Chlorinated Isocyanurates

                   Summary of Requirements
Within 90 Days of Receipt ef this RED

-    Sign and submit both data call-in response forms  attached to
     the generic and product specific DCIs (Appendix F,
     Attachments B and C; and Appendix 6,  Attachments  B  and  C).

Within 6 Months From the Date ef This HBP

     For each product that does not qualify for a generic  data
     exemption you must submit or cite the required generic
     product chemistry data listed in the generic DCI  (Appendix
     F).  If you cite data that has been reviewed by the Agency
     and determined to be acceptable you must submit a list  of
     the studies and the corresponding EPA identifier  numbers
     (i.e., Accession or MRID numbers).  Be sure to follow data
     formatting requirements in P.R. Notice 86-5.  Failure to
     adequately comply with the data requirements specified  in
     this RED may result in the Notice of Intent to Suspend  your
     product.  All data submitted to fulfill requirements  listed
     in Appendix F should be sent to:

               Document Processing Desk (RED-SRRD-0569)
               Office of Pesticide Programs (H7504C)
               Environmental Protection Agency
               401 M Street, S.W.
               Washington, D.C.  20460-0001

Within 8 Months From the Date of This RED

     Submit a completed Application for Reregistration (EPA  Form
     8570-1).

     Submit five copies of the label and labeling revised  as
     specified by the RED and in accordance with current
     requirements.

     Submit two completed copies of the Confidential Statement of
     Formula (EPA Form 8570-4).

     Submit a completed Certification With Respect to  Data
     Compensation (EPA Form 8570-31), if applicable.   EPA  Form
     8570-31 is required to establish ownership of product
     specific data only and allows only two options: development
     of data (owner submission method); and citing of  specific
     data (selective method requiring a data matrix).  The cite-
     all method of support is not an acceptable option for

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responding to the product specific data requirements of the
RED.

Submit the required data or references to data as specified
by the RED/DCI for product specific data (Appendix G).
Please note that products that are listed in Table III and
Table IV of the EPA grouping of End-Use Products (Appendix
G, Attachment D) did not fall into any batch.  Therefore the
acute toxicology data required in the product specific DCI
(Appendix G) must be submitted for these products.  (i.e.,
the grouping of similar products for purposes of submitting
acute toxicology data does not apply to those products
listed in Table III and Table IV of Appendix G, Attachment
D).  All data submitted to fulfill requirements listed in
Appendix G should be sent to:

          Document Processing Desk (RED/RD/PM32)
          Office of Pesticide Programs (H7504C)
          Environmental Protection Agency
          401 H Street, S.W.
          Washington, D.C.  20460-0001

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 ^^>,
  ^ TJ
      I         UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
      /                    WASHINGTON, D.C.  20460
                                                          OFFICE OF
                                                        PESTICIDES AND TOXIC
                                MAY  7 1993                 SUBSTANCES
 CERTIFIED MAIL
 Dear  Registrant:

      I  an pleased to announce that the Environmental Protection
 Agency  (the "Agency")  has completed its reregistration
 eligibility decision on the pesticide active ingredients
 dichloro-s-triazinetrione,  potassium dichloro-s-triazinetrione
 sodium  dichloro-s-triazinetrione,  trichloro-s-triazinetrione and
 sodium  dichloro-s-triazinetrione dihydrate.

 *u    EnfJ?ed i8  ? *rq*trtien Eligibility Document (RED1 for
 the pesticide active ingredients dichloro-s-triazinetrione,
 potassium dichloro-s-triazinetrione,  sodium dichloro-s-
 triazinetrione, trichloro-s-triazinetrione and sodium dichloro-s-
 triazinetrione dihydrate,  hereafter referred to as the
 chlorinated isocyanurates.   The RED is the Agency's evaluation of
 the chlorinated isocyanurates data base,  its conclusions
 regarding human and environmental risks associated with the
 current product uses,  and its decisions and conditions under
 which uses and products will be eligible for reregistration.
 Also enclosed are the  EPA RED fact* and the Pesticide
Rereqjstration Handbook which provide instructions to registrants
 on how  to respond to any labeling and data requirements specified
 in the  RED and how to  reregister products.

     The  RED identifies outstanding product specific data
requirements for  end-use products and manufacturing-use products.
These requirements are listed on the Requirements status and
Registrant's Response  Form,  which,  along with the Data Call-in
Pesponse  form listing  all of your company's products subject to
the RED,  is  included as an Attachment.   Instructions for
completing both forms  are contained in the RED package.  All
product specific  data  must be submitted and found acceptable by
the Agency before a product can be reregistered.
                                                          Prin/ta 0' SK. JK1 Pfpt

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     Generic data requirements usually will have been fulfilled
prior to making a reregistration eligibility decision.   However,
there may be some instances where additional generic data are
required.  If generic data requirements need to be fulfilled,  all
registrants must complete the appropriate Data Call-in Response
Fora and Requirements Status and Registrant's Response Form.
These forms are in the appendices to the RED.

     The RED identifies any specific labeling requirements such
as restricted use classification, groundwater hazard statements,
endangered species precautions, etc., necessary for
reregistration based on a review of the generic data for the
active ingredient.  In addition, in order to be reregistered, all
product labeling must be in compliance with format and content
labeling as described in 40 CFR S156.10 and all labeling changes
imposed by Pesticide Regulation (PR) Notices, and any label
changes imposed by this RED.

     The Pesticide Reregistration Handbook contains detailed
instructions for compliance with the RED and must be followed
carefully.  There are several key points to remember in preparing
your response to the RED:

Within 90 Pays of Your Receipt of this Letter

1.   For ach product which is subject to this RED, you must
     complete, sign and submit the data call-in  (Del) r*spons*
     forms attached to th* RED  [Appendix F, Attachment B and C
     (if applicable) has forms for generic data; and Appendix G,
     Attachments B and C, has forms for product specific data].
     Follow the instructions in Attachments B and C for
     completing those forms and submit the forms to the
     appropriate address specified in the Data Call-ins.  Not*
     that th* DCI forms for generic data ar* to b* a*nt to th*
     Special Rviw and R*r*gistration Division  (us* th* mailing
     distribution cod* RED-SRRD-0569 for your g*n*ric response).
     Th* DCI forms for product  pcific data ar* to b* **nt to
     th* Registration Division  (us* th* mailing distribution cod*
     RED-RD-PM32 for your product specific r*spona*).

2.   No tim* *jct*nsions will b* granted for  submitting tn* 90-day
     r*spons*.  If the Agency does not receive  a response for a
     product, it may issue a Notice of Intent to Suspend  (NOIS)
     for that product.

3.   Any requests for data waiv*rs or tim* *xt*nsions to  tn* 8-
     month deadlin* must b* submitted as part of your 90-day
     r*spons*.  Such requests will generally not be  considered if
     submitted later than the 90-day response.

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 Within 8  Months  of  the Date of this Letter

 1.    For  each product, you must submit a completed Application
      for  Reregistration  (EPA Form 8570-1), five copi of the
      label and labeling  revised as specified by the RED and in
      accordance  with current requirements, tvo completed copies
      of the Confidential Statement of Formula (CSF) (EPA Form
      8570-4), a  completed Certification with Respect to Citation
      of Data (EPA Form 8570-31), and bAta or references to data
      (see item 2 below).

 2.    You  must submit or  cite the required product specific data
      as part of  your commitment for reregistration.  For most
      products, you  will  probably be citing data which have
      already been submitted to the Agency.  In these cases, you
      must submit a  list  of the studies and the corresponding EPA
      identifier  numbers  (i.e., ACCESSION or MRID numbers).
      Before citing  these studies, you must make sure that they
      meet the Agency's current acceptance criteria (Appendix F,
      Attachment  E).  Be  sure to follow data formatting
      requirements in P.R. Notice 86-5.  Failure to adequately
      comply vith the data requirements specified in this RED may
      result in the  Notice of Intent to Suspend your product.

 3.    The  labeling and CSF which you submit for each product must
      comply with -P.R. Notice 91-2 (Appendix D).  That Notice
      requires that  the amount of active ingredient declared in
      the  ingredient statement must be stated as the nominal
      concentration  rather than the lower certified limit.  You
      have two.options for submitting a CSF:  (1) accept the
      standard certified  limits (see 40 CFR S158.175) 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 S158.175(e).

4.    Send your Application for Registration to the Registration
      Division Product Manager 32 (PM 32) who is assigned to the
      product, Ruth  Douglas.  Use the correct address shown on
      page 6 of the  enclosed Product Reregistration Handbook
      (Appendix E).  Note that the mailing distribution code for
      your response  is RED-RD-PM32.

      Questions on product specific data requirements and labeling
 (for  both End-use and Manufacturing-use products) should be
directed to the  Registration Division Product Manager 32 Team
member for the chlorinated isocyanurates, Barbara Pringle at
 (703) 305 - 6484.   Questions on the generic data requirements
should be directed  to Karen Samek, the chemical Review Manager in
the Special Review  and Reregistration Division at  (703) 308 -
8051.

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     The Agency is prepared to meet with any registrants who have
questions about responding to the chlorinated isocyanurates RED.
If you wih to meet with the Agency, you must contact M. Friagle
within two week! o your receipt of the RBD.  The Agency intends
to have one combined meeting with interested registrants.  "
there are any requests for such a meeting, the Agency will notify
all registrants who requested a meeting of the date, location and
time.  Requests for a meeting will not extend the 90-day or 8-
month response deadlines.
                                   Sincerely yours,
                                   Daniel M. Barolo, Director
                                   Special  Review and
                                      Reregistration Division
Enclosures

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                    United States
                    Environmental Protection
                    Agency    	
                     Office of Prevention, Pesticides
                     And Toxic Substances
                     (H-7508W)
EPA-738-F-92-CnO
September 1992
&EPA   R.E.D.   FACT
                    Chlorinated
                    Isocyanurates
         Pesticide
    Reregistration
        Use Profile
    All pesticides sold or used in the United States must be registered by
EPA, based on scientific studies showing that they can be used without
posing unreasonable risks to people or the environment. Because of
advances in scientific knowledge, the law requires that pesticides which
were first registered years ago be reregistered to ensure that they meet
today's more stringent standards.
    In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency imposes
any regulatory controls that are needed to effectively manage each
pesticide's risks. EPA then reregisters pesticides that can be used without
posing 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 Document, or RED. This
fact sheet summarizes the information in the RED for the chlorinated
isocyanurates, which include the following five antimicrobial compounds:
          dichloro-s-triazinetrione
          potassium dichloro-s-triazinetrione
           sodium dichloro-s-triazinetrione
           trichloro-s-triazinetrione
           sodium dichloro-s-triazinetrione dihydrate

     The chlorinated isocyanurates are registered for use as disinfectants,
sanitizers, algaecides, fungicides, fungistats, bactericides,  bacteriostats,
microbicides and microbistats. These five compounds are used primarily
as disinfectants and algicides in swimming pools and to a lesser extent in
industrial cooling water systems.  Minor uses include sanitizing and
disinfecting food and non-food contact surfaces and sanitizing laundry.

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     Regulatory-       The chlorinated isocyanurates first were registered in the United
         History   States in 1958 for use as disinfectants, sanitizers, algicides and fungicides.
                    In 1980, EPA issued a Data Call-In requiring additional toxicity data to
                    assess the potential for kidney damage from exposure to these compounds.
                    The Agency issued a Registration Standard for the chlorinated
                    isocyanurates in May 1988 which evaluated the kidney toxicity data and
                    required additional information to support the indoor and aquatic non-food
                    uses. Currently, technical and end use products  are registered containing
                    chlorinated isocyanurates as active ingredients.
Human Health
  Assessment
  Toxicity
       The chlorinated isocyanurates have low acute oral and dermal toxicity
  but are very irritating to the eyes, and have been placed in Toxicity
  Category I (indicating the highest level of acute toxicity) for this effect.
  They are very mild skin irritants and are not considered to be skin
  sensitizers.
       A subchronic toxicity study showed effects in the urinary bladders of
  male mice and rats.  Chronic toxicity studies (2-year feeding studies) using
  rats and mice showed no oncogenic effects at any dose level. The
  chlorinated isocyanurates are not teratogenic or mutagenic. Metabolism
  studies show that they are  rapidly absorbed, distributed and excreted
  unmetabolised.
  Dietary Exposure
       No exposure  to the chlorinated isocyanurates is expected through  the
 diet.  Therefore,  no tolerances (maximum residue limits) or exemptions
 from the requirement of a tolerance are established or required for these
 compounds.  Their use as food and non-food contact surface sanitizers  is
 regulated by the Food and Drug Administration (FDA),  which has
 established food additive regulations as necessary (please see 21  CFR
 178.1010). Their use in commercial egg washing is regulated by the U.S
 Department of Agriculture.
      No international Codex Maximum Residue Levels are established for
 the chlorinated isocyanurates.
 Occupational and Residential Exposure
      Some occupational and residential exposure to the chlorinated
 isocyanurates can be expected based on their currently registered uses,
 primarily in swimming pools and to a lesser degree in industrial  cooling
 water systems. However, because the compounds are of low toxicity
 (except for acute eye irritation), occupational and  residential exposure
 monitoring data are not required.  Current product labeling protects
swimmers by prohibiting reentry into treated swimming pools/spas with
greater than 3 parts  per million (ppm) chlorine.

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                     Human Risk Assessment
                          The chlorinated isocyanurates do not appeal to cause acute (except
                     eye irritation), subchronic or chronic toxicity. Dietary exposure to these
                     compounds is not expected, and only limited residential and occupational
                     exposure is anticipated.  Current product labeling warns users that these
                     compounds are very irritating to the eyes, and prohibits swimmers' reentry
                     into treated pools if chlorine levels exceed 3 ppm. Therefore, the
                     chlorinated isocyanurates' human health risks are adequately mitigated by
                     product label precautions.
  Environmental
    Assessment
Additional Data
        Required
 Environmental Fate
      All of the chlorinated isocyanurates form hypochlorous acid when
 dissolved in water. A weak acid and oxidizing agent, hypochlorous acid
 reacts readily with ammonia, amines, sulfides, sulfites, and nitrites present
 in the water.  Antimicrobial activity results from the oxidation reactions
 with microbial enzyme systems. Isocyanuric acid and cyanuric acid remain
 and, under anaerobic conditions, degrade rapidly to carbon dioxide and
 ammonia.  These products are highly soluble in water and would be rapidly
 excreted by aquatic organisms; therefore, no accumulation in mammals,
 fish or nontarget aquatic organisms is likely.
 Ecological Effects
      The chlorinated isocyanurates are practically nontoxic to birds.
However, they are very highly toxic to coldwater fish, highly toxic to
 warmwater fish, highly toxic to freshwater invertebrates, and very highly
 toxic to estuarine and marine organisms.
 Environmental Risk Assessment
      Nontarget organisms may be exposed to the chlorinated isocyanurates
 through indirect discharges or effluents,  or through accidental releases or
 spills. EPA does not conduct hazard assessments for these exposures, but
 is requiring relevant precautionary labeling for all chlorinated isocyanurate
 products used where an effluent may occur (please see Product Labeling
 Changes Required, below).

      Additional generic product chemistry data are required for
 reregistration of certain technical or manufacturing use chlorinated
 isocyanurate products.
      Product-specific data, including product chemistry, acute toxicology
 and in some cases efficacy studies, also  are required for reregistration.

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  Product Labeling
Changes Required
         Regulatory
        Conclusion
          For More
        Information
     The labels of all registered chlorinated isocyanurate products must
comply with EPA's current pesticide labeling requirements. Any product
label which allows both manufacturing and end use must be amended to
specify only one use or the other.
     Any chlorinated isocyanurate product used where an effluent may
occur must bear the following Environmental Hazard label statement:
     "This pesticide is  toxic to fish and aquatic organisms. Do not
     discharge effluent  containing this product into lakes, streams, ponds,
     estuaries, oceans or public waters unless this product is specifically
     identified and addressed in an NPDES permit.  Do not discharge
     effluent containing this product to sewer systems without previously
     notifying the sewage treatment plant authority.  For guidance, contact
     your State Witer Board  or Regional Office of the EPA."
     A summary of the label additions/changes required for chlorinated
isocyanurate technical or manufacturing use products appears in the RED.
     The following additions/changes are required in the labels and
labeling of chlorinated isocyanurate end-use products:
       Include the reentry statement, "Reentry into treated swimming
     pools/spas is prohibited above levels of 3 ppm of chlorine."
       Products  with commercial egg wash treatment on the label, as
     well as sanitizing  solutions for food contact surfaces, must be in
     compliance with FDA requirements.  The directions for use in
     sanitizing eggs must be  similar to language prescribed in the RED.
       Label claims must be revised to reflect the nominal concentration
     of the active ingredient.

       All registered pesticide products containing chlorinated
isocyanurates as active ingredients are not likely to cause unreasonable
adverse effects in people or the environment, and are eligible for
reregistration. These products will be reregistered once any required
generic data, product-specific data and revised labeling are received and
accepted  by EPA.
       Registered products containing chlorinated isocyanurates as well
as other active ingredients will be reregistered once the other active
ingredients also are determined to be eligible for reregistration.

     EPA is requesting public comments on the Reregistration Eligibility
Document (RED)  for the chlorinated isocyanurates during a 60-day time
period, as announced in a Notice of Availability published in the Federal
Register.  To obtain a copy of the RED or to submit written comments,
please  contact the  Public Response and Program Resources Branch, Field
Operations Division (H-7506C), Office of Pesticide Programs (OPP),  US
EPA, Washington, DC 20460, telephone 703-305-5805.

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     In the future, the chlorinated isoeyanurates RED will be available
from the National Technical Information Service (NTIS), 5285 Port Royal
Road, Springfield, VA 22161, telephone
703^87-4650.
     For more information about the chlorinated isocyanurates or about
EPA's pesticide reregistration program, please contact the Special Review
and Reregistration Division (H-7508W), OPP, US EPA, Washington,  DC
20460, telephone 703-308-8000. For information about reregistration of
individual chlorinated isocyanurate products, please contact the Registration
Division  (H-7505C), OPP, US EPA, Washington,.DC 20460, telephone
703-305-7964.
     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, 24 hours a day, seven days a
week, or lax your inquiry to 806-743-3094.

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     United State*       Pesticides and      September, 1992
     Environmental Protection    Toxic Substances
     Agency	(H-7508W)	
EPA Reregistration
      Eligibility Document
      (RED)
      Chlorinated
      Isocyanurates

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REREGISTRATION ELIGIBILITY DOCUMENT


     CHLORINATED ISOCYANURATES

                   LIST A
                  CASE  0569
                September/ 1992
         ENVIRONMENTAL PROTECTION AGENCY
          OFFICE OF PESTICIDE PROGRAMS
     SPECIAL REVIEW AND REREGISTRATION DIVISION
               WASHINGTON/ D.C.

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               GLOSSARY OF TERMS AND ABBREVIATIONS
ADI



a.i.

ARC

CAS

CSF

EEC




EP

EPA

FIFRA

FFDCA

HDT

K+CWHR

LC50
LD50
LOT

LEL

MP

MPI
Acceptable Daily Intake.  Also known as the Reference
Dose or RfD.

Active Ingredient

Anticipated Residue Contribution

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

Kernel plus Cob with Husk Removed

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 ppra.

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.

Lowest Dose Tested

Lowest Effect Level

Manufacturing Use Product

Maximum Permissible Intake

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            GLOSSARY OF TERMS AND ABBREVIATIONS  CONT'D
MRID      Master Record Identification (number).  EPA's system of
          recording and tracking studies submitted to the Agency.
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
RfD       Reference Dose
RS        Registration Standard
TMRC      Theoretical Maximum Residue Contribution
                               ii

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                        TABLE OF CONTENTS

EXECUTIVE SUMMARY 	 1

I.   INTRODUCTION 	 2

II.  CASE OVERVIEW	3

     A.   CHEMICAL OVERVIEW 	 	 3

     B.   USE PROFILE	5

     C.   DATA REQUIREMENTS	'.	13

     D.   REGULATORY HISTORY  	  13

III. SCIENCE ASSESSMENT OF THE CHLORINATED ISOCYANURATES  . .  13

     A.   PRODUCT CHEMISTRY ASSESSMENT  	  13

     B.   HUMAN HEALTH ASSESSMENT 	  14

          1. Hazard Assessment  	  14

               a. Acute Toxicity
               b. Subchronic Toxicity
               c. Chronic Toxicity and Carcinogenicity
               d. Developmental Toxicity
               e. Reproduction
               f. Mutagenicity
               g. Metabolism

          2. Exposure Assessment  ..... 	  17

               a. Dietary Exposure
               b. Occupational and Residential Exposure

          3. Risk Characterization	19

     C.   ENVIRONMENTAL ASSESSMENT  	 	  20

          1. Environmental Fate	20

          2. Ecological Effects 	  21

               Ecological Effects Profile
                    a. Avian Studies
                    b. Aquatic Studies
                    c. Aquatic Invertebrates
                    d. Estuarine and Marine Organisms

          3. Risk Assessment	28

                               iii

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IV. RISK MANAGEMENT AND REREGISTRATION DECISION THE
           CHLORINATED ISOCYANURATES  	  29

     A.   DETERMINATION OF ELIGIBILITY  	  29

     B.   REGULATORY POSITION	30

 V. ACTIONS REQUIRED BY REGISTRANTS 	  31

     A.   MANUFACTURING USE PRODUCTS  	  31

          1. Additional generic Data Requirements
          2. Labeling Requirements for Manufacturing-Use Products

     B.   END USE PRODUCTS	33

          1. Additional Product Specific Data Requirements
          2. Labeling Requirements for End-Use Products

VI. APPENDICES	36

     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 Reregistrations of the
                  Chlorinated Isocyanurates

     APPENDIX D - List of Available Related Documents

     APPENDIX E - Pasticide Reregistration Handbook

     APPENDIX F - Generic Data Call-in

          Attachment A - Chemical Status Sheet

          Attachment B - Generic DCI Response Forms (Form A) plus
                         Instructions

          Attachment C - Requirements Status and Registrants'
                         Response Forms (Form B)  plus
                         Instructions

          Attachment D - List of all Registrant(s)  Subject to
                         This DCI and List of Products Subject to
                         This Generic DCI
                                IV

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     Attachment E - EPA Acceptance Criteria
     Attachment F - Cost Share/Data Compensation Forms
APPENDIX G - Product Specific Data Call-in
     Attachment A - Chemical Status Sheet
     Attachment B - Product Specific DCI Response Forms
                    (Form A) plus Instructions
     Attachment C - Requirements Status and Registrants'
                    Response Forms (Form B) plus
                    Instructions
     Attachment D - EPA Grouping of End-Use Products for
                    Meeting Acute Toxicology Data
                    Requirements for Reregistration
     Attachment E - List of all Registrant(s) sent this DCI
     Attachment F - EPA Acceptance Criteria
     Attachment G - Cost Share/Data Compensation Forms

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EXECUTIVE SUMMARY


     The chlorinated isocyanurates are currently registered for
use as disinfectants, sanitizers, algaecides,  fungicides,
fungistats, bactericides, bacteriostats,  microbicides and
microbistats.  The chlorinated isocyanurates include five
antimicrobial compounds as follows: dichloro-s-triazinetrione
(081401), potassium dichloro-s-triazinetrione (081403),  sodium
dichloro-s-triazinetrione (081404), trichloro-s-triazinetrione
(081405), and sodium dichloro-s-triazinetrione dihydrate
(081407).  These compounds hereafter will be referred to
collectively as the chlorinated isocyanurates.

     The Agency has determined that all products which contain
the chlorinated isocyanurates as the active ingredient are
eligible for reregistration for all registered uses.

     In May 1988, the Agency issued a registration standard
entitled "Guidance for the Reregistration of Pesticide Products
Containing Chlorinated Isocyanurates As the Active Ingredient
(NTIS PB88-220660).  The registration standard summarized the
available data supporting the registrations of the chlorinated
isocyanurates and required additional data to assure that the
proper use of the pesticides posed no potential adverse.effects
to man or the environment.  The Agency has completed its review
of the chlorinated isocyanurates data base including the data
submitted in response to the 1988 Registration Standard.

     The Agency has determined that all registered uses under the
perview of the Agency will not cause unreasonable risk to humans
or the environment and are eligible for reregistration.   No
tolerances or exemptions from the requirement of a tolerance are
required to support the existing uses for the registered
chlorinated isocyanurate products.  The Agency, however, is
requiring additional product chemistry data to complete the
generic data base for some manufacturing-use/technical products.
These products will be reregistered once these data are submitted
to and accepted by the Agency.  Products for which additional
generic product chemistry must be submitted to fill existing data
gaps are listed in Appendix F.

     Before reregistering the applicable products, the Agency is
requiring that product specific data and revised labeling be
submitted within 8 month*; of the issuance of this document.
These data requirements include product chemistry and acute
toxicology testing and are listed in Appendix G.  After reviewing
these data and the revised labels, the Agency will reregister a
product based on whether or not that product meets the
requirements in section 3(c)(5) of FIFRA.  Those products which

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contain other active ingredients will be eligible for
reregistration only when the other active ingredients are
determined to be eligible for reregistration.
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.

     Section 4(g)(2)(A) of FIFRA states that in Phase 5 "the
Administrator shall determine whether pesticides containing such
active ingredient are eligible for reregistration" before calling
in data on products and either reregistering products or taking
other "appropriate regulatory action."  Thus, reregistration
involves a thorough review of the scientific data base underlying
a pesticide's registration.  The purpose of the Agency's review
is to reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criterion of FIFRA.

     This document presents the Agency's decision regarding the
reregistration of the chlorinated isocyanurates.  The document
consists of five sections.  Section I is this introduction.
Section II describes the chlorinated  isocyanurates, their uses
and regulatory history.  Section III discusses the human health
and environmental assessment based on the data available to the
Agency.  Section IV discusses the reregistration decision for the
chlorinated isocyanurates and Section V discusses product
reregistration.  Additional details concerning the1 Agency's
review of available data are available on request.
          EPA's reviews of  specific reports and  information on
          the set of registered uses considered  for EPA's
          analyses may be obtained from:   EPA, Freedom of
          Information, 401, M  St., S.W., Washington, D.C.  20460.

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 II.  CASE OVERVIEW
 A.   CHEMICAL OVERVIEW
      The following active ingredients are covered by this
      Reregistration Eligibility Document:
 1.    Common Names: Dichloro-s-triazinetrione,  dichloroisocyanuric
      acid.
      Chemical Name: l,3-Dichloro-s-triazine-2,4,6 (1H,3H,5H)
      Trade Name:  ACL 70.
      Chemical  Family:  Halogenated triazines.
      Office of Pesticide  Programs Chemical  Code:  081401.
      CAS Registry No:  2782-57-2.
      Empirical Formula: C3HN3O3C12.

2.    common Names:   Potassium dichloro-s-triazinetrione;-
      Potassium dichloroisocyanurate.
      Chemical  Name:  l,3-Dichloro-s-triazine-2,4,6  (1H,3H,5H)
      trione potassium  salt.                                 '
      Trade  Names: ACL  59; P.O. I.e.
      Chemical  Family:  Halogenated  triazines.
      Office  of Pesticide Programs  Chemical Codes 081403.
      CAS Registry No:  2244-21-5.
     Empirical Formula: C3N3O3C12K.

3.   Common Names: Sodium dichloro-s-triazinetrione; sodium
     dichloroisocyanurate.
     Trade Names: ACL 60; CDB 60; CDB 63; S.D.I.C.

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      Chemical Family: Halogenated triazines.
      Office of Pesticide Programs Chemical Code: 081404.
      CAS Registry No: 2893-78-9.
      Empirical Formula: C3N3O3Cl2Na.

 4.   Common Names:  Trichloro-s-triazinetrione;
      trichloroisocyanuric acid; trichloroisocyanurate.
      Chemical Name: l,3,5-trichloro-s-triazine-2,4,6  (1H,3H,5H)
      trione.
      Trade Names: ACL 90 Plus; CDS 90; T.I.C.A.; TCCA.
      Chemical Family: Halogenated triazines.
      Office of Pesticide Programs Chemical code: 081405.
      CAS Registry No: 87-90-1.
      Empirical Formula:  C3N3O3C13.

 5.    Common Names:   Sodium dichloro-s-triazinetrione dihydrate;
      sodium dichloroisocyanurate dihydrate.
      Chemical Name:  l,3-Dichloro-s-triazine-2,4,6 (1H,3H,5H)
      trione sodium salt  dihydrate.
      Trade  Names: ACL 56;  CDB Clearon; DICD.
      Chemical Family:  Halogenated triazines.
      Office of Pesticide Programs chemical Code: 081407.
      CAS Registry No:  51580-86-0.
      Empirical Formula:  C3N303C12N2.2H2O.

     The dechlorinated s-triazinetrione,  isocyanuric acid   (OPP
Chemical Code: 081402) was not considered under  the  1988
Registration Standard  and is  not  being considered in this
reregistration eligibility document since it has no  pesticidal
properties BST. S.  It acts only  as an inert chemical stabilizer
for the hypochlorous acid derived from other sources.

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     Although the penta-s-triazinetrione,  (OPP Chemical Code:
081406) was considered in the 1988 Registration Standard,  it is
not being considered in this reregistration eligibility document
since no active products remain registered with the Agency.


B.   USE PROFILE

The following is information on the active registered uses with
specific use sites and application methods.  A detailed table of
both eligible and ineligible uses of the chlorinated
isocyanurates is in Appendix A.


1.   Chemical Name: Dichloro-s-triazinetrione

     Case number: 0569

     Chemical Code: 081401

     CAS Reg Number: 2782-57-2

     Type of Pesticide: Disinfectant, Sanitizer.

     Use Sites:
     INDOOR FOOD:
     Dairies/cheese processing plant equipment  (food contact),
     Dairies/cheese processing plant premises (non-food contact),
     Dairy farm milk handling facilities/equipment, Dairy farm
     milking equipment, Eating establishments equipment/utensils
     (food contact), Eating establishments food handling and
     serving areas  (non-food contact), Food processing plant
     equipment (food contact), Food processing plant premises
     (non-food contact).

     INDOOR NON-FOOD:
     Commercial/institutional/industrial floors,
     Commercial/institutional/industrial premises/equipment.

     INDOOR MEDICAL:
     Hospital noncritical items, Hospital/medical  institutions
     non-conductive floors, Hospitals/medical institutions
     premises (human/veterinary).


     INDOOR RESIDENTIAL:
     Household/domestic dwellings contents, Household/domestic
     dwellings indoor premises, Residential floors.

     Pests Controlled: Bacteria.

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     Formulation Types Registered:
     TYPE:  End use.
     FORM:  Liquid soluble concentrate.

     Methods and Rates of Application:
     TYPES OF TREATMENT:  Mop, Sponge-on, Wiperon, Scrub,
     Equipment treatment, Indoor premise treatment.

     EQUIPMENT:  Mop, Sponge, Cloth, Brush, Mechanical scrubber,
     Not on all labels.

     TIMING:  As needed.

     RATE OF APPLICATION:  117 - 234 ppm available chlorine by
     weight.

     Use Practices Limitations: Strong oxidizing agent; Do not
     mix with other chemicals or materials.


2.   Chemical Name: Potassium Dichloro-s-Triazinetrione

     case Number:  0569

     Chemical coda: 081403

     CAS Reg Number:  2244-21-5

     Type of Pesticide: Disinfectant, Sanitizer,  Algicide,
     Fungicide/fungistat.

     Use Sites:
     AQUATIC NON-FOOD RESIDENTIAL:
     Swimming pool water systems.

     INDOOR FOOD:
     Dairies/cheese processing plant equipment (food contact),
     Dairies/cheese processing plant premises (non-food contact)
     Dairy farm milk  handling facilities/equipment,  Dairy farm
     mxlking equipment,  Eating establishments equipment/utensils
     (food contact),  Egg washing treatments (commercial),  Food
     processing plant equipment (food contact), Food processing
     plant premises (nonfood  contact),  Food processing water
     systems, Meat  processing plant equipment (food contact),
     Meat  processing  plant premises (nonfood contact),  Poultry
     processing plant equipment (food contact), Poultry
     processing plant premises (nonfood contact).

     INDOOR NON-FOOD:
     Commercial/institutional/industrial floors,  Eating
     establishments food  handling and serving areas  (nonfood

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 contact),  Egg washing treatments (hatching),  Laundry
 (commercial).

 INDOOR MEDICAL:
 Hospitals/medical institutions premises (human/veterinary).

 INDOOR RESIDENTIAL:
 Bathroom premises/hard surfaces, Household/domestic
 dwellings  contents,  Household/domestic dwellings indoor
 premises.  Refuse/solid waste containers (garbage cans),
 Residential floors,  Toilet bowls (interior surfaces).

 Pests:  Algae, bacteria and fungi.

 Formulation Types Registered:
 TYPE:   End use,  Technical grade.
 FORM:   Granular,  Pelleted/tableted,  Solid soluble
 concentrate.

 Methods and Rates of Application:
 TYPES OF TREATMENT:   Immersion,  Spray,  Surface  treatment,
 Dip, Indoor premise  treatment,  Pour-on,  Brush-on,  Equipment
 treatment,  Circulation method,  Fog,  Rinse, Wash,  Water-
 treatment.

 EQUIPMENT:  Tank,  Sprayer,  Brush, Soak,  By hand,  Not on all
 labels.

 TIMING:  Initial,  Subsequent/maintenance,  Shock/slug. As
 needed.

 RATE OF APPLICATION:   1 - 1326  ppm available  chlorine by
 weight.                                                 *

 Use Practices Limitations:  Strong oxidizing agent;  Do not
 mix with other chemicals  or materials.


 Chemical Name:  Sodium dichloro-s-triazinetrione

 Case Number:  0569

 Chemical code:  081404

 CAS Reg Number:  2893-78-9

 Type of Pesticide: - Microbicide/microbistat,  Disinfectant,
 Samtizer,  Fungicide, Algicide,  Bacteriostat.

 Use Sites:
AQUATIC FOOD CROP:  Human drinking water systems.

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AQUATIC NON-FOOD INDUSTRIAL:
Air washer water systems, Commercial/industrial water
cooling systems, Evaporative condenser water systems, Sewage
systems, Heat exchanger water systems,
Lakes/ponds/reservoirs (without human or wildlife use),
Industrial scrubbing systems.

AQUATIC NON-FOOD RESIDENTIAL:
Swimming pools, Hot tubs and spas, Ornamental ponds/aquaria,
Domestic/commercial non potable water (waterbed water).

GREENHOUSE FOOD CROP:
Mushroom houses-empty premise/equipment.

INDOOR FOOD:
Poultry (egg/meat), Egg handling rooms and equipment
(commercial), Egg washing treatments (hatching and
commercial), Dairy farm milk handling facilities/equipment,
Dairy farm milking equipment, Household/domestic dwellings
indoor food handling areas, Dairies/cheese and meat
processing plant premises and equipment (food and non-food
contact), Poultry processing plant equipment (food contact),
Eating establishments food handling areas (food and non-food
contact), Food dispensing equipment/vending machines.

INDOOR NON-FOOD:
Egg plants/hatcheries/brooder rooms, shoe baths (hatching),
Mushroom houses-empty premises/equipment,
Pasteurizer/warmer/cannery cooling water systems, Eating
establishments food handling and serving areas (non-food
contact), Commercial/institutional/industrial
premises/equipment (indoor), Laundry (commercial), Diapers
(commercial laundry), Refuse/solid waste containers  (garbage
cans).

