United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA 738-F-94-027
September 1994
4»EPA Reregistration
Eligibility Decision (RED)
Sodium and Zinc Salts of
2-Mercaptobenzothiazole
Recycled/Recyclable
Printed with Soy/Canola Ink on paper that
contains at least 50% post-consumer recycled fiber
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3k)
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 2380 which
includes the active ingredients sodium 2-mercaptobenzothiazole and zinc 2-
mercaptobenzothiazole. The enclosed Reregistration Eligibility Decision (RED) contains the
Agency's evaluation of the data base of these chemicals, 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.
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 Kathleen Depukat at 703-308-8587.
Sincerely yours,
ctor
Enclosures
ris P* True, Jr.-,. Actiflj
Jp^ial-Review and
Reregistratipn Division
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1 DATA CALL-IN (DO) 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 REQTJESTS-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. Matt;
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
SODIUM AND ZINC SALTS OF 2-MERCAPTOBENZOTHIAZOLE
LISTB
CASE 2380
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
SODIUM AND ZINC SALTS OF 2-MERCAPTOBENZOTHIAZOLE REREGISTRATION
ELIGIBILITY DECISION TEAM i
EXECUTIVE SUMMARY . vi
I. INTRODUCTION 1
H. CASE OVERVIEW 2
A. Chemical Overview 2
1. Sodium 2-Mercaptobenzothiazole 2
2. Zinc 2-Mercaptobenzothiazole 2
B. Use Profile 3
C. Data Requirements 6
D. Regulatory History 6
ffl. SCIENCE ASSESSMENT 7
A. Physical Chemistry Assessment 7
B. Human Health Assessment 8
1. Toxicology Assessment 8
a. Acute Toxicity 8
b. Subchronic Toxicity 10
c. Chronic Toxicity and Carcinogenicity 10
d. Developmental Toxicity 11
e. Reproductive Toxicity 11
f. Mutagenicity 11
g. Metabolism and Dermal Absorption . 11
h. Reference Dose (RfD) for Chronic Oral Exposure 12
2. Exposure Assessment 12
a. Dietary 12
b. Occupational and Residential 13
3. Risk Assessment 14
a. Occupational and Residential 14
C. Environmental Assessment 15
1. Environmental Fate 15
a. Environmental Fate Assessment 15
2. Ecological Effects 15
a. Ecological Effects Data 16
(1) Terrestrial Data - Avian 16
(2) Aquatic Data 16
b. Ecological Effects Risk Assessment 16
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IV. RISK MANAGEMENT AND REREGISTRATION DECISION 18
A. Determination of Eligibility 18
1. Eligibility Decision 19
2. Eligible Uses 19
B. Regulatory Position 20
3. Endangered Species Statement 22
4. Personal Protective Equipment (PPE) for Handlers
(Mixer/Loader/Applicators) 22
5. Entry Restrictions for Occupational-Use Products (NonWPS Uses)
23
V. ACTIONS REQUIRED BY REGISTRANTS 23
A. Manufacturing-Use Products ; . . . . 23
1. Additional Generic Data Requirements 23
2. Labeling Requirements for Manufacturing-Use Products 24
B. End-Use Products 24
1. Additional Product-Specific Data Requirements 24
2. Labeling Requirements for End-Use Products 25
C. Existing Stocks 25
VI. APPENDICES 27
APPENDIX A. Table of Use Patterns Subject to Reregistration 29
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 37
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of 2-Mercaptobenzothiazole and Salts 49
APPENDIX D. List of Available Related Documents 59
APPENDIXE 63
PR Notice 86-5 65
PR Notice 91-2 83
APPENDIX F. Product Specific Data Call-In 89
Attachment 1. Chemical Status Sheet 103
Attachment 2. Product Specific Data Call-in Response Forms (Form A
inserts) Plus Instructions 105
Attachment 3. Product Specific Requirement Status and Registrant's
Response Forms (FormB inserts) and Instructions Ill
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 117
Attachment 5. EPA Acceptance Criteria . 121
Attachment 6. List of All Registrants Sent This Data Call-in (insert) Notice
' 135
Attachment 7. Cost Share Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 137
APPENDIX G. FACT SHEET 147
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SODIUM AND ZINC SALTS OF 2-MERCAPTOBENZOTfflAZOLE
REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Rafael Prieto
Eddie Brandt
Phyllis Johnson
Environmental Fate and Effects Division
Jean Holmes
Bill Evans
Laura Parsons
Health Effects Division
Flora Chow
Charles Frick
Pat McLaughlin
Winston Dang
Registration Division
Bipin Gandhi
Tom Ellwanger
Mary Waller
Valdis Goncarous
Joanne Miller
Special Review and Reregistration Division
Kathleen Depukat
Kathy Davis
Biological Analysis Branch
Economic Analysis Branch
Biological Analysis Branch
Science Analysis and Coordination Staff
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Chemical Coordination Branch
Chemical Coordination Branch
Toxicology Branch II
Occupational and Residential Exposure Branch
Registration Support Branch
Registration Support Branch
Registration Support Branch
Antimicrobial Program Branch
Fungicide-Herbicide Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
Policy and Special Projects Staff
Jean Frane
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Office of Compliance:
Phyllis Flaherty
Office of General Counsel:
Kevin Lee
Office of Research and Development:
Vivian Williams
11
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GLOSSARY OF TERMS AND ABBREVIATIONS
AE
a.i.
CAS
CSF
DRES
DWEL
EEC
EP
EPA
FDA
FIFRA
FFDCA
GLC
GRAS
HA
HDT
LC50
Acid equivalent
Active Ingredient
Chemical Abstracts Service
Confidential Statement of Formula
Dietary Risk Evaluation System
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.
Estimated Environmental Concentration. The estimated pesticide concentration
in an environment, such as a terrestrial ecosystem.
End-Use Product
U.S. Environmental Protection Agency
Food and Drug Administration
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Gas Liquid Chromatography
Generally Recognized As Safe as designated by FDA
Health Advisory (HA) The HA values are used as informal guidance to
municipalities and other organizations when emergency spills or contamination
situations occur.
Highest Dose Tested
Median Lethal Concentration. A statistically derived concentration of a
substance that can be expected to cause death in 50% of test animals. It is
usually expressed as the weight of substance per weight or volume of water, air
or feed, e.g., mg/1, mg/kg or ppm.
m
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GLOSSARY OF TERMS AND ABBREVIATIONS
LD
'50
LEL
LOG
LOEL
MCLG
MP
MPI
MOB
MRID
N/A
NPDES
NOEL
OPP
PADI
PAM
ppm
PRN
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
Parts Per Million
Pesticide Registration Notice
IV
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GLOSSARY OF TERMS AND ABBREVIATIONS
Q*i The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer
Risk Model
RED Reregistration Eligibility Decision
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.
TGAI Technical Grade Active Ingredient
TMRC Theoretical Maximum Residue Contribution
TLC Thin Layer Chromatography
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EXECUTIVE SUMMARY
The U. S. Environmental Protection Agency (referred to as "the Agency") has
completed an assessment of the potential human health and environmental risks associated with
the pesticide uses of the sodium and zinc salts of 2-mercaptobenzothiazole. The Agency has
determined that pesticide products containing either of these chemicals as active ingredients,
labeled and used as specified in this Reregistration Eligibility Decision document (RED) will
not cause unreasonable risk to humans or the environment. Therefore, the Agency has
concluded that products containing the sodium and zinc salts of 2-mercaptobenzothiazole are
eligible for reregistration.
The sodium and zinc salts of 2-mercaptobenzothiazole are used as fungicides,
microbiocides and bacteriostats. The end-use products are formulated as wettable powders,
emulsifiable concentrates, and ready-to-use liquids for industrial use. These salts are used as
preservatives for adhesives, latex/oil paints, paper products, metal working cutting fluids, and
textile fibers. There are no registered food uses.
Toxicologically, the Agency classifies 2-mercaptobenzothiazole as a non-quantifiable
"Group C" (possible human) carcinogen. The sodium salts are classified as Toxicity Category
I, high toxicity, for skin and eye effects because their pH is greater than 10. The zinc salts
are classified as Toxicity Category HI, moderate to low acute toxicity, for acute skin and eye
effects.
The metal working cutting fluid use of the sodium salt of 2-mercaptobenzothiazole is
the only use pattern which has an effluent discharge into aquatic environments. The acute
Level of Concern is exceeded for endangered aquatic organisms for this, use pattern. As the
sodium salt of 2-mercaptobenzothiazole will be discharged at a number of different sites, it is
reasonable to assume that endangered, species..are located.in some of these habitats. When the
Agency completes its Endangered Species Program, additional precautionary labeling may be
required to mitigate the risk to endangered aquatic species. Also, the Agency has required a
hydrolysis study on the technical grade of sodium 2-mercaptobenzothiazole for the
reregistration of the salts of 2-mercaptobenzothiazole. Hydrolysis data were required to help
confirm the environmental assessment.
Before reregistering the products containing the sodium and zinc salts of 2-
mercaptobenzothiazole, 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 and acute
toxicity testing for each registration. After reviewing these data and any revised labels and
finding them acceptable in accordance with Section 3(c)(5) of 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, the Federal Insecticide, Fungicide, and Rodenticide Act (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 ingredients are eligible for reregistration" 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 the sodium and zinc salts of 2-mercaptobenzothiazole. The document
consists of six sections. Section I is the introduction. Section II describes the salts of 2-
mercaptobenzothiazole, its uses, data requirements and regulatory history. Section in
discusses the human health and environmental assessment based on the data available to the
Agency. Section IV presents the reregistration decision for the sodium and zinc salts of 2-
mercaptobenzothiazole. Section V discusses the reregistration requirements for the sodium
and zinc salts of 2-mercaptobenzothiazole. 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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CASE OVERVIEW
A. Chemical Overview
The following active ingredients are covered by this Reregistration Eligibility
Decision:
1. Sodium 2-Mercaptobenzothiazole
Common Name:
2-Mercaptobenzothiazole, sodium
salt
Chemical Name:
Sodium 2-Mercaptobenzothiazole
OPP Chemical Code: 051704
CAS Registry Number: 2492-26-4
Empirical Formula: C7H4NS2Na
2. Zinc 2-Mercaptobenzothiazole
Common Name:
2-Mercaptobenzothiazole, zinc salt
Chemical Name:
Zinc 2-Mercaptobenzothiazole
OPP Chemical Code: 051705
CAS Registry Number:. 155-04-4
Empirical Formula: C14H8N2S4Zn
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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 the salts of 2-
mercaptobenzothiazole is in Appendix A.
For 2-Mercaptobenzothiazole, sodium salt:
Type of Pesticide:
Use Sites:
INDOOR NON-FOOD:
Bacteriostat, Fungicide,
Microbiocide/Microbiostat (sh'me-forming bacteria
and fungi) - Preservatives/Industrial Preservatives.
