v>EPA
United States
Environmental Protection
Agency
                   Office of Prevention, Pesticides EPA 738-R-93-007
                   And Toxic Substances    June 1993
                   (H-7508W)
Reregistration
Eligibility Document
(RED)
10, 10'-OXYBISPHENOX-
ARSINE (OBPA)
                       Printed on Recycled Paper

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F

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                UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                               WASHINGTON, D.C. 20460
                                                                        OFFICE OP
                                                                   PREVENTION. PESTICIDES
                                                                    AND TOXC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
       Enclosed is  a Reregistration  Eligibility Document (RED) for the pesticide active
ingredient  10,10'- Oxybisphenoxarsine, hereafter referred  to  as  OBPA.   The RED is  the
Agency's evaluation of OBPA's 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 is the EPA RED facts and  the
Pesticide Reregistration Handbook which provides 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 Response 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.

       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 Form  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 classifica-
tion, groundwater hazard statements, endangered species precautions, etc., necessary for reregis-
tration 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 §156.10  and all  labeling changes  imposed by Pesticide Regulation (PR)
Notices, and  any label changes imposed by this RED.

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       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 Davs of Your Receipt of this Letter

1.     For each product which is subject to this RED, you must complete, sign and submit
       the data call-in (DCI) response forms attached to the RED [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. The DCI forms for product specific data are to be sent
       to the Registration Division (use the mailing distribution code RED-RD-PM22 for
       your product specific response).

2.     No time extensions  will be granted for submitting  the 9")-day responses.  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 waivers or time extensions to the 8-month  deadline must be
       submitted  as  part of your 90-day response.  Such requests will generally not be
       considered if submitted later than the 90-day response.
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 copies of the label and labeling revised as specified by the RED and
       in accordance with current  requirements, two. 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 data or references to data (see
       item 2 below).

2.     You must submit or cite the required product specific data as part of your commit-
       ment 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 G, Attachment E). 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.

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       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 §158.175) or (2) provide certified limits that are
       supported by the analysis of five batches.  If you choose the second option, you must
       submit  or  cite  the data for the five batches along with a  certification statement as
       described in 40 CFR §158.175(e).

       Send your  Application for Registration to the Registration Division Product Manager
       22 (PM 22) who is assigned to the  product, Cynthia Giles-Parker.  Use the correct
       address shown on page 6 of the enclosed  Product Registration Handbook (Appendix
       E).  Note that the mailing distribution code for your response is RED-RD-PM22.
       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
22 Team member for OBPA, at (703)  305 - 5540.

       Any questions  in regard to this RED  should be directed to Venus Eagle, Chemical
Review Manager, Reregistration Branch, Special Review and Reregistration Division at
(703) 308 - 8045.

       The Agency is prepared to meet with any registrants who have questions about respond-
ing to the OBPA RED.  If you wish to meet with the Agency, you must contact Ms. Cynthia
Giles-Parker within two weeks of your receipt of the RED. The Agency intends to have one
combined  meeting with interested registrants.  If 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,
                                                 iel 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-93-003
June 1993
                 R.E.D.   FACTS
                 10,  10'-  OXYBISPHENOX-

                ARSINE  (OBPA)	

     Pesticide       All pesticides sold or used in the United States must be registered by
Reregistration  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 its
                decision and explains why in a Reregistration Eligibility Document, or
                RED.  This fact sheet summarizes the information in the RED for 10, 10'-
                Oxybisphenoxarsine (OBPA).
   Use Profile
     OBPA is a bacteriostat, disinfectant (bacteriocide/germicide) and
fungicide. It is registered to prevent the growth of microorganisms in
plastics which are fabricated into shower curtains, floor coverings, wall
coverings, coated fabrics, marine upholstery, automotive vinyl trim, vinyl
molding,  tarpaulins, awnings, gaskets, weather stripping, caulking, ditch
liners and swimming pool liners. OBPA also is used as a preservative in
adhesives, coatings and specialty products, in paper and paper and plastic
products, in textiles, fibers and cordage, in carpets, and in other pesticides.
     OBPA is formulated as an emulsifiable concentrate, pelleted/tableted,
soluble concentrate/liquid and ready-to-use liquid.  The concentration
varies from  1 to 5 percent, based on the total weight of formulation.
   Regulatory       OBPA was initially registered as a pesticide in the United States in
       History  1965.  EPA issued a Registration Standard for OBPA in October 1981
                (NTIS PB82-172271). The Registration Standard required additional
                product chemistry data, a hydrolysis study and an activated sludge
                metabolism study, which was later waived. In September 1991, EPA

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                   issued a Data Call-In (DCI) requiring product ciemistry data and a repeat
                   of the hydrolysis study (which was later rescinded).
                         EPA has now completed its review of the OBPA data base, including
                   the data submitted in response to the 1991 DCI.

Human Health        OBPA shows a high degree of acute toxicity when administered
  Assessment  oraUy a™* to the skin and eyes.  It has been placed in Toxicity Category I
                   indicating the highest degree of acute toxicity for these effects.
                         In subacute feeding studies using rats, animals fed the highest dose
                   levels had retarded growth, liver effects and an accumulation of arsenic in
                   the liver and kidneys.  In a subacute inhalation study, rats and guinea pigs
                   sacrificed 48 hours after their last exposure to OBPA had mild to moderate
                   heart effects and the rats had liver effects.  Animals kept four months
                   longer with no further exposure showed no effects of OBPA.
                         OBPA dees not appear to cause developmental or reproductive
                   toxicity, and shows no mutagenic activity.  Metabolism studies show that
                   arsenic accumulates  in the liver and kidneys as a result of exposure to
                   OBPA, however this arsenic is cleared from the body after two weeks.

                   Dietary Exposure
                         OBPA is not registered for use on food, feed or processed
                   commodities. Therefore, dietary exposure or risk is not expected.

                   Occupational and  Residential Exposure
                         Although occupational and residential exposure to OBPA occurs,
                   such exposure is indirect and/or extremely low  level.  Direct occupational
                   exposure during production of pesticide or plastic products containing
                   OBPA is mitigated by the use of closed systems and appropriate protective
                   gloves and eyewear.  Indirect residential and other human exposure to
                   OBPA in treated plastics is low because only a small percent of OBPA is
                   added to these products, and only small amounts of OBPA are released,
                   very slowly.

                   Human Risk Assessment
                         OBPA  does not pose human dietary risks  since no food-related uses
                   are  registered and dietary exposure is not anticipated.
                        The potential for occupational exposure to OBPA is minimal
                   provided that OBPA  is used in a closed system and that appropriate
                   Personal Protective Equipment (PPE) is worn.  Residential exposure to
                   OBPA is indirect and low level.  No additional  uses are proposed that
                   would significantly increase human exposure to OBPA.  Therefore, the


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                     potential human risks from exposure to OBPA pesticides are likely to be
                     minimal.
  Environmental
    Assessment
Environmental Fate
     No further environmental fete data are needed because of the very
limited environmental exposure expected from current uses of OBPA.  The
Registration Standard required an activated sludge study, which was later
waived, and a hydrolysis study.  The hydrolysis study was  found deficient,
but the Agency later determined that an additional hydrolysis study was not
needed based on the fact that OBPA-treated materials will  not result in
significant levels of residues being released into the environment.  An
extractability study on pool liners and vinyl baby pants showed that
leaching would  not result in residues that exceed the 50 ppb maximum
limit established for arsenic in drinking water.
                     Ecological Effects
                           Studies usually required to determine effects on birds, fish and other
                     nontarget organisms are waived because of OBPA's indoor, industrial use
                     pattern.  Avian and aquatic toxicity information is needed only to assess the need
                     for precautionary label statements.
                           Since OBPA is highly corrosive, it would be very highly toxic to birds.
                     Existing acute oral rat studies confirm that OBPA is highly toxic to terrestrial
                     organisms.
                           Aquatic studies show that OBPA is very highly toxic to both freshwater
                     and marine fish, and to freshwater aquatic and marine invertebrates, on an acute
                     basis.


                     Ecological Effects Risk Assessment
                           OBPA is an indoor, non-food,  industrial use pesticide which is
                     incorporated into plastics,  textiles, adhesives, etc.. The Agency does not
                     conduct risk assessments for nontarget organisms  for indoor uses without
                     effluent.  Should residues of OBPA in effluent ever exceed 1.75 ppb, aquatic
                     organisms would be acutely at risk.
Additional Data        BPA is requiring product-specific data, including product chemistry
        Required  &"<* acute toxicity studies, as well as revised Confidential Statements of
                     Formula and revised labeling for reregistration of pesticide products
                     containing OBPA.

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  Product Labeling        The labels of all registered pesticide products containing OBPA must
Changes Required  comply with EPA's current pesticide labeling requirements.  End-use and
                       manufacturing use products also must bear the following label statement in
                       the Environmental Hazards section:
                             "This pesticide is toxic to fish,  aquatic invertebrates, birds, and
                             mammals. Do not discharge effluent containing this product into
                             lakes, streams, ponds,  estuaries, oceans, or other waters unless in
                             accordance with the requirements of a National Pollutant Discharge
                             Elimination System (NPDES) permit and the permitting authority  has
                             been notified in writing prior to discharge. Do not discharge effluent
                             containing this product into sewer systems without previously
                             notifying the local sewage treatment plant authority.  For guidance
                             contact your State Water Board or Regionjd Office of EPA."
                             In addition, labels must consistently reflect any potential eye and skin
                       hazard (Danger, Warning or Caution Signal Wcwxls) and recommend
                       appropriate protective equipment (protective eyeware [goggles or face
                       shield], waterproof gloves, long sleeved shirts and long-legged pants, shoes
                       and socks).
        Regulatory
        Conclusion
     The use of currently registered pesticide products containing OBPA
in accordance with approved labeling will not pose unreasonable risks or
adverse effects to humans or the environment. Therefore, all uses of these
products are eligible for reregistration.
     These OBPA products will be reregistered once the required product-
specific data, revised Confidential Statements of Formula and revised
labeling are received and accepted by EPA.  Products which contain other
active ingredients in  addition to OBPA will be eligible for reregistration
only when all of their other active ingredients also are determined to be
eligible.
          For More
       Information
     EPA is requesting public comments on the Reregistration Eligibility
Document (RED) for OBPA 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 comment*., please contact the
Pesticide Docket, Public Response and Program Resources Branch, Field
Operations Division (H-7506C), Office of Pesticide Programs (OPP), US
EPA, Washington, DC 20460, telephone 703-305-5805.
     Following the comment period, the OBPA RED will be available
from the National Technical Information Service (NTIS), 5285 Port Royal
Road, Springfield, VA 22161, telephone 703-487-4650.
     For more; information about OBPA or about EPA's pesticide
reregistration program, please contact the Special Review and
Reregistration Division (H-7508W),  OPP, US EPA, Washington, DC

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20460, telephone 703-308-8000.  For information about reregistration of
individual products containing OBPA, please contact Product Manager -
Cynthia Giles-Parker, Registration Division (H-7505C), OPP, US EPA,
Vtoshington, DC 20460, telephone 703-305-5540.
     For information about the health effects of pesticides, or for
assistance  in recognizing and managing pesticide poisoning symptoms,
please contact the National Pesticides Telecommunications Network
(NPTN).  Call toll-free 1-800-858-7378, between 8:00 am and 6:00 pm
Central Time, Monday through Friday.

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                               OBPA
                 Summary of Requirements
Within 90 Davs of Receipt of this RED

1.    Sign and submit  data call-in response forms attached to the product specific DCI
      (Appendix G, Attachment 8 and C).

Within 8 Months From the Date of this RED

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

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

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

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 responding to the product specific
      data requirements  of the RED.

5.    Submit the required data or references to data as specified by the RED/DCI  for product
      specific data (Appendix G). Please note that products listed in Table I (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 I of Appendix G,  Attachment D).  All data submitted to fulfill
      requirements listed in Appendix G should be sent to:

                                    Document Processing Desk (RED/RD/PM22)
                                    Office of Pesticide Programs (H7504C)
                                    Environmental Protection Agency
                                    401 M Street, S.W.
                                    Washington, D.C.   20460-0001

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REREGISTRATION ELIGIBILITY DOCUMENT

   10,10'-OXYBISPHENOXARSINE (OBPA)

                  LIST A

                 CASE 0044
           ENVKONMENTAL-mOTECTION-ACENCY
             OFHCE-OF-nsnCIDE-FROGRAMS
         SPECIAL-KEVIEW-AND'IlEREraSTOA'nON-DIVISION

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 OBPA REREGISTRATION ELIGIBILITY TEAM

 Office of Pesticide Programs:

 Biological*and •Economic- Analysis-Division
 Rafael Prieto
 Alan Halvorson

 Environmental-Fate-and'Effects-Division

 David Farrar
 Richard Lee
 Patricia Ott

 Health-Effects-Division

 Linda Kutney
 Patricia McLaughlin
 Jeff Evans

 Registration • Division

 Theresa Stowe
 Joanne Hayes
 Bipin Gandhi

 Special-Review and-Reregistration Division

 Venus Eagle
Carol Stangle
Gene Frane
 Biological • Analysis- Branch
 Economic Analysis Branch
 Science Analysis and Coordination Staff
 Ecological Effects Branch
 Environmental Fate and Ground water Branch
 Chemical Coordination Branch
 Toxicology Branch n
 Occupational and Residential Exposure Branch
Fungicide-Herbicide Branch
Registration Support Branch
Registration Support Branch
Reregistration-Branch
PolicyPlanning-and-Operations-Branch
Policy and Special Projects Staff

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                  GLOSSARY OF TERMS AND ABBREVIATIONS

a.i.          Active Ingredient

CAS         Chemical Abstracts Service

CSF         Confidential Statement of Formula

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

EP          End-Use Product

EPA         U.S. Environmental Protection Agency

FZFRA       Federal Insecticide, Fungicide, and Rodenticide Act

FFDCA      Federal Food, Drug, and Cosmetic Act

HDT         Highest Dose Tested

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

LDjo         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). It is expressed as a weight of substance per unit weight  of animal,
             e.g., mg/kg.

