United States Office of Prevention,
Environmental Protection And Toxic Subctancas
Agency (H-7508W)
vvEPA Reregistration
Eligibility Document
(RED)
Streptomycin and
Streptomycin Sulfate
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
SEP 3 0 1992
OFFICE OF
P€STiciO€S*NOTOXIC
SUBSTANCES
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency (the "Agency") has
completed its reregistration eligibility decision on the pesticide active ingredients streptomycin
and streptomycin sulfate.
Enclosed is a Reregistratton Eligibility Document (RED) for the pesticide active
ingredients streptomycin and streptomycin sulfate, hereafter referred to as streptomycin. The
RED is the Agency's evaluation of streptomycin's and streptomycin sulfate's data base, its
conclusions regarding human and environmental risks associated with the current product uses,
and its decisions and conditions under which uses and products will be eligible for
rereregistration. Also enclosed is the EPA RED facts and the Pesticide Rereglsfration
Handbook which provides instructions to registrants on how to respond to any labeling and data
requirements specified in the RED and how to reregister products.
The RED identifies outstanding product specific data requirements for end-use products
and manufacturing-use products. These requirements are listed on the Requirements Status and
Registrant's Response Forrnr which, along with the Data Call-In Response Form listing all of
your company's products subject to the RED, is included as an Attachment. Instructions for
completing both forms are contained in the RED package. All product specific data must be
submitted and found acceptable by the Agency before a product can be reregistered.
Generic data requirements usually will have been fulfilled prior to making a reregistration
eligibility decision. However, there may be some instances where additional generic data are
required. If generic data requirements need to be fulfilled, all registrants must complete the
appropriate Data Call-In Response Form and Requirements Status and Registrant's Response
Form. These forms are in the appendices to the RED.
The RED identifies any specific labeling requirements such as restricted use classifica-
tion, groundwater hazard statements, endangered species precautions, etc., necessary for reregis-
tration based on a review of the generic data for the active ingredient. In addition, in order to
Printed on Recycled Paper
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be reregistered, all product labeling must be in compliance with format and content labeling as
described in 40 CFR §156.10 and all labeling changes imposed by Pesticide Regulation (PR)
Notices, and any label changes imposed by this RED.
The Pesticide Reregistration Handbook contains detailed instructions for compliance with
the RED and must be followed carefully. There are several key points to remember in preparing
your response to the RED:
Within gQ.-P.av.g of Your Receipt of this_Leger
1. For eagh product which is subject to this RED, you must complete, sign and submit
the data call-in (DCI) response forms attached to the RED [Appendix G, Attachments
B and C, has forms for product specific data]. Follow the instructions in Attachments
B and C for completing those forms and submit the forms to the appropriate address
specified in the Data Call-Ins. Note that the DCI forms for generic data are to be
sent to the Special Review and Reregistration Division (use the mailing distribution
code RED-SRRD-0169 for your generic response). The DCI forms for product
specific data are to be sent to the Registration Division (use the mailing distribution
code RED-RD-PM21 for your product specific response).
2. No time extensions will be granted for submitting the 90-day responses. If the
Agency does not receive a response for a product, it may issue a Notice of Intent to
Suspend (NQIS) for that product.
3. Any requests for data waivers or time extensions to the 8-month deadline must be
submitted as part of your 90-day response. Such requests will generally not be
considered if submitted later than the 90-day response.
Within 8 Months of the Date of this Letter
1. For each product, you must submit a completed Application for Reregistration (EPA
Form 8570-1), five copies of the label and labeling revised as specified by the RED and
in accordance with current requirements, |wo completed copies of the Confidential
Statement of Formula (CSF) (EPA Form 8570-4), a completed Certification with
Respect to Citation of Data (EPA Form 8570-31), and data or references to data (see
item 2 below).
2. You must submit or cite the required product specific data as part of your commit-
ment for reregistration. For most products, you will probably be citing data which have
already been submitted to the Agency. In these cases, you must submit a list of the
studies and the corresponding EPA identifier numbers (i.e., ACCESSION or MRID
numbers). Before citing these studies, you must make sure that they meet the
Agency's current acceptance criteria (Appendix F, Attachment E). Be sure to follow
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data formatting requirements in P.R. Notice 86-5. Failure to adequately comply with
the data requirements specified in this RED may result in the Notice of Intent to Suspend
your product.
3. The labeling and CSF which yoy submit for each product must comply with P.R. Notice
91-2 (Appendix D), That Notice requires that the amount of active ingredient declared
in the ingredient statement must be stated as the nominal concentration rather than the
lower certified limit. You have two options for submitting a CSF: (1) accept the
standard certified limits (see 40 CFR §158.175) or (2) provide certified limits that are
supported by the analysis of five batches. If you choose the second option, you must
submit or cite the data for the five batches along with a certification statement as
described in 40 CFR §158.175(e).
4. Send your Application for Registration to the Registration Division Product Manager
21 (PM 21) who is assigned to the product, Susan T. Lewis. Use the correct address
shown on page 6 of the enclosed Product Reregistration Handbook (Appendix E). Note
that the mailing distribution code for your response is RED-RD-PM21.
Questions on product specific data requirements and labeling (for both End-use and
Manufacturing-use products) should be directed to the Registration Division Product Manager
21 Team member for streptomycin and streptomycin sulfate, Benjamin C. Chambliss at (703)
305 - 7382. Questions on the generic data requirements should be directed to Theresa A.
Stowe, the Chemical Review Manager in the Special Review and Reregistration Division at
(703) 308 - 8043.
The Agency is prepared to meet with any registrants who have questions about respond-
ing to the streptomycin RED. If you wish to meet with the Agency, you must contact Mr.
Chambliss within two weeks of your receipt of the RED. The Agency intends to have one
combined meeting with interested registrants. If there are any requests for such a meeting, the
Agency will notify all registrants who requested a meeting of the date, location and time.
Requests for a meeting will not extend the 90-day or 8-month response deadlines.
Sincerely yours,
Daniel M. Barolo, Director
Special Review and
Reregistration Division
Enclosures
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REREGISTRATION ELIGIBILITY DOCUMENT
STREPTOMYCIN AND STREPTOMYCIN SULFATE
LIST A
CASE 0169
September, 1992
U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGIOTRATION DIVISION
WASHINGTON, D.C.
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI
a.i.
ARC
CAS
CSF
EEC
EP
EPA
FIFRA
FFDCA
HDT
LC50
LD,
LDT
LEL
MP
Acceptable Daily Intake. Also known as Reference Dose or RfD.
Active Ingredient
Anticipated Residue Contribution
Chemical Abstracts Service
Confidential Statement of Formula
Estimated Environmental Concentration. The estimated pesticide concentration
in an environment, such as a terrestrial ecosystem.
End-Use Product
U.S. Environmental Protection Agency
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Highest Dose Tested
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 express-
ed as the weight of substance per weight or volume of water or feed, e.g., mg/1
or ppm.
Median Lethal Dose. A statistically derived single dose that 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.
Lowest Dose Tested
Lowest Effect Level
Manufacturing-Use Product
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TABLE OF CONTENTS
GLOSSARY
EXECUTIVE SUMMARY
I. INTRODUCTION
n. CASE OVERVIEW
A. CHEMICAL OVERVIEW
B. USE PROFILE
C. ESTIMATED USAGE OF THE PESTICIDE STREPTOMYCIN
D. DATA REQUIREMENTS
. ' D. REGULATORY HISTORY
m. SCIENCE ASSESSMENT OF STREPTOMYCIN
A. PRODUCT CHEMISTRY ASSESSMENT
B. HUMAN HEALTH ASSESSMENT
1. Toxicplogy Assessment
a. Acute Toxicity
b, Subchronic Toxicity
c. Chronic Toxicity
d. Developmental Toxicity
e. Reference Dose (RfD) for Chronic Oral Exposure
f. Antibiotic Resistance
g. Human Data
2. Exposure Assessement
a. Dietary Exposure
b. Occupational and Residential Exposure
3. Risk Assessment
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GLOSSARY OF TERMS AND ABBREVIATIONS (cont.)
MRID Master Record Identification (number). EPA's system of recording and tracking
studies submitted.
N/A Not Applicable
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
ppm Parts Per Million
RfD. Reference Dose
RS Registration Standard
TMRC Theoretical Maximum Residue Contribution
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C. ENVIRONMENTAL ASSESSMENT
1. Environmental Fate
2- Ecological Effects
a. Ecological Hazard
b. Ecological Effects Risk Assessment
IV. RISK MANAGEMENT AND REREGISTRATION DECISION OF
STREPTOMYCIN
A. DETERMINATION OF ELIGIBILITY
1. Eligibility Decision
, 2. Eligible and Ineligible Uses
B, REGULATORY POSITION
I- Tolerance Reassessment
2. Labeling Rationale
V. ACTIONS REQUIRED BY REGISTRANTS
A. MANUFACTURING-USE PRODUCTS
1. Additional Generic Data Requirements
2. Labeling Requirements for Manufacturing-Use Products
B. END-USE PRODUCTS
i. Additional Product Specific Data Requirements
2. Labeling Requirements for End-Use Products
VI. APPENDICES
APPENDIX A - Table of Use Patterns Subject to Reregistration
APPENDIX B - Table of the Generic Data Requirements and Studies Used to Make the
Reregistration Decision
APPENDIX C - Streptomycin Bibliography: Citations Considered to be Part of the Data
Base Supporting the Reregistration of Streptomycin
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APPENDIX D - List of Available Related Documents
APPENDIX E - Pesticide Reregistration Handbook
APPENDIX F - Generic Data Call-In
Attachment A - Generic Chemical Status Sheet
Attachment B - Generic DCI Response Forms (Form A) plus Instructions
Attachment C - Generic DCI Requirements Status and Registrant's Response
Forms (Form B) plus Instructions
Attachment D - List of all Registram(s) sent the Generic and Product Specific DCI
Attachment E - EPA Acceptance Criteria
Attachment F - Generic DCI Cost Share/Data Compensation Forms
APPENDIX G - Product Specific Data CaJI-In
Attachment A - Product Specific DCI Chemical Status Sheet
Attachment B - Product Specific DCI Response Forms (Form A) plus Instructions
Attachment C - Product Specific DCI Requirements Status and Registrants'
Response Forms (Form B) plus Instructions
Attachment D - EPA's Grouping of End-Use Products for Meeting Acute
Toxicology. Data Requirements
Attachment E - Product Specific Data Call-In Cost Share and Data Compensation
Forms
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the reregistration of products with active ingredients registered
prior to November I, 1984, The amended Act provides a schedule for the reregistration
process to be completed in nine years. There are five phases to the reregistration
process. The first four phases of the process focus on identification of data requirements
to support the reregistration of an active ingredient and the generation and submission
of data to fulfill the requirements. The fifth phase is a review by the U.S.
Environmental Protection Agency (referred to as "the Agency") of all data submitted to
support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall
determine whether pesticides containing such active ingredient are eligible for
registration" before calling in data on products and either reregistering products or taking
"other appropriate regulatory action." Thus, reregistration involves a thorough review
of th.e 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" criterion of FIFRA.
This document presents the Agency's decision regarding the reregistration of
streptomycin. The document consists of six sections. Section I is the introduction.
Section II describes streptomycin, its uses, data requirements and regulatory history.
Section III discusses the human health and environmental assessment based on the data
available to the Agency. Section IV discusses the reregistration decision for
streptomycin. Section V discusses the reregistration requirements for streptomycin.
Section VI is the Appendices which support this Reregistration Eligibility Document.
Additional details concerning the Agency's review of applicable data are available on
request,1
EPA's reviews of data on the set of reg-istered uses
considered for EPA's analysis may be obtained from the
QPP Public Docket, Field Operations Division (H7506C),
Office of Pesticide Programs, EPA, Washington, D.C. 20460
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EXECUTIVE SUMMARY
Streptomycin is a human antibiotic drug which is also currently registered in the United
States for use as an antibiotic bactericide/bacteriostat, fungicide, and algicide. The registrations
containing streptomycin as an active ingredient control bacterial and fungal diseases of selected
fruit, vegetables, seed, specialized field crops, and ornamental crops, and algae in ornamental
ponds and aquaria. This Reregistration Eligibility Document (RED) addresses the eligibility for
reregistration of products containing streptomycin for control of bacteria, fungi and algae. The
formulations of streptomycin are dust, wettable powder, wettable powder/dust, and pelleted/
tableted.
A Registration Standard for streptomycin and streptomycin sulfate, hereafter referred to
as streptomycin, was issued in September, 1988 (NTIS PB89-129738). The Registration
Standard summarized the available data supporting the reregistration of products containing
streptomycin used for the control of bacteria, fungi and algae. The Registration Standard
required additional data to assure that the proper use of the pesticide posed no potential adverse
effects to man or the environment. The Agency has completed its review of the streptomycin
data base including the data submitted in response to the 1988 Registration Standard.
The Agency has determined that the use of streptomycin to control bacteria, fungi and
algae will not cause unreasonable risk to man or the environment and all uses are eligible for
reregistration. However, the Agency is requiring certain other generic data to be submitted.
These data include product chemistry on the technical formulation, a hydrolysis study, and an
invertebrate toxicity study. The Agency regards these data as necessary to confirm the
reregistration eligibility decision put forth in this document. Reregistration of all products will
proceed in the absence of the confirmatory data noted above. Although the Agency does not
anticipate any changes in its regulatory position based on these confirmatory data, if the product
chemistry, hydrolysis, and invertebrate toxicity data identify a risk that requires modification of
the reregistration eligibility decision, the Agency will publish its rationale in the Federal Register
(FR) and notify all affected registrants of its decision.
Before reregistering the applicable products, the Agency is requiring that product specific
data, revised Confidential Statements of Formula (CSF), and labeling be submitted within 8
months of the issuance of this document. These data include product chemistry for each
registration and acute toxicology testing. After reviewing these data and the revised labels, the
Agency will reregister a product based on whether or not that product meets the requirements
in Section 3(c)(5) of FIFRA. Those products which contain other active ingredients will be
eligible for reregistration only when the other active ingredients are determined to be eligible
for reregistration.
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n. CASE OVERVIEW
A, Chemical Overview
The following active ingredients are covered by this Reregistration Eligibility
Document:
Common Name: Streptomycin and Streptomycin Sulfate
Chemical Name: O2-Deoxy-2-(methyIamino)-5-L-glucopyranosyl-(l-
>2)-O-5-deoxy-3-C-formyl-<5-L-lyxofuranosyl-(l-
> 4)-N,N'-bis(aminoiminomethyl)-D-streptamine
Chemical Family: Aminoglycoside antibiotic isolated from the
bacterium Streptomyces griseus
CAS Registry Number: 57-92-1 and 3810-74-0 (streptomycin sulfate)
OPP Chemical Code; 006306 and 006310 (streptomycin sulfate)
Empirical Formula: C^Hj^Qji and C^HMN^O^S, (streptomycin sulfate)
Trade and Other Names: Agri-Mycin 17s, Agri-Strep*, Plantomycin* and
Streptomycin 3000 Dust*
Basic Manufacturer: Pfizer, Inc.
B. Use Profile
The following is information on the active registered uses with specific use sites
and application methods. A detailed table of both eligible and ineligible uses of
streptomycin is included in Appendix A. In addition, a detailed table of the
methods, application rates and limited use restrictions is included in Appendix A.
Type of Pesticide: Antibiotic bacteritide/bacteriostat, fungicide, algicide
Use Sites: Terrestrial food crop use on celery, crabapples,
pears, peppers, and quince;
Terrestrial food and feed crop use on apples, beans,
potatoes, and tomatoes;
Terrestrial non-food crop use on sugar beets (grown
for seed), tobacco, ornamental herbaceous plants,
ornamental woody shrubs and vines;
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Terrestrial outdoor residential use on ornamental
herbaceous plants, ornamental woody shrubs and
vines;
Aquatic non-food residential use on ornamental
ponds and aquaria.
Algae
Fireblight
Halo blight
Bacterial blight
Bacterial wilt
Fireblight
Bacterial stem rot
Fireblight
Fireblight
Fireblight
Bacterial spot
Bacterial leaf spot
Fireblight
Soft rot, Black leg
Crown gall
Bacterial blight
Blue moid, Wildfire
Bacterial spot
Pests: Aquariums
Apples and Pears
Beans
Celery
Chrysanthemums
Cotoneaster
Dieffenbachia
Flowering Crabapple -
Flowering Quince
Hawthorne
Peppers
Philodendron
Pyracantha
Potato
Roses
'' Sugar beets
Tobacco
Tomato
Formulation Types Registered:
For streptomycin: 0.15% and 0.30% dust
For streptomycin sulfate: 0.01% dust, 15.00% pelleted/tableted, 21.20%
wettable powder, 21.1% and 62.6% wettable powder/dust
C. Estimated Usage of the Pesticide Streptomycin
This section summarizes the best estimates available for the pesticide uses of
streptomycin. These estimates are derived from a variety of published and
proprietary sources available to the Agency. The data are reported on an
aggregate and site (crop) basis and reflect annual fluctuations in use patterns and
variability in data from information sources. The quantity of pesticides used on
crops that are grown on relatively few acres and the quantity of infrequently used
pesticides are both difficult to ascertain. Non-agricultural uses of pesticides may
also be difficult to quantify. Quantitative data are not available for all sites of
streptomycin application.
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The domestic basic producer of streptomycin is Pfizer, Inc. Data on production,
sales and distribution are confidential business information and are protected
under Section 7 (d) and Section 10 of FIFRA, as amended, and thus cannot be
disseminated.
Streptomycin is a bactericide registered for foliar treatment of: apples, celery,
crabapples, pears, peppers, tobacco, tomatoes and ornamentals including
amhurium, cotoneaster, flowering crabapple, dieffenbachia, hawthorn,
philodendron, pyraeantha, flowering quince and roses. Registered sites for seed,
seed piece or bed treatment includes: beans, celery, potatoes, sugar beets,
tobacco, and tomatoes. Other sites include chrysanthemum (cuttings) and aquaria
water.
The table below summarizes streptomycin use by site, this usage represents a
moderate increase from the previous usage estimate (the 1987 high-end estimate
was 57,000 Ibs. active ingredient). Most sites have a very small percentage of
acreage treated with streptomycin, so small that these figures remain consistent
over time. It is important to note that streptomycin usage may vary greatly from
year to year, depending on weather conditions.
Streptomycin is used primarily on pome fruit (although resistance to streptomycin
has been reported, the total use of streptomycin on pome fruit has increased),
ornamentals and tobacco. Based upon the available data, apples and pears
account for 58%, nursery and landscape uses for 17%, tobacco use for 7%, and
other uses (including celery, potatoes, sugar beets, and ornamentals not included
in landscape and nursery stock) for 15% of the total use of streptomycin. Each
remaining site accounts for no more than 1 % of the total use of streptomycin
(pounds a.L),
On the major crop, pears, up to 80% of acreage is treated with streptomycin.
Among the other crops, less than 5 % of tobacco and pepper acreage are treated,
with each remaining site having less than 1% of its acreage treated with
streptomycin. Usage estimates of seed, seed piece or bed treatments may be
under reported because of sampling methods.
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DOMESTIC USAGE OF STREPTOMYCIN AS A PESTICIDE
TYPICAL RECENT YEARS (1987 - 1991)
SITE
Pears'
Apples'
Nursery Stock
Tobacco
Landscape
Maintenance
Tomatoes
Dried Beans and Peas
Peppers
OTHER3
TOTAL
LBS. A.I.
(1,000)
18-60
8-30
5- IS
3 -10
<7
<1
<1
<1
<15
<60 - <140
% OF
TOTAL USE
39
19
10
7
<7
<1
<1
<1
IS
100
% OF SITE
TREATED
<8Q
<1
NA -
<5
NA
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A Registration Standard for streptomycin was issued in September, 1988, This
document required data to support the uses identified in the 1988 Registration
Standard. The Reregistration Eligibility Document reflects a reassessment of all
data submitted in response to the Registration Standard.
There are currently sixteen end-use products containing streptomycin registered
in the United States. No technical or manufacturing-use product is currently
registered.
ID. SCIENCE ASSESSMENT OF STREPTOMYCIN
The Agency has conducted a thorough review of the scientific data base for streptomycin
for the purposes of determining the reregistration eligibility of this pesticide. These
findings are summarized below.
A. Product Chemistry Assessment
Streptomycin, produced by the soil bacterium, Streptomyces griseus. is an
aminoglycoside antibiotic. It may be produced on an industrial scale by aerobic
fermentation, followed by isolation and purification by ion exchange.
There are several product chemistry requirements which are not fully satisfied for
technical streptomycin sulfate. They include the following: Chemical Identity
(GLN 61-1), Formation of Impurities (GLN 61-2b), Preliminary Analysis (GLN
62-1), and Dissociation Constant (QLN 63-10). The Agency regards these data
as necessary to confirm the reregistration eligibility decision put forth in this
document. The physical and chemical properties of the streptomycin sulfate
technical grade of the active ingredient (TGAI) are summarized below:
TGAI
Molecular Weight
Color
Physical State
Odor
Melting Point
Boiling Point
Bulk Density
Solubility
Vapor Pressure
Dissociation Constant
Oct./Water Part. Coeff.
pH
Stability
Streptomycin sulfate
1467.48
Light tan
Solid (STP)
Odorless
168°C
N/A (TGAI is a solid)
1.78g/ml
> 200 g/100ml in water
Waived
Data Gap
Waived
5.5 (Ig sampie/SmI water)
Not photosensitive; not sensitive to metal or
metal ions. Slightly decreased potency
following 24 months at 37°C,
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B. Human Health Assessment
1. Toxicology Assessment
Much of the data available to support the reregistration of streptomycin are
reviews conducted by the Food and Drug Administration on dihydrostreptomycin
(FDA, 1986), Streptomycin is similar in action to dihydrostreptomycin and its
toxicity would not be expected to significantly differ from that of dihydro-
streptomycin. All generic toxicological data requirements for streptomycin have
been waived based on extensive information available from studies conducted in
animals in support of its use as a human drug,
a. Acute Toxicity
The oral LD50 for streptomycin in rats has been'reported to be
9,000 mg/kg (Thompson, 1977). The oral LD50 in mice has also
been reported to be 9,000 mg/kg (BCPC, 1972). This is low
toxicity and is classified as Toxicity Category IV.
b. Subchronig Toxicity
FDA concluded that a NOEL of 40 mg/kg/day was obtained in a
90-day study with cats in which the animals were dosed orally with
40 mg/kg/day dihydrostreptomycin, or in some cases, injected
intramuscularly with 75 - 200 mg/kg/day dihydrostreptomycin.
The cats receiving dihydrostreptomycin intramuscularly lost the
righting reflex in 3 weeks whereas those treated orally did not.
Gross pathology and histopathology were unremarkable.
A 90-day study was conducted in guinea pigs. It was concluded
that 40 mg/kg/day dihydrostreptomycin administered orally
produced no hearing loss.
c. Chron|c Toxicity
A 2-year feeding study in rats was conducted employing doses of
0, 1, 5 and 10 mg/kg/day dihydrostreptomycin. Based on the
data, dihydrostreptomycin does not appear to have carcinogenic
potential. The only adverse effect noted was reduced body weight
gain in males in the 10 mg/kg/day group. The NOEL was
determined to be 5 mg/kg/day.
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Developmental Toxicity
In a developmental toxicity study in rabbits, the animals were
dosed with 5 and 10 mg/kg/day of dihydrostreptomycin from days
6 - 19 of gestation. The FDA review concluded that there were
no teratogenic effects at either dose. The NOEL for teratogenic
effects in the rabbit was 10 mg/kg/day.
Reference Dose (RfD) for Chronic Oral Exposure
A provisional ADI (PADI) or RfD for streptomycin of 0.05 mg/kg
bwt/day can be established based on a NOEL of 5.0 mg/kg
bwt/day from a two year feeding study in rats, which demonstrated
as an effect reduced body weight gain, and utilizing an uncertainty
factor of 100. The Joint FAO/WHO Expert Committee on Food
Additives has not established an ADI for streptomycin.
f. Antibiotic Resistance
In a study conducted for FDA, beagle dogs were fed a diet of 0,
2, or 10 /ig/g of dihydrostreptomycin per gram of feed. The 2
ftg/g level was selected to represent a residue level of the
antibiotic. In both treatment groups, administration of the
medicated feed resulted in a shift from a predominantly
dihydrostreptomycin-susceptible coliform fecal population to a
resistant population. An increase in the prevalence of
dihydrostreptomycin resistance was observed after 15 days of
dihydrostreptomycin-supplemented feeding and persisted during the
post-treatment phase of the study. Although it has not been tested
for, the same potential may exist for the development of chemical
resistance in the respiratory flora.
g. Human Data
Streptomycin has been available for use in humans as an antibiotic
for urinary infections since the late 1940s. The usual route of
administration is through intramuscular injection 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. A variety of allergic
reactions have been observed in sensitive patients treated with
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streptomycin. These reactions include: erythema, rashes,
urticaria, purpura, drop in blood pressure, headache, nausea and
vomiting. The following effects have been observed after
prolonged therapy for tuberculosis; vertigo, tinnitus, diplopia
after rapid movement of the head, and deafness.
2, Exposure Assessment
a- Dietary
The nature of streptomycin residues in plants and animals is
adequately understood; the residue of concern is streptomycin. In
view of the long use of streptomycin as a drug, and to the low
residues expected in or on RACs, no metabolism data have been
required. No residues were detected in the commodities for which
tolerances have been established when these commodities were
treated according to registered uses.
Currently, tolerances of 0,25 ppm are established in 40 CFR
180,245 for negligible residues of streptomycin (the residue of
concern) in or on the raw agricultural commodities listed below.
The tolerance of 0.25 ppm was based on the limit of detection of
the enforcement method submitted to the Agency.
Commodity
' 1. Celery, peppers, and tomatoes (treatment of
seedling plants before transplanting)
2. Potatoes (treatment of seed pieces)
3. Pome fruits (apples, crabapples, pears and quince;
foliar application)
Although the Agency finds these tolerances to be acceptable, the
Agency considers the expression "negligible residues" as obsolete
and will revise 40 CFR 180.245 to delete the reference to
"negligible residues."
In addition, the Agency required bean data depicting streptomycin
residues in or on beans, bean vines, and bean hay following seed
treatment according to registered labels. The Agency is requesting
that the registrant propose an appropriate tolerance for strepto-
mycin in or on beans (succulent and dried), based on the
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results of the field trials. The available bean data indicate that
tolerances of 0,25 ppm for dry beans, bean forage, bean hay and
bean straw grown from treated seed and at 0,50 ppm for succulent
beans grown from treated seed are needed. No tolerances or data
depicting streptomycin residues in bean cannery waste are
required.
The current SLN (State Local Need) registration, OR850037, calls
for foliar treatment of sugar beets grown for seed. Use restrictions
prevent any livestock/human exposure to treated plants/seeds. The
foliar application rate is 50 to 200 ppm, 250 times less than the
labeled seed treatment rate for beans. Based on the bean data, the
difference in application rates, the interval between seed crop
treatment and root crop harvest, dilution effects, and label
restrictions, no tolerances or supporting residue data are required
to support the SLN registration for streptomycin on sugar beets
grown for seed which the Agency considers to be a nonfood use.
The Agency has adequate data to support registered uses on all the
above RACs and tobacco. There are no proposed or established
CODEX (international) tolerances for streptomycin. There are no
Canadian tolerances, and the Mexican tolerances for streptomycin
are currently harmonized with U.S. tolerances. No other
harmonization issues remain to be resolved. Because streptomycin
is used in veterinary medicine, tolerances for streptomycin residues
have also been established by FDA and US DA.
b. Occupational and Residential Exposure
Streptomycin, as one of the early antibiotic drugs (developed in the
1940s) possesses an accumulation of toxicological data and
knowledge regarding its use as a bacterieide for humans. The
totality of this data indicates that streptomycin does not meet the
Agency's toxicity criteria which would trigger the requirement for
occupational/residential exposure monitoring data. Streptomycin,
however, has produced various allergic reactions in some human
patients. Therefore, label statements are required restricting the
reentry into treated fields and specifying the use of certain
protective clothing and equipment (PPE) while handling and
applying end-use products for commercial use on agricultural crops
and ornamentals. For the specific label language, refer to Section
V, Labeling Requirements,
10
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i
3. Risk Assessment
From the late 1940s, streptomycin has been available as an aminoglyco-
side antibiotic for humans. The drug continues today as part of the
arsenal for endocarditis, tularemia, bubonic plague, and tuberculosis. On
account of its low oral absorptivity, the drug is usually administered by
intramuscular injection. Streptomycin is still used in veterinary medicine
to help prevent infections in fowl, calves, and swine. Estimation of
dietary risk by the Dietary Risk Evaluation System (ORES) utilized a
Reference Dose (RfD) of 0,05 mg/kg bwt/day, based on a no-observed-
effect level (NOEL) of 5.0 mg/kg bwt/day and an uncertainty factor of
100. The NOEL is taken from a two-year rat feeding study which
demonstrated reduced body-weight gain as the most lexicologically
significant effect. This RfD has been approved by the EPA Health Effects
Division RfD Peer Review Committee (06/18/92).
The Agency has conducted a dietary risk analyses (ORES) for
streptomycin. Food uses included in the analysis were the established
tolerances (40 CFR 180.245) supported in the reregistration of
streptomycin. All EPA-published food uses for this chemical are being
supported through reregistration. Tolerances on celery, peppers, pome
fruits, potatoes, and tomatoes are established at 0.25 ppmt the limit of
detection of the enforcement method submitted. Residues considered in
the analysis were the published uses previously mentioned and the
proposed tolerances from the use of streptomycin as a seed treatment on
beans (0.25 ppm for dry beans, 0.5 ppm for succulent beans). These
tolerances reflect the limit of detection of the method and actual residue
levels of streptomycin on beans are probably lower.
The DRES chronic exposure analysis used tolerance level residues and
100% crop treated to estimate the Theoretical Maximum Residue
Contribution (TMRC) for the overall U.S. population and 22 population
subgroups. The TMRC for the overall population from the EPA-
published uses of streptomycin is 0.000899 mg/kg bwt/day, which
represents 1.8% of the RfD. The proposed use on beans contributes an
additional 0.000167 mg/kg bwt/day of exposure, raising the TMRC for
the general population to 0.001066 mg/kg bwt/day, or 2.1 % of the RfD.
The DRES subgroup most highly exposed (non-nursing infants less than
one year old) has a TMRC of 0.003006 mg/kg bwt/day, or 6% of the
RfD. The proposed use on beans raises the exposure to 0.003476 mg/kg
bwt/day, or 7% of the RfD. Because of the assumptions of tolerance
level residues and 100 percent crop treated, it is likely that these values
overestimate the exposure and risk. Even so, the chronic dietary risk
posed by these uses of streptomycin are well below the level at which the
Agency would have concern. Summaries of the residue data used in this
analysis and the analysis itself are included in the streptomycin public
docket
11
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I
Given the assumptions of tolerance-level residues and 100% crop treated,
as well as the fact that tolerances are set at the limit of detection because
no residues were actually found, these exposure values are most likely
overestimates of exposure. In summary, the dietary risk from
streptomycin appears minimal.
