United States      Prevention, Pesticides    EPA 738-R-94-027
        Environmental Protection   And Toxic Substances    September 1994
        Agency	(7508W)	
&EPA  Reregistration
        Eligibility Decision (RED)
        Sodium and Zinc Salts of
        2-Mercaptobenzothiazole

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                   UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                     WASHINGTON, B.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,
                                                     Louis P. True, Jr., Acting Director
                                                     Special Review and
                                                      Reregistration Division
Enclosures

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              SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
              THE REREGISTRATION ELIGIBILITY DECISION (RED)

1.  DATA CALL-IN (PCI) OR "90-DAY RESPONSE" If generic data are required for
reregistration, a DCI letter will be enclosed describing such data.  If product specific data
are required, another DCI letter will be enclosed listing such requirements.  If both generic
and product specific data are required, a combined Generic and Product Specific letter will
be enclosed describing such data.  Complete the two response forms provided with each DCI
letter (or four forms for the combined) by following the instructions provided. You must
submit the response forms for each product and for each DCI within 90 days of the date
of this letter (RED issuance date); otherwise, your product may be suspended.

2.  TIME  EXTENSIONS AND DATA WAIVER REQUESTS No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for data waivers must be submitted  as part of the
90-day response. Requests for time extensions should be submitted in the 90-day response,
but certainly no later than the  8-month response date. All data waiver and time extension
requests must be accompanied by a full justification. All waivers and time extensions must be
granted by EPA in order to go into effect.

3.  APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE" You must
submit the following items for each product within eight months of the date  of this letter
(RED issuance date).

      a.  Application for Reregistration (EPA Form 8570-1).  Use only an original
application form. Mark it "Application for Reregistration."  Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.

      b.  Five copies of draft labeling which complies with the RED and current regulations
and requirements.  Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies.  Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately.  You may delete uses
which the RED says are ineligible for reregistration. For further labeling guidance,  refer to
the labeling section of the EPA publication " General Information on Applying for Registration
in  the U.S., Second Edition, August 1992" (available from the National Technical Information
Service, publication #PB92-221811;  telephone number 703-487-4650).

      c.  Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's  acceptance criteria (attached to the DCI).

      d.  Two copies of the  Confidential Statement of Formula (CSF) for each basic and
each alternate formulation.  The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration.  You have two options for submitting a CSF:  (1) accept the standard certified
limits (see  40  CFR §158.175)  or (2)  provide certified limits that are supported by the analysis
of five batches.  If you choose the second option, you must submit or cite the data for the five
batches along  with a certification statement as described in 40 CFR §158.175(e).   A copy of
the CSF is enclosed; follow the instructions on its back.

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      e.  Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.

4.  COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.

5.  WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)

By U.S. Mail:

      Document Processing  Desk (RED-SRRD-PRB)
      Office of Pesticide Programs (7504C)
      EPA, 401 M St. S.W.
      Washington, D.C. 20460-0001

By express:

   Document Processing Desk (RED-SRRD-PRB)
      Office of Pesticide Programs (7504C)
      Room 266A, Crystal Mall 2
      1921 Jefferson Davis Hwy.
      Arlington, VA 22202

6.  EPA'S REVIEWS—EPA  will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections.  EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.

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         REREGISTRATION ELIGIBILITY DECISION

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

II.    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

III.   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
      APPENDIX E	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 (Form B 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-MERCAPTOBENZOTHIAZOLE
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
                                         n

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                  GLOSSARY OF TERMS AND ABBREVIATIONS


AE          Acid equivalent

a.i.          Active Ingredient

CAS         Chemical Abstracts Service

CSF         Confidential Statement of Formula

DRES        Dietary Risk Evaluation System

DWEL       Drinking Water Equivalent Level (DWEL) The DWEL represents a medium
             specific  (i.e. drinking water) lifetime exposure at which adverse, non
             carcinogenic health effects are not anticipated to occur.

EEC         Estimated Environmental Concentration. The estimated pesticide concentration
             in an environment, such as a terrestrial ecosystem.

EP          End-Use Product

EPA         U.S. Environmental Protection Agency

FDA         Food and Drug Administration

FIFRA       Federal Insecticide, Fungicide, and Rodenticide Act

FFDCA      Federal Food, Drug, and Cosmetic  Act

GLC         Gas Liquid  Chromatography

GRAS        Generally Recognized As Safe as designated by FDA

HA          Health Advisory (HA)  The HA values are used as informal guidance to
             municipalities and other organizations when emergency spills or contamination
             situations occur.

HOT         Highest Dose Tested

LC50         Median Lethal Concentration.  A statistically derived concentration of a
             substance that can be expected to cause death in 50% of test animals. It is
             usually expressed as the weight of substance per weight or volume of water, air
             or feed,  e.g., mg/1, mg/kg or ppm.
                                         in

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                  GLOSSARY OF TERMS AND ABBREVIATIONS
LD
   50
LDlo

LEL

LOG

LOEL

MCLG



MP

MPI

MOE

MRID


N/A

NPDES

NOEL

OPP

PADI

PAM

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*!         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 III, 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 III
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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II.    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:     155044


                  •     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:          Bacteriostat, Fungicide,
                                  Microbiocide/Microbiostat (slime-forming bacteria
                                  and fungi) - Preservatives/Industrial Preservatives.

       Use Sites:

       INDOOR NON-FOOD:      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:       End Use

                                 FORM:       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:     Adhesives, Industrial
                           Coatings,  Industrial
                           Paints, Latex/Oil/Varnish (Applied Film)
                           Paper/Paper Products
                           Textiles/Textile Fibers/Cordage

Target Pests:        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:        End Use

                           FORM:       Soluble Concentrate/Liquid,
                                         Wettable Powder

Method and Rates of Application:


Equipment -                Calender, press, metering pump and not specified.

Method and Rate -          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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       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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III.   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
1.73g/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 mmHgat22.5°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%lossat284°C;
degradation is faster above
284°C
It is a reducing agent.
B.     Human Health Assessment

       1.      Toxicology Assessment

              The toxicological 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
conjunctival  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,
                       9

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zinc 2-mercaptobenzothiazole did not elicit a sensitization response
(MRID41571905).

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
typhimuriumfmammalian 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 41045604). 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.

                   Table 3.
POUR LIQUID
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:

                           200 mg/kg/day x  1000 ug/mg
       MOE  =                   4.18jjg/kg/day       .      47,000
                              14

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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.
                                    15

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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 (EC50
       of 2.9 ppm for Daphnia magna) (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 toxicity 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.
                       16

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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
Metal Working Cutting
Fluids
Typical Exposure
Scenarios
0.0051
High Exposure
Scenarios
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
LC50
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.
                                     19

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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-mercaptobenzothiazole 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 toxicological and environmental properties of biocides in
effluent streams was not always readily available or considered in writing
permits.

       EPA's Office of Pesticide Programs 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.
                             21

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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-mercaptobenzothiazole and


                                          23

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       products formed during hydrolysis, as discussed above in Section III.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.
                                    24

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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 time frames will  be established case-by-case, depending on
the number of products involved, the number of label changes, and other factors. Refer
to "Existing Stocks of Pesticide Products; 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.
                                    25

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26

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VI.  APPENDICES
       27

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28

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APPENDIX A. Table of Use Patterns Subject to Reregistration
                           29

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30

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Date 06/06/94  )  Time 17:13
                                                APPENDIX A  )  CASE 2380,  [2-Mercaptobenzothiazole,]  Chemical 051704  [2-Mercaptobenzothiazole, Na
                                                                                                                                                            LUIS 1.4  )  Page 1
SITE Application Type, Application        Form(s)  Min. Appl.
  Timing, Application Equipment  )                 Rate  (AI un-
  Surface Type (Antimicrobial only) & Effica-      less noted
  cy Influencing Factor (Antimicrobial only)       otherwise)
                                                                   Max. Appl.  Soil  Max.
                                                                     Rate  (AI Tex.  Apps
                                                                 unless noted Max.  @ Max
                                                                   otherwise)  Dose  Rate
Maximum Dose  Min.  Restr.        Geographic Limitations       Use
 /crop cycle Interv Entry   Allowed                Disallowed  Limitations
    or /year (days)  Interv                                     Codes
                    [day(s)]
USES ELIGIBLE FOR REREGISTRATION

NON-FOOD/NON-FEED
EMULSIONS, RESIN/LATEX/POLYMER

Industrial preservative treatment.,  During   SC/L  W
manufacture.,  Measuring container.,  Not
Applicable., Not applicable for this use.

Industrial preservative treatment.,  During   SC/L  W
manufacture.,  Metering pump., Not
Applicable., Not applicable for this use.

Preservative treatment.,  Not on label.,  Not  SC/L  V
on label., Not Applicable.,  Not applicable
for this use.
                                                                         Use Group: INDOOR NON-FOOD

                                                                      W   160   *   NS                 NS NS     NS
                                                                      W   160   *   NS
                                                                      V    21   *   NS
                                                                                                       NS NS     NS
                                                                                                       NS NS     NS
                                                                                                                                                            CIS, C24
METALWORKING CUTTING FLUIDS

Preservative treatment.,  Not on label.,       SC/L  W    24
Measuring container., Not Applicable.,  Not
applicable for this use.

Preservative treatment.,  Not on label.,       SC/L  W    24
Metering pump., Not Applicable., Not
applicable for this use.

Preservative treatment.,  Not on label.,  Not  SC/L  V    10
on label.,  Not Applicable.,  Not applicable
for this use.

PAPER/PAPER PRODUCTS

Industrial preservative treatment.,  During   SC/L  W   396
manufacture., Not on label.,  Not
Applicable.,  Not applicable for this use.

SPECIALITY INDUSTRIAL PRODUCTS

Industrial preservative treatment.,  During   SC/L  W    40
manufacture., Measuring container.,  Not
Applicable.,  Not applicable for this use.
Industrial preservative treatment.,  During
manufacture., Metering pump., Not
Applicable.,  Not applicable for this use.
                                             SC/L  W
                                                                         Use Group: INDOOR NON-FOOD

                                                                      W   160   *   NS                 NS NS     NS
                                                                      W   160   *   NS
                                                                      V    21   *   NS
                                                                                                       NS NS     NS
                                                                                                       NS NS     NS
                                                                         Use Group: INDOOR NON-FOOD

                                                                      W   792   *   NS                 NS NS     NS



                                                                         Use Group: INDOOR NON-FOOD

                                                                      W   160   *   NS                 NS NS     NS
                                                                                                                                                            CIS, C24
                                                               CIS, C24
                                                                      W   160   *   NS
                                                                                                       NS NS     NS

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Date 06/06/94  )  Time 17:13
                                                APPENDIX A  )  CASE 2380,  [2-Mercaptobenzothiazole,]  Chemical  051704  [2-Mercaptobenzothiazole,  Na
                                                                                      LUIS  1.4   )   Page
SITE Application Type, Application        Form(s)  Min. Appl.      Max. Appl. Soil  Max.
  Timing, Application Equipment  )                 Rate  (AI un-      Rate  (AI Tex.  Apps
  Surface Type  (Antimicrobial only) & Effica-      less noted    unless noted Max.  @ Max
  cy Influencing Factor  (Antimicrobial only)       otherwise)      otherwise) Dose  Rate
                       Maximum Dose  Min.  Restr.        Geographic Limitations       Use
                        /crop cycle Interv Entry   Allowed                Disallowed  Limitations
                           or /year (days) Interv                                     Codes
                                            [day(s) ]
USES ELIGIBLE FOR REREGISTRATION

NON-FOOD/NON-FEED (con't)
TEXTILES/TEXTILE FIBERS/CORDAGE

Padding treatment., Not on label., Not on    SC/L  V 1263
label., Porous., Not applicable for this
use.

WET-END ADDITIVES/INDUSTRIAL PROCESSING CHEMICALS

Preservative treatment., Not on label., Not  SC/L  W    5
on label., Not Applicable., Not applicable
for this use.

