United States         Office of Prevention, Pesticides  EPA 738-R-93-024
Environmental Protection     And Toxic Substances      December 1993
Agency	(7508W)	

Reregistration

Eligibility Decision (


Barium Metaborate
                           Recycled/Recyclable
                           Printed with Soy/Canola Ink on paper that
                           contains at least 50% recycled fiber

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 m
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
              WASHINGTON, D.C. 20460
                                                       JAN 2 5 B9d
                                                                             OFFICE OF
                                                                       PREVENTION, PESTICIDES AND
                                                                          TOXIC SUBSTANCES
 CERTIFIED MATT.
 Dear Registrant:

        I am pleased to announce that the Environmental Protection Agency has completed its
 reregistration eligibility review and decisions on the pesticide chemical case barium
 metaborate monohydrate.  The enclosed Reregistration Eligibility Derision (RED) contains
 the Agency's evaluation  of the data base of this chemical, its conclusions of the potential
 human health and environmental risks of the current product uses, and its decisions and
 conditions under which these uses and products will be eligible for reregistration.  The RED
 includes the data and labeling requirements for products for reregistration. It may also
 include requirements for additional data (generic) on the active ingredientfs) to confirm the
 nsk assessments.

       To assist you with a proper response, read the  enclosed document entitled "Summary
 of Instructions for Responding to the RED".  This summary also refers to other enclosed
 documents which include further instructions.  You must follow all instructions and submit
 complete and timely responses.  The first set of required responses are due 90 days from
 the date of this letter. The second set of required responses are due  8 months from the
 date of this letter. Complete and timely responses will avoid the Agency taking the
enforcement action of suspension against your products.
                                                                    Recycled/Recyclable
                                                                    Primed with Soy/Canda Ink on paper that
                                                                    contains at least 50% recycled fiber

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      If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregistration Division representative Mr.
Franldin Gee at (703) 308-8008. If you have any questions on the generic data, please
contact Ms. Brigid Lowery at (703) 308-8053.
                                                     Sincerely yours,
                                                     Daniel M. Barolo, Director
                                                     Special Review and
                                                       Reregistration Division
Enclosures

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                     United States
                     Environmental Protection
                     Agency
                       Prevention, Pesticides
                       And Toxic Substances
                       (7508W)
EPA-738-F-93-019
December 1993
&ERA    R.E.D.    FACTS
                    Barium  Metaborate

         Pesticide      All pesticides sold or used in the United States must be registered by
    Registration  EPA, based on scientific studies showing that they can be used without posing
                    unreasonable risks to people or the  environment.  Because of advances in
                    scientific knowledge,  the law requires that pesticides which were  first
                    registered years  ago be reregistered  to ensure that they meet today's more
                    stringent standards.
                        In evaluating pesticides for reregistration,  EPA obtains and reviews a
                    complete set of studies from pesticide producers, describing the human health
                    and environmental effects of each pesticide.  The Agency imposes any regu-
                    latory 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
                    feet sheet summarizes  the information in the RED document for barium
                    metaborate monohydrate, referred to as barium metaborate.
      Use Profile
     Barium metaborate is a microbiocide/microbiostat used as an industrial
preservative in the manufecturing process of paints, paper/paper products,
industrial adhesives and coatings.  Barium metaborate products are formulated
as soluble concentrates and ready-to-use solutions. They are added to paints,
paper/paper products,  adhesives and coatings  during the manufecturing
process using a method that involves open pouring into a metering pump.
     A newly registered  product which contains a  mixture of barium
metaborate and another pesticide active ingredient, and is used as a fungicide
to protect walls, ceilings and pipes from mold and bacteria using a brush or
airless spray, is not subject to this RED.
     Barium metaborate is a compound of boron, which is ubiquitous in the
environment and occurs naturally hi soils, water,  food and forage crops.
Boron is an essential nutrient for plants as well as an essential element for
many organisms.

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    Regulatory
        History
     Barium metaborate was first registered in the United States in 1960 as
broad spectrum bactericide and fungicide.  Currently, four end use products
(three of which are covered by this RED) and no technical or manufacturing
use pesticide products are registered which contain barium metaborate as an
active ingredient.
     In April  1983,  EPA  issued  a  Registration  Standard for  barium
metaborate (NTIS #PB84-168376).  In February  1991, EPA  issued a Data
Call-in (DCI) for  this chemical,  requiring product chemistry,  ecological
effects and toxicity data.
     Initially, the barium metaborate reregistration case also contained the
active  ingredient sodium metaborate.   Since sodium metaborate is more
similar to  boric  acid, however, it was included hi  the  Boric Acid RED,
completed  hi September 1993.
Human Health
  Assessment
Human Toxicity
      Since only indoor, non-food uses are covered by this RED, EPA did not
require the submission of chronic toxicity, carcinogenicity or reproductive
toxicity studies.
      Barium metaborate generally is of moderate to low acute toxicity, and
has been placed hi Toxicity Category III for most acute effects including oral
and dermal toxicity, acute inhalation, and eye irritation.   It has been placed
in Toxicity Category IV (indicating the lowest degree of acute toxicity) for
dermal irritation.
      An acute neurotoxicity study using rats showed no treatment-related
effects.  A combined subchronic toxicity and neurotoxicity study using rats
showed a treatment-related decrease hi forelimb grip strength in high dose
males, and increased ambulatory activity  hi high dose males and mid- and
high dose females.
      A developmental toxicity study using rabbits showed a maternal toxicity
no observed effect level (NOEL) of 10 mg/kg/day, and a lowest observed
effect level (LOEL) of 20 mg/kg/day.  The NOEL for developmental toxicity
was 20 mg/kg/day,  the highest  dose tested.  Barium metaborate shows no
evidence of mutagenicity.
Dietary Exposure
      Barium metaborate has no registered food or feed uses.  Therefore, no
dietary exposure is expected to occur as a result of its pesticide uses.
Occupational and Residential Exposure
      The barium metaborate products subject to  this  RED are  added to
paints, paper/paper products, adhesives and coatings during the manufacturing
process, using a method that involves open pouring into a metering pump.
During this process, dermal exposure to mixers, loaders and applicators could
be significant.  However, EPA's assessment  indicates  that the  margin of
exposure (MOE) for factory workers involved hi these activities is 190,  which

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Environmental
  Assessment
                          is well over the 100-fold acceptable margin.  The risk to mixers/loaders/
                          applicators is considered minimal.  Post-application exposure also is expected
                          to pose minimal risks.
                          Human Risk Assessment
                               No food uses of barium metaborate are registered; therefore no dietary
                          risks are posed.  The industrial preservative uses, which involve open pouring
                          application methods,  could involve significant worker  exposure.  However,
                          the risks posed are minimal.

                          Environmental Fate
                               Barium metaborate is one of the boron-containing salts (berates), which
                          are ubiquitous in the  environment.  Surface soil, unpolluted waterways and
                          seawater all typically contain significant amounts of boron as borate.  In some
                          areas such as the American Southwest, boron occurs  naturally in surface
                          waters in concentrations that have been shown to be toxic to commercially
                          important plants.
                               EPA is not requiring any environmental fate data for barium metaborate.
                          The Agency does not believe that the pesticide uses covered by this RED add
                          significantly  to the amount of boron already  present in,  or pose  any
                         unreasonable risk to, the environment.
                         Ecological Effects
                              Barium  metaborate is slightly  toxic to bobwhite quail on an acute oral
                         toxicity basis, but is practically non-toxic to birds on a subacute basis.  It is
                         practically non-toxic to bluegill sunfish but slightly toxic to rainbow trout and
                         aquatic invertebrates.
                         Ecological Effects Risk Assessment
                              Barium metaborate applied indoors is not likely to be released to  the
                         environment in significant amounts in effluent. Any minor amounts that are
                         released would dissociate rapidly to naturally-occurring ionic components.
                         Any exposure to fish, wildlife  or endangered species would be regulated
                         under the National Pollutant  Discharge Elimination System (NPDES) permit
                         program.  Therefore, risk to fish, wildlife and endangered species is minimal.

   Additional Data       EPA  is requiring product-specific data including product chemistry and
           Required   acute toxicity studies, revised Confidential Statements of Formula (CSF), and
                         revised product labeling  for  reregistration of barium metaborate industrial
                         preservative products.


  Product Labeling       The labeling of all end-use  products containing barium metaborate must
Changes Required   comply with EPA's current pesticide labeling requirements. In addition:

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 Regulatory
Conclusion
   For More
Information
•  Personal Protective Equipment (PPE) Requirements
     Since exposure  to  mixers/loaders/applicators  during open pouring
     methods  could be  significant,  the following PPE is  required for all
     industrial preservative end-oise products:
     •  Long-sleeved shirt and long pants;
     •  Socks and shoes;
     •  Chemical-resistant gloves.
•  Environmental Hazard Statement
     The following effluent discharge statement must appear on the labels of
     all end-use products:
     "Do not discharge effluent containing this product into lakes, streams,
     ponds, estuaries, oceans or other waters unless hi accordance with the
     requirements of a National Pollutant Discharge Elimination System
     (NPDES) permit and the  permitting  authority has  been  notified hi
     writing prior to discharge.  Do not discharge effluent containing this
     product to sewer systems without previously notifying the local sewage
     treatment plant authority. For guidance contact your State Water Board
     or Regional Office of the EPA."

     The use  of microbiocide industrial preservative products  containing
barium metaborate,  registered  prior  to  July  1,  1993,  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 required product-specific  data,
Confidential Statements of Formula and revised labeling  are received and
accepted by EPA.
      The newly registered barium metaborate product, which also contains
another active ingredient, will be reregistered after the other active ingredient
is determined to be eligible for reregistration.

      EPA is  requesting public  comments on  the  Reregistration 'Eligibility
Decision (RED) document  for barium metaborate during a 60-day time
period, as announced in a Notice of Availability published hi the Federal
Register.  To  obtain a copy  of the RED  document  or to submit written
comments, please contact the Pesticide Docket, Public Response and Program
Resources Branch, Field Operations Division (7506C), Office  of Pesticide
Programs (OPP), US EPA, Washington, DC 20460, telephone 703-305-5805.
      Following the comment period, the barium metaborate RED document
 will be available from the National Technical Information Service (NTIS),
 5285 Port Royal Road, Springfield, VA 22161,  telephone 703-487-4650.

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     For more information about EPA's pesticide reregistration program, the
barium metaborate RED, or  reregistration of individual products subject to
this  RED, please contact the  Special Review and Reregistration Division
(7508W), OPP, US EPA, Washington, DC 20460, telephone 703-308-8000.
     For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact the
National  Pesticides Telecommunications Network (NPTN).  Call toll-free
1-800-858-7378, 8:00 am to 6:00 pm Central Time, Monday through Friday.