The Agency is aware of data exhibiting the induction by streptomycin of
drug-resistant microfiora in the intestine [Sec. III.B.l.f.J. A recent
assessment of the impact of drug residues (in food) on the generation of
"drug resistance" in humans has focused on the relative significance of (1)
the potency of ingested antibiotic residues in food for producing drug-
resistant microfiora, and (2) the quantity of drug-resistant microfiora
already on or in the food ingested. More research has been suggested in
order to ascertain the relative magnitudes of these two contributions to a
drug-resistant population of microfiora in the mammalian intestine. At
present, the Agency has no data showing that food residues of strepto-
mycin possess a significant or even measurable potential for developing
in the human intestine streptomycin-resistant strains of microorganisms at
levels above background levels acquired from the drug-resistant
microorganisms ingested with food.
Workers may be exposed to streptomycin during use. There is a potential
for an allergic response from individuals that are streptomycin-sensitive.
Specific label requirements limiting inhalation exposure would mitigate
this potential risk. These label requirements would also address concerns
for the potential development of streptomycin-resistant microorganisms in
the respiratory tract.
C. Environmental Assessment
1. Environmental Fate
Since there are no ecological or health effects concerns from this naturally
occurring antibiotic, all environmental fate requirements, except for
hydrolysis data (Guideline Reference No. 161-1), are waived. The
hydrolysis study is being called in but the data are considered
confirmatory. The unavailability of the hydrolysis data at this time will
not delay reregistration of eligible products.
Hydrolysis is the only environmental fate data requirement that will be
imposed for streptomycin. Ail other data requirements were waived based
on the information found in a literature search conducted by the Agency
which led to the following conclusions. Pseudomonas 'fluorescens
12
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I
degrades streptomycin in water in the pH range of 6-8.1, but not at pH 5.
Also, streptomycin is stable in sterilized soil and degrades in 2-3 weeks
in non-sterilized soil with active P. fluprescens cultures. The lag time for
degradation of streptomycin in soil decreases with later applications,
indicating an inducible response. The major degradate of streptomycin in
both soil and water was methylamine. Another degradation study in water
found that 90% of the labeled streptomycin was found as CO2 and cell
materials .while 10% was found as urea. Streptomycin (500-1,000 |itg/ml)
did not move beyond 0.5 cm of depth when applied to saturated sandy soil
and exhibited activity at 9 and 32 days when applied at 1,000 and 2,500
Mg/g soil, respectively. Adsorption and consequent immobilization of
streptomycin appears to increase with increasing clay and organic matter
content. Streptomycin was also detected at concentrations of 2.4 - 4.6 and
7.4 - 38 Mg/ml of tomato plant sap when a sandy clay soil was treated
with 1,000 and 2,500 ^g/g soil, respectively.
2. Ecological Effects
The Agency has reviewed the available information for streptomycin and
has determined that all ecological effects data requirements, except for an
Aquatic Invertebrate ECSO study, are satisfied. The Aquatic Invertebrate
ECM study is being called in but the data are considered confirmatory.
The unavailability of these data at this time will not delay reregistration
of eligible products.
a. Ecplogical Hazard
i. Effects on Birds
An acute avian oral toxicity study on bobwhite quail
showed that streptomycin has an LD5Q 5: 2,000 mg/kg.
These data indicate that streptomycin is practically non-
toxic to upland bird species on an acute oral basis. In two
subacute avian dietary studies on bobwhite quail and
mallard duck, the LC» S 5,620 and 4640 ppm, respective-
ly. These data also indicate that streptomycin is practically
non-toxic to birds on a dietary and acute oral basis. These
studies fulfill Agency minimum data requirements to
establish the toxicity of streptomycin in birds.
13
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«
2, Effects on Freshwater Invertebrates
No studies were received on the effects of streptomycin on
freshwater invertebrates, however, a literature search
conducted by the Agency resulted in finding one study that
can be used as supplemental data. This study was
considered supplemental because information on the study
methods was not reported. This study was acceptable for
use in the hazard assessment, but does not fulfill the
guideline requirements for an aquatic invertebrate toxicity
study. These data suggest that streptomycin is practically
non-toxic to freshwater invertebrates. To establish the
toxicity of streptomycin to aquatic invertebrates, a 48-hour
acute study using the technical grade of streptomycin is
required. The test organisms should be firs$ instar Paponia
magna.
3. Effects on Freshwater Fish
Two 96-hour freshwater fish toxicity studies on rainbow
trout (coldwater species) and bluegill (warmwater species)
were submitted to establish the acute toxicity of strepto-
mycin to freshwater fish. The LC50 is > 180 ppm for both
studies. These data indicate that streptomycin is slightly
toxic to both cold water and warm water species of fish.
The guideline requirements are fulfilled for acute toxicity
testing on freshwater fish.
4. Effects on Non-Target Insects
An acute honey bee study was submitted to establish the
toxicity to honey bees. These data indicate that strepto-
mycin is practically non-toxic to honey bees and fulfills the
Agency's requirements for this study.
5. Effects on Non-Target Plants
No studies have been required for the effects of strepto-
mycin on non-target plants. However, a literature search
conducted by the Agency resulted in two scientific articles
that demonstrated phytotoxic effects. Although these
studies would not satisfy guideline requirements, they are
sufficient for the purpose of assessing hazard to non-target
plants and no additional data are required.
14
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i
b. Ecological Effects Risk Assessment
Streptomycin is currently registered for use on Terrestrial Food
and Feed Crops; Terrestrial Non-Food Crops; Ornamental and/or
Shade Trees; Ornamental Herbaceous Plants; Ornamental Woody
Shrubs and Vines; and Ornamental Ponds/Aquaria. It is registered
as an aJgicide, baeteriocide/bacteriostat and a fungicide. The most
common method for foliar application is by ground equipment such
as airblast. Other methods of application include aircraft, duster
attachments or hand-held sprayers.
1. Terrestrial Species
Streptomycin is applied to apple and pear orchards at the
maximum rate of 0.3 Ib ai/A in West Coast States and at
0.50 Ib ai/A in other areas of the United States. Residues
are found on both the crop and surrounding vegetation.
Based on the maximum application rates, the following
maximum residues could occur immediately after a single
application:
Substrate Residues at 0.5 ib ai/A
Leaves & leafy crops 63
Forage (alfalfa & clover) 29
Fruit 3.5
Streptomycin is applied several times throughout the
growing season. No information is available concerning
the persistence of streptomycin on plant surfaces, therefore,
the potential for residue accumulation, if any, cannot be
determined. The acute LDW for bobwhite quail is greater
than 2,000 mg/kg and the dietary LC50 for bobwhite quail
.and mallard duck is 5,620 ppm and 4,640 ppm, respective-
ly. Based on the maximum expected residues when
compared to the LCM's, streptomycin should not have an
acute effect on birds.
2. Freshwater Organisms
The available data on streptomycin indicates that it is
practically non-toxic to freshwater organisms including
Daphoia. bluegill sunfish and rainbow trout. The EC30
determined for Daphnia is 650 ppm. The LCso for both
bluegill and rainbow trout is greater than 180 ppm.
15
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i
Following a direct application to water, the following
residues would result in 6 inches and 6 feet of water.
Application._Eatg Aquatic Residues fppbl
fib ai/A) 6 inches 6 feet
0.5 367 31
• Based on the expected residues when compared to the
aquatic LCSO for fish and the EC50 for Daphnia. strepto-
mycin poses minimal risks to aquatic fauna.
3, Non-Target Insects
An LD50 greater than 100 micrograms was determined for
honey bees. These data indicate that streptomycin is
practically non-toxic to honey bees and adverse effects are
not likely to occur.
4. Non-Target Plants
The studies with species of algae indicate that streptomycin
is toxic to algae. The EC^ was determined to be 0.86
mg/1 for the most sensitive species. Based on the
maximum label application rates and the expected residues
for use on apples and pears, significant adverse impact on
algae could occur if direct application occurred. Strepto-
mycin is also labeled at lower application rates for use in
ornamental ponds, fountains and aquaria to control algae.
Dose levels for the tablet (slow release) form of strepto-
mycin used in aquatic environments could not be
determined.
5. Endangered Species
The use of streptomycin as described, is not expected to
pose significant risk to threatened and endangered species.
In summaiy, data indicate that streptomycin is practically non-toxic
to bobwhite quail on an acute oral basis; to bobwhite quail and
mallard ducks on a dietary basis; to coldwater and warmwater fish
species; and to honey bees. No data were submitted for an aquatic
invertebrate acute toxicify study. Scientific literature was used to
support the hazard assessment. This study was deficient for the
16
-------
I
purposes of an aquatic invertebrate study; however, it did provide
supplemental data that was adequate to support a hazard
assessment. A valid aquatic invertebrate study will be necessary
to confirm the hazard assessment. Because of the demonstrated
effects on aquatic plants, precautionary labeling for all non-aquatic
uses is required. For specific precautionary labeling language,
refer to Section V, Labeling Requirements.
IV. RISK MANAGEMENT
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission
of relevant data concerning an active ingredient, whether products containing the
active ingredient are eligible for reregistration. The Agency has previously
' identified and required the submission of the generic (i.e. active ingredient
specific) data required to support reregistration of products containing
streptomycin as an active ingredient. The Agency has completed its review of
these generic data, and has determined that the data are sufficient to support
reregistration of all products containing streptomycin. Appendix B identifies the
generic data requirements that the Agency reviewed as part of its determination
of reregistration eligibility of streptomycin, and lists the submitted studies that the
Agency found acceptable.
The data identified in Appendix B were sufficient to allow the Agency to assess
the registered uses of streptomycin and to determine that these uses of
streptomycin can be used without resulting in unreasonable adverse effects to man
and the environment. The Agency therefore finds that all products containing
streptomycin/streptomycin sulfate as the active ingredients are eligible for
reregistration. The reregistration of particular products is addressed in Section
V of this document.
The Agency made its reregistration eligibility determination based upon the target
data base required for reregistration, the current guidelines for conducting
acceptable studies to generate such data and the data identified in Appendix B.
Although the Agency has found that all uses of streptomycin are eligible for
reregistration, it should be understood that the Agency may take appropriate
regulatory action, and/or require the submission of additional data to support the
registration of products containing streptomycin, if new information comes to the
Agency's attention or if the data requirements for reregistration (or the guidelines
for generating such data) change.
17
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i
1. Eligibility Decision
The Agency has sufficient information on the 'health effects of
streptomycin and on its potential for causing adverse effects in fish and
wildlife and the environment. The Agency therefore concludes that
products containing streptomycin for all uses are eligible for
reregistration. The Agency has determined that additional data for
product chemistry, ecological effects, and environmental fate are required
for confirmatory purposes.
The Agency has determined that streptomycin products, labeled and used
as specified in this Reregistration Eligibility Document, will not pose
unreasonable risks or adverse effects to humans or the environment.
2. Eligible and Ineligible Uses
The Agency has determined that the uses of streptomycin for beans (seed
treatment); celery, peppers, and tomatoes (treatment of the seedling plants
before transplanting); potatoes (seed piece treatment); pome fruit (foliar
treatment); sugar beets (grown for seed only); selected ornamental shrubs
and trees; and ornamental ponds and aquaria are eligible for reregistration
at this time.
B. Regulatory Position
The following is a summary of the regulatory positions and rationales for
streptomycin. Where labeling revisions are imposed, specific language is set
forth in Section V of this document.
1. Tolerance Reassessment
The term "negligible residues'* is considered by the Agency to be obsolete
and will be deleted from 40 CFR 180.245, Adequate data exist to support
the existing tolerances of 0,25 ppm for residues of streptomycin in or on
the raw agricultural commodities celery, peppers, and tomatoes from
treatment of the seedling plants, before transplanting; potatoes from
treatment of seed pieces; and pome fruits,
Tolerances of 0,25 ppm should be established for streptomycin residues
in or on dry beans, bean forage, and bean hay grown from treated seed
and 0.50 ppm in or on succulent beans grown from treated seed. No
tolerances or data depicting streptomycin residues in bean cannery waste
are required. No residue data are required to support the SLN registration
for streptomycin on sugar beets grown for seed, which is considered by
the Agency to be a nonfood use.
18
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I
There are no proposed or established CODEX (international) tolerances
for streptomycin. There are no Canadian tolerances, and the Mexican
tolerances for streptomycin are currently harmonized with U.S. tolerances.
No other harmonization issues remain to be resolved. Because
streptomycin is used in veterinary medicine, tolerances for streptomycin
residues have also been established by FDA and USDA.
2. Labeling Rationale
a. Because streptomycin has produced various allergic reactions in
some human patients and there may be some potential for the
development of streptomycin resistant microorganisms in the
respiratory tract, the Agency is requiring label statements
restricting the reentry into treated fields and specifying the use of
certain protective clothing and equipment (PPE)- while handling
and applying end-use products for commercial use on agricultural
crops and ornamentals. The specific label language is in Section V,
Labeling Requirements.
b. Because streptomycin is used to control algae, products that are
not used as an algicide in ornamental ponds and aquaria must have
appropriate aquatic plant hazard labeling. The specific label
language is in Section V, Labeling Requirements.
V. ACTIONS REQUIRED BY REGISTRANTS
This section is designed to assist the registrant by listing all of the data requirements and
responses necessary for the reregistration of both manufacturing-use and end-use
products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of streptomycin
products for the above eligible uses has been reviewed and determined to
be substantially complete. However, some of the product chemistry
guidelines have not been completely fulfilled. All of the product
chemistry data were originally required in the Registration Standard and
are therefore not included in the generic Data Call-In for the RED.
Further, registrants are reminded that any changes, since the Registration
Standard was issued in 1988, in the manufacturing process for the
technical grade of streptomycin, and any detection of new impurities since
that time, must be reported to the Agency.
19
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i
In addition to product chemistry, the Agency has determined that
confirmatory data are required for the Invertebrate Toxicity (GLN 72-2a),
and Hydrolysis (GLN 161-1) studies. These new generic data
requirements are being called in and are listed in Appendix F.
Labeling Requirements for Manufacturing-Use Products
No technical or manufacturing-use products are currently registered.
However, if any are registered, they will be required to meet the
requirements of 40 CFR 156.10, this RED, and other current policies.
End-Use Products
1. Additional Product-Specific Data Requirements
Based on the reviews of the generic data for the active ingredient strepto-
mycin, the products containing streptomycin with uses for beans (seed
treatment); celery, peppers, and tomatoes (treatment of the seedling plants
before transplanting); potatoes (seed piece treatment); pome fruit (foliar
treatment); sugar beets (grown for seed only); selected ornamental shrubs
and trees; tobacco (seedling; foliar treatment) and ornamental aquaria are
eligible for reregistration. Section 4(g)(2)B) of FIFRA calls for the
Agency to obtain any needed product-specific data regarding the pesticide
after a determination of eligibility has been made. The product specific
data requirements are listed in Appendix G, the Product Specific Data
Call-In Notice.
The product specific data were called in with the issuance of the 1988
Registration Standard. Registrants must review previous data submissions
to ensure that they meet current EPA acceptance criteria (Appendix F;
Attachment E) and if not, commit to conduct new studies. If a registrant
believes that previously submitted data meet current testing standards, then
study MRJD numbers should be cited according to the instructions in the
Requirement Status and Registrants Response Form provided for each
product.
2. Labeling Requirements for End-Use Products
The labels and labeling of all products must comply with EPA's current
regulations and requirements as specified in 40 CFR §156.10. Please
follow the instructions in the Pesticide Reregistration Handbook with
respect to labels and labeling.
The Agency has determined that the current label precautions are still
applicable and are required for product reregistration. The following
additional (or revised) label statements are required in the human hazards
section:
20
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a. The labels of products registered for commercial use on
agricultural crops and ornamentals must include the following
restricted entry statement: "Entry into treated fields is prohibited
for 12 hours following application,"
b. The labels of products registered for commercial use on
agricultural crops and ornamentals must include the following
protective clothing statement; "Prolonged or frequently repeated
skin contact may cause allergic reactions in some individuals. Do
not breathe dust or spray mist. Wear a MSHA/NIOSH approved
TC-21C dust/mist filtering respirator, long sleeved shirt, pants,
shoes, and chemical-resistant gloves while handling or applying
this product. Wash thoroughly after handling or applying."
c. In the environmental hazards section, all products, except for those
used as an algicide in ornamental aquaria and ponds, must have the
following label statement: "This product may be hazardous to
aquatic plants. Do not apply directly to water, areas where surface
water is present or to intertidal areas below the mean high water
mark. Do not contaminate water by cleaning of equipment or
disposal of wastes."
21
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i
APPENDIX A
Table of Streptomycin Use Patterns
Subject to Rereglstration
-------
The following table shows the eRgfofe and ineligible uses of streptomycin. It does not show any changes resulting from
the RED review itself. Changes that result from the RED review, e.g. PHI, application rates, etc. are specified in Section
IV.
APPENDIX A- Cm* 01 69 Chemical 006306 (Streptomycin)
uses
EUQMX
PON
REREO.
FOOD/
FEED
USES
p.Ul
M
dknt
dint by
aircraft or
ground
•qufpnwnt
20b/Mlor
0.15
fomxitubon
•nd40
ftl/BO for
0.30
foftfiUMraofi
20 fc/w
for 0.15
ffMftlUMtKPfl
b/Mfor
0.3O
Not
Not
Not
IMMltlmKl
Not
Do not
W»Y
nNMnM
1O
AW*.
Awl
p.t.1
W
dint bv
•kcr«ft of
ground
20 fcta lor
O.15
parcmit
fomuMloit
«nd40
•>/Mlvt
O.3O
Not
Not
Not
Nat
Not
Do not
for 0.1 5
pmcwil
OtMVi HI
formutotiofi
•od 40
fc/Mlor
0.30
p0fc0nt
fonfmiptlon
USES W-
EUGtBUE
FOR
NONE
-------
APPENDIX A- CM* 01 69 Chemical 006310 (Streptomycin SuMatal
toilnfito-
nrryctn
|p|Mir*f«n
lo«tr«pto-
myctn
COOUttf)
uses
KM
RERCQ
FOOD/
FEED USES
wcttabU
GO mull
Horn
a.s
fate
MMUfci*
powdw/
•pray
lOOppm
100 ppm
Do not
wtv
liuitb
PMT
Mown
foliar
•wtiabto
powdtt
•nd
WMUM*
IKKw
du*t
•prcywidi
mlmo
(.11 to «/M
forWMt
COM!
.SI
a in 10
W.rt
30 d^
*><*&
MMuUlWt
fatoom.
-------
APPENDIX A- C«««0169 Owmicil OOS310 (Streptomycin SuKatc)
lo •trvpto-
to ttrapto-
•••1 iidm
iiiyutvi
CIMltMIt}
w*tMbl*
•1 ffl B.Ml
POVff
Ant
tfwtt
not on
label)
Rnri
iiiiiiiiiiiBi
•^pin
OTKNMB flOt
watt abb
powder/
duM
•pf*V wNh
200 ppm
200 pom
A.B
fote
prtdM
powdot
.2« fc d/M
(.31
.61
C0M1I
powder/
dutC
a to 10
WMt
S0«tey
A.B
p*td
toitar
powder/
dust
not on
IteS
A.B
powdef/
Ant
•Md
ttm
witfi wufty-
50.000
§O*OOO
Do Hot MM
tn*t*4
•Mdfot
food
-------
APPENDIX A • CM* 0163 CtMinical 006310 (Streptomycin SuHat*)
Ippiimfwt
to itnpio-
feimntora
to Mr«|Ma-
oanuml
1 to/too
•MiM
IMI
NWM
DO MM UM
trwtMf
fond M
tMd
pUlpOMI
PotMO
|M|ui|MMM
100 npn
lOOppm
Nona
Da MMUM
load or
A.B
WttM*
200 HMI
200 ppm
HOM
MOM
Ant
NONFOOD/
MOMFKO
USES
lotto
•pray with
200 ppm
200 ppm
NMM
Nan*
DO MM
gfuaor
cut gr*«ft
kvntock
f«*d. Do
•ftMTTWOl
Of
to
kv««iock.
-------
OtfMnwMgl
•nd/w
•hafotr***
OtfMmwiUl
ptarrt*
p)«m
•hrub* end
•htvbt and
folw
GUttlflO
Woom
lolw
fdlMT
dull
wntttcbl*
powitar
VMtWM*
powdw/
powtfw/
AMI
pawrtw
po«*d«r/
dutt
A - Cat* 0169 Chwnteal 006310 (Streptomycin Suff««»
label)
wHh
•pray with
•pmy with
to
10O ppm
BO ppm
200 ppm
2 MA
200 ppm
lOOppm
SO ppm
(ppmrafem
to Btiopto-
100 ppm
GO ppm
200 ppm
200 ppm
10O ppm
Noiw
UMMffiMl
•pelted
-------
APPENDIX A - CWM 0169 Chemical 006310 (Streptomycin Sulfate)
(ppmnrfen
toMieptO-
(ppm Mien
loftbepto*
mycM
content)
OmmMnul
woody
powder
end
w*iUMe
powder/
frejuipmeiit
20Oopm
NOM
200 ppm
NOM
1OO ppm
2OOpfim
NMM
100 ppm
MOM
6lo7
powdw/
dud
C.K
OnMnwnul
WMMfei*
powd«r
60 ppm
MO ppm
NOM
NOM
•pwifwd
C.K
OtlMUMMIIal
llWlMMMMM
ptwitt
powder
qx«V with
200 ppm
200 ppm
NOM
NOM
C.K
Uoomend
woody
•iMUlMMMl
MTIM
powder
eprey witfi
eprcyer
100 ppm
200 ppm
NOM
NOM
•peoified
awl
-------
USESM-
fUOMJE
FOR
RERCQ
C,K
a
•n
•hrutaind
OrtwTwnUi
pond/
•quMi*
,^-ptont
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-------
APPENDIX B
Table of the Generic Data Requirements
and Studies Used to Make the
Reregistration Decision
-------
1
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for
the pesticide streptomycin covered by this Reregistration Eligibility Document. It contains
generic data requirements that apply to streptomycin in all products, including data requirements
for which a "typical formulation" is the test substance.
The data table is organized in 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 in the Pesticide Assessment Guidelines,
which are available from the National Technical Information Service, 5285 Port
Royal Road, Springfield,.VA 22161 (703) 487 - 4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the
data requirements apply. The following letter designations are used for the given
use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3, Bibliographic citation (Column 3), 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 (MRBD) number, but may be a "GS" number if no
MRID number has been assigned. Refer to the Bibliography appendix for a
complete citation of the study.
"fc
-------
APPENDIX B
Data Supporting Guideline Requirements for the Registration of Streptomycin
REQUIREMENT
USE PATTERN CITATION
PRODUCT CHEMKTTRY
61-1 Chemical Identity
61-2 Start. Mat. & Mnfg. Process
61-3 Formation of Impurities
62-1 Preliminary Analysis
63-2 Color
63-3 Physical State
63-4 Odor
63-5 Melting Point
63-6 .Boiling Point
63-7 Density
63-8 Solubility
63-9 Vapor Pressure
63-10 Dissociation Constant
63-11 Octanol/Water Partition
63-12 pH
63-13 Stability
64-1 Submittal of Samples
ABCGK 41445401 - DATA GAP
ABCGK 41445401, 42044701, Pfizer letter (SEE BIBLIOGRAPHY)
ABCGK 41445401, 42044701 - DATA GAP
ABCGK 41445401 - DATA GAP
ABCGK 41445401
ABCGK 41445401
ABCGK 41445401
ABCGK 41445401
ABCGK N/A - TGAI is a solid at room temperature
ABCGK 41445401
ABCGK 41445401
ABCGK N/A - TGAI is a solid
ABCGK DATA GAP
ABCGK N/A - TGAI is polar and water soluble
ABCGK 41445401
ABCGK 41445401,42044701
ABCGK RESERVED - If samples arc required, the Agency will request them
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Streptomycin
REQUIREMENT
USE PATTERN CITATION
ECOLOGICAL EFFECtS
71-1A Acute Avian Oral - Quail/Duck ABCK
71-2A Avian Dietary (LC^ - Quail ABCK
71-2B Avian Dietary (LCj^ - Duck ABCK
72-1A Fish Acute (UC^ - Bluegill ABCK
72-lC Fish Acute (LC^ - Trout ABCK
72-2A Aquatic Invertebrate (EC») ABCK
72-^ Aquatic Organism Accumulation ABCK
123-2 Aquatk Plant Growth ABCK
141-1 Honey Bee Acute Contact ABCK
41777701
41777702
107412
103395
103394
DATA CAP
WAIVED
Articles (SEE BIBLIOGRAPHY)
41777703
TOXICOLOGY
All toxicological data requirements were waived based on existing animal and human data. Toxicological references are listed
in the Bibliography (Appendix Q.
81-1 Acute Oral Toxicity - Rat ALL
81-2 Acute Dermal Toxicity - ALL
Rabbit/Rat
81-3 Acute Inhalation Toxicity - Rat ALL
81-4 Primary Eye Irritation - Rabbit ALL
WAIVED
WAIVED
WAIVED
WAIVED
3
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Streptomycin
REQUIREMENT
USE PATTERN CITATION
TOXICOLOGY
81-5 Primary Dermal Irritation -
Rabbit
81-4! Dermal Sensitization - Guinea
Pig
81-7 Acute Delayed Neurotoxicity -
Hen
82- 1 A 90-Day Feeding - Rodent
82-1 B 90-Day Feeding - Non-rodent
82-2 21-Day Dermal - Rabbit/Rat
82-3 90-Day Dermal • Rodent
82-4 90-Day Inhalation - Rat
82-5A 90-Day Neurotoxicity - Hen
82-SB 90-Day Neurotoxicity - Mammal
85- 1 A Chronic Feeding Toxicity -
Rodent
8MB Chronic Feeding Toxicity - Non-
Rodent
83-2A Oncogenicity - Rat
83-2B Oncogenicity - Mouse
ALL
WAIVED
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
4
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Streptomycin
REQUIREMENT USE PATTERN CITATION
TOXICOLOGY
83-2B Oncogenicity - Mouse
83-3A Developmental Toxicity - Rat
83-3B Developmental Toxicity - Rabbit
83-4 2-Generalion Reproduction -
Rat
84-2 A Gene Mutation (Ames Test)
84-2B Structural Chromosomal
Aberration
84-4 Other Genotoxic Effects
85-1 General Metabolism
ENVIRONMENTAL FATE
161-1 Hydrolysis
161-2 Photodegradation - Water
161-3 Photodegradation - Soil
162-1 Aerobic Soil Metabolism
162-2 Anaerobic Soil Metabolism
163-1 Leaching/ Adsorption/Desorptlon
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
DATA GAP
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
5
-------
APPENDIX B
Data Supporting Guideline Requirements for the Registration of Streptomycin
REQUIREMENT
ENVIRONMENTAL FATE
165-1 Confined Rotational Crop
165-4 Bioaccumulation In Fish
USE PATTERN
ABCK
ABCK
CITATION
WAIVED
WAIVED
RESIDUE CHEMISTRY
171-4C Residue Analytical Method -
Plants
171-4K Crop Field Trials
Beans (succulent and dry)
Celery
Peppers
Pome fruits
Potatoes
Tomatoes
AB
AB
00103383, 00103386, 00103390, 00108026
Gustafson Analytical Report (SEE BIBLIOGRAPHY)
00103384, 00108022
00065578, 00103384
00103377, 00103386, 00103390
00103384
00103384, 00108022
-------
-------
APPENDIX C
STREPTOMYCIN BIBLIOGRAPHY
Citations Considered to be Part of the Data Base
Supporting the Reregistration of Streptomycin
-------
i
GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY, This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere
in the Reregistration Eligibility Document. Primary sources for studies in this biblio-
graphy have been the body of data submitted to EPA and its predecessor agencies in
support of past regulatory decisions. Selections from other sources including published
literature, in those instances where they have been considered, are 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 submittted. 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 also attempted 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 uses whenever a 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 further explanation). In a few cases,
entries added to the bibliography late in the review may be preceded by a nine character
temporary identifying 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 con-
ventions used reflect the standard of the American National Standards Institute (ANSI),
expanded to provide for certain special needs.
a. Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the
Agency has shown a identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the first
submitter as the author.
b. Document Date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced the
date from the evidence contained in the document. When the date appears as
(19??), the Agency was unable to determine or estimate the date of the document.
*£>.
-------
c. Title. In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the Agency in the past, the trail-
ing parentheses include (in addition to any self-explanatory text) the following
elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known submission appears
immediately following the word "received".
(2) Administrative Number. The next element immediately following the
word "under" is the registration number, experimental use permit number,
petition number, or other administrative number associated with the
earliest known submission,
(3) Submitter. The third element is the submitter. When authorship is de-
faulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume in
which the original submission of the study appears. The six-digit
accession number follows the symbol "CDL", which stands for "Company
Data Library". This accession number is in turn followed by an alpha-
betic suffix which shows the relative position of the study within the
volume.
-------
APPENDIX C
Streptomycin Bibliography
MRID Citation
00065578 Pfipharmecs (1958) [Efficacy of Streptomycin on Peppers, Tomatoes,
Pears, Apples, Tobacco and Chrysanthemums], (Compilation;
unpublished study, including published data, received May 26,
1954?; November 7, 1955?; January 22, 1954?; February 20,
1958 under 1007-6; CDL: 229886-A),
00103377 Pfipharmecs (1968) [Streptomycin Residue Analyses - Pears]. (Compi-
lation; unpublished study received January 21, 1969 under 1007-
24; CDL: 005381-B).
00103383 Chas. Pfizer & Co., Inc. (1964) Streptomycin Residue Determination on
Apples. (Unpublished study received September 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 March 14, 1966 under 1007-24;
submitted 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
December 21, 1960 under 1007-24; prepared by Univ. of
California - Davis, Agricultural Experiment Station; CDL:
119407-B).
00103394 Pitcher, F. (1974) Agri-Strep: Rainbow Trout (Salmo gairdneri):
Test No. 678. (U.S. Environmental Protection Agency,
Pesticides Regulation Div., Animal Biology Laboratory;
Unpublished study; CDL: 129168-A),
00103395 Pitcher, F.; McCann, J. (1974) Agri-Strep: Bluegill (L. macrochi-
rus). (U.S. Environmental Protection Agency, Chemical &
Biological Investigations Branch, Technical Services Div.;
Unpublished study; CDL: 131Q68-A).
-------
B
APPENDIX C
Streptomycin Bibliography
MRID Citation
00107412 Fink, R, (1974) Final Report: Eight-Day Dietary LC50 - Mallard
Ducks: Streptomycin Sulfate: Project No. 105-107. (Unpublish-
ed study received March 18, 1974 under 618-28; prepared by
Truslow Farms, Inc., submitted by Merck & Co., Inc., Rahway,
NJ; CDL: 128709-B).
00108022 Interregional Research Project No, 4 (1972) Summary of Merck Strepto-
mycin Trials on Celery, Pepper, Potato and Tomato. (Compila-
tion; unpublished study received October 20, 1972 under
1E1095; CDL: 090855-A).
41445401 Dowd, N.; Defoe, J. (1990) Streptomycin Sulfate Technical - Product
Chemistry Data. Unpublished study prepared by Pfizer, Inc.,
Quality Control Division. 157 p.
41777701 Campbell, S,; Hoxter, K.; Smith, G. (1991) Streptomycin Sulfate
Technical: An Acute Oral Toxicity Study with the Northern
Bobwhite: Lab Project Number: 260-105. Unpublished study
prepared by Wildlife International Ltd. 19 p.
41777702 Long, R.; Hoxter, K.; Smith, G. (1991) Streptomycin Sulfate
Technical: A Dietary LC50 Study with the Northern Bobwhite:
Lab Project Number: 260-104. Unpublished study prepared by
Wildlife International Ltd. 17 p.
