United States
         Environmental Protection
         Agency
Office of Prevention, Pesticides  EPA 738-R-93-023
And Toxic Substances     December 1993
(7508W)        	
&EPA Registration
         Eligibility Decision (
         Lithium Hypochlorite
                                     Printed on Recycled Paper

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                United States
                Environmental Protection
                Agency
                      Prevention, Pesticides
                      And Toxic Substances
                      (75O8W)
EPA-738-F-93-018
December 1993
                 R.E.D.    FACTS
                 Lithium  Hypochlorite

     Pesticide       All pesticides sold or distributed in the United States must be registered
Reregistration  by EPA, based on scientific studies showing that they can be used without
                posing unreasonable risks to people or the environment. Because of advances
                in scientific knowledge, the law requires that pesticides which were first
                registered years ago  be reregistered to ensure that they meet today's more
                stringent standards.
                     In evaluating pesticides for reregistration, EPA obtains and reviews a
                complete set of studies from pesticide producers, describing the human health
                and environmental effects of each pesticide.   The Agency imposes any
                regulatory  controls that are needed to effectively  manage each pesticide's
                risks.  EPA  then reregisters pesticides that can be used  without posing
                unreasonable risks to human health or the environment.
                     When a pesticide is eligible for reregistration, EPA announces this and
                explains why in a Reregistration Eligibility Decision (RED) document. This
                feet sheet  summarizes  the information in the RED  document for lithium
                hypochlorite.
   Use Profile
     Lithium hypochlorite is an algicide, disinfectant, fungicide and food
contact  surface sanitizer.  Its primary pesticidal use is to control algae,
bacteria and mildew in  swimming pool water systems, hot tubs and spas;
approximately 2,000,000 pounds of the active ingredient were used for this
purpose in 1989. It also is used to sanitize food and cheese processing plant
equipment, dairies, and eating establishment equipment and utensils. Lithium
hypochlorite is formulated as a .ready-to-use liquid and a soluble solid
concentrate.  It is applied to swimming pool water using a skimmer basket,
and to equipment or utensils by hand or through use of a dish washing
machine.  Lithium is an element that occurs naturally at low levels in food
and drinking water.
   Regulatory      Lithium hypochlorite was first registered in the U.S. in 1963, and has
       History  been used chiefly as a sanitizer in swimming pools.  The Food and Drug
                Administration (FDA)  lists the chemical as a sanitizer on food contact
                surfaces (please see 21 CFR 178.1010).  EPA's Office of Water regulates

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                   discharges  into water  systems  through  the  National  Pollutant  Discharge
                   Elimination System (NPDES) permit program.
                        EPA issued a Data Call-in (DCI) Notice in September 1992 requiring
                   product chemistry and ecological effects data for lithium  hypochlorite.
                   Currently,  40  pesticide products are registered which contain this active
                   ingredient,  and no new uses are pending.
Human Health
  Assessment
Toxicity
     In laboratory animal studies, technical grade lithium hypochlorite has
been  shown  to  be highly corrosive, placing it in Toxicity Category I
(indicating the highest  degree  of  acute  toxicity) for both eye and, skin
irritation.   It is moderately acutely toxic  in acute oral and dermal toxicity
studies, placing it in Toxicity Category m for oral toxicity and Toxicity
Category IV for dermal toxicity.  No mutagenic effects were seen in a battery
of studies.
     Studies on human use of  lithium-containing drugs, including chronic
use, have not shown any reason  for concern over continued human exposure
to lithium  following its use as a pesticide.  The medicinal exposures are at a
much higher level than that which results from the compound's pesticide uses.
Studies of people who swam in pools or bathed in spas treated with lithium
hypochlorite/ chloride  show no significant absorption of lithium  through
human skin.  Accidentally swallowing pool or spa water should not increase
exposure to lithium beyond that which occurs ordinarily through ingesting
food and drink.
                   Dietary Exposure
                        No dietary  exposure is expected from the pesticide uses of lithium
                   hypochlorite since no food or feed uses are registered.