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REREGISTRATION ELIGIBILITY DECISION

         BARIUM METABORATE

                 LIST A

              CASE 0632
        ENVIRONMENTAL PROTECTION AGENCY
          OFFICE OF PESTICIDE PROGRAMS
      SPECIAL REVIEW AND REREGISTRATION DIVISION

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                         TABLE OF CONTENTS

 BARIUM METABORATE REREGISTRATION ELIGIBILITY DECISION
       TEAM	m

 GLOSSARY OF TERMS AND ABBREVIATIONS  	  iv

 EXECUTIVE SUMMARY	  ^

 I.    INTRODUCTION	   j

 H.   CASE OVERVIEW	     2
      A.    Chemical Overview	                                   2
      B.    Use Profile	'.'.'.'.'.'.'.'.'.'.'.'.'.'.'.'.'.'.'.'.'.   2
      C.    Data Requirements and Regulatory History	       3

 m.   SCIENCE ASSESSMENT	  4
      A.    Physical Chemistry Assessment  	..........  4
      B.    Human Health Assessment	.........   5
            1.    Toxicology Assessment 	  5
                 a.   Acute Toxicity	  5
                 b.   Subchronic Toxicity  	  5
                 c.    Developmental Toxicity 	[    6
                 d.   Mutagenicity	  6
                 e.    Neurotoxicity . . .  .	  7
                 f .    Reference Dose	  7
           2.    Exposure Assessment	               7
                 a.    Dietary Exposure	  7
                 b.    Occupational and Residential	  7
           3.    Risk Assessment  	"  9
                 a.    Dietary	    9
                 b.    Occupational and Residential	  9
      C.   Environmental Assessment	 . .        10
           1.     Environmental Fate	     10
                 a.    Environmental Chemistry, Fate and Transport  ......  10
                 b.    Environmental Fate Assessment	  11
           2.     Ecological Effects	     11
                 a.    Ecological Effects Data	  11
                      (1)   Terrestrial Data	   11
                      (2)   Aquatic Data 	'.'.'.'.'.'.'.   12
                 b.    Ecological Effects Risk Assessment	   13

IV.  RISK MANAGEMENT AND REREGISTRATION DECISION	  14
     A.    Determination of Eligibility	         	  14
           1.     Eligibility Decision	'.'.'.'.'.'.'.'.'.'.'.'.'.	  14
           2.     Eligible and Ineligible Uses 	'.'.'.'.'.'.'.'.'.'.'.  15

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      B.    Regulatory Position	  15
            1.    Tolerance Reassessment	  15
            2.    Restricted Use Classification	  15
            3.    Labeling Rationale	  15

V.    ACTIONS REQUIRED BY REGISTRANTS	  16
      A.    Manufacturing-Use Products	  16
            1.    Additional Generic Data Requirements	  16
            2.    Labeling Requirements for Manufacturing-Use Products	  16
      B.    End-Use Products	  16
            1.    Additional Product-Specific Data Requirements  	  16
            2.    Labeling Requirements for End-Use Products	  17
      C.    Existing Stocks  	  18

VI.   APPENDICES

      Appendix A - Use Patterns Subject to Reregistration

      Appendix B - Table of the Generic Data Requirements and Studies Used to Make the
      Reregistration Decision

      Appendix C - Citations Considered to be Part of the Data Base Supporting the
      Reregistration of Barium Metaborate

      Appendix D - List of Available Related Documents

      Appendix E - Summary of Instructions for Responding to the RED;
               - Instructions for the Confidential Statement of Formula

      Appendix F - Product Specific Data Call-In
             Attachment 1 -
             Attachment 2 -

             Attachment 3 -

             Attachment 4 -

             Attachment 5 -
             Attachment 6 -
             Attachment 7 -
Chemical Status Sheet
Product Specific DCI Response Forms (Form A) plus
Instructions
Requirements Status and Registrants' Response Forms
(Form B) plus Instructions
EPA Batching of End Use Products for meeting Acute
Toxicology Data Requirements.
EPA Acceptance Criteria
List of all Registrant(s) sent this DCI
Cost Share/Data Compensation Forms
                                        11

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  BARIUM METABORATE REREGISTRATION ELIGIBILITY DECISION TEAM

  Office of Pesticide Programs:

  Biological and Economic Analysis Division
 Rafael Prieto
 Phyllis Johnson

 Environmental Fate and Effects Division

 Brinson Conerly-Perks
 Richard Lee
 Mary Frankenberry

 Health Effects Division

 Pat McLaughlin
 Winston Dang
 Jane Smith

 Policy and Special Projects Staff
 Kennan Garvey

 Registration Division

 Mary Waller
 Theresa Stowe
 Shyam Mathur

 Special Review and Rerepistration Division
 Biological Analysis Branch
 Biological Analysis Branch
 Environmental Fate and Groundwater Branch
 Ecological Effects Branch
 Science Analysis and Coordination Staff
 Toxicology Branch I
 Occupational and Residential Exposure Branch
 Chemical Coordination Branch
 Registration Support Branch
 Fungicide-Herbicide Branch
 Registration Support Branch
Brigid Lowery
Barry O'Keefe
Carol Stangel

Office of General Counsel:
Pesticides and Toxic Substances Division
Jim Curtin

Office of Compliance Monitoring:
Policy and Grants Division
Shruti Sanghavi
Reregistration Branch
Reregistration Branch
Planning and Reregistration Branch
Pesticide Branch
Pesticides Enforcement Policy Branch
                                        111

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  CAS

  CSF

  EEC


  EP

  EPA

  FIFRA

  FFDCA

 HDT

 LC50
 LD
   '50
LDto

LEL

LOEL

MOE



MP

MPI
       GLOSSARY OF TERMS AND ABBREVIATIONS

  Active Ingredient

  Chemical Abstracts Service

  Confidential Statement of Formula

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

  End-Use Product

  U.S. Environmental Protection Agency

  Federal Insecticide, Fungicide, and Rodenticide Act

 Federal Food, Drug, and Cosmetic Act

 Highest Dose Tested

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

 Median Lethal Dose.  A statistically derived single dose that can be expected
 to cause death in 50% of the test animals when administered by the route
 indicated (oral,  dermal, inhalation).  It is expressed as a weight of substance
 per unit weight of animal, e.g., mg/kg.

 Lethal Dose-low. Lowest Dose at which lethality occurs

 Lowest Effect Level

 Lowest Observed Effect Level

 Margin of Exposure.  A numerical value that characterizes the amount of
 safety to a toxic chemical - a ratio of exposure to a lexicological endpoint
 usually a NOEL.

Manufacturing-Use Product

Maximum Permissible Intake
                                        IV

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                 GLOSSARY OF TERMS AND ABBREVIATIONS

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.

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  EXECUTIVE SUMMARY

         This Reregistration Eligibility Decision (RED) addresses the eligibility for
  reregistration of products containing barium inelaborate monohydrate, referred to in this
  document as barium metaborate, registered prior to July 1, 1993.

         Barium metaborate was originally registered in the United States in November 1960
  Banum metaborate is a fungicide, bacteriostat, microbiocide/microbiostat and is used as an
  industrial preservative in the manufacturing process of paints, paper/paper products
  adhesives, and coatings to protect against slime-forming bacteria and fungi. It is u^ed as a
  preservative in paper formulation to protect paper products from microbiological degradation
  during  storage.  At higher concentrations it is used to impart mold resistance in paints
  coatings, latex/oil/varnish paints (applied film), and paper/paper products. Use has bin
  permitted as a component in the manufacture of paper and paperboard under U S Food and
  Drug Administration Regulations 21 CFR 176.180,  "components of paper and paperboard in
  contact with dry food."  Since U.S. FDA regulates this use, there is no need for EPA
  regulation in this area. Furthermore,  barium metaborate may be applied by brush or airless
  spray to walls,  ceilings, pipes, etc. as a fungicide to protect against molds and bacteria  The
 product that contains this use is a mixture of barium metaborate and another active ingredient
 and was registered after July 1,  1993; therefore,  it is not included in this RED.

        A Registration Standard for barium metaborate was issued in April 1983 (NTIS
 #PB84-168376) which evaluated the studies available to the Agency. Product chemistry data
 and an acute rat inhalation study were required in the April 1983 Registration Standard
 Subsequently, a Data Call-in (DO) was issued February 1991 for this chemical.  The DCI
 required submittal of product chemistry data, ecological effects data, and toxicology data
 This Reregistration Eligibility Decision reflects a  reassessment of all data which were
 submitted in response to the Registration Standard and DCI. Appendix B includes all data
 requirements identified by the Agency to support  the reregistration of all barium metaborate
 uses registered prior to July  1, 1993.

       Sodium metaborate was included in the same case as barium metaborate when the lists
 of the active ingredients undergoing reregistration were published in 1989  The Agency
 however, determined that sodium metaborate should be reregistered with boric acid since it is
 the sodium salt of bone acid. Sodium metaborate was included in the Boric Acid RED
 which was issued in September 1993.
T i  t  T!f Agency ^ determined that the uses of barium metaborate registered prior to
July 1, 1993 will not cause unreasonable risk to humans or the environment and are eligible
for reregistration.                                                               6

       Before reregistering the products containing barium metaborate, the Agency is
requiring that product specific data, revised Confidential Statements of Formula (CSF) and
revised labeling be submitted within eight months of the issuance of this document These
                                         VI

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data include product chemistry for each registration and acute toxicity testing. After
reviewing these data and any revised labels and finding them acceptable in accordance with
Section 3(c)(5) of FIFRA, the Agency will reregister a product. Those products which
contain other active ingredients will be eligible for reregistration only when the other active
ingredients are determined to be eligible for reregistration.
                                           vu

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 I.     INTRODUCTION

        In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
 amended to accelerate the reregistration of products with active ingredients registered prior to
 November 1, 1984. The amended Act provides a schedule for the reregistration process to be
 completed in nine years. There are five phases to the reregistration process. The first four
 phases of the process focus on identification of data requirements to support the reregistration
 of an active ingredient and the generation and submission of data to fulfill the requirements
 The fifth phase is a review by the U.S.  Environmental Protection Agency (referred to as "the
 Agency") of all data submitted to support reregistration.

       FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
 whether pesticides containing such active ingredient are eligible for registration" before
 calling in data on products and either reregistering products or taking "other appropriate
 regulatory action." Thus, reregistration involves a thorough review of 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 uses of barium metaborate monohydrate, referred to in this document as barium
 metaborate, which were registered prior to July 1, 1993.  The document consists of six
 sections. Section I is the introduction. Section H describes barium metaborate, its 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 barium metaborate. Section V discusses the product reregistration
 requirements  for barium metaborate.  Finally, Section VI is the Appendices which support
 this Reregistration FJigibility Decision.  Additional details  concerning the Agency's review of
applicable data are available on request.

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H.     CASE OVERVIEW

       A.    Chemical Overview

             The following active ingredient is covered by this Reregistration Eligibility
       Document:
       •     Common Name:

       •     Chemical Name:

       •     CAS Registry Number:

       •     OPP Chemical Code:

       •     Case:

       •     Empirical Molecular
             Formula:

       •     Molecular Weight:

       •     TGAI:
Barium metaborate

Barium metaborate monohydrate

13701-59-2

011101

0632
241

Barium metaborate monohydrate
              Trade and Other Names:  Busan 11-M1

              Basic Manufacturer:      Buckman Laboratories International Inc., U.S.A
       B.     Use Profile

              The following is information on the uses registered prior to July 1, 1993 with
       an overview of use sites and application methods.  A detailed table of these uses is
       provided in Appendix A.