LD,,,         Lethal Dose-low. Lowest Dose at which lethality occurs

LKT,         Lowest Effect Level

MP          Manufacturing-Use Product

MPI         Maximum Permissible Intake

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

N/A         Not Applicable
                                        ii

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 NPDES



 NOEL



 OPP




 PADI




 ppm



 RfD




 R5




 TD




 TC




 TMRC



TEP
  GLOSSARY OF TERMS AND ABBREVIATIONS (cent.)



 National Pollutant Discharge Elimination System



 No Observed Effect Level



 Office of Pesticide Programs



 Provisional Acceptable Daily Intake



 Parts Per Million



 Reference Dose



 Registration Standard




 Toxic Dose. The dose at which a substance produces a toxic effect.



Toxic Concentration. The dose at which a substance produces a toxic effect.



Theoretical Maximum Residue Contribution.



Typical End-Use Product
                                     iii

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                        TABLE OF CONTENTS

OBPA REREGISTRATTON ELIGIBILITY TEAM  	    i

GLOSSARY OF TERMS AND ABBREVIATIONS  	ii

EXECUTIVE SUMMARY	   vi


I.     INTRODUCTION	   1

IL    CASE OVERVIEW	   2
      A.   Chemical Overview	   2
      B.   U§e Profile	   2
      C.   Data Requirements	   4
      D.   Regulatory History	   4

m.   SCIENCE ASSESSMENT	   4
      A.   Physical Chemistry Assessment  	   4
      B*   Human Health Assessment	   5
           1.    Toxicology Assessment  	   5
                 a.   Acute Tozichy	   5
                 b.   Subchronic Toxidty	   6
                 c.   Developmental Tozichy and Reproductive Toxicity ....   7
                 d.   Mutagenicfty	   7
                 e.   Metabolism	   7
           2.    Exposure Assessment  	   7
                 a.   Dietary Exposure	   7
                 b.   Occupational and Residential	   7
           3.    Risk Assessment  	,	   8
                 a.   Dietary	   8
                 b.   Occupational and Rfiflgitfal	   9
      C.   Environmental Assessment	   9
           1.    Environmental Fate	   9
           2.    Ecological Effects  	  	   9
                 a.   Ecological Effects Data	   10
                      (1)    Terrestrial Data - Effects on Birds	   10
                      (2)    Aquatic Data  	   11
                      (3)    Effects to Non-target Aquatic Invertebrates ....   13
                      (4)    Non-Target Estuarine and Marine Organisms  ...   13
                      (5)    Non-Target Insects	   13
                      (6)    Non-Target Plants 	   14

IV.   RISK MANAGEMENT AND REREGISTRATION DECISION	   14
      A.   Determination of Eligibility	   14
                                   IV

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V.
      1.    Eligibility Decision	   15
      2.    Eligible and Ineligible Uses  	   IS
B.    Regulatory Position	   15
      1.    Tolerance Reassessment	   15
      2.    Labeling Rationale	   15
            a.     Manufacturing Use	   15
            b.     End Use	   15

ACTIONS REQUIRED BY REGISTRANTS	   16
A.    Manufacturing-Use Products	   16
      1.    Additional Generic Data Requirements	   16
      2.    Labeling Requirements for Manufacturing-Use Products	   16
B.    End-Use Products	   16
      1.    Additional Product-Specific Data Requirements	   16
      2.    Labeling Requirements for End-Use Products	   17
VI.   APPENDICES

      Appendix A - Use Patterns Subject to Reregistration

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

      Appendix  C - Citations Considered  to be  Part of  the Data Base Supporting the
      Reregistration of OBP A

      Appendix D - List of Available Related Documents

      Appendix B - Pesticide Reregistration Handbook

      Appendix F - Generic Data Call-In

      Appendix G - Product Specific Data Call-In
            Attachment A -
            Attachment B -

            Attachment C -

            Attachment D -

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

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 EXECUTIVE SUMMARY

       This Reregistration Eligibility  Document (RED)  will  address  the eligibility for
 reregistration of products containing 10, 10'- Oxybisphenoxarsine (OBPA).

       OBPA is a bacteriostat, disinfectant (bacteriocide/gennicide) and fungicide pesticide. Its
 use  category is:   indoor non-food.   This arsenic-containing  helerocyclic  compound is
 incorporated  into  flexible vinyl sheeting  and  extrusions,  silicons caulking compounds,
 thermoplastic adhesives, polyurethane, and latex emulsions (not including paints, ink bases and
 textiles) to prevent the growth of microorganisms.  Although flexible! vinyls and silicones in
 themselves are  resistant to microbiological  deterioration, the use of OBPA formulations in
products made from these materials is necessary due to microbial susceptibility of plasticizers,
 lubricants, and fillers which are added to obtain desirable physical and! chemical properties.

       OBPA  is formulated  as  an emulsifiable  concentrate,  pelleted/tableted,   soluble
concentrate/liquid and ready-to-use liquid.  The concentration varies irom 1 to 5%, based on
total weight of formulation.

       OBPA was initially registered as a pesticide in 1965. A Registration Standard was issued
 October 30, 1981 (NTIS PB82-172271).  This Registration Standard summarized the available
data supporting the reregistration of products containing OBPA which were used as indoor (non-
rood) antimicrobials. The Registration Standard also required additional product chemistry, a
hydrolysis study and an activated sludge metabolism  study, which was later waived.  A Data
Call-in (DO), dated September 30,1991, was issued requiring product chemistry and the repeat
of the hydrolysis study.  The Agency has now completed its review of the OBPA data base
including the data submitted in response to the 1991 DCL

       The Agency has determined that the uses of OBPA as currently registered will not cause
unreasonable risk to humans or the environment and  these uses are eligible for reregistration.
The Agency is not requiring any additional generic studies to be submitted at this time.

       Before reregistering the products containing OBPA, the Agency is requiring that product
specific data, revised Confidential  Statements of Formula (CSF)  and revised  labeling be
submitted within eight months of the issuance of this document. These data include product
chemistry for each registration and acute toxicity testing. After reviewing these data and any
revised labels and finding them  acceptable,  the  Agency will reregister a product based on
whether or not it meets the requirements in Section 3(c)(5) of FIFRA. Those products which
contain other active ingredients in addition to OBPA will be eligible for leregistration only when
all of the other active ingredients are determined to be eligible for rerejnstration.
                                          VI

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I.     INTRODUCTION

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

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

This document  presents the  Agency's decision regarding the reregistration eligibility of the
registered uses of OBPA. The document consists of six sections. Section I is the introduction.
Section n describes OBPA,   its uses, data requirements and regulatory history. Section ffl
discusses the human health and environmental assessment  based on the data available to the
Agency. Section IV presents the reregistration decision for OBPA . Section V discusses the
reregistration requirements for OBPA. Finally, Section VI is the Appendices which support this
Reregistration Eligibility Document. Additional details concerning the Agency's review  of
applicable data are available on request.1
    lEPA's reviews of data on the set of registered uses considered for EPA's analysis may be
obtained from the OPP Public Docket, Field Operations Division (H7506C), Office of Pesticide
Programs, EPA, Washington, DC 20460.

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H.    CASE OVERVIEW

      A.    Chemical Ovierview

            The following active ingiedient(s) axe covered by this Reregistration Eligibility
      Document:

      •     Common Name:    OBPA
      •     Chemical Name:    10,10'-Oxybisphenoxarsine
      •     Chemical Family;   Thenarsazine oxide
      •     CAS Registry Number:   58-36-6
            OFF Chemical Code:     012601
      •     Empirical Formula:
            Molecular Weight:
502
            Trade and Other Names:  Policida P-4
      •     Basic Manufacturer:      Morton Thiokol, Inc.
      B.    Use Profde

            Following is information on the current registered uses with an overview of use
      sites and application methods.  A detailed table of the uses of OBPA is found  in
      Appendix A.
            For OBPA:
            Type of Pesticide:
Bacteriostat, Disinfectant (bacteriocide/gennicide)
and Fungicide.


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Use Sites:
       INDOOR NON-FOOD:
       Industrial Adhesives
       Resin/Latex/Polymer Emulsions
       Plastic Products
       Speciality Industrial Products
       Textiles/Textile Fibers/Cordage
Target Pests:
Deterioration/spoilage bacteria, Mold.
Formulation Types
       Registered

       Type:

       Form:
End use, Manufacturing use

Emulsifiable concentrate, Liquid soluble concentrate, Solid
soluble  concentrate,  Solid formulation not  identified
(manufacturing use)
Methods and Rates of Application

      Types of Treatment: Industrial preservative


      Equipment:  Not applicable


      Timing: During manufacture
      Rate of Application:

      Industrial adhesives:
      From 150 up to 500 ppm of active ingredient by weight

      Resin/latex/polymer emulsions:
      From 150 up to 400 ppm of active ingredient by weight

      Plastic products:
      From 300 up to 500 ppm of active ingredient by weight

      Specialty industrial products:
      From 150 up to 400 ppm of active ingredient by weight

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              Textiles/textile fibers/cordage:
              From 400 up to  1000 ppm of active ingredient by weight
             Use Practices Limitations: Product should noi: be used on items which
                                       come into contact with food stuffs nor items
                                       of clothing or infiint wear.  Do not apply
                                       directly to water.
C.    Data Requirements

       Data required in the October 1981 Registration Standard for OBPA include studies
on product chemistry, a hydrolysis study and an activated sludge metabolism study,
which was later waived.  These data were required to support the uses listed in the
Registration Standard.  Appendix B includes all data requirements identified by the
Agency for currently registered uses needed to support reregisxation.
D.     Regulatory History

       OBPA was registered  in the United States in 1965 for use as a disinfectant
(bacteriocide/gennicide), bacteriostat, and fungicide.  A Registration Standard for OBPA
was issued in October 1981 (NTIS PB82-172271) which evaluated studies submitted as
a result of (1) an open literature search as of August 14,1981 (2) the Agency's April 20,
1979 decision document to remove OBPA from the RebuttaMe Presumption Against
Registration (RPAR) list and (3) the data submitted by the registrants up through the time
of publication of the  1981  Registration Standard.  A Data Call-In (DO) was issued in
September 1991 for OBPA requiring additional product chemistry for Morton Thiokol,
Inc. and a repeat hydrolysis; study  to replace the existing iitudy which was found
deficient.  This Registration Eligibility  Document reflects a reassessment of all data
which were submitted in response to the Registration Standard and subsequent DCI.
SCIENCE ASSESSMENT

A.     Physical Chemistry Assessment

       OBPA is a white odorless powder which has a density of 0.489 g/ml.  It is
insoluble in water. The vapor pressure is extremely low of less than 2.0 x 10~7 at 25.T
C.  This chemical is stable to sunlight and a temperature of 54* C.  It is also stable to
aluminum, copper, galvanized! steel and stainless steel.  OBPA is not an oxidizing and
reducing agent and is non-flammable, non-explosive and non-corrosive.

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B.     Human Health Assessment

       1.     Toxicology Assessment

             The toxicological  database on OBPA is adequate and  will  support
       registration.

             a.     Acute Toxicity

                    Several acute toxicity studies of each type have been done with
             OBPA, some of which do not provide complete information. The more
             completely reported studies are summarized here.  In general, the acute
             oral toxicity studies with technical OBPA found LDSO's from about 15 to
             40 mg/kg. A more complete report of a test in rats with technical OBPA
             had an LD50 of 36.9 mg/kg in males and of 31.6 in females (Anspach,
             1977, GS044002).  The toxic effects included congested adrenals, kidneys,
             and lungs, irritated digestive systems, and depleted fat stores.   These
             results indicate toxicity category I.

                    The results  found in acute dermal toxicity studies with technical
             OBPA varied widely.  A study with rabbits using technical OBPA found
             an LD50 of 414 mg/kg (Anspach, 1977, GS044002).  One that used
             technical OBPA on rats reported an LD50 of 121 mg/kg (Litton Bionetics,
             1978, GS044039).  OBPA is in Toxicity category I for dermal toxicity.

                    An acute inhalation toxicity study with guinea pigs  estimated the
             LC50  at 1279  mg/L, results which place this compound in toxicity
             category IV for inhalation (Ballantyne, 1978, 05015857).

                    Two primary eye irritation studies in rabbits with technical OBPA
             found  cornea!  opacity,  conjunctivitis, and  iritis  (Anspach,  1977,
             00013643; GS044002). In one study the effects lasted through 72 hours.
             The Agency considers this material to be in toxicity category I  for eye
             irritation.

                    Results in different  primary skin  irritation  studies were quite
             varied. One study with technical OBPA applied to intact and abraded skin
             of rabbits found  slight to severe  edema  and peripheral or  spotted
             erythema, results which fall in toxicity category n  (Anspach, 1977,
             0013643). Another study applied technical material to intact and abraded
             rabbit  skin for 24 hours;  the  results indicated  toxicity  category HI
             (Anspach, 1977, GS044002).   The Agency considers that OBPA is in
             category n for dermal irritation.

