United States        Office of Prevention, Pesticides   EPA 738-R-93-OI9
          Environmental Protection    And Toxic Substances      September (993
          Agency          .(7508W)	.
xvEPA  Registration
          """  ibiiity Decision
          Inorganic  Halides
                                   Printed on Recycled Paper

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                United States
                Environmental Protection
                Agency
                      Office of Prevention, Pesticides  EPA-738-F-93-01 5
                      And Toxic Substances September 1993
                      . (H-7508W)
                 R.E.D.    FACTS
                 inorganic   Halides
     Pesticide       All pesticides sold or used in the United States must be registered by
Reregistration   EPAป 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 undue hazards 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 for sodium bromide
                 and sodium chloride, which made up the reregistration case called
                 Inorganic Halides.
   Use Profile
     Sodium bromide is used as a microbiocide. to control algae, bacteria
and fungi in pasteurizer and cannery cooling water recirculation systems, .
pulp and paper mill water systems, and ornamental ponds and aquaria. It
also is an active ingredient in pesticide products used to repel moths from
clothing, and fleas from pets and their sleeping quarters.  Products are
formulated as liquid or solid soluble concentrates, tablets or granules.
Sodium bromide has been used for many years in medicine as a sedative.
    Regulatory
        History
     Sodium chloride is one of two active ingredients in a disenfectant
used to treat feeding and watering appliances, equipment and premises in
poultry operations. Sodium chloride is also the sole active ingredient
impregnated into polyethylene whcih is placed around gardens as a barrier
to slugs and snails.


     Sodium bromide was first registered as a pesticide in the U.S. in
1975.  Currently, 32  pesticide products contain the active ingredient
sodium bromide.

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                         Products containing sodium chloride were first registered as
                    pesticides in the U.S. in 1954. At present, 2 pesticide products contain
                    sodium chloride as an active ingredient.


Human Health   Toxicity
  Assessment        Sodium bromide is of low acute oral and moderate dermal toxicity,
                    and has been placed in Toxicity Category m for these effects.  (Category I
                    indicates the highest and Category IV the lowest degree of acute, toxicity.)
                    It causes mild eye and skin irritation, and for those effects it has been
                    placed in Toxicity Category IV.                    •   '

                          The human health effects of bromides following oral exposure are
                    well known.  The bromine salts have a depressant effect on the nervous
                    system when administered at levels of  1 to 2 grams per day.  This effect is
                    slowly reversed when treatment is stopped.

                         Sodium chloride is of low acute oral toxicity and causes moderate
                    eye irritation; it has been placed in Toxicity Category HI for these effects.
                     It causes mild skin irritation and for this effect has been placed hi. Toxicity
                    Category IV.

                         Sodium chloride, known as salt, sea salt and table salt, is abundant  in
                    nature.  It is used primarily to season or preserve food and  is consumed by
                    people daily, especially in commercially prepared and preserved foods.
                    Consumption of more than the minimum daily requirement  of salt may
                    contribute to high blood pressure in some populations.

                    Dietary Exposure
                          Dietary exposure to sodium bromide and sodium chloride is not
                    expected to occur as a result of their pesticidal uses.  None  of the currently
                    registered pesticide products involve food or feed uses,  and  no tolerances
                    (residue limits in food) are established, for these pesticides as a result of
                    these uses.                                   _' ' :

                    Occupational and Residential Exposure
                          The potential for mixer/loader/applicator exposure exists primarily
                    from fogging- or misting-type applications of the disenfectant containing
                    sodium chloride, and from handling the liquid formulation of sodium
                    bromide.  These exposures are considered minimal or low, however, and
                    are do not pose human toxicity concerns.

                    Human Risk Assessment

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                   Applicator Exposure
                        The risk from occupational exposure to sodium bromide and sodium
                   chloride is considered to be minimal.  Their toxicity (or lack of toxicity) in
                   humans is well documented.  No additional hazard or exposure data are
                   required for reregistration eligibility.  Based on the low toxicity, minimal
                   exposure risk and limited pesticidal uses of sodium bromide and sodium
                   chloride, the risks to humans are considered negligible.

Environmental        EPA did not perform an environmental assessment of sodium
  Assessment   chloride. The registered uses result in insignificant exposure to the
                   environment. Sodium chloride occurs abundantly hi the natural
                   environment. It is a component of seawater, and is in the diets of most
                   terrestrial animals.  Although it can be toxic in large amounts, especially to
                   freshwater aquatic organisms, the use of sodium chloride as registered will
                   not result in any significant exposure to non-target organisms in the
                   environment.

                        The following assessment addresses sodium bromide only.


                   Environmental Fate
                        Sodium bromide itself has no pesticidal activity. It dissociates  in
                   water to sodium and bromide ions. Activators such as chlorine and sodium
                   hypochlorite react with the bromine ion to form hypobromous acid, which
                   is the actual pesticide.  The chemistry of hypobromous acid has been well
                   documented in the literature.

                         When used in cooling towers and water systems, sodium bromide
                   effectively controls algae, bacteria and fungal slime.  It is injected into  the
                   service water with or after an activator (either chlorine gas or sodium
                   hypochlorite), producing the active disinfectant hypobromous acid, an
                   effective microbiological control treatment.  As hypobromous acid passes
                   through a heat exchange unit, it is converted back to bromide ion and
                   water.  Discharge of hypobromous acid is limited by the National Pollutant
                   Discharge Elimination System (NPDES) permit program.          .
                                >            .               _
                         The Agency conducted a Tier Ic Estimated Environmental
                    Concentration (EEC) model for hypobromous acid, to demonstrate the
                    maximum concentration likely to occur immediately downstream from  an
                    industrial (point source) discharge site.  EECs were calculated for both
                    "high exposure case" and  "typical" sites.  The worst  case EEC for all use
                    sites tested was 450 parts per billion (ppb), and the typical sites ranged
                    from 0.38 to 0.75 ppb. These estimated concentrations  are discussed hi
                    relation to ecological effects, below.

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                     Ecological Effects
                          Sodium bromide is practically non-toxic to upland game birds and
                     waterfowl on both an acute oral and a dietary basis. However, sodium
                     bromide as hypobromous acid is highly toxic to freshwater fish, aquatic
                     invertebrates and estuarine and marine organisms.

                          In two aquatic residue monitoring studies conducted at powerplants
                     on the Potomac River in Maryland, bromine as hypobromous acid
                     measured at the point of discharge exceeded the levels of concern for
                     estuarine species hi one study, and for all aquatic species in the second
                     study.  Significant residue levels were detected 80 meters downstream;
                     residues were no longer detectable between 80 and 130 meters
                     downstream.

                     Ecological Effects Risk Assessment
                          As discussed earlier, EPA conducted a Tier Ic EEC screening model
                     for hypobromous acid to estimate the maximum concentration that occurs;  :
                     immediately downstream from an industrial point source discharge site.
                     The results for the high exposure case are comparable to the amounts
                     detected in the two Potomac River aquatic residue studies,  one of which
                     showed high concentrations of hypobromous acid as far downstream as 80
                     meters.  Based on these studies, the Agency presumes risk to freshwater
                     and estuarine fish and invertebrates at the point of discharge and
                     downstream to 80 meters.

                          However,  the modeling results for "typical" sites are well below the
                     levels of concern for fish and invertebrates.  These results indicate that
                     sodium bromide can be used at typical sites without impact most of the
                     time.  Since the discharge of hypobromous acid is limited by the NPDES
                     permit program administered by EPA's Office of Water, the Agency will
                     be able to control the discharge of hypobromous acid on a site-by-site basis
                     so that toxic levels are avoided.                       .  •

                          Based on  this modeling, EPA also presumes a 'risk to endangered   .
                     freshwater and estuarine/maruie organisms  in "worst case" situations.
                     However, "typical" discharge levels are below those of concern for
                     endangered species.                                    •
Additional Data        EPA has sufficient generic data to support reregistration of all
        Required   products containing sodium bromide. Due to the nature of the pesticide

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                        and the amount of information available in the public literature, EPA
                        required no generic data for reregistration of sodium chloride.

                             EPA is requiring product-specific data including acute toxicology,
                        chemistry and efficacy studies, as well as revised Confidential Statements
                        of Formula and revised labeling, for reregistration of pesticide products
                        containing sodium bromide and sodium chloride.
  Product Labeling   The labels of all registered pesticide products containing sodium bromide
Changes Required   and sodium chloride must comply with EPA's current pesticide labeling
                        requirements.  In addition, all products containing sodium bromide must
                        contain the following effluent discharge statement:

                                   "This product is toxic to fish and aquatic invertebrates. Do not
                                   discharge effluent containing this product into lakes, streams,
                                   ponds, estuaries, oceans or other water unless hi accordance
                                   with the requirements of a National Pollution 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 EPA."
          Regulatory   The use of currently registered pesticide products containing sodium
         Conclusion   bromide and sodium chloride as labeled and specified in the RED
                         document will not pose unreasonable risks or adverse effects to humans or
                         the environment.  Therefore, all uses of these products are eligible for
                         reregistration.                       .                             .

                              These products will be reregistered once the product-specific data,
                         revised (if necessary) Confidential Statements of Formula and revised
                         labeling are received and accepted by EPA.
            For  More              EPA is requesting public comments on the Reregistration
         Information   Eligibility Decision (RED) document for the Inorganic Halides (sodium
                         bromide and sodium chloride) during a 60-day time period, as announced
                         in a Notice of Availability published in the Federal Register.  To obtain a

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copy of the RED document or to submit written comments, please contact
the Pesticide Docket, Public Response and Program Resources Branch,
Field Operations Division (H-7506C), Office of Pesticide Programs (OPP),
US EPA, .Washington, DC 20460, telephone 703-305-5805.

     Following the comment period, the Inorganic Halides 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 Inorganic Halides RED, or reregistration of individual products  .
containing sodium bromide or sodium chloride, please contact the Special
Review and Reregistration Division (H-7508W), OPP,  US EPA,
Washington, DC 20460, telephone 703-308-8000.
      For information about the health effects of pesticides, or for
assistance hi 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 Tune, Monday through Friday.

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REREGISTRATION ELIGIBILITY DECISION

               Inorganic Halides

                    LIST D


                   CASE 4051
             ENVmONMENTAL'PROTECTION-AGENCY
               OFFICE-OF-PESTICIDE-PROGRAMS
          SPECIAL-REVIEW-AND-REREGISTRATION-DIVISION

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                        TABLE OF CONTENTS


INORGANIC HALIDES REREGISTRATION ELIGIBILITY TEAM	 .    i

GLOSSARY OF TERMS AND ABBREVIATIONS  	          ii

EXECUTIVE SUMMARY	•	   *v

I.     INTRODUCTION .	         i r .    1

H.    CASE OVERVIEW  . .-;. . .	    2
      A.     Chemical Overview	-.    2
      B.     Use Proffle	    2
      C.     Regulatory History	• • •  •	•    5

HI.   SCIENCE ASSESSMENT	    6
      A.     Physical Chemistry Assessment  	• • •    6
      B.     Human Health Assessment	    7
            1.    Toxicology Assessment  	    7
                 a.   Acute Toxicity	; . . .	    7
                 b.   Other Toxicological Considerations	    8
            2.    Exposure Assessment	    9
                 a.   Dietary   . . .	    9
                 b.   Occupational and Residential	    9
            3.    Risk Assessment	    9
      C.     Environmental Assessment	    9
            .1.    Environmental Fate of Sodium Bromide	   10
            2.    Ecological Effects	   12
                 a.   Ecological Hazard	 .  .	   12
                      (1)    Avian Testing	12
                      (2)    Aquatic Organism Testing	   13
                      (a)    Freshwater Fish Toxicity  .	   13
                      (b)    Freshwater Invertebrate Toxicity	   13
                      (c)    Estuarihe/Marine Toxicity	   14
                      (d)    Aquatic Residue Monitoring	   14
                      (e)    Disciplinary Review Summation- . :	   15
            3.    Ecological Risk Assessment	 .  ._ . .;.	"15
            4.    Endangered Species	   16

IV.   RISK MANAGEMENT AND REREGISTRATION DECISION	   16
      A.     Eligibility Decision	'.   16
            1.    Eligible and Ineligible Uses	   17

V.    ACTIONS REQUIRED BY REGISTRANTS	  17
      A.     Manufacturing-Use Products	   17

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            1.    Additional Generic Data Requirements	  17
            2.    Labeling Requirements for Manufacturing-Use Products	  17
      B.    End-Use Products	  18
            1.    Additional Product-Specific Data Requirements  	  18
            2.    Labeling Requirements for End-Use Products . . . : .	  18
      C.    Existing Stocks  	  19

VI.   APPENDICES	•  21
      APPENDIX A. Table of Use Patterns Subject to Reregistration	  23
      APPENDIX B. Table of the Generic Data Requirements and .Studies Used
            to Make the Reregistration Decision	  —35—
      APPENDIX C. Citations Considered to be Part of the Data Base Supporting
            the Reregistration of Inorganic Halides	  —43—
      APPENDIX D. List of Available Related Documents	  —53—
      APPENDIX E	  —57—
            PR Notice  86-5	  —59—
            PR Notice  91-2	  —79—
      APPENDIX F. Product Specific Data Call-in	  —85—
            Attachment 1. Chemical Status Sheet	• • •  —99—
            Attachment 2. Product Specific Data Call-In Response Forms (Form
                  A inserts) Plus Instructions	  —101—
            Attachment 3. Product Specific Requirement Status and Registrant's
                  Response Forms (Form B  inserts) and Instructions  .....  —105—
            Attachment 4. EPA Batching of End-Use Products for Meeting Data
                  Requirements for Reregistration	—111—
            Attachment 5. EPA Acceptance Criteria 	—119—
            Attachment 6. List of All Registrants Sent This Data Call-In (insert)
                  Notice	—133—
            Attachment 7. Cost Share Data Compensation Form, and Confidential
                  Statement of Formula Form	 .  —135—

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 INORGANIC HALIDES REREGISTRATION

 Office of Pesticide Programs:

 Biological and Economic Analysis Division

 Cynthia Szymanski
" Rafael Prieto
 Michele Pethel

 Environmental • Fate • and -Effects • Division

 Betsy Grim
 Constance Hoheisel
 R. David Jones
 Renee Lamb

 Health- Effects- Division

 Jane Smith
 Flora Chow

 Registration- Division

 Rob Travaglini
 Shyam Mathur
 Van Seabaugh

 Special Review and Reregistration Division

 Mark Wilhite
 Bruce Sidwell
ELIGIBILITY TEAM
 Biological Analysis Branch
 Biological Analysis Branch
 Biological Analysis Branch
 Science Analysis and Coordination Staff
 Environmental Fate and Groundwater Branch
 Environmental Fate and Groundwater Branch
 Ecological Effects Branch
  Chemical Coordination Branch
  Chemical Coordination Branch
  Antimicrobial Program Branch
  Registration Support Branch
  Registration Support Branch
  Accelerated Reregistration Branch
  Accelerated Reregistration Branch
  Office of Compliance Monitoring:

  Beverly Updike

  Office of General Counsel:
                                i

  Victoria Mattison

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                  GLOSSARY OF TERMS AND ABBREVIATIONS

a.i.          Active Ingredient

CAS         Chemical Abstracts Service

CSF       .  Confidential Statement of Formula

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

GRAS       Generally Recognized As Safe as designated by FDA

HDT         Highest Dose Tested

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

             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.             •              .   ,

LDte         Lethal Dose-low. Lowest Dose at which lethality occurs  • • '  •  '

LEL         Lowest Effect Level                                  '   •

LOEL       Lowest Observed Effect Level

MP         Manufacturing-Use Product
LD
   50
                                         n

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                 GLOSSARY OF TERMS AND ABBREVIATIONS

MPI        Maximum Permissible Intake


MOE       Margin Of Exposure (PAD)

MRID      Master Record Identification (number).  EPA's system of recording and tracking
            studies submitted.

