United States Prevention, Pesticides EPA 738-R-94-021
Environmental Protection And Toxic Substances September 1994
Agency (7508W)
4>EPA Reregistration
Eligibility Decision (RED)
Disodium
cyanodithioimido-
carbonate (DCDIC)
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1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case and active
ingredient disodium cyanodithioimidocarbonate. The enclosed Reregistration Eligibility
Decision (RED) contains the Agency's evaluation of the data base of this chemical, its
conclusions of the potential human health and environmental risks of the current product uses,
and its decisions and conditions under which these uses and products will be eligible for
reregistration. The RED includes the data and labeling requirements for products for
reregistration. It may also include requirements for additional data (generic) on the active
ingredient to confirm the risk assessments.
To assist you with a proper response, read the enclosed document entitled "Summary
of Instructions for Responding to the RED". This summary also refers to other enclosed
documents which include further instructions. You must follow all instructions and submit
complete and timely responses. The first set of required responses are due 90 days from
the date of this letter. The second set of required responses are due 8 months from the
date of this letter. Complete and timely responses will avoid the Agency taking the
enforcement action of suspension against your products.
If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregistration Division representative
Franklin Gee at (703) 308-8008. Address any questions on required generic data to the
Special Review and Reregistration Division representative Bonnie Adler at 308-8523.
Sincerely yours,
Louis R. True, Acting
Director
Special Review and
Reregistration Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1. DATA CALL-IN (PCI) OR "90-DAY RESPONSE" If generic data are required for
reregistration, a DCI letter will be enclosed describing such data. If product specific data
are required, another DCI letter will be enclosed listing such requirements. If both generic
and product specific data are required, a combined Generic and Product Specific letter will
be enclosed describing such data. Complete the two response forms provided with each DCI
letter (or four forms for the combined) by following the instructions provided. You must
submit the response forms for each product and for each DCI within 90 days of the date
of this letter (RED issuance date); otherwise, your product may be suspended.
2. TIME EXTENSIONS AND DATA WAIVER REQUESTS No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for data waivers must be submitted as part of the
90-day response. Requests for time extensions should be submitted in the 90-day response,
but certainly no later than the 8-month response date. All data waiver and time extension
requests must be accompanied by a full justification. All waivers and time extensions must be
granted by EPA in order to go into effect.
3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE" You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately. You may delete uses
which the RED says are ineligible for reregistration. For further labeling guidance, refer to
the labeling section of the EPA publication "General Information on Applying for Registration
in the U.S., Second Edition, August 1992" (available from the National Technical Information
Service, publication #PB92-221811; telephone number 703-487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's acceptance criteria (attached to the DCI).
d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. 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). A copy of
the CSF is enclosed; follow the instructions on its back.
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e. Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.
4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5. WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS—EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILITY DECISION DISODIUM
CYANODITHIOIMIDOCARBONATE
LISTC
CASE 3065
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
DISODIUM CYANODITHIOIMIDOCARBONATE REREGISTRATION ELIGIBILITY
DECISION TEAM i
EXECUTIVE SUMMARY vi
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Regulatory History 4
III. SCIENCE ASSESSMENT 5
A. Physical Chemistry Assessment 5
B. Human Health Assessment 6
1. Toxicology Assessment 6
a. Acute Toxicity 7
b. Subchronic Toxicity 7
c. Developmental Toxicity 7
d. Mutagenicity 8
2. Exposure Assessment 8
a. Dietary Exposure 8
b. Occupational and Residential 8
3. Risk Assessment 11
a. Dietary 11
b. Occupational 11
C. Environmental Assessment 13
1. Environmental Fate 13
a. Environmental Chemistry, Fate and Transport 13
b. Environmental Fate Assessment 13
2. Ecological Effects 15
a. Ecological Effects Data 15
(1) Terrestrial Data 15
(2) Aquatic Data 15
(3) Non-Target Insects Data 15
(4) Non-Target Plants Data 16
b. Ecological Effects Risk Assessment 16
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 17
A. Determination of Eligibility 17
1. Eligibility Decision 18
2. Eligible and Ineligible Uses 18
B. Regulatory Position 18
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1. Tolerance Reassessment 18
2. Effluent Discharge/Aquatic Risk Rationale 18
3. Endangered Species Statement 20
4. Labeling Rationale 20
V. ACTIONS REQUIRED BY REGISTRANTS 21
A. Manufacturing-Use Products 21
1. Additional Generic Data Requirements 21
2. Labeling Requirements for Manufacturing-Use Products 21
B. End-Use Products 22
1. Additional Product-Specific Data Requirements 22
2. Labeling Requirements for End-Use Products 22
C. Existing Stocks 23
VI. APPENDICES 25
APPENDIX A. Table of Use Patterns Subject to Reregistration 27
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 33
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of Disodium Cyanodithioimidocarbonate 41
APPENDIX D. List of Available Related Documents 49
APPENDIX E 53
PR Notice 86-5 55
PR Notice 91-2 73
APPENDIX F. Generic Data Call-in 79
Attachment 1. Chemical Status Sheet 95
Attachment 2. Generic DCI Response Forms Inserts (Form A) plus
Instructions 99
Attachment 3. Requirements Status and Registrants' Response Forms
Inserts (Form B) plus Instructions 103
Attachment 4. List of Registrant(s) sent this DCI (Insert) 109
APPENDIX G. Product Specific Data Call-in Ill
Attachment 1. Chemical Status Sheet 125
Attachment 2. Product Specific Data Call-in Response Forms (Form A
inserts) Plus Instructions 127
Attachment 3. Product Specific Requirement Status and Registrant's
Response Forms (Form B inserts) and Instructions 133
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 137
Attachment 5. EPA Acceptance Criteria 145
Attachment 6. List of All Registrants Sent This Data Call-in (insert) Notice
159
Attachment 7. Cost Share Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 161
APPENDIX H. FACT SHEET 171
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DISODIUM CYANODITHIOIMIDOCARBONATE REREGISTRATION
ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Rafael Prieto
Phyllis Johnson
Environmental Fate and Effects Division
Mary Frankenberry
Brinson Conerly-Perks
R. David Jones
Norm Cook
Al Vaughan
Health Effects Division
Linda Kutney
Irving Mauer
Winston Dang
Registration Division
Amelia Acierto
Mary Waller
Valdis Goncarovs
Special Review and Reregistration Division
Bonnie Adler
Kathy Davis
Office of Compliance Monitoring
Biological Analysis Branch
Biological Analysis Branch
Science Analysis and Coordination Staff
Environmental Fate and Groundwater Branch
Environmental Fate and Groundwater Branch
Ecological Effects Branch
Ecological Effects Branch
Chemical Coordination Branch
Toxicology Branch I
Occupational and Residential Exposure Branch
Registration Support Branch
Registration Support Branch
Antimicrobial Program Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
Beverly Updike
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Office of General Counsel:
Pesticides and Toxic Substances Division
Kevin Lee Pesticides Branch
Office of Water:
Permits Division
Donna Reed Water Quality and Industrial Permits Branch
11
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GLOSSARY OF TERMS AND ABBREVIATIONS
AE Acid equivalent
a.i. Active Ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CSF Confidential Statement of Formula
DRES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium
specific (i.e. drinking water) lifetime exposure at which adverse, non
carcinogenic health effects are not anticipated to occur.
EEC Estimated Environmental Concentration. The estimated pesticide concentration
in an environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
GLC Gas Liquid Chromatography
GRAS Generally Recognized As Safe as designated by FDA
HA Health Advisory (HA) The HA values are used as informal guidance to
municipalities and other organizations when emergency spills or contamination
situations occur.
HOT Highest Dose Tested
LC50 Median Lethal Concentration. A statistically derived concentration of a
substance that can be expected to cause death in 50% of test animals. It is
111
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GLOSSARY OF TERMS AND ABBREVIATIONS
LD
50
LDlo
LEL
LOG
LOEL
MCLG
MP
MPI
MOE
MRID
N/A
NPDES
NOEL
OPP
PADI
PAM
PPE
usually expressed as the weight of substance per weight or volume of water, air
or feed, e.g., mg/1, mg/kg 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.
Lethal Dose-low. Lowest Dose at which lethality occurs
Lowest Effect Level
Level of Concern
Lowest Observed Effect Level
Maximum Contaminant Level Goal (MCLG) The MCLG is used by the
Agency to regulate contaminants in drinking water under the Safe Drinking
Water Act.
Manufacturing-Use Product
Maximum Permissible Intake
Margin Of Exposure
Master Record Identification (number). EPA's system of recording and
tracking studies submitted.
Not Applicable
National Pollutant Discharge Elimination System
No Observed Effect Level
Office of Pesticide Programs
Provisional Acceptable Daily Intake
Pesticide Analytical Method
Personal Protective Equipment
IV
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GLOSSARY OF TERMS AND ABBREVIATIONS
ppm Parts Per Million
PRN Pesticide Registration Notice
Q*! The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer
Risk Model
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TC Toxic Concentration. The concentration at which a substance produces a toxic
effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TMRC Theoretical Maximum Residue Contribution
TLC Thin Layer Chromatography
WPS Worker Protection Standard
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EXECUTIVE SUMMARY
The U.S. Environmental Protection Agency (hereafter referred to as the
"Agency") has determined that the uses of disodium cyanodithioimidocarbonate
(DCDIC) as currently registered will not cause unreasonable risk to humans or the
environment and these uses are eligible for reregistration. Although there is some
concern about potential effects to aquatic organisms exposed to the effluent resulting
from the industrial use of DCDIC, the Agency concludes that the discharge of effluent
containing residues of DCDIC will not generally cause unreasonable adverse effects on
the environment. The Agency's Office of Pesticide Programs (OPP) and Office of Water
(OW) will share information that will improve the regulation of this biocide's use at
specific sites across the country and will identify any new, unanticipated adverse effects
information that would affect the national registration status of this biocide. The Agency
is requiring confirmatory data on chemistry, hydrolysis, and mutagenicity. Additionally,
the use of personal protective equipment is required to reduce risks of developmental and
acute toxicity for those who handle DCDIC products.
DCDIC is used as an industrial bactericide and slimicide. It is registered for use
in food processing water systems, oil-field systems, cooling water systems, sugar mills
and paper mills and as a formulating technical material.
Before reregistering the products containing DCDIC, the Agency is requiring that
product specific data, revised Confidential Statements of Formula (CSF) and revised
labeling be submitted within eight months of the issuance of this document. These data
include product chemistry for each registration and acute toxicity testing. After
reviewing these data and any revised labels and finding them acceptable in accordance
with Section 3(c)(5) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),
the Agency will reregister a product. 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.
VI
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I. INTRODUCTION
In 1988, FIFRA was amended to accelerate the reregistration of products with
active ingredients registered prior to November 1, 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 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 the scientific data base underlying a pesticide's registration. The purpose of
the Agency's review is to reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for additional data on health and
environmental effects; and to determine whether the pesticide meets the "no
unreasonable adverse effects" criterion of FIFRA.
This document presents the Agency's decision regarding the reregistration
eligibility of the registered uses of DCDIC. The document consists of six sections.
Section I is the introduction. Section II describes DCDIC, 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 presents the
reregistration decision for DCDIC. Section V discusses the reregistration requirements
for DCDIC. Finally, Section VI is the Appendices which support this Reregistration
Eligibility Decision. Additional details concerning the Agency's review of applicable
data are available on request.
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II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Decision:
• Common Name: DCDIC
• Chemical Name: Disodium cyanodithioimidocarbonate
• CAS Registry Number: 138932
• OPP Chemical Code: 63301
• Empirical Formula: C2N2S2Na2
Na+S'\
• Structural Formula: (H^ON
Trade and Other Names: DCDIC
Basic Manufacturer: Buckman Laboratories
B. Use Profile
The following is information on the currently registered uses with an overview
of use sites and application methods. A detailed table of these uses of DCDIC is in
Appendix A.
For disodium cyanodithioimidocarbonate:
Type of Pesticide: Microbicide/microbistat (slime-forming bacteria, algae and
fungi)
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Use Sites:
Aquatic non-food industrial:
Pulp/Paper Mill Water Systems
Air Conditioner/Refrigeration Condensate Water Systems
Air Washer Water Systems
Commercial/Industrial Water Cooling Systems
Evaporative Condenser Water Systems
Secondary Oil Recovery Injection Water
Heat Exchanger Water Systems
Indoor food:
Food Processing Water Systems (cane and beet sugar mills)
Target Pests:
Aquatic non-food industrial:
Green and blue green algae, Spore-forming and non-spore-
forming fungi, Sulfate-reducing bacteria as Desulfovibrio sp.,
Iron bacteria, Oscillatoria sp., Scenedesmus sp., Chlorella sp.
Fragilaria sp., Melosira sp., Lepocinclis sp., Ulothrix sp.,
Slime-forming bacteria, fungi and algae.
Indoor food:
Sucrose-reducing bacteria, Odor-causing bacteria, Slime-
forming bacteria, Leuconostoc mesenteroides and Bacillus
stearothermophilus.
Formulation Types Registered:
Type: End use, Manufacturing use
Form: Soluble concentrate/liquid
Method and Rates of Application:
Types of Treatment -
Water treatment, Water recirculating system treatment.
Equipment -
Measuring container, Metering pump, Drip-feed device, and not
specified.
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Timing -
Shock/slug, Continuous feed (initial), Intermittent (slug) (initial),
Intermittent (slug) (subsequent), and not specified.
Rate of Application -
Aquatic non-food industrial: From less than 1 up to 7 ppm active
ingredient by volume.
Indoor food: From 3 to 4 ppm active ingredient by weight.
Use Practices Limitations:
Higher temperatures (up to about 65° C, or 150° F) and pH values
below 5.5 increase effectiveness. Do not discharge effluent containing this
pesticide into sewage systems without notifying the sewage plant authority. Do
not discharge effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or public water (NPDES license restriction).
C. Regulatory History
Products containing DCDIC as an active ingredient were registered in the
United States as early as 1957 for use as an industrial bactericide and slimicide.
Currently, fifty-seven products are registered for use in food processing water systems,
oil-field systems, cooling water systems, sugar mills and paper mills and as a
formulating technical material. The Agency issued one Data Call-In Notice on
September 30, 1992, under Phase IV of reregistration. Under this DCI the Agency
required data for product chemistry, toxicology, ecological effects, and environmental
fate.
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III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
1. Product Chemistry
DCDIC is a microbicide produced by a purely synthetic process. A
Confidential Statement of Formula and revised label are required as
confirmatory data. The Agency considers this information necessary to confirm
the reregistration eligibility decision put forth in this document. The physical
and chemical properties of the DCDIC technical grade of the active ingredient
are summarized below:
63-2 Color
63-3 Physical State
63-4 Odor
63-6 Boiling Point
63-7 Density
63-8 Solubility
63-9 Vapor Pressure
63-10 Dissociation
Constant
63-11 Octanol/water
Partition
Coefficient
63-12 pH
63-13 Stability
vivid orange/strong orange
transparent liquid @ about 20 °C
pungent, like ammonia
109°C
1.2719 kg/m3 (requires verification
for consistency and be expressed in g/ml)
< 4.2 ppm in acetonitrile
< 82 ppm in octanol
<9.16x 106torr @ ~25°C
<1.89x 105torr @ ~ 35°C
<1.79x 105torr @ ~44°C
Not applicable (non-aq. product)
Not applicable (polar chemical)
13.2
Stable for 14 days under the following conditions:
ambient temperature (23°C); broad spectrum light;
stainless steel, galvanized steel, copper metals and iron
ions. Slight decrease in percent active ingredient
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63-14 Oxidizing and
reducing action
63-15 Flammability
63-16 Explodability
63-17 Storage Stability
63-18 Viscosity
63-20 Corrosion
characteristics
observed when test substance is exposed to zinc ions, with
significant decrease after exposure to elevated
temperatures, aluminum metal, aluminum and
copper ions.
Not applicable (does not contain oxidizing
and reducing agents).
Not applicable (does not contain a combustible liquid).
Not applicable (not potentially explosive).
The concentration of DCDIC decreased by 10.5% after
one year storage at RT as determined by HPLC.
4.179cSt (4.179mm2/s)
No corrosion of packing material
detected after one year.
B. Human Health Assessment
1. Toxicology Assessment
The toxicological data base for DCDIC is adequate and supports
reregistration eligibility. Acute toxicity studies were conducted on the 32% active
ingredient, the only formulation used for testing.
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a. Acute Toxicity
SUMMARY OF ACUTE TOXICOLOGY RESULTS
MRID
41592601
41592602
42952501
NONE
41592603
41592604
GUIDELINE
81-1 Acute Oral
81-2 Acute dermal
81-3 Acute Inhalation
81-4 Eye Irritation*
81-5 Primary dermal
81-6 Skin sensitization
RESULT
LD50 = 268-386 mg/kg
LD50 > 2000 mg/kg
LC50 = 3.02mg/L
Data waived
PII=1.8
Weak sensitizer
CATEGORY
II
III
III
I
II
NA**
* Since the registrant acknowledges that theproduct(s) may be an eye as well as a dermal irritant (Tax. Cat. II),
the Agency has waived data requirements for a primary eye irritation study in rabbits (Guideline 81-4).
* * NA = Not applicable
b. Subchronic Toxicity
Adequate data from a 90-day dermal study (guideline 82-3) are available (MRID
40974801). The test article was applied for 13 weeks to the shaved backs of Sprague-
Dawley rats at doses of 0, 25, 125 or 250 mg/kg/day. Dermal irritation (erythema) was
observed at all doses of DCDIC (i.e., dermal NOEL was less than 25 mg/kg/day), but
systemic effects (reduced absolute and cumulative body weight gain, and food
consumption) were noted only at 125 mg/kg/day and above (i.e. systemic NOEL = 25
mg/kg/day). No gross internal organ effects were observed at any dose.
c. Developmental Toxicity
Adequate data from two oral gavage studies are available. In the first study
(MRID 41009301), rats were dosed with 0, 2, 6 or 18 mg/kg/day. Both maternal (based
on decreased body weight gain at 18 mg/kg/day) and developmental (based on increased
skeletal variants at the same highest dose tested) NOELs were established at the mid-dose,
6 mg/kg/day. Hence there is no definitive determination as to whether the developmental
effects of DCDIC as noted in this study represent a primary (direct fetal) effect, or if the
effects are secondary (indirect) to maternal toxicity.