Emulsions, Resin/Latex/Polymer
Metal Working Cutting Fluids
Paper/Paper Products
Specialty Industrial Products
Textiles/Textile Fibers/Cordage
Wet-End Additives/Industrial
Processing Chemicals
INDOOR RESIDENTIAL: Wood Protection Treatment to Buildings/Products
Indoor
Target Pests:
Mold, mildew, and bacteria and fungi which cause
degradation of aqueous industrial products.
Formulation Types Registered:
TYPE:
FORM:
End Use
Soluble Concentrate/Liquid
Method and Rates of Application:
Types of Treatment:
Preservative/industrial preservative for metal
working cutting fluids, emulsions, hydroxyethyl
cellulose solutions, protective colloids, waxes,
polishes, starch paste, alginate paste, and casein
solutions - industrial preservative treatment,
preservative treatment - 5 to 240 ppm.
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Equipment -
Method and Rate -
Timing -
Use Practice Limitations:
Industrial preservative of paper and paper products
(non-food contact) 396 to 792 ppm.
Preservative of cotton fabric - adding treatment -
1263 ppm.
Mold protection of wood veneer - dip - 120 ppm.
Measuring container, metering pump, and not
specified.
See Types of Treatment.
During manufacture, not specified.
Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans, or
public waters unless this product is specifically
identified and addressed in NPDES permit. Do
not discharge effluent containing this product to
sewer systems without previously notifying the
sewage treatment plant authority. Preservative
treatment of metal working cutting fluids would be
periodically repeated at not greater than 5-week
intervals. Do not use for the manufacture of
mold-resistant paper and paperboard intended for
food packaging purposes.
For 2-Mercaptobenzothiazole, zinc salt:
Type of Pesticide:
Bacteriostat, Fungicide,
Microbiocide/Microbiostat (slime-forming bacteria
and fungi).
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Use Sites:
INDOOR NON-FOOD:
Target Pests:
Adhesives, Industrial
Coatings, Industrial
Paints, Latex/Oil/Varnish (Applied Film)
Paper/Paper Products
Textiles/Textile Fibers/Cordage
Mold, mildew, bacteria and fungi which cause
degradation of aqueous industrial products, fabrics, and
yarns; slime-forming bacteria and fungi in industrial
water systems.
Formulation Types Registered:
TYPE:
FORM:
Method and Rates of Application:
End Use
Soluble Concentrate/Liquid,
Wettable Powder
Equipment -
Method and Rate -
Calender, press, metering pump and not specified.
Preservative/industrial preservative for starch and
protein adhesive dispersions, and paper coatings -
industrial preservative treatment, preservative
treatment - 75 to 200 ppm active ingredient.
Preservative/industrial preservative for latex paint
-industrial preservative treatment, preservative
treatment - 625 to 2250 ppm active ingredient.
Industrial preservative of paper and paper products
(non-food contact) - 400 ppm active ingredient.
Preservative of industrial yarns and fabric -
preservative treatment - 750 to 1200 ppm active
ingredient.
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Timing -
Use Practice Limitations:
During manufacture, continuous feed, initial,
intermittent, subsequent/maintenance.
Do not use for the manufacture of mold-resistant
paper and paperboard intended for food packaging
purposes. Do not use in formulation containing
metallic dryer. Preclean for heavily soiled areas.
C. Data Requirements
Appendix B includes all data requirements identified by the Agency for
currently registered uses needed to support reregistration.
D. Regulatory History
Sodium 2-mercaptobenzothiazole was registered in the United States as early as
1949 to R. T. Vanderbilt Company, Inc. as an active ingredient in an industrial
preservative product. Currently, only one product is registered for use in wood and
paper/paperboard treatment and as a preservative in metal working cutting fluids,
emulsions, textiles and pastes.
Zinc 2-mercaptobenzothiazole was registered in the United States as early as
1955 to R. T. Vanderbilt Company, Inc. as an active ingredient in an industrial
preservative product. Currently, two products are registered for use as a preservative
in adhesives, textiles, paints, coatings, and paper products.
Data Call-in Notices were issued in 1991 to acquire additional generic data
including product chemistry, ecotoxicity and toxicology data for reregistration for these
two active ingredients.
2-Mercaptobenzothiazole was registered in the United States as early as 1956 to
Betz Laboratories as an active ingredient. Currently, there are no registered products;
all the products have been cancelled.
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SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
The data submitted pertaining to the physical and chemical characteristics of
sodium 2-mercaptobenzothiazole and zinc 2-mercaptobenzothiazole are adequate and
summarized below in Table 1.
Table 1.
Characteristic
Color
Physical State
Odor
Melting Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition
Coefficient
pH
AI 051704
Sodium 2-MBT
Solid - pale yellow to yellow
Liquid - deep yellow to dark
brown
Solid
Mercaptan-sulfur smell
159.81° C to 180.38° C
1.47g/cm3
Water 100%
Isopropanol 7.10 g/100 ml
DMF 6.00 g/100 ml
Acetone 1.60 g/100 ml
Insoluble in Xylene
24 mm HG at 25°C
Pka=11.6 for 50% solution
Kow = 0.64 at 25°C
10 for 1 % solution
> 11.5 for 50% aqueous
material
AI 051705
Zinc 2-MBT
Pale yellow to yellow
Solid
Sulfur like
178.47° C
1.73 g/cm3
Insoluble in Water
Isopropanol 0.84 g/100 ml
DMF 9.96 g/100 ml
Acetone 5.52 g/100 ml
Xylene 1.00 g/100 ml
0.9 mm Hg at 22.5°C
Complete ionization is
expected
Kow= 11.4at25°C
5.55 for 1% suspension in
water
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Characteristic
Stability
Oxidizing/Reducing
Reaction
AI 051704
Sodium 2-MBT
Stable in liquid form in the
alkaline medium.
Precipitates out in presence
of acids or heavy metals.
Solid form' is stable in sealed
moisture proof container.
Material is hygroscopic and
vulnerable to oxidation.
It is a reducing agent.
AI 051705
Zinc 2-MBT
2.06% loss at 284°C;
degradation is faster above
284°C
It is a reducing agent.
B. Human Health Assessment
1. Toxicology Assessment
The lexicological data bases for the sodium and zinc salts of 2-
mercaptobenzothiazole are adequate to support reregistration. While the
Agency required only data on acute, developmental, and subchronic toxicology
and mutagenicity because of these pesticides' use patterns, data from other
studies were available. These data are summarized below.
a. Acute Toxicity
The acute toxicity data on the salts of 2-mercaptobenzothiazole
are summarized in Table 2. Based on a pH of 11.5 for the sodium salt,
the acute dermal toxicity, primary eye irritation, primary dermal and
dermal sensitization studies were waived. This high pH value places the
sodium salt of 2-mercaptobenzothiazole in Toxicity Category I for
dermal toxicity, eye irritation, and skin irritation. The acute inhalation
toxicity studies for both salts were not required because under the
directions of use, the active ingredient and/or the end-use products, will
not result in an inhalative material.
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Table 2.
Summary of Acute Toxicity Data on Sodium and Zinc 2-Mercaptobenzothiazole
Guideline
81-1
81-1
81-2
81-4
81-5
81-6
Description
Oral LD50 - rat
(Sodium salt)
Oral LD50 - rat
(Zinc salt)
Dermal LD50 - rabbit
(Zinc salt)
Primary Eye Irritation -
rabbit
(Zinc salt)
Primary Skin Irritation
- rabbit
(Zinc salt)
Dermal Sensitization -
guinea pig
(Zinc salt)
Test Results
1476 mg/kg (M&F)
1615 mg/kg (M)
1337 mg/kg (F)
5505 mg/kg (M&F)
5735 mg/kg (M)
5221 mg/kg (F)
> 2000 mg/kg
Minimal Irritant
Slight Dermal Irritant
No Sensitization
Toxicity
Category
III
IV
III
III
IV
N/A
In an acute oral study in Sprague-Dawley rats of sodium 2-
mercaptobenzothiazole, the LD50 was 1476 mg/kg for the combined
sexes, 1615 mg/kg for males and 1337 mg/kg for females (MRID
41567201). In an acute oral study in Sprague-Dawley rats of zinc 2-
mercaptobenzothiazole, the LD50 was 5505 mg/kg for the combined
sexes, 5735 mg/kg for males and 5221 mg/kg for females (MRID
41571901). In an acute dermal toxicity study in New Zealand White
Rabbits, the LD50 was > 2000 mg/kg (MRID 41571902). In a primary
eye irritation study, the application of 74.06% zinc 2-
mercaptobenzothiazole in the eyes of New Zealand White Rabbits caused
conjunctiva! redness, chemosis, and discharge (MRID 41571903). In a
dermal irritation study, 0.5 grams of zinc 2-mercaptobenzothiazole in
New Zealand White Rabbits caused a slight dermal irritation in one of
three rabbits. No other dermal irritation was observed (MRID
41571904). In a dermal Sensitization study with Hartley guinea pigs,
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zinc 2-mercaptobenzothiazole did not elicit a sensitization response
(MRID 41571905).
b. Subchronic Toxicity
A 13-week dermal toxicity study with sodium 2-
mercaptobenzothiazole was conducted with Sprague Dawley rats. Doses
of 0, 200, 1000, or 2000 mg/kg/day were applied daily for 91 days.
The NOEL was 200 mg/kg/day. The LOEL was 1000 mg/kg/day,
based on statistically significant increased relative liver weights in 1000
and 2000 mg/kg/day females. No other adverse effects due to treatment
were found (MRID 42146301).
c. Chronic Toxicity and Carcinogenicity
In a carcinogenicity study conducted by NTP, F344/N rats were
dosed with 2-mercaptobenzothiazole by gavage for 103 weeks. The
animals were dosed 5 days/week at 0, 375, or 750 mg/kg for males and
0, 188, or 375 mg/kg for females. There were increased incidences of
pituitary adenomas/adenocarcinomas and of adrenal gland pheochromo-
cytomas in the dosed females and increased incidences of adrenal gland
pheochromocytomas/malignant pheochromocytomas and of preputial
gland adenomas/carcinomas in the dosed males. Increased incidences of
mononuclear cell leukemia and pancreatic acinar cell adenomas were
also present in low dose males. Inflammation and ulceration of the
forestomach occurred in all dosed rats, and there was increased
mortality in dosed males (Dieter, 1988).
NTP also tested 2-mercaptobenzothiazole for carcinogenicity in
B6C3F1 mice. Doses of 0, 375, or 750 mg/kg were given by gavage on
five days per week for 103 weeks. There appeared to be an increased
incidence of hepatocellular adenomas and carcinomas in the low dose
females, but not in the high dose females or in the male mice. Mortality
was high in the high dose females. Of the mice that died early, most
had lung hemorrhage and congestion (Dieter, 1988).
2-Mercaptobenzothiazole has been classified as a Group C
possible human carcinogen. There was some evidence of adrenal gland
tumors in male and female rats and some evidence of preputial gland
tumors in male rats. Other tumor evidence was considered equivocal
(Dapson and Rinde, 1992).