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     TABLE OF ACUTE TOXIOTY DATA
TEST
Acute Oral LD*, (rat)
Acute Dermal LDM
(rat, rabbit)
Acute Inhalation LC«n
(guinea pig)
Eye Irritation
(rabbit)
Skin Irritation
(rabbit)
RESULT
15-40 mg/kg
121-414 mg/kg
1279 mg/L
Cornea! Opacity
Varies
(edema, erythema)
TOXIOTY CATEGORY
I
I
IV
I
n
b.     Subchronic Toxtdty

       In a 35-day feeding study, 10 rats/sex/dose were given 0, 1,  10,
30, 100, or 300 ppm of OBPA in the diet (the percent active ingredient
was  not stated;  Franz and  Shrader 1959,  00024936;  Oxen 1959,
00024940).  Generally, animals at the two higher doses had retarded
growth, higher liver weights, increased testes weights, proliferation of the
portal bile duct, and accumulation of arsenic in liver and kidneys.  The
NOEL was 10 ppm (approximately 0.5 mg/kg/dj.y).

       A rat feeding study lasting 92 days gave doses of 0,0.03,0.1,0.3,
1.0 or 3.0 mg/kg/day to 10 rats/sex/dose (unspecified percent active
ingredient; McCollister et al. 1969, GS044042). Ilie high dose group had
retarded  growth as well as lack of fat in the mesentery;  there were
microscopic liver lesions and inflammatory cellular infiltrates in  the
periportal area with bile duct hyperplasia.  Arsenic accumulated in  the
liver and kidney at all doses fln<* in the fat and hair in some of the higher
doses.  The NOEL was 1.0 mg/kg/day.

       In an inhalation study,  both rats and guinea pigs were exposed to
1-2 mg/M3 of technical OBPA (percent not stated) during five days  per
week for 30 days (IPC  1957, 00013591; Ballaniyne 1978, 05015857).
Half of the animals were sacrificed 48 hours after the last exposure and
the others were kept without further exposure for four months.  The rats
and guinea pigs killed at 48 hours had mild to moderate pulmonary
congestion and hemorrhaging;  only the rats had hejMtic involvement. The
animals killed four months later showed no effects of OBPA.

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       c.     Developmental Toxicity and Reproductive Toridty

             An investigation of the effect of OBPA on fetal development and
       toxicity used dermal applications at 0.3, 3.0 or 30.0 mg/kg on pregnant
       rats (Beliles and Makris 1978, GS0440007). However, the animals also
       ingested the material put on their skin and the actual doses are uncertain.
       All high-dose rats and one mid-dose rat died during the test.  There was
       no evidence of compound-related  teratogenicity or inhibition of fetal
       development from the surviving animals.  There was some evidence of
       fetal toxicity in the mid-dose group and the NOEL was estimated at 0.3
       mg/kg.
       d.     Mutagenicity

             A mouse lymphoma test was considered negative for mutagenicity
       with and without activation (Brusick and Weir 1976, 00013644).  A
       mutagenicity study in S* cerevisiae and JL typhimurium with and without
       activation did not show mutagenicity (Brusick and Weir 1976,00013647).
       An investigation of the metabolites of OBPA used the urine of rats treated
       with OBPA in the method of Durston and Ames. There was no indication
       of mutagenic activity with urine from treated or untreated rats (Beliles and
       Makris 1978, GS044007).
       e.     Metabolism

             Metabolism  studies in  which OBPA was  applied to the skin
       generally found arsenic accumulation in the liver and kidney with removal
       from the body through both feces and urine (Olson et al.1959, 00026092;
       Dow 1964,00024935; Ballantyne 1978,05015857).  There are indications
       that the arsenic is cleared from the body after two weeks.
2.     Exposure Assessment

       a.     Dietary Exposure

             OBPA is not used on food, feed or processed commodities; dietary
       exposure to OBPA is not expected.

       b.     Occupational and Residential

             OBPA is an antimicrobial and antifungal pesticide used to treat
       polyvinylchloride  (PVC),   polyuiethane,  and  ethylene-vinylacetate
       copolymer plastics. These plastics are fabricated into shower curtains,

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       floor coverings, wall coverings, ditch liners,  coated fabrics (including
       mattresses), vinyl molding,  marine upholstery, automotive vinyl trim,
       tarpaulins,  awnings,  gaskets  (automotive, refrigerator,  dishwasher),
       weather stripping, caulking, and swimming pool liners.  Plastic products
       intended for indoor use contain up to 0.06% OBPA and plastic products
       intended for outdoor use contain up to 0.05% OBPA.

             OBPA formulations range in concentrations from 1 to 5%.  The
       OBPA formulations are either liquids or pelletai/tableted forms utilizing
       a resin carrier.

             Occupational and iygid«ntiai exposure data were not required in the
       1981 Registration Standard for OBPA based on the following reasons:
             1)  direct occupational exposure to OBPA is mitigated by the use
             of closed systems, when producing OBPA technical and OBPA
             formulations, or  when producing  plastic  products  containing
             OBPA;

             2)  indirect human exposure to OBPA ;in treated plastics is low
             due to the low percent of OBPA added to plastic coupled with the
             slow release of small amounts of OBPA from the plastic matrix;
             and

             3)  no additional uses are proposed that may result in significant
             increases in human exposure.

             (Inhalation exposure  from OBPA-treated products is negligible
             since it has a low vapor pressure.)

             Based on the low potential for exposure ix> OBPA, exposure data
       are not required to support the reregistration of the current uses of OBPA,
       provided  that (1)  manufacturing is  under  closed  systems,  and (2)
       appropriate Personal Protective Equipment (PPE) is used.
3*    Risk Assessment

      a.     Dietary

             There are no registered food or feed uses of OBPA, and therefore,
      dietary exposure or risk from OBPA is not expected.
                             8


-------
c.
        b.     Occupational and Residential

               The potential for occupational exposure to OBPA is minimal
        provided that OBPA is used in a closed system and that appropriate
        protective eyewear and gloves are used.  Therefore, the potential risk for
        acute or chronic toxicity from exposure to  OBPA is also likely to be
       In 1991, the Agency received a research proposal concerning the
potential linkage between OBPA-treated mattresses to Sudden Infant Death
Syndrome (SIDS).  The proposal to investigate this environmental factor
as a possible cause of SIDS was submitted by Dr. Julius Goldberg of the
Loyola University Medical Center in Chicago, Illinois. As support for the
proposal was  the  hypothesis that toxic gases may  be produced by
microfungi which attack PVC plastic material, Some of these fungi can
break down the arsenates  in the  PVC,  and produce trimethyl arsine
(AUsop and  Hawksworth,  1992).    However,  in  that  study,  the
investigators could not  draw any general  conclusions regarding the
significance of biofilms or other fungi that were isolated; this was due
primarily to the limited number of mattress covers studied and the use of
unmatched controls.

       At the present tune, there is no evidence to suggest that OBPA is
linked  to SIDS.  A causal relationship between SIDS and environmental
factors (or genetic factors) has not been established.

Environmental Assessment
  1.    Environmental Fate

        The Agency finds that no further environmental fate data are needed
  because of the very limited exposure expected with current uses of this chemical.
  The Registration Standard required a hydrolysis study and an activated sludge
  study, which was later waived. The hydrolysis study was found deficient, but the
  Agency later determined that an additional hydrolysis study was not needed based
  on the fact that OBPA-treated material will not  result in significant levels of
  residues being released into the environment.  An extractability study on pool
  liners and vinyl baby pants showed that leaching would not result in exceedance
  of the 50 ppb maximum daily dietary intake for arsenic in  drinking water.
  2.    Ecological Effects

        No further ecological effects toxicity data are required to support current
  uses of this chemical.

-------
a.     Ecological Effects Data

       Topical Summaries

       (1)    Terrestrial Data - Effects on Birds

             'Two studies were submitted  and both were found to be
       scientifically sound.
Author
Fink
Fink
Dat»
1976
1976
MRZO Mo.
00012:648
00012:649
      Avian  Acute  Toxicitv  Test —  Technical Active  Ingredient

      The following tests are normally required to measure toxicity of
      technical grade active ingredient (TGAI):

      • One avian single-dose oral study on either a waterfowl species
      (preferably  mallard duck)  or  an upkind  species (preferably
      bobwhite quail).

      •  One subacute dietary study on either a waterfowl species
      (preferably  mallard duck)  or  an uphmd  species (preferably
      bobwhite quail).
      No studies were conducted on the technical material, therefore
      normally a data gap would exist. However, the usual studies will
      be  waived because:   1) the  material iis highly corrosive and
      therefore will be very highly toxic to birds; 2) existing acute oral
      rat  data (45  mg/kg males  and IS  mg/l:g females) confirm the
      pesticide's high toxicity to terrestrial orgjjiisms; 3) the indoor use
      pattern does  not require a  risk assessment for birds, and avian
      toxicity information  is  needed  only  to assess the  need for
      precautionary label statements.
              cute Toxicit  Test — Tical   id-Use Product
      Studies are not required to support indoor non-food (industrial) use
      patterns.  The single available  acute oral toxicity study for a
      typical end-use product (TEP) is:
                      10

-------
S|MCiM
.

Avian oral
Mallard
duck
%Ta«t
Malarial

6%
TEP

ID*
mg/kg
product
> 10,000


Author


FJfMC


Dm*


1976


MRIDNo.


00013648


Fitfflb
RwiufrMMnti

No
raquiramant

 Hie data indicate  that OBPA (5%) is practically  non-toxic  to
 mallard duck (waterfowl species) on an acute oral basis.
The  single available  subacute dietary  toxicity study is listed
below:
*.,„
Avian ditt.
Botwhitt
quail
X Tart
Material
5 X
TEP
U»
KM product
>10,000
Author
Fink
Date
1976
MID Mo.
00013640
Fulfill*
Rwpri navntv
Ho
raqufraawtt
These data indicate that OBPA (5%) is practically non-toxic to
bobwbite quail (upland bird species) on a subacute dietary basis.
(2)    Aquatic Data

Nine studies (in five reports) were submitted under this topic. All
were found acceptable for use in a hazard assessment.
Author
Buccafusco
Heitmuller
Bentley
Lee & Regel
WARF
Date
1977
1980
1976
1974
1973
MRIDNo.
GS044009
00030658
00013641
GS044067
00013611
The minimum ffyfa required for establishing the acute toxicity of
OBPA to freshwater fish is one fish acute toxicity study with the
technical material.  The preferred test species is either rainbow
trout or bluegill sunfish.
                11

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Fish Acute Toxicitv Test — Technical Active Ingredient
The acceptable acute toxicity data are listed below:
*—
Rainbow
•wit
aunfiah
filkAAMBtlABuf
minnow
%A.L
96.6%
96.6%
96.6%
LC.
ppb,.J.
3.5
t.O
•.0
A—
BlMMMlflMOO
•— *""
lialuuuiai
.-.
1977
1S77
1990
ID*
0804400*
0*044009
00030669
jj^,
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requirements for Ash acute toxicity tests for OBPA with the typical
end-use product.    These studies  showed  that the 5%  OBPA
formulated product is practically non-toxic  to freshwater fish in
acute exposure.  However,  other studies using the products with
lower contents of OBPA (2 & 3% a.i.) were found to be highly
toxic to freshwater fish on an acute basis.
(3)    Effects to Non-target Aquatic Invertebrates

Two studies were found acceptable for use in a hazard assessment:
Author
Browne
Heitmuller
Date
1980
1979
HRZD Mo.
00030657
00030656
The requirement to establish the acute toxicity of OBPA to aquatic
invertebrates is a 48-h. DadUM acute toxicity study using the
technical material.  The acceptable toxicity data are listed below:
Specie*
Uaphaia
aagoa.
Grass
shrimp
\ Test
Material
99.0 %
95.6 %
LCM
ppb a.i.
4.8
50.0
Author
Browne
Heitmull
er
Date
1980
1979
MAID NO.
00030657
00030656
Fulfill*
Raquirema
nts
Yes
Yes
The Daphnia  test fulfills the guideline  requirement for acute
freshwater invertebrate toxicity testing.   The data indicate that
OBPA is very highly toxic to freshwater aquatic invertebrates.  A
marine acute invertebrate toxicity study is not required for this
end-use.   However, the grass shrimp study would  fulfill  the
guideline requirement for a marine invertebrate study.  That study
shows that OBPA is very highly toxic to a marine invertebrate on
an acute basis.
(4)    Non-Target Estuarine and Marine Organisms

       No toxicity data are required for the end-uses registered.

(5)    Non-Target Insects
                13

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                                 No toxicity data axe required for the end-uses registered.

                           «5)    Non-Target Plants

                                 No toxicity data are required for the end-uses registered.


                    b.     Ecological Effects Risk Assessment

                           OBPA is an indoor non-food use pesticide which is incorporated
                    into plastics, adhesives, textiles etc.  The Agency does not conduct risk
                    assessments for nontarget organisms for indoor uses without effluent.
                    Risk assessments for uses with  effluent are based on residues in natural
                    waters  receiving the effluent.  Should such residues of OBPA exceed
                    1.75 ppb, aquatic organisms are acutely at risk,  This level is based on
                    acute LC50 for the technical  active ingredient is low as 3.5 ppb for an
                    aquatic organism (rainbow bout).


IV.   RISK MANAGEMENT AND REREGISTRATION DECISION

      A.    Determination of Eligibility

             Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission
      of relevant data concerning an active ingredient, whether products containing the active
      ingredient are eligible for reregistxation.  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  OBPA 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 all products containing OBPA.  Appendix B
      identifies the generic data requirements that the Agency leviewed  as  part of its
      determination of reregistration eligibility of OBPA, and lists die submitted studies that
      the Agency found acceptable.

             The data identified in Appendix B were sufficient to allow the Agency to assess
      the registered uses of  OBPA and to determine that OBPA can be used without resulting
      in unreasonable adverse effects to man or the environment. Ths Agency therefore finds
      that all products containing OBPA as the active ingredient axe eligible for reregistration.
      The reregistration of particular products is addressed in Section V of this document.