N/A        Not Applicable                               '.

NPDES     National Pollutant Discharge Elimination System                      .

NOEL      No Observed Effect Level

OPP        Office of Pesticide Programs

PADI      Provisional Acceptable Daily Intake

ppm        Parts Per Million

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 dose at which a substance produces a toxic effect.

TMRC      Theoretical Maximum Residue Contribution..
                                         m

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 EXECUTIVE SUMMARY
       The Environmental Protection Agency, hereafter  referred to as the  "Agency" has
 completed its reregistration assessment  of the available information on the pesticide active
 ingredients sodium bromide and sodium chloride, which make up the case named Inorganic
-Halides. It has been determined that the currently registered uses will not cause unreasonable
• risk to humans or the environment and are therefore eligible for reregistration.

       Sodium bromide is registered for use as a microbiocide hi water recirculation systems
 associated with pasteurizer/cannery cooling systems, pulp/paper mill water systems, ornamental
 ponds and aquaria. It is also used in pesticide products to repel moths from clothing and fleas
 from pets, and their sleeping quarters.

     Sodium chloride is one of two active ingredients hi a disenfectant used to treat feeding and
 watering appliances, equipment and premises hi poultry operations. Sodium chloride is the sole
 active ingredient impregnated into polyethylene which is placed around gardens as a barrier to
 slugs and snails.                                ,

       The Agency has determined that  the uses  of these  active  ingredients  as currently
 registered pose no unreasonable risk to  humans or the environment. Although there is some
 concern about effects to aquatic organisms exposed to the effluent resulting from the industrial
 use of sodium'bromide,  such  discharge  is limited under the Agency's National Pollutant
 Discharge Elimination System (NPDES) permitting program.

       Before reregistering products containing sodium bromide or sodium chloride, the Agency
 is requiring that product specific data on acute toxicology, chemistry, and efficacy, revised
 Confidential Statements of Formula, and revised labeling be submitted within eight months of
 the issuance of this document. After reviewing these data and revised labels and finding them
 acceptable hi accordance with Section 3(c)(5) of FIFRA, the Agency will reregister products.
 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.
                                            IV

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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
 hi nine years There are five phases to the reregistration process.  The first four phases of the
 process focus on identification of data requirements to support the reregistration of an active
 " ingredient and the generation and submission of data to fulfill the requirements.  The fifth phase
 is a review by the U.S. Environmental Protection Agency (referred to as "the Agency ) of all
 data submitted to support reregistration.

         FIFRA Section 4(g)(2)(A) states that in Phase 5  "the  Administrator shall determine
 whether pesticides containing such active ingredient are eligible for registration" before calling
 in data on products and either reregistering products  or  taking other appropnate 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 sodium chloride and sodium bromide.  The document consists of  six
  sections  Section I is the introduction.  Section H describes the inorganic halides, then: uses, data
  requirements and regulatory history. Section HI discusses the human health and environmental
   assessment based on  the data available to the Agency. Section IV presents the reregistration
   decision for sodium  chloride  and sodium bromide.  Section  V discusses the reregistration
   requirements for sodium chloride and sodium bromide . 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.1
       'EPA's reviews of data on the set of registered uses considered for EPA's analysis may be
   obtained from the OPP Public Docket, Field Operations Division (H7506C), Office of Pesticide
   Programs, EPA, Washington, DC 20460.

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H.    CASE OVERVIEW

      A.    Chemical Overview

            The following active ingredients are covered by this Registration Eligibility
      Decision:
            Chemical Name:
            Chemical Code:  ,

            Empirical Formula:

            Basic Manufacturer:
Sodium bromide
            CAS Registry Number:    7647-15-6
013907

NaBr

 Great Lakes Chemical Corporation and Ethyl
 Corporation.
       •     Chemical Name:

       •     Common Name:

       4     CAS Registry Number:

       •     Chemical Code:

       •     Empirical Formula:
Sodium Chloride

Common salt or Salt

7647-14-5

 013905

 NaCl
       B.    Use Profile

       CHEMICAL:      Sodium Bromide

       TYPE OF PESTICIDE:  .
       Water disinfectant, Sanitizjer, Slimicide (slime-forming  algae,  bacteria  and  fungi),
       Bactericide, Algicide, Fungicide, Mollusc control agent

       USE SITES:
       AQUATIC NON-FOOD INDUSTRIAL:
       Pulp/paper mill water systems (fresh and sea water effluent water systems)

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Industrial waste disposal systems (waste water treatment systems)
Air washer water systems
Recirculating and once-through industrial and commercial water cooling systems, Influent
systems (flow-through filters,  lagoons)
Evaporative condenser water systems
Sewage systems (secondary and tertiary waste water systems)
Heat exchanger water systems
Industrial processing water
Industrial scrubbing system

AQUATIC NONrFOOD RESIDENTIAL:
Swimming pool water systems (spas, hot tubs)
Ornamental ponds/aquaria (fountains)
Domestic/commercial non-potable water (waterbed water and therapeutic pools)

INDOOR FOOD:
Food processing water systems

INDOOR NON-FOOD:
Pasteurizer/warmer/cannery cooling water systems (brewery pasteurizers)

PESTS:
Aquatic environmental bacteria; Slime forming algae, bacteria and fungi; Asiatic clam
(Corbiculd), Barnacle,  Zebra  mussel (Dreissena)

FORMULATION TYPES REGISTERED:

TYPE: End use, Manufacturing use

FORM:  Liquid soluble concentrate; Solid soluble concentrate -Tablets, Granules

METHODS AND RATES OF APPLICATION:

TYPES OF TREATMENT:
Water recirculating system treatment, Water once-through system treatment, Water
treatment, Sewage wastewater effluent treatment   .

 EQUIPMENT:           ,     .                         "   .'
 Tablet feeder or Not specified

 TIMING:
 Continuous feed  (initial and  subsequent), Intermittent (slug, initial and subsequent),
 Initial, Subsequent/maintenance, Shock/slug or Not specified

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RATE OF APPLICATION:
Aquatic non-food industrial:
  From less than 1 ppm up to 27 ppm of active ingredient by weight
Aquatic non-food residential:
  From less than 1 ppm up to 44 ppm of active ingredient by weight.
  (Pulp and paper mills: 0.5 to 5.0 ppm residual bromine)
Indoor non-food:     :
  From 1 ppm up to 13 ppm of active ingredient by weight
Indoor food:                                 .
  22 ppm of active ingredient by weight

USE PRACTICES LIMITATIONS:
pH: Maintain a minimum of 7.2 up to a maximum of 8.0  (Swimming pools, Spas and
 Hot tubs)
CHEMICAL:       Sodium Chloride

TYPE OF  PESTICIDE:  Molluscicide,  Disinfectant in combination  with  20.4%
potassium peroxymonosulfate (general/broad spectrum control of animal pathogens),
Virucide, Fungicide (mold/mildew), Fungicide/Fungistat (fungi pathogenic to animals)

USE SITES:

INDOOR RESIDENTIAL:
Air treatments (commercial/household)

TERRESTRIAL NON-FOOD & OUTDOOR RESIDENTIAL:
Perimeters of Gardens

INDOOR FOOD:  .
Poultry (egg/meat) - poultry house premises
Poultry Processing Plant Premises (nonfood contact)

INDOOR NON-FOOD:                                    .
Egg Handling Equipment (hatching)                          ,
Egg Handling Rooms (hatching)                         "

PESTS:
Snails and slugs; Bacteria- Streptococcus pyogenes. Campvlobacter pvforidas. Klebsiella
pneumoniae. Salmonella typhimurium. Salmonella choleraesuis. Staphylococcus aureus.
Pseudomonas aeruginosa.  Staphvlococcus epidermidis.  Mvcoplasma gallisepticum:

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Viruses- Newcastle Disease, Infectious Bronchitis, Infectious Bursal Disease, Avian
Laryngotracheitis,  Avian Influenza, Marek's Disease;   Fungi-  Aspergillus flayus,
Aspergillus fumigatus. Candida albicans.

FORMULATION TYPES REGISTERED:

Impregnated Material
(10% sodium chloride)

Soluble Concentrate/Solid                      .              ,
(1.5% sodium chloride with 20.4% potassium peroxymonosulfate)

METHODS AND RATES OF APPLICATION:

Impregnated Material
Place slug and snail barrier around perimeter of garden.  Recess into soil 1/2 inch.  No
application rate specified.
 Soluble Concentrate/Solid

 Apply a 1% or 2%  solution (= 150 ppm NaCl or 300 ppm NaCl) to surfaces to be
 disinfected.  For cleaning and disinfecting, use at a rate of 15 gallons of solution per
 1000 sq. ft.; for disinfecting, use at a rate of 7.5 gallons of solution per 1000 sq. ft.
 Allow 10 minute contact time, then rinse with potable water. For air sanitizing, fog with
 a 1-2% solution until surfaces are moist.  Allow at least 2 hours before entering area that
 has been fogged.
 USE PRACTICES LIMITATIONS

 Impregnated Material
 Do not use for three consecutive seasons.
 Soluble Concentrate/Solid
 See Methods and Rates of Application above.
 C.     Regulatory History

        Products containing sodium chloride as an active ingredient were first registered
 in 1954 for use as wood preservatives,  a use which is no longer registered. There are

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currently only two products registered containing sodium chloride as an active ingredient.
      Products containing sodium bromide as an active ingredient have been registered
since 1975. There are currently 32 such products registered.

SCIENCE ASSESSMENT

A.    Physical Chemistry Assessment
Chemical Name:

Empirical Formula:

Molecular weight:

Melting Point:

Density:

Solubility:

Dissociation constant:


pH:



Chemical Name:

Empirical Formula:

Molecular weight:

Melting Point:

Density:

Solubility:
Sodium bromide

NaBr

102.90

755 ฐC

3.210 at 0ฐC

Sodium bromide is soluble in water.

As a water solution of a strong electrolyte, sodium
bromide is 100% dissociated.

Sodium bromide is a neutral salt. Aqueous solution
(46%) has a pH of 7.


Sodium Chloride

NaCl

58.44

800ฐC        ,                 '          .

2.165 at 0ฐC            ".  / .

100 parts by weight of water dissolves 36.0 parts of
salt at 20ฐC; 39.1 parts at 100ฐC; and 39.2 parts at
107ฐC(the b. p. of saturated solution); the salt is
soluble hi glycerine, slightly soluble in alcohol or
liquid ammonia and insoluble in concentrated HC1.

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  B.    Human Health Assessment

        I.     Toxicology Assessment
               a.     Acute Toxicity

        The table below summarizes the toxicity results and categories for technical grade
        sodium chloride  and  sodium  bromide.  Because  of its  abundance  in  the
        .environment  and  low toxicity to humans, no toxicity data were required for
        sodium chloride.  For sodium bromide, acute inhalation data were not required
        because of the lack of potential inhalation exposure to humans and because of its
        low toxicity.      ;

                      Acute Toxicity - Sodium Chloride
Test
Acute Oral (rat)
Acute Dermal (rabbit)
Acute Inhalation
Eye Irritation
Dermal Irritation
Skin Sensitization
*Sax and Lewis, 1989
Acute
Test
Acute Oral (rat)2
Result*
3000 mg/kg
WAIVED
WAIVED
moderate
mild
WAIVED

Toxicity - Sodium Bromide
Result
4200 mg/kg (males and
Category
m
-
.
m
rv
' -


Category
ni
      Acute Dermal (rabbit)3

         Acute Inhalation
        females)
4500 mg/kg (females)
 3900 mg/kg (males).

   >2000mg/kg

    WAIVED
m  ,
2MRID 14889, 40670804

3MRID 148890

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         Eye Irritation4                  mild     '              IV

       Dermal Irritation5                 mild                   IV

       Skin Sensitization6	nonsensitjzing	-;_

               b.     Other lexicological Considerations
               Sodium.chloride, commonly known as salt, sea salt, and table salt, is
         abundant in nature and primarily used to season or preserve food or in industrial
         processes: It is consumed daily by humans especially in commercially prepared
         and preserved foods. It is hypothesized that consumption of salt in excess of the
         rninimum daily requirement may contribute to  high blood pressure in some
         individuals.

               Sodium and potassium salts of bromide have been used for many years hi
         prescription  and  proprietary sedatives.  Consequently, the health  effects of
         bromides following oral exposure are well known. The central nervous system
         depressant effects of the bromide salts hi humans occur when administration is
         repeated daily  at dose levels  on the order of 1 to 2 grams per day. The effect is
         slowly reversed when dosing is stopped. Bromide ion acts hi the organism by
         replacing chloride ion  and inhibiting depolarization and transmission hi nerve
         cells.

               A  Salmonella tvphimurium reverse mutation  assay  (Ames assay)  was
         conducted using a 99% technical sodium bromide.  Strains TA 1535,  TA 1537,
         TA  1538, TA 98,  and TA 100  were tested with and without S9  metabolic
         activation.  No increase hi reverse mutations were observed at concentrations up
         to 5000 ug/plate (MRID 40670808).                                       .