41777703 Winter, P.; Hoxter, K,; Smith, G.' (1991) Streptomycin Sulfate
Technical: An Acute Contact Toxicity Study with the Honey
Bee: Lab Project Number: 260-106. Unpublished study
prepared by Wildlife International Ltd. 14 p.
42044701 DeFoe, J.; Dowd, N. (1991) Streptomycin Sulfate Technical: Product
Chemistry Data. Unpublished study prepared by Pfizer, Inc.
37 p.
British Crop Protection Council (1968) Pesticide Manual, 3rd ed.,
Worcestershire, England.
Brock, T.D. (1979) Biology of Microorganisms. 3rd ed., Prentice-Hall
Inc., New Jersey.
-------
I
APPENDIX C
Streptomycin Bibliography
MRID Citation
EPA (1988) Guidance for the Reregistration of Pesticide Products
Containing Streptomycin and Streptomycin Sulfate as the Active
Ingredient. Case No. 0169, 540/RS-88-097, Washington, D. C.
20460.
FDA (1986) Memorandum of R. L. Gillespie to P. Gushing on
Dihydrostreptomycin, dated January 9, 1986.
Fenton, L; Klein, D. Studies on the Bacterial Degradation of
Streptomycin Using Radioactively-Labeled Compounds.
University of Minnesota, St. Paul.
Gustafson, Inc. (1992) Analytical Reports of Streptomycin Residue in
Beans dated August 20, 1992. (CBRS No. 10453). Gustafson,
Inc., Dallas, Texas.
Harass, M.; Kindig, A.; Taub, F. (1985) "Responses of Blue-green
and Green Algae to Streptomycin in Unialgal and Paired
Culture". Aquatic Toxicology. 6, p. 1-11.
Kruger, W. (1961) The Activity of Antibiotics in Soils II. Movement,
Stability, and Biological Activity of Antibiotics in Soils and
Their Uptake by Tomato Plan 301-313.ts. South African
Journal of Agricultural Science. 4(3);
Lehninger, A. L. (1975) Biochemistry. 2nd ed., Worth Publishers, New
York.
Merck Index (1983) 10th ed., Merck and Co., New Jersey.
Muller, Hans-Gunther. (1982) "Sensitivity of Daphnia magna Strauss
Against Eight Chemotherapeutic Agents and Two Dyes".
Bulletin of Environmental Contamination Toxicology. 28, p. 1-2.
Physicians Desk Reference (1988) 42nd ed.
Pfizer, Inc. (1992) Letter from S. Bigelow to S. Lewis (EPA) dated
06/30/92.
Pramer, D.; Starkey, R. L. (1961) Determination of Streptomycin in
Soil and the Effect of Soil colloidal Material on its Activity.
New Jersey Agricultural Research Station, Rutgers University.
.&.**
* •-.,
-------
i
APPENDIX C
Streptomycin Bibliography
MRID Citation
Pramer, D.; Starkey, R. L. (1972) Decomposition of Streptomycin in
Soil & by an Isolated Bacterium, Soil Science. 114(6): 451-455.
Symposium: Microbiolog|cal Significanceof Prug Residues in Food.
Animal Health Institute and FDA-Center for Veterinary
Medicine, Rockville, MD, June 8-9, 1992.
Thompson, W. T. (1970) Agricultpral Chemical?. Book IV., Thompson
Publications, Fresno, California, p. 35.
World Health Organization (1968) Twelfth Report of the Joint
FAQ/WHO Expert Committee on Food Additives. Geneva, 1-8 July,
1968, Technical Report Series No. 430.
-------
L
-------
«•
t
APPENDIX D
List of Available Related Documents
-------
i
-------
V
/'
APPENDIX D
The following is a list of available documents related to streptomycin. Its purpose is to provide
a path to more detailed information if it is needed. These accompanying documents are part of
the Administrative Record For streptomycin and are included in the EPA's Office of Pesticide
Programs Public Docket.
1. Health and Environmental Effects Science Chapters
2. Detailed Label Usage Information System (LUIS) Report
3. Streptomycin RED Fact Sheet
4. PR Notice 91-2 (Included in this RED) Pertains to the Label Ingredient Statement
5. Summary of the Residue Data Used in the DRES Analysis and the DRES
Analysis Tables
Federal publications on streptomycin are available and may be purchased from the
National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161.
1. Pesticide Fact Sheet (No. 186) for Streptomycin: NTIS Stock No. PB89-129720.
2. Guidance for the Reregistration of Pesticide Products Containing Streptomycin
and Streptomycin Sulfate as the Active Ingredient (The 1988 Registration
Standard): NTIS Stock No. PB89-129738.
-------
-------
i
APPENDIX E
Pesticide Reregistration Handbook
-------
IS
••
-------
Pesticide
Reregistration
Handbook
How to Respond to
the Reregistration
Eligibility Document
(RED)
-------
-------
•0V TO RZSPOHD TO TIE
JUOOGISTRATIOH ILICJIILITY DOCCHZMT (RZD)
oetosn ittt
-------
•BBJMXSYIAfXQB
m*m or
I. Introduction
A. Purpose and Content
B. lerefistration llifibility
C. leregistration Process
II. Instructions for Responding
A. How and When to Respond
B. When Ho Response
-------
i. nmtooocnta
Kandboo* provides instructions to regiatrmnta eon hew to
respond to the Beregiatratien Eligibility Document (hereafter
* J end how to reregister product*.
referrod to ee the
t be
Section Z 1« tftis iatreduetlOB,
Section XI contains stap-by-etep instruction* which
followed fey registrants rMpondlag to th« UD.
Soetion 211 provid«» additional in»truction« on tho format,
contant and othor a*p*et* of fanorie data, product «p*cific data
and laiMl*/lah«liiiff which aay ba roquirsd to bo •uhmittod.
Ootailod inatruetioni aro is tha Apeoadlx.
Undar Soction i of tho Fodoral Inaoctieida, Pongieida and
lodanticido Xct (nnU), as aaandod in !•••, If A ia raquir«d to
raraciatar paaticidaa that war a f ir«t rog iatarad baf ora Kovoabar 2,
!••«. Tha RED daaeriba* in data11 tho autojact chamieal, it* uaaa
and ita ragulatory history; daacribaa DA'a daciaion eonearninf tha
aligibility of tha uoaa of tho ohaaleal fee raragiatration; and
axpiaino tho sclantifie and rogulatory baaoa for this dociaion.
DA'S raviavs, of tha data by aciantifio diaciplins axa availabia
upon rofuast. Apeondieos to tho UD eontaiai (i) a Data Dall-ln
notioo which roo^iiros vubmiaaioa of foaorio and product spocific
data anal which .firao diroctiona fee raapondinf, (1) a Hating of
exiatiag studios that satisfy ganorio data roquiraaonts and (3) a
bibliography of tho ganoric studios OA Has ravii '
e.
aai mtrm*. 1
marogistration iirfolvos a thorough roriov of tho seiantific
data bmso nndarlying a postioido's registration, tha purpeoo of
tTA's review ia to reassess the potential bafarda arising froa tha
currently registered osea of toe poaticide, to dotarmino whathar
tho data base ia subotantially ooaploto e* there ia need for
additional generic data, and to determine whather tho pestieide is
eligible for rorogistratioR. thia decision ia iewed as tho UD.
aYA's science reviews and information on tho registered
uses oonsidared for OA'a analyses may bo obtained front »x,
Preedoa ef Information, 401 II ft., i.w., Vasaiiiftan, D.C. 10410.
-------
If the RID declarea that eoaa or *11 uaea of tha chaaical are
eligible for reregiatration, affected regietrenta auat first
reapond within to daya of receipt to the data call-in portion of
the MS. within • aentha of receiving the Bio, regietrenta auat
•ubait or cite any data and labela/lafealing retired for each
product. I»A haa until 14 aontha after the «0 ia ieeued (i.*.t
i month* attar th« rmqictranta« • aontu d««dlin«) to r*vi*v th*
•umiagion for «ach product and da«ida wtiatoar to raragiatar it
baaad oa t&a folloviag oritarias
—vhatJxar all of tfea product apacifle data and lafeala/lafealinf
ara aocaptabla,
—vbathar all of tha uaaa on tha la^al/labaling ara aligibla,
—vbathar all of tha activa inqrradianta in tha product ara
aligihla, and
—if no Liat l toxic inart ingradiant ia containad in tha
product (a Liat 1 inart ia pamittad only if %11 data
for it hava baan autoaittad and IPA datawinaa
that tha inart doaa net poaa any unraaaonabla advaraa
affacta In that product).
Producta which »aat all of thaaa eritaria vill ba
rarafiatara*. Product* vhich do not aaat all of thaaa eritaria,
but which hava accaptabla product apacifle data and labalinf , will
ba procaaaad aa aaa&daaata in ordar to iaplaaant labal chanfaa
raquirad toy tha HO..
ion
mnA Whan to
Thia aaction providaa diractiona for aubaitting tiaaly and
adaquata raapenaaa nacaaaary to rara^iatar products containing tha
activa inoradlant covarad by tha no. tagiatranta auat fellow
thaea atapc exactly to avoid auapanaion ef their producta. 112.
produote eoataiaiag taa aatlve iagradiaat ia taa UX> [i.a.,
•aaufaat«ri»9 «ae predvata, aa« vae produata aa« apaalal leeai aaad
(•!• ar aeetioa i4a) vafiatratieaa] ara aubjaat ta taa ra^uircawata
ef tfe* OB. figure & au»»ariiaa how and when to raapond to the
«0. 4 etap-by-atap explanation foll<
inatancea, m »ay conclude that certain changaa to product
labal a/label ing vast be i«plamanted rapidly. If tie UB raquira.
expedited lafcel/lafceUag elasffea, refiatraata nat auboit taa itoma
balow by tae deedliae «fe«ified ia tie BID. It expedited laJ>al
changaa are not required, go to Stop S.
a. Ipylieatieft far Befiatretiea (If* fora 1570-1). Coaplete
-------
fc
and sign tbo for*. In Soetion XX, inaort tho phrmsa •Bapodltod
Baoadaoat la Baspoaao to tao Borofistratioa alifibilltf soeoaaat
for (iasort oaso aaao for aaamloal}." Application* for oxpodlto*
labol eaaafos will bo prooossod aa application* for aaondad
rofistratioB. Boo oalf aa origiaal applloatioa form with a rod
idoatifiar atambar la tbo wppor rlgat-aaad ooraor.
b. fivo II) oopioa of rwisod draft labol aad labaliag•
•afar to tbo no for labol/laboliag ehanfos and follow tha
instructions in Soetlea XXX.C. and tho Ippondix of this Handbook
for rovislag tho labol and labollag for oaoh product.
Xf taa UB rofBiras foaorla or
fov vast follow taa dirootioas la tao data
Ell roflstraats auat rospoad for all
prodtiot spoaifis data*
oall-ia aotioa la tho
produot
rospoaso
odaoto vitfcla ffdara of rooolpti products for wrniek aa adoo^ata
apoaaa la aot rooalTod oa tiao vill ko i«to$oo* to ovapoaaloa. la
•• •*^«B*ia
-------
nans i.
IBB
raooocts (MM
to UIHXD to TO
&OCCXBX* (us) rot lunryftcTSBjao cos
), OB-BOS raoeecfo cits) •»« oncui,
•HI it
•nt at
ai
•pceifisd ia US
•utaait fone within
to «ay« for ganaric
and product ap«cific
data.
Ar« any of tha uaaa on tha labal
aligihla for rarafi»tr«tion?
Xra any uaaa on tha labal
.f for raragiatration?
Yaa
Do you wish to
inaligtiJla
to* OM! nan
• KM ci«oi ovfeait
a*f liaaUaa vitlia
• omtla. Zf
for *«ea 0 t
• OUI (14a)
apfliaatioa vitlia
0 •••tls. If
*• fartaar r**p«aa«
•••aaoary.
'tiM oqtoo»a of
IPX's roviov.
!• aeeaptajbl*,
ttw latel will
rarogistratiooi
11 fe« lOMMt.
io accaptaJ»la,
th« latel will b«
•taop«d aoeaptad
and * Mtio* at
roragistratiaa
will IM
-------
I
6. »*9*B*t tpeeifi* Data. T« Vaat fOll«W the
ia taa Beta eall-Xa »otiee IB the MB ami ia e»eUea ni of
•aadboot. B*vpoa*ee t* the dat* **11 ia a** tea vitmia
veeeipt ef the H& aa< *BhBiMi*a or *itatiea at data !•
«f
«f
taia
«urr«mt 0eafii**titl
f*
of
and
ati«a and
for tto«'
vill no
|t)
F*CB tITp-4/
ctr foru vurt b« »ubmitt«d for
for Mel titan*!* f*ml*ttm. if
»lt*nuit« fervului, tb«y vlll ••% be r«r*glrt*r*4
longer b« *ee*ptal»l*. »* App*Mix of tfei* latidboole
Instruction* for completing tto* Of form.
*. C«rtifio«ti»a vltfe l*if**t t* eit*tlm *f Mt* cm f*xm
•170-Jl). ni* fora *u*t b* oo*pl«t*d, *ifn*d and *otomitt*4 for
**eh product to ***ur* tb*t to* d*t* oo^p*n*«tion provi*ion* of
F171U *x* Mt.
if no a*** ef • p**tieid* *r* *ligibl* for r*r*fl*trationf it
i* nnlik*iy th*t you will b* r*quir*d to *ubmit product *p*cific
dat* or labeling. 9*** of an aetiv* ingr*di*nt a*y b* d*cl*r*6
iA*lifil)l* for r*r*gietratien for tvo po*«ibl« r***oo*i
an
— Availabl* d*t* indie*t* th*t
*p*eial r*vi*v h*v« b**a
or
I
of tb* eritaria for
-Additional g*n*rie d*t* »r* r*qoirad.
In th* first in*t*nc*, if tha *ctiv« ingr*di*nt i* pl*o*d into
*p*eial r*vi*v, r*r*gi»tration aotiviti** a**oeiat*d vitli tbo*«
u*** of th* oh*aio*l ajr* *topp*d until D*. B*)C** * final
d*t*rain*tion. At that tia«, If A vill iadie*t* wbieh «•** a*y b*
*4if ibl* for r*r*f i*tratio9 and which a*** *r* to b* cane*ll*d. If
•oa* or *11 of ta* pr*viou*ly in*lifibl* a*** P*OO*J* *ligibl* for
r*r*gi*tr*tioo, BPA vill *tart th* r*r*gi*tratioo proe*** for
produot* eontaining only alifibl* as***
Za th* t*cond inetano*, ba**d 1901 th* r*ri*v of atodi** for
an activ* infr*di*nt during r*r*gi*tratioa, additional g*n*rie dat*
C*.f., Moond* or third-tier vtodi**) may b* n**d*d (*M th* «D).
In auch oa**ar th* ch«aioal«* oa** vill BO* b* *lififel* for
r*r*fi*tratio« until th* additional generic data have been
•ubaltted to and rerieved and found toceptable hf 0t>. If th* data
are reviewed and found to b* icceptable, m vill indicate vhieh
BMC vill be eligible for reregUtrttion and vill initiate
reregiatratlon of producta containing previoualy ineligible aa*a.
If th* data ar* not subaitted, producta oontainlag th* activ*
ingredient say be atiip*nd*d.
-------
C. Mhare fep Kaaaond
By U.S. Hall;
Document Processing Oeak (iaaert liatribvtioa oode)
Office of Pesticide Programs (H7504C)
•itvironaental Protection Agency
401 N Street, S.V.
B.C. a04«o-oooi
ay expreaa Mil or by band delivery*
#
Document Processing Desk (iasert Aiatribetioa
Office of Pesticide Programs (S7504C)
Room 2f«A, Crystal nail 2
Itai Jaff arson Davia Highway
Arlington, VA 91202
fveaa aailiag addressee aad taa falloviag diatribntiea a«€aa
•oat bo vaad to aaaura taa ti»alf racaipt aad prooaaai&f of your
•vbsiaaioaa. Vet aaiaf taaa aay aigaifioaatly da lay taa haadlieg
of yon* anbaiaaieaai
o (vaara BEX la taa oaaa oo4o giraa oa taa froat of
taa mi—oca thia diatritoution coda for mil raaponaaa pertaining
to or containing tMi>ria d^ta. tuch raaponaaa includa the to-day
raaponaa forma for generic data or hard copiaa of generic data.
B19-I&-P1C0 (vlere 0 ia tie trotfaet »a»ager teaa
uaa thia diatribution coda for all raaponaaa pertaining to or
containing pyodnat ap,»ei,gio data ar labeling, iiich raaponaaa would
include expedited labeling aaandaenta, to-day raaponaaa to product
apeeifie data requlreaenta, hard copiea of product apeeifie data
and applications for reragiatration.
III.
09 DATA. AKB
this section provides additional instructions concerning
responses required for generic data, product specific data and
labela/labeliag.
&. fiftn*
During Bta'a evaluation of ea active ingredient for
reregistration, additional generie data requirements may be
identified that registrants swat fulfill. In SOBS instances these
data requirements would Have to be satisfied before an active
ingredient or some of its uses could be declared eligible for
reregistration. Sa other eases, these new data requlramenta would
not affect the eligibility of the active ingredient, but would be
necasaary to confirm Da's assessment of that chemical.
-------
Any on data reouiraaanta and bow th*y affact r*rw?lrtr»tion
•ligtbility of a ahaaleal arti diaeuaaad is th* XXX>. If naw ganaric
data r*guira»anta ax* lapoaad la a Data fiall-In Votlea in tha no,
ragiatranta mat raapond aa daacribad In that Rotiea. Tba RED aiao
contains instruction* for eoaplatiaf thasa forma, a citation of
•PA's lagal authority for requiring tha oav data, a Hating of
options availaJbla te r*giat*aata for satisfying tha data
raquiramanta and tha aaaa of tha contact parson for Jjrt?uixiaa.
(* Bfoduet iTaagifle Pata
•
Product apaeifie data aay ba raqair*d for tha rarafiatrmtion
of aaeh paatielda product in thraa araaa—product ohaaiatry, acut«
toxicity and affieacy.
Fellovinf ara inatructiona for aubaitting product-apacifie
data and a diaeuaaloa of DA'a policy on inart infradianta.
All data raquiraaanta for KPa, IPs and fZJfa (lie1 a) ara
apaeifiad in tha Data Call-in Votlea in tha 110. In addition;
—If you cita data fro* anothar idantical, rsgistarad
product, you wist idantify tha I?A registration nuabar of that
product.
—If tha product-spaeifie data submittad or citad do not
partain to an idantical foraulation to tha product subalttad for
raraglstratioit, than nav product~*paelfie data ara rsqulrad to ba
BubBittad by tha daadlina apaeifiad la tha Data Call-in Votiea.
Tha only axcaption is for products which BPA "groups" togathar a
baing alvilar anough to dapand en tha saaa data. Such grouping*
ara diacussad tn tha appandlx to tha HIS (for aeuta toxicity
purpoaaa, for axaapla), if it was faaaibla to do so.
IMS i«pla»aTJtad a ttratagy for ragalatlnf Inart
inoradlanta vhioh affacta tha rarafiatratlon of paatielda producta.
fills atratagy, ia*uad on April It, !••? (SI fx 13305-1330») and
updatad on Wovaabar », Ittf (§4 FX 4l)l>4-4l)it}, adoptad eartaln
polielaa daaignad to raduca tha potantial for advaraa affacta from
paatlcida product* containing intantionally addad Inart
bvgradianta. B>A dividad tha fcnomi Inart ingradianta into four
catagoriiaai
—Inarta of texieelofieal eoncara (List 1) for which availabla
data daaonctrat* toxic affacta of ooncarn (ineludaa about so
ehaaleala).
-------
—Potantially toxic inarta (List 3) for which only lialtad
data ax* availabla, but such data or tha ehsmieal atructura auggaat
tha potantial for toxicity (inoludas about fO ehamicala}.
—Xnarts of unknown toxicity (List 3) for which no data or
baaaa for suspoetlag toxic offacts ara availabla (ineludss up to
2,000 chamicala).
— Inarts of minimal oonearn (List 4) which ara ganarmlly
rsgardad aa innocuous (includaa about 290 chamicala) .
Whan a US ia iasuad and any usas of aa activa ingradiant ara
daclarad aligibla for raragiatration, all products containing that
activa ingradiant will ba aubjact to rarafliatration. If A will, aa
part of tha raraqiatration raviaw, axamina tha inart ingradianta of
aach product prior to raraqiatration to anaura that thay do not
praaant unraaaonabla riaXa. In raviavlng tha product chamiatry
data, »A vill idantify Uat I inarta. BTA vill continua to
ancouraga ragiatrmnta to aliminata any List 1 inarta praaant.
Haragiatratic* of product* containing only List 2r S or 4 inarta
will bo unaffactad by tha inarta atratagy.
conaiatant vita tha atratagy on inarta, a prodvat ooataimiag
a Ust 1 iaart iagradiant vill §gi ba raragiatarad aatil a full
risk aaaaaamaat of tba produot has baam ooatfaetatf, baaa4 oa tha
data eallad ia for that iaart iagratfiamt. Hovavar, tha axisting
registration of a product containing a List 1 inart vill ramain
valid as long as tha product boars tha raquirad labol warning and
is in complianca with any outatanding MX, or othar activity undar
tha inarta atratagy.
aaf srodvst •sataiaiaf a List a* I o» 4 iaart |§z ba
raragiatarad if it Boots all ataar rsfairssiaats fat raragiatzatiea.
As tha inarta stratogy is iaplaaantad and data for tha List 2 and
3 inarts ara rarisvod, EfA may aova thasa inarta to tha othar
Lists. If aa inart wars movad to List I, products containing that
inart voold baooma inoligibla for rarogiatration. Inart
ingradianta vast also mast normal registration and tolaranea
raquiramants, as applicabla.
tbo data eall-ia notioo in tha no spoeifiao tha acuta
toxicity data raquirod for rarag iatration of oaeb M7 or 0. it
indicatas vhathar any of tha standard tasts hava boaa waivad and,
if so, vhy.
Zf faasibla, OA vUl "bates* products that ara aimilar with
raspact to tnair acntta toxicity so that ' ono sot of taata can
support rarogiatration of aach baatch of products. This approach
vill impoaa tha laast amount of tost inf. naeassary to aoaqtiataly
support tha rag iatration and labaling for pootieida product*. Tha
-------
sain benefit* ef thi* approach are te minimi*a the need for animal
tasting, reduce the expense to registrant* te fenerata the test*
aad decrease the resources D*A BAst spend OB reviewiao t
teglfftrmat* say contact other registrants with products in the
•betcB* te decide whether to provide or depend OB oae set of 4
alternatively, reglstranta say eheeee to conduct their own stadia*.
Oacwialt tlM D«t* call-la action ef tlM USD
vb«th*x Product f*rf«£«*ae« data ax« r»quir«d.for
Product performance (efficacy} data are generated ia stadia*
dasigaed to decoseat how candidate pesticide formulation* perform
as pest control agents, ffeese data include tests run te determine
whether a formulation is lethal to certain pest species, te
document the effectiveness ef tha formulation ia controlling pest
species ia actual use situations, and to determine whether certain
claim* beyond sere control of a post (e.g., *ai*-menth residual
effect,* *kllls warfarin resiatant souse mice,- etc.) are
justified.
DA has standard protocols for oartaia efficacy tests. In
general, standard method* have bean developed for tests needed to
subatantiata claim* that have been made frequently for pesticide
products. As the scope ef potential pertieidal claims is extremely
broad, the Agency does not have standard methods for tests needed
to substantiate many pesticide olaiss, especially those that ara
uncommon, fas Product Performance Ouidelines, ftubdivisiea a, offer
general guidance for developing protocols for efficacy tasting.
fropoaed protocola should ba submitted to BPA for review before
tests are initiated.
•ion fJmiwe*> Sallev
fives the AdmiMatrator of BtA authority *to waive data
requirements pertaining to efficacy* but doss) not require that
efficacy-data requiremeata ba waived for any class of pesticide
product registered under lection 3 of the Act. As a matter of
policy, Oft doss mot require submission of efficacy data to support
many types ef pesticide! claim* but doss require submiasloa of soeh
data for certain types of claims. AS noted Ia 40 en IM.440, thi*
•fjplios to the jiliiiilgn cf efficacy data rather than to
••Mfetaa of efficacy data. Bit* expects each regiatrant to
through tssting that his products arm efficacious when used
ia •iMMHitanna with ccsswaly accepted post control practices.*
Ifcis foneral policy netwlta.tandiaa;» 0* mmy, at any time,
require • registrant to submit efficacy data to support any elaim
made for a prestos*, m also may require that oartaia claim* of
•«p"»^«r»» ••'^•^P »•• sjp*p '•^••^••^•'^•i"™' • •— -———• — ^^^^ei "SFem^oseB^ "•*
effectiveness bo established before • ~
ioction I refistratioa is
-------
b« Claim* and
a tof
ich
•ubmiMion of efficacy data at reregi*tratiei* typically is
required for the following types ef product* i
1. product* claimed to control mieroorfani*** that
pose potential threat* to public health*
S. product* claimed to control vertebrate peeta that
may dlractly or indirectly transmit diaaaaaa to
human*)
3. potentially vary bastrdoua product* for which ZPA
dataninaa that it ia nacaaaary to conduct a *riak~
banafita" analyaia;
4. product* of typaa for which WX haa raaaona (a. 9.,
coftaumar complaint*, onlilwly claim*, unuaual uaa
pattama, ate.} to quaation olaima; and
and
c.
To remain in compliance vita FtfBA, the label and labeling of
each product must be revised to meet the requirements for
reregistration as described below. •Labeling* include* tha
container label and -any written, printed or graphic matter that
accompanies tha pesticide in O.i, commerce at any time (such as
technical bulletins, collateral labeling, etc.}. Ipplieatiems for
aev uses ar labeling ehsage* that to met partaia te reregietratiea
must be filed aaparataiy from the appliaatiea for raregiatratiea
iaaeribed im Step I earlier* Cbange* to labeling which muat ba
made for reregistration include, but are not limited to:
1. Labeling change* specified in the no. fuch change* may
include statements, en WUTIZCTSS rat, greundvater hasarda,
protective clothing/equipment, endangered species, environmental
hasards, etc. *
1. The format and content of labeling as described ia 40 CF1
1*4.10. When farther scute testing is naedad, the currently
accepted precautionary •tatament* will usually be retained until
testlnf is completed and the data arm reviewed.
S. Labeling change* required by Pesticide Regulatory (PR)
notices, regulations, regulatory decisions and policies issued by
IPa which arm relevant to the pesticide, your product's labeling
must reflect any applicable requirements which an in effect at the
time the no is issued. Seme existing notices are referred ta in
•action 1. of the Appendix.
-------
&. Confidential ttat«Mist of fennla and instruct!
B. Instruction* for tab«l eantaata
C. Mapl* L*b«l For»at«--O«»«r*l UM • kMtrietad Hi
(40
-------
-------
*EPA
llCEil
D
it.
,
-------
The confidential Statement of Formula (CSf) Form 1570-4 must
be used. Two legible, signed copies of the form are required.
Following are basic instructions*
a. All the blocks on the fox
completely.
must be filled IB and answered
b. If any block is net applicable, Baric it B/A.
e. The CSF must b« signed, dated and the telephone number of
the responsible party mst be provided. *
d. All applicable information which i* en the product-
specific data submission mist also be reported on the
e. All weights reported under item ? must be in pounds per
gallon for liquids and pounds per cubic feet for eolids.
f. Flashpoint Bust be
extension in inches.
in degrees Fahrenheit and flame
f. for all active ingredients, the EPA Registration {Timbers
for the currently registered source products must be reported under
column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all
actives and inerts and all common names for the trade names must be
reported.
i. For the active ingredients, the percent purity of the
source- products Bust be reported under column 10 and must be
exactly the same as on the source product's label.
j. All the weights in columns 13.a. and 13.b. must be in
pound*, kilograms, or grams. In no case will volumes be accepted.
Do not mix tnglish' and metric system units (i.e.,, pounds and
kilograms).
Jt. All tns items under column 13.to. must total 100 percent*
1. All items under columns 14.a. and 14.b. for the active
ingredients must represent purs active form.
m. Tbs uppor and lower certified limits for ail active and
inert ingredients must fellow the 40 CfM 1SI.17S instructions. An
explanation must be provided if the proposed limits are different
than standard certified limits.
»
n. When new CSFs are submitted and approved, all previously
submitted CSFs become obsolete for that specific formulation.
-------
i
l«JWTJ.«»
40 cm 134.10 and Pesticide lagulatory (».B.) Metioas require
that specific labeling statements appear at certain location* on
| tba label. The sample label formats in Appendix C show where these
1
statements are to be placed
Item l. WbODCCT HAn - The name, brand or trademark is required to
located on tba front panel, preferably centered in the upper
part of tba panel, Tna name of a product vill mot be accepted if
it is falsa or mis leading. [40 cm l*«.10(bM
Item i. COKPUrt HUfS AMD ADOftXts - The name and address of tbe
producer, registrant or person for whom tbe product is produced are,
required on tbe label and should be located at tbe bottom of the
front panel or at the and of tba label text. (40 en 15«.10(o)]
Item 1. MIT OONTHITS - A net contents statement is required en all
labels or oa tbe container of tbe pesticide. Tbe preferred
location is tbe bottom of tbe front panel immediately above the
company nama and address, or at tbe end of tbe label text. Tbe net
contents must be expressed in tbe largest suitable unit, e.g., "1
pound 10 ounces" rather than "If ounces." In addition to English
units, net contents may be expressed in metric units. [40
Ztaa 4 . If* «G11TTUT10I» MOXBE1 - Tna rof istration mabar assifnad
to tba pasticida product must appaar on tba labal , pracadad by tba
pbraaa "IT* ftaf istration lo.f- or "OA 1*9. >o.* Tna rofiatratien
numbar must bo sat in typo of a siia and styla similar to etbar
print on tbat part of tba labal on vnieb it appaars and most run
para Hal to it. Tha rag istration numbar and tba roquirad
idantifyinf phrasa must not appaar in sueb a mannar as to suggast
or imply rocommandation or andorsamant of tba product by tba
Agancy. (40 C« 15«.10(«}]
Itaa S. . XPA BSTAALIimaxT vuxmt - Tna OA astablianmant nombar,
proeadad by tba phrasa «»A 1st." is tba final aatabliahmant at
wbiob tba product was produeod, and may appaar in any auitabla
location oa tba labal or iamadiata oontainor. ft must also appaar
on tba vrmppar or owtsido oontainar of tbo packaga if tba SfA
astablianmant numbar on tba immadiata oontainor cannot «a claarly
road throogb suob wrappar or oontainar. (4§ Cf« l*4.10(f)]
Itam «A. nWMDIBrrl ITATHUUTI * la ingradiants statamant is
normally ra
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formulation*, tba pound* par gallon of activa ingradiant must ba
indicatad on the labal. [40 em 13«. I0(h) (iv) J
Xtam »C. mas TO U USED ZM ZMC120IOIT fTATWEHT - Tba aeeaptabla
common n*a*f if thara is en*, sball b* uaad, follow** fey tba
cbamieal cam*. if no cowan MM has b**n astabliabad, tba
ebaaical HUM alon* aball b* usad. Cbamicala ralatad to tba »ctiv«
ii)9r«dlwit «r« •llovvtf to bm listad anlx If •ffictcy data
mipportlng «uch elalju ara rubaittad or rafarancad. It auch data
ara providad, tha ralatad ebaaicala »uat ba liatad aajarata^y and
not aa a portion of tha activa ingradiant.