             The Agency made its reregistration eligibility determination based upon the target
      data base required for reregistration, the current guidelines for conducting acceptable
      studies to generate such data iml  the data identified in Appendix B.   Although the
      Agency has found that all uses of OBPA are eligible for Registration, it should be
      understood that the Agency may take appropriate regulatory atrion, and/or require the
      submission of additional data  to support the registration of products containing OBPA,
                                         14

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if new information comes to the Agency's attention or if the data requirements for
reregistration (or the guidelines for generating such data) change.

       1.     Eligibility Decision

              Based on the reviews of the generic data for the active ingredient OBPA,
       the Agency has sufficient information on the health effects of OBPA and on its
       potential for causing adverse effects in fish and wildlife and the environment.
       Therefore, the Agency concludes that products containing OBPA for all uses are
       eligible for reregistration.

              The Agency has determined that OBPA products, labeled and used as
       specified in this Reregistration Eligibility Document, will not pose unreasonable
       risks or adverse effects to humans or the environment

       2.     Eligible and Ineligible Uses

              The Agency has determined  that all uses of OBPA are eligible for
       reregistration.
B.     Regulatory Position

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

       1.     Tolerance Reassessment

             There are no registered uses for OBPA in or on food or feed.

       2.     Labeling  Rationale

             The "Environmental Hazards" section should include the following:

             a.    Manufacturing Use

             "This pesticide is toxic to fish, aquatic invertebrates, birds, and mammals.
             Do not discharge  effluent containing  this product into  lakes, streams,
             ponds, estuaries, oceans or  other waters unless in accordance with the
             requirements  of a National Pollutant  Discharge Elimination  System
             (NPDES)  permit and the permitting authority has been notified in writing
             prior to discharge.  Do not discharge effluent containing this product into
             sewer systems without previously notifying the local  sewage treatment
             plant authority.  For guidance contact you State Water Board or Regional
             Office of the EPA."
                                   15

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                   b.     End Use
                   Indoor (Industrial use) - Same language as for the manufacturing use.

V.    ACTIONS REQUIRED BY REGISTRANTS

      This section specifies the data requirements and responses necessary for the reregistration
of both manufacturing-use and end-use products.
      A.    Manufacturing-Use Products

             1.     Additional Generic Data Requirements

                   The generic data base supporting the reregistraticn of OBPA for the above
             eligible uses has been reviewed  and determined to bo substantially complete.
             However, some of the product chemistry guidelines hive not been completely
             fulfilled.

                   All of the product chemistry data for OBPA were originally required in
             the Registration Standard and are therefore not included in a generic Data Call-In
             for the RED.

                   There are no new generic  data being called-in for OBPA.

             2.     Labeling Requirements for Manufacturing-U!* Products

             The "Environmental Hazards" section is to include the following:

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

                   In addition, labels  must consistently reflect any potential eye and skin
             hazard (Danger, Warning or Caution Signal Words) and recommend appropriate
             personal protective equipment (protective eyeware {goggles or face shield}, long
             sleeved shirts and long-legged pants, waterproof gloves, shoes and socks).


      B.     End-Use Products

             1.     Additional Product-Specific Data Requirements
                                        16

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

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

       Same language as for the manufacturing use.

       End-use product labeling and personal protective equipment requirements
will be determined upon submission or citation and review of acute toxicity
studies conducted on the end-use product.
                             17

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    APPENDIX A
 Table of Use Patterns
Subject to Reregis
         18

-------
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-------
           APPENDIX B
Table of the Generic Data Requirements
     and Studies Used to Make the
       Reregistration Decision
                20

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

   The data table is organized in the following format:

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

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

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

   3.  Bibliographic citation (Column 3).  If the Agency has acceptable data in its files, this
       column lists the identifying number of each study. This normally is the Master Record
       Identification (MRID) number, but may be a "GS" number if no MRID number has been
       assigned.  Refer to the Bibliography appendix for a complete citation of the study.
                                         21

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      APPENDIX C
     BIBLIOGRAPHY
Considered to be Part of the Data fi
 Supporting R
           28

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

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

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

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

   a. Author.  Whenever the author could confidently be identified, the Agency has chosen
      to show a personal author. When no individual was identified,  the Agency has shown
      a identifiable laboratory or testing facility as the author. When no author or laboratory
      could be identified,  the Agency has shown the first submitter as the author.
   b. Document Date.  The date of the study is taken directly from the document. When the
      date is followed by a question mark, the bibliographer has deduced the date from the
      evidence contained in the document.  When the date appears as (19??), the Agency was
      unable to determine or estimate the date of the document.
                                         29

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

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

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

   (2)    Administrative Number.  The next element  immediately following the word
          "under" is the registration number, experimental use jpermit number, petition
          number, or  other administrative number associated with the earnest  known
          submission.
(3)
(4)
          Submitter. The third element is the submitter. When authorship is de-faulted to
          the submitter, ti% element is omitted.
         Volume Identification ( Accession Numbers'}.  The final! element in the trailing
         parentheses identifies the EPA accession number of ttie volume in which the
         original submission of ithe study appears.  The six-digit accession number follows
         the symbol "CDL", which stands for "Company Data Library". This accession
         number is in turn followed by an alphabetic suffix which shows the relative
         position of the study within the volume.
                                      30

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 BIBLIOGRAPHY
 PRODUCT CHEMISTRY BIBLIOGRAPHY

 42517401     Lawson,   P.   (1992)   Product   Identity  and  Composition   for
             10,10'-Oxybis-10-H-Phenoxarsine (OBPA). Unpublished study prepared by Akzo
             Chemicals Inc. 24 p.

 42517402     Clark,  A.  (1992)  Physical  and  Chemical  Characteristics Testing  For
             10,10'-Oxybis-10-H-Phenoxarsine (OBPA): Guideline 62: Lab Project Number
             0922-042: 3130-F(02).   Unpublished  study prepared by  Midwest Research
             Institute. 75 p.

 42517403     Clark,  A.  (1992)  Physical  and  Chemical  Characteristics  Testing  for
             10,10'-Oxybis-10-H-Phenoxarsine (OBPA): Guideline 63: Lab Project Number
             0922-042: 3130-F(01).   Unpublished  study prepared by  Midwest Research
             Institute. 50 p.
ECOLOGICAL EFFECTS BIBLIOGRAPHY
00013611    WARF Institute, Incorporated (1973) Report: WARF No. 3031960. (Unpublished
            study received May 31, 1973 under 2829-96; sub-mitted by Ventron Corp.,
            Beverly, Mass.; CDL:006984-D)

00013641    Bentley, R.E. (1976) Acute Toxicity  of Vimyzene [sic] SB-1 to Blue-gill
            (JJL ~ Lepomis macrochirus/i - ) and Rainbow Trout 0* — Salmo p ~gairdneri/t ~).
            (Unpublished study received Feb 5, 1976 under 2829-115; prepared by EG&G,
            Bionomics, submitted by Ventron  Corp., Beverly, Mass.; CDL:226171-V)

00013648    Fink, R.  (1976) Final Report:  Eight-Day Dietary LC=5(T-Bobwhite Quail:
            Project No. 121-105.   (Unpublished study received on un-known date under
            2829-115; prepared by Truslow Farms, Inc. in cooperation with Maryland, Dept.
            of Agriculture, Div. of Inspection and Regulation, submitted by Ventron Corp.,
            Beverly, Mass.; CDL:228092-A)

00013649    Fink, R. (1976) Final Report: Acute Oral LD=5
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 00030656    Heitmuller, T. (1979) Acute Toxicity of 10,10'-Oxybi5phenoxarsine (OBPA) to
             Grass  Shrimp   (~Palaemonetespugio~M):  Report   No.  BP-79-11-167.
             (Unpublished study received May 29,1980 under unknown admin, no.; prepared
             by EG&G, Bionomics, submitted by Thiokol Corp., Ventron Div., Danvers,
             Mass.; CDL:242904-A)

 00030657    Browne, A.M. (1980) Hie Acute Toxicity of lO^O'-Cxybisphenoxarsine to the
             Water  Flea-Daphnia-magna-Straus:   UCES  Project No. 11507-57-02.
             (Unpublished study received May 29,1980 under unknown admin, no.; prepared
             by Union Carbide Corp., submitted by Thiokol Corp., Ventron Div., Danvers,
             Mass.;CDL:242904-D)

 00030658    Heitmuller, T. (1980) Acute Toxicity of OBPA (10,10 -Oxybisphenoxarsine) to
             Sheepshead Minnows (p - Cyprinodon - variegatus - p): Report No. BP-80-2-30.
             (Unpublished study received May 29,1980 under unknown admin, no.; prepared
             by EG&G, Bionomics, submitted by Thiokol Corp., Ventron Div., Danvers,
             Mass.; CDL:242904-B)

 GSO44009    Buccafusco, RJ. (1977) Acute Toxicity of OBPA to Bluegill and Rainbow Trout.
             (Unpublished study prepared by EG and G Bionomics)

 GS044067    Lee, T. and Regel, L. (1974) Fish Toxicity. Testing Report of WARP Institute,
             No. 3121308.

 00131955    Buccafusco, R. (1977) Acute Toxicity of 10, lO'-Oxybi'tphenoxarsine to Bluegill
             (Lepomis macrochirus) and Rainbow Trout (Salmo gairdiieri). Unpublished study;
             .100 p.

 00147990    Regel, L.  (1974)  Fish Toxicity: WARF No. 312B08. Unpublished study
             prepared by WARF Institute.  16 p.
TOXICOLOGICAL BIBLIOGRAPHY
00013643     Anspach,  P.S.  (1977)  Acute Toxicity  and  Irritation  Studies  of  99.9%
             10,10'-Oxybisphenoxarsine: 76-990-21.  (Unpublished study  received Feb. 16,
             1977 under 2829-115; prepared by International Bio-Resuarch, Inc., submitted by
             Ventron Corp., Beverly, Mass.; CDL:228087-B)

00013644     Brusick, D.J.; Weir, R. J. (1976) Mouse Lymphoma Mutagenicity Evaluation of
             10,10'-Oxybisphenoxarsine: Final Report; LBI Project No. 2548. (Unpublished
             study received Nov. 9,1976 under 2829-115; prepared ty Litton Bionetics, Inc.,
             submitted by Ventron Corp., Beverly, Mass.;  CDL:228088-A)
                                       32

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00013647    Brusick,   D.J.;   Weir,   R.  J.   (1976)   Mutagenicity   Evaluation   of
             10,10'-Oxybisphenoxarsine (Technical): Final Report; LBI Project No. 2547.
             (Unpublished study received Jul. 15, 1976 under 2829-115; prepared by Litton
             Bionetics, Inc., submitted by Ventron Corp., Beverly, Mass.; CDL:228091-A)

00013591    International Paint Company (1957?) Report on the Comparative Toxicology of
             Phenarsazine oxide and Phenoxarsine  oxide  with  Additional Data  for  the
             Inhalation Toxicity of DM. (Unpublished study received Sep. 9, 1970 under
             2693-21; CDL:105338-A)

00024935    Dow   Chemical  Company   (1964)   Toxicological   Properties    of
             10,10'-Oxybisphenoxarsine.  (Unpublished  study  received Nov. 2,  1964;
             CDL:121914-A)

00024936    Fiantz, G.C.; Shrader, S.A. (1959) Results of a 35-day Dietary Feeding Study
             of 10,10'-Oxybisphenoxarsine to Rats.  (Unpublished study received Nov.  2,
             1964; prepared by Dow Chemical  Co. with Biochemical  Research Laboratory;
             CDL:121914-B)

00024937    Olson, K.J.  (1959) Skin Contact-Irritation. (Unpublished  study received Nov 2,
             1964 under unknown udmin  no.; prepared by Bio-chemical Research Laboratory,
             submitted by ?; CDL:121914-C)

00024938    Olson, K.J.  (1959) Bye Contact Test.  (Unpublished study  received Nov 2, 1964
             under unknown admin,  no.;  prepared by Biochemical Research  Laboratory,
             submitted by ?; CDL:121914-D)

00024940    Oxen,  F.  (1959) Summary  of Pathology on Male &  Female Rats Fed
             10,10'-Oxybisphenoxarsine in the Diet for 30 Days. (Unpublished study received
             Sep.2, 1965; CDL:121914-G)

00024941    Olson, K.J. (1959) Acute Oral Toxicity.  (Unpublished study received Nov 2,
             1964 under unknown admin, no.; prepared by Bio-chemical Research Laboratory,
             submitted by ?; CDL:121914-H)

00026092    Olson,  K.J.; Nunemaker,  R.B.; Shrader,  S.A.; et al.  (1959) Skin Contact
             Absorption (Unpublished study received Nov. 2,1964; prepared by Biochemical
             Research Laboratory with Dow Chemical Co., CDL:121914-F)

GS044002    Anspach, P.S. (1977)  Acute Toxicity and Irritation Studies of OBPA (95.6%).
             (Unpublished study prepared by Hill TopTesting Services, Inc.)
                                        33

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 GS044004   Babish, J.G. (1978) The Acute Dermal Toxicity (LDjo) of OBPA with Sprague-
             Dawley  Rats.   (Unpublished study prepared  by Food and Drag  Research
             Laboratories, Inc.)

 GS044007   Bellies,   R.P.;  Makris,   S.L.   (1978)   Teratology   Study  in   Rats.
             10,10'-Oxybisphenoxarsine:  LBI  Project No.  2081
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00131943    Thiokol Corp. (1976) [Study-Chemistry: Vinyzene]. (Compilation; unpublished
             study received May 16, 1977 under unknown admin, no.; CDL:251349-A)

GS044011    Cadmus,  E.L.  (1973a) Extractability of Vinyzene BP-5, Laboratory Report
             submitted by Ventron Corporation, Beverly, MA, Mar 30.