               An in vitro cytogenic  assay was performed using human lymphocytes and
         99% technical sodium bromide.   The  tests were negative for chromosomal
         aberrations at concentrations up  to  5000 ug/ml with and without  metabolic
         activation (MRID 40670809).               .

                An unscheduled DNA synthesis assay  was conducted using hela cells and
         99% sodium bromide.   The tests were negative  with: and without  metabolic
4MRID 148891

5MRID 148892, 40670807

6MRID 41019601

                                       8

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      activation even  at concentrations  causing  toxicity (25,600  ug/ml)  (MRID
      40670810).
      2.     Exposure Assessment

             a.     Dietary

             Dietary exposure to sodium chloride and sodium bromide is not expected
      to occur as a result  of pesticidal uses on.food since no, currently  registered
      products involve food or animal feed uses.

             b.     Occupational and  Residential

             The potential for mixer/loader/applicator exposure exists primarily from
      the fogging/misting type  applications associated with the disenfectant  containing
      sodium chloride and from handling the liquid formulation of sodium bromide.
      The exposure,  however, is considered minimal or low. Since the exposure is
      minimal and no human toxicity concerns exist, no additional exposure data are
      required.

      3.     Risk Assessment      -

      The risks from occupational exposure are considered to be minimal based on the
low toxicities of sodium bromide and sodium chloride. The toxicity (or lack of toxicity)
of these compounds is well documented hi humans.  The inherent function of sodium
chloride and the metabolic pathways of sodium bromide in humans and domestic animals
are known. No additional  hazard  or exposure data are required for reregistration
eligibility.  Based on these factors and the limited pesticidal uses, the human risks are
considered to be negligible .                               .                       .

C.     Environmental Assessment

       The Agency did not perform an  environmental assessment of sodium chloride.
The registered uses, as an ingredient in a poultry cage and equipment disinfectant and
as a barrier to slugs around gardens, are  insignificant with regard to exposure of sodium
chloride to  the environment.   Sodium chloride  occurs abundantly 'hi the natural
environment. It is a component of seawater, and hi the diets of most terrestrial animals.
Although it can  be toxic in, large amounts, especially to freshwater aquatic  organisms,
the use of sodium chloride as registered will not result in any significant exposure to non-
target organisms hi the environment. For the currently registered uses, sodium chloride
is present in low amounts, or is used hi indoor situations only. Since sodium chloride
readily  dissolves,  no  environmental fate assessment was necessary.  Therefore,  the
Agency does not require any environmental fate or ecological effects data  for sodium

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chloride. The following environmental assessment addresses sodium bromide only.

       1.     Environmental Fate of Sodium Bromide

       Sodium  bromide per se is a stable salt with no pesticidal activity.   The salt
dissociates hi water to sodium and bromide ions which do  not undergo any further
degradation.   Activators such as  chlorine and sodium hypochlorite  react with the
dissociated bromine ion to form hypobromous acid (HOBr), which is the actual pesticide.
The chemistry of hypobromous acid has been well documented hi the literature.

       Sodium  bromide is used hi conjunction with chlorine and sodium hypochlorite
during waste-water treatment.process.  Hypobromous acid  can oxidize organic, and
inorganic material present in effluent  water and has a reported half life of about 125
hours. Depending on the amount of material present with which hypobromous acid can
react, a shorter half life than 125 hours is expected.  Another mode of dissipation of
hypobromous acid in waste water is via reaction with ammonia to form bromamines.
These chemical reactions can  result hi as much as 50% reduction  hi the amount of
hypobromous within seconds.   However,  "fresh"  hypobromous acid  is continuously
introduced into the system.

       Hypobromous acid is reported hi the literature to be a weaker oxidizing agent than
hypochlorous acid (HOC1), which is currently registered for use hi once-through cooling
towers. In equivalent amounts hypobromous acid should pose a lesser environmental risk
than hypochlorous acid since the amount of total residual oxidant is lower.

       When used hi commercial and industrial cooling towers, recirculating cooling-
water systems,  once-through water systems, effluent water systems such as flow-through
filters, heat-exchange water systems,  and industrial water scrubbing systems, sodium
bromide effectively controls algae, bacteria, and fungal slime.   The sodium bromide
solution usually is mixed with activators such as chlorine gas, calcium hypochlorite (60%
available   chlorine),   sodium  hypochlorite   (5%   available   chlorine),   potassium
monopersulfate (4.5%. active oxygen), and ozone.

       The chemistry of the fouling control agent, sodium bromide, is straightforward.
The sodium bromide is injected into the service water-either before, after,,or at the same
point as the activator (either 99.9% chlorine gas or-12.5% sodium hypochlorite). No
matter what the sodium bromide/activator mole ratio is (usually one-to-one), the  active
disinfectant is hypobromous,acid Because of its superior performance hi high pH and
ammonia-containing water,, hypobromous acid is an effective microbiological control
treatment. As  hypobromous acid passes through the heat-exchange unit, it is converted
back to bromide ion (Br) and water.   The major portion of the hypobromous acid is
converted to bromide ion as it reacts with the fouling organism present hi the water. All
but a small portion is fed to the service water and subsequently discharged to the source
as  the bromide ion.  A small portion of the hypobromous acid reacts with organic


                                    10

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substances (ultimately producing carbon dioxide and water).

       In water, hypobromous acid ionizes to form hydrogen and hypobromite ions,
which are powerful oxidants and will oxidize organic substances present in water to form
bromide  ion and water.  At a  pH of 8, 88% of the bromine is  in  the  form of
hypobromous acid, while only 26% of the chlorine is in the form of hypochlorous acid.
In solution, the bromide ion does not hydrolyze and is not altered by ultraviolet radiation
(sunlight).

       A Tier Ic EEC7 (estimated environmental concentration)  model was conducted
by the Agency.  A Tier Ic EEC demonstrates the maximum concentration likely to occur
immediately downstreamrfrom an industrial (point source) discharge site. The EEC's are
high exposure case,  1 in. 10 year EEC's.  For the high exposure case site, it would be.
expected that the EEC would be equaled or exceeded once every 10 years, i.e., there is
a 10% chance in any given year that the EEC will be equaled or exceeded.    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 flow were also calculated.
Results are  as follows:
                   Tier Ic EECs for Hypobromous Acid
                              	               	
•===========================
Use Site, Type
Food Processing
Pulp and Paper Mills
General Industrial Waste Disposal, Air
Washer Systems, Sewage Systems
Water Cooling Towers, Evaporative
Condensers, Heat Exchangers
.
High Exposure
Case
270 ppb
270 ppb
270 ppb
270 ppb
=======
=—======
Typical
0.38 ppb
0.75 ppb
0.38 ppb
0.43 ppb
=a=
A Tier Ic EEC is a preliminary or lower tier exposure assessment for industrial biocides.

                                     11

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        Tier Ic EECs for Hypobromous Acid on a Bromine Basis
Use Site, Type
Food Processing
Pulp and Paper Mills . . ,-
General Industrial Waste Disposal, Air
Washer Systems, Sewage Systems
Water Cooling Towers, Evaporative
Condensers, Heat Exchangers
High Exposure
Case
450 ppb
450 ppb
450 ppb
450 ppb
Typical
0.63 ppb
1.2 ppb
0.63 ppb
0.72 ppb
       A discussion of these results as they pertain to risk assessment follows in the
Ecological Risk Assessment section below.

       2.     Ecological Effects                                 .

             a.     Ecological Hazard

                    (1)    Avian Testing

             In order to establish the toxicity of microbiocides to birds,  one avian.
       single-dose oral  (LD50)  study on one species (preferably mallard or bobwhite
       quail) and one subacute  dietary study (LC50) were required. The results follow.
                           Avian Acute Toxicitv
Species
Bobwhite quail
% Test Material
(TGAI) (Sodium
bromide) ,
99.23
LDjo
> 2250 mg/kg
Conclusion
practically non
toxic
                                    12

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                  Avian Subacute Toxicitv
Species
Bobwhite quail
Mallard duck
% Test
Material
99.23
99.23
LC50
> 5633 ppm
> 5633 ppm
Conclusion
practically non toxic
practically non toxic
             (2)    Aquatic Organism Testing

       Since hypobromous acid is formed from both bromine chloride and sodium
bromide when added to water, studies using technical bromine chloride (100%
a.i.) have been used to support the data requirements for aquatic organism testing
for sodium bromide.  Results from these studies are presented below.

                    (a)     Freshwater Fish Toxicity

             The minhnum data required to establish toxicity of sodium bromide
       to fish is a 96-hour acute toxicity study with either a cold water (rainbow
       trout) or warm water (bluegill sunfish) species.
Species
Rainbow trout
Bluegill sunfish
% Test Material
(TGAI) bromine
chloride
100
100
LC50 (as bromine)
0.31 ppm
0.52 ppm
Conclusion
highly toxic
highly toxic
                    (b)    Freshwater Invertebrate Toxicity,

              The minimum data required to establish toxicity of sodium bromide
       to freshwater invertebrates is a 48-hour acute toxicity test.
                             13

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Species




Daohnia magna
% Test
Material
(TGAI)
bromine
chloride
100
LC50 (as
bromine)



1.07 ppm
Conclusion


-

highly toxic
                   (c)     Estuarine/Marine Toxicity

           •  Estuarine/marine testing is required to support use in once-through
      cooling towers, oil  recovery drilling muds/packer fluids, secondary oil
      recovery injection waters, and pulp and paper mills.
Species



Sheepshead minnow
Mysid shrimp
Eastern oyster
% a.i. (TGAI)
sodium bromide
measured as
bromide
46
46
46
96-hour LC50 (as
bromine)


0.19 ppm
0.18 ppm
0.47 ppm
Conclusion



highly toxic
highly toxic
highly toxic
                    (d)    Aquatic Residue Monitoring

       Aquatic residue monitoring studies of once-through cooling systems in
freshwater and estuarine environments have been submitted to support registration
of sodium bromide.

       One study was conducted at a powerplant on the Potomac River hi Charles
County, MD.  At this point, the river is estuarine.  A once-through cooling
system is employed at the plant. This study was designed to examine bromine
chloride as a potential substitute for chlorine when used in condenser cooling
systems.  Two 15 day trials were made using continuous dose rates of bromine
chloride and chlorine. Application rates were 510 and 135 ppb bromine chloride.

       The study indicates that the highest discharge residue (104 ppb, measured
at the point of discharge) of bromine  as  hypobromous acid, from an initial
continuous application of 510 ppb, exceeds the LOG (Level of-Concern - 1/2
LC50) for mysid  shrimp, 90 ppb, and sheepshead minnow, 95 ppb.
                             14

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             Another study was conducted at a powerplant in Carroll County, MD.
      This Publicly Owned  Treatment Works  (POTW) uses aeration  followed  by
      disinfection, and in this study chlorine in the absence of bromide  and chlorine
      with bromide (bromide in both  cases from sodium bromide) were used as
      disinfection.

             This study indicates  that the highest bromine  or  hypobromous acid
      concentration (1081.6 ppb) in the effluent exceeds the LOCs (level of concern)
      for all aquatic species at the point of discharge.  Residue concentrations as high
      as 135.2 ppb were detected  80 meters downstream. Residues were no longer
      detectable between 80 and 130 meters downstream.
                          (e)    Disciplinary Review Summation

             Sodium bromide has been found to be practically non-toxic to both upland
      game birds and  waterfowl on both an acute oral and  a dietary basis.   Sodium
      bromide (as hypobromous acid) is considered highly toxic to both warm water
      and cold water fish, as well as to aquatic invertebrates and to estuarine/marine
      organisms.

      3.     Ecological Risk Assessment

      As noted above  the Agency conducted a Tier Ic EEC  (estimated environmental
concentration) for hypobromous acid.  The results for the "high exposure case"  are
comparable with the values obtained from the previously mentioned residue monitoring
studies.    These  studies showed high concentrations  of hypobromous  acid as  far
downstream as 80 meters.

      The calculated "high exposure  case" EEC, i.e. cases  of extreme exposure, for.
hypobromous acid as bromine for all use sites tested is 450 ppb.  This EEC exceeds the
Levels of Concern (LOCs) for fish (1/2 LC50s = 155 ppb rainbow trout and 260 ppb for
the bluegill sunfish), and for estuarine/marine fish and invertebrates (1/2 LC50s = 90 ppb
mysid shrimp, 95 ppb sheepshead minnow and 235 ppb eastern oyster), but not for
Daphnia magna (1/2 LC50 = 535 ppb). Also, the residue monitoring studies, which were
conducted with application rates exceeding the permitted levels, indicate .that the highest
bromine or hypobromous acid concentration (1081.6 ppb) in the effluent exceeds the
LOCs for all aquatic species at the point of discharge.  Residue concentrations as high
as 135.2 ppb were detected 80 meters downstream.  Therefore,  the Agency presumes risk
to freshwater and  estuarine  fish  and invertebrates at the  point  of discharge and
downstream to 80 meters.

       However,  results for  "typical"  sites,   i.e.   industrial  sites. with  median
concentrations, resulted hi a range from 0.38 ppb to 0.75 ppb  for all sites tested. These


                                    15

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      values are well below the LOCs for fish and invertebrates as given above. This would  -
      indicate that this chemical can be used at typical sites without impact most of the time.
      Since the discharge of hypobromous acid is regulated by the National Pollutant Discharge
      Elimination System (NPDES) permit program of the Office of Water, the Agency would
      be able to control the discharge of hypobromous acid so that toxic levels are avoided on
      a site-by-site basis . Results from the modeling indicate that hypobromous acid can be
      used at typical sites most  of the  tune, without producing effluents above levels of
      concern.

             4.     Endangered Species                   '  \  '
                             \
             The calculated EEC (45.0 ppb) exceeds 1/20 the LCjo (risk criteria for endangered
      aquatic species)  for rainbow trout  (15.5  ppb),  for bluegill sunfish (26 ppb), for
      sheepshead minnow (9.5 ppb), for mysid shrimp (9.0 ppb), for eastern oyster (23.5 ppb)
      and for Daphnia magna (53.5 ppb). Therefore, the Agency presumes a risk to endangered
      freshwater and  estuarine/marine  organism for  "high exposure case" discharge of.
      hypobromous acid. Results from the modeling indicate that hypobromous acid can be
      used at typical use sites, most of the time, without producing effluents above the levels
      of concern for endangered  species.