INDOOR MEDICAL:
Hospital semicritical items  (catheters/inhalation
equipment).

INDOOR RESIDENTIAL:
Residential floors, Laundry  (household/coin operated).

Pests:  Bacteria, Slime-forming algae, bacteria and fungi.

Formulation Types Registered:
TYPE:  End use. Manufacturing use.
FORM:  Soluble concentrate/solid, Tablet,,Granular.
                           8

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     Methods and Rates of Application:
     TYPES OF TREATMENT:
     Feeding and watering appliance treatment, Indoor premise
     treatment. Transportation vehicle treatment, Rinse, Spray,
     Brush-on, Mop, Egg treatment, Wash, Pour-on, Wipe-on,
     Immersion, Circulation method, Circulate-in-place (CIP)
     treatment, Equipment treatment, Dip, Soak, Water
     recirculating system treatment, Water treatment, Fog, Flush
     treatment, Surface treatment, Scrub, Contact and/or surface
     treatment.

     EQUIPMENT:
     Sprayer, Brush, Mechanical sprayer, Machine apparatus,
     Cloth, By hand, Skimmer basket, Pail, Portable
     chlorinator/brominator unit, Sponge, Tank, Dish washing
     machine, Sink, Washing machine.

     TIMING:
     As needed, Continuous feed (initial and subsequent),
     Intermittent (slug) (initial and subsequent), Shock/slug,
     Initial/Subsequent maintenance, Winterizing, Morning, Night
     time, Not on all labels.

     RATE OF APPLICATION:
     Available chlorine:  1 - 1062 ppm.

     Use Practices Limitations: None.


4.   Chemical Name: Trichloro-s-triazinetrione

     Case Number: 0569

     Chemical Code: 081405

     CAS Reg Number: 87-90-1

     Type of Pesticide: Microbicide/microbistat (slime forming
     bacteria, fungi, algae), Disinfectant,  Sanitizer, Fungicide,
     Algicide, Bacteriostat.

     Use Sites:
     AQUATIC NON-FOOD INDUSTRIAL:
     Air washer water systems, Commercial/industrial water
     cooling systems, Evaporative condenser water systems,
     Secondary oil recovery injection water, Sewage systems, Heat
     exchanger water systems, Lakes/ponds/reservoirs  (without
     human or wildlife use), Industrial scrubbing system, Oil
     recovery drilling muds/packer fluids.

     AQUATIC NON-FOOD RESIDENTIAL:
     Swimming pool water systems, Ornamental ponds/aquaria.

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INDOOR FOOD:
Poultry (egg/meat), Egg handling equipment and washing
treatments  (commercial), Dairy farm milk handling
facilities/equipment, Dairy farm milking equipment,
Agricultural/farm structures/buildings and equipment,
Agricultural/farm premises, Household/domestic dwellings
indoor food handling areas, Pasteurizer/warmer/cannery
cooling water systems, Human drinking water systems, Food
processing plant premises and equipment (food and non-food
contact), Dairies/cheese processing plant premises and
equipment (food and non-food contact), Meat processing plant
premises and equipment (food and non-food contact), Poultry
processing plant premises and equipment (food and non-food
contact), Fish/seafood processing plant premises and
equipment (food and non-food contact), Eating establishments
equipment/utensils and food handling areas  (food contact).

INDOOR NON-FOOD:
Animals (laboratory/research), Eggplants/hatcheries/brooder
rooms/shoe  baths  (hatching), Eating establishments food
handling and serving areas  (nonfood contact),
Commercial/institutional/industrial premises/equipment
(indoor), Commercial/institutional/industrial floors,
Leather/leather products, Laundry  (commercial).

INDOOR MEDICAL:
Hospitals/medical  institutions premises  (human/veterinary),
Hospital noncritical items  (bedpans/furniture),
Hospital/medical  institutions non-conductive floors.

INDOOR RESIDENTIAL:
Laundry  (household/coin-operated), Bathroom premises/hard
surfaces.

PESTS:  Black  and green  algae, Sulfate-reducing bacteria,
Slime-forming  bacteria,  algae and  fungi,  Daulfovibriodesulfuricans,
Pscudomonas sp., Bacillus sp.

FORMULATION TYPES REGISTERED!
TYPE: End use, Manufacturing use.
FORM: Soluble  granular,  Tablets,  Sticks,  Solid soluble
concentrate.

METHODS AND RATES OF APPLICATION:
TYPES OF TREATMENT:
Feeding and watering appliance treatment, Wash, Spray,
Circulate-in-place (CIP)  treatment,  Immersion,  Premise
treatment,  Water  recirculating  system treatment, Water
treatment,  Broadcast,  Sprinkle,  Water once-through system
treatment.  Brush-on,  Swab,  Soak,  Rinse,  Wash, Sewage
treatment.  Mop, Wipe-on,  Fog,  Sponge-on,  Immersion,  Surface


                            10

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treatment, Preservative treatment.

EQUIPMENT:
Pressure sprayer, Tablet feeder, Skimmer basket,  By hand,
Brush, Mop, Cloth, Fogging, Sponge, Tank, Metering pump,
Washing machine, Portable chlorinator unit.

TIMING:
Continuous feed  (initial), Continuous feed (subsequent),
Intermittent (slug)(initial), Intermittent
(slug)(subsequent), Initial, Subsequent/maintenance,
Shock/slug, Winterizing.

RATE OF APPLICATION: Available chlorine: 1-971 ppm by
weight.

USE PRACTICES LIMITATIONS: None.
Chemical Name: Sodium Dichloro-s-triazinetrione Dihydrate

Case number: 0569

Chemical Code: 081407

CAS Reg Number: 51580-86-0

Type of Pesticide: Microbicide/microbistat, Disinfectant,
Sanitizer, Fungicide, Algicide.

Use Sites:
AQUATIC NON-FOOD INDUSTRIAL:
Air washer water systems, Commercial/industrial water
cooling systems, Evaporative condenser water systems, Sewage
systems, Heat exchanger water systems, Lagoons (without
human or wildlife use), Industrial scrubbing system.

AQUATIC NON-FOOD RESIDENTIAL:
Hot tubs, Spas, Swimming pool water systems, Ornamental
fountains.

INDOOR FOOD:
Poultry houses, Egg handling equipment, Commercial egg
washing treatments, Hatching egg washing treatments, Dairy
farm milk handling facilities/equipment, Dairy farm milking
equipment, Household/domestic dwellings indoor food handling
areas, Human drinking water systems, Food processing plant
premises and equipment  (food and non-food contact),
Dairies/cheese processing plant premises and equipment  (food
and non-food contact), Meat processing plant premises and
equipment (food and non-food contact), Poultry processing
plant premises and equipment (food and non-food contact),

                           11

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Fish/seafood processing plant premises and equipment (food
and non-food contact), Eating establishments, Eating
establishments equipment/utensils (food contact), Milk shake
machines, Soft serve ice cream machines.

INDOOR NON-FOOD:
Hatching egg washing treatments, Pasteurizer/warraer/cannery
cooling water systems, Eating establishments food handling
and serving areas  (non-food contact),
Commercial/institutional/industrial premises/equipment,
Laundry  (commercial), Diapers (commercial laundry).

INDOOR MEDICAL:
Surgical fluid waste sanitizer.

INDOOR RESIDENTIAL:
Household/domestic dwellings indoor premises, Residential
floors, Laundry  (household/coin-operated), Toilet bowls
(interior surfaces), Bathroom premises/hard surfaces,
Refuse/solid waste containers (garbage cans).

Pests: Slime-forming bacteria, fungi and algae.

Formulation Types Registered:
TYPE:  End use, Manufacturing use.
FORM:  Soluble concentrate/solid, Pelleted/tableted.

Methods and Rates of Application:
TYPES OF TREATMENT: Circulation method, Water recirculating
system treatment, Feeding and watering appliance treatment,
Flush treatment, Egg treatment, Dip, Immersion, Spray,
Surface treatment, Wash, Water treatment, Indoor premise
treatment, Rinse, Pour-on, Wipe-on, Brush-on, Not on all
labels.

EQUIPMENT: Sprayer, Automatic sprayer, Tank, Mechanical
sprayer, Washing machine, Tablet dispenser, Skimmer basket,
Automatic decontamination machine.

TIMING: Initial, Shock/slug, Subsequent/maintenance.

RATE OF APPLICATION:
Indoor medical:  99% active ingredient.

Available chlorine:
Aquatic non-food industrial:  1 - 199 ppra by weight.
Aquatic non-food residential: 1 - 113 ppm by weight.
Indoor food: 59 - 671 ppm by weight.
Indoor non-food: 6 - 426 ppm by weight.
Indoor residential: 106 - 426 ppm by weight.

Use Practices Limitations: None.

                           12

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 C.   DATA REQUIREMENTS

     Data required  in the May  1988 Registration Standard for the
 chlorinated  isocyanurates included studies on product chemistry,
 ecological effects, and toxicology. These data were required to
 support  indoor and  aquatic non-food uses of these chemicals.
 Both generic data  (Table A) and product specific data for
 manufacturing-use products (Table B) were called-in.  Please
 refer to Appendix B for details of the complete data base for the
 chlorinated  isocyanurates.  Appendix B includes all satisfied
 data requirements identified by the Agency for current use groups
 that are needed to  support reregistration.  The data tables in
 Appendix B reflect  the Agency's reassessment of the data required
 for the  reregistration of the  chlorinated isocyanurates for the
 use patterns being  supported.

 D.   REGULATORY HISTORY

     The chlorinated isocyanurates were first registered in the
 United States in 1958 for use  as disinfectants, sanitizers,
 algicides, and fungicides.  A  Data Call-in was issued March 26,
 1980 for the chlorinated isocyanurates requiring additional
 toxicity data to assess the potential for kidney toxicity as a
 result of exposure  to these compounds.  A Registration Standard
 for the  Chlorinated Isocyanurates was issued in May 1988 (NTIS
 #PB88-220660) which evaluated  the studies submitted as a result
 of the 1980  DCI.  (Note that the use index for the 1988 -
 registration standard is available under NTIS #PB89-122147).  The
 1988 standard also  required additional data to support the indoor
 and aquatic  non-food uses for  the chlorinated isocyanurates.
 This reregistration eligibility document reflects a reassessment
 of all data  which were submitted in response to the Registration
 Standard.


 III. SCIENCE ASSESSMENT OP THE CHLORINATED ISOCYANURATES


     The Agency has conducted  a thorough review of the scientific
data base for the chlorinated  isocyanurates for the purposes of
determining  the reregistration eligibility of these pesticides.
These findings are  summarized below.

A.   PRODUCT CHEMISTRY ASSESSMENT


     Chemical Characteristics:

     Color:   White.

     Physical state:  Crystalline solid.

                                13

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     Odor:  Slight odor of chlorine.

     Melting point:  225-250 C.

     Bulk density:  Powder, 0.50-0.65 g/ml; regular, 0.82-1.0
                    g/ml; granular, 0.85-0.96 g/ml; extra
                    granular, 0.92-0.95 g/ml.

     Solubility:    Dichloro-s-triazinetrione, 0.8 g/100 g water
                    at 25 C; potassium dichloro-s-triazinetrione,
                    9 g/100 g water at 25 C; sodium dichloro-s-
                    triazinetrione, 24.8 g/100 g water at 26.8 C;
                    trichlor-s-triazinetrione, 1.2 g/100 g water
                    at 25 C; sodium dichloro-s-triazinetrione
                    dihydrate, 26.2 g/100 g water at 25 C.

     Vapor pressure:  Very small, impossible to measure.

     Stability:  Stable and relatively inert when dry.

     Unusual handling characteristics:  Strong oxidizing agents
                                        which should be kept away
                                        from heat and flames.

     The May 1988 Registration Standard required additional
generic product chemistry data for each technical chlorinated
isocyanurate.  Although data gaps exist for some studies for some
products, these requirements are not critical to the
reregistration decision or environmental assessment of the
chlorinated isocyanurates.  The Agency is requiring additional
product chemistry data at this time to satisfy these data gaps in
the product chemistry data base for these chemicals.


B.   HUMAN HEALTH ASSESSMENT

     1.   Hazard Assessment

          The isocyanurates have been divided into three groups
     for the purposes of acute toxicity testing.  The division is
     primarily on the basis of chemical structure and secondarily
     on the potential or actual effects related to the level of
     triazine ring chlorination.  These groups are: (i)
     isocyanuric acid; (ii) the dichloroisocyanurate group
     (including the acid, the potassium salt, the sodium salt,
     and the dihydrated sodium salt); (iii) trichloroisocyanuric
     acid.

          Since the chronic effects of chlorine for humans are
     well known, EPA determined that isocyanuric acid can
     represent all the chlorinated isocyanurates for the purpose
     of conducting metabolism,  subchronic, chronic,

                                14

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developmental, and mutagenicity studies.  By using the
nonchlorinated s-triazinetrione as the test substance, the
effects of the triazinetrione moiety could be distinguished
from those of the chlorine.  Sodium isocyanurate was
considered to be toxicologically equivalent to isocyanuric
acid and, as such, was selected as a suitable test substance
for the development of toxicity data.

     All toxicity data requirements have been met.  The
effects and toxicity of the chlorinated isocyanurates are
well understood and no further information is needed to
evaluate human health risks.

     a.   Acute Toxicity
TEST
Oral LD50  rat
Dermal LD50  rabbit
Eye irritation  rabbit
Dermal irritation  rabbit
RESULTS WITH
TRICHLOROISOCYANURATE
1500 mg/kg
> 10.0 g/kg
very irritating
mild irritation
CATEGORY
III
III
I

     The available data indicate that the chlorinated
     isocyanurates have low acute oral and dermal toxicity
     but are very irritating to the eyes.  The chlorinated
     isocyanurates are very mild primary dermal irritants
     and are not considered to be dermal sensitizers.   Acute
     inhalation studies are not required because vaporiza-
     tion and respirable dust are not expected.  Eye
     irritation testing with trichloroisocyanurate is not
     required since it is known that the chlorinated
     isocyanurates are generally very irritating to the
     eyes.   Delayed neurotoxicity data are not required
     because the chlorinated isocyanurates are not
     organophosphates.

     b.    Subchronic Toxicity

          When sodium  isocyanurate was given in the drinking
     water for 13 weeks,  the NOEL was 896 ppm (72 mg/kg/day)
     for male rats and 1792 ppm (522 rog/kg/day) for male
     mice.   The toxic  effects observed were hyperplasia of
     the urinary bladder and calculi in male mice,  and
     hyperplasia in the lining of the urinary bladder in  the
     male rats.   The NOEL was 5375 ppm for female rats (371
     mg/kg/day)  and for female mice (1582 rog/kg/day).
                          15

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      A subchronic  oral  study  in a nonrodent species is
 not required  because the metabolism of sodium isocyanu-
 rate is similar  in rats and dogs.  Neither 21-day nor
 90-day subchronic  dermal studies are required because
 of  a lack  of  toxicity in subchronic oral studies at
 doses far  above  use concentrations.  Subchronic
 inhalation and neurotoxicity  'studies are not required
 for the reasons  given under the associated acute
 topics.

 c.    Chronic  Toxicity and Carcinogenicity

      The LOEL in rats was 5375 ppm (371 mg/kg/day for
 males)  based  on  decreased survival and lesipns in the
 heart and  urinary  tract of males dosed in the drinking
 water for  2 years;  the  NOEL was 2400 ppm (154
 ing/kg/day)   Carcinogenic effects were not noted at any
 dose in the 2-year rat  study  or in a 2-year mouse study
 involving  doses  up to 5375 ppm (1523 mg/kg/day for
 males or 1582 mg/kg/day for females) in the drinking
 water.   The dose level  of 5375 ppm was reported to be
 the limit  of water solubility for sodium isocyanurate.
 A chronic  oral study in a nonrodent species is not
 required because the metabolism of sodium isocyanurate
 is  similar in rats  and  dogs.

 d.    Developmental  Toxicity           ]

      In  rats, sodium isocyanurate was not teratogenic
 and the  NOELs for  both  maternal and fetal toxicity were
 >5  g/kg/day.  In one study in rabbits, the NOELs for
 maternal (weight loss)  and fetal toxicity (decreased
 length)  were 50  mg/kg/day and 200 mg/kg/day,
 respectively, with  no teratogenic effects.  Another
 study in rabbits found  the maternal NOEL was 500
 mg/kg/day  (the highest  dose tested), and the
 developmental NOEL  was  200 mg/kg/day; the developmental
 LOEL was 500 mg/kg/day, with  increased incidences of
 hydrocephaly and post-implantation loss.

 a.    Reproduction

     A three-generation rat reproduction study found a
NOEL  of  5375 ppra for both adult reproductive and
offspring effects.  For adult systemic toxicity, the
LOEL was 5375 ppm  (371  mg/kg/day)  and the NOEL was 1200
ppm  (77  mg/kg/day), respectively,  with urinary bladder
calculi  in the F2 males.
                      16

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     f.   Mutagenicity

          Sodium isocyanurate was not mutagenic in studies
     designed to detect the potential to induce gene
     mutation, structural chromosomal aberrations, or
     altered sister chromatid exchange frequency.

     g.   Metabolism

          Metabolism studies in both the rat and dog,
     following administration of [ C]sodium isocyanurate by
     the oral and intravenous routes, demonstrated rapid
     absorption, distribution, and excretion of
     unmetabolized isocyanurate.  The elimination half-life
     in rats was 32-43 minutes following 5 mg/kg I.V. or
     oral administration. The half-life was 122-148 minutes
     after oral dosing at 500 mg/kg.  At the 5 mg/kg dose,
     excretion was largely via the urine with about 5% in
     the feces.  At the 500 mg/kg oral dose, 55-70% (rats)
     or 27-86% (dogs) was excreted in the feces and the
     remainder in the urine.  These studies adequately
     elucidate the absorption, metabolism, and excretion of
     the chlorinated isocyanurates.

2.   Exposure Assessment

     a.   Dietary Exposure

          The chlorinated isocyanurates include five
     antimicrobial compounds as follows:  dichloro-s-
     triazinetrione  (081401), potassium dichloro-s-
     triazinetrione  (081403), sodium dichloro-s-
     triazinetrione  (081404), trichloro-s-triazinetrione
     (081405), and sodium dichloro-s-triazinetrione
     dihydrate (081407).  These compounds will be hereafter
     referred to as s-triazinetrione compounds in this
     section.

          The industrial/agricultural uses of the s-
     triazinetrione as a food contact surface sanitizer are
     not subject to residue chemistry data requirements
     under 40 CFR 158.125; these uses are regulated by FDA
     according to 21 CFR 178.1010 (b)2 and (c)2.  Thus,
     there are currently no tolerances or exemptions from
     the requirements of a tolerance established for the
     s-triazinetrione compounds, and none are needed.

          The May 1988 Guidance Document for Chlorinated
     Isocyanurates (page 15) required the establishment of
     or exemption from a  tolerance for the use of
     chlorinated isocyanurate formulations as poultry
     drinking water sanitizers and as egg sanitizers because

                           17

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these uses were not specifically included in the Code
of Federal Regulations.  This action is no longer
appropriate; the uses of s-triazinetrione compounds
(Chemical Code 081403, 15% SC/L, EPA Reg. No. 5185-62)
in poultry drinking water have been canceled.  The
issue pertaining to uses of s-triazinetrione compounds
as a commercial egg sanitizer is addressed in detail
below.

     The s-triazinetrione compounds are registered for
use as food and non-food contact surface sanitizers in
agricultural premises  (including commercial egg wash
treatments and dairy farm milk handling
facilities/equipment), food/feed handling
establishments, commercial/institutional/industrial
sites, and residential sites.  Use of the s-
triazinetrione compounds as a food contact surface
sanitizer  (including the shells of intact eggs) is
regulated by the FDA according to 21 CFR 178.1010
(b)(2) and  (c)(2).  This regulation stipulates that
aqueous solutions containing dichloroisocyanuric acid,
trichloroisocyanuric acid, or the sodium or potassium
salts of these acids,  with or without the bromides of
potassium, sodium or calcium will not provide more than
100 ppm of available halogen determined  as available
chlorine.  NOTE: Although 21 CFR 178.1010 does not
provide specific reference to the commercial treatment
of  eggs for human consumption,  the Agency interprets
this regulation to  include food-grade,  intact egg
shells as  food contact surfaces.

     There are no residue chemistry data requirements
for s-triazinetrione  compounds  with respect  to  the
registered uses of  these compounds as  food  and  non-food
contact surface sanitizers  (excluding  commercial  egg
wash treatments).   For those s-triazinetrione products
with commercial egg wash treatment on  the label,  refer
to  the end-use product label requirements  {section  V(B)
 (2)(b) of  this document}  for further  information.


b.   Occupational  and Residential  Exposure

     The  1988  Registration  Standard  for the Chlorinated
Isocyanurates  did  not require  occupational  or
residential exposure data.   The chlorinated
isocyanurates  are  used primarily as  disinfectants and
algicides  in swimming pools and to a lesser extent in
industrial cooling water systems.   For these uses,  the
chlorinated isocyanurates are  applied as solids with
resulting  concentrations ranging from 1-3 ppm for
swimming  pools and 0.5-107  ppm for industrial water

                       18

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     systems  including cooling water, although, initial
     doses  of up  to  21.3 ppm  for swimming pools and 1062 ppm
     for industrial  water  systems may be required.  Other
     minor  uses include sanitizing and disinfecting food and
     non-food contact surfaces and laundry sanitizing uses.
     For these minor uses,  aqueous solutions are applied as
     sprays or by mopping,  scrubbing, flooding, sponging, or
     immersion at concentrations ranging up to 1326 ppm.
     Note:  ppm is expressed as available chlorine.

         Occupational and residential exposure can be
     expected based  on the currently registered uses of
     these  chemicals. Current label requirements  concerning
     swimmer  exposure are  as  follows:

     Reentry  - Reentry  into treated  swimming pools/spas  is
     prohibited  above levels  of  3  ppm of chlorine.

3.    Risk Characterization

     DIETARY

          Dietary exposure to the chlorinated  isocyanurates
     is not expected.  There  are no tolerances established
     for residues of these compounds because tolerances or
     exemptions  from the requirements  of a tolerance for the
     s-triazinetrione compounds  are not necessary.  A food
     additive regulation allowing the use of s-triazinetrione
     compounds as a sanitizing rinse on food-processing
     equipment and utensils,  and on other food-contact
     articles (including the shells of intact eggs)  has been
     established  (21 CFR 5178.1010).

     OCCUPATIONAL AND RESIDENTIAL

          The chlorinated  isocyanurates do not appear to
     induce  significant acute (except eye irritation),
     subchronic or chronic toxicity based on available
     information.  As already mentioned in the acute
     toxicity discussion,  it is known that these compounds
     are generally very irritating to the eyes.

          Although some occupational and residential
     exposure can be expected from use of the chlorinated
     isocyanurates,  the toxicity data indicate these
     compounds do not meet the Agency's toxicity criteria
     for the requirement  of  postapplication/reentry and/or
     mixer/loader/applicator exposure monitoring data.
     Accordingly, occupational and  residential exposure data
     are not required to  support the reregistration of the
     chlorinated isocyanurates.
                           19

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C. ENVIRONMENTAL ASSESSMENT

      1.   Environmental Fate

      The  Agency  has  reviewed data submitted in support of
      registration, and the general literature, for environmental
      effects  for chlorinated isocyanurates and their
      dechlorinated end-products, isocyanuric acid and cyanuric
      acid and has determined that the data base is adequate and
      will support reregistration.

      In disinfection by chlorination, a chlorinating agent is
      added to the water in sufficient amounts so as to produce a
      residual free chlorine concentration after all of the
      chlorine demand has been satisfied.  Residual free chlorine
      is defined  as the sum of the concentrations of hypochlorous
      acid and hypochlorite anion; the amount of chlorination
      needed to reach residual free chlorine is known as
      breakthrough chlorination.

      All  of_the  chlorinated isocyanurates form hypochlorous acid
      when dissolved  in water.  Hypochlorous acid is a weak acid
      (dissociation constant 3.7 x 10  at 25 C) which dissociates
      into hypochlorite anions and hydronium ions; however, in the
      pH range 7  to 8 and below, hypochlorous acid is the
      predominant species.  Hypochlorous acid (which is the
      species  of  actual pesticidal activity) is an oxidizing
      agent.   It  reacts readily with ammonia, amines, sulfides,
      sulfites, and nitrites present in the water.  Antimicrobial
      activity results from the oxidation reactions with microbial
      enzyme systems.  All of these oxidation reactions consume
      residual free chlorine, with the concomitant reduction of
      hypochlorous acid/hypochlorite to chloride anions.

      Released hypochlorous acid from chlorinated isocyanurates
      can  react with  the dechlorinated isocyanurate/cyanurate
      moieties since  there is an equilibrium between residual free
      chlorine and the dechlorinated moieties; this equilibrium
      complex  reduces the loss of residual free chlorine to
      sunlight.   As  free residual  chlorine  is used  up,
      isocyanuric acid and cyanuric acid remain.

      The moieties remaining after all chlorine is consumed are
     the  symmetrical triazines isocyanuric acid and cyanuric
      acid. These two chemical's are known to co-exist in a pH-
     dependent equilibrium. Although they are not prone to
      abiotic  degradation (hydrolysis; direct photolysis) or
     aerobic microbial degradation, anaerobic conditions favor
     2Betz Laboratories,  Inc.,  Trevose,  PA.,,  BETZ Handbook for
Industrial Water Conditioning, Seventh Edition, 1976

                                20

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 their rapid degradation to carbon dioxide and ammonia.  The
 triazine moiety is essentially non-toxic,  based on available
 mammalian metabolism and oral and dermal toxicity studies.
 No accumulation in mammals, fish, or non-target aquatic
 organisms is expected.   The dechlorinated products are
 highly soluble in water (ca 2000 ppm)  and would be rapidly
 excreted by aquatic organisms.

 The rate and mechanism of decomposition of hypochlorous acid
 are dependent on pH, concentration,  temperature, light, the
 presence of organic and inorganic matter,  and the redox
 potential of the medium. Since hypochlorous acid is a weak
 acid it is found practically undissociated at the neutral pH
 range recommended for the use of chlorinated isocyanurates,
 which for swimming pool waters has been established as  7.2
 to 7.6.

 REFERENCES

 - Wojtowicz, J.A., "Chlorine Monoxide, Hypochlorous Acid  and
 the Hypochlorites", in Kirk-Othmer Encyclope_dia_O-f Chemigal
 Technology. Vol.5, Wiley Interscience, New York, 3rd.
 Edition, 1979; pp. 580-611.

 - Smolin, E.H and Rapoport, L., "S- Triazines and
 Derivatives", in The Chemistry of Heterocyclic Compounds. A.
 Weissberger, Consulting Editor, Interscience Publishers,  New
 York, 1959; pp. 17-24 and 389-392.

 - Greenwood, N.N. and Earnshaw, A. Chemistry of the
 Elementsr Pergamon Press, Oxford, UK, 1984.

 - Cotton, A.F. and Wilkinson, G. Advanced Inorganic
 Chemistry. John Wiley and Sons, New York, Fifth Edition,
 1988.
2.  Ecological Effects

 The Agency has reviewed data submitted in support of
 registration and the general literature for ecological
 effects of chlorinated isocyanurates and their dechlorinated
 end-products isocyanuric acid and cyanuric acid and has
 determined that the data base is adequate and will support
 reregistration.  The Agency has based its assessment on data
 developed using the chlorine derivative trichloro-s-
 triazinetrione.  All of the chlorine derivatives will
 release hypochlorous acid on contact with water.  Trichloro-
 s-triazinetrione was chosen as the test chemical because it
 produces the highest percent (90%) available chlorine as
 compared to sodium dichloro-s-triazinetrione which produces
 64.2% available chlorine.  Therefore, only data on

                            21

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     trichloro-s-triazinetrione is needed to support
     reregistration.  However, all other data (chlorine
     derivatives) were evaluated and cited.


Affects on Birds

   Tr ichloro-s-tr iaz inetr ione


     Eight studies were evaluated under this topic.

          Author           pate
          Fink, R.         1976
          Robaidek, E.     1985
          Pink, R.         1975
          Fink, R.         1975
          Beavers, J.      1984
          Robaidek, E.     1984
          Beavers, J.      1984
          Robaidek, E.     1984


     In order to characterize the toxicity of isocyanurates to
     birds, valid data from the following  tests on the technical
     material are required:   Two subacute  dietary studies on one
     species of waterfowl  (preferably mallard duck) and one
     species of upland game bird  (preferably bobwhite quail or
     ring-necked pheasant) ; an avian single-dose oral study on
     one  species  (preferably  mallard duck  or bobwhite quail) .

     The  avian acute  oral  toxicity  studies reviewed are listed
     below:

                                                       Fulfills
                         LD50                           Guideline
     Species      %ai   mo/ka   Astbar.       Data
      Mallard                                              _  ,
        duck      100   1890   Fink,  R.        1976     Partial*
      Bobwhite
        quail      97   1674   Robaidek, E.    1985     Yes

      * Birds were 14 days old instead of at least 16 weeks old
      and food' was not withheld prior to dosing.

      There are sufficient data available to characterize
      technical trichloro-s-triazinetrione as slightly toxic to
      birds.  The avian acute oral guideline requirement has been
      satisfied with data from the evaluated documents.
                                 22

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The subacute dietary toxicity studies reviewed are listed
below:
Species
                   LC50
% ai  fppml
Bobwhite
quail
Mallard
duck
Mallard
duck
Mallard
duck
Bobwhite
quail
Bobwhite
quail

100

100

?*

?*

?*

?*

7235

>10,000

>5620

>5000

>5620

>5000
                            Author         Date


                            Fink, R.       1975

                            Fink, R.       1975

                            Beavers, J.    1984

                            Robaidek, E.   1984

                            Beavers, J.    1984

                            Robaidek, E.   1984
                                               Fulfills
                                              Guideline
                                               Requirements
                                               Yes

                                               Yes

                                               Partial

                                               Partial

                                               Partial

                                               Partial
*The avian dietary LCrp studies partially satisfy the requirement
because the percent of ai is unknown.


     There are sufficient data available to characterize trichloro-s
triazinetrione as practically nontoxic to upland game birds when
administered in their feed.  The guideline requirements for an avian
subacute dietary toxicity test on the technical grade of trichloro-s
triazinetrione was satisfied by data contained in the evaluated
documents .


Effects on Fish

     Four studies were evaluated under this topic.

       Author
       McCann, J.A. ; Pitcher, F.G.
       McCann, J.A. ; Pitcher, F.G.
       Barrows, B.
       Barrows, B.

     The minimum data required for characterizing the acute toxicity
     of isocyanurates to fish are the results of two 96-hour studies
     with technical grade material.  The studies must be performed  on
     one coldwater species  (preferably rainbow trout) and one
     warmwater species (preferably bluegill sunf ish) .
                                         1973
                                         1973
                                         1985
                                         1984
                           23

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     The fish acute toxicity studies reviewed are listed below:
Species,

Rainbow
  trout
Rainbow
  trout
Rainbow
  trout
Bluegill
      LCso
% ai  (pprol
100
100
?*
100
0.37
0.33
0.08
0.20
 Author           Date

McCann, J.A.,;    1973
  Pitcher, F.G.
McCann, J.A.;     1973
  Pitcher, F.G.

Barrows, B.       1985

Barrows, B.       1984
 Fulfills
Guideline
 Reguirements

   Yes

   Yes


   No

   Yes
*A formulated product was used instead of technical grade material.


     There are sufficient data available to characterize
trichloro-s-triazinetrione as very highly toxic to fish.. The
fish acute guidelines requirement has been satisfied by data
contained in the evaluated documents.


Chr9nic_Effects on Fish  (From Sodium Hvpochlorite Standard)

     The maximum allowable toxic concentration (MATC) ranged from
     0.11 to 0.23 ppm for fathead minnow (21-day study).


Effectson Invertebrates

     Three studies were evaluated under this topic.
               Author
            LeBlanc, G.A.
            Barrows, B.
            Surprenant, D.;
            Hoberg  J.
                         Date
                         1976
                         1985

                         1984
     The minimum data required to characterize the acute toxicity
     of isocyanurates to freshwater invertebrates is a 48-hour
     aquatic study with the technical grade material.  The test
     organisms should be first instar Daohnia roagna or early
     instar amphipods, stoneflies, or mayflies.


     The freshwater invertebrates studies reviewed are listed
     below:
                                24

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                                                      Fulfills
                                                    Guideline
     Species   %aj   ^ppin)    Author         Date    Requirements
     Daphnia
      B>aqna     ?*   0.25     LeBlanc, G.A.  1976       Partial
     Daphnia
      maqna     100  0.19     Barrows, B.    1985       Yes
     Daphnia                  Surprenant, D;
      maana     100  0.8      Hoberg, J.     1985       Yes
     *The percent of active ingredient is unknown.

     There are sufficient data available to characterize
technical trichloro-s-triazinetrione as highly toxic to
freshwater invertebrates.  The invertebrate Guidelines
requirement has been satisfied by the evaluated documents.

Chronic Effects on Invertebrates fFrom the Sodium Hvpochlorite
Standard)

     The MATC ranged from 0.11 to 0.4 ppm for American oysters
     (30-day study).

Effects on Estuarine and Marine Organisms

     No studies were submitted for review on the isocyanurates.
     However, data cited in the Sodium Hypochlorite Sta'ndard are
     being utilized to support this Reregistration Eligibility
     Document because all of the chlorine derivatives will
     release hypochlorous acid on contact with water.

     Sixteen studies from the Sodium Hypochlorite Standard were
     included under this topic.

     Author                        pate
     Roosenburg etal.             1980
     Roberts et al.                1975
     Roberts and Gleeson           1978
     Roberts et al.                1975
     Roberts and Gleeson           1975 and 1978
     Roberts et al.                1978 and 1979
     Roberts et al.                1978 and 1979
     Thatcher                      1978
     Buckley                       1976
     Thatcher                      1978
     Roberts et al.                1975
     Bellance and Bailey           1977
     Thatcher                      1978
     Roberts et al.                1975
     Thatcher                      1978
     Roberts et al                 1973 and 1979

                               25

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Estuarine and marine organism toxicity tests on technical
and formulated pesticides are required to support
registration if there is an intended direct application to
an estuarine or marine environment or if the pesticide may
be expected to enter these environments in significant
concentrations because of use or mobility pattern.  These
studies include acute LC50 testing on shrimp, oyster, and
estuarine fish.

Acute estuarine and marine testing will be required on the
hypochlorite salts since hypochlorites are discharged into
estuarine and marine waterways.

The following information is taken from Ambient Water
Quality Criteria for Chlorine, prepared for U.S. EPA,
Environmental Criteria and Assessment Office, Cincinnati,
Ohio, by Tobler, J.; Conn, W.E., Jolley, R.; Carpenter, J.j
Ferguson, M.; Stair, D.; Sigmon, C.; Hinkle, C.; Mattice,
J.; Middaugh, D.; Cummings,R.; Science Applications, Inc.,
Oak Ridge, Tennessee, June 29, 1981.