GS044012    Cadums,  E.L.  (1973b) Extractability of Vinyzene BP-10 from Light gauge
             Plasticized Vinyl Film used as Baby Pants' Material, Laboratory Report submitted
             by Ventron Corporation, Beverly, MA, Oct 1.

GS044023    Hamilton, N.F. (1978) Laboratory Report Evaluating the Diffusive Properties of
             New Biocided ATV-129, C-10545, and RH-893 in Three Polymer Systems
             Compared to OBPA. Test 78-49 Part I.  (Unpublished study received? under an
             unknown admin, no.; prepared by Ventron Corp., Beverley, MA)

GS044024    Hamilton, N.F. (1978) Efficacy Study of PVC Films Containing OBPA:  Test 78-
             49 Part IB.   (Unpublished study received? under an unknown admin, no.;
             prepared by Ventron Corp., Beverley, MA)

GS044030    Kirkpatrick, D.  (1977a)  Laboratory report on  Silicons  Sealant,  sample no.
             ED805-3082. (Unpublished report received ? under an unknown admin, no.;
             prepared by the Consumer Protection Safety Commission; submitted by ?)

GS044034    Kugler, D.J.  (1974) Arsenic Survey at Ventron Corp.

GS044048    Porter,  W.K. (1973) U.S.  Consumer  Product  Safety  Commission's Analyst
             Worksheet on G.E. Silicone sealer white, Nov. 11.

GS0440SS    United  States Department of Health, Education, and Wealfare  (1962) Public
             Health  Service Drinking Water Standards,  1962.    Public Health  Service
             Publication No. 956, Washington, DC, U.S. Government Printing Office.

GS0440S6    Ventron Corporation (1978)  Extraction of 10,10'-  Oxybisphenoxarsine from
             Plasticized Vinyl Films.

GS044062    Weingast, J. (1976) Arsenic Survey at Ventron Corp.

GS044080    Aldous, K.M. (1977) Analysis of Silicone Caulking Compounds  for Arsenic
             Content. (Unpublished study prepared by the N. Y State Department of Health)
                                        35

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         APPENDIX D
TJgt of Available
             36

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                                   APPENDIX D


 The following is a list of available documents related to Oxybisphenoxarsine (OBPA).  Its
 purpose is to provide a path to more detailed infonnation if it is required. These accompanying
 documents are part of the Administrative Record for OBPA and are included in the EPA's Office
 of Pesticide Programs Public Docket.

    1.  Health and Environmental Effects Science Chapters

    2.  Detailed Label Usage Infonnation System (LUIS) Report

    3.  OBPA RED Fact Sheet (included in this RED)

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

Federal publications on OBPA are available and may be purchased from the National Technical
Infonnation Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161.

       • Guidance for the Reregistration of Pesticide Products Containing OBPA as the Active
      Ingredient (The 1981 Registration Standard):  NTIS Stock No. PB82-172271.

      • OBPA Data-Call-in (DO) of 9-30-91.
                                       37

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               UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

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

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

ATTENTION: Persons Responsible for Federal Registration  of
Pesticide Products.

SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement

I. PURPOSE:

     The purpose of this notice is to clarify the Office of
Pesticide Program's policy with respect to the statement of
percentages in a pesticide's label's ingredient statement.
Specifically, the amount  (percent by weight) of ingredient(s)
specified in the ingredient statement on the label must  be stated
as the nominal concentration of such ingredient(s), as that term
is defined in 40 CFR 158.153(i). Accordingly, the Agency has
established the nominal concentration as the only acceptable
label claim for the amount of active ingredient in the product.

II. BACKGROUND

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

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

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

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

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

III. REQUIREMENTS

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

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

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

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IV. PRODUCTS THAT REQUIRE EFFICACY DATA

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

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

V. COMPLIANCE SCHEDULE

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

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

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

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

VI. FOR FURTHER INFORMATION

Contact Tyrone Aiken for information or questions concerning
this notice on (703) 557-5024
                                 Ann« S. tindaay, Director
                                 Registration Division (Ji-7505

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        APPENDIX E





Pesticide RencktratRm Handbook
            38

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United Stales    Office of        October 1991
Environmental Protection Pesticide Programs
Agency	^	
Pesticide
Reregistration
Handbook

How to Respond to
the Reregistration
Eligibility Document
(RED)
                Printed on Recycled Paper

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    PESTICIDE  RERBGISTRATION HANDBOOK
          HOW  TO RESPOND TO THE



REREGISTRATION ELIGIBILITY DOCUMENT (RED)
      OFFICE OF PESTICIDE PROGRAMS




     ENVIRONMENTAL PROTECTION AGENCY




               OCTOBER 1991
                                          Printed on Recycled Paper

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                  PRODUCT REREGI8TRATION EAHDBOOK

                         TABLE OP CONTENTS
 I.  Introduction
      A.  Purpose and Content
      B.  Reregistration Eligibility Document
      C.  Reregistration Process
 II.   Instructions for Responding
      A.  How and When to Respond
      B.  mien No Response Is Needed
      B.  Where to Respond
 III.   Submission of Data and Labels/Labeling
      A.  Generic Data
      B.  Product Specific Data
          1.   Product Chemistry
          2.   Acute Toxicity
          3.   Product Performance
      C.  Labels/Labeling
Appendix
     A.  Confidential  statement of Formula and Instructions
     B.  Label Contents
     C.  Sample Label Formats—General Use & Restricted Use
     D.  Label Regulations (40 CFR 156.10)

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                PESTICIDE REREGISTRATION HANDBOOK

 I.   INTRODUCTION

      A.   Purpose and Content  of this HflP^fo?PK

      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 XI 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 Rereoistration Eligibility Pocu.rn.ent (RED)

      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 reviews 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 Rereoistration 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 REE', 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.r
 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 ir. 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 the 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
 (8LK or Section 24c) 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.    Are  Expedited Label  Chances Reciuired?    In  some
 instances, EPA  may conclude that  certain  changes  to  product
 labels/labeling must be implemented  rapidly.  I:C the RED requires
expedited label/labeling changes, registrants muiit 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).11  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.    rive  (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 Bust respond for all
 products within »o davs of receipt; products for which an adequate
 response is  not received on time will be subject to suspension. He
 time extensions will be  given for responding within 90 davs.

     Step 3.    Are Uses of a Pesticide Eligible for Rereai strati on?
 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 any uses of a
 chemical  are  eligible  for reregistrationt   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 e 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.*1
 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  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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 FIGURE 1.  BOW AND VEEN TO RESPOND TO TEE REREGISTRATION
            ELIGIBILITY DOCUMENT (RED) TOR MANUFACTURING USE
            PRODUCTS  (KPs), END-USE PRODUCTS (EPS) and SPECIAL
            LOCAL NEEDS REGISTRATIONS (SLNs).
      STEP it   Are expedited label revisions required?

                        Yes      S\ NO

                Submit application
                and labels on
                expedited schedule
                specified in RED.

      STEP 2s   Are data required?

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

                Do you vish  to
                delete ineligible
                uses  from label?
For each HP t EP
fi SLN  (24c) submit
application within
8 months,  if
the submission
is acceptable,
the label will be
stamped accepted
as an amendment.
Ma reregistration
vill be issued.
                      No
                       Yes
       For each HP c EP
       & SLN (24c)  submit
       application vithin
       * months.  If
       the submission
       is acceptable,
       the label vill be
       stamped accepted
       and a notice of
       reregistration
       vill be issued.
No further response
necessary.  Await
the outcome of
EPA's review.

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     c.   Product Specific Data.  Yon must follow the instructions
in thf Data  Call-in  Notice  in the RED  and in Section III of this
Handbook.  Responses to th« data call in art due within »o davs 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 forms 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 met;

     —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 code)
      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:

      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
 aust  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-xxx  (where JQDC 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-In Notice in the RED,
 registrants must respond as described in that Notice.  The RED also
 contains  instructions for completing these foi-ms, 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 Data

     Product specific data may be required for the reregistration
 of each pesticide product in three areas—product 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 date.   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 Ingredients

     EPA  has  implemented  a  strategy   for  regulating  inert
 ingredients which affects the reregistration of pesticide products.
This strategy,  issued on April 22,  1987  (52  FP  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 l  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 DCI, or other  activity under
 the  inerts strategy.

     Any  product  containing a  List  2,  3   or 4  inert  mav  be
 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 1, 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  HP 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.  The

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main benefits of this approach are to minimize ithe 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*1 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 isfficacy  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 6, 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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     b.  Claims and  Products for Which Efficacy Data
          Are Required
     Submission  of efficacy data at  reregistration typically is
 required  for the following types of products:

           l.   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
aev uses or labeling changes that  do not pertain to reregistratios
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:

     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 Formats—General Use & Restricted Use
D.  Label Regulations (40 CFR 156.10)

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      Instructions for  Completing the  Confidential  Statement  of
 Formula

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

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

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

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

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

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

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

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

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

      i.   For the active ingredients, the percent  purity  of the
 source  products must  be  reported  under  column  10 and must   be
 exactly  the same as on  the source product's label.

      j.   All  the weights  in  columns  13.a.  and 13.b.  must be  in
 pounds,  kilograms, or grains.   In  no  case will volumes be  accepted.
 Do  not  mix English and  metric  system units   (i.e.,  pounds  and
 kilograms).

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

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

     m.  The upper and lower  certified limits for all  active and
 inert ingredients must follow the 40 CFR 158.175 instructions.  An
 explanation must be provided  if the proposed limits are different
 than standard certified limits.

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

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               B.  INSTRUCTIONS FOR IABEL CONTENTS

     40 CFR 156.10 and Pesticide Regulatory  (P.R.) Notices require
that specific  labeling statements appear at certain locations on
the label.  The sample label formats in Appendix C show where these
statements are to be placed.

Item 1.  PRODUCT NAME - The name, brand or trademark is required to
be located  on the front panel, preferably  centered in the upper
part of the panel.  The name of a product will not be accepted if
it is false or misleading.  [40 CFR 156.10(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 156.10(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., "1
pound 10 ounces" rather than "26 ounces."  In addition to English
units, net  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
print on that part of the label on which it appears and must run
parallel  to  it.    The  registration  number  and  the  required
identifying phrase must not appear in such a manner as to suggest
or  imply recommendation  or endorsement  of the  product by  the
Agency.  [40 CFR 156.10(e)]

Item 5.  EPA ESTABLISHMENT NUMBER - The EPA establishment number,
preceded by the phrase "EPA Est." is 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
on the  wrapper or outside container of  the package if  the  EPA
establishment number on the immediate container cannot be clearly
read through such wrapper or container.  [40 CFR 156.10(f)]

Item 6A.   INGREDIENTS STATEMENT -  An ingredients  statement is
normally required on the  front panel.   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  enlv  if efficacy  data
 supporting such claims are submitted or referenced.  If such data
 are provided,  the  related chemicals must  be lilted separately and
 not as a portion of  the  active ingredient.

 Item 6D.  INERT INGREDIENTS RECLASSIFIED AS ACTPTE INGREDIENTS -If
 EPA has reclassified chemicals  from inert inerredient  status to
 active  ingredient status, registrants  of affe
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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 toxic ity, 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 156.10(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.lO(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 uses 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
          separate  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
          labels.     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  (REI)
has been established  by the Agency,  it  must be included  on the
label.  Additional worker protection statements may be required in

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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-].  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  :Ln 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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LABEL FORMAT FOR UNCLASSIFIED PRODUCTS

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LABEL FORMAT FOR PRODUCTS CLASSIFIED FOR RESTRICTED USE

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§nvlf»i«"»nt 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  gi*<™ 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 recipient^),
 and the date the  document was re-
 ceived or provided by the Agency.
  (d) Availability of docket and indi-
 ces (1) The Agency wQl  make avail-
 able to  the public  for inspection  and
 copying the docket and index for  any
 Registration Standard.
  (2)  The Agency  will establish  and
                      of persons who
                            §156.10

these persons. Annually. EPA will re-
quire that persons on the list renew
their requests for inclusion on the list.
  (3) The Agency will issue •mm»iiy m
the FEDERAL REGISTER (in conjunction
with the annual schedule notice speci-
fied in 1155.25)  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.

• 165J4  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(cX2XB» to submit chronic health
(Including, but not limited to. chronic
feeding,  oncogenidty  and reproduc-
tion) or teratology studies.
  (b) Interested persons may 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    156—LABELING    REQUIRE-
  MENTS FOR PESTICIDES  AND DE-
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
                                      AUTBOUTT: 7 T7B.C. U6-136y.