IV.   RISK MANAGEMENT AND REREGISTRATION DECISION

      A.    Eligibility Decision                          ,- .
                                                         s
              Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission
       of relevant data concerning an active ingredient, whether products containing the active
       ingredient are eligible for  reregistration. As discussed hi the previous sections of this
       document, no generic data were required for sodium chloride due to its nature and the
       amount of information already available hi the  public literature. Generic data were
       required for  sodium bromide.  Appendix B  identifies these.generic data, which the
       Agency reviewed as part  of its determination of reregistration eligibility  for sodium
       bromide, and lists the submitted studies that the Agency found acceptable.  The Agency
       has completed its review of these generic data and information, and has determined that
       the data are sufficient to support reregistration of all products containing either of these
     '  active  ingredients. This information and data enabled the Agency  to determine that
       sodium bromide and sodium chloride can be used without  resulting  in unreasonable
       adverse effects to humans and the  environment. The Agency" therefore finds that, all
       products containing sodium bromide  or sodium chloride as "an active ingredient are
       eligible for reregistration.   The reregistration of particular products is addressed hi
       Section V of this document.

              The Agency has determined  that sodium bromide products  and sodium chloride
       products, labeled and  used as specified hi this  Reregistration  Eligibility Decision


                                           16

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      document,  will  not pose unreasonable risks  or adverse effects to humans  or the
      environment. Although the Agency has found that all uses of sodium bromide and sodium
      chloride 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 sodium bromide and sodium chloride,  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.     Eligible and Ineligible Uses

                    The Agency has determined that all uses of all currently registered sodium
             bromide and sodium  chloride products are eligible for reregistration.
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  [NAME OF
             CHEMICAL] for the above eligible uses has been reviewed and determined to be
             substantially complete.
              2.     Labeling Requirements for Manufacturing-Use.Products
                           Effluent Discharge Labeling Statements

                     All manufacturing-use or end-use products that may be contained hi an
              effluent discharged tq 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


                                           17

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      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.

             Registrants must review previous data submissions to ensure that they meet
       current EPA acceptance criteria (Appendix F; Attachment E) and if not, commit
       to  conduct new studies.   If a registrant believes that previously submitted data
       meet  current testing standards,  then study MRID numbers should be  cited
       according to the instructions hi the Requirement .Status and Registrants Response
       Form provided for each product.

       2.     Labeling Requirements for End-Use Products

       Worker Protection Standard

             Any product whose labeling reasonably permits use hi the production of
       an agricultural plant on any  farm, forest, nursery, or greenhouse must comply
       with the labeling requirements of PR Notice 93-7,  "Labeling Revisions Required
       by the Worker Protection Standard (WPS), and PR Notice 9311, "Supplemental
       Guidance for PR Notice 93-7, which reflect the requirements of EPA' s labeling
       regulations for worker protection statements (40 CFR part 136, subpart K).
       These labeling revisions  are necessary to implement" the" Worker Protection
       Standard for Agricultural Pesticides (40 CFR part 170) and must be completed
       in accordance with, and within the deadlines specified hi, PR. Notices 93-7 and
       93-11. Unless otherwise specifically directed hi this RED, all statements required
       by PR Notices 93-7 and 93-11 are to be on the product label exactly as instructed
       hi those notices.
                                    18

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             After April 21, 1994, except as otherwise provided in PR Notices 93-7
      and 93-11, all products within the  scope of those  notices must bear WPS PR
      Notice complying labeling when they are  distributed or sold by the primary
      registrant or any supplementally registered distributor.

             After October 23, 1995, except as otherwise provided hi PR Notices 93-7
      and 93-11, all products within the  scope of those notices must bear WPS PR
      Notice complying labeling when they are distributed or sold by any person.

             The labels and labeling of all products must comply with EPA's current
      regulations and requirements as specified in 40 CFR ง156.10.

      Effluent Discharge Labeling Statements                               ,

             Refer to  subsection A.  above for labeling  requirements  for  effluent
      discharge.

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 [add chemical
names here] products bearing old labels/labeling for 26 months from the date of issuance
of this RED.  Persons other than the registrant may distribute or sell such products for
50  months from the date of the issuance of this RED.    .      .
                                    19

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20

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VI.   APPENDICES
       21

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22

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APPENDIX A.  Table of Use Patterns Subject to
               Reregistration
                     23

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24

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-------
APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
                        —35—

-------
—36—

-------
                              GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case Inorganic Halides covered by this Reregistration Eligibility
Decision Document.  It contains generic data requirements that apply to Inorganic Halides  hi
all products, including data requirements for which a "typical formulation"  is the test
substance.

       The data table is organized hi the following format:

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

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

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

       3.  Bibliographic citation (Column 3).  If the Agency has acceptable data hi 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.
                                        —37—

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—38—

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-------
APPENDIX C.  Citations Considered to be Part of the
Data Base Supporting the Reregistration of Inorganic
                     Halides
                      —43^

-------
-44-

-------
                              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 hi the Reregistration Eligibility Document. Primary sources for studies in
      this bibliography have been the body of data submitted to EPA and its predecessor
      agencies hi 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 hi 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 hi 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 hi 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 hi 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, hi 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
as (19??), the Agency was unable to determine or estimate the date of the
document.

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

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

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

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

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

(4)    Volume Identification (Accession Numbers).  The final element hi 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.

-------
                               BIBLIOGRAPHY
MRID
CITATION
00148889     Stroderd, A. (1990) Acute Oral Toxicity (LD50) Study in Albino Rats with
             Sodium Bromide Solution, 46%: Project Number: WIL-12036. Prepared by
             WIL Research Laboratories, Inc. 26 p.

00148890     Stroderd, A. (1990) Acute Dermal Toxicity (LD50) Study in Albino Rabbits
             with Sodium Bromide Solution, 46%.  Prepared by WIL Research
             Laboratories, Inc: 25 p.

00148891     Stroderd, A. (1990) Primary Eye Irritation Study in Albino Rabbits with
             Sodium Bromide Solution, 46%: Project Number: WIL-12039. Prepared by
             WIL Research Laboratories, Inc. 20 p.

00148892     Stroderd, A. (1990) Primary Dermal Irritation Study in Albino Rabbits with
             Sodium Bromide Solution, 46%: Project Number: WIL-12038. Prepared by
             WIL Research Laboratories, Inc.  17 p.

00160134     Great Lakes Chemical Corp. (1986) Product Chemistry/Manufacturing and
             Analytical Methods for Sodium Bromide.  8 p.

40086301     Ethyl Corp. (1987) Sodium Bromide Product Chemistry. Unpublished
             compilation.  27 p.

40086302     Ethyl Corp. (1987) Sodium Bromide Product Chemistry. Unpublished
             compilation.  18 p.

40086303     Ethyl Corp. (1987) Sodium Bromide Product Chemistry. Unpublished study.
             3p.                                         .

40669900     Sodium Bromide/Bromine Chloride Industry task Force (1988) Submission of
             Toxicology Data to Support the Conditional Registration for Sodium Bromide
             and Bromine Chloride.  Transmittal of 4 studies.      ~   • ;

40669901     Fletcher, D. (1988)'21-Day Acute Oral LD50 Study with Sodium Bromide
             Technical in Mallard Ducks: BLAL Study No. 87DD53. Unpublished study
             prepared by Bio-Life Associates, Ltd.  27 p.

40669902     Surprenant, D. (1990) Acute Toxicity of Bromine Chloride to Rainbow Trout
             (Salmo gairdneri): Study Number: 1199.0387.6100.103. Prepared b
             Springborn Bionomics, Inc.  61 p.

                                      —47—

-------
                                BIBLIOGRAPHY
 MMD
                               CITATION
-40669903     Surprenant, D. (1990) Acute Toxicity of Bromine Chloride to Bluegill
              (Lepomis macrochirus): Study Number: 1199.0387.6100.100, Prepared by
              Springborn Bionomics, Inc.  36 p.
40669904
40670801
40670802
40670803
40670804
              Hughes, J. (1990) Acute Toxicity of Bromine Chloride to the Water flea
              (Daphnia magna): Project Number: 0950-02-1100-1. Prepared by Malcolm
              Pirnie, Inc. 21p.

              Frances, J., comp. (1988) Product Identity: Sodium Bromide.  Unpublished
              compilation prepared by Dead Sea Bromine Co.  13 p.

              Frances, J., comp. (1988) Analysis and Certification of Product Ingredients:
              2270/8806/62.  Unpublished compilation prepared by Dead Sea. Bromine Co.
              Frances, J., comp. (1988) Physical and Chemical Characteristics: Sodium
              Bromide: 2270/8806/63. Unpublished study prepared by Dead Sea Bromine
              Co. 7 p.

              Gardner, J. (1988) Acute Oral Toxicity to Rats of Sodium Bromide, Technical
              Grade: Rept. No. 88278D/DSB 8/AC.  Unpublished study prepared by
              Huntingdon Research Centre Ltd.  18 p.
 40670805    Kynoch, S.; Parcell, B. (1988) Acute Dermal Toxicity to Rabbits of Sodium
              Bromide, Technical Grade: Rept. No. 88584D/DSB 9/AC. Unpublished study
              prepared by Huntingdon Research Centre Ltd. 17 p.        •    .

 40670806    Liggett, M. (1988) Irritant Effects on the Rabbit Eye of Sodium Bromide
              Technical Grade: Rept. No. 88201D/DSB 11/SE. Unpublished study prepared
              by Huntingdon Research Centre Ltd. 9 p.

 40670807    Liggett, M. (1988) Irritant Effects on Rabbit Skin of Sodium Bromide
              Technical Grade: Rept. No. 88111D/DSB 10/SE. Unpublished study prepared
              by Huntingdon Research Center Ltd. 9 p.

-------
                               BIBLIOGRAPHY
MRID
CITATION
40670808     Jones, E.; Wilson, L. (1988) Ames Metabolic Activation Test to Assess the
             Potential Mutagenic Effect of Sodium Bromide: Kept. No. DSB 4/88137.
             Unpublished study prepared by Huntingdon Research Centre Ltd.  21 p.

40670809     Brooker, P.; Akhurst, L.; Gray, V.; et al. (1988) Sodium Bromide Technical
             Grade Metaphase Chromosome Analysis of Human Lymphocytes Cultured in
             vitro: Kept. No. DSB 5/88447.  Unpublished study prepared by Huntingdon
             Research Centre Ltd. 22 p.

40670810    Henderson, L.; Proudlock, R. (1988) Assessment of Unscheduled DNA Repair
             Synthesis in Mammalian Cells After Exposure to Sodium Bromide (Technical
             Grade): Rept. No. DSB 6/88454.  Unpublished study prepared by Huntingdon
             Research Centre Ltd. 23 p.                                   ,

40670811    Grimes, J.; Jaber, M. (1988) Sodium Bromide: An Acute Oral Toxicity Study
             with Bobwhite: Final Report: Proj. No. 238-103. Unpublished study prepared
             by Wildlife International Ltd.  19 p.

40670812    Grimes, J.; Jaber, M. (1988) Sodium Bromide: A Dietary LC50 Study with
             the Mallard: Proj. No. 238-102.  Unpublished study prepared by Wildlife
             International Ltd. 18 p.

40670813    Grimes, J.; Jaber, M. (1988) Sodium Bromide: A Dietary LC50 Study with
             the Bobwhite: Proj.  No. 238-101.  Unpublished  study prepared by Wildlife
             International Ltd. 18 p.                          .   :

 40701001    Surprenant, D. (1990) Acute Toxicity of Hypobromous Acid to Mysid Shrimp
             (Mysidopsis bahia) under flow-through conditions: SLS Study
             #1199.0188.6190.515.  Prepared by Springborn  Life Sciences,  Inc. 33 p.

 40701002    Surprenant, D. (1990) Acute Toxicity of Hypobromous Acid to Eastern
             Oysters (Crassosstrea virginica) under flow-through conditions: SLS Study No.
              1199.0188.6109.504=  Prepared by Springborn Life Sciences, Inc. 36 p.
                                ^                         .           •
 40701003     Surprenant, D.  (1990)  Acute  Toxicity of Hypobromous Acid to Sheepshead
              Minnow (Cyprinodon variegatus) under flow-through conditions:  SLS Study  -
              #1199.0188.6190.505.  Prepared by Springborn Life Sciences, Inc. 34 p.

 40757001     Bongers, L.; O'Connor, T. (1990) Bromine Chloride An Alternative to
              Chlorine for Fouling Cotrol in Condenser  Cooling Systems: Study Number:

-------
                                BIBLIOGRAPHY
MRTO
CITATION
             EPA-600/7-77-053. Prepared by Martin Marietta Corporation. 171 p.

41019601    Kynoch, S.; Parcell, B. (1988) Delayed Contact Hypersensitivity in the
          '   Guinea-Pig with Sodium Bromide Technical Grade: 881235D/DSB 30/SS.
             Unpublished study prepared by Huntingdon Research Centre Ltd. 21 p.

41064101    Enright, A.; Bongers, L. (1989) Residue Monitoring An Evaluation of the
             Decay and Dissipation of Oxidants Resulting from the Use of Bromine-based
             Disinfectants for the Treatment of POTW Effluents. Unpublished study
             prepared by Versar, Inc. 85 p.

42128601    Cowlyn, T. (1991) Sodium Bromide: Determination of Vapour Pressure: Final
             Report:  Lab Project Number: 91/BMP012/0600. Unpublished study prepared
             by Life  Science Research Ltd. and Department of Physical Chemistry at Leeds
             University. 37 p.

42484201    Van Logten, M.; Rauws, A.; Kroes, R. et al. (1976) Semichrpnic tpxicity
             studies of sodium bromide in rats on a normal diet amd a low chloride diet.
             Med. Fac. Landbouw. Rijksuniv. Gent. 41:(2):  1976:1499-1507

42484202    Sangster, B.;  Blom J.; Sekhuis, V. (1983) The influence of sodium bromide in
             man: a study  in human volunteers with special emphasis on the endocrine and
             the central nervous system. Fd. Chem. Toxic. 21(4), 1883:409-419.
                                       —50—

-------
                                 BIBLIOGRAPHY

  The following are references from the open literature cited in this document:

  Clayton, G. D., and Clayton, F. E.,  eds., 1982. Patty's Industrial Hygiene and Toxicology.
  3rd Revised Ed. Wiley     Interscience, NY.

