designation* are used for the given use patterns:
A • Terrestrial, food
B * Terrestrial, non-food
C * Aquatic, food
D * Aquatic, non-food.
E = Greenhouse, food
F = Greenhouse, non-food >-^
G * Forestry
H « Domestic outdoor
I a Indoor
Any other designations will be defined in a footnote to the table
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.TGUIDE-2
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that satisfy this data
requirement. These data may be cited by other registrants
in accordance with data compensation requirements of
Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
the Agency may possess data on one of two required species,
or may possess data on one test substance but not all.
The term may also indicate that the data available to
EPA are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to be acceptable. If this is the case, a footnote to
the table will usually say so.
NO - EPA either possesses no data which are sufficient
to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or a'dditional inforr
nation.
5. Bibliographic citation (Column 5). If the Agency has
acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no
MRID number has been assigned. Refer to the Bibliography
Appendices for.a complete citation of the study.
6. Must additional data be submitted? (Column 6). This
column indicates whether the data must be submitted to the
Agency. If column 3 indicates that the Agency already has
data, this column will usually indicate HO. If. column 3
indicates that the Agency has only partial 'data or no data,
this column will usually indicate YES. In some cases, even
though the Agency does not have the data, EPA will not require
its submission because of the unique characteristics of the
chemical; because data on another chemical can be used to
fulfill the data requirement; or because the data requirement
has been waived or reserved. Any such unusual situations
will be explained in a footnote to the table.
7. Timeframe for submission (Column 7). If column 5 requires
that data be submitted,this column indicates when the data
are to be submitted, based on the issuance date of the Regis-
tration Standard. The timeframes are those established either
as a result of a previous Data Call-in letter, >o*^standardized
timeframes established by PR Notice 85-5 (August 22, 1985).
8. Footnotes (at the end of each table). Self-explanatory.
3U
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TABLE A
GENERIC DATA REQUIREMENTS FOR STREPTOMYCIN
Test Use Does EPA
Data Requirement Substance1 Pattern Have Data?
Part 158
Subpart C - Product Chemistry
Product Identity
61-2 - Description of Beginning TGAI All No
Materials and Manufac-
turing Process
61-3 - Discussion of Formation TGAI All No
of Impurities
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis TGAI All No
Physical and Chemical
Characteristics
Bibliographic Must Additional Time Frame
Citation2 Data Be ? for
Submitted? Submission3
N/A Yes4 6 months
N/A Yes5 6 months
N/A Yes6 12 months
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63.-6 - Boiling Point
63-7 - Density, Bulk Density,
or Specific Gravity
TGAI
TGAI
TGAI
TGAI
TGAI
All
All
All
All
All
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
Yes7
Yes7
Yes7
Yes7'8
Yes7'9
6 months
6 months
6 months
6 months
6 months
TGAI
All
No
N/A
Yes'
6 months
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TABLE A
GENERIC DATA REQUIREMENTS FOR STREPTOMYCIN
Data Requirement
Test Use Does EPA
Substance1 Pattern Have Data?
Bibliographic Must Additional Time Frame
Citation^ Data Be for
Submitted? Submission^
Part 158
Subpart C - Product Chemistry (Continued)
63-8
63-9
63-10
63-11
63-12
63-13
Other
- Solubility
- Vapor Pressure
- Dissociation
Constant
TGAI or PAI All No
TGAI or PAI All No
TGAI or PAI All No
- Octanol/Water Partition
Coefficient PAI All No
- pH
- Stability
Requirements:
TGAI All No
TGAI All No
N/A
N/A
N/A
N/A
N/A
N/A
Yes7 6 months
Yes7 6 months
Yes7 6 months
Yes7'1*-1 6 months
Yes7*11 6 months
Yes7 6 months
64-1 - Submittal of
Samples
N/A
N/A
N/A
N/A
N/A
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TABLE A
GENERIC DATA REQUIREMENTS FOR STREPTOMYCIN
I/ TGAI - technical grade of the active ingredient. PAI - purified active ingredient.
2/ Not applicable. Although product chemistry data may have been submitted in the past, the Agency has determined
that these data nust be resubmitted for each pesticide. New requirements have been introduced and previously
submitted data must be updated. Therefore, bibliographic citations for the old data are not applicable.
3/ Data must be submitted within the indicated time frame, starting with the date of receipt of this Guidance Document.
4/ Complete information must be provided regarding the nature of the process (batch or continuous), the relative
amounts of beginning materials and the order in which they are added, the chemical equations for each intended
reaction, equipment used to produce each intermediate and the final product, reaction conditions, the duration of
each step of the process, purification procedures, and quality control measures. In addition, the name and address
of the manufacturer, producer, or supplier of each beginning material used in the manufacture of each product must
be provided, along with information regarding the properties of those materials.
5/ A detailed discussion of all impurities that are or may be present at _>0.1%, based on knowledge of the beginning
~~ materials, chemical reactions (intended and side) in the manufacturing process, and any combination during and
after production must be submitted.
6/ Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for
~~ certified limits are required. Complete validation (accuracy and precision) must be submitted for each
analytical method used.
7/ Physiochemical characteristics (color, physical state, odor, melting point, boiling point, specific gravity,
~~ solubility, vapor pressure, dissociation constant, partition constant, pH, and stability) as required in 40 CFR
158.120 and more fully described in the Pesticide Assessment Guidelines, Subdivision D, must be submitted.
8/ Data needed if the technical chemical is a solid at room temperature.
9/ Data required if the technical product is a liquid at room temperature.
TO/ Data required if the technical product is organic and nonpolar.
TT/ Data required if the test substance is dispersible in water.
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TABLE A
GENERIC DATA REQUIREMENTS FOR STREPTOMYCIN
Does EPA
Data Requirement Composition1 Have Data?
Bibliographic Must Additional Time Frame
Citation Data Be for
Submitted? Submission^
§158.240 Residue Chemistry
171-2
171-3
171-4
171-4
- Chemical Identity No
- Directions for Use Yes
- Nature of Residue
(metabolism)
- Plants PAIRA No
- Livestock PAIRA No
- Residue Analytical TGAI Yes
N/A
See Use Index
N/A
N/A
00103383. 00103386
No3
No
No4
No5
No
OJ Method
171-4 - Storage Stability
TEP
No
00103390. 00108026
N/A
No6
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR STREPTOMYCIN
Data Requirement
Composition1
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data Be
Submitted?
Time Frame
for
Submission^
§158.240 Residue Chemistry - (Continued)
171-4 - Magnitude of the residue
in plants
Root and Tuber
Vegetables
- potatoes
Leafy Vegetables
- celery
cn
Legume Vegetables
- beans (succulent
aid dry)
Fruit mj Ve-jet.ibles
TEP
- tomatoes
Yes
Yes
No
Yes
Yes
00103384
N/A
No
00103384. 00108022 No
Yes
00065578. 00103384 No
00103384. 00108022 No
6 months
171-4.
Pome Fruits
Tobacco
Magnitude of Residue in
Meat/MiIk/Poultry/Eggs
Yes
No
No
00103377. 00103386. No
00103390
N/A No8
N/A No9
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR STREPTOMYCIN
FOOTNOTES:
I/ Test Substance: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabeled;
TEP = Typical end-use product; EP = End-use product.
2/ Data must be submitted within the indicated time frame, starting with the date of receipt of this Guidance
Document.
3/ The same chemical identity data are required as under 158.120, with emphasis on impurities that could
constitute residue problems. Refer to Product Chemistry Data Requirements tables.
4/ Data were not submitted regarding the nature of the residue of streptomycin in plants. It has been
determined that these data are not required.
5/ Data were not submitted regarding the nature of the residue of streptomycin in animals. Data on the
metabolism of streptomycin in food animals are not needed because the exposure of livestock to residues of
streptomycin in feed items, if any, involves only apple and tomato pomace (and, possibly, beans and their vines
and hay) at the present time. Streptomycin residues from this exposure route are expected to be insignificant in
relation to use of streptomycin as a livestock drug via animal feeds or by injection.
6/ Because residues are not detectable in crops resulting from the registered uses and because the residue contribution
to the human diet, if any, resulting from pesticidal crop uses is expected to be insignificant compared to that
resulting from the livestock antibiotic use, this data requirement is considered to be inapplicable.