                                     1166.10 Labeling requirement*.
                                      (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-

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  §156.10

  lations In this Part The contents of a
  label must show dearly and  promi-
  nently the following:
   (1) The name,  brand, or trademark
  tinder which the product is sold as pre-
  scribed in paragraph (b) of this sec-
  tion;
   (11)  The name and address  of the
  producer,  registrant, or person for
  whom produced as prescribed in para-
  graph (c) of this section;
   (ill) The net contents as prescribed
  in paragraph (d) of this section:
   (iv)   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;
   Ort) An ingredient statement as pre-
 scribed in  paragraph (g) of this sec-
 tion;
   (vil) Warning or precautionary state-
 ments as prescribed in paragraph (h)
 of this section;
   (viii) The directions for use as pre-
 scribed in paragraph (1) of this section;
 and
    AH required label text must:
   (A) Be set in 6-polnt or larger type;
   (B) Appear on a clear contrasting
 background; and
   (C) Not be obscured or crowded.
   (3) Lanffuaye to be sued. 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-l-i9
 other-langusge  versions of the label-
 ing.
  (4) Placement of Label—(1) General
 The label shall appear on or be secure.
 ly attached i» the Immediate contain.
 er  of the  pctsticide product. For pur-
 poses of this Section, and the mi*.
 branding provisions of the Act. "se-
 curely  attached"  shall mean  that a
 label can  reasonably  be expected to
 remain affixed during the foreseeable
 conditions and period of use. If the im-
 mediate container is enclosed within a
 wrapper or outside container through
 which the lalbel cannot be clearly read.
 the label  must also  be  securely  at-
 tached to such outside wrapper or con-
 tainer, if it is a part of the package as
 customarily ttistrtbuted or sold.
  (ii) Tan* car* and  other bulk con-
 tainer*—(A) Transportation. While a
 pesticide product is in transit, the ap-
 propriate provisions of 49 CFR Parts
 170*189, concerning the transportation
 of hazardous materials, and specifical-
 ly those pro'risions concerning the  la-
 beling, marking and placarding of haz-
 ardous mateiials and the vehicles car-
 rying them,  define the basic Federal
 requirementi. In addition, when any
 registered  pisticide  product is trans-
 ported  In  a  tank car, tank truck  or
 other mobile or portable bulk contain-
 er,  a  copy oi  the accepted label must
 be  attached to the shipping papers,
 and left with the consignee at the time
 of delivery.
  (B) Storage. When  pesticide prod-
 ucts  are  stared  in bulk containers,
 whether mobile or stationary, which
 remain in  the custody of the user, a
 copy of the label of labeling, including
 all appropriate directions for use, shall
 be securely attached to the container
 in the Immediate  vicinity of the dis-
 charge control valve.
  (5)  Falte or misleading statements.
 Pursuant to  section 2B  Examples of statements
 or  representations  in the  labeling
which constitute misbranding include:
  (1) A false  or **»toltiMllinig statement
concerning the  composition of  the
product;

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               Protection Agency

   (ID A false or misleading statement
 concerning the effectiveness  of the
 Product as a pesticide or device;
   (ill) A false or misleading statement
 -bout the value of  the product for
 purposes  other than  as a pesticide or
 device;
    "Among  the  least toxic chemi-
 cals known"
  (C) "Pollution approved"
  (6) Final printed labeling. (1) Except
 as provided in  paragraph (aX6Xil) of
 this section, final printed  labeling
 must be submitted and  accepted prior
 to registration.  However, final printed
 labeling need not  be submitted until
 draft label texts have been provision-
 ally accepted by the Agency.
  (11) Clearly legible reproductions or
 photo reductions will be accepted for
 unusual labels such as those  silk-
screened directly onto glass  or metal
containers or large bag or drum labels.
Such reproductions must be of micro-
film reproduction quality.
                            § 156.10

  (b) Name, brand, or trademark. (1)
The name, brand, or trademark under
which the pesticide  product Is sold
shall appear on the front panel of the
label.
  (2) No name, brand, or trademark
may appear on the label which:
  (i) Is false or misleading, or
  (tl) Has not been approved by  the
Administrator through registration or
supplemental  registration as an addi-
tional name pursuant to 1152.132.
  (c) Name and address of producer,
registrant,  or person for whom pro-
duced. An  unqualified name and  ad-
dress given on the label shall be con-
sidered as the name and address of the
producer. If the registrant's name ap-
pears on the label and the registrant is
not the producer, or if the name of the
person for whom  the  pesticide was
produced appears on the label, it must
be qualified by appropriate wording
such as "Packed for * • V "Distribut-
ed by • • V or "Sold by	to show
that the name is not that of the pro-
ducer.
  (d) Net weight or meature of con-
tent*. (1) The net weight or measure
of content shall be exclusive of wrap-
pers or other materials and shall be
the average content unless explicitly
stated as a minimum quantity.
  (2)  If the pesticide is a liquid, the
net  content  statement  shall  be  in
terms of liquid measure at 68* F (20*C>
and shall be expressed in conventional
American units of fluid ounces, pints,
quarts, and gallons.
  (3) If 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, Le., "1 pound 10 ounces" rather
tban "26 ounces."
  (5) In addition to the required units
specified,  net  content may  be  ex-
pressed in metric units.
  (6)  Variation above tnintmum eon-
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 mifiimnm i* not permit-
ted. In no case shall the average con-

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  { 156.10

  tent of the packages In a shipment fall
  Thi rtflrtrttlon
 J£5l not appear to such a mumer u
 toinraest or Imply recommendation
 or endorsement of the product by the
  (f ) 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.
  (g) Ingredient statement— (1) 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 m 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 tngi^dlftnt statement Is a
complete analysis of the pesticide, the
term "analysis" shall not be used as a
heading for the Ingredient statement
  (2) Petition of ingredient statement
(I) The ingredient  statement Is nor-
mally required on the front panel of
         40 CJf* Ch. I (7-1-89 Edition)

the label. If there Is an outside con-
tataer or wrapper through which the
ingredient statement cannot be clearly
read, the Ingredient statement must
fi«o appear era 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 uppear elsewhere.
  (II) The text of the Ingredient state-
ment must  inn  parallel with  other
text on the piinel on which it appears,
arm must be1 clearly  distinguishable
from and must not be placed In the
body of other text.
  ($) Names ito be used in ingredient
statement The name used for each in-
gredient  shiiU  be  the   accepted
common name. If  there  Is  one, fol-
lowed  by  this chemical  name.  The
common nanui may be used alone only
If it Is well known. If no common name
has  been  established,  the  ctifFftteal
name alone sliall 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(cx6).
  (4) Statements  of percentages. The
percentages  of ingredients  shall be
stated In terras of weight-to-weight.
The sum of percentages of the active
and the Inert ingredients shall be 100.
Percentages stall 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 urea, a statement of the
weight of active  ingredient  per  unit
volume of the pesticide formulation
      also  apt>ear In the  Ingredient
 -*- .«.
  (5) Accuracy o/ stated percentages.
The percentage* 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:

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                Protection Agoncy
       jn cases where It IB determined
         pesticide formulation changes
            composition  significantly,
           ct must bear the following
  ctatement in a prominent position on
  the label: "Not for sale  or use after
  CdsteJ."
    (11) The product must meet all label
  Hifm* up to the expiration time indl-
  ^ted 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
  tfatt  such ingredients) may pose a
  hazard to man or the environment.
   (fa)  Warnings  and precautionary
 statement*.  Required  warnings and
 precautionary statements  concerning
                                                                   § 156.10

                                       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 sice, and prominence are given
                                       below.
                                         (1) Required front panel statement*.
                                       With the  exception of  the  child
                                       hazard warning statement, the text re-
                                       quired on the front panel of the label
                                       is determined by the Toxidty 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:
 Hart Morion
                    1
                                       TntoHycsttgorfM
                                                                    IV
            Up to wtd metudng SO
              mo/kp,
            Upto«ndMm«ng ^
  rmttLOii
            Up to and induing 200
                FromSOtnil

                From a. tnt 2 mg/M»r_

                From 200 ttiru 2000 __
From 000 ttmt SOOO mo/
 kg.
From 2. «vu 20 ng/Mv-

From 2,000 thm 20,000 „
                                                                       mg/
                 V jd^M
                 f ovyv*
                            Conotli
                              •vMnBIO MHPWl 7
                                             kiN§Hun iw*w
Skin •nteti..
Coma**.
                            SCVOT Mtefen it 72
                              Hem.
                                              hnn.
                                                  MtttfOA d 72
QrwMrfMntompyiHw.

QrMMrtwi 204)00.

ND viiiRiiuix
                                                MU or MgM WWton «
                                                  72 hours.
  (i) Human hazard signal word—(A)
 Toxicity Category L All pesticide prod-
 ucts meeting  the criteria of Toxicity
 Category X shall bear  on the  front
 panel the signal word "Danger." In ad-
 dition  if the product was assigned to
 Toxicity Category I on the basis of its
 oral, inhalation or dermal toxlclty (as
 distinct from akin and eye  local ef-
 fects) the word "Poison" shall appear
 in red on a background of  distinctly
 contrasting  color and the skull and
 crossbones shall appear in immediate
 proximity to the word "poison."
  (B) Toxicitv Category II. All pesti-
 dde products meeting the criteria of
 Toxicity Category II shall bear on the
 front panel the signal  word "Warn-
 ing."
  (C) Toxicitv Category  III. All pesti-
 cide products  meeting the criteria of
Toxicity Category m shall  bear on
the front panel the signal word "Cau-
tion."
                                        (D) Toxicitv Category IV. All pesti-
                                      cide products meeting the criteria of
                                      Toxicity Category IV shall bear on the
                                      front panel the signal word "Caution."
                                        (E) U»e of signal words. Use of any
                                      signal word(s) associated with a higher
                                      Toxicity  Category is not permitted
                                      except when  the Agency determines
                                      that such labeling is necessary to pre-
                                      vent unreasonable adverse effects on
                                      man or the environment. In no case
                                      shall more than one  human  hazard
                                      signal word appear on the front panel
                                      of a label.
                                        (11) Child haeard warning. Every pes-
                                      ticide product label shall bear on the
                                      front panel the statement "keep out of
                                      reach  of  children."  Only  in cases
                                      where the likelihood of contact with
                                      children  during distribution, market-
                                      ing, storage or use is demonstrated by
                                      the applicant to be extremely remote,
                                      or if the nature of the pesticide is such

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  §U6.1§

  that it is approved for use on Infanta
  or amall children, may the Administra-
  tor waive this requirement.
   (Ill)  Statement  of practice!  treat-
  mate—(A)  Toxicity  Category  /.A
  statement of practical treatment (first
 aid or other) shall appear on the front
 panel of the label of all pesticides fall-
 ing into Toxldty  Category I on  the
 frarit of oral, inhalation or dermal tox-
 teity.   The   Agency  may,, however,
 permit reasonable  variations In  the
 placement of the statement of practi-
 cal treatment Is some reference such
 as "See statement of  practical  treat-
 ment on back panel" appears on  the
 front panel near the  word "Poison"
 and the skull and crossbones.
  (B) Other  toxidtv categories. The
 statement of practical treatment is not
 required on the front panel except as
 described In paragraph (hXIXiiiXA) of
 tills section. The applicant may. how-
 ever, include such a front panel state-
 ment at his option.  Statements  of
 practical  treatment are,  however, re-
 quired  elsewhere  on  the label  in
 accord  with paragraph (hX2> of this
 section  if they do  not appear on  the
 front paneL
  (lv> Placement and prominence.  All
 the require front panel warning  state-
 ments shall be grouped  together on
 the label, and shall appear with suffi-
 cient  prominence  relative  to  other
 front panel text and graphic material
 to make  them unlikely  to be  over-
 looked under customary conditions of
purchase and use. The following table
shows the minimm^ type size require-
         40 em Ch. I (7.1-89

menu  for the  front  panel warniQ.
statements on various sizes of labels:
    of Ivbol wort pofw in
Bond i
                            10
                            «
                            14
                            It
 I
 I
10
  (2) Other required warning* and pr*.
cautionary statements.  The  warnings
and precautionary  statements as re-
quired below atiall appear together on
the label under the general heading
"Precautionary   Statements"   and
under  appreciate  subheadings  of
"Hazard to Humans and Domestic Ani-
mals,*'  "Environmental Hazard" npui
"Physical or Chemical Hazard."
  (i) Hazard to human* and  domettic
animate. (A) Wbere a hazard exists to
humans or domestic animals, precau-
tionary statements  are  required  Indi-
cating  the  particular  hazard,  the
routeis) of exposure and the precau-
tions to be  taken to avoid  accident,
injury or damage. The  precautionary
paragraph shall be Immediately pre-
ceded by the appropriate hazard signal
word.
  (B) The folloiring table depicts  typi-
cal precautionary statements.  These
statements  mtut  be modified  or ex-
panded to reflect specific hazards.
  To**
                                                    •Mn«nd«y*lMoJ
                    •t OMvloviNid [inhilod or ibtofbod
          VvouQh sttnj. Do not bfoofho vopor Cdutt or vpfoy
           (FfOflt
                               (v
            Oo not 901 to tiyvt, on thta, or on
                     ^tm ^^L^^ ^^1^.1^ ——-*
                     Or svDO OTMIO ffjnO
                   •^••OHAd «^
                   nvmnii or
                   If M*MSbM*Mril rMBBMia** A*
                   • VlWowVwlJ IWW^PM fjr
          thfouQh tfw cWnj. Oo not braMths) mpovs (duM of
          •pray nUtU. Pe not got m •»•>. on 
        i ay* [and trtdnl Mutton. Do not got to ayat.
     ^_- •Ai^K ^» ^tfh ^UMlft^Mk U*«^^d It ^H^hSbM^^tft ft*A*k_
     sjn ZWH sji ijn Bjajimsjj nswfnsui «• zfSfvsHoojpojii. B>*T|^
                     tmautad.}
          Oat
                        or Mn «*h ptanry ot
         [NO pfs)00MOtsVy
    tNoi