              Barium metaborate is a fungicide, bacteriostat, microbiocide/microbiostat and
       is used as an industrial preservative in the manufacturing process of paints,
       paper/paper products, adhesives, and coatings to protect against slime-forming
       bacteria and fungi.  It is used as a preservative in paper formulation to protect paper
       products from microbiological degradation during storage. At higher concentrations it
       is used to impart mold resistance in paints, coatings, latex/oil/varnish paints (applied
       film),  and paper/paper products.  Use has been permitted for the manufacture of
       paper and paperboard under U.S. Food and Drug Administration Regulations 21 CFR
       176.180, "components of paper and paperboard in contact with dry food."  There is

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  no need for EPA regulation in this area. Furthermore, barium metaborate may be
  applied by brush or airless spray to walls, ceilings, pipes, etc. as a fungicide to
  protect against molds and bacteria. The product that contains this use is a mixture of
  barium metaborate and another active ingredient and was registered after July 1,
  1993; therefore, it is not covered in this RED.

  Use group/sites:

  Indoor non-food: industrial  adhesives, industrial coatings, latex/oil/varnish (applied
  film) paints, paper/paper products, wet-end additives/industrial processing chemicals.

  Target pests:

  Slime-forming bacteria and fungi

 Application type:

 Industrial preservative treatment

 Application timing:

 During manufacture

 Rates of Application:

 Adhesives:
       0.05 to 0.5 percent based on the weight of the solution
 Industrial coatings:
       1 to 3 percent based on total weight of coating
 Latex/oil/varnish (applied film) paints
       5 to 20 percent based on the total weight of the  coating
 Paper/paper products:
       0.05 to 0.5 percent based on the weight of the solution
 Wet-end additives/industrial processing chemicals:
       0.05 to 0.5 percent based on the weight of the solution

 C,   Data Requirements and Regulatory History

      Barium metaborate was originally registered in the United States in November
 1960 for use as a broad spectrum bactericide and fungicide. A Registration Standard
for barium  metaborate was issued in April 1983 (NTIS #PB84-168376) which
evaluated the studies available to the Agency.  Product chemistry data and an acute
rat inhalation study were required to support the uses listed in the Registration
Standard.  A Data Call-in Notice was issued in February 1991 which required product

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      chemistry data, ecological effects data, and toxicology data. This Reregistration
      Eligibility Decision reflects a reassessment of all data which were submitted in
      response to the Registration Standard and Data Call-In. Appendix B includes all data
      requirements identified by the Agency to support the reregistration of all uses of
      barium metaborate registered prior to July 1,  1993.

             Sodium metaborate was included in the same case as barium metaborate when
      the lists of the active ingredients undergoing reregistration were published in 1989.
      The Agency, however, determined that sodium metaborate should be reregistered with
      boric acid; therefore, it was included in the Boric Acid RED which was issued in
      September 1993.

      SCIENCE ASSESSMENT

      A.    Physical Chemistry Assessment

      The physical and chemical characteristics of the TGAI of barium metaborate are
described below (MRID numbers 00137047 and 42173701):
       Color:

       Physical state:

       Odor:

       Melting Point:

       Density:

       Vapor Pressure:

       Dissociation Constant:

       Octanol/Water Partition
       Coefficient:

       pH:

       Stability:
White

Powder

None

Fused between 1367.5°C to 1482.5°C

1.07 g/cm3 at 25°C

8.1xlO-7Torr

pK, = 8.9


less than 2

9.76 (concentration 100 ppm in water)

Barium metaborate is stable at ambient temperature and
elevated temperature (54°C).  It is also stable to
galvanized steel and stainless steel and is stable in the
presence of ferric oxide and zinc acetate for 14 days.

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      B.    Human Health Assessment

            1.    Toxicology Assessment

                  The lexicological data base on barium inelaborate is adequate;
            therefore, the Agency is not requiring any additional toxicological data. The
            uses of barium metaborate fall under the use group "indoor non-food."  The
            Agency does nol routinely require the submittal of chronic toxicity,
            carcinogencity, and reproductive loxicity dala to support ihe indoor non-food
            use group. The results of Ihe sludies Ihe Agency required for barium
            metaborate do nol trigger the need for ihe additional toxicological testing.  The
            resulls of ihe required sludies  are summarized below.

                  a.     Acute Toxicity

                       The results of Ihe acute testing are found in the table below.
    ACUTE MAMMALIAN TOXICITY DATA FOR BARIUM METABORATE
                              (90% MATERIAL)
 GDLN
 81-1
 TEST
 Acute oral LD50 (rat)
RESULT
530 mg/kg (9)
850 mg/kg (d)
TOXICITY
CATEGORY

      m
                                                               MRID
                                                                  00139192
81-2
Acute dermal LD50
(rabbil)
                               > 2000 mg/kg
                      m
                  00139216
81-3
Acute inhalation LC50
(rat)
 >  3.54 mg/L
                                                     m
                  00137048
81-4
Eye irrilation (rabbil)
                                 reversible
                                  irrilation
                      m
                  00139192
81-5
Dermal irrilation
(rabbit)
                                no irrilation
                      IV
                  00139192
81-6
Skin sensitization
(guinea pig)
                                  negative
                     N/A
                 b.     Subchronic Toxicity
                  41396401
                  40898401
                       In a combined oral subchronic loxicity and neurotoxicity sludy
                rate were given 0, 1000, 5000, or 10000 ppm barium inelaborate in Ihe
                diel for 90 days.  The NOEL was 1000 ppm (70 mg/kg/day in males

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and 80 mg/kg/day in females) and the LOEL was 5000 ppm (349
mg/kg/day in males and 406 mg/kg/day in females).  At the high dose,
there were reduced body weight gains in both sexes and decreased food
consumption, red blood cells, hemoglobin, hematocrit, and liver
weights.  There were increased relative brain weights. High dose
males also had decreased total protein, cholesterol, globulin, testes
weights, and small or soft testes with aspermatogenesis.  At the mid-
dose (LOEL), there were reduced body weight gains and reduced
relative brain weights in females, as well as decreased total protein,
cholesterol and globulin in males. There was an apparent treatment-
related decrease in one of the functional neurological observations,
forelimb grip strength, for the high dose males and increased
ambulatory activity in mid-dose females and in both sexes at the high
dose.  (MRED 42747801) (preliminary notification MRIDS 42310501,
42663401; range finding report MRID 42724201).

c.     Developmental Toxicity

       In a developmental toxicity study, rabbits were given 0, 2, 10,
or 20 mg/kg/day of barium metaborate.  The doses were given by
gavage on gestation days 7 through 19. The NOEL for maternal
toxicity was 10 mg/kg/day.  The maternal LOEL was 20 mg/kg/day
based on death of one animal at this dose along with impaired mobility
and hypoactivity of another one. The NOEL for developmental toxicity
was 20 mg/kg/day, the highest dose tested. (MRID 42720502)
(preliminary information MRID 42314301; range finding report MRID
42720501).

d.     Mutagenicity

       The Agency reviewed three genotoxicity tests to support the
reregistration of barium metaborate: i) Salmonella assay ("Ames"
assay); ii) mammalian cells in culture forward gene mutation assay; and
iii) in vivo cytogenetics.  In an Ames assay with strains, TA98, TA100,
TA1535, TA1537, and TA1538 of Salmonella typhimuriwn, barium
metaborate did not cause a positive response with or without metabolic
activation (MRID 42132601).  An in vivo micronucleus assay in mice
was negative for chromosomal aberrations (MRID 42207501).
Furthermore, a mouse lymphoma study with barium metaborate did not
show any  mutagenicity. (MRIDS 42151401  and 42873201).

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  e.     Neurotoxicity

        In an acute neurotoxicity study, rats were administered a single
  dose of barium metaboiate via gavage at levels of 0, 25, 50, 100, and
  200 mg/kg.  The NOEL for acute neurotoxicity was 25 mg/kg and the
  LOEL was 50 mg/kg based on impairment of gait in males at this and
  the higher doses. Li females there was impairment of gait at the 200
  mg/kg on day 0.  There were no adverse effects on  survival, body
  weight/gain, brain weight or dimensions, and no clinical signs,
  locomotor activity changes, or neuropathological lesions were observed
  in either sex of rat that were treatment related. No signs of toxicity
  were apparent on days 7 and 14 in either sex. (MRID 42734701) (range
  finding reports MRIDS 42343601 and 42501201)  Furthermore,  the
  Agency required a 90-day mammal neurotoxicity study. In response
  the registrant combined the 90-day neurotoxicty study with the 90-day
  oral  toxicity study (see section m.B.l.b).

  f.     Reference Dose

       A Reference Dose has not been determined for barium
 metaborate since there are no registered food uses.
 Exposure Assessment

 a.     Dietary Exposure

       Barium metaborate has no food uses; therefore, no dietary
 exposure is expected to occur.

 b.     Occupational and Residential

       The barium metaborate products covered in this RED were
 registered prior to July 1,  1993. These products can be added into
 paints, paper/paper products, and coating material during  the
 manufacturing process. During the manufacturing process, barium
 metaborate is used as a preservative (e.g., as a starch slurry
 preservative) in paper coating formulations to protect paper products
 from microbiological degradation during storage. At higher
 concentrations it is used to impart mold resistance to coated paper and
paper board.  Use has been permitted for the manufacture of paper and
paperboard under  U.S. Food and Drug Administration Regulations 21
 CFR 176.180, "components of paper and paperboard in contact with
dry food."  It is also used in latex paints (in-can), oil/varnish (applied

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film), and coatings to impart resistance to mold.  From these uses, the
potential for mixer/loader/applicator exposure exists during the pouring
or pumping of barium metaborate into the product for preservation (i.e.
paint, etc.).  The Agency expects the "pour liquid" for the preservative
use to provide the highest potential for exposure to barium metaborate.
The exposure assessment for this use is found below (Section IH.B.2.b-
1).

b-1. Mixer/Loader/Applicator Exposure from Pour Liquid Use of
Barium Metaborate during Manufacturing

       Barium metaborate products can be formulated as soluble
concentrates and ready to use solutions (e.g., 90%, 52%, 50%) and
added into the paints, paper/paper products,  and coating material during
the manufacturing process.   The method of open pouring into a
metering pump is used as a general industrial practice and provides the
highest potential for mixer/loader/applicator  exposure to barium
metaborate.  While conducting open pouring operations of barium
metaborate the potential dermal exposure could be significant, however,
the potential inhalation exposure is considered minimal because of the
low vapor pressure of barium metaborate. After reviewing the entire
lexicological data base the Agency determined that barium metaborate
should be regulated on the basis of a Margin of Exposure (MOE)
instead of a RfD.   The lowest NOEL is 10 mg/kg/day based on
maternal toxicity in a developmental study.  This compound meets the
Agency's  toxicity and exposure criteria for requiring exposure
monitoring data. These data requirements for mixer/loader/applicator
are met by the Chemical Manufacturers Association (CMA) exposure
assessment database (MRID 41412201). The registrant is a participant
in the CMA exposure study. This database was used to estimate
mixer/loader/applicator combined inhalation and dermal exposure based
on the type of application, in this case, the pour liquid for the
preservative use (see table below). The estimated combined dermal and
inhalation daily exposure of barium metaborate to the handler is 52.6
ug/kg/day under the use scenario as preservative.
                       8

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            Daily Exposure to Barium Metaborate for Mixers/Ix>aders/Appiicatdr
                           * from use during manufacturing  -
  SCENARIO: Pour Liquid
  Setting
,  MCS*
(ug/lb ai)
Ib aimed
Body Weight
                                                                         Daily
                                                                        Exposure
                                                                      fug/kg/day)
  Assumption: Three hundred gallons of paint have been handled and treated with liquid
  concentrate barium metaborate (90% ai) by open pouring application method based on
  weight; therefore, a total of 24.3 Ib ai was added per day per worker, based on maximum
  use rates representing the worst case situation.
  * MCS = Maximum Credible Sum was derived from the CMA study.  It is a unit of
exposure that is the quantitative measurement of micrograms of active ingredient exposure
per pound of active ingredient handled by workers.

                   b-2. Post-Application Worker Exposure

                         Based on the uses in/on paper/paper board, latex paints,
                   oil/varnishes and coatings and given the low vapor pressure of barium
                   metaborate, the post-application exposure to workers is expected to be
                   minimal.