10
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d. Developmental Toxicity
2-Mercaptobenzothiazole was given to Sprague Dawley rats by
gavage on gestation days 6 through 15 in a developmental toxicity study.
The doses were 0, 300, 1200, or 1800 mg/kg/day. The NOEL for
maternal toxicity was 300 mg/kg/day. The LOEL was 1200 mg/kg/day,
based on hair loss, increased salivation, and urine staining at the two
higher doses. The high dose animals also showed reduced body weight
gain and food consumption. The NOEL for developmental toxicity was
1200 mg/kg/day, and the LOEL was 1800 mg/kg/day, with greater post
implantation loss (MRID 41422202).
e. Reproductive Toxicity
In a two-generation reproduction study, Crl:CD COBS BR rats
were fed 2-mercaptobenzothiazole at 0, 2500, 8750, or 15000 ppm in
the diet (0, 194, 695, or 1195 mg/kg/day for males and 0, 218, 783, or
1327 mg/kg/day for females). The reproductive/systemic NOEL was
2500 ppm, a threshold NOEL based on a slight decrease in body weight
at this dose. The LOEL was 8750 ppm, based on decreased body
weight at the two higher doses, as well as liver toxicity and increased
kidney weights with increased brown pigment in the kidneys. Males at
the two higher doses also had increased incidence of basophilic tubules
in the kidney cortex (MRID 41912501).
f. Mutagenicity
2-Mercaptobenzothiazole was evaluated in the Ames Salmonella
typhimurium/ma.mma]ia.n microsome assay and was nonmutagenic in
strains TA1535, TA1537, TA100, TA1538, and TA98, with and
without activation (MRID 41045601). This compound did not induce
mutations at the HGPRT locus in Chinese hamster ovary cells (MRID
41045602). However, 2-mercaptobenzothiazole did cause forward gene
mutation in mouse lymphoma cells, with and without activation (MRID
41045603). This test substance was negative in an in vivo mouse
micronucleus assay (MRID 41045.604). 2-Mercaptobenzothiazole did
not induce unscheduled DNA synthesis in rat primary hepatocytes
(MRID 41525501).
g. Metabolism and Dermal Absorption
Male and female Fischer 344 rats were dosed orally with separate
single doses (one high and one low dose) of radiolabeled 2-
mercaptobenzothiazole and of radiolabeled 2-mercaptobenzothiazole
11
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disulfide. Both compounds appeared to be absorbed readily and
excreted in a similar manner, mainly via the urine. About 50% was
excreted in urine within 8 hours. Measurable amounts of label were
found in feces, whole blood and plasma. The data demonstrate
absorption and binding of both substances following oral exposure.
Single dermal doses of these same two compounds were applied
to male and female Fischer 344 rats and to female Hartley guinea pigs.
Both compounds were absorbed through the skin, with the main route of
excretion via the urine. The majority of the dose remained on the skin
and was only partly removed by washing. Thus, there was potential for
continued absorption and local dermal toxicity. Based on these data, it
is assumed that dermal absorption may be 38% of the dose. (MRIDs
41123401, 41123402, 41123403).
h. Reference Dose (RfD) for Chronic Oral Exposure
Although these pesticides are not currently registered for food
uses, the RfD for 2-mercaptobenzothiazole was determined to be 0.65
mg/kg/day based on results of the rat reproductive toxicity study
described above. The NOEL was 194 mg/kg/day (2500 ppm) for
reproductive and systemic effects. An uncertainty factor of 100 was
used to account for inter-species extrapolation and intra-species
variability, with an additional factor of three to account for the lack of
chronic toxicity data in a non-rodent species.
2. Exposure Assessment
a. Dietary
A food additive tolerance has been established for 2-
mercaptobenzothiazole in food grade adhesives (see 21 CFR 175.105).
Current labeling allows the adhesive use only for products containing the
zinc salt. This area is under the jurisdiction of the U.S. Food and Drug
Administration and is not directly regulated by EPA.
A tolerance also exists for the use of 2-mercaptobenzothiazole in
food grade paper and paperboard (see 21 CFR 176.300). However,
current labeling for the products containing the zinc and sodium salts of
2-mercaptobenzothiazole restrict the use to non-food materials in paper
and paperboard manufacture.
12
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b. Occupational and Residential
For products containing sodium or .zinc 2-mercaptobenzothiazole,
application methods such as open pouring of the liquid concentrate, and
open pouring of the powder into adhesives, paints, and other industrial
products present the potential for dermal and inhalation exposure to
applicators. Dermal exposure would be the primary route of exposure.
Therefore, the Agency required an applicator dermal exposure study.
The registrant is a participant in the Chemical Manufacturers
Association (CMA) Antimicrobial Exposure Assessment Study (MRID
41412201). The study fulfills the data requirement for an
applicator/mixer/loader exposure study. An exposure and risk
assessment for applicator/mixer/loaders has been done based on that
study. All exposure estimates in the CMA study reflect typical work
practice during the industrial use of the biocide. The estimates represent
combined dermal and inhalation exposure.
To estimate potential exposure to applicators/mixers/loaders from
sodium or zinc 2-mercaptobenzothiazole products, the Agency used the
end-use product, Vancide 51, containing 2.4% of sodium 2-
mercaptobenzothiazole as the active ingredient, to represent exposure for
both sodium and zinc 2-mercaptobenzothiazole. Vancide 51 is added as
(1) a preservative for paste by adding 1.0% Vancide 51 to the starch
paste based on the weight of the starch; and (2) for metal working
cutting fluids.
TableS.
\ > KHmLI&lOlD
Setting
Preservative
Metal Working
Cutting Fluid
MCS*
(ug/lb ai)
130
100
Ibai/
used
2.25
0.23
BW**
(kg)
70
70
Daily Exp.
(ug/kg/day)
4.18
0.33
* MCS = Maximum Credible Sum was derived from CMA Study.
** BW = Body Weight
Daily Exposure (ug/kg/day) = (MCS X Ib ai/used) / BW
13
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Post-application exposure from the treated paint, adhesives,
textiles and other treated industrial products are not considered
significant because of the low concentration/dilution factor as compared
to the exposure to the applicators, mixers, and loaders. There will be
low potential for any significant residential exposure from these uses.
3. Risk Assessment
a. Occupational and Residential
2-Mercaptobenzothiazole was classified as carcinogenicity
Category C (possible human carcinogen; non-quantifiable). While a
linear, multi-stage model for carcinogenicity risk assessment was not
appropriate because the uses of the pesticide products are not likely to
result in repeated human exposure, over a significant portion of the
human life span, margins of exposure (MOEs) were calculated to,
quantify the risk to applicators/mixers/loaders. The Agency conducted
an assessment to estimate the short and intermediate risk from sodium 2-
mercaptobenzothiazole to applicators/mixers/loaders for the preservative
and metal working cutting fluid uses. For the occupational risk
assessment the NOEL is 200 mg/kg/day based upon an increase in the
liver weights of female rats treated with higher doses. It also used the
calculated daily exposure estimates above. The calculated MOEs appear
below in Table 3.
Margin of Exposure (MOE) = NOEL/Daily Exposure
For example, the MOE calculation for the preservative use is:
MOE =
200 mg/kg/day x 1000 /ng/mg
4.18/ig/kg/day * 47,000
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Table 4.
Risk Calculation
Setting
Preservative
Metal Working
Cutting Fluid
Daily Exposure
(ug/kg/day)
4.18
0.33
MOE
47,000
600,000
The MOE is a measure of how closely the high end exposure
approaches the NOEL (the highest dose at which no effects were
observed in the laboratory test). In general, an MOE over 100 does not
trigger a risk concern. As can be seen by the data presented in Table 3,
the MOEs for the preservative and metal working cutting fluid uses of
zinc and sodium salt of 2-mercaptobenzothiazole exceed 100 by several
orders of magnitude. Therefore, additional toxicology or exposure
studies were not required.
C. Environmental Assessment
1. Environmental Fate
a. Environmental Fate Assessment
A hydrolysis study is required for industrial use pesticides in
which effluent is potentially discharged into aquatic environments.
While the Agency has required this study on sodium 2--
mercaptobenzothiazole to be submitted based on the use pattern and the
results of the environmental exposure model discussed below, major
environmental exposure to the sodium and zinc salts of 2-
mercaptobenzothiazole is not expected. The Agency will use the
hydrolysis data to confirm this assessment by determining the
degradation rate of the active ingredient and products formed during
hydrolysis.
2. Ecological Effects
Sufficient ecotoxicological data have been submitted to characterize the
toxicity of the sodium and zinc salts of 2-mercaptobenzothiazole to nontarget
terrestrial and aquatic organisms.
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a. Ecological Effects Data
(1) Terrestrial Data - Avian
Avian studies conducted with the technical grade of 2-
mercaptobenzothiazole indicate that this chemical is practically
nontoxic (LD50 > 2150 mg/kg) to birds on an acute oral basis
(MRID 42267101) and slightly toxic (LC50 > 3387 ppm) on a
dietary basis (MRID 42428501).
(2) Aquatic Data
Aquatic studies conducted with the technical grade of 2-
mercaptobenzothiazole indicate that it is highly toxic to
freshwater fish (LC50 of 0.73 ppm for rainbow trout) (MRID
42233201) and moderately toxic to freshwater invertebrates (ECSO
of 2.9 ppm forDaphnia magnd) (MRID 42226001).
b. Ecological Effects Risk Assessment
As summarized above, sufficient information exists to establish
that 2-mercaptobenzothiazole is practically nontoxic to birds on an acute
oral basis and slightly toxic to birds on a dietary basis. The results of
other toxieity studies indicate that 2-mercaptobenzothiazole may be
highly toxic to freshwater fish (Rainbow trout LC50 = 0.73 ppm) and
moderately toxic to aquatic invertebrates (Daphnia EC50 = 2.9 ppm).
The use patterns of these chemicals except for sodium 2-
mercaptobenzothiazole's use in metal working cutting fluids, suggest
sodium and zinc 2-mercaptobenzothiazole would not pose adverse risks
to avian and aquatic species.
Unlike agricultural pesticides in which aquatic organisms can be
exposed to pesticides via runoff and drift, nontarget aquatic organisms
are expected to be exposed to industrial microbiocides through a point
source discharge. In the case of 2-mercaptobenzothiazole, the metal
working cutting fluids use of the sodium salt is the only use pattern
which has an effluent discharge into aquatic environments and,
therefore, poses potential exposure to nontarget aquatic organisms.
To aid in the aquatic risk assessment of 2-mercaptobenzothiazole,
the Agency used a screening model to assess the estimated environmental
concentration of residue levels of this chemical in the receiving stream
from the metal working cutting fluid use.