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                Protection Agency
    in snvir^nmental hazard*. Where a
    *     exists to non target organisms
           humans and  domestic ani-
     i.  recautionary statements are re-
  »     stating  the  nature  of the
         and  the appropriate  precau-
        to  avoid  potential  accident,
        or  damage. Examples of the
         statements and  the  drcum-
        under which they are required
        f a pesticide intended for out-
      use contains an active ingredient
      g. mft«itMHMi acute oral LDw of
  too or less, the statement "This Pesti-
  dde is Toxic to Wildlife" is required.
   •**«»*»*i«, 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.
       ^Ideguocy and  clar-
ity of direction*. Directions  for use
must be stated in terms which can be
easily read and understood by the av-
erage person likely to use or to super-
vise the use of the pesticide. When fol-
lowed, directions must be adequate to
protect  the public  from  fraud and
from personal injury and to  prevent
unreasonable  adverse effects  on the
environment.
      (ii) Placement of directions for me.
    Directions may appear on any portion
    of the label provided that they are
    conspicuous enough to be easily read
    by the user of the pesticide product.
    Directions for use may appear  on
    printed or graphic matter which  ac-
    companies the pesticide provided that:
      (A) If required by the Agency, such
    printed or graphic matter is securely
    attached to each package of the pesti-
    cide, or  placed  within  the  outside
    wrapper or bag:

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 §156.10

   (B) The label bears a reference to
 the directions for use in accompanying
 leaflets 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.
   (Hi) Exception* to  requirement  for
 direction for tite—  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  advene  ef-
fects  on man or the  environment; and
    The product is also a drug and
regulated under the provisions of the
Federal Food, Drug 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 f ormulaton in preparing
pesticides for sale to the public, pro-
vided that:
  (1)  There   is  information readily
available to  the formulatar* on  the
composition, toxidty, methods of use,
applicable restrictions or  limitations,
         40 Cm Ch. I (7-1-69 Edition)

 and effectivenais of the product  for
 pesticide purposes;
  (*> The label clearly states that the
 product Is  intended  for use only in
 manufacturing, formulating,
 or repacking for use as a pesticide and
 specifies the tyi»e(s) of pesticide prod-
 ucts Involved;
   (J) The product as finally manufac-
 tured, formulated, mixed, or repack-
 aged is registerel; and
   (.4) The Adixiinistrator determines
 that  such directions are not necessary
 to prevent unreasonable advene ef-
 fects on man or the environment.
   (2) Content* (if Direction* for  Ute.
 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."
   (U) immediately  below the  state-
 ment of use cliisslfication, the state-
 ment "It is a violation of Federal law
 to use this product in a manner incon-
 sistent with its libeling."
   (Ill) The site(s> of application, as for
 example the crops. Miimaia, areas, or
 objects to be treated.
   (iv)  The  tariiet  pestts)  associated
 with each site.
  (v)  The dosage rate associated with
 each site and pent.
  (vi) The metbiod of application, in-
 cluding instructions for dilution, if re-
 quired, and typiKs) of application ap-
 paratus or equipment required.
  (vii) The frequency and timing of ap-
 plications necessary to obtain effective
 results without causing unreasonable
 adverse effects on the environment.
  
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                 Protection Agoncy
     .  | AHJ limitations or restrictions on
    ... required to prevent unreasonable
   SeSe effects, such as:
     (A) Required Intervals between ap-
   plication and harvest of food or feed
   fifOPS.
      [Reserved]
    (E> For restricted use pesticides, a
   jtatement that the pesticide may be
   applied under the direct supervision of
   .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
   (F)  Other pertinent  information
  which the Administrator determines
  to be necessary for the protection of
  man and the environment.
   (j) Statement of Use Classification,
  By October 22. 1976, all pesticide prod-
  ucts must bear on their labels a state-
  ment of use classification as described
  in paragraphs (J) (1) and (2) of this
  section. Any pesticide product for
  which some uses are classified for gen*
  era! use and  others for restricted use
  shall  be separately labeled according
  to the labeling standards set forth in
  this subsection, and shall be marketed
 as separate  products with different
 registration numbers, one bearing di-
 rections only for general use(s)  and
 the other bearing  directions for re-
 stricted use(s) except that, if a product
 has both restricted use(s) and general
 useCs), both of these uses may appear
 on a product labeled for restricted use.
 Such products shall be subject to the
 provisions  of  paragraph (JX2) of this
 section.
   (1) General  Use Classification. Pesti-
 cide products bearing directions  for
 use(s> classified  general shall  be la-
 beled with the exact  words "General
 Classification" Immediately below the
 heading "Directions for Use." And ref-
 erence  to  the general  classification
 that suggests  or implies that the gen-
eral utility of the pesticide extends
beyond those  purposes and  uses con-
tained in the Directions for Use wd be
                              § 156.10

  considered a false or misleading state-
  ment under the statutory definitions
  of mlsbranding.
    (2)  Restricted  Use  Classification,
  Pesticide  products  bearing direction
  for  use(s) classified restricted shall
  bear statements of restricted use clas-
  sification  on the front panel  as  de-
  scribed below.
   (1) Front panel statement of restrict-
  ed use classification. (A) At the top of
  the front panel of the label, set in type
  of the same «itnfa«iit« sizes as required
  for human hazard  signal words (see
  table in paragraph (hXIXiv) of this
 section), and appearing with sufficient
 prominence relative to  other text and
 graphic material on the front panel to
 make  it unlikely  to  be  overlooked
 under customary conditions  of pur-
 chase  and use.  the statement  "Re-
 stricted Use Pesticide" shall appear.
   
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   APPENDIX F






Generic Data Call-in
       39

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No generic data are being called-in for:



     Oxybisphenoxarsine (OBPA)
                40

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      APPENDIXG






Product Specific Data CaD-In
          41

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                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                               WASHINGTON, D.C. 20460
                              DATA CALL-IN NOTICE
                                                                        OFFICE OF
                                                                    PREVENTION. PESTICIDES
                                                                    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 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 IH-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 3-31-96).

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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 Thh; Notice
       Section V  - Registrants' Obligation To Report Possible Unrsasonable
                   Adverse Effects
       Section VI - Inquiries And Responses To This Notice

    The Attachments to this Notice are:

       A - Data Call-In Chemical Status Sheet
       B - Product-Specific 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 Rerepistration
       E - EPA Acceptance Criteria
       F - List of Registrants Receiving This Notice
       G - Cost Share and Data Compensation Forms, and Product
           Specific Data Report Form

SECTION I.  WHY YOU ARE RECEIVING THIS  NOTICE

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

SECTION II.  DATA REQUIRED BY THIS NOTICE

H-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.

H-B.  SCHEDULE FOR SUBMISSION OF DATA

    You are required to submit the data or otherwise satisfy the data requirements specified in


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Attachment C, Requirements Status and Registrant's Response Form, within the timeframes
provided.

n-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 3rc)(2)(B^ NOTICES
     ISSUED  BY THE AGENCY

     Unless otherwise noted herein, this Data Call-In does not in any way supersede or change
the requirements of any previous Data Call-Ms1), or any other agreements entered into with the
Agency pertaining to such prior Notice.  Registrants must comply with the requirements of all
Notices to avoid issuance of a Notice of Intent to Suspend their affected products.

SECTION III.  COMPLIANCE WITH REQUIREMENTS  OF THIS NOTICE

ffl-A. SCHEDULE FOR  RESPONDING TO THE AGENCY

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

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 III-B.  OPTIONS FOR RESPONDING TO THE AGENCY

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

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

       There are two forms that accompany this Notice of which, depending upon your
 response, one or both must be used in your response to the Agency.  These  forms are the Data-
 Call-in Response Form, and the Requirements Status and Registrant's Response Form.
 Attachment B and Attachment C.  The Data Call-In Response Form must be  submitted as part of
 every response to this Notice.  In addition,  one  copy of the Requirements Status and
 Registrant's Response Form must be submitted for each product listed on the Data Call-In
 Response Form unless the voluntary cancellation option is selected or unless the product is
 identical to another (refer to the instructions for completing the Data Call-In Response Form in
 Attachment 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 chose to voluntarily cancel your product, further sale and distribution of your
 product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.

       2. Satisfying the Product Specific Data Requirements of this Notice  There are various
options available to satisfy the product specific data requirements of <:his Notice.  These options
 are discussed in Section III-C of this Notice and comprise options 1 through  6 on the
 Requirements Status and Registrant's Response Form and item numbers 7a and 7b on the Data
 Call-In Response Form. Deletion of a use(s) and the low volume/minor use option are not valid
 options for fulfilling product specific data requirements.

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       3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section III-D of this Notice and are covered by option 7 on the Requirements
Status and Registrant's Response Form. If you choose one of these options, you must submit
both forms as well as any other information/data pertaining to the option chosen to address the
data requirement.

ni-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE

       If you acknowledge on the Data Call-In Response Form that you agree to satisfy the
product specific data requirements (i.e.  you select item number 7a or 7b), then you must select
one of the six options on the Requirements Status and Registrant's Response Form related to
data production for each data requirement.  Your option selection should be entered under item
number 9, "Registrant Response." The six options related to data production are the first six
options discussed under item 9 in the instructions for completing the Requirements Status and
Registrant's Response Form. These six options are listed immediately below with 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 timeframe (Developing Data)
       (2)    I have entered into an agreement with one or more registrants to develop data
             jointly (Cost Sharing)
       (3)    I have made offers to cost-share (Offers to Cost Share)
       (4)    I am submitting an existing study that has not been submitted previously to the
             Agency by anyone (Submitting an Existing  Study)
       (5)    I am submitting or citing data to upgrade a study classified by EPA as partially
             acceptable and upgradeable (Upgrading a Study)
       (6)    I am citing an existing study that EPA has classified as acceptable or an existing
             study that has been submitted but not reviewed by the Agency (Citing an Existing
             Study)

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

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

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 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 shidl an extension request be
 considered if it is submitted at or after the lapse of the subject deadline.

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

       Option 3. Offer to Share in  the Cost  of Data Development — This option only applies  to
 acute toxicity and certain efficacy data as described in option 2 above.  If you have made an
 offer to pay in an attempt to enter into an agreement or amend an existing agreement to meet
 the requirements of this Notice and have been unsuccessful,  you may request EPA (by selecting
 this option) to exercise its discretion not to suspend your registration! s),  although you do not
 comply with  the data submission requirements of this Notice.  EPA  has determined that as a
 general policy, absent other relevant considerations, it will not suspend the registration of a
product of a registrant who has in good faith sought and continues to seek to enter into a joint
data development/cost sharing program, but  the other registrant(s) developing the data has
refused to accept your offer. To  qualify for this option, you must submit documentation  to the
 Agency proving that you have made an offer to another registrant (who has an obligation to
 submit data) to share in the burden  of developing that data.  You must also submit to the
 Agency a completed EPA Form 8570-32, Certification of Offer to Cost Share in the
Development of Data, Attachment G. In addition, you must demons xate 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

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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 Form and a
Requirements Status and Registrant's Response Form committing to develop and submit the data
required by this Notice.

       In order for you to avoid suspension under this option, you may not withdraw your offer
to share in the burdens of developing the data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this Notice.  If the other registrant
fails to develop the data or for some other reason is subject to suspension, your registration as
well as that of the other registrant will normally be subject 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,

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

       You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you 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.

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

      a. You must certify 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 data*  means any laboratory worksheets, records, memoranda,  notes, or exact
      copies thereof, that are the result of original observations and activities of a study and
      are necessary  for the reconstruction and evaluation of the report of that study.  In the
      event that exact transcripts of raw data have been prepared (e.g., tapes which have been
      transcribed verbatim, dated, and verified accurate by signature),  the exact copy or exact
       transcript may be substituted for the original source as raw data.  'Raw data' may
       include photographs, microfilm or microfiche copies, computer  printouts, magnetic
       media, including dictated observations,  and recorded data from automated instruments."
      The term "specimens", according to 40 CFR 160.3(k), means "any material derived
      from a test system for examination  or analysis."

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                                                                                        8
       b. Health and safety studies completed after May 1984 must iilso 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 die 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 Registration Phase 3
       Technical Guidance and that  the study has been conducted according to the Pesticide
       Assessment Guidelines (PAG) or meets the purpose of the PAG (both available from
       NTIS).  A study not conducted according to the PAG  may be submitted to the Agency
       for consideration if the registrant believes that the study clearly meets the purpose of the
       PAG. The registrant is referred to 40 CFR 158.70 which states the Agency's policy
       regarding acceptable protocols. If you wish to submit the study, you must, in addition to
       certifying that the purposes of the PAG are met by the study, clearly articulate the
       rationale why you believe the study meets the purpose of the PAG, including copies of
       any supporting information or data.  It has been the Agency's experience  that studies
       completed prior to January 1970 rarely satisfied the purpose of the PAG and that
       necessary raw data are usually not available for such studies.

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

       If you know of a study pertaining to any requirement in this Notice which does not meet
the criteria outlined above but does contain factual information regarding  unreasonable adverse
effects, you must notify the Agency of such a study.  If such  study : s 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.

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

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

       The criteria for submitting an existing study, as specified in Option 4 above, apply to all
data submissions intended to upgrade studies.  Additionally your submission 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 6f Citing Existing Studies - If you choose to cite a study that has been
previously submitted to EPA, that study  must have been previously classified by  EPA as
acceptable or it must be a study which has not yet been reviewed by the Agency.  Acceptable
toxicology studies generally will have been classified as "core-guideline" or "core minimum."
For all other disciplines the classification would be  "acceptable."  With respect to any studies
for which you wish to select this option you must provide the MRID number of the study you
are citing and, if the study has been reviewed by  the Agency, you must provide the Agency's
classification of the study.

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

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

III-D REQUESTS FOR DATA WAIVERS

             If you request a waiver for product specific data because you believe it is
inappropriate,  you  must attach a complete justification for the request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies.  (Note: any
supplemental data must be submitted in the format required by PR Notice 86-5).  This will be
the only opportunity to state  the reasons  or provide  information in support of your request.  If
the Agency approves your waiver request, you will  not be required to supply the data pursuant
to section 3(c)(2)(B) of FIFRA.  If the Agency denies your waiver request, you must choose an
option for meeting the data requirements of this Notice within 30 days of the receipt of the
Agency's decision.  You must indicate and submit the option  chosen on the Requirements Status
and Registrant's Response Form.  Product specific data requirements for product chemistry,
acute toxicity and efficacy (where appropriate) are required for all products and the Agency
would grant a waiver only under extraordinary circumstances. You should also be aware that
submitting a waiver request will not automatically extend the  due date for the study  in question.