            3.     Risk Assessment

                   a.     Dietary

                         There are no registered food uses of barium metaborate;
                   therefore, no dietary risk exists.

                   b.     Occupational and Residential

                   b-1. Risk Assessment for Mixer/Loader/Applicators

                         The Margin of Exposure (MOE) for factory workers involved in
                   mixer/loader activities may be estimated by the following equation:

                               MOE =   NOEL
                                         Exposure (mg/kg/day)

                  For regulatory purposes the toxicological endpoint of concern is

                                        9

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             maternal toxicity observed in the developmental study on rabbits at
             20 mg/kg/day in the form of mortality, impaired mobility and
             hypoactivity. The NOEL for the study is 10 mg/kg/day.  The potential
             exposure based on the worst-case scenario is 0.0526 mg/kg/day.
             Therefore, the MOE for factory workers involved in
             mixer/loader/applicator activities is 190.  An MOE of 100 or greater is
             considered acceptable.  The risk to mixers/loaders/applicators is
             considered to be minimal.

             b-2.  Post-application -workers

                    The risk associated with post application exposure to workers is
             considered minimal since exposure is limited by the low vapor pressure
             of barium metaborate.
C.     Environmental Assessment

       1.     Environmental Fate
             a.     Environmental Chemistry, Fate and Transport

                    In nature, boron does not occur in its elemental (uncombined)
             form.  However, boron compounds are widely found in soil and water.
             Much of the naturally occurring boron is present in inorganic species
             where the boron is bound to oxygen.  These form a variety of "berate"
             compounds, which have similar properties, and include barium
             metaborate, BaBjOt.HaO, the subject of this document. These borate
             ions are combined with various metallic ions also occurring naturally,
             and dissociate into the respective borate and metallic ions when
             dissolved in water.  A common form of borate is the negatively
             charged ion BOs3" which occurs in association with positively charged
             metal ions such as sodium and barium.  An additional example is the
             compound known as borax, which has the formula Na2B4O7 and in the
             solid state is associated with ten molecules of water of crystallization.
             In these forms, boron serves as an essential micronutrient for
             microorganisms, thereby becoming bound to an organic component in
             plants or microorganisms.

                    In soil the concentration of boron (expressed as elemental boron)
             can range from 5-150 ppm.  A typical surface soil might contain 50
             ppm boron. Boron salts (combinations of borates with metal ions) also
             occur naturally in low concentrations in lakes, ponds, rivers, and
             oceans.  In some geographical areas such as the American Southwest,
             boron occurs in concentrations in surface waters that have been shown
                                    10

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       to be toxic to plants of commercial importance. Seawater boron
       concentrations average 4.5 mg/liter.  The average concentration for
       boron in surface waters has been reported to range from 0.001 mg/liter
       to 0.1 mg/liter.

       b.     Environmental Fate Assessment

              The Agency is not requiring any environmental fate data at this
       time. No studies have been  submitted regarding the environmental fate
       of boron salts, and none have been reviewed.  It is doubtful that the
       information which would be  developed by performing standard
       environmental fate studies would justify the effort.  Since soils are
       naturally rich in these boron  compounds, high background levels would
       make analyses unusually difficult.  Analytical procedures could not
       distinguish between native and added boron compounds without the use
       of isotopic labeling.  Moreover, the normal degradative processes
       would only produce compounds which are already present in the
       environment,  such as the metaborate salts with different hydration
       states.

2.     Ecological Effects

       a.     Ecological Effects Data

             The ecological effects  data base on barium metaborate is
       adequate; therefore, the Agency is not requiring any additional
       ecological effects data. The results of the ecological toxicity testing are
       summarized in this section.

             (1)     Terrestrial Data

                   In September 1991, the Agency received notification of
             potential adverse effects from preliminary results of the acute
             avian oral study being  conducted on the bobwhite quail (MRID
             42033601). The information was submitted because of possible
             neurotoxicity in quail treated with barium metaborate at doses
            ranging from 486 to 2250 mg/kg. This study was not designed
            to address the neurotoxic potential of barium metaborate.  The
            Agency has reviewed data from an acute neurotoxicity study in
            rats and combined rat subchronic oral toxicity and neurotoxicity
            study (see section m.B.l.e).

                   The terrestrial data indicate that barium metaborate is
            slightly toxic to bobwhite quail on an acute oral toxicity basis.

                            11

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A single dose oral toxicity study administered to bobwhite quail
resulted in an LD50 value of 1254 mg/kg [MRID 42339501 and
MRID 42546001 (final amended report)]. However, barium
metaborate is practically non-toxic to birds, both an upland
species (bobwhite quail) and a waterfowl species (mallard duck)
on a subacute dietary toxicity basis.  Avian subacute dietary
toxicity studies demonstrate IXys  > 5620 ppm for both
bobwhite quail [MRID 42338701 and MRID 42546701
(amended final report)] and mallard duck [MRID 42338702 and
MRID 42546702 (amended final report)].

(2)    Aquatic Data

      Three studies were conducted on the 90% material for
aquatic toxicity, two on fish and one on an aquatic invertebrate.
Data on end-use products are not required for the registered uses
of barium metaborate. The available acute toxicity data indicate
that barium metaborate is practically non-toxic to bluegill
sunfish with a LC5o=151 ppm (MRID 42338601) but slightly
toxic to rainbow trout with a LC50=62 ppm (MRID 42338602).
It is also slightly toxic to Daphnia magna with a EC50= 19 ppm
based on a 48 hour acute toxicity test (MRID 42338603).
                12

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            SUMMARY OF ECOLOGICAL EFFECTS TOXICITY TESTS
            	(TERRESTRIAL AND AQUATIC DATA)
 GUIDELINE
 #
 SPECIES
%
A.I.
                   (mg/kg)/
                   NOEL (mg/kg)
AUTHOR
                                                DATE
MRTO
 Avian Single-Dree Oral Toxicity Test
 71-la
 bobwhite
 quail
                            90%
       LDjo = 1254
       NOEL = 292
                                                   Campbell &
                                                   Lynn
 Avian Subacute Dietary Toxicity Tests
            1992
42546001
 71-2a
 bobwhite
 quail
                           90%
      LCjo > 5620
      NOEL = 1780
                                                   Campbell et
                                                   al.
            1992
42546701
71-2b
 mallard
 duck
                           90%
           > 5620
      NOEL = 5620
                                                   Campbell et
                                                   al.
            1992
42546702
Acute Freshwater Fish Toxicity Tests
72-la
bluegill
sunfish
                           90%
          = 151 ppm
      NOEL = 42.8
                                                  Linott
           1992
                                                                        42338601
72-lc
rainbow
trout
                           90%
      LCs, = 62 ppm
      NOEL = 14.9
                                                  Linott
           1992
                                                                       42338602
Non-target Aquatic Invertebrate Toxicity Test
72-2a
Daphnia
magna
                           90%
      19 ppm
                                                  Linott
           1992
                  b.    Ecological Effects Risk Assessment

                        Barium metaborate is registered as a microbiocide for indoor
                  non-food end-use. Because of the indoor, in-product nature of the use
                  of this chemical, it is not expected that barium metaborate will be
                  released to the environment in significant amounts through the effluent
                  from a manufacturing plant.  Furthermore, any minor amount  of the
                  chemical that would be released in this manner would be expected to
                  dissociate rapidly to its naturally occurring ionic components.  Little
                  direct exposure to fish, wildlife, and endangered species is expected
                  from the use of this chemical and any potential exposure would be
                  regulated under permit by the National Pollutant Discharge Systems;
                  therefore, risk to fish,  wildlife, and endangered species will be minimal
                  from the microbiocidal use of this chemical.
                                       13

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IV.    RISK MANAGEMENT AND REREGISTRATION DECISION

       A.    Determination of Eligibility

             Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after
       submission of relevant data concerning an active ingredient, whether products
       containing the active ingredients are eligible for reregistration.  The Agency has
       previously identified and required the submission of the generic (i.e. active ingredient
       specific) data required to support reregistration of products containing barium
       metaborate active ingredient.  The Agency has completed its review of these generic
       data, and has determined that  the data are sufficient to support reregistration of
       products containing barium metaborate registered prior to July 1, 1993. Appendix B
       identifies the generic data requirements that the Agency reviewed as part of its
       determination of reregistration eligibility of barium metaborate, and lists the submitted
       studies that the Agency found acceptable.

             The data identified  in Appendix B were sufficient to allow the Agency to
       assess the uses of barium metaborate registered prior to July 1, 1993 and to determine
       that these uses will not result in unreasonable adverse effects to humans and the
       environment. The Agency finds that all products registered prior to July 1, 1993
       which contain barium metaborate as the sole active ingredient are eligible for
       reregistration. The reregistration of particular products is addressed in Section  V of
       this document.  Those products that contain other active ingredients will be eligible
       for reregistration only when the other active ingredients are determined to be eligible
       for reregistration.

             The Agency made its reregistration eligibility determination based upon  the
       target data base required for reregistration, the current guidelines for conducting
       acceptable studies to generate such data, and the data identified in Appendix B.  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 barium metaborate, if new information comes to the Agency's attention or
       if the data requirements for registration (or the guidelines for generating such data)
       change.

             1.    Eligibility Decision

                    Based on the reviews of the generic data for the active ingredient
             barium metaborate, the Agency has sufficient information on the health  effects
             of barium metaborate products subject to this RED and on its potential for
             causing adverse effects in fish and wildlife'and the environment.  Therefore,
             the Agency concludes  that products containing barium metaborate registered
             prior to July 1, 1993 are eligible for reregistration.  Those products that
             contain other active ingredients will be eligible for reregistration only when the
                                           14

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       other active ingredients are determined to be eligible for reregistration.

       2.    Eligible and Ineligible Uses

             The Agency has determined that all uses of barium inelaborate products
       registered prior to July 1, 1993 are eligible for reregistration.

B.     Regulatory Position

       The Agency has determined that the uses of barium metaborate registered prior
to July 1, 1993 will not cause unreasonable risk to humans or the environment and
are eligible for reregistration. The following is a summary of the regulatory positions
and rationales for barium metaborate.  Where labeling revisions are imposed, specific
language is set forth in Section V of this document.
       1.
Tolerance Reassessment
             There are no registered food or feed uses for barium metaborate;
      therefore, no tolerances or exemptions from the requirement of a tolerance are
      established for this chemical.