                   Occupational and Residential Exposure
                        During  application of   pesticide  products  that  contain  lithium
                   hypochlorite, workers may experience dermal and inhalation exposure (for
                   example, while hand-washing utensils).   However, this exposure does  not
                   pose significant concerns except to the eye and skin of workers who handle
                   concentrated or solid formulations.  Appropriate label precautions requiring
                   eye and skin protection will continue to mitigate these risks.  Post-application
                   exposure is considered minimal, as the exposure is to a diluted material.
                   Human Risk Assessment
                        Since lithium hypochlorite has no food or feed uses, dietary risk is not
                   expected.  The chemical causes severe irritation and is corrosive to eyes and
                   skin, but exhibits only moderate acute oral and dermal toxicity.  To protect

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                   applicators' eyes and skin, appropriate label precautions  regarding use of
                   protective clothing (including safety glasses or goggles and chemical-resistant
                   gloves)  continue  to  be required.   No human health risk of concern is
                   expected.
Environmental
  Assessment
Environmental Fate
     Lithium hypochlorite, like all the hypochlorite salts, forms hypochlorous
acid when dissolved in water; it is hypochlorous acid that exhibits actual
pesticidal activity.  Its  mode of action is its oxidizing (sanitizing) effect on
organic and inorganic  contaminants.   This disinfection by  chlorination is
achieved by maintaining a "free residual chlorine" concentration.
     The major environmental/ecological  concern would  be if discharged
effluent  treated  with hypochlorites   showed  free  residual  chlorine
concentrations that exceeded those stipulated under NPDES permits. Since
there are many forms  of cations  used to form hypochlorite salts (e.g.,
calcium, sodium, and lithium), it would be difficult to trace the source of
contamination in cases where free residual chlorine  concentrations are too
high.
     EPA conducted a Tier Ic Estimated Environmental Concentration (EEC)
model  to  assess the residue levels of lithium hypochlorite in the receiving
stream from several use sites.   This model  provides a reasonable worst case
estimate  of the maximum  concentrations that may occur  immediately
downstream from an industrial point source discharge site under typical and
high exposure scenarios. Results are discussed below.
                   Ecological Effects
                        Lithium hypochlorite is considered slightly toxic to nontoxic to avian
                   species, and it is not expected to be found in the environment at levels of
                   concern. Therefore, risk to avian species is expected to be minimal. Toxicity
                   to fish and aquatic invertebrates, however, is considered very high.

                   Ecological Effects Risk Assessment
                        The results of the Tier Ic EEC stream flow screening model described
                   above show  that  levels  of concern would be exceeded during both high
                   exposure and typical exposure  scenarios for fish and aquatic invertebrates.
                   Therefore, aquatic organisms may be at risk from typical use/exposure as well
                   as from high use/exposure.
                        The discharge of water containing residues of lithium hypochlorite is
                   regulated by the NPDES permit program  administered by EPA.  Exposure
                   and risk to freshwater aquatic organisms should be considered in determining
                   acceptable levels for such permits so that toxic levels are avoided.

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                        Endangered Species
                             Both the typical and the high exposure scenarios described above exceed
                        the levels of concern for endangered aquatic organisms.  Effluent containing
                        lithium hypochlorite should not be discharged into streams or waterways that
                        endangered aquatic organisms are known to frequent.  EPA is working with
                        the U.S. Fish and Wildlife Service to develop a program to avoid jeopardizing
                        the continued existence of identified species by the use of pesticides.  When
                        this program  goes into effect, endangered species labeling will be required.

   Additional Data       The generic data base for lithium hypochlorite is substantially complete.
           Required  The Agency is requiring product-specific data, including product chemistry
                        and acute toxicity studies, as well as revised  Confidential Statements  of
                        Formula (CSF) and revised labeling for reregistration.
  Product Labeling
Changes Required
      All end-use products containing lithium hypochlorite must comply with
 EPA's current pesticide product labeling requirements. In addition:

     Effluent Discharge Statement - All end-use (and manufacturing use)
 products that may be contained in an effluent discharged to the waters of the
 U.S.  or municipal sewer systems must bear the following statement:
      "This product is toxic to fish.  Do not discharge effluent containing this
      product into lakes, streams, ponds, estuaries, oceans or other  waters
      unless in  accordance with the requirements of a National Pollutant
      Discharge Elimination  System (NPDES)  permit and the  permitting
      authority has been notified in writing prior to  discharge.  Do not
      discharge  effluent containing  this product to sewer systems without
      previously notifying the local sewage treatment plant authority.  For
      guidance contact your State Water Board or Regional Office  of EPA."
         Regulatory
         Conclusion
      The currently registered uses of lithium hypochlorite could pose risks
 to aquatic organisms under certain conditions as industrial effluent containing
 the parent chemical is released into receiving waters. However, the uses will
 not cause unreasonable adverse effects to humans or the environment, and are
 eligible for reregistration.
      Products containing  lithium hypochlorite as the sole active ingredient
 will be reregistered once the required product-specific data, CSF and revised
 labeling are received and accepted by EPA.  Products also containing other
 active ingredients will be reregistered only after the other active ingredients
 also are determined to be eligible for reregistration.
           For More
        Information
      EPA is requesting public comments on the Reregistration Eligibility
 Decision (RED) document for lithium hypochlorite during a 60-day time
period, as announced in a Notice of Availability published in the Federal

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Register.  To obtain a copy of the RED document  or to submit written
comments, please contact the Pesticide Docket, Public Response and Program
Resources Branch, Field Operations Division (7506C), Office of Pesticide
Programs (OPP), US EPA, Washington, DC 20460, telephone 703-305-5805.
     Following the comment period, the lithium hypochlorite RED document
will be available from the National Technical Information Service (NTIS),
5285 Port Royal Road, Springfield, VA 22161, telephone 703-487-4650.
     For more information about EPA's pesticide reregistration program, the
lithium hypochlorite RED, or reregistration of individual products containing
lithium hypochlorite, contact the Special Review and Reregistration Division
(7508W), OPP, US EPA, Washington, DC 20460, telephone 703-308-8000.
     For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact the
National Pesticides Telecommunications Network (NPTN).  Call toll-free 1-
800-858-7378, between 8:00 am and 6:00 pm Central Time, Monday through
Friday.

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REREGISTRATION ELIGIBILITY DECISION

             Lithium Hypochlorite

                    LISTC

                  CASE 3084
            ENVIRONMENTAL PROTECTION AGENCY
              OFFICE OF PESTICIDE PROGRAMS
         SPECIAL REVIEW AND REREGISTRATION DIVISION

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                         TABLE OF CONTENTS
LITHIUM HYPOCHLORITE REREGISTRATION ELIGIBILITY DECISION
      TEAM	    i

GLOSSARY OF TERMS AND ABBREVIATIONS	iii

EXECUTIVE SUMMARY	   v

I.     INTRODUCTION	   1

H.    CASE OVERVIEW	   2
      A.   Chemical Overview	   2
      B.   Use Profile	   2
      C.   Regulatory History	   3


IH.   SCIENCE ASSESSMENT	   4
      A.   Physical Chemistry Assessment  	   4
      B.   Human Health Assessment	   5
           1.    Toxicology Assessment 	   5
                 a.    Acute Toxicity	   5
                 b.    Reproductive and Developmental Toxicity  	   6
                 c.    Mutagenicity	   7
                 d.    Metabolism	   7
                 e.    Other Toxic Endpoints	   7
           2.    Exposure Assessment  	   8
                 a.    Dietary Exposure	   8
                 b.    Occupational and Residential	   8
           3.    Risk Assessment  	   8
                 a.    Dietary	   9
                 b.    Occupational and Residential	   9
      C.   Environmental Assessment	   9
           1.    Environmental Fate	9
                 a.    Environmental Chemistry, Fate and Transport	   9
                 b.    Environmental Fate Assessment	  11
           2.    Ecological Effects  	  13
                 a.    Ecological Effects Data	  13
                       (1)   Terrestrial Data	  13
                       (2)   Aquatic Data  	  13
                 b.    Ecological Effects Risk Assessment	  13
                       (1)   Industrial Biocide Use Pattern
	...... ...	  13
                       (2)   Swimming Pool Use Pattern
	:.  14

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

V.    ACTIONS REQUIRED BY REGISTRANTS	   17
      A.    Manufacturing-Use Products	   17
            1.    Additional Generic Data Requirements	   18
            2.    Labeling Requirements for Manufacturing-Use Products	   18
      B.    End-Use Products	   18
            1.    Additional Product-Specific Data Requirements	   18
            2.    Labeling Requirements for End-Use Products	   19
      C.    Existing Stocks  	   19