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The screening model, a Tier Ic EEC (estimated environmental
concentration), determines the maximum concentration that occurs
immediately downstream from an industrial (point source) discharge
site. These calculated EECs are those for a high exposure site with a
return frequency of 1 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-ten year EEC has a 10%
probability of being equaled or exceeded in any single year at a given
site or would be equaled 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
for the metal working cutting fluid use pattern.
Table 5.
Tier Ic EECs (ppm) for Sodium 2-Mercaptobenzothiazole
Type of Use Site
Typical Exposure
Scenarios
High Exposure
Scenarios
Metal Working Cutting
Fluids
0.0051
6.400
An acute Level of Concern (LOG) is exceeded when the EEC
value equals or exceeds 1/2 the LC50 values for aquatic organisms. A
chronic LOG is exceeded when the EEC value of the exposure model
equals or exceeds 1/100 the acute LC50 values for aquatic organisms.
As can be seen from Table 5 below, the acute and chronic LOG
values for freshwater fish and invertebrates are greater than the typical
exposure scenario EEC values . Therefore, if the receiving streams
never have a flow rate below their mean flow condition, there is
minimal risk to freshwater aquatic organisms in these waters under those
conditions.
However, for the high exposure scenario, a high acute and
chronic risk to freshwater aquatic organisms is indicated.
17
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Table 6.
Median Lethal Concentration Values (ppm)
For Aquatic Organisms Exposed
to Sodium 2-Mercaptobenzothiazole for
the Metal Working Cutting Fluids Use Pattern
Category
^^50
1/2 LC50
(Acute LOG)
1/20 LC50
(En. Sp. LOG)
1/100 LC50
(Chronic LOG)
Freshwater Fish
0.73
0.365
0.146
0.0073
Freshwater Invertebrates
2.9
1.45
0.58
0.029
The LOG for endangered aquatic species is exceeded when the
estimated EEC value equals or exceeds 1/20 the LC50 values. The high
exposure scenario for 2-mercaptobenzothiazole exceeds the LOG for
endangered freshwater fish and invertebrate species. As sodium 2-
mercaptobenzothiazole will be discharged at a number of different sites,
it is reasonable to assume that endangered species are located in some of
these aquatic habitats. Effluent containing sodium 2-
mercaptobenzothiazole should not be discharged into streams and other
waterways where endangered aquatic organisms are known to reside.
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 the sodium and
zinc salts of 2-mercaptobenzothiazole active ingredients. 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 the sodium and zinc salts of 2-
mercaptobenzothiazole. Appendix B identifies the generic data requirements that the
Agency reviewed as part of its determination of reregistration eligibility of the sodium
and zinc salts of 2-mercaptobenzothiazole, and lists the submitted studies that the
18
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Agency found acceptable.
The data identified in Appendix B were sufficient to allow the Agency to assess
the registered uses of the sodium and zinc salts of 2-mercaptobenzothiazole and to
determine that these salts of 2-mercaptobenzothiazole can be used without resulting in
unreasonable adverse effects to humans and the environment. The Agency therefore
finds that all products containing the sodium and zinc salts of 2-mercaptobenzothiazole
as the sole active ingredients are eligible for reregistration. The reregistration of
particular products is addressed in Section V of this document.
The Agency made its reregistration eligibility determination based upon the
target data base required for reregistration, the current guidelines for conducting
acceptable studies to generate such data and the data identified in Appendix B.
Although the Agency has found that all uses of the sodium and zinc salts of 2-
mercaptobenzothiazole are eligible for reregistration, it should be understood that the
Agency may take appropriate regulatory action, and/or require the submission of
additional data to support the registration of products containing these active
ingredients, 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 reviews of the generic data for the active ingredients, the
Agency has sufficient information on the health effects of the sodium and zinc
salts of 2-mercaptobenzothiazole and on its potential for causing adverse effects
in fish, wildlife and the environment. Therefore, the Agency concludes that
products containing these salts of 2-mercaptobenzothiazole for all uses are
eligible for reregistration when the Agency has determined that the other active
ingredients in those products are also eligible for reregistration.
The Agency has determined that the sodium and zinc salts of 2-
mercaptobenzothiazole products, labeled and used as specified in this
Reregistration Eligibility Decision document, will not pose unreasonable risks
or adverse effects to humans or the environment.
2. Eligible Uses
The Agency has determined that all uses of the sodium and zinc salts of
2-mercaptobenzothiazole are eligible for reregistration.
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B. Regulatory Position
The following is a summary of the regulatory positions and rationales for the
sodium and zinc salts of 2-mercaptobenzothiazole. Where labeling revisions are
imposed, specific language is set forth in Section V of this document.
1.
Tolerance Reassessment
A food additive tolerance has been established for 2-
mercaptobenzothiazole in food grade adhesives (see 21 CFR 175.105). Current
labeling allows the adhesive use only for products containing the zinc salt. This
area is under the jurisdiction of the U.S. Food and Drug Administration and is
not directly regulated by EPA.
A tolerance also exists for the use of 2-mercaptobenzothiazole in food
grade paper and paperboard (see 21 CFR 176.300). However, current labeling
for the products containing the zinc and sodium salts of 2-
mercaptobenzothiazole restrict the use to non-food materials in paper and
paperboard manufacture.
2. Effluent Discharge/Aquatic Risk Rationale
The Agency has determined that discharge to surface waters of effluent
containing sodium 2-mercaptobenzothiazole 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 National Pollutant
Discharge Elimination system (NPDES) which is''administered by the EPA's
Office of Water (OW) with the states.
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 preliminary estimate of
environmental concentrations for sodium 2-mercaptobenzothiazole indicated that
under typical exposure conditions this biocide did not meet or exceed the
Agency's Levels of Concern (LOCs) for aquatic organisms. However, LOCs
were exceeded for sodium 2-mercaptobehzothiazole under the high exposure
modeling 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
20
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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 lexicological and environmental properties of biocides in
effluent streams was not always readily available or considered in writing
permits.
EPA's Office of Pesticide Programs and Office of Water 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 Office of Water 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 unacceptable effects on a local level
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 use of sodium 2-mercaptobenzothiazole does 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 organisms exposed to the' effluent resulting from its use, the Agency has
concluded that unreasonable adverse effects from the uses of sodium 2-
mercaptobenzothiazole 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.
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3. Endangered Species Statement
The Agency has concerns, about the exposure of threatened and
endangered aquatic species to the sodium and zinc salts of 2-
mercaptobenzothiazole as discussed above in the science assessment chapters.
Currently, the Agency 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.
The Agency plans to publish a description of the Endangered Species
Program in the Federal Register in 1994 and by 1995 have enforceable county-
specific bulletins available. Because the Agency is taking this approach for
protecting endangered and threatened species, it is not imposing label
modifications at this time through the RED. Rather, any requirements for
product use modifications will occur in the future under the Endangered Species
Protection Program.
Sodium 2-mercaptobenzothiazole's metal working cutting fluid use
pattern may result in an effluent discharge into aquatic environments, and
therefore, has potential exposure to nontarget aquatic organisms. The LOG for
endangered aquatic organisms is exceeded for this use pattern. Effluent
containing sodium 2-mercaptobenzothiazole should not be discharged into
streams and other waterways where endangered aquatic organisms are known to
reside.
4. Personal Protective Equipment (PPE) for Handlers
(Mixer/Loader/Applicators)
For each end-use product, PPE requirements for pesticide handlers will
be set during reregistration in one of two ways:
If the Agency has no special concerns about the acute or other
adverse effects of an active ingredient, the PPE for pesticide
handlers will be based on the acute toxicity of the end-use
product.
If the Agency has special concerns about an active ingredient due
to very high acute toxicity or to certain other adverse effects,
22
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such as allergic effects or delayed effects (cancer, developmental
toxicity, reproductive effects, etc.):
In the RED for that active ingredient, the Agency may
establish minimum or "baseline" handler PPE
requirements that pertain to all or most occupational end-
use products containing that active ingredient.
These minimum PPE requirements must be compared
with the PPE that would be designated on the basis of the
acute toxicity of each end-use product.
The more stringent choice for each type of PPE (i.e.,
bodywear, hand protection, footwear, eyewear, etc.) must
be placed on the label of the end-use product.
The Agency has determined that use of these pesticides is not likely to
result in repeated human exposure over a significant portion of the human life
span. Therefore, the establishment of active ingredient based PPE requirements
are not warranted at this time. The PPE for pesticide handlers will be based on
the acute toxicity of the end-use product.
5. Entry Restrictions for Occupational-Use Products (NonWPS Uses)
Exposure to sodium and zinc 2-mercaptobenzothiazole treated products,
such as latex and oil paints, adhesives, paper products, and metal working
cutting fluids, is expected to occur. However, the Agency has determined that
since the exposure to the sodium and zinc salts of 2-mercaptobenzothiazole is
negligible, as diluted in the treated products, such exposures do not warrant
special restrictions.
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 the salts of 2-
mercaptobenzothiazole for the above eligible uses is substantially complete. A
hydrolysis study has been required to confirm the environmental assessment by
determining the degradation rate of sodium 2-mercaptobenzothiazple and
23
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products formed during hydrolysis, as discussed above in Section IE.C.I.a.
2. Labeling Requirements for Manufacturing-Use Products
Effluent Discharge Labeling Statements
Future manufacturing-use products containing sodium or zinc 2-
mercaptobenzothiazole 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 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
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. These products include product
chemistry for each registration and acute toxicity testing.
Registrants must review previous data submissions to ensure that they
meet current EPA acceptance criteria (Appendix G; Attachment 5) 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.
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2. Labeling Requirements for End-Use Products
Effluent Discharge Labeling Statements
Refer to subsection A. above for labeling requirements for effluent
discharge for the metal working cutting fluid use of sodium 2-
mercaptobenzothiazole only.
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 Reregistration
Eligibility Decision (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 tune 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; Statement of Policy"; Federal Register,
Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell sodium and
zinc 2-mercaptobenzothiazole products bearing old labels/labeling, i.e., labels absent
the modifications specified in this RED document, except as noted below, 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
your products.
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APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
37
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38
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case 2-Mercaptobenzothiazole and Salts covered by this Reregistration
Eligibility Decision Document. It contains generic data requirements that apply to 2-
Mercaptobenzothiazole and Salts in all products, including data requirements for which a
"typical formulation" is the test substance.
The data table is organized in the following format:
* Data Requirement (Column 1). The data requirements are listed in the order in
which they appear in 40 CFR Part 158. the reference numbers accompanying each test refer
to the test protocols set in the Pesticide Assessment Guidelines, which are available from the
National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703)
487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files,
this column lists the identifying number of each study. This normally is the Master Record
Identification (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.
39
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APPENDIX C. Citations Considered to be Part of the Data
Base Supporting the Reregistration of 2-
Mercaptobenzothiazole and Salts
49
-------
50
-------
GUIDE TO APPENDIX C
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.
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.
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.
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
51
-------
as (19??), the Agency was unable to determine or estimate the date of the
document.
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.
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.