' Sax, N. I., and Lewis, R. J. Sr, 1989. Dangerous Properties of Industrial Materials. 7th Ed.
  Van Nostrand  .     Reinhold, New  York.                           •

  Windholz, Martha, et al:, eds., 1983. The Merck Index. Tenth Edition. Merck and
  Company: Rahway, NJ.  .       •  ,

•> Zendzian, R., 1990. EPA internal memorandum.
                                        —51—

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-52—

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APPENDIX D.  List of Available Related Documents
                     —53—

-------
—54—

-------
       The following is a list of available documents related to inorganic halides. 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 inorganic halides  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.     Inorganic Halides 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
                                          -55—

-------
—56—

-------
APPENDIX E.  PR Notices 86-5 and 91-2
                 —57—

-------
—58—

-------
PR Notice 86-5
     —59—

-------
—60—

-------
              UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                            WASHINGTON, D.C. 20460

                                 July 29, 1986

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

          NOTICE TO PRODUCERS,  FORMULATOKS,  DISTRIBUTORS
          •  .             AND REGISTRANTS

Attention:     Persons 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 ง10(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.             •   ' . •  .

III. Effective Date

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

IV.  Background

     On September 26, 1984, EPA published proposed regulations  in
the Federal Register  (49 FR 37956)  which include.Requirements for
Data Submission  (40 CFR ง158.32), and  Procedures for  Claims of
Confidentiality  of Data  (40 CFR ง158.33). These  regulations


                              —61—

-------
 specify the format for data submitted to EPA under Section 3  of
 FIFRA and Sections 408 and 40'9 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
 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 QPP 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 compatible 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 ง3.  The objective of  ...
 the screen is to avoid the additional costs 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 application
 packages the data formatting requirements described herein.

      OPP has also established a public docket which imposes
 deadlines for inserting into the docket documents submitted  in
 connection with-Special Reviews and Registration Standards (see
 40  CFR  ง154.15 and  ง155.32).  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 of all_applicable
 data requirements and an indication of  how  each is satisfied--the
 statement of the method of support for  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 •
 follows the  index on the next page,  and samples of some of the
 requirements are  attached.  Except  for. the  language  of 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.

                                —62—

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                              - 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
      D. 2  Statement-of Data  Confidentiality Claims
                  .  (based on FIFRA ง10 (d) (1) )   	8'-    13
      D. 3  Confidential Attachment	;  8      15
      D. 4  Supplemental Statement of Data Confidentiality     '     •  -
             Claims- (other  than those based  on FIFRA  ง10 (d) (I)'). 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 for review in support  of a single  regulatory
 action, along with a transmittal document and other  related
 administrative material  (e.g. the method of support  statement,
 EPA  Forms 8570-1, 8570-4,  8570-20, etc.) as appropriate.

      Data submitters must  organize each  submittal package  as
 described in this Notice.  The transmittal  and-any other admin-
 istrative material must be 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).
                                —63—

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 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--i.e.,  a registration application,
 petition,  experimental use permit (EUP) ,  ง3 (c) (2) (B)  data
 call-in, ง6(a)(2) submittal, or, a special review;  the transmittal
 date; and a list  of all individual studies included in the
 package in the order of their appearance, showing (usually by
 Guideline 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
 application for  an EUP should be subdivided into sections A, B,
 C,	of the petition or application, as defined in 40 CFR 180.7
 and 158.125,  (petitions) or Pesticide Assessment Guidelines,
 Subdivision I  (EUPs) as appropriate.

      When a submittal package supports a tolerance petition and
 an application for a registration or an EUP, list the petition
 studies first, then the balance of the studies.  Within these two
 groups  of studies follow the instructions above.

 C.    Individual  Studies

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

       Each study  must  be  consecutively paginated,.beginning from .
 the  title  page as page 1,   The  total number  of  pages in the com-
 plete study must be  showji  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.

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     When a single study is extremely long, binding it in mul-
tiple volumes is permissible so long as the entire study is pag-
inated in a single series, and each volume is plainly identified
by the study title'and its position in the multi-volume sequence.

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

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

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

     Product chemistry data submitted in support of a technical
product, other manufacturing-use product, an experimental use
permit, an import tolerance petition, or an end-use product
produced from unregistered source ingredients, should be bound as
a single- study for each Guideline series  (61, 62, ..and 63) for
conventional pesticides, or for the equivalent subject range for
biorational pesticides.  The first of the three -studies in a
complete product  chemistry submittal for a biochemical pesticide
would cover Guidelines 151-10, 151-11, and 151-12; the second
would cover Guidelines 151-13, 151-15, and.151-16; the third
would cover Guideline 151-17. The first study for a microbial  .
pesticide would cover Guidelines  151-20, 151-21, and'151-22; the
second would cover Guidelines 151-23 and "151-25; the third would
cover Guideline 151-26.                         -  -

    . Note particularly that product chemistry studies are likely
to  contain Confidential Business  Information as defined in FIFRA
ง10(d)(1)(A),  (B), or  (C) , and if so must be handled as described
in  section D.3. of this notice.                               . .
                              —65—

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      c.   Residue Chemistry Studies.    Guidelines 171-4,  153-3,
 and 153-4 are extremely broad in scope;  studies addressing
 residue  chemistry requirement's must thus be defined at a level
 below'that of the Guideline code.  The general principle,
 however,  of limiting a study to the report of a single 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 commodities should be reported as a single study.  When
 multiple field trials.are associated with a single crop, all sucn
 trials should be reported as a single study.  ,

 D.   Organization-of Bach 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

Always

One of the two alternative.
forms of this statement
is always required.

If study reports laboratory
work subject to GLP require-
ments
Example

Page 12

Page 13



Page 16
For certain toxicology studies  (When
flagging requirements are finalized.)

Always  - with an English language
translation if required.

At submitter's option

If CBI  is  claime.d under FIFRA
ง10 (d) (1) (A),  (B) ,  or  (C).
  CBI Attachment
 If  CBI  is  claimed under  FIFRA
 ง10 (d) (1) (A) ,  (B) ,  or  (C)   ,   Page  15
  Supplemental Statement   Only if confidentiality is    Page 14
  of Data Confidentiality  claimed on a basis other than
  Claims                   FIFRA'ง10(d)(1)(A),  (B),  or (C)

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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). . Gite only individuals with primary intellectual  -
 responsibility for the content of the study.  Identify them
 plainly as authors, to distinguish them from the performing
 laboratory, study sponsor, or other names that may also appear on
 the title page.

 d.   Study Date.  The title page must include a single date for
 the study.  If parts of the study were performed at different
 times, use only the date of the latest element in the study.

 e.   Performing Laboratory Identification.  If the study reports
 work done by one or more laboratories, include on the title page
 the name and address of the performing laboratory or
 laboratories, and the laboratory's internal project number(s) for
 the 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 on the title page elements a. through d. for the
 previously submitted study, along with the EPA Master Record
 Identifier  (MRID) or Accession number of the earlier study if you
 know these numbers.   (Supplements submitted in the same submittal
 package as the primary study  should be. appended to and bound with
 the primary study.  Do not include supplements to more than one.
 study  under a  single title page).

 g.     Facts of Publication.   If the study is a reprint of a pub-
 lished document, identity on  the title page all-relevant facts of
 publication, . such as the' journal title, volume, issue., inclusive
 page numbers,  and publication date.
                                —67—

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D.2.  Statements  of  Data Confidentiality Claims Under FIFRA
      Each submitted study must be accompanied by one of the two
 alternative forms of the statement of Data Confidentiality Claims
 specified in the proposed regulation in ง158.33 (b)  and (c)   (See
 Attachment 3).   These statements apply only to claims of data
 confidentiality based on FIFRA ง10 (d) (1) (A) ,  (B) ,  or (C) .   Use
 the appropriate alternative form of the statement either to
 assert a claim of ง10 (d) (1) data confidentiality (ง158. 33 (b))  or
 to waive such a claim (ง158 .33 (c) ) .  In either case, the
-statement must be signed and dated, arid must include the typed
'name and title of the official who signs it.   Do not. make CBI
 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
 ง10 (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 to. 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
 ง10 (d) (1) on which the  confidentiality claim  is based.

 D.4.  Supplemental Statement of  Data  Confidentiality Claims  (See
      Attachment 4)

       If you wish to make  a claim of  confidentiality for any
 portion  of  a  submitted  study  other than  described by FIFRA ง10 (d)
  (1) (A) ,  (B) ,  or (C) ,  the  following provisions  apply:          •

       - The specific information to which the  claim  applies must'
       be  clearly marked  in the body of the' study -as -subject to a-..
       claim of confidentiality.

       - A Supplemental Statement of 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.

                                —68—

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 D.5. Good Laboratory Practice Compliance Statement

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

 E.   Reference to Previously Submitted Data

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

 F.   Physical Format Requirements
'>
      All elements in the data submittal package must be  on
 uniform 8 1/2 by 11 inch white paper, printed on one side only  in
 black  ink, with high contrast and good resolution.  Bindings  for
 individual studies must be secure, but easily removable  to permit
 disassembly  for microfilming.  Check with EPA for  special
 instructions before submitting data in any medium  other  than
 paper, such as film or magnetic media.

 Please be particularly attentive to the following  points:

      •   Do not include  frayed or torn pages.

      •   Do not include  carbon copies, or copies  in other  than
           black  ink.

      •   Make  sure that  photocopies  are  clear,  complete, and
            fully  readable.

      •   Do not include  oversize  computer printouts or  fold-out •
           pages.

      •   Do not bind  any documents with  glue  or binding tapes.

      •   Make  sure  that  all  pages  of each  study,  including any.
            attachments  or  appendices,  are  present and'in' correct
            sequence.                      "          •  ' •

      Number of  Copies  Required - All  submittal  packages  except
  those  associated with  a ^Registration  Standard or Special Review
  (See Part  G below)  must be provided In three complete,  identical
  copies.   (The  proposed regulations specified two copies; three
  are now being  required to expedite and reduce the cost of
  processing data into the  OPP Pesticide Document Management  System
  and getting it  into review.)
                                —69—

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 G.    Special Requirements for Submitting Data to the  Docket

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

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

      •    Remove the "Confidential Attachment".

      •    Excise from the body of the study any information  you
           claim as confidential, even if it does not  fall within
           the scope of FIFRA ง10(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".

 V.     For Further Information

      For further information contact John Carley, Chief,
 Information Services Branch, Program Management and Support
 Division,  (703) 305-5240.                             '
                              W.  Ak*rain
                       freting otrtctor,
                                    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 Good Laboratory Practice Statements
 Attachment 7.  Format Diagrams for Submittal Packages and Studies
                               —70—

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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 joint submitters is empowered to
           act on behalf of all joint  submitters  in any  matter
           concerning  data compensation or subsequent use or
           release of  the data.•
 Company Official:.
                     Name                Signature- :-
                •'  '      O
 Company Name:	_,	.	_	•	
 Company Contact:
                     Name                Phone
                               —71-

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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)

                         —72—

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                          ATTACHMENT  3

            STATEMENTS OF DATA CONFIDENTIALITY CLAIMS

1. No claim of confidentiality under FIFRA ง10(d)(1)(A),(B), or
(0 .

       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 6ง10(d) (1) (A) ,  (B) , or.  (C) .
  Company
  Company Agent:

         Title
Typed Name
                                                    Date:
                     Signature
2. Claim of confidentiality under FIFRA  ง10(d)(1)(A),  (B),  or
 (C) .

             STATEMENT OF DATA CONFIDENTIALITY CLAIMS
  Information claimed confidential  on the  basis  of  its  falling
  within the scope of FIFRA ง10(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:

          Title
Typed Name
                                                     Date:
                     Signature
 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 Pestlci-de Analytical .
 Methods Manual, and therefore cannot be claimed as confidential.
 OPP implements this policy by returning submitted analytical
 methods, for which confidentiality claims have been made, to the
 submitter,  to obtain the confidentiality waiver before they can
 be processed.
                               —73—

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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 ง10(d)(1)(A),  (B),  or (C),  but for which you claim
•confidential treatment  on 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.  >''

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

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

      •    If you assert that the information  in voluntarily sub-
           mitted, indicate whether  you believe disclosure  of this
           information might tend to lessen the'availability to
           EPA of similar information in the future,  and  if so,
           how.                                  -• •:  •
                                —74—

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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 cros^ reference number is used in the study
                            in place ฃff the following words or phrase at the
                            indicated volume and page references.
   DELETED WORDS OR PHRASE:	_	

   PAGE     LINE  REASON FOR THE DELETION
                                         PJ-V.y1c.nt.
      6
     12
    100
14
25
19
Identity of Inert  Ingredient
                                               FIFRA REFERENCE

                                               ง10(d) (1) (C)
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):
  PAGE
   20.
            Reproduce the deleted paragraph(s) here
LINES REASON FOR THE DELETION          ,        FIFRA REFERENCE

2-17  Description of the quality control process   ง10(d)(1)(C)
 Example  3.  (Confidential
                   that have been deleted  from the study)
  CROSS  REFERENCE NUMBER 7. This cross reference number noted on a place-
                          holder page is used in place  of the following
                          whole pages at the indicated  volume and page
                          references.

   DELETED  PAGE(S):  are attached immediately behind this page. •   •         .

   PAGE  LINES      REASON FOR THE DELETION                 . .FIFRA REFERENCE

   20. 2-17 Description of the product manufacturing process'  ง10(d)(1)(A)
                                    —75—

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                              •  ATTACHMENT 6.
                 SAMPLE GOOD  LABORATORY PRACTICE  STATEMENTS
     This study meets the requirements for 40 CFR Part 160
           Submitter	•	'
           Sponsor   	
           Study Director
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_
 Exc
3le 3
     The submitter of this  study was  neither the sponsor of this j*tudy nor
     conducted  it,  and  does not know whether  it has  be_en .conducted in
     accordance with 40 CFR Part  160.                     _   ;
           Submitter
                                      —76—

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                          ATTACHMENT 7.
                  FORMAT OP THE SUBMJTTAL PACKAGE
LEGEND
                    Transmittal Docunent.

                        Related Administrative Materials
                        fe.g.. Method of Support Statement, ซtc.J


                              Other materials about the subnittal
                              <••ซซ*  suปnafi*8 of groups of studies
                              to aid  in  their review).

                                     Studies, submitted as unique
                                     physical entities, accordino
                                     to  the format below.
                   FORMAT OP SUBMITTED STUDIES


            Study title page.

                Statement of Confidentiality Claim.
                                        ,'„

                    CLP and flagging* statement* - as appropriate.

                         Body of the study, with English
                         language translation if required.