        Species                    LC50 ppm

American oyster
  (Crassostra virainica)
  (larvae)                         48-hr 0.026
  (Straight-hinged larvae)         96-hr 0.046
  (Juvenile)                       96-hr 0.023
Copepod                            48-hr 0.05
  (Acartia tonsal                  48-hr 0.029-0.067
Crab                                      !
  (Pagarus longicarpus)
  (larvae)                         96-hr 0.06
Crab
  (Panoplus herbstii)              48-hr 0.06
  (larvae)                         96-hr 0.02-0.04
Shrimp
  (Pandalus goniurus)              96-hr 0.09
Coho salmon                        96-hr 0.07
                                   96-hr 0.032
Atlantic silverside                96-hr.0.037
Spot                               96-hr 0.09
Pacific sand lance
  (juvenile and adult)             96-hr 0.082
Naked goby                         96-hr 0.08
English sole                       96-hr 0.073

There are sufficient data to characterize sodium
hypochlorite as very highly toxic to estuarine and marine
organisms.  The Guidelines requirement for estuarine and
marine organism testing has been satisfied.

                           26

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Chronic Effects on Estuarine and Marine Organisms (From
Sodium Hvpochlorite Standard)

     No studies were submitted for review on the isocyanurates.
     However, data in the Sodium Hypochlorite Standard are being
     utilized to support this Reregistration Eligibility
     Document.

     Four studies from the Sodium Hypochlorite Standard were
     included under this topic.

            Author                 Date

            Linden et al.          1977
            Buckley et al.         1976
            Bongerts et al.        1977
            Linden et al.          1980

     The following is taken from Ambient Water Quality Criteria
     for Chlorine, prepared for U.S. EPA, Environmental Criteria
     and Assessment Office, Cincinnati, Ohio, by Tobler, J.;
     Conn, W.E.; Jolley, R.; Carpenter, J.; Ferguson, M.; Stair,
     D,; Sigraon, C.; Hinkle, C.; Mattice, J.; Middaugh, D.;
     Gumming, R.; Science Applications, Inc., Oak Ridge,
     Tennessee, June 29, 1981.

     Embryolarvae and/or life cycle tests on the technical and
     formulated pesticide are required to support registration if
     the pesticide product is used in or is expected to be
     transported to water from the intended use site.

                Exposure
  Species         Time      Cone, fppm)        Effect

American oyster  15 days   0.035 - 0.085   14% - 34% reduction
 (Crasspstrea                              in shell deposition
  virainica)     15 days   0.014 - 0.062   14% - 34% reduction
                                           in shell deposition

Coho salmon      12 weeks  0.003 - 0.009   Reduction in hemoglo-
                                           bin and hematocrit;
                                           lysed erythrocytes;
                                           increased number of
                                           immature and abnormal
                                           cells.

Spot             20 days  0.014 - 0.062    Decreased blood pH


     There is sufficient information to characterize the
     hypochlorites as chronically very highly toxic to estuarine
     and marine invertebrates and fish.

                                27

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      ECOLOGICAL EFFECTS PROFILE

      Technical Trichloro-s-triazinetrione

      a.   Avian Studies

      Acute oral LD50s of 1674 and 1890 mg/kg were determined
 for bobwhite quail and mallard duck,  respectively,  given
 oral doses of technical trichloro-s-triazinetrione  (Robaidek
 1985, 1500962; Fink, R. 1976,  132603).   Trichloro-s-
 triazinetrione can be characterized as slightly toxic to
 birds when administered as an acute oral dose.

      Subacute dietary LCsos ranging from > 5000 ppm to >
 10,000 were determined for bobwhite quail and mallard duck
 for technical trichloro-s-triazinetrione (Robaidek  1984,
 150964;  Fink, R. 1975, 132426).  Trichloro-s-triazinetrione
 can be characterized as practically nontoxic to birds when
 administered in the diet.

      b.   Aquatic Studies

      Acute 96-hour LC50s of 0.08 and 0.20 ppm were
 determined for rainbow trout and bluegill sunfish,
 respectively (Barrows 1985, 150966; Barrows 1984, 150965).
 Technical trichloro-s-triazinetrione can be characterized as
 very highly toxic to coldwater fish and highly toxic to
 warmwater fish.

      c.   Aquatic Invertebrates

      An acute 48-hour LC50 of 0.19 ppm was determined for
 Daphnia magna (Barrows 1985, 1500967).  Technical trichloro-
 s-triazinetrione can be characterized as highly toxic to
 freshwater invertebrates.

      d.   Estuarine and Marine Organisms    ;

      An acute 48-hour EC50 of 0.26 ppm and 96-hour LC50  of
 0.09 ppm for oyster and spot (see Sodium Hypochlorite
 Standard, A. Stavola 1981).  Trichloro-s-triazinetrione can
 be characterized as very highly toxic to estuarine and
 marine organisms.

3. Risk Assessment

 Exposure of nontarget organisms to chlorinated isocyanurates
 may occur via indirect discharge (effluents) or via
 accidental release  (spills).  The Agency does not conduct
 hazard assessments based on these routes of exposure but
 does,'however, require some basic studies to establish
 precautionary label statements:

                            28

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               Precautionary Labeling

     Manufacturing-use and end-use products used where an
     effluent may occur.

     This pesticide is toxic to fish and aquatic organisms.  Do
     not discharge effluent containing this product into lakes,
     streams, ponds, estuaries, oceans or public waters unless
     this product is specifically identified and addressed in an
     NPDES permit.  Do not discharge effluent containing this
     product to sewer systems without previously notifying the
     sewage treatment plant authority.  For guidance,  contact
     your State Water Board or Regional Office of the EPA.


IV. RISK MANAGEMENT AND REREGISTRATION DECISION FOR THE
    CHLORINATED ISOCYANURATES

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
     ingredient 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 chlorinated
     isocyanurate as an 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 chlorinated
     isocyanurate.  Appendix B identifies the generic data
     requirements that the Agency reviewed as part of its
     determination of reregistration eligibility of the
     chlorinated isocyanurates, and lists the submitted studies
     that the Agency found acceptable.

          The data identified in Appendix B are sufficient to
     allow the Agency to conduct a reasonable risk assessment for
     the registered uses of the chlorinated isocyanurates.  The
     data available to the Agency support the conclusion that the
     registered uses of the chlorinated isocyanurates will not
     result in unreasonable adverse effects to the environment.
     The Agency has determined that all products which contain
     the chlorinated isocyanurates as the active ingredient are
     eligible for reregistration for all registered uses.  The
     reregistration of particular products is addressed in
     section V of this document.

          The Agency made its reregistration eligibility
     determination based upon the target data base required for
     reregistration,  the current guidelines for conducting

                                29

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     acceptable studies to generate such data,  and the data
     identified in Appendix B.   Although the Agency has found
     that products containing the chlorinated isocyanurates are
     eligible for reregistration, it should be understood that
     the Agency may take appropriate regulatory action, and/or
     require the submission of additional data to support
     reregistration of products containing the chlorinated
     isocyanurates, if new information comes to the Agency's
     attention or if the data requirements for registration (or
     the guidelines for generating such data) change.

          The following is a summary of the regulatory positions
     and rationales for the chlorinated isocyanurates.  Where
     label revisions are imposed, specific language is set forth
     in Section V of this document.

     Eligibility Decision

          The Agency has sufficient information on the health
     effects of the chlorinated isocyanurates and on their
     potential for causing adverse effects in fish and wildlife
     and the environment for all uses registered for these
     chemicals.  The Agency therefore concludes that products
     containing the chlorinated isocyanurates for these uses are
     eligible for reregistration.  Only product chemistry data on
     certain manufacturing use products are still needed.  The
     Agency has determined that the chlorinated isocyanurate
     products, labeled and used as specified in this
     Reregistration Eligibility Document, will not pose
     unreasonable risks or adverse effects to humans or the
     environment.

     Eligible and Ineligible Uses

     The Agency has determined that all aquatic food and non-food
     industrial and residential, greenhouse food, Indoor Medical
     and Indoor residential, as well as, all Indoor food and non-
     food uses are eligible for reregistration at this time.

B.   REGULATORY POSITION

          Tolerance Reassessment

     There are currently no tolerances or exemptions from the
     requirements of a tolerance established for the chlorinated
     isocyanurate compounds and the Agency believes that none are
     needed.  Further, there are no minor use considerations or
     Codex Maximum Residue Levels for the Chlorinated
     isocyanurates.
                                30

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          Endangered Species Statement:

          The Agency will not impose a special label advisory
          statement for endangered species at this time because
          the chlorine released from the chlorinated
          isocyanurates is so volatile there is little likelihood
          of exposure based on the registered patterns of use or
          from accidental spills.

          Efficacy Data

          Although the Agency has data in its files which
          adequately demonstrate the efficacy of hypochlorous
          acid, microbiological efficacy data will be required
          for some products.


 V. ACTIONS REQUIRED BY REGISTRANTS

     This section is designed to assist the registrant by listing
all of the data requirements and responses necessary for the
reregistration of both manufacturing-use (generic) and end-use
(product specific) products.

A. MANUFACTURING USE PRODUCTS

     1.   Additional Generic Data Requirements

          The generic data base supporting the reregistration of
     the chlorinated isocyanurates products has been reviewed and
     determined to be substantially complete.  Although the
     generic product chemistry data requirements for some
     products are acceptable, additional product chemistry data
     are required to support the reregistration of other
     manufacturing-use/technical products.   The products for
     which additional data are required will be reregistered once
     these data are submitted to and accepted by the Agency.  The
     generic product chemistry data requirements and the products
     for which additional data are required are listed in
     Appendix F.   Registrants are also reminded that any changes,
     since the registration standard was issued in 1988, in the
     manufacturing process for the technical chlorinated
     isocyanurates, and any detection of new impurities since
     that time, must be reported to the Agency.

     2.   Labeling Requirements for Wanufacturing-Use Products

          The labels and labeling of all products must comply
     with EPA's current regulations and requirements.  Follow the
     instructions i-n the Product Reregistration Handbook with
     respect to labels and labeling.  Any product label which

                                31

-------
allows both manufacturing and end use must be amended to
specify only manufacturing or end use.  In this situation,
if a registrant amends his/her label to specify
manufacturing use only and wishes to retain end use
registration, he/she must apply for a separate end-use
product registration.

     Based on the reviews of the generic data, the following
additional (or revised) label statements are required:

a.   In the directions for use, the following statement must
     appear:

     "Formulators using this product are responsible for
     obtaining EPA registration of their formulated
     products."

b.   In the directions for use, the following statement
     regarding acceptable use patterns must appear:

     "For formulation into end-use products intended for
     (list acceptable sites)."

c.  . The following Environmental Hazard statement is
     required for any use that results in discharge into the
     aquatic environment:

     "This pesticide is toxic to fish and aquatic organisms.
     Do not discharge effluent containing this product into
     lakes, streams, ponds, estuaries, oceans or public
     waters unless this product is specifically identified
     and addressed in an NPDES permit.  Do not discharge
     effluent containing this product to sewer systems
     without previously notifying the sewage treatment plant-
     authority.  For guidance, contact your State Water
     Board or Regional Office of the EPA."

d.   Under the Note to Physician, located near the Statement
     of Practical Treatment, the "If Swallowed" statement
     must read as follows:

     "IF SWALLOWED, drink large amounts of water.  DO NOT
     induce vomiting.  Avoid alcohol.  Call a physician or
     poison control center immediately."

     For products in category I for eye irritation, add the
     following:

     "Probable mucosal damage may contraindicate the use of
     gastric lavage."
                           32

-------
     e.   The current label claim for the technical chlorinated
          isocyanurates must be revised to reflect the nominal
          concentrations of the active ingredients as required in
          PR Notice 91-2.

B. END USE PRODUCTS

     1.   Additional Product-Specific Data Requirements

          Based on the reviews of the generic data for
     chlorinated isocyanurates, the products containing the
     chlorinated isocyanurates are eligible for reregistration.
     Section 4(g)(2)(B)  of FIFRA calls for the Agency to obtain
     any needed product-specific data regarding the pesticide
     after a determination of eligibility has been made.  The
     product specific data requirements are listed in Appendix G,
     the Product Specific Data Call-in Notice.

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

          The Agency has decided to continue its current policy
     of waiving the product-by-product efficacy data requirement
     normally levied on sanitizers and disinfectants for
     chlorinated isocyanurate formulations.   The Agency has
     concluded that the published literature can reasonably be
     extrapolated to the full range of these products.  For those
     products for which this waiver cannot be granted product
     specific efficacy requirements will be provided.

     2.   Label Requirements for End-Use Products

          The labels and labeling of all products must comply
     with EPA's current regulations and requirements.   Follow the
     instructions in the Product Reregistration Handbook with
     respect to labels and labeling.   Any product label which
     allows both manufacturing and end use must be amended to
     specify only manufacturing pj; end use.   In this situation,
     if a registrant amends his/her label to specify
     manufacturing use only and wishes to retain end use
     registration,  he/she must apply for a separate end-use
     product registration.

          The  Agency has determined that the current label
     precautions are still applicable and are required for

                               33

-------
product reregistration.  The following additional (or
revised) label statements are required:

a.   The labels must include the following reentry
     statement:  Reentry into treated swimming pool/spas is
     prohibited above levels of 3 ppm of clorine.

b.   Chlorinated isocyanurate products with commercial egg
     wash treatment on the label must contain the following:

     Only clean, whole eggs can be used for sanitizing.
     Dirty, cracked or punctured eggs cannot be sanitized.

     If the product is intended for use as both a cleaner
     and a sanitizer, separate directions for use as a
     cleaner must be provided and followed by a potable
     water rinse, preceding the directions for use as a
     sanitizer with a fresh solution.

     The directions for use in sanitizing eggs must be
     similar to the following:

          "To sanitize clean shell eggs intended for food or
          food products, spray with a solution of & ounce(s)
          of product in & gallon(s) of water (providing x
          ppm active).  The solution must be equal to or
          warmer than the eggs, but not to exceed 130 F.
          Wet eggs thoroughly and allow to drain.  Eggs that
          have been sanitized with this chlorine compound
          may be broken for use in the manufacture of egg
          products without a prior potable water rinse.
          Eggs must be reasonably dry before casing or
          breaking.  The solution must not be reused for
          sanitizing eggs."

          X  Specify

     If the product is intended or recommended for use in
     plants operating under the U.S. Department of
     Agriculture egg grading and egg products inspection
     programs, authorization must be obtained for the
     specific product.  You should consult:

          Compounds and Packaging Section
          Food Ingredient Assessment Division, PSB
          U.S. Department of Agriculture, FSIS
          Building 306, BARC-East
          Beltsville, MD  20705

     If there is any question concerning compliance of the
     product with 21 CFR 178.1010, you should consult:
                           34

-------
          Division of Food and Color Additives
          HF-330 CFSAN
          Food and Drug Administration
          200 C Street SW
          Washington, D.C.  20209

c.   Label claims for end-use products containing
     chlorinated isocyanurates must be revised to reflect
     the nominal concentration of the active ingredient(s)
     in accordance with PR Notice 91-2.
                           35

-------

-------
            APPENDIX A

Table of Chlorinated Isocyanurate Use Patterns
         Subject to Reregistration

-------

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-------
                APPENDIX B

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

-------

-------
                       GUIDE TO APPENDIX B

     Appendix B contains listings of data requirements which
support the reregistration for the pesticide covered by this
Reregistration Eligibility Document. Appendix B contains generic
data requirements that apply to the pesticide in all products,
including data requirements for which a "typical formulation" is
the test substance.

     The data table are generally organized according to the
following format:

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

     2.   Use Pattern (Column 2}.  This column indicates the use
patterns to which the data requirement applies.  The following
letter designations are used for the given use patterns:

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

     Any other designations will be  defined  in a footnote to the
table.

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

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-------
                 APPENDIX C



       Chlorinated Isocyanurates Bibliography


Citations Considered to be Part of the Data Base Supporting
   the Reregistration of the Chlorinated Isocyanurates

-------

-------
                  GUIDE TO APPENDIX C

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

UNITS OF ENTRY.  The unit of entry in this bibliography is
called a "study".  In the case of published  materials,  this
corresponds closely to an article.  In the case  of
unpublished materials submitted to the Agency the Agency has
sought to identify documents at a level parallel to  the
published article from within the typically  larger volumes
in which they were submitted.  The resulting "studies"
generally have a distinct title  (or at least a single
subject), can stand alone for purposes of review, and can be
described with a conventional bibliographic  citation.  The
Agency has attempted also 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 at any time specific reference is required.   It  is
not related to the six-digit "Accession Number" which has
been used to identify volumes of submitted  studies;  see
paragraph 4(d)(4) below for  further explanation.  In a few
cases, entries added to the  bibliography  late in the review
may be preceded by a nine-character temporary identifier.
These entries are listed  after all MRID entries.  This
temporary identifier number  is also to be used  whenever
specific reference is needed.

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

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

-------
b.   Document date.  When the date appears as four digits
     with no question marks, the Agency took it directly
     from the document.  When a four-digit date is followed
     by a question mark the bibliographer deduced the date
     from evidence in the document.  When the date appears
     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 Agency
     bibliographers to create or enhance a document title.
     Any such editorial insertions are contained between
     square brackets.

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

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

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

     (3)  Submitter.  The third element is the submitter,
          following the phrase "submitted by."  When
          authorship is defaulted to the submitter, this
          element is omitted.

     (4)  Volume Identification (Accession Numbers).  The
          final element in the trailing parentheses
          identifies the EPA accession number of the volume
          in which'the original submission of the study
          appears.  The six-digit accession number follows
          the symbol "CDL," standing 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.
          For example, within accession number 123456, the
          first study would be 123456-A; the second, 123456-
          B; the 26th, 123456-Z; and the 27th, 123456-AA.

-------
                            APPENDIX C

              Chlorinated Isocyanurates Bibliography


                 _ _ citation
 00019383   LeBlanc,  G.A.  (1976)   Trichloro-s-triazinetrione: Acute
                Toxicity  of  ACL-85  to  "Daphnia_magna '#.
                (Unpublished study  received Aug  10,  1977 under
                230-50; prepared  by EG&G,  Bionomics  for Monsanto
                Co.,  submitted  by FMC  Corp.,  Industrial Chemical
                Group,  Philadelphia, Pa.;  CDL: 231918-H)

 00026193   McCann, J.A. ;  Pitcher, F.G.  (1973)  $Camp Rapid Algae
                Cure: Toxicity  to RainBow  Trout/:  Test No.  555.
                (U.S. Environmental Protection Agency, Pesticides
                Regulation Div. ,  Agricultural Research Center,
                Animal  Biology  Laboratory, unpublished report) .

 00026195   McCann, J.A. ;  Pitcher, F.G.  (1973)  $Spot-Out: Toxicity
                to Rainbow Trout/:  Test  NO. 583.  (US Environmental
                Protection Agency,  Pesticides Regulation Div.,
                Agricultural Research  Center,  Animal Biology
                Laboratory,  Unpublished  report.)

 00056478   Hu, H.C.  (1981)   Hydrolysis Study  of  Aqueous Sodium
                Salt  Solutions  of 2 , 4 , 6-Trihydroxy-l, 3 , 5-triazine.
                (Unpublished study  received Jan  26,  1981 under
                unknown admin,  no.;  prepared  by  FMC  CORP.,
                submitted by Monsanto  Co., Washington, DC;   CDL
                244259-A)

00063477   Rajasekaran, D. ;  Biava,  C.; Thorstenson,  J.H.; et al.
                (1981)  13-week  Toxicity  Study in Rats:  IRDC No.
                167-151.  (Unpublished study  received Apr 9, 1981
                under unknown Admin. No.;  prepared by California,
                San Francisco Medical  Center,  submitted by
                Monsanto  Co., Washington,  DC,; CDL:  244797-A)

00091031   Sharraa, R. (1981)   An  Evaluation  of  the Mutagenic
                Potential of Sodium Cyanurate Using  the in-vivo
                Rat Bone  Marrow Cytogenetic Assay: SRI Project
                LSC-2923, Task  2; Monsanto Study No. SR-80-522.
                Final rept.   (Unpublished study received Jan  4,
                1982 under 524-107;  prepared  by  SRI  International,
                submitted by Monsanto  Co., Washington, D.C.
                CDL:246547-A)

-------
                            APPENDIX C

              Chlorinated Isocyanurates Bibliography
MRIP
Citation
 00094882   Stewart,  B.E.  (1981) An  Evaluation of the Effect of
                Monosodium  Cyanurate  on  Sister Chromatid Exchange
                Frequencies in  Cultured  Chinese Hamster Ovary
                Cells:  SRI  Project  LSC-2923,!Task  1. Final rept.
                (Unpublished study  received  Feb 17, 1982 under
                1528-984; prepared  by SRI  International, submitted
                by Oli'n Corp.,  Stanford, Conn. , CDL: 246826-A)

 00094883   Kirby, P.E.;  Pizzarello,  R.F.; Brauninger, R.M.; et
                al.   (1981)  Evaluation Test  Article Cyanuric Acid
                (Sodium Salt)  (MRI  #582) for Mutagenic Potential
                Employing the L5178Y  TK+/- MUtagenesis Assay:
                Study No. 013-312-582-7.  (Unpublished study
                received  Feb. 17, 1982 under 1258-984; prepared by
                EG&G Mason  Research Institute, submitted by Olin
                Corp.,  Stanford Conn,; CDL:  246826-B)

 00105168   Schardein,  J.;  Laughlin,  K.; Blair, M.  (1982)
                Teratology  Study  in the  Rat  with   Monosodium
                Cyanurate:   167-159.   (Unpublished study received
                June 11,  1982 under unknown  admin, no.; prepared
                by International  Research  and Development Corp.,
                submitted by Monsanto Co., Washington, DC; CDL:
                247700-A)

 00124782   Serota,  D.; Fezio,  W,;  Hepner, K.; et  al. (1982)
                Thirteen-week Toxicity Study in Mice: Monsodium
                Cyanurate:  Project  No. 2169-100. Final rept.
                (Unpublished study  received  Jan 6, 1983 under  524-
                107; prepared by  Hazleton  Laboratories America,
                Inc., submitted by  Monsanto  Co., Washington, DC;
                CDL: 249192-A)

00126361   Monsanto Co.  (1983) Two Year Oncbgenicity Study  in
                Mice: $Cyanurate/.   (Unpublished study received
                Feb. 17,  1983 under 524-107; CDL:249688-B)

00126362    Blair,  M.; Jefferson,  N.; Geil, R.  (1982) Chronic
                Toxicity  and Oncogenicity  Study in Rats:  $S-
                Triazinetriol/:   167-157.   (Unpublished study
                received  Feb 17,  1983 under  524-107; prepared by
                International Research and Development Corp.,
                submitted by Monsanto Co., Washington, DC;  CDL
                249688-C)   .                 \

-------
                  APPENDIX C

    Chlorinated Isocyanurates Bibliography
                          Citation
 00128287
 00131014
00132426
00132427
00132510
00132603
  Chadwick, M. /  Hayes,  D.; McComish, M. ; et al.  (1982)
      Disposition  and Metabolism of  14C- labeled Sodium
      Cyanurate  in Dog:  C-86329.  (Unpublished study
      received Apr.  29,  1983 under 524-107; prepared  by
      Arthur  D.  Little,  Inc., submitted by Monsanto Co.,
      Washington.  DC; CDL; 250097-A)

  Chadwick, M, ;  Hayes,  D. ; Branfman, A.; et al.  (1983)
      Disposition  and Metabolism of  14C-labeled Sodium
      Cyanurate  in Rat:  C-86329. Rev.   (Unpublished
      study received Aug 29, 1983 under 524-107;
      prepared by  Arthur D. Little,  Inc., submitted by
      Monsanto Co., Washington, DC;  CDL: 251124-A)

Fink, R.  (1975) Eight-day Dietary LC50--Mallard Duck:
      ACL  85: Trichloro-s-triazinetrione: Project No.
      139-113.   Final rept.  (Unpublished study received
      Oct  12, 1983  under 230-47; prepared by Truslow
      Farms,  Inc.,  submitted by FMC  Corp., Philadelphia
      PA;  CDL 251626-E)

Fink, R.  (1975) Eight-day Dietary LC50~Bobwhite Quail:
      ACL  85: Trichloro-s-triazinetrione Project No.
      139-112. Final rept. (Unpublished study received
      Oct  12, 1983  under 230-47; prepared by Truslow
      Farms, Inc.,  submitted by FMC  Corp., Philadelphia,
      PA;  CDL: 251626-F)

Consultox Laboratories, Ltd. (1974) Monosodium
     Cyanurate Teratogenicity Study in the Rabbit: CL
      73:  101: 899.  (Unpublished study received Oct  12,
      1983 under 230-47; submitted by FMC Corp.,
     Philadelphia, PA;  CDL: 251642-A)

Fink, R.  (1976)  Acute Oral LD50~Mallard Duck:  ACL-85:
     Trichloro-s-triazinetrione: Project NO. 139-120.
     Final rept.   (Unpublished study received Oct 12,
     1983 under 230-47; prepared by Wildlife
     International, Ltd.,  submitted by FMC Corp.,
     Philadelphia, PA;  CDL: 251626-G)

-------
                            APPENDIX C       ;

              Chlorinated  Isocyanurates Bibliography


HRID	Citation 	


00144301  Beavers, J. (1984) A Dietary LC50 Study in the Mallard
               with Trichloroisocyanurate Acid: Final Report:
               Wildlife International Ltd. Project No. 201-105.
               Unpublished study prepared by Wildlife
               International Ltd. 14 p.

00144302  Beavers, J. (1984) A Dietary LC50 Study in the Bobwhite
               with Trichloroisocyanurate Acid Final Report:
               wildlife International Ltd. Project No: 201-104.
               Unpublished study prepared by Wildlife
               International Ltd- 14 p.

00150286  Schardein, J. (1985) Three Generation Reproduction
               Study in Rats with Sodium  Salt  of Cyanuric Acid
               (S-Triazinetriol):  Final  Report: Study No.  497-
               001. Unpublished  study prepared by International
               Research and Development Corp.  981 p.

00150962  Robaidek, E.  (1985) Avian Single-dose Oral  LC50  (in)
               Bob White  Quail  (Colinus virginianus):
               {Trichloroisocyanuric Acid}: Final Report:  Study
               No. 6026-435.  Unpublished study prepared by
               Hazelton Laboratories America,  Inc. -26 p.

00150963  Robaidek, E.  (1984) Avian Dietary LC50  {in} Mallard
               Duck  (Anasplatyrhynchos):  {Trichloroisocyanuric
               Acid}:   Final Report: Study NO.  6026-449.
               Unpublished  study prepared by Hazleton
               Laboratories America, Inc.  15  p.

00150964  Robaidek, E.  (1984) Avian Dietary LC50  (in)  Bob  Quail
               (Colinus virginianus):  {Trichloroisocyanuric
               Acid}:   Final Report Study No.  6026-425.
               Unpublished  study prepared by Hazleton
               Laboratories America,  Inc.  12  p.

00150965  Barrows, B.  (1984) The Acute Toxicity Of  TCCA/G
               (Trichlorocyanuric Acid)  to the Bluegill Sunfish,
               Lepomis  macreochirus,  in a Static Test System:
               Biospheric Project No.  84E/058BG.   Unpublished
               study prepared  by Biospherics,  Inc.   11 p.

-------
                            APPENDIX C

              Chlorinated Isocyanurates  Bibliography


MRID	Citation	


00150966  Barrow, B.  (1985) The Acute Toxicity of
               Trichlorocyanuric Acid (TCCA/G) to the Rainbow
               Trout, Salmo gairdneri, in a Static Test System:
               Biospheric Project No. 84E-058RT.  Unpublished
               study prepared by Biospheric, Inc.  11 p.

00150967  Barrows, B. (1985) The Static Acute Toxicity of TCCA/G
               (Trichlorocyanuric Acid)  to the Water Flea,
               Daphnia magna Straus:  Biospherics Project No.
               84E-058DM. Unpublished study prepared by
               Biospherics, Inc.11 p.

00154329  Surprenant, D., Hoberg, J.  (1984) Acute Toxicity of
               Trichloroisocyanurate to the Daphnids (Daphnia
               nagma):  Report BW-84-10-1668.  Unpublished study
               prepared by Springborn Bionomics, Inc.  13 p.

40046502  Richter, J. (1986) Product Chemistry Study:
               Trichloro-S-Triazinetrione.  Unpublished study
               prepared by IMI - Institute for Research and
               Development Ltd. and Fertilizers  & Chemicals Ltd.
               25 p.

40046503 Richter, J.  (1986) Product chemistry Study:
               Trichloro-S-Triazinetrione.  Unpublished study
               prepared by IMI - Institute for Research and
               Development Ltd. and Fertilizers  & Chemicals Ltd.
               36 p.

40200401 Richter, J.  (1986) Product Chemistry Study:
               Trichloro-S-Triazinetrione: Supplement: Lab
               Project: 3307/R4-1577.  Unpublished compilation
               prepared by Fertilizers & Chemicals Ltd. in
               cooperation with IMIInstitute  for Research  &
               Development, Ltd.  7 p.

40046502 Richter, J.  (1986) Product Chemistry Study:
               Trichloro-S-Triazinetrione.  Unpublished study
               prepared by IMI - Institute for  Research and
               Development Ltd. and Fertilizers  & Chemicals  Ltd.
               25 p.

-------
MRID
                           APPENDIX C

              Chlorinated  Isocyanurates Bibliography


                                   Citation	
40046503 Richter, J. (1986) Product Chemistry Study:
               Trichloro-S-Triazinetrione.  Unpublished study
               prepared by IMI - Institute for:Research and
               Development Ltd. and Fertilizers & Chemicals Ltd.
               36 p.

40200401 Richter, J. (1986) Product Chemistry Study:
               Trichloro-S-Triazinetrione: Supplement: Lab
               Project: 3307/R4-1577.  Unpublished compilation
               prepared by Fertilizers & Chemicals Ltd. in
               cooperation with IMIInstitute for Research &
               Development, Ltd.  7 p.

40046502 Richter, J. (1986) Product Chemistry  Study:

Trichloro-S-Triazinetrione.  Unpublished study prepared by IMI -
Institute for Research and Development Ltd.  and Fertilizers &
Chemicals Ltd. 25 p.

40046503 Richter, J. (1986) Product Chemistry  Study:
               Trichloro-S-Triazinetrione.   Unpublished study
               prepared by IMI  -  Institute  for Research and
               Development Ltd. and Fertilizers  &  Chemicals Ltd.
               36 p.

40200401 Richter, J. (1986) Product Chemistry  Study:
               Trichloro-S-Triazinetrione:  Supplement:  Lab
               Project: 3307/R4-1577.  Unpublished compilation
               prepared by Fertilizers &  Chemicals Ltd.  in
               cooperation with IMIInstitute for Research &
               Development, Ltd.   7  p.


40351801  US  Environmental Protection  Agency (1984)  Ambient Water
               Quality Criteria for Chlorine - 1984.   Office of
               Water Regulations and Standards,  Criteria and
               Standards.Div.   Available from NTIS,  PB85-2274-
               429.

-------
                            APPENDIX C

              Chlorinated Isocyanurates Bibliography


 MRID	    Citation
 40414401  Doshida,  A.  (1987)  Trichloroisocyanuric AcidProduct
                Chemistry  ...Product  Identity  and Composition:
                Laboratory  Project  ID:  001/87.  Unpublished
                compilation prepared  by Nippon Soda Co., Ltd. 43p.

 40414402  Doshida,  A.  (1987)  Trichloroisocyanuric AcidProduct
                Chemistry  ...Analysis and  Certification of Product
                Ingredients:  Laboratory Project ID; 002/87.
                Unpublished compilation prepared by Nippon Soda
                Co., Ltd.   138  p.

 40414403  Doshida,  A.  (1987)  Trichloroisocyanuric AcidProduct
                Chemistry  ...Physical and  Chemical
                Characteristics: Laboratory  Project ID: 003/87.
                Unpublished compilation prepared by Nippon Soda
                Co., Ltd.   95 p.

 40802401  Todhunter,. J.  (1988)  Product Analysis Data  and
                Certification of Limits for  Cdf Chimie's Oniachlor
                90,  Oniachlor 60, Oniachlor  EC TICA Granular  and
                SDIC Granular:  Project ID. CDF/PRODANAL.SUB.
                Unpublished study prepared by  Todhunter, Mandava,
                and  Assoc.  46 p.

 40829001  Olin Corp. (1988)  Description of Manufacturing
                Processes;  discussion of Composition  and
                Certification for:  i.  Trichloro-s-triazinetrione;
                sodium dichloro-s-triazinetrione; sodium
                dichloro-s-triazinetrione  dihydrate.  Unpublished
                study.   15  p.

40879501 Nelson, G. (1988)  Product Chemistry:  ACL 90 Plus
                Chlorinating  Composition:  Laboratory  Project  ID
                MSL-8173.   Unpublished study prepared by Monsanto
                Co.  131 p.

40898501 Nelson, G. (1988)  Product Chemistry:  ACL 60 Chlorinating
                Composition:  Project  ID: MSL-8201.  Unpublished
                study prepared  by Monsanto Co.  58 p.

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                           APPENDIX C

             Chlorinated  isocyanurates Bibliography


MRID	Citation   	
40898601 Nelson, G. (1988) Product Chemistry:  ACL 56 Chlorinating
               Composition: Project ID: MSL-8202.  Unpublished
               study prepared by Monsanto Co.  '150 p.

40927401 Nelson, G. (1988) Product Chemistry:  ACL 59 Chlorinating
               Composition: Laboratory Project;ID MSL-8215.
               Unpublished study prepared by Mbnsanto Co.  160 p.

40933103 Mandava, N.; Todhunter, J. (1988) Hi-Lite 60P ...:
               Product Chemistry: Physical and!Chemical
               Characteristics and Other Requirements.
               Unpublished study prepared by Nissan Chemical
               Industries Ltd.  27 p.

40933104 Mandava, N.; Todhunter, J. (1988) Hi-Lite 90P ...:
               Product Chemistry: Product Identity and
               Composition.  Unpublished study prepared by Nissan
               Chemical Industries, Ltd.  32 p.

40933107 Mandaya, N.; Todhunter, J. (1988) Hi-Lite 90G ...:
               Product Chemistry: Product Identity and
               Composition.  Unpublished study prepared by Nissan
               Chemical Industries, Ltd.  32 p.

40933112 Mandava, N.; Todhunter, J.  (1988) Hi-Lite  60G ...:
               Product Chemistry: Physical and Chemical
               Characteristics  and Other Requirements.
               Unpublished study prepared by Nissan  Chemical
               Industries Ltd.   27 p.         \

40933115 Mandava, N.; Todhunter, J.  (1988) Nissan D.C.C.Na.
               Granular  ...: Product  Chemistry:  Physical and
               Chemical characteristics  and Other Requirements.
               Unpublished study prepared by Nissan Chemical
               Industries, Ltd.  27 p.

40933116 Mandava, N.; Todhunter, J.  (1988) Nissan T.C.C.A.
               Granular  ...: Product  Chemistry:  Product  Identity
               and  Composition.  Unpublished  study prepared by
               Nissan Chemical  Industries, Ltd.   32 p.
                                10

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                            APPENDIX C

              Chlorinated  Isocyanurates Bibliography


                                    Citation	
 40992403 Richter,  J.  (1989)  [Product Chemistry]:  ''              <
                Trichloro-s-triazinetrione Tablets:  Laboratory  '.-';,;
                Project:  1988-12.   Unpublished study prepared by,1'
                Fertilizers & Chemicals Ltd.   25 p.             v  -

 41010602 Three-V Chemical Corp.  (1989)  Product Specific Data:   "-
                Analysis  and  Certification of Product Ingredients?
                Oxidan TCA.   Unpublished compilation.   11 p,

 41010702 Three-V Chemical Corp.  (1989)  Oxidan: Analysis and
                Certification of  Product Ingredients.   Unpublished
                study.   10 p.                                   ;

 41044301 Quintini,  M.  (1989)  Trichloro-s-triazinetrione:  Product
                Specific  Data:  Laboratory Project ID:  API 101-88.
                Unpublished study  prepared by Apital Produzioni
                Industrial! S.p.A.   4 p.                        /

 41044401 Quintini,  M.  (1989)  sodium Dichloro-s-triazinetrione: ;  ,
                Product Specific Data:  API 102=88.   Unpublished
                study  prepared by  Apital Produzibni  Industrial!
                S.p.A.  3  p.