Ita»
-------
Xtaa 7C.
assigned • oxcy aegory en e bass of orml, derm*!, or
Inhalation toxieity, the word "Poison* shall appear OB the label in
red an • background of distinctly contrasting oolor and the skull
and erossbonaa shall appear ia immediate proximity to the word
(40
Item 70. tTATBCBfT OF WACTiaU, fltlATKBR1 - A Stateaent of
practical treatment (first aid or other) ahall appear on tha label
of pesticide product* in texieity categories I, XI, and 2ZX. £40
cm 15«.10(h) (1) (iii))
Xtaa 71. KtmotAL rrxTWWT * flaa atataaant *aa« tida (or lack)
Paaal for Additional Pracautieaazy ttataaanta* i» r«quir«d on tb«
front panal for all product*, «tnlaaa all r*quir«d praeautienary
*tata»anta appaar on tha front panal. [40 CfR l§4.iO(h)(l)(iii)].
XtM i. tXDt/MCX PMfll, PWtCXDTIOlomY IA3XLUK: - Th« pracautionary
atatasanta liatad b«lov vuat appaar tofatnar on th« lafeal undar tna
h*«dir*g •PRlCADTIOltARy rTATDOXT*.- Th« prafarrad location ia at
tha top of tha aida or back panal praeadiaf tha direction* for uaa,
and it ia prafarrad that thaaa atataaanta b« •urrotindad by a block
outlina. lach of tha thraa hatard warning atataaanta auat ba
haadad by tha appropriata hasard titla. [40 Cfl l$«.10(h)(2)]
Xtaa §A. KXZAAC TO HUKAJJS AjfO DOKUTXC XJTDOL1 - Whar« a hazard
axiata to huaana or domaatic aniaala, pracautionary atataaanta ara
raquirad indicating tha particular ha»ard, tha routa(a) of axpoaura
and tha precaution* to ba taken to avoid aocidant, injury or
daaafa. (40 crm l$«.10(h)(2)(i)]
Xtaa ••. BfVXloaQCDITJtL EX1AJUD - ibar* a hasard axiata to non*
targat organisa* axcluding huaana and doaaatie aniaala,
pracautionary atataaanta ara raquirad atating tha natura of tha
has ard and tha appropriata precaution* to avoid potential aocidant,
injury, or daaafa. [40 en 15«.10(h) (2) (ii))
Xtaa tC. • PiyixatZ. OK COKICXL HWAltD - rLAXXXJILTTY Pracautionary
•tataaanta relating to flaaaahillty of a product ara raquirad to
appaar on tha label if it meet* tha criteria in tha PHfS/CBXK
Labeling Appendix. Tha requirement is baaed an tha reaulta of the
flaahpoint datarainationa and flaaa ertanaion taata raquirad to be
aubaittad for all products. These atataaanta ara to ba located in
the aide/back panel precautionary atataaanta section, preceded by
tha heading "Physical/Chemical lasards." Koto that no signal word
is used ia conjunction with tha flaaaahillty atataaanta.
Xtaa »A. nmxefSD Ml cuaJincATloaj . FITHA aac. J(d) roqnirea
that mil peaticide foranlations/usas be claaaifiad for aither
general or restricted ass. Product* elassiflsd for rastrletad u*a
aay ba liaitad to u*e by certified applicators or parsons under
their direct supervision (or aay be subject to other restrictions
that aay ba iapcaad by regulation). If year product has
classified for restricted uee, than thasa requirements apply:
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1. All **as rastxiotad. tbo following *tatamant* mu*t ba plaoad
IA • blade box at tha top of tha front panal of tha labal and
labaliagt
*. Ta* etatamant «!**trictad Oaa P**ticida* muat appear at
tao tap of tlM treat panal of ta* labal. Tha atatamant
•tut ba *at ia typo of tha *as* minimum sis* a* raquirad
for human hazard signal word (saa tab la in 40 cm
I5«.10(h) (1) (iv) J. Wo ctatamant* of any kind My appaar
"*bovo tai*
b. Tba raaaoa.for tha tha raatrictad us« cltaaif ication *uat
appaar bvlov tha WSf atafeamant. Tha IBS will praacriba
thia atataaaant.
c. A cianury atatamant of tha tarms of raatriction nut
appear diractly balev thia raaaen stataaant on tha front
penal. If BM ia raatrictad to cart if lad applicators,
tha follewinf Btataaant ia raquiradi "For ratall aala to
and UM only by Cartifiad Applicator* or paraona undar
thair direct auparviaion and only for thoaa uaaa eovarad
by tha Cartifiad Applicator's Cartlfication.* Tha RED
vill apacify vhat atataaant ma»t b« u»ad.
a, §o*a bat aot all vaaa raatriotad. if tha KEO atataa that soaa
uaaa ara elaaaifiad for raatrictad uaa, and ao»a ara
unclaaaifiad, aavaral couraaa of action ara availablar
a. Ton Bay labal tha product for Haatrictad uaa. If you do
mo, you aay includa on tha labal uaaa that ara
unraetrictad, but you may not diatinqruiah thaa on tha
labal a* baing unraatrictad.
b. You may dalata all raatrictad uaaa from your la^al and
•ubait draft labeling baaring only unraatrictad uaaa.
e. Yea My "«plit" your rogiatration, i.«., rogiatar two
aaparmta products vitii idantical formulations, ena
D*ariag only unraatrictad usa«, and th* othar baaring
r««trict*d u***. To do ao, anabmit two application* for
rmroglstration, aaeb containing all forma and nacaaaary
labals. loth application* abould b« aubmittad
•ianltanoously. Wot« that ta« product* vill b« aaaignad
Mparata rogiatration numbor*.
Ita» *••, WfOtl vaamnatf - ftll product* mu»t baar th* mivuaa
•tat*a«atr "It i* ft violation of Fadaral lav to iimo tai* product in
• Manor inconai*tant vita it* labeling.- Thi* atatam*nt appaars
ot tha b«finning of ta* diraction* for OM( diractly banaata tha
haading of that ooetioa.
Itaa 104. UBflKY fTATPOMT * If * raatrictad antry intarval (MX)
ha* boon aatabliahad by tha &f*aeyf it mu*t bo includad on tha
labol. Additional vorJcar protaction atatam«nt* My bo rsfuirod in
-------
with l* »otioa U-l,
it, !••!.
* All labels ara raquirad to
Viopoaal at*
, ific oontainara, aisaa, and ohaaleal oontant.
faaaa inatruetieea *aat •ba groupad and appaar ondar tha baading
•ftorafa and Diapoaal" la tha diraetloaa for wo. ttia haadiag
•not ba aat la tha a*aa typa aisaa aa racjoirad for tha oMld hasar*
Bafar to F.B. Mtioaa tl-1 and §4-1 to datarmiaa tha
and dlapoaal inatraotiona appropriata far four prodiaeta.
K* on - Mx*etion* for OM aovt IM vtatad
sta« ioc. pmcria
la tana which oaa ba aaaily raad and ondantood br tha avaraga
paraoa liJcaly to «oa or to aoparriaa tha aaa of tha pootioida.
IDiaa follovad, diractiona waft ba adaquata to protoct tha public
froa fraud and froa paraonal injury and to pravant mraaaonabla
advavaa affaeta en tha aaviro&aant. (40 en l*4.iO(i) (I))
OOUATDtAL XAKLUIC .
lullatlna, laaflata, circular*, broeburaa, data aaaato, flfars, or
otbar writtan or graphic prlntad aattar which i« rafarrad to oa th»
labal or which is to aoeoopany tha product ara taraad collatarml
labeling, tuch labal ing aay not baar elaiaa or rapraaaatationa
that diffar in avbatanea froa thoca accaptad ia oonnaction with
rogiatration of tha product. Collataral labal ing «uat ba aada part
of tha raaponaa to tha KB and aubaittad for rarriav.
-------
« i
*
PRODUCT
NAME
KEEP OUT OF REACH OF CHlOflEN
CAUTION
STORAGE AND
W8P03AL
P
B
3
M
-------
RESTRICTED USE
PESTICIDE M
to i lM*rf r*«MMi*f
Dw« to
(*for
. *D«« to -high «c«t« t««telty.")
PRODUCT
NAME
KEEP OUT OP REACH OP CHUMCM
DANGER-PQtSON
inc
a
2
-------
-------
II wortdai dftjm after ta* ttem
With fMptet te ft
lor wWeh ttM
ttel ft
Of ft , --- i----i -
ftf4 ftBd ft WPT Of 0KB
IB mpooM to tUftt ^ .
19 worklat dftf» ftfter rwotpt
tat Atttcy. or II worfetat daj. tf
aoMrted ft copfid«a-
otretaf tat
It) A OBpf of tat ------- . . . .
aottof ftnaotiadaf tlM lopiaaot of tat
S?ttfttlOB ttftadftfd (wtthto 10
. wttot dftfi ftfter tat puWJcattoe of
Tat Atoaey
ftnd loop oumm
todti to tat doektt for OBCB
tk« atftedftrd. tbt tedos wffl iaottado,
(1) A tot of often aotti&c
Aftoef ftad a&f ponoo or pftfty
onttidt of lOftniaMBt* oaotAlntng tat
.„. of tot aottiat, tat
of Pftrieipftati ftad lat BftBM of
tt> An* _
docfctt by tmt, wont or fortpJtotttJ,
•ad tat dfttt lao documtot wm m>
larpraridodbyUM/
BftteUiB ft nftfflnf mt of meat
hftv* oMomaftfiy roouoited thai
IIM.W
vttb tlM ftcmiftl Mhodalt
fioi m 11M J§) ft aotiet
ttM ftfiflftbCttf of docki*"
C4>~ ' ~
HW* flMIMMPqH* » MWNPBH* IB "» • • •• «**•"•" WMVHPWr IPMk
•raQaafllty of a JUci*tr*tioc ttaadard
VfQ ftimcnnv* UM ftttflftbCttr of taa
• UU4
Cft) TlM At«ae7 vffl toraw to tiM
ooi tt) Tat Aftner wffl nxaU
•alt to tat pttbltoioe tMptctio
topytoc tat docUt ftad iadoz for «ny
•ad fttmSaMIttf of ltefiitr»»
(1) Cooevrntft prvrtooaly
torod aettrt tafrtdioBt; ot
IS) Goaotr&f a prtvioyaly ...
aedrt iatrtditat, aod tht lUftitratiem
ttaadard ftfttet that r»firtnaU^ygj
bt ft^utrtd Cttadtf F1TRA ttcUoc
Kcxix»)> to Mbalt ohrook aoalth
CiaehidlBf. but aot Halted to, ehrook
fotdtat, OBoefftaiet^p aod rtprodue-
tfoo) or teimtolofy ttudita.
-------
IIM.lt
to tato Part. Tb*
BO* eaew dearly
thefeilewtoa:
iteats of a other-lanfuao
fimotmtnt of
I (T-t-tf
of tat
which the product to told w pre-
IB paragraph (b> of tato ete-
CH> Tat name aad address of the
producer, rtfistarmnt, or^pereoo for
whom produced at prescribed ta para*
graph of thto tectioa;
CMU The net aectenu
ta paragraph C4> of tato i
Or) The product
aomber at prescribed ta paragraph
of thto section;
Tat produdnff tftablishmeat
Bomber at prttcribed ta paragraph
ttf *t*fr tOCtiOBi
cvttt) Tat olnetioBt for HM M
•erfotd to pamrapa (i) of late
and
(Iz) Tb* QM el«MSf!eatioB(f) M
•erfbtd la parur»Ph
ouir»d OB tat labtl&at by th« Act or
tat r»tui»tJooi la tate part mu»t a*
eltarly loftoto to a panoa with normal
fWoB. and BOH at plaotd with mica
ooaipieoouccwoi (M oomparvd wtth
inpaic aaatur oa ta« laatllnc) aad
iipriond ta meh t«nai w to rtndtr ft
tfray to at r»ad and und«nrtood by
tat ordinary tndJTkJual uzxJ«r
iff ooadftJoaa of pureaaM aad
(A) ••
CBI
set tn t-potat
A
(O Ifot at obtcurtd or
(1) £«iifiMpi lo If «M*\ All
tea*! or laatll&f tot ahan appear to
tat todiab laaruata. Howrrtr, tte
At«oey aay rtqulrt or tat apeUmat
nay prcpott addltJoaal tot ta other
lantuacei M to ooacMtrtd aeetetary to
proteet toe pubtte. Wata addirtonal
tort IB aoothtr Jaafuaft to aeeeHary.
all labtBat rtqulrtmtnta wffl at a>
pMtd totally to beta tat fef&aa aad
OB or b*
C4)
Tht label thaU
ly gtfffhtd to
or of lat pertkidt product. For
of tato •tetloa, aad tat
proriatoat of tat Act, -».
ourtly gfttphttj" •***" meaa ***! §
laatl caa rtanmably at tipected i«
rtaata afQxtd durlai tat fnreimljli
toadittoaf aad period of ota. if tat tot
•ediitt ooBtaintr to •nrloted wtthta §
wrapper or outjdd* **»*
watch tat laatl cannot bt dearly rtad.
tat laatl Butt alie at atcunay at.
taeatd to meh ovtctdt wrapper or ooo-
Utoer, tf tt to a part of tat packat t as
rily dlctrfbuttd or eold.
Ctt)
U
ardoua mattrlali aad tat fthleltt car •
rytaf them, dtflat tat batic Ftdtnl
ftQtilrtat&ta. ta additkm. when aay
rtftetertd pevtlefdt product to traai-
ported ta a tank ear, tank truck or
other aobflt or portable bulk eoatain-
or, a copy of tat accepted label mutt
be attached to tht ihlpplat papen,
aad left with tat eoaaffatt at tht tint
ofdeUrery.
(V) itoraea When ptetictdt prod-
ucta art ftored ta bulk container*.
whttaer BobQe or itatloaary, which
ta tat cuitody of tat oeer, a
0007 of the label of labellm, todudin*
afl appropriatt direetfeat for ate, laaU
bt teeurely attached to tat container
to tht tmrnertlatt fWatty of tat
(I)
or mtottodii*
of tat
Furfuant to eMUoa XaXIXJ
Act a petUciae or a depict declared
•nbfoot to the
I ISS.1**, to mlabnnded tf tt»
to falet or mWtailtng ta aay
tMoal elattna, impUt of itatemenu
or reprtatntAtioat to the laatltaf
which ooattttnto Biabnaol&f taetude:
Ctl A fftlie or mttltadfuf itateBeat
oompceitiOB of the
ft
-------
CbJ
of tbt Tbt
lUi.lt
CD
of tbt
tbsaojft
to
tftbt
Or)Afft]ttar
trttb otbtr pottlddti or
Any •fiftiaoat dtrtetiy or tad^
kapiyinc tbftt tit* ptttkldt or
of tbt ftdtnl ~
of ft
CJ> Wo
tbt
flii I» filM of BUted&v, or
til) KM not bate tpptm«J 19 tbt
or tbroogli
toppltm«nU]
tfena BUM pumtaat to 1 U14JX
awtditett if tbt
tat aal OH tueo prtadptJ
Afrtditati ovoa tboocb tfe*
of UM etlMr
i& tbt
Iftti A tro« if«t»nnpt OMd to web
wmj M to iHt i falM or ntatediaf
iHMBlrm to tht pircMMT!
ctttt) T'f**?1 diselslBtn viiidi
•r dettiet from labeling •tat^i
ozuter UM Act acd tb«M
tbt iftbti «fajLD bt
i at tbt ntat and addnoi of tbt
producer. If tbt
i tbt tebtf md tbt rtflftrsai it
• tbt producer, or tf tbt naat of tbt
lor whom tbt pttfiddt «w
OMI oa tbt Itbtl. it matt
by •oproBrtatt vordtag
toeh tt "Ptcktd lor • » »."
td by
• » «-
tbt
• « - to tbow
Of ffrf
OK) dates M to tbt Mltty of
Mflltlfli or tt* tntndtanta,
•ttt«B«Btf Midi H -mf•, "
-noetoxk to buauuM tad p«tr with
« vtthoot Mich
ll T^ITf
Ml Ml mffM or fitmt V oon-
towA (l> Tbt ntt vtlfbt or •oarert
of coottnt dun bt tstftattt of wno-
ptn or otbor ••lortek tad ihaD bt
tbt a«or*ft ofiBttat unltti txpttemy
otctod M A nUntnun yiftntttr
(1) if tbt Bjttteliii to ft liquid, tbt
(x)
lUUntata OB tbt am/1
ltttr o
ItHUtttf
tbt
to:
ont tbftfl bt in
of Betid mtwurt at IT 9 C1TCJ
•nd ibftQ bt txprttttd ta
Amtrtofta onttt of fluid
CAJ -csontatot •& attaral
tbt
I
(•)
Ctl Htbt pttdddt to aoUd or
mlrtart of ttquid and tettd. tbt ntt
oontont fUUKBtat tnan bt te ttrat of
m
(ftXtxn)
bt tobaftttd and toetpttd prior
~ r, flBil prtottd
bt Mbmfttod o&tfl
drmft tabol ttxta hfttt
ntt OBBtOBt tfMB bt
of tbt brio* totobk
-1 pound It
tban-W
<•) IB addition to tbt ftftind
' ffrt BMJF tot
tnttMtritnttt.
vffi bt
MOB M
aootetod for
ttot or aroond an
bit f^p tO tbt
biff
bolov ft vuttd atetmuni to not
ahaQ tbt ftftntt
rr
-------
llM.lt
ton* of th* pack!***! to a shJpmeat fall
SiMtfredii5*Btifyfaf Pbraoo
MC appear ta wea a maaaer at
**^*^ _^^e^ ~ ^^^ »™ *B^M»rfao)o* *M AiJa^la. t^jaflh
tO OHO*** JJ^ — y^ praauei by a*
* ert ch. i cM-tt MM*
, n taer* to aa oatdd* OB
^_ _ wrapper through which U
tagf*dl*Bt itatemeat eaaaot bt dear;
• "— taoTOdfcat ruttmtnf ma
OB each outald* eaataiai
If ta* aft* or form of th
plae* th* tagredient trattmeot OB th
front rtrvri of tt>* iahel. p*r*"*liii-oi
may to* fraat*d for th* tojrmditn.
atai*m*at to appear tla*wh*r*.
at) T&* text of
t*rt OB th* p*A*l OB which It apptait,
aad muot too clearly JffPM*)tuW!aM*
from aad mu*t not to* placed to th*
body of other tost.
(1) Nmm to a* «**d is
'. The pr
rotlftratioa auaoor proood-
•d toy th* pBno* "»A JaV. of th*
fltoal *ftahU*hm«nt at which th* prod-
produced fi*r appear IB aay
loeaitoa on ta* label or tmm*-
ataiaer. It auat appear OB th*
if *|>4 XFA trttMtfhnTTnt iw*>
tot d«*rly r*a4
throufta meh wrapper or eoautacr. .
<«) Aiffttflml flaMtfiufit-cl) OtiM^
•i Tb« tobti of atefa pwddot produet
aat OMT » rtaumtnt which eoatatai
tbi B«a§ aad pcromtac* toy valffet of
tin tfltAJ p
ooBtofo toy voifJit of aQ men tattodt*
omtoi aad tf th* pootteide eoatatao or*
ooBte IB aay fora, § «tat*a«nt of too
porooBtocoo of total aad vator-ooiutolo
anoBlo ealemated a* *loaoatoJ or*
Th* aetrr* tacrodlaBti mu*t too
aad tao men tamdloBto toy th*
tniredlenta,- or tao atam.
terfotnaof
OBOH too ta tao
typo oat, too alK&ed to tao
lw»> ~ •
," " ^ to
aot rocufrod for paottddoi which oa>
atotem*»i The aam* ua*d for atch ta>
ahaU too ta* aeotpted
aaao. tf then to on*, fol-
_ toy ta* chemical aam*. Th*
oommofi aaao aay too aotd alone only
tf tt to w*a known, if no common aam*
BOO toooa tfttHlihttl. th* chemical
aaao aloao anafl too nood. la no eaat
•ffl tao no* of a trademark or preprt*.
tary aaae too permitted naleat such
nam* hat b*«& accepted aiaoommoa
aaao toy tao Administrator oader th*
aataortty of eeetloa JKcxi).
(4) Moltmtiilt c/ ptronfagt*. Th*
of Bfridlcati ahaU bt
a term* of voifht-to-wtifht.
of pereeaUf** of th* aettv*
aad tao men tafrodloBti IBO& to* 100.
Fareoatata* ahaU not too tKpreemi by
a rant* of fitiMo mea w "»-MV" If
the VOOB of tao pevtidde product art
• votfAt of actrf* tafr*di>
area, a statement of th*
of actrf* t&frodioBt par aatt
of
of ololof .
ftfoa oboS too 00 pro-
oodaoatt-
tf then may to* oa-
ooBBploto aaalyoto of tbo
'•aaaJyito''aHaa aot b*
for th« ~
(SI Tbjo tD4TwdiOBk ctatoBMBt li
ffonl poaoi of
ta* fotoo Hated for
than too th*
to*
V&feB
tao foflowtot 1*,
-------
OM foOovf&f etwcnlcml
fas tele
OB ttM troet
tad
Cornte or OM tltor
product ami n*tt aO tofetl mat* onrx^rnint ooctant,
to OM optntUoe ttaM iafi- typt rt». tad pmfn
twritirt ttM
to to
t tf b«
«C
te
ur Will
to nua or ttM
ttM Uxt
«nir«4 OB ttM froot puMl of ttM
to drtarmizM* ter ttM Toxldty
if of ttM p
-------
i lM.lt
B to appwad far oae ea taf aata
_ _jafl ehUdraa. am* tha,
tar walta thto raajuinoaaafc.
-~ ~ ****** o/ »fa*ttoai -
jtorictty CtofifoiT £
ofpngOealttaataMgcJ^
tf) fhaj] appear oa ta* traas
of taa laaal of aS Bartietrtai fafl*
^J2ffi£S?sr45js-
itt far taa froat
Maaata oa vartous
• ii i iii i 11 ••——^— •• *2*
of taa ftatattwat of pnea>
to torn* nrf ««aoa auch
ii*«.
H«»tl.
M«»».
14
It
t&«
ft)
•adtiMakii!!
Ol) OO*r
•uttoMfit of ormrticaJ traataaat to not
raoulrad oa taa froat paaal azoapt aa
iJaauriml to para«raph fToninfwt- All
taa raqiaira froat paaal warntof ftato*
maata aaafl ba groupad toftthar oa
taa labtl, aad ahaH appaaf with suifl-
daat proaviaanoa ralattTt to othar
troat paaal text aad graphic malarial
to makatham unlflwij to oa ottr*
pnrffhaaa aad na. The feflowiaf taale
**Bacard to Humane aad Domattic
mala," *TBBTtronm«taJ Haaard" aad
"P&fiieal or Cbamical Baaafd."
(1) Jr«f«*i to hnmam atwl demotic
•aiaicia. (A) Whart a hacard udjti to
huaaag or donaatle aniiaalt. pracau*
tioaary ftatamanti act raajulrad todi-
aattat UM particular ham*, t&t
reutaca) of axpoaim utd tha praeau-
tfoaa to oa takas to avoid aeeidaat,
taluff or daaaia. Tha pmsutioour
pafa^raph fh%B ba tuunadiataly pit*
oadad sf tha approprlata haaard
IS) Tha foQevtaf tabla dapieta
ftataoiaota. Thaaa
ba modtflad.or as>
Sim tMMBMi M m HHHW
-------
to
if tho ^fcto pcatkid* It
lad tho otrccB&> vfiAtlt (flafer to nqufrvd.
vttiefe thty an nquind <*) For aow taToMat f ettar
_^ . tfee to igtoiltwtl
Mttt* tacradlni mat trwtnucta, p*ttVS4» task to
if
B •
t
ffeb aevt* LC* of I
fttt lftb«l
CT) Par an outdoor
tnuadwJ for oot- a«ufttic applimtlani
»dJ«* *•** tb> flfttttSen *Tta«p 001 of
erlwa. peodi or itnaaft. Do net
ii Toadc WftUr by rtaanhig of
potftt of VftfUft.**
» pvtleidt tnUnd»d for oat- OB) fHi^ocI or rfkmUMf
Aper «• oaotftlw aa ftetttt tncrtdMBt Wanatof Hftloatnti OB U»
fts artaa tent* onl LD« of 100 ttj or «xp3oatr« eharaettrtatlai of tbo
r lam or ft •ofeteut* dlKarr ^ partldtft
*•«<
i i cm * •
m P •« m iwr ar f • • <
» Mn MR it HIM « • *•
mmt
. I V M
wf»aj<
Hi
ifrwtteM. OUwttflM for ooa M tbt teM p«tMoi Hat tbif
•not bt iCafed to Urnf vtakh out to oonapteoooa onoofb to bo
oaafly ra»d and andantood If tho «f- by tho ooar of U>o gaitteHi
to naw oa* tA avaor* DtnetJoM ftr uoo MOJI
wwaT WBBMP <^*t _iwy ^^^^^^» «^ri^» ^r^p^^r^^^^^ ^^^^ ^^^^^ ^^^^^^
tbo MO of tbt pootWdo. WboA tel> ptotod or ptpfcit mtti
irocdOM moot bo adaqxitta to oeaipaaiat tho pooticMo pcotidad
tho oMfe from ftMi Mi (A) If roqutrod If tbt Aioatf
aatf t» prttont prtatotf or gnphk m*ttor to
tbo ittaelMd to oach pockact of tio
«Mt. or Haettf wtthto tho
-------
llfi.1t
C»i Tte latel ba*n a rofaraaoa to
taa dtroctloBa for oaa ta aeoooxpaaylaf
laafiata or etrculan, men aa "too «•
raotioaa ta tte tneloaad circular" aad
that tt to net
cuti Jtetptioiu la imnuimml tw
ttnette* for ••» CA) Dtta£«d dtr«o»
ttocN for aa* nay bo oc&itud from la*
battaf of paatkidoi wlUefcara tatoBdod
nHHik MUUB jHMfciva1 nfV IMJ
otter ttea paattdda product* ta
rtftdar maaufacturtof prooaaaaa,
pwtldod that
(J) Tte Utel tfMrtf atew ttet tte
product H tatoBdad far aa* only ta
tte typoci) of product* i
CD Adoouftta information aneh aa
teehaicftl data ateata or bulletin*, to
ftvtfiabi* to tte trad* apadfjlaf tte
typ* of product terolfad aad tta
oaa ta naai ~
(I) TIM product wffl net OOOM tote
tut hftads of UM ffatnl publk
•fur toeorpenUoc tote fiaiatad
thst Kteh dtrteUotM wt net
to pnvnt
I*eu ee maa or Uu nTirocu&«nt.
(B) Ottaltetf dtrtettaM far uat
b« onillM from tba iftfetltef of
ddt product* for wbleh «J« to Uatt«d
to phjtidaai, fftntaArlaai, or
(1) TIM tefetl da*rty «Uta§ thai Uu
prodoet to for.aot oatr by
III
rocvlatad oador tte proTtaioea of tte
Marat feo«% Oruf aad CoaaMttc Aet
CO Pttafltd dtroctlooi tar u*a aMjr
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I
APPENDIX F
Generic Data Call-in
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I
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.,.- ••«,,.
f^ "i UNITED STATES ENVIRONMENTAL PROTECTION AGf NCY
~ "! WASHINGTON, D.C. 20410
DATA CALL-IK NOTICE
CERTIFIED -MAIL " Qro - ft nrau'Jo-sj.
« U 1992 Ii.iST*ICES
Dear Sir or Madam:
'This Notice requires you and other registrants of pesticide
products containing the active ingredient identified in
Attachment A of this Notice, the Data gall-In Chemical Status
SJii££, to submit certain data as noted herein to the U.S.
Environmental Protection Agency (EPA, the Agency). These data
are necessary to maintain the continued registration of your
product(s) containing this active ingredient. Within §0 days
after you receive this Kotice you must respond as set forth in
Section III below. Your response must state:
1. how you will comply with the requirements set forth in
this Notice and its Attachments A through E; or
2. why you believe you are exempt from the requirements
listed in this Notice and in Attachment C,
and R«qi«trant*s Response Fora, (see section
XII-B)j or
3. why you believe EPA should not require your submission
of data in the Banner specified by this Notice (see
section III-D).
If yen do not respond to this Notice, or if you do not
satisfy EPA that you will comply with its requirement* or should
be exempt or excused from doing so, then the registration of your
product (s) subject to this Notice will bet subject to suspension.
we have provided a list of all of your products subject to this
Notice In Attachment B, n*ta call-in Response rarm^ as well as a
list of all registrants who were sent this Notic* (Attachment D).
The authority for this Notice is section 3(c)(2)(B) of the
Federal Insecticide* Fungicide and Rodenticide Act as amended
(FIFRA), 7 U.S.c. section 136a(c)(2)(B). collection of this
information is authorized under the Paperwork Reduction Act by
0KB Approval No. 2070-0107 (expiration date 12-31-12).
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This Notice is divided into six sections and five
Attachments. The Notice itself contains information and
instructions applicable to all Data Call-in Notices. The
Attachments contain specific chemical information and
instructions. The six sections of the Notice are:
Section I
Section II
Section III
Why You Are Receiving This Notice
Data Required By This Notice
Compliance With Requirements Of This
Notice
Section IV - Consequences Of Failure To Comply With
This Notice
Section V - Registrants' Obligation To Report
Possible Unreasonable Adverse Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
Attachment A
Attachment B
Attachment C
- Data Call-In Chemical Status Sheet
- Data Call-in Response Fora
- Requirements Status And Registrant's Response
Form
Attachment 0 - List Of All Registrants Sent This Data
Call-In Notice . .
Attachment E - cost Share And Data Compensation Forms
SECTION I. WHY, jy.01? ARE RECgyyjWG THIS NOTICE
The Agency has reviewed existing data for this active
ingredient and reevaluated the data needed to support continued
registration of the subject active ingredient. This reevaluation
identified additional data necessary to assess the health and
safety of the continued use of products containing this active
ingredient. You have been sent this Notice because you have
product (s) containing the subject active ingredient.
SECTION II. pftTjA^REOOIRED BY THIS NOTICg
IX-A.
The data. required by this Notice are specified in
Attachment C, Requirements Status and Registrant's Response Fora.
Depending on the results of the studies required in this Notice,
additional testing may be required.
ffCHESUI
* JIMISSIOtf OF PATA
You Are required to submit .the data or otherwise satisfy the
data requirements specified in Attachment C, Requirement* status
and Registrant's Response Feng, within the time frames provided.
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II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in
accordance with test standards outlined in the Pesticide Assessment
Guidelines for those studies for which guidelines have been
established.
These EPA Guidelines are available from the National Technical
Information Service (NTIS) , Attn: Order Desk, 52B5 Port Royal Road,
Springfield, Va 22161 (tel: 703-417-4650}.
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are elso acceptable if the OICD-
recommended test standard* conform to those specified in the
Pesticide Data Requirements regulation (40 CFR I 158.70). When
using the OECD protocols, they should be modified as appropriate so
that the data generated by the study vill satisfy the, requirements
of 40 CFR S 158. Normally, the Agency vill not extend deadlines
for complying with data requirements when the studies vere not
conducted in accordance with acceptable standard** The OECD
protocols are available from OECD, 1750 Pennsylvania Avenue N.W.,
Washington, D.C. 20006.
All nev studies and proposed protocols submitted in response
to this Data call-In Notice must be in accordance; with Good
Laboratory Practices [40 CFR Part 160. 3(a) (6) ] .