Tj Tolerances must be proposed for streptomycin residues in or on beans (succulent and dried), bean vines, and bean hay
to reflect the registered seed-treatment use on beans. The available data indicate that a tolerance at the detection
r/ limit of the method (0.25 ppm) would be appropriate. In the case of bean vines and bean hay, an alternative
would be to propose a livestock feeding restriction.
8/ No data are available to assess the exposure of man to residues of streptomycin in or on tobacco and its
products. Since the use of streptomycin on tobacco is limited to seed bed applications, it is unlikely that
detectable streptomycin residues would be present in or on tobacco at harvest. Thus, residue data are not
required for this topic.
9/ The dietary intakes for beef and dairy cattle, poultry and swine from the consumption of feed items potentially
~~ bearing streptomycin residues are expected to be insignificant in relation to use of streptomycin as a drug in
animal feeds. Residue data are not required for this topic.
-------
OJ
TABLE A
GENERIC DATA REQUIREMENTS FOR STREPTOMYCIN
Data Requirement
§158.290 Environmental Fate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis
Photodegradat ion
161-2 - In Water
161-3 - On Soil
161-4 - In Air
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
163-4 - Aerobic Aquatic
MOBILITY STUDIES:
Use Does EPA
Composition1 Pattern2 Have Data?
PAIRA A,B,F No
PAIRA A,B No
PAIRA A No
PAIRA
PAIRA A,B,F No
PAIRA A No
PAIRA No
PAIRA No
Bibliographic Must Additional
Citation Data Be
Submitted?
Yes
Yes
Yes
Yes
Yes
No7
No7
Time Frame
for
Submission^
9 months
9 Months
9 months
27 months
27 months
1&3-1 - Leaching and
Adsorption/
Desorption
PAIRA
A,B,F
No
Yes
12 months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR STREPTOMYCIN
Data Requirement
Use Does EPA
Composition1 Pattern2 Have Data?
Bibliographic Must Additional
Citation Data Be
Submitted?
Time Frame
for
Submission-^
§158.290 Environmental Fate (oont'd)
MOBILITY STUDIES (cont'd);
163-2 - Volatility (Lab) TEP
164-3 - Volatility (Field) TEP
DISSIPATION STUDIES-FIELD:
ACCUMULATION STUDIES;
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
PAIRA
TEP
A,F No
A,F No
164-1
(xl
OC 164-2
164-5
- Soil
- Aquatic
- Soil, Lc
(Sediment)
>ng term
TEP
TEP
TEP
A,B
A
No
No
No
No
No
No4
No4
Yes
No4
Reserved5
Yes
Reserved^
27 months
39 months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR STREPTOMYCIN
Data Requirement
Use Does EPA
Composition1 Pattern2 Have Data?
Bibliographic Must Additional Time Frame
Citation Data Be for
Submitted? Submission-^
§158.290 Environmental Fate (cont'd)
ACCUMULATION STUDIES (cont'd);
165-3 - Irrigated Crops TEP
165-4 - In Fish PAIRA
165-5 - In Aquatic Nontarget TEP
Organisms
A,B
No
No
No
No
Yes
No
12 months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR STREPTOMYCIN
Use Does EPA Bibliographic Must Additional Time Frame
Data Requirement Composition1 Pattern2 Have Data? Citation Data Be for
Submitted? Submission-^
§158.390 Reentry Protection
132-1
132-1
133-3
133-4
- Foliar Dissipation TEP A,B No
- Soil Dissipation TEP A,B No
- Dermal Exposure TEP A,B No
- Inhalation Exposure TEP A,B No
No4
No4
No4
No4
§158.440 Spray Drift
201-1
202-1
- Droplet Size Spectrum TEP A,B No
- Drift Field Evaluation TEP A,B No
No4
No4
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR STREPTOMYCIN
FOOTNOTES:
I/ Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabeled;
~~ TEP = Typical end-use product.
2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, NonFood,; C = Aquatic, Food
~ Crop; D = Aquatic, Nonfood; E = Greenhouse, Food Crop; F = Greenhouse, Nonfood; G = Forestry; H = Domestic Outdoor;
I = Indoor.
3/ Data must be submitted within the indicated time frame, starting with the date of receipt of this Guidance Document.
4/ Available toxicological data does not trigger the need for this study.
5/ Data may be required pending the results of the Short-Term Field Dissipation study.
6/ Data may be required pending the results of the Confined Accumulation Rotational Crops study.
7/ Not a requirement since there are no aquatic uses for streptomycin.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR STREPTOMYCIN
Use Does EPA Bibliographic Must Additional Time Frame
Data Requirement Composition1- Pattern Have Data? Citation Data Be for
Submitted? Submission
§158.340 Toxicology
ACUTE TESTING:
81-1 - Acute Oral - Rat TGAI No
81-2 - Acute Dermal - TGAI No
81-3 - Acute Inhalation - Rat TGAI No
81-4 - Eye Irritation - Rabbit TGAI No
81-5 - Dermal Irritation - TGAI No
Rabbit
81-6 - Dermal Sens itizat ion - TGAI No
Guinea Pig
81-7 - Delayed Neurotoxicity - TGAI No
Hen
SUBCHRONIC TESTING:
82-1 - 90-Day Feeding
- Rodent TGAI No
- Non-rodent TGAI No
No2
No2
No2
No2
No2
No2
No3
No2
No2
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR STREPTOMYCIN
Use Does EPA
Data Requirement Composition1 Pattern Have Data?
§158.340 Toxicology (cont'd)
SUBCHRONIC TESTING (cont'd):
82-2 - 21-Day Dermal TGAI No
82-3 - 90-Day Dermal TGAI No
82-^1 - 90-Day Inhalation TGAI No
82-5 - 90-Day Neurotoxicity TGAI No
CHRONIC TESTING:
83-1 - Chronic Toxicity
2 Species:
- Rodent, and TGAI No
- Nonrodent TGAI No
83-2 - Oncogenicity Study
2 Species:
- Rat, and TGAI No
- Mouse TGAI No
Bibliographic Must Additional Time Frame
Citation Data Be for
Submitted? Submission
No2
No2
No2
No3
No2
No2
No2
No2
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR STREPTOMYCIN
Data Requirement
Use Does EPA
Compos it ion*- Pattern Have Data?
Bibliographic Must Additional Time Frame
Citation Data Be for
Submitted? Submission
§158.340 Toxicology (cont'd)
CHRONIC TESTING (cont'd);
83-3 - Teratogenicity
2 Species:
- Rat, and
- Rabbit
TGAI
TGAI
No
No
No2
No2
83-^4 - Reproduction - Rat
MUTAGENICITY TESTING:
TGAI
84-2 - Gene Mutation (Ames Test) TGAI
84-2 - Stractur.il Chromosomal TGAI
Aberration
84-2 - Other Medianisms of TGAI
Mutagenicity
SPECIAL TESTING;
«k
85-1 - General Metabolism PAI OR PAIRA
No
No
No
No
No
No2
No2
No2
No2
No2
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR STREPTOMYCIN
FOOTNOTES:
I/ Composition: TGAI = Technical grade active ingredient; PAI = Pure active ingredient; PAIRA = Pure active ingredient,
radiolabeled; Choice = Choice of several test substances determined on a case-by-case basis.
2/ This data requirement is waived based on the availability of human data.
3/ This test is required only for compounds which are organophosphate inhibitors of chlolinesterase, or related
to such inhibitors or metabolites of such inhibitors. Streptomycin is not an organophosphate, therefore a
study is not required.
LH
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR STREPTOMYCIN
ON
§158
Use Does EPA
Data Requirement Compos it ion*- Pattern^ Have Data?
.490 Wildlife and
Bibliographic Must Additional
Citation Data Be
Submitted?
Time Frame
for
Submission3
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1
71-2
71-3
- Acute Avian Oral TGAI A,B,F No
Toxicity
- Avian Subacute Dietary
Toxicity
- Upland Game Bird, and TGAI A,B,F No
- Waterfowl TGAI A,B,F No
- Wild Mammal Toxicity TGAI A,B,F No
Yes
Yes
No4
No5
9 months
9 months
71-4 - Avian Reproduction
-Upland game bird TGAI A,B,F
-Waterfowl - TGAI A,BfF
71-5 - Simulated and Actual TEP A,B
>4 Field Testing
Mammals and Birds
No
No
No
No4
No4
No4
-------
TABLE A
GENERIC DATA REQUIREMENFS FOR STREPTOMYCIN
Use Does EPA
Data Requirement Composition1 Pattern^ Have Data?