 41044402  Quintini,  M.  (1988)  Sodium Dichloro-s-triazinetrione:
                Product Chemistry:  Laboratory Project ID API
                102-88.  Unpublished study prepared  by Apital
                Produzioni Industrial!  S.p.A.   3 p.

41044501  Quintini,  M.  (1989)  sodium Dichloro-s-triazinetrione
                Dihydrate:  Product  Specific Data:  Laboratory
                Project ID API  103-88.   Unpublished  study prepared
                by Apital  Produzioni Industrial! S.p.A. 3 p.

41044502 Quintini,  M.  (1988)  Sodium Dichloro-s-triazinetrione
                Dihydrate:  Generic  Data:  Product Chemistry:
                Laboratory Project  ID API 103-88.  Unpublished
                study prepared  by Apital Produzioni  Industrial!
                S.p.A.  3  p.
                                11

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                           APPENDIX C

             Chlorinated  isocyanurates Bibliography


MRID	Citation	
41054103 Mandava, N.; Todhunter, J. (1989)  Nissan D.C.C.Na.
               Dihydrate Granular: Product Chemistry:  Physical
               and chemical Characteristics and Other
               Requirements.  Unpublished study prepared by
               Nissan Chemical Industries,  Ltd.  130 p.


41072201 Doshida, A. (1987) Sodium dichloroisocyanurate
               dihydrateProduct Chemistry (Sodium
               dichloro-s-triazinetrione dihydrate): Product
               Identity and Composition: Project ID: Nisso/Chiba
               No. 011/87. Unpublished study prepared by Nippon
               Soda Co. , Ltd.  .22 p.

41072203 Doshida, A. (1987) Sodium dichloroisocyanurate
               DihydrateProduct Chemistry (Sodium.
               Dichloro-s-triazinetrione Dihydrate): Physical and
               Chemical Characteristics: Project ID: Nisso/Chiba
               No. 013/87.  Unpublished study  prepared by Nippon
               Soda Co., Ltd. 93 p.

41119301 Shikoku Chemicals Corp.  (1989) Analysis and
               Certification of Product Ingredients: Neo-Chlor
               90: Shikoku-1989-3. Unpublished study prepared by
               Shikoku Chemicals Corp.  11 p.

41513601 Skirkanich, N.  (1990)  Product Chemistry:  Thrifty
               Granular, Thrifty Black Algaecide,  Thrifty  Sticks,
               Thrifty 1" Tablets  and Thrifty  3" Tablets.
               Unpublished study prepared  by Olin  Corp.  Research
               canter.   26 p.
                                12

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       APPENDIX D



List of Available Related Documents

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     Th following is a list of available documents related to
the chlorinated isocyanurates.  Its purpose is to provide a path
to more detailed information if it is needed.   These accompanying
documents are part of the Administrative Record for the
chlorinated isocyanurates and are included in the EPA's Office of
Pesticide Programs Public Docket.

     1.   Health and Environmental Effects Science Chapters

     2.   Detailed Label Usage Information System (LUIS) Report

     3.   Chlorinated Isocyanurate RED Fact Sheet

     4.   PR Notice 91-2 (included in this RED) pertains to the
          Label Ingredient Statement

     Federal publications on the chlorinated isocyanurates are
available and may be purchased from the National Technical
Information Service (NTIS)  5285 Port Royal Road, Springfield, VA
22161. (Phone #: (703) 487-4650.

   .  1.   Guidance for the Reregistration of Pesticide  Products
          Containing Chlorinated Isocyanurates as the Active
          Ingredient  (The 1988 Registration Standard):
          NTIS Stock No. PB88-220660.

     2.   "Compendium of Acceptable Uses"  (The use  index for" the
          1988 Registration Standard) NTIS'Stock No. PB89-122147.

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                   UNfTtD STAT18 ENV1RONMIMTAL
                              WASHNOTOM, O.C.
                            PA MOT1C1 91-2
                                                         * stews *aroac
               NOTICE TO MANUFACTURERS,  PRODUCERS,
                        AMD REGISTRANTS  OF PESTICIDES
  ATTEKTIOM:                                  R.giatration of
  I.    PURPOSE:
                                     .i2E5H*<> '  * t.rm i,
                                                   th  Agency   has
                                                   aecptabl
                                                   product.
 II   BACKGROUND
                                                                .




              !? S?  noainal concentration  th* only 4cc.pt ab la
              or th uount of aetiv* igrodint in th product!
                                                      Utd in th
                                                      l rflcting
                               40  CF* 13.10(9)(3).  Th certified
 n,.         *.             ctiv  i9rdit  ar  intndd  to
153^73* wjT *           manufacturing practice variations 40 CFR
                                                            Pnntta of s~ctt rt f

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                                2.
 The  upper and lower certified liaits,  which must be proposed in
 connection with a product's registration, represent the  amounts of
 an ingredient that may legally be present 40 CFR 153.175. The lower
 certified liait is used as  the  enforceable  lover limit for the
 product  coaposition according to FIFRA section  12(a)(l)(C), while
 the  noainal concentration  appearing  on the label  would  be the
 routinely achieved concentration used  for calculation  of dosages
 and  dilutions.

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

     It  is important for registrants to not* that certified liaits
 for  active ingredients  are  not  considered to  be trade  secret
 information  under FIFRA  section  10(b).   In  this respect  the
 certified liait* will be  routinely provided by EPA to States for
 enforcement purposes, since the nominal concentration appearing on
 th  label  may  not  represent the  enforceable  coaposition  for
 purpose* of section 12(a)(l)(C).

 ZZZ. RZQCXMHBITS

     As  described below under Unit V.   CQNfUAJiCl SOaOOll," all
 currently registered  products as well as all applications for new
 registration must: comply with this  Notice by specifying the nominal
 concentration  expressed as  a percentage by weight as the  label
 claim  in the ingredient(s) statement and equivalence statements  if
 applicable (e.g.,  elemental arsenic, metallic  sine,  salt of  an
 acid).  In addition, the requirement for performing sample analyses
 of five or more representative samples must be fulfilled. Copies of
 the  raw analytical  data  must be  submitted with   the  noainal
 ingredient label  claim.  Further  information  about the  analysis
 requirement say ba found in the 40 cm 131.170.  All products are
 required to  provide certified  liaits  for  each active,  inert
 ingredient,  imparities of  toxicological ignificancaU.e., upper
 liait(a)  only) and on  a  case by casa basis as specified by EPA.
 Tbasa  limits* are to  ba set baaed  oa representative sampling  and
 chemical analysis(i.a., quality control) of the product.

     Tho format of the ingredient  statement oust conform to 40  CFR
 ISC-Labaling  Requirements For Pesticides and  Devices.

     After July 1. 1T,  all peaticids> ingredient statements aust
ba changed to noainal concentration.

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 tV.  PROOCCTS THAT RfQOIM ITflCXCt DATA

      AH paaticidas ar i?quird to be  afficacioua.  Tharafora
 the eartifiad lovar liaits may not be iowar  than tha minimum
 lavai to acaiava Cficacy.  This is axtraaaly  important Cor
 products which ara intandad to control  pasts which threaten tha
 pualic haalth, a.g.,  cartain antimicrobial and rodantieida
 products.  Rafar to 40 cm isa.so.

      In thosa casas whara fficacy liaits hava baan stablishad,
 tha Aqancy will not sceapt careifiad lovar liaits which ara balow
      laval for tha shalf lifa o tha product.
 ".  COMPLXANCZ SCHZOCLE

      As dascribad aarliar,  tha purposa  of  this Hotica is to aaka
 tha raqistration procass aora  uniform and  aora aanaqiabla Cor
 both tha agancy and tha raqulatad covaunity.  it  is tha Agancy's
 intantion to iaplaaant tha  raquiraaants of this notica as
 saoothly as possibla so as  not to disrupt  or dalay tha Aqancy's
 high priority programs,  i.a.,  raragistration, naw chaaical, or
 fast track (7IFKA saction 3(c)(3)(8).  Thar a fora,
 applicants/ragistrants ara  axpactad to  comply with th
 raquiramants of this Notica as Collovst
           (1)   Baginnirxj July i,  191, all nav
                ragistrations aufeaittad to tha
                ar to comply with th raqulraa^nta of this
                Mocica.

           (2)   Roqistrants having products aubjace to
                raraqistration undar rXTKA section 4 (a) arm to
                comply with th rmqairmnt of this Hotica whan
                pacific products ar callad in by th Mancy
                undor Phas v of th Raraqistration trepan.

           (3)   All othsr products/ applications) that arm
                nee subjace to (1) and (2) above will hava until
                July l, 197, to comply with this Monica.
                Such applications) should notsj Conversion
                to Vominal Concantration* on the application
                font. These types of- amendments will no be
                handled as "Fast Track* applications but
                will be handled as routine requests.

                  ZVfOWUTZOM

     Contsce Tyrone) Aiken for information or qoestions concaming
this nOtiCS) Ott (703) 537-5024.
                                             >
                                             ^- '
                                 Anne) t.  Lindsay, Oirestor
                                 Registration Division (H-7305

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      APPENDIX E
Pesticide Reregistration Handbook

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         Unftad States    Office of       Octobar 1991
         Environmental Protection Pesticide Programs
         Agency _,	
v>EPA     Pesticide
          Reregistration
          Handbook
          How to Respond to
          the Reregistration
          Eligibility Document
          (RED)
                          Printed c"

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    PESTICIDE REREGISTRATION HANDBOOK
          HOW TO RESPOND TO  THE




REREGISTRATION ELIGIBILITY DOCUMENT (RED)
       OFFICE OF PESTICIDE PROGRAMS




     ENVIRONMENTAL  PROTECTION AGENCY




               OCTOBER 1991
                                   Printed on

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                  PRODUCT REREGISTRATION HANDBOOK

                        TABLE OF CONTENTS
 I.   Introduction
     A.   Purpose  and Content                           1
     B.   Reregistration Eligibility Document           1
     C.   Reregistration Process                        1
 II.  Instructions for Responding
     A.   How and  When to Respond                       2
     B.   When No  Response Is Needed                    "5
     B.   Where to Respond                              6
 III.  Submission  of Data and Labels/Labeling
     A.   Generic  Data                                  6
     B.   Product  Specific Data                         7
          1.  Product Chemistry                        7
          2.  Acute Toxicity                           8
          3.  Product Performance                      9
     C.   Labels/Labeling                               10
Appendix
     A.   Confidential. Statement of Formula  and Instructions
     B.   Label Contents
     C.   Sample Label FormatsGeneral Use  &  Restricted  Use
     D.   Label Regulations  (40 CFR 156.10)

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                PESTICIDE REREQISTRATION HANDBOOK

 I.  INTRODUCTION

      A.  Purpose and Content of this Handbook

      This Handbook provides instructions to registrants  on how to
 respond  to the  Reregistration Eligibility  Document  (hereafter
 referred to as the "RED")  and how  to reregister  products.

      Section I is this introduction.

      Section II contains step-by-step  instructions which must be
 followed by registrants responding to the RED.

      Section III provides additional  instructions on the format,
 content and other aspects of generic  data, product specific  data
 and labels/labeling which  may be required to  be  submitted.

      Detailed  instructions are in  the Appendix.

      B-   The Rereaistration Eligibility Document fREDl

      Under Section  4  of the  Federal Insecticide,  Fungicide and
 Rodenticide Act (FIFRA), as  amended in 1988, EPA is required to
 reregister pesticides that were first registered before November 1,
 1984.   The RED describes in detail the subject chemical,  its  uses
 and its regulatory history; describes EPA's decision concerning the
 eligibility of the uses of the chemical for reregistration; and
 explains  the scientific and  regulatory bases for this  decision.
 EPA's  reviews1 of the data by scientific  discipline are  available
 upon request.   Appendices  to the  RED contain: (1) a  Data Dall-In
 Notice  which requires submission of generic  and product specific
 data and  which gives directions for responding,  (2)  a listing of
 existing  studies that  satisfy generic data requirements  and  (3)  a
 bibliography of the generic studies EPA has reviewed.

     C.   The Rerecriatration Process

     Reregistration involves a thorough review of the scientific
 data base underlying a pesticide's registration.  The purpose of
 EPA's review is to reassess the potential hazards arising from the
 currently registered uses  of the pesticide,  to  determine whether
 the  data base  is  substantially complete  or there  is  need for
 additional generic data, and to determine whether the pesticide  is
 eligible  for reregistration.  This decision is issued as the RED.
        EPA's  science reviews and  information on the  registered
uses  considered for  EPA's analyses  may be  obtained from:  EPA,
Freedom of Information, 401 M  St.,  S.W.,  Washington,  D.C.  20460.

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     If the RED declares that some or all uses of the chemical are
eligible  for  reregistration,  affected  registrants  must  first
respond within 90 days of receipt to the data call-in portion of
the RED.  Within 8 months of receiving the RED, registrants must
submit  or  cite any  data  and labels/labeling . required  for each
product.  EPA has until 14 months after  the RED is issued (i.e.,
6 months after the  registrants'  8 month deadline)  to review the
submission for  each  product  and  decide  whether. to reregister it
based on the following criteria:

     whether all of the product  specific data and labels/labeling
      are acceptable,

     whether all of the  uses on the label/labeling are  eligible,

     whether all of the active  ingredients  in the product are
      eligible, and

     if no List 1 toxic inert ingredient is contained  in  the
       product  (a List 1 inert is permitted only  if  all data
       for it have been submitted and EPA determines
       that the inert does not pose any unreasonable  adverse
       effects  in that product).           ,

     Products   which  meet  all   of  these  criteria   will  be
reregistered.   Products which do not meet,all of  these criteria,
but which have acceptable product specific data and labeling, will
be processed as amendments  in order to  implement label changes
required by th RED..

II.  INSTRUCTIONS FOR RESPONDING

     A.  How and When to  Respond

     This  section  provides directions  for  submitting timely and
adequate responses necessary to reregister products containing the
active  ingredient  covered by  the RED.   Registrants must  follow
these  steps  exactly to avoid suspension  of  their products.  All
products  containing  the  active  ingredient in  the RED  (i.e.,
manufacturing use products/ end use products and special local need
(SLH or Section 24o)  registrations] are subject to the requirements
of the RED.   figure 1 summarizes how and when to respond to  the
RED.  A step-by-step explanation follows.

     Step  1.    Ara  Expedited  Label  Changes  Required?.    In  some
instances,  EPA  may  conclude that  certain  changes  to  product
labels/labeling must be  implemented  rapidly.   If  the RED requires
expedited label/labeling changes, registrants must submit the items
below  by  the deadline specified in  the RED.  If expedited label
changes are  not required, go to  Step 2.

     a.    Application for Registration (EPA Form 8570-1) .  Complete

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 and sign the  form.   in Section II,  insert the phrase "Expedited
 Amendment in Response to the Reregistration Eligibility Document
 for (insert ease name for chemical)."   Applications  for expedited
 label  changes will  be  processed  as  applications  for  amended
 registration.   Use only  an  original  application  form with a red
 identifier number in  the upper  right-hand  corner.

      b.   Five  (5) copies  of revised  draft  label  and labeling.
 Refer  to the  RED  for  label/labeling changes  and  follow  the
 instructions in Section III.C.  and the Appendix of this Handbook
 for revising the label  and  labeling for each product.

      Step 2.  Are data required?  If the RED requires generic or
 product specific data,  you must follow  the directions  in the data
 call-in notice in the RED.   All registrants must respond for all
 products within 90 days of receipt?  products  for which an adequate
 response is  not received on time will  be subject to suspension. No
 tjme extensions will be given for responding within  90 dava.

           3-    Are Uses of a  Pesticide Eligible for Rereaistratign?
 If  any uses of  the active ingredient (s) covered  by  the RED are
 eligible for reregistration, follow these instructions.  If no. uses
 are  eligible, no. further  response  may be needed  (see page  5).

      EPA's  decision on the  eligibility of each of  the uses of the
 active ingredient (s)  is  presented in the RED.   If anv uses of a
 chemical   are  eligible  for   reregistration,   registrants  for
 manufacturing-use  products  (MPs),  end-use  products  (EPS)  and
 special  local needs registrations  (SLNs),  must  submit the  items
 below for each product within 8 months of the date of issuance of
 the  RED:

      a.   Application  for Reregistration (use EPA Form 8570-1).
 Complete and sign the form.  In Section II of that  form,  check the
 box "Other" and insert the phrase "Application for Reregistration."
 Use only an original application form with a red  identifier number
 in the upper right-hand corner.
                (S)  copies of  revised draft  label and  labeling.
Refer  to the  RED for  labeling changes  specific to  the  active
ingredient,  follow the  instructions  in  Section  III.C.  of  this
Handbook and refer to the Appendix of this Handbook for guidance on
current requirements  for labels and labeling.   If  there  are
ineligible uses on the label or labeling,  you may delete  such uses
and avoid all requirements and consequences which may be associated
with ineligible uses  (e.g, generic data requirements,  cancellation,
suspension, etc.).   If you delete certain uses now and those uses
become  eligible  for  reregistration  later,   you must  submit  an
amendment application to add those uses back  to the  label.

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FIOURB 1.  HOW AND WHEN TO RESPOND TO  THE IREREGISTRATION
           ELIGIBILITY DOCUMENT (RED)  POR MANUFACTURING USB
           PRODUCTS (MPS)/ END-USE PRODUCTS  (EPS)  and SPECIAL
           LOCAL NEEDS REGISTRATIONS (SLNs).
     STEP l:   Are expedited label revisions  required?
                       Yes

               Submit application
               and labels on
               expedited schedule
               specified in RED.

     STEP 2:   Are data required?

                       Yes

               Submit forms within
               90 days for generic
               and product specific
               data.
                     No
                      No
     STEP 3:
                   ^^^
Are any of the uses on the label
eligible for reregistration?
                             Yes
               Are any uses on the  label
               ineligible  for reregistration?
                      Yes

               Do you wish to
               delete ineligible
               uses  from label?
                       .Yes
                      No
For each HP &  EP
& SLH  (240)  submit
application within
8 month*.   If
the submission
is acceptable,
the label  will be
stamped accepted
as an  amendment.
No reregistration
will be issued.
       for each HP  t EP
       6 SLN  (24o)  submit
       application  within
       8 months.  If
       the submission
       is acceptable,
       the label  will  be
       stamped accepted
       and a  notice of
       reregistration
       will be issued.
No further response
necessaxy.  Await
the outcome of
EPA's review.

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      c.    Product specific Data.  You must follow the instructions
 in the Data Call-in Notice in the RED  and  in Section ill of this
 Handbook.   Responses to the data call in are  due within 90 days of
 receipt of  the RED and submission or citation of data  is due within
 8  months of the  issuance of the RED.

      d.    Two  (2) copies of the current Confidential.statement of
 Formula  (EPA Form 8570-4, revised February 85).  Two completed and
 signed CSF forma must be submitted for the  basic formulation and
 for each alternate  formulation,  if CSFS are not provided for the'
 alternate  formulas, they  will  not  be  reregistered  and  will  no
 longer be  acceptable.  The Appendix of this Handbook has specific
 instructions for completing the CSF  form.

      e.  Certification With Respect to Citation of Data  (EPA Form
 8570-31).   This  form must  be  completed,  signed and submitted for
 each product to  assure that  the  data  compensation provisions of
 FIFRA are met.

      B.  When No Response  is  Needed

      If no  uses of a pesticide are eligible for reregistration, it
 is  unlikely that you will  be  required  to submit product  specific
 data or labeling.    Uses of  an active ingredient may be  declared
 ineligible  for reregistration for two possible reasons:

      Available data indicate that one or more of the criteria for
 an  in-depth special  review have been metj

      Additional generic data are required.

      In the first instance,  if the active ingredient is placed into
 special  review,  reregistration activities associated  with  those
 uses  of  the  chemical  are  stopped  until   EPA  makes   a   final
 determination.   At that time, EPA will indicate which uses may be
 eligible for reregistration and which uses are to be cancelled.  If
 some  or all  of the previously ineligible uses become eligible for
 reregistration,  EPA will  start  the reregistration process for
 products containing  only eligible uses.

      In the second instance,  based upon the  review of studies for
 an active ingredient during reregistration, additional generic data
 (e.g., second- or third-tier studies) may be needed (see  the RED).
 In  such cases,  the  chemical's uses  will  not  be  eligible for
 reregistration   until  the  additional  generic  data  have been
 submitted to and  reviewed and  found acceptable by EPA.  If the data
 are  reviewed and found to  be  acceptable, EPA will indicate which
uses  will   be eligible  for   reregistration  and will   initiate
 reregistration of products containing previously  ineligible uses.
 If  the data are not  submitted,  products containing the  active
 ingredient  may be suspended.

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     C.  Where to Respond

By U.S. Mail:

     Document Processing Desk (insert distribution  coda)
     Office of Pesticide Programs (H7504C)
     Environmental Protection Agency
     401 M Street, S.W.
     Washington, D.C. 20460-0001

By express mail or by hand delivery:
                                        t
     Document Processing Desk (insert distribution  code)
     Office of Pesticide Programs (H7504C)
     Room 266A, Crystal Mall 2
     1921 Jefferson Davis Highway
     Arlington, VA 22202

     These mailing .addresses and the following distribution codes
must be used to assure the  timely receipt  and processing of your
submissions.  Not using them may significantly delay the handling
of your submissions:

     RED-SRRD-Jope (where xxx is  the case code given  on the front of
the RED)use this distribution code for all responses pertaining
to or containing generic data.  Such responses include the 90-day
response forms for generic data or hard copies of generic data.

     RED-RD-PMxx  (where xx is the Product Manager team number)
use  this  distribution  code  for  all  responses pertaining  to or
containing product specific data or labeling.  Such  responses would
include expedited labeling amendments,  90-day responses to product
specific data  requirements,  hard copies of product specific data
and applications for reregistration.


III.  SUBMISSION OF DATA AND LABELS/LABELING

     This  section  provides  additional instructions  concerning
responses  required for generic data,  product  specific  data  and
labels/labeling.

     A.  Generic Data

     During  EPA's  evaluation   of  an  active  ingredient   for
reregistration,  additional  generic   data  requirements  may  be
identified that registrants must fulfill.  In some  instances these
data requirements would  have  to  be  satisfied  before  an  active
ingredient  or  some  of its  uses  could be declared eligible  for
reregistration.  In other cases, these new data requirements would
not affect the eligibility of the active ingredient,  but would be
necessary to confirm EPA's assessment  of that chemical.

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      Any new data requirements and how they affect reregistration
 eligibility of a chemical are discussed in the RED.  If new generic
 data requirements are imposed  in a Data Dall-ln Notice in the RED,
 registrants must respond as described in that Notice.  The RED also
 contains instructions  for  completing  these forms, a citation  of
 EPA's legal  authority for requiring the  new  data,  a listing  of
 options  available   to  registrants  for  satisfying  the   data
 requirements and the name of the  contact person for inquiries.

      B.   Product Specific
      Product specific data may be required for the  reregistration
 of each pesticide product  in three areasproduct chemistry,  acute
 toxicity and efficacy.
      1-   Product Chemistry
      Following are  instructions  for submitting  product-specific
 data and a discussion of EPA's policy on inert ingredients.

           a.   Data

      All data  requirements for  MPs, EPs  and SLNs  (24c's)  are
 specified in  the  Data Call-in  Notice in  the RED.   In  addition:

       If  you cite  data  from   another  identical,   registered
 product,  you must  identify the EPA  registration number of  that
 product .

      --If the  product-specific data  submitted or cited do  not
 pertain  to an identical formulation to the product submitted for
 reregistration., then new product-specific data are required  to be
 submitted by  the deadline  specified  in  the Data  Call-in Notice.
 The  only exception is for products which EPA  "groups"  together a
 being similar enough to depend on the same data.  Such groupings
 are  discussed  in the  appendix to  the  RED  (for acute  toxicity
 purposes,  for example),  if it  was  feasible  to  do  so.

          b.   Inert  Ingredient?

      EPA   has  implemented  a  strategy  for  regulating   inert
 ingredients which affects the reregistration of pesticide products.
This  strategy,  issued on April 22,  1987 (52 FR  13305-13309)  and
updated on November  22,  1989 (54 FR  48314-48316),  adopted certain
policies designed to reduce the potential for adverse  effects from
pesticide   products   containing    intentionally  added   inert
ingredients.   EPA divided  the  known inert ingredients  into four
categories:

      Inerts of toxicological  concern (List 1) for which available
data  demonstrate   toxic effects  of  concern  (includes about  50
chemicals) .

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     Potentially toxic inerts  (List  2)  for which only limited
data are available, but such data or the chemical structure suggest
the potential for toxicity (includes  about 60 chemicals).

     Inerts of unknown toxicity  (List ;3)  for which no data or
bases for suspecting toxic effects are available  (includes up to
2,000 chemicals).

     --Inerts of minimal concern  (List  4)  which are  generally
regarded as innocuous (includes about 290  chemicals).

     When a RED is issued and any uses of an active ingredient are
declared eligible for reregistration, all products containing that
active ingredient .will be subject to reregistration.  EPA will, as
part of the  reregistration review, examine  the inert ingredients of
each product prior to reregistration to  ensure that they  do not
present unreasonable  risks.   In reviewing the  product  chemistry
data,  EPA  will  identify  List  1  inerts.   EPA  will continue to
encourage registrants to eliminate  any  List 1  inerts present.
Reregistration of products containing  only List 2,  3  or 4  inerts
will be unaffected by the inerts strategy.

     Consistent with the strategy on inerts,  a product containing
a List  1 inert  ingredient will not be reregistered until  a full
risk assessment  of the product has been  conducted,  based  on  the
data called in for that inert  ingredient.   However, the existing
registration of  a  product containing a List 1  inert will  remain
valid as long as the product bears the required label warning and
is in compliance with any outstanding DC1, or other  activity under
the inerts  strategy.

     Any  product  containing  a List  2,   3   or 4  inert  max  b
reregistered if it meets all other requirements for reregistration.
As the inerts strategy  is implemented and data  for  the  List 2 and
3  inerts are reviewed,  EPA may move  these  inerts  to  the other
Lists.  If an inert were moved to List l,  products containing that
inert  would   become   ineligible  for  reregistration.    Inert
ingredients must  also meet  normal  registration  and tolerance
requirements, as applicable.

     2.  Acute Toxicitv

     The  data call-in notice  in  the RED   specifies  the acute
toxicity data  required for reregistration of each MP  or  EP.   It
indicates whether any of the standard  tests  have been waived and,
if so, why.

     If feasible, EPA will  "batch" products  that are similar with
respect  to  their  acute toxicity  so  that  one set of tests can
support reregistration of each baatch of  products.   This approach
will  impose the least  amount  of testing - necessary to  adequately
support the registration and labeling for pesticide products.  T*e

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 main benefits of this approach are to minimize the need  for animal
 testing,  reduce the expense to registrants to generate the tests
 and  decrease  the  resources  EPA must  spend on  reviewing data.
 Registrants may contact other registrants with products in the same
 "batch" to decide whether to provide or depend on  one set  of data;
 alternatively, registrants may choose to conduct their own  studies.

      3.  Product Performance

      Consult  the  Data  Call-in section of the RED  to determine
 whether Product Performance data  are  required.for  your product.

      Product performance  (efficacy) data are generated in studies
 designed  to document how candidate pesticide formulations perform
 as pest control agents.  These data include tests  run to determine
 whether  a  formulation is  lethal  to certain  pest  species,  to
 document  the effectiveness of  the formulation in controlling pest
 species in  actual use situations, and to determine  whether certain
 claims beyond mere control of  a  pest (e.g., "six-month  residual
 effect,"     "kills  Warfarin  resistant house  mice," -etc.)  are
 justified.

      EPA  has  standard  protocols  for certain  efficacy  tests.  In
 general,  standard methods have  been developed for  tests needed to
 substantiate claims that  have been made frequently  for pesticide
 products.  As the scope  of potential pesticidal claims is extremely
 broad,  the  Agency does  not have standard methods  for tests needed
 to substantiate many pesticide claims,  especially those  that are
 uncommon.  The Product Performance Guidelines, Subdivision G, offer
 general guidance for developing  protocols for efficacy  testing.
 Proposed  protocols should be submitted to EPA for  review before
 tests are initiated.

      a.   Efficacy Data  Submission Waiver Policy

      FIFRA gives the Administrator of EPA  authority "to  waive data
 requirements  pertaining to efficacy" but does not require that
 efficacy  data  requirements be waived for  any class of pesticide
 product registered under Section 3  of  the Act.   As a matter of
 policy, EPA does not require submission of efficacy data to support
 many types of pesticidal claims but does require submission of such
 data  for certain types of claims.  As  noted in 40 CFR 158.640, this
 waiver  applies to the  submission of efficacy data rather than to
 the generation of efficacy data.   EPA expects each  registrant to
 "ensure through testing that his products are efficacious when used
 in accordance  with  commonly accepted  pest  control  practices."

     This general policy notwithstanding, EPA  may,  at any time,
 require a registrant to submit  efficacy data to support any claim
made  for  a  product. EPA  also may require that certain claims of
effectiveness  be established before  a Section 3   registration  is
granted.

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                               10

     b.  Claims and Products for  Which  Efficacy Data Generally
          Are Required

     Submission of  efficacy  data at reregistration typically is
required for the following types  of products:

          1.   products claimed to control  microorganisms that
               pose potential threats to public health;

          2.   products claimed to control vertebrate pests  that
               may  directly  or  indirectly  transmit  diseases to
               humans;

          3.   potentially very hazardous products for  which EPA
               determines that it is  necessary to conduct a "risk-
               benefits" analysis;

          4.   products of types for which EPA has reasons (e.g.,
               consumer complaints,  unlikely claims,  unusual use
               patterns, etc.) to question claims; and

     C.  Labels and Labeling

     To remain in compliance with FIFRA, the label and labeling of
each  product  must  be  revised   to meet  the  requirements  for
reregistration  as  described  below.    "Labeling"  includes  the
container  label  and-any written,  printed  or  graphic  matter that
accompanies  the  pesticide in U.S. commerce at any time (such as
technical bulletins, collateral labeling, etc.).  Applications for
new uses or labeling changes that do not pertain to reregistration
must be  filed separately from the application for reregistration
described  in Step 3 earlier.  Changes to  labeling which must be
made for reregistration  include,  but are not limited to:
                                            i
     1.  Labeling changes  specified  in the RED.  Such changes may
include  statements,  on  RESTRICTED  USE,  groundwater hazards,
protective  clothing/equipment, endangered species, environmental
hazards, etc.

     2.  The  format and content of labeling as described in 40 CFR
156.10.    When further  acute testing is needed,  the  currently
accepted precautionary statements will  usually be  retained until
testing  is completed  and the data are  reviewed.

     3.   Labeling  changes required by  Pesticide  Regulatory (PR)
Notices, regulations,  regulatory decisions and policies issued  by
EPA which  are relevant to the pesticide.  Your product's labeling
must reflect any applicable requirements which are in effect at the
time the RED is  issued.   Some existing notices are referred to in
Section  B.  of the Appendix.

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APPENDIX
A.  Confidential Statement of Formula and Instructions
B.  Instructions for Label Contents
C.  Sample Label FormatsGeneral Use & Restricted Use
D.  Label Regulations- (40 CFR 156.10)

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     instruction? for  Completing  tha Confidential  Statement  of
     The Confidential Statement of  Formula  (CSF)' Form 8570-4 must
be used.  Two legible, signed copies  of  the form are required.
Following are basic instructions:

     a.  All the blocks on the form  must  be  filled in and answered
completely.

     b.  If any block is not applicable, mark it N/A.

     c.  The CSF must be  signed, dated and the telephone number of
the responsible party must be provided.

     d.   All  applicable information which is on the product-
specific data submission must also be reported on .the CSF.

     e.  All weights  reported under  item 7 must be in pounds per
gallon  for liquids and pounds per cubic feet for solids.

     f.    Flashpoint must  be  in  degrees  Fahrenheit  and  flame
extension in inches.

     g.  For all active  ingredients, the EPA Registration Numbers
for the currently registered source products must be reported under
column  12.

     h.   The  Chemical Abstracts  Service   (CAS)  Numbers  for all
actives and inerts and all common names  for the trade names must be
reported.

     i.   For the  active ingredients,  the percent purity  of the
source  products must be  reported under  column ; 10  and  must be
exactly the same as  on the source  product's label.
in
      1.   All the  weights in columns  13. a.  and 13. b. must be
 nounds, kilograms,  or grams.  In no case will volumes be accepted.
 D^not Sx English1 .aid metric  system units  (i.e.,. pounds  and
 kilograms) .

      Jc.   All the; items under column 13. b.  must total 100 percent.

      1.   All item* under columns 14^a. and  14. b.  for the active
 ingredients must represent pure active form.

      m.   The upper and  lower certified limits for all active and
 inert ingredients must follow the 40 CFR 158.175 Jjfajf^fJJ- ejj
 explanation must b provided if the proposed limits  are different
 than standard certified limits.

      n.   When new  CSFs are submitted  and approved, all previous. /
 submitted CSFs become- obsolete for that specific formulation.