                             Appendices to the study.
                                 Title rao* off the Confidential
                                 Attachment.

                                      Confidential Attachment.

                                          Supplemental  Statement
                                          of Confidentiality Claims,

                                      * When _flagging requirements
                                       are finalised.
                Documents which Must be submitted  as
              _ appropriate to ปซซt eitaOiisrted  rซquirซปents.

                f     Documents submitted at submitter's  ootion.
              -J
                          —77—

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—78—

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PR Notice 91-2
     —79—

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—80—

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              UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                            WASHINGTON, D.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 policy 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(i). Accordingly, the Agency has
established the nominal concentration  as the only acceptable
label claim for the amount  of active ingredient in the product.

II. BACKGROUND         -                                       '

     For some  time the Agency has  accepted  two different methods
of 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 good 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

                               —81—

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 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 tor
 calculation of dosages and dilutions.

      The nominal concentration would in fact state the greatest
-degree of accuracy that is warranted with respect to actual
 product composition because the nominal concentration would be
 the amount of active ingredient typically found in ..the product.

      It is important"for registrants to note that certified
 limits for 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  tor
 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 concentration expressed as a percentage by weight  as  the
 label  claim in the  ingredient(s)  statement and equivalence
 statements  if  applicable  (e.g., elemental arsenic, metallic  zinc,
 salt of an  acid).  In addition, the requirement for performing
 sample analyses  of  five or more representative samples  must  be
 fulfilled.  Copies  of the  raw analytical data must be submitted
 with the  nominal ingredient label claim. Further  information
 about  the analysis  requirement may be  found  in the  40 CFR
 158.170.  'All  products  are required to  provide certified limits
 for each active,  inert  ingredient, impurities of  toxicological
 significance(i.e.,  upper  limit(s) only)  and  on  a- .case by case
 basis  as  specified by EPA. These  limits  are  to be set based on.
 representative sampling and chemical analysis(i.e.,  quality
 control)  of the  product.                   .•

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

       After July 1,  1997,  all pesticide ingredie&t Statements must
 be changed to nominal concentration.
                                —82—

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 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 control pests which threaten the
 public health, e.g., certain antimicrobial and rodenticide
„products. Refer to 40 CFR 153.640.

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

 V. COMPLIANCE SCHEDULE

      As described earlier, the purpose of this Notice is to make
 the registration process more uniform and more manageable  for
 both the agency and the regulated community. It  is the Agency s
 intention to  implement the requirements of this  notice js
 smoothly as possible so as not to disrupt or delay the Agency s
 hiqh 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.     .-'

       (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.
                                —83—

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

VI. FOR FURTHER INFORMATION
          i                                         ^       t
Contact Tyrone Aiken., for information or questions concerning
this notice on  (703) -308-7031.
                                 Ann* S.  f&ndaay.  Director
                                               Division  (H-75O5
                               —84—

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APPENDIX F. Product Specific Data Call-In
                 —85—

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—86—

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                              DATA CALL-IN N(
CERTIFIED MAIL
Dear Sir or Madam:


This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet, to
submit certain product specific data as noted herein to the  U.S. Environmental Protection
Agency (EPA, the Agency). These data are necessary to maintain the continued registration of
your produces) 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 hi this Notice and its
              Attachments A through G; or

       2.     Why you believe you are exempt from the requirements listed in this Notice and
              hi 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 ffl-D),.

       If you  do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing  so, then the,,registration of
your product(s) subject to this Notice will be subject to suspension.  We have, provided a list of
all of your products subject to this Notice hi Attachment 2, Data Call-In Response Form, as  well
as a list of all registrants who were- sent this Notice (Attachment 6).           .          .

       The authority for this Notice is section 3(c)(2)(B) of the  Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B).  Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107
(expiration date 12-31-92).
     This Notice is divided into six sections and seven Attachments.  The Notice itself contains

                                        —87—

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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 H -  Data Required By This Notice
       Section HI-  Compliance With Requirements Of This Notice
       Section IV- Consequences Of FaUure To Comply With This Notice
       Section V  - Registrants' Obligation To Report PossibleUnreasonable Adverse
                   Effects   "     ••**  •••^  •    .;-  ".  >.-.-i:
       Section VI - Inquiries* And Responses to This Notice

    The Attachments to this Notice
                                ••     ";-.*• "JfSM1^"-ป"•  • JT
       1  -   Data Call-In Chemical Status Sheet
       2  -   Product-Specific Data Call-In Response Form
       3  .   Requirements Status and Registrant's Response Form
       4  _    EPA Groupinp  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 AKF. RECETvTNrT THIS NOTICE

       The Agency has reviewed existing data for this active ingredient and reevaluated the data
 needed to support continued registration of fie 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 REQUIRE RY THIS NOTICE

 II-A. DATA REQUIRED    .                        --

        The product  specific  data required  by this  Notice are specified hi Attachment  3,
 Requirements Status  and Reentrant's Response Form.   Depending'on the results  of  the studies
 required in this Notice,  additional testing may be required.
    ^                            ^-   •,...   .-' :.'   '  *.ป _ •'
 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 Regent's Response Form, within the time frames
  provided.
                                          —88—

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 H-C.  TESTING PROTOCOL

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

       These EPA Guidelines are available from the National Technical  Information Service
" (NTIS), Arm: 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 ง 158.70).   When using the OECD
 protocols they should be modified as  appropriate so that the data generated by the study wdl satisfy
 the requirements of 40 CFR ง 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.

        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(cV^fg> NOTICES
       TSSUED BY THE AGENCY
                                                         s.
       Unless otherwise noted herein, this Data Call-in does not in anv wav supersede or change the
  requirements of anv previous Data Call-MsX 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.

  SFrTTON TTT  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 andTCB.
                                *. .                               '                  •

  ffl-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

                                          —89—

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 requirements of this Notice is contained in Section m-C.   A discussion of options relating to
 requests for data waivers is contained in Section ffl-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 Pp-gnirements Status and Registrant's Response Form, Attachment 2 and
 Aiit^y^t 7 THป rปats raii-Tn Response Form must be submitted as part of every response to this
 Notice  In addition, one copy of the Requirements Status and Registrant's Response Form must
 be submitted for  each product listed on the Data Call-in Response Form  unless the voluntary
 cancellation option is selected or unless the product is identical to another (refer to the instructions
 for completing the r>ata rail-Tn Response Form in Attachment 2).  Please note that the company s
 authorized representative is required to sign the first page of the Data Call-In Response Form and
 Requirements Status and Registrant's Response Form (if this form is required) and initial any
 subsequent pages. The forms contain separate detailed instructions on the response options. Do not
" alter the printed material. If you have questions or need assistance hi preparing your response, call
 or write the contact person(s) identified hi Attachment 1.

        1  Voluntary Cancellation - You may avoid the requirements of this Notice by requesting
 voluntary cancellation of your produces) containing the active ingredient that is the subject of this
 Notice If you wish to voluntarily cancel your product, you must submit a completed Data Call-in
 Response Form, indicating your election of this option. Voluntary cancellation is item number 5
 on the Data Gallon Response Form. If you choose this option, this is the only form that you are
 required to complete.

        If you chose to voluntarily cancel your product, further sale and distribution of your product
  after the effective date of cancellation must be in accordance with the Existing  Stocks provisions
  of this Notice which are contained hi 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 IH-C of this Notice and comprise options 1 through 6 on the Requirements
  Status and Registrant's Response Form and item numbers 7a and 7b on the Data Call-In Response
  Form. Deletion of a use(s) and the low volume/minor use option are not valid options for fulfilling
  product specific data requirements.

         3. Request for Product Specific- Data Waivers.  Waivers for product specific data are
  discussed in Section HI-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 options, you must submit both forms
  as  well  as any other information/data pertaining  to the option  chosen to address  the  data
  requirement.

  m-C  SATISFYING THE DATA REOUIRFMENTS OF THIS NOTICE

         If you acknowledge on the Data Call-in Response Form that you agree to satisfy the product
  specific  data requirements (i.e.  you select item number-7a or 7b), then you must select one of the

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six options on the Requirements Status and Registrant's Response Form related to data production
for each data requirement.   Your option selection should be entered under  item  number  9,
"Registrant Response." The six options related to data production are the first six options discussed
under item 9 in the instructions for completing the Requirements Status and Registrant's Response
Form.  These six options are listed immediately below with information in parentheses to guide
registrants to additional instructions provided in this Section.  The options are:

       (1) .   I will generate and submit data within the specified time frame (Developing Data)
       (2)    I have entered info an agreement with one or more registrants to develop data jointly
              (Cost Sharing),
       (3)    I have made offers to cost-share (Offers to Cost Share)
       (4)    I am submitting an existing study  that has not been submitted previously to the
              Agency by anyone (Submitting an Existing Study)                          .
       (5)    I am submitting or citing data to upgrade a study classified  by  EPA as partially
              acceptable and upgradeable  (Upgrading a Study)
       (6)    I am citing an existing study that EPA has classified as acceptable or an existing
              study that has been submitted but not reviewed by the Agency (Citing an Existing
              Study)

       Option 1. Developing Data ~ If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced herein and
in the attachments.   All data generated and submitted must comply with the  Good Laboratory
Practice (GLP) rule  (40 CFR Part 160), be conducted according to the Pesticide Assessment
Guidelines (PAG), and be in conformance with the requirements of PR Notice 86-5.

        The time frames  in the Requirements Status and Registrant's Response Form are the time
frames that the Agency is allowing for the  submission of completed study reports.  The noted
deadlines run from the date of the receipt of this Notice by the registrant.  If the data are not
submitted by the deadline, each registrant  is subject to receipt of a Notice of  Intent to Suspend the
affected registrations).

        If you cannot submit the data/reports to the Agency in the time required by this Notice and
 intend to seek additional time to meet the requirements^), you must submit a request to the Agency
 which includes:  (1)  a detailed description of the expected difficulty and (2) a proposed schedule
 including alternative dates for meeting such requirements on a step-by-step basis.  You must explain
 any technical or laboratory difficulties and provide documentation from the laboratory performing
 the testing.  While EPA is considering your request, the original deadline remains. The Agency
 will respond to your request in writing. If EPA does not grant your request, the original deadline
 remains.  Normally, extensions can be requested only hi cases of extraordinary .testing problems
 beyond the expectation or control of the registrant. Extensions will not be given in submitting the
 90-day responses.  Extensions will not be considered if the request for extension is not made in a
 timely fashion; hi 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 hi the attached
 data tables that your product and at least  one other product are similar for purposes of depending

                                           —91—

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on the same data.  If this is the case, data may be generated for just one of the products hi the
group. The registration number of the product for which data will be submitted must be noted hi
the agreement to cost share by the registrant selecting this option.  If you choose to enter into an
agreement to share in the cost of producing the required data but will not be submitting the data
yourself, you must provide the name of the registrant who will be submitting the data.  You must
also provide EPA with documentary evidence that an agreement has been formed.  Such evidence
may be your letter offering to join in an agreement and the other registrant's acceptance of your
offer, or a written statement by the parties that an agreement exists. The agreement to produce the
data need not specify all of the terms of the final arrangement between the parties or the mechanism
to resolve the terms. Section.3(c)(2)(B) provides that if the parties cannot resolve the terms of the
agreement they may resolve then* differences  through binding arbitration.

       Option 3. Offer to Share hi the Cost of Data Development — This option only applies to
acute toxicity and certain efficacy data as described hi option 2 above.  If you have made an offer
to pay hi an attempt to enter  into an agreement or amend  an existing agreement to meet the
requirements of this Notice and have been unsuccessful, you may request EPA (by selecting this
option) to exercise its discretion not to suspend your registration^),  although you do not comply
with the data submission requirements of this Notice. EPA has determined that as a general policy,
absent other relevant considerations, it will not suspend the registration of a product of a registrant
who has hi good faith sought and continues  to seek to enter into a joint data development/cost
sharing program, but the other registrant(s) developing the data has refused to accept your offer.
To qualify for this option, you must submit documentation to the Agency proving that you have
made an offer to another registrant (who has  an obligation to submit data) to share hi the burden
of developing that data.  You must also submit to the Agency .a completed EPA Form 8570-32,
Certification of Offer to Cost Share hi the Development of Data, Attachment 7.  In addition, you
must demonstrate that the other registrant to whom the offer was made has not accepted your offer
to enter  into a cost sharing agreement by including a copy of your offer and proof of the other
registrant's receipt of that offer (such as a certified mail receipt).  Your offer must, hi addition to
anything else, offer to share hi the burden of producing the data upon terms to be agreed or failing
agreement to be bound by binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii) and must
not qualify this offer.   The other registrant must also inform EPA of its election of an option to
develop and submit the data required by this Notice by submitting a Data Call-In Response Form
and a Requirements Status and Registrant's Response Form  committing  to develop and  submit the
data required by this Notice.

       In order for you to avoid suspension under this option, you may not withdraw your offer
to share hi 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 Noticed If fhe other registrant fails
to develop the data or for some other reason  is subject to suspension, your registration as well as
that of the other registrant will normally be subject to initiation of suspension proceedings, unless
you commit to submit, and do submit the required data hi 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 hi
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.

                                          —92—

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Do not use this option if you are submitting data to upgrade a study. (See Option 5).

      You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the required
date of submission.  The Agency may determine at any tune that a study is not valid and needs to
be repeated.

       To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:                     ,

       a.     You must certify atthetime that the existing study is submitted that the raw data and
              specimens from the study are available for audit and  review and you must,identify
              where they are available. This must be done in accordance with the requirements
              of the Good Laboratory Practice (GLP) regulation, 40 CFR Part 160. As stated in
              40 CFR 160.3(j) "  'raw data'  means any  laboratory worksheets,  records,
              memoranda,  notes,  or  exact copies thereof,  that are the  result of original
              observations and activities of a study and are necessary for the reconstruction and
              evaluation of the report of that study.  In the event that exact transcripts  of raw data
              have been prepared (e.g., tapes which have been transcribed  verbatim, dated, and
              verified accurate by signature), the exact copy or exact transcript may be substituted
              for the original source as raw data.  'Raw data' may include photographs, microfilm
              or microfiche copies, computer  printouts,  magnetic media,  including dictated
              observations, and recorded  data from  automated  instruments."   The  term
              "specimens", according to 40 CFR 160.3(k), means "any material derived from a
              test system for examination or analysis."