§158.490 Wildlife and
Aquatic Organisms (cont'd)
AQUATIC ORGANISM TESTING
72-1 - Freshwater Fish Toxicity
-Warmwater TGAI A,B,F No
-Coldwater TGAI A,B,F No
72-2 - Acute Toxicity to Fresh- TGAI A,B,F No
•fc* water Invertebrates
72-3 - Acute LCso Estuarine and
Marine Organisms
- Fish TGAI A,B No
- Oyster TGAI A,B No
Bibliographic Must Additional
Citation Data Be
Submitted?
No6
No6
No6
No6
No6
Time Frame
for
Submission^
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR STREPTOMYCIN
Data Requirement
Use Does EPA
Composition^- Pattern2 Have Data?
Bibliographic Must Additional Time Frame
Citation Data Be for
Submitted? Submission3
CC
§158.490 Wildlife and
Aquatic Organisms (cont'd)
AQUATIC ORGANISM TESTING (oont'd)
72-3 - Acute Toxicity to Estuarine
and Marine Organisms
- Shrimp TGAI A,B
72-^1 - Fish Early Life Stage
and Aquatic Invertebrate
Life Cycle
-Fish TGAI A, B
-Invertebrates TGAI A,B
72-5 - Fish Life Cycle TGAI A,B
72-6 - Aquatic Organism TGAI A,B
Accumulation
No
No
No
No
No
No6
No6
No6
Yes
12 months
72-7 - Simulated or Actual Field
Testing
- Aquatic Organisms
TEP
A,B
No
No
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR STREPTOMYCIN
FOOTNOTES:
If Composition: TGAI = Technical grade of the active ingredient; TEP = Typical end-use product.
2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Nonfood Crop; C = Aquatic,
Food Crop; D = Aquatic, Nonfood; E = Greenhouse, Food Crop; F = Greenhouse, Nonfood; G = Forestry; H = Domestic
Outdoor; I = Indoor.
3/ Due dates refer to the number of months following the registrant's receipt of this Registration Standard,
unless otherwise indicated.
4/ Generally, to establish the toxicity of a technical product to birds, the Guidelines requirement is for two
avian dietary studies; but due to the low toxicity of streptomycin to mammals, only one avian dietary study
is required.
5/ Data requirement is waived because of the low acute toxicity to mammals.
6/ Since there are no aquatic uses for streptomycin, no higher tier (estuarine and chronic) aquatic studies are
required at this time.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR STREPTOMYCIN
Data Requirement
Use Does EPA
Composition^ Pattern^ Have Data?
Bibliographic Must Additional Time Frame
Citation Data Be for
Submitted? Submission
§158.540 Plant Protection
121-1 - TARGET AREA
PHYTOTOXICITY3
NONTARGET AREA PHYTOTOXICITY3
TEP
A,B
No
No
122-1
122-1
122-2
123-1
123-1
123-2
•»
124-1
124-2
TIER I
- Seed Germination/
Seedling Emergence
Vegetative Vigor
Aquatic Plant Growth
TIER II
Seed Germination/
Seedling Emergence
Vegetative Vigor
Aquatic Plant Growth
TIER III
Terrestial Field
Aquatic Field
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TEP
TEP
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING STREPTOMYCIN
Data Requirement
Use Does EPA
Composition1 Pattern Have Data?
Bibliographic Must Additional Time Frame
Citation Data Be for
Submitted? Submission^
Part 158
Subpart C - Product Chenistry
Product Identity
61-1 - Product Identity MP
and Disclosure of
Ingredients
61-2 - Description of Beginning MP
Materials and Manufac-
turing Process
61-3 - Discussion of Formation MP
of Impurities
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis MP
of Product Samples
62-2 - Certification of MP
Ingredient Limits
62-3 - Analytical Methods MP
to Verify Certified
Limits
All
All
All
All
All
All
No
No
No
No
No
N/A
N/A
N/A
Yes4
Yes5
Yes6
Yes
Yes8
6 months
6 Months
6 Months
12 Months
12 Months
12 Months
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING STREPTOMYCIN
Use
Data Requirement Composition1 Pattern
Does EPA
2 Have Data?
Bibliographic Must Additional Time Frame
Citation Data Be for
Submitted? Submission3
Physical and Chemical Characteristics
63-2
63-3
63-4
63-7
63-12
62-14
cn
~ 62-15
63-16
63-17
63-18
63-19
63-20
- Color
- Physical State
- Odor
- Density, Bulk Density,
or Specific Gravity
-pH
- Oxidizing or reducing
action
- Flammability
- Explodability
- Storage Stability
- Viscosity
- Miscibility
- Corrosion
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
All
All
All
All
All
All
All
All
All
All
All
All
No
No
No
No
No
No
No
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Yes10
Yes10
Yes10
Yes10
Yes7' 10
Yes10' 12
Yes10'13
Yes10'14
Yes10
Yes10' 15
Yes10' 16
Yes10
6 months
6 months
6 months
6 months
6 months
6 months
6 months
6 months
15 months
6 months
6 months
15 months
Characteristics
Other Requirements
64-1 - Submittal of Samples
N/A
N/A
N/A
N/A
No
-------
FOOTNOTES FDR PRODUCT SPECIFIC DATA REQUIREMENTS TOR MANUFACTURING-USE PRODUCTS CONTAINING STREPTOMYCIN
I/ Composition: MP = Manufacturing-Use Product
2/ Not applicable. Although product chemistry data may have been submitted in the past, the Agency has
determined that these data must be resubmitted for each pesticide. New requirements have been introduced
and previously submitted data must be updated. Therefore, bibliographic citations for the old data are
not applicable.
3/ Data must be submitted within indicated time frame, starting with the date of receipt of this Guidance
Document.
4_/ The chemical name, nominal concentration, Chemical Abstracts (CAS) Registry Number, and purpose of the
active ingredient and each intentionally added inert must be provided. For the active ingredient, the
following must also be provided: the product, common and trade names; the molecular, structural, and
empirical formulas; the molecular weight or weight range; and any experimental or internally assigned
company code numbers.
5_/ Complete information must be provided regarding the nature of the process (batch or continuous); the
relative amounts of beginning materials and the order in which they are added; the chemical equations
for each intended reaction; equipment used to produce each intermediate and the final product; reaction
conditions; the duration of each step of the process; purification procedures; and quality control
measures. In addition, the name and address of the manufacturer; producer; supplier of each beginning
material used in the manufacture of each product must be provided; along with information regarding
the properties of those materials.
6/ A detailed discussion of all impurities that are or may be present at >0.1%, based on knowledge of
the beginning materials, chemical reactions (intended and side) in the manufacturing process, and any
contamination during and after production must be submitted.
7/ Five or more representative samples must be analyzed for the amount of active ingredient and each
impurity for which certified limits are required. Complete validation data (accuracy and precision)
must be submitted for each analytical method used.
8/ Upper and lower limits for the active ingredient and each intentionally added inert, and upper limits
for each impurity present at _>0.1% (w/w) and each "toxicologically significant" impurity present at
>p.l% (w/w) must be provided and certified. Also, an explanation of how each certified limit was
established must be provided (e.g., sample analysis using validated analytical procedures, quantatative
estimate based on amounts of ingredients used, etc.). Limits for impurities not associated with the active
ingredient need be provided only if they are considered to be of toxicological significance, regardless
of the concentration at which they are present. Certifications must be submitted on EPA Form 8570 Rev. 2-85.
9/ Analytical methods must be provided to determine the active ingredient, and each toxicologically significant
^impurity and intentionally added inert for which certified limits are required. Each method must be
'accompanied by validation studies indicating its accuracy and precision. These methods must be suitable for
enforcement of certified limits.
10/Physiochemical characteristics (color, physical state, odor, melting point, boiling point, specific gravity,
solubility, vapor pressure, dissociation constant, partition coefficient, pH, and stability) as required
in 40 CFR 158.120 and more fully described in the Pesticide Assessment Guidelines, Subdivision D, must be
submitted.