52
-------
BIBLIOGRAPHY
MRID
CITATION
41045601 Godek, E.G.; Naismith, R.W.; Matthews, R.J. 1984. Ames
Salmonella/Microsome Plate Test. Study No. PH301-CMA-001-83.
Unpublished study conducted by Pharmakon Research International and
submitted by CMA.
41045602 Godek, E.G.; Naismith, R.W.; Matthews, R.J. 1984. CHO/HGPRT
Mammalian Cell Forward Gene Mutation Assay. Study No. PH314-CMA-001-
83. Unpublished study conducted by Pharmakon Research International and
submitted by CMA.
41045603 Cifone, M.A.; Myhr, B.C. 1985. Mutagenicity Evaluation of
Mercaptobenzothiazole in the Mouse Lymphoma Forward Mutation Assay.
Study No. 20989. Unpublished study conducted by Litton Bionetics and
submitted by CMA.
41045604 Sorg, R.M.; Naismith, R.W.; Matthews, R.J. 1984. Genetic Toxicology
Micronucleus Test. Study No. PH309A-CMA-001-83. Unpublished study
conducted by Pharmakon Research International and submitted by CMA.
41123401 Hill, D.L. 1986. Disposition of 2-Mercaptobenzothiazole-Ring UL-14C and 2-
Mercaptobenzothiazole Disulfide-Ring-UL-14C in Fischer 344 Male and
Female Rats Dosed Orally. Study No. SORI-86-451. Unpublished study
conducted by Southern Research Institute and submitted by CMA.
41123402 Hill, D.L. 1987. Absorption and Disposition of 2-Mercaptobenzothiazole-Ring
UL-14C and 2-Mercaptobenzothiazole Disulfide-Ring-UL-14C in Fischer 344
Male and Female Rats and Female Guinea Pigs Dosed Topically. Study No.
SORI-86-1200. Unpublished study conducted by Southern Research Institute
and submitted by CMA.
41123403 Hill, D.L. 1986. Washing Efficacy in Removal of 2-Mercaptobenzothiazole-
Ring UL-14C and 2-Mercaptobenzothiazole Disulfide-Ring-UL-14C from
Fischer 344 Male and Female Rats and Female Guinea Pigs Dosed Topically.
Study No. SORI-86-1137. Unpublished study conducted by Southern Research
Institute and submitted by CMA.
41412201 Popendorf, W.; Selilm, M.; Kross, B. 1990. Chemical Manufactureres
Association. Antimicrobial Exposure Assessment Study: Lab Project ID:
53
-------
BIBLIOGRAPHY
MRID
CITATION
Q626. Unpublished study prepared by Univ. of Iowa, Institute of Agricultural
Medicine and Occupational Health. 209 p.
41422201 Rodwell, D. 1989. Range-finding Teratology Study in Rats with MBT: Final
Report: Lab Project Number: 3205.1 Unpublished study prepared by
Springborn Life Sciences, Inc. 125 p.
41422202 Rodwell, D.E. 1989. Teratology Study in Rats with MBT. Study No. SLS
3205.2. Unpublished study conducted by Springborn Laboratories and
submitted by R.T. Vanderbilt Co.
41525501 Curren, R.D. 1990. Unscheduled DNA Synthesis in Rat Primary Hepatocytes.
Study No. T9190.380. Unpublished study conducted by Microbiological
Associates and submitted by R.T. Vanderbilt. Also 41544801.
41567201 Reagan, E. 1990. Acute Oral LD50 of Sodium 2-Mercaptobenzothiazole
(NACAP) in Sprague-Dawley Rats: Lab Project Number 90.3530.021.
Unpublished study prepared by Food and Drug Research Laboratories. 84 p.
41571901 Reagan, E. 1990. Acute Oral LD50 Study of Zinc 2-Mercaptobenzothiazole
(ZETAX) in Sprague-Dawley Rats. Unpublished study prepared by Food and
Drug Laboratories.
41571902 Reagan, E. 1990. Acute Dermal Toxicity Study of Zinc, 2-
Mercaptobenzothiazole (ZETAX) in New Zealand White Rabbits. Unpublished
study prepared by Food and Drug Research Laboratories.
41571903 Reagan, E. 1990. Primary Eye Irritation Study of Zinc 2-
Mercaptobenzothiazole (ZETAX) in New Zealand White Rabbits. Unpublished
study prepared by Food and Drug Research Laboratories.
41579904 Reagan, E. 1990. Primary Dermal Irritation Study of Zinc 1-
Mercaptobenzothiazole (ZETAX) in New Zealand White Rabbits. Unpublished
study prepared by Food and Drug Research Laboratories.
41571905 Biesemeier, J.A. 1990. Dermal Sensitization Study of Zinc, 2-
Mercaptobenzothiazole (Zetax) in Guinea Pigs. Study No. 90.3530.020.
Unpublished study conducted by FDRL and submitted by R.T. Vanderbilt.
54
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BIBLIOGRAPHY
MRID
CITATION
41601401 Flynn, F. 1990. Product Identity and Composition of Sodium 2-
Mercaptobenzothiazole. Unpublished study prepared by R. T. Vanderbilt Co,
Inc. 44 p.
41601402 Flynn, F. 1990. Analysis and Certification of Product Ingredients of Sodium 2-
Mercaptobenzothiazole (50 percent aqueous solution). Unpublished study
prepared by R. T. Vanderbilt, Co., Inc. 17 p.
41601403 Flynn F.; Agahigian, H. 1990. Physical and Chemical Characteristics of
Sodium 2-Mercaptobenzothiazole. Unpublished study prepared by R. T.
Vanderbilt in association with Baron Consulting Co. 7 p.
41602301 Flynn, F. 1990. Product Identity and Composition of Zinc 2-
Mercaptobenzothiazole. Unpublished study prepared by R. T. Vanderbilt Co,
Inc. 17 p.
41602302 Flynn, F. 1990. Analysis and Certification of Ingredients of Zinc 2-
Mercaptobenzothiazole. Unpublished study prepared by R. T. Vanderbilt Co.,
Inc. 14 p.
41602303 Flynn F.; Agahigian, H. 1990. Physical and Chemical Characteristics of Zinc
2-Mercaptbbenzothiazole. Unpublished study prepared by R. T. Vanderbilt in
cooperation with Baron Consulting Co. 6 p.
41651201 Flynn F.; Agahigian, H. 1990. Physical and Chemical Characteristics of
Sodium 2-Mercaptobenzothiazole. Unpublished study prepared by R. T.
Vanderbilt in association with Baron Consulting Co. 4 p.
41651401 Flynn F.; Agahigian, H. 1990. Physical and Chemical Characteristics of Zinc
2-Mercaptobenzothiazole. Unpublished study prepared by R. T. Vanderbilt in
cooperation with Baron Consulting Co. 4 p.
41912501 Rodwell, D.E. 1990. Two-Generation Reproduction Study in Rats with MBT.
Study No. 3205.5. Unpublished study conducted by Springborn Laboratories
and submitted by R.T. Vanderbilt Co.
42146301 Siglin, J.C. 1991. A 91 Day Dermal Toxicity Study in .Rats with MBT. Study
No. 3248.1. Unpublished study conducted by Springborn Laboratories and
submitted by R.T. Vanderbilt Co. 345 p.
55
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BIBLIOGRAPHY
MRID
CITATION
42226001 Collins, M. 1992. 2-Mercaptobenzothiazole (ROKON) -Acute Toxicity to
Daphnids (Daphnia magnd) Under Static Conditions. Lab Project Number: 92-
2-4118. Unpublished study prepared by Springborn Laboratories, Inc. 58 p.
42233201 Collins, M. (1992) "(2-Mercaptobenzothiazole) (ROKON): Toxicity to
Rainbow Trout (Oncorhynchus myldss) under Static Conditions": Lab Project
Number: 92-2-4125. Unpublished study prepared by Springborn Labs, Inc. 55
P.
42267101 Pederson, C.; Helsten, B. (1992) 2-Mercaptobenzo-thiazole (ROKON) - 14
Acute Oral LD50 Study in Bobwhite Quail: Lab Project Number: BLAL 121-
005-03. Unpublished study prepared by Bio-Life Associates, Ltd. 45 p.
42428501 Pederson, C.; Helsten, B. (1992) 2-Mercaptobenzo-thiazole (ROKON): 8-Day
Acute Dietary LC50 in Bobwhite Quail: Lab Project Number: 121-004-01.
Unpublished study prepared by Bio-Life Associates, Ltd. 68 p.
42478701 Flynn, P.; Gallagher, T. 1990. Supplement to MRID 41602302. Analysis and
Certification of Product Ingredients. Unpublished study prepared by R. T.
VanderbiltCo., Inc. 6.p.
42580801 Flynn, F.; Gallagher, T. 1992. Solubility of Sodium 2-Mercaptobenzothiazole.
Unpublished study prepared by R. T. Vanderbilt Co., Inc. 6 p.
42598001 Wells, D. 1992. Stability of Sodium 2-Mercaptobenzo-thiazole. Supplement to
MRID 41601403: Lab Project Number: 92-10-4471. Unpublished study
prepared by Springborn Labs, Inc. 52 p.
42601301 Wells, D. 1992. Stability of Zinc 2-Mercaptobenzo-thiazole. Supplement to
MRID 41602303. Unpublished study prepared by Springborn Labs. Inc. 57 p.
42700701 Uniroyal Chemical Co., Inc. 1993. OXAF Accelerator: Product Chemistry,
Discussion of Beginning Materials, Manufacturing Process and Theoretical
Formation of Impurities: A Supplement. Unpublished Study. 48 p.
42848201 Gallagher, T.; Flynn, F. 1993. Oxidizing/Reducing Action of Sodium 2-
Mercaptobenzothiazole. Unpublished study prepared by R. T. Vanderbilt Co.,
Inc. 6 p.
56
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BIBLIOGRAPHY
MRID
CITATION
42867801 Gallagher, T.; Flynn, F. 1993. Solubility of Zinc 2-Mercaptobenzothiazole and
Oxidizing/Reducing Action of Zinc 2-Mercaptobenzothiazole. Unpublished
study prepared by R. T. Vanderbilt Co., Inc. 9 p.
43206101 Gallagher, T.; Flynn, F. 1994. Storage Stability of Sodium 2-
Mercaptobenzothiazole. Unpublished study prepared by R. T. Vanderbilt Co.,
Inc. and B. F. Goodrich Specialty Polymers and Chemicals Division. 8 p.
43206102 Gallagher, T.; Flynn, F. 1994. Corrosion Characteristics of Sodium 2-
Mercaptobenzothiazole. Unpublished study prepared by R. T. Vanderbilt Co.,
Inc. 13 p.
43283901 Gallagher, T.; Flynn, F. 1994. Storage Stability Study of Zinc 2-
Mercaptobenzothiazole. Unpublished study prepared by R. T. Vanderbilt Co.,
Inc. lip.
Dapson, S. C.; Rinde, E. 1992. U.S. EPA HED Carcinogenicity Peer Review.