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

        c.     You must certify that each study fulfills the acceptance criteria for the Guideline
              relevant  to the study provided in  the FIFRA Accelerated Reregistration Phase 3
              Technical Guidance and that the study has been conducted according  to the Pesticide
              Assessment Guidelines (PAG) or meets the purpose of the PAG (both available from
              NTIS).  A study  not conducted according to the PAG may be submitted to the
              Agency  for consideration if the registrant believes that the study clearly meets the
              purpose  of the PAG.  The registrant  is referred to 40 CFR 158.70 which states the
               Agency's policy regarding acceptable protocols. If you wish to submit the study, you
              must, hi 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.

                                           —93—

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

       If you know of a study pertaining to any requirement in this Notice which does not meet
 the criteria outlined above but does contain factual information regarding unreasonable adverse
• effects, you must notify the Agency of such a study.  If such  study is in the Agency's files, you
 need only cite it along with the notification.  If not in the Agency's files, you must submit a
 summary and copies as required by PR Notice 86-5.             ,

       Option 5. Upgrading a Study - If a study has been classified as partially acceptable, and
 upgradeable,  you may submit data to upgrade that study.   The Agency will  review the data
 submitted and determine if the requirement is satisfied. If the Agency decides the requirement is
 not satisfied,  you may still be required to submit new data normally without any time extension.
 Deficient, but upgradeable  studies  will normally be classified as  supplemental.  However,  it is
 important to  note that not all studies classified as supplemental are upgradeable.  If you have
 questions regarding the classification of a study or whether a study may be upgraded, call or write
 the contact person listed in Attachment 1.  If you submit data to upgrade an existing study you must
 satisfy or supply information to correct งU deficiencies in the study identified by EPA. You must
 provide a clearly articulated rationale of how the deficiencies have been remedied or corrected and
 why the study should be rated as acceptable to EPA. Your submission must also specify the MRID
 number(s) of the study which you are attempting to upgrade and must be in conformance with PR
 Notice 86-5.                                             .                   .
                                                          s
        Do not submit additional data for the purpose of upgrading a study classified as unacceptable
 and determined by the Agency as not capable of being upgraded.

        This option should also be used to cite  data that has been previously submitted to upgrade
 a study, but has not yet been reviewed by the Agency.  You must provide the MRID number of
 the data submission as well as the MRID number of the study being upgraded.

        The criteria for submitting an existing  study, as specified in Option 4  above, apply to all
 data submissions intended to upgrade studies.   Additionally your submission  of data  intended to
 upgrade studies must be accompanied by a certification that you comply with each of those criteria
 as well as a certification regarding protocol compliance with Agency requirements.

        Option 6. Citing Existing Studies ~ If you choose to cite a study that has been previously
 submitted to EPA, that study must have been previously classified by EPA-as acceptable or it must
 be a  study which has not yet been reviewed by the Agency.  Acceptable toxicology  studies
 generally will  have been  classified as  "core-guideline"  or "core minimum.11   For all other
 disciplines the classification would be "acceptable." With respect to any studies for which you wish
 to select this option you must provide the MRID number of the study you are citing and, if the
 study has been reviewed by the Agency, you must provide the Agency's classification of the study.

        If you are citing a study of which you are not the original data submitter, you must submit
 a  completed copy of  EPA Form 8570-31, Certification with Respect  to Data Compensation
 Requirements.

                                          —94—

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       Registrants who select one of the above 6 options  must meet all of the requirements
 described in the instructions for completing the Data Call-in Response Form and the Requirements
 Status and Registrant's Response Form, as appropriate.

 IH-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 of this Notice within 30 days of the receipt of the Agency's decision.
 You must indicate and submit  the option chosen on the Requirements Status and Registrant's
 Response Form.  Product specific data requirements for product chemistry, acute toxicity and
 efficacy (where appropriate) are required for all products and the Agency would grant a waiver only
 under extraordinary circumstances. You should also be aware that submitting a waiver request will
 not automatically extend the due date for the study in question. Waiver requests submitted
 without adequate supporting rationale will be denied and the original due date will remain hi force.

 IV.  CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE

 TV-A NOTICE OF INTENT TO SUSPEND

        The Agency may issue a Notice of Intent to Suspend products subject to this Notice due to
 failure by a registrant .to comply  with the requirements of this Data Call-In Notice,  pursuant to
 FIFRA section 3(c)(2)(B).  Events which may be the basis for issuance of a Notice  of Intent to
 Suspend include, but are not limited to, the following:

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

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

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

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

         5.     Failure to take a required action or submit adequate information pertaining to any
               option chosen to  address the data  requirements (e.g.,  any required  action or
               information pertaining  to submission or  citation  of existing studies or offers,
               arrangements, or arbitration on the sharing of costs or the formation of Task Forces,
               failure to comply with the terms of an agreement or arbitration concerning joint data
               development or failure to comply with any terms  of a data waiver).

                                           —95—

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      6.     Failure to submit supportable certifications as to the conditions of submitted studies,
             as required by Section ffl-C of this Notice.

      7.     Withdrawal of an offer to share in the cost of developing required data.

      8.     Failure of the registrant to whom you have tendered an offer to share in the cost of
             developing data and provided proof of the registrant's receipt of such offer or failure
             of a registrant on whom you rely for a generic  data exemption either to:

             a.     inform EPA of intent to develop and submit the data required by this Notice
                    on a Data Gall-In Response Form and a Requirements Status and Registrant's
                    Response Form:

             b.     fulfill the  commitment to develop and submit the data as required by this
                    Notice; or

             c.     otherwise  take  appropriate  steps to meet the  requirements stated in this
                    Notice, unless you commit to submit and do submit the required data hi 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
suspension include, but are not limited to, failure to meet any of the following:

       1.  EPA requirements specified in the Data Call-In Notice or other documents incorporated
      by reference (including, as  applicable,  EPA  Pesticide  Assessment Guidelines,  Data
      Reporting  Guidelines, and GeneTox Health Effects Test Guidelines) regarding the design,
      conduct, and reporting of required studies.  Such requirements include, but are not limited
      to, those relating to test material, test procedures, selection of species, number of animals,
      sex and distribution of animals, dose and effect levels to be tested Or attained, duration of
      test,  and, as applicable,  Good Laboratory Practices.          ,.   , •                ' .
          *           * *           ^                     '
       2.  EPA requirements regarding the submission of protocols, including the incorporation of
       any changes required by the Agency following review.

       3.  EPA requirements regarding the reporting of data, including the manner of reporting,
       the completeness  of results, and the adequacy of any required supporting (or raw) data,
       including, but not limited to, requirements referenced or included in this Notice or contained
       in  PR 86-5.  All studies must be submitted in the form of a final report; a preliminary
       report will not be considered  to fulfill the submission  requirement.
                                         —96—

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IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS

       EPA has statutory authority to permit continued sale, distribution and use of existing stocks
of a pesticide product which has been suspended or cancelled if doing so would be consistent with
the purposes of the Act.

       The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not be
consistent with the Act's  purposes.   Accordingly, the  Agency anticipates  granting registrants
permission to sell, distribute, or use existing stocks of suspended produces) only hi exceptional
circumstances.  If you believe such disposition of existing stocks of your produces) which may be
suspended for failure to comply-with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be consistent with the Act. You
must also explain why an "existing stocks" provision  is necessary, including a statement of the
quantity of existing stocks and your estimate of the time required for their sale, distribution, and
use.  Unless you meet this  burden the Agency will not consider any request  pertaining to the
continued sale, distribution,  or use of your existing stocks after suspension.

       If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will have, under  most
circumstances, one year from the date your 90 day response to this Notice is due, to sell, distribute,
or use existing stocks. Normally, the Agency will allow persons other man the registrant such as
independent distributors, retailers and end users to sell, distribute pr 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.

       Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result in the Agency granting  any additional time to  sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due unless you demonstrate
to the  Agency that you are hi 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  hi 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 RFPQRT POSSIBLE
UNREASONABLE ADVERSE EFFECTS                       .

        Registrants  are  reminded that FIFRA section 6(a)(2) states that  if at any tune 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.

                                          —97—

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SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE

      If you have any questions regarding the requirements and procedures established by Jhis
Notice, call the contact ฃrson(s) listed in Attachment 1, the IHtu mil-Tti Chemical Status Sheet.

      AU responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data  0.11-Tn Response  Form and  ป .5"ggg
p^Lments Stater -~ซ ^ctrsnfs Resnonse Form (Attachment 2 f d /^hment 3 fDrpraduct
mdfic data) and any other documents required by this Notice, and should to submitted to the
Set  pLon(s) identified in Attachment 1.  If the voluntary cancellation or, generic data
exemption option is chosen, qdy the Data Call-Tn Response Form need be submitted.   .
       The Office of Compliance Monitoring (OCM) of the  Office of
 Substances (OPTS), EPA, wiU be monitoring the data being generated in response to this Notice.
 Attachments
                                       Sincerely yours,
                                       Daniel M. Barolo, Di
                                       Special Review and
                                         Reregistration Division
        1 -   Data Call-in Chemical Status Sheet
        2 -   Product-Specific Data Call-in Response Form
        3 _   Requirements Status and Registrant's Response Form
        4 .   EPA  Groupinp  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
                                          —98—

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Attachment 1. Chemical Status Sheet
               —99—

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INORGANIC HALIDES DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

       You have been sent this Product Specific Data Call-in Notice because you have
produces) containing inorganic halides .

       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
inorganic halides . 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 Tojacology 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 inorganic halides
Product Specific Data Call-In (Attachment 7).  Instructions and guidance accompany each form.

DATA REQUIRED BY THIS NOTICE

       The additional data requirements needed to complete the database for inorganic halides
are contained in the Requirements Status and Registrant's Response. Attachment 3.  The
Agency has concluded that additional data on inorganic halides are needed for specific
products  These data are required to be submitted to the Agency within the time frame listed.
These data are needed to fully complete the reregistration of all eligible inorganic halides
products.

 INQUIRIES AND RESPONSES TO  THIS NOTICE

        If you .have any questions regarding the generic database of inorganic halides , please
 contact Mark Wilhite  at (703)  308-8586.

        If you have any questions regarding the product specific data requirements and
 procedures established by this Notice, please contact C.P.  Moran  (703) 308-8590
        All responses to this Notice for  the Product Specific data requirements should be
        submitted to:
              Accelerated Reregistration Branch, Chemical. Review Manager Team 81
              Product Reregistration Branch
              Special Review and Reregistration Branch 7508W     _    ,;
                      •'         0                              -
              Office of Pesticide Programs
              U.S.  Environmental Protection Agency
              Washington, D.C. 20460

              RE: Inorganic Halides
                                         —100—

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Attachment 2. Product Specific Data Call-In Response
      Forms (Form A inserts) Plus Instructions
                       —101-

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—102—

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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  reregistration 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.

ItemTa.     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 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.                                     .:               ..."
                                           -103—

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—104—

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Attachment 3. Product Specific Requirement Status and
   Registrant's Response Forms (Form B inserts) and
                    Instructions
                       —105—

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—106—

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INSTRUCTIONS  FOR  COMPLETING   THE   "REQUIREMENTS  STATUS  AND
REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA

Item 1-3.     Completed by EPA.  Note the unique identifier number assigned by EPA in item 3.
             This number must be used in the transmittal document for any data submissions in
             response to this Data Call-In Notice.

Item 4.       The guidelines reference  numbers of studies required to support the product's
          ,   continued  registration are  identified.    These  guidelines,  in  addition to  the
             requirements specified in the Notice, govern the conduct of the required studies.
             Note that series 61  and 62 in  product chemistry are now listed under 40 CFR
             158.155 through 158.180, Subpartc.

Item 5.       The study title associated with the guideline reference number is identified.

Item 6.       The use patters (s) of the pesticide associated with the product specific requirements
             is (are) identified.  For most product specific data requirements, all use patterns are
             covered by the data requirements. In, the case of efficacy data, the required studies
             only pertain to products which have the use sites and/ or pests indicated.

Item 7.       The substance to be tested is identified by EPA.  For product specific data, the
             product as formulated for  sale and distribution is the test substance, except in rare
             cases.

Item 8.       The due date for submission of each study is identified.  It is normally based  on 8
             months after issuance of the Reregistration Eligibility Documents unless EPA
             determines that a longer time period is necessary.

Item 9.       Enter Only one of the following response codes  for each data requirement to show
             how you intend to comply with the data  requirements listed hi this table.  Fuller
             descriptions of each option are contained hi 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 hi
             the Data Call-In Notice.                    _                            .

             2.     I have entered into an agreement with one or more registrants to develop data
             jointly (Cost Sharing). I am submitting a copy of this agreement.  I understand that
             this option is available on for acute toxicity or certain efficacy data and only if EPA
             indicates in an attachment to this notice  that my product is similar.  Enough to
             another  product to qualify  for this  option.  I certify that  another party in the
             agreement is committing to submit or provide the required data; if the required study
             is not submitted on tune, my product my  be subject to suspension.

             3.     I have made offers to share in the cost to develop data (Offers to Cost Share).

                                         —107—

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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 hi 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 m-C.l.) apply as well.

4.     By me  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 hi option 4 in the Data Call-In Notice (Section m-C.l.) and will meet the
attached acceptance criteria (for acute toxicity and product chemistry data).  I will
attach the needed supporting information along with this response.  I also certify that
I have determined that this study will fill the data requirement for which I have
 indicated this choice.

 5.      By  the specified due date, I will submit or cite data to upgrade a  study.
 classified by the Agency as partially acceptable and .upgrade (upgrading a study).
 I will submit  evidence of the Agency's  review indicating that  the study may be
 upgraded and  what information is required to do so.   I will provide the MRID or
 Accession number of the study at the due date. I understand that the conditions for
 this Option outlined Option 5 in the Data Call-In Notice (Section III-C.l.) apply.

 6.     By the specified due date, I  will cite an existing study that the Agency has
 classified as acceptable or an existing study that has been submitted but not reviewed
 by the Agency (Citing an Existing Study). If I am citing another registrant's study,
 I understand that this option is available only for acute toxicity  or certain efficacy
 data and only if the cited study was conducted on my product, an identical product
 or a  product which EPA has "grouped." with  one or more other  products  for
 purposes of depending on the same data.  I may also choose this option if I am citing
 my own data. In either case,  I will provide the MRID or Accession number (s)
 number (s) for the cited data on a "Product Specific Data Report"  form or in a
  similar format.   If I cite another registratrant's data, J wffl 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 hi 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

                             —108—  '

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              request, I will not be require to supply the data pursuant to Section 3(c) (2) (B) of
              FIFRA.   If the Agency denies my waiver request, I must choose a method of
              meeting the data requirements of this Notice by the due date stated by this Notice.
              In this case, I must, within 30 days of my  receipt of the Agency's written decision,
              submit a revised "Requirements Status chosen.  I also understand that the deadline
              for submission of data as specified by the original data cal-in notice will not change.