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                 B.   INSTRUCTIONS  FOR TABEL CONTENTS


       40 CFR 156.10 and Pesticide Regulatory  (P.R.) Notices require
       fJSf,   TH.     tngi statements appear at certain locations on
       aDeJ. .  Tne amn I a 1 a Vial  ^^.-.4._ i_	a-._^_
  Item 1.  PRODUCT NAME - The name, brand or trademark is required to
  *  3OCat*? n th,G frnt pane1' Preferably  centered .in  the upper
  pa      ^he Pane;!-'   The name f a product will not be accepted if
  it  is  false or misleading.  [40 CFR I56.10(b)]

  Item 2.   COMPANY NAME AND ADDRESS - The  name  and  address of the
  producer, registrant or person  for whom the product  is produced are
  required on the  label  and should be  located at the bottom of the
  front  panel or at the end of the label text. [40 CFR I56.10(c)]

  Item 3.  NET CONTENTS - A net contents statement is  required on all
  labels  or on  the container  of the pesticide.   The.  preferred
  location is the  bottom of the front panel  immediately  above the
 company name and address, or at the end of the label text.  The net
 contents must be expressed in the largest suitable unit, e.g.  "i
 pound 10 ounces" rather than "26 ounces."  in addition to English
'? fA,I\    contents  may  be expressed  in metric units.    [40 CFR
 156 . 10  (d) ]

 Item 4 . EPA REGISTRATION NUMBER - The registration number assigned
 to the  pesticide product must appear  on the label, preceded by the
 phrase  "EPA Registration No.,"  or "EPA Reg. No."  The registration
 number  must be set in  type  of a size and style  similar to other
               -P*art of *he label on wnich it appears  and must run
             *       ^f  re9istration  number  and  the  required
             phrase must not  appear  in such a manner as to suggest
                                                              the
 Item  5.   EPA ESTABLISHMENT NUMBER - The EPA establishment number
 S?S! tJ  y ^* hrase  "EPA  Est-" i the  final  establishment at
 which the product was  produced, and may  appear in  any suitable
 location on  the label or immediate container.  It must also appear
 n* J?fi ^raPPer or outside container  of the  package if  the  EPA
 establishment number on the immediate  container cannot De clearly
 read  through such  wrapper  or  container.   [40 CFR I56.10(f)]

 Item  6A.   INGREDIENTS STATEMENT - An  ingredients  statement is
^^l7/^1^  n tha front pane1'   The ingredients  statement
must  contain the  name and percentage  by  weight of  each active
 ingredient  and  the  total percentage   by   weight  .of  all  inert
 ingredients.   The  preferred  location   is  immediately below  the
product  name.   The ingredients statement must run  parallel with,
and be clearly distinguished  from,  other  text on the panel.   it
must not be placed in the  body of other text.   [40  CFR 156. 10 (g) ]

Item  6B.   POUNDS  PER GALLON  STATEMENT - For  liquid  agricultural

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formulations,  the pounds per gallon of active ingredient must be
indicated on the label.  [40 CFR 156.10(h)(iv)]

Item 6C.  NAMES TO BE USED IN INGREDIENT STATEMENT - The acceptable
common name,  if there  is one,  shall  be used,  followed by the
chemical name.    If no  common  name  has been  established,  the
chemical name alone  shall be used.  Chemicals related to the active
ingredient  are  allowed  to be  listed  only  if  efficacy data
supporting such claims are submitted or referenced.   If  such data
are provided, the related chemicals must be  listed separately and
not as a portion of the active ingredient.

Item 6D.  INERT INGREDIENTS RECLASSIFIED AS ACTIVE INGREDIENTS -  If
EPA has  reclassified chemicals  from  inert  ingredient  status  to
active ingredient  status,  registrants of affected  products  must
change the  ingredient  statement accordingly (See  52  FR 13307-8,
April 22,  1987).   If such  pesticides have  food uses, tolerances
must either be established for such uses, or an exemption from the
requirement for tolerances must be obtained.

Item 6E.  NOMINAL CONCENTRATION - The amount of active ingredient
declared   in  the   ingredient  statement must  be  the  nominal
concentration of the product as defined in  40 CFR 158.153(i) and
described  in P.R. Notice  91-2.

Item  7.    WARNINGS  AND PRECAUTIONARY  STATEMENTS -  Front panel
precautionary  statements  must  be grouped  together, preferably
within a block outline.   The  table below  shows the  minimum type
size requirements  for various  size labels.
Size of  Label  on
Front  Panel
in square  Inches

5 and  under

above  5  to 10

above  10 to  15

above  15 to  30

over 30
Signal Word
Minimum Type Size
All Capitals	

6 point

10 point

12 point

14 point

18 point
"Keep Out of Reach
of Children"
Minimum Type Size

6 point

6 point

8 point

10 point

12 point
 Item 7A.   CHILD HAZARD WARNING STATEMENT - The statement "Keep Out
 of Reach of Children" must be located on the front panel above the
 signal word except where contact with children during distribution
 or use is unlikely.   [40 CFR  I56.10(h)(1)(ii)]

 Item 7B.    SIGNAL WORD  -  The  signal word  (DANGER,  WARNING,   or
 CAUTION)  is required on the front panel immediately below the child
 hazard warning statement.  [40  CFR  156.10(10(1) (i) ]

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 Item  7C.    SKULL &  CROSSBONES  AND WORD  "POISON"  - On  products
 assigned  a  toxicity Category I on the basis of  oral,  dermal,  or
 inhalation toxicity, the word "Poison" shall appear on the label in
 red on a  background  of distinctly contrasting color and the skull
 and  crossbones  shall appear in  immediate proximity to  the  word
 POISON.   [40 CFR 156.10(h)(1)(i)].

 Item  7D.    STATEMENT OF PRACTICAL TREATMENT  - A  statement  of
 practical treatment  (first aid  or  other) shall appear on the label
 of pesticide products in toxicity Categories I,  II,  and III.   [40
 CFR 156.10(h)(1)(iii)]

 Item 7E.  REFERRAL  STATEMENT -  The statement "see  Side (or Back)
 Panel for Additional Precautionary Statements" is required on the
 front panel  for all products,  unless  all required  precautionary
 statements appear on the front panel.   [40 CFR I56.l0(h)(1)(iii)].

 Item 8.  SIDE/BACK PANEL PRECAUTIONARY LABELING - The precautionary
 statements listed below  must  appear together on the label under the
 heading "PRECAUTIONARY STATEMENTS."  The preferred location is at
 the top of the side or back panel preceding the directions for use,
 and it is preferred that these  statements  be  surrounded by a block
 outline.   Each  of  the  three hazard  warning statements must be
 headed by the appropriate hazard title.   [40 CFR 156.10(h)(2)]

 Item 8A.  HAZARD TO  HUMANS AND  DOMESTIC  ANIMALS  -  Where a hazard
 exists to humans or domestic  animals, precautionary statements are
 required indicating the  particular hazard, the route(s)  of exposure
 and  the  precautions  to be  taken to  avoid accident,  injury or
 damage.   [40 CFR 156.10(h)(2)(i)]

 Item 8B.   ENVIRONMENTAL HAZARD -  Where  a hazard exists to non-
 target   organisms   excluding   humans   and  domestic  animals,
 precautionary statements are required stating the  nature  of the
 hazard and the appropriate precautions to avoid potential accident,
 injury, or damage.   [40 CFR  156.10(h)(2)(ii)]

 Item 8C.   PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY Precautionary
 statements relating  to  flammability of a product are required to
 appear on the  label  if it  meets  the criteria  in  the  PHYS/CHEM
 Labeling Appendix.  The requirement is based on the  results of the
 flashpoint determinations and flame extension tests  required  to be
 submitted for all products.   These statements are to be located in
 the side/back panel  precautionary  statements section,  preceded by
the heading "Physical/Chemical Hazards."   Note that no signal word
 is used in conjunction with  the flammability statements.

 Item 9A.   RESTRICTED USE CLASSIFICATION - FIFRA sec. 3 (d) requires
 that all  pesticide  formulations/uses be classified  for either
general or restricted use.  Products classified  for restricted use
may be limited  to use  by certified applicators or persons  under
their direct supervision (or may  be subject  to other  restrictions
that may  be imposed by regulation) .   If your  product has  been
classified for  restricted use,  then these requirements apply:

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1.    All~ue restricted.  The following statements must be placed
     in a black box at the top of the front panel  of the label and
     labeling:

     a.   The statement  "Restricted Use Pesticide" must appear at
          the top of the.front panel of the label.  The statement
          must be set in type of the same minimum  size as required
          for  human hazard  signal word  [see table  in  40  CFR
          156.10(h)(1)(iv) ].   No statements of any kind may appear
          above this RUP statement.

     b.   The reason.for the the restricted use classification must
          appear below the RUP statement.   The RED will prescribe
          this statement.

     c.   A  summary  statement of  the  terms of  restriction must
          appear directly below this reason statement on the front
          panel.   If use  is  restricted to' certified  applicators,
          the following  statement is required:  "For retail sale to
          and use  only  by Certified Applicators  or persons under
          their direct supervision  and  only for those uses covered
          by the Certified Applicator's Certification."   The  RED
          will specify what statement must be used.

2.    Some but not all uses restricted.  If the RED states that some
     uses  are  classified  for  restricted  use,  and  some  are
     unclassified, several courses of action are available:

     a.   You may label the product for Restricted use.  If you do
          so,  you  may include   on  the  label  uses  that  are
          unrestricted, but  you  may not distinguish them on  the
          label as being unrestricted.

     b.   You may  delete  all restricted uses from your label and
          submit draft  labeling bearing only unrestricted uses.

     c.   You  may "split" your registration,  i.e.,  register two
          separata products  with  identical  formulations,  one
          bearing  only  unrestricted uses,  and the other bearing
          restricted uses.   To do  so,  submit two applications  for
          reregistration, each containing  all forms and necessary
          label*.     Both   applications   should   be  submitted
          simultaneously.  Note that the products will  be  assigned
          separate registration numbers.

Item 9B.   MISUSE  STATEMENT  - All  products must bear the misuse
statement, "It is a violation of Federal law to use this product in
a manner inconsistent with its labeling."   This  statement appears
at the beginning of the directions for use,  directly  beneath the
heading of that  section.

Item 10A.  REENTRY STATEMENT - If a restricted entry interval (RED
has been established by  the Agency,  it  must be included on tr.e
label.  Additional worker protection statements may be required .n

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accordance'with PR Notice 83-2, March 29, 1983.

Item 10B.  STORAGE AND DISPOSAL BLOCK - All labels are required to
bear  storage  and disposal  statements.    These  statements  are
developed  for  specific containers,  sizes, and  chemical  content.
These instructions must  be grouped and  appear  under  the heading
"Storage and Disposal"  in the directions for use.  This heading
must be set in  the same type sizes as required for the child hazard
warning.   Refer to P.R.  Notices  83-3  and 84-1 to  determine the
storage and disposal instructions appropriate for your products.

Item IOC.  DIRECTIONS FOR USE - Directions for use must be stated
in terms which can be easily read and understood by  the average
person  likely  to  use or  to  supervise  the use  of the pesticide.
When followed,  directions must  be adequate to  protect the public
from fraud  and from personal injury and to  prevent unreasonable
adverse effects on the environment.   [40 CFR 156.10(i)(2)]

COLLATERAL LABELING .

Bulletins,  leaflets,  circulars,  brochures, data  sheets, flyers, or
other written or graphic printed matter which is referred to on the
label or which is to  accompany the  product  are termed collateral
labeling.   Such labeling may not bear  claims  or representations
that differ  in substance from  those accepted  in connection with
registration of the product.  Collateral labeling must be made part
of the response to the RED and  submitted for review.

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   Environmental ProtectIon Agency

   submitter has asserted a  confidential
   business information claim concerning
   the material).
    (5) A copy of each document, propos-
   ^ Or other  item of written material
   concerning the Registration Standard
   provided by the Agency to any person
   or  party   outside  of   government
   (within  15 working days after the item
   is made available  to  such person or
   party).
    (6) A copy of the Registration Stand-
   ard:
    (7) With respect  to  a Registration
  Standard for which the Agency  has
  determined that a substantially com-
  plete chronic health  and  teratology
  data base exists, a copy of the FEDERAL
  REGISTER notice concerning availabil-
  ity of a  proposed Registration Stand-
  ard, and a copy of each comment re-
  ceived in response  to that notice
  (within 10 working days after receipt
  by the Agency, or 15 working days if
  the submitter has asserted  a confiden-
  tial business  information  claim  con-
  cerning the material).
   (8) A copy of the FEDERAL REGISTER
  notice announcing the issuance of the
  Registration   Standard  (within   10
  working days  after  the publication  of
  the notice).
   (c) Index of the docket. The Agency
 will establish and  keep  current  an
 index to the docket for each Registra-
 tion Standard. The index will  include,
 but is not limited to:
   (1) A list of each  meeting between
 the Agency  and any person or party
 outside of government, containing the
 date and  subject of the meeting, the
 names of  participants and the name of
 the person requesting the meeting.
   (2) A list of each document in the
 docket by title, source or recipients),
 and the  date  the  document  was  re-
 ceived or provided by the Agency.
  (d) Availability of docket  and indi-
 ces. (1) The Agency will make avail-
 able to the public for inspection and
 copying the docket and  index  for any
 Registration Standard,
  (2) The Agency will  establish  and
 maintain a mailing list of persons who
 have specifically requested  that they
 receive Indices for Registration Stand-
 ard dockets. On a quarterly basis, EPA
will distribute the indices of new mate-
rials placed  in the  public  docket to
                              154.10

 these persons. Annually, E ""A will re-
 quire that persons on the list renew
 their requests for inclusion on the list.
   (3) The Agency will issue annually in
 the FEDERAL REGISTER (in conjunction
 with the annual schedule notice speci-
 fied  in  S 155.25) a notice announcing
 the availability of docket indices.
   (4) Each FEDERAL REGISTER notice of
 availability of a Registration Standard
 will announce the availability of the
 docket index for that Standard.

  155.34  Notice of availability.
   (a) The Agency will issue in the FED-
 ERAL REGISTER a notice announcing the
 issuance and  availability of  Registra-
 tion Standard which:
   (1) Concerns  a previously  unregis-
 tered active ingredient; or
   (2) Concerns a previously registered
 active ingredient, and the Registration
 Standard states  that  registrants  will
 be required  (under FIFRA  section
 3(c)(2)(B)) to submit  chronic health
 (including, but not limited to, chronic
 feeding,  oncogenicity  and reproduc-
 tion) or teratology studies.
  (b)  Interested  persons ma"y submit
 comments  concerning  any  Registra-
 tion Standard described  by paragraph
 (a) of this section at any  time.
  (c) The Agency will issue in the FED-
 ERAL REGISTER a notice announcing the
 availability of, and providing opportu-
 nity for comment  on, each  proposed
 Registration Standard which concerns
 a  previously registered active ingredi-
 ent for which the Agency has deter-
 mined that a substantially  complete
 chronic  health  and  teratology data
 base  exists. Following the comment
 period and  issuance of  the Registra-
 tion Standard, the Agency will issue in
 the FEDERAL REGISTER a notice of avail-
 ability of the Registration Standard.

 PART    156LABEUNO   REQUIRE-
  MENTS FOR PESTICIDES AND  DE-
  VICES

 AUTHORITY: 7 U.S.C. l36-136y.

 154.10  Labeling requirements.
 (a)  General(1)  Content*  of   the
label  Every  pesticide products shall
bear a label containing  the informa-
 tion specified by the Act and the regu-
                                    75

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 156.10

 lations in this Part. The contents of a
 label must show clearly and promi-
 nently" the following:
  (i) The name,  brand,  or  trademark
 under which the product is sold as pre-
 scribed in paragraph  (b) of this sec-
 tion;
  (ii) The name and  address of the
 producer,  registrant,  or  person for
 whom produced as prescribed in para-
 graph (c) of this section;
  (iii)  The net contents as prescribed
 in paragraph (d) of this section;
  Civ)   The   product   registration
 number as prescribed in paragraph (e)
 of this section;
  (v)  The   producing  establishment
 number as prescribed in paragraph (f)
 of this section;
  (vi) An Ingredient statement as pre-
 scribed in paragraph  (g) of this sec-
 tion;
  (vii) Warning or precautionary state-
 ments as prescribed in paragraph (h)
 of this section;
  (vlil) The  directions for use as pre-
 scribed in paragraph (i) of this section;
 and
  (ix)  The use classiflcation(s) as pre-
 scribed in paragraph (j) of this section.
  (2) Prominence and  legibility, (i) All
 words, statements, graphic representa-
 tions,  designs or other information re-
 quired on the labeling by  the  Act or
 the regulations in this part must  be
 clearly legible to a person with normal
 vision, and must be placed with such
 conspicuousnes* (a  compared  with
 other word*, statements, designs,  or
 graphic matter on the labeling) and
 expressed in such terms-as to render it
 likely to be read  and understood  by
 the ordinary individual under custom*
-ary conditions of purchase and use.
  (ii) All required label text must:
  (A) Be set in 6-point or larger type;
  (B>  Appear  on  a clear  contrasting
 background; and
  (C) Not be obscured or crowded.
  (3) Language to 6 used. All required
 label or labeling text shall appear  in
 the English language. However, the
 Agency may require or the applicant
 may propose additional text in other
 languages as is considered necessary to
 protect  the public. When additional
 text in another language is necessary,
 all labeling requirements  will be  ap-
 plied equally to both the English and
         40 CFR Ch. I (7-1-89 Edition)

 other-language versions of the label.
 ing.
   (4) Placement of Label
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   Environmental Protection Agoncy

    (U, A false or misleading statement
   concerning, the effectiveness  of  the
   product as a pesticide or device;
    (j]D A false or misleading statement
  about the value of  the product  for
  purposes other than  as a pesticide or
  device;
    
 and shall be expressed in conventional
 American units of fluid ounces, pints,
 quarts, and gallons.
  (3) Ii the pesticide  is solid or semi-
solid, viscous or pressurized,  or is a
mixture  of  liquid and  solid, the  net
content statement shall be in terms of
 weight   expressed   as   avoirdupois
 pounds and ounces.
  (4) In all cases, net content shall be
stated in terms of the largest suitable
 units, i.e., "1 pound 10 ounces" rather
than "26 ounces."
  (S) In addition to the required uniti
specified, net content  may  be  ex-
pressed in metric units.
  (6) Variation  above minimum  con-
tent or around an average is permissi-
ble only to  the extent that it repre-
sents deviation unavoidable in  good
manufacturing  practice.   Variation
below a stated minimum is not permit-
 ted. In no case shall the average con-
                                    77

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 156.10

 tent of the packages In a shipment fall
 &. _.^ +VA *+*t/4 *v*rAJ?C contfCilw.
 DC10W vne svtca *  v* **-   ntirn&tfr.
  (e)  Product   registration   num^e^
 The  registration number "f1*^ of
 the P^tlcldewprodu^ .t the
         K   i     w "
 preceded by  the Pg"  "^-PA Reg.




     ^ It Th Registration number
     the required  Identifying  phrase
      not SSear in such a manner as
 ouggest or imply recommendation
 o? endorsement of the product by the

  (fT Producing establishments regis-
 tration number. The producing estab-
 lishment registration number  preced-
 ed by the phrase "EPA Est.", of the
 final establishment at which the prod-
 uct was produced may appear in any
 suitable location on the label or imme-
 diate  container. It must appear on the
 wrapper or outside  container of the
 package if the EPA establishment reg-
 istration number  on the  immediate
 container  cannot  be  clearly  read
 through such wrapper or container.
  Cg> Ingredient statementU) Gener-
 al The label of each pesticide product
 must  bear a statement which contains
 the name and percentage by weight of
 each  active ingredient, the  total per-
 centage by weight of all inert ingredi-
 ents;  and if the pesticide contains ar-
senic  in any form, a statement of the
percentages of total and water-soluble
arsenic calculated  as  elemental  ar-
senic. The active  ingredients must be
designated by the term "active ingredi-
ents" and the inert ingredients by the
term "inert ingredients," or  the singu-
lar forms of these terms when appro-
priate. Both terms shall  be in the
same  type size, be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" is
not required  for pesticides which con-
 tain  100  percent  active  Ingredients.
Unless the ingredient  statement is  a
 complete analysis of the pesticide, the
 term  "analysis" shall not be used as a
 heading for the ingredient statement.
  (2) Position of ingredient  statement
 (i) The ingredient statement  is nor-
 mally required on the front panel of
        40 CFt Ch. I (7-1-89 Edition)

tn label.  If there Is an outside con-
tainer or wrapper through which the
Ingredient statement cannot be clearly
read,  the  Ingredient statement must
also appear on such outside container
or wrapper. If the size or form of the
package  makes  it  Impracticable  to
place  the ingredient statement on the
front  panel of the label, permission
may be  granted for the ingredient
statement to appear elsewhere.
  (11) The  text of the Ingredient state-
ment  must  run parallel with other
text on the panel on which It appears,
and  must be clearly distinguishable
from  and must not be  placed In the
body of other text.
  (3) Names to be used in ingredient
statement The name used for each in-
gredient   shall   be   the   accepted
common  name,  if  there is one, fol-
lowed by  the chemical name.  The
common name may be used alone only
if it Is well known. If no common name .
has  been  established,  the chemical
name alone shall be used. In  no case
will the use of a trademark or  proprie-
tary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of section 25(c)(6).
   (4)  Statements of percentages.  The
percentages  of  ingredients shall be
stated in terms of weight-to-weight.
The sum of percentages of the active
and the inert ingredients shall be 100.
Percentages shall not be expressed by
a range of values such as "22-25%." If
the uses  of the pesticide product are
expressed as weight of active ingredi-
ent per unit area, a statement of the
weight of active ingredient per unit
volume of the  pesticide formulation
shall  also appear in  the  ingredient
statement.
   (5) Accuracy  of  stated percentages.
The percentages given shall be as pre-
cise as possible reflecting good manu-
 facturing practice. If there may be un-
 avoidable variation between manufac-
 turing batches,  the  value  stated for
 each  active ingredient shall be the
 lowest  percentage  which   may  be
 present.
   (6)  Deterioration. Pesticides  which
 change  in  chemical composition sig-
 nificantly must meet the following la-
 beling requirements:
                                    78

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   |j|VJronmntl Prott!n Agency

    /n In cases where  it la determined
   ht a pesticide -formulation changes
   hmical  composition  significantly,
   fhe product must bear the following
   tatement in a prominent position on
            "
Not
                         or use
    (ii) The product must meet all label
  claims up to the expiration time indi-
  cated on the label.
    (7) Inert ingredients. The Adminis-
  trator may  require the name of any
  inert ingredients ) to be listed in the
  ingredient statement If he  determines
  that such  ingredient(s)  may  pose a
  hazard to man or the environment.
   (h)  Warning  and  precautionary
  statements.  Required  warnings  and
  precautionary statements  concerning
                             154.10

the  general  areas  of  toxicologies!
hazard  including hazard to children,
environmental hazard, and physical or
chemical hazard fall into two groups;
those required on the front  panel of
the  labeling and those which may
appear  elsewhere.  Specific  require-
ments concerning content, placement,
type size, and  prominence are given
below.
  (1) Required front panel statements.
With the   exception  of  the child
hazard warning statement, the text re-
quired on the front panel of the label
is determined by the Toxlcity Catego-
ry of the pesticide. The category is as-
signed  on  the basis  of the  highest
hazard shown by any of the indicators
in the table below:
rtazvti indicators
Oral LDt* 	
inhalation LC. 	
Eye affects 	
Stan effect*. .

Toncrty catagone*
I
Up to and including SO
mg/kg.
Up to and mcKong .2
mg/uter.
Up to and including 200
mg/kg.
Corrowve: eomeal
opacity not reversbf*
witnn 7 day*.
Corrouve

II [ HI | IV
From 50 mru 500 mg/kg..
From .2 mru 2 mg/Mer 	
From 200 mru 2000


day*; rritaoon .
peraietlng for 7 day*.
Saver* irritation at 72
hour*.
From 500 thru 5000 mg/
kg.
From 2. mnj 20 mg/liter...
From 2.000 thru 20,000....
No eomeal opacity:
irritation raver**!*
wrtUMii 7 day*.
Mooerate irritation at 72
nour*.
Greater man
Greater man
Greater man
72 hour*.
5000 mg/
20 mg/liter.
20,000.
mtafloo at
  (i) Human hazard signal word
-------
 156.10
      it is approved for use on infanta
 or small children, may the Administra-
 tor waive this requirement.
   (Ill) Statement  of practical  treat-
 ment- e^a^a^aA a^^*a^aa*a^kA f^ weut^b^ad
           irrDim pvnvi Mswnivre ov prvcacew
           gum*].
          U^_.  t^gt fe^had kt g^^^^a^B.^^ut PUiJkA^aMA
          MMy  OV IW H WBWWJ linnaJJO
           trough e aUnJ. Oo not breath* vapor* Cduat or
           pray nMl. Do not gat in eyea, on akin, or on
           doting. CApproprlaliiftratiid rtaiarnenta reoured.].
IV.
 akin]. Avoid bfaatHnq vapor* Cduat or apray miatl
 Avoid contact wNh Hdn Ceyee or donng]. CAppro-
 priaM fttt aid atatamant raqured.].
No precautionary ataMrnants raojund.] ..........................
Corroeive. eauaaa ay* and akin damage Cor dun
 irritation]. Do not gat in eyea. on skin,  or on
 dotting. Wear goggle* or lace anMd and  rubber
 gtovaa wnan nandfcig. HamvM or fatal if *nr*Hod.
 CAppropnata 
 proprtala flrat akt statement ieojuired*j

Avoid contact w*tt eWn, aye* or dotting. In CM o<
 contact immediately flueh aye* or aWn witt plenty at
      Get  medical attention H irritation penata.
                                                            iment* required.]
CNopi
                                       80

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     j^o
                 Proon Agency
      environmental hazards. Where a
   (U * exists to non  target organisms
        __  humans  and  domestic  ani-
     '^ecautionary statements are re-
        stating  the  nature  of  the
        and the  appropriate  precau-
       to  avoid  potential  accident,
 f iury  or  d*131**6- Examples of  the
 risard statements and  the  circum-
  tances under which they are required

  (A) If * pesticide intended for out-
 door use contains an  active ingredient
 Irith a mammalian acute oral LDH of
 Too or less, the statement "This  Pesti-
 cide is Toxic to Wildlife" is required.
  (B) If a  pesticide intended for out-
 door use contains an active ingredient
 with a fish acute LC  of 1 ppm or less,
 the statement "This Pesticide is  Toxic
 to Fish" is required.
  (C) If a  pesticide intended for out-
door use contains an active ingredient
with an avian  acute oral LDM of  100
       or less, or  a subacute  dietary
                                          LC.. of 500 ppm or less, tht  statement
                                          "This Pesticide is Toxic to Wildlife" is
                                          required.
                                            (D) If either accident history or field
                                          studies demonstrate that use of the
                                          pesticide  may result  in fatality to
                                          birds,  fish or mammals, the statement
                                          "This pesticide  is extremely  toxic to
                                          wildlife (fish)" is required.
                                            (E) For uses involving foliar applica-
                                          tion to agricultural crops, forests, or
                                          shade trees,  or for mosquito  abate-
                                          ment  treatments,  pesticides toxic to
                                          pollinating insects must bear appropri-
                                          ate label cautions.
                                            (F) For  all outdoor uses other than
                                          aquatic  applications the label must
                                          bear the caution "Keep out of lakes,
                                          ponds or streams. Do not contaminate
                                          water  by cleaning of equipment  or dis-
                                          posal of wastes."
                                            (iii)  Physical or chemical hazards.
                                          Warning statements on the flammabil-
                                          ity or explosive characteristics  of the
                                          pesticide are required as follows:
               Fla*n point
                                                      Requred text
                               (A) PMf SSURIZEO COMTAINCRS
 Flasn pom at or below 20* F: if mere  a flashback at
  any valve openng.
 Flash pant above 20* F and not over 80* F or H the
  flam* extension is more than 18 in long at a distance
  of 6 in from the flam*.
 Al other pressurized container!		
                                     Extremely flammable. Content* under pressure. Keep away from
                                      fire, spark*, and,heated surfaces. Do not puncture or incinerate
                                      container. Exposure to" temperature* tbove 130* F may cause
                                      bursting.
                                     Flammable. Contents under  presaur*.  Keep away  from  heat
                                      spark*, and open flame. Do  not puncture or inenerate container.
                                      Exposure to temperature* tbove 130* F may caua* burnng.
                                     Contents under pressure. Oe not UM or store near heat or open
                                      dame. Do not  puncture or incnerat* comamar.  Exposure to
                                      temperature* above, 130* F may cause bursting.
                              (B) NONtWfUUMIZCD CONTAIN***}
At or bdow 20* F	

Above 20* F and not over 80* F..
Above W F and not over 1 SO*
                                    Extremely flammable. Keep away from fire, spark*, and heated
                                      surface*.
                                    Flammatt*). Keep away from heat and open Itena.
                                    Do not UM or store near heat or open flame.
  (i)  Direction* for  tfie- General
requirements
-------
156.10

  (B) The .label bears a reference  to
the directions for use In accompanying
leaflet* or  circulars, such as "See di-
rections in  the  enclosed circular:" and
  (C) The  Administrator determines
that it is not necessary for such direc-
tions to appear  on the label.
  (iil)  Exceptions  to  requirement  for
direction for use  The  Administrator  determines
that such directions are not necessary
to  prevent unreasonable adverse  ef-
fects on man or the environment.
  (B) Detailed  directions for use may
be omitted from the labeling of pesti-
cide products for which sale Is limited
to physicians,  veterinarians, or drug-
gists, provided that:
  U) The label clearly states that the
product is  for  use  only by  physicians
or veterinarians;
  (2)  The  Administrator  determines
that such directions are not necessary
to  prevent unreasonable adverse ef-
fects on man or the environment; and
  (3> The product I* also a drug and
regulated under the  provisions of the
Federal Food, Drue and Cosmetic Act.
  (C) Detailed  directions for use may
be omitted from the labeling of pesti-
cide products which are intended for
use only by formulators In preparing
pesticides for sale to the public, pro-
vided that:
  U)  There  is  information  readily
available to the  formulators on  the
composition, toxicity, methods of use.
applicable  restrictions or limitations.
        40 CFR PU I (7.1-89 Edition)

and effectiveness of the product  for
pesticide purposes;
  (2) The label clearly states that  the
product Is  intended for use only in
manufacturing,  formulating, mixing.
or repacking for use as a pesticide and
specifies the type(s) of pesticide prod-
ucts involved;
  (3) The product as finally manufac-
tured,  formulated, mixed,  or  repack-
aged is registered; and
  (4)  The  Administrator  determines
that such directions are not necessary
to prevent unreasonable adverse  ef-
fects on man or the environment.
  (2)  Contents of Directions for  Use.
The directions  for use shall include
the following, under the headings "Di-
rections for Use";
  (i) The statement of use classifica-
tion as prescribed in paragraph (j) of
this section   immediately  under  the
heading "Directions for Use."
  (ii) Immediately below  the  state-
ment of use  classification, the state-
ment "It is a violation of Federal law
to use this product in a manner incon-
sistent with its labeling."
  (ill) The site(s) of  application, as for
example the  crops,  animals, areas, or
objects to  be treated.
  (iv)  The target pest(s) associated
with each  site.
  (v) The  dosage rate associated  with
each site and pest.
  (vi) The method of application. In-
cluding instructions for dilution, if re-
quired, and type(s) of application ap-
paratus or equipment required.
   (vli) The frequency and timing of ap-
plications  necessary to obtain effective
results without causing unreasonable
 adverse effects on the environment.
   (viii) Specific limitations on reentry
 to areas where the pesticide has been
 applied,   meeting   the requirements
 concerning  reentry provided  by 40
 CFR Part 170.
   (ix)  Specific  directions concerning
 the storage and disposal of the pesti-
 cide and its container, meeting the re-
 quirements of 40 CFR Part 165. These
 instructions  shall   be grouped  and
 appear under the heading  "Storage
 and Disposal." This heading must be
 set in type of the same minimum size*
 as required for the child hazard  warn-
 ing. (See Table in i 162.10(h)(l)(lv
                                     82

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     j
               Protection Agoney
          limitations or restrictions on
   c* required to  prevent unreasonable
  iSerse effects, such as:
   (A) Required  intervals  between ap-
   lication and harvest of food or feed

  cr(B> Rotational crop restrictions.
   ,) Warnings as required against use
    certain crops, animals, objects, or
  in or adjacent to certain areas.
   (D) [Reserved]
   (E) Pr restricted use pesticides,  a
  statement that  the  pesticide may be
  aoptied under the direct supervision of
  a certified applicator who is not phys-
  ically present at  the site of application
  but  nonetheless  available   to  the
  person applying the pesticide, unless
  the Agency has determined  that the
 pesticide  may only be  applied  under
 the direct supervision of a certified ap-
 plicator who is physically present.
   
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 APPENDIX F



Generic Data Call-In

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      \      UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

       Jj                 WASHINGTON, D.C. 20460
                               MAY   7  1993


                       DATA CALL-IN NOTICE
                                                     AND TOXIC SUBSTANCES

 CERTIFIED MAIL
Dear Sir or Madam:


This Notice requires you and other registrants  of pesticide
products containing the active  ingredient  identified  in
Attachment A of this Notice, the Data Call-In Chemical  Status
Sheet, to submit certain data as noted herein to the  U.S.
Environmental Protection Agency (EPA, the Agency).  These  data
are necessary to maintain the continued  registration  of your
product(s) containing this active ingredient.   Within 90 days
after you receive this Notice you must respond  as set forth  in
Section III below.  Your response must state:

     l.   how you will comply with the requirements set forth  in
          this Notice and its Attachments A through F;  or

     2.   why you believe you are exempt from the requirements
          listed in this Notice and  in Attachment C,  Requirementa
          Status and Registrant's Response  Form,  (see section
          III-B); or

     3.   why you believe EPA should not require your submission
          of data in the manner specified  by this Notice (see
          section III-D).

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

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


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      This Notice i3 divided into six sections and six
Attachments.  The Notice itself contains information and
instructions applicable to all Data Call-in Notices.   The
Attachments contain specific chemical information and
instructions.  The six sections of the Notice are:

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

     The Attachments to this Notice are:       :

     Attachment A - Data Call-In Chemical Status Sheet
     Attachment B - Data Call-In Response Form
     Attachment C - Requirements Status And Registrant's Response
                    Form
     Attachment D - List Of All Registrants Sent This Data
                    Call-In Notice
     Attachment E - EPA Acceptance Criteria
     Attachment F -' Cost Share and Data Compensation Forms


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.  This reevaluation
identified additionaldata necessary to assess the health and
safety of the continued use of products containing this active
ingredient.  You have been sent this Notice because you have
product(s) containing the subject active  ingredient.

SECTION II.  DATA REQUIRED BY THIS NOTICE

II-A.  DATA KBOVIRBP
                                               i
     The data required by this Notice are specified in
Attachment C, Requirements Status and Registrant's  Response Form.
Depending on the results of the studies  required in this Notice,
additional testing may be required.

1I-B.  SCHEDULE FOR SUBMISSION OF DATA

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

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 II-C.  TESTING
      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.

      Thes.e EPA Guidelines are available from the National Technical
 Information Service (NTIS) ,  Attn:  Order Desk,  5285 Port Royal Road
 Springfield, Va 221S1 (tel:  703-487-4650).

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

      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) ].


 I3:-D.  REGISTRANTS  RECEIVING PREVIOUS SECTION 3 (eU21 fBl NOTICES
       ISSUED BY  THE AGENCY             -*.  vi iu-vf v*vw
       Unless  otherwise noted herein,  thia Data oii-Tg dpea_..not in
any way  supersede  or change the requirement  of anv 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 NOTIC^

III-A.   SCHEDULE FOR RESPONDING TO THE AGENCY

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

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III-B.  OPTIONS FOR RESPONDING TO THE AGENCY

     The options for responding to this Notice are:  1)  voluntary
cancellation, 2} delete use(s), (3) claim generic data exemption,
(4) agree to satisfy the data requirements imposed by this Notice
or  (5) request a data waiver(s).

     A discussion of how to respond if you chose the Voluntary
Cancellation option, the Delete Use(s) option or the Generic  Data
Exemption option is presented below.  A discussion of the various
options available for satisfying the data requirements of this
Notice is contained in Section III-C.  A discussion of options
relating to requests for data waivers is contained in Section III-
D.                                               i

     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
Zojon, Attachment B and the Requirements Status and Registrant's
Response Form. Attachment C. The Data Call-In Response Form must be
submitted as part of every response to this Notice.  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
identified in Attachment A.

     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
provision* of this Notice which are  contained in Section IV-C.