Memorandum 10025.
Dieter, M.P. 1988. National Toxicology Program Technical Report on the
Toxicology and Carcinogenesis of 2-Mercaptobenzothiazole (CAS No. 149-30-
4) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Technical Report No.
332.
Office of Prevention and Toxic Substances. 1992. Summary of Stream Dilution
Factor Program (SDFP) Outputs for 40 Industrial Categories (Updated January,
1991, 1Q10 & 3Q5 Added October, 1992).
57
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58
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APPENDIX D. List of Available Related Documents
59
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60
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The following is a list of available documents related to the Sodium and Zinc Salts of
2-Mercaptobenzothiazole. 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 Sodium
and Zinc Salts of 2-Mercaptobenzothiazole 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. 2-Mercaptobenzothiazole and Salts 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
61
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62
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APPENDIX E. PR Notices 86-5 and 91-2
63
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64
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PR Notice 86-5
65
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66
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
July 29,1986
PR NOTICE 86-5
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS
AND REGISTRANTS
Attention:
Subject:
I. Purpose
Persons responsible for Federal registration of
pesticides.
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).
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)(l). This Notice
does not apply to.commercial, financial, or production
information, which are, and must continue to be, submitted
differently under separate cover.
III. 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
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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 OFF 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 satisfiedthe
statement of the method of support f9r the application.
Typically, many requirements are satisfied by reference to data
previously submittedeither 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
follows 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.
A.
B.
C.
D.
- INDEX-
Text Example
Page Page
Organization of the Submittal Package 3 17
Transmittal Document 4
Individual Studies 4
C. 1 Special Considerations for Identifying Studies . . 5
Organization of each Study Volume 6
D. 1 Study Title Page 7
11
17
12
68
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E.
F.
G.
D. 2 Statement of Data Confidentiality Claims
(based on FIFRA §10(d)(1)) 8
D. 3 Confidential Attachment 8
D. 4 Supplemental Statement of Data Confidentiality
Claims (other than those based on FIFRA §10(d)(1)) 8
D. 5 Good Laboratory Practice Compliance Statement . . 9
Reference to Previously Submitted Data 9
Physical Format Requirements & Number of Copies .... 9
Special Requirements for Submitting Data to the Docket 10
13
15
14
16
A. Organization of Submittal Package
A "submittal package" consists of all studies submitted at
the_same time for 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
UOint submitters; the regulatory action in support of which the
package is being submittedi.e., a registration application,
petition, experimental use permit (EUP), §3(c)(2)(B) data
call-in, §6(a)(2) submittal, 9r 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
69
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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 petition 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
conventional bibliographic citation including author< date, and
title. Studies generally correspond in scope to a single Guide-
line requirement for supporting data, with S9me exceptions dis-
cussed in section C.I. Each study included in a submittal
package must be bound as a separate entity. (See comments on
binding 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 volumes 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.I 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 control 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
70
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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
conventional 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 would 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,
however, of limiting a study to the report of a single inves7
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 cr9p or fromprocessing 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 commodities 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.
Oraanization 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 laboratory Page 16
work subject to GLP require-
ments
For certain toxicology 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)
71
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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 Identification. 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 wprk. Clearly distinguish the laboratory's project
identifier from any other reference numbers provided by the study
sponsor or submitter.
£ 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
previously 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) .
Facts of Publication. If the study is a reprint of a pub-
ished d9cument, identity on the title page all relevant facts of
publication, such as the journal title, volume, issue, inclusive
page numbers, and publication date.
;
D.2. Statements of Data Confidentiality Claims Under FIFRA
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) ] I. 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
72
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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
portion of a submitted study other than described by FIFRA §10(d)
(1)(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 to 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 should 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 on one side only in
black ink, with high contrast and good resolution. Bindings for
individual studies must be secure, but easily removable to permit
73
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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 proposed regulations 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 or Special Review must be provided in four copies, from 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".
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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
Attachment 2
Attachment 3
Attachment 4
Attachment 5
Attachment 6
Attachment 7
Sample Transmittal Document
Sample Title Page for a Newly Submitted Study
Statements of Data Confidentiality Claims
Supplemental Statement of Data Confidentiality
Claims
Samples of Confidential Attachments
Sample G9od Laboratory Practice Statements
Format Diagrams for Submittal Packages and Studies
75
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1.
ATTACHMENT 1
ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*
Name and address of submitter (or all joint submitters**)
*Smith Chemical Corporation
1234 West Smith Street
Cincinnati, OH 98765
-and-
Jones Chemical Company
5678 Wilson Blvd
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 pr.
long as all four elements are include
practice so
Indicate which of the joint 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:
Company Name
Company Contact:
Name
Signature
Name
Phone
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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)
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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:
Title
Typed Name
Date:
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:
Tvped 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
Methods 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.
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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 you claim
confidential 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 timeuntil a specific date or
event, or permanentlyfor 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.
Enclose 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 those harmful effects and explain why
they should be viewed as substantial.
If you assert that the information 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.
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ATTACHMENT 5
EXAMPLES OF SEVERAL CONFIDENTIAL ATTACHMENTS
Example 1. (Confidential word or phrase that has been deleted
Erom the study)
CROSS REFERENCE NUMBER 1
DELETED WORDS OR PHRASE:
This cross reference number is used in the study in place of the
following paragraph(s) at the indicated volume and page
references.
Ethylene Glycol
PAGE
REFERENCE
6
28
100
LINES REASON FOR THE DELETION
14
25
19
Identity of Inert Ingredient
FIFRA
§10(d)(C)
Example 2. (Confidential paragraph(s) that have been deleted from the study)
CROSS REFERENCE NUMBER 5
DELETED PARAGRAPH(S):
This cross reference number is used in the study in place of the
following paragraph(s) at the indicated volume and page
references.
PAGE
20.
Reproduce the deleted paragraph(s) here
LINES REASON FOR THE DELETION
2-17 Description of the quality control process
FIFRA REFERENCE
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 paragraphs) at the indicated volume and page
references.
DELETED PAGES(S): are attached immediately behind this page
REASON FOR THE DELETION FIFRA REFERENCE
PAGES
35-41.
Description of product manufacturing process
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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
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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
LEGEND
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
\....r-- \ 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.
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PR Notice 91-2
83
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84
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
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 Program'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
ls_d£f:!-n?d,I:Lr\-40 CFR 158. 153 (i). 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
^ ,FoF-fOI?e 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
enc°mPas,s an₯ such "good manufacturing practice" variations 40
JLbo.l75(C) (3) .
The upper and lower certified limits, which must be proposed
in connection with a product's registration, represent the
,
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)(l)(C), while the nominal concentration appearin
the label would be the routinely achieved concentration used
calculation of dosages and dilutions.
The nominal concentration would in fact state the greatest
degree of accuracy that is warranted with respect to actual
on
or
85
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product compositi9n because the nominal concentration would be
the amount of active ingredient typically found in the product.
It is important for registrants to note that certified
limits for actiye ingredients are n9t 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 nomxnal 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 concentration 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. Copies 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 provide certified limits
for each active, inert ingredient, impurities of toxicological
significance(i.e., upper limit(s) only) 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 n9t be lower then the minimum
level to achieve efficacy. This is extremely important for
products which are intended to control 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) above 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)
87
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APPENDIX F. Product Specific Data Call-In
-------
90
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DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants 9f 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 t9 maintain the continued registration
of your product(s) containing this active ingredient. Within 90
days after you receive this Notice you must respond as set forth
in Section III below. Your response must state:
1. How you will comply with the requirements set forth in
this Notice and its Attachments A through G; or
2. Why you believe you are exempt from the requirements
listed in this Notice and in Attachment 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
Section II
Section III -
Notice
Section IV -
This Notice
- Why You Are Receiving This Notice
Data Required By This Notice
Compliance With Requirements Of This
Consequences Of Failure To Comply With
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Section V -
Section VI -
Registrants' Obligation To Report
Possible Unreasonable Adverse Effects
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 of End-Use Products for Meeting Acute
Toxicology Data Requirements for Reregistration
5 - EPA Acceptance Criteria
6 - List of 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, Recruirements 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, Recruirements 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 pr9tocols 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) yoluntary 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 of 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 f9rm is required)and initial any subsequent pages.
The_forms contain separate detailed instructions on the response
options. 09 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
93
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election of this option. Voluntary cancellation is item number 5
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 chose to voluntarily cancel your product, further sale
and distribution of y9ur 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.
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/min9r use option are not
valid options for fulfilling product specific data requirements.
3. Request for Product Specific Data Waivers. Waivers for
product specific data are discussed in Section III-D of this Notice
and are covered by option 7 on the Requirements Status and
Registrant's Response Form. If you choose one of these 9ptions,
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. y9u
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 inf9rmation 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.
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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 t9 receipt of a Notice of Intent to Suspend the affected
registration(s).
If y9u 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), y9u 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 9nly in cases of extraordinary testing
problems bey9nd the expectati9n or C9ntrol 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 N9tice and have been
unsuccessful,.you may request EPA (by selecting this 9ption) 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 documentati9n 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
95
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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 9ther 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 arbitrati9n 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 t9
initiation of suspensi9n proceedings, unless you C9mmit 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 t9 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 f9r 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
a-re 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 data1 means any laboratory
worksheets, records, memoranda, notes, or exact C9pies
there9f{ that are the result of original observations and
activities 9f 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
data1 may include photographs, microfilm or microfiche
C9pies, computer printouts, magnetic media, including
dictated observations, and recorded data from automated
96
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instruments." The term "specimens", according to 40 CFR
ibU.J(k), means "any material derived from a test system
for examination or analysis . "
Health and. safety studies completed after May 1984 must
also contain all . GLP-required quality assurance and
^aJntXirSontr21-,rnformat:!-on' 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.
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
H&e4_ ??ncy f2r 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.
i- A If Y2U su£mit ai? existing study, you must certify that the
study meets all requirements of the criteria outlined above.
*r«*- If £°U1~k2OW of a studY pertaining to any requirement in this
Notice which does not meet the criteria outlined above but does
f°"ta:i:"<-fac£ual information regarding unreasonable adverse effects,
££« ^f^n?tliyi the ASencY °f such a study. If such study is in
the Agency's files, y9u 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
^PS^iS a2c^ptabi? and upgradable, .you may submit data to
Up>?^ th*£ 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
fSSCJS^i- ? uPg^aded, call or write the contact person listed in
=a C5m?nt4=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
PRNotYcU'86e5a mP ng t0 upgrade and must be in conformance with
97
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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 9f 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 ab9ve 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
nustification for the request, including technical reasons, data
and references to relevant EPA regulations, guidelines or policies.
(Note: any supplemental data must be submitted in the format
required by PR Notice 86-5}. This will be the only opportunity to
state the reasons or provide information in support of your
request. If the Agency approves your waiver request, you will not
be required to supply the data pursuant to section 3(c)(2)(B) of
FIFRA. If the Agency denies your waiver request, you must choose
an option for meeting the data requirements 9f 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 n9t 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
98
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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:
Failure to respond as required by this Notice within 90
days of your receipt of this Notice.