A similar indeterminate interpretation is obtained from the results of the second
study (MRID 41009401) in which rabbits were dosed with 0, 3, 10 or 30 mg/kg/day. The
NOEL for maternal effects (based upon decreased activity, limb morbidity and deaths at
the mid-dose tested, 10 mg/kg/day) and the NOEL for developmental effects (based upon
increased resorption and decreased litter size at the same mid-dose) were 3 mg/kg/day, the
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lowest dose tested. In addition, the highest dose tested (HDT), 30 mg/kg/day, produced
a 50% increase in the number of does without viable fetuses, and more severe embryo
toxicity, as manifested by decreased live litter size, with a corresponding increase in
resorption and post-implantation loss.
d. Mutagenicity
The following mutagenicity studies were reported with these results. A Gene
Mutation Test (Ames; MRID 40425101) had negative results in Salmonella strains exposed
to toxic concentrations of up to 50-100 (A/ml, with/without activation. The Chromosome
Damage in vitro Study (MRIDs 41177901/40425102) tested positive for inducing sister-
chromatid exchanges in activated (S9) cultures of Chinese hamster cells at non-toxic doses.
The DNA Damage/Repair in vitro Study (MRID 40425103) proved negative for inducing
unscheduled DNA synthesis in primary rat hepatocytes at concentrations producing
cytotoxicity (compromising cell survival).
Although the Agency does not believe that there is a genetic risk, confirmatory data
are required for a mammalian cells in culture forward gene mutation assay, based on the
positive result in the Chromosome Damage in vitro Study. The study is one of the three
mutagenicity tests required under the new guidelines (March, 1991) for Subdivision F,
Series 84 of Part 158. Results of the study will be evaluated to determine whether there
is a potential heritable risk.
2. Exposure Assessment
a. Dietary Exposure
The uses of DCDIC in sugar beet and sugar cane mills are food uses
regulated by FDA as noted in 21 CFR 173.320. A food additive tolerance has been
established. The Agency defers to FDA regarding dietary exposure.
In addition, a food tolerance has been established for DCDIC for food
contact with food grade paper, paperboard (21 CFR 176.300), and adhesives (21 CFR
175.105). These uses are no longer active and are not supported for reregistration.
b. Occupational and Residential
Mixer/loader/applicator Exposure
The application techniques for the soluble concentrate/liquid include metering
pumps and measuring containers (intermittent and continuous feed and slug treatments).
There is potential for mixer/loader/applicator exposure and mixer/loader/applicator
exposure monitoring could be required.
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Data from the Chemical Manufacturers Association (CMA) Antimicrobial
Exposure Study (MRID 41412201) are applicable to the uses of DCDIC. The
antimicrobial exposure study and label usage information were used to estimate exposure
to mixer/loaders.
a). The following information was used for the
exposure assessments:
Use Quantity per Treatment
Secondary Oil 210,000 gallons (1.5 fluid oz.product per 1,000
Recovery Water: gallons)
Pulp/Paper Mills or 10,000 tons (1.6 fluid oz. product per 1,000 tons of
Cane/Beet Sugar Mills: pulp)
Water Cooling Towers: 5,000 gallons (3.0 fluid oz. product per 1,000
gallons of water)
Sample calculation for water cooling tower use:
For 3.0 fluid ounces of end-use product (NM-35-1, containing 14.7% DCDIC
equal to 1.5 Ib. per gallon of NM-35-1) applied to 1,000 gallons of water by metering
pump or open pouring application methods, into a total final volume of 5000 gallons, the
total poundage of a.i. added in each treatment can be expressed as:
3.0oz X 1.5 Ib a.i./gal X 5,000 gal/1,000 gal = 0.1761b.
128 oz/gal
b). Estimates of exposure by pouring and meter pumping
Data from the CMA exposure study are not chemical specific but provide exposure
estimates for certain use scenarios. Exposure values are expressed as "Maximum Credible
Sum" which is considered a reasonable worst-case estimate of an exposure dose for a
single day. In general, workers may be exposed several times a week over the first
several weeks when the water systems are initially charged with the
microbicide/microbistat to control the bacteria, fungi or algae population. Following those
first treatments, to maintain the system, the antimicrobial treatments are generally on non-
consecutive days. Total exposure is estimated at 26 days a year.
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Assumptions:
< Exposure estimates assume protective clothing and equipment was
consistent with that used during the CMA study.
< Dermal and inhalation exposure is combined.
< An individual weighs 60 kg
< Exposure estimate reflects one actual day of exposure.
Table 1. Pour liquid.
POUR LIQUID
Setting
Secondary Oil Recovery Water Injection
Pulp/Paper and Sugar Mills
Water Cooling Towers
MCS*
(ug/lb ai)
130
130
27130
Ibai/
treatment
3.69
0.19
0.18
BW**
(kg)
60
60
60
Daily Exposure***
(ug/kg/day)
8.00
0.40
80.00
MCS = Maximum Credible Sum was derived from CMA Study.
BW = Body Weight
Daily Exposure (ug/kg/day) = (MCS X Ib ai/used) / BW
Table 2. Pump liquid.
PUMP LIQUID
Setting
Secondary Oil Recovery Water Injection
Pulp/Paper and Sugar Mills
Water Cooling Towers
MCS*
(ug/lb ai)
10
10
930
Ibai/
treatment
3.69
0.19
0.18
BW**
(kg)
60
60
60
Daily Exposure***
(ug/kg/day)
0.60
0.03
2.70
* MCS = Maximum Credible Sum was derived from CMA Study.
** BW = Body Weight
*** Daily Exposure (ug/kg/day) = (MCS X Ib ai/used) / BW
Post-application exposure
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Hydrolysis
A study, "Hydrolysis of 14C-DCDIC in Aqueous Solutions Buffered at pH 5,7, and
9," suggests that at pHs 5 and 7, the only significant degradates are thiocyanate (SCN),
with possible amounts of 3-amino-l,2,4-dithiazole-5-thione (thione). At pH 9, SCN ,
thione, and 3-amino-l,2,4-dithiazole-5-oxone (oxone) are all definitely present as
degradates. Although toxic degradates such as hydrogen cyanide (HCN) and cyanide (CN
) were not found under these study conditions, it is possible that under some circumstances
(i.e., higher temperature or pHs) a different degradation pathway would lead to the
formation of HCN and CN".
Based on the hydrolysis study discussed above, post-application worker exposure
to HCN and CN at pulp and paper mills, cane or beet sugar mills is possible. However,
the Agency believes such exposure via dermal or inhalation routes would be minimal.
3. Risk Assessment
a. Dietary
Although DCDIC has food uses (sugar beets and sugar cane), these uses are
under FDA purview (21 CFR 173.320). The Agency defers to FDA regarding
dietary risk assessment.
b. Occupational
Acute oral toxicity is moderately high for DCDIC (toxicity category II) and
acute dermal toxicity is moderate (toxicity category III). Products may also be eye
and dermal irritants (toxicity category II). DCDIC may induce developmental
toxicity in humans, based on developmental studies in rats and rabbits. And, there
is concern for possible heritable effects. Section IV addresses these concerns.
The Agency calculated exposure and risk estimates for developmental
toxicity using data provided by the CM A antimicrobial exposure study. Estimates
of the margins of exposure (MOE) for the three use settings and with the "pour
liquid" and the "pump liquid" techniques are given in Table 3. MOEs are based
on the exposure estimates presented above and a developmental toxicity NOEL of
3 mg/kg/day from the rabbit study, the more sensitive species tested.
11
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Table 3. Margins of exposure.
Setting
Secondary Oil Recovery Water Injection
Pulp, Paper and Sugar Mills
Water Cooling Towers
Margins of Exposure*
Pour Liquid
380
7300
38
Pump Liquid
4,900
94,000
1,100
* Margin of Exposure (MOE) = NOEL/Exposure
All MOE estimates are considered conservative because of the worst-case
assumptions e.g., not all workers were wearing protective clothing and equipment, and
the exposure is assumed to be 100% absorbed. Actual dermal absorption of DCDIC may
be 10% or less according to generally available information on the properties of salts. If
a 10% dermal absorption factor were included in the MOE calculations, all of the MOE
numbers would increase by a factor of 10. With adjustments for risk mitigation measures
(protective clothing and equipment) and the use of a data-derived dermal absorption factor,
the MOEs are expected to be higher than the presently calculated values.
The highest risk (the lowest MOE) appears to result from exposure to workers
during the "open pour" application of DCDIC to cooling tower water. For this exposure
scenario, the MOE is estimated to be 38. Because of the worst-case assumptions described
above, the probable MOE is likely to be higher than 38. Applying a 10% dermal
absorption factor increases the MOE to 380. The MOE for the same worker in the closed
delivery system of "pump liquid" is estimated to be 1100. All other potential worker
exposure involving DCDIC resulted in MOEs of well over 100. Therefore, risk of
developmental toxicity to workers exposed to DCDIC is expected to be low when
appropriate protective equipment and clothing are used.
Mixer/loader/applicator exposure to formulated end-use products for open pouring
uses is expected. Label restrictions for appropriate personal protective equipment
(protective eyewear, chemical resistant gloves, footwear, socks, long-sleeved shirt, long
pants) are required. In addition, because of concern regarding mixer/loader inhalation
exposure to DCDIC and potential DCDIC degradates, a respirator with either an organic-
vapor-removing cartridge with a prefilter approved for pesticides (MSHA/NIOSH
approval number prefix TC-23C), or a canister approved for pesticides (MSHA/NIOSH
approval number prefix TC-14G) is required during open pouring.
Because post-application exposure to DCDIC is likely to be minimal, the potential
risk for developmental toxicity is believed to be negligible. Residential exposure and
potential risk to homeowners are not expected based on the use patterns for DCDIC,
however, additional information concerning the quantification of hydrocyanic acid
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(hydrogen cyanide, or HCN), cyanide (CN"), thiocyanate (SCN"), and all other groups
with the potential to form CN", at the range of pHs for which the DCDIC compounds are
used, is required as confirmatory data.
C. Environmental Assessment
1. Environmental Fate
DCDIC is an industrial biocide used for controlling microbial growth in air washer
systems, industrial water cooling towers, evaporative condensers, heat exchangers, pulp
and paper mills, secondary oil recovery injection water, and sugar mills. For these uses
DCDIC has potential for environmental exposure. Other than these aquatic non-food
industrial uses, all other uses of the chemical are for indoor food processing water
systems, where minimal exposure to the environment is expected.
a. Environmental Chemistry, Fate and Transport
Based on DCDIC's current use patterns, the Agency required only a hydrolysis
study. Results of this study have been discussed above. In summary, DCDIC hydrolyzes
to thiocyanate and SCN, thione, and 3-amino-l,2,4-dithiazole-5-oxone. Because of
possible HCN and/or CN formation under certain circumstances, the Agency is requiring
additional data to confirm this. With the exception of the final report on hydrolysis, there
are no further data required to support the indoor uses at this time. The requirement for
hydrolysis data has been partially satisfied, although products of hydrolysis have yet to be
fully identified. Additionally, the data suggest that the process of hydrolysis is rapid at
all pHs, ranging from about 2.5 minutes at pH 5 to 844 minutes at pH 9.
b. Environmental Fate Assessment
The Agency would normally require extensive supporting data for the secondary
oil recovery use due to concerns for potential groundwater contamination. However, the
Agency believes that properly encased and functioning injection wells will preclude contact
between materials placed down the well and any aquifer in the vicinity. Therefore, the
Agency concludes that DCDIC will not present a hazard to groundwater from this
particular use and no further data pertaining to this use are required.
For the other aquatic industrial uses of this chemical, many carry National
Pollutant Discharge Elimination System (NPDES) permit restrictions. The Agency has
calculated the Tier Ic estimated environmental concentrations (EEC) for all uses except
for pulp and paper mills. Appropriate data to assess potential risks posed by pulp and
paper mill use will be shared with the Agency's Office of Water (OW) for uses by the
permit writer.
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A Tier Ic EEC determines the maximum concentration that occurs immediately
downstream from an industrial (point source) discharge site. The calculated EECs are
those for a high exposure site with a return frequency of one in 10 years. The high
exposure site represents a site that would be expected to produce larger EECs than 90%
of all sites with the specified use pattern. A one in 10 year EEC has a 10% probability
of being equaled or exceeded in any single year at a given site or, would be equalled or
exceeded once every ten years at that site on a long term average. This is similar to the
site and frequency assumptions that are generally being used for agricultural pesticides.
EECs for a 50% (typical) site at mean stream flow were also calculated. EECs for all
these uses except pulp and paper mills are listed in Table 4.
Table 4. Tier Ic EECs for Disodium cyanodithioimidocarbonate
Use Site
Air Washer Systems
Industrial Cooling Towers - Group A
Industrial Cooling Towers - Group B
Industrial Cooling Towers - Group C
Industrial Cooling Towers - Group D
Evaporative Condensers
Heat Exchangers
Secondary Oil Recovery Injection Water
Sugar Mills - Group A
Sugar Mills - Group B
High Exposure Case
1.6 ppm
5.0 ppm
4.0 ppm
3.0 ppm
2.0 ppm
4.0 ppm
3.0 ppm
0.8 ppm
1.3 ppm
5.5 ppm
Typical Exposure Case
.0056 ppm
.0080 ppm
.0064 ppm
.0048 ppm
.0032 ppm
.0064 ppm
.0048 ppm
.0028 ppm
.0028 ppm
.0183 ppm
Groups within a use refer to one or more products with a similar application pattern for that use site.
If an EEC does not exceed the level of concern (LOG), it indicates that it is highly
likely that the chemical can be discharged into receiving waters without causing adverse
effects. If the EEC does exceed the LOG, it may indicate that the pesticide can have a
potential adverse impact on the environment. Because Tier Ic EECs make many very
conservative assumptions and only screen the environmental fate of the pesticide, they may
significantly overestimate the true exposure to the chemical. A higher tier EEC
calculation which more accurately reflects the fate and transport properties of DCDIC
would likely show that the risk is less than that reported here. Waste water treatment
prior to discharge, restriction on discharge during low flow periods and other methods
which may be available through the NPDES permitting process and degradation and
dilution of the pesticide in the waste stream may reduce concentrations below the level of
concern at each site using the pesticide. All DCDIC product labels require that discharge
of the pesticide with waste water be in compliance with an NPDES permit.
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2. Ecological Effects
a. Ecological Effects Data
Of three avian studies submitted, the Agency has determined that two mallard
studies can be used to support reregistration of DCDIC. Six submitted aquatic studies are
adequate for risk assessment: three freshwater aquatic studies and, three estuarine studies.
(1) Terrestrial Data
Based on two mallard studies, (MRIDs 00025563, 40643201) DCDIC is
considered practically nontoxic to birds with acute oral LD50=3211 mg ai/kg and
dietary LC50 > 10,000 ppm ai.
(2) Aquatic Data
Freshwater Studies
Based on three freshwater aquatic studies, (MRIDs 41870601, 41913001,
41897001) this chemical is considered no more than slightly toxic to freshwater
fish and moderately toxic to freshwater aquatic invertebrates. Acute toxicity
values are: LC50=74 mg ai/L for rainbow trout; LC50= 120 mg ai/L for bluegill;
and, EC50 = 8.3 mg ai/L for daphnids.
Estuarine/Marine Studies
Based on the three estuarine studies, (MRIDs 43151501, 43151502,
43151503) DCDIC is considered to be practically non-toxic to fish and moderately
to highly toxic to estuarine invertebrates. Acute toxicity values are: LC50= 120
mg ai/L for sheepshead minnow; EC50=1.6 mg ai/L for eastern oyster; and,
LC50 = 0.16 mg ai/L for shrimp.
(3) Non-Target Insects Data
Nontarget insect testing is not required based on the use patterns of
DCDIC.
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(4) Non-Target Plants Data
Nontarget plant testing is not required based on the use patterns of DCDIC.
b. Ecological Effects Risk Assessment
Terrestrial
Because of the current use patterns of DCDIC, it is not expected to be
found in the terrestrial environment at levels of concern. Therefore, risk to birds
is expected to be minimal.
Aquatic
DCDIC is considered to be no more than slightly toxic to freshwater and
estuarine/marine fish, and moderately to highly toxic to aquatic invertebrates. The
Agency has calculated (Table 4, above) Tier Ic EECs for aquatic residues
occurring immediately downstream from industrial discharge sites except for the
pulp and paper mill use. A stream flow screening model was used to determine
a "high exposure case" and a "typical exposure case" EEC for each use site.
The Agency considers that the LOG is exceeded when the EEC value equals
or exceeds 1/2 the LC50 or EC50 for a freshwater aquatic organism. For DCDIC,
the freshwater fish LOG is 37 ppm, and the aquatic invertebrate LOG is 4.15 ppm.
Typical exposure case EECs do not exceed LOCs for any of the use sites. High
exposure case EECs do not exceed the LOG for freshwater fish, but exceed the
aquatic invertebrate LOG for some cooling towers and sugar mills. Based on the
acute toxicity values and the EECs provided, freshwater aquatic invertebrates may
be at risk from effluents at high exposure sites.
Only certain use sites are associated with estuarine exposure. For DCDIC,
these would be industrial cooling towers, oil recovery sites, and pulp/paper mills.
For estuarine/marine organisms, typical exposure case EECs do not exceed LOCs
for any of the use sites. High exposure case EECs do not exceed the LOG for
estuarine/marine fish. The LOG for estuarine invertebrates, however, is 0.08
ppm. This level of concern is exceeded only at the high exposure scenario for all
industrial cooling towers and for secondary oil recovery sites. Thus,
estuarine/marine aquatic invertebrates may be at risk from effluents at high
exposure (once in 10 years, average) for industrial cooling tower and oil recovery
sites.
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Endangered Species
The LOG for aquatic endangered species is 1/20 the LC50. The endangered
species LOCs are 3.7 ppm for freshwater fish, 0.415 ppm for freshwater
invertebrate, 6 ppm for estuarine fish, and 0.008 ppm for estuarine/marine aquatic
invertebrates. Typical exposure case EECs do not exceed LOCs for any of the use
sites. High exposure case EECs exceed the endangered freshwater fish LOG for
certain industrial cooling towers, evaporative condensers, and sugar mills but do
not exceed the estuarine fish LOG for any uses. High exposure case EECs exceed
the endangered aquatic invertebrate LOG (freshwater and estuarine) for all uses
listed. Assessment for pulp/paper mills was not conducted.
DCDIC is expected to be discharged at a number of different sites.
Endangered species may be exposed to effluents at these sites. Based on the above
discussions, effluents containing DCDIC should not be discharged into aquatic
habitats where endangered species are known to live.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
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
ingredients 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 DCDIC 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 DCDIC. Appendix B identifies the
generic data requirements that the Agency reviewed as part of its determination of
reregistration eligibility of DCDIC 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 DCDIC and to determine that DCDIC can be used without resulting in
unreasonable adverse effects to humans and the environment as discussed below in the
Regulatory Position. The Agency therefore finds that all products containing DCDIC as
the active ingredient 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 DCDIC are eligible for reregistration, it should be understood
17
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that the Agency may take appropriate regulatory action, and/or require the submission of
additional data to support the registration of products containing DCDIC if new
information comes to the Agency's attention or if the data requirements for registration
(or the guidelines for generating such data) change.