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                                                                                       10
Waiver requests submitted without adequate supporting rationale will be denied and the original
due date will remain in force.

SECTION IV.  CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE

IV-A NOTICE OF INTENT TO SUSPEND

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

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

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

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

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

5.  Failure to take a required action or submit adequate information pertaining to any option
   chosen to address the data requirements (e.g., any required action or information pertaining
   to submission or citation of existing studies or offers, arrangemerts, 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 o * submitted studies, as
   required by  Section III-C of this Notice.

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

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

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

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                                                                                      11

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

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

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

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

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

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

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

IV-C EXISTING STOCKS OF SUSPENDED OR 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

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                                                                                       12

 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 besn 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 ths.t 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 sh;dl 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 Chemical Status
Sheet.

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

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                                                                                     13
       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,



                                             £&i, UBM<4»*<~/
                                           Daniel M. Barolo, Director
                                           Special Review and
                                              Reregistration Division
                 Attachments

      A  - Data Call-In Chemical Status Sheet
      B  - Product-Specific Data Call-In Response Form
      C  - Requirements Status and Registrant's Response Form
          for the Product Specific Data Call-in
      D  - EPA Grouping of End-Use Products for Meeting Acute
          Toxicology Data Requirements for Reregistration
      E - EPA Acceptance Criteria
      F - List of Registrants Receiving This Notice
      G  - Cost Share and Data Compensation Forms, and Product
          Specific Data Report Form

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          ATTACHMENT A






Product Specific DCI Chemical Status Sheet
                42

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                                ATTACHMENT A

                                      OBPA

        PRODUCT SPECIFIC DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION

   You have been sent this Product Specific Data Call-In Notice because you have products
containing OBPA.
   This Product Specific Pafr Call-In Chemical Status Sheet, contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of
OBPA products. 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 Form (Attachment C), (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirements for Reregistration (Attachment D),
(5) EPA Acceptance  Criteria (Attachment E), (6) List of Registrants Receiving this Notice
(Attachment F), and  (7) the Cost Share and Data Compensation Forms (Attachment G) in
replying to this OBPA Product Specific Data Call-In. Instructions and guidance accompany each
form.
DATA REQVfflgp BY THIS NOTICE

   The additional data requirements needed to complete the product specific database for OBPA
are contained in the Requirements Status and Registrant's Response (Attachment C).  The
Agency has concluded that additional data on OBPA are needed for specific products. While
product specific data requirements were imposed in the 1981 Registration Standard, a complete
listing is provided in Attachment C.  If you, as a registrant of an OBPA product, responded to
the 1981 Registration Standard and submitted the data relating to your specific product, simply
choose response number 6 and cite the  MRID number that was assigned to  your study.
Otherwise, these data are required to be submitted to the Agency within the time-frame listed.
These data are needed to complete the reregistration of all eligible OBPA products.
                 RESPONSES TO THIS NOTICE
   Any questions in regards to this RED, should be directed to Venus Eagle, Chemical Review
Manager, Reregistration Branch,  Special Review and Reregistration Division, at (703) 308 -
8045.
                                        43

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   If you have any questions regarding the product specific data requirements and procedures
established by this Notice, please contact Cynthia Giles-Parker (703) 305 - 5540.
   All responses to this Notice for the product specific data requirements should be submitted
to:
       Cynthia Giles-Parker, Product Manager 22
       Fungicide-Herbicide Branch
       Registration Division  (H7505C)
       Office of Pesticide Programs
       U.S. Environmental Protection Agency
       401 M Street, S.W.
       Washington, D.C.  20460

       RE:   OBPA
                                         44

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                ATTACHMENT B
Product Specific Data Call-in Response Forms (Form A)
                 plus Instructions
                      45

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

 Item 1-4.     Already completed by EPA.

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

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

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

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

Items 8-11.Self-explanatory.

Note: You may provide additional information that does not fit on this form in a signed letter
      that accompanies this form.  For example, you may wish to report that your product has
      already been transferred to another 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.
                                        46

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                ATTACHMENT C

Product Specific Data Call-in Requirements Status and
Registrant's Response Forms (Form B) plus Instructions
                        47

-------
 INSTRUCTIONS   FOR   COMPLETING  THE   "REQUIREMENTS   STATUS
 REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA
AND
Item 1-3     Completed by EPA. Note the unique identifier number assigned by EPA in item
             3.   This number must  be used in the transmittal  document  for any data
             submissions in response to this Data Call-In Notice.

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

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

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

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 Registration Eligibility Documents unless EPA
             determines that a longer time period is necessary.

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

1. I will generate and submit data by the specified due date (Developing Data).  By indicating
   that I have chosen this option,  I certify that I will comply with all the requirements
   pertaining to the conditions for submittal of this study as outlined in the Data Call-In Notice.

2. I have entered into an agreement with one or more registrants to develop data jointly (Cost
   Sharing).   I am submitting a copy  of this agreement.  I understand that  this option is
   available on for acute  toxicily or certain efficacy data and only if EPA indicates in an
   attachment to this notice that my product is similar.  Enough to another product to qualify
   for this option.  I certify that another party in the agreement is committing to submit or
   provide the required data; if the required study is not submitted on time, my product my be
   subject to suspension.
                                         48

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3.  I have made offers to share in the cost to develop data (Offers to Cost Share).  I understand
    that this option is available only for acute toxicity or certain efficacy data and only if EPA
    indicates in an attachment to this Data Call-In Notice that my product is similar enough to
    another product to qualify for this option. I am submitting evidence that I have made an
    offer to another registrant (who has an obligation to submit data) to share in the cost of that
    data.   I am also submitting a  completed " Certification of offer to Cost Share in the
    Development Data" form.  I am including a copy of my offer and prooof of the other
    registrant's receipt of that offer. I am identifying the party which is committing to submit
    or provide the require data; if the required study is not submitted on time, my product may
    be subject to suspension.  I understand that other terms under Option 3 in the Data Call-In
    Notice (Section ffl-C.l.) apply as well.

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

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

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

7.  I request a waiver  for this study  because it is inappropriate for my product (Waiver
    Request).  I am attaching a complete justification  for this request,  including technical
    reasons, data and references to relevant EPA regulations, guidelines or policies. [Note: any
    supplemental data must be submitted in the format required by  P.R. Notice  86-5].   I
    understand that this  is my only opportunity to state the reasons or provide information in
    support of my request.  If the Agency approves my waiver request, I will not be require to
                                          49

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

Items 10-13.  Self-explanatory.

NOTE:       You may provide additional infonnation that does not fit on this fonn 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
                                         50

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               ATTACHMENT D
EPA's Grouping of End-Use Products for Meeting Acute
   Toxicology Data Requirements for Reregistration
                      51

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                                 ATTACHMENTD

EPA*S  DECISION NOT TO BATCH END-USE  PRODUCTS  CONTAINING  10.10*-
Oxvbisphenoxarsine (OBPA) FOR PURJ'PSIES QFMKKTTNG ACUTE TOXICFTY DATA
REOUIREMENTS FOR REREGISTRATION
    In an effort to reduce the time, resources and number of animals needed to fulfill the acute
toxicity data requirements for reregistration of end-use products containing the active ingredient
OBPA, the Agency considered batching end-use products.  This process involves grouping
similar products for purposes of acute toxicity. Factors considered in the sorting process include
each product's active and inert ingredients (identity, percent composition and biological activity),
type of formulation (e.g., emulsifiable concentrate, aerosol, wettable powder, granular, etc.),
and labeling (e.g., signal word, use classification, precautionary labeling, etc.).

    However, batching of end-use products containing OBPA was not possible after considering
the available information described above.  Table I lists all the end-use products containing
OBPA. These products were either considered not to be similar for pirposes of acute toxicity
or the Agency lacked sufficient information for decision making purpoiies. Registrants of these
products are responsible for meeting the acute toxicity data requirements for each product.

    If a registrant chooses to rely upon previously submitted acute toxicity data, he/she may do
so provided that the data base is complete and valid by today's standards (see acceptance criteria
attached), and the formulation has not been significantly altered since submission and acceptance
of the acute toxicity data. Regardless of whether new data is generated or existing data is cited,
the registrant must clearly identify the material tested by its EPA registration number.

    In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-In Notice and its attachments appended to the RED. The DCI
Notice contains two response forms which are to be completed and submitted to the Agency
within 90 days of receipt.  The first form, "Data Call-In Response,* asls whether the registrant
will meet the data requirements for each product. The second form, "Requirements Status and
Registrant's Response,* lists the product specific data required for each product, including the
standard  six acute toxicity  tests.  A registrant must select one of the  following options:
Developing Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing
Study (Option 5) or Citing an Existing Study (Option 6). Since the end-use products containing
OBPA could not be batched, registrants cannot choose from the remaining options:  Cost sharing
(Option 2) or Offers to Cost Share (Option 3).
                                         52

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Table I. End-Use Products Not Batched Containing OBPA
EPA REG. NO.
34688-37
% of OBPA
1.0
Formulation Type
liquid
34688-38 1 2.0 liquid
34688-46 5.0
liquid
34688-49 ' 5.0 > liquid
2829-82 • 1.0 ; liquid
2829-96
2.0
liquid
2829-102 ! 1.0 j liquid
2829-104
2829-105
1.0
2.0
liquid
liquid
2829-109 < 2.0 j liquid
2829-110
2.0 | liquid
2829-115 J 5.0 j pellets
2829-120 j 96.0 ; powder
2829-125
5.0 j liquid
2829-90 ! 2.0 ! liquid
                                        53

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  ATTACHMENT E
EPA Acceptance Criteria
        54

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                          SUBDIVISION D
Guideline

Series 61
Series 62
Series 63
        Study Title

Product Identity and Composition
Analysis and Certification of Product Ingredients
Physical and Chemical Characteristics

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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.l%
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)
      	 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

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

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               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 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 «tep 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
                                                                      _l

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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.

 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.

 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 fie 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.]

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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.
-
 1. Description of color.
 2. Description of physical state.
 3. Description of odor.
 4. Indication of melting point (in Ce).
 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 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.

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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

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   81-2 Acute Dermal toxicity  in the Rat, Rabbit or Guinea  Pig
                       ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?

 1.	Identify material  tested (technical, end-use product,  etc)
 2.
 3.*
 4.
 5."
 6.*.
 7.
 8.

 9.
10/

11.
12.'
13.'
14."
At least 5 animals/sex/group
Rats 200-300 gin, 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 mg/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.

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   81-2 Acute Dermal Toxicity in the Rat, Rabbi*: 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 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.
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?

  !•	 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, O.l 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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                                                                          1
               81-5 Primary Dermal Irritation Study
                       ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
 1.
 2."

 3.
 4.'
 5."
 6.'

 7.
 8."

 9.

10.



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

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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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   _
  3.*
 8.*
               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.
        Technical form of the active ingredient tested.
        Positive control utilized.
        Species utilized, domestic laying hen 8-14 months of age.
        Dosing oral by gavage or capsule (dermal or inhalation
        may be used).
        An acute oral LD is determined.
        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



List of Registrants sent this DCI
            55

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           ATTACHMENT G

Product Specific Data Call-In Cost Share and
        Data Compensation Forms
                 56

-------

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    r/EPA
United States Environmental Protection Agency
            Washington,  DC 20460
   CERTIFICATION  WITH RESPECT TO
 DATA  COMPENSATION  REQUIREMENTS
OKI Nft, 2070-0107
         2070-0087
Appreval  Espitee  9-U-M
 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 SU S.W., Washington, DC 20460; and to the Office
 of Management and Budget. Paperwork Reduction Project (20704)106). Washington, DC 20503.

 Please fill In blanks  below.
Company Name
Product HUB*
Company
EPA Re?
Number
f. Mo.
(Certify that

1. 'for each study died in support of registration or reregistration under the Federal Insecticide. Fungicide and
   Rodentictie Act (FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained me
   written permission of the original data submitter to cite that study.

   That for each study cfted in support of registration or reregistration 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 tited 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, I any. The companies I have notified are: (check one)
   U  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 died in support of
   registration or reregistration under FIFRA.
Signature
Oat*
Km* a«* T1U* (PiMM Type «r MM)
     •RAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the
         t or reregistration of my products, to the extent required by FIFRA sections 3(C)(1)(D) and 3(c)(2)(D).
Signature ^ .
*
»•«•.
Hun and Title (Please Type or Print)

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    &EPA
United Status Environmental Protaetlon Agency
            Washington, DC 20460
   CERTIFIICATION OF  OFFER TO COST
SHARE  IN THE  DEVELOPMENT  OF DATA
OMB fcte.
        1070-9097
 Public reporting burden tor this coBectton of Information is estimated to average 1!5 minutes per response, incfaxfing
 time for reviewing instructtons. searching exfattlng 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 bur Jen, 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 (20704106), Washington, DC 20503.    .

 Please nil in  blanks below.
 I Certify that:

 My company is wiling 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 sliare in the cost of developing
 My firm has offered in writing to enter into such an agreement. That offer vras Irrevocable and included an
 offer to be bound by arbitration decision under section 3(c)(2)(B){iii) of Fl FRA 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):
                                                                          Data of Offer
Certification:
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.
 Signature of Company'* Authorized Repraeentatlv*
                                                Oat*
 Nam* and Tide (Pleas* Type or Print)
 BPA rum sfTfraa (*-»D

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