1.
2.
3.
4.
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.
Failure to submit on the required schedule an adequate
progress report on a study as required by this Notice.
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 t9 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
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
UNACCEPTABLE
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
99
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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 incorp9rated 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 leyels to be tested or attained,
duration of test, and, as applicable, Good Laboratory
Practices.
the submission of protocols,
any changes required by the
2. EPA requirements regardinc
including the incorp9ration of
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 to7> 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 rep9rt 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) 9nly in exceptional
circumstances. If you believe such disposition 9f existing stocks
of your product(s) which may be suspended for failure to comply
with this Notice should be permitted, y9u have the burden of
clearly demonstrating to EPA that granting such permission W9uld be
consistent with the Act. You must also explain why an "existing
stocks" provision is necessary, including a statement 9f the
quantity of existing stocks and your estimate of the time required
for their sale, distribution, and use. Unless y9u 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 risk concerns will be determined on case-by-
case basis.
100
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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 y9u 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 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 n9t 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 Call-In 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, J^? 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 Recruirements for Rereqistration
101
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5 - EPA Acceptance Criteria
6 - List of Registrants Receiving This Notice
7 - Cost Share and Data Compensation Forms, and Product
Specific Data Report Form
102
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Attachment 1. Chemical Status Sheet
103
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SODIUM AND ZINC SALTS OF 2-MERCAPTOBENZOTHIAZOLE DATA CALL-IN
CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-in Notice
because you have product(s) containing sodium and zinc salts of 2-
Mercaptobenzothiazole.
This Product Specific Data Call-In Chemical Status Sheet,
contains an 9veryiew of data required by this notice,and point of
contact for inquiries pertaining to the reregistration of sodium
and zinc salts of 2-Mercaptobenzothiazole. 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 Toxicolpgy 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 sodium and zinc sodium salts
of 2-Mercaptobenzothiazole 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 f9r sodium and zinc salts of 2-Mercaptobenzothiazole are
contained in the Requirements Status and Registrant's Response.
Attachment 3. The Agency has concluded that additional data on the
sodium and zinc salts of 2-Mercaptpbenzpthiazole are needed for
specific prpducts. These data'are required to be submitted to the
Agency within the time frame listed. These data are needed to
fully complete the reregistrati9n of all eligible the sodium and
zinc salts of 2-Mercaptobenzothiazole products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of
the sodium and zinc salts of 2-Mercaptobenzothiazole, please
contact Kathleen Depukat at (703) 308-8587.
tIf 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:
Sue Rathman
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: Sodium and Zinc Salts of 2-Mercaptobenzothiazole
104
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Attachment 2. Product Specific Data Call-In
Response Forms (Form A inserts) Plus
Instructions
105
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106
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Item 6.
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).
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.
For each manufacturing use product (MUP) for which you wish
to maintain registration, you must agree to satisfy the
data requirements by responding "yes."
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.
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.
Item 7a.
Item 7b.
NOTE:
107
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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, Subpart C.
Item 5. The study title associated with the guideline reference
number is identified.
Item 6. The use pattern(s) of the pesticide ass9ciated 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
datarequirements 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. 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 pr9vide
the required data; if the required study is n9t 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
108
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Requirements" form (EPA Form 8570-29) and (2) two completed
and signed copies of the Confidential Statement of Formula
(EPA Form 8570-4).
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 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
CallTIn 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) .
By the specified due date, I will submit an existing study
that has not been submitted previously to the Agency bv
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
FornL85JPr29). and (2) two completed and signed copies of
the Confidential Statement of Formula (EPA Form 8570-4) .
By the specified due date, I will submit or cite data to
upgrade a study classified by the Agency as partially
acceptable and upgradable (Upgrading a Study). I will
submit evidence of the Agency's review indicating that the
study may be upgraded and what information is required to
do so. I will provide the MRID or Accession number of the
study at the due date. I understand that the conditions
for this option outlined Option 5 in the Data Call-in
Notice (Section III-C.l.) apply. 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) .
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
109
-------
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 C9nducted on my product, an
identical product or a product which EPA has "grouped" with
one or more other products for purposes of depending 9n 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 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 9f 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.
110
-------
Attachment 3. Product Specific Requirement
Status and Registrant's Response Forms (Form
B inserts) and Instructions
111
-------
112
-------
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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, Subpart c.
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 9n 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
113
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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 IIIrC.l.) apply as well.
4. By the specified due date, I will submit an existing
study that has not been submitted previously to the Agency
by anyone (submitting an Existing Study). I certify that
this study will meet all the requirements for submittal of
existing data outlined in option 4 in the Data Call-in
Notice (Section III-C.l.) and will meet the attached
acceptance criteria (for acute toxicity and product
chemistry data). I will attach the needed supporting
information along with this response. I also certify that
I have determined that this study will fill the data
requirement for which I have indicated this choice.
5. By the specified due date, I will submit or cite data
to upgrade a study classified by the Agency as partially
acceptable and 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 f9rmat
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 t9 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
114
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30 days of my. receipt 9f 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.
ITOTEiYqu 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
115
-------
116
-------
Attachment 4. EPA Batching of End-Use
Products for Meeting Data Requirements for
Reregistration
117
-------
118
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EPA'S BATCHING OF PRODUCTS CONTAINING THE SODIUM AND ZINC SALTS OF
2-MERCAPTOBENZOTHIAZOLE 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 ingredients sodium and
zinc salts of 2-mercaptobenzothiazoIe, 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.
Using available information, batching has been accomplished by the process described in the
preceding paragraph. 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 lexicological 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 t9day's standards (see acceptance criteria attached), the foimulation 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. If more
than one confidential statement of formula (CSF) exists for a product, the registrant must indicate the
formulation actually tested by identifying the corresponding CSF.
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 CalJ-Ih 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.
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The table below shows two EPA registrations which were placed into one batch.
BATCH NO.
1
EPA REG.
NO.
1965-26
34822-5
% of 2-Mercaptobenzothiazole & salts & other active
ingredients
4.0% - 2-Mercaptobenzothiazol, zinc salt
46.0% - Zinc dimethyldithiocarbamate
4.0% - 2-Mercaptobenzothiazol, zinc salt
46.0% - Zinc dimethyldithiocarbamate
Formulation Type
Wettable Powder
Wettable Powder
The table below shows one EPA registration which was not batched because it contained
different salts of the active ingredients and different inerts. In addition, the concentration of active and
inert ingredients varied from the other registrations.
EPA REG. NO.
1965-8
% of 2-Mercaptobenzothiazole & salts
& other active ingredients
2.4% - 2-Mercaptobenzothiazol, sodium salt
27.6% - Sodium dimethyldithiocarbamate
Formulation Type
Soluble Concentrate
120
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Attachment 5. EPA Acceptance Criteria
121
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122
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SUBDIVISION D
Guideline
Series 61
Series 62
Series 63
Study Title
Product Identity and Composition
Analysis and Certification of Product Ingredients
Physical and Chemical Characteristics
123
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61 Product Identity and Composition
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1 Name of technical material lesled (include producl 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 IF <0.1%.
4. Purpose of each active ingredient and each intentionally-added inert.
5. Chemical name from Chemical Abstracls 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 Regislration 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 descnbes composition,
properties or toxicity.
8. Description of manufacturing process.
Statement of whether batch or continuous process.
~^^2 Relative amounts of beginning materials and order in which they are added.
Description of equipment.
~~2 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 eslablished 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).
124
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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 o, 7, and 8.
Does your study meet the following acceptance criteria?
1.
2.
3.'
4.
5.
8.
10.
Five or more representative samples (batches in case of batch process) analyzed for each active ingredient and
<*u impurities present ca98%.
Analyses conducted for certain trace toxic impurities at lower than 0.1 % (examples, nitrosamines in the case of
products containing dinitroanilines or containing secondary or tertiary amines/alkanolamines plus nitrites;
polyhalogenated dibenzochpxins and dibenzofurans). [Note that in the case of nitrosamines both fresh and stored
Complete and detailed description of each step in analytical method used to analyze above samples
Matement or precision and accuracy of analytical method used to analyze above samples
Identities and quantities (including mean and standard deviation) provided for each analyzed ingredient
Upper and lower certified limits proposed for each active ingredient and intentionally added inert alone with
explanation of how the limits were determined. e
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.
Analytical methods to verify certified limits of each active ingredient and impurities (latter not required if exempt
rrom requirement of tolerance or if generally recognized as safe by FDA) are fully described
Analytical methods (as discussed in #9) to verify certified limits validated as to their precision and accuracy
125
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63-4 Odor
63 Physical and Chemical Characteristics
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered.
Docs 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
2^3 Based on visual inspection at about 20-25 ° C
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 about20-25 ° C *,., . j -,u
Density of technical grade active ingredient reported in g/ml or the specific gravity of hquids reported with
reference to water at 20° C. [Note: Bulk density of regisTered products may be reported in Ibs/ft 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 hi g/100 ml (other units like ppm acceptable if sparingly soluble)
63-9 Vapor Pressure .... -f
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
~~3 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
Experimentally determined and description of procedure provided (preferred method-45 Fed. Register 77350)
~^^2 Data supporting reported value provided
63-12 pH
Measured at about 20-25° C
~^2 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
126
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SUBDIVISION F
Guideline Study Title
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
127
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81-1 Acute Oral Toxicity in the Rat
ACCEPTANCE CRITERIA
2!"
Does your study meet the following acceptance criteria?
Identify material tested (technical, end-use product, etc).
At least 5 young adult rats/sex/group.
f 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. Indivjdual 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.
128
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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/grpup.
3.; Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-450 gm.
4. Dosing, single dermal.
5. Dosing duration at least 24 hours.
6.* Vehicle control, only if toxicity of vehicle is unknown.
7. Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg).
8. Application site clipped or shaved at least 24 hours before dosing.
9. Application site at least 10% of body surface area.
10- Application site covered with a porous nonirritating cover to retain test material and to prevent
ingestipn.
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.
129
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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 yapor hazard based on toxicity and expected use or
contains particles of inhalable size for man (aerodynamic diameter 15 iaa 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.
130
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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. P°.se> °-l ml if a "'quid; 0.1 ml or not more than 100 mg if a solid, paste or participate 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 fir, then daily until eyes are normal
or 21 days (whichever is shorter).
9.* Individual daily observations.
Criteria marked wilh an * arc supplemental and may not be required for every study.
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81-5 Primary Dermal Irritation Study
ACCEPTANCE CRITERIA
Docs 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. .. , ., . . . t
8 Application site covered with a gauze patch held in place with nommtatong tape.
9. Material removed, washed with water, without trauma to application site.
10. AppHcation 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.
J- j ^
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81-6 Dermal Sensitization in the Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1.
2.