1. Eligibility Decision
Based on the review of the generic data for the active ingredient DCDIC, the
Agency has sufficient information on the potential health and environmental effects from
the uses of this pesticide. The Agency has determined that DCDIC products, labeled and
used as specified in this Reregistration Eligibility Decision, will not pose unreasonable
risks to humans or the environment. Therefore, the Agency concludes that products
containing DCDIC for all uses are eligible for reregistration.
2. Eligible and Ineligible Uses
The Agency has determined that all uses of DCDIC are eligible for reregistration.
B. Regulatory Position
The following is a summary of the regulatory positions and rationales for DCDIC.
Where labeling revisions are imposed, specific language is set forth in Section V of this
document.
1. Tolerance Reassessment
Food Additive Tolerances for sugar beet and sugar cane mills have been set by
FDA under 21 CFR 173.320. The Agency defers to FDA regarding dietary exposure to
these uses.
In addition, food additive tolerances have been established for DCDIC for food
contact with food grade paper, paperboard, (21 CFR 176.300) and adhesives (21 CFR
175.105). These uses are no longer active and are not supported for reregistration.
2. Effluent Discharge/Aquatic Risk Rationale
The Agency has determined that discharge to surface waters of effluent containing
DCDIC may result from its use as a pesticide. Its use as a pesticide and its potential
release to the environment subjects it to the requirements of both FIFRA and the NPDES
program which is administered by the Agency's Office of Water (OW) with the states.
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By their nature, industrial biocides are often toxic to aquatic organisms. This is
evident from the ecotoxicology data presented in the Science Assessment presented above.
The effect to the environment of discharges containing biocides depends heavily upon the
volume, concentration, and other constituents of a particular discharge, as well as such
features as the size, nature, and flow rate of waters receiving the discharge. The Tier Ic
EECs modelling of DCDIC indicated that under typical exposure conditions for uses other
than pulp and paper mills this biocide did not meet or exceed the Agency's LOCs for
aquatic organisms. However, LOCs were exceeded for aquatic invertebrates under the
high exposure scenario.
FIFRA permits EPA to require the generation of data on the effects of biocides and
to set general limits and conditions of use of a biocide through statements on its labeling.
However, these mechanisms do not readily provide for adaptation to varied and changing
local conditions. Consequently, generalized regulation of a pesticide under FIFRA could
inadequately restrict pesticide use under some local conditions. The NPDES process is
designed to take local conditions into account through the issuance of permits for the
discharge of pollutants to bodies of water. However, historically, specific information
about the toxicological and environmental properties of biocides in effluent streams was
not always readily available or considered in writing permits.
EPA's Office of Pesticide Programs (OPP) and OW intend to cooperate in the
oversight of biocide uses to better employ the advantages offered by each program while
avoiding unnecessary overlap in regulation. Under FIFRA, OPP will require the
generation and submission to the Agency of information that will be used by OPP to
identify extraordinary hazards that could affect national registration of biocide products
use. Current information and that gathered in the future will be shared with the OW
where it can be made available to NPDES permit writers in addressing local aquatic
effects of biocide use. In addition, OW will alert OPP to any additional information that
becomes available concerning unanticipated aquatic effects of the use of this biocide for
OPP's use in national registration decisions for these products. This approach should
provide sufficient environmental safeguards while avoiding redundant effort since it allows
OPP to control the general approval of the biocide as required by FIFRA, but includes a
mechanism for recognizing and dealing with potential local unacceptable effects through
the NPDES program. Improved limitations on use under FIFRA and more accurate
NPDES permitting decisions and accompanying permit limits for industrial biocides may
be developed in the future as the information gathering and exchange program between
the Offices progresses.
The Agency believes that the above process, coupled with the Agency's finding that
the majority of uses of DCDIC do not raise extraordinary concerns about adverse effects
from its potential discharge to surface waters, adequately addresses the test for
reregistration of a pesticide under FIFRA — "when used in accordance with widespread
and commonly recognized practice it will not generally cause unreasonable adverse effects
on the environment." Therefore, despite some concerns about potential effects to aquatic
19
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organisms exposed to the effluent resulting from its use, the Agency has concluded that
unreasonable adverse effects from the uses of DCDIC involving discharge to water are
generally unlikely under the condition that an effluent discharge label statement
(recognizing that any such discharge is subject to the NPDES process) is required for all
products which have a potential for discharge to surface waters.
3. Endangered Species Statement
The Agency has concerns about the exposure of threatened and endangered species
to DCDIC as discussed above in the science assessment chapter.
Currently, the Agency in conjunction with the U.S. Fish and Wildlife Service and
other federal and state agencies is developing a program ("The Endangered Species
Protection Program") to identify all pesticides whose use may cause adverse impacts on
endangered and threatened species and to implement mitigation measures that will
eliminate the adverse impacts. The program would require use modifications or a generic
product label statement, requiring users to consult county-specific bulletins. These
bulletins would provide information about specific use restrictions to protect endangered
and threatened species in the county. Consultations with the Fish and Wildlife Service will
be necessary to assess risks to newly listed species or from proposed new uses.
4. Labeling Rationale
The Agency is imposing protective clothing and equipment for workers involved
in the application of DCDIC products. Because (1) DCDIC is an eye and skin irritant and
(2) a developmental toxicity concern exists, label restrictions for the use of appropriate
personal protective equipment (PPE) are prudent to reduce the potential exposure from
open pouring of formulated end-use products. These PPEs include protective eyewear,
chemical-resistant gloves, footwear, socks, long-sleeved shirt, and long pants.
In addition, because of concern regarding mixer/loader inhalation exposure to
DCDIC and potential DCDIC degradates, a respirator with either an organic-vapor-
removing cartridge with a prefilter approved for pesticides (MSHA/NIOSH approval
number prefix TC-23C) or a canister approved for pesticides (MSHA/NIOSH approval
number TC-14G) is required during open pouring.
In order to remain in compliance with FIFRA, it is the Agency's position that the
labeling of all registered pesticide products containing DCDIC must comply with the
Agency's pesticide labeling requirements currently in place as well as those required
through this document. The Agency has determined that the current end-use label
precautions and those required through this document are appropriate and required for
product reregistration.
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Because all uses could result in discharged effluents which contain residues of
DCDIC and these effluents are covered under NPDES permits, it is the Agency's position
that label precautions must continue to include the NPDES permit required directive.
V. ACTIONS REQUIRED BY REGISTRANTS
This section specifies 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 disodium
cyanodithioimidocarbonate for the above eligible uses has been reviewed and determined
to be substantially complete. There is a concern for genetic risk based on the positive
Chromosome Damage in vitro Study. As confirmatory testing, a mammalian cell in
culture forward gene mutation assay is required to maintain the continued registration of
DCDIC. Results of the study will be evaluated to determined whether there is a potential
heritable risk and if additional testing is appropriate.
Additionally, because of the concerns regarding potential post-application exposure
to HCN and CN , the Agency requires the registrant to provide quantification of
hydrocyanic acid (hydrogen cyanide or HCN), cyanide (CN), thiocyanate (SCN), and all
other groups with the potential to form CN", at the range of pHs for which the DCDIC
compounds are used, as confirmatory data.
A revised Confidential Statement of Formula and revised labeling are required as
confirmatory data.
2. Labeling Requirements for Manufacturing-Use Products
Effluent Discharge Labeling Statements
All manufacturing-use or end-use products that may be contained in an effluent
discharged to the waters of the United States or municipal sewer systems must bear the
following revised effluent discharge labeling statement:
"Do not discharge effluent containing this product into lakes, streams,
ponds, estuaries, oceans or other waters unless in accordance with the
requirements of a National Pollutant Discharge Elimination System
(NPDES) permit and the permitting authority has been notified in writing
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prior to discharge. Do not discharge effluent containing this
product to sewer systems without previously notifying the local
sewage treatment plant authority. For guidance contact your State
Water Board or Regional Office of the EPA."
All affected products distributed or sold by registrants and distributors
(supplemental registrants) must bear the above labeling by October 1, 1995. All products
distributed or sold by persons other than registrants or supplemental registrants after
October 1, 1997 must bear the correct labeling. Refer to PR Notice 93-10 or 40 CFR
152.46(a)(l) for additional information.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Based on the reviews of the generic data for the active ingredient DCDIC, the
products containing DCDIC with uses for the control of algae and bacteria in commercial
and industrial water systems 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.
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 MRID 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.
Effluent Discharge Labeling Statements
Refer to subsection A. above for labeling requirements for effluent discharge.
Personal Protective Equipment
"For open pouring of this product workers must wear eyewear, chemical-
resistant gloves, footwear, socks, long-sleeved shirt, long pants and a
respirator with either an organic-vapor-removing cartridge with a prefilter
approved for pesticides (MSHA/NIOSH approval number prefix TC-23C)
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or a canister approved for pesticides (MSHA/NIOSH approval
number prefix TC-14G)."
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling
for 26 months from the date of the issuance of this RED. Persons other than the registrant
may generally distribute or sell such products for 50 months from the date of the issuance
of this RED. However, existing stocks time frames will be established case-by-case,
depending on the number of products involved, the number of label changes, and other
factors. Refer to "Existing Stocks of Pesticide Products; State of Policy;" Federal
Register, Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell DCDIC
products bearing old labels/labeling for 26 months from the date of issuance of this RED.
Persons other than the registrant may distribute or sell such products for 50 months from
the date of the issuance of this RED. Registrants and persons other than registrants remain
obligated to meet pre-existing Agency imposed label changes and existing stocks
requirements applicable to products they sell or distribute.
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VI. APPENDICES
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APPENDIX A. Table of Use Patterns Subject to Reregistration
27
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APPENDIX A - Case 3065, [Disodium Cyanodithioimidocarbonate] Chemical 063301 [Disodium Cyanodithioimidocarbonate]
Application Application Application Surface
Type Timing Equipment Type
USES ELIGIBLE FOR REREGISTRAT
Form
ION
Minimum
Application
Rate
(ppm a.i.)
Maximum
Application
Rate
(ppm a.i.)
Max. *
Apps.
Max. *
Apps. @
Max. Rate
Min. Interval
Between Apps.
@ Max. Rate
(Days)
Restricted
Entry
Interval
Geographic
Limitations
Allowed
Disallowed
Use Pattern Limitations
FOOD/FEED USES
Site: Food Processing Water Systems Use Group: INDOOR FOOD
water treatment, continuous feed (initial), measuring
container, NA
water treatment, continuous feed (initial), metering pump,
NA
water treatment, continuous feed (initial), NOL, NA
SC/L
SC/L
SC/L
3 W
3 W
3 W
3 W
3 W
13 W
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NA
NA
NA
NA
NA
NA
NS
NS
Do not discharge effluent containing this pesticide into sewage
systems without notifying the sewage plant authority. Do not
discharge effluent containing this product into lakes, streams,
ponds, estuaries, oceans, or public water (NPDES license
restriction)
NON-FOOD/NON-FEED USES
Site: Air Washer Water Systems Use Group: AQUATIC NON-FOOD INDUSTRIAL
water treatment, intermittent (slug) (initial) , NOL, NA
water treatment, intermittent (slug) (subsequent), NOL, NA
SC/L
SC/L
2 W
1 W
4 W
4W
NS
NS
NS
NS
NS
1
NS
NS
NA
NA
NA
NA
Preclean claim; NPDES license restriction
Preclean claim; NPDES license restriction
Site: Commercial/Industrial Water Cooling Systems Use Group: AQUATIC NON-FOOD INDUSTRIAL
water recirculating system treatment, intermittent (slug)
(initial) , measuring container, NA
water recirculating system treatment, intermittent (slug)
(subsequent) , measuring container, NA
water recirculating system treatment, intermittent (slug)
(initial), metering pump, NA
water recirculating system treatment, intermittent (slug)
(subsequent) , metering pump , N A
water recirculating system treatment, intermittent (slug)
(initial), NOL, NA
SC/L
SC/L
SC/L
SC/L
SC/L
2V
IV
2V
IV
IV
3V
3V
3V
3V
5V
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
1
NS
1
1
NS
NS
NS
NS
NS
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Preclean claim
Preclean claim
Preclean claim
Preclean claim
Preclean claim; NPDES license restriction; Do not
discharge effluent containing this pesticide into
sewage systems without notifying the sewage plant
authority; Do not discharge effluent containing this
product into lakes, streams, ponds, estuaries,
oceans, or public water (NPDES license restriction)
29
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APPENDIX A - Case 3065, [Disodium Cyanodithioimidocarbonate] Chemical 063301 [Disodium Cyanodithioimidocarbonate]
Application Application Application Surface
Type Timing Equipment Type
USES ELIGIBLE FOR REREGISTRAT
Form
ION
Minimum
Application
Rate
(ppm a.i.)
Maximum
Application
Rate
(ppm a.i.)
Max. *
Apps.
Max. *
Apps. @
Max. Rate
Min. Interval
Between Apps.
@ Max. Rate
(Days)
Restricted
Entry
Interval
Geographic
Limitations
Allowed
Disallowed
Use Pattern Limitations
Site: Commercial/Industrial Water Cooling Systems Use Group: AQUATIC NON-FOOD INDUSTRIAL (Continued from previous page)
water recirculating system treatment, intermittent (slug)
(subsequent), NOL, NA
water treatment, intermittent (slug) (initial) , NOL, NA
water treatment, intermittent (slug) (subsequent), NOL, NA
SC/L
SC/L
SC/L
< IV
2V
IV
5V
4V
4V
NS
NS
NS
NS
NS
NS
1
7
NS
1
NS
NS
NS
NA
NA
NA
NA
NA
NA
Preclean claim; NPDES license restriction; Do not
discharge effluent containing this pesticide into
sewage systems without notifying the sewage plant
authority; Do not discharge effluent containing this
product into lakes, streams, ponds, estuaries,
oceans, or public water (NPDES license restriction)
Preclean claim; Do not discharge effluent
containing this product into lakes, streams, ponds,
estuaries, oceans, or public water (NPDES license
restriction)
Preclean claim; Do not discharge effluent
containing this product into lakes, streams, ponds,
estuaries, oceans, or public water (NPDES license
restriction)
Site: Evaporative Condenser Water Systems Use Group: AQUATIC NON-FOOD INDUSTRIAL
water treatment, intermittent (slug) (initial) , NOL, NA
water treatment, intermittent (slug) (subsequent), NOL, NA
SC/L
SC/L
2 V
1 V
4 V
4 V
NS
NS
NS
NS
1
1
7
NS
NS
NA
NA
NA
NA
Preclean claim; Do not discharge effluent
containing this pesticide into sewage systems
without notifying the sewage plant authority; Do
not discharge effluent containing this product into
lakes, streams, ponds, estuaries, oceans, or public
water (NPDES license restriction)
Preclean claim; Do not discharge effluent
containing this pesticide into sewage systems
without notifying the sewage plant authority; Do
not discharge effluent containing this product into
lakes, streams, ponds, estuaries, oceans, or public
water (NPDES license restriction)
Site: Heat Exchanger Water Systems Use Group: AQUATIC NON-FOOD INDUSTRIAL
water treatment, intermittent (slug) (initial) , measuring
container, NA
water treatment, intermittent (slug) (subsequent), measuring
container, NA
SC/L
SC/L
2V
IV
3V
3V
NS
NS
NS
NS
NS
1
NS
NS
NA
NA
NA
NA
Preclean claim
Preclean claim
Site: Heat Exchanger Water Systems Use Group: AQUATIC NON-FOOD INDUSTRIAL (Continued from previous paee)
30
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APPENDIX A - Case 3065, [Disodium Cyanodithioimidocarbonate] Chemical 063301 [Disodium Cyanodithioimidocarbonate]
Application Application Application Surface
Type Timing Equipment Type
USES ELIGIBLE FOR REREGISTRAT
water treatment, intermittent (slug) (initial), metering pump ,
NA
water treatment, intermittent (slug) (subsequent), metering
pump, NA
Form
ION
SC/L
SC/L
Minimum
Application
Rate
(ppm a.i.)
2 V
1 V
Maximum
Application
Rate
(ppm a.i.)
3V
3V
Max. *
Apps.
NS
NS
Max. *
Apps. @
Max. Rate
NS
NS
Min. Interval
Between Apps.
@ Max. Rate
(Days)
NS
1
Restricted
Entry
Interval
NS
NS
Geographic
Limitations
Allowed
NA
NA
Disallowed
NA
NA
Use Pattern Limitations
Preclean claim
Preclean claim
Site: Pulp/Paper Mill Water Systems Use Group: AQUATIC NON-FOOD INDUSTRIAL
water treatment, NOL, drip-feed device, NA
water treatment, NOL, measuring container, NA
water treatment, NOL, metering pump, NA
SC/L
SC/L
SC/L
NC
NC
NC
NC
NC
NC
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NA
NA
NA
NA
NA
NA
NS
NS
NS
Site: Secondary Oil Recovery Injection Water Use Group: AQUATIC NON-FOOD INDUSTRIAL
water treatment, continuous feed (initial), measuring
container, NA
water treatment, continuous feed (initial), metering pump,
NA
SC/L
SC/L
IV
IV
2V
2V
NS
NS
NS
NS
NS
NS
NS
NS
NA
NA
NA
NA
NS
NS
Abbreviations used
Header:
Form:
Rate:
In general:
ppm a.i. = parts per million of active ingredient; Max. # Apps. = maximum number of applications
Max. # Apps. @ Max. Rate = maximum number of applications at maximum rate
Min. Interval Between Apps. @ Max. Rate (Days) = minimum interval between applications at maximum rate (in days)
SC/L = Soluble Concentrate/Liquid
W = calculated by weight; V = calculated by volume; NC = not calculated; < 1 = less than one
NOL = not specified on the label; NA = not applicable; NS = not specified
31
-------
32
-------
APPENDIX B. Table of the Generic Data Requirements and Studies Used to Make the Reregistration Decision
33
-------
34
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case Disodium Cyanodithioimidocarbonate covered by this
Reregistration Eligibility Decision Document. It contains generic data requirements that apply
to Disodium Cyanodithioimidocarbonate 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
0 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 (MRID) 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.