VI.   APPENDICES	   21
      APPENDIX A. Table of Use Patterns Subject to Reregistration	   23
      APPENDIX B. Table of the Generic Data Requirements and Studies Used
            to Make the Reregistration Decision	   27
      APPENDIX C. Citations Considered to be Part of the Data Base Supporting
            the Reregistration of Lithium Hypochlorite  	   33
      APPENDIX D. List of Available Related Documents	   41
      APPENDIX E	   45
            PR Notice 86-5	   47
            PR Notice 91-2	   67
      APPENDIX F. Product Specific Data Call-in	   73
            Attachment 1. Chemical Status Sheet	   87
            Attachment 2. Product Specific Data Call-in Response Forms (Form
                  A inserts) Plus Instructions  	   89
            Attachment 3. Product Specific Requirement Status and Registrant's
                  Response Forms (Form B inserts) and Instructions  	   93
            Attachment 4. EPA Batching of End-Use Products for Meeting Data
                  Requirements for Reregistration	   99
            Attachment 5. EPA Acceptance Criteria  	105
            Attachment 6. List of All Registrants Sent This Data Call-in (insert)
                  Notice	119
            Attachment 7. Cost Share Data Compensation Form, and Confidential
                  Statement of Formula Form	121

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 LITHIUM HYPOCHLORITE REREGISTRATION ELIGIBILrrY DECISION TEAM
 Office of Pesticide Programs:
 Biological and Economic Analysis Division
 Martin S. Lewis
 Rafael Prieto

 Environmental Fate and Effects Division

 Sharlene Matten
 Silvia Termes
 R. David Jones
 Dana Lateulere

 Health Effects Division

 Linda Kutney
 Pat McLaughlin
 William Hazel
 Winston Dang

 Registration Division

 Wallace  Powell
 Shyam Mathur
 JoAnne Hayes

 Policy and Special Projects Staff

 Deborah Hartman

 Special Review  and Reregistration Division

 Ron Kendall
 Teung Chin

 Office of Compliance Monitoring:

 Shruti Sanghavi

 Office of General Counsel:

Bret R. Williams
 Biological Analysis Branch
 Economic Analysis Branch
 Science Analysis and Coordination Staff
 Environmental Fate and Groundwater Branch
 Environmental Fate and Groundwater Branch
 Ecological Effects Branch
 Chemical Coordination Branch
 Toxicology Branch n
 Chemistry Branch-Reregistration Support
 Occupational and Residential Exposure Branch
Antimicrobial Program Branch
Registration Support Branch
Registration Support Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
Pesticides Enforcement Policy Branch

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11

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 a.i.

 CAS

 CSF

 EEC


 EP

 EPA

 FDA

 FIFRA

 FFDCA

 GRAS

 HDT

 LCSO
LD
   '50
LD,0

TJRT.

LOEL

MP

MPI
      GLOSSARY OF TERMS AND ABBREVIATIONS

 Active Ingredient

 Chemical Abstracts Service

 Confidential Statement of Formula

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

 End-Use Product

 U.S. Environmental Protection Agency

 Food and Drug Administration

 Federal Insecticide, Fungicide, and Rodenticide Act

 Federal Food, Drug, and Cosmetic Act

 Generally Recognized As Safe as designated by FDA

 Highest Dose Tested

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

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

 Lethal Dose-low.  Lowest Dose at which lethality occurs

 Lowest Effect Level

 Lowest Observed Effect Level

Manufacturing-Use Product

Maximum Permissible Intake
                                        111

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                  GLOSSARY OF TERMS AND ABBREVIATIONS


MOE        Margin Of Exposure (PAD)

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

N/A         Not Applicable

NPDES      National Pollutant Discharge Elimination System

NOEL       No Observed Effect Level

OPP         Office of Pesticide Programs

PADI        Provisional Acceptable Daily Intake

ppm         Parts Per Million

Q*i          The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk
             Model

RED         Reregistration Eligibility Decision

RfD         Reference Dose

RS          Registration Standard

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

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

TMRC       Theoretical Maximum Residue Contribution.
                                         IV

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EXECUTIVE SUMMARY
       Lithium hypochlorite is an algicide, disinfectant, fungicide and food contact sanitizer.
It is produced by FMC Lithium Division and Olin Corporation and is registered  for use in
swimming pool water systems (including hot tubs and spas), and also on food processing plant
equipment, dairies/cheese processing plant  equipment,  and  in eating establishments  for
equipment/utensils.  Lithium hypochlorite is listed by the FDA for use as a sanitizer on food
contact surfaces in 21 CFR  178.1010.   Lithium discharges into water systems are regulated
through NPDES permits.