-Items 10-13. Self-explanatory.

        NOTE: You may provide additional information that does not fit on this form in a signed
 letter that accompanies this form.   For example,  you may wish to report that your product has
 already been transferred to another company or that you have already voluntarily cancelled this
 product. For these cases, please supply all relevant details so that EPA can ensure that its.records
 are correct.
                                           —109—

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-110—

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

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—112—

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 EPA'S BATCHING OF PRODUCTS CONTAINING SODIUM BROMIDE AND SODIUM
 CHLORIDE (INORGANIC  HALIDES)  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
 bromide or sodium chloride, 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, wetlable  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 hi the
 preceding paragraph. Frequently acute toxicity data on individual products has been found to be
 incom-  plete. Notwithstanding the batching process, the Agency reserves the right to require,
 at any tune, acute toxicity data for an individual product should the need arise.

      Registrants of products within a batch may choose to cooper- atively generate, submit or
 cite a single battery of six acute toxicological studies to represent all the products within that
 batch. It is the registrants' option to participate hi the process with all other registrants, only
 some of the other registrants, or only their own products within a batch, of to generate all the
 required acute toxicological studies for each of their own pro- ducts.  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 sub- milled 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 cited, the
 registrant must clearly identify the material tested by its EPA registration number. If more than
 one Confidential Statement Of Formula (CSF) exists for a product registration, the registrant
 must indicate the formulation actually tested by identifying the corresponding CSF.

      In deciding how to meet the product specific dala require- ments, registrants must follow the
  directions given  hi the Data Call-In Notice and its attachments appended to  Ihe 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, *Requiremenls Slatus and
  Registrant's Response," lists the product specific data required for each product, including the.
  standard six acute toxic- ity tesls" A registrant who wishes to participate hi 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 hi a batch, the
  choices are  Options 1, 4,  5  or 6.  However,  a registrant should know that choosing not to

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                                                        —114—

 participate in a batch does not preclude other registrants in the batch from citing his/her studies
 and offering to cost share (Option 3) those studies.

       Table I indicates 3  batches including 29 products containing the active ingredient sodium
 bromide.

'Table I.          "                                              ,
                                                               % Sodium Bromide (NiBr), And Any
                                                               Other Active hgradfent
                                                                                             Ready-To-Use-Solution
                                                                                              Soluble Concentrate
                                                                                              Soluble Concentrate
                                                                                              Technical Chemical
                                                                                              Reidy-To-Use-Sokition
                                                                                              Ready-To-Use-Sokrbon
                                                                                              Ready-To-Use-Solution
                                                                                              Formulation Intermediate
                                                                                              Ready-To-Use-Solution
                                                                                              Ready-To-Uje-Solution
                                                                                              Ready-To-Use-Solution
                                                                                              Ready-To-Use-Solution
                                                                                              Ready-To-Use-Solution
                                                                                              Formulation bitermediate
                                                                                              Ready-To-Use-Solution
                                                                                              Ready-To-Use-Solution
                                                                                              Formulation 'Intermediate
                                                                                              Formulation Intermediate
                                                                 4.0 NaBr
                                                                 9E.O Sodium dkhloro-
                                                                     iwcyanurate
                                                                     dihvdrate
                                                                  7.0 NaBr
                                                                 89.0 Trichloro-j-triarine-
                                                                     trione
                                                                  7.0 NaBr
                                                                 89.0 Sodium dichloro-s-
                                                                     triazinetrione

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                             —115—
Batch No.


EPA Reg. No.
•MBMMMI^HIi^M
935-73
935-74
935:75 . ,
935-76
935-78
5185-376 ,
% Sodium Bromide (NaBr), And Any
Other Active Ingredient
••^••••••••••i
7.0 NaBr
92.0 Trichtoro-s-triazine-
tronB
7.0 NaBr
89.0 Sodium dichloro-s-
triarinetrione
7.0 NaBr
92.0 Trichloro-s-triazine-
trkme
7.0 NaBr
92.0 Sodium dfchoro-s-
triarinetrione
9.2 NaBr
88.0 Trichloro-s-triazine-
trione
14.6 NaBr
81.6 Sodium dichloro-s
triazinetrione
Formulation
•••^••••••••••B
PelletedrTableted
Granular
PeSetedJTableted :
.PeHetedfTableted
Pelleted/Tableted
Granular
     Table II lists 6 products containing sodium bromide or sodium
chloride as an active ingredient,  which were not considered to be
similar for purposes of acute toxicity or the Agency lacked suffic-
ient information for decision making and were not placed  in any
batch.  Registrants of these products  are  responsible  for meeting
the acute toxicity data requirements for each product.
Table II.
EPA Registration Number
170B-168
5736-90
5736-94
62432-1
65501-1
7616-65
% Sodium Bromide (NaBr), and any other -
active ingredient
42.8 NaBr
2.6 'NaBr
1.7 NaBr
1.5 Sodium chloride
20.4 Potassium peroxymonosulfate
20.0 Sodium chloride
3.8 NaBr
Formulation
Ready-To4JseSolution
Ready-To-Use-Sokition
Ready-To-Use-Sokition
Soluble Concentrate
Impregnated Material
Ready-To-Use-Solution

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—116—

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-117—

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               —119—
Attachment 5. EPA Acceptance Criteria

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—120—

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                                      —121—

                                 SUBDIVISION D
Guideline           Study Title

Series 61  .         Product Identity and Composition
Series 62           Analysis and Certification of Product Ingredients  ซt'.
Series 63           Physical and Chemical Characteristics            ics

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                                               —122—

                                  61 Product Identity and Composition
 ACCEPTANCE CRITERIA
-Does your study meet the following acceptance criteria?

 j.	    Name of technical material tested (include product name and trade name, if appropriate).

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

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


 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 omer beginning materials,       the     Mowing:

           	  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.                       -,   1
            	  Description of measures taken to assure quality of final product.

   9        Discussion of formation of impurities based on established chemical theory addressing (1) each impurity
    *	   which may be present  at >: 0.1% or was  found at .> 0.1% by product analyses and (2) .certain
            toxicologically significant impurities (see #3).

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                                               —123—

                          62 Analysis and Certification of Product Ingredients


                                       ACCEPTANCE CRITERIA

The following criteria apply to the technical grade of the active ingredient being reregistered.  Use a table to present
the information in items 6, 7, and 8.

Does your study meet the following acceptance criteria?

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

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                                               —124^-

                                63 Physical and Chemical Characteristics

                                       ACCEPTANCE CRITERIA


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

1 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
                        ption of physic*! state provided using terms such as "solid, granular, volatile liquid"
            Based on visual inspection at about 20-25ฐ 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 ฐC
     	  Any observed decomposition reported

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

  63-7 Density, Bulk Density, Specific Gravity

     	  D^^f^hSgrade active ingredient reported in g/ml or the specific gravity of liquids reported
     	  with reference to water at 20ฐ C. [Note: Bulk density of registered products may be reported in Ibs/tt
            or Ibs/gallon.]                                                       •      .
     -SjMubi^rndned in distilled water and representative polar and non-polar solvents, including those used in
             formulations and analytical methods for the pesticide
      _  Measured at about 20-25ฐ C                            -                 , .   ,
             Reported in g/100 ml (other units like ppm acceptable if sparingly soluble).  ,
   63-9
                       at 250 c (or canted by extrapolation from measurements made at higher temperature if
             pressure too low to measure at 25ฐ  C)
             Experimental procedure described
             Reported in mm Hg (torr) or other  conventional units.
   63-10 Dissociation Constant
       	  Experimental method described
       '      Temperature of measurement specified (preferably about
             20-25 ฐC)

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                                                —125—

63-11 Octanol/water Partition Coefficient
          Measured at about 20-25ฐ C                                       *   *    i. A A* * *  v^^r
    	  Experimentally determined and description of procedure provided (preferred method-45 Fed. Register

          77350)
          Data supporting reported value provided


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


63-13 Stability
    	   Sensitivity to metal.ions and metal determined
      •'    stability at normal and elevated temperatures
           Sensitivity to sunlight determined

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                                             —126—

                                          SUBDIVISION F
Guideline          Study Title

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

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                                                —127—

                                   81-1  Acute Oral Toxicity in the Rat


                                        ACCEPTANCE CRITERIA
_ Does your study meet the following acceptance criteria?

  1.	identify material tested (technical, end-use product, etc).
  2.	At least 5 young adult rats/sex/group.                      .        -
  3.	Dosing, single oral may be administered over 24 hrs.
  4."	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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                                                —128^-

                       81-2 Acute Dermal toricity 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.Okg or guinea pigs 35CM50 gm.
  4.	Dosing, single dermal.   ,   "%
  5.      Dosing duration at least 24.hours.
  6.*	Vehicle control, only if toxipity of vehicle is unknown.
  7.'Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg).
  3'.      Application site clipped or shaved at least 24 hours before dosing.
  9.      Application site at least 10% of body surface area.
  10.	Application site covered with a porous nonirritating cover to retain test material and to prevent
          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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                                              —129—

                               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/sexygroup.
 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, 22ฐ C (ฑ2ฐ), relative humidity 40-60%.
 7.	Monitor rate of air flow.
 g.	Monitor actual concentrations of test material in breathing zone.
 9      Monitor aerodynamic particle size for aerosols.
 lo'.IT Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration of
        respirable substance).
 11.	 Individual observations at least once a day.
 12.     Observation period to last at least 14 days.
 13.	 Individual body weights.
 14.     Gross necropsy on all animals.

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                                               —130—

                               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 .>.! 1.5.
 3.	6 adult rabbits.            ".       -
 4._	Dosing, instillation into the conjunctiva! sac of one eye
        per animal.
 5.	Dose, 0.1 ml if a liquid; 0.1 inl or not more than  100 mg if a solid, paste or paniculate substance.
 6.     Solid or granular test material ground to a fine dust.
 7.	Eyes not washed for at least 24 hours.
 g,	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).
 p.*	Individual daily observations.
                      Criteria marked with an * are supplemental and may not be required for every study.

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                                                —131—

                                   81-5 Primary DermSl Irritation. Study

                                         ACCEPTANCE CRITERIA


  Does your study meet the following acceptance criteria? cep;

-  i.	Identify material tested (technical, end-use product! .etc).
   2.	Study not required if material is corrosive or hasiapH 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 hotpecprior to dosing.
   7.     Application site approximately 6 cm2.          • 6 >
   g.	Application site covered with a gauze patch helda^place with nonirritating tape.
   9      Material removed, washed with water, without tflauma to application site.
   10 ~7 Application site examined and graded for irritatiograt 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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                                               —132—

                              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 of the following methods is utilized:
      	Freund's complete adjuvant test
      ~~~~~~" Guinea pig maximization'.test
         •    Split adjuvant technique
      	Buehler test
      	Open epicutaneous test
      3HH 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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                              -133—
Attachment 6. List of All Registrants Sent This Data CaH-In (insert)
                             Notice

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-134—

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                           —135—
Attachment 7. Cost Share Data Compensation Form, and Confidential
                  Statement of Formula Form

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—136—

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—137—
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—138—

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                                                 —139—

Instructions for Completing the Confidential Statement of Formula

          The Confidential Statement of Formula (CSF) Form 8570-4 must be used. T.wo legible, signed
          copies of the form are required. Following are basic instructions:
4  '
         :     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 label.
               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.

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—140—

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                                           —141—
   ?/EPA
United States Environmental Protection Agency
            Washington, DC 20460
   CERTIFICATION OF  OFFER TO COST
 SHARE  IN THE DEVELOPMENT OF DATA
Form Approved

OMB No. 2070-0108
        2070-0057
Approve! Exp!rปt 3-31-96
Public reporting burden for this cofiection 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
compteting-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 Poficy
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 Xante
Product >"amc
Company Number
KPA Reg.\o.
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)(Iu) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
  Name of Flrm(*>
                                                                           Date of Offer
Certification:          •           -T                                 •

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 afl 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
Namซ and
of Company'* Authorized RepreeentaHve
Dal*
Till* (Plus* Type or Print)
 EPA Form 8570-32 (S/91)   Replaces EPA Form 8580. which is obsolete

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—142—

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                                            —143—
     wEPA
United State*  Environmental Prottctlon Agency
            Washington,  DC 20460

   CERTIFICATION WITH RESPECT  TO
 DATA  COMPENSATION REQUIREMENTS
OKI N*. 2070-010?
        2070-WI7
Apfr*nl fspltM 3J1-96
  Public reporting buftJen for this colection of Information is estimated to average 15 minutes per response, inducing
  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, inducing suggestions for reducing this burden, to Chief, Information Policy
  Branch, PM-223. U.S. Environmental Prelection 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 blank* below.
ewnpiny NMM .
Product NซM
Company Number
DA tog. Mo.
 I Certify that:

 1.  For each study tited in support of registration or ^registration under the Federal Insecticide, Fungicide and
    Rodenticjde Act (FIFRA) that is an exclusive use study, I am the original ora suborner, or I have obtained the
    written permission of the original data submitterป dte that study.

 2.  That lor each study cted in support of registration or nuegistration under FIFRA that is NOT an exclusive use
    study, I am the original data submtoer.or I have obtained the wrtten permission of me origirtai data sgbmfter. or I
    have notified in writing thecompanyfjes) that submited data 1 have eked and have oHeredio: (a) Pay
    compensation tor those data in accordance wBh sections 3(C)(1)(D) and 3(0(2)(D) of FJFRA: and (b) Commence
    negotiation to dtleimint which data are subject to the condensation nM^rtimrt of nFIM and the amount of
    compensation due. f any.  Hie companies I htve notified are:  (check one)
    IJ  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 t have previously compDed wBi section 3(0(1X0} of FIFRA for the studies I have died in support ol
    registration or rengistration under F1FRA.
Signature
Nwm w* Till* (PIMM Tyป* *r Print)
Dfltf
.'
QEMERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, wUh regard to the
registration or reregistration of my products, to the extent required by FlFRA sections 3(cKl)(D) and 3(0{2)(b).

Dab-
KMHซ ซM Till* (PtMM Typซ ซr Print) .'
EPA Form ปJ70.J1 (4*0)

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