35
-------
36
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Disodium
Cyanodithioimidocarbonate
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-1
61-2A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/water Partition Coefficient
PH
Stability
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
N/A
ALL
ALL
ALL
ALL
N/A
N/A
ALL
ALL
41683601
41683601, 42632501
41683601, 42632501
41683602
41683602
41683602
41683603
41683603
41683603
41683603
41683603
42951601
42951601
41683603
42951601
37
-------
Data Supporting Guideline Requirements for the Reregistration of Disodium
Cyanodithioimidocarbonate
REQUIREMENT
63-14
63-15
63-16
63-17
63-18
63-19
63-20
Oxidizing and Reducing Acting
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion characteristics
USE PATTERN
N/A
N/A
N/A
ALL
ALL
N/A
ALL
CITATION(S)
42771701
41683603
42771701
ECOLOGICAL EFFECTS
71-1A
71-2A
71-2B
72-1A
72-1C
72-2A
72-3A
72-3B
72-3C
122-1A
Acute Avian Oral - Quail/Duck
Avian Dietary - Quail
Avian Dietary - Duck
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
Estuarine/Marine Toxicity - Fish
Estuarine/Marine Toxicity -
Mollusk
Estuarine/Marine Toxicity -
Shrimp
Seed Germination/Seedling
F
F
F
F
F
F
F
F
F
25563
42981301
40643201
41913001
41870601
41897001
43151503
43151502
43151501
WAIVED
Emergence
38
-------
Data Supporting Guideline Requirements for the Reregistration of Disodium
Cyanodithioimidocarbonate
REQUIREMENT
USE PATTERN
CITATION(S)
122-IB Vegetative Vigor
122-2 Aquatic Plant Growth
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
82-3
83-3A
83-3B
84-2A
84-2B
84-4
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization - Guinea Pig
90-Day Dermal - Rodent
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
Gene Mutation (Ames Test)
Structural Chromosomal
Aberration
Other Genotoxic Effects
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
OCCUPATIONAL/RESIDENTIAL EXPOSURE
133-3
233
Dermal Passive Dosimetry
Estimation of Dermal Exposure at
ALL
WAIVED
WAIVED
41592601
41592602
42952501
WAIVED
41592603
41592604
40974801
41009301
41009401
40425101
41177901,40425102
40425103
RESERVED
41412201
Indoor Sites
39
-------
Data Supporting Guideline Requirements for the Reregistration of Disodium
Cyanodithioimidocarbonate
REQUIREMENT USE PATTERN CITATION(S)
ENVIRONMENTAL FATE
160-5 Chemical Identity ALL 41683601
161-1 Hydrolysis ALL 42968001, 42595601*
* PARTIALLY SATISFIED, MORE DATA REQUIRED
40
-------
APPENDIX C. Citations Considered to be Part of the Data
Base Supporting the Reregistration of Disodium
Cyanodithioimidocarbonate
41
-------
42
-------
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 bibliography have been the body of data submitted to EPA and its predecessor
agencies in support of past regulatory decisions. Selections from other sources
including the published literature, in those instances where they have been considered,
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 submitted. The resulting "studies" generally have a
distinct title (or at least a single subject), can stand alone for purposes of review and
can be described with a conventional bibliographic citation. The Agency has 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 used 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 identifier. These entries are listed after all MRID entries. This
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
conventions 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 an 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
43
-------
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
trailing 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
defaulted 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 alphabetic suffix which shows the relative position of the study within
the volume.
44
-------
BIBLIOGRAPHY
MRID
CITATION
00025563 Najarian, G.; Piccirillo, V.J. (1978) Final Report: Acute Oral LDaeSO- in
Mallard Ducks: Project No. 197-164. (Unpublished study received Oct 11,
1978 under 1448-54; prepared by Hazleton Laboratories America, Inc.,
submitted by Buckman Laboratories, Inc., Memphis, Tenn.; CDL:241676-B)
40425101 Jagannath, D. (1987) Mutagenicity Test on DCDIC in the Ames
Salmonella/Microsome Reverse Mutation Assay: HLA Study No. 9971-0-401.
Unpublished study prepared by Hazleton Laboratories America, Inc. 31 p.
40425102 Muril, H. (1987) Mutagenicity Test on DCDIC in an in vitro Cytogenic Assay
Measuring Sister Chromatid Exchange Frequencies in Chinese Hamster Ovary
(CHO) Cells: HLA Study No. 9971-0-438. Unpublished study prepared by
Hazleton Laboratories America, Inc. 20 p.
40425103 Cifone, M. (1987) Mutagenicity Test on DCDIC in tbe Rat Primary Hepatocyte
Unscheduled DNA Synthesis Assay: HLA Study No. 9971-0-447. Unpublished
study prepared by Hazleton Laboratories America, Inc. 28 p.
40643201 Carr, S.; Piccirillo, V. (1978) Disodium Cyanodithioimidocarbonate: Subacute
Dietary LC50 in Mallard Ducks: Project No. 197-165. Unpublished study
prepared by Hazleton Laboratories. 7 p.
40974801 Siglin, J. (1988) 91-day Dermal Toxicity Study in Rats with DCDIC: Final
Report: SLS Study No. 3138.21. Unpublished study prepared by Springborn
Life Sciences, Inc. 443 p.
41009301 Rodwell, D. (1988) Teratology Study in Rats with DCDIC: Final Rept: SLS
Study No. 3138.23. Unpublished study prepared by Springborn Life Sciences,
Inc. 328 p.
41009401 Rodwell, D. (1988) Teratology Study in Rabbits with DCDIC: Final Rept: SLS
Study No. 3138.25. Unpublished study prepared by Springborn Life Sciences,
Inc. 228 p.
41177901 Murli, H. (1989) Mutagenicity Test on DCDIC in an in vitro cytogenetic Assay
Measuring Sister Chromatid Exchange Frequencies in Chinese Hamster Ovary
(CHO) Cells: Final Report: ProjectID: HLA Study No. 10855-0-438; Project
No. 20990. Unpublished study prepared by Hazleton Laboratories America,
Inc. 20 p.
45
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BIBLIOGRAPHY
MRID
CITATION
41412201 Popendorf, W.; Selim, M.; Kross, B. (1990) Chemical Manufacturers
Association Antimicrobial Exposure Assessment Study: Lab Project ID: Q626.
Unpublished Study prepared by Univ. of Iowa, Institute of Agricultural
Medicine and Occupational Health. 209 p.
41592601 Naas, D. (1990) Acute Oral Toxicity (LD50) Study in Albino Rats with
DCDIC: Lab Project Number: WIL-94031. Unpublished study prepared by
Wil Research Laboratories, Inc. 92 p.
41592602 Naas, D. (1990) Acute Dermal Toxicity (LD50) Study in Albino Rabbits with
DCDIC: Lab Project Number: WIL-94032. Unpublished study prepared by
WIL Research Laboratories, Inc. 35 p.
41592603 Naas, D. (1990) Primary Dermal Irritation Study in Rabbits with DCDIC: Lab
Project Number: WIL-94033. Unpublished study prepared by WIL Research
Laboratories, Inc. 21 p.
41592604 Naas, D. (1990) Skin Sensitization Study in Albino Guinea Pigs with DCDIC:
Lab Project Number: WIL-94034. Unpublished study prepared by WIL
Research Laboratories, Inc. 47 p.
41683601 McNeel, T. (1990) Product Chemistry for DCDIC: Product Identity,
Manufacturing Process, Discussion of Impurities. Unpublished study prepared
by Buckman Laboratories International, Inc. 34 p.
41683602 McNeel, T. (1990) Product Chemistry for DCDIC: Preliminary Analysis,
Certified Limits and Enforcement Analytical Techniques: Lab Project Number:
107-01. Unpublished study prepared by Buckman Laboratories International,
Inc. 27 p.
41683603 McNeel, T. (1990) Product Chemistry for DCDIC: Physical/Chemical
Properties. Unpublished study prepared by Buckman Laboratories
International, Inc. 27 p.
41870601 Machado, M. (1991) (DCDIC) Acute Toxicity to Rainbow Trout
(Oncorhynchus mykiss) under Flow-Through Conditions: Final Report: Project
Numbers: 91-3-3712; 995.0390.6126.108. Unpublished study prepared by
Springborn Laboratories, Inc. 62 p.
46
-------
BIBLIOGRAPHY
MRID
CITATION
41897001 Putt, A. (1991) DCDIC-Acute Toxicity to Daphnids (Daphnia magna) Under
Flow-through Conditions: Final Report: Lab Project Number: 91-4-3739:
995.0390.6127.115. Unpublished study prepared by Springborn Laboratories,
Inc. 64 p.
41913001 Machado, M. (1991) (DCDIC)-Acute Toxicity to Bluegill Sunfish (Lepomis
macrochirus) Under Flow-Through Conditions: Lab Project Number:
91-5-3752: 995. 0390. 6125. 105. Unpublished study prepared by Springborn
Laboratories, Inc. 64 p.
42632501 McNeel, T.; Conaway, L.; Barbee, D. (1990) Product Chemistry for DCDIC.
Unpublished study prepared by Buckman Labs International, Inc. 34 p.
42771701 Whetzel, J. (1993) Determination of Storage Stability and Corrosion
Characteristics of DCDIC: Lab Project Number: 82/91-BUG. 13. Unpublished
study prepared by Twin City Testing Corp. 30 p.
42951601 Siemann, L. (1993) Product Chemistry for DCDIC: Series 63, Physical and
Chemical Characteristics: Lab Project Number: 3437-F. Unpublished study
prepared by Midwest Research Institute. 48 p.
42952501 Rush, R. (1993) An Acute Whole-Body Inhalation Toxicity Study in Rats with
DCDIC: Lab Project Number: 3138.98. Unpublished study prepared by
Springborn Laboratories, Inc. (SLS). 124 p.
42968001 Gohdes, M. (1993) Hydrolysis of (carbon 14)-DCDIC in Aqueous Solutions
Buffered at pH 5, 7 and 9: Supplement to the Final Report: Lab Project
Number: WHI 6176-171. Unpublished study prepared by Hazleton Wisconsin,
Inc. 53 p.
42981301 Pedersen, C.; Solatycki, A. (1993) Disodium Cyanodithioimidocarbonate
(DCDIC); 8-Day Acute Dietary LD50 in Bobwhite Quail: Lab Project Number:
127-003-01R; 127-003-01. Unpublished study prepared by Bio-Life Associates,
Ltd. 76 p.
43151501 Bettencourt, M. (1994) DCDIC-Acute Toxicity to Mysid Shrimp (Mysidopsis
bahia) Under Flow-Through Conditions: Final Report: Lab Project Number:
94-1-5143: 995.0593.6168.515. Unpublished study prepared by Springborn
Labs, Inc. 67 p.
47
-------
BIBLIOGRAPHY
MRID CITATION
43151502 Dionne, E. (1994) DCDIC-Acute Toxicity to Eastern Oyster (Crassostrea
virginica) Under Flow-Through Conditions: Final Report: Lab Project Number:
94-1-5146: 995.0593.6170.504. Unpublished study prepared by Springborn
Labs, Inc. 66 p.
43151503 Bettencourt, M. (1994) DCDIC-Acute Toxicity to Sheepshead Minnow
(Cyprinodon variegatus) Under Flow-Through Conditions: Final Report: Lab
Project Number: 94-2-5158: 995.0593.6169.505. Unpublished study prepared
by Springborn Labs, Inc. 68 p.
48
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APPENDIX D. List of Available Related Documents
49
-------
50
-------
The following is a list of available documents related to Disodium
Cyanodithioimidocarbonate. It's purpose is to provide a path to more detailed information if it
is needed. These accompanying documents are part of the Administrative Record for
Disodium Cyanodithioimidocarbonate 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. Disodium Cyanodithioimidocarbonate RED Fact Sheet
4. PR Notice 86-5 (included in this appendix)
5. PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
51
-------
52
-------
APPENDIX E. PR Notices 86-5 and 91-2
53
-------
54
-------
PR Notice 86-5
55
-------
56
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
tpno1 WASHINGTON, D.C. 20460
July 29, 1986
OFFICE OF
PR NOTICE 86-5 PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS
AND REGISTRANTS
Attention: Pers9ns responsible for Federal registration of
pesticides.
Subject: Standard format for data submitted under the
Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) and certain provisions of the Federal
Food, Drug, and Cosmetic Act (FFDCA).
I. Purpose
To require data to be submitted to the Environmental
Protection Agency (EPA) in a standard format. This Notice also
provides additional guidance about, and illustrations of, the
required formats.
II. Applicability
This PR Notice applies to all data that are submitted to EPA
to satisfy data requirements for granting or maintaining
pesticide registrations, experimental use permits, tolerances,
and related approvals under certain provisions of FIFRA and
FFDCA. These data are defined in FIFRA §10(d)(1). This Notice
does not apply to commercial, financial, or production
information, which are, and must continue to be, submitted
differently under separate cover.
Ill. Effective Date
This notice is effective on November 1, 1986. Data formatted
according to this notice may be submitted prior to the effective
date. As of the effective date, submitted data packages that do
not conform to these requirements may be returned to the
submitter for necessary revision.
IV. Background
On September 26, 1984, EPA published proposed regulations in
the Federal Register (49 FR 37956) which include Requirements for
Data Submission (40 CFR §158.32), and Procedures for Claims of
Confidentiality of Data (40 CFR §158.33). These regulations
specify the format for data submitted to EPA under Section 3 of
FIFRA and Sections 408 and 409 of FFDCA, and procedures which
must be followed to make and substantiate claims of confiden-
tiality. No entitlements to data confidentiality are changed,
either by the proposed regulation or by this notice.
OPP is making these requirements mandatory through this
Notice to gain resource-saving benefits from their use before the
57
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entire proposed regulation becomes final. Adequate lead time is
being provided for submitters to comply with the new
requirements.
V. Relationship of this Notice to Other OPP Policy and Guidance
While this Notice contains requirements for organizing and
formatting submittals of supporting data, it does not address the
substance of test reports themselves. "Data reporting" guidance
is now under development in OPP, and will specify how the study
objectives, protocol, observations, findings, and conclusions are
organized and presented within the study report. The data
reporting guidance will be C9mpatible with submittal format
requirements described in this Notice.
OPP has also promulgated a policy (PR Notice 86-4 dated
April 15, 1986) that provides for early screening of certain
applications for registration under FIFRA §3. The objective of
the screen is to avoid the additional C9sts and prolonged delays
associated with handling significantly incomplete application
packages. As of the effective date of this Notice, the screen
will include in its criteria for acceptance of applicati9n
packages the data formatting requirements described herein.
OPP has also established a public docket which imposes
deadlines for inserting int9 the docket documents submitted in
connection with Special Reviews and Registration Standards (see
40 CFR §154.15 and §155.32). To meet these deadlines, OPP is
requiring an additional copy of any data submitted to the docket.
Please refer to Page 10 for more information about this
requirement.
For several years, OPP has required that each application
for registration or other action include a list 9f all applicable
data requirements and an indication of how each is satisfied--the
statement of the method of support f9r the application.
Typically, many requirements are satisfied by reference to data
previously submitted--either by the applicant or by another
party. That requirement is not altered by this notice, which
applies only to data submitted with an application.
VI. Format Requirements
A more detailed discussion of these format requirements
foll9ws the index on the next page, and samples of some of the
requirements are attached. Except for the language 9f the two
alternative forms of the Statement of Data Confidentiality Claims
(shown in Attachment 3) which cannot be altered, these samples
are illustrative. As long as the required information is
included and clearly identifiable, the form of the samples may be
altered to reflect the submitter's preference.
- INDEX-
Text Example
Page Page
A. Organization of the Submittal Package 3 17
B. Transmittal Document 4 11
C. Individual Studies 4
C. 1 Special Considerations for Identifying Studies . . 5
D. Organization of each Study Volume 6 17
D. 1 Study Title Page 7 12
58
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D. 2 Statement of Data Confidentiality Claims
(based on FIFRA §10 (d) (1)1 8 13
D. 3 Confidential Attachment 8 15
D. 4 Supplemental Statement of Data Confidentiality
Claims (other than those based on FIFRA §10(d)(1) ) 8 14
D. 5 Good Laboratory Practice Compliance Statement . . 9 16
E. Reference to Previously Submitted Data 9
F. Physical Format Requirements & Number of Copies .... 9
G. Special Requirements for Submitting Data to the Docket 10
A. Organization of Submittal Package
A "submittal package" consists of all studies submitted at
the same time f9r review in support of a single regulatory
action, along with a transmittal document and other related
administrative material (e.g. the method of support statement,
EPA Forms 8570-1, 8570-4, 8570-20, etc.) as appropriate.
Data submitters must organize each submittal package as
described in this Notice. The transmittal and any other admin-
istrative material must be gr9uped together in the first physical
volume. Each study included in the submittal package must then
be bound separately.
Submitters sometimes provide additional materials that are
intended to clarify, emphasize, or otherwise comment to help
Product Managers and reviewers better understand the submittal.
If such materials relate to one study, they should be
included as an appendix to that study.
- If such materials relate to more than one study (as for
example a summary of all studies in a discipline) or to the
submittal in general, they must be included in the submittal
package as a separate study (with title page and statement
of confidentiality claims).
B. Transmittal Document
The first item in each submittal package must be a trans-
mittal document. This document identifies the submitter or all
joint submitters; the regulatory action in support of which the
package is being submitted--!.e., a registration application,
petition, experimental use permit (EUPT, §3 (c) (2) (B) data
call-in, §6(a)(2) submittal, or a special review; the transmittal
date; and a list of all individual studies included in the
gackage in the order of their appearance, showing (usually by
uideline reference number) the data requirement(s) addressed by
each one. The EPA-assigned number for the regulatory action
(e.g. the registration, EUP, or tolerance petition number) should
be included in the transmittal document as well, if it is known
to the submitter. See Attachment 1 for an example of an
acceptable transmittal document.
The list of included studies in the transmittal of a data
submittal package supporting a registration application should be
subdivided by discipline, reflecting the order in which data
requirements appear in 40 CFR 158.
The list of included studies in the transmittal of a data
submittal package supporting a petition for tolerance or an
59
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application for an EUP should be subdivided into sections A, B,
C,.... of the petition or application, as defined in 40 CFR 180.7
and 158.125, (petitions) or Pesticide Assessment Guidelines,
Subdivision I (EUPs) as appropriate.
When a submittal package supports a tolerance petiti9n and
an application for a registration or an EUP, list the petition
studies first, then the balance of the studies. Within these two
groups of studies follow the instructions above.
C. Individual Studies
A study is the report of a single scientific investigation,
including all supporting analyses required for logical complete-
ness. A study should be identifiable and distinguishable by a
C9nventional bibliographic citation including author, date, and
title. Studies generally correspond in scope to a single Guide-
line requirement for supporting data, with 39016 exceptions dis-
cussed in section C.I. Each study included in a submittal
Eackage must be bound as a separate entity. (See comments on
inding studies on page 9.)
Each study must be consecutively paginated, beginning from
the title page as page 1. The total number of pages in the com-
plete study must be shown on the study title page. In addition
(to ensure that inadvertently separated pages can be reassociated
with the proper study during handling or review) use either of
the following:
- Include the total number of pages in the complete study on
each page (i.e., 1 of 250, 2 of 250, ...250 of 250).
- Include a company name or mark and study number on each
page of the study, e g , Company Name-1986-23. Never reuse
a study number for marking the pages of subsequent studies.
When a single study is extremely long, binding it in mul-
tiple V9lumes is permissible so long as the entire study is pag-
inated in a single series, and each volume is plainly identified
by the study title and its position in the multi-volume sequence.
C.1 Special Considerations for Identifying Studies
Some studies raise special problems in study identification,
because they address Guidelines of broader than normal scope or
for other reasons.
a. Safety Studies. Several Guidelines require testing for
safety in more than one species. In these cases each species
tested should be reported as a separate study, and bound
separately.