II-D, REGISTRANTS RECEIVING PREVIOUS SECTION KcM2\CR) NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-in dogs, not j,n.
any_wav supersede pr change the requirements of any previous Data
Call-in fs^P or any other agreements entered into with the Agency
pertaining to such prior Notice** Registrants must comply with the
requirement* of all Notice* to avoid issuance of a Notice of Intent
to suspend their affected product*.
SECTION III* eOMPT.TXNCg WITH ..... f^Q||^|gfgyrc*S OF THIS HOTTCE
IXZ-JU 3CHBI7WTi7i TOB RESPONDING TQ.THE AGPfcy
The appropriate response* initially required by this Notice
must b« submitted to the Agency within f 0 day* after your receipt
of thi* Notice). Pailur* to adequately respond to this Notice
within 90 day* of your receipt vill b* a basi* for issuing a Notice
of Intent t'j Suspend (NOIS) affecting your product*. Thi* and other
bases for issuance) of NOIS due to failurs to comply vita thi*
Notic* ar« presented in Section IV-A and ZV-B.
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III-B. OPTIOM5 FOR RESPONDING TO THE
Th» options for responding to this Notice are: 1) voluntary
cancellation, 2) delete use(s), (3) claim generic data exemption,
(4) agree to satisfy the data requirements imposed by this Notice
or (5) request a data waiver(s).
A discussion of how to respond if you chose the Voluntary
Cancellation option, the Delete Use(s) option or the Generic Data
Exemption option is presented below. A discussion of the various
options available for satisfying the data requirements of this
Notice is contained in Section III-C. A discussion of options
relating to requests for data vaivers is contained in
Section III-D.
There are two forms that accompany this Notice of which,
depending upon your response, one or both must be used in your
response to the Agency. These forms are the Data-Call-in Response.
•ZfiQh Attachment B an
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registrations may b* obtained from the Registration Support and
Emergency Response Branch, Registration Division, (703) 357-2126.
If you choose to delete the use(s) subject to this Notice or
uses subject to specific data requirements, further sale,
distribution, or use of your product after one year from the due
date of your 90 day response, must bear an amended label.
3. generic Data Exemption - Under section 3(c)(2)(DJ of
FIFRA, an applicant for registration of a product is exempt from
.the requirement to submit or cite generic data concerning an active
ingredient if the active ingredient in the product is derived
exclusively from purchased, registered pesticide products
containing the active ingredient. EPA has concluded, as an
exercise of its discretion, that it normally will not suspend the
registration of a product which would qualify and continue to
qualify for the generic data exemption in section 3(c)(2)(D) of
FIFRA. To qualify, §11 of the following requirements must be met:
a. The active ingredient in your registered product must be
present solely because of incorporation of another
registered product which contains the subject active
ingredient and is purchased from a source not connected
with youi
b* Every registrant who is the ultimate source of the active
ingredient in your product subject to this DC1 must be in
compliance with the requirements of this Notice and must
remain in compliance; and
c. You must have provided to EPA an accurate and current
"Confidential Statement of Formula11 for each of your
products to which this Notice applies*
!
To apply for the Generic Data Exemption you must submit a
completed Data Call-in Response Fern. Attachment B and all
supporting documentation* The Generic Data Exemption is item
number ia on the pa£»:j?all-In Response Font- If you claim a
generic data exemption you are not required to complete the
Requirement* Status and Registrant's Response Fern. Generic Data
Exemption: cannot. b« selected as an option -for product specific
data. - •;'• - • •
,,*,
If you are- granted a Generic Data Exemption, you rely on the
•fforts of other parsons to provide the Agency vita, the- required
data. If the) registrant(s) who have committed to generate and
submit thev required data fail to taxe appropriate steps to meet the
requirements or ar* no longer in compliance, with this Data Call-In
Notice, the Agency trill consider that both they and you are not in
compliance and will normally initiate proceedings to suspend the
registrations of both your and their product(s), unless you commit
to submit and do submit the required data within the specified
time. Zn such cases the Agency generally will not grant a time
extension for submitting the data.
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4 . Satisfying th* Data Requirements of this jflotiee There are
various options available to satisfy the data requirements of this
Notice. These options are discussed in Section III-C of this
Notice and comprise options 1 through 6 on the Requirements sta,frjs
and Registrant's- Response Form and option fib and 7 on the Pat 3
Ca j, 1 - 1 n Re s pens f Form . If you choose option 6b or 7, you must
submit both forms as veil as any other information/data pertaining
to the option chosen to address the data requirement.
5. Request for Data Waivers. " Data vaivers are discussed in
Section JII-D of this Notice and are covered by options 8 and 9 on
the Requirements Status and Registrant1 s Response Form. If you
choose one of these options, you Bust submit both forms as well as
any other information/data pertaining to the option chosen to
address the, data requirement.
C SATISFYING THE PAT* REQUIREMENTS OF IS NOTICE
If you acknowledge on the Data Call-In Response Fora that you
agree to satisfy the data requirements (i.e. you select option 6b-
and/or 7) , then you must select one of the six options on the
Requirements Status and Registrant's Response Form related to data
production for each data requirement. Your option selection shoulc
be entered under item number 9, "Registrant Response." The six
options related to data production are the first six options
discussed under item 9 in the instructions- for completing the
Requirements Status and Registrant fs Response Form. These six
options are listed immediately below with information in
parentheses to guide registrants to additional instructions
provided in this Section. The. options are:
(1) I vill generate and submit data within the specif iec
timeframa. {Developing Data)
(2) X have entered into an agreement with one or more
registrants to develop data jointly (Cost Sharing)
(3) X have Bade offers to cost-share (Offer* to Cost
Share)
(4) X an submitting an existing study that has- not been
submitted previously to the Agency by anyone.
.;-:-• (Submitting an Existing Study)
* • ""• (S) X am submitting or citing data to upgrade a study
• !(t" classified by EPA a* partially acceptable and
- • upgradeable (Upgrading a Study)
|f) X am citing an existing study that EPA has
classified as acceptable or an existing study that
• has b*en submitted but not reviewed by the Agency
(Citing an Existing Study)
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Option l. Developing pata —— it you choose to develop the
required data it must be in confonnanee with Agency deadlines and
with other Agency requirements as referenced herein and in .the
attachments. All data generated and submitted smst comply with the
Good Laboratory Practice (CLP) rule (40 CFR Part 160}, be conducted
according to the Pesticide Assessment Guidelines (PAG), and be in
confonnance with the requirements of PR Notice 86-5. In addition,
certain studies require Agency approval of test protocols in
advance of study initiation. Those studies for which a protocol
must be submitted have been identified in the Requirements States
and Registrant's Response Form -and/or footnotes to the form. If
you wish to use a protocol which differs from the options discussed
in Section II-C of this Notice, you must submit a detailed
description of the proposed protocol and your reason for wishing to
use it. The Agency nay choose to reject a protocol not specified
in Section II-C. If the. Agency rejects your protocol you will be
notified in writing, however, you should be aware, that rejection of
a proposed protocol will not be a basis for extending the deadline
for submission of data.
A progress report aust be submitted for each study within 90
days from the date you are required to commit to generate-or
undertake some other means to address that study requirement, such
as mafci ig an offer to cost share or agreeing to share in the cost
of developing that study. A 90-day progress report must be
submitted for all studies. This 90-day progress report must
include the date the study vas or will b* initiated and, for
studies to b* started within 12 months of commitment, the name and
address of the laboratory(ies) or individuals who are or will be
conducting the study.
In addition, if the time frame for submission of a final
report is more than 1 year, interim reports must be submitted at 12
month intervals from the date you are required to commit to
generate or otherwise address the requirement for the study.
In addition to the other Information specified in the preceding
paragraph, at a minimum, a brief description of current activity on
and the status of the study must b* included as wall as a full
description of any problems encountered sine* the last progress
report. .. .
The- tiaev frames in the Requirements Status and Registrant's
Response] Fora are. the time frames that the Agency is allowing for
the submission, of completed study reports or protocols. The noted
deadlines nut froa the date of the receipt of this Notice by the
registrant^ If the data are not submitted by the deadline, each
registrant is subject to receipt of a Notice of Intent to Suspend
the affected registration(s).
If you cannot submit the data/reports to the Agency in the
time required by this Notice and intend to seek additional time to
meet the requirements(s), you must submit a request to the Agency
which includes: (1) a detailed description of the expected
difficulty and (2) a proposed schedule including alternative dates
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8
for meeting such requirements on a step-by-step basis. You -must
explain any technical or laboratory difficulties and provide
documentation from the laboratory performing the testing. While
EPA is considering your request, the original deadline remains.
The Agency vill respond to your request in writing. If EPA does
not grant your request, the original deadline remains. Normal-ly,
extensions can be requested only in cases of extraordinary testing
problems beyond the expectation or control of the registrant.
Extensions will not be given in submitting the 90-day responses.
Extensions will not be considered if the request for extension is
not made in a timely fashion; in no event shall an extension
request be considered if it is submitted at or after th* lapse of
the subject deadline.
QpjRien 2. Agreement to Share in Cost to Develop Data — If
you choose to enter into an agreement to share in the cost of
producing th* required data but will not be submitting th* data
yourself, you must provide th* name of th* registrant who vill be
submitting th* data. You must also provide EPA with documentary
evidence that an agreement has been formed. Such evidence may b*
your letter offering to join in an agreement and the other
registrant's acceptance of your offer, or a written statement by
th* parties that an agreement exists. Th* agreement to produce the
data need not specify all of th* terms of th* final arrangement
between th* parties or th* mechanism to resolv* th* terms. Section
3(c)(2)(B) provides that if th* parties cannot resolve the terms of
th* agreement they nay resolv* their differences through binding
arbitration.
Opt;.jon.,,: 3. Of far to Shire |,njfeheQost. of Da^a p^yeyopment — If
you hav* mad* an offer to pay in an attempt to enter into an
agreement or amend an existing agreement to meet th* requirements
of this Notic* and hav* been unsuccessful, you nay request EPA (by
selecting this option) to exercise Its discretion not to suspend
your registration(s), although you do net comply with th* data
submission requirements of this Notice. EPA has determined that as
a general policy, absent other relevant considerations, it will not
suspend the registration of a product of a registrant vho has in
good faith sought end continues to seek to enter into.a joint data
d*v*lopm*nt/cost sharing program, but the oth«r registrant(s)
developing, the) data has refused to accept your offer. To qualify
for this option, you must submit documentation to the Agency
proving that you have made an offer to another registrant (who has
an obligation to submit data) to share in the burden of developing
that data. You must also submit to the Agency a completed EPA Form
8570-32, Certification of Offer to Coat Share) in th* Development of
Data, Attachment B. Zn addition, you must demonstrate that the
other registrant to whom the offer vas made has not accepted your
offer to enter into a costsharing agreement by including a copy of
your offer and proof of the other registrant's receipt of that
offer (such as a certified vail receipt). Your offer must, in
addition to anything else, offer to share In the burden of
producing the data upon terms to be agreed or failing agreement to
be bound by binding arbitration as provided by FIFRA section
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3(c)(2){B)(iii) and must not qualify this offer. The other
registrant must also inform EPA of its election of an option to
develop and submit the data required by this Notice by submitting a
Pjata Call-In Response Form and a peguirements Status and
peoistrLant.Ls-.-Sesponse Form committing to develop and submit the
data required by this Notice.
In order for you to avoid suspension under this option, you
Day not withdraw your offer to share in the burdens of developing
the data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice. If the other registrant fails to develop the data or for
some other reason is subject to suspension, your registration as
well as that of the other registrant vill normally be subject to
initiation of suspension proceedings, unless you commit to submit,
and do submit the required data in the specified time frame. In
such cases, the Agency generally will not grant a time extension
for submitting the data.
Option 4. Submitting an Existing g^udy —• If you choose to
submit an existing study in response to this Notice, you must
determine that the study satisfies the requirements imposed by this
Notice. You may only submit a study that has not been previously
submitted to the Agency or previously cited by anyone. Existing
studies are studies which predate issuance of this Notice. Do not
use this option if you are submitting data, to upgrade a study. (See
Option 5).
You should be aware that if the Agency determines that the
study is not acceptable, the Agency will require you to comply with
this Notice, normally without an extension of the required date of
submission. The Agency stay determine at any time that a study is
not valid and needs to b* repeated.
To meet the requirements of the DCI Notice for submitting an
existing study, all of the following three criteria must be clearly
met:
a. You must certify at the time that the existing study is
submitted that the rav data and specimen* from the study are
available for audit and review and you Bust identify where
they are available. This must be don* in accordance with
the requirements of the Good Laboratory Practice (CLP)
regulation, 40 CFR Part 160. As stated in 40 CFR 160.3(j)
• '[r] aw data1 means any laboratory worksheets, records,
memoranda, notes, or exact copies thereof, that are the result
of original observations and activities of a study and are
necessary for the reconstruction and evaluation of the report
of that study. In the event that exact transcripts of raw
data have been prepared (e.g., tapes which have been
transcribed verbatim, dated, and verified accurate by
signature), the exact copy or exact transcript may be
substituted for the original source as rav data. 'Rav data1
may include photographs, microfilm or microfiche copies.
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i
10
computer printouts, magnetic media, including dictated
observation*, and recorded data from automated instruments."
The term "specimens", according to 40 CFR 160.3(k), means "any
material derived from a test system for examination or
analysis.11
b. Health and safety studies completed after May 1984 must
also contain all GLP-required quality assurance and quality
control Information, pursuant to the requirements of 40 CFR
Fart 160. Registrants must also certify at the time of
submitting the existing study that such CLP information is
available for post-Kay 1984 studies by including an
appropriate statement on or attached to the study signed by an
authorized official or representative of the registrant.
c. You aust certify that each study fulfills the acceptance
criteria for the Guideline relevant to the study provided in
the FIFRA Accelerated Reregistration Phase 3 Technical
Guidance and that the study has been conducted according to
the Pesticide Assessment Guidelines (PAG) or meet* the purpose
of the PAG (both available from NTIS). A study not conducted
according to the PAG may be submitted to the Agency for
consideration if the registrant believe* that the study
clearly meet* the purpose of the PAG. The registrant is
referred to 40 CFR 15S.70 which states the Agency1* policy
regarding acceptable protocols, if you wish to submit the
study, you must, in addition to certifying that the purposes
of the PAG are met by the study, clearly articulate the
rationale why you believe the study meet* the purpose of the
PAG, including copies of any supporting information or data.
It ha* been the Agency1* experience that studie* completed
prior to January 1970 rarely satisfied the purpose of the PAG
and that necessary raw date are usually not available for such
studies.
Zf you submit an existing study, you must certify that the
study meet* all requirement* of the criteria outlined above.
If EPA ha* previously reviewed a protocol for a study you are
submitting, you must identify any action taJcen by the Agency on the
protocol and auat indicate, a* part of your certification, the
manner in vhich all Agency comment*, concern*, or i*sue* vere
addre***d in th« final protocol and »tudy.
Iff you"know of a study pertaining to any requirement in this
Notice which doe* not meet the criteria outlined above but does
contain factual information regarding unreasonable adverse effects,
you sni*t notify the Agency of *uch a study. If *uch *tudy is in
the Agency'* file*, you need only cite it along with the
notification. Zf not in the Agency'* file*, you mu*t submit a
summary and copies a* required by PR Notice 86-3.
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11
Qption 5.Jgpgradina a Study — If a study has been classified
as partially acceptable and upgradeable, you may submit data to
upgrade that study. The Agency will review the data submitted and
determine if the requirement is satisfied. If the Agency decides
the requirement is not satisfied, you may still be required to
submit new data normally without any time extension. Deficient,
but upgradable studies will normally be classified as
supplemental. However, it is important to note that not all
studies classified as supplemental are upgradeable. If you have
questions regarding the classification of a study or whether a
study may be upgraded, call or write the contact person listed in
Attachment A. If you submit data to upgrade an existing study you
must satisfy.or supply information to correct all deficiencies in
the study identified by EPA. You must provide a clearly
articulated rationale of how the deficiencies have been remedied or
corrected and why the study should be rated as acceptable to EPA.
Your submission must also specify the MRID number(s) of the study
which you are attempting to upgrade and must b* in conformance with
PR Notice 86-5.
•
Do not submit additional data for the purpose of upgrading a •
study classified as unacceptable and determined by the Agency as
not capable of being upgraded.
This option should also b* used to cite data that has been
previously submitted to upgrade a study, but has not yet been
reviewed by the Agency. You must provide the MRID number of the
data submission as well as the KRIS number of the study being
upgraded.
The criteria for submitting an existing study, as specified in
Option 4 above, apply to all data submissions intended to upgrade
studies* Additionally your submission of data intended to upgrade
studies must be accompanied by a certification that you comply with
each of those criteria as veil as a certification regarding
protocol compliance with Agency requirements.
Option 6. citing Existing Studies — if you choose to cite a
study that has been previously submitted to EPA, that study Bust
have been previously classified by EPA mm acceptable or it wist bet
a study vhich has not yet been reviewed toy the Agency. Acceptable
toxicology studies generally vill have been classified as "core-
guidelinev* or* "cor* minimum.1* For ecological effect* studies, the
classification generally would be a reting'of "core." For all
other disciplines the classification would be "acceptable." With
respect to any studies for vhich you wish to select this option you
oust provide the KRID number of the study you are citing and, if
the study hats been reviewed by th* Agency, you must provide the
Agency's classification of the study.
If you are citing a study of vhich you ara not the original
data submitter, you mist submit a completed copy of EPA Form
8570-31, Certification vith Respect to Date Compensation
Requirements.
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12
D REQUESTS FOR DATA WAIVED
Thar* are two types of data waiver responses to this Notice.
The first is a request for a low volume/minor use waiver ani the
second is a waiver request based on your belief that the data
requirement(s) are inapplicable and do not apply to your product.
1. Low Vo^uiae/Miflor Use Waiver — Option 8 on the Requirements
Status and Registrant's Response Fora. Section 3(c)(2)(A) of FIFRA
requires EPA to consider the appropriateness of requiring data for
lev volumei minor use pesticides. In implementing this provision
EPA considers as lev volume pesticides only those active
ingredients whose total production volume for all pesticide
registrants i* small. In determining whether to grant a low
volume, minor use waiver the Agency will consider the extent,
pattern and volume of use, the economic incentive to conduct the
testing, the importance of the pesticide, and the exposure and risk
from use of the pesticide. If an active ingredient is used for
both high volume and low volume uses, a low volume exemption will
not be approved. If all uses of an active ingredient are low
volume and the combined volumes for all uses are also low, then an
exemption may be granted, depending on review of other information
outlined below. An exemption will not be granted if any registrant
of the active ingredient elects to conduct the testing. Any
registrant receiving a low volume minor use waiver must remain
within the sale* figures in their forecast supporting the waiver
request in order to remain qualified for such waiver. If granted a
waiver, a registrant will be required, as a condition of the
waiver, to submit annual sales reports. The Agency will respond to
requests for waivers in writing.
To apply for * low volume, minor use waiver, you must submit
the following information, as applicable to your product(s), as
part of your 90-day response to this Notice:
a(i). Total company sales (pound* and dollar*) of all
registered product(s) containing the active ingredient.
If applicable to the active ingredient, include
foreign sales for those products that are not
registered, in this country but are applied to sugar
(can* or beet), coffee, bananas, cocoa, and other
.. such. crop*. Present the above information by year
• ' . for each of th* past five years. . •
il. Provide an estimate of the sales (pound* and dollars)
of the active ingredient for each major use site.
Present the above information by year for each of the
past five year*.
*&..
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13
b. Total direct production cost of product(s) containing
the active ingredient by year for the past five years.
Include information on raw material cost, direct
labor cost, advertising, sales and marketing, and any
other significant costs listed separately.
c. Total indirect production cost (e.g. plant overhead,
amortized plant and equipment) charged to product(s)
containing the active ingredient by year for the past
five years. Exclude all non-recurring costs that were
directly related to the active ingredient, such as
costs of initial registration and any data development.
d(i). A list of each data requirement for which you seek
a waiver. Indicate the type of waiver sought and
the estimated cost to you (listed separately for
each data requirement and associated test) of
conducting the testing needed to fulfill each of
these data requirements.
ii. A list of each data requirement for which you are not
seeking any waiver and the estimated cost to you
(listed separately for each data requirement and
associated test) of conducting the testing needed to
fulfill each of these data requirement*.
e. For each of the next ten year*, a year-by-year fore-
cast of company sales (pound* and dollar*) of the
active ingredient, direct production cost* of product(s)
containing the active ingredient (following the
parameter* in item 2 above), indirect production
costs of product(s) containing the active ingredient
(following the parameter* in item 3 above), and
costs of data development pertaining to the active
ingredient.
f. A description of the importance) and unique benefit* of
the active ingredient to user*. Discuss the use
pattern* and the effectiveness of the- active ingredient
relative to registered alternative chemical* and
non-chemical control strategies. Focu* on benefit*
unique to the active ingredient, providing information
that, i* a* quantitative) a* po«»ibl*. If. you do> not
have,quantitative data upon which to base your estimates,
* then preaent the reesoning used to derive- your estimates.
To assist the Agency In determining the degree of
importance of the active ingredient in term* of it*
benefit*, you should provide Information on any of
the- following factors, a* applicable to your product{*):
(a) documentation of the u*efulne*» of the active)
ingredient In Integreted Peat Management, (b) description
of the-beneficial Impact* on the environment of use
of the active Ingredient, a* opposed to it* registered
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. , 14
alternatives, (c) information on th« breakdown of the
active ingredient after use and on its persistence in
the environment, and (d) description of its usefulness
against a pest(s) of public health significance.
Failure to submit sufficient information for the Agency to
make a determination regarding a request for a low volume/minor use
vaiver vill result in denial of the request for a waiver.
2. Request forWaiver of Data — Option 9 on the Reouirenentq
Status and Registrant's Response Fora. This option nay be used if
you believe that a particular data requirement should not apply
because the corresponding use is no longer registered or the
requirement is inappropriate. You aust submit a rationale
explaining why you believe the data requirements should not apply.
You oust also submit thm current label(s) of your product(s) and,
if a current copy of your Confidential Statement of Formula is not
already on file you must submit a current copy.
*
You vill be informed of the Agency's decision in writing. If
the Agency determines that the data requirements of this Notice do*
not apply to your product(s), you will not be required to supply
the data pursuant to section 3(c)(2)(B). If EPA determine3that
the data >re recruit-ad for vour product t&\. you ..must choose a itethod
off meetingthe requirements of this Notice withinthe time frame
provided by thj.s Notice. Within 30 days of your receipt of the
Agency's written decision, you must submit a revised Requirements.
Status and Registrant's Response Form indicating the option chosen.
IV. . CONSEOPENCES OF FAILURE TO COMPLY WITH THIS NOTICE" "
IV-A. NOTICE O* INTENT TO SUSPEND
Til* Agency may issue a Notic* of Intent to Suspend products
subject to this Notice due to failure by a registrant to comply
with the requirement* of this Data Call-In Notice, pursuant to
FIFRA section 3(c)(2)(B). Events which may be the basis for
issuance of a Notice of Intent to Suspend. Include, but: are not
limited, to, the, following:
1. Failure to respond, as required by this Notic* within 90
day* of your receipt of this Notice- ,
2. Failure* to submit on the required schedule an acceptable
proposed or final protocol when such, i* required to be
submitted, to the Agency for review.
3. Failure to submit on the required schedule an adequate
progress report on a study as required by this Notice.
.4. Failure to submit on the required schedule acceptable
dat* as required by this Notice.
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5. Failure to take a required action or submit adequate
information pertaining to any option chosen to address the
data requirements (e.g., any required action or information
pertaining to submission or citation of existing studies or
offers, arrangements, or arbitration on the sharing of costs
or the formation of Task Forces, failure to comply with the
terns of an agreement or arbitration concerning joint data
development or failure to comply with any terms of a data
vaiver) .
6. Failure to submit supportable certifications as to the
conditions of submitted studies, as required by Section III-c
of this Notice.
7. withdrawal of an offer to share in the cost of developing
required data.
8. Failure of the registrant to whom you have tendered an
offer to share in the cost of developing data and provided
proof of the registrant's receipt of such offer or failure of
a registrant en whoa you rely for a generic data exemption
either to:
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16
1. EPA requirements specified in the Data Call-in Notice or
other documents Incorporated by reference (including, as
applicable, EPA Pesticide Assessment Guidelines, Data
Reporting Guidelines, and GeneTox Health Effects Test
Guidelines) regarding the design, conduct, and reporting of
required studies. Such requirements include, but are not
limited to, those relating to test material, test procedures,
selection of species, number of animals, sex and distribution
of animals, dose and effect levels to be tested or attained,
duration of test, and, as applicable, Good Laboratory
Practices.
2. EPA requirements regarding the submission of protocols,
including the incorporation of any changes required by the
Agency following review.
3. EPA requirements regarding the reporting of data,
including the manner of reporting, the completeness of
results, and the adequacy of any required supporting (or rav)
data, including, but not limited to, requirements referenced*
or included in this Notice or contained in PR 86-5. All
studies must be submitted in the fora of a final report,* a
preliminary v sport will not be considered to fulfill the
submission requirement.
iv-c gyyyy INC STOCKS OF SUSPENDED OR cAKeET^go PRODUCTS
EPA has statutory authority to permit continued sale,
distribution and use of existing stocks of a pesticide product
which has been suspended or cancelled if doing so would be
consistent with, the purposes of the Act.
The Agency has determined that such disposition by registrants
of existing stock* for a suspended registration when a section
3(c)(2)(B) data request is outstanding would generally not be
consistent with the Act's purposes. Accordingly, the Ageney
anticipate* granting registrants permission to sell, distribute, or
use existing stock* of suspended product (*) only in exceptional
circumstances.- Zf you believe such disposition of existing stock*
of your product (s) which nay be suspended for failure to comply
with thi* Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting, such, permission would be
consistent with the Act. You must al*o explain 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, distribution, and use. Unless you meet this burden
the Ageney vill not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after
suspension.
Zf you request a voluntary cancellation of your product (s) as
a response to this Notice and your product is in full compliance
with all Agency requirements, you will have, under most
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17
circumstances, one year from the date your 90 day response to this
Notice im due, to sell, distribute, or u*« existing stocks.
Normally, the Agency will allow parsons ether than the registrant
such as independent distributers, r*tail*rs and end users to sail,
distribute or us* such existing stocks until the stocks are
exhausted. Any sale, distribution or use of stocks of voluntarily
cancelled products containing an active ingredient for which the
Agency has particular risk concerns will be determined on case-by-
case basis. - ,
Requests for voluntary cancellation received after the 90 day
response period required by this Notice will not result in the
Agency granting any additional time to sell, distribute, or use
existing stocks beyond e year from the date the 90 day response was
due unless you demonstrate to the Agency that you are in full
compliance with all Agency requirements, including the requirements
of this Notice. For example,- if you decide to voluntarily cancel
your registration six months before e 3 year study is scheduled to
be submitted, all progress reports and ether information necessary
to establish that you have been conducting the study in an
acceptable and good faith manner must have been submitted to the
Agency, before EFA will consider granting an existing stocks
provision.
SECTION V. REGISTRANTS' OBLIGATION T
ADVERSE EFFECTS
Registrants are reminded that F1FRA section 6 (a) (2) states
that if at any time after a pesticide is registered a registrant
has additional factual information regarding unreasonable adverse
effects on the environment by the pesticide, the registrant shall
submit the information to the Agency. Registrants must notify the
Agency of any factual information they have, from whatever source, :
including but not limited to interim or preliminary results of
studies, regarding unreasonable adverse effects on man or the
environment. Tills requirement continues as long as the products
are registered by the Agency*
S1CTZOH "VI"* TMOPTETEg XNP MSPQHSES TO THIS HOTTCE
Zf you have any questions regarding the requirements and
procedures- established by this notice, call the contact person
listed in Attachment A, the Pats C«ll»In Chemical Statu^ fihaat.
All response* to this Notice (other than voluntary
cancellation requests and generic data exemption claims) must
include a completed Pffra Call-in Response form (Attachment ») and a
completed ffoguirenents ftatus and Registrant *« Response Fora
(Attachment C) and any other documents required by this notice, and
should be submitted to the contact person identified in Attachment
A. If the voluntary cancellation or generic data exemption option
is chosen, only the Pats Call-In Response Far* need be submitted.
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L
is
Tha Offiea of complianea Monitoring (OCM) of ttoa Offiea of
Paatieidaa and Toxic Subatancaa (OPTS)» EPA, will ba monitoring tha
data bainf ganoratad in rasponaa to thia Kotiea.
sincaraly.
Danial M. Barolo, Diractor
Spaeial Raviav and
Raragiatration Diviaion
A
B
C
D
E
Attachinanta
Data Call-In Chamieal Statua Shaa-t
Data Call-In Rasponaa Forn
Ratuiramanta Statua and
Raaponaa Fora
of R«oi« tranta Raeatvin Thia
_
— Coat Shara and Data Conpanaation Forma
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ATTACHMENT A
Generic Data Call-in Chemical Status Sheet
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ATTACHMENT A
STREPTOMYCIN: GENERIC DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have products contain-
ing streptomycin.
This Generic Data Call-in Chemical Status Sheet, contains an overview of data required
by this notice, and point of contact for inquiries pertaining to the reregistration of streptomycin.
This attachment is to be used in conjunction with (1) the Generic Data Call-In Notice, (2) the
Generic Data Call-in Response Form (Attachment B), (3) the Requirements Status and
Registrant's Form (Attachment C), (4) a list of registrants receiving this DCI (Attachment D),
(5) the EPA Acceptance Criteria (Attachment E), and (6) the Cost Share and Data Compensation
Forms in replying to this Streptomycin Generic Data Call-In (Attachment F). Instructions and
guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for streptomy-
cin are contained in the Rjqyjremjents Status and Regjstrajjt'j^Response (Attachment C). The
Agency has concluded that new ecological effects and environmental fate data on technical
streptomycin sulfate are needed. In addition, some of the product chemistry guidelines have not
been completely fulfilled. All of the product chemistry data were originally required in the
Registration Standard and are therefore not included in the generic Data Call-In for the RED.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Theresa A. Stowe at (703) 308 - 8043.
All responses to this Notice for the generic data requirements should be submitted to:
Theresa A. Stowe, Chemical Review Manager
Reregistration Branch, Section I
Special Review and Reregistration Division (H7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460
RE: STREPTOMYCIN
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ATTACHMENT B
Generic Data Call-in Response Forms (Form A) plus Instructions
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SPECIFIC INSTRUCTIONS FOR
THI DATA CALL-IN RESPONSE FORM
This form is designed to be used to respond to call-ins for
generic and product specific data for the purpose of
reregistering pesticides under the Federal Insecticide Fungicide
and Rodenticide Act. Fill out this form each time you are
responding to a data call-in for which EPA has sent you the form
entitled "Requirements Status and Registrant's Response."
Items 1 -4 will have been preprinted on the form. Items 5
through 7 must be completed by the registrant as appropriate.
Items 8 through 11 must be completed by the registrant before
submitting a response to the Agency.
Public reporting burden for this collection of information
is estimated to average 15 minutes per response, including time
for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and
reviewing the collection of information. Send comments regarding
the burden estimate or any other aspect of this collection of
information, including suggesting for reducing this burden, to
Chief(/ Information Policy Branch, PM-223, U.S. Environmental
Protection Agency, 401 M St., S.W., Washington, D.C. 20460; and
to the Office of Management and Budget, Paperwork Reduction
Project 2070-0107, Washington, D.C. 20503.
INSTRUCTIONS
Item 1. This item identifies your company name, number and
address.