     2.  Use Deletion - You may avoid the requirements of this
Notice by eliminating the uses of  your product to  which the
requirements apply.  If you wish to  amend your registration to
delete uses, you must submit the Requirements Status and
Registrftyfe'* Response Form, a  completed application for amendment,
a copy of your proposed amended labeling, and all  other information
required for processing the application.  Use deletion is
option number 7 on the Requirements  Status  and Registrant's

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  Response F9CT.   You must  also  complete a BaaCall-ln
  by signing the  certification,  iteS number 8
      om^
  .557?2126     S^aency Response Branch, Registration Division,  (703)


       If you  choose  to delete the use(s) subject to this Notice or
  uses subject to  specific data requirements, further sale,
  distribution,  or use  of your product after one year from the due
  date of your 90  day response, must bear an amended label.

       3-  generic pata Exemption - Under section 3(c)(2)(D)  of
  FIFRA, an applicant for registration of a product is exempt from
  the  requirement  to  submit or cite generic data concerning an active
  ingredient if  the active ingredient in the product isderived
  exclusively  from purchased, registered pesticide products
  containing the active  ingredient.  EPA has concluded,  as an
  exercise of  its  discretion, that it normally will not suspend the
         ji0n.f  a Pro?ucS which would qualify and continue to
         Jr  the9eneri<= ^ta exemption in section 3(c) (2) (D)  of
         TO qualify,  all of the following requirements must be met:

      a.   The active ingredient in your registered product must be
           present solely because of incorporation of another
           registered product which contains the subject active
           ingredient and is purchased from a source not connected
           With you;                                        ""<=<- weu

      b.   Every registrant who is the ultimate source of the active
           ingredient in your product subject to this DCI must be in
           compliance with the requirements of this Notice and must
           remain in  compliance;  and

      c.   You must have provided to EPA an accurate and current
           "Confidential Statement of Formula" for each of your
           products to which this Notice applies.

      To apply for the Generic Data Exemption you must submit a
completed Data Call -In Response  Form.  Attachment B and all
supporting documentation.   The Generic Data Exemption ia item  
number 6a on  the  Data Call-in Reanonss Pn.   If you claim a
generic data  exemption you are not required to complete the
RsgAlirementa  Status  and Registrant' a Response Por^.  Generic Data
Exemption cannot  be  selected as  an option for product specific
CL2LC3L 

      If you are granted a  Generic  Data Exemption,  you rely on the
efforts of other  persons to provide the Agency with the required
data.   If the registrant (s)  who  have committed to generate and
submit  the required  data fail  to take appropriate steps to meet the
requirements  or are  no longer in compliance with this Data Call-in
Notice, the Agency will consider that both they and you are not in

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compliance and will normally initiate proceedings  to suspend the
registrations of both your and their product (s), unless you commit
to submit and do submit the required data within the specified
time.  In such cases the Agency generally will  not grant a time
extension for submitting the data.             ;
     4. Satisfying the Data Requirements Q^  ^ia  Notice  There are
various options available to satisfy the data requirements  of this
Notice.  These options are discussed in Section III-C of this
Notice and comprise options 1 through 6 on the Requirements Status
and Registrant's Response Form and option 6b and  7 on the Pfltft
Call -In Response Form. If you choose option 6b or 7,  you must
submit both forms as well as any other information/data pertaining
to the option chosen to address the data requirement.

     5. Request for Data Waivers.  Data waivers are discussed  in
Section III-D of this Notice and are covered by options  8 and  9  on
the Requirements Status and Real at rant ' a Response Form.   If you
choose one of these options, you must submit both forms  as  well  as
any other information/data pertaining to the option chosen  to
address the data requirement.

III-C  SATISFYING THE DATA REQUIREMENTS OF THIS NQTICB

     If you acknowledge on the Data Call -In Response Form that you
agree to satisfy the data requirements  (i.e. you select option 6b
and/or 7} , then you must select one of the six options on the
Requirements Status and Recriptr?nt ' a Response ! Form related to data
production for each data requirement.  Your option selection should
be entered under item number 9,  "Registrant Response."  The six
options related to data production are the first six options
discussed under item 9 in the instructions for completing  the
Requirements Status and Registrant's Response Form   These six
options are listed immediately below with information in
parentheses to guide registrants  to additional instructions
provided in this Section.  The options are:

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

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      Potion 1.  Developing Data --If you choose to  develop  the
 required data it must be in conformance with Agency deadlines and
 with other Agency requirements as referenced herein and in  the
 attachments.  All data generated and submitted must comply  with  the
 Good Laboratory Practice (GLP)  rule (40 CFR Part 160),  be conducted
 according to the Pesticide Assessment Guidelines (PAG),  and be in
 conformance with the requirements of PR Notice 86-5.   In addition,
 certain studies require Agency approval of test protocols in
 advance of study initiation.   Those studies for which a protocol
 must be submitted have been identified in the Requirements  Status
 and Registrant's Response Form and/or footnotes to  the form.  If
 you wish to use a protocol which differs from the options discussed
 in Section II-C of this Notice,  you must submit a detailed
 description of  the proposed protocol and your reason for wishing to
 use it.  The Agency may'choose to reject a protocol not specified
 in Section II-C.  If the Agency rejects your protocol you will be
 notified in writing, however,  you should be aware that rejection of
 a proposed protocol will not be a basis for extending the deadline
 for submission  of data.

      A progress report must be submitted for each study within 90
.days from the date you are required to commit to generate or
 undertake some  other means to address that study requirement, such
 as making an offer to cost share or agreeing to share in the cost
 of developing that study.  A 90-day progress report must be
 submitted for all studies.   This 90-day progress report must
 include the date the study was or will be initiated and, for-
 studies to be started within 12 months of commitment, the name and
 address of the  laboratory(ies)  or individuals who are or will be
 conducting the  study.

      In addition,  if the time frame for submission  of a final
 report is more  than 1 year, interim reports must be submitted at 12
 month intervals from the date you are required to commit to
 generate or otherwise address the requirement for the study.
 In addition to  the other information specified in the preceding
 paragraph,  at a minimum,  a brief description of current activity on
 and the status  of the study must be included as well as a  full
 description of  any problems encountered since the last progress
 report.

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

      If  you cannot submit the data/reports to the Agency in the
 time required by this Notice and intend to seek additional time to
meet the requirements(s), you must submit a request  to  the Agency

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which includes:  (1)  a detailed description of the expected
difficulty and (2)  a proposed schedule  including alternative dates
for meeting such requirements on a step-by-step basis.  You must
explain any technical or laboratory difficulties and provide
documentation from the laboratory performing  the testing.  While
EPA is considering your request,  the original deadline remains.
The Agency will respond to your request in writing.  If EPA does
not grant your request, the original deadline remains.  Normally,
extensions can be requested only in cases  of  extraordinary testing
problems beyond the expectation or control of the-registrant.
Extensions will not be given in submitting the 0-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 Coat  to  Develop Data  --  If
you choose to enter into an agreement to share  in  the  cost  of
producing the required data but will not be  submitting the  data
yourself, you must provide the name of the registrant  who will  be
submitting the data.  You must also provide  EPA with documentary
evidence that an agreement has been formed.   Such evidence  may be
your letter offering to join in an agreement and the other
registrant's acceptance of your offer,  or a written statement  by
the parties that an agreement exists.  The agreement  to produce the
data need not specify all of the terms of the final arrangement
between the parties or the mechanism to resolve the terms.   Section
3(c)(2)(B) provides that if the parties cannot resolve the terms of
the agreement they may resolve their differences through binding
arbitration.                                  !

     Option 3. Offer to Share in the Coat of Data Development  -- If
you have made an offer to pay in an attempt  to enter into an
agreement or amend an existing agreement  to meet the requirements
of this Notice and have been unsuccessful, you may request EPA (by
selecting this option) to exercise its discretion not to suspend
your registration(s), although you do not comply with the data
submission requirements of this Notice.   EPA has determined that as
a general policy, absent other relevant considerations,  it will not
suspend the registration of a product  of  a registrant who has  in
good faith sought and  continues to seek to enter into a  joint  data
development/cost sharing program, but  the other registrant(s)
developing the data has refused to accept your offer.  To qualify
for this option, you must submit  documentation to the Agency
proving that you have made an  offer  to another registrant  (who has
an obligation to submit data)  to  share in the burden  of  developing
that data.  You must also submit  to  the Agency a  completed BPA Form
8570-32, Certification of Offer  to  Cost Share in  the  Development  of
Data, Attachment E.  In addition,  you  must demonstrate that the
other registrant to whom the offer was made  has not accepted  your
offer to enter into a  costsharing agreement  by  including a copy of
your offer and proof of the  other registrant's  receipt of  that

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 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
 b
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     of that study.   In the event that  exact  transcripts of raw
     data have been prepared (e.g.,  tapes  which have been
     transcribed verbatim,  dated, and verified accurate by
     signature),  the exact  copy or exact transcript may be
     substituted for the original source as raw data.   'Raw data1
     may include photographs,  microfilm or microfiche  copies,
     computer printouts, magnetic media, including dictated
     observations,  and recorded data from  automated instruments.11
     The term "specimens",  according to 40 CFR 160.3(k), means  "any
     material derived from a test system for  examination or
     analysis."

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

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

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

     If EPA has previously reviewed  a protocol for a  study you are
submitting, you must identify any action  taken by the Agency on the
protocol and must indicate, as part  of your  certification, the
manner in which all Agency comments, concerns, or issues were
addressed in the final  protocol  and study,   i

     If you know of a study pertaining to any  requirement  in this
Notice which does not meet  the  criteria outlined above but does

                                 10

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 contain factual information regarding unreasonable adverse effects
 you must notify the Agency of such a study.   If such  stSSy 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 A.  If  you submit data to upgrade an existing study  you
 must satisfy or supply information to correct all deficiencies  in
 the study identified by EPA.  You must provide a clearly
 articulated rationale of how the deficiencies have been  remedied or
 corrected and why  the study should be rated  as acceptable  to EPA
 Your submission must also specify the MRID number(s)  of  the study
 which you are attempting to upgrade and must be in conformance  with
 PR Notice 86-5.

      Do not submit additional data for the purpose of upgrading a
 study classified as .unacceptable and determined by the Agency as
 not capable of  being upgraded.

      This  option should also be used to cite data that has been
 previously submitted to upgrade a study,  but has not yet been
 reviewed by the  Agency.   You must  provide the MRID number  of the
 data  submission  as well as the MRID number of the study  beincr
 upgraded.                                              *      3

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

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

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must provide the MRID number of the study you are citing and, if
the study has been reviewed by the Agency,  you.must provide the
Agency's classification of the study.

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

III-D  REQUESTS FOR DATA WAIVERS

     There are two types of data waiver responses to  this  Notice.
The first is a request for a low volume/minor use waiver and  the
second is a waiver request based on your belief that  the data
requirement(s) are inapplicable and do not apply to your product.

1. Low Volume/Minor Use Waiver --  Option 8 on the Requirements
Status and Registrant's Response Form.  Section 3(c)(2)(A) of FIFRA
requires EPA to consider the appropriateness of requiring  data for
low volume, minor use pesticides.  In implementing  this  provision
EPA considers as low volume pesticides only those  active
ingredients whose total production volume for all pesticide
registrants is small.  In determining.whether to grant a low
volume, minor use waiver the Agency will consider the extent,
pattern and volume of use, the economic incentive to conduct the
testing, the importance of the pesticide, and the exposure and risk
from use of the pesticide.  If an active ingredient is used for
both high volume and low volume uses, a low volume exemption will
not be approved.  If all uses of an active ingredient are low
volume and the combined volumes for all uses are also low, then an
exemption may be granted, depending on review of other information
outlined below.  An exemption will not be granted if any  registrant
of the active ingredient elects to conduct the  testing.  Any
registrant receivincr a low volume minor use waiver must remain
within the sales figures in their forecast supporting the waiver
request in order to remain qualified  for such waiver.  If granted a
waiver, a registrant will be required, aa a condition of  the
waiver, to submit annual sales reports.  The Agency will  respond to
requests for waiver* in writing.

     To apply for a low volume, minor use waiver, you must submit
the following information, as  applicable to your product(s),  as
part of your 90-day response to  this  Notice:

     a.    (i). Total company sales  (pounds and dollars) of all
          registered product(s)  containing the active ingredient.
          If applicable to the active ingredient, include foreign
          sales for those products  that are not registered in this
          country but are applied to sugar (cane or  beet),  coffee,
          bananas, cocoa, and other such crops. Present  the above
          information by year for each of the  past  five years.
                                 12

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      (ii).   Provide an estimate  of  the  sales  (pounds and
      dollars)  Of the active ingredient  for each major use
      site.   Present the above  information by year for each of
      the past  five years.

 b.    Total  direct production cost of product(s) containing the
      active ingredient by year for  the  past five years.
      Include information on raw  material cost, direct labor
      cost,  advertising,  sales  and marketing, and any other
      significant costs listed  separately.

 c.    Total  indirect production cost  (e.g. plant overhead,
      amortized plant and equipment) charged to product(s)
      containing  the active  ingredient by year for the past
      five years.   Exclude all  non-recurring costs that were
      directly  related to the active ingredient, such as costs
      of  initial  registration and any data development.

 d.    (i). A list  of each data  requirement for which you
      seek a waiver.   Indicate  the type  of waiver sought
      and the estimated cost  to you  (listed separately for
      each data requirement and associated test) of
      onducting the  testing needed to fulfill each of
      these  data requirements.

      (ii).   A  list  of  each data  requirement for which you
      are not seeking any waiver  and the estimated cost -to
      you (listed  separately  for  each data requirement and
      associate'd test)  of conducting the testing needed to
      fulfill each of these data  requirements.

e.    For each  of  the next ten  years, a  year-by-year fore- cast
      of company sales  (pounds  and dollars) of the  active
      ingredient,  direct production costs of product(s)
      containing the active ingredient (following the
     parameters in  item 2 above), indirect production costs of
     product(s) containing the active ingredient (following
     the parameters  in item  3 above), and costs of data
     development pertaining  to the active ingredient.

f.   A description of  the importance and unique benefits of
     the active ingredient to users.  Discuss the use patterns
     and the effectiveness of  the active ingredient relative
     to registered alternative chemicals and non-chemical
     control strategies.  Focus  on benefits unique to the
     active ingredient, providing information that is as
     quantitative as possible.    If you  do not have
     quantitative data upon  which to base your estimates, then
     present the reasoning used  to derive your estimates.  To
     assist  the Agency in determining the degree of importance
     of the  active ingredient  in terms  of its benefits, you
     should  provide information  on any  of the following
                            13

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          factors,  as applicable to your product (s):  (a)
          documentation of the usefulness of  the  active  ingredient
          in Integrated Pest Management,  (b)  description of the
          beneficial impacts on the environment of  use of the
          active ingredient, as opposed to its registered
          alternatives, (c)  information on the breakdown of the
          active ingredient after use and on its  persistence in the
          environment, and  (d) description of its usefulness
          against a pest(s)  of public health significance.


     Failure to submit sufficient information for the Agency to
make a determination regarding a request for a low volume/minor use
waiver will result in denial of the request for a waiver.

2.  Request for- Waiver of Data  --  Option 9 on the Reguirementa
status and Registrant-- ' Regponae Form.  This option may be used if
you believe that a particular data requirement should not apply
because the corresponding use is no longer registered or the
requirement is inappropriate.  You must submit a rationale
explaining why you believe  the data requirements should not apply.
You must also submit the current label (s) of your product (s)  and,
if a current copy of your Confidential Statement of Formula is not
already on file you must submit a  current copy.

     You will be informed of  the Agency's decision in writing.   If
the Agency determines  that  the data requirements of this Notice  do
not apply to your product (s), you  will  not be required  to supply
the data pursuant to  section  3(c) (2) (B) .  Iff SPA determines that
the data ar^> -required for your product (s) .you must  choose a mechoa
of meeting the reauirgmentg of  fchia Noticft within  the time. frame
r*wTfted bv thin Notice.  Within  30 days of  your receipt of the
BSSffS Sri"" decision,  you must  submit  a revised Requirements
fifcatua and Registrant  Response  Form indicating the option chosen.
IV.  CONSEQUENCES  OF FAILURE TO COMPLY WITH THIS MQTICB

IV-A NOTICE OP TNTBNT TO SUSPEND

     The Agency may issue a Notice of Intent to Suspend products
subject to thia 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
Swuuiee of a Notice of Intent to Suspend include, but are not
limited to, the following:
                                  14

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

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

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

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

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

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

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

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

      a.  inform EPA of intent to develop  and  submit the data
      required by this Notice on a Data Call-In  Reaponae Form
      and a Requirements Status and Registrant Va_jReapQn8^_JgLoJcnu

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

      c.  otherwise take appropriate steps to  meet the
      requirements stated in this Notice,

unless you commit, to submit and do submit the required data in
the specified time frame.

9.  Failure  to take any required or appropriate steps,  not
mentioned above,  at any time following the  issuance  of this
Notice.

                             15

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IV-B.  BASIS FOR DETERMINATION THAT  SUBMITTED STUDY IS
      PNACCBPTABLE

     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.
                                            i
IV-C  EXISTING STOCKS OP  SUSPENDED OR CANCELLED  PRODUCTS

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

     The Agency has determined that  such disposition by  registrants
of existing stocks for a  suspended  registration  when a  section
3 (c)(2)(B) data request  is outstanding  would generally  not  be
consistent with the Act's purposes.   Accordingly, the Agency
anticipates granting  registrants permission to sell, distribute,  or
use existing stocks of  suspended product(s) only in  exceptional
circumstances.  If you believe such disposition of existing stocks
of your product(s) which may be suspended for  failure  to comply
with this Notice  should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be
consistent with the Act.  You must also  explain why an "existing

                                 16

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

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


                                 17

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

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

                             Sincerely yours,
          A
          B
          C

          D
          B
          P
                             Daniel M. Barolo, Director
                             Special Review and  |
                               Reregistration Division
         Attachments

Data Call-in Chemical Status Sheet
Data Call-in Response Form
Requirements Status and Registrants
Response Form
List of Registrants Receiving This Notice
EPA Acceptance Criteria
Cost Share and Data Compensation Forms
                                  18

-------
ATTACHMENT A



 Chemical Status Sheet

-------

-------
                            ATTACHMENT A

    CHLORINATED ISOCYANURATES:  DATA CALL-IN CHEMICAL  STATUS SHEET
 INTRODUCTION
      You have been sent  this  Generic Data  Call -In Notice because
 you have product (s)  containing  technical chlorinated  isocyanurates
           Generic  Data  Call-in  Chemical Status Sheet, contains an
 overview of  the  data  required by  this notice, and point of contact
 for inquires pertaining to  the  reregistration of the chlorinated
 isocyanurates.   This  attachment is  to be used in conjunction with
 (1)  the  Generic  Data  Call-In Notice,  (2) the Generic Data Call-In
 Response Form (Attachment B) ,  (3) The Requirements Status and
 Registrant's Response form  (Attachment C) ,  (4) a list of
 registrants  subject to  this DCI and List of Products Subject to
 this generic DCI (Attachment D) ,  (5) the EPA Acceptance Criteria
 (Attachment  E) ,  and  (6)  the Cost  Share and Data Compensation Forms
 in  replying  to this chlorinated isocyanurate Generic Data Call -In
 (Attachment  F) .  Instructions and guidance accompany each form.


 DATA REQUIRED BY THIS NOTICE

     The additional data requirements needed to complete the
 generic database for  the chlorinated isocyanurates are contained in
 the Requirements Status  and Registrant 'a Response Form. Attachment
 C.  The Agency has concluded that additional product chemistry data
 on certain technical/manufacturing  use products are needed.  These
 data are needed  to fully complete the reregistration of all
 eligible chlorinated  isocyanurate products.

 INQUIRIES AND RESPONSES  TO THIS NOTICE

     If you  have any questions  regarding the generic data
requirements  and procedures established by this Notice, please
contact Karen Samek at  (703) 308-8051.

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

        Document Processing Desk  (RED-SRRD-0569)
        Office of Pesticide Programs  (H7504C)
        Environmental Protection  Agency
        401 M Street, S.W.
        Washington, D.C.  20460-0001


        RE: Chlorinated  Isocyanurates

-------

-------
           ATTACHMENT B

Generic Data Call-in Response Forms (Form A) Plus
                Instructions

-------

-------
                      SPECIFIC INSTRUCTIONS FOR
                    THE  DATA CALL-IN RESPONSE FORM
 ^no      J0rm is designed to be used to respond to call-ins for
 generic and product specific data for the purpose of rereqisteri

            o5f ?hth%Federal HInsectici^ Fungicide and SxSnticl
                  1fn ea        you are responding to a data
      Items 1 -4 will have been preprinted on the form.  Items  5
 through 7 must be completed by the registrant as appropriate.
 Items 8 through 11 must be completed by the registrant  before
 submitting a response to the Agency.
 oot-^       rePrtin9 ^rden for this  collection of  information is
 estimated to average 15 minutes  per response,  including time  for
 fJX1^11? ^ructions, searching existing data  sources,  gathering
 S?iS* tain^n? *he datFa needed,  and completing  and  reviewing the*
 collection of information.   Send comments  regarding  the burden
 estimate or any other aspect of  this collection  of information,
 including suggesting for reducing this burden, to Chief
 Information Policy Branch,  PM-223,  U.S.  Environmental  Protection
 Agency,  401 M St.,  S.W.,  Washington, B.C.  20460;  and to the Office
 of Management and  Budget, Paperwork Reduction  Project  2070-0107
 Washington,  D.C. 20503.                                   uxu/,

 INSTRUCTIONS        :    ~ - ~ - ' -- - - 

 Item  1.    This item identifies your company name, number and
           address .

 Item  2.    This item identifies the  case  number,  case name, EPA
           chemical  number and chemical name.

 Item  3.    This item identifies the  date  and type  of  data call-in.

 Item  4.    This item identifies the  EPA product registrations
           relevant  to  the data call-in.  Please note that you are
           also responsible  for informing the Agency  of  your
           response  regarding any  product that you believe may be
           covered by this data call-in but  that  is not  listed by
           the  Agency in Item 4.   You must bring any  such apparent
           omission  to  the Agency's  attention within  the period
           required  for submission of this response form.

Item 5.   Check this item for each  product  registration you wish
          to cancel voluntarily,  if a registration  number is
          listed for a  product for  which you previously requested
          voluntary  cancellation, indicate  in Item 5. the date of
          that request.  You  do not need to complete any item on
          the Requirements Status and  Registrant's Response Form
          for any product that is voluntarily cancelled.

-------
Item 6a.   Check this item if  this  data call-in; is for generic data
          as indicated in Item 3 and  if you are eligible for a
          Generic Data Exemption for  the chemical listed in Item 2
          and used in the subject  product.  By electing this
          exemption, you agree to  the terms and conditions of a
          Generic Data Exemption as explained in the Data Call -In
          Notice.                            :

          If you are eligible for  or  claim a Generic Data
          Exemption, enter the EPA registration Number of each
          registered source of that active ingredient that you
          use in your product.

          Typically, if you purchase  an  EPA- registered product
          from one or more other producers (who, with respect to
          the incorporated product, are  in compliance with this
          and any other outstanding Data Call -In Notice) , and
          incorporate that product into  all  your products, you
          may complete this item for  all products  listed on  this
          form.  If, however, you  produce the  active ingredient
          yourself, or use any unregistered  product (regardless
          of the fact that some of your sources are registered) ,
          you may not claim a Generic Data Exemption and you may
          not select this item.

Item 6b.  Check this Item if the data call-in is a generic data
          call-in as indicated in Item 3 and if you are agreeing to
          satisfy the generic data requirements of this data call-
          in.  Attach the Requirements status: and Registrant's
                    Form  that  indicates how you will satisfy those
          requirements .

Item 7a.  Check this item if this call-in is a data call-in as
          indicated in Item 3 for a manufacturing use product
           (MUP) , and if your product is a manufacturing use product
          for which you agree to supply product -specific data.
          Attach fho' Requirements Status and Registrants' Response
          Form that indicates how you will  satisfy those
          requirements .

Item 7b.  Check this item if this call-in is a data call-in  for an
          end use product  (EOT) as  indicated in  Item  3 and if  your
          product is a end use product  for  which you  agree to
          supply product- specific data.  Attach  the Requirements
          Sfcatug and Registrant- ' Regnonge  Form  that  indicates how
          you will satisfy those requirements.

Item 8.   This certification statement  must be signed by an
          authorized representative of  your company and the
          person signing must  include his/her  title.   Additional
          pages used in  your response must  be  initialled and
          dated in the space provided for the  certification.

Item 9.    Enter the date of  signature.

Item 10.   Enter the name of  the person EPA should contact with
           questions  regarding your response.

Item 11.   Enter  the phone number of your company contact.

-------
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-------
            ATTACHMENT C

Requirements Status and Registrants' Response Forms
            (Form B) Plus Instructions

-------

-------
               SPECIFIC INSTRUCTIONS FOR COMPLETING
       THE REQUIREMENTS  STATUS AND REGISTRANT'S RESPONSE FORM

                            Generic  Data


     This form is designed to be used for registrants to respond to
call-ins for generic and product-specific data as part of EPA's
reregistration program under the Federal Insecticide Fungicide and
Rodenticide Act.  Although the form is the same for both product
specific and generic data, instructions for completing the forms
differ slightly.  Specifically,  options for satisfying product
specific data requirements do not include (1) deletion of uses or
(2) request for a low volume/minor use waiver.  These instructions
are for completion of generic data requirements.

     EPA has developed this form individually for each data call-in
addressed to each registrant, and has preprinted this form with a
number of items.  DO NOT use this form for any other active
ingredient.

     Items 1 through 8  (inclusive) will have been preprinted on the
form.  You must complete all other  items on this form by typing or
printing legibly.

     Public reporting burden for this collection of information is
estimated to average 30 minutes per response, including time for
.reviewing instructions, searching existing data sources, gathering
and maintaining the data needed, and completing and reviewing  the
collection of information.  Send comments regarding the burden
estimate or any other aspect of this collection of information,
including suggesting for reducing this burden, to Chief,
Information Policy Branch,  PM-223,  U.S. Environmental Protection
Agency, 401 M St., S.W., Washington, D.C. 20460; and  to the Office
of Management and Budget, Paperwork Reduction Project 2070-0107,
Washington, D.C. 20503.

-------

-------
 INSTRUCTIONS

 Item l. This item identifies your company name,  number,  and
         address.

 Item 2. This item identifies the case number,  case name,  EPA
         chemical  number and chemical name.

 Item 3. This item identifies the date"and type of  data call-in.

 Item 4. This item identifies the guideline reference  numbers of
         studies required to support the product(s)  being
         reregistered.   These guidelines,  in addition  to
         requirements specified in the Data Call-In Notice,  govern
         the conduct of the required studies.

 Item 5. This item identifies the study title associated  with the
         guideline reference number and whether protocols and 1, 2,
         or 3-year progress reports are required  to be submitted in
         connection with the study.   As noted in  Section  III of the
         Data Call-In Notice,  90-day progress reports  are required
         for all studies.

         If an asterisk appears in Item 5,  EPA  has  attached   -
         information relevant to  this guideline reference number to
         the Requirements  Status  and Registrant's Response Form.

 Item 6.  This item identifies the code associated with the
         use pattern of the pesticide.   A brief description
         of each code follows:

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


Item 7.   This  item  identifies the  code assigned to the  substance
          that must be used for  testing.  A  brief  description of
          each  code  follows:

-------
        EP
        MP
        MP/TGAI

        PAI
        PAI/M

        PAI/PAIRA

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        PAIRA/M

        PAIRA/PM

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Metabolites
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Ingredient Radiolabelled
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Pure Active Ingredient Radiolabelled and
Metabolites
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Typical End-Use Product
Typical End-Use Product, Percent Active
8Ingredient Specified
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Typical End-Use Product or Pure Active
Ingredient and Metabolites
Technical Grade Active Ingredient
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Active Ingredient
Technical Grade Active Ingredient or Pure
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Typical End-Use Product
Metabolites
Impurities           j
Degradates
See: guideline comment
Item 8. This item identifies the time frame allowed for submission
        of the study or protocol identified in item 2.  The time
        frame runs from the date of your receipt of the Data Call-
        in Notice.

Item 9. Enter the appropriate Response Code or Codes to show how
        you intend to comply with each data requirement.  Brief
        descriptions of each code follow.  The Data Call-In Notice
        contains a fuller description of each of these options.

        1.  (Developing Data) I will conduct a new study and submit
            it within the time frames specified in item 8 above.
            By indicating that I have chosen this option, I certify
            that I will comply with all the requirements pertaining
            to the conditions for submittal of this study as
            outlined in the Data Call-In Notice and that I will
            provide the protocols and progress reports required  in
            item 5 above.
        2.   (Agreement to Cost Share)  I  have  entered into an
            agreement with one or more registrants  to develop data

-------
     jointly.  By indicating that I have chosen this  option
     I certify that I will comply with all the requirements
     pertaining to sharing in the cost of developing  data  as
     outlined in the Data Call-In Notice.

 3.  (Offer to Cost Share)  I have made an offer to  enter
     into an agreement with one or more registrants to
     develop data jointly.   I am submitting a  copy  of the
     form "Certification of Offer to Cost Share in  the
     Development of Data" that describes this
     offer/agreement.   By indicating that I have chosen this
     option,  I certify that I will comply with all  the
     requirements pertaining to making an offer to  share in
     the cost of developing data as outlined in the Data
     Call-In Notice.

 4.  (Submitting Existing Data)  I am submitting an  existing
     study that has never before been submitted to  EPA.  By
     indicating that I have chosen this option,  I certify
     that this study meets  all the requirements pertaining
     to  the conditions for  submittal of existing data
     outlined in the Data Call-In Notice and I have attached
     the needed supporting  information along with this
     response.

 5.   (Upgrading a Study)  I  am submitting or citing  data to
     upgrade  a study that EPA has classified as partially
     acceptable and potentially upgradeable.   By indicating
     that  I have chosen this  option,  I certify that I have
     met all.the requirements  pertaining to the conditions
     for  submitting or citing  existing data to upgrade a
     study described in the Data Call-in Notice.  I am
     indicating on attached correspondence  the Master Record
     Identification Number  (MRID)  that EPA  has assigned to
     the data  that  I am citing as well as the  MRID  of the
     study I am attempting  to  upgrade.

6.   (Citing a  Study)  I  am citing an existing  study that has
    been  previously classified by EPA as acceptable, core,
    core minimum,  or  a  study  that  has not  yet been reviewed
    by the Agency.  I am providing the Agency's
    classification of the study.

7.   (Deleting Uses) I am attaching an application  for
    amendment  to my registration deleting  the uses for
    which the data are  required.

8.   (Low Volume/Minor Use Waiver Request)' I have read the
    statements concerning low volume-minor use data  waivers
    in the Data Call-In Notice  and I  request  a low-volume
    minor use waiver of  the data requirement.   I am
    attaching a detailed justification to  support  this
    waiver request including,  among other  things,  all
    information required to support  the request.   I
    understand that, unless modified by the Agency in

-------
            writing, the data requirement as stated in the Notice
            governs.                         ;
                                             |
        9.  (Request for Waiver of Data) I have read the statements
            concerning data waivers other than low-volume minor-use
            data waivers in the Data Call-In Notice and I request a
            waiver of the data requirement.  I am attaching an
            identification of the basis for this waiver and a
            detailed justification to support this waiver request.
            The justification includes, among other things, all
            information required to support the request.  I
            understand that, unless modified by the Agency in
            writing, the data requirement as stated in the Notice
            governs.

Item 10.  This item must be signed by an authorized representative
          of your company.  The person signing must include his/her
          title, and must initial and date all other pages of this
          form.                              i

Item 11.  Enter the date of signature.

Item 12.  Enter the name of the person EPA should contact with
          questions regarding your response. '

Item 13.  Enter the phone number of your company contact.

-------
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ATTACHMENT E



EPA Acceptance Criteria

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                           SUBDIVISION D
Guideline       .       Study Title

Series 61   Product Identity and Composition
Series 62   Analysis and Certification of Product Ingredients
Series 63   Physical and Chemical Characteristics

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                61 Product Identity and Composition


                        ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

1.	 Name of technical material tested (include product name and
      trade name, if appropriate)
2.	 Name, nominal concentration, and certified limits (upper and
      lower) for each active ingredient and each intentionally-
      added inert ingredient
3.	 Name and upper certified limit for each impurity or each
      group of impurities present at > 0.1% by weight and for
      certain toxicologically significant impurities (e.g.,
      dioxins, nitrosamines)  present at <0.1%
4.	 Purpose of each active ingredient and each intentionally-
      added inert
5.	 Chemical name from Chemical Abstracts index of Nomenclature
      and Chemical Abstracts Service (CAS)  Registry Number for each
      active ingredient and,  if available,  for each .intentionally-
      added inert
6.	 Molecular, structural,  and empirical formulas, molecular
      weight or weight range, and any company assigned experimental
      or internal code numbers for each active ingredient
7.	 Description of each beginning material in the manufacturing
      process
      	 EPA Registration Number if registered; for other
           beginning materials, the following:
      	 Name and address of manufacturer or supplier
      	 Brand name, trade name or commercial designation
      	 Technical specifications or data sheets by which
           manufacturer or supplier describes composition,
           properties or toxicity
8.	 Description of manufacturing process
      	 Statement of whether batch or continuous process
      	 Relative amounts of beginning materials and order in
           which they are added
      	 Description of equipment
      	 Description of physical conditions  (temperature,
           pressure, humidity) controlled in each step and the
           parameters that are maintained
      	 Statement of whether process involves intended chemical
           reactions

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8. (continued)
9.
	 Plow chart with chemical equations jfor each intended
     chemical reaction                  |
	 Duration of each step of process   \
	 Description of purification procedures '
	 Description of measures taken to assure quality of final
     product

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

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                61 Product Identity and Composition


               GUIDANCE  FOR SUMMARIZING STUDIES


The following criteria apply  to the technical grade of  the  active
ingredient being reregistered.   Items 1, 2,  3,  and 5 can be satisfied
for most registered products by submission of the Certified Statement
of Formula Ingredients Page (EPA Form 8570-4} .  Items 7 and 8 can be
satisfied  for most  technical grade  active ingredients  (TGAIs)  by.
submission of a  flow  chart with  chemical equations for each intended
chemical reaction.  The flow chart should include complete chemical
structures  and  names  for each reactant  and product  of all  the
reactions.


1. Name of technical material (include product name and trade name,
   if appropriate).
2. Description of each active and intentionally-added inert
   ingredient,  including name, concentration, and certified limits.
3. Name and upper limit for all impurities present at > 0.1% and
   those toxicologically significant impurities present at <0.1%.
4. The purpose of each active and intentionally-added inert  
   ingredient.
5. Chemical name and' Registry Number for each active and
   intentionally-added inert ingredient (if available).
6. Molecular, structural, and empirical formulas, molecular weight,
   and any experimental or internal code number for each active
   ingredient.
7. Description of each beginning material in the manufacturing
   process.
8. Description of manufacturing process.
9. Discussion of formation of impurities based on established
   chemical theory.

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        62 Analysis and Certification of  Prodiict  Ingredients


                        ACCEPTANCE CRITERIA  :

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

Does your study meet the following acceptance criteria?

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

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        62 Analysis and Certification of Product Ingredients


                  GUIDANCE FOR SUMMARIZING STUDIES


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


 1. Number of representative samples analyzed for all active
    ingredients and all impurities at .> 0.1%.

 2. Degree of accountability or closure in analyses in item #1.

 3. Chemical names of  toxic impurities which were analyzed for
    levels <0.1%.

 4. Brief description(s) of analytical method(s) used to measure
    active ingredients and impurities in items #1 and #3.