WOOD PROTECTION TREATMENT TO BUILDINGS/PRODUCTS INDOOR

Dip., Not on label., Not on label.           SC/L  V   120
   Use Group: INDOOR NON-FOOD

V  1263   *   NS                 NS NS



   Use Group: INDOOR NON-FOOD

W   240   *   NS                 NS NS



   Use Group: INDOOR RESIDENTIAL

V   120   *   NS                 NS NS
CIS,  C24
CIS,  C24
                                                                                                                                                             CIS,  C24

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Date 06/06/94  )  Time 17:13                    APPENDIX A  )  CASE 2380,  [2-Mercaptobenzothiazole,]  Chemical  051704  [2-Mercaptobenzothiazole,  Na           LUIS 1.4  )   Page 3
  HEADER ABBREVIATIONS
  Max. Apps ® Max Rate        : Maximum number of Applications at Maximum Dosage Rate
  Min. Interv (days)          : Minimum Interval between Applications  (days)
  Restr.  Entry Interv  (days)  : Restricted Entry Interval  (days)

  SOIL TEXTURE FOR MAX APP.  RATE
  *       :  Non-specific
  C       :  Coarse
  M       :  Medium
  F       :  Fine
  O       :  Others

  FORMULATION CODES
  RTU     :  LIQUID-READY TO USE
  SC/L    :  SOLUBLE CONCENTRATE/LIQUID

  ABBREVIATIONS
  AN      :  As Needed
  NA      :  Not Applicable
  NS      :  Not Specified (on label)
  UC      :  Unconverted due to lack of data  (on label), or with one of following units: bag, bait, bait block,  bait  pack,  bait  station,  bait  station(s),  block,  briquet,
            briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser,  drop,  eartag,  grains,  lure,  pack,  packet,  packets,  pad,  part,
            parts, pellets,  piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick,  strip,  tab,  tablet,  tablets,  tag,  tape, towelette,  tray,  unit,  --

  APPLICATION RATE
  DCNC    :  Dosage Can Not be Calculated
  No Calc :  No Calculation can be made
  W       :  PPM calculated by weight
  V       :  PPM Calculated by volume
  cwt     :  Hundred Weight
  nnE-xx  :  nn times  (10 power -xx); for instance,  "1.234E-04" is equivalent to ".0001234"

  USE LIMITATIONS CODES
  CIS :  Do not discharge effluent containing this pesticide into sewage systems without notifying  the  sewage treatment  plant  authority.
  C24 :  Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or public water.   (NPDES license  restriction)
  * NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS  (HOURS,DAYS, ETC.) DESCRIBED IN THE  LIMITATION.

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Date 06/15/94  )  Time 16:02
                                                APPENDIX A  )  CASE 2380,  [2-Mercaptobenzothiazole,] Chemical 051705  [2-Mercaptobenzothiazole  Zn]
                                                                                      LUIS 1.4   )  Page  1
SITE Application Type, Application        Form(s)  Min. Appl.      Max. Appl. Soil  Max.
  Timing, Application Equipment  )                 Rate  (AI un-      Rate  (AI Tex.  Apps
  Surface Type  (Antimicrobial only) & Effica-      less noted    unless noted Max.  @ Max
  cy Influencing Factor  (Antimicrobial only)       otherwise)      otherwise) Dose  Rate
                       Maximum Dose  Min.  Restr.        Geographic Limitations       Use
                        /crop cycle Interv Entry   Allowed                Disallowed  Limitations
                           or /year (days) Interv                                     Codes
                                           [day(s) ]
USES ELIGIBLE FOR REREGISTRATION

NON- FOOD/NON- FEED
ADHESIVES,  INDUSTRIAL

Preservative treatment., Not on label., Not  SC/L  W
on label.,  Not Applicable., Not applicable
for this use.
                                             WP
                                                   W
COATINGS,  INDUSTRIAL
Preservative treatment., Not on label., Not  WP    W
on label., Not Applicable., Not applicable
for this use.

COMMERCIAL/INDUSTRIAL WATER COOLING SYSTEMS

Water treatment., Initial., Metering pump.,  SC/L  V
Not Applicable., Not applicable for this
use.

Water treatment., Subsequent/maintenance.,   SC/L  V
Metering pump., Not Applicable., Not
applicable for this use.

PAINTS, LATEX/OIL/VARNISH  (APPLIED FILM)

Industrial preservative treatment., During   SC/L  W
manufacture., Not on label.,  Not
Applicable.,  Not applicable for this use.

                                             WP    W

Preservative treatment., Not on label., Not  SC/L  V
on label., Not Applicable., Not applicable
for this use.

PAPER/PAPER PRODUCTS

Industrial preservative treatment., During   SC/L  W
manufacture., Calender., Not Applicable.,
Not applicable for this use.

                                             WP    W

Industrial preservative treatment., During   SC/L  W
manufacture., Press., Not Applicable., Not
applicable for this use.
   Use Group: INDOOR NON- FOOD

W  200    *   NS                 NS NS     NS



W  188    *   NS                 NS NS     NS

   Use Group: INDOOR NON- FOOD

W   75    *   NS                 NS NS     NS



   Use Group: AQUATIC NON-FOOD INDUSTRIAL

V   20    *   NS                 NS NS     NS
V    8    *   NS
W 2250    *   NS

V 1250    *   NS
W  400    *   NS

W  400    *   NS
                                 NS NS     NS
   Use Group: INDOOR NON- FOOD

W 1200    *   NS                 NS NS     NS
NS NS

NS NS
   Use Group: INDOOR NON-FOOD

W  400    *   NS                 NS NS
NS NS

NS NS
NS

NS
NS

NS
                                             WP

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Date 06/15/94  )  Time 16:02
                                                APPENDIX A  )  CASE 2380,  [2-Mercaptobenzothiazole,] Chemical  051705  [2-Mercaptobenzothiazole  Zn]
                                                                                                                                                            LUIS  1.4   )   Page
SITE Application Type, Application        Form(s)  Min. Appl.      Max. Appl. Soil  Max.
  Timing, Application Equipment  )                 Rate  (AI un-      Rate  (AI Tex.  Apps
  Surface Type (Antimicrobial only) & Effica-      less noted    unless noted Max.  @ Max
  cy Influencing Factor (Antimicrobial only)       otherwise)      otherwise) Dose  Rate
                                                                                             Maximum Dose  Min.  Restr.        Geographic Limitations        Use
                                                                                              /crop cycle  Interv Entry   Allowed                 Disallowed  Limitations
                                                                                                 or /year  (days) Interv                                      Codes
                                                                                                                  [day(s)]
USES ELIGIBLE FOR REREGISTRATION

NON-FOOD/NON-FEED (con't)
PULP/PAPER MILL WATER SYSTEMS

Water treatment., Continuous feed            WP    W
(initial)., Not on label., Not Applicable.,
Not applicable for this use.

Water treatment., Intermittent               WP    W
(slug)(initial)., Not on label., Not
Applicable.,  Not applicable for this use.

TEXTILES/TEXTILE FIBERS/CORDAGE

Preservative treatment.,  Not on label.,  Not  SC/L  W
on label.,  Not Applicable.,  Not applicable
for this use.
                                                                         Use Group: AQUATIC NON-FOOD INDUSTRIAL

                                                                      W    9    *   NS                 NS NS     NS
                                                                      W    9    *   NS
                                                                                                       NS NS     NS
                                                                         Use Group: INDOOR NON- FOOD

                                                                      W 1200    *   NS                 NS NS     NS
                                             WP
                                                                      W 1125    *   NS
                                                                                                       NS NS     NS

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Date 06/15/94  )  Time 16:02                    APPENDIX A  )  CASE 2380,  [2-Mercaptobenzothiazole,]  Chemical  051705  [2-Mercaptobenzothiazole Zn]            LUIS 1.4  )   Page 3
  HEADER ABBREVIATIONS
  Max. Apps ® Max Rate        : Maximum number of Applications at Maximum Dosage Rate
  Min. Interv (days)          : Minimum Interval between Applications  (days)
  Restr.  Entry Interv  (days)  : Restricted Entry Interval  (days)

  SOIL TEXTURE FOR MAX APP.  RATE
  *       :  Non-specific
  C       :  Coarse
  M       :  Medium
  F       :  Fine
  O       :  Others

  FORMULATION CODES
  SC/L    :  SOLUBLE CONCENTRATE/LIQUID
  WP      :  WETTABLE POWDER

  ABBREVIATIONS
  AN      :  As Needed
  NA      :  Not Applicable
  NS      :  Not Specified (on label)
  UC      :  Unconverted due to lack of data  (on label), or with one of following units: bag, bait, bait  block,  bait  pack,  bait  station,  bait  station(s),  block,  briquet,
            briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser,  drop,  eartag,  grains,  lure,  pack,  packet,  packets,  pad,  part,
            parts, pellets,  piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick,  strip,  tab,  tablet,  tablets,  tag,  tape, towelette,  tray,  unit,  --

  APPLICATION RATE
  DCNC    :  Dosage Can Not be Calculated
  No Calc :  No Calculation can be made
  W       :  PPM calculated by weight
  V       :  PPM Calculated by volume
  cwt     :  Hundred Weight
  nnE-xx  :  nn times (10 power -xx); for instance,  "1.234E-04" is equivalent to ".0001234"

  USE LIMITATIONS CODES
  A30 :  Preclean for heavily soiled areas.
  * NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS  (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.

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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:

       1.  Data Requirement (Column 1). The data requirements are listed in the order in
which they appear  in 40 CFR Part 158. the reference numbers accompanying each test refer
to the test protocols set in the Pesticide Assessment Guidelines, which are available from the
National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161  (703)
487-4650.

       2.  Use Pattern  (Column 2).  This  column indicates the use patterns for which the data
requirements apply.  The following letter  designations are used for the given use patterns:

                           A      Terrestrial food
                           B      Terrestrial feed
                           C      Terrestrial non-food
                           D      Aquatic food
                           E      Aquatic non-food outdoor
                           F      Aquatic non-food industrial
                           G      Aquatic non-food residential
                           H      Greenhouse food
                           I       Greenhouse non-food
                           J       Forestry
                           K      Residential
                           L      Indoor food
                           M     Indoor non-food
                           N      Indoor medical
                           0      Indoor residential

       3.  Bibliographic citation  (Column 3).  If the Agency has acceptable data in its files,
this column lists the identifying number of each study.  This normally is the Master Record
Identification (MRID) number, but may be a "GS" number  if no MRID number has been
assigned.  Refer to the  Bibliography appendix for a complete citation of the study.
                                          39

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40

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                                      APPENDIX B
 Data Supporting Guideline Requirements for the Reregistration of Sodium 2-Mercaptobenzothiazole
REQUIREMENT
USE PATTERN
    CITATION(S)
PRODUCT CHEMISTRY
61-1       Chemical Identity
61-2A     Start. Mat. & Mnfg. Process
61-2B     Formation of Impurities
62-1       Preliminary Analysis
62-2       Certification of limits
62-3       Analytical Method
63-2       Color
63-3       Physical State
63-4       Odor
63-5       Melting Point
63-6       Boiling Point
63-7       Density
63-8       Solubility
63-9       Vapor Pressure
63-10      Dissociation Constant
63-11      Octanol/Water Partition
63-12      pH
63-13      Stability
63-14      Oxidizing/Reducing Action
    MO
    MO
    MO
    MO
    MO
    MO
    MO
    MO
    MO
    MO
    MO
    MO
    MO
    MO
    MO
    MO
    MO
    MO
    MO
         41601401
         41601401
         41601401
         41601402
         41601402
         41601402
         41601403
         41601403
         41601403
         41601403
         41601403
         41601403
         42580801
41601403, 41651201
         41601403
41651201, 41601403
         41601403
         42598001
         42848201
                                                41

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Data Supporting Guideline Requirements for the Reregistration of Sodium 2-Mercaptobenzothiazole
REQUIREMENT
63-15
63-16
63-17
63-18
63-20
Flammability
Explodability
Storage stability
Viscosity
Corrosion characteristics
USE PATTERN
MO
MO
MO
MO
MO
CITATION(S)
41601403
41601403
43206101
41601403
41651201, 43206102
ECOLOGICAL EFFECTS
71-1A
71-2A
72-1C
72-2A
Acute Avian Oral - Quail/Duck
Avian Dietary - Quail
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
MO
MO
MO
MO
42267101
42428501
42233201
42226001
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
82-1A
82-3
83-3A
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization - Guinea Pig
90-Day Feeding - Rodent
90-Day Dermal - Rodent
Developmental Toxicity - Rat
MO
MO
MO
MO
MO
MO
MO
MO
MO
41567201
Waived
Waived
Waived
Waived
Waived
Waived
42146301
41422201, 41422202
                                             42