Extensive supplemental reports of pathology reviews, feed
analyses, historical C9ntrol data, and the like are often assoc-
iated with safety studies. Whenever possible these should be
submitted with primary reports of the study, and bound with the
primary study as appendices. When such supplemental reports are
submitted independently of the primary report, take care to fully
identify the primary report to which they pertain.
Batteries of acute toxicity tests, performed on the same end
use product and covered by a single title page, may be bound
together and reported as a single study.
b. Product Chemistry Studies. All product chemistry data
within a submittal package submitted in support of an end-use
product produced from registered manufacturing-use products
should be bound as a single study under a single title page.
Product chemistry data submitted in support of a technical
product, other manufacturing-use product, an experimental use
permit, an import tolerance petition, or an end-use product
60
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produced from unregistered source ingredients, should be bound as
a single study for each Guideline series (61, 62, and 63) for
C9nventional pesticides, or for the equivalent subject range for
biorational pesticides. The first of the three studies in a
complete product chemistry submittal for a biochemical pesticide
would cover Guidelines 151-10, 151-11, and 151-12; the second
would cover Guidelines 151-13, 151-15, and 151-16; the third
would cover Guideline 151-17. The first study for a microbial
pesticide would cover Guidelines 151-20, 151-21, and 151-22; the
second W9uld cover Guidelines 151-23 and 151-25; the third would
cover Guideline 151-26.
Note particularly that product chemistry studies are likely
to contain Confidential Business Information as defined in FIFRA
§10(d)(1)(A), (B) , or (C), and if so must be handled as described
in section D.3. of this notice.
c. Residue Chemistry Studies. Guidelines 171-4, 153-3,
and 153-4 are extremely broad in scope; studies addressing
residue chemistry requirements must thus be defined at a level
below that of the Guideline code. The general principle,
h9wever, of limiting a study to the report of a single inves-
tigation still applies fully. Data should be treated as a single
study and bound separately for each analytical method, each
report of the nature of the residue in a single crop or animal
species, and for each report of the magnitude of residues
resulting from treatment of a single crop or from processing a
single crop. When more than one commodity is derived from a
single crop (such as beet tops and beet roots) residue data on
all such C9mmodities should be reported as a single study. When
multiple field trials are associated with a single crop, all such
trials should be reported as a single study.
D. Organization of Each Study Volume
Each complete study must include all applicable elements in
the list below, in the order indicated. (Also see Page 17.)
Several of these elements are further explained in the following
paragraphs. Entries in the column headed "example" cite the
page number of this notice where the element is illustrated.
Element
Study Title Page
Statement of Data
Confidentiality
Claims
Certification of Good
Laboratory Practice
Flagging statements
Body of Study
Study Appendices
Cover Sheet to Confi-
dential Attachment
When Required Example
Always Page 12
One of the two alternative Page 13
forms of this statement
is always required
If study reports Iaborat9ry Page 16
work subject to GLP require-
ments
For certain t9xicology studies (When
flagging requirements are finalized.)
Always - with an English language
translation if required.
At submitter's option
If CBI is claimed under FIFRA
§10 (d) (1) (A) , (B) , or (C)
CBI Attachment
If CBI is claimed under FIFRA
§10 (d) (1) (A) , (B) , or (C) Page 15
Supplemental Statement Only if confidentiality is Page 14
of Data Confidentiality claimed on a basis other than
Claims FIFRA §10(d)(1)(A), (B), or (C)
61
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D.I. Title Page
A title page is always required for each submitted study,
published or unpublished. The title page must always be freely
releasable to requestors; DO NOT INCLUDE CBI ON THE TITLE PAGE.
An example of an acceptable title page is on page 12 of this
notice. The following information must appear on the title page:
a. Study title. The study title should be as descriptive as
possible It must clearly identify the substance(s) tested and
correspond to the name of the data requirement as it appears in
the Guidelines.
b. Data requirement addressed. Include on the title page the
Guideline number(s) of the specific requirement(s) addressed by
the study.
c. Author(s). Cite only individuals with primary intellectual
responsibility for the C9ntent 9f the study. Identify them
plainly as authors, to distinguish them from the performing
laboratory, study sponsor, or other names that may also appear on
the title page.
d. Study Date. The title page must include a single date for
the study. If parts of the study were performed at different
times, use only the date of the latest element in the study.
e. Performing Laboratory IdentificatJ9n. If the study reports
work done by one or more laboratories,Include on the title page
the name and address of the performing laboratory or
laboratories, and the laboratory's internal project number(s) for
the work. Clearly distinguish the laboratory's project
identifier from any other reference numbers provided by the study
sponsor or submitter.
f. Supplemental Submissions. If the study is a commentary on
or supplement to another previously submitted study, or if it
responds to EPA questions raised with respect to an earlier
study, include 9n the title page elements a. through d. for the
previ9usly submitted study, along with the EPA Master Record
Identifier (MRID) or Accession number of the earlier study if you
know these numbers. (Supplements submitted in the same submittal
package as the primary study should be appended to and bound with
the primary study. Do not include supplements to more than one
study under a single title page).
g. Facts of Publication. If the study is a reprint of a pub-
lished d9cument, identity on the title page all relevant facts of
publication, such as the J9urnal title, volume, issue, inclusive
page numbers, and publication date.
D.2. Statements of Data Confidentiality Claims Under FIFRA
§10(d) (1) .
Each submitted study must be accompanied by one of the two
alternative forms of the statement of Data Confidentiality Claims
specified in the proposed regulation in §158.33 (b) and (c) (See
Attachment 3). These statements apply only to claims of data
confidentiality based on FIFRA §10(d)(1)(A), (B), or (C). Use
the appropriate alternative form of the statement either to
assert a claim of §10(d)(l) data confidentiality (§158.33(b)) or
to waive such a claim (§158.33(c)). In either case, the
statement must be signed and dated, and must include the typed
name and title of the official who signs it. Do not make CBI
62
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claims with respect to analytical methods associated with pet-
itions for tolerances or emergency exemptions (see NOTE Pg 13).
D.3. Confidential Attachment
If the claim is made that a study includes confidential
business information as defined by the criteria of FIFRA
§10(D)(1)(A), (B), or (C) (as described in D.2. above) all such
information must be excised from the body of the study and
confined to a separate study-specific Confidential Attachment.
Each passage of CBI so isolated must be identified by a reference
number cited within the body of the study at the point from which
the passage was excised (See Attachment 5).
The Confidential Attachment to a study must be identified by
a cover sheet fully identifying the parent study, and must be
clearly marked "Confidential Attachment." An appropriately
annotated photocopy of the parent study title page may be used as
this cover sheet. Paginate the Confidential Attachment
separately from the body of the study, beginning with page 1 of X
on the title page. Each passage confined t9 the Confidential
Attachment must be associated with a specific cross reference to
the page(s) in the main body of the study on which it is cited,
and with a reference to the applicable passage(s) of FIFRA
§10(d)(1) on which the confidentiality claim is based.
D.4. Supplemental Statement of Data Confidentiality Claims (See
Attachment 4)
If you wish to make a claim of confidentiality for any
)ortion of a submitted study other than described by FIFRA £
[I)(A), (B), or (C), the following provisions apply:
- The specific information to which the claim applies must
be clearly marked in the body of the study as subject to a
claim of confidentiality.
- A Supplemental Statement 9f Data Confidentiality Claims
must be submitted, identifying each passage claimed confi-
dential and describing in detail the basis for the claim.
A list of the points to address in such a statement is
included in Attachment 4 on Pg 14.
- The Supplemental Statement of Data Confidentiality Claims
must be signed and dated and must include the typed name and
title of the official who signed it.
D.5. Good Laboratory Practice Compliance Statement
This statement is required if the study contains laboratory
work subject to GLP requirements specified in 40 CFR 160. Sam-
ples of these statements are shown in Attachment 6.
E. Reference to Previously Submitted Data
DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED
FOR ANOTHER PURPOSE unless EPA specifically requests it. A copy
of the title page plus the MRID number (if known) is sufficient
to allow us t9 retrieve the study immediately for review. This
prevents duplicate entries in the Agency files, and saves you
the cost of sending more copies of the study. References to pre-
viously submitted studies smpuld not be included in the transmit-
tal document, but should be incorporated into the statement of
the method of support for the application.
F. Physical Format Requirements
All elements in the data submittal package must be on
uniform 8 1/2 by 11 inch white paper, printed 9n one side only in
black ink, with high contrast and good res9lution. Bindings for
individual studies must be secure, but easily removable to permit
63
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disassembly for microfilming. Check with EPA for special
instructions bef9re submitting data in any medium other than
paper, such as film or magnetic media.
Please be particularly attentive to the following points:
• Do not include frayed or torn pages.
• Do not include carbon copies, or copies in other than
black ink.
• Make sure that photocopies are clear, complete, and
fully readable.
• Do not include oversize computer printouts or fold-out
pages.
• Do not bind any documents with glue or binding tapes.
• Make sure that all pages of each study, including any
attachments or appendices, are present and in correct
sequence.
Number of Copies Required - All submittal packages except
those associated with a Registration Standard or Special Review
(See Part G below) must be provided In three complete, identical
copies. (The prop9sed regulati9ns specified two copies; three
are now being required to expedite and reduce the cost of
processing data into the OPP Pesticide Document Management System
and getting it into review.)
G. Special Requirements for Submitting Data to the Docket
Data submittal packages associated with a Registration Stan-
dard 9r Special Review must be provided in four C9pies, fr9m one
of which all material claimed as CBI has been excised. This
fourth copy will become part of the public docket for the RS or
SR case. If no claims of confidentiality are made for the study,
the fourth copy should be identical to the other three. When
portions of a study submitted in support of an RS or SR are
claimed as CBI, the first three copies will include the CBI
material as provided in section D of this notice. The following
special preparation is required for the fourth copy.
• Remove the "Supplemental Statement of Data
Confidentiality Claims".
• Remove the "Confidential Attachment".
• Excise from the body of the study any information you
claim as confidential, even if it does not fall within
the scope of FIFRA §10(d)(1)(A), (B), or (C). Do not
close up or paraphrase text remaining after this
excision.
• Mark the fourth copy plainly on both its cover and its
title page with the phrase "Public Docket Material -
contains no information claimed as confidential".
64
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V. For Further Information
For further information contact John Carley, Chief,
Information Services Branch, Program Management and Support
Division, (703) 305-5240.
/S/
James W. Akerman
Acting Director,
Registration Division
Attachment 1. Sample Transmittal Document
Attachment 2. Sample Title Page for a Newly Submitted Study
Attachment 3. Statements of Data Confidentiality Claims
Attachment 4. Supplemental Statement of Data Confidentiality
Claims
Attachment 5. Samples of Confidential Attachments
Attachment 6. Sample G9od Laboratory Practice Statements
Attachment 7. Format Diagrams for Submittal Packages and Studies
65
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ATTACHMENT 1
ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*
1. Name and address of submitter (or all joint submitters**)
"Smith Chemical Corporation Jones Chemical Company
1234 West Smith Street -and- 5678 Wilson Blvd
Cincinnati, OH 98765 Covington, KY 56789
"Smith Chemical Corp will act as sole agent for all submitters.
2. Regulatory action in support of which this package is
submitted
Use the EPA identification number (e.g. 359-EUP-67) if you know
it. Otherwise describe the type of request (e.g. experimental
use permit, data call-in - of xx-xx-xx date).
3. Transmittal date
4. List of submitted studies
Vol 1. Administrative materials - forms, previous corres-
pondence with Project Managers, and so forth.
Vol 2. Title of first study in the submittal (Guideline
No.)
Vol n Title of nth study in the submittal (Guideline
No.)
* Applicants commonly provide this information in a tran-
smittal letter. This remains an acceptable practice so
long as all four elements are included.
* Indicate which of the J9int submitters is empowered to
act on behalf of all joint submitters in any matter
concerning data compensation or subsequent use or
release of the data.
Company Official:
Name Signature
Company Name
Company Contact:
Name Phone
66
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ATTACHMENT 2
SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY
Study Title
(Chemical name) - Magnitude of Residue on Corn
Data Requirement
Guideline 171-4
Author
John C. Davis
Study Completed On
January 5, 1979
Performing Laboratory
ABC Agricultural Laboratories
940 West Bay Drive
Wilmington, CA 39897
Laboratory Project ID
ABC 47-79
Page 1 of X
(X is the total number of pages in the study)
67
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ATTACHMENT 3
STATEMENTS OF DATA CONFIDENTIALITY CLAIMS
1. No claim of confidentiality under FIFRA §10(d)(1)(A),(B), or (C).
STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS
No claim of confidentiality is made for any information contained in this
study on the basis of its falling within the scope of FIFRA
6§10(d)(1)(A), (B), or (C).
Company
Company Agent: Typed Name Date:
Title Signature
2. Claim of confidentiality under FIFRA §10(d)(1)(A), (B), or (C).
Information claimed confidential on the basis of its falling within the
scope of FIFRA §10(d)(1)(A), (B), or (C) has been removed to a
confidential appendix, and is cited by cross-reference number in the body
of the study.
Company:
Company Agent: Typed Name Date:
Title Signature
STATEMENT OF DATA CONFIDENTIALITY CLAIMS
NOTE: Applicants for permanent or temporary tolerances should
note that it is OPP policy that no permanent tolerance, temporary
tolerance, or request for an emergency exemption incorporating an
analytical method, can be approved unless the applicant waives
all claims of confidentiality for the analytical method. These
analytical methods are published in the FDA Pesticide Analytical
Meth9ds Manual, and therefore cannot be claimed as confidential.
OPP implements this policy by returning submitted analytical
methods, for which confidentiality claims have been made, to the
submitter, to obtain the confidentiality waiver before they can
be processed.
68
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ATTACHMENT 4
SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
For any portion of a submitted study that is not described
by FIFRA §10(d)(1)(A), (B), or (C), but for which y9u claim
C9nfidential treatment 9n another basis, the following informa-
tion must be included within a Supplemental Statement of Data
Confidentiality Claims:
• Identify specifically by page and line number(s) each
portion of the study for which you claim
confidentiality.
• Cite the reasons why the cited passage qualifies for
confidential treatment.
• Indicate the length of time--until a specific date or
event, or permanently--for which the information should
be treated as confidential.
• Identify the measures taken to guard against undesired
disclosure of this information.
• Describe the extent to which the information has been
disclosed, and what precautions have been taken in con-
nection with those disclosures.
• Encl9se C9pies of any pertinent determinations of
confidentiality made by EPA, other Federal agencies, of
courts concerning this information.
• If y9u assert that disclosure of this information would
be likely to result in substantial harmful effects to
you, describe th9se harmful effects and explain why
they should be viewed as substantial.
• If you assert that the informati9n in voluntarily sub-
mitted, indicate whether you believe disclosure of this
information might tend to lessen the availability to
EPA of similar information in the future, and if so,
how.
69
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ATTACHMENT 5
EXAMPLES OF SEVERAL CONFIDENTIAL ATTACHMENTS
Example 1. (Confidential word or phrase that has been deleted
from the study)
CROSS REFERENCE NUMBER 1 This cross reference number is used in the study in place of the
following paragraph (s) at the indicated volume and page
references.
DELETED WORDS OR PHRASE: Ethylene Glycol
PAGE LINES REASON FOR THE DELETION FIFRA
REFERENCE
6 14 Identity of Inert Ingredient §10(d)(C)
28 25
100 19
Example 2. (Confidential paragraph(s) that have been deleted from the study)
CROSS REFERENCE NUMBER 5 This cross reference number is used in the study in place of the
following paragraph (s) at the indicated volume and page
references.
DELETED PARAGRAPH(S) :
( )
( Reproduce the deleted paragraph (s) here )
PAGE LINES REASON FOR THE DELETION FIFRA REFERENCE
20. 2-17 Description of the quality control process § 1 0 (d) ( 1) (C)
Example 3. (Confidential pages that have been deleted from the study)
CROSS REFERENCE NUMBER 7 This cross reference number is used in the study in place of the
following paragraph (s) at the indicated volume and page
references.
DELETED PAGES(S): are attached immediately behind this page
PAGES REASON FOR THE DELETION FIFRA REFERENCE
35-41. Description of product manufacturing process § 10 (d) (1) (A)
70
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ATTACHMENT 6.
SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
Example 1.
This study meets the requirements for 40 CFR Part 160
Submitter
Sponsor
Example 2.
This study does not meet the requirements of 40 CFR Part 160, and
differs in the following ways:
1.
2.
3.
Submitter
Sponsor
Study Director_
Example 3.
The submitter of this study was neither the sponsor of this study nor
conducted it, and does not know whether it has been conducted in
accordance with 40 CFR Part 160.
Submitter
71
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ATTACHMENT 7.
FORMAT OF THE SUBMITTAL PACKAGE
Transmittal Document
Related Administrative Materials
(e.g. Method of Support Statement, etc.)
Other materials about the submittal
(e.g., summaries of groups of studies
to aid in their review).
Studies submitted as unique
to the format below.
FORMAT OF SUBMITTED STUDIES
• Study title page.
Statement of Confidentiality Claims.
GLP and flagging* statements - as appropriate.
Body of the study, with English
language translation if required.
Appendices to the study.
Title Page of the Confidential
Attachment.
Confidential Attachment.
Supplemental Statement
of Confidentiality Claims
When flagging requirements
are finalised.
Documents which must be submitted as
appropriate to meet established requirements.
Documents submitted at submitter's option.
LEGEND
72
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PR Notice 91-2
73
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74
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, B.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
PR NOTICE 91-2
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,
AND REGISTRANTS OF PESTICIDES
ATTENTION: Persons Responsible for Federal Registration of
Pesticide Products.
SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement
I. PURPOSE:
The purpose of this notice is to clarify the Office of
Pesticide P^gram's P9licy with respect to the statement of
percentages in a pesticide's label's ingredient statement.
Specifically, the amount (percent by weight) of ingredient(s)
specified in the ingredient statement on the label must be stated
as the nominal concentration of such ingredient(s), as that term
is defined in 40 CFR 158.153(1). Accordingly, the Agency has
established the nominal concentration as the only acceptable
label claim for the amount of active ingredient in the product.
II. BACKGROUND
For some time the Agency has accepted two different methods
9f identifying on the label what percentage is claimed for the
ingredient(s) contained in a pesticide. Some applicants claimed a
percentage which represented a level between the upper and the
lower certified limits. This was referred to as the nominal
concentration. Other applicants claimed the lower limit as the
percentage of the ingredient(s) that would be expected to be
present in their product at the end of the product's shelf-life.
Unfortunately, this led to a great deal of confusion among the
regulated industry, the regulators, and the consumers as to
exactly how much of a given ingredient was in a given product.
The Agency has established the nominal concentration as the only
acceptable label claim for the amount of active ingredient in the
product.