The Agency has determined that the uses of lithium hypochlorite as currently registered will not
cause  unreasonable risk to  humans or  the  environment  and these uses  are eligible  for
reregistration.  The Agency does have some concern about possible adverse effects to aquatic
organisms from the discharge of effluent from industrial uses into the environment.  However,
such discharge is limited through the National Pollution Discharge Elimination System which
the Agency defers to for regulation.

Before reregistering the products containing lithium hypochlorite, 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 for each registration.  After reviewing
these data and any revised labels and finding them acceptable in accordance with Section 3(c)(5)
of FEFRA, the Agency will reregister a product.  Those products which contain other active
ingredients will be eligible for reregistration only when all the other active ingredients in those
products are determined to be eligible for reregistration.

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 I.      INTRODUCTION

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

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

 This document presents the Agency's decision regarding the reregistration eligibility of the
 registered uses of lithium hypochlorite. The document consists of six sections. Section I is the
 introduction.  Section n describes  lithium  hypochlorite,  its uses, data  requirements  and
 regulatory history. Section m discusses the human health and environmental assessment based
 on the data available to the Agency. Section IV presents the reregistration decision for lithium
 hypochlorite . Section  V discusses the reregistration requirements for Lithium Hypochlorite .
 Finally, Section VI is  the Appendices which support this Reregistration Eligibility Decision.
 Additional details concerning the Agency's review of applicable data are available on request1.
    l. EPA's review of data in the set of registered uses considered for EPA analysis may be
obtained from the EPA Public Docket, Field Operations Division, 7506C, EPA, Washington
D.C. 20461.

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H.    CASE OVERVIEW

      A.    Chemical Overview

             The following active ingredient is  covered by  this Reregistration Eligibility
      Decision:

           Common Name:    Lithium hypochlorite


           Chemical Name:    Lithium hypochlorite


           CAS Registry Number:     13840-33-0


           OPP Chemical Code:      14702
             Empirical Formula:
LiOCl
             Trade and Other Names:   Lithio Lithium hypochlorite; Formula 2
             Basic Manufacturer:
Olin Corporation
EMC Lithium Division
      B.    Use Profile
             The following is information on the current registered uses with an overview
      of use sites and application methods. A detailed table of these uses of lithium
      hypochlorite is in Appendix A.

      Lithium Hypochlorite:

      Type of Pesticide:   Algicide, Disinfectant, Fungicide and Food contact sanitizer.

      Use Sites:    Aquatic Non-Food Residential: swimming pool water systems
                    (including hot tubs and spas).

                    Indoor Food: Food processing plant equipment, Dairies/cheese
                    processing plant equipment, Eating establishments equipment/utensils.

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 Target Pests:        Bacteria, Aquatic Algae and bacteria, Mildew.

 Formulation Types Registered:    Type-Manufacturing use, End use.Fonn-Liquid
                                  Ready-to-use, Soluble solid concentrate.

 Method and Rates of Application:

       Equipment-   Aquatic non-food residential: skimmer basket.
                     Indoor Food:  By Hand, Dish washing machine.

       Method and Rate -   Aquatic non-food residential: Water treatment, from 1 to
                           13 ppm available chlorine by weight.
                           Indoor food: Equipment treatment, from 43 ppm by
                           weight to 181 ppm available chlorine by volume.

       Timing -      Aquatic non-food residential: Initial, Subsequent/maintenance,
                     Shock/slug, Winterizing

                     Indoor-food: Not specified

 Use Practices Limitations:

             Minimum pH of 7.2 and maximum pH of 7.8 for aquatic non-food
             residential, Preclean claim for sanitizing.
C.    Regulatory History
       Pesticide products containing lithium hypochlorite as an active ingredient were
first registered in the United States in 1963.  Currently, there are 40 products
registered by 17 companies. These products are chiefly used in swimming pools as a
sanitizer.  Most of the registered products are granular and ready-to-use.  A few
products are registered for use in indoor food areas.