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 Data Supporting Guideline Requirements for the Reregistration of Sodium 2-Mercaptobenzothiazole
REQUIREMENT                               USE PATTERN                               CITATION(S)
83-4       2-Generation Reproduction - Rat            MO                                       41912501
84-2A     Gene Mutation (Ames Test)                 MO             41045601,41045602,41045603,41045604
84-4       Other Genotoxic Effects                    MO                                       41525501
85-1       General Metabolism                       MO                     41123401,41123402,41123403
231       Applicator Dermal Exposure                MO                                       41412201
ENVIRONMENTAL FATE
160-5      Chemical Identity                         MO                                       41601401
161-1	Hydrolysis	MO	Required
                                                43

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44

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                                      APPENDIX  B
  Data Supporting Guideline Requirements for the Reregistration of Zinc 2-Mercaptobenzothiazole
REQUIREMENT
USE PATTERN
    CITATION(S)
PRODUCT CHEMISTRY
61-1       Chemical Identity
61-2A     Start. Mat. & Mnfg. Process
61-2B     Formation of Impurities
62-1       Preliminary Analysis
62-2       Certification of limits
62-3       Analytical Method
63-2       Color
63-3       Physical State
63-4       Odor
63-5       Melting Point
63-7       Density
63-8       Solubility
63-9       Vapor Pressure
63-10      Dissociation Constant
63-11      Octanol/Water Partition
63-12      pH
63-13      Stability
63-14      Oxidizing/Reducing Action
63-15      Flammability
    M
    M
    M
    M
    M
    M
    M
    M
    M
    M
    M
    M
    M
    M
    M
    M
    M
    M
    M
         41602301
41602301, 42700701
41602301, 42700701
         41602302
         41602302
41602302, 42478701
         41602303
         41602303
         41602303
         41602303
         41602303
41602303, 42867801
         41651401
         41602303
         41651401
         41602303
41602303, 42601301
         42867801
         42867801
                                                 45

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  Data Supporting Guideline Requirements for the Reregistration of Zinc 2-Mercaptobenzothiazole
REQUIREMENT
USE PATTERN
                     CITATION(S)
63-16       Explodability
63-17       Storage stability
ECOLOGICAL EFFECTS
71-1A      Acute Avian Oral - Quail/Duck
71-2A      Avian Dietary - Quail
72-1C      Fish Toxicity Rainbow Trout
72-2A      Invertebrate Toxicity
TOXICOLOGY
81-1        Acute Oral Toxicity - Rat
81-2        Acute Dermal Toxicity -
           Rabbit/Rat
81-3        Acute Inhalation Toxicity - Rat
81-4        Primary Eye Irritation - Rabbit
81-5        Primary Dermal Irritation - Rabbit
81-6        Dermal Sensitization - Guinea Pig
82-3        90-Day Dermal - Rodent
83-3A      Developmental Toxicity - Rat
83-4        2-Generation Reproduction - Rat
84-2A      Gene Mutation (Ames Test)
84-4        Other Genotoxic Effects
     M
     M

     M
     M
     M
     M

     M
     M

     M
     M
     M
     M
     M
     M
     M
     M
     M
                         41602303
                         43283901

                         42267101
                         42428501
                         42233201
                         42226001

                         41571901
                         41571902

                           Waived
                         41571903
                         41571904
                         41571905
                         42146301
                41422201, 41422202
                         41912501
41045601, 41045602, 4145603, 4145604
                         41525501
                                                  46

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  Data Supporting Guideline Requirements for the Reregistration of Zinc 2-Mercaptobenzothiazole
REQUIREMENT                            USE PATTERN                             CITATION(S)
ENVIRONMENTAL FATE
160-5     Chemical Identity                      M                                    41602301
161-1	Hydrolysis	M	Waived
                                            47

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48

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APPENDIX C.  Citations Considered to be Part of the Data
         Base Supporting the Reregistration of 2-
            Mercaptobenzothiazole and Salts
                          49

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50

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                               GUIDE TO APPENDIX C

1.      CONTENTS OF BIBLIOGRAPHY.  This bibliography contains citations of all studies
       considered relevant by EPA in arriving at the positions and conclusions stated
       elsewhere in the Reregistration Eligibility Document. Primary sources for studies in
       this bibliography have been the body of data submitted to EPA and its predecessor
       agencies in support of past regulatory decisions. Selections from other sources
       including the published literature, in those instances where they have been considered,
       are included.

2.      UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the
       case of published materials, this corresponds closely to an article. In the case of
       unpublished materials submitted to the Agency, the Agency has sought to identify
       documents at a level parallel to the published article from within the  typically larger
       volumes in which they were submitted. The resulting "studies" generally have a
       distinct title (or at least a single subject), can stand alone for purposes of review and
       can be described with a conventional bibliographic citation.  The Agency has also
       attempted to  unite basic documents and commentaries upon them, treating them as a
       single study.

3.      IDENTIFICATION OF ENTRIES.  The entries in this bibliography are sorted
       numerically by Master Record Identifier, or "MRID number".  This  number is unique
       to the citation, and should be used whenever a specific reference is required.  It is not
       related  to the six-digit "Accession Number" which has been used to identify volumes of
       submitted studies (see paragraph 4 (d) (4) below for further explanation).  In a few
       cases, entries added to the bibliography late in the review may be preceded by  a nine
       character temporary identifier. These  entries are listed after all MRID entries.  This
       temporary identifying number is also to be used whenever specific reference is needed.

4.      FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
       consists of a citation containing standard elements followed,  in the case of material
       submitted to  EPA, by a description of the earliest known submission. Bibliographic
       conventions used reflect the standard of the American National Standards Institute
       (ANSI), expanded to provide for certain special needs.

       a     Author.  Whenever the author could confidently be identified, the Agency has
             chosen to show a personal author.  When no individual was identified, the
             Agency has shown an identifiable laboratory or testing facility as the  author.
             When no author or laboratory could be identified, the Agency has shown the
             first submitter as the author.

       b.     Document date.  The date of the study is taken directly from the document.
             When the date is followed by a question mark, the bibliographer has deduced
             the date from the evidence contained in the document.  When the date appears


                                           51

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       as (19??), the Agency was unable to determine or estimate the date of the
       document.

c.      Title.  In some cases, it has been necessary for the Agency bibliographers to
       create or enhance a document title.  Any such editorial insertions are contained
       between square brackets.

d.      Trailing parentheses. For studies submitted to the Agency in the past, the
       trailing parentheses include (in addition to any self-explanatory text) the
       following elements describing the earliest known submission:

       (1)    Submission date.  The date of the earliest known submission appears
             immediately following the word "received."

       (2)    Administrative number.  The next element immediately following the
             word "under" is the registration number, experimental use permit
             number, petition number, or other administrative number associated
             with the earliest known submission.

       (3)    Submitter.  The third  element is the submitter.  When authorship is
             defaulted to the submitter, this element is omitted.

       (4)    Volume Identification (Accession Numbers).  The final element in the
             trailing parentheses identifies the EPA accession number of the volume
             in which the original submission  of the study appears.  The six-digit
             accession number follows the symbol "CDL," which stands for
             "Company Data Library." This accession number is in turn followed by
             an alphabetic suffix which shows the relative position of the study within
             the volume.
                                    52

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                               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 CM A.

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 CM A.

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 CM A.

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

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                                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 MET: 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 MET. 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-Mercaptobenzothiazole.  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 MET.
             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 MET. 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 magna) 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 (Oncorhynchusmykiss) 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, F.; Gallagher,  T. 1990.  Supplement to MRID 41602302.  Analysis and
             Certification of Product Ingredients. Unpublished study prepared by R. T.
             Vanderbilt Co., 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

   tpno1                        WASHINGTON, D.C. 20460

                                  July 29, 1986

                                                            OFFICE OF
                                PR NOTICE 86-5         PREVENTION, PESTICIDES
                                                      AND TOXIC SUBSTANCES


          NOTICE TO PRODUCERS,  FORMULATORS, DISTRIBUTORS
                         AND REGISTRANTS

Attention:     Pers9ns responsible for  Federal registration of
               pesticides.

Subject:       Standard format for data submitted under the
               Federal Insecticide, Fungicide, and Rodenticide
               Act  (FIFRA)  and certain provisions of  the Federal
               Food, Drug,  and Cosmetic Act  (FFDCA).

I.    Purpose

     To require data to be  submitted to the  Environmental
Protection Agency  (EPA) in  a standard  format. This Notice  also
provides additional guidance about, and illustrations of,  the
required formats.

II.   Applicability

     This PR Notice applies to all data that are submitted to EPA
to satisfy data requirements for granting  or maintaining
pesticide registrations, experimental use  permits, tolerances,
and related approvals under certain provisions of FIFRA and
FFDCA.  These data are defined in FIFRA §10(d)(1).  This Notice
does not apply to commercial, financial, or production
information, which are, and must continue  to be, submitted
differently under separate  cover.

Ill.  Effective Date

     This notice is effective on November  1, 1986. Data formatted
according to this notice may be submitted  prior to the  effective
date.  As of the effective  date, submitted data packages that do
not conform to these requirements may be returned to  the
submitter for necessary revision.

IV.   Background

     On September 26, 1984, EPA published  proposed regulations  in
the Federal Register (49 FR 37956) which include Requirements for
Data Submission  (40 CFR §158.32), and  Procedures for  Claims of
Confidentiality of Data (40 CFR §158.33).  These regulations
specify the format for data submitted  to EPA under Section 3 of
FIFRA and Sections 408 and  409 of FFDCA, and procedures which
must be followed to make and substantiate  claims of confiden-
tiality.  No entitlements to data confidentiality are changed,
either by the proposed regulation or by this notice.

     OPP is making these requirements mandatory through this
Notice to gain resource-saving benefits from their use  before the


                                67

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entire proposed regulation becomes final.  Adequate lead time is
being provided for submitters to comply with the new
requirements.

V.   Relationship of this Notice to Other OPP Policy and Guidance

     While this Notice contains requirements for organizing and
formatting submittals of supporting data,  it does not address the
substance of test reports themselves.  "Data reporting" guidance
is now under development in OPP, and will specify how the study
objectives, protocol, observations, findings, and conclusions are
organized and presented within the study report. The data
reporting guidance will be C9mpatible with submittal format
requirements described in this Notice.

     OPP has also promulgated a policy (PR Notice 86-4 dated
April 15, 1986) that provides for early screening of certain
applications for registration under FIFRA §3.  The objective of
the screen is to avoid the additional C9sts and prolonged delays
associated with handling significantly incomplete application
packages.  As of the effective date of this Notice,  the screen
will include in its criteria for acceptance of applicati9n
packages the data formatting requirements described herein.

     OPP has also established a public docket which imposes
deadlines for inserting int9 the docket documents submitted in
connection with Special Reviews and Registration Standards  (see
40 CFR §154.15 and §155.32).  To meet these deadlines, OPP is
requiring an additional copy of any data submitted to the docket.
Please refer to Page 10 for more information about this
requirement.

     For several years, OPP has required that each application
for registration or other action include a list 9f all applicable
data requirements and an indication of how each is satisfied--the
statement of the method of support f9r the application.
Typically, many requirements are satisfied by reference to data
previously submitted--either by the applicant or by another
party.  That requirement is not altered by this notice, which
applies only to data submitted with an application.

VI.   Format Requirements

     A more detailed discussion of these format requirements
foll9ws the index on the next page, and samples of some of the
requirements are attached.  Except for the language 9f the two
alternative forms of the Statement of Data Confidentiality Claims
(shown in Attachment 3) which cannot be altered, these samples
are illustrative.  As long as the required information is
included and clearly identifiable, the form of the samples may be
altered to reflect the submitter's preference.

                             -  INDEX-
                                                            Text Example
                                                            Page   Page
A.   Organization of the Submittal Package	3      17

B.   Transmittal Document	4      11

C.   Individual Studies 	  4

     C. 1  Special Considerations for Identifying Studies  .  .  5

D.   Organization of each Study Volume	6      17

     D. 1  Study Title Page	7      12


                                   68

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     D. 2  Statement of Data Confidentiality Claims
                   (based on FIFRA §10 (d) (1)1   	8      13
     D. 3  Confidential Attachment	8      15
     D. 4  Supplemental Statement of Data Confidentiality
            Claims  (other than those based on FIFRA §10(d)(1) )  8      14
     D. 5  Good Laboratory Practice Compliance Statement   .  .  9      16

E.   Reference to Previously Submitted Data 	  9

F.   Physical Format Requirements & Number of Copies   ....  9

G.   Special Requirements for Submitting Data to the Docket   10
A.   Organization of Submittal Package

     A "submittal package" consists of all studies submitted at
the same time f9r review in support of a single regulatory
action, along with a transmittal document and other related
administrative material  (e.g. the method of support statement,
EPA Forms 8570-1, 8570-4, 8570-20, etc.) as appropriate.