Current regulations require that the percentage listed in
the active ingredient statement be as precise as possible
reflecting go9d manufacturing practices 40 CFR 156.10(g)(5). The
certified limits required for each active ingredient are intended
to encompass any such "good manufacturing practice" variations 40
CFR 158.175(c)(3).
The upper and lower certified limits, which must be proposed
in connection with a product's registration, represent the
amounts of an ingredient that may legally be present 40 CFR
158.175. The lower certified limit is used as the enforceable
lower limit for the product composition according to FIFRA
section 12(a)(1)(C), while the nominal concentration appearing on
the label would be the routinely achieved concentration used for
calculation of dosages and dilutions.
The nominal concentration would in fact state the greatest
degree of accuracy that is warranted with respect to actual
75
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product compositi9n because the nominal concentration would be
the amount of active ingredient typically found in the product.
It is imp9rtant for registrants to note that certified
limits for active ingredients are not considered to be trade
secret information under FIFRA section 10(b). In this respect the
certified limits will be routinely provided by EPA to States for
enforcement purposes, since the nominal concentration appearing
on the label may not represent the enforceable composition for
purposes of section 12(a)(1)(C).
III. REQUIREMENTS
As described below under Unit V. " COMPLIANCE SCHEDULE," all
currently registered products as well as all applications for new
registration must comply with this Notice by specifying the
nominal C9ncentrati9n expressed as a percentage by weight as the
label claim in the ingredient(s) statement and equivalence
statements if applicable (e.g., elemental arsenic, metallic zinc,
salt of an acid). In addition, the requirement for performing
sample analyses of five or more representative samples must be
fulfilled. C9pies of the raw analytical data must be submitted
with the nominal ingredient label claim. Further information
about the analysis requirement may be found in the 40 CFR
158.170. All products are required to pr9vide certified limits
for each active, inert ingredient, impurities of toxicological
significance(i. e., upper limit(s) 9nly) and on a case by case
basis as specified by EPA. These limits are to be set based on
representative sampling and chemical analysis(i.e., quality
control) of the product.
The format of the ingredient statement must conform to 40
CFR 156-Labeling Requirements For Pesticides and Devices.
After July 1, 1997, all pesticide ingredient Statements must
be changed to nominal concentration.
IV. PRODUCTS THAT REQUIRE EFFICACY DATA
All pesticides are required to be efficacious. Therefore,
the certified lower limits may not be lower then the minimum
level to achieve efficacy. This is extremely important for
products which are intended to C9ntrol pests which threaten the
public health, e.g., certain antimicrobial and rodenticide
products. Refer to 40 CFR 153.640.
In those cases where efficacy limits have been established,
the Agency will not accept certified lower limits which are below
that level for the shelf life of the product.
V. COMPLIANCE SCHEDULE
As described earlier, the purpose of this Notice is to make
the registration process more uniform and more manageable for
both the agency and the regulated community. It is the Agency's
intention to implement the requirements of this notice as
smoothly as possible so as not to disrupt or delay the Agency's
high priority programs, i.e., reregistration, new chemical, or
fast track (FIFRA section 3(c)(3)(B). Therefore,
applicants/registrants are expected to comply with the
requirements of this Notice as follows:
(1) Beginning July 1, 1991, all new product registrations
submitted to the Agency are to comply with the
requirements of this Notice.
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(2) Registrants having products subject to reregistration
under FIFRA section 4(a) are to comply with the
requirements of this Notice when specific products are
called in by the Agency under Phase V of the
Reregistration Program.
(3) All other products/applications that are not subject to
(1) and (2) ab9ve will have until July 1, 1997, to
comply with this Notice. Such applications should note
"Conversion to Nominal Concentrations on the
application form. These types Or amendments will not be
handled as "Fast Track" applications but will be
handled as routine requests.
VI. FOR FURTHER INFORMATION
Contact Tyrone Aiken for information or questions concerning
this notice on (703) 308-7031.
/s/
Anne E. Lindsay, Director
Registration Division (H-7505C)
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APPENDIX F. Generic Data Call-in
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GENERIC DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient(s) identified in Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet,
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(s). 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 1
through 4; or,
2. why you believe you are exempt from the requirements listed in this Notice and in
Attachment 3, Requirements Status and Registrant's Response Form, (see section III-B);
or,
3. why you believe EPA should not require your submission of data in the manner 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 will 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 2, Data Call-in Response Form, as well as a
list of all registrants who were sent this Notice (Attachment 4).
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 OMB Approval No. 2070-0107
(expiration date 12-31-92).
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 - Why You Are Receiving This Notice
Section II - Data Required By 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
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The Attachments to this Notice are:
Attachment 1 - Data Call-in Chemical Status Sheet
Attachment 2 - Data Call-in Response Form
Attachment 3 - Requirements Status And Registrant's Response Form
Attachment 4 - List Of All Registrants Sent This Data Call-in Notice
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient(s) and reevaluated the
data needed to support continued registration of the subject active ingredient(s). This reevaluation
identified additional data necessary to assess the health and safety of the continued use of products
containing this active ingredient(s). You have been sent this Notice because you have product(s)
containing the subject active ingredient(s).
SECTION II. DATA REQUIRED BY THIS NOTICE
A. DATA REQUIRED
The data required by this Notice are specified in Attachment 3, Requirements
Status and Registrant s Response Form. Depending on the results of the studies required
in this Notice, additional testing may be required.
B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements
specified in Attachment 3, Requirements Status and Registrant's Response Form, within
the time frames provided.
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 §
158.70). When using the OECD protocols, they should be modified as appropriate so that
the data generated by the study will satisfy the requirements of 40 CFR § 15o. Normally,
the Agency will not extend deadlines for complying with data requirements when the
studies were 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)].
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D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-in does not in any way supersede or
change the requirements of any previous Data Call-in(s), 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 REQUIREMENTS OF THIS NOTICE
A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice must be submitted to
the Agency within 90 days after your receipt of this Notice. Failure to adequately respond
to this Notice within 90 days of your receipt will be a basis for issuing a Notice of Intent
to Suspend (NOIS) affecting your products. This and other bases for issuance of NOIS due
to failure to comply with this Notice are presented in Section IV-A and IV-B.
B. OPTIONS FOR RESPONDING TO THE AGENCY
The 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
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
Data-Call-in Response Form (Attachment 2) and the Requirements Status and Registrant's
Response Form (Attachment 3). The Data Call-In Response Form must be submitted as
part of every response to this Noticed Flease note that the company's authorized
representative is required to sign the first page of the Data Call-in Response Form and
Requirements Status and Registrant's Response Form (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 identified in Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by
requesting voluntary cancellation of your product(s) containing the active
ingredient (s) that is the subject of this Notice. If you wish to voluntarily cancel
your product, you must submit a completed Data Call-In Response Form
indicating your election of this option. Voluntary cancellation is item number b
on the Data Call-In 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. Use Deletion - You may avoid the requirements of this Notice by
eliminating the uses or your product to which the requirements apply. If you wish
to amend your registration to delete uses, you must submit the Requirements Status
and Registrant's Response Form, a completed application for amendment, a copy
of your proposed amended labeling, and all other information required for
processing the application. Use deletion is option number 7 on the Requirements
Status and Registrant's Response Form. You must also complete a Data Call-In
Response Form by signing the certification, item number 8. Application forms for
amending registrations may be obtained from the Registration Support and
Emergency Response Branch, Registration Division, (703) 308-8358.
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)(D) of FIFRA, an applicant
for registration of a product is exempt from the requirement to submit or cite
generic data concerning an active ingredient(s) if the active ingredient(s) in the
product is derived exclusively from purchased, registered pesticide products
containing the active ingredient(s). 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, all of the following requirements must be met:
a. The active ingredient(s) in your registered product must be present
solely because of incorporation of another registered product which
contains the subject active ingredient(s) and is purchased from a source not
connected with you; and,
b. every registrant who is the ultimate source of the active
ingredient (s) in your product subject to this DCI 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 Formula" 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 Form, Attachment 2 and all supporting documentation. The
Generic Data Exemption is item number 6a on the Data Call-In Response Form.
If you claim a generic data exemption you are not required to complete the
Requirements Status and Registrant s Response Form. Generic Data Exemption
cannot be selected as an option for product specific data.
If you are granted a Generic Data Exemption, you rely on the efforts of
other persons to provide the Agency with the required data. If the registrant^)
who have committed to generate and submit the required data fail to take
appropriate steps to meet the requirements or are no longer in compliance with this
Data Call-In Notice, the Agency will 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. In such cases the Agency generally will
not grant a time extension for submitting the data.
4. Satisfying the Data Requirements of this Notice - There are various options
available to satisfy the data requirements of this Notice. These options are
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discussed in Section III-C of this Notice and comprise options 1 through 6 on the
Requirements Status and Registrant's Response Form and option 6b and 7 on the
Data Caii-ln Response Form! it you choose option 6b or 7, you must submit both
forms as well as any other information/data pertaining to the option chosen to
address the data requirement.
5. Request for Data Waivers. Data waivers are discussed in Section III-D of
this Notice and are covered by options 8 and 9 on the Requirements Status and
Registrant's Response Form. If you choose one of these options, you must submit
both forms as well as any other information/data pertaining to the option chosen
to address the data requirement.
C. SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-in Response Form that you agree to satisfy
the data requirements (i.e. you select option 6b and/or '(), 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 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 (GLP) rule (40 CFR Part 160), be conducted according to the
Pesticide Assessment Guidelines (PAG), and be in conformance 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 Status and
Registrant's Response Form and/or footnotes to the form. It you wish to use a
protocol which differs from the options discussed in Section II-C of this Notice,
ou must submit a detailed description of the proposed protocol and your reason
'or wishing to use it. The Agency may choose to reject a protocol not specified
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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 or data.
A progress report must 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 making 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 9T)-day progress report must include the date the
study was or will be initiated and, for studies to be 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 be included as well as a full description of any problems encountered since
the last progress report.
The time frames in the Requirements Status and Registrant's Response
Form are the time frames that the Agency is allowing for the submission of
completed study reports or protocols. The noted deadlines run from 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 requirement(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 will respond to your request in writing. If EPA
does not grant your request, the original deadline remains. Normally, 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 the lapse of the subject deadline.
Option 2, Agreement to Share in Cost to Develop Data —
If you choose to enter into an agreement to share in the cost of producing
the required data but will not be submitting the data yourself, you must provide the
name of the registrant who will be submitting the data. You must 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.
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Option 3, Offer to Share in the Cost of Data Development —
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 unsuccessful, you may request EPA (by selecting 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 will 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 (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 Cost Share in the Development of Data.
In addition, you must demonstrate that the other registrant to whom the offer was
made has not accepted your offer to enter into a cost sharing 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 FIFRA 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 Data Call-In Response Form and a Requirements Status
and Registrant's Response Form 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 well as that of the other
registrant will 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 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 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 may
determine at any time that a study is not valid and needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing
study, all of the following three criteria must be clearly met:
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a. You must certify at the time that the existing study is submitted that
the raw data and specimens from the study are available for audit and
review and you must identify where they are available. This must be done
in accordance with the requirements of the Good Laboratory Practice
(GLP) regulation, 40 CFR Part 160. As stated in 40 CFR 160.3(7) " raw
data 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. Raw data
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(7), 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 GLP
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 NTIS). 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 raw data are usually not available for such studies.
If you submit an existing study, you must certify that the study
meets all requirements of the criteria outlined above.
If EPA has previously reviewed a protocol for a study you are
submitting, you must identify any action taken by the Agency on the
protocol and must indicate, as part of your certification, the manner in
which all Agency comments, concerns, or issues were addressed in the
final protocol and study.
If you know of a study pertaining to any requirement in this Notice
which does not meet the criteria outlined above but does contain factual
information regarding unreasonable adverse effects, you must notify the
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Agency of such a study. If such a study is in the Agency's files, you need
only cite it along with the notification. If not in the Agency's files, you
must submit a summary and copies as required by PR Notice 86-5.
Option 5, Upgrading 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 upgradeable 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 1. 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 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
must provide the MRID number of the data submission as well as the MRID
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 well 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 must be
a study which has not yet been reviewed by the Agency. Acceptable toxicology
studies generally will have been classified as 'core-guideline" or ' core minimum.'
For ecological effects studies, the classification generally would be a rating of
"core." 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 Form 8570-31, Certification with
Respect to Data Compensation Requirements.
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D. REQUESTS FOR DATA WAIVERS
There are two types of data waiver responses to this Notice. The first is a request
for a low volume/minor use waiver and 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 Volume/Minor Use Waiver — Option 8 on the Requirements Status
and Registrant's Response Eorm. Section 3(c)(2)(A) of FIFKA requires EPA to
consider the appropriateness of requiring data for low volume, minor use
pesticides. In implementing this provision EPA considers as low volume pesticides
only those active ingredient (s) whose total production volume for all pesticide
registrants is 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 (s) 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(s) 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(s) elects to conduct the testing. Any
registrant receiving a low volume minor use waiver must remain within the sales
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 a 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. Total company sales (pounds and dollars) of all registered
product(s) containing the active ingredient(s). If applicable to the active
ingredient(s), include foreign sales for those products that are not registered
in this country but are applied to sugar (cane or beet), coffee, bananas,
cocoa, and other such crops. Present the above information by year for
each of the past five years.
b. Provide an estimate of the sales (pounds and dollars) of the active
ingredient (s) for each major use site. Present the above information by
year for each of the past five years.
c. Total direct production cost of product (s) containing the active
ingredient (s) 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.
d. Total indirect production cost (e.g. plant overhead, amortized plant
and equipment) charged to product(s) containing the active ingredient(s) by
year for the past five years. Exclude all non-recurring costs that were
directly related to the active ingredient(s), such as costs of initial
registration and any data development.
e. 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.
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f. 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 requirements.
g. For each of the next ten years, a year-by-year forecast of company
sales (pounds and dollars) of the active ingredient(s), direct production
costs of product(s) containing the active ingredient(s) (following the
parameters in item c above), indirect production costs of product(s)
containing the active ingredient(s) (following the parameters in item d
above), and costs of data development pertaining to the active ingredient (s).
h. A description of the importance and unique benefits of the active
ingredient (s) to users. Discuss the use patterns and the effectiveness of the
active ingredient(s) relative to registered alternative chemicals and
non-chemical control strategies. Focus on benefits unique to the active
ingredient(s), providing information that is as quantitative as possible. If
you do not have quantitative data upon which to base your estimates, then
present the reasoning used to derive your estimates. To assist the Agency
in determining the degree of importance of the active ingredient (s) in terms
of its benefits, you should provide information on any of the following
factors, as applicable to your product(s):
(1) documentation of the usefulness of the active ingredient (s)
in Integrated Pest Management, (b) description of the beneficial impacts on
the environment of use of the active ingredient(s), as opposed to its
registered alternatives, (c) information on the breakdown of the active
ingredient(s) 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 waiver will result in denial of the request
for a waiver.
2. Request for Waiver of Data —Option 9 on the Requirements Status and
Registrant s Response FofrrT This option may 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 must submit a rationale
explaining why you believe the data requirements should not apply. You must also
submit the 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 will 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 determines that the data are required for your prpduct(s), you
must choose a method of meeting the requirements of this Notice within the time
frame provided by this 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.
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IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
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 a
Notice of Intent to Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt
of this Notice.
2. Failure to submit on the required schedule an acceptable proposed or final
protocol when such is 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 data as required by
this Notice.
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 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, or failure of a registrant on whom you rely for a generic data
exemption 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 Status
and Registrant's Response Form; of,
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.
9. Failure to take any required or appropriate steps, not mentioned above, at
any time following the issuance of this Notice.
B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
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The Agency may determine that a study (even if submitted within the required
time) is unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend.
The grounds for suspension include, but are not limited to, failure to meet any of the
following:
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 or 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 form of a final report; a preliminary report will not be considered to fulfill the
submission requirement.
C. EXISTING STOCKS OF SUSPENDED OR CANCELLED 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 Federal Insecticide, Fungicide, and
Rodenticide 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
produces) only in exceptional circumstances. If you believe such disposition of existing
stocks of your product(s) which may 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.
If 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 circumstances, one year from the date your 90 day response to this
Notice is due, to sell, distribute, or use existing stocks. Normally, the Agency will 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(s) 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,
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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. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE UNREASONABLE
ADVERSE EFFECTS
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 listed in Attachment 1, the Data Call-In Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-in Response Form (Attachment 2) and a
completed Requirements Status and Registrant's Response Form (Attachment 3) and any other
documents required by this Notice, ana should be submitted to the contact person identified in
Attachment 1. If the voluntary cancellation or generic data exemption option is chosen, only the
Data Call-In Response Form need be submitted.
The Office of Compliance (OC) of the Office of Enforcement and Compliance Assurance
(OECA), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
Louis P. True, Jr., Acting Director
Special Review
and Reregistration Division
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Attachment 1. Chemical Status Sheet
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Disodium Cyanodithioimidocarbonate DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have product(s)
containing Disodium Cyanodithioimidocarbonate.
This Generic Data Call-In Chemical Status Sheet contains an overview of data required
by this notice, and point or contact tor inquiries pertaining to the reregistration of Disodium
Cyanodithioimidocarbonate. 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 2), (3) the
Requirements Status and Registrant's Form (Attachment 2), (4) a list of registrants receiving this
DCI (Attachment 4), (5) the EPA Acceptance Criteria (Attachment 5), and (6) the Cost Share and
Data Compensation Forms in replying to this Disodium Cyanodithioimidocarbonate Generic Data
Callln (Attachment F). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for Disodium
Cyanodithioimidocarbonate are contained in the Requirements Status and Registrant's Response,
Attachment C. The Agency has concluded that additional product chemistry data on Disodium
Cyanodithioimidocarbonate are needed. These data are needed to fully complete the reregistration
of all eligible Disodium Cyanodithioimidocarbonate products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Bonnie Adler at (703) 308-8523.
All responses to this Notice for the generic data requirements should be submitted to:
Bonnie Adler, Chemical Review Manager
Accelerated Reregistration Branch
Special Review and Registration Division (7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Disodium Cyanodithioimidocarbonate
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Attachment 2. Generic DCI Response Forms Inserts (Form
A) plus Instructions
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SPECIFIC INSTRUCTIONS FOR THE GENERIC 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 ease number, ease 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 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. Cheek 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 the Requirements
Status and Registrant's Response Form 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
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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 Requirements Status and Registrant's
Response Form that indicates how you will satisfy those requirements.
Item 7a. Check this item if this call-in if a data call-in as indicated in Item 3 for a
manufacturing use product (MUP), and if your product is a manufacturing
use product for which you agree to supply product-specific data. Attach
the Requirements Status and Registrants Response Form 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 an end use product for which
you agree to supply product-specific data. Attach the Requirements Status
and 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 your company and the 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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Attachment 3. Requirements Status and Registrants'
Response Forms Inserts (Form B) plus Instructions
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SPECIFIC INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANTS RESPONSE FORM
Generic Data
This form is designed to be used for registrants to respond to call-in- 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 or 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 items. 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 form by typing or printing legibly.