-------
TABLE B
FOOTNOTES COKfTINUED - PRODUCT SPECIFIC DftTA REQUIREMENTS FOR STREPTOMYCIN
_ll/Data required if the test substance is dispersible in water.
_12/Data required if the product contains an oxidizing or reducing agent.
L3/Data required if the product contains combustible liquids.
14/Data required if the product is potentially explosive.
lj>/Data required if the product is a liquid.
16/Data required if the product is a liquid and is to be diluted with petroleum solvents.
-------
SUMMARY-1
LABEL CONTENTS
40 CFR 156.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. [40 CFR 156.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency.
[40 CFR 156.10(6)1
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container
[40 CFR 156.10U)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredien
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. [40~CFR 156.10(g)l
56
-------
SUMMARY-2 .
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of- Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. [40 CFR 156.10(h)(1){ii)]
Item 7s. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. [40 CFR 156.10(h) {1)(i ) ]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity, the word "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. [40 CFR 156.10(h) (1) (i ) ]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A Statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. [40 CFR 156.10(h) (1) (iii ) ]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR 156.10(h)(l)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 156.10(h) (2)].
57
-------
SUMMARY-3
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 156.10(h ) (2 ) (i ) ]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 156.10(h) (2 ) (ii ) ]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria
in the PHYS/CHEM Labeling Appendix. The requirement is
based on the results of the flashpoint determinations and
flame extension tests required to be submitted for all products.
These statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word is
used in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted use may be limited to use by certified applicator:
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe' that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR Part 152, Subpart I. You will be
notified of the Agency's classification decision.
5b
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SUMMARY-:4
Classification Labeling Requirements
If your product has been claaalfled for restricted use,
the following label requirements apply:
1. All uses restricted,
a. The statement "Restricted Uae Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard signal word (see table in MO
CPR
b. Directly below this statement on the front panel,
a summary statement of the terms of restriction must
appear (including the reasons for restriction if specified
In Section I). If use is restricted to certified applicators,
the following statement la required: "For retail sale
to and use only by Certified Applicators or persons
under their direct supervision and only for those uses
covered by the Certified Applicator's Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label uses that
are unrestricted, . but you may not distinguish them
on the label as being unrestricted.
b. You nay delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregiatration, each containing all foras and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
Item 9B. MISUSE STATEMENT - All products Bust bear the
misuse statement, "It is a violation of Federal law to use
this product in a Banner inconsistent with its labeling.*
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
-------
SUMMARY-5
Item 10A. REENTRY STATEMENT - If a reentry interval
has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the direction
for use. This heading must be set in the same type" sizes as
required for the child hazard warning. Refer to Appendix II,
STOR, PEST/DIS, and CONT/DIS to determine the storage and
disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment.
[40 CFR 156.101
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from those
accepted in connection with registration of the product. It
should be made part of the response to this notice and submitted
for review.
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SUMMARY-6
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
»>
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. NO.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
ui A r n i nn )
Signal word
— • — '
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
ON LABEL
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Req. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed by. . ._," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
c\
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SUMMARY-7
ITEM
7C
7D
7E
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red) .
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards ,
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMFNT9
Must be grouped under the headings in
8A, 8B, and 8C;^ preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
ro
-------
SUMMARY-8
ITEM
8C
9A
9B
10A
10B
IOC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Stora-je and
>hsjx>sal block
Di rect ions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with Clash
points under
150°P
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
di rect ions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Required statement is:
"It is a violation of Federal law
to use this product in a manner
inconsistent with its labeling."
Must be set apart and clearly distin-
guishable from from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
•"N
Al
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Chapter 1—Environmental Protection Agency
§156.10 Labeling Requirements
previously cited as §162.10
(a) General—(1) Contents of the label. Every pesticide
product shall bear a label containing the information specified by
the Act and (;he regulations in this Part. The contents of a
Label must show clearly and prominently the following:
(i) The name, brand, or trademark under which the product is
sold as prescribed in paragraph (b) of this section;
(ii) The name and address of the producer, registrant, or
person for whom produced as prescribed in paragraph (c) of this
section;
(iii) The net contents as prescribed in paragraph (d) of this
section;
(iv) The product registration number as prescribed in paragraph
(e) of this section;
(v) The producing establishment number as prescribed in para-
graph (f) of this section;
(vi) An ingredient statement as prescribed in paragraph (g) of
this section;
(vii) Warning or precautionary statements as prescribed in
paragraph (h) of this section;
(viii) The directions for use as prescribed in paragraph (i)
of this section; and
(ix) The use classification(s) as prescribed in paragraph (j)
of this section.
(2) Prominence and legibility. (i) All words, statements,
graphic representations, designs or other information required on
the labeling by the Act or the regulations in this part must be
clearly legible to a person with normal vision, and must be placed
with such conspicuousness (as compared with other words, state-
ments, designs, or graphic matter on the labeling) arid expressed
in such terms as to render it likely to be read and understood
by the ordinary individual under customary conditions of purchase
and use.
Mi> All required label text m'is«-?
(A) Be set in 6-point or larger type;
(B) Appear on a clear contrasting background; and
(C) Not be obscured or crowded.
(3) Language to be used. All required label or labeling text
shall appear In the English language. However, the Agency may
require or the applicant may propose additional text in other
languages as is considered necessary to protect the public. When
additional text in another language is necessary, all labeling
requirements will be applied equally to both the English and
other-language versions of the labeling.
(4) Placement of Label—(i) General. The label shall appear
on or be securely attached to the immediate container of the
64
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pesticide product. For purposes of this Section, and the mis-
branding provisions of the Act, "securely attached" shall mean
that a label can reasonably be expected to remain affixed during
the foreseeable conditions and period of use. If the immediate
container is enclosed within a wrapper or outside container
through which the label cannot be clearly read, the label must
also be securely attached to such outside wrapper or container,
if it is a part of the package as customarily distributed or
sold.
(ii) Tank cars and other bulk containers—(A) Transportation.
While a pesticide product Ti Tn transit, the appropriate
provisions of 49 CFR Parts 170-189, concerning the transportation
of hazardous materials, and specifically those provisions con-
cerning the labeling, marking and placarding of hazardous materials
and the vehicles carrying them, define the basic Federal require-
ments. In addition, when any registered pesticide product is
transported in a tank car, tank truck or other mobile or portable
bulk container, a copy of the accepted label must be attached to
the shipping papers, and left with the consignee at the time of
delivery.
(B) Storage. When pesticide products are stored in bulk
containers, whether mobile or stationary, which remain in the
custody of the user, a copy of the label of labeling, including
all appropriate directions for use, shall be securely attached to
the container in the immediate vicinity of the discharge control
valve.
(5) False or misleading statements. Pursuant to section
2(q)(l)(A) of the Act, a pesticide or a device declared subject
to the Act pursuant to S 162.15, is misbranded if its labeling is
false or misleading in any particular including both pesticidal
and non-pesticidal claims. Examples of statements or representations
in the labeling which constitute misbranding include:
(i) A false or misleading statement concerning the composition
of the product;
(ii) A false or misleading statement concerning the effectiveness
of the product as a pesticide or device;
(iii) A false or misleading statement about the value of the
pro^uc*- ?«- purposes other than as a pesticide or device;
(iv) A false or misleading comparison with other pesticides or
devices;
(v) Any statement directly or indirectly implying that the
pesticide or device is recommended or endorsed by any agency of
the Federal Government;
(vi) The .name of a pesticide which contains two or more
principal active ingredients if the name suggests one or more but
not all such principal active ingredients even though the names
of the other ingredients are stated elsewhere in the labeling;
(vii) A true statement used in such a way as to give a false
or misleading impression to the purchaser;
(viii) Label disclaimers which negate or detract from labeling
statements required under the Act and these regulations;
' 65
-------
(ix) Claims as to the safety of the pesticide or its ingredients,
including statements such as "safe," "nonpoisonous,", "noninjurious,"
"harmless" or "nontoxic to humans and pets" with or without such
a qualifying phrase as "when used as directed"; and
(x) Non-numerical and/or comparative statements on the safety
of the product, including but not limited to:
(A) "Contains all natural ingredients";
(B) "Among the least toxic chemicals known"
(C) "Pollution approved"
(6) Final printed labeling. (i) Except as provided in
paragraph (a)(6)(ii) of this section, final printed labeling must
be submitted and accepted prior to registration. However, final
printed labeling need not be submitted until draft label texts
have been provisionally accepted by the Agency.