     Data submitters must organize each submittal package as
described in this Notice.  The transmittal and any other admin-
istrative material must be grouped together in the first physical
volume.  Each study included in the submittal package must then
be bound separately.

     Submitters sometimes provide additional materials that are
intended to clarify, emphasize, or otherwise comment to help
Product Managers and reviewers better understand the submittal.

        If such materials relate to one study, they should be
     included as an appendix to that study.

     - If such materials relate to more than one study  (as for
     example a summary of all studies in a discipline) or to the
     submittal in general, they must be included in the submittal
     package as a separate study  (with title page and statement
     of confidentiality claims).

B.   Transmittal Document

     The first item in each submittal package must be a trans-
mittal document.  This document identifies the submitter or all
joint submitters; the regulatory action in support of which the
package is being submitted--!.e., a registration application,
petition, experimental use permit (EUPT, §3(c)(2)(B) data
call-in,  §6(a)(2) submittal, 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 petiti9n and
an application for a registration or an EUP, list the petition
studies first,  then the balance of the studies.  Within these two
groups of studies follow the instructions above.

C.   Individual Studies

     A study is the report of a single scientific investigation,
including all supporting analyses required for logical complete-
ness.   A study should be identifiable and distinguishable by a
C9nventional bibliographic citation including author, date, and
title.   Studies generally correspond in scope to a single Guide-
line requirement for supporting data, with 39016 exceptions dis-
cussed in section C.I.  Each study included in a submittal
 Eackage must be bound as a separate entity.  (See comments on
 inding studies on page 9.)

     Each study must be consecutively paginated, beginning from
the title page as page 1.  The total number of pages in the com-
plete study must be shown on the study title page.  In addition
(to ensure that inadvertently separated pages can be reassociated
with the proper study during handling or review) use either of
the following:

     - Include the total number of pages in the complete study on
     each page (i.e., 1 of 250, 2 of 250,  ...250 of 250).

     - Include a company name or mark and study number on each
     page of the study, e g ,  Company Name-1986-23.    Never reuse
     a study number for marking the pages of subsequent studies.
     When a single study is extremely long, binding it in mul-
tiple V9lumes is permissible so long as the entire study is pag-
inated in a single series,  and each volume is plainly identified
by the study title and its position in the multi-volume sequence.

C.1  Special Considerations for Identifying Studies

     Some studies raise special problems in study identification,
because they address Guidelines of broader than normal scope or
for other reasons.

     a. Safety Studies.  Several Guidelines require testing for
safety in more than one species. In these cases each species
tested should be reported as a separate study,  and bound
separately.

     Extensive supplemental reports of pathology reviews, feed
analyses, historical C9ntrol data, and the like are often assoc-
iated with safety studies.   Whenever possible these should be
submitted with primary reports of the study, and bound with the
primary study as appendices.  When such supplemental reports are
submitted independently of the primary report,  take care to fully
identify the primary report to which they pertain.

     Batteries of acute toxicity tests, performed on the same end
use product and covered by a single title page, may be bound
together and reported as a single study.

     b. Product Chemistry Studies.   All product chemistry data
within a submittal package submitted in support of an end-use
product produced from registered manufacturing-use products
should be bound as a single study under a single title page.

     Product chemistry data submitted in support of a technical
product, other manufacturing-use product, an experimental use
permit, an import tolerance petition, or an end-use product


                                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
C9nventional pesticides, or for the equivalent subject range for
biorational pesticides.  The first of the three studies in a
complete product chemistry submittal for a biochemical pesticide
would cover Guidelines 151-10,  151-11,  and 151-12; the second
would cover Guidelines 151-13,  151-15,  and 151-16; the third
would cover Guideline 151-17. The first study for a microbial
pesticide would cover Guidelines 151-20, 151-21,  and 151-22; the
second W9uld cover Guidelines 151-23 and 151-25;  the third would
cover Guideline 151-26.

     Note particularly that product chemistry studies are likely
to contain Confidential Business Information as defined in FIFRA
§10(d)(1)(A), (B) ,  or  (C),  and if so must be handled as described
in section D.3.  of this notice.

     c.   Residue Chemistry Studies.   Guidelines 171-4, 153-3,
and 153-4 are extremely broad in scope; studies addressing
residue chemistry requirements must thus be defined at a level
below that of the Guideline code.  The general principle,
h9wever, of limiting a study to the report of a single inves-
tigation still applies fully.  Data should be treated as a single
study and bound separately for each analytical method, each
report of the nature of the residue in a single crop or animal
species, and for each report of the magnitude of residues
resulting from treatment of a single crop or from processing a
single crop.  When more than one commodity is derived from a
single crop  (such as beet tops and beet roots) residue data on
all such C9mmodities should be reported as a single study.  When
multiple field trials are associated with a single crop, all such
trials should be reported as a single study.
D.
Organization of Each Study Volume
     Each complete study must include all applicable elements in
the list below, in the order indicated.  (Also see Page 17.)
Several of these elements are further explained in the following
paragraphs.   Entries in the column headed "example" cite the
page number of this notice where the element is illustrated.
Element

Study Title Page

Statement of Data
Confidentiality
Claims

Certification of Good
Laboratory Practice
Flagging statements
Body of Study
Study Appendices

Cover Sheet to Confi-
dential Attachment
                    When Required                 Example

                    Always                        Page 12

                    One of the two alternative    Page 13
                    forms of this statement
                    is always required

                    If study reports Iaborat9ry   Page 16
                    work subject to GLP require-
                    ments

                    For certain t9xicology studies (When
                    flagging requirements are finalized.)

                    Always - with an English language
                    translation if required.

                    At submitter's option

                    If CBI is claimed under FIFRA
                    §10 (d) (1) (A) ,  (B) ,  or (C)
CBI Attachment
Supplemental Statement
of Data Confidentiality
Claims
                    If CBI is claimed under FIFRA
                    §10 (d) (1) (A) ,  (B) ,  or (C)      Page 15

                    Only if confidentiality is    Page 14
                    claimed on a basis other than
                    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 IdentificatJ9n.   If the study reports
work done by one or more laboratories,Include on the title page
the name and address of the performing laboratory or
laboratories, and the laboratory's internal project number(s) for
the work.  Clearly distinguish the laboratory's project
identifier from any other reference numbers provided by the study
sponsor or submitter.

f.   Supplemental Submissions.  If the study is a commentary on
or supplement to another previously submitted study, or if it
responds to EPA questions raised with respect to an earlier
study, include 9n the title page elements a. through d. for the
previ9usly submitted study, along with the EPA Master Record
Identifier (MRID) or Accession number of the earlier study if you
know these numbers.   (Supplements submitted in the same submittal
package as the primary study should be appended to and bound with
the primary stuay.  Do not include supplements to more than one
study under a single title page).

g.    Facts of Publication.  If the study is a reprint of a pub-
lished d9cument, identity on the title page all relevant facts of
publication,  such as the J9urnal title, volume, issue, inclusive
page numbers, and publication date.


D.2. Statements of Data Confidentiality Claims Under FIFRA
§10(d) (1) .

     Each submitted study must be accompanied by one of the two
alternative forms of the statement of Data Confidentiality Claims
specified in the proposed regulation in §158.33 (b) and (c)    (See
Attachment 3).   These statements apply only to claims of data
confidentiality based on FIFRA §10(d)(1)(A), (B),  or  (C).   Use
the appropriate alternative form of the statement either to
assert a claim of §10(d)(l) data confidentiality  (§158.33(b)) or
to waive such a claim (§158.33(c)).  In either case, the
statement must be signed and dated, and must include the typed
name and title of the official who signs it.  Do not make CBI
                                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
 )ortion of a submitted study other than described by FIFRA £
 [I)(A),  (B),  or  (C),  the following provisions apply:
     - The specific information to which the claim applies must
     be clearly marked in the body of the study as subject to a
     claim of confidentiality.

     - A Supplemental Statement 9f Data Confidentiality Claims
     must be submitted, identifying each passage claimed confi-
     dential and describing in detail the basis for the claim.
     A list of the points to address in such a statement is
     included in Attachment 4 on Pg 14.

     - The Supplemental Statement of Data Confidentiality Claims
     must be signed and dated and must include the typed name and
     title of the official who signed it.

D.5. Good Laboratory Practice Compliance Statement

     This statement is required if the study contains laboratory
work subject to GLP requirements specified in 40 CFR 160.  Sam-
ples of these statements are shown in Attachment 6.

E.    Reference to Previously Submitted Data

     DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED
FOR ANOTHER PURPOSE unless EPA specifically requests it.   A copy
of the title page plus the MRID number (if known)  is sufficient
to allow us t9 retrieve the study immediately for review.  This
prevents duplicate entries in the Agency files, and saves you
the cost of sending more copies of the study.  References to pre-
viously submitted studies smpuld not be included in the transmit-
tal document, but should be incorp9rated into the statement of
the method of support for the application.

F.    Physical Format Requirements

     All elements in the data submittal package must be on
uniform 8 1/2 by 11 inch white paper, printed 9n one side only in
black ink, with high contrast and good res9lution.  Bindings for
individual studies must be secure, but easily removable to permit


                                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 prop9sed regulati9ns specified two copies; three
are now being required to expedite and reduce the cost of
processing data into the OPP Pesticide Document Management System
and getting it into review.)

G.   Special Requirements for Submitting Data to the Docket

     Data submittal packages associated with a Registration Stan-
dard 9r Special Review must be provided in four C9pies, fr9m one
of which all material claimed as CBI has been excised.   This
fourth copy will become part of the public docket for the RS or
SR case.  If no claims of confidentiality are made for the study,
the fourth copy should be identical to the other three.  When
portions of a study submitted in support of an RS or SR are
claimed as CBI, the first three copies will include the CBI
material as provided in section D of this notice.  The following
special preparation is required for the fourth copy.

     •    Remove the "Supplemental Statement of Data
          Confidentiality Claims".

     •    Remove the "Confidential Attachment".

     •    Excise from the body of the study any information you
          claim as confidential, even if it does not fall within
          the scope of FIFRA §10(d)(1)(A),  (B),  or  (C).  Do not
          close up or paraphrase text remaining after this
          excision.

     •    Mark the fourth copy plainly on both its cover and its
          title page with the phrase "Public Docket Material -
          contains no information claimed as confidential".
                                74

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V.    For Further Information

     For further information contact John Carley, Chief,
Information Services Branch, Program Management and Support
Division, (703) 305-5240.
                              /S/

                         James W. Akerman
                         Acting Director,
                         Registration Division
Attachment 1.   Sample Transmittal Document
Attachment 2.   Sample Title Page for a Newly Submitted Study
Attachment 3.   Statements of Data Confidentiality Claims
Attachment 4.   Supplemental Statement of Data Confidentiality
               Claims
Attachment 5.   Samples of Confidential Attachments
Attachment 6.   Sample G9od Laboratory Practice Statements
Attachment 7.   Format Diagrams for Submittal Packages and Studies
                                75

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                          ATTACHMENT 1

       ELEMENTS  TO  BE  INCLUDED  IN THE  TRANSMITTAL  DOCUMENT*

1.   Name and address of submitter  (or all joint submitters**)

"Smith Chemical  Corporation              Jones Chemical Company
 1234 West Smith Street       -and-      5678 Wilson Blvd
 Cincinnati, OH 98765                    Covington, KY 56789



"Smith Chemical  Corp will  act as  sole  agent  for all submitters.

2.   Regulatory action in support of which this package is
     submitted

Use the EPA identification number  (e.g. 359-EUP-67) if you know
it.  Otherwise describe the type of request  (e.g.  experimental
use permit, data call-in - of xx-xx-xx date).

3.   Transmittal date

4.   List of submitted studies

     Vol 1.    Administrative materials - forms, previous corres-
               pondence with Project Managers, and so forth.

     Vol 2.    Title of first study in the submittal (Guideline
               No.)

     Vol n     Title of nth study in the submittal (Guideline
               No.)

     *    Applicants commonly provide this information in a tran-
          smittal letter.   This remains an acceptable practice so
          long as all four elements are included.