Item 2. This item identifies the case number, case name, EPA
chemical number and chemical name.
Item 3. This itea identifies the date and type of data call-in.
Item 4. This item identifies the EPA product registrations
relevant to the data call-in. Please note that you are
also responsible for informing the Agency of your
response regarding any product that you believe may be
covered by this data call-in but that is not listed by
the Agency in Item 4. You must bring any such apparent
omission to the Agency's attention within the period
required for submission of this response form.
Item 5. Check this item for each product registration you wish
to cancel voluntarily. If a registration number is
listed for a product for which you previously requested
voluntary cancellation, indicate in Item 5 the date of
that request. You do not need to complete any item on
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i
Requirements Status and Registrant;.'s. Besponse Fora
for any product that is voluntarily cancelled.
Item 6a. Check this item if this data call-in is for generic
data as indicated in Item 3 and if you are eligible for
a Generic Data Exemption for the chemical listed in
Item 2 and used in the subject product. By electing
this exemption, you agree to the terms and conditions
of a Generic Data Exemption as explained in. the Data
Call-in Notice.
If you are eligible for or claim a Generic Data
Exemption, enter the EPA registration Number of each
registered source of that active ingredient that you
use in your product. ;
Typically, if you purchase an EPA-registered product
from one or more other producers (who, with respect to
the incorporated product, are in compliance with this
and any other outstanding Data Call-In Notice), and
incorporate that product into all your products, you
may complete this item for all products listed on this
form. If, however, you produce the active ingredient
yourself, or use any unregistered product (regardless
of the fact that some of your sources are registered),
you may not claim a Generic Data Exemption and you may
not select this item.
Item 6b. Check this Item if the data call-in is a generic data
call-in as indicated in Item 3 and if you are agreeing
to satisfy the generic data requirements of this data
call-in. Attach the Requirementsgtatus and
ge_gjjjJrgajrfe!_s Pfgponsf ,fg..rn that indicates how you will
satisfy those requirements,
Item 7a. Check this item if this call-in is a data call-in as
indicated in Item 3 for a manufacturing use product
(HUP), and if your product is a manufacturing use
product for which you agree to supply product-specific
data. Attach the fteguiremeflts Status ^and, Jleglstyants*
ge.sp_ppse Fora that indicates how you will satisfy those
requirements.
Item 7b. Check this item if this call-in is a data call-in for
an end use product (EUP) as indicated in Item 3 and if
your product is a end use product for which you agree
to supply product-specific data. Attach the
gecn3ireree:i|ts Status aq4 Registrant's,Response Form that
indicates how you will satisfy those requirements.
Item 8. This certification statement must be signed by an
authorized representative of ycur company and the
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i
person signing must include his/her title. Additional
pages used in your response must be initialled and
dated in the space provided for the certification.
Item 9. Enter the date of signature.
Item 10. Enter the name of the person EPA should contact with
questions regarding your response.
Item 11'. Enter the phone number of your company contact.
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I
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DRAFT COPY
of
United States Environmental Protection Agency
Washington, D. C. 20460
DATA CALL-IN RESPONSE
Far* Approved
CM Ho. 2070-0107
Approval titplrea 12-3
INSTRUCTIONS: Pleas* type or print in ink. PlMM read carefully the attached instructions and supply the Information requested on this torsi.
Use addition*I sheet(a) If necessary.
I * Company naaja end Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case i end isM
0169 Streptomycin
1. Date end Type of DCI
PRODUCT SPECIFIC
SEP 30 1992
4. EM Product
Registration
5. 1 wish to
cancel this
product regis-
tration volun-
tarily.
6. Generic Data
6a. I mm claiming a Generic
Data Exemption because I
obtain the active Ingredient
fro* the source EPA regis-
tration number listed below.
6b. 1 agree to satisfy Generic
Data requlreawnts as indicated
on the attached for* entitled
•Requirements Status and
Registrant's Response."
7. Product Specific Data
7a. Ny product Is a HUP and
I agree to satisfy the NUP
requl raatnts on the attached
for* entitled "tequlregents
Status and Registrant's
Response.*
_ **£_lL
7b. Ny product Is an W
I agree to satisfy the i
requirements on the att
form entitled "Require*
Status and Registrant's
Response.11
NNNNNN-NNNNN
N.A.
N.A.
8. Certification
I certify that the statements *ada on this for* and alt attachments are true, accurate, and complete.
I acknowledge that any knowingly false or Misleading stateacnt a*y be punishable by fine. Imprisonment
or both under applicable law.
Signature and title of Company's Authorlied Representative^
9. Data
10. Haste of Company Contact
II. Phone Number
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i
ATTACHMENT C
Generic Data Call-in Requirements Status and
Registrant's Response Forms (Form B) plus Instructions
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SPECIFIC IKSfRUCTIONS FOR
THB REQUIREMENTS SfATOS AHD REGISTRANT' S R1SPONSB FORM
Senarie Data
This form is designed to be used for registrants to respond
to call-ins for generic and product-specific data as part of
EPA's reregistration program under the Federal Insecticide
Fungicide and Rodenticide Act. Although the form is the same for
both product specific and generic data, Instructions for
completing the forms differ slightly. Specifically, options for
satisfying product specific data requirements do not include (1)
deletion of uses or (2) request for a low volume/minor use
waiver. These instructions are for completion of generic data
requirements.
EPA has developed this form individually for each data call-
in addressed to each registrant, and has preprinted this form
with a number of iteas. DO NOT use this form for any other
active ingredient.
Items 1 through 8 (inclusive) will have been preprinted on
the form. You must complete all other items on this fora by
typing or printing lagibly.
Public reporting burden for this collection of information
is estimated to average 30 minutes per response, including time
for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and
reviewing the collection of information. Send comments regarding
the burden estimate or any other aspect of this collection of
information, including suggesting for reducing this burden, to
Chief, Information Policy Branch, PM-223, U.S. Environmental
Protection Agency, 401 H St., S,W., Washington, D.C. 20460; and
to the Office of Management and Budget, Paperwork Reduction
Project 2070-0107, Washington, D.C. 20503.
-„ „ •« ,«iMt»—,•-•• .-*•„ ,-- -- -- r. -*:-i>.;.: ^ji:_™L;_I." IZt-^
- . y^: T ~TT5.'1'" "" ""—"•"""*~'"~"5S- -- -•
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INSTRUCTIONS
Item 1. This item identifies your company name, number, and
address.
Item 2. This item identifies the case number, case name, EPA
chemical number and chemical name.
Item 3. This item Identifies the date and type of data call-in.
Item 4. This item identifies the guideline 'reference numbers of
studies required to support the product(s) being
reregistered. These guidelines, in addition to
requirements specified in the Data Call-In Notice,
govern the conduct of the required studies.
Item S. This item identifies the study title associated with
the guideline reference number and whether protocols
and 1, 2, or 3-year progress reports are required to be
submitted in connection with the study. As noted in
Section III of the Data Call-in Jfotico, 90-day progress
reports are required for all studies.
If an asterisk appears in Item 5, EPA has attached
information relevant to this guideline reference number
to the Requirements Status and Registrant's Response
Form.
Item 6. This item identifies the code associated with the use
pattern of the pesticide. A brief description of each
code follows:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E • Aquatic non-food outdoor
P Aquatic non-food industrial
•G Aquatic non-food residential
H * Greenhouse food
I Greenhouse non-food crop
J Forestry
K Residential
L indoor food
M , Indoor non-food
H Indoor medical
0 Indoor residential
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Item 7. ,This item identifies the code assigned to the substance
that Bust be used for testing. A brief description of
each code follows:
EF
MP
MP/TGAI
PAI
PAI/M
PAI/PAIRA
PAIRA
PAIRA/M
PAIRA/PM
TEP
TEP %
TIP/MET
TEP/PAI/M
TGAI
TGAI/PAI
TGAI/PAIRA
TGAI/TEP
MET
IMP
DEGR
*
End-Use Product
Manufacturing-Use Product
Manufacturing-Use Product and Technical
Grade Active Ingredient
Pur* Active Ingredient
Pure Active Ingredient and Metabolites
Purs Active ingredient or Pure Active
Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled and
Metabolites
Pure Active Ingredient Radiolabelled and
Plant Metabolites
Typical End-Use Product
Typical End-Use Product, Percent Active
Ingredient Specified
Typical End-Use Product and Metabolites
Typical End-Use Product or pure Active
Ingredient and Metabolites
Technical Grade Active Ingredient
Technical Grade Active Ingredient or
Pure Active Ingredient
Technical Grade Active Ingredient or
Pur* Active Ingredient Radiolabelled
Technical Grade Active Ingredient or
Typical End-Use Product
Metabolites
Impurities
Degradates
See: guideline comment
Itam 8. This item identifies the time frame allowed for
submission of the study or protocol identified in
item 2. The tine frame runs from the date of your
receipt of the Data Call-in Hotice.
Item 9. Enter the appropriate Response Code or Codes to show
how you intend to comply with each data requirement.
Brief descriptions of each code follow. The Data Call-
in Hotice contains a fuller description of each of
these options.
1. (Developing Data) I will conduct a new study and
submit it within the time frames specified in item
8 above. By indicating that I have chosen this
option, I certify that I will' comply with all the
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requirements pertaining to the conditions for
submittal of this study as outlined in the Data
call-in Notice and that I will provide the
protocols and progress reports required in item 5
above.
2. (Agreement to Cost Share) I have entered into an
agreement with one or more registrants to develop
data jointly. By indicating that I have chosen
this option, I certify that I will comply with all
the requirements pertaining to sharing in the cost
of developing data as outlined in the Data Call-In
Notice.
3. (Offer to Cost Share) I have made an offer to
enter into an agreement with one or more
registrants to develop data jointly. I an
submitting a copy of the form "Certification of
Offer to cost Share in.the Development of Data"
that describes this offer/agreement, ly
indicating that I have chosen this option, I
certify that I will comply with all the
requirements pertaining to making an offer to
share in the cost of developing data as outlined
in the Data Call-in Notice.
4. (Submitting Existing Data) I as submitting an
existing study that has never before been
submitted to EPA. By indicating that I have
chosen this option, I certify that this study
meets all the requirements pertaining to the
conditions for submittal of existing data outlined
in the Data Call-In Notice and I have attached the
needed supporting information along with this
response.
5. (Upgrading a Study) I aa submitting or citing data
to upgrade a study that EPA has classified as
partially acceptable and potentially upgradeable.
By indicating that I have chosen this option, I
certify that I have net all the requirements
pertaining to the conditions for submitting or
citing existing data to upgrade a study described
In the Data Call-In Notice. I am indicating on
attached correspondence the Master Record
_ Identification Number (MHID) that EPA has assigned
' to the data that I am citing as veil as the MRID
of .the study I aa attempting to upgrade.
6. (Citing a Study) I am citing an existing study
that has been previously classified by SPA as
acceptable, core, core minimuia, or a study that
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has not yet been reviewed by the Agency. I am
providing the Agency's classification of the
study.
7. (Deleting Uses) I aa attaching an application for
amendnent to my registration deleting the uses for
' which the data are required.
3. (Low Volume/Minor Use Waiver Request) I have read
the statements concerning low volume-minor use
data waivers in the Data Call-in Notice and I
request a low-volume minor use waiver of the data
requirement. I am attaching a detailed
justification to support this waiver request
including, among other things, all information
required to support the request. I understand
that, unless modified by the Agency in writing,
the data requirenent as stated in the Notice
governs.
9. (Request for Waiver of Data) I have read the
statements concerning data waivers other than low-
volume minor-use data waivers in the Data Call-in
Notice and I request a waiver of the data
requirement. I am attaching an identification of
the basis for this waiver and a detailed
justification to support this waiver request. The
justification includes, among other things, all
information required to support the request. I
understand that, unless modified by the Agency in
writing, the data requirement as stated in the
Notice governs.
Item 10. This item must be signed by an authorized
representative of your company. The person signing
must include his/her title, and must initial and date
all other pages of this form.
Item 11. Enter the date of signature.
Item 12. Cnttr the name of the person EPA should contact with
questions regarding your response.
Item 13. Enter the phone number of your company contact.
|j8|^Hg^.yv-^j^-r=^Ta¥#^&efete>i
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i
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DRAFT COPY
Page 1 of 1
United States Environmental Protection Agency
Washington, D,C. 20460
REQUIREMENTS STATUS AMD REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the infornation requested
Use additional sheet(s) if necessary
1. Covpany mm and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Retirement
Hunter
72-2 (a) *
161*1 *
5, Study Title
Invertebrate toxic ity
Hydrolysis
f
2. Cast * and Mane
0169 Streptomycin
Cheat cal f and Name 006310
Streptomycin sulfate
Progress
Reports
1
2
3
6, Use
Pattern
ABCGK
ABCGK
7. Test
Substance
TGAI
TGAI
10, Certification
1 certify that the statements made on this for* and all attachment! are trut, accurate, and conplete
1 *£*"?"*$* th»fs»ny knowingly faUe or ni*leading statement iiay be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
t2. Nane of Company Contact
a.
Fro
12
12
form Approved
OMB Ho. 2070-0107
Approval Expires tZ-31-92
on this fora.
3. Date and Type of DCI
GENERIC
SEP 3 0 1992
TiM
•e
mos.
:• WQSv'K -
9. Registrant
Response
11. Data
13. Phone Mumber
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Page 1 of l
United States Environmental Protection Agency
Washington, D.C. 20460
* COMMENTS FOR GUIDELINE REQUIREMENTS
Case i and Name
0169 Streptomycin
ChMrical f and Mwne
006310 Streptomycin sulfate
GUIDELINE
COMMENT
72-2(a)
161-1
Sufficient non-guideline information is available to perform a preliminary ecological
hazard assessment. However, the data are insufficient to confirm the reported findings,
A new study will be needed to confirm the freshwater invertebrate hazard assessment.
All environmental fate data requirements, except for hydrolysis, are waived. Hydrolysis
data at pH's of 5, 7, and 9 are required.
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**£•
' '
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i
ATTACHMENT D
List of Registrants Receiving the Generic
and Product Specific Data Call-in
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i
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Page 1 of 1
United States Environmental Protection Agency
Washington, D. C. 20460
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Case I and Name: 0169 Streptomycin
Co. Nr. Company Name
Additional Name
Address
City 6 State
Zip
000070 WILBUR-ELLIS COMPANY
000554 A6SCO INC
000618 MERCK i CO INC
001007 PFIZER IMG. - SPECIALTY CHEMICALS
002596 HAITI MOUNTAIN COUP
007401 VOLUNTARY PURCHASING GROUP, INC.
01010? CORN KIT CHEMICAL COMPANY
034704 WILLIAM M. NAHLMIG
054644 SECURITY PMDUCTS COMPANY Of OELAW
060258 NOMMVIA (MISERY COMPANY
AGENT FOR; NEICK t CO INC
AGENT FOR: PIATTE CHEMICAL CO., IN
SOX 164S8
BOX 458
NILLSKXOUCH RD
235 EAST 42NO ST
700 FRANK E. ROOGERS BLVD. SO
P. 0. BOX 460
•OX 410
- MX 667
780! METRO PARKUAY SOX 59084
18331 EAST FOOTHILL BOULEVARD
FRESNO CA
GRABFORKS NO
THREE BRIDGES NJ
NEW YORK NY
HARRISON NJ
•WHAM TX
MCCOOK HE
GREELEY CO
MINNEAPOLIS MM
A2USA CA
93755
58ZOI
08887
1001?
07029
75418
69001
80632
55420
91702
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i
ATTACHMENT E
EPA Acceptance Criteria
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SUBDIVISION D
Guideline Study Title
Series 61 Product Identity and Composition
Series 62 Analysis and Certification of Product Ingredients
Series 63 Physical and Chemical Characteristics
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61 Product Identity and Composition
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Name of technical material tested (include product name and
trade name, if appropriate)
2. Name, nominal concentration, and certified limits (upper and
lower) for each active ingredient and each intentionally-
added inert ingredient
3. Name and upper certified limit for each impurity or each
group of impurities present at :> 0.1% by weight and for
certain toxicologically significant impurities (e.g.,
dioxins, nitrosamines) present at <0.1%
4. .__ Purpose of each active ingredient and each intentionally-
added inert
5. Chemical name from Chemical Abstracts index of Nomenclature
and Chemical Abstracts Service (CAS) Registry Number for each
active ingredient and, if available, for each intentionally-
added inert
6. Molecular, structural, and empirical formulas, molecular
weight or weight range, and any company assigned experimental
or internal code numbers for each active ingredient
7. Description of each beginning material in the manufacturing
process
EPA Registration Number if registered; for other
beginning materials, the following:
Name and address of manufacturer or supplier
Brand name, trade name or commercial designation
Technical specifications or data sheets by which
manufacturer or supplier describes composition,
properties or toxicity
8. Description of manufacturing process
Statement of whether batch or continuous process
Relative amounts of beginning materials and order in
which they are added
Description of equipment
Description of physical conditions (temperature,
pressure, humidity) controlled in each step and the
parameters that are maintained
Statement of whether process involves intended chemical
reactions
**&?
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i
8. (continued)
Flow chart with chemical equations for each intended
chemical reaction
Duration of each step of process
Description of purification procedures
Description of measures taken to assure quality of final
product
9. Discussion of formation of impurities based on established
chemical theory addressing (1) each impurity which may be
present at > 0.1% or was found at > 0.1% by product analyses
and (2) certain toxicologically significant impurities
(see #3)
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61 Product Identity and Composition
GUIDANCE FOR SUMMARIZING STUDIES
The following criteria apply to the technical grade of the active
ingredient being reregistered. Items 1, 2, 3, and 5 can be
satisfied for most registered products by submission of the
Certified Statement of Formula Ingredients Page (EPA Form 8570-4}.
Items 7 and 8 can be satisfied for most technical grade active
ingredients (TGAIs) by submission of a flow chart with chemical
equations for each intended chemical reaction. The flow chart
should include complete chemical structures and names for each
reactant and product of all the reactions.
1. Name of technical material (include product name and trade name,
if appropriate).
2. Description of each active and intentionally-added inert
ingredient, including name, concentration, and certified limits.
3. Name and upper limit for all impurities present at >. 0.1% and
those toxicologically significant impurities present at <0.1%.
4. The purpose of each active and intentionally-added inert
ingredient.
5. Chemical name and Registry Number for each active and
intentionally-added inert ingredient (if available).
6. Molecular, structural, and empirical formulas, molecular weight,
and any experimental or internal code number for each active
ingredient.
7. Description of each beginning material in the manufacturing
process.
8. Description of manufacturing process.
9. Discussion of formation of impurities based on established
chemical theory.
i ;£P. *
»\ - J
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I
62 Analysis and Certification of Product Ingredients
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active
ingredient being reregistered. Use a table to present the
information in items 6, 7, and 8.
Does your study meet the following acceptance criteria?
1. Five or more representative samples (batches in case of
batch process) analyzed for each active ingredient and all
impurities present at v 0.1%
2. Degree of accountability or closure ,> ca 98%
3, Analyses conducted for certain trace toxic impurities at
lower than 0.1% (examples, nitrosamines in the case of
products containing dinitroanilines or containing secondary
or tertiary amines/alkanolamines plus nitrites;
polyhalogenated dibenzodioxins and dibenzofurans) [Note
that in the case of nitrosamines both fresh and stored
samples must be analyzed.]
4, Complete and detailed description of each step in analytical
method used to analyze above samples
5. Statement of precision and accuracy of analytical method
used to analyze above samples
6. Identities and quantities (including mean and standard
deviation) provided for each analyzed ingredient
7. Upper and lower certified limits proposed for each active
ingredient and intentionally added inert along with
explanation of how the limits were determined
8._ Upper certified limit proposed for each impurity present at
>, 0.1% and for certain toxicologically significant
impurities at
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62 Analysis and Certification of Product Ingredients
GUIDANCE FOR SUMMARIZING STUDIES
The following criteria apply to the technical grade of the active
ingredient being reregistered,
1. Number of representative samples analyzed for all active
ingredients and all impurities at > 0.1%.
2. Degree of accountability or closure in analyses in item #1,
3. Chemical names of toxic impurities which were analyzed for
levels <0.1%.
4. Brief description(s) of analytical method(s) used to measure
active ingredients and impurities in items #1 and #3.
5. Statement of precision and accuracy of method(s) in item #4.
6. Chemical name and quantities observed (range, mean, standard
deviation) for each ingredient (actives and impurities)
analyzed in item #1.
7. Proposed upper and lower certified limits for each active
• ingredient and intentionally added inert with brief explanation
of how limits were determined.
8. Proposed upper certified limit for each impurity present at
>*0.1% and certain toxicologically significant impurities at
<0.1% with brief explanation of how limits were determined.
9. Brief description of analytical method(s) used to verify
certified limits (if same methods as item #4, may reference
latter).
10. Statement of precision and accuracy of method(s) in item #9
(may reference item f5 if applicable).
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63 Physical and Chemical Characteristics
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active
ingredient being reregistered,
Does your study meet the following acceptance criteria?
63-2 Color
Verbal description of coloration (or lack of it)
Any intentional' coloration also reported in terms of
Munsell color system
63-3 Physical State
Verbal description of physical state provided using terms
such as "solid, granular, volatile liquid"
Based on visual inspection at about 20-25° C
63-4 Odor
Verbal description of odor (or lack of it) using terms
such as "garlic-like, characteristic of aromatic
compounds"
Observed at room temperature
63-5 Melting Point
Reported in C°
Any observed decomposition reported
63-6 Boiling Point
. Reported in C°
Pressure under which B.P. measured reported
Any observed decomposition reported
63-7 Density, Bulk Density, Specific Gravity
Measured at about 20-25° c
Density of technical grade active ingredient reported in
g/jnl or the specific gravity of liquids reported with
reference to water at 20° C. [Notes Bulk density of
registered products may be reported in Ibs/ft or
Ibs/gallon.]
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i
63-8 Solubility
Determined in distilled water and representative polar and
non-polar solvents, including those used in formulations
and analytical methods for the pesticide
Measured at about 20-25" C
Reported in g/100 ml (other units like ppm acceptable if
sparingly soluble)
63-9 Vapor Pressure
Measured at 25° C (or calculated by extrapolation from
measurements made at higher temperature if pressure too
low to measure at 25° C)
Experimental procedure described
_ Reported in mm Hg (torr) or other conventional units
63-10 Dissociation Constant
Experimental method described
Temperature of measurement specified (preferably
about 20 - 25° C)
63-11 Octanol/water Partition Coefficient
Measured at about 20-25* C
Experimentally determined and description of procedure
provided (preferred method-45 Fed. Register 77350)
Data supporting reported value provided
63-12 pH
Measured at about 20 - 25° C
Measured following dilution or dispersion in distilled
water
63-13 Stability
Sensitivity to metal ions and metal determined
Stability at normal and elevated temperatures
Sensitivity to sunlight determined
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63 Physical and Chemical Characteristics
GUIDANCE FOR SUMMARIZING STUDIES
The following criteria apply to the technical grade of the active
ingredient being reregistered.
1. Description of color.
2. Description of physical state.
3. Description of odor.
4. Indication of melting point (in C°).
5. Indication of boiling point (in C°).
6. Indication of density, bulk density, and specific gravity.
7. Indication of solubility.
8. Indication of vapor pressure.
9. Indication of dissociation constant.
10. Indication of octanol/water partition coefficient.
11. Indication of PH.
12. Description of stability.
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SUBDIVISION F
Guideline Study.Tittle
81-1 " Acute Oral Toxicity in the Rat
81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
81-3 Acute Inhalation Toxicity in the Rat
81-4 Primary Eye Irritation in the Rabbit
81-5 Primary Dermal Irritation study
81-6 Dermal Sensitization in the Guinea Pig
81-7 Acute Neurotoxicity in the Hen
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i
81-1 Acute Oral Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1, Identify material tested (technical, end-use product, etc)
2. At least 5 young adult rats/sex/group
3. Dosing, single oral may be administered over 24 hrs.
4.j* Vehicle control if other than water.
5. Doses tested, sufficient to determine a toxicity category
or a limit dose (5000 mg/kg).
6V Individual observations at least once a day.
7. Observation period to last at least 14 days, or until all
test animals appear normal whichever is longer.
8. Individual daily observations.
9. Individual body weights.
10. Gross necropsy on all animals.
Criteria marked with a * are supplemental and may not be required
for every study.
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i
81-1 Acute Oral Toxieity in the Rat
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g. solid, liquid, percent
AI in technical, end-use product, etc.
2, The number of animals/dose/sex tested.
3* Dosing route and regimen.
4. Vehicle used
5. Doses tested and results
6. Individual observations on day of dosing and for at
least 14 days.
7. Summarization of body weights
8. Summarization of gross necropsy
9; Significance of changes from the Acceptance Criteria
*
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i
81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc)
2. At least 5 animals/sex/group
3.*, Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-
450 gm.
4._ Dosing, single dermal.
5. Dosing duration at least 24 hours.
6.*, Vehicle control, only if toxicity of vehicle is unknown.
7. Doses tested, sufficient to determine a toxicity category
or a limit dose (2000 mg/kg).
8. Application site clipped or shaved at least 24 hours
before dosing
9. Application site at least 10% of body surface area.
10. Application site covered with a porous nonirritating cover
to retain test material and to prevent ijngestion.
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
Criteria marked with a * are supplemental and may not be required
for every study.
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81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. The number of animals/sex/dose
3. Weight range of animals
4. Verification of single, dermal exposure
5. Duration of dermal exposure
6. Statement of vehicle control
7. Doses tested and results
8. Preparation of application site
9. Area of application site (percent body surface)
10. Occlusion of test material on application site
11. Individual, observations on day of dosing and for at
least 14 days or until all animals appear normal (whichever is
longer).
12. Summarization of body weights
13. Summarization of gross necropsy
14. Significance of changes from Acceptance Criteria
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81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc)
2, Product is a gas, a solid which may produce a significant
vapor hazard based on toxicity and expected use or contains
particles of inhalable size for man (aerodynamic diameter
IS urn or less).
3. At least 5 young adult rats/sex/group
4. Dosing, at least 4 hours by inhalation.
5. Chamber air flow dynamic, at least 10 air changes/hour, at
least 19% oxygen content.
6. Chamber temperature, 22° C (±2), relative humidity 40-60%.
7. Monitor rate of air flow
8. Monitor actual concentrations of test material in breathing
zone.
9. Monitor aerodynamic particle size for aerosols.
10. Doses tested, sufficient to determine a toxicity category
or a limit dose (5 mg/L actual concentration of respirable
substance).
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13, Individual body weights.
14. Gross necropsy on all animals.
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81-3 Acute Inhalation Toxicity in the Rat
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. Statement of the inhalability of test substance
3. The number of animals/sex/dose
4. Duration of inhalation exposure
5-. Number of chamber air changes/hour and the percent oxygen
content of chamber air
6. Ranges for chamber air temperature and relative humidity
7. Air flow rate
8. Analytical concentrations of test material in breathing zone
.9. Results of aerosol particle-size determination
10. Doses tested (or limit dose of 5mg/L or highest attainable)
11. Individual observations on day of dosing and for at least 14
days,
12. Summarization of body weights
13. Summarization of gross necropsy
14. Significance of changes from Acceptance Criteria
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81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc)
2. Study not required if material is corrosive, causes severe
dermal irritation or has a pH of < 2 or >. 11.5.
3. 6 adult rabbits
4. Dosing, instillation into the conjunctival sac of one eye
per animal.
5.. Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if
a solid, paste or particulate substance.
6. Solid or granular test material ground to a fine dust.
7. Eyes not washed for at least 24 hours.
8. Eyes examined and graded for irritation before dosing and
at l, 24, 48 and 72 hr, then daily until eyes are normal or
21 days (whichever is shorter).
9.i individual daily observations.
Criteria narked with a * are supplemental and may not be required
for every study.
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i
81-4 Primary Eye Irritation in the Rabbit
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid, liquid, percent Al
in technical, end-use product, etc.
2. State if material is corrosive, cause severe dermal irritation
or has a pH of <2 or >11.5
3. Number of adult rabbits tested
4. State method of dosing, i.e., instillation into the
conjunctival sac of one eye per animal
5. Dose administered - "
6. Note whether solid or granular test material has been ground to
a fine dust
7. State whether eyes were washed and at what tine post
instillation (not less than 24 hours)
8. State whether eyes were examined and graded for irritation
before dosing and at what periods after dosing
9. Individual daily observations afterwards, until eyes are normal
or for 21 days
10. Significance of changes from Acceptance Criteria
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81-5 Primary Dermal Irritation Study
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested {technical, end-use product, etc)
2. Study not required if material is corrosive or has a
pH of <2 or >, 11.5.
3. 6 adult animals.
4, Dosing, single dermal.
5. Dosing duration-4 hours.
6. Application site shaved or clipped at least 24 hours prior
to dosing
7. Application site approximately 6 cm.
8. Application site covered with a gauze patch held in place
with nonirritating tape
9. Material removed, washed with water, without trauma to
application site
10. Application site examined and graded for irritation at I,
24, 48 and 72 hr, then daily until normal or 14 days
{whichever is shorter).
11.i Individual daily observations.
Criteria marked with a * are supplemental and may not be required
for every study.
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81-5 Primary Dermal Irritation Study
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. State if material is corrosive, has a pH <2 or >11.5, or has a
dermal LD 50 <200 mg/kg
3. Number of adult animals tested
4. Amount applied
5. Duration of dermal exposure
6. Preparation of application site (shaved or clipped at specified
time before dosing)
7. Area of application site
8. Method for occlusion of application site
9. Note removal of test material and if skin was washed with water
10. State times post application when site was graded for
irritation
11. Individual observations for day of dosing and individual
daily observations thereafter
12, Significance of changes from Acceptance Criteria.
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81-6 Dermal Sensitization in the Guinea Pig
ACCEPTANCE CRITERIA
dose your study meet the following acceptance criteria?
I. Identify material tested (technical, end-use product, etc)
2. Study not required if material is corrosive or has a
pH of '<2 or > 11.5.
3.' _ One of the following methods is utilized;
Freund's complete adjuvant test
Guinea pig maximization test
Split adjuvant technique
Buehler test
Open epicutaneous test
Mauer optimization test
Footpad technique in guinea pig
4. Complete description of test
5.j* Reference for test.
6. Test followed essentially as described in reference
document.
7. Positive control included (may provide historical data
conducted within the last 6 months)
Criteria marked with a * are supplemental and ttay not be required
for every study.
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i
81-6 Dermal Sensitization in the Guinea Pig
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc,
2. State if material is corrosive or has pH <2 or >n.5.
3. State specific method utilized
4. Complete description of specific method
5. Reference for the specific method employed
6. Note adherence of the protocol to that in the reference for
the specific method utilized
7, State the positive control tested
8. Significance of changes from Acceptance Criteria
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(
81-7 Acute Neurotoxicity in the Hen
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Study performed on an organophosphate cholinesterase
inhibiting compound.
2. Technical form of the active ingredient tested.
3..* Positive control utilized.
4.___ Species utilized, domestic laying hen 8-14 months of age.
5. Dosing oral by gavage or capsule (dermal or inhalation
may be used).
6. An acute oral LD is determined.
7. Dose tested equal to an acute oral LD or a limit test of
5000 mg/kg.
8.*, Dosed animals may be protected with atropine and/or 2-
PAM.
Sufficient test animals so that at least 6 survive.
Negative (vehicle) control group of at least 6 hens
Positive control of at least 4 hens, (if used)
Test dose repeated if no signs of delayed neurotoxicity
observed by 21 days after dosing.