      2.     Restricted Use Classification

             Barium metaborate does not meet the criteria for a Restricted Use
      Pesticide.

      3.     Labeling Rationale

             a.     Since the mixers/loaders/applicators exposure for barium
      metaborate by using open pouring methods could be significant the Agency is
      now requiring PPE (Personal Protective Equipment) (i.e. long-sleeved shirt,
      long pants, socks, shoes, chemical-resistant gloves) for
      mixers/loaders/applicators of end-use products.

            b.     Although the Agency does not expect effluent from the
      microbiocidal use of these products to contain  more than minimal amounts of
      barium metaborate, the Agency requires an environmental hazard statement on
      end-use products registered for industrial preservative uses. The
      environmental hazard statement currently on product labels must  be revised
      according to PR Notice 93-10, issued July 29,  1993. The specific language is
      set forth in section V.
                                  15

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                    c.     Due to the indoor and in-product nature of its use, minimal
             direct exposure to endangered species is expected from the use of this
             chemical; therefore, the effect on endangered species from the reregistered
             uses of this chemical is considered minimal. Accordingly, the Agency is not
             requiring any endangered species labeling at this time.

                    At the present time, EPA is working with the U.S. Fish and Wildlife
             Service and other federal and state agencies to develop a program to avoid
             jeopardizing the continued existence of listed species by the use of pesticides.
             When the Endangered Species Protection Program is implemented and
             subsequent guidance is given, endangered species labeling amendments may be
             required on affected end-use products. Labeling statements for end-use
             products will likely refer users to county specific bulletins specifying detailed
             limitations on use to protect endangered species.

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 Agency is  not requiring additional data to support the reregistration
             of the active ingredient barium metaborate.

             2.     Labeling Requirements for Manufacturing-Use Products

                    There are no registered technical or manufacturing-use products for
             barium metaborate. In the future, if any are registered, they will be required
             to meet the requirements of 40 CFR  156.10, this RED, and other current
             policies.

      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
             F, the Product Specific Data Call-In  Notice.

                    Registrants  must review previous data submissions to ensure that  they
                                          16

-------
 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 for the Requirement Status and
 Registrants Response Form provided for each product.

2.     Labeling Requirements for End-Use Products

       The labels and labeling of all products must comply with EPA's current
regulations and requirements as specified in 40 CFR §156.10.

       a.     Personal Protective Equipment

             Since the mixer/loader/applicator exposure for barium
       metaborate by using open pouring methods  could be significant, the
       Agency is now requiring the following  PPE (Personal Protective
       Equipment) for mixers/loaders/applicators of end-use products:

             • long-sleeved shirt and long pants;
             • socks and shoes;  and
             • chemical-resistant gloves.

      b.     Environmental Hazard Statement

             The following revised effluent discharge labeling statement must
      appear on all manufacturing and end-use products subject to this RED:

      "Do not discharge effluent containing this product into lakes, streams,
      ponds, estuaries, oceans or other waters unless in accordance with the'
      requirements of a National Pollutant Discharge Elimination System
      (NPDES) permit and the permitting authority has been notified in
      writing prior to discharge. Do not discharge effluent containing this
      product to sewer systems without previously notifying the local  sewage
      treatment plant authority. For guidance contact your State Water Board
      or Regional Office of the EPA."

            All affected products distributed or sold by registrants and
      distributors (supplemental registrants) must bear the above labeling by
      October 1, 1995.  All products distributed or sold by persons other than
      registrants or supplemental registrants after October 1, 1997 must bear
      the correct labeling.  Refer to PR Notice 93-10 or 40 CFR 152.46(a)(l)
      for additional information.
                           17

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C.     Existing Stocks

       Registrants may generally distribute and sell products bearing old
labels/labeling for 26 months from the date of the issuance of a 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 a 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 barium
metaborate 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.
                                   18

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             APPENDIX A




USE PATTERNS SUBJECT TO REREGISTRATTON
                 19

-------
20

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             APPENDIX B

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for the Registration of Barium Metaborate
                 23

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28

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               APPENDIX C

             BIBLIOGRAPHY

Citations considered to be Part of the Data Base
Supporting Reregistration of Barium Metaborate
                  29

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30

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

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

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

 FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
 consists of a citation containing standard elements followed, in  the case of material
 submitted to the Agency, 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.
b.
Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the
Agency has shown a identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the
first submitter as the author.

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

                            31

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       as (19??), the Agency was unable to determine or estimate the date of the
       document.
c.     Title.  In some cases, it has been necessary for the Agency's bibliographers to
       create or enhance a document title. Any such editorial insertions are contained
       between square brackets.

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


       (2)
       (3)


       (4)
Submission Date.  The date of the earliest known submission appears
immediately following the word "received".

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.

Submitter.  The third element is the submitter. When authorship is de-
faulted to the submitter, this element is omitted.

Volume Identification  (Accession  Numbers').  The final element in the
trailing parentheses identifies the Agency 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.
                                    32

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 00137047
 00137048
 00139192
 00139216
 40898401
42033601
42132601
42151401
42173701
42207501
 Buckman Laboratories, Inc. (1983) CChemistry: Barium Metaborate
 Monohydrate & Others | . (Compilation; unpublished study received Dec 27
 1983 under 1448-17; CDL:252065-A)

 Coate, W.; Zoetis, T.; Hardy, R. (1983) Acute Inhalation Toxicity Study in
 Rats-Busan 11-Ml-Project No. 197-178.  Final rept. (Unpublished study
 received Dec 27, 1983 under 1448-17; prepared by Hazleton Laboratories
 America, Inc.,  submitted by Buckman Laboratories, Inc., Memphis TN'
 CDL:252065-B)

 Raltech Scientific Services, Inc. (1979) Busan 11-M1, Lot No. 47601, Nov.
 17, 1978: CAcute Oral LD50/Prim Skin Irritation on Rats & Rabbits  I : Lab
 No. 709240.

 Boynton, B.; Angevine, D. (1979) Acute Dermal Toxicity-Male and Female
 Rabbits: CBusan 11-M1 | : RT No. 709240.  (Prepared by Raltech Scientific
 Services, Inc.).

 Kreuzmann, J. (1988) Delayed Contact Hypersensitivity Study in Guinea Pigs:
 Busan 11 Ml: Study No. 88-3288-21.  Unpublished  study prepared by Hill
 Top Biolabs, Inc. 28 p.

 Campbell, S.; Lynn, S. (1991) Busan 11-M1: An Acute Oral Toxicity Study
 with the Northern Bobwhite: Lab Project Number: 210/117.  Unpublished
 study prepared by Wildlife International Ltd.  21 p.

 San, R.; Olson, S. (1991) SalmoneUa/Mammalian-Microsome Plate
 Incorporation Mutagenicity Assay (Ames  Test) with a Confirmatory Assay:
 Busan  11-M1: Lab Project Number: TA081.501014.  Unpublished study
 prepared by Microbiological Associates, Inc.  52 p.

 Bigger, C.; Clarke, J.  (1991) L5178Y TKCplus  | /-Mouse Lymphoma
 Mutagenesis Assay with a Confirmatory Assay CBusan 11-M1: Final Report | :
 Lab Project Number: TA081.701020.  Unpublished study pre pared by
 Microbiological Assoc., Inc. 35 p.

 Siemann, L. (1992) Product Chemistry for Busan 11-M1: Lab Project
 Number: 9929-F.  Unpublished study prepared by Midwest Research Institute
42 p.

Putman, D.; Young, R. (1992) Micronucleus Cytogenetic Assay in Mice: Lab
Project Number: TA081.122.  Unpublished study prepared by Microbiological
Associates, Inc.  28 p.
                                        33

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42310501    Lamb, I. (1992) 28-Day Dietary Range-finding Study of Busan 11-M1 in Rats:
            Lab Project Number: WIL-94043.  Unpublished study prepared by WIL
            Research Labs.  Inc.  6 p.

42314301    Drake, K. (1992) Developmental Toxicity Study of Busan 11-M1 in Rabbits:
            Lab Project Number: WIL/94042.  Unpublished study prepared by Buckman
            Laboratories International, Inc.  31 p.

42338601    Lintott, D. (1992) Busan 11-M1: Acute Toxicity to Bluegill, Lepomis
            macrochirus, under Static Test Conditions: Lab Project Number: J9107001C.
            Unpublished study prepared by Toxikon Environmental Sciences. 47 p.

42338602    Lintott, D. (1992) Busan 11-M1: Acute Toxicity to Rainbow Trout,
            Oncorhynchus mykiss, under Static Test Conditions: Lab Project Number:
            J9107001D. Unpublished study prepared by Toxikon Environmental Sciences.
            47 p.

42338603    Lintott, D. (1992) Busan 11-M1: Acute Toxicity to the Water Flea, Daphnia
            magna, under Static Test Conditions: Lab Project Number: J9107001B.  .
            Unpublished study prepared by Toxikon Environmental Sciences. 46 p.

42338701    Cambell, S.; Grimes, J.; Lynn, S. (1992) Busan 11-M1: A Dietary LC50
            Study with the Northern Bobwhite: Lab Project Number: 210-115.
            Unpublished study prepared by Wildlife International Ltd.  18 p.

42338702    Campbell,  S.; Grimes, J.; Lynn, S. (1992) Busan  11-M1: A Dietary LC50
            Study with the Mallard: Lab Project Number: 210-116.  Unpublished study
            prepared by Wildlife International Ltd. 18 p.

42339501    Campbell,  S.; Lynn, S. (1992) Busan 11-M1: An Acute Oral Toxicity Study
            with the Northern Bobwhite: Lab Project Number: 210-117. Unpublished
            study prepared by Wildlife Intl., Ltd. 23 p.

42343601    Lamb, I. (1991) A Range-Finding Acute Study of Busan 11-M1 in Rats:
            Audited Draft: Lab Project Number: WIL-94045.  Unpublished study prepared
            by WIL Research Labs., Inc.  194 p.

42501201    Lamb, I. (1992) A Range-finding Acute Study of Busan 11-M1  in Rats: Final
            Report: Lab Project Number: WIL-94045.  Unpublished study prepared by
            WBL Research Labs, Inc. 192 p.

42546001     Campbell, S.; Lynn, S. (1992) Busan 11-M1: An  Acute Oral Toxicity  Study
             with the Northern Bobwhite: Amended Final Report: Lab Project Number:
             210-117.  Unpublished study prepared by Wildlife International Ltd. 35 p.
                                        34

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 42546701
 42546702
 42663401
 42720501
 42720502
42724201
42734701
42747801
42873201
 Campbell, S.; Grimes, J.; Lynn, S. (1992) Busan 11-M1: A Dietary LC50
 Study with the Northern Bobwhite: Amended Final Report: Lab Project
 Number: 210-115.  Unpublished study prepared by Wilflife International Ltd
 33 p.

 Campbell, S.; Grimes, J.; Lynn, S. (1992) Busan 11-M1: A Dietary LC50
 Study with the Mallard: Amended Final Report: Lab Project Number:
 210-116. Unpublished study prepared by Wilflife International Ltd. 33 p.