As part of the reregistration process, a Data Call-in Notice was issued on September
24, 1992, for lithium hypochlorite requiring registrants to generate and submit
product chemistry and ecological effects data to complete the target data base for
reregistration. These data have been submitted to the Agency and are incorporated
into this reregistration decision.

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Lithium hypochlorite is listed by the FDA for use as a sanitizer on food contact
surfaces in 21 CFR 178.1010. Discharges of effluent containing lithium into water
systems are regulated through National Pollutant Discharge Elimination System
(NPDES) permits.  No new uses are pending as of the date of this RED.
SCIENCE ASSESSMENT

A.    Physical Chemistry Assessment

      The chemical lithium hypochlorite is manufactured by chlorinating a solution
containing lithium hydroxide and sodium hydroxide in the presence of diluents such as
sodium sulfate and potassium sulfate.
      LiOH + NaOH + C12
>  LiOCl + NaCl + H,0
       The solution of LiOCl thus produced is continuously cooled (to avoid thermal
decomposition) and spray dried.  The spray dried fines (maximum particle size 30
mu) are compacted, granulated, and screened to produce a granular product of about
-10 to  +70 mesh particle size.  The Physical/Chemical Properties of lithium
hypochlorite are summarized below:

Molecular Weight:  58.4

Physical State:      Granular solid

Odor:  Odorless or with slight odor of chlorine

Melting Point:      135 C with decomposition

Bulk Density:      58 Ibs/ft3

Solubility:   Total solubility in water-43 % by weight at 25C

Vapor Pressure:    Water (22 mm Hg) at 20 C

Dissociation Constant:    3.2 x 10'8 (of HOC1 in aqueous solution)

pH:    9.9(available C12 - 100 ppm); 10.3(available C12 - 200 ppm); 10.7
       (available C12 - 300  ppm) in water at 25 C.

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Stability:
Oxidizing/
Reducing:
Stable and retains 90% of available chlorine when stored in fiber
containers with aluminum overwrap at 75F(23.88 C)
and 75% relative humidity for 4 months.
Lithium hypochlorite with 39% available chlorine has some oxidizing
effect.
Explodability:
Storage Stability:
       Formulations of 39 % available chlorine or less are not classed
       as dangerous articles under Interstate Commerce Commission
       Regulations.

       During 60 days' storage at 43 C lithium hypochlorite loses 12%
       of available chlorine. The storage stability data for lithium
       hypochlorite containing 1% to 10% available chlorine show that
       it is identical or similar to that of sodium hypochlorite solution.
B.     Human Health Assessment

       1.     Toxicology Assessment

             The lexicological data base on lithium hypochlorite is adequate and will
       support reregistration eligibility. The primary toxicological consideration is
       the effect from exposure to the lithium ion that is produced from the reaction
       of lithium hypochlorite with water produces hypochlorous acid and lithium
       ions. Hypochlorous acid (which is an oxidizing agent and the chemical species
       showing actual pesticidal activity) acts by oxidizing organic and inorganic
       chemical contaminants.  As hypochlorous acid exerts its oxidizing effect, the
       chlorine reduces to chloride ions.   Thus the end - products of lithium
       hypochlorite are chloride and lithium ions, both ubiquitous in the environment,
       and adverse effects from the incremental lithium hypochlorite contribution are
       not expected.

             a.      Acute Toxicity

                    Data from an acute oral toxicity study in rats indicated LD50s of
             748 rag/kg for males and 555 mg/kg for females.  This study, which
             used technical lithium hypochlorite, indicates category HI toxicity
             (MRID 40803901).  A second acute oral toxicity study (MRID  234351)
             in  rats  that was conducted only in male animals is useful for indicating
             the nature of the observed effects.  The effects in the rats were
             primarily due to the corrosive nature of the  substance and included
             inflamed gastric mucosa and lungs, distended stomach, congested
             kidneys, yellow purulent material in chest cavity, and labored
             respiration. The oral LD50 for males in this study was 286 mg/kg.