Observation period 21 days after each dose.
Individual daily observations.
Individual body weights.
Individual necropsy not required.
Histopathology performed on all animals. Tissue to be
fixed in sin preferably using whole animal perfusion
techniques. At least three sections of each of the
following tissues:
_brain, including medulla oblongata
"spinal cord; upper cervical, mid-thoracic and
"lumbro-sacral regions
jtibial nerve; proximal regions and branches
'sciatic nerve
criteria marked with a * are supplemental and nay not be required
for every study.
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I
ATTACHMENT F
Generic Data Call-In Cost Share and Data Compensation Forms
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&EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Farm Approved
OMB No. 2070-01 Of
Approval Eiplftt 12-31.92
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project {2070-0106}, Washington. DC 20503.
Please fill in blanks below.
Company Name
Company Number
Chemical Name
EPA Chemical Number
1 Certify that:
My company is wilting to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodentteide Act (F1FRA), if necessary. However, my company would prefer to
enter Into an agreement with one or more registrants to develop jointly or share in the cost of developing
data-
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3{c){2)(B)(iii5 of FIFRA if final agreement on ail
terms could not be reached otherwise. This offer was made to the following firm{s) on the following
date(s):
Nam* el
Oil* of Offer
Certification:
I certify that I am duty authorized to represent the company named above, and that the statements tnat I have made on
this form and ail attachments therein are true, accurate, and complete. I acknowledge that any knowingly {*J*«
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r/EPA
United statta Environmental
Washington, DC
CERTIFICATION WITH
DATA COMPENSATION
Protection Agency
20410
RESPECT TO
REQUIREMENTS
Form Approved
OH• No. 3070.01 Of
Approval Eip!r»» 12-31-9J
Public reporting burden for this collection of Information is estimated io average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please nil In blanks below.
Company Nam*
Chemical Mam*
Company Numbar
EPA CiMmlcal Numb«f
I Certify that
t. For each study cited in support of registration or registration under the Federal Insecticide, Fungicide and
Rodenticde Act (FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the
written permission of the original data submitter to cite thai study.
2. That for each study cried in support of registration or reregistratton under FIFRA that is NOT an exclusive use
study, I am the original data submitter, or I have obtained the written permission of the original data submitter, or I
have notified in wrting the cornpanyfjes) that submitted data I have cited and have offered to: (a) Pay
compensation for those data in accordance with sections 3(c)(i)(D) and 3(c)(2)(D) of FIFRA; and (b) Commence
negotiation to determine which data are subject to the compensation requirement of FIFRA and the amount of
compensation due, tf any. The companies I have notified are; (check one}
11 AD companies on the data submitters' fist for the active ingredient listed on this form (Cite-All
Method or Cite-All Option under the Selective Method). (Also sign the General Offer to Pay
below.)
[ 1 The companies who have submitted the studies Us ted on the back of ihis form or attached
sheets, or indicated on the attached 'Requirements Status and Registrants' Response Form,"
3. That 1 have previously compiled wfth section 3(c)(1)(D) of FIFRA for the studies 1 have dted In support of
registration or rtmgistration under FIFRA.
j Sif nature
!
Oat*
Man* and TUla (Ptaaa* Type «r Mni)
j
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the
registration or ^registration of my products, to the extent required by FIFRA sections 3(e)(1)(D) and 3(c)(2)(0).
Signature
Oat*
Name and Till* (Pitas* Typ* at Print)
SPA fetm 1179*31 (4-M)
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APPENDIX G
Product Specific Data Call-in
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UNFTEO STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, O.C. 204M
•no*"
DATA CAIX-IN NOTICE
SE
CERTIFIED MAIL tUtSTANCCS
crp q n 100^ anise &
OC.r O U Iw^ P«TlCOii*ND TOXIC
Dear Sir or Madam:
This Notice requires you and other registrant* of pesticide
products containing the active ingredient identified in
Attachment A of this Notice, the Data Call-in gh.enjLcjal-JJtfttHf ' '
Sheet. to submit certain product specific data as noted herein to
the U.S. Environmental Protection Agency (EPA, the Agency).
These data are necessary to maintain the continued registration
of your product(s) containing this active ingredient. Within 90
days after you receive this Notice you must respond as set forth
in Section III below. Your response must state:
1. How you will comply with the requirements set forth in
this Notice and its Attachments A through G; or
2. Why you believe you are exempt from the requirements
listed in this Notice and in Attachment C,
Ijpguj^ements Status and. gecis^rant's, R-esponse Fern, (see
section III-B)} or
3. Why you believe EPA should not require your submission
of product specific data in the Banner specified by this
Notice (see section III-D).
If you do not respond to this Notice, or if you do not
satisfy EPA that you vill comply with its requirements or should
be exempt or excused from doing so, then the registration of your
product(s) subject to this Notice will be subject to suspension.
We have provided a list of all of your products subject to this
Notice in Attachment B, pata Call-in Response Fora, as veil as a
list of all registrants who vere sent this Notice (Attachment 7).
The authority for this Notice is section 3(c)(2)(B) of the
Federal Insecticide, Fungicide and Rodsntieide Act as amended
(FIFRA), 7 U.S.C. section 136a(c)(2)(1). Collection of this
information is authorized under the Paperwork Reduction Act by
OKB Approval No. 2070-0107 (expiration date 12-31-92).
ftfrurf on iHtcra*? P«t»f
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This Notice is divided into six •actions and seven
Attachments, The Notice itself contains information and
instructions applicable to all Data Call-In Notices. The
Attachments contain specific chemical information and
instructions. The six sections of the Notice are:
Section I - Why You Axe Receiving This Notice
Section II - Data Required ly This Notice
Section III - Compliance With Requirements Of This
Notice
Section IV - Consequences Of Failure To Comply With
This Notice
Section V - Registrants' Obligation To Report
Possible Unreasonable Adverse Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
- A - Data Call-In Chemical ....... Status ..... §he e^
B - Qa^.,. Call -In Response form
C - R.equiremep^.8 jSfratus and Regjs.t.r, a.nt ' s ....... Respensf fora
D - EPA grouping of Jind-Ose.- Products,.-. for Meeting Acute
- Toxicoogy Data Reuirements ,„
E - EPJy Acceptance ....... Criteria
F ~ Ljst of Registrants Reeeiyi^f^Thif . Notice
G - Cost ......... Share and Data Compensation Forms. and product
Spied f ic _J>ata_ _Re.pQ.rt__ fgra
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
. The Agency has reviewed existing data for this active
ingredient and reevaluated the data needed to support continued
registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product
specific data. No additional generic data requirements are being
imposed. You have been sent this Notice because you have
product (s) containing the subject active Ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The product specific data required by this Notice are
specified in Attachment Cf Requirements Sj:atu.s_ ........ and Re-qls-tr^anVj
Response Fora. Depending on the results of the studies required in
this Notice, additional testing may be required.
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II""B- SCHEDUU YQf, SUBMISSION OF PATA
You arc required to submit the data or otherwise satisfy the
data requirements specified in Attachment C, Requirements Status
and_ Registrant's Responsejperm. vithin the timeframes provided.
II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in
accordance with test standards outlined in the Pesticide Assessment
Guidelines for those studies- for which guidelines have been
established.
These EPA Guidelines 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 (40 CFR f 1S8.70). When
using the OECD protocols, they should be modified as appropriate so
that the data generated by the study vill satisfy the requirements
of 40 CFR f 15S. Normally, the Agency vill not extend deadlines
for complying with data requirements vhen the studies vere not
conducted in accordance with acceptable standards. The OECD
protocols are available from OECD, 1750 Pennsylvania Avenue N.W,,
Washington, D.C. 20006.
- All new studies and proposed protocols submitted in response
to this Data Call-In Notice must be in accordance with Good
Laboratory Practices [40 CFR Part 160.3(a)(6)].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3feimfB^ NOTICES '
ISSUED By THE AGENCY
Unless otherwise noted herein, thif Data Call-in, do,es i>ot in
any., vav supersede or change the __requirement s_ of any previous Data
Call-Inj[si r or any other agreements entered into with the Agency
pertaining to such prior Notice. Registrants must comply with the
requirements of all Notices to avoid issuance of a Notice of Intent
to Suspend their affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTSOFTHJS NOTICE
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice
for product specific data Bust be submitted to the Agency vithin 90
days after your receipt of this Notice. Failure to adequately
respond to this Notice vithin 90 days of your receipt vill be a
basis for issuing a,Notice of Intent to Suspend (NOIS) affecting
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your products. This and other bases for issuance of HOIS due to
failure to comply with this Notice are presented in Section IV-A "
and IV-B.
III-B. OPTIONS FORRESPONDING TO THE AGENCY
The options for responding to this Notice for product specific
data are: (a) voluntary cancellation, (b) agree to satisfy the
product specific data requirements imposed by this Notice or (c)
request a data waiver (s) . ,. .• -
»" *
A discussion of how to respond if you choose the Voluntary
Cancellation option is presented below. A discussion of the
- various options available for satisfying the product specific data
requirements of this Notice is contained in Section III-C. A
discussion of options relating to requests for data waivers is
contained in Section III-D.
There are two forms that accompany this Notice of which,
depending upon your response, one or both must be used in your
response to the Agency. These forms are the Dat.a-CaJ.l-In gegponse
ESXM, and the Requirements $$_a£us_ and_ Jjecfistrant' s Response Tpr?n.
Attachment B and Attachment C. The Data Call-In Response,. jfqrn must
be submitted as part of every response to this Notice. In
addition, one copy of the Requirements Status and Recris.tr.ant;'s
Respons_e_Fgrn_ must be submitted for each product listed on the
Bafea^QaJ.l-In Respqnse Form unless the voluntary cancellation option
is selected or unless the product is identical to another (refer to
the instructions for completing 'the Data Call-^n Stspojise. Form in
Attachment B). Please note that the company's authorized
representative is required to sign the first page of the Qaty .CalI-
yn' Response Fort| and Requirements ?.^q,.ti|an,and_ Regjs^ra.nt '.s_ pesfiionse
J&BB (if this form is required) and initial any subsequent pages.
The forms contain separate detailed instructions on the response
options. Do not alter the printed material. If you have questions
or need assistance in preparing your response, call or write the
contact person(s) identified in Attachment A.
*
1. Voluntary Cancellation - You may avoid the requirements of
this Notice by requesting voluntary cancellation of your product(s)
containing the active ingredient that is the subject of this
Notice. If you wish to voluntarily cancel your product, you must
submit a completed pafra,, Ca^l-In Response Fprpr indicating your
election of this option. Voluntary cancellation is item number 5
on the pa.fcj.jga}4-lp Response Form. If you choose this option, this
is the only form that you are required to complete.
If you choose to voluntarily cancel your product, further sale
and distribution of your product after the effective date of
cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-c.
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2. Satisfying the; _P_rodjj[ct ..... Specific Data Requirements of th|a
Notice . There are various options available to satisfy the product
specific data requirements of this Notice. These options are
discussed in Section III-C of this Notice and comprise options 1
through 6 on the Requirements „ Sfrafcus_.and ^Bejristrant* s Response
and item .numbers 7a and 7b on the pata __CaJ.l«»ln_ Response Form.
Deletion of a use(s) and the low volume/minor use option are not
valid options for fulfilling product specific data requirements.
3. He.gues_t ..... f Qr -f**°^ugt Specif jg ........ Pfftp Wajyerf. Waivers for
product specific data are discussed in Section III-D of this Notice
and are covered by option 7 on the Requirements Status and
pea i s t ran t ' s Response Forp . If you choose this option, you must
submit both forms as veil as any other information/data pertaining
to the option chosen to address the data requirement.
IIJ-C SATJTS_FV_ING THIS DATA R^QtgRggNTS jQF^.THIS
If you acknowledge on the Data Call-in Response Form that you
agree to satisfy the product specific data requirements (i.e. you
select option 7a or 7b) , then you must select one of the six ~
options on the Requirements Status and Registrant's RepppflPfi Fora
related to data production for each data requirement. Your option
selection should be entered under item number 9, "Registrant
Response." . The six options related to data production are the
first six options discussed under item 9 in the instructions for
completing the Requirements Status and Registrant ' s Response Form.
These six options are listed immediately below with information in
parentheses to guide registrants to additional instructions
provided in this Section. The options are:
(1). I will generate and submit data within the specified
time frame (Developing Data)
(2) I have entered into an agreement with one or more
registrants to develop data jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been
submitted previously to the Agency by anyone (Submitting
an Existing Study)
(5) I am submitting or citing data to upgrade a study
classified by EPA as partially acceptable and upgradeable
(Upgrading a Study)
(6) I am citing an existing study that EPA has classified as
acceptable or an existing study that has been submitted
but not reviewed by the Agency (Citing an Existing Study)
Option .1. Developing Data — . If you choose to develop the
required data it must be in conformance with Agency deadlines and
with other Agency requirements as referenced herein and in the
attachments. All data generated and submitted must comply with the
Good Laboratory Practice (GUP) rule (40 CFR Part 160) , be conducted
according to the Pesticide Assessment Guidelines (PAG) , and be in
conformance with the requirement* of PR notice 86-5.
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The time frames in the Requirements Status and
Response Fora are the time frames that the Agency is allowing for
the submission of completed study reports. The noted deadlines run
from the date of the receipt of this Notice by the registrant. It
the data are not submitted by the deadline, each registrant is
subject to receipt of a Notice of Intent to Suspend the affected
registration (s) .
Zf you cannot submit the data/reports to the Agency in the time
required by this Notice and intend to seek additional time to meet
the requirements (s ) , you must submit a request to the Agency which
includes: (1) a detailed description of the expected difficulty and
(2) a proposed schedule including alternative dates for meeting
such requirements on a step-by-step basis. You must explain any
technical or laboratory difficulties and provide documentation from
the laboratory performing the testing. While EPA is considering
your request, the original deadline remains. The Agency vill
respond to your request in writing. If EPA does not grant your
request, the original deadline remains.' Normally, extensions can
be r«quested only in cases of extraordinary testing problems beyond
the expectation or control of the registrant. Extensions vill not
be given in submitting the 90-day responses. Extensions vill not
be considered if the request for extension is not made in a timely
fashion; in no event shall an extension request be considered if it
is submitted at or after the lapse of the subject deadline.
Ogtion 2__t Aerree_ .......... to; Share in Cost to. Develop Data —Registrants
may onl,y choose this option for acute toxicity data and certain
efficacy data apd only if EPA has indicated in the attached data
tables that your product and at least one other product are similar
for purposes of depending on the same data. If this is the case,
data may be generated for just one of the products in the group.
The registry |.g_n nUIBfrgr of the product for which data Mill b*
submitted must be noted in the agreement to cost share by the
registrant selecting this option. Zf you choose to enter into an
agreement to share in the cost of producing the required data but
vill not be submitting the data yourself, you oust provide the name
of the registrant arho vill be submitting the data. You aust also
provide EPA with documentary evidence that an agreement has been
formed. Such evidence may be your letter offering to join in an
agreement and the other registrant's acceptance of your offer, or a
written statement by the parties that an agreement exists. The
agreement to produce the data need not specify all of the terms of
the final arrangement between the parties or' the mechanism to
resolve the terms. Section 3(c)(2)(B) provides that if the parties
cannot resolve the terms of the agreement they may resolve their
differences through binding arbitration.
Option 3. Offer to Share in the Cost o.^ Data Development —
This option only applies to acute toxicity and certain efficacy
data as described in option 2 above. If you have made an offer to
pay in an attempt to enter into an agreement or amend an existing
agreement to meet the requirements of this* Notice and have been
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unsuccessful, you may request EPA (by •electing this option) to
exercise its discretion not to suspend your registration ( s) ,
although you do not comply with the data submission requirements of
this Notice. EPA has determined that as a general policy, absent
other relevant considerations, it vill not suspend the registration
of a product of a registrant who has in good faith sought and
continues to seek to enter into a joint data development/cost
sharing program, but the other registrant(s) developing the data
has refused to accept your offer. To qualify for this option, you
must submit documentation to the Agency proving that you have made
an offer to another registrant (vho has an obligation to submit
data) to share in the burden of developing that data. You Bust
also submit to the Agency a completed EPA Form 8570-32,
Certification of Offer to Cost Share in the Development of Data,
Attachment C. In addition, you must demonstrate that the other
registrant to whom the offer vas made has not accepted your offer
to enter into a costsharing agreement by including a copy of your
offer -and proof of the other registrant's receipt of that offer
(such as a certified mail receipt). Your offer must, in addition
to anything else, offer to share in the burden of producing the.
data upon terms to be agreed or failing agreement to be bound by
binding arbitration as provided by FZFRA section 3(c) (2) (B) (iii)
and must not qualify this offer. The other registrant must also
inform EPA of its election of an option to develop and submit the
data required by this Notice by submitting a Dafra Call-in Response
fqntt and a Requirements Status and ^Registrant's Response Fppn
committing to develop and submit the data required by this Notice ,
In order for you to avoid suspension under this option, you may
not withdraw your offer to share in the burdens of developing the
data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice. If the other registrant fails to develop the data or for
some other reason is subject to suspension, your registration as
veil as that of the other registrant vill normally be subject to
initiation of suspension proceedings, unless you commit to submit,
and do submit the required data in the specified tine frame. In
such cases, 'the Agency generally vill not grant a time extension
for submitting the data.
Option 4 , gu^bmi,ttino' an gxJtSt^ng Study — • If you choose to
submit an existing study in response to this Notice, you must
determine that the study satisfies the requirements imposed by this
Notice. You nay only submit a study that has not been previously
submitted to the Agency or previously cited by anyone. Existing
studies are studies vhich predate issuance of this Notice. Do not
use this option if you are submitting data to upgrade a study. (See
Option 5) .
You should be avare that If the Agency determines that the
study is not acceptable, the Agency vill require you to comply vith
this Notice, normally vithout an extension of the required date of
submission. The Agency may determine at any time that a study is
.not valid and needs to be repeated.
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To meet the requirements of the DCI Notice for submitting an
existing study, all of the following thr««..criteria must be clearly
met:
a. You must certify at the time that the existing study is
submitted that the rav data and specimens from the study are
available for audit and review and you must identify vhere they
are available. This must be done in accordance with
the requirements of the Good Laboratory Practice (GLF)
regulation, 40 CFR Part 160. As stated in 40 CFR 160.3(j)
* '[r]aw data1 means any laboratory worksheets, records,
memoranda, notes, or exact copies thereof, that are the result
of original observations and activities of a study and are
necessary for the reconstruction and evaluation of the report
of that study. In the event that exact transcripts of raw data
have been prepared (e.g., tapes which have been transcribed
verbatim, dated, and verified accurate by signature), the exact
copy or exact transcript may be substituted for the original
source as raw data. 'Maw data1 may include photographs,
microfilm or microfiche copies, computer printouts, magnetic
media, including dictated observations, and recorded data from
automated instruments." The term "specimens", according to 40
CFR 160.3(k), means "any material derived from a test system
for examination or analysis."
b. Health and safety studies completed after May 1984 must also
contain all GLP-required quality assurance and quality control
information, pursuant to the requirements of 40 CFR Part 160.
Registrants must also certify at the time of submitting the
existing study that such CLP information is available for post-
May 1984 studies by including an appropriate statement on or
attached to the study signed by an authorized official or
representative of the registrant.
c. You must certify that each study fulfills the acceptance
criteria for the Guideline relevant to the study provided in
the FIFRA Accelerated Reregistration Phase 3 Technical Guidance
and that the study has been conducted according to the
Pesticide Assessment Guidelines (PAG) or meets the purpose of
the PAG (both available from NTTS). A study not conducted
according to the PAG may be submitted to the Agency for
consideration if the registrant believes that the study clearly
meets the purpose of the PAG. The registrant is referred to 40
CFR 158.70 which states the Agency's policy regarding
acceptable protocols. If you wish to submit the study, you
must, in addition to certifying that the purposes of the PAG
are met by the study, clearly articulate the rationale why you
believe the study meets the purpose of the PAG, including
copies of any supporting information or data. It has been the
Agency's experience that studies completed prior to January
1970 rarely satisfied the purpose of the PAG and that necessary
rav data are usually not available for such studies.
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If you submit an existing study, you Bust certify that th*
study meets all requirements of the criteria outlined above.
Zf you know of a study pertaining to any requirement in this
Notice which does not Beet the criteria outlined above but does
contain factual information regarding unreasonable adverse effects,
you must notify the Agency of such a study. Zf such study is in
the Agency's files, you need only cite it along with the
notification. If not in the Agency's files, you aust submit a
summary and copies as required by PR Notice 86*5.
Option 5. Pleading a _ study — If a study has been classified
as partially acceptable and upgradeable, you may submit data to
upgrade that study. The Agency will review the data submitted and
determine if the requirement is satisfied. Zf the Agency decides
the requirement is not satisfied, you may still be required to
submit new data normally without any time extension. Deficient,
but upgradeable studies will normally be classified as
supplemental. However, it is important to note that not all
studies classified as supplemental are upgradeable. Zf you have
questions regarding the classification of a study or whether a
study aay be upgraded, call or write the contact person listed in
Attachment A* If you submit data to upgrade an existing study you
must satisfy or supply information to correct all deficiencies in
the study identified by EPA. You must provide a clearly
articulated rationale of how the deficiencies have been remedied or
corrected and why the study should be rated as acceptable to EPA.
Your submission aust also specify the KRJD number (s) of the study
which you are attempting to upgrade and aust be in conformance with
PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a
study classified as unacceptable and determined by the Agency as
not capable of being upgraded.
This option should also be used to cite data that has been
previously submitted to upgrade a study, but has not yet been
reviewed by the Agency. You aust provide the MRID number of the
data submission as veil as the KRID number of the study being
upgraded.
The criteria for submitting an existing study, as specified in
Option 4 above, apply to all data submissions intended to upgrade
studies. Additionally your submission of data intended to upgrade
studies aust be accompanied by a certification that you eoaply with
each of those criteria as veil as a certification regarding
protocol compliance with Agency requirements.
Option 6. Citing Existing Studies —If you choose to cite a
study that has been previously submitted to EPA, that study must
have been previously classified by EPA as acceptable or it aust be
a study which has not yet been reviewed by £he Agency. Acceptable
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toxicology studies generally vill have been classified as "core-
guideline" or "core minimum.* For all other disciplines the
classification would be "acceptable." With respect to any studies
for which you wish to select this option you must provide the MRID
number of the study you are citing and, if the study has been
reviewed by the Agency! you must provide the Agency's
classification of the study.
If you are citing a study of which you are not the original
data submitter, you must submit a completed copy of EPA Fora
S570-31, Certification with 'Respect to ....... pa£a ....... poqpensfttipn
Requirements .
Registrants who select one of the above 6 options must meet all
of the requirements described in the instructions for completing
the Dajfra ....... Call-In Response Form and the Requirements Status and
Registrant's Response Form, as appropriate.
III-D REOOESTS FOR DATA WAIVERS
If you request a waiver for product specific data because you
believe it is inappropriate, you must attach a complete
justification for the request, including technical reasons, data
and references to relevant EPA regulations, guidelines or policies.
(Note: any supplemental data must be submitted in the format
required by PR Notice 86-5) . This will be the only opportunity to
state the reasons or provide information in support of your
request. If the Agency approves your waiver request, you will not
be required to supply the data pursuant to section 3(c) (2) (B) of
FIFRA. If the Agency denies your waiver request, you must choose
an option for meeting the data requirements of this Notice within
30 days of the receipt of the Agency's decision. You must indicate
and submit the option chosen on the Requirements Status and
Registrant ' s Responf e Form. Product specific data requirements for
product chemistry, acute toxicity and efficacy (where appropriate)
are required for all products and the Agency will grant a vaiver
only under extraordinary circumstances. You should Also be aware
that submitting a vaiver request will nqt> automatically extend the
due date for the study in question. Waiver requests submitted
without adequate supporting rationale will be denied and the
original due date will remain in force.
IV. CONSEOPENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products
subject to this Notice due to failure by a registrant to comply
with the requirements of this Data Call-In Notice, pursuant to
FIFRA section 3(c) (2) (B) . Events which may be the basis for
issuance of ft Notice of Intent to Suspend include, but are not
limited to, the following:
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1. Failure to respond as required by this Notice within so
days of your receipt of this Kotic*.
2. Failure to submit on the required schedule an acceptable
proposed or final protocol if such is required to be submitted
to the Agency for reviev.
3. Failure to submit on the required schedule an adequate
progress report on a study if required by this notice.
4 . Failure to submit on the required schedule acceptable
data as required by this Notice.
5. Failure to taJce a required action or submit adequate
information pertaining to any option chosen to address the data
requirements (e.g., any required action or information
pertaining to submission or citation of existing studies or
offers, arrangements, or 'arbitration on the sharing of costs or
the formation of Task Forces, failure to comply with the terms
of an agreement or arbitration concerning Joint data
development or failure to comply with any terms of a data
waiver) .
6. Failure to submit supportable certifications as to the
conditions of submitted studies, as required by Section III-C
of this Notice.
7. Withdrawal of an offer to share in the cost of developing
required data.
8. Failure of the registrant to whom you have tendered an offer
to share in the cost of developing data and provided proof of
the registrant's receipt of such offer either to:
a. Inform EPA of intent to develop and submit the data
required by this Notice on a Data Call -In Response Form and a
Requirements gta,frus .......... and Registrant's Raspons^ Fora;
b. Fulfill the commitment to develop and submit the data as
required by this Notice; or
c. Otherwise take appropriate steps to meet the requirements
stated in this Notice, unless you commit to submit and do
submit the required data in the specified time frame.
i. Failure to take any required or appropriate steps, not
mentioned above, at any time following the issuance of this
Notice.
ZV-B*. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
The Agency nay determine that a study (even if submitted within
the required time) is unacceptable and constitutes a basis for
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issuance of a Notice of Zntent to Suspend. Th* grounds for
suspension include, but are not limited to, failure to meet any of
the fol loving:
1. SPA requirements specified in the Data Call-in Notice or
other documents incorporated by reference (including, as
applicable, EPA Pesticide Assessment Guidelines, Data Reporting
Guidelines, and GeneTox Health Effects Test Guidelines)
regarding the design, conduct, and reporting of required
studies. Such requirements include, but are not limited to,
- those relating to test material, test procedures, selection of
species, number of animals, sex and distribution of animals,
dose and effect levels to be tested or attained, duration of
test, and, as applicable. Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols (if
applicable), including the incorporation of any changes
required by the Agency following review.
3. 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 86*5. All studies must be submitted
in the fora of a final report; a preliminary report will not be
considered to fulfill the submission requirement. * .
ZV-C EXISTING g TQCyS OF SUSPENDED OR CAN CEfrtrfi?
EPA has statutory authority to permit continued sale,
distribution and use of existing stocks of a pesticide product
which has been suspended or cancelled if doing so would be
consistent with the purposes of the Act.
The Agency has determined that such disposition by registrants
of existing stocks for a suspended registration when a section
3(c)(2)(B) data request is outstanding would generally not be
consistent with the Act's purposes. Accordingly, the Agency
anticipates granting registrants permission to sell, distribute, or
use existing stocks of suspended product (s) only in exceptional
circumstances. Zf you believe such disposition of existing stocks
of your product (s) which nay be suspended for failure to comply
with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be
consistent with the Act. You must also explain 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, distribution, and use. Unless you meet this burden
the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after
suspension.
Zf you request* a voluntary cancellation of your product(s) as a
response to this Notice and your product is in full compliance with
-------
13
all Agency requirements, you vill have, under most circumstances,
on* year from the data your 90 day response to this Notice is due,
to sell, distribute, or use existing stocks. Normally, the Agency
vill allow persons other than the registrant such as independent
distributors, retailers and end users to sell, distribute or use
such existing stocks until the stocks are exhausted. Any sale,
distribution or use of stocks of voluntarily cancelled products
containing an active ingredient for which the Agency has particular
risk concerns will be determined on a case-by-case basis.
Requests for voluntary .cancellation received afJfeej: the 90 day
response period required by .this Notice will not result in the
Agency granting any additional tine to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was
due unless you demonstrate to the Agency that you are in full
compliance with all Agency requirements, including the requirements
of this Notice. For example, if you decide to voluntarily cancel
your registration six months before a 3 year study is scheduled to
be submitted, all progress reports and other information necessary
to establish that you have been conducting the study in an
acceptable and good faith manner must have been submitted to the
Agency, before EPA will consider granting an existing stocks
provision.
SECTION V. REGISTRANT'S ' QgLIGATION TO REPORT PQSSTBT.E
VERSE EFFEC
Registrants are reminded that FIFRA section 6 (a) (2) states that
if at any time after a pesticide is registered a registrant has
additional factual information regarding unreasonable adverse
effects on the environment by the pesticide, the registrant shall
submit the information to the Agency. Registrants must notify the
Agency of any factual information they have, from whatever source,
including but not limited to interim or preliminary results of
studies, regarding unreasonable adverse effects on man or the
environment. This requirement continues as long as the products
are registered by the Agency..
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and
procedures established by this Notice, call the contact person (s)
listed in Attachment A, the Data Call-in Chemical status sheet.
All responses to this Notice (other than voluntary cancellation
requests) must include a completed Data Call-In Response Fora and a
completed Requirements status and Registrant's Response Fora
(Attachment B and Attachment C) and any other documents required by
this Notice, and should be submitted to the contact person (s)
identified in Attachment A. If the voluntary cancellation option is
chosen, only the patfr Call-In Response Form need be submitted.
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I
14
Th» Office of Compliance Monitoring (OCM) of the Offic» of
Pesticides and Toxic Substances (OPTS), EPA, will be monitoring the
data being generated in response to this Notice.
Sincerely yours,
A -
B -
C -
D -
I -
G -.-
Daniel M. Barolo, Director
./-•''Special Review and
Reregistration Division
Attachments
DataCall-In Chemical Status Sheet
Data Call-In Response forq
Requirements Status and Registrant'sResponseform
EPA Grouping of End-Use Products for Meeting Acute
ToxicologyData Requirements for Reregistration
EPA Aeeep^anc.e Criteria
.of_RfgisJ;rants Receiving This.. Notice
and Product
S^are an<3 . Da_ta_ Compensation formsj,
Specific Data ReportForm
-------
ATTACHMENT A
Product Specific Chemical Status Sheet
-------
ATTACHMENT A
STREPTOMYCIN: PRODUCT SPECIFIC DATA CALL-IN CHEMICAL STATUS
SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have products
containing streptomycin.
This Product Specific Data Call-In Chemical Status, Sheet- contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of
streptomycin. This attachment is to be used in conjunction with (1) the Product Specific Data
Call-In Notice, (2) the Product Specific Data Call-In Response Form (Attachment B), (3) the
Requirements Status and Registrant's Form (Attachment C), (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirements for Reregistration (Attachment D)
(5) a list of registrants receiving this DCI (Attachment E), (6) the Cost Share and Data
Compensation Forms in replying to this Streptomycin Product Specific Data Call-In (Attachment
F). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the product specific database for
streptomycin are contained in the Requirements Status and Registrant's Response. (Attachment
C). The Agency has concluded that additional data on streptomycin are needed for specific
products. While product specific data requirements were imposed in the 1988 Registration
Standard, a complete listing is provided in Attachment C, If you, as a registrant of a
streptomycin product, responded to the 1988 Registration Standard and submitted the data
relating to your specific product, simply choose response number 6 and cite the MRID number
that was assigned to your study. Otherwise, these data are required to be submitted to the
Agency within the timeframe listed. These data are needed to fully complete the reregistration
of all eligible streptomycin products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic data requirements of streptomycin, please
contact Theresa A. Stowe at (703) 308 - 8043,
If you have any questions regarding the product specific data requirements and pro-
cedures established by this Notice, please contact Benjamin C. Chambliss (703) 305 - 7382.