 Drake, K. (1993) Letter Sent to Office of Pesticide Programs dated Feb.  10,
 1993: Interim data from a 90 day dietary subchronic/neurotoxicity study:
 barium metaborate. Prepared by Buckman Labs., International, Inc. 50 p.

 Lamb, I. (1993) A Range-Finding Developmental Toxicity Study of BUSAN
 11-M1 in Rabbits: Final Report: Lab Project Number: WIL-94041.
 Unpublished study prepared by WIL Research Laboratories, Inc.  276 p.

 Lamb, I. (1993) A Developmental Toxicity Study of BUSAN 11-M1 in
 Rabbits: Final Report: Lab Project Number: WIL-94042. Unpublished study
 prepared by WIL Research Laboratories, Inc. 334 p.

 Lamb, I.  (1993)  A 28-day Dietary Range-finding Study of Busan 11-M1 in
 Rats: Final Report: Lab Project Number:  WIL-94043. Unpublished study
 prepared by WIL Research Labs, Inc. 381 p.

 Lamb, I. (1993)  An Acute Neurotoxicity Study of Busan 11-M1 in Rats: Final
 Report: Lab Project Number: WIL-94038. Unpublished study prepared by
 WIL Research Laboratories, Inc.  1096 p.

 Lamb, I. (1993)  A Combined Oral Subchronic (13 Week) Toxicity and
 Neurotoxicity Study of Busan 11-M1 in Rats: Final Report: Lab Project
 Number: WIL-94044.  Unpublished study prepared by WIL Research
 Laboratories, Inc. 1253 p.

 Martin, T.; Drake, K. (1993) Supplemental Data to Mouse Lymphoma Assay
 with Busan 11-M1 (MRTO No. 42151401) Analysis of Dosing Solutions.
 Unpublished study prepared by Buckman Laboratories International, Inc.  22
P-
                                        35

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36

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         APPENDIX D




LIST OF AVAILABLE DOCUMENTS
            37

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                                   APPENDIX D


      The following is a list of available documents related to barium metaborate. Its
purpose is to provide a path to more detailed information if it is requried.  These
accompanying documents are part of the Administrative Record for Barium Metaborate and
are included in the Agency's Office of Pesticide Programs Public Docket.

             1. Health and Environmental Science Chapters

             2. Detailed Label Usage Information System (LUIS) Reports

             3. Barium Metaborate Fact Sheet (included in this RED)

             4. PR Notice 91-2 pertains to the Label Ingredient Statement

      Federal publications on barium metaborate are available and may be purchased from
the National Technical Information Service (NTES), 5285 Port Royal Road, Springfield, VA
22161.

             1. Guidance for the Reregistration of Pesticide Products Containing Barium
             Metaborate as the Active Ingredient: NTIS # PB84-168376
                                         38

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                  APPENDIX E



     Instructions for Responding to the RED and




Instructions for the Confidential Statement of Formula
                      39

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

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

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

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

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

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

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

       d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient  as the nominal
                                         40

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 concentration.  You have two options for submitting a CSF:  (1) accept the standard
 certified limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by
 the analysis of five batches. If you choose the second option, you must submit or cite the
 data for the five batches along with a certification statement as described in 40 CFR
 §158.175(e).  A copy of the CSF is enclosed; follow the instructions on its back.

       e- Certification With Respect to Citation of Data  Complete and sign this form
 (EPA form 8570-29) for each product.  Cite-all is not a valid option for reregistration.

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

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

 By U.S. Mail;

       Document Processing Desk (RED-SRRD-PRB-XXXX)*
       (XXXX — the case code for the RED)
       Office of Pesticide Programs (H7504C)
       EPA, 401 M St.  S.W.
       Washington, D.C. 20460-0001

 By  express:

    Document Processing Desk (RED-SRRD-PRB-XXXX)*
       Office of Pesticide Programs (H7504C)
       Room 266A, Crystal Mall 2
       1921 Jefferson Davis Hwy.
       Arlington, VA 22202

6. EPA'S REVIEWS-EPA will screen all  submissions for completeness; those which are
not  complete will be returned with a request for corrections.  EPA will 'try to respond to data
waiver  and time extension requests within 60 days.  EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has  been issued.
                                       41

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     INSTRUCTIONS FOR THE CONFIDENTIAL STATEMENT OF FORMULA

       Two copies of the Confidential Statement of Formula (CSF) (EPA Form 8570-4) are
required to be signed and completed for each basic and each alternate formulation.  When
new CSFs are submitted and approved, all previously submitted CSFs become obsolete for
that specific formulation.

       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. 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 lower certified limits in pure active forms must not fall below the efficacious
       level per P.R. Notice 91-2.
                                         42

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n.  The upper and lower certified limits for all 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.
                                  43

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      APPENDIX F
Product Specific Data Call-In
            45

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                   UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                  WASHINGTON, D.C. 20460


                                 DATA CALL-IN NOTTPF.
  CERTIFIED MATT.
         OFFICE OF
   PREVENTION, PESTICIDES AND
      TOXIC SUBSTANCES
 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 Sh«* to
 submit  certain product specific data as  noted  herein to the U.S. Environmental Protection
 Agency (EPA, the Agency).  These data are necessary to maintain the continued registration of
 your product(s) containing this active ingredient. Within 90 days after you receive this Notice
 you must respond as set forth in Section HI below.  Your response must state:

        1.     How you will comply with the  requirements set forth in this Notice  and its
               Attachments A through G; or

       2.     Why you believe you are exempt  from the requirements listed in this Notice and
               in Attachment 3,   Requirements  Status and Registrant's Response  Form  (see
               section HI-B); or                                          	' V

       3.     Why you believe EPA should not require your submission of product specific
               data in the manner specified by this Notice (see section UI-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 produces) subject to this Notice will be subject to suspension. We have provided a list of
 all of your products subject to this Notice in Attachment 2, Data Call-in Response Form as well
 as a list  of all registrants who were sent this Notice (Attachment 6).

       The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
 and  Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection  of this
 information is authorized under the Paperwork Reduction Act by OMB Approval No  2070-0107
.(expiration date 3-31-96).
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Recycled/Recyclablo
Printed with Soy/Canola Ink on paper thai
contains at least 50% recycled fiber

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    This Notice is divided into six sections and seven Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices.  The Attachments contain
specific chemical information and instructions.  The six sections of the Notice are:

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

   The Attachments to this Notice are:

      1  -   Data Call-In Chemical Status Sheet
      2  -   Product-Specific Data Call-In Response Form
      3  -   Requirements Status and Registrant's Response Form
      4  -   EPA Grouping  of End-Use  Products for  Meeting  Acute  Toxicology  Data
             Requirements for Reregistration
      5  -   EPA Acceptance Criteria
      6 -   List of Registrants Receiving This Notice
      7 -   Cost Share and Data Compensation Forms, and Product Specific Data Report
             Form


SECTION I.  WHY YOU ARE RECEIVING THIS NOTICE

      The Agency has reviewed existing data for this active ingredient and reevaluated the data
needed to support continued registration of the  subject active ingredient.   The Agency has
concluded that the only  additional data necessary are product specific data.  No  additional
generic data requirements are being imposed. You have been sent this Notice because you have
produces) containing the subject active ingredient.

SECTION H.  DATA  REQUIRED BY THIS NOTICE

H-A.  DATA REQUIRED

      The product specific data required  by  this  Notice are specified in Attachment 3,
Requirements Status and Registrant's Response Form.  Depending  on the  results of the studies
required in this Notice, additional testing may be required.

H-B.  SCHEDULE FOR SUBMISSION OF DATA
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     You are required to submit the data or otherwise satisfy the data requirements specified in
  Attachment 3,  Requirements Status and Registrant's Response. Porm   within the time frames
  provided.
 II-C. TESTING PROTOCOL

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

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

 ,™^ J*°tOC°1S aPProved by the Organization for Economic Cooperation and Development
 (OECD) are also acceptable if the OECD-recommended test standards conform to those specified
 in the  Pesticide Data  Requirements regulation (40 CFR §  158.70).  When using the OECD
 protocols, they should be modified as appropriate so that the data generated by the study will satisfy
 the requirements of 40 CFR § 158.  Normally, the Agency will not extend deadlines for complying
 with data requirements  when the studies were not conducted in  accordance with acceptable
 standards.  The OECD protocols are available from OECD, 1750 Pennsylvania Avenue N W
 Washington, D.C. 20006.                                                            '  ''

       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)].
n"D-  REGISTRANTS RECEIVING PREVIOUS SECTION
     ISSUED BY THE AGENCY                 "
                                                                  NOTICES
      Unless otherwise noted herein, this Data Call-in does not in anv wav supersede or change the.
requirements of any previous Data Call-In(s), or any other agreements entered into with the Agency
pertaining to such prior Notice.  Registrants must comply with  the requirements of all Notices to
avoid issuance of a Notice of Intent to Suspend their affected products.

SECTION III.  COMPLIANCE WITH REQUIREMENTS OF  THIS NOTICE

III-A.  SCHEDULE FOR RESPONDING TO THE AGENCY

       The appropriate responses initially required by this Notice for product specific data must
be submitted to the Agency within 90 days after your receipt of this Notice.  Failure to adequately
respond to this Notice within 90  days of your receipt will be a basis for issuing a Notice of Intent
to Suspend (NOIS) affecting your products. This and other bases for issuance of NOIS due to
failure to comply with this Notice are presented in Section IV-A and IV-B.
                                          49

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III-B.  OPTIONS FOR RESPONDING TO THE AGENCY

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

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

       There are two forms that accompany this Notice of which, depending upon your response,
one or both must be used in your response  to  the Agency.   These forms are the Data-Call-in
Response 'Form, and the Requirements Status and Registrant's Response Form. Attachment 2 and
Attachment 3. The Data Call-In Response Form must be submitted as part of every response to this
Notice. In addition, one copy of the Requirements Status and Registrant's Response Form must
be submitted for each product listed on  the Data Call-in Response Form unless the  voluntary
cancellation option is selected or unless the product is identical to another (refer to the instructions
for completing the Data Call-in Response Form in Attachment 2).  Please note that the company's
authorized representative is required to sign the first page of the Data Call-In Response  Form and
Requirements Status and Registrant's Response Form (if this form is required) and initial any
subsequent pages. The forms contain separate detailed instructions on the response options. Do not
alter the printed material.  If you have questions or need assistance in preparing your response, call
or write the contact person(s) identified in Attachment 1.

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

       If you chose to voluntarily cancel your product, further sale and distribution of your product
after the effective date of cancellation must be in accordance with  the Existing Stocks  provisions
of this Notice which are contained in Section IV-C.
       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 HI-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.
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and
        3: Request for Product Specific Data Waive.™   Waivers for product specific data are
                SS^"D Ff ** £otice Td •* covered by option 7 « «* £2££^L£
               s B expense Form. If you choose one of these options, you mustTubmit both forms
             **      info™ation/data pertaining to  the option chosen  to address  the Tfc
            •
       SATISFYING THE DATA REOUIRRMRNTS OF THTS NOTTCR
                                                      that you agree to satisfy the product
                                                                                 the
        If you acknowledge on the Date Call-Tn

  2x ontionf T p6mentS (i'e' T **"
  for Sh LT   R^mremen* S^" and Registrant's Response Form related to data production
  for each data requirement.   Your option selection  should be  entered  under  item number 9

  uSK r T"- ", ^ S" ,°Pti0nS rdated t0 ^ Pr°duction ^ the fot ^ op"ns d"cu LS
  under item 9 in the instructions for completing the Requirement. Status and tt«y«L.t'« p~ ^
  SS» T f 6 ?H\°Pti?nS ^ KSted immediately below with information  in parentheses to guide
  registrants to additional instructions provided in this Section. The options are:
      (1)
      (2)

      (3)
      (4)

      (5).