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 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 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 5. 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
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Item 6.
submitted in connection with the study. As noted in Section III of the Data Call-In
Notice, 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.
This item identifies the code associated with the use pattern of the pesticide. A
brief description of each code follows:
A.
B.
C.
D.
E.
F.
G.
H.
I.
J.
K.
L.
M.
N.
0.
Terrestrial food
Terrestrial feed
Terrestrial non-food
Aquatic food
Aquatic non-food outdoor
Aquatic non-food industrial
Aquatic non-food residential
Greenhouse food
Greenhouse non-food crop
Forestry
Residential
Indoor food
Indoor non-food
Indoor medical
Indoor residential
Item 7.
This item identifies the code assigned to the substance that must be used for
testing. A brief description of each code follows.
EP
MP
MP/TGAI
PAI
PAI/M
PAI/PAIRA
PAIRA
PAIRA/M
PAIRA/PM
TEP
TEP_*
TEP/MET
TEP/PAI/M
TGAI/PAIRA
TGAI
TGAI/TEP
TGAI/PAI
MET
IMP
End-Use Product
Manufacturing-Use Product
Manufacturing-Use Product and Technical Grade
Active Ingredient
Pure Active Ingredient
Pure Active Ingredient and Metabolites
Pure 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 or Pure Active
Ingredient Radiolabelled
Technical Grade Active Ingredient
Technical Grade Active Ingredient or Typical
End-Use Product
Technical Grade Active Ingredient or Pure Active
Ingredient
Metabolites
Impurities
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DEGR Degradates
*See: guideline comment
Item 8. This item identifies the time frame allowed for submission of the study or protocol
identified in item 2. The time frame runs from the date of your receipt of the Data
Call-In Notice.
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 Notice 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 requirements pertaining to
the conditions for submittal of this study as outlined in the Data Call-in
Notice and that I will provide the protocol 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 am submitting a copy of
the form "Certification of Offer to Cost Share in the Development of Data"
that describes this offer/agreement. By 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 am 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 am 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 met 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 (MRID) that EPA has assigned to the data that I am citing as well
as the MRID of the study I am attempting to upgrade.
6. (Citing a Study) I am citing an existing study that has been previously
classified by EPA as acceptable, core, core minimum, or a study that has
not yet been reviewed by the Agency. I am providing the Agency's
classification of the study.
7. (Deleting Uses) I am attaching an application for amendment to my
registration deleting the uses for which the data are required.
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8. (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 requirement 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. Enter the name of the person EPA should contact with questions regarding your
response.
Item 13. Enter the phone number of your company contact.
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Attachment 4. List of Registrant(s) sent this DCI (Insert)
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APPENDIX G. Product Specific Data Call-in
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DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment 1 of this Notice, the Data Call-In Chemical Status 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
ofyour 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 3, Requirements Status and Registrant's Response Form, (see
section III-B); or
3. Why you believe EPA should not require your submission of product specific
data in the manner 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 will 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 2, Data Call-In Response Form, as
well as a list of all registrants who were sent this Notice (Attachment 6).
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 OMB Approval No. 2070-
0107 (expiration date 12-31-92).
This Notice is divided into six sections 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 Are Receiving This Notice
Section II - Data Required By 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
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Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-in Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Grouping or End-Use Products tor Meeting Acute Toxicology Data
Requirements tor Reregistration
EPA
5 - EPA Acceptance Criteria
6 - List or Registrants Receiving This Notice
7 - Cost Share and Data Compensation Forms, and Product Specific Data Report
Form
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 3,
Requirements Status and Registrant's Response Form. Depending on the results of the studies
required in this Notice, additional testing may be required.
II-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment 3, Requirements Status and Registrant's Response Form, within the time frames
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 § 158.70). When using the OECD
protocols, they should be modified as appropriate so that the data generated by the study will
satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend deadlines for
complying with data requirements when the studies were not conducted in accordance with
acceptable standards. The OECD protocols are available from OECD, 1750 Pennsylvania
Avenue N.W., Washington, D.C. 20006.
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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 3(c)(2)(B) NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-in does not in any way supersede or change
the requirements of any previous Data Call-in(s), 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 REQUIREMENTS OF THIS NOTICE
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for product specific data must
be submitted to the Agency within 90 days after your receipt of this Notice. Failure to
adequately respond to this Notice within 90 days of your receipt will be a basis for issuing a
Notice of Intent to Suspend (NOIS) affecting your products. This and other bases for issuance of
NOIS due to failure to comply with this Notice are presented in Section IV-A and IV-B.
III-B. OPTIONS FOR RESPONDING 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 chose 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 Data-Call-in
Response Form and the Requirements Status and Registrant's Response Form, Attachment 2 and
Attachment 3. The Data Call-in Response Form must be submitted as part of every response to
this Notice. In addition, one copy or the Requirements Status and Registrant's Response Form
must be submitted for each product listed on the Data Call-In Response 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-In Response Form in Attachment 2). Please note that
the company's authorized representative is required to sign the first page of the Data Call-In
Response Form and Requirements Status and Registrant's Response Form (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 1.
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 Data Call-
In Response Form, indicating your election of this option. Voluntary cancellation is item number
b on the Data Calf-In Response Form. If you choose this option, this is the only form that you
are required to complete.
If you chose 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 Product Specific Data Requirements of this 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 Status and Registrant's Response Form and item numbers 7a and 7b on the Data
Call-In Response Form. Deletion of a use(s) and the low volume/minor use option are not valid
options lor fulfilling product specific data requirements.
3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section 111-D ol this Notice and are covered by option 7 on the Requirements Status
and Registrant's Response Form. If you choose one of these options, you must submit both
forms as well as any other information/data pertaining to the option chosen to address the data
requirement.
III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form that you agree to satisfy the
product specific data requirements (i.e. you select item number 7a or 7b), 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 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)
I have made offers to cost-share (Offers to Cost Share)
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 (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide Assessment
Guidelines (PAG), and be in conformance with the requirements of PR Notice 86-5.
The time frames in the Requirements Status and Registrant's Response Form 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. 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 for meeting such requirements on a step-by-step basis. You
must explain any technical or laboratory difficulties and provide documentation from the
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laboratory performing the testing. While EPA is considering your request, the original deadline
remains. The Agency will respond to your request in writing. If EPA does not grant your
request, the original deadline remains. Normally, 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 the lapse of the subject deadline.
Option 2, Agreement to Share in Cost to Develop Data — Registrants may only choose
this option for acute toxicity data and certain efficacy data and 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 registration number of the product for which data will be submitted
must be noted in the agreement to cost share by the registrant selecting this option. If you choose
to enter into an agreement to share in the cost of producing the required data but will not be
submitting the data yourself, you must provide the name of the registrant who will be submitting
the data. You must 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 of 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 unsuccessful, you may request EPA (by selecting this
option) to exercise its discretion not to suspend your registration^), 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 will 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 (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 Cost Share in the Development of Data,
Attachment 7. In addition, you must demonstrate that the other registrant to whom the offer was
made has not accepted your offer to enter into a cost sharing 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 FIFRA 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 Data Call-In Response Form and a Requirements Status and Registrant's
Response Form 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
well as that of the other registrant will 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.
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Option 4, Submitting an Existing 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 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 may determine at any time that a study is not valid and
needs to be 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 raw data
and specimens from the study are available for audit and review and you must
identify where they are available. This must be done in accordance with the
requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR Part
160. As stated in 40 CFR 160.3(j) " 'raw data' 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. Raw data' 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 GLP 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 NTIS). 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
raw data are usually not available for such studies.
If you submit an existing study, you must certify that the study meets all requirements of
the criteria outlined above.
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If you know of a study pertaining to any requirement in this Notice which does not meet
the criteria outlined above but does contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study. If 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 must submit a
summary and copies as required by PR Notice 86-5.
Option 5, Upgrading 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 upgradeable 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 1. 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 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 must provide the MRID number of
the data submission as well as the MRID 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 well 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
must be a study which has not yet been reviewed by the Agency. Acceptable toxicology studies
generally will 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 Form 8570-31, Certification with Respect to Data Compensation
Requirements.
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-in Response Form and the
Requirements Status and Registrant's Response Form, as appropriate.
III-D REQUESTS 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
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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 Response Form. Product specific data requirements for product chemistry,
acute toxicity and efficacy (where appropriate) are required for all products and the Agency
would grant a waiver only under extraordinary circumstances. You should also be aware that
submitting a waiver request will not 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. CONSEQUENCES 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 a Notice of Intent to
Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
2. Failure to submit on the required schedule an acceptable proposed or final protocol
when such is 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 data as required by this
Notice.
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 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 or
failure of a registrant on whom you rely for a generic data exemption 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 Status and
Registrant's Response Form;
b. fulfill the commitment to develop and submit the data as required by this
Notice; or
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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.
9. Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEP TABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds
for suspension include, but are not limited to, failure to meet any of the following:
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 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 form of a final report; a
preliminary report will not be considered to fulfill the submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED 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 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. If you believe such disposition of existing stocks of your product(s) which may
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.
If 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
circumstances, one year from the date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will 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
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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 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. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
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 1, the Data Call-In Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data CalHn Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment 2 and Attachment 3 for
product specific data) and any other documents required by this Notice, and should be submitted
to the contact person(s) identified in Attachment 1. If the voluntary cancellation or generic data
exemption option is chosen, only the Data Call-In Response Form need be submitted.
The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
Louis P. True, Jr., Acting Director
Special Review and
Reregistration Division
Attachments
1 - Data Call-in Chemical Status Sheet
2 - Product-Specific Data Call-in Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Grouping of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
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5 - EPA Acceptance Criteria
6 - List of Registrants Receiving This Notice
7 - Cost Share and Data Compensation fr'orms, and Product Specific Data Report
Form
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Attachment 1. Chemical Status Sheet
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DISODIUM CYANODITHIOIMIDOCARBONATE DATA CALL-IN CHEMICAL STATUS
SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing Disodium Cyanodithioimidocarbonate.
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
Disodium Cyanodithioimidocarbonate. 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 2), (3) the Requirements Status and Registrant's Form (Attachment 3), (4) EPA's
Grouping of End-Use Products for Meeting Acute Toxicology Data Requirement (Attachment 4),
(5) the EPA Acceptance Criteria (Attachment 5), (6) a list of registrants receiving this DCI
(Attachment 6) and (7) the Cost Share and Data Compensation Forms in replying to this
Disodium Cyanodithioimidocarbonate Product Specific Data Call-In (Attachment 7). Instructions
and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for Disodium
Cyanodithioimidocarbonate are contained in the Requirements Status and Registrant's Response,
Attachment 3. The Agency has concluded that additional data on Disodium
Cyanodithioimidocarbonate are needed for specific products. These data are required to be
submitted to the Agency within the time frame listed. These data are needed to fully complete
the reregistration of all eligible Disodium Cyanodithioimidocarbonate products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of Disodium
Cyanodithioimidocarbonate, please contact Bonnie Adler at (703) 308-8523.
If you have any questions regarding the product specific data requirements and procedures
established by this Notice, please contact Franklin Gee at (703) 308-8008.
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Ed Setron
Chemical Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Disodium Cyanodithioimidocarbonate
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Attachment 2. Product Specific Data Call-In Response Forms
(Form A inserts) Plus Instructions
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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." 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.
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 canceled this product. For these cases, please supply all relevant details
so that EPA can ensure that its records are correct.
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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, SubpartC.
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 Reregistration Eligibility Document unless EPA
determines that a longer time period is necessary.
Item 9. Enter only one of the 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 me 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 pertainingto the conditions for submittal of this study as outlined in the
Data Call-In Notice. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form (EPA
Form 8570-29) and (2) two completed and signed copies of the Confidential
Statement of Formula (EPA Form 8570-4).
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 may be subject to suspension. By the specified due
date, I will also submit: (1) a completed "Certification With Respect To Data
Compensation Requirements" form (EPA Form 8570-29) and (2) two completed
and signed copies of the Confidential Statement of Formula (EPA Form 8570-4).
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 offer to another registrant (who has an obligation to
submit data) to share in the cost of that data. I am also submitting a completed
130
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"Certification of Offer to Cost Share 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. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
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. By the specified due date, I will also submit a completed "Certification With
Respect To Data Compensation Requirements" form (EPA Form 8570-29) to
show what data compensation option I have chosen. By the specified due date, I will
also submit: (1) a completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed copies
of the Confidential Statement of Formula (EPA Form 8570-4).
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 o in the Data Call-In Notice (Section III-C.l.) apply. By the
specified due date, I will also submit: (1) a completed "Certification With Respect
To Data Compensation Requirements" form (EPA Form 8570-29) and (2) two
completed and signed copies of the Confidential Statement of Formula (EPA Form
8570-4).
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 same data. I may also choose this option if I am citing my own
data. In either case, I will provide the MRID or Accession number(s) for the cited
data on a "Product Specific Data Report" form or in a similar format. By the
specified due date, I will also submit: (1) a completed "Certification With Respect
To Data Compensation Requirements" form (EPA Form 8570-29) and (2) two
completed and signed copies of the Confidential Statement of Formula (EPA Form
8570-4).
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
131
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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. By the specified due date, I will also submit: (1)
a completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
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 canceled this product. For these cases, please supply all relevant details
so that EPA can ensure that its records are correct.
132
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Attachment 3. Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and
Instructions
133
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134
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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 guidelines 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, Subpartc.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use patters (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 Reregistration Eligibility Documents unless EPA
determines that a longer time period is necessary.
Item 9. Enter Only one of the 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 on 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 my 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 offer 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 Share 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 require 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.
135
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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 upgrade (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 same data. I may also choose this option if I am citing my own
data. In either case, I will provide the MRID or Accession number (s) number (s) for
the cited data on a "Product Specific Data Report" form or in a similar format. If I
cite another registratrant's data, I will submit a completed "Certification With Respect
To Data Compensation Requirements" form.
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 require 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 chosen. I also understand that the deadline for
submission of data as specified by the original data cal-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.
136
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Attachment 4. EPA Batching of End-Use Products for
Meeting Data Requirements for Reregistration
137
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138
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EPA'S BATCHING OF DISODIUM CYANODITHIOIMIDOCARBONATE (DCDIC)
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 products containing the active ingredient disodium
cyanodithioimidocarbonate (DCDIC), 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, and
frequently acute toxicity data on individual 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 product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite
a single battery of six acute toxicological studies to represent all the products within that batch. It
is the registrants' option to participate in the process with all other registrants, only some of the other
registrants, or only their own products within a batch, or to generate all the required acute
toxicological 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 that the
data base is complete and valid by today's standards (see acceptance criteria attached), the
formulation tested is considered by EPA to be similar for acute toxicity, and the formulation has not
been significantly 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: 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.
The tables below show the products which were batched together in batches numbered one through
four.
139
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BATCH
NO.
1
EPA REG,
NO.
1448-115
1760-27
7053-18
9403-10
9619-11
10807-136
10827-71
11743-6
12480-2
14804-4
20375-8
22558-5
31964-7
% of Disodium Cyanodithioimidocarbonate
& Other Active Ingredients
3.68% - Disodium Cyanodithioimidocarbonate
5.07% - Potassium N-methyldithiocarbamate
3.68% - Disodium Cyanodithioimidocarbonate
5.07% - Potassium N-methyldithiocarbamate
3.68% - Disodium Cyanodithioimidocarbonate
5.07% - Potassium N-methyldithiocarbamate
3.68% - Disodium Cyanodithioimidocarbonate
5.07% - Potassium N-methyldithiocarbamate
3.68% - Disodium Cyanodithioimidocarbonate
5.07% - Potassium N-methyldithiocarbamate
3.68% - Disodium Cyanodithioimidocarbonate
5.07% - Potassium N-methyldithiocarbamate
3.68% - Disodium Cyanodithioimidocarbonate
5.07% - Potassium N-methyldithiocarbamate
3.68% - Disodium Cyanodithioimidocarbonate
5.07% - Potassium N-methyldithiocarbamate
3.68% - Disodium Cyanodithioimidocarbonate
5.07% - Potassium N-methyldithiocarbamate
3.68% - Disodium Cyanodithioimidocarbonate
5.07% - Potassium N-methyldithiocarbamate
3.68% - Disodium Cyanodithioimidocarbonate
5.07% - Potassium N-methyldithiocarbamate
3.68% - Disodium Cyanodithioimidocarbonate
5.07% - Potassium N-methyldithiocarbamate
3.68% - Disodium Cyanodithioimidocarbonate
5.07% - Potassium N-methyldithiocarbamate
Formulation Type
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
140
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BATC
HNO.
1
(Cont.)
2
EPA REG.
NO.
32852-11
34859-2
36532-1
40951-5
45388-2
45591-5
54310-2
55160-3
64864-11
1685-91
10088-70
12479-3
17866-5
30942-4
39529-2
40840-2
43553-6
% of Disodium Cyanodithioimidocarbonate
& Other Active Ingredients
3.68% - Disodium Cyanodithioimidocarbonate
5.07% - Potassium N-methyldithiocarbamate
3.68% - Disodium Cyanodithioimidocarbonate
5.07% - Potassium N-methyldithiocarbamate
3.68% - Disodium Cyanodithioimidocarbonate
5.07% - Potassium N-methyldithiocarbamate
4.20% - Disodium Cyanodithioimidocarbonate
5.80% - Potassium N-methyldithiocarbamate
3.68% - Disodium Cyanodithioimidocarbonate
5.07% - Potassium N-methyldithiocarbamate
3.68% - Disodium Cyanodithioimidocarbonate
5.07% - Potassium N-methyldithiocarbamate
3.68% - Disodium Cyanodithioimidocarbonate
5.07% - Potassium N-methyldithiocarbamate
3.68% - Disodium Cyanodithioimidocarbonate
5.07% - Potassium N-methyldithiocarbamate
3.68% - Disodium Cyanodithioimidocarbonate
5.07% - Potassium N-methyldithiocarbamate
4.90% - Disodium Cyanodithioimidocarbonate
6.76% - Potassium N-methyldithiocarbamate
4.90% - Disodium Cyanodithioimidocarbonate
6.76% - Potassium N-methyldithiocarbamate
4.90% - Disodium Cyanodithioimidocarbonate
6.76% - Potassium N-methyldithiocarbamate
4.90% - Disodium Cyanodithioimidocarbonate
6.76% - Potassium N-methyldithiocarbamate
4.90% - Disodium Cyanodithioimidocarbonate
6.76% - Potassium N-methyldithiocarbamate
3.80% - Disodium Cyanodithioimidocarbonate
5.20% - Potassium N-methyldithiocarbamate
4.90% - Disodium Cyanodithioimidocarbonate
6.76% - Potassium N-methyldithiocarbamate
4.90% - Disodium Cyanodithioimidocarbonate
6.76% - Potassium N-methyldithiocarbamate
Formulation Type
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
141
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BATCH
NO.