 S. Statement of precision and accuracy of method(s) in item #4.

 6. Chemical name and quantities observed  (range, mean, standard
    deviation)  for each ingredient  (actives and impurities)
    analyzed in item #1.

 7. Proposed upper and lower certified limits for each active
    ingredient and intentionally added inert  with brief explanation
    of how limits were determined.

 8. Proposed upper certified limit for each impurity present at
    >=0.1% and certain toxicologically significant  impurities at
    <0.1% with brief explanation of how limits were determined.

 9. Brief description of analytical method(s) used  to verify
    certified limits  (if same methods as item #4, may reference
    latter).

10. Statement of precision and accuracy of method(s) in item #9
    (may reference item #5 if applicable).

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              63  Physical and Chemical Characteristics .


                        ACCEPTANCE CRITERIA


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

Does your study meet the following acceptance criteria?

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

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

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

63-5 Melting Point
     	 Reported in C                        :
     	 Any observed decomposition reported

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

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

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

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

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

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

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

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

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             63 Physical and Chemical Characteristics


                 GUIDANCE FOR SUMMARIZING STUDIES


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


 1. Description of color.
 2. Description of physical state.
 3. Description of odor.
 4. Indication of melting point (in C).
 5. Indication of boiling point (in C).       :
 6. Indication of density,  bulk density,  and specific gravity.
 7. Indication of solubility.                  ;
 8. Indication of vapor pressure.
 9. Indication of dissociation constant.
10. Indication of octanol/water partition coefficient.
11. Indication of PH.                         !
12. Description of stability.                  !

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                           SUBDIVISION F
Guideline              Study Title

  81-1    Acute Oral Toxicity in the Rat
  81-2    Acute Dermal Toxicity in the Rat,  Rabbit or Guinea Pig
  81-3    Acute Inhalation Toxicity in the Rat
  81-4    Primary Eye Irritation in the Rabbit
  81-5    Primary Dermal Irritation Study
  81-6    Dermal Sensitization in the Guinea Pig
  81-7    Acute Neurotoxicity in the Hen

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                81-1 Acute Oral Toxicity in the.Rat


                       ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

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

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               8l-i Acute Oral Toxicity in the Rat


                GUIDANCE  FOR  SUMMARIZING  STUDIES
1. The form of pesticide tested,  e.g. solid,  liquid, percent
   AI in technical,  end-use product,  etc.
2. The number of animals/dose/sex tested.
3. Dosing route and regimen.
4. Vehicle used
5. Doses tested and results
6. Individual observations on day of dosing and for at
   least 14 days.
7. Summarization of body weights
8. Summarization of gross necropsy
9. Significance of changes from the Acceptance Criteria

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


                        ACCEPTANCE CRITERIA    j


Does your study meet the following acceptance criteria?

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

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


                  GUIDANCE FOR SUMMARIZING STUDIES


 1.  The form of pesticide tested, e.g., solid, liquid, percent AI
     in technical, end-use product, etc.
 2.  The number of animals/sex/dose
 3.  Weight range of animals
 4.  Verification of single, dermal exposure
 5.  Duration of dermal exposure
 6.  Statement of vehicle control
 7.  Doses tested and results
 8.  Preparation of application site
 9. Area of application site  (percent body surface)
10. Occlusion of test material on application site
11.  Individual observations on day of dosing and for at
    least 14 days or until all animals appear normal  (whichever is
    longer).
12. Summarization of body weights
13. Summarization of gross necropsy
14. Significance of changes from Acceptance Criteria

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             81-3 Acute Inhalation Toxicity in the Rat


                        ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

 1.	 Identify material tested (technical, end-use product,  etc)
 2.	 Product is a gas, a solid which may produce a significant
        vapor hazard based on toxicity and expected use or contains
        particles of inhalable size for man  (aerodynamic diameter
        15 um or less).
 3.	 At least 5 young adult rats/sex/group
 4.	 Dosing, at least 4 hours by inhalation.
 5.	 chamber air flow dynamic, at least 10 air changes/hour, at
        least 19% oxygen content.
 6.	 Chamber temperature, 22 C  (2), relative humidity 40-60%.
 7.	 Monitor rate of air flow
 8.	 Monitor actual concentrations of test material in breathing
        zone.
 9.	 Monitor aerodynamic particle size for aerosols.
10.     Doses tested, sufficient to determine a toxicity category
        or a limit dose  (5 mg/L actual concentration  of respirable
        substance).
11.	 individual observations at  least once a day.
12.	 Observation period to last  at least  14 days.
13.	 Individual body weights.
14.	 Gross necropsy on all animals.

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            81-3 Acute Inhalation Toxicity in the Rat


                 GUIDANCE  FOR .SUMMARIZING  STUDIES


 1. The form of pesticide tested, e.g., solid, liquid, percent AI
    in technical, end-use product, etc.
 2. Statement of the inhalability of test substance
 3. The number of animals/sex/dose
 4. Duration of inhalation exposure
 5. Number of chamber air changes/hour and the percent oxygen
    content of chamber air
 6. Ranges for chamber air temperature and relative humidity
 7. Air flow rate
 8. Analytical concentrations of test material in breathing zone
 9. Results of aerosol particle-size determination
10. Doses tested (or limit dose of 5mg/L or highest attainable)
11. Individual observations on day of dosing and for at least 14
    days.
12. Summarization of body weights
13. Summarization of gross necropsy
14. Significance of changes from Acceptance Criteria

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             81-4 Primary Eye Irritation in the Rabbit
                        ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?

 1.	 Identify material tested (technical, end-use product,  etc)
 2.	 Study not required if material is corrosive, causes severe
        dermal irritation or has a pH of <. 2 or >, 11.5.
 3.	 6 adult rabbits
 4.	 Dosing, instillation into the conjunctival sac of one eye
        per animal.
 5.	 Dose, 0.1 ml if a liquid; 0.1 ml or not; more than 100 mg if
        a solid, paste or particulate substance!.
 6.	 Solid or granular test material ground to a fine dust.
 7.	 Eyes not washed for at least 24 hours. ;
 8.	 Eyes examined and graded for irritation before dosing and
        at 1, 24, 48 and 72 hr, then daily until eyes are normal or
        21 days  (whichever is shorter).
 9.*	 individual daily observations.         ;
Criteria marked with a * are supplemental and may not be required for
every study.

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            81-4 Primary Eye Irritation in the Rabbit



                  GUIDANCE FOR SUMMARIZING STUDIES



 1. The form of pesticide tested, e.g., solid, liquid, percent AI
    in technical, end-use product, etc.
 2. State if material is corrosive, cause severe dermal irritation
    or has a pH of <2 or >11.5
 3. Number of adult rabbits tested
 4. State method of dosing,  i.e.,  instillation into the conjunctival
    sac of one eye per animal
 5. Dose administered
 6. Note whether solid or granular test material has been ground to
    a fine dust
 7. State whether eyes were washed and at what  time post instillation
    (not less than 24 hours)
 8. State whether eyes were examined and graded for irritation before
    dosing and at what periods after dosing
 9. Individual daily observations afterwards,  until eyes are normal
    or for 21 days
10. Significance of changes from Acceptance Criteria

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                81-5  Primary Dermal Irritation Study
                        ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?

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

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                81-5  Primary Dermal  Irritation Study


                  GUIDANCE  FOR  SUMMARIZING  STUDIES


 1. The form^of pesticide tested, e.g., solid, liquid, percent AI
    in technical, end-use product, etc.
 2. State if material is corrosive,  has a pH <2 or >11.5, or has a
    dermal LD 50 <200 mg/kg
 3. Number of adult animals tested
 4. Amount applied
 5. Duration of dermal exposure
 6. Preparation of application  site  (shaved or clipped at specified
    time before dosing)
 7. Area of application site
 8. Method for occlusion of application site
 9. Note removal of test material and if skin was washed with water
10. State times post  application  when site  was  graded for irritation
11. Individual observations for day of dosing and individual daily
    observations thereafter
12. Significance of changes from Acceptance Criteria.

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           81-6 Dermal Sensitization in the Guinea Pig


                        ACCEPTANCE CRITERIA  .


dose your study meet the following acceptance criteria?

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

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            81-6 Dermal  Sensitization  in  the Guinea Pig


                 GUIDANCE  FOR SUMMARIZING STUDIES


1. The form of pesticide tested, e.g., solid,  liquid,  percent AI
   in technical,  end-use product,  etc.
2. State if material is corrosive or has pH <2 or >11.5.
3. State specific method utilized
4. Complete description of specific method
5. Reference for the specific method employed
6. Note adherence of the protocol to that in the reference for
   the specific method utilized
7. State the positive control tested
8. Significance of changes from Acceptance Criteria

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                81-7 Acute Neurotoxicity in the Hen

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

 1.	 Study performed on an organophosphate cholinesterase
        inhibiting compound.
 2.	 Technical form of the active ingredient tested.
 3.*,	 Positive control utilized.
 4.	 Species utilized, domestic laying hen 8-14 months of age.
 5.	 Dosing oral by gavage or capsule (dermal or inhalation
        may be used).
 6.	 An acute oral .LD is determined.
 7.	 Dose tested equal to an acute oral LD or a limit test of
        5000 mg/kg.
        Dosed animals may be protected with atropine and/or 2-PAM.
        Sufficient test animals so that at least 6 survive.
        Negative (vehicle) control group of at least 6 hens
        Positive control of at least 4 hens,  (if used)
        Test dose repeated if no signs of delayed neurotoxicity
        observed by 21 days after dosing.      :
        Observation period 21 days after each dose.
        Individual daily observations.         :
        Individual body weights.
        Individual necropsy not required.
        Histopathology performed on all animals.  Tissue to be
        fixed in sin preferably using whole animal perfusion
        techniques.  At least three sections of each of the
        following tissues:
             brain, including medulla oblongata
             "spinal cord; upper cervical, mid-thoracic and
             ~lumbro-sacral regions
             tibial nerve; proximal regions and branches
             "sciatic nerve
Criteria marked with a * are supplemental  and may not be required
for every study.                               <

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      ATTACHMENT F



Cost Share and Data Compensation Forms

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       &EPA
                                                       Protection Agency
                                                       20460
United States  Environmental
            Washington,  DC
   CERTIFICATION WITH  RESPECT TO
DATA  COMPENSATION  REQUIREMENTS
                                                                            Form Approred

                                                                            OMB No. 2070-0107
                                                                                     2070-0057
                                                                            Approval  Expire*  3-31-t

Public reporting burden for this collection of information is estimated to averagTlS minutes per response Z^~"
tune for rev.ew.ng .nstructwns, searching existing data sources, gathering arx?maintaining thVdataWede^Tan?

       ^
       PM 2% U?^ma^'^Q ^stons for reducing this burden, to Chief, Information Policy
fr,Sl  iii^f'ro'Ynental Protecton Agency. 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.

Please fill In blanks below.
   Company  Name
   Chemical Nam*
  I Certify that:
                                                                           Company Number
                                                                          EPA  Chemical Number
  1.
 3.
               ,,r, J? Support of reO'stralJon or ^registration under the Federal Insecticide, Fungicide and
           Act (FIFRA) that is an exclusive use study. I am the original data submitter, or I have obtained the
 wntten permission of the original data submitter to crte that study.                        cwumwuine

 That for each study cited in support of registration or reregistratton 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 wnting 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
 22J^!J!i?teTne W5? data are Subject to the "'"Pa"'"'' requirement of FIFRA and the amount of
 compensation due. rf any.  The companies I have notified are: (check one)

 I ] All companies on the data submitters' list 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 Pav
    below.)                                                                     '

 I ] The companies who have submitted me studies listed on the back of this former attached
    sheets, or indicated on the attached -Requirements Status and Registrants' Response Form."

That I have previously complied with section 3(c)(i)(D) of FIFRA for the studies I have cited in support of
registration or reregistratton under FIFRA.                                           * wn 
  Signature
  Name and TUIe (Pleaae Type or Print)
 GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the
 registration or reregistratton of my products, to the extent required by FIFRA sections 3(C)(1)(D) and 3(c)(2)(D)

                                                                          Date
 Name and Title (Please Type or Print)
EPA Form *570-31 (4-90)

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   r/EPA
United States Environmental Protection  Agency
            Washington, DC 20460
   CERTIFICATION  OF OFFER TO  COST
 SHARE  IN THE DEVELOPMENT  OF DATA
form Approve**

OUf Mo. 2070-0107
        2070-0057
Approval EspU*  3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information.  Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223, U.S. Environmental Protection Agency. 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington. DC 20503.
Please fill In blanks below.
Company Nam*
Chamlcal Nam*
1
Company Number
EPA Chemical Number
1 r>ftr*!f% hat
My company Is willing to develp and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and RodentfckJe Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share In the cost of developing
data.                                                             !

My firm has offered In writing to enter into such an agreement.  That offer was Irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA  If final agreement on all
terms could not be reached otherwise. This offer was made to the following  firm(s) on the following
date(s):
  Nam* of Ftrm(a)
                                                                            Oat* of Offer
Certification:

I certify that I am duty authorized to represent the company name above, and that the statements that I have made on
this form and all attachments therein are tiue, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Reproaontatlv*
Nam* and Title (Pleaae Typo or Print)

Date


 1PA Fom M7W2 (-1)
   Replace* EPA Form a3O-, which la obaotat*

-------
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    APPENDIX G



Product Specific Data Call-in

-------

-------
               UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                          WASHINGTON, D.C. 20460
                                                      MAY  7 1993
                        DATA CALL-IN NOTICE              OFFCEOF
                                                     PREVENTION, PESTCIDES
                                                      AND TOXC SUBSTANCES
 CERTIFIED MAIL
Dear  Sir  or Madam:


This  Notice requires  you and other registrants of pesticide
products  containing the active ingredient identified in Attachment
A of  this Notice,  the Data Call-in Chemical Status sheafrf  to submit
certaxn 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 III
below.  Your response must state:

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

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

      3. Why you  believe EPA should not require your submission  of
        product  specific data in the manner specified by this
        Notice (see section Ill-D).

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

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

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

     The Attachments to.this Notice are:        !

     A  - Data Call-In Chemical Status Sheet
     B  - Data Call-In Response Form
     C  - Requirements Status and Registrant's Response Form
     D  - EPA Grouping of End-Use Products for Meeting Acute
          Toxicology Data Requirements for Rereaistration
     E -  List of Registrantsfs^ sent this PCI
     F  - EPA Acceptance Criteria
     G  - Cost Share and Data Compensation Forms
SECTION I.  WHY YOU ARE RECEIVING THIS NOTICE  .

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

SECTION II.  DATA REQUIRED BY THIS NOTICE

II-A.  DATA REQUIRED

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

II-B.  SCHEDULE FOR SUBMISSION OF DATA

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

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 II-C.   TESTING  PROTOCOL

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

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

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

     All  new studies and proposed protocols submitted in response
 to this Data Call-In Notice must be in accordance with Good
 Laboratory Practices  [40 CFR Part 160.3(a)(6)].

 II-D.  REGISTRANTS RECEIVING PREVIOUS SECTION 3(e1L21CBI_NOTICBS
       ISSUED BY THE AGENCY

       Unless otherwise noted herein, this Data_C,a3JLr In does not in
 anv wav supersede or change the requirements of anv previous_Jlata
 Call-ln(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 NOTICB.

 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 No.tice 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.

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

     There  are two  forms  that accompany this Notice of which,
 depending  upon your response, one or both must be used in your
 response to the  Agency.  These forms are the Data-Call-In Response
 JEojau, and  the Requirements Status and Registrant's Response Form.
 Attachment B  and Attachment C.  The Data Callrin 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 B).   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 A.

     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 choose  to voluntarily cancel your  product, further sale
and distribution of your product after the effective date  of
 cancellation  must  be in  accordance with  the Existing Stocks
provisions of this Notice which are contained in Section  IV-C.

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discussed in Section Ili-c of this Notice and
through 6 on the Requirement status
                    and 7b on the
                   equrement status *nH p^j,p
 XLti nflbers 7a and 7b on the DJj^Call-ln R^ponJ ^SS5Sg-
 Deletion, of a use(s) and the low volume/minor use option are not
 valid options for fulfilling product specific data requirement
        Bequest for Product SpetH f Jc Data Waivera .   Waivers for
         Secific'data are discussed in Section lil-D S Sis Notice
         CVer*d by Ptin 7 n the RQuirm.nt.... Status *nH   NOtlCS
      >   ^% Regponi5?* For-  If you choose this option/you must
     iS   ?   ^ aS WSl1 aS any ther informatioS/dat4 pertaining
    the option chosen to address the data requirement.   *"" fc*in:Ln3

 I3:I-C  SATISFYING THK DATA REQUIREMENTS OP THIS NOTT^B

 a,,1? voufcac|powjedge on the Data Call-in ReaprmA Form that you
 agree to satisfy the product specific data requirements (i e  yoS

 ontfSn^Sn1?? ?a r-7b)'  then yU wamt ^lect one of the siS' Y
 rS?i?oH ?  Sh! ^eW^emg"tP Status -ami ReaifltMnt..a Regpnnga Form
 fSSr?ftto data production for each data requirement.  Your op?iSn
 selection should be entered under item number 9, "Registrant
   rstSOT                            data produci   ar  the
 rn^L^  ES S dfscussed un<*er item 9 in the instructions for
 completing the Requirements Status and Registrant's Resmonsg For
      t.                        immediately belo  with
 SSSSS5 ?J ^9Uide fe9istrants ^ additional instructions
 provided in this Section.   The options are:

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

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

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

    If you cannot submit the data/reports to the Agency  in the time
required by this Notice and intend to seek additional time to meet
the requirements(s), you must submit a request  to the Agency which
includes: (1) a detailed description of  the expected difficulty and
(2) a proposed schedule including alternative dates for  meeting
such requirements on a step-by-step basis.  You must explain any
technical or laboratory difficulties and provide documentation from
the 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. Agree 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 mist 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 Snare  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
pav 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 G.  In addition, you must demonstrate that the other
 registrant to whom .the offer was made has not accepted your offer
 to  enter  into a  costsharing agreement by including a copy of your
 offer and proof  of the other registrant's receipt of that offer
 (such as  a certified mail receipt).  Your offer must, in addition
 to  anything else, offer to share in the burden of producing the
 data  upon terms  to be  agreed or failing agreement to be bound by
 binding arbitration  as provided by FIFRA section 3(c)(2)(B)(iii)
 and must  not qualify this offer.   The other registrant must also
 inform EPA of its election of an option to develop and submit the
 data  required by this  Notice by submitting a Data Call-in Response
 ESSB.and  a Requirements Status and Registrant's Response Form
 committing to develop  and submit the data required by this Notice.

    In order for you to avoid suspension under this option, you may
 not withdraw your offer to share in the burdens of developing the
 data.  In addition,  the other registrant must fulfill its
 commitment to develop  and submit the data as required by this
 Notice.   If the  other  registrant fails to develop the data or for
 some  other reason is subject to suspension, your registration as
 well  as that of  the  other registrant will normally be subject to
 initiation of suspension proceedings, unless you commit to submit,
 and do submit the required data in the specified time frame.  In
 such  cases, the  Agency generally will not grant a time extension
 for submitting the data.


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

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

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

    a. You must certify at the time that  the  existing study is
    submitted that the raw data and specimens from the study are
    available for audit and review and you  must  identify where they
    are available.  This must be done in  accordance with
    the requirements of the Good Laboratory Practice  (GLP)
    regulation, 40 CFR Part 160. As stated  in 40 CFR,160.3(j)
    " '[r]aw data1 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 data1 may  include  photographs,
    microfilm or microfiche copies, computer  printouts, magnetic
    media, including dictated observations, and  recotded  data from
    automated instruments."  The term-"specimens", according to 40
    CPR 160.3(k), means "any material derived from a  test system
    for examination or analysis."

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

    c. You must certify that each study fulfills the acceptance
    criteria for the Guideline relevant to the study provided in
    the PIPRA 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
    CPR 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.
                                  8

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 a^1,H5fm^e,SU?^it an.existing study,  you must certify that the
 study meets all requirements of the criteria outlined above.
 Mn            f 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

 ? Aa^,n?t1^ thS AgenCy f SUCh a studv'   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 gfrudy -- 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 A.  If you submit data to upgrade an existing study you
 must satisfy or supply information to correct all  deficiencies in
 the study identified by EPA.   You must provide a clearly
 articulated rationale of how the deficiencies have been remedied  or
 corrected and why the study should be rated  as acceptable to EPA
 Your submission must also specify the MRID number (s) of the study
 SS S f.yU of6 attemPtin9 to upgrade and must be in conformance with
 JET iC fiOC x C* 8 o  5 *

     Do not submit additional  data for the purpose  of upgrading a
 study classified  as unacceptable and determined by the Agency as
 not capable of being upgraded.                               y

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

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

    Option  6.  Citing Existing Studies --  if  you choose to cite a
study that has been previously submitted to  EPA,  that study must
have been previously classified by EPA as acceptable or it must  be
a study which has  not yet been reviewed by the Agency.  Acceptable
toxicology studies  generally  will  have been  classified as "core-

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guideline* or "core minimum.*  For all other disciplines  the
classification would be ."acceptable.". With respect to  any  studies
for which you wish to select this option you must provide the MRID
number of the study you are citing and, if the study has  been
reviewed by the Agency, you must provide the Agency's
classification of the study.

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

    Registrants who select one of the above 6 options must  meet  all
of the requirements described in the instructions for completing
the Data Call -In Response Form and the
          ' s Response Form, as appropriate.
III-D  REQUESTS FOR DATA WAIVERS                  '.

    If you request a waiver for product specific data because you
believe it is inappropriate, you must attach a complete
justification for the request , including technical reasons ,  data
and references to relevant EPA regulations, guidelines or policies.
(Note: any supplemental data must be submitted in the format
required by PR Notice 86-5) .  This will be the aaly. opportunity to
state the reasons or provide information in support of your
request.  If the Agency approves your waiver request, you will not
be required to supply the data pursuant to section 3(c) (2) (B) of
FIFRA.  If the Agency denies your waiver request, you must choose
an option for meeting the data requirements of this Notice within
30 days of the receipt of the Agency's decision.  You must indicate
and submit the option chosen on the Requirements Status and
Rfsgintr?"^'8 Response Form.  Product specific data' requirements for
product chemistry, acute toxicity and efficacy  (where appropriate)
are required for all products and the Agency will grant a waiver
only under extraordinary circumstances.  You should also be aware
that submitting a waiver request will aat automatically extend the
due date for the study in question.  Waiver requests submitted
without adequate supporting rationale will be denied and the
original due date will remain in force.

IV.  CONSEQUENCES OP PAILUBB TO COMPLY WITH THIS NOTICE

IV- A NOTTCS OP TMTBNT 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.          i

                                 10

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     2.  Failure to submit on the required schedule an acceptable
     proposed or final protocol if 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 if 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* ,iFaflure to submit  supportable certifications as to the
     conditions of submitted studies,  as required by Section III- c
     of this Notice.

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

     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 either to:

     a. Inform EPA of intent to develop and submit the data
     required by this Notice on a Data Call-XrLResponae Form  and a
     Requirements Status and Registrant's ReapQMg Form;

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

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

    9.  Failure to take any required  or appropriate steps, not
    mentioned above,  at any time following the issuance of this
    Notice.

IV-B-  BASIS  FOR DBTBRMTNATIQN THAT SUBMITTED STOPY Tfl
    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:
                                 11

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    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  (if
    applicable), 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.
                                                  i
IV-C  EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS

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

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

    If you request a voluntary cancellation of  your product(s)  as a
response to this Notice and your product  is in full compliance with
all Agency requirements, you will have, under most  circumstances,
one ylar 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

                                  12               :

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 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 a 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 A, the Data Call-In ChemigaJLStatus Sheet.

    All responses to this Notice  (other than voluntary cancellation
requests)  must include a completed Data Calljjn_Responae Form and a
completed Requirements Status and Registrant's ResponseForm
 (Attachment B and Attachment C) and any other documents required by
this Notice, and should be submitted to the contact  person(s)
identified in Attachment A. If the voluntary cancellation option is
chosen, only the Data Call-In Response Form need  be  submitted.
                                 13

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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,
    A
    B
    C
    D

    E
    F
    6
                      Daniel M.  Barolo,  Director
                      Special Review and
           Reregistration Division

                 Attachments

- Data Call-in Chemical Status Sheet
- Data Call -In Response Form
- Requirements Status and Registrant's Response Form
  EPA Grouping of End-Use Products for Meeting Acute
             Data Requirements for Rerediatration
       of Registrants Sent This PCI
  EPA Acceptance Criteria
  Coat Share and Data Compensation Forms
                                  14

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ATTACHMENT A



 Chemical Status Sheet

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                            ATTACHMENT A

   CHLORINATED ISOCYANURATES: DATA CALL-IN CHEMICAL STATUS SHEET


INTRODUCTION

    You have been sent this Product Specific Data Call-in Notice
because you have product(s) containing the chlorinated
isocyanurates.

    This Product Specific Data Call-In Chemical Status Sheet.
contains an overview of the data required by this notice, and point
of contact for inquires pertaining to the reregistration of the
chlorinated isocyanurates.  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 B) , (3)
The Requirements Status and Registrant's Response form (Attachment
C), (4) EPA Grouping of End-Use Products for Meeting Acute
Toxicology Data Requirements for Reregistration (Attachment D); (5)
list of registrants receiving this DCI  (Attachment E), (6) the EPA
Acceptance Criteria (Attachment F), and  (7) the Cost Share and Data
Compensation Forms in replying to this chlorinated isocyanurate
Generic Data Call-in (Attachment G).  Instructions and guidance
accompany each form.

DATA REQUIRED BY THIS NOTICE

    The additional data requirements  needed to complete the
database for the chlorinated isocyanurates are contained  in the
Requirements Status and Registrant's  Response Form. Attachment C.
The Agency has concluded that additional product chemistry data and
toxicology data are needed for specific products.  These  data are
needed to fully complete the reregistration of all eligible
chlorinated isocyanurate 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 Barbara Pringle at  (703) 305-6484.

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

     Document Processing Desk  (RED/RD/PM32)
     Office of Pesticide Programs  (H7504C)
     Environmental Protection Agency
     401 M Street, S.W.
     Washington, D.C.  20460-0001

     RE: Chlorinated Isocyanurates

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             ATTACHMENT B

Product Specific Data Call-in Response Forms (Form A)
                Plus Instructions

-------

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                SPECIFIC INSTRUCTIONS FOR COMPLETING
                   THE DATA CALL-IN RESPONSE FORM

                        Product Specific Data


     This form is designed to  be used to respond to call-ins for
 generic and product  specific  data for the purpose  of reregistering
 Acf 1CF??? ^r the Federal  insecticide Fungicide and RodentfciS
 call in iir-^iS-  H^D^ SaCh time yU are ^spending to a data
      '                                              '
     Items  1-4  will  have been preprinted on the form.   Items  5
 through 7  must be completed by the registrant  as  appropriate
 Items  8 through 11  must be completed by the registrant before
 submitting a response  to the Agency.
^PU?1iCVrep0rtin9 burden  for  this  collection  of  information  is
estimated to average 15 minutes  per response,  including  time  for
fnrt1^^18*^10*8' searching  existing data  sources,  gathering
and maintaining the data needed, and  completing  and reviewing the
collection of information.   Send comments regarding the  burden
estimate or any other aspect of  this  collection  of  information,
including suggesting for reducing  this burden, to Chief,
Information Policy Branch, PM-223, U.S. Environmental  Protection
Agency, 401 M St., S.W., Washington,  D.C. 20460; and to  the Office
of Management and Budget, Paperwork Reduction  Project  2070-0107
Washington,  D.C. 20503.

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

 Item 1-4.  Already completed by EPA.

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

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

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

 Item 7b.   For  each  end use product (EP)  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.

JQT_S:   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.

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-------
            ATTACHMENT C

Requirements Status and Registrants' Response Forms
            (Form B) Plus Instructions

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

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

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

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

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

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

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

Item 9. Enter only one of the following response code* for each
        data requirement; to show how you intend to comply with the
        data requirements listed in this table.  Fuller
        descriptions of each option are contained in the Data Call-
        in Notice.

    1.   I will generate and submit data by the specified due date
        (Developing Data).   By indicating that I have chosen this
        option,  I certify that I will comply with all the
        requirements pertaining to the conditions for submittal  of
        this study as outlined in the Data Call-In Notice.

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

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Che required data; if the required study is not  submitted
on time, my product may be subject to suspension.

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

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

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

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

-------
        cite another registrant's data, I will submit a completed
        "Certification With Respect To Data Compensation
        Requirements" form.

    7.  I request a waiver for this study because it is
        inappropriate for my product  {Waiver Request).  I am
        attaching a complete justification for this request,
        including technical reasons, data and references to
        relevant EPA regulations, guidelines or policies.   [Note:
        any supplemental data must be submitted in-the format
        required by P.R. Notice 86-5].  I understand that this is
        my only opportunity to state the reasons or provide
        information in support of my request.  If the Agency
        approves my waiver request, I will not be required to
        supply the data pursuant to Section 3(c)(2)(B) of FIFRA.
        If the Agency denies my waiver request, I must choose a
        method of meeting the data requirements of this Notice by
        the due date stated by this Notice.  In this case, I must,
        within 30 days of my receipt of the Agency's written
        decision, submit a revised "Requirements Status and
        Registrant's Response" Form indicating the option chosen.
        I also understand that the deadline for submission of data
        as specified by the original data call-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.

-------

-------


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III  5

 E5 
-------

-------
            ATTACHMENT D

EPA Grouping of End-Use Products for Meeting Acute
   Toxicology Data Requirements for Reregistration

-------

-------
                                                              PRODUCTS FOR MEE ACUTE
  ?fitf
  chlonnated .socyanurates, the  Agency has batched products which can be considered sTmlr for

  Kn^d'SrS"1^- FaCtrS CnSidered '" th6 Srtin9 PrC6SS indude ^ch produc '  cTitand
  inert ingredients ddent.ty, percent composition and biological  activity), type of formulation (e a
  emuls.f.ab e concentrate, aerosol, wettable powder, granular, etc.), and iabeHng (eg.,sS word  use

  a's'-s'Sn^r603?'0"^ 'abelin9'  etC-K Nte that the A9enCV is not desc^"" batched products
  or h'e idenS ^e patteTn" *"* PrdUCtS "**"
  fro,,    Batching HaS been accomP|ished usina the readily available information described above  and
  frequently acute  toxicity  data on  individual end-use products has been found to be incomplete
  Notwithstanding the batching process, the Agency reserves the right to require, at any time  acute
  toxicity data for an individual end-use product should the need arise.
                   f ^'^ PfdUCtS within a batch mav choos8 to cooperatively generate, submit
        a angle battery of s.x acute toxicological studies to represent all the products within that batch
  It ,s the registrams' option to participate in the process with all other registrants, only some oHhe
  other registrants, or only their own products within a batch, or to generate all  he reauTed acut!

  abSh 9h 3 ?UdieS fr 6aCh f the!r Wn Pr0dUCtS'  lf a reaistrant chooses fotneratTthe data for
  ehnnl t   ,   mUSt US8 ne f the PrdUCtS Within the batch as the te material. If a reg'stran
  chooses to rely upon prev.ously submitted acute toxicity data, he/she may do so provided that the

                                                                              "
                                              (S6e 3CCePtanC8 Cri*a attached>'              n
         nti           V   u     be Sim"ar fr acute toxicitv'  and the formulation has not been
 s.gmficant y altered smce submission and acceptance of the acute toxicity. data. Regardless of whether

 ~                      ^ " referenC6d' n^m  dearly identify the test
        In deciding how to meet the product specific data requirements, registrants must follow the

 ronc ! fl'Ven '" the ?3ta Ca'Mn Ntice and its attachmems appended to the RED. T^e DC Not ce
 contains two response forms which are to be completed and submitted to the Agency within 90 davs

 rflaru1tT5e fifSVrm; "Dati,Cal|-|n ResPns'- ks whether the registramw^. meet the data
 nTthl   I  / each Pfduct-  ^ second form- "Requirements Status and Registrant's Response -

 A Battnt  h  SP6
-------
purposes of acute toxicity or the Agency lacked sufficient information for decision making purposes.
Registrants of these products are responsible for meeting the acute toxicity data requirements for each
product.                                                                  !
Table I.
B*tch
1



2
EPA Rog. No.
230-75
230-78
524-345
524-349
524-357
602-141
602- 182
602-293
1757-98
6284-49
7124-60
8791-53
8791-54
34S71-7
43680-9
45309-21
53254-4

230-72
524-353
624-359
524-36O
881-12
1072-17
1270-211
4313-48
4875-19
10428-18
% Dichloroitocyanuratas and any othar active
ingredients
40
40
40
40
40
65 '
65
65 I
45 i
55.6
57
40
40
54
54
57
40
 .- ' :. ' " "
28
28
25
25
28
28
28 !
28 ;
28
28
Formulation Typa II
granular ||
granular ||
granular ||
granular
powder
powdar
powder ||
granular |j
granular
granular
granular
powdar
granular ||
powdar
powder
granular
powder

granular |
granular |
granular |
powder
powdar
granular
powder
powder
granular
. powder

-------
II Batch






3



















4





EPA Reg. No.
  
35495-11
40457-4
40871-6
48211-69
58880-1

230-76
524-361 '
524-362
524-363
1791-4O
4875-18
5768-12
5870-33
7546-17
8791-58
8791-59
10634*19
35495-12
37741-2
41831-6
49292- 1O
50600-4
62353-1
64864-6

524-371
524-372
524-373
875-89
875-94
875-98
% Dichloroisocyanurates and any other active
ingredients
28
23
28
28
28

25
25
25
25
25
25
25
25
30
25
25
25
25
25
25
25
25
25
26.5

34
34
34
25.8
13.8
6.9
'""^
Formulation Type


powder

powder







powder




















-------
Batch





5

6

7

8

EPA Reg. No.
1677-141
1677-149
1706-142
4462-39
5736-17
7116-5
8540-14
9152-19
10508-6
10932-8
65020-3

5389-14
6198-5
6198-7
6198-13

524-364
524-365
524-366
524-367
8791-56

23O-74
524-368
24-369
8791-55

1270-181
4313-49
6198-6

% Dichloroisocyanuratea and anv other activa ;
ingredients
22.25
28
18
20
17
6.8
25
16.5
'16 '
34
30 I
I
23.85 |
25
25
25 !