      (6)
              I will generate and submit data within the specified time frame (Developing Data)
                            10 ^ agreement With °ne or more ^strants to develop data jointly
              I have made offers to cost-share (Offers to Cost Share)
              I am submitting an existing study that has not been submitted previously to the
              Agency by anyone (Submitting an Existing Study)
              I am submitting or citing data to upgrade a study classified by EPA as partially
              acceptable and upgradeable (Upgrading a Study)

              V? l^u^ 6XiSting StUdy ** EPA has classified as acceptable or an existing
              study fliat has been submitted but not reviewed by the Agency  (Citing an Existing
       Option 1  Devrinpinp Daft. - If you choose to develop the required data it must be in

        ^^5t^fdlln&S "5 ^ Other AgenCy ^—Sas referencedTerl and
 in the attechments.  AU data generated and submitted must comply with the Good

 SLs ^Gf anfb CFR Pf 160>' ^ C°ndUCted aCC°rding *> *e F^
 Ouidelmes (PAG), and be in conformance with the requirements of PR Notice 86-5.

       The time frames in the Requirements Status and Intrant's Respond. Pnr^ ^e the time
 frames that the Agency is allowing for the  submission of completed study report  The
 deadlines run from the date of the receipt of this Notice by the registrant  ?f the

                      ' "* regiStrant 1S ^ t0 -eiplof a NLe of Intent
intend to S °!2? ^ ^ data/repOrts to ** A§ency » *e time required by this Notice and
mtend 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)
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including alternative dates for meeting such requirements on a step-by-step basis. You must explain
any technical or laboratory difficulties and provide documentation from the laboratory performing
the testing.  While EPA is considering your request, the original deadline remains. The Agency
will respond to your request in writing.  If EPA does not grant your request, the original deadline
remains. Normally,  extensions can be requested only in cases of extraordinary testing problems
beyond the expectation or control of the registrant. Extensions will not be given in submitting the
90-day responses.  Extensions will not be considered if the request for extension is not made in a
timely fashion; in no event shall an extension request be considered if it is submitted at or after the
lapse of the subject deadline.

       Option 2. Agreement to Share in Cost to Develop Data  - Registrants may only choose this
option for acute toxicity data and certain efficacy data and only if EPA has indicated in  the attached
data tables  that your  product and at least one other product are similar for purposes of depending
on the same data. If this is the case, data may be generated  for just one of the products in the
group.  The registration number of the product for which data will be submitted must be noted in
the agreement to cost share by the registrant selecting this option.  If you choose to enter into an
agreement  to share in the cost of producing the required data but will not be submitting the data
yourself, you must provide the name of the registrant who will be submitting the data.  You must
also  provide EPA with documentary evidence that an agreement has been formed.  Such evidence
may be your letter offering to join in an agreement and the other registrant's acceptance of your
offer, or a written statement by the parties that an agreement exists. The agreement to produce the
data need not specify all of the terms of the final arrangement between the parties or the mechanism
to resolve the terms.  Section 3(c)(2)(B) provides  that if the parties cannot resolve the  terms of the
agreement  they may  resolve their  differences through binding arbitration.

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

                                            52

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 develop and submit the data required by this Notice by submitting a Data Call-Tn

                    Not!"' *£"S *eSP°nSP F0rm committing to develop andubmit the
 tn  H                  * ™oid suspension under Ms option, you may not withdraw your offer
 to share in the burdens of developing the data. In addition, the other registrant must fulfill its
 commitment to develop and submit the data as required by this Notice.  If the other registrant fails
 Lt oVf1hP ^H      °rl°r T Other reaS°n iS  SUbjeCt to susPension, your registration as well as
 that of the other registrant will normally be subject to initiation of suspension proceedings unless
 you commit to submit, and do submit the required data in the specified time fnrnie. In such ™ses
 the Agency generally will not grant a time extension for submitting the data.

       Option 4  Submitting an Fxistinp Study -  If you choose  to submit an existing study in
 response to this Notice, you must determine that the study satisfies the requirements imposed by
 this Notice  You may only submit a study that has not been previously submitted to the Agency
 or previously cited by anyone.  Existing studies  are studies which predate issuance of this Notice
 Do not use this option if you are submitting data to upgrade a study. (See Option 5).

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

       To meet the requirements of the DCI Notice for submitting an existing study  all of the
following three criteria must be clearly mt*-                                      y'

       a.     You must certify at the time that the existing study is submitted that the raw data and
             specimens from the study are available for audit and review and you must identify
             where they are available.  This must  be done in accordance with  the requirements
             of the Good  Laboratory Practice (GLP) regulation, 40 CFR Part 160. As stated in
             40  CFR 160.30  "  '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
                                         53

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            requirements of 40 CFR Part 160.  Registrants must also certify at the time of
            submitting the existing study that such GLP information is available for post-May
            1984 studies by including an appropriate statement on or attached to the study signed
            by an authorized official or representative of the registrant.

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

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

      Option 5. Upgrading a Study - If a study has been classified as partially acceptable and
upgradeable,  you  may submit data to upgrade that study.   The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the requirement is
not satisfied,  you may still be required to submit new data normally without any time extension.
Deficient, but upgradeable  studies  will normally be classified as supplemental.  However, it is
important to  note that not all studies classified as  supplemental are upgradeable.  If you have
questions regarding the classification of a study or whether a study may be upgraded, call or write
the contact person listed in Attachment 1.  If you submit data to upgrade an existing study you must
satisfy or supply information to correct all deficiencies in the study identified by EPA. You must
provide a clearly articulated rationale of how the deficiencies have been remedied or corrected and
why the study should be rated as acceptable to EPA.  Your submission must also specify the MRID
numbers) of the study which you are attempting to upgrade and must be in conformance with PR
Notice 86-5.
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    A A ,D° ^°tfvbmiu adAditional data for the purpose of upgrading a study classified as unacceptable
  and determined by the Agency as not capable of being upgraded.
             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.
   .   .         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
 LI f y •« f hSK ^ Tet %" ieViewed by ** Agency-   A^ptable toxicology studies
 generally will have  been classified  as  "core-guideline"  or  "core minimum."   For all other
 disciplines the classification would be "acceptable. "  With respect to any studies for which you wish
 to select this option you must provide the MRID number of the study you are  citing and  if the
 study has been reviewed by the Agency, you must provide the Agency's classification of the study.

       If you are citing a study of which you are not the original data submitter, you must submit
 a completed copy of EPA Form 8570-31,  Certification  with Pesnect to ^l c^*™
 xequirements.                                                                   - —

       Registrants who select one of the above 6 options must meet all  of  the requirements
 derated 1 in the instructions for completing the Data Call-in T^pon^ Form and the Requirement.
 Status and Registrant's Response Form, as appropriate.                             -

 in-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
 It ™? JehereT £ f6™,! E?A r£Sulations' *uidelines or policies.  (Notel any supplemental
 data must be  submitted in the format required by PR Notice 86-5).  This will be the onlv
 opportunity to state the reasons or provide information in support of your request  If the Age^v"

 ma^o^T %£*l ^ f ^ ^ ^^ t0 SUPply '** data Pursuant to s^
 J(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 Requirement. Status and  Repi^nt^
S-Sp°nse. *?or™-  ^oduct specific data requirements for product chemistry, acute toxicity and
efficacy (where appropriate) are required for all products and the Agency would grant a waive? only
under extraordinary circumstances. You should also be aware that submitting a waiver request wiU
noj automatically extend the due date for the study in question.  Waiver requests submitted
without adequate supporting rationale will be denied and the original due date will  remain in force.
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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).

       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 Call-In Response Form and a Requirements Status and Registrant's
                    Response Form:

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

              c.     otherwise take appropriate steps to  meet the requirements  stated in this
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        9.
       Notice, unless you commit to submit and do submit the required data in the
       specified time frame.

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 SUB1V
 UNACCEPTABLE
                                          ED STUDY TS
        The Agency may determine that a study (even if submitted within the required time) is
 unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend  The grounds for
 suspension include, but are not limited to, failure to meet any of the following:

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

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

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

IV-C EXISTING STOCKS OF SUSPENDED OR CANCHT.TED PRODUCTS

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

       The Agency has determined  that such disposition  by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not be
consistent with the  Act's  purposes.   Accordingly, the Agency  anticipates  granting registrants
permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing'stocks of your 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

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quantity of existing stocks and your estimate of the time required for their sale, distribution, and
use.  Unless you  meet this burden the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.

      If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will have, under  most
circumstances, one year from the date your 90 day response to this Notice is due, to sell, distribute,
or use existing stocks. Normally, the Agency will allow persons other than the registrant such as
independent distributors, retailers and end users to sell, distribute or use such existing stocks until
the stocks are exhausted. Any sale, distribution or use of stocks of voluntarily cancelled products
containing an active ingredient for which the Agency has particular risk concerns will  be
determined on case-by-case basis.

      Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result  in the Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due unless you demonstrate
to the Agency that you are in full compliance with all Agency requirements,  including the
requirements of this Notice. For example, if you decide to voluntarily cancel your registration  six
months  before a  3 year study is  scheduled  to be submitted, all progress  reports and  other
information necessary to establish that you have been conducting the study in an acceptable and
good faith manner must have been submitted to the Agency, before EPA will consider granting an
existing stocks provision.

SECTION V.  REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS

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

SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE

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

      All responses  to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-In Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment 2 and Attachment 3 for product
specific data) and any other documents required by  this Notice, and should  be submitted to  the
contact  person(s)  identified in Attachment 1.  If  the  voluntary cancellation or generic data
exemption option  is chosen, only the Data Call-In Response Form need be submitted.
                                           58

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

                                       Sincerely yours,
                                       Daniel M. Barolo, Director
                                       Special Review and
                                        Reregistration Division
Attachments

       1  -
      2  -
      3  -
      4  -

      5  -
      6  -
      7  -
Data Call-In Chemical Status Sheet
Product-Specific Data Call-in Response Form
Requirements Status and Registrant's Response Form
EPA  Batching of  End-Use  Products  for  Meeting
Acute  Toxicology  Pat;
Requirements for Reregistration
EPA Acceptance Criteria
List of Registrants Receiving This Notice
Cost Share and Data Compensation Forms, and Product Specific Data Report Fr
                                         59

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60

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Attachment 1. Chemical Status Sheet
               61

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BARIUM METABORATE:  DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

      You have been sent this Product Specific Data Call-In Notice because you have
produces) containing barium metaborate.