(ii) Clearly legible reproductions or photo reductions will be
accepted for unusual labels such as those silk-screened directly
onco glass or metal containers or large bag or drum labels. Such
reproductions must be of microfilm reproduction quality.
(b) Name, brand, or trademark. (1) The name, brand, or
trademark under which the pesticide product is sold shall appear
on the front panel of the label.
(2) No name, brand, or trademark may appear on the label which:
(i) Is false or misleading, or
(ii) Has not been approved by the Administrator through
registration or supplemental registration as an additional name
pursuant to $ 162.6(b)(4).
(c) Name and address of producer, registrant, or person for
whom produced. An unqualified name and address given on the
label shall be considered as the name and address of the producer.
If the registrant's name appears on the label and the registrant
is not the producer, or if the name of the person for whom the
pesticide was produced appears on the label, it must be qualified
by appropriate wording such as "Packed for ***," "Distributed by
***," or "Sold by ***" to show that the name is not that of the
producer.
(d) Net weight or measure of contents. (1) The net weight or
measure of content shall be exclusive of wrappers or other
materials and shall be the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide is a liquid, the net content statement
shall be in terms of liquid measure at 68°F (20°C) and shall be
expressed in conventional American units of fluid ounces, pints,
quarts, and gallons.
(3) If the pesticide is solid or seraisolid, viscous or
pressurized, or is a mixture of liquid and solid, the net content
statement shall be in terras of weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content shall be stated in terms of the
largest suitable units, i.e., "1 pound 10 ounces" rather than
"26 ounces."
66
-------
(5) In addition to the required units specified, 'net content
may be expressed in metric units,
(6) Variation above minimum content or around an average is
permissible only to the extent that it represents deviation
unavoidable in good manufacturing practice. Variation below a
stated minimum is not permitted. In no case shall the average
content of the packages in a shipment fall below the stated
average content.
(e) Product registration number. The registration number
assigned to the pesticide product at the time of registration
shall appear on the label, preceded by the phrase "EPA Registration
No.," or the phrase "EPA Reg. No." The registration number shall
be set in type of a size and style similar to other print on that
part of the label on which it appears and shall run parallel to
it. The registration- number and the required identifying phrase
shall not appear in such a manner as to suggest or imply
recommendation or endorsement of the product by the Agency.
(f) Producing establishments registration number. The producing
establishment registration number preceded by the. phrase "EPA
Est.", of the final establishment at which the product was produced
may appear in any suitable location on the label or immediate
container. It must appear on the wrapper or outside container of-
the package if the EPA establishment registration number on the
immediate container cannot be clearly read through such wrapper
or container.
(g) Ingredient statement—(1) General. The label of each
pesticide product must bear a statement which contains the name
and percentage by weight of each active ingredient/ the total
percentage by weight of all inert ingredients; and if the pesticide
contains arsenic in any form, a statement of the percentages of
total and water-soluble arsenic calculated as elemental arsenic.
The active ingredients must be designated by the term "active
ingredients" and the inert ingredients by the term J* inert
ingredients," or the singular forms of these terms when appropriate.
Both terms shall be in the same type size, be aligned to the same
margin and be equally prominent. The statement "Inert Ingredients,
none" is not required for pesticides which contain 100 percent
active ingredients. iini««« nhe ingredient statement i? a complete
analysis of the pesticide, the term "analysis" shall not be used
as a heading for the ingredient statement.
(2) Position of ingredient statement. (i) The ingredient
statement is normally required on the front panel of the label.
If there is an outside container or wrapper through which the
ingredient statement cannot be clearly read, the ingredient
statement must also appear on such outside container or wrapper.
If the size or form of the package makes it impracticable to place
the ingredient statement on the front panel of the label/ permission
may be granted for the ingredient statement to appear elsewhere.
(ii) The text of the ingredient statement must run parallel
with other text on the panel on which it appears, and must b«
clearly distinguishable from and must not be placed in the body
of other text.
.67
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(3) Names to be used In ingredient statement. The name used
for each ingredient shall be the accepted common name, if there
is one, followed by the chemical name. The common name may be
used alone only if it is well known. If no common name has been
established, the chemical name alone shall be used. In no case
will the use of a trademark or proprietary name be permitted unles
such name has been accepted as a common name by the Administrator
under the authority of Section 25(c)(6).
(4) Statements of percentages. The percentages of ingredients
shall be stated in terms of weight-to-weight. The sum of per-
centages of the active and the inert ingredients shall be 100.
Percentages shall not be expressed by a range of values such as
"22-25%." If the uses of the pesticide product are expressed as
weight of active ingredient per unit area, a statement of the
weight of active ingredient per unit volume of the pesticide
formulation shall also appear in the ingredient statement.
(5) Accuracy of stated percentages. The percentages given
shall be as precise as possible reflecting good manufacturing
practice. If there may be unavoidable variation "between manu-
facturing batches, the value stated for each active ingredient
shall be the lowest percentage which may be present.
(6) Deterioration. Pesticides which change in chemical
composition significantly must meet the following labeling re-
quirements :
(i) In cases where it is determined that a pesticide formulatio
changes chemical composition significantly, the product must bear
the following statement in a prominent position on the label: "No
for sale or use after [date]."
(ii) The product must meet all label claims up to the expiratio
time indicated on the label.
(7) Inert ingredients. The Administrator may require the name
of any inert ingredient(s) to be listed in the ingredient statemen
if he determines that such ingredient(s) may pose a'hazard to man
or the environment.
(h) Warnings and precautionary statements. Required warnings
and precautionary statements concerning the general areas of
toxicological hazard including hazard to children, environmental
hazard, and physical or chcaicil hazard fall into two groups; thos
required on the front panel of the labeling and those which may
appear elsewhere. Specific requirements concerning content,
placement/ type size, and prominence are given below.
(1) Required front panel statements. With the exception of the
child hazard warning statement, the text required on the front
panel of the label is determined by the Toxicity Category of the
pesticide. The category is assigned on the basis of the highest
hazard shown by any of the indicators in the table below:
-------
Hazard Indicators
Oral LD
50
Inhalation LC
50
Dermal LD,
50
Eye effects
Skin effacts
1
Up to and
Includ Ing
50 mg/kg
Up to and
Includ Ing
.2 «g/Hter
Up to and
Including
200 «g/Kg
Corroslva;
cornea! opacity
not reversible
within 7 days
Corroslva
Toxicity c
1 1
F-om 50 thru
500 mg/kg
From .2 thru
2 mg/l Itar
From 200
thro 2000
Cornea 1 opacity
reve.-slble
within 7 days;
Irritation
persisting for
7 days
Seva-a Irritation
at 72 hours
:ategor!es
1 1 1
F-om 500 thru
5000 mg/kg
F-om 2 thru
20 mg/Mtar
From 2,000 thru
20,000
No cornea 1 -opacity;
Irritation
reversible
within 7 days
Mode-ate Irritation
at 72 hou-s
!
IV
Greater than
5000 mg/kg
Greater than
20 «g/l 'ter
Greater than
20,000
No Irritation
Mild or si ight
Irritation at
72 hours
(i)
Human hazard signal word.--(A) Toxicity Category I. All
pesticide products meeting the criteria of Toxicity Category I
shall bear on the front panel the signal word "Danger." In
addition if the product was assigned to Toxicity Category I on
the basis of its oral, ir.halati-rr. or dermal toxicity (as distinct
from skin and eye local effects) the word "Poison" shall appear
in red on a background of distinctly contrasting color and the
skull and crossbones shall appear in immediate proximity to the
word "poison."
All pesticide products meeting the
II shall bear on the front panel*
(B) Toxicity Category II.
criteria of Toxicity Category
the signal word "Warning."
(C) Toxicity Category III.
criteria of Toxicity Category
the signal word "Caution."
(D) Toxicity Category IV.
criteria of Toxicity Category
the signal word "Caution."