6 !
6
6
18
I
18
;'' -.-j^:  ' I
18
18
18
18
'''.'.  ';"::.. "-:.v *:?'' '
5.6
- 5.6
5.6
"-'- v':. ,:'''"-'  ' ' '\
Formulation Type II
powder
granular
granular
powder ||
granular
granular
granular
granular
granular ||
powder ||
powder ||

granular |
powder
powder
tablet

granular
powder
granular
granular
powder



granular
powder
powder
granular
II




granular
granular
granular






-------
Batch
9

10

11

12

13

14

IS
:.-. *;.;::'/;* ^v/;
16
EPA Rag. No.
1258-1160
1258-1161
1258-1165
1258-1166

1258-1159
1258-1162
1258-1163
1258-1164

3525-40
3525-53
3525-84
5185-311
9157-24

6284-30
7364-29
8791-5
8791-13
'.'.;'- ' '' " '"' '". *' " ' '" ''.' ' ':'"''
3522-18
6284-48
:;:! ..:::,;. . : ,.;'" :"'; .'' ' ''.'
5389-6
5768-14

3573-49
3573-51
-. -. '. .'.'.:.: '.'.'.' '<::.
1124-67
6466-12
% Dichloroisocyanurates and any othar active
ingrediants
50
50
50
50

25
25
25
25

57
57
57
64.6
60

49.1
49.1
47.5
49.1

86
87.7
?' ' - ;
6
6
" . ' ' ' "'.''
0.9
0.9

0.3
0.8
II
Formulation Typa
tablets
tablets
tablets
tablets

tablets
tablets
tablets
tablets

powder
powder
powder
granular
granular

granular
granular
granular
granular
;->:; ' . ,
tablet*
granular
-






granular ||
granular ||
''''?:'" ' "; ,' II
powder |
J
powdar g

1
powdar |
powdar I

-------
Batch

17



18


19


20


21


22


23


24






EPA Rag. No.

3635-44
3640-61
65020-2

602-185
5389-10

1317-65
1677-91

833-44
48925-1

1677-53
7350-14

3635-101
3635-209

230-73
58262-1

4829-14
4329-19
4829-40
4829-50
4829-51


% Dichloroisocyanuratas and any othar active
ingredients

2.5
3.2
5.4

17.5
16.1

20.25
29
i
29
25

20.25 :
18

15
34

5.6
5.6
< , "'
6O dichloroisocyanuraM
1 benzyl ammonium chloride
60 dichloroUocyanuraM
1 benzyl ammonium chloride
60 dichloroiiocyanurata 
1 benzyl ammonium chlorid*
64 dichloroiiocyanuraM
1 benzyl ammonium ohlorida
64 dichloroitocyanurata
1 benzyl ammonium chlorida '.

"- 	 -'. ' 	 .,....,;.,,:.--.-.,.;. ...,,<......;;;. ..,;;....:.:;..
Formulation Type II

powder
powder
granular

powder
powder

granular
powder ||

powder I
powder ||

powder
powder

powder ||
granular

powder
powdar

tablet*
tablet*
tablet*
powdar
	
tablet*

.::.;.?' A I

-------
Batch
25
EPA Rag. No.
524-377
524-395
524-404
5185-376
% Dichloroisocyanurates and any other activa
ingredients
96 dichloroisocyanurata
4 sodium bromida
39 dichloroisocyanurata
7 sodium bromida
89 dichloroisocyanurate
7 sodium bromida
81.S dichloroisocyanurata
1 4.6 sodium bromida
Formulation Type
granular
granular
granular
granular
Batch 26.      The following batch consist of products {tablets, powder and granular formulations)
               containing dichloroisocyanurates as the active ingredient in concentrations ranging from
               98-100 % .
       148-1167
       230-50
       230-57
       230-60
       230-63
       230-69
       275-78
       278-50
       523-313
       524-105
       524-108
       524-325
       524-335
       524-338
       524-379
       524-381
       524-383
       524-385
       524-388
       524-389
       1258-745
       1258-852
       1258-861
       1258-886
       1258-897
       1258-898
       1258-9O3
       1258-9O7
       1258-984
       1258-1042
       1258-1065
       1258-1106
       1258-1107
       1258-1137
       1258-1138
       1258-1139
       1258-1140
1258-1141
1258-1142
1258-1143
1258-1144
1258-1145
1258-1151
1258-1152
1258-1153
1258-1154
1258-1155
1258-1156
1258-1157
1258-1158
1258-1174
1317-80
1677-44
1729-93
1729-135
1729-144
2136-33
2292-96
3432-12
3432-37
3432-50
3525-41
3525-56
3525-57
4524-42
4591-71
4829-26
4829-53
4829-54
4829-60
4829-62
4829-64
4829-68
4829-69
4875-15
5185-54
5185-194
5185-226
5185-278
5185-315
5185-316
5185-319
5736-43
6199-2
6199-4
6284-3
6284-20
6284-27
6284-28
6284-42
6284-52
6809-8
7124-20
7124-31
7152-17
7152-21
7364-45
7364-60
7368-6
7368-37
7616-2
7616-47
8033-6
8544-10
8544-13
8544-20
8791-4
8791-12
8791-27
8791-31
8791-43

-------
 8791-44
 SS66-24
 8959-38
 8959-40
 9157-5
 9157-18
 9157-23
 9157-28
 9157-31
 9215-2
 9215-8
 9411-7
 10079-3
 10133-11
 10182-10
 10182-13
 10182-31
 10182-59
 10336-3
 10598-8
 10897-1
 10897-7
 10897-9
 10897-31
 10932-10
 11329-8
 11411-1
 12014-27
 12014-42
 12014-44
 12465-51
 15127-9
 15127-10
 15127-11
 33906-1
 33908-4
 33906-5
 33906-7
 33980-2
 33980-3
 34571-14
 35909-10
 36234-3
 37428-1
 37982-19
 37982-23
 41134-1
 41134-3
 41134-5
 41702-6
 41702-12
 42177-8
 42177-18
 42177-30
 42177-57
 42177-58
, 42448-3
 43973-2
 43973-5
 45309-12
45309-46
45387-15
47033-7
48242-1
51624-3
53254-2
53254-3
53346-1
53346-2
                                          8

-------
        53346-3
        53348-4
        54309-14
        54998-2
        57787-6
        57787-9
        57787-16
        62498-1
Table II.
                                         ^  Trichloroisocyanurates and any other active
                                                        ingredient
                    4829-80

                    4829-81

                    4829-82

                    4829-83

                    4829-84

                    4829-85

                    6284-43

                    6284-46

                    7124-1

                    7124-6

                    7124-37

                    7124-42

                    7124-61

                    7124-62

                    7124-63

                    7124-64

                    7124-68

                   7124-66

                   7124-67

                   7124-68

                   7124-69
83.7
83.7
63.7
63.7

63.7
 63
 63
 63
 66

 68
 67
 70
 66

 66
 66
66
65

65
65
65
                                                          65
                                   able
                                   able
                                  table
 able
                                  tablets
                                   able
 able
granule

 tablaM
 tablau

 tablets

 tablet

 tablau

 tablet*

 tablet*
                                  tablet*
                                                                                            tablets

-------
Batch








28

EPA Rag. No.
7152-43
7152-87
7364-42
8544-4
8791-29
12465-16
42177-68
45309-7
45309-8
45309-15
45309-2O
45309-52

1258-1187
1258-1188
1258-1189
1258-1191
4829-116
4829-117
4829-118
5185-349
5185-397
7124-15
7618-8
7618-51
8791-0
8791-61
8791-62
8791-63
8791-64
9291-6
42177-47
% Trichloroisocyanurates and any other active
ingredient
66 !
66
60 !
70
67
67  !
67 ;
67
67
67 ;
67 i
67

78.0
78.6
78.6
78.6
78
78
78
89
86.3
81
82
82
80
70
70
80
80
63
89
Formulation Type IJ
granular ]|
tablet
tablets
granular
tablet*
tablets ||
tablets
tablets II
tablets 1
tablets  ||
tablets ||
tablets ||
I
stick
tablets
tablets
granular
tablets
tablets
tablets
tablets
tablets I
granular ||
tablets
tablets
tablets
tablets
tablets
tablet*
tablets
tablet*
_ _______ ^j
tablet* I
10

-------
Batch


29

30
EPA Reg. No.
42177-48
42177-50
42177-52

4582-65
4582-66
4582-67

524-394
524-402
524-410
524-41 1
524-425
6284-29
% Trichioroisocyanurates and any othar active
ingredient
89
89
89

0.6
0.6
0.6

Trichloroisocyanurate 92
Sodium bromide 7
Trichloroisocyanurate 92
Sodium bromide 7
Trichloroisocyanurate 92
Sodium bromide 7
Trichloroisocyanurate 92
Sodium bromide 7
Trichloroisocyanurate 88
Sodium bromide 9.2
TricWoroisocyanurate 96
Formulation Type
tablets
tablets
stick

powder
powder
powder

tablets
tablets
tablets
tablet*
tablets
tablet*
Batch 31:      The following batch consist of products (sticks, tablets and  granular formulations)
               containing trichloroisocyanurates as the active ingredient in concentrations ranging
               from 93- 100% .
148-916
148-1279
148-1280
148-1281
230-47
230-48
230-58
230-69
230-61
230-79
230-80
230-81
230-82
230-83
230-84
230-85
230-87
524-107
524-323
524-324
524-336
524-337
524-348
524-374
524-380
524-387
524-399
524-414
524-438
1258-853
1258-855
1258-893
1258-905
1258-922
1258-992
1258-993
1258-994
1258-995
1258-996
1258-997
1258-998
1258-1059
1258-1060
1258-1061
1258-1062
1258-1075
1258-1083
1258-1133
1729-92
1729-95
1729-98
1729-99
1729-100
1729-101
1729-120
1729-138
1729^143
                                                11

-------
  1729-145
  1729-14S
  3432-23
  3432-24
  3432-35
  3432-36
  3432-44
  3432-43
  3432-51
  3432-61
  3525-38
  3525-42
  3525-72
  3525-73
  3525-74
  3525-75
  3525-76
  3878-138
  4591-72
  4843-47
  4827-77
  4829-55
  4829-59
  4829-61
  4829-63
  4829-67
  4829-74
  4829-75
  4829-86
  4829-87
 4829-89
 4829-125
 5185-10O
 5185-114
 5185-143
 5185-144
 5185-159
 5185-318
 5185-348
 5185-351
 185-352
 5185-370
 5185-371
 5185-379
 6199-3
 6199-5
 6284-11
 6284-12
 6284-19
 6284-26
 6284-31
 6284-32
 6284-33
 6284-35
 6284-36
 6284-37
 7124-12
 7124-14
 7124-18
 7124-22
7124-24
7124-44
 7124-53
 7124-70
 7124-71
 7124-72
 7124-95
 7124-99
 7152-39
 7364-41
 7364-43
 7364-44
 7364-49
 7364-51
 7364-55
 7364-57
 7368-19
 7368-21
 7368-27
 7369-61
 7368-70
 7616-18
 7616-28
 7616-50
 7616-60
 7619-39
 8033-4
 8544-11
 8544-12.
 8544-15
 8791-2
 8791-3
 8791-6
 8791-7
 8791-11
 8791-26
 8791-28
 8791-32
 8791-33
 8791-36
 8791-37
 8791-38
 8791-42
 8866-25
 8959-42
9157-6
 9157-17
9157-27
9157-29
9157-32
9157-35
9215-3
9215-6
9215-7
 10182-11
 10182-12
 10182-32
 10182-33
 10182-42
10182-51
10182-52
10182-53
10182-54
10182-55
10336-7
10598-7
10707-37
10897-2
10897-8
10897-11
10897-16
10897-17
10897-30
11329-9
11411-3
11411-5
11411-6
11411-7
11411-8
12014-35
12014-36
12014-37
12014-39
12014-40
12014-45
12014-56
12465-36
12465-39
12465-48
12477-11
13812-3
15127-4
15300-21
27581-31
33458-15
33906-2
33906-3
33906-6
33980-1
33980-4
33980-5
33980-6
34571-12
36284-1
36284-4
36284-6
37428-3
37982-4
37982-6
41134-2
41134-4
41702-7
41702-8
41702-9
42177-17
42177-18
42177-22
42177-23
42177-24
42177-26
42177-36
42177-67
43973-3
43973-4
45309-9
45309-16
                                                 12

-------
  45309-22
  45309-23
  45309-24
  45309-27
  45309-47
  45309-48
  45309-51
  45387-13
  45387-16
 45387-17
 45387-18
 47033-8
 48242-2
 48242-4
 48520-10
 48520-11
 53254-1
 53254-5
 53254-6
 53735-2
 53735-3
 53735-4
 53735-5
 53735-6
 54998-1
54998-3
54998-6
57091-1
57091-2
57787-1
57787-8
57787-12
62498-3
62498-4
62498-5
63041-1
Table III.
                            % Diohloroiocyanurate and any other active
                                           ingredient
                                    Formulation Type
                                         dichioroisocyanuratt
                                            citric acid
                                 36.7    dichloroitocyanurate
                                  8.7    copper sulfate
                                                 13

-------
                         % Dichloroitocyanurates and any other activs
                                        ingredient
                                        dichloroisocyanurate
                                          potassium iodine
Table IV shows 19 products containing trichloroisocyahurates as the active ingredient and that were
either  considered not to be similar for purposes of acute toxicity or the Agency lacked sufficient
information for decision making and were not placed in any batch. Registrants of these products are
responsible for meeting the acute toxicity data requirements for each product.
Table IV.
     EPA Rtfl. No.
      
       541-173
Trichloroitocyanurate*
       Mi
        10
Formulation Type
   MHI
    powder
        t02O-4
       USS-909
       4843-29
       4829-94
       SI 85-400
        7124-2
       7124-50
        62
        25
       38.8
       93.33
        30
        50
                                      granular
                                      granular
    solution
     tabUU
     tablet*
     tablet*
    granular
                                                 14

-------
EPA Rag. No.
7152-33
7152-34
7152-37
7616-48
8791-1
9157-33
10147-10
15300-17
37982-22
46043-2
46043-3
Trichloroisocyanurata*
99
99
99
30.3
79
70
15
20
99
99
99
Formulation Type
tablet*
tablet*
tablets
tablet*
granular
tablet*
granular
powder
granular
tablets
tablets
15

-------

-------
           ATTACHMENT E



List of All Registrant(s) Sent This Data Call-In Notice

-------

-------
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-------

-------
ATTACHMENT F



EPA Acceptance Criteria

-------

-------
                          SUBDIVISION D
Guideline              Study Title

Series 61      Product Identity and Composition
Series 62      Analysis and Certification of Product Ingredients
Series 63      Physical and Chemical Characteristics

-------
               61 Product Identity and Composition
                                                I

                       ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

1.	 Name of technical material tested (include product name  and
      trade name, if appropriate)
2.	 Name, nominal concentration,  and certified limits (upper  and
      lower) for each active ingredient and each intentionally-
      added inert ingredient
3.    Name and upper certified limit for each impurity or each
  	 group of impurities present at > 0.1% by weight and for
      certain toxicologically significant impurities (e.g.,
      dioxins, nitrosamines) present at <0.1%   ;
4.    Purpose of each active ingredient and eachf intentionally-
      added inert                               ;   
5.    Chemical name from Chemical Abstracts index of Nomenclature
  	 and Chemical Abstracts Service (CAS) Registry Number for each
      active ingredient and, if available,  for each intentionally-
      added inert                               I
6.	 Molecular, structural, and empirical formulas, molecular
  	 weight or weight range, and any company assigned experimental
      or internal code numbers for each active ingredient
7.	 Description of each beginning material in the manufacturing
      process
      	 EPA Registration Number if registered;  for other
           beginning materials,  the following:
      	 Name  and address of manufacturer  or supplier
          '_ Brand name, trade name  or  commercial designation
      ~~~~~" Technical specifications or data  sheets by which
           manufacturer or  supplier describes composition,
           properties or toxicity               !
8.    Description of manufacturing process
  	 	 Statement of whether  batch or  continuous process
      ~~~~ Relative amounts of beginning  materials and  order  in
           which they are added
       	 Description of equipment
      	 Description of physical conditions (temperature,
      	 pressure, humidity)  controlled in each step  and  the
           parameters that  are maintained
      	 Statement of whether process involves intended chemical
           reactions
                                                                            .J

-------
8. (continued)


      	 Flow chart with chemical equations for each intended
           chemical reaction
      	 Duration of each step of process
      	 Description of purification procedures
      	 Description of measures taken to assure quality of final
           product


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

-------
               61 Product Identity and composition


               GUIDANCE FOR  SUMMARIZING  STUDIES  !


The following criteria apply to the technical grade of the active
ingredient  being reregistered.   Items  1,  2,  3,  and  5 can  be
satisfied  for  most registered  products  by submission  of  the
Certified Statement of Formula Ingredients Page  (EPA Form 8570-4).
Items 7  and 8 can  be  satisfied for most technical  grade active
ingredients  (TGAIs)  by submission of a  flow  chart with chemical
equations for  each intended  chemical  reaction.   The  flow  chart
should include complete chemical structures  and  names  for each
reactant and product.of all the reactions.      j


1. Name of technical material  (include product name  and trade name,
   if appropriate).
2. Description of each active and intentionally-added inert
   ingredient, including name, concentration, and certified limits.
3. Name and upper limit for all impurities present at > 0.1% and
   those toxicologically significant impurities present at <0.1%.
4. The purpose of each active and intentionally-added inert
   ingredient.                                  ;
5. Chemical name and Registry Number for each active and
   intentionally-added inert  ingredient  (if available).
6. Molecular, structural, and empirical formulas, molecular weight,
   and any experimental or internal code number  for each  active
   ingredient.
7. Description of each beginning material in the manufacturing
   process.
8. Description of manufacturing process.        |
9. Discussion of formation of impurities based  on  established
   chemical theory.

-------
       62  Analysis  and Certification of Product Ingredients


                       ACCEPTANCE CRITERIA

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

Does your study meet the following acceptance criteria?

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

-------
       62 Analysis and Certification of Product Ingredients


                GUIDANCE  FOR SUMMARIZING STUDIES


The following criteria apply to the technical grade of the active
ingredient being reregistered.
                                             !
                                             I
 1. Number of representative samples analyzed for all active
    ingredients and all impurities at > 0.1%.

 2. Degree of accountability or closure in analyses in item #1.

 3. Chemical names of toxic impurities which were analyzed for
    levels <0.1%.                            ;

 4. Brief description(s)  of analytical method(s) used to measure
    active ingredients and impurities in items #1 and #3.

 5. statement of precision and accuracy of method(s)  in item #4.

 6. Chemical name and quantities observed  (range, mean, standard
    deviation) for each ingredient  (actives  and  impurities)
    analyzed in item #1.                     j

 7. Proposed upper and lower certified limits  for  each active
    ingredient and intentionally added inert with brief explanation

    of how limits were determined.

 8. Proposed upper certified limit  for each  impurity present  at
    >=oTl% and certain toxicologically significant impurities at
    <0.1% with brief explanation of how  limits were determined.
                                             i   n.
 9. Brief description of  analytical method(s)  used to verify
    certified limits  (if  same  methods as item #4,  may reference
    latter).
                                             I
10. Statement of precision and accuracy  of method(s) in item #9
     (may reference  item #5 if  applicable).

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              63  Physical and Chemical Characteristics


                        ACCEPTANCE CRITERIA


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

 Does your study meet the following acceptance criteria?

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

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

 63-4 Odor
      	 Verbal description of  odor (or lack  of it) using terms
            such as "garlic-like,  characteristic of aromatic
            compounds"
      	 Observed at room  temperature
!-
 63-5 Melting Point
      	 Reported in Ce
      	 Any observed decomposition reported

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

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

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

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

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

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

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

63-13 Stability
     	 Sensitivity to metal ions and metal determined
         Stability at normal and elevated temperatures
         Sensitivity to sunlight determined
                                 8

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             63  Physical  and  Chemical Characteristics


                 GUIDANCE FOR SUMMARIZING  STUDIES


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


 1. Description of color.
 2. Description of physical state.
 3. Description of odor.
 4. Indication of melting point (in C).
 5. Indication of boiling point (in C).
 6. Indication of density, bulk density,  and specific gravity.
 7. Indication of solubility.
 8. Indication of vapor pressure.
 9. Indication of dissociation constant.
10. Indication of octanol/water partition coefficient.
11. Indication of PH.
12. Description of stability.

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                          SUBDIVISION F
Guideline              Study Title             |

  81-1      Acute Oral Toxicity in the Rat     ;
  81-2      Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
  81-3      Acute Inhalation Toxicity in the Rat
  81-4      Primary Eye Irritation in the Rabbit
  81-5      Primary Dermal Irritation Study    :
  81-6      Dermal Sensitization in the Guinea Pig
  81-7      Acute Neurotoxicity in the Hen     ;
                                10

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               81-1 Acute Oral Toxicity in the Rat


                       ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

 1.	 Identify material tested (technical, end-use product, etc)
 2.	 At least 5 young adult rats/sex/group
 3.	 Dosing, single oral may be administered over 24 hrs.
 4.*.	 Vehicle control if other than water.
 5-	 Doses tested, sufficient to determine a toxicity category
        or a limit dose (5000 mg/kg).
 6.	 Individual observations at least once a day.
 7.	 Observation period to last at least 14 days, or until all
        test animals appear normal whichever is longer.
 8.	 Individual daily observations.
 9.	 Individual body weights.
10.	 Gross necropsy on all animals.

Criteria marked with a * are supplemental and may not be required
for every study.
                                11

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              81-1 Acute Oral Toxicity in the Rat
                GUIDANCE FOR SUMMARIZING  STUDIES
1. The form of pesticide tested, e.g. solid, liquid, percent
   AI in technical, end-use product, etc.
2. The number of animals/dose/sex tested.
3. Dosing route and regimen.
4. Vehicle used
5. Doses tested and results
6. Individual observations on day of dosing and for at
   least 14 days.
7. Summarization of body weights
8. Summarization of gross necropsy
9. Significance of changes from the Acceptance Criteria
                               12

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


                       ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

 1.	Identify material tested (technical, end-use product, etc)

         At least 5 animals/sex/group
         Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-
         450 gm.
         Dosing, single dermal.
         Dosing duration at least 24 hours.
         Vehicle control, only if toxicity of vehicle is unknown.
         Doses tested,  sufficient to determine a toxicity category
         or a limit dose (2000 ing/kg).
         Application site clipped or shaved at least 24 hours
         before dosing
         Application site at least 10% of body surface area.
         Application site covered with a porous nonirritating cover
         to retain test material and to prevent ingestion.
         Individual observations at least once a day.
         Observation period  to last at least 14  days.
         Individual body weights.
         Gross necropsy on all animals.

Criteria marked with a * are supplemental and may not be required
for every study.
                                13

-------
                                              I

   81-2 Acute Dermal Toxicity in the Rat,  Rabbit  or Guinea Pig
                GUIDANCE FOR SUMMARIZING STUDIES
                                              |


 1.  The form of pesticide tested,  e.g.,  solid,jliquid,  percent AI
    in technical,  end-use product, etc.        :
 2.  The number of animals/sex/dose
 3.  Weight range of animals
 4.  Verification of single, dermal exposure
 5.  Duration of dermal exposure
 6.  Statement of vehicle control
 7.  Doses tested and results                  I
 8.  Preparation of application site           |
 9.  Area of application site (percent body surface)
10.  Occlusion of test material on application site
11.  Individual observations on day of dosing and for at
    least 14 days or until  all  animals appear normal (whichever is
    longer).
12.  Summarization of body weights
13.  Summarization of gross necropsy
14.  Significance of changes from Acceptance Criteria
                                14

-------
            81-3 Acute Inhalation Toxicity in the Rat


                       ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

 !	 Identify material tested (technical, end-use product, etc)
  2-	 Product is a gas,  a solid which may produce a significant
        vapor hazard based on toxicity and expected use or contains
        particles of inhalable size for man (aerodynamic diameter
        15 urn or less).
 3.	 At least 5 young adult rats/sex/group
 4.	 Dosing, at least 4 hours by inhalation.
 5-	 Chamber air flow dynamic,  at  least 10 air changes/hour, at
        least 19% oxygen content.
 6-	 Chamber temperature, 22 C (2), relative humidity 40-60%.
 7.	 Monitor rate of air flow
 8.	Monitor actual concentrations of test material in breathing
        zone.
 9-	 Monitor aerodynamic particle size for aerosols.
1	 Doses tested, sufficient to determine a toxicity category
        or a limit dose (5  mg/L  actual concentration of respirable
        substance).
11.	 Individual observations at least once a day.
12.	 Observation period to last at least 14 days.
13.	 Individual body weights.
14.	 Gross necropsy on all animals.
                                15

-------
           81-3 Acute Inhalation Toxicity in the Rat


                GUIDANCE FOR SUMMARIZING STUDIES


 1.  The form of pesticide tested, e.g.,  solid,  liquid,  percent AI
    in technical,  end-use product, etc.
 2.  Statement of the inhalability of test substance
 3.  The number of animals/sex/dose
 4.  Duration of inhalation exposure            ;
 5.  Number of chamber air changes/hour and the percent oxygen
    content of chamber air
 6.  Ranges for chamber air temperature and relative humidity
 7.  Air flow rate
 8.  Analytical concentrations of test material in breathing zone
 9.  Results of aerosol particle-size determination
10.  Doses tested (or limit dose of 5mg/L or highest attainable)
11.  Individual observations on day of dosing and for at least 14
    days.
12.  Summarization of body weights
13.  Summarization of gross necropsy
14.  Significance of changes from Acceptance Criteria
                                16

-------
            81-4 Primary Eye Irritation in the Rabbit


                       ACCEPTANCE CRITERIA



Does your study meet the following acceptance criteria?

 1.	 Identify material tested (technical, end-use product, etc)
 2.	 Study not required if material is corrosive, causes severe
        dermal irritation or has a pH of < 2 or > 11.5.
 3.	 6 adult rabbits
 4.	 Dosing, instillation into the conjunctival sac of one eye
        per animal.
 5-	 Dose, 0.1 ml if a liquid; 0.1 ml or not more than  100 mg if
        a solid, paste or particulate substance.
 6.	 Solid or granular test material ground to a fine dust.
 7.	 Eyes not washed for at least 24 hours.
 8.	 Eyes examined and graded for irritation before dosing and
        at 1, 24, 48 and 72 hr, then daily until eyes are  normal or
        21 days (whichever is shorter).
 9.*.	 individual daily observations.

Criteria marked with a * are supplemental and may not be required
for every study.
                                17

-------
           81-4  Primary  Eye  Irritation in the Rabbit

                                               r
                 GUIDANCE  FOR  SUMMARIZING STUDIES


 1. The form of pesticide tested, e.g.,  solid,  liquid,  percent AI
    in technical, end-use product, etc.
 2. State if material is corrosive, cause severe dermal irritation
    or has a pH of <2 or >11.5
 3. Number of adult rabbits tested
 4. State method of dosing,  i.e., instillation into the
    conjunctival sac of one eye per animal
 5. Dose administered                          >
 6. Note whether solid or granular test material has been ground to
    a fine dust
 7. State whether eyes were washed and at what time post
    Instillation (not less than 24 hours)
 8. State whether eyes were examined and graded for irritation
    before dosing and at what periods after dosing
 9. Individual daily observations afterwards, until eyes are normal
    or for 21 days
10. Significance of changes from Acceptance Criteria
                                18

-------
               81-5 Primary Dermal Irritation Study


                       ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

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

Criteria marked with a * are supplemental and may not be required
for every study.
                                19

-------
              81-5  Primary Dermal  Irritation Study
                GUIDANCE FOR SUMMARIZING STUDIES
 1.  The form of pesticide tested,  e.g.,  solid,  liquid, percent AI
    in technical,  end-use product,  etc.
 2.  State if material is corrosive,  has  a pH <2 or  >11.5,  or  has
    a dermal LD 50 <200 mg/kg
 3.  Number of adult animals tested
 4.  Amount applied                             [
 5.  Duration of dermal exposure                I
 6.  Preparation of application site (shaved or clipped at
    specified time before dosing)
 7.  Area of application site
 8.  Method for occlusion of application site
 9.  Note removal of test material and if skin was washed with
    WSltS
10. State times post application when site was graded for

11. Individual observations for day of dosing and individual
    daily observations thereafter
12. Significance of changes from Acceptance Criteria.
                                20

-------
           81-6 Dermal Sensitization in the Guinea Pig


                       ACCEPTANCE CRITERIA


dose your study meet the following acceptance criteria?

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

Criteria marked with a * are supplemental and may not be required
for every study.
                                21

-------
           81-6  Dermal  Sensitizatidn in the Guinea Pig
                 GUIDANCE  FOR  SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid,  liquid,  percent AI
   in technical, end-use product, etc.
2. State if material is corrosive or has pH <2 or >11.5.
3. State specific method utilized
4. Complete description of specific method    !
5. Reference for the specific method employed
6. Note adherence of the protocol to that in the reference for
   the specific method utilized
7. State the positive control tested
8. Significance of changes from Acceptance Criteria
                                22

-------
               81-7 Acute Neurotoxicity in the Hen

                       ACCEPTANCE CRITERIA

Does your study meet the following acceptance criteria?

 1.	 Study performed on an organophosphate cholinesterase
        inhibiting compound.
 2.	 Technical form of the active ingredient tested.
 3.*.	 Positive control utilized.
 4.	 Species utilized, domestic laying hen 8-14 months of age.
 5.	 Dosing oral by gavage or capsule (dermal or inhalation
        may be used).
 6.	 An acute oral LD is determined.
 7.	 Dose tested equal to an acute oral LD or a limit test of
        5000 mg/kg.
 8.*.	 Dosed animals may be protected with atropine and/or 2-
        PAM.
        Sufficient test animals so that at least 6 survive.
        Negative (vehicle) control group of at least 6 hens
        Positive control of at least 4 hens, (if used)
        Test dose repeated if no signs of delayed neurotoxicity
        observed by 21 days after dosing.
        Observation period 21 days after each dose.
        Individual daily observations.
        Individual body weights.
        Individual necropsy not required.
        Histopathology performed on all animals.  Tissue to be
        fixed in sin preferably using whole animal perfusion
        techniques.  At least three sections of each of the
        following tissues:
             _brain, including medulla oblongata
             "spinal cord; upper cervical, mid-thoracic and
             "lumbro-sacral regions
        	tibial nerve; proximal regions and branches
        	sciatic nerve


Criteria marked with a * are supplemental and may not  be required
for every study.
                                23

-------

-------
      ATTACHMENT G



Cost Share and Data Compensation Forms

-------

-------
                            United States Environmental  Protection  Agency
                                         Washington,  DC  20460
                               CERTIFICATION WITH  RESPECT TO
                            DATA  COMPENSATION  REQUIREMENTS
Fona Approved

OUt No. 2070-

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

 Please fill In blanks  below.
Company Nama
Product HUM
Company Numbar
BPA R*g. No.
 I Certify that:

1.  For each study cited in support of registration or reregistratton under the Federal insecticide, Fungicide and
    Rodenticide Act (FIFRA) that is an exclusive use study. I am the original data submitter, or I have obtained the
    written permission of the original data submitter to cite that study.

2.  That for each study cited in support of registration or reregistratton 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)
    I ]  The companies who have submitted the studies listed on the back of this form or attached
        sheets, or indicated on the attached "Requirements Status and Registrants' Response Form,"

3.  That I have previously complied with section 3(c)(i )(D) of FIFRA for the studies I have cited in support of
    registration or  reregistratton under FIFRA.
Signature
Data
Nana and Till* (Plaaaa Typo or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the
registration or reregistratton of my products, to the extent required by FIFRA sections 3(c)(1)(D) and 3(c)(2)(D).
Signature _ .
Data
Nama and Tftla (Plaaaa Typa or Print)
EPA  Form 1570-31 (4-90)

-------
   r/EPA
United States Environmental  Protection  Agency
            Washington, DC  20460
   CERTIFICATION  OF OFFER TO  COST
 SHARE  IN THE DEVELOPMENT OF  DATA
OVI Me. 1070-0107
        2070-0057
Approval Ciplr**
 Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
 time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
 completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
 aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
 Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
 of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.

 Pleise fill In blanks below.
Company Nam*
product Mao*
F
Company Number
EPA Rg. MO.
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 Rodenticide Act (FIFRA), if necessary.  However, my company would prefer to
enter Into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.                                                          !

My firm has offered In writing to enter into such an agreement.  That offer was Irrevocable and included an
offer  to be bound  by arbitration decision under section 3(c)(2){B)(iii) of FIFRA If final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
  Nam* of Flrm(a)
                                                                           Dal* of Offer
Cert'rffcatfon:                                                    i

I certify that I am duly authorized to represent the company name above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
SIgnalur*
Nam* and
of Company'* Authorized R*pr***ntatlv*
i
0*1*
Tltl* (Picas* Typ* or Print) ,
 EPA Form S70-32 (S-tl)
  R*plao* EPA Form 1580-6, which I* obaolct*

-------
                              LABEL
  PRESENTED BY JERRY A. MOORE. ACTING CHIEF, EPA STANDARDS AND LABELING.
                     EPA'S  SECTION 3  REGULA-
                     TIONS KEYED FOR BOTH RE-
                     STRICTED USE AND GENERAL
  The pesticide label is the final result of the registration
  and/or registration process and reflects the  risks and
  benefits of a given pesticide to the user. The label is not
  only the primary source of information to the  user, it is
  also the primary tool of pesticide regulation. The label, in
  a sense,  is a  legal document. Improvement of pesticide
  labels benefits both the industry and the public.
  The reregistration  process provides  for overall
  improvement in labels. Certain of the.changes in label are
  requirements,  other changes-are recommendations. The
 charts that follow will clearly indicate what is required
 and what is  preferred.  It is  hoped  that avoidance of
 all-inclusive requirements will allow  flexibility  in those
 labels which may not fit the more standard situations.
 The Section 3  Regulations require that certain statemems
 must appear  at  certain  locations on  the  label.  The
 designation of specific areas  of the label for specific
 information is known as format labeling. This  is not a
 new concept,  i.e..  signal  words have been required to
 appear on the front panel. The application of the concept
 to the entire label is new. If pesticide users know to look
 at the same locations or, labels for certain  kinds of
 information, we should be able to better train and educate
 people, thus improving the understanding of the proper
 use of pesticides. We ask your cooperation in making the
 format label a viable concept.  We recognize the  potential
 conflict between marketing concepts of product identity
and  the  standardization  which results from format
labeling. However,  the primary purpose  of the  pesticide
label  is a  means of use communication  and  regulation.
Marketing is a  secondary purpose, although a very real
 purpose. Leeway for product individuality is provided in
 format labels, but only with the recognition that the label
 is a legal document to instruct the user on use and safety

 RESTRir-rln ""Tu ?"" * 't* leeway in the cas <*
 RESTRICTED use labels since these products are not for
 use by the general public.
 The tables on  the  following  pages outline  the  basic

 strT'   . ,    J^^r ISM 3nd 3re ke>'ed t0 
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            jize C! LUUCI
           on Front Panel
           in Square Inches
                oignal Wora as rcequir'ed
                  Minimum Type Size
                     All Capitals
'Keep >ut of Reac-

  as Required
5 and under
above 5 to 1 0
above 1 0 to 15
above 15 to 30
over 30
A point
10 point
1 2 point
14 point
1 8 point




	 1 2 ooint
=-  3
              -BODONI BOLD 18 & 12 Pt.-

.POISON . DANGER . WARNING .  CAUTION.
         KEEP OUT OF REACH OF CHILDREN

            Keep Oat of Reach  of Children
=-  5
              -BOOONI BOLD 14 & 10 Pt.-

   .POISON  .  DANGER  .  WARNING  .  CAUTION.

          KEEP OUT OF  REACH OF CHILDREN

              Keep Ov< ( Reach of Children
 ~  o
              -BODONI BOLD 12 & 8 Pt.-

       .POISON .  DANGER  . WARNING . CAUTION.

             KEEP OUT OF REACH OF CHILDREN

                Keep Oat of Reach of Chlldroi
                -BODONI BOLD 10 & 6 Pu-

          .POISON . DANGER . WARNING .  CAUTION.

                  KCCF 
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U.S. GOVERNMENT PRINTING OFFICE:  1993-515-003-87109

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