     *    Indicate which of the J9int submitters is empowered to
          act on behalf of all joint submitters in any matter
          concerning data compensation or subsequent use or
          release of the data.


Company Official: 	
                    Name                Signature

Company Name       	

Company Contact:  	 	
                    Name                Phone
                                76

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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)
                         77

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                            ATTACHMENT 3

             STATEMENTS  OF DATA CONFIDENTIALITY CLAIMS

1. No claim of confidentiality under FIFRA §10(d)(1)(A),(B),  or (C).

        STATEMENT OF NO  DATA CONFIDENTIALITY CLAIMS
   No  claim of  confidentiality is made for any information contained  in this
   study on the basis of  its falling within the scope of FIFRA
   6§10(d)(1)(A),  (B),  or (C).


   Company 	


   Company Agent: 	Typed Name	 Date:	


   	Title	  	Signature	
2. Claim of confidentiality under FIFRA §10(d)(1)(A),  (B),  or (C).
   Information  claimed confidential on the basis of its falling within the
   scope of FIFRA §10(d)(1)(A),  (B), or (C) has been removed to a
   confidential appendix, and is  cited by cross-reference number in the body
   of  the study.


    Company: 	


    Company Agent: 	Typed Name	 Date:	


   	Title	  Signature 	
             STATEMENT OF DATA  CONFIDENTIALITY  CLAIMS

NOTE: Applicants for  permanent or temporary tolerances  should
note that  it is OPP policy that no permanent tolerance,  temporary
tolerance,  or request for an emergency  exemption incorporating an
analytical  method, can be approved unless the applicant  waives
all claims  of confidentiality for the analytical method.   These
analytical  methods are published in the FDA Pesticide Analytical
Meth9ds  Manual, and therefore cannot be claimed as confidential.
OPP implements this policy by returning submitted analytical
methods,  for which confidentiality claims have been  made,  to the
submitter,  to obtain  the  confidentiality waiver before  they can
be processed.
                                  78

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                          ATTACHMENT 4

      SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
     For any portion of a submitted study that is not described
by FIFRA §10(d)(1)(A), (B),  or (C),  but for which y9u claim
C9nfidential treatment 9n another basis, the following informa-
tion must be included within a Supplemental Statement of Data
Confidentiality Claims:

     •    Identify specifically by page and line number(s) each
          portion of the study for which you claim
          confidentiality.

     •    Cite the reasons why the cited passage qualifies for
          confidential treatment.

     •    Indicate the length of time--until a specific date or
          event,  or permanently--for which the information should
          be treated as confidential.

     •    Identify the measures taken to guard against undesired
          disclosure of this information.

     •    Describe the extent to which the information has been
          disclosed, and what precautions have been taken in con-
          nection with those disclosures.

     •    Encl9se C9pies of any pertinent determinations of
          confidentiality made by EPA, other Federal agencies, of
          courts concerning this information.

     •    If y9u assert that disclosure of this information would
          be likely to result in substantial harmful effects to
          you, describe th9se harmful effects and explain why
          they should be viewed as substantial.

     •    If you assert that the informati9n in voluntarily sub-
          mitted, indicate whether you believe disclosure of this
          information might tend to lessen the availability to
          EPA of similar information in the future, and if so,
          how.
                                79

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                                   ATTACHMENT 5

              EXAMPLES OF SEVERAL  CONFIDENTIAL ATTACHMENTS

Example  1.  (Confidential  word or phrase  that has  been  deleted
from  the study)
    CROSS REFERENCE NUMBER 1       This cross reference number is used in the study in place of the
                                     following paragraph (s) at the indicated volume and page
                                     references.
    DELETED WORDS OR PHRASE:              Ethylene Glycol
    PAGE         LINES  REASON FOR THE DELETION                      FIFRA
    REFERENCE
     6            14     Identity of Inert Ingredient                           §10(d)(C)
    28           25
    100           19
Example 2. (Confidential paragraph(s) that have been deleted from the study)
 CROSS REFERENCE NUMBER 5       This cross reference number is used in the study in place of the
                                   following paragraph (s) at the indicated volume and page
                                   references.
  DELETED PARAGRAPH(S) :
        (                                                                   )
        (       Reproduce the deleted paragraph (s) here                              )
 PAGE         LINES REASON FOR THE DELETION               FIFRA REFERENCE
  20.           2-17   Description of the quality control process          § 1 0 (d) ( 1) (C)
Example 3. (Confidential pages that have been deleted from the study)
 CROSS REFERENCE NUMBER 7      This cross reference number is used in the study in place of the
                                  following paragraph (s) at the indicated volume and page
                                  references.
 DELETED PAGES(S): are attached immediately behind this page

 PAGES        REASON FOR THE DELETION               FIFRA REFERENCE
 35-41.        Description of product manufacturing process            § 10 (d) (1) (A)
                                           80

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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
                                    81

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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
                               v   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
                                               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.
                                       82

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PR Notice 91-2
      83

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84

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              UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                             WASHINGTON, B.C. 20460
                                                          OFFICE OF
                                                     PREVENTION, PESTICIDES
                                                     AND TOXIC SUBSTANCES
                          PR NOTICE 91-2

         NOTICE  TO MANUFACTURERS,  PRODUCERS,  FORMULATORS,
                  AND REGISTRANTS OF PESTICIDES

ATTENTION: Persons Responsible for Federal Registration of
Pesticide Products.

SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement

I.  PURPOSE:

     The purpose of this notice is to clarify the Office of
Pesticide 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
is defined in 40 CFR 158.153(1).  Accordingly, the Agency has
established the nominal concentration as the only acceptable
label claim for the amount of active ingredient in the product.

II.  BACKGROUND

     For some time the Agency has accepted two different methods
9f identifying on the label what percentage is claimed for the
ingredient(s) contained in a pesticide. Some applicants claimed a
percentage which represented a level between the upper and the
lower certified limits. This was referred to as the nominal
concentration. Other applicants claimed the lower limit as the
percentage of the ingredient(s) that would be expected to be
present in their product at the end of the product's shelf-life.
Unfortunately, this led to a great deal of confusion among the
regulated industry, the regulators, and the consumers as to
exactly how much of a given ingredient was in a given product.
The Agency has established the nominal concentration as the only
acceptable label claim for the amount of active ingredient in the
product.

     Current regulations require that the percentage listed in
the active ingredient statement be as precise as possible
reflecting go9d manufacturing practices 40 CFR 156.10(g)(5). The
certified limits required for each active ingredient are intended
to encompass any such "good manufacturing practice" variations 40
CFR 158.175(c)(3).

     The upper and lower certified limits, which must be proposed
in connection with a product's registration, represent the
amounts of an ingredient that may legally be present 40 CFR
158.175. The lower certified limit is used as the enforceable
lower limit for the product composition according to FIFRA
section 12(a)(1)(C),  while the nominal concentration appearing on
the label would be the routinely achieved concentration used for
calculation of dosages and dilutions.

     The nominal concentration would in fact state the greatest
degree of accuracy that is warranted with respect to actual


                                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 imp9rtant for registrants to note that certified
limits for active ingredients are not considered to be trade
secret information under FIFRA section 10(b).  In this respect the
certified limits will be routinely provided by EPA to States for
enforcement purposes, since the nominal concentration appearing
on the label may not represent the enforceable composition for
purposes of section 12(a)(1)(C).

III. REQUIREMENTS

     As described below under Unit V. " COMPLIANCE SCHEDULE," all
currently registered products as well as all applications for new
registration must comply with this Notice by specifying the
nominal C9ncentrati9n expressed as a percentage by weight as the
label claim in the ingredient(s)  statement and equivalence
statements if applicable (e.g., elemental arsenic, metallic zinc,
salt of an acid).  In addition, the requirement for performing
sample analyses of five or more representative samples must be
fulfilled. C9pies of the raw analytical data must be submitted
with the nominal ingredient label claim. Further information
about the analysis requirement may be found in the 40 CFR
158.170. All products are required to pr9vide certified limits
for each active, inert ingredient, impurities of toxicological
significance(i.e.,  upper limit(s) 9nly) and on a case by case
basis as specified by EPA.  These limits are to be set based on
representative sampling and chemical analysis(i.e., quality
control) of the product.

     The format of the ingredient statement must conform to 40
CFR 156-Labeling Requirements For Pesticides and Devices.

     After July 1,  1997, all pesticide ingredient Statements must
be changed to nominal concentration.

IV. PRODUCTS THAT REQUIRE EFFICACY DATA

     All pesticides are required to be efficacious. Therefore,
the certified lower limits may not be lower then the minimum
level to achieve efficacy.  This is extremely important for
products which are intended to C9ntrol pests which threaten the
public health, e.g., certain antimicrobial and rodenticide
products. Refer to 40 CFR 153.640.

     In those cases where efficacy limits have been established,
the Agency will not accept certified lower limits which are below
that level for the shelf life of the product.

V. COMPLIANCE SCHEDULE

     As described earlier,  the purpose of this Notice is to make
the registration process more uniform and more manageable for
both the agency and the regulated community. It is the Agency's
intention to implement the requirements of this notice as
smoothly as possible so as not to disrupt or delay the Agency's
high priority programs,  i.e.,  reregistration,  new chemical, or
fast track (FIFRA section 3(c)(3)(B). Therefore,
applicants/registrants are expected to comply with the
requirements of this Notice as follows:

     (1)  Beginning July 1, 1991, all new product registrations
          submitted to the Agency are to comply with the
          requirements of this Notice.
                                86

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     (2)  Registrants having products subject to reregistration
          under FIFRA section 4(a) are to comply with the
          requirements of this Notice when specific products are
          called in by the Agency under Phase V of the
          Reregistration Program.

     (3)  All other products/applications that are not subject to
          (1) and  (2) ab9ve will have until July 1, 1997, to
          comply with this Notice. Such applications should note
          "Conversion to Nominal Concentrations on the
          application form. These types Or amendments will not be
          handled as "Fast Track" applications but will be
          handled as routine requests.

VI. FOR FURTHER INFORMATION

Contact Tyrone Aiken for information or questions concerning
this notice on (703) 308-7031.


                                   /s/
                         Anne E. Lindsay, Director
                         Registration Division (H-7505C)
                                87

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88

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APPENDIX F. Product Specific Data Call-in
                    89

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90

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                       DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:


This Notice requires you and other registrants of pesticide
products containing the active ingredient identified in
Attachment 1 of this N9tice, 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 C9ntinued 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 t9 this Notice will be subject t9 suspensi9n.
We have provided a list of all of your products subject to this
N9tice 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 secti9n 3(c)(2)(B)  of the
Federal Insecticide, Fungicide and Rodenticide Act as amended
(FIFRA), 7 U.S.C. section 136a(c)(2)(B).   Collection of this
information is authorized under the Paperwork Reduction Act by
OMB Approval No.  2070-0107  (expiration date 12-31-92) .
      This Notice is divided into six sections and seven
Attachments.  The Notice itself contains information and
instructions applicable to all Data Call-in Notices.  The
Attachments contain specific chemical information and
instructions.  The six sections of the Notice are:

     Section I    - Why You Are Receiving This Notice
     Section II  -  Data Required By This Notice
     Section III -  Compliance With Requirements Of This
     Notice
     Section IV -   Consequences Of Failure To Comply With
     This Notice
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     Section V  -   Registrants' Obligation To Report
                    Possible Unreasonable Adverse Effects
     Section VI -   Inquiries And Responses To This Notice

     The Attachments to this Notice are:

     I  - Data Call-In Chemical Status Sheet
     2  - Product-Specific Data Call-In Response Form
     3  - Requirements Status and Registrant's Resp9nse 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, Requirements Status and Registrant's
Response Form.  Depending on the results of the studies required in
this Notice, additional testing may be required.

II-B.  SCHEDULE FOR SUBMISSION OF DATA

     You are required to submit the data or otherwise satisfy the
data requirements specified in Attachment 3, Requirements Status
and Registrant's Response Form, within the time frames provided.


II-C.  TESTING PROTOCOL

     All studies required under this Notice must be C9nducted in
accordance with test standards outlined in the Pesticide Assessment
Guidelines for those studies for which guidelines have been
established.

     These EPA Guidelines are available from the National Technical
Information Service (NTIS),  Attn: Order Desk, 5285 Port Royal Road,
Springfield, Va 22161 (tel:  703-487-4650).

     Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if the OECD-
recommended test standards conform to those specified in the
Pesticide Data Requirements regulation  (40 CFR § 158.70).  When
using the OECD protocols, they should be modified as appropriate so
that the data generated by the study will satisfy the requirements
of 40 CFR § 158.  Normally,  the Agency will not extend deadlines
for complying with data requirements when the studies were not
conducted in accordance with acceptable standards.  The OECD
protocols are available from OECD, 1750 Pennsylvania Avenue N.W.,
Washington, D.C. 20006.
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     All new studies and proposed protocols submitted in response
to this Data Call-in Notice must be in accordance with Good
Laboratory Practices [40 CFR Part 160.3(a)(6)].

II-D.  REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES
       ISSUED BY THE AGENCY

       Unless otherwise noted herein, this Data Call-In does not in
any way supersede or change the requirements of any previous Data
Call-In(s),or any other agreements entered into with the Agency
pertaining to such prior Notice.  Registrants must comply with the
requirements of all Notices to avoid issuance of a Notice of Intent
to Suspend their affected products.

SECTION III.  COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE

III-A.  SCHEDULE FOR RESPONDING TO THE AGENCY

      The appropriate responses initially required by this Notice
for product specific data must be submitted to the Agency within 90
days after your receipt of. this Notice.  Failure to adequately
respond to this Notice within 90 days of your receipt will be a
basis for issuing a Notice of Intent to Suspend (NOIS) affecting
your products. This and other bases for issuance of. NOIS due to
failure to comply with this Notice are presented in Section IV-A
and IV-B.

III-B.  OPTIONS FOR RESPONDING TO THE AGENCY

     The options for responding to this Notice for product specific
data are: (a) voluntary cancellation,  (b)  agree to satisfy the
product specific data requirements imposed by this notice or (c)
request a data waiver(s).

     A discussion of how to respond if you chose the Voluntary
Cancellation option is presented below.  A discussion of the
various options available for satisfying the product specific data
requirements of this Notice is contained in Section III-C.  A
discussion of options relating to requests for data waivers is
contained in Section III-D.

     There are two forms that accompany this Notice of which,
depending upon your response, one or both must be used in your
response to the Agency.  These forms are the Data-Call-in Response
Form, and the Requirements Status and Registrant's Response Form,
Attachment 2 and Attachment 3.  The Data Call-In Response Form must
be submitted as part of every response to this Notice.  In
addition, one copy 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 V9luntary cancellation option is
selected or unless the product is identical to another  (refer t9
the instructions for completing the Data Call-In Resp9nse 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 pr9duct, you must
submit a completed Data Call-In Response Form,  indicating your


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election of this option.  Voluntary cancellation is item number 5
9n the Data Call-In Response Form. If you choose this option, this
is the only form that you are required to complete.

     If y9u 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 9f 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 t9 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 t9 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 rrrare
          registrants to develop data jointly (Cost Sharing)
     (3)  I have made 9ffers 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 9r 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.  Y9u must
explain any technical or laboratory difficulties and provide
documentati9n 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
 ormed.  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


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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) (iiij
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 9f 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) .
         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
          are available for audit and review and you must identify
          where they are available.  This must be done in
          accordance with the requirements of the Good Laboratory
          Practice (GLP) regulation, 40 CFR Part 160. As stated in
          40 CFR 160.3(j)  " 'raw data' means any laboratory
          worksheets, records, memoranda, notes, or exact 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
          data' may include photographs, microfilm or microfiche
          C9pies, computer printouts, magnetic media, including
          dictated observations, and recorded data from automated


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          instruments."  The term "specimens", according to 40 CFR
          160.3(k), means "any material derived from a test system
          for examination or analysis."

     b.   Health and safety studies completed after May 1984 must
          also contain all GLP-required quality assurance and
          quality control information, pursuant to the requirements
          of 40 CFR Part 160.  Registrants must also certify at the
          time of submitting the existing study that such GLP
          information is available for post-May 1984 studies by
          including an appropriate statement on or attached to the
          study signed by an authorized official or representative
          of the registrant.

     c.   You must certify that each study fulfills the acceptance
          criteria for the Guideline relevant to the study provided
          in the FIFRA Accelerated Reregistration Phase 3 Technical
          Guidance and that the study has been conducted according
          to the Pesticide Assessment Guidelines (PAG)  or meets the
          purpose of the PAG (both available from NTIS).   A study
          not conducted according to the PAG may be submitted to
          the Agency for consideration if the registrant believes
          that the study clearly meets the purpose of the PAG.  The
          registrant is referred to 40 CFR 158.70 which states the
          Agency's policy regarding acceptable protocols. If you
          wish to submit the study,  you must, in addition to
          certifying that the purposes of the PAG are met by the
          study,  clearly articulate the rationale why you believe
          the study meets the purpose of the PAG, including copies
          of any supporting information or data.  It has been the
          Agency's experience that studies completed prior to
          January 1970 rarely satisfied the purpose of the PAG and
          that necessary raw data are usually not available for
          such studies.


     If you submit an existing study, you must certify that the
study meets all requirements of the criteria outlined above.

     If y9u know of a study pertaining to any requirement in this
Notice which does not meet the criteria outlined above but does
contain factual information regarding unreasonable adverse effects,
you must notify the Agency of such a study.  If such  study is in
the Agency's files, 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
as partially acceptable and upgradeable, you may submit data to
upgrade that study.  The Agency will review the data submitted and
determine if the requirement is satisfied.  If the Agency decides
the requirement is not satisfied,  you may still be required to
submit new data normally without any time extension.  Deficient,
but upgradeable studies will n9rmally be classified as
supplemental.  However, it is important to note that not all
studies classified as supplemental are upgradeable.  If you have
questions regarding the classification of a study or whether a
study may be upgraded, call or write the contact pers9n listed in
Attachment 1.  If you submit data to upgrade an existing study you
must satisfy or supply information to correct all deficiencies in
the study identified by EPA.  You must provide a clearly
articulated rationale of how the deficiencies have been remedied or
corrected and why the study sh9uld be rated as acceptable to EPA.
Your submission must also specify the MRID number(s) of the study
which you are attempting to upgrade and must be in conformance with
PR Notice 86-5.


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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
Opti9n 4 above, apply to all data submissions intended to upgrade
studies.  Additionally y9ur submission of data intended to upgrade
studies must be accompanied by a certification that you comply with
each of those criteria as well as a certification regarding
protocol compliance with Agency requirements.

     Option 6, Citing Existing Studies -- If you choose to cite a
study that has been previously submitted to EPA, that study must
have been previously classified by EPA as acceptable or it must be
a study which has not yet been reviewed by the Agency.  Acceptable
toxicology studies generally will have been classified as "core-
guideline" 9r "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 y9u 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
justification for the request, including technical reasons,  data
and references to relevant EPA regulations,  guidelines or policies.
(Note: any supplemental data must be submitted in the format
required by PR Notice 86-5).  This will be the only opportunity to
state the reasons or provide information in support of your
request.  If the Agency approves your waiver request, you will not
be required to supply the data pursuant to section 3 (c)(2)(B) of
FIFRA.  If the Agency denies your waiver request, you must choose
an option for meeting the data requirements 9f this Notice within
30 days 9f the receipt of the Agency's decision.  You must indicate
and submit the option chosen on the Requirements Status and
Registrant'sResponse 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
with9ut 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
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     The Agency may issue a Notice of Intent t9 Suspend products
subject to this Notice due to failure by a registrant to comply
with the requirements of this Data Call-in Notice, pursuant to
FIFRA section 3(c)(2)(B).   Events which may be the basis for
issuance of a Notice of Intent to Suspend include, but are not
limited to, the following:

     1.   Failure to respond as required by this Notice within 90
          days of your receipt of this Notice.

     2.   Failure to submit on the required schedule an acceptable
          prop9sed or final protocol when such is required to be
          submitted to the Agency for review.

     3.   Failure to submit on the required schedule an adequate
          progress report on a study as required by this Notice.

     4.   Failure to submit on the required schedule acceptable
          data as required by this Notice.

     5.   Failure to take a required action or submit adequate
          information pertaining to any option chosen 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 C9Sts 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 9f 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 t9 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


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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 incorporated by reference  (including, as
     applicable, EPA Pesticide Assessment Guidelines, Data
     Reporting Guidelines, and GeneTox Health Effects Test
     Guidelines) regarding the design, conduct, and reporting of
     required studies.  Such requirements include, but are not
     limited to, those relating to test material, test procedures,
     selection of species, number of animals, sex and distribution
     of animals, dose and effect levels to be tested or attained,
     duration of test, and, as applicable, Good Laboratory
     Practices.

     2.  EPA requirements regarding the submission of protocols,
     including the incorporation of any changes required by the
     Agency following review.

     3.  EPA requirements regarding the reporting of data,
     including the manner of reporting, the completeness of
     results, and the adequacy 9f any required supporting  (or raw)
     data, including, but not limited to, requirements referenced
     or included in this Notice or contained in PR 86-5.  All
     studies must be submitted in the form of a final report; a
     preliminary 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.  Acc9rdingly, 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 n9t C9nsider 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 N9tice 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.
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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' OBLIGATION TO REPORT POSSIBLE
            UNREASONABLE ADVERSE EFFECTS

     Registrants are reminded that FIFRA section 6(a)(2) states
that if at any time after a pesticide is registered a registrant
has additional factual information regarding unreasonable adverse
effects on the environment by the pesticide, the registrant shall
submit the information to the Agency.  Registrants must notify the
Agency of any factual information they have, from whatever source,
including but not limited to interim or preliminary results of
studies, regarding unreasonable adverse effects on man or the
environment.  This requirement continues as long as the products
are registered by the Agency.

SECTION VI.  INQUIRIES AND RESPONSES TO THIS NOTICE

     If you have any questions regarding the requirements and
procedures established by this Notice, call the contact person(s)
listed in Attachment 1, the Data Call-In Chemical Status Sheet.

     All responses to this Notice (other than voluntary
cancellation requests and generic data exemption claims) must
include a completed Data Call-In Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment 2
and Attachment 3for 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 9ption is chosen, only the
Data Call-In Response Form need be submitted.

     The Office of Compliance Monitoring (OCM)  of the Office of
Pesticides and Toxic Substances (OPTS), EPA, will be monitoring the
data being generated in response to this Notice.

                              Sincerely yours,
                              Louis P. True, Jr., Acting Director
                              Special Review and
                                Reregistration Division
Attachments
     1  - Data Call-In Chemical Status Sheet
     2  - Product-Specific Data Call-In Response Form
     3  - Requirements Status and Registrant's Resp9nse Form
     4  - EPA Grouping of End-Use Products for Meeting Acute
          Toxicology Data Requirements for Reregistration
                                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 overview 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 Toxicol9gy 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-Mercaptobenzothiazole are needed for
specific pr9ducts. 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.

     If you have any questions regarding the product specific data
requirements and procedures established by this Notice, please
contact Franklin Gee at (703)  308-8008.

     All responses to this Notice for the Product Specific data
     requirements should be submitted to:

          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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   INSTRUCTIONS  FOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR
                       PRODUCT SPECIFIC DATA

Item 1-4. Already completed by EPA.

Item 5.   If  you  wish to  voluntarily cancel  your product, answer
          "yes."   If  you choose  this  option,  you will not have  to
          provide  the  data  required by the Data Call-in Notice and
          you will  not have to complete  any  other forms.   Further
          sale and distribution of your product after  the  effective
          date  of  cancellation  must be  in  accordance  with the
          Existing  Stocks  provision  of  the  Data  Call-in Notice
          (Section IV-C).

Item 6.   Not applicable since this form calls in product  specific
          data  only.    However,  if  your  product is  identical  to
          another product and you qualify for  a data exemption, you
          must  respond with "yes" to  Item 7a  (MUP)  or 7B  (EUP)  on
          this  form,  provide the EPA registration numbers of your
          source(s);  you would not complete the "Requirements Status
          and Registrant's  Response"  form.  Examples of  such products
          include  repackaged  products  and   Special   Local   Needs
          (Section  24c)  products which are  identical  to  federally
          registered products.

Item 7a.  For each manufacturing use  product (MUP)  for which you wish
          to  maintain  registration,  you must  agree  to satisfy the
          data requirements by responding "yes."