2
(Cont.)
3
EPA REG.
NO.
56151-1
56244-1
57333-1
1448-180
7053-17
7547-20
7547-21
8540-20
11712-30
20375-6
44392-4
47158-4
47251-5
49271-3
51661-9
56567-3
59907-2
% of Disodium Cyanodithioimidocarbonate
& Other Active Ingredients
4.90% - Disodium Cyanodithioimidocarbonate
6.76% - Potassium N-methyldithiocarbamate
4.90% - Disodium Cyanodithioimidocarbonate
6.76% - Potassium N-methyldithiocarbamate
4.90% - Disodium Cyanodithioimidocarbonate
6.76% - Potassium N-methyldithiocarbamate
7.35% - Disodium Cyanodithioimidocarbonate
10.15% - Potassium N-methyldithiocarbamate
7.35% - Disodium Cyanodithioimidocarbonate
10.15% - Potassium N-methyldithiocarbamate
7.35% - Disodium Cyanodithioimidocarbonate
10.15% - Potassium N-methyldithiocarbamate
7.35% - Disodium Cyanodithioimidocarbonate
10.15% - Potassium N-methyldithiocarbamate
7.35% - Disodium Cyanodithioimidocarbonate
10.15% - Potassium N-methyldithiocarbamate
7.35% - Disodium Cyanodithioimidocarbonate
10.15% - Potassium N-methyldithiocarbamate
7.35% - Disodium Cyanodithioimidocarbonate
10.15% - Potassium N-methyldithiocarbamate
7.35% - Disodium Cyanodithioimidocarbonate
10.15% - Potassium N-methyldithiocarbamate
7.35% - Disodium Cyanodithioimidocarbonate
10.15% - Potassium N-methyldithiocarbamate
7.35% - Disodium Cyanodithioimidocarbonate
10.15% - Potassium N-methyldithiocarbamate
7.35% - Disodium Cyanodithioimidocarbonate
10.15% - Potassium N-methyldithiocarbamate
7.35% - Disodium Cyanodithioimidocarbonate
10.15% - Potassium N-methyldithiocarbamate
7.35% - Disodium Cyanodithioimidocarbonate
10.15% - Potassium N-methyldithiocarbamate
7.35% - Disodium Cyanodithioimidocarbonate
10.15% - Potassium N-methyldithiocarbamate
Formulation Type
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
142
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BATCH
NO.
4
EPA REG.
NO.
1448-53
1448-54
1448-128
40308-4
46773-5
% of Disodium Cyanodithioimidocarbonate
& Other Active Ingredients
14.70% - Disodium Cyanodithioimidocarbonate
20.30% - Potassium N-methyldithiocarbamate
14.70% - Disodium Cyanodithioimidocarbonate
20.30% - Potassium N-methyldithiocarbamate
14.70% - Disodium Cyanodithioimidocarbonate
20.30% - Potassium N-methyldithiocarbamate
14.70% - Disodium Cyanodithioimidocarbonate
20.30% - Potassium N-methyldithiocarbamate
14.70% - Disodium Cyanodithioimidocarbonate
20.30% - Potassium N-methyldithiocarbamate
Formulation Type
Liquid
Liquid
Liquid
Liquid
Liquid
The table below shows the four remaining products which were not batched. These products were
not considered similar for purposes of acute toxicity. The registrants of these products are
responsible for meeting the acute toxicity data requirements specified in the data matrix.
EPA REG.
NO.
402-125
1448-75
1448-93
46412-2
%of
1.84%
2.53%
32.00%
14.50%
18.00%
Disodium Cyanodithioimidocarbonate
& Other Active Ingredients
- Disodium Cyanodithioimidocarbonate
- Potassium N-methyldithiocarbamate
- Disodium Cyanodithioimidocarbonate
- Disodium Cyanodithioimidocarbonate
- Sodium N-methyldithiocarbamate
9.79% - Disodium Cyanodithioimidocarbonate
13.51% - Potassium N-methyldithiocarbamate
Formulation Type
Liquid
Liquid
Liquid
Liquid
143
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144
-------
Attachment 5. EPA Acceptance Criteria
145
-------
146
-------
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
147
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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 lexicologically significant impurities (e.g., dioxins, nitrosamines) present "af < 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.
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 lexicologically
significant impurities~(see #3).
148
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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, Y, 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 > 0.1%.
2. Degree of accountability!)!" closure _>_ ca 98%.
3. Analyses conducted for certain trace toxiclmpurities 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 lexicologically significant
impurities at < 0.1% along with explanation of how limit determined.
9. Analytical methods to verify certified limits of each active ingredient and impurities (latter not required if exempt
from requirement of tolerance or if generally recognized as safe by FDA) are fully described.
10. Analytical methods (as discussed in #9) to verify certified limits validated as to their precision and accuracy.
149
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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/ml or the specific gravity of liquids reported with
reference to water at 20° C. [Note: Bulk density of registered products may be reported in lbs/ft3 or
Ibs/gallon.]
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
150
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SUBDIVISION F
Guideline Study Tide
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
151
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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.r Dosing, single oral may be administered over 24 hrs.
4.*^ Vehicle control if other than water.
5. Doses tested, sufficient to determine a toxicity category or a limit dose (5000 mg/kg).
6. 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 an * 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
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 oefore 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
ingestion.
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 an * are supplemental and may not be required for every study.
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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 15 pm 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.
154
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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 1, 24, 48 and 72 hr, then daily until eyes are normal
or 21 days (whichever is shorter).
9.^ Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
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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 cm2.
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 1, 24, 48 and 72 hr, then daily until normal or 14 days
(whichever is shorter).
11 .^ Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
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81-6 Dermal Sensitization in the Guinea Pig
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
pHof <2or >11.5.
3. One offhe 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.^ 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 an * are supplemental and may not be required for every study.
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158
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Attachment 6. List of All Registrants Sent This Data Call-In (insert) Notice
159
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160
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Attachment 7. Cost Share Data Compensation Forms, Confidential
Statement of Formula Form and Instructions
161
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162
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164
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed copies of the form are
required. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of the responsible party must be provided.
d. All applicable information which is on the product specific data submission must also be reported on the
CSF.
e. All weights reported under item 7 must be in pounds per gallon for liquids and pounds per cubic feet for
solids.
f. Flashpoint must be in degrees Fahrenheit and flame extension in inches.
g. For all active ingredients, the EPA Registration Numbers 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 must be reported under column 10
and must be exactly the same as on the source product's laoel.
j. All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or grams. In no case will
volumes be accepted. Do not mix English and metric system units (i.e., pounds and kilograms).
k. All the items under column 13.b. must total 100 percent.
1. All items under columns 14.a. and 14.b. for the active ingredients must represent pure active form.
m. The upper and lower certified limits for ail active and inert ingredients must follow the 40 CFR 158.175
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.
165
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166
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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
2070-0057
Approval Expires 3-31-96
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
Product Name
Company Number
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 could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Name of Firm(s)
Date of Offer
Certification:
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 all attachments therein 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.
Signature
Name and
of Company's Authorized Representative
Date
Title (Please Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA Form 8580, which is obsolete
167
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168
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&EPA
United States Environmental
Washington, DC
CERTIFICATION WITH
DATA COMPENSATION
Protection
20460
Agency
RESPECT TO
REQUIREMENTS
OUf M*. 3070-0107
2070-0057
Approval Expire* 3-31-96
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 Nam*
Product N«M
Company Numbar
SPA *•?. HO.
I Certify that:
1. For each study cited in support of registration or ^registration under the Federal Insecticide, Fungicide and
Rodenticide 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 that study.
2. That for each study cited in support of registration or ^registration 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 writing the company(ies) 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 FIFRA; 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: (check one)
[ ] 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 wfth section 3(c)(i )(D) of FIFRA for the studies I have cited in support of
registration or reregistratton under FIFRA.
Signature
Date
Name and Till* (Pl«aa« Typ* or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to me
registration or reregistratton of my products, to the extent required by FIFRA sections 3(C)(1)(D) and 3(c)(2)(D).
Signature
Date
Name and Title
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170
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APPENDIX H. FACT SHEET
171
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United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-94-017
September 1994
R.E.D. FACTS
Pesticide
Reregistration
Use Profile
Disodium
cyanodithioimido-
carbonate (DCDIC)
All pesticides sold or distributed in the United States must be registered
by EPA, based on scientific studies showing that they can be used without
posing unreasonable risks to people or the environment. Because of advances
in scientific knowledge, the law requires that pesticides which were first
registered years ago be reregistered to ensure that they meet today's more
stringent standards.
In evaluating pesticides for reregi strati on, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human health
and environmental effects of each pesticide. The Agency imposes any
regulatory controls that are needed to effectively manage each pesticide's
risks. EPA then reregisters pesticides that can be used without posing
unreasonable risks to human health or the environment.
When a pesticide is eligible for reregi strati on, EPA announces this and
explains why in a Reregi strati on Eligibility Decision (RED) document. This
fact sheet summarizes the information in the RED document for reregi strati on
case 3065, disodium cyanodithioimidocarbonate or DCDIC.
Disodium cyanodithioimidocarbonate or DCDIC is a microbicide/
microbistat used in water treatment systems. Specifically, it is used as an
industrial biocide and slimicide to control slime-forming bacteria, algae and
fungi in food processing water systems (cane and beet sugar mills), pulp and
paper mill water systems, other commercial/industrial water cooling systems,
and secondary oil recovery injection water. DCDIC is formulated as a soluble
concentrate/liquid, and is applied through use of a measuring container,
metering pump or drip-feed device.
Current use practice limitations prohibit discharge of effluent containing
DCDIC into sewage systems without notifying the sewage plant authority,
and into lakes, streams, ponds, estuaries, oceans or public waters except in
accordance with an NPDES permit.
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Regulatory
History
Human Health
Assessment
DCDIC was registered in the U.S. as early as 1957 for use as an
industrial bactericide and slimicide. EPA issued a reregi strati on Phase 4 Data
Call-In (DCI) in September 1992, requiring product chemistry, toxicology,
ecological effects and environmental fate data. Currently, 57 pesticide
products are registered which contain the active ingredient DCDIC.
Toxicity
DCDIC generally is of moderate acute toxicity but causes eye irritation
and has been placed in Toxicity Category I (indicating the greatest degree of
acute toxicity) for this effect. DCDIC is in Toxicity Category II for acute oral
and primary dermal effects, and Toxicity Category III for acute dermal and
inhalation effects. (Toxicity Category I indicates the greatest degree of acute
toxicity and Category IV the least.)
In a subchronic toxicity study using rats, dermal irritation was observed
at all doses but systemic effects were noted only at the highest dose levels.
No gross internal organ effects were observed at any dose.
In two developmental toxicity studies using rabbits and rats, DCDIC
caused both maternal and fetal effects at and above mid-dose. No definitive
determination could be made as to whether the fetal effects observed were
caused by DCDIC directly or occurred indirectly as a result of maternal
toxicity.
DCDIC was not mutagenic in two out of three required studies.
Although EPA does not believe that there is a genetic risk, the Agency is
requiring that the third study be repeated as confirmatory information.
Dietary Exposure
Food additive tolerances (maximum limits for residues in processed
foods) have been established by the Food and Drug Administration (FDA) for
the sugar beet and sugar cane mill uses of DCDIC (please see 21 CFR
173.320). EPA defers to FDA regarding this dietary exposure to DCDIC.
Additional food additive tolerances have been set for residues of DCDIC in
food grade paper, paperboard (21 CFR 176.300) and adhesives (21 CFR
175.105). However, these uses are neither active nor supported for
reregi strati on.
Occupational and Residential Exposure
Pesticide handlers-mixers, loaders and applicators—may be exposed to
DCDIC when adding it to the metering pumps and measuring containers of
food processing or industrial water systems.
EPA's exposure assessment, which considered combined dermal and
inhalation exposure, indicates that the highest risk appears to result from the
open pour application of this pesticide to cooling tower water. The margin of
exposure (MOE) for this use pattern is only 38, significantly less than the
100-fold margin believed to be acceptable. However, due to the worst-case
assumptions involved in the analysis, the actual risk to workers is expected to
be at least 10% less, making the MOE 380 or more. Risks of developmental
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toxicity to workers are expected to be low when appropriate protective
equipment and clothing are used.
To mitigate acute as well as chronic toxicity hazards during open
pouring of DCDIC, use of personal protective equipment (PPE) is required
including protective eyewear, chemical resistant gloves, footwear, socks, a
long-sleeved shirt, long pants and a respirator.
Post-application exposure is minimal posing negligible risk to workers.
Residential exposure and risk to homeowners are not expected, based on the
pesticide's use patterns.
Human Risk Assessment
Although DCDIC has two food uses (sugar beets and sugar cane), both
are under FDA's purview. EPA defers to FDA regarding DCDIC's dietary
risk.
The open pouring method of applying DCDIC to cooling tower water
appears to pose the greatest risk of developmental toxicity to applicators.
However, EPA's worst case exposure assessment probably results in an
overestimate of risk; the actual risk to workers is expected to be low when
appropriate protective equipment and clothing are used, as required by the
RED document. Post-application exposure and risk are likely to be minimal.
Residential exposure and risk to homeowners are not anticipated based on
DCDIC's use patterns.
Environmental
Assessment
Environmental Fate
The secondary oil recovery use of DCDIC normally would require
extensive data regarding potential ground water impacts. However, properly
encased injection wells preclude contact between materials placed down the
well and any aquifer in the area; so EPA believes the chemical is not likely to
present a hazard to ground water through this use. Other aquatic industrial
uses carry National Pollutant Discharge Elimination System (NPDES) permit
restrictions, limiting industrial discharges to acceptable levels for each site.
Ecological Effects
DCDIC is practically nontoxic to birds, no more than slightly toxic to
freshwater and estuarine/marine fish, and moderately to highly toxic to
aquatic/estuarine invertebrates.
Ecological Effects Risk Assessment
Because of its current use patterns, DCDIC is not likely to be found at
levels of concern in the terrestrial environment, or to pose risks to birds.
EPA used a Tier Ic Estimated Environmental Concentration (EEC)
model to assess residue levels occurring immediately downstream from
industrial discharge sites. High exposure and typical exposure scenarios were
developed for each use site. Typical exposure case EECs do not exceed levels
of concern for any use sites; however, high exposure case EECs exceed levels
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Additional Data
Required
Product Labeling
Changes Required
of concern for aquatic invertebrates at some industrial cooling towers and
sugar mills. Thus, freshwater aquatic invertebrates may be at risk from
effluent at high exposure sites. Similarly, estuarine and marine aquatic
invertebrates may be at risk from effluent at high exposure industrial cooling
tower and oil recovery sites.
While the use of DCDIC as a pesticide is regulated by EPA's Office of
Pesticide Programs (OPP) under the federal pesticide law, FIFRA, the
discharge of effluent containing DCDIC to surface waters is regulated under
the NPDES permit program administered by EPA's Office of Water (OW)
with the states. The NPDES process takes local conditions into account in
issuing permits for the discharge of pollutants to bodies of water. EPA's OPP
and OW will share information and cooperate in overseeing the use of
biocides such as DCDIC.
Endangered Species
The high exposure case scenarios described above exceed the levels of
concern for endangered fish at certain industrial sites, and those for
endangered aquatic invertebrates at all sites. Effluent containing DCDIC
should not be discharged into aquatic habitats where endangered species are
known to live.
EPA is working with the U.S. Fish and Wildlife Service to develop a
program to identify pesticides whose use may cause adverse impacts on
threatened and endangered species, and to implement mitigation measures that
will eliminate the adverse impacts. This program will require labeling that
directs users to county-specific bulletins for information about use restrictions
to protect endangered and threatened species in the county.
The generic data base for DCDIC is substantially complete. However,
for confirmatory purposes, EPA is requiring an additional mutagenicity study
and data indicating the products of hydrolysis. The Agency also is requiring
product-specific data, including product chemistry and acute toxicity studies,
as well as revised Confidential Statements of Formula and revised labeling for
reregi strati on.
All end-use products containing DCDIC must comply with EPA's
current pesticide product labeling requirements. In addition:
Effluent Discharge Statement - All end-use (and manufacturing use)
products that may be contained in an effluent discharged to the waters of the
U.S. must bear the following revised effluent discharge statement:
"Do not discharge effluent containing this product into lakes, streams,
ponds, estuaries, oceans or other waters unless in accordance with the
requirements of a National Pollutant Discharge Elimination System
(NPDES) permit and the permitting authority has been notified in
writing prior to discharge. Do not discharge effluent containing this
product to sewer systems without previously notifying the local sewage
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treatment plant authority. For guidance contact your State Water Board
or Regional Office of EPA."
PPE Requirements - All end-use product labels must bear the following
statement:
"For open pouring of this product, workers must wear eyewear,
chemical-resistant gloves, footwear, socks, long-sleeved shirt, long
pants and a respirator with either an organic-vapor-removing cartridge
with a prefilter approved for pesticides (MSHA/NIOSH approval
number prefix TC-23C) or a canister approved for pesticides
(MSHA/NIOSH approval number prefix TC-14G)."
Regulatory
Conclusion
The use of currently registered products containing DCDIC in
accordance with approved labeling will not pose unreasonable risks or adverse
effects to humans or the environment. Therefore, all uses of pesticide
products containing DCDIC are eligible for reregi strati on.
Although there is some concern about potential effects on aquatic
organisms exposed to effluent from industrial use of DCDIC, discharge of
such effluent generally will not cause unreasonable adverse effects on the
environment. EPA's OPP and OW will share information to improve the
regulation of DCDIC's use at specific sites across the country.
Products containing DCDIC will be reregistered once the required
confirmatory generic data, product-specific data, revised Confidential
Statements of Formula and revised labeling are received and accepted by
EPA, and after the other active ingredients in these products also are
determined to be eligible for reregi strati on.
For More
Information
EPA is requesting public comments on the Reregi strati on Eligibility
Decision (RED) document for DCDIC during a 60-day time period, as
announced in a Notice of Availability published in the Federal Register. To
obtain a copy of the RED document or to submit written comments, please
contact the Pesticide Docket, Public Response and Program Resources
Branch, Field Operations Division (7506C), Office of Pesticide Programs
(OPP), US EPA, Washington, DC 20460, telephone 703-305-5805.
Following the comment period, the DCDIC RED document will be
available from the National Technical Information Service (NTIS), 5285 Port
Royal Road, Springfield, VA 22161, telephone 703-487-4650.
For more information about EPA's pesticide reregi strati on program, the
DCDIC RED, or reregi strati on of individual products containing DCDIC,
please contact the Special Review and Reregi strati on Division (7508W), OPP,
US EPA, Washington, DC 20460, telephone 703-308-8000.
For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact
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the National Pesticides Telecommunications Network (NPTN). Call toll-free
1-800-858-7378, between 8:00 am and 6:00 pm Central Time, Monday
through Friday.
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