Identify material tested (technical, end-use product, etc).
Study not required if material is corrosive or has a
SHof <2or >11.5.
ne offfie following methods is utilized:
Freund's complete adjuvant test
Guinea pig maximization test
Split adjuvant technique
Buehler test
4.
5.51
6.-
7."
Open epicutaneous test
Mauer optimization test
Footpad technique in guinea pig.
Complete description of test.
Reference for test.
Test followed essentially as described in reference document.
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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134
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Attachment 6. List of All Registrants Sent This Data Call-in (insert) Notice
135
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136
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Attachment 7. Cost Share Data Compensation Forms, Confidential
Statement of Formula Form and Instructions
137
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138
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141
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142
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svEPA
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 (RFRA), 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 Flrm(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 of Company's Authorized Representatlvo
Date
Nam* and TIHe (Please Type or Print)
KPA Form 8570-32 (5/91) Replaces EPA Form 8580, which is obsolete
143
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144
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&EPA
United States Environmental Protection Agency
Washington. DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
NO. 2070-0107
2070-OOS7
3-31-9*
Public reporting burden for this collection of information is estimated to average 15 mfrwtes 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.
Pleas* fill In blanks below.
Company Number
SFA R»9. No.
I Certify that:
1.
For each study cited in support of registration or ^registration under the Federal Insecticide, Fungicide and
Rodenticide Act (FIFHA) 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.
That for each study died 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 oompany(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) oJ FIFRA: and (b) Commence
negotiation to determine which data are subject to the compensation requirement of FIFRA and the amount of
compensation due, I any. The companies I have notified are: (check one)
[1 Thecompanies who have submitted the studies listed on the back of this form or attached
sheets, or indicated on the attached "Requirements Status and Registrants' Response Form.'
3. That I have previously complied with section 3(C)(1)(D) of FtFRA for the studies I have tiled in support of
registration or ^registration under FIFRA.
Signature
Nama u* not (Picas* Type or Print}
Date
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, wtth regard to the
registration or ^registration of my products, to the extent required by FIFRA sections 3(e)(i)(D) and 3(c)(2)(D).
Signature
Date
Nam* and TIM* (p|*aa* Typ* or Print)
EPA Form 570.31 (4-tO
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146
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APPENDIX G. FACT SHEET
147
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148
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United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-94-024
September 1994
R.E.D. FACTS
Pesticide
Reregistration
Use Profile
Sodium and Zinc
Salts of 2-Mercapto-
benzothiazole
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 reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency imposes
any regulatory controls that are needed to effectively manage each
pesticide's risks. EPA then reregisters pesticides that can be used without
posing unreasonable risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this and
explains why in a Reregistration Eligibility Decision (RED) document. This
fact sheet summarizes the information in the RED document for
reregistration case 2380, the sodium and zinc salts of
2-mercaptobenzothiazole.
This case includes two active ingredients, the sodium and zinc salts of
2-mercaptobenzothiazole, which are used as fungicides, microbiocides and
bacteriostats. These salts are used as preservatives for adhesives, latex and
oil paints, paper products, metal working cutting fluids and textile fibers.
Sodium 2-mercaptobenzothiazole is used in the form of a soluble
concentrate or liquid to control mold, mildew, bacteria and fungi which
cause aqueous industrial products to degrade. The metal working cutting
fluid use of the sodium salt of 2-mercaptobenzothiazole is the only use
pattern where effluent containing the chemical is discharged into aquatic
environments, potentially exposing non-target aquatic organisms, including
endangered species. This use pattern exceeds the acute Level of Concern
(LOG) for endangered aquatic organisms. The Agency, therefore, has
determined that effluent containing sodium 2-mercaptobenzothiazole should
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not be discharged into streams and other waterways where endangered
aquatic organisms are known to reside. When the Agency completes its
Endangered Species Program, additional precautionary labeling may be
required to mitigate the risk to endangered species.
Zinc 2-mercaptobenzothiazole is used in the form of a soluble
concentrate or liquid and wettable powder to control mold, mildew, bacteria
and fungi which degrade aqueous industrial products, fabrics, and yarns;
and slime-forming bacteria and fungi in industrial water systems.
There are no registered food uses for either the sodium or zinc salts of
2-mercaptobenzothiazole.
Regulatory Sodium 2-mercaptobenzothiazole was first registered as a pesticide in
History the United States in 1949 in an industrial preservative product. Currently,
only one product is registered, for use in wood and paper/paperboard
treatment and as a preservative in metal working cutting fluids, emulsions,
textiles and pastes.
Zinc 2-mercaptobenzothiazole was first registered as a pesticide in the
United States in 1955 in an industrial preservative product. Currently, two
products are registered for use as preservatives in adhesives, textiles, paints,
coatings and paper products.
The parent compound, acid of 2-mercaptobenzothiazole, was
registered as a pesticide active ingredient in 1956. However, all products
containing that chemical have since been canceled.
Human Health
Assessment
Toxicity
Zinc 2-mercaptobenzothiazole has been placed in Toxicity Category
IE, which indicates moderate to low acute toxicity, for acute skin and eye
effects. However, the sodium salt is placed in Toxicity Category I,
indicating the highest degree of acute toxicity, for skin and eye effects
because it is extremely acidic (with a Ph of 11.5).
The acid of 2-mercaptobenzothiazole is classified as a non-quantifiable
"Group C" carcinogen; a possible human carcinogen. A linear, multi-stage
model for cancer risk assessment was not appropriate because the use of this
pesticide is not likely to result in repeated human exposure over a significant
portion of the human life span. Margins of Exposure (MOEs) were
calculated to quantify the risk to applicators/mixers/loaders. The MOEs for
the preservative and metal working cutting fluid uses of zinc and sodium
2-mercaptobenzothiazole exceed 100 (the margin considered acceptable) by
several orders of magnitude. Therefore, additional exposure studies were
not warranted, and the Agency required data on acute, developmental and
subchronic toxicity and mutagenicity only.
Occupational and Residential Exposure
The methods of application for products containing sodium or zinc
2-mercaptobenzothiazole that include open pouring of liquid concentrate,
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and open pouring of powder into adhesives and paints, present the potential
for dermal and inhalation exposure to applicators. Dermal exposure is the
primary route of exposure of sodium and zinc 2-mercaptobenzothiazole.
EPA was concerned about the risks of dermal and inhalation exposure
associated with the application of sodium 2-mercaptobenzothiazole for the
metal working cutting fluid use, and required a dermal exposure study to
assess the risks to workers. The study was designed to reflect typical work
practice involving the biocide in industrial use. The final assessment of the
study indicated that some absorption into the skin occurred. However, since
there are no special lexicological concerns about the sodium or zinc salts,
EPA is not imposing Personal Protective Equipment (PPE) requirements on
use of the products.
Post-application exposure from treated paint, adhesives, textiles and
other treated industrial products are not considered significant because of the
low concentration/dilution factor to the treated products. There are no
residential uses of sodium or zinc 2-mercaptobenzothiazole. Therefore, the
potential for any significant residential exposure is very low.
Human Risk Assessment
The sodium and zinc salts are not registered for any food or feed
related uses, so no dietary risks are posed. The potential for residential
exposure and risk is very low.
Workers (mixers, loaders and applicators) may be exposed to these
pesticides, especially during open pouring of liquid and powder
formulations. However, the Agency has determined that use of these
pesticides is not likely to result in repeated human exposure over a
significant portion of the human life span. The establishment of active
ingredient based PPE requirements is not warranted at this time. The PPE
for pesticide handlers will be based on the acute toxicity of the end-use
product.
Environmental Environmental Fate
Assessment A hydrolysis study has been required on the technical grade of sodium
2-mercaptobenzothiazole for industrial use products where effluent is
potentially discharged into aquatic environments. While the Agency has
required the study to be based on the industrial use pattern, major
environmental exposure to the sodium salt is not expected. The Agency will
use the results of the study to confirm this assessment and the degradation
rate of the active ingredient and products formed during hydrolysis.
Ecological Effects Risk Assessment
2-Mercaptobenzothiazole is almost nontoxic to birds on an acute oral
basis and is only slightly toxic to birds on a dietary basis. However, it is
highly toxic to freshwater fish and moderately toxic to aquatic invertebrates.
The use patterns of the sodium and zinc salts, except for sodium
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Additional Data
Required
Product Labeling
Changes Required
2-mercaptobenzothiazole's use in metal working cutting fluids, indicate that
they will not pose risks to avian and aquatic species.
Unlike agricultural situations, where aquatic organisms can be exposed
to pesticides via runoff or spray drift, nontarget aquatic organisms would be
exposed to industrial microbiocides through a point source discharge. The
metal working cutting fluids use of the sodium salt is the only use pattern
which may result in an effluent discharge into aquatic environments. It
therefore poses the potential for exposure to nontarget aquatic organisms,
including endangered species.
EPA's aquatic risk assessment indicates that minimal risk is posed to
freshwater aquatic organisms in receiving streams at mean flow rates.
However, under high exposure conditions, a high acute and chronic risk is
posed to freshwater aquatic organisms. The high exposure scenario also
exceeds the LOG for endangered freshwater fish and invertebrate species.
Therefore, effluent containing sodium 2-mercaptobenzothiazole should not
be discharged into streams and other waterways where endangered aquatic
organisms are known to reside.
A hydrolysis study has been required to confirm the environmental
assessment by determining the degradation rate of sodium 2-mercapto-
benzothiazole and products formed during hydrolysis. EPA also is
requiring product-specific data including product chemistry and acute
toxicity studies, revised Confidential Statements of Formula (CSFs), and
revised product labeling for reregistration of products containing sodium or
zinc salts of 2-mercaptobenzothiazole.
The labels of all registered pesticide products containing sodium and
zinc salts of 2-mercaptobenzothiazole must comply with EPA's current
pesticide labeling requirements. The following statement also must appear
on the labels of sodium 2-mercaptobenzothiazole end use products with the
metal working cutting fluid use:
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 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."
When the Agency completes the Endangered Species Program,
additional precautionary labeling may be required to mitigate the risk to
endangered species.
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Regulatory
Conclusion
For More
Information
The use of registered products containing sodium or zinc salts of
2-mercaptobenzothiazole will not pose unreasonable risks or adverse effects
to humans or the environment, provided that these products are used in
accordance with the restrictions on product labeling. Therefore, all uses of
these products are eligible for reregisteation. Sodium or zinc salts of
2-mercaptobenzothiazole products will be reregistered once the confirmatory
generic data, the required product-specific data, Confidential Statements of
Formula and revised labeling are received and accepted by EPA.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for sodium and zinc salts of
2-mercaptobenzothiazole 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 sodium and zinc salts of
2-mercaptobenzothiazole 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 reregistration program,
the sodium and zinc salts of 2-mercaptobenzothiazole RED, or reregistration
of individual products containing sodium and zinc salts of
2-mercaptobenzothiazole, please contact the Special Review and
Reregistration 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
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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