-------
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Susan J. Lewis, Product Manager 21
Herbicide and Fungicide Branch
Registration Division (H7505C)
Office of Pesticide Programs
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460
RE: STREPTOMYCIN
-------
-------
i
ATTACHMENT B
Product Specific Data Call-In Response Forms (Form A) plus Instructions
£f
-------
-------
i
INSTRUCTIONS FOR COMPLETING THE "DATA CALL-IN RESPONSE" FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. If you wish to voluntarily cancel your product, answer
"yes.11 If you choose this option, you will not have to
provide the data required by the Data Call-In Notice and
you will not have to complete any other forms. Further
sale and distribution of your product after the effective
date of cancellation must be in accordance with the
Existing Stocks provision of the Data Call-In Notice
(Section IV-C).
Item 6. Not applicable since this form calls in product specific
data only. However, if your product is identical to
another product and you qualify for a data exemption, you
must respond with "yes" to Item 7a (MUP) or 7B (EUP) on
this form, provide the EPA registration numbers of your
source(s); you would not complete the "Requirements
Status and Registrant's Response" form. Examples of such
products include repackaged products and Special Local
Needs {Section 24c> products which are identical to
federally registered products.
Item 7a. For each manufacturing use product (MUP) for which you
wish to maintain registration, you must agree to satisfy
the data requirements by responding "yes."
Item 7b. For each end use product (EUP) for which you wish to
maintain registration, you must agree to satisfy the data
requirements by responding "yes." If you are requesting
a data waiver, answer "yes" here; in addition, on the
"Requirements Status and Registrant's Response" form
under Item 9, you must respond with option 7 (Waiver
Request) for each study for which you are requesting a
waiver. See Item 6 with regard to identical products and
data exemptions.
Items 8-11. Self-explanatory.
HOTS: You may provide additional information that does not fit
on this form in a signed letter that accompanies this
form. For example, you may wish to report that your
product has already been transferred to another company
or that you have already voluntarily cancelled this
product. For these cases, please supply all relevant
details so that EPA can ensure that its records are
correct.
-------
I
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA
Item 1-3 Completed by EPA. Note the unique identifier number
assigned by EPA in Item 3. This number must be used in
the transmittal document for any data submissions in
response to this Data Call-In Notice.
Item 4. The guideline reference numbers of studies required to
support the product's continued registration are
identified. These guidelines, in addition to the
- requirements specified in the Notice, govern the conduct
of the required studies. Note that series 61 and 62 in
product chemistry are now listed under 40 CFR 158.155
through 158.180, Subpart C,
Item 5. The study title associated with the guideline reference
number is identified.
Item 6. The use pattern(s) of the pesticide associated with the
product specific requirements is (are) identified. For
most product specific data requirements, all use patterns
are covered by the data requirements. In the case of
efficacy data, the required studies only pertain to
products which have the use sites and/or pests indicated.
Item 7. The substance to be tested is identified by EPA. For
product specific data, the product as formulated for sale
and distribution is the test substance, except in rare
cases.
Item 8, The due date for submission of each study is identified.
It is normally based on 8 months after issuance of the
Eeregistration Eligibility Document unless EPA determines
that a longer time period is necessary.
Item 9. Enter only one of tbe following response codes for each
data requirement to show how you intend to comply with
the data requirements listed in this table. Fuller
descriptions of each option are contained in the Data
Call-in Notice.
1. I will generate and submit data by the specified due date
(Developing Data). By indicating that I have chosen this
option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal
of this study as outlined in the Data Call-in Notice.
2. I have entered into an agreement with one or more
registrants to develop data jointly (Cost Sharing). I am
submitting a copy of this agreement. I understand that
this option is available only for acute toxicity or
certain efficacy data and only if EPA indicates in an
attachment to this Notice that my product is similar
-------
enough to another product to qualify for this option. I
certify that another party in the agreement is committing
to submit or provide the required data? if the required
study is not submitted on time, my product nay be subject
to suspension.
3. I have made offers to share in the cost to develop data
(Offers to Cost Share) . I understand that this option is
available only for acute toxicity or certain efficacy
data and only if EPA indicates in an attachment to this
Data Call-in Notice that my product is similar enough to
another product to qualify for this option. I am
submitting evidence that I have made an offor to another
registrant (who has an obligation to submit data) to
share in the cost of that data. I am also submitting a
completed "Certification of Offer to Cost Scare in the
Development Data" form. I am including a copy of my
offer and proof of the other registrant's receipt of that
offer. I am identifying the party which is committing to
submit or provide the required data; if the required
study is not submitted on time, my product may be subject
to suspension. I understand that other terms under
Option 3 in the Data Call-in Notice (Section III-C.l.)
apply as well.
4. By the specified due date, I will submit an existing
study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study). I
certify that this study will meet all the. requirements
for submittal of existing data outlined in Option 4 in
the Data Call-in Notice (Section III-C.l.) and will meet
the attached acceptance criteria (for acute toxicity and
product chemistry data). I will attach the needed
supporting information along with this response. I also
certify that I have determined that this study will fill
the data requirement for which I have indicated this
choice.
5. By the specified due date, I will submit or cite data to
upgrade a study classified by the Agency as partially
acceptable and upgradable (Upgrading a Study). I will
submit evidence of the Agency's review indicating that
the study may be upgraded and what information is
required to do so. I will provide the MRID or Accession
number of the study at the due date. I understand that
the conditions for this option outlined Option 5 in the
Data Call-in Notice (Section III-C.l.) apply.
6. By the specified due date, I will cite an existing study
that the Agency has classified as acceptable or an
existing study that has been submitted.but not reviewed
by the Agency (Citing an Existing study). If I am citing
another registrant's study, I understand that this option
is available only for acute toxicity or certain efficacy
-------
data and only if the cited study was conducted on my
product, an identical product or a product which EPA has
"grouped" with one or more other products for purposes of
depending on the sane data. I may also choose this
option if I am citing my own data. In either case, I
will provide the KRID or Accession number (a) for the
cited data on a "Product Specific Data Report" form or in
a similar format. If I cite another registrant's data,
I will submit a completed "Certification With Respect To
Data Compensation Requirements11, fora.
7. , I request a waiver for this study because it is
inappropriate for my product (Waiver Request). I am
attaching a complete justification for this request,
including technical reasons, data and references to
relevant EPA regulations, guidelines or policies. [Note:
any supplemental data must be submitted in the format
required by P.R. Notice 86-5], I understand that this is
my only opportunity to state the reasons or provide
information in support of my request. If the Agency
approves my waiver request, I will not be required to
supply the data pursuant to Section 3(c)(2)(B) of FIFRA.
If the Agency denies my waiver request, I must choose a
method of meeting the data requirements of this Notice by
the due date stated by this Notice. In this case, I
must, within 30 days of my receipt of the Agency's
written decision, submit a revised "Requirements Status
and Registrant's Response" Form indicating the option
chosen. I also understand that the deadline for
submission of data as specified by the original data
call-in notice will not change.
Items 10-13. Self-explanatory.
NOTE; You may provide additional information that does not fit
on this form in a signed letter that accompanies this
form. For example, you may wish to report that your
product has already been transferred to another company
or that you have already voluntarily cancelled this
product. For these cases, please supply all relevant
details so that EPA can ensure that its records are
correct.
-------
DRAFT COPY
Page 1 o
United States Environmental Protection Agency
Washington, D. C. 20460
DATA CALL-IN RESPONSE
For* Approved
OMB Ho. 2070-010?
Approval Expire* 12
INSTRUCTIONS: Please type or print in Ink. Please read carefully the attached instructions and supply the information requested on this font.
Use additional sheet(s) If necessary.
1. Company name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case • and Nine
0169 Streptomycin
S. Date and Type of DC!
PRODUCT SPECIFIC
SEP 3 0 1992
4. KPA Product
Registration
S. t wish to
cancel this
product regis-
tration volun-
tarily.
6. Generic Data
6a. I a* claiming a Generic
Data Exemption because I
obtain the active Ingredient
from the source EPA regis-
tration nu*er listed belou.
6fa. I agree to satisfy Generic
Data requirements a* indicated
on the attached fora entitled
"Requirements Status and
Registrant's Response.*
J, Product Specific Data
fa. Hy product fa a HUP and
I agree to satisfy the HUP
requirements on the attached
for* entitled "Requirements
Status and Registrant's
Response.*
7b. My product is an 1
1 agree to satisfy tfa
requirement• on the •'
form entitled "Requiri
Status and Registrant'
Response.*
NNNNNN-NNNNN
N.A.
N.A.
8. Certification
I certify that the statement* nada on this form and all attachmenta are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement mty be punishable by fine, imprisonment
or both under applicable IBM.
Signature and Title of Company's Authorised Representative
9. Date
10. Name of Company Contact
11. Phone NMfcer
-------
#v
-------
ATTACHMENT C
Product Specific Data Call-in Requirements Status and
Registrant's Response Forms (Form B) plus Instructions
-------
-------
I
INSTRUCTIONS FOR COMPLETING TH1 "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE" FORM FOR PRODUCT 8P1CZFZC DATA
Item 1-3 Completed by EPA. Not* the aaitue identifier auabar
assigned by EPA in Item 3. This number must be used in
the traasmittal document for aay data. submissions in
response to this Data Call-in Notic*.
Item 4. Thm guideline reference numbers of studies required to
support the product's continued registration are
identified. These guidelines, in addition to the
- requirements specified in the Notice, govern the conduct
' of the required studies. Note that series 61 and 62 in
product chemistry are now listed under 40 CFR 158.155
through 158.180, Subpart C.
Item 5. The study title associated with the guideline reference
number is identified.
• •'•»*
Itea f. The use pattern(s) of the pesticide associated with the
product specific requirements is (are) Identified. For
most product specific data requirements, all use patterns
are covered by the data requirements. In the case of
efficacy data, the required studies only pertain to
products which have the use sites and/or pests indicated.
Item 7. The substance to be tested is identified by EPA. For
product specific data, the product as formulated for sale
and distribution is the test substance, except in rare
cases.
Itea 8. The due date for submission of each study is identified.
It is normally based on 8 months after issuance of the
Reregistration Eligibility Document unless EPA determines
that a longer time period is necessary.
Item 9. Eater only one of the following response codes foreach
data requirement to show how you intend to comply with
the data requirements listed in this table. Fuller
descriptions of each option are contained in the Data
Call-in Notice.
* "•
1. .1 will generate and submit data by the specified due date
(Developing Data}. By indicating that I have chosen this
option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal
of this study as outlined in the Data Call-In Notice.
2. I have entered into an agreement with one or more
registrants to develop data jointly (Cost Sharing). I am
submitting a copy of this agreement. X understand that
this option is available only for acute toxicity or
certain efficacy data and only if EPA Indicates in an
attachment to this Notice that my product is similar
-------
enough to another product to qualify for this option. I
certify that another party in the agreement is committing
to submit or provide the required data; if the required
•tudy is not submitted on tine, ay product nay be subject
to suspension.
3. I have made offers to share in the cost to develop data
(Offers to Cost Share). I understand that this option is
available only for acute toxicity or certain efficacy
data and only if EPA indicates in an attachment to this
Data Call-in Notice that ay product is similar enough to
another product to qualify .for this option. I am
submitting evidence that Z have Bade an offer to another
registrant (who has 'an obligation to submit data) to
share in the cost of that data. Z am also submitting a
completed "Certification of Offer to Cost Share in the
Development Data** form. Z am including a copy of my
offer and proof of the other registrant's receipt of that
offer. Z am identifying the party which is committing to
submit or provide the required data; if the required
study is not submitted on time, my product may be subject
to suspension. Z understand that other terms under
Option 3 in the Data Call-in Notice (Section III-C.l.)
apply as veil.
4. By the specified due date, Z will submit an existing
study that has not been submitted previously to the
Agency by anyone (Submitting aa Existing Study). z
certify that this study will meet all the. requirements
for submittal of existing data outlined in Option 4 in
the Data Call-in Notice (Section III-C.l.) and will meet
the attached acceptance criteria (for acute toxicity and
product chemistry data). Z will attach the needed
supporting information along with 'this response. Z also
certify that Z have determined that this study will fill
the data requirement for which Z have indicated this
choice.
5. ly the specified due date, Z will submit or cite data to
upgrade a study classified by the Agency as partially
acceptable and upgradable (Upgrading a Study). z will
submit evidence of the Agency's review indicating that
the study may be upgraded and what information is
required to do so. Z will provide the KRZD or Accession
number of the study at the due date. Z understand that
the conditions for this option outlined option 5 in the
Data Call-in Notice (Section III-C.l.) apply.
6. By the specified due date, Z will cite an existing study
that the Agency has classified as acceptable or an
existing study that has been submitted.but not reviewed
by the Agency (Citing an existing Study). If I am citing
another registrant's study, Z understand that this option
is available only for acute toxicity or certain efficacy
-------
data and only if the cited study vac conducted on my
product, an Identical product or a product which EPA has
"grouped** with one or more other products for purposes of
depending on the same data. I nay also choose this
option if I an citing my own data. In either case, I
will provide the KRID or Accession number(s) for the
cited data on a "Product Specific Data Report" form or in
a similar format. If I cite another registrant's data,
I vill submit a completed "Certification With Respect To
Data Compensation Requirements" form,
7. . I request a waiver for this study because it is
inappropriate for ay product (Waiver Bequest). Z am
attaching a complete justification for this request,
including technical reasons, data and references to
relevant EPA regulations, guidelines or policies. [Note:
any supplemental data must be. submitted in the format
required by P.R. Notice 86-53. * understand that this is
my only opportunity to state the reasons or provide
information in support of my request. If the Agency
approves my vaiver request, I vill not be required to
supply the data pursuant to Section 3(c)(2)(B) of FIFRA.
If the Agency denies my vaiver request, I must choose a
method of meeting the data requirements of this Notice by
the due date stated by this Notice. In this case, I
must, vithin 30 days of my receipt of the Agency's
written decision, submit a revised "Requirements Status
and Registrant's Response" Form indicating the option
chosen. I also understand that the deadline for
submission of data as specified by the original data
call-in notice vill not change.
Items 10-13. Self-explanatory.
KOTE: You may provide additional information that does not fit
on this form in a signed letter that .accompanies this
form. For example, you may wish to report that your
product has already been transferred to another company
or that you have already voluntarily cancelled this
product. For these cases, please supply all relevant
details so that EPA can ensure that its records are
cdrrect.
-------
i
-------
DRAFT COPY
Page 1 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: pleas* type or print In Ink. Picas* read, carefully the attached instructions and supply the Information requested
lit* additional She*t(s) If necessary.
1. Company naae and Address . * 2. Case i and Nam*
SAMPLE COMPANY 0169 Streptomycin
NO STREET ADDRESS
NO CITY, XX 00000 EPA Reg. No. NNNNNN-NNNNN
4. Guideline
Requirement
iuabw
61-1
61-2 (a)
61-2 (b)
62~3.ir.' '"..~."i
63-7~7rl "T"
63-14"": " "" ™
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63-16
S. Study Title
prod] CN*mi ™ p£vlar dieancaj^
Product Identity ft compos It1on(1)
Descrlp of starting s»t*H*U,(1,2)
production ft formulation
' proe
Plscuasfon of formation of (1,3)
Preliminary analysts (1,4)
Analytical Method (1)
'"Density
M^^M9iSMml?MK lll^l^iPIi'
Oxldltlni or reducing action (10)
EiptodablKty (12)
f
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Reports
1
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2
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3
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6. Us*
Pattern
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ABCDEFGHIJKLMNO
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ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
7. Test
Substance
Form Approved
CHI Mo. M70-0107
Approval Expire* 12-31-92
on this fora.
3. Pat* and Type of PCI
PRODUCT SPECIFIC
IDf NNNNNN-PD-NNNN
SEP 3 0 1992
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10. Certification 11.
I certify that the statements amde on this fan and all sttechments are true, accurate, and complete.
I acknowledge that any knowingly false or aHe leading statement may b* punlshabla by f Int. Imprisonment
or both under applicable law.
Signature and Title of Company 'a Author! ted •eprasentatfv*
1i. Nmme of Company Contact 13.
8. Tia»
Frame
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Phone Number
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DRAFT COPY
Page 2 of
United states Environmental Protection Agency For* Approved
Washington, D. C. 20460
OM No. 2070-0107
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE . , .
, Approval Expire* 12-31-'
iNSTRUCTIONS: Hease type or print In Ink. Please read carefully
Us* additional sheet (s) If necessary.
1. Coapany naaa and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
•equlreacnt
•uafcer
63*17
63-18
63-19
63-20
.'••''
81-1
81-2
81-3
81-4
81-S
81-6
S. Study Title
Storage stability (38)
Viscosity (13)
Klsclblllty 1141
Corrosion characteristics
Acute Toxic - tegular Chemical
the attached instructions and supply the Information requested on this font.
2. Case f and Naac
0169 Streptomycin
3. Oat* and Type of DC I
PRODUCT SPECIFIC
IDf NNNNNN-RD-NNNN
EPA Reg. No. NNNNNN-NNNNN
Acute oral toxlclty-rat (1,36.37)
Atute denest . <1,2,3f)
to* iclty- rabbit/rat
: Acute Inhalation to*tcl ty-r*t (1)
Prlaary eye Irritation-rabbit (2)
»rl«sry denes I Irritation (1,1)
Deraal sensltlzatton (4)
1
|
f
Progress
Reports
1
2
3
6. Use
Pattern
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
Initial to Indicate certification as to information on this page
(full text of certification Is on pao* one).
?. Test
Substance
EP
EPfPI?!! illillili:
MP/EP"" """"'"""'"""•
lift
?®!?Zlfif. W KfmffSSfMXt '
:?«w :MSt;*«;1iit.
MP/EP and TGAI
MP/El||an4IlCGAl
laCl5 :/T6fffi''$'Mif&t' ;::;!^|VIIM. ^*
"*/ Jir:-.'.v€WH*i.,vv*.NfaT%A
MP/EP
MP/ER!Illllllliil
MP/EP'"""'""""^""™""^
8. Tlaa
Fraae
l:;5;8-:IIOSi
8 BOS.
||r8;-«os:||-
8 DOS.
yijtijs^^'tS'
S?::iK8Si:;-:®r¥":-?-x-:"?::;.'
'-^SS^r^':''^"'!^'-:^-^'-^^:-''''
8 mos.
. 8 «O»|||
6 »6I-1|
8 BOS.
• ' 8 aosl|
8 DOS,
9. leflifte
•esponW^^
"•fif ; I '' :|||
t • :::-:' '£•'• :•' x-y-vi-
':'$•& ;?: '. - ]&%
''.•$%? ->t«: ;' ' ;"::':.:.y>'
•>-,•;':'. ';':•:' •; -A¥>-:;::"
:$r<:- ;-x- =S >:;XA'::
."'-:•:•> K-l«: x •'- "';-""••;•:":•
?'|S|y :i j|:f
;p;®iliffi
Date
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L
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DRAFT COPY
Page1 of
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES HMD KEY DEFIHATIONS FOR GUIDELINE REQUIREMENTS
Case f and Name: 0169 Streptomycin
Boys M> • •anufacturIng-use product; E* • end-use product; provided fonuletors purchase their active Ingredlent(s) free) e registered source, they need not sutelt or <
dete pertelnlng to the purchased product. (VOTE: If e product Is e 100 percent repack see of another registered product that Is purchased, and any use for the product dt
not differ fras those of the purchased and registered source, user* ere not subject to any dste requi resents Identified In the tables.}; Tt* « typlcel end-use product;
TCAI • technical erode of the active Ingredient; Mi • •pure1' active Ingredient; PAIIA • •pure" active Ingredient, redlolebeted.
ete«wtee Key:
A * Terrestrial food crop • - Terrestrial food feed crop C * Terrestrial nonfood crop V - Aquatic food crop I * Aquatic nonfood outdoor
F • Aquatic nonfood Industrial • * Aquatic nonfood residential • * Greenhouse food crop I - greenhouse nonfood crop J • Forestry f
K - •esldentlet outdoor I - indoor food N - Indoor nonfood • * Indoor Nodical 0 » Indoor res I dent let
Footnotes:
follewlm notes are referenced In colon two (5. Study Title) of tlw KOUHtMHITS STA1US AW DtStSTMHT'S PJEVOKE fora.1
1 •equlraairits pertaining to product Identity, coapoeltlon. analysts, and certl fleet Ion of lnfr«4fantt are detailed further In tlw follonlnj sections: *tM.H5 for
product Identity end composition (61-1); *1SS.1oO, 1SB.162, «nd 158.145 for description of start Inf waterlals and •snufacturini process (41-2); *1Sa.167 for
discussion of fonaatlon of lapurltles (6t-3>; • 158.17X1 for prottalnsry analysis 162-1); MM. 175 for certification of lisilts {62-2}; and *15a.180 for anforceawit
analytical Methods (42-3).
t A oetMMtltf cHapm and/or brief description of tlw production process nil! suffice If tlw pesticide Is not already inter Ml K«l« production and m •xpsrts«Tta(
UM ptraft U being sought.
] If the pesticide Is not already under full scale production and an experimental UM persilt It soupjtt, a discussion of unintentional Infrodlsnts shall to suteltted
tlw extant this InforsMtion Is svsl table.
4 looulrod to support the r»§ I strati on of each sisnufscturina-usa product flncludlnf registered T«ls) M wll M snd-uoe product* produced by an Intsfrsted systo*.
Data on other end-use products will be required on a cese-by-ceee bests. For pesticides In the development state, • rudleentary product analytical swthod and data
Hill suffice to support en experlMtntel use persilt.
S Certified IMts are not required for Inert Ingredients In products proposed for experlaentel use.
9 •.•quired If test substances ere dfapersible with water.
10 Required If product contains en oxidizing or reducing agent.
11 lequlred If product contains cosfcustlMe liquids.
11 ••quired If product Is potentially explosive.
IS lequlred If product la e liquid.
14 ••quired ff product Is an eaulslf (able liquid end Is to be diluted with petroleue solvents.
M MocMfd Stability Data rapt rod for e aifiiBua of 12 saittv at 20 dogma or 25 «fc*jnww C. and If the psdtsne
iaPMMbto, e* eeletii* turtdlty of SM or mbx Merahnuav conditicni Mhidi reflect Urn m^aettd etxnpi
OkwdltJcMBV Ot lle»
In. en Irfwlsbt. ^,.1 Ce. ... ~
^~, -- , ^ *+•*** -
tw^daZiatreted e potontiel to eoVersety effect the visual systssi. teXstrsnte should consult tilth the e-eney for
of protocols
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DRAFT COPY Page 2 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AMD KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case i and Name: 0169 Streptomycin
Footnotes (cont.):
prior to Initiation of etudlee.
37 Tettlng of th* EP dilution It required If It emn be reasonably anticipated that tlw retulti of nidi testing my Htt the criteria for rMtrlctlon to UM by certified
applicator* tpecifled In 40 CFI ISI.ITOfb) or th* criteria for Initiation of ipectai review specified In 40 CFI 154.7 (e)(t).
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fs
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ATTACHMENT D
EPA's Grouping of End-Use Products for Meeting Acute
Toxicology Data Requirements for ReregLstration
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ATTACHMENT D
EPA'S BATCHING OF STREPTOMYCIN AND STREPTOMYCIN SULFATE END-USE
PRODUCTS FOR MEETING ACUTE TOXICITY DATA REQUIREMENTS FOR
REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the
acute toxicity data requirements for reregistration of end-use products containing the active
ingredients streptomycin and streptomycin sulfate, the Agency has batched products which can
be considered similar for purposes of acute toxicity. Factors considered in the sorting process
include each product's active and inert ingredients (identity, percent composition and biological
activity), type of formulation (e.g., emulsifiable concentrate, aerosol, wettable powder, granular,
etc.), and labeling (e.g., signal word, use classification, precautionary labeling, etc.). Note that
the Agency is not describing batched products as "substantially similar" since some products
within a batch may not be considered chemically similar or have identical use patterns.
Batching has been accomplished using the readily available information described above.
Frequently acute toxicity data on individual end-use products has been found to be incomplete.
Notwithstanding the batching process, the Agency reserves the right to require, at any time,
acute toxicity data for an individual end-use product should the need arise.
Registrants of end-use products within a batch may choose to cooperatively generate,
submit or cite a single battery of six acute lexicological studies to represent all the products
within that batch. It is the registrant's option to participate in the process with all the other
registrants, only some of the other registrants, or only their own products within a batch, or to
generate all the required acute lexicological studies for each of their own products. If a
registrant chooses to generate the data for a batch, he/she must use one of the products within
the batch as the test material. If a registrant chooses to rely upon previously submitted acute
toxicity data, he/she may do so provided thai Ihe dala base is complete and valid by today's
standards (see acceptance criteria in Appendix F, Attachment E), the formulation tested is
considered by EPA to be similar for acute toxicity, and the formulation has not been significant-
ly altered since submission and acceptance of the acute toxicity data. Regardless of whether new
data is generated or existing data is referenced, registrants must clearly identify the test material
by EPA Registration Number,
In deciding how to meet the product specific data requirements, registrants must follow
the directions given in the Data Call-In Notice and its attachments appended to the RED, The
DCI Notice contains two response forms which are to be completed and submitted to the Agency
within 90 days of receipt. The first form, "Data Call-In Response", asks whether the registrant
will meet the data requirements for each product. The second form, "Requirements Status and
Registrant's Response", lists the product specific data required for each product, including the
standard six acute toxicity tests. A registrant who wishes to participate in a batch must decide
whether he/she will provide the data or depend on someone else to do so. If a registrant
supplies the data to support a batch of products, he/she must select one of the following options:
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i
Developing Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing
Study (Option 5) or Citing an Existing Study (Option 6). If a registrant depends on another's
data, he/she must choose among: Cost Sharing (Option 2), Offers to Cost Share (Option 3) or
Citing an Existing Study (Option 6). If a registrant does not want to participate in a batch, the
choices are Options 1, 4, 5 or 6. However, a registrant should know that choosing not to
participate in a batch does not preclude other registrants in the batch from citing his/her studies
and offering to cost share (Option 3) those studies.
Table I contains three different batches with each one containing two products.
TABLE I
1
2
3
;-:a:*:::r«;-::i*;:t:Kfe-;i-CvJi:::?ifeSK:f
m^mmm
618-101
34704-577
618-72
34704-425
618-28
56644-31
llllpll^is|i|||
21.20
21.20
62.60
0.30
21.20
21.20
Streptomycin sulfate
Streptomycin sulfate
Streptomycin sulfate
Streptomycin
Streptomycin sulfate
Streptomycin sulfate
pOTMfi
Powder
Powder
Powder
Powder
Powder
Powder
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Ten products (Table II) were either considered not to be similar for purposes of acute
toxicity or the Agency lacked sufficient information for decision making and were not placed
in any batch. Registrants of these products are responsible for meeting the acute toxicity data
requirements for each product.
TABLE O
EPA REG. M>,
70-259
554-108
618-100
2596-41
7401-311
10107-94
10107-98
34704-156
34704-338
34704-675
% ACTIVE ;
21.20
8.00
0.01
62.50
15.00
21.20
7.30
0.01
7.30
0.01
7.33
0.01
0.15
7.33
0.01
ACTIVE INGREDIENTS
Streptomycin sulfate
Maneb
Streptomycin sulfate
Streptomycin sulfate
Streptomycin sulfate
Streptomycin sulfate
Captan
Streptomycin sulfate
Captan
Streptomycin sulfate
Captan
Streptomycin
Streptomycin
Captan
Streptomycin
FORMULATION
Powder
Powder
Powder
Tablet
Powder
Powder
Powder
Powder
Powder
Powder
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ATTACHMENT E
Product Specific Data Call-In
Cost Share and Data Compensation Forms
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r/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
Form Approved
OM§ No. 2070-01 OS
Approval Expires 12-31 -82
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time lor reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please fill in blanks below.
Company Nam*
Product Name
EPA Reg. No,
I Certify that:
1,
For each study cited in support of registration or reregistration under the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) that is an exclusive use study, I am the original data submitter, or 1 have obtained the
written permission of the original data submitter to cite that study.
That for each study cited in support of registration or reregistration under FIFHA that is NOT an exclusive use
study, I am the original data submitter, or l have obtained the written permission of the original data submrtttr, or I
have notrfied in writing the company(ie$S that submitted data I have cited and have offered to: (a) Pay
compensation for those data in accordance with sections 3{c){1)(D) and 3(c)(2){D) of FIFHA; and (b) Commence
negotiation to determine which data are subject to the compensation requirement of FIFRA and the amount of
compensation due, if any. The companies I have notified are:
[ I The companies who have submitted the studies listed on the back of this form or attached
sheets, or indicated on the attached "Requirements Status and Registrants' Response Form,*
3. That I have previously complied with section 3(c)(i)(D) of FIFRA for the stydies I have cited in support of
registration or reregistration under FIFRA.
Sijnalur*
Dtt«
Nam* and TIM* (Pica** Type ar Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the
registration or reregistration of my products, to the txtent required by FIFRA sections 3(C)(1 )(D) and 3(c}(2}(0).
Signature
Dai*
Nim* and Till* (?!*••* Typ* or Print)
EPA Form 1570-31 (4-90)
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i
US Environmental Protection Agency Registration Standard (or:
Washington, DC 20460
&EPA Product Specific
wu t-\ Dgta ReDort
Registration
Guideline No.
Sec. 158.120
Product
Chemistry
Si-1
61-2 fa}
ii-2fb)
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-9
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-ti
63-19
63-20
63-21
Sec, 158,135
Toxicology
81-1
81-2
81-3
81-4
81-3
81-6
Name of Test
Identity of Ingredients
Statement of composition
Discussion of formation of ingredients
Preliminary analysis
Certification of limits
Analytical method* for enforcement limit*
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-density, or specific gravity
Solubility
Vapor pressure
Dissociation constant
Octanol/water partition coefficient
pH
Stability
Oxidizing/reducing reaction
Rammabiiity
Explodability
Storage stability
Viscosity
Miscibility
Corrosion Characteristics
Dielectric breakdown voltage
Acute oral toxicrty, rat
Acute dermal toxictty , rabbit /rat/g.pig
Acute inhalation toxioty, rat
Primary eye irritation, rabbit
Primary dermal irritation
Dermal s»n*rtization
Testing not
required for my
product listed
above
(Chick 6«wwJ
»
EPA Registration Number
I am complying with
Data Requirements by •
Citing MR ID No,
Submitting Data
fAffaefteoV
(Cbtek oetew)
"crm Approved
OMB *2070-QOJ
Expire* 11-30-85
(far EPA Uie
Only)
Accession
numbers
assigned
Certification
I certify that the statements I have made on this form and all attachments thereto are
true, accurate, and complete. I acknowledge that any knowingly false or misleading
statement may be punishable by fine or imprisonment or both under applicable law.
yped Name and Title
Signature
Date
EPA Form 8580-4 (Rev. S-W) Previous edition is obsolete.
m
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I
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r/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
Approval Esplrti 12-31-91
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the OWice
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Pleast fill In blanks balow.
Company Name
Product Name
EPA Reg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all
terms coyld not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Name ef Flrm(»)
Data of Offer
CertHicatkm:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and ail attachments therein are true, accurate, and complete, I acknowledge thai any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company'* Authorized
Date
Name and Title (Please Type or Print)
EPA Form 1570-32
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