Item 7b.  For each end  use product (EUP)  for  which  you wish  to
          maintain registration, you must agree to satisfy the data
          requirements by responding  "yes."  If you are requesting a
          data  waiver,  answer  "yes" here;   in  addition,  on the
          "Requirements Status and Registrant's Response" form  under
          Item 9,  you must  respond with Option  7 (Waiver Request) for
          each study for which you are  requesting a waiver.   See Item
          6 with regard  to identical  products  and data exemptions.

Items 8-11.   Self-explanatory.

NOTE:      You may provide additional  information that does not  fit  on
          this  form in a signed letter that accompanies this  form.
          For example, you may wish  to report  that your product has
          already  been transferred  to another company or  that you
          have already voluntarily canceled this product.   For  these
          cases, please  supply all relevant details so that EPA can
          ensure that  its records are  correct.
                                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 9f
          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
          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.  By the
          specified due date,  I will also  submit:  (1)  a  completed
          "Certification   With  Respect   To  Data   Compensation
          Requirements" form  (EPA Form 8570-29) and (2)  two completed
          and signed  copies of the Confidential Statement of Formula
          (EPA Form 8570-4).

     2.    I  have  entered  into an  agreement   with one  or  more
          registrants to develop data jointly (Cost Sharing).  I am
          submitting  a copy  of  this agreement.   I  understand that
          this option is available only for acute toxicity  or certain
          efficacy data and only if EPA indicates in  an attachment to
          this Notice  that my product  is similar enough to another
          product to  qualify  for this option.  I  certify that another
          party in the agreement is committing to submit or provide
          the required data; if the required study is 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).

3.    I have  made  offers to share in  the cost to develop data
     (Offers to Cost Share).   I understand that this  option is
     available only for  acute toxicity or certain efficacy data
     and only  if  EPA indicates in an  attachment  to  this Data
     Call-in Notice that my product is similar enough to another
     product  to qualify  for  this  option.   I  am  submitting
     evidence  that  I have made an offer to another  registrant
     (who has an obligation to submit data)  to share in the cost
     of  that  data.     I am  also  submitting  a   completed
     "Certification of  Offer  to Cost Share in the Development
     Data" form.   I am including a copy of my offer and proof of
     the  other registrant's  receipt  of  that  offer.    I  am
     identifying  the  party which  is committing  to  submit or
     provide  the  required data; if  the  required  study is not
     submitted on  time,  my product may be subject  to suspension.
     I understand  that  other  terms  under Option  3 in the Data
     Call-in Notice  (Section  III-C.l.)  apply as  well.  By the
     specified due date,  I will also  submit:  (1)  a  completed
     "Certification   With   Respect   To  Data   Compensation
     Requirements"  form  (EPA Form 8570-29) and (2)  two completed
     and signed copies of  the Confidential Statement  of Formula
     (EPA Form 8570-4).

4.    By the specified due  date,  I will submit an existing study
     that  has  not  been  submitted previously  to  the Agency by
     anyone (Submitting  an Existing Study).   I certify that this
     study  will  meet all the  requirements  for  submittal  of
     existing  data outlined  in Option  4 in  the  Data Call-in
     Notice  (Section III-C.l.)  and  will  meet   the attached
     acceptance  criteria  (for  acute   toxicity  and product
     chemistry  data) .    I will  attach  the  needed  supporting
     information along with this response.  I also certify that
     I  have determined that  this  study  will  fill  the data
     requirement for which I have indicated this choice.   By the
     specified  due  date,  I   will   also  submit  a   completed
     "Certification   With   Respect   To  Data   Compensation
     Requirements"  form (EPA Form 8570-29)  to  show what data
     compensation  option  I have chosen.   By the specified due
     date,  I will  also  submit:  (1)  a completed "Certification
     With Respect To Data Compensation Requirements"  form  (EPA
     Form  8570-29)  and  (2) two completed and signed  copies of
     the Confidential Statement of Formula (EPA Form 8570-4) .

5.    By the  specified due date,  I  will submit or cite data to
     upgrade  a study classified  by  the Agency  as  partially
     acceptable and upgradable  (Upgrading  a Study).   I will
     submit evidence of  the Agency's review indicating that the
     study may be upgraded and what informati9n 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).

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


                           109

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          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 on the
          same data.  I  may  also choose this option if I am citing my
          own  data.  In either case,  I  will provide  the MRID  or
          Accession number (s)  for  the  cited data  on  a  "Product
          Specific Data  Report"  form or in a  similar  format.   By the
          specified due date,  I will also  submit:   (1) a  completed
          "Certification   With   Respect   To   Data  Compensation
          Requirements"  form (EPA Form 8570-29) and (2)  two completed
          and signed copies  of the Confidential Statement  of  Formula
          (EPA Form 8570-4).

     7.   I  request a  waiver  for   this  study  because   it   is
          inappropriate for  my product  (Waiver  Request).    I  am
          attaching  a  complete  justification  for   this request,
          including  technical   reasons,  data   and  references   to
          relevant  EPA  regulations, guidelines or policies.   [Note:
          any  supplemental  data  must be  submitted  in  the  format
          required  by P.R.  Notice 86-5].  I understand that  this  is
          my  only  opportunity   to  state  the  reasons  or  provide
          information  in support  of my  request.   If  the  Agency
          approves  my waiver request,  I will  not  be required  to
          supply  the data pursuant  to Section 3(c)(2)(B)  of  FIFRA.
          If the  Agency denies  my waiver request,  I must choose  a
          method of meeting the  data requirements of this  Notice  by
          the due date stated by this N9tice.  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 9ption  chosen.
          I also understand  that the deadline  for submission  of  data
          as specified by the original data call-in  notice will  not
          change.   By the specified due date, I will also submit:  (1)
          a   completed    "Certification  With   Respect   To   Data
          Compensation Requirements" form (EPA Form 8570-29)  and (2)
          two  completed  and  signed  copies  of  the  Confidential
          Statement  of  Formula  (EPA Form 8570-4).

Items 10-13.  Self-explanatory.

NOTE:      You may provide additional information that  does not fit on
          this form in  a signed letter that accompanies  this form.
          For example, you  may  wish to report that your product  has
          already  been  transferred to another company or that  you
          have already voluntarily canceled this  product.   For these
          cases,  please  supply  all relevant details  so that  EPA can
          ensure that its records are correct.
                                110

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 Attachment 3. Product Specific Requirement
Status and Registrant's Response Forms  (Form
        B  inserts)  and Instructions
                     111

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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 9f
          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 tpxicity 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 prpvide
          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 III-C.l.) apply as well.

4.   By the specified due date, I will submit an existing
study that has not been submitted previously  to the Agency
by anyone  (submitting an Existing Study).  I certify  that
this study will meet  all the requirements for submittal  of
existing  data outlined in  option  4  in the  Data Call-in
Notice  (Section  III-C.l.)  and  will  meet   the  attached
acceptance  criteria  (for  acute  toxicity  and  product
chemistry  data) .   I will  attach the  needed supporting
information along  with this response.  I also certify  that
I  have determined  that  this  study  will  fill  the  data
requirement for which I have indicated this  choice.

5.   By the specified due  date,  I will submit or cite  data
to upgrade a  study classified  by the Agency as partially
acceptable and 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 f9rmat. If I cite an9ther registratrant's data, I
will submit a completed "Certification With  Respect To  Data
Compensation Requirements" form.

7.   I  request a  waiver  for  this  study  because  it  is
inappropriate  for my  product  (Waiver Request).    I  am
attaching  a  complete   justification  for  this  request,
including  technical  reasons,   data  and  references  to
relevant EPA  regulations,  guidelines or policies.   [Note:
any  supplemental  data  must be  submitted  in  the   format
required by P.R. Notice 86-5].   I understand that this  is
my  only  opportunity to  state  the  reasons or  provide
information  in support  of my  request.   If  the  Agency
approves my waiver request, I will not be require  to  supply
the data pursuant  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  of. the Agency's written decision,
          submit  a  revised  "Requirements  Status  chosen.    I  also
          understand that  the deadline  for  submission of  data as
          specified by  the  original  data cal-in notice  will  not
          change.

Items 10-13.   Self-explanatory.

     NOTE:You may  provide additional information that  does not fit on
this  form   in  a  signed  letter that  accompanies  this  form.   For
example, you may  wish to  report that  your product has already been
transferred to another company or that you have already voluntarily
cancelled this  product.  For these cases, please supply all relevant
details so that EPA can ensure that its records are correct.
                                115

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116

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  Attachment  4. EPA Batching of End-Use
Products for Meeting Data Requirements for
              Reregistration
                    117

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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-mercaptobenzothiazole, 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 today's standards (see acceptance criteria attached), the formulation tested is considered by EPA
to be  similar for acute toxicity, and the formulation has not been significantly altered since submission
and acceptance of the acute toxicity data. Regardless of whether new data is generated or existing data
is referenced, registrants must clearly identify the test material by EPA Registration Number.  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 Call-In Response," asks whether the  registrant will meet the data
requirements for each product. The second form, "Requirements Status and Registrant's Response," lists
the product specific data required for each product, including the standard six acute toxicity tests. A
registrant who wishes to participate in a batch must decide whether he/she will provide  the data or
depend on someone else to do so.  If a registrant supplies the data to support a batch of products, he/she
must  select one of the following options: Developing Data (Option 1),  Submitting an Existing Study
(Option 4), Upgrading  an Existing Study (Option 5) or Citing an Existing Study (Option 6).  If a
registrant depends on another's data, he/she must choose among:  Cost  Sharing (Option 2), Offers to
Cost  Share (Option 3) or Citing an Existing Study (Option 6).  If a registrant does not want to
participate in a batch, the choices are Options 1,  4, 5 or 6.  However,  a registrant should know that
choosing not to participate in a batch does not preclude other registrants in the batch from citing his/her
studies and offering to cost share (Option 3) those studies.

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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            Study Title

Series 61            Product Identity and Composition
Series 62            Analysis and Certification of Product Ingredients
Series 63            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 tested (include product name and trade name, if appropriate).

2.	    Name, nominal concentration, and certified limits (upper and lower) for each active ingredient and each
          intentionally-added inert ingredient.

3.	    Name and upper certified limit for each impurity or each group of impurities present at _>_ 0.1% by weight and
          for certain lexicologically significant impurities (e.g., dioxins, nitrosamines)  present "af < 0.1%.

4.	    Purpose of each active ingredient and each intentionally-added inert.

5.	    Chemical name from Chemical Abstracts index  of Nomenclature and Chemical Abstracts Service (CAS)
          Registry  Number for each active ingredient and, if available, for each intentionally-added inert.

6.	    Molecular, structural, and empirical formulas, molecular weight or weight range, and any company assigned
          experimental or internal code numbers for each active ingredient.

7.	    Description of each beginning material in the manufacturing process.
          	  EPA Registration Number if registered;
                 for other beginning materials, the following:
          	  Name and address of manufacturer or supplier.
          	  Brand name, trade name or commercial designation.
          	  Technical specifications or data  sheets by which manufacturer or supplier describes composition,
                 properties  or toxicity.

8.	Description of manufacturing process.
          	  Statement of whether batch or continuous process.
          	  Relative amounts of beginning materials and order in which they are added.
          	  Description of equipment.
          	  Description of physical conditions (temperature, pressure, humidity)  controlled in each step and the
                 parameters that are maintained.
          	  Statement of whether process involves intended chemical reactions.
          	  Flow chart with chemical equations for each intended chemical reaction.
          	  Duration of each step of process.
          	  Description of purification procedures.
          	  Description of measures taken to assure quality of final product.

9.	    Discussion of formation of impurities based on established chemical theory addressing (1) each impurity which
          may be present at _>_ 0.1% or was found at _>_ 0.1% by product analyses and (2) certain lexicologically
          significant impurities~(see #3).
                                                    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 6, Y, and 8.

Does your study meet the following acceptance criteria?