All pesticide products meeting the
III shall bear on the front panel
All pesticide products meeting the
IV shall bear on the front panel
-------
(E) Use of signal words. Use of any signal word(s) associated
with a higher Toxicity Category is not permitted except when the
Agency determines that such labeling is necessary to prevent
unreasonable adverse effects on man or the environment. In no
case shall more than one human hazard signal word appear on the
front panel of a label.
(ii) Child hazard warning. Every pesticide product label shall
bear on the front panel the statement "keep out of reach of
children." Only in cases where the likelihood of contact with
children during distribution, marketing, storage or use is
demonstrated by the applicant to be extremely remote, or if the
nature of the pesticide is such that it is approved for use on
infants or small children, may the Administrator waive this
requirement.
(iii) Statement of practical treatment—(A) Toxicity
Category I. A statement of practical treatment (first aid or
other) shall appear on the front panel of the label of all
pesticides falling into Toxicity Category I on the basis of oral,
inhalation or dermal toxicity. The -Agency may, however, permit
reasonable variations in the placement of the statement of
practical treatment is some reference such as "See statement of
practical treatment on back panel" appears on the front panel
near the word "Poison" and the skull and crossbones.
(B) Other toxicity categories. The statement of practical
treatment is not required on the front panel except as described
in paragraph {h){1)(iii)(A) of this section. The applicant may,
however, include such a front panel statement at his option.
Statements of practical treatment are, however, required elsewhere
on the label -in accord with paragraph (h)(2) of this section if
they do not appear on the front panel.
(iv) Placement and prominence. All the required front panel
warning statements shall be grouped together on the label, and
shall appear with sufficient prominence relative to other front
panel text and graphic material to make them unlikely to be over-
looked under customary conditions of purchase and use. The
following table shows the minimum type size requirements for the
front panel warning statements on various sizes of labels:
Size of label front panel
in square inches
Above 5 to 10
Above 10 to 15
Over 30
Points
Required
signal word,
all capitals
6
10
12
14
18
"Keep out
of reach of
Children"
6
6
8
10
12
-------
(2) Other required warnings and precautionary statements. The
warnings and precautionary statements as required below shall appear
together on. the label under the general heading " Pre'caut ionary
Statements" and under appropriate subheadings of "Hazard to Humans
and Domestic Animals," "Environmental Hazard" and "Physical or
Chemical Hazard."
(i) Hazard to humans and domestic animals. (A) Where a hazard
exists to humans or domestic animals, precautionary statements
are required indicating the particular hazard, the route(s) of
exposure and the precautions to be taken to avoid accident, injury
or damage. The precautionary paragraph shall be immediately
preceded by the appropriate hazard signal word.
(B) The following table depicts typical precautionary statements.
These statements must be modified or expanded to reflect specific
hazards.
I
| Toxic Iry
| category
Precautionary statements by toxicIty category
Oral, Inhalation, or dermal toxlclty
Skin and eye local effects
IV . . .
Fatal (poisonous) If swallowed (Inhaled or
absorbed through skin). Do not breathe
vapor [dust] or spray mist). Do not get
In eyes, on skin, or on clothing (Front
panel statement of practical t-eatnent
rac;u'red.>.
May be fatal If s wall owed (Inhaled or
absorbed through the skin). Do not breathe
vapors (dust or spray «lst). Do not get In
eyes, on skin, or on clothing. (Appropriate
first aid statements required.!.
Harmful If swallowed (Inhaled or absorbed
through the skin). Avoid breathing vapors
(dust or spray «l«t|. Avoid contact with
sk'n (eyes or clothing). (Appropriate
first aid statement required.).
(No precautionary statements required.).
Corrosive, causes eye and skin damage (or
skin Irritation). Do not get In eyes, on
skin, or on cloth'ng. Wear goggles or face
shield and rubber gloves when handling.
Harmful or fatal If swallowed.
(Appropriate first aid statement required.)
Causes eye (and sktnl Irritation. Do not
get In eyes, on skin, or on clothing.
Harmful If swallowed. (Appropriate first
aid statement required.!.
Avoid contact with sk"ln, eyes or clothing.
In case of contact Immediately flush
eyes or skin with plenty of water. Get
medical attention If Irritation persists.
I No precautionary statements required.!,
(ii) Environmental hazards. Where a hazard exists to non-
target organisms excluding humans and domestic animals, precautionar
statements are required stating the nature of the hazard and the
appropriate precautions to avoid potential accident, injury or
-------
damage. Examples of the'hazard statements and the circumsta
under which they are required follow:
(A) If a pesticide intended for outdoor use contains an a<
ingredient with a mammalian acute oral LD5Q of 100 or less,
statement "This Pesticide is Toxic to Wildlife" is required.
(B) If a pesticide intended for outdoor use contains an ai
ingredient with a fish acute LC5Q of 1 ppm or less, the stats
"This Pesticide is Toxic to Fish" is required.
(C) If a pesticide intended for outdoor use contains an a<
ingredient with an avian acute oral LD5Q of 100 mg/kg or les:
a subacute dietary LC^Q of 500 ppm or less, the statement "Tl
Pesticide is Toxic to Wildlife" is required.
(D) If either accident history or field studies demonstra
that use of the pesticide may result in fatality to birds, f
or mammals, the statement "This pesticide is extremely toxic
wildlife (fish)" is required.
(E) For uses involving foliar application to agricultural
crops, forests, or shade trees, or for mosquito abatement
treatments, pesticides toxic to pollinating insects must beai
appropriate label cautions.
(F) For all outdoor uses other than aquatic applications
label must bear the caution "Keep out of lafces, ponds or str<
Do not contaminate water by cleaning of equipment or disposa
wastes."
(iii) Physical or chemical hazards. Warning statements o
flammability or explosive characteristics of the pesticide a
required as follows:
Flash point
Required text
(A) PRESSURIZED CONTAINERS
Flash point at or be lew 20*F; If there Is a
flashback at any valve opening.
Flash point above 20*F end not over 80*F or If
the flam* extension Is «ore than 18 In. long
at a distance of 6 I n. tro» the fl<
AI I other pressurized containers .
Extremely flammable. Contents under pressure
Keep away from fire, sparks, and heated
surfaces. Oo not puncture or Incinerate
container. Exposure to temperatures above
I50*F r*y c«"^» *«•«•«« ing.
Flammable. Contents under pressure. Keep an
from heat, sparks, and open flame. Do not
puncture or Incinerate container. Exposure
temperatures above 150*F «ay cause bursting
Contents under pressure. Oo not use or store
near heat or open flame. Oo not puncture o
Incinerate container. Exposure to tempera-
tures above 130*F may cause bursting.
(B) NONPRESSURIZEO CONTAINERS
At or be lew 20'F
| Eitr
ly f leasable. K»«o a«ay »ro» fire,
and heated surfaces.
Above 20'F and not over 80*F .......... | ' i a— able. Keep a-ay from heat and open Ha*
Above 80*F and not over IWF ......... I Oo *ot me or store near heat or open flame.
-------
(i) Directions for Use—(1) General requirements—(i) Adequacy
and clarity of directions. Directions for use must be stated in
terms which can be easily read and understood by the average
person likely to use or to supervise the use of the pesticide.
When followed, directions must be adequate to protect the public
from fraud and from personal injury and to prevent unreasonable
adverse effects on the environment.
(ii) Placement o£ directions for use. Directions may appear
on any portion of the label provided that they are conspicuous
enough to be easily read by the user of the pesticide product.
Directions for use may appear on printed or graphic matter which
accompanies the pesticide provided that:
(A) If required by the Agency, such printed or graphic matter
is securely attached to each package of the pesticide, or placed
within the outside wrapper or bag;
(B) The label bears a reference to the directions for use in
accompanying leaflets or circulars, such as "See directions in
the enclosed circular." and
(C) The Administrator determines that it is not necessary for
such directions to appear on the label.
(i i i) Exceptions to requirement for direction-for use—(A)
Detailed directions for use may be omitted from labeling of
pesticides which are intended for use only by manufacturers of
products other than pesticide products in their regular manu-
facturing processes, provided that:
(^) The label clearly shows that the product is intended for
use only in manufacturing processes and specifies the type(s) of
products involved.