      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
barium metaborate.  This attachment is to be used in conjunction with (1) the Product Specific
Data Call-in Notice, (2) the Product Specific Data Call-In Response Form (Attachment 2), (3)
the Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA
Acceptance Criteria (Attachment 5), (6) a list of registrants receiving this DCI (Attachment 6)
and (7) the Cost Share and Data Compensation Forms in replying to this  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 barium metaborate
are contained in the Requirements Status and Registrant's Response. Attachment 3. The
Agency has concluded that additional data on barium metaborate 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 barium metaborate
products.

INQUIRIES AND RESPONSES TO THIS NOTICE

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

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

             Mr.  C. P. Moran
             Special Review and Reregistration Division (7508W)
             Office of Pesticide Programs
             U.S. Environmental Protection Agency
             Washington, D.C. 20460

             RE:  Barium Metaborate
                                           62

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Attachment 2. Product Specific Data Call-In Response
      Forms (Form A inserts)  Plus Instructions
                        63

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64

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 INSTRUCTIONS  FOR COMPLETING  THE  "DATA CALL-IN RESPONSE" FORM  FOR
 PRODUCT SPECIFIC DATA
 Item 1-4.

 Item 5.
Item 6.
              Already completed by EPA.

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

              Not applicable since this form calls in product specific  data only. However, if your
              product is identical to another product and you qualify for a data exemption you
              must respond with "yes" to Item 7a (MUP) or 7B (EUP) on this form, provide the
              EPA  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.

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

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

Items 8-11.   Self-explanatory.

      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.
Item 7a.


Item 7b.
                                         65

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Attachment 3. Product Specific Requirement Status and
  Registrant's Response Forms (Form B inserts) and
                    Instructions
                        69

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-------
 INSTRUCTIONS  FOR  COMPLETING  THE  "REQUIREMENTS  STATUS  AND
 REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA
 Item 1-3.
 Item 4.
 Item 5.

 Item 6.
Item 7.
Item 8.
Item 9.
  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.

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

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

 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.

 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.                                                             v

 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.

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

 1.    I will generate  and submit data by the specified due date  (Developing Data)
By indicating that I have chosen this option, I certify that I will comply with all the
requirements pertaining  to the conditions for submittal of this study as outlined in
the Data Call-In Notice.
              -  i       0
            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 onlv if EPA
            indicates in an attachment to this notice  that my product is similar.  Enough to
            another product to qualify for this option.   I certify  that another party in the
            agreement is committing to submit or provide the required data; if the required study
            is not submitted on time, my product my be subject to suspension.

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

                                          71

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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  in the Development Data" form.
I am including a copy of my offer and proof of the other registrant's receipt of that
offer.  I am  identifying the party  which is committing to submit or provide the
require data;  if the required study  is not submitted on time, my  product may be
subject to suspension.  I understand  that other terms under  Option 3 in the Data
Call-In Notice (Section m-C.l.) apply as well.

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

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

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

7.     I request a waiver for this study because it is  inappropriate for my product
(Waiver Request). I am attaching a complete justification for this request, including
technical reasons, data and references to relevant EPA regulations, guidelines or
policies. [Note: any supplemental data must be submitted in the format required by
P.R. Notice 86-5]. I understand that this is my only opportunity to state the reasons
or provide information in support of my request.  If the Agency approves my waiver

                               72

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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.
                                          73

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Attachment 4. EPA Batching of End-Use Products for
   Meeting Data Requirements for Reregistration
                      79

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      EPA'S BATCHING OF BARIUM METABORATE PRODUCTS FOR MEETING
         ACUTE TOXICITY DATA REQUIREMENTS FOR REREGKTRATION

         In an effort to reduce the time, resources and number of animals needed to fulfill the
  acute toxicity data requirements for reregistration of products containing the active ingredient
  barium metaborate,  the Agency has batched products which can be considered  similar for
  purposes of acute toxicity.  Factors considered in the sorting process include each product's
  active and inert  ingredients  (identity, percent composition and biological activity)  type of
  formulation (e.g., emulsifiable concentrate, aerosol,  wettable powder, granular,  etc )  and
  labeling (e.g., signal word,  use classification,  precautionary labeling, etc.).   Note that the
  Agency is not describing batched products as "substantially similar" since some products within
  a batch may not be considered chemically similar or have identical use patterns.

        Using available information, batching has been accomplished by the process described
  in the preceding paragraph. Notwithstanding the batching process, the Agency reserves the right
  to require,  at any time, acute toxicity data for an individual product should the need arise.

        Registrants of products within a batch may choose to cooperatively generate  submit or
  cite a single battery of six acute toxicological studies to represent all the products within  that
  batch. It is the registrants' option to participate in the process with all other registrants 'only
  some of the other registrants, or only their own products within a batch, or to generate all the
 required acute toxicological studies for each of their own products. If a registrant chooses to
 generate the data for a batch, he/she must use one of the products within the batch  as the  test
 material. If a registrant chooses to rely upon previously submitted acute toxicity data he/she
 may do so Provided that the data base is complete and valid by today's standards (see acceptance
 criteria attached),  the formulation tested is considered by EPA to be similar for acute toxicity
 and the  formulation has not been significantly altered since submission and acceptance of the
 acute toxicity data. Regardless of whether new data is generated or existing data is referenced
 registrants must clearly identify  the test material by EPA Registration Number.  If more than
 one confidential statement of formula (CSF) exists for a product, the registrant must indicate the
 formulation actually tested by identifying the corresponding CSF.

       In deciding how to meet the product specific data requirements, registrants must follow
 the directions given in the Data Call-in Notice and its attachments appended to  the RED  The
 SS^on°H COITS *^° reS°nf formS Which m t0 be comPleted and submitted to the Agency
 w 1 ^?tffyH°/reCei?t-  Theflrstform' "DataCall-InResponse/'askswhetherthereg^trant
 will meet he data requirements for each product.  The second form, "Requirements StaL and
 Registrant s Response," lists the  product specific data required  for each^roduct, including the
 standard  six acute toxicity tests.  A  registrant who wishes to participate in a batch must decide
 whether  he/she will provide the data or depend on someone  else to do so.   If a registrant
 supplies the data to support a batch of products, he/she must select one of the following
          o^ ^r^ 1X S"bmUtin|an ExistinS Stud"y (Option 4), Upgrading an'
       ?f     } °l     g m ExiStmg StUdy (0ption 6>' If a registrant de^nds on another's
    , 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 inVbatch, the
choices are Options 1,  4, 5 or  6.  However, a registrant should know that choosing not to
                                          81

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

The table below shows the three products which were batched together.
BATCH NO.
1
EPA REG. NO.
1448-105
1448-106
1448-17
% of Barium Metaborate
52.00% - Barium Metaborate
50.00% - Barium Metaborate
90.00% - Barium Metaborate
Formulation Type
Ready-to-Use Solution
Ready-to-Use Solution
Soluble Concentrate
                                            82

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    &EPA
                           United
Protection
20460
Agtney
       States  Environmental
            Washington, DC

   CERTIFICATION  WITH RESPECT  TO
DATA  COMPENSATION REQUIREMENTS
Perm Approved

OUt He. 2070-0107
        2070-0057
Approval Expires  3-31-M
IPubfic reporting burden for this collection of Information is estimated to average 15 minutes per response, including
•tune tor reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
•completingi and reviewing the collection of Information.  Send comments regarding the burden estimate or any other
******  nlTlf?11??*" of Wonrofon. including suggestions for reducing this burden, to Chief, Information Policy
       . PM-223, U.S. Environmental Protection Agency, 401 M St.. S.W.. Washington, DC 20460; and to the Office
  r Management and Budget. Paperwork Reduction Project (2070-0106), Washington. DC 20503.

 •lease fill in blanks below.
  Dinpany  Mam*
 chemical Name
                                                                         Company Number
                                                                         EPA Chemical Number
  Htifythat:
   For each study cited in support of registration or reregJstratfen under the Federal Insecticide. Fungicide and
   Rodenticide Act (FIFRA) that is an exclusive use study, t am the original data submitter, or I have obtained the
   written permission of the original data submitter to cite that study.

   That for each study died in support of registration or reregistratten under FIFRA that is NOT an exclusive use
   study, I am the original data submitter, or I have obtained the written permission of the original data submitter or I
   have notified in writing the company(ies} that submitted data I have cited and have offered to-  (a) Pay
   compensation for those data in accordance with sections 3(C}{1 )(D) and 3(c)(2)(D) of FIFRA: and (b) Commence
   negotiation to determine which data are subject to the compensation requirement of FIFRA and the amount of
  compensation due, if any. The companies I have notified are: (check one)

   IJ  All companies on the data submitters* fist for the active ingredient listed on this form (Cite-All
      Method or Cite-All Option under the Selective Method). (Also sign the General Offer to Pay
      below.)


   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,'

  That I have previously complied with section 3(c)(1)(D) of FIFRA for the studies I have cited in suoDort of
  registration or reregistratton under FIFRA.
 •^	
lignature
  »e and Title (Pleaae Type or Print)
                                                                        Date
 ENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the
 jstraton or reregistratten of my products, to the extent required by FIFRA sections 3(c)(l)(D) and 3(c)(2){D).
 i nature
    and Title (Please Type or Print)
                                                                        Date
  Form C570-31 (4-90)

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      _  	           United

     &EPA    -
     \rimmm  «f%SHAR
       States Envlronmantal Protection
           Washington,  DC  20460
  CERTIFICATION  OF OFFER TO COST
SHARE IN THE DEVELOPMENT  OF DATA
Fee*

OMB M*. aOTO-0107
        2070-0057
Approval Explraa 3-31-JT6
  Pubfic reporting burden lor the collection of information is estimated to average 15 minutes per response inckidina
  time for reviewing instructions, searching existing data sources, gathering andmaintaining th?datenwdetland
  COmpleS2ind IfViewin0 the coltectton of formation. Send comments regarding the burden estinSeVr any-other
  aspect of tins collection of information, including suggestions for reducing this bureten, t
  Branch. PM-223. U.S. Environmental Protection Agency, 401 M St.. S.w!. Washington.
  of Management and Budget. Paperwork Reduction Project (2070-0106). Washington. DC 20503.

  Pleas* fin in blanks below.
  Company Mima
  Chamlcal Nam*
                                                                         Company Numbar
                                                                         EPA Chamlea! Numbar
  I Certify that:

  My company is willing to develp and submit the data required by EPA under the authority of the Federal
  Insecticide. Fungicide and Rodentfcide Act (FIFRA), if necessary.  However, my company would prefer to
  enter Into an agreement wfth one or more registrants to develop jointly or share In the cost of developing
  data.                                                                                 •  K  "

  My firm has offered in writing to enter Into such an agreement. That offer was Irrevocable and included an
  offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA If final agreement on all
  terms could not be reached otherwise. This offer was made to the following firm(s) on the followina
Idate(s):                                                                              *
  Kama of Hrm(«)
                                                                          Data of Offar
 I certify that I am duly authorized to represent the company name above, and that the statements that I have made on
 "tis form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
 listeading statement may be punishable by fine or imprisonment or both under applicable law.
 Signatura of Company'a Authorfead Rapraaantatfva
 Nama and TUIa (Plaaaa Typa or Print)
                                               Data
lEPA Form W7042
                          Raplaoaa EPA Form *5SO-6, which la obaoteta

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