 1.	  Five or more representative samples (batches in case of batch process) analyzed for each active ingredient and
         all impurities present at > 0.1%.
 2.	  Degree of accountability!^ closure _>_ ca 98%.
 3.	  Analyses conducted for certain trace toxiclmpurities at lower than 0.1% (examples, nitrosamines in the case of
         products  containing dinitroanilines or containing secondary or  tertiary amines/alkanolamines  plus nitrites;
         polyhalogenated dibenzodioxins and dibenzofurans). [Note that in the case of nitrosamines both fresh and stored
         samples must be analyzed.].
 4.	  Complete and detailed description of each step in analytical method used to analyze above samples.
 5.	  Statement of precision and accuracy of analytical method used to analyze above samples.
 6.	  Identities and quantities (including mean and standard deviation)  provided for each analyzed ingredient.
 7.	  Upper and lower certified limits proposed for each active ingredient and intentionally added inert along with
         explanation of how the limits were determined.
 8.	  Upper certified limit proposed for each impurity present at > 0.1% and for certain lexicologically significant
         impurities at < 0.1% along with explanation of how limit determined.
 9.	  Analytical methods to verify certified limits of each active ingredient and impurities (latter not required if exempt
         from requirement of tolerance or if generally recognized as safe by FDA) are fully described.
10.	Analytical methods (as discussed in 19) to verify certified limits validated as to their precision and accuracy.
                                                     125

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                                   63 Physical and Chemical Characteristics

                                          ACCEPTANCE CRITERIA


The following criteria apply to the technical grade of the active ingredient being reregistered.

Does your study meet the following acceptance criteria?

63-2 Color
   	  Verbal description of coloration (or lack of it)
   	  Any intentional coloration also reported in terms of Munsell color system

63-3 Physical State
   	  Verbal description of physical state provided using terms such as "solid,  granular, volatile liquid"
   	  Based on visual inspection at about 20-25E C

63-4 Odor
   	  Verbal description of  odor (or lack of  it) using  terms such as  "garlic-like, characteristic  of aromatic
          compounds"
   	  Observed at room temperature

63-5 Melting Point
   	  Reported in EC
   	  Any observed decomposition reported

63-6 Boiling Point
   	  Reported in EC
   	  Pressure under which B.P. measured reported
   	  Any observed decomposition reported

63-7 Density, Bulk Density, Specific Gravity
          Measured at about 20-25E C
   	  Density of technical grade active ingredient reported in g/ml or the specific gravity of liquids reported with
          reference  to water at  20E  C. [Note:  Bulk density of registered products may be reported  in lbs/ft3  or
          Ibs/gallon.]

63-8 Solubility
   	  Determined in  distilled water and representative polar and non-polar solvents, including those  used  in
          formulations and analytical methods for the pesticide
          Measured at about 20-25E C
   	  Reported in g/100 ml (other units like ppm acceptable if sparingly soluble)

63-9 Vapor Pressure
   	  Measured at 25E C (or calculated by extrapolation from measurements made at higher temperature if pressure
          too low to  measure at 25E C)
   	  Experimental procedure described
   	  Reported in mm Hg (torr) or other conventional units

63-10 Dissociation Constant
   	  Experimental method described
          Temperature of measurement specified (preferably about
          20-25EC)

63-11 Octanol/water Partition Coefficient
   	  Measured at about 20-25E C
   	  Experimentally determined and description of procedure provided (preferred method-45 Fed. Register 77350)
   	  Data supporting reported value provided

63-12 pH
          Measured at about 20-25E C
   	  Measured following dilution or dispersion in distilled water

63-13 Stability
   	  Sensitivity to metal ions and metal determined
   	  Stability at normal and elevated temperatures
   	  Sensitivity to sunlight determined
                                                     126

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                                             SUBDIVISION F
Guideline         Study Tide

 81-1           Acute Oral Toxicity in the Rat
 81-2           Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
 81-3           Acute Inhalation Toxicity in the Rat
 81-4           Primary Eye Irritation in the Rabbit
 81-5           Primary Dermal Irritation Study
 81-6           Dermal Sensitization in the Guinea Pig
                                                   127

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                                      81-1 Acute Oral Toxicity in the Rat


                                          ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

 1.	Identify material tested (technical, end-use product, etc).
 2.	At least 5 young adult rats/sex/group.
 3.r	Dosing, single oral may be administered over 24 hrs.
 4.*^	Vehicle control if other than water.
 5.	Doses tested, sufficient to determine a toxicity category or a limit dose (5000 mg/kg).
 6.	Individual observations at least once a day.
 7.	Observation period to last at least 14 days, or until all test animals appear normal whichever is longer.
 8.	Individual daily observations.
 9.	Individual body weights.
10.	Gross necropsy on all animals.
                         Criteria marked with an * are supplemental and may not be required for every study.

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                         81-2  Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig


                                          ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

 1.	Identify material tested (technical, end-use product, etc).
 2.	At least 5 animals/sex/group.
 3.*	Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-450 gm.
 4.	Dosing, single dermal.
 5.	Dosing duration at least 24 hours.
 6.^	Vehicle control, only if toxicity of vehicle is unknown.
 7.~	Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg).
 8.	Application site clipped or shaved at least 24 hours oefore dosing.
 9.	Application site at least 10% of body surface area.
10.	Application site covered with a porous nonirritating cover to retain test material and to prevent
      ingestion.
11.	Individual observations at least once a day.
12.	Observation period to last at least 14 days.
13.	Individual body weights.
14.	Gross necropsy on all animals.
                         Criteria marked with an * are supplemental and may not be required for every study.

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                                   81-3 Acute Inhalation Toxicity in the Rat


                                          ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

 1.	Identify material tested (technical, end-use product, etc).
 2.	Product is a gas, a solid which may produce a significant vapor hazard  based on toxicity and expected use or
        contains particles of inhalable size for man (aerodynamic diameter 15 pm or less).
 3.	At least 5 young adult rats/sex/group.
 4.	Dosing, at least 4 hours by inhalation.
 5.	Chamber air flow dynamic, at least  10 air changes/hour, at least 19% oxygen content.
 6.	Chamber temperature, 22E 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.	Dose, 0.1 ml if a liquid;  0.1  ml or not more than 100 mg if a solid, paste or particulate substance.
 6.	Solid or granular test material ground to a fine dust.
 7.	Eyes not washed for at least 24 hours.
 8.	Eyes examined and graded for irritation before dosing and
        at 1, 24, 48 and 72 hr, then daily until eyes are normal
        or 21 days (whichever is shorter).
 9.^	Individual daily observations.
                         Criteria marked with an * are supplemental and may not be required for every study.

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                                    81-5  Primary Dermal Irritation Study

                                          ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

 1.	Identify material tested (technical, end-use product, etc).
 2.	Study not required if material is corrosive or has a pH of < 2 or > 11.5.
 3.	6 adult animals.
 4.	Dosing, single dermal.
 5.	Dosing duration 4 hours.
 6.	Application site shaved or clipped at least 24 hours prior to dosing.
 7.	Application site approximately 6 cm2.
 8.	Application site covered with a gauze patch held in place with nonirritating tape.
 9.	Material removed, washed with water, without trauma to application site.
10.	Application site examined and  graded for irritation at 1, 24, 48 and 72 hr,  then daily until normal or 14 days
        (whichever is shorter).
11.^	Individual daily observations.
                         Criteria marked with an * are supplemental and may not be required for every study.

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                                 81-6  Dermal Sensitization in the Guinea Pig

                                          ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

1.	Identify material tested (technical,  end-use product, etc).
2.	Study not required if material is corrosive or has a
      pHof <2or  >11.5.
3.	One offhe following methods is utilized:
      	Freund's complete adjuvant test
      	Guinea pig maximization test
      	Split adjuvant technique
      	Buehler test
      	Open epicutaneous test
      	Mauer optimization test
      	Footpad technique in guinea pig.
4.	Complete description of test.
5.^	Reference for test.
6.~	Test followed essentially as described in reference document.
7.	Positive control included (may provide historical data conducted within the last 6 months).
                         Criteria marked with an * are supplemental and may not be required for every study.

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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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140

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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be  used. Two legible, signed copies of the form are
required.  Following are basic instructions:
     a. All the blocks on the form must be filled in and answered completely.
     b.      If any block is not applicable, mark it N/A.
     c.      The CSF must be signed, dated and the telephone number of the responsible party must be provided.
     d.      All applicable information which is on the product specific data submission must also be reported on the
             CSF.
     e.      All weights reported under item 7 must be in pounds per gallon for liquids and pounds per cubic feet for
             solids.
     f.      Flashpoint must be in degrees Fahrenheit and flame extension in inches.
     g.      For all active ingredients, the EPA Registration Numbers for the currently registered source products
             must  be reported under column 12.
     h.      The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all common names for the
             trade  names must be  reported.
     i.      For the active ingredients, the percent purity of the source products must be reported under column 10
             and must be exactly the same as on the source product's laoel.
     j.      All the weights in columns 13.a. and 13.b. must be  in pounds, kilograms, or grams. In no case will
             volumes be accepted. Do not mix English and metric system units (i.e., pounds and kilograms).
     k.      All the items under column 13.b. must total 100 percent.
     1.      All items under columns 14.a.  and 14.b. for the active ingredients must represent pure active  form.
     m.     The upper and lower certified limits for ail active and inert ingredients must follow the 40 CFR 158.175
             instructions. An explanation must be provided if the proposed limits are different than standard certified
             limits.
     n.      When new CSFs are  submitted and approved, all previously submitted CSFs become obsolete for that
             specific formulation.
                                                   141

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142

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    ?/EPA
United States  Environmental  Protection Agency
            Washington,  DC  20460
   CERTIFICATION  OF OFFER TO COST
SHARE  IN THE  DEVELOPMENT  OF DATA
Form Approved

OMB No.  2070-0106
         2070-0057

Approval  Expires 3-31-96
 Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
 time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
 completing and reviewing the collection of information.  Send comments regarding the burden estimate or any other
 aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
 Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
 of Management and Budget, Paperwork Reduction Project (2070-0106), Washington,  DC 20503.

 Please fill in blanks below.
  Company Name
                                                                            Company Number
  Product Name
                                                                           EPA Reg. No.
 I Certify that:

 My company is willing to develop and submit the data required by EPA under the authority of the Federal
 Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary.  However, my company would prefer to
 enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
 data.

 My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
 offer  to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all
 terms could not be reached otherwise.  This offer was made to the following firm(s) on the following
 date(s):
  Name of Firm(s)
                                                   Date  of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
 Signature of Company's Authorized Representative
                                                                            Date
 Name and Title (Please Type or Print)
 EPA 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
LVd^pfM


OKI
2070-0107
2070-0037
       3 31 96
   Public reporting txjrden for this collection of information is estimated lo average 15 minutes per response, includino
   time for rev.ew.ng .nstructwns, 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 20S03.
   Pleast fill In blankt below.


Company Numb«r
BPA R«g. No.
 I Certify that:
 1.
For each study cited in support of registration or ^registration under the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) that is an exclusive use study. I am the original data submitter, or I have obtained the
written permission of the original data submitter to cite that study.

That for each study cited in support of registration or ^registration under FIFRA that is NOT an exclusive use
study. I am the original data submitter, or I have obtained the written permission of the original data submitter or I
have notified in writing the company(ies) that submitted data I have cited and have offered to:  (a)  Pay
compensation for those data in accordance with sections 3(C)(1)(D) and 3(c)(2)(D) of FIFRA: and (b) Commence
negotiation to determine which data art subject to the compensation requirement of FIFRA and the amount of
compensation due. if any.  The companies I have notified art: (check one)
    [ ]  The companies who have submitted the studies listed on the back of this form or attached
        sheets, or indicated on the attached •Requirements Status and Registrants' Response Form.'

 3.  That I have previously complied with section 3(c)(i )(D) of FIFRA for the studies I have cited in support of
    registration or ^registration under FIFRA.
Signature
Nam* and Tllto (?!••*• Type or Print)
Date

 GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the
 registration or ^registration of my products, to the extent required by FIFRA sections 3(C)(1)(D) and 3(c)(2)(D).
 Signature
 Nam* and Tttta (Ptoaaa Typ» or Print)
EPA Form 1570-11 (4-90)

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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             Prevention, Pesticides         EPA-738-F-94-024
                Environmental Protection       And Toxic Substances         September 1994
                Agency	(7508W)	


                R.E.D.   FACTS
                Sodium  and Zinc


                Salts  of  2-Mercapto-


                     benzothiazole	
     PGStJCJdG      All pesticides sold or distributed in the United States must be
RGTGClistration  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.

   USG ProfilG      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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    Regulatory
         History
Human  Health
  Assessment
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.

      Sodium 2-mercaptobenzothiazole was first registered as a pesticide in
the United States in 1949 in an industrial preservative product.  Currently,
only one product is registered, for use in wood and paper/paper board
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.

Toxicity
      Zinc 2-mercaptobenzothiazole has been placed in Toxicity Category
III, 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 toxicological 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
   AsSGSSITIGnt        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  reregistration. 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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