(2) Adequate information such as technical data sheets or
bulletins, is available to the trade specifying the type of
product involved and its proper use in manufacturing processes;
(_3) The product will not come into the hands of the general
public except after incorporation into finished products; and
M) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(B) Detailed directions for use may be omitted from the labeling
of pesticide products for which sale is limited to ohysicians,
veterinarians, or druggists, provided that:
(I) The label clearly states that the product is for use only
by physicians or veterinarians;
(2) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment; and
(_3). The product is also a drug and regulated under the provisions
of the Federal Food, Drug and Cosmetic Act.
(C) Detailed directions for use may be omitted from the labeling
of pesticide products which are intended for use only by formulators
in preparing pesticides for sale to the public, provided that:
(I) There is information readily available to the formulators
on the composition, toxicity, methods of use, applicable restriction
or limitations/ and effectiveness of the product for pesticide
purposes ;
-------
(2^ The label clearly states that the product is -intended £or
use only in manufacturing, formulating, mixing, or repacking for
use as a pesticide and specifies the type(s) of pesticide products
involved;
( 1_) The product as finally manufactured, formulated, mixed, or
repackaged is registered; and
(_4) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
env ironment.
(2) Contents of Directions for Use. The directions for use
shall include the following, under the headings "Directions for
Use" :
(i) The statement of use classification as prescribed in
162.10(j) immediately under the heading "Directions for Use."
(ii) Immediately below the statement of use classification,
the statement "It is a violation of Federal law to use this
product in a manner inconsistent with its labeling."
(iii) The site(s) of application, as for example the crops,
animals, areas, or objects to be treated.
(iv) The target pest(s) associated with each site.
(v) The dosage rate associated with each site and pest.
(vi) The method of application, including instructions for
dilution, if required, and type(s) of application apparatus or
equipment requried.
(vii) The frequency and timing of applications necessary to
obtain effective results without causing unreasonable adverse
effects on the environment.
(viii) Specific limitations on reentry to areas where the
pesticide has been applied, meeting the requirements concerning
reentry provided by 40 CFR Part 170.
(ix) Specific directions concerning the storage and disposal
of the pesticide and its container, meeting the requirements of
40 CFR Part 165. These instructions shall be grouped and appear
under the heading "Storage and Disposal." This heading must be
set in type of the same minimum sizes as required for the child
hazard warning (See Table in § 162.10(h)(1)(iv}.)
(x) Any limitations or restrictions on use required to prevent
unreasonable adverse effects, such as:
(A) Required intervals between application and harvest of food
or feed crops.
(B) Rotational crop restrictions.
(C) Warnings as required against use on certain crops, animals,
objects, or in or adjacent to certain areas.
(D) [Reserved]
(E) For restricted use pesticides, a statement that the
pesticide may be applied under the direct supervision of a
certified applicator who is not physically present at the site of
application but nonetheless available to the person applying the
pesticide, unless the Agency has determined that the pesticide
may only be applied under the direct supervision of a certified
applicator who is physically present.
74
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PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A.
Flashpoint at or below
20°F;' or if there is a
flashback at any valve
opening.
B.
Flashpoint above 20°F
and not over 30°F;' or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
All Other Pressurized
Containers
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F-.
D. Flashpoint above
150°F.
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. bo not
puncture or incinerate
container. Exposure to
temperatures above 130°?
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. DO
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
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STOR-1
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading:
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL."
Storage Instructions:
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occur
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
76
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CONT/DIS-1
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear
instructions appropriate to the type of
container disposal
container.
1. Domestic use products must
container disposal statements:
Container Type
bear one of the following
Statement
Non-aerosol products
(bottles, cans, iars)
Non-aerosol products
(baqs)
Aerosol products
Do not reuse container (bottle, can, jar).
Rinse thorouqhly before discardinq in trash.
Do not reuse bag. Discard -bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2. All other products must bear container disposal instructions
based on container type, listed below:
Container Type
Statement
Metal
containers
(non-aerosol)
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused^-, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
OUt Of SHOK6.
Return e-npty cylinder for reuse (or
similar wor dinq )
Manufacturer may replace tr. :s pnrase with one indicating
whether and how fiber drum ~av oe reused.
-------
PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those intended solely for domestic
use, must bear explicit instructions about pesticide disposal. The
statements listed below contain the exact wording that must appear on
the label of these products:
1. The labels of all products, except domestic use, must, contain the
statement, "Do not contaminate water, food, or feed by storage or disposal."
2. Except those products intended solely for domestic use, the labels
of all products that contain active ingredients that are Acute Hazardous
wastes or are assigned to Toxicity Category I on the basis of oral or
dermal toxicity, or Toxicity Category I or II on the basis of acute
inhalation toxicity must bear the following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal of
excess pesticide, spray mixture, or rinsate is a violation of Federal
Law. If these wastes cannot be disposed of by use according to
label instructions, contact your State Pesticide or Environmental
Control Agency, or the Hazardous Waste representative at the nearest
EPA Regional Office for guidance."
3. The labels of all products, except those intended for domestic use,
containing active or inert ingredients that are Toxic Hazardous wastes
or meet any of the criteria in 40 CFR 261, Subpart C for a hazardous
waste must bear the following pesticide disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess pesticide,
spray mixture, or rinsate is a violation of Federal Law. If these
wastes cannot be disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control Agency, or the
Hazardous waste representative at the nearest EPA Regional Office
for guidance."
4. Labels for all other products, except those intended for domestic
use, must bear the following pesticide disposal statement::
"Wastes resulting from the use of this product may be disposed of on
site or at an approved waste disposal facility."
5. Products intended for domestic use only must bear the following
disposal statement: "Securely wrap original container in several layers
of newspaper and discard in trash."
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APPENDIX III
-------
BIBGUIDE-1
GUIDE TO USE OF THIS BIBLIOGRAPHY
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have b'een the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
80
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(F) Other pertinent information which the Administrator
determines to be necessary for the protection of man and the
env i ronment.
(j) Statement of Use Classification. By October 22, 1976, all
pesticide products must bear on their labels a statement of use
classification as described in paragraphs (j)(l) and (2) of this
section. Any pesticide product for which some uses are classified
for general use and others for restricted use shall be separately
labeled according to the labeling standards set forth in this
subsection, and shall be marketed as separate products with
different registration numbers, one bearing directions only for
general use(s) and the other bearing directions for restricted
use(s) except that, if a product has both restricted use(s) and
general use(s), both of these uses may appear on a product labeled
for restricted use. Such products shall be subject to the
provisions of § 162 .10(j ) (2).
(1) General Use Classification. Pesticide products bearing
directions for use(s) classified general shall be labeled with
the exact words "General Classification" immediately below the
heading "Directions for Use." And reference to the general
classification that suggests or implies that the general utility.
of the pesticide extends beyond those purposes and uses contained
in the Directions for Use will be considered a false or misleading
statement under the statutory definitions of misbranding.
(2) Restricted Use Classification. Pesticide products bearing
direction for use(s)classified restricted shall bear statements
of restricted use classification on the front panel as described
below:
(i) Front panel statement of restricted use classification.
(A) At the top of the front panel of the label, set in type of
the same minimum sizes as required for human hazard signal words
(see table in $ 162.10(h)(1)(iv))/ and appearing with sufficient
prominence relative to other text and graphic material on the
front panel to make it unlikely to be overlooked under customary
conditions of purchase and use, the statement "Restricted Use
Pesticide" shall appear.
(B) Directly below this statement on the front panel, a summary
statement of the terms of restriction imposed as a precondition
to registration shall appear. If use is restricted to certified
applicators, the following statement is required: "For retail
sale to and use only by Certified Applicators or persons under
their direct supervision and only for those uses covered by the
Certified Applicator's certification." If, however, other
regulatory restrictions are imposed, the Administrator will define
the appropriate wording for the terms of restriction by regulation
(k) Advertising. (Reserved)
(40 FR 28268, July 3, 1975; 40 FR 32329, Aug. 1, 1975; 40 FR
38571, Aug. 21, 1975, as amended at 43 FR 5786, Feb. 9, L978]
81
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Streptomycin Standard
MRID CITATION
00065578 Pfipharmecs (1958) [Efficacy of Streptomycin on Peppers, Tomatoes,
Pears, Apples, Tobacco and Chrysanthemums]. (Compilation; un-
published study, including published data, received May 26,
1954?; Nov 7, 1955?; Nov 13, 1953?; Jan 22, 1954?; Feb 20, 1958
under 1007-6; CDL:229886-A)
00103377 Pfipharmecs (1968) [Streptomycin Residue Analyses—Pears]. (Com-
pilation; unpublished study received Jan 21, 1969 under 1007-24;
CDL:005381-B)
00103383 Chas. Pfizer & Co., Inc. (1964) Streptomycin Residue Determination
on Apples. (Unpublished study received Sep 24, 1967 under
8F0693; CDL:091202-G)
00103384 Interregional Research Project No. 4 (1972) [Streptomycin Residue
Determination in Various Crops, Dairy Products and Animal
Tissues]. (Compilation; unpublished study received on unknown
date under 1E1095; CDL:093407-A)
00103386 Carroll, V. (1966) Streptomycin Residue Determination on Apples.
(Unpublished study received Mar 14, 1966 under 1007-24; sub-
mitted by Pfipharmecs, Div. of Pfizer, Inc., New York, NY;
CDL:101536-A)
00103390 Pfipharmecs (1960) Agri-mycin 100 Spray and Dust Field Trials on
Pears, Apples and Walnuts. (Unpublished study received Dec 21,
1960 under 1007-24; prepared by Univ. of California—Davis, Ag-
ricultural Experiment Station; CDL:119407-B)
00108022 Interregional Research Project No. 4 (1972) Summary of Merck Strep-
tomycin Trials on Celery, Pepper, Potato and Tomato. (Compila-
tion; unpublished study received Oct 10, 1972 under 1E1095; CDL:
090855-A)
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APPENDIX IV
-------
Form Approved. OMB No. 2070-0057 Approval txpirts 11-00-S
FIFHA SECTION 3(C)(2)(B) SUMMARY SHEET
€PA REGISTRATION NO
PRODUCT NAME
APPLICANT'S NAME
DATE GUIDANCE QOCUMENT ISSUED
With respect to the requirement to submit "generic" data imposed by the FIFRA action 3(C)(2)(B) notice contained in the referenced
Guidance Document, I am responding in the following manner:
D 1. I will submit data in a timely manner to satisfy the following requirements. If the test procedures I will use deviate from (or are not
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group. OECD
Chemicals Testing Programme, I enclose the protocols that I will use:
CH 2. I have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(B)Hi) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
D3. I enclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
respect to the following data requirements:
O 4. I request that you amend my registration by deleting the following uses (this option a not available to applicants for new products):
D 5. I request voluntary cancellation of the registration of this product (Th» option is not available fo applicants for new product!)
REGISTRANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
EPA form KtO-1 (10421
84
-------
OMB Approval No. 2070-005
Expiration Date 11/30/89
GENERIC DATA EXEMPTION STATEMENT
EPA Product Registration Number:_
Registrant's Name and Address:
As an authorized representative of the registrant of the product identified above, I
certify that:
(1) I have read and am familiar with the terms of the Notice from EPA dated
concerning a requirement for submission of "generic" data on the active
ingredient named under FIFRA Section 3(c)(2)(B).
(2) My firm requests that EPA not suspend the registration of our product, despite
our lack of intent to submit the generic data in question, on the grounds that the product
contains the active ingredient solely as the result of the incorporation into the product
of another product which contains that active ingredient, which is registered under FIFRA
Section 3, and which is purchased by us from another producer.
(3) An accurate Confidential Statement of Formula (CSF) for the above-identified
product is attached to this statement. That formula statement indicates, by company name,
registration number, and product name, the source of the subject active ingredient in my
firm's product, or
The CSF dated ^_^ on file with EPA is complete, current and accurate anc
contains the information requested on the current CSF Form 8570-4. The registered
source(s) of the above named active ingredient in my product(s) is/are
and their registration number(s) Is/are . ~
fty firm will apply for an amendment to the registration prior to changing the source
of the active ingredient In our product.
(4) I understand, and agree on behalf of my firm, that 1f at any time any portion o1
this Statement is no longer true, or if my firm fails to comply with the undertakings mad<
in this Statement, my firm's product's registration may be suspended under FIFRA Section
3(c)(2)(B).
(5) I further understand that if my firm is granted a generic data exemption for thi
product, my firm relies on the efforts of other persons to provide the Agency with the
required generic data. If the registrant(s) who have committed to generate and submit thi
required data fail to take appropriate steps to meet requirements or are no longer in
compliance with this Notice's data requirements, the Agency will consider that both they
and my firm are not in compliance and will normally Initiate proceedings to suspend the
registrations of my firm's product(s) and their product(s), unless ray firm commits to
submit and submits the required data in the specified time frame. I understand that, in
such cases, the Agency generally will not grant a time extension for submitting the data.
Registrant's authorized representative:
(Signature
Dated:
n _ Hyped]
EPA Fora 8570-27 ' 85
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OMB Approval I
2070-C
Expires 11/30,
EPA Reg. No.
PRODUCT SPECIFIC DATA REPORT
Date
Guidance Document for
"Registration
Guideline No.
sec. ibti.izu
PRODUCT
CHEMISTRY
bl-1
bl-2
bl-3
b2-l
b2-2
bZ-3
b3-Z
63-3
63-4
63-b
63-6
63-7
63-8
63-9
63-10
63-11
63-12
Name of Test
Identity of
ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-
density, or
specific gravity
Solubility
vapor pressure
Dissociation
constant
octanoi /water
partition
coefficient
pH
Test not^
required
for my
product
Ms ted
above
(check
below)
I am complying with
data requirements by
citing MR ID
Number or
EPA Accession
Number
5u omit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
•
•*
• i
EPA Form 8580-4
86
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OMB Approval No.
2070-005
Expires 11/30/89
EPA Reg. No.
PRODUCT SPECIFIC DATA REPORT (confd)
Date
Guidance Document for
1
1
1
1
1
1
1
1
Registration !
Guideline No. !
Sec. 153.120 i
PRODUCT J
CHEMISTRY ,'
(confd) !
63-13 T
63-14 T
i
i
63-15 T
63-16 T
63-1/ T
63-18 T
63-19 T
63-2U T
i
i
63-21 T
i
i
sec. 158.135 ;
TOXICOLOGY !
Bl-l J
i
i
BI-Z ;
t
•
81-3 ;
•
8i-4 ;
i
i
81-5 i
i
i
81-6 i
i
i
8i- / ;
i
•
Name of Test
Stabi Mty
Oxi di 21 ng/reduci ng
reaction
F 1 aranabl l i ty
Expiodabi nty
storage stabi nty
viscosity
Ml SCI 01 Mty
corrosion
characteristics
dielectric break-
down voltage
Acute oral
toxiclty, rat
Acute dermal
toxiclty. rabbit
Acute inhalation,
toxiclty. rat
primary eye
Irritation, rabbit
Primary dermal
Irritation
oermai sensitfza-
tlon,
Acute Delayed
neurotoxldty. hen
Test not
required
for my
product
listed
above
(check
bel ow )
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
submi t-
tlng
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
EPA Form 8580-4 (confd)
87
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•d. OMB He. 3O70-OQ97 Ext
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
(To cue/fry. ctrtifyALL four /Mm*/ ?OR DEVELOPMENT OF DATA
1. 1 am duly authorized to represent the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
NAME OF FIRM
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
EPA COMPANY NUMBER
(This firm or group of firms is referred to below as "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer
into an agreement with one or more other registrants to develop jointly, or to share in the coct of developing, the following
items or data:
3. My firm has off and in writing to inter into such an agreement Copies of the offers are attached. That offer we* irrevocable and included an o
bound by an arbitration decision under FIFRA Section 3(d(2)(B)(iii) if final agreement on all terms could not be retched otherwise. This offer <
•(• the fallowing firm(s) on the following deteU):
NAMK OF FIRM
OAT! OF OFFER
However, none of those firm(j) accepted my offer.
4. T»y firm requests that EPA not suspend the registration(s) of my firm's product(s), if any of tht firms named in paragraph ('.
have agreed to submit the data listed in paragraph (2) above in accordance with tht Notice. I understand EPA will promptly
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3
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