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 The dermal LDJO was approximately 8100 mg/kg for female and male
 rabbits, which is category IV toxicity (MRID# 234351). The effects
 were dermal necrosis, severe erythema, anorexia, depression, and lack
 of body fat.

 The corrosive nature of lithium hypochlorite puts this compound in
 toxicity category I for both eye irritation and dermal irritation.  A
 dermal sensitization study, which used solid lithium hypochlorite as a
 10% solution in saline, did not demonstrate any dermal sensitization
 (MRID 252294).

Acute Toxicity Study Results- Lithium Hypochlorite
TEST
Oral LD50 - Rat '
Dermal LD50 - Rabbit
Eye Effects - Rabbit
Skin effects - Rabbit
Dermal sensitization -
Guinea pig
RESULT (MG/KG)
746 mg/kg for males
555 mg/kg for females
8100 mg/kg both sexes
Severe irritation
Severe irritation
Not sensitizing
CATEGORY
m
IV
I
I
N.A. ,
 b.     Reproductive and Developmental Toxicity

        In a developmental toxicity study four groups of 25 female rats
 were given, by gavage, lithium hypochlorite on gestation days six through
 fifteen (MRID 40648101) with one additional group of 25 rays as control.
 The dose levels were 0, 10,  50, 100, or 500 mg/kg/day using 30% test
 substance in water.  The maternal and developmental NOELs were 100
 mg/kg/day of lithium hypochlorite, which is equivalent to 4.1 mg/kg/day
 of lithium.  The maternal LOEL was at 500 mg/kg/day, based on deaths,
 reduced  weight  gain,  reduced  food consumption,  and inflamed and
 congested respiratory system. The developmental LOEL was also at 500
 mg/kg/day, where the fetuses showed reduced fetal weight, dilated renal
 pelvis, bifid vertebrae, wavy ribs, and unossified foot bones.

 A survey of animal studies in the published literature (MRID 41367401)
 generally found the no-effect levels at or above 4.5 mg/kg/day of lithium.
 None of the studies showed developmental effects  at levels below those
 which showed maternal toxicity.  Human studies related to pregnancy and

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 lithium drag consumption were of various types and had varied findings,
 but all dealt with much higher levels of lithium intake than are expected
 from pesticide use.

 c.    Mutagenicity

       Technical lithium  hypochlorite was negative, with and  without
 metabolic activation, in an Ames test for mutagenicity using five strains
 of Salmonella (MRID 40545702). A study of unscheduled DNA synthesis
 in rat hepatocytes using technical lithium  hypochlorite was also negative
 (MEED  40545704).    Lithium hypochlorite  was  negative  in  the
 CHO/HGPRT mutation  assay  with and  without activation  (MRED
 40545701).   A test for  chromosome aberration  in CHO  cells with
 technical lithium hypochlorite was positive (MRED 40545703). However,
 a test for chromosomal aberrations in rat bone marrow cells was negative
 with lithium hypochlorite (MRED 40907500).

 d.    Metabolism

       The lithium  ion is rapidly  absorbed  after  ingestion  and is
 distributed through the body.  It is excreted by the kidney and most of the
 ion is  excreted within 6-8 hours after ingestion (MRED 240927).

 e.     Other Toxic Endpoints

       The average background level of lithium in human serum has been
 reported as 0.014 mg/L, which comes primarily from the natural content
 of lithium  in food and drinking water (MRED  41367401). It has been
 estimated that the natural sources of lithium provide 2.3-4.9 tag/day of
 lithium.

 Lithium carbonate has been used as a human drug since about 1970. The
 intake levels are 179 to 282 mg/day of lithium ion and they provide about
 4.16 to 8.33 mg/L of lithium in the serum (MRED 41367401).  For the
 therapeutic use, the reported maximum no-toxicity levels are 10.41 to
 13.88 mg/L in serum.  These levels are far higher than the background
 levels  and higher than any expected from pesticide use  of lithium
 hypochlorite.  In addition, lithium orotate and lithium aspartate salts are
 sold as over-the-counter mineral supplements that provide about 5 mg of
 lithium per daily dose.  Clinical and epidemiologic studies on human use
 of lithium-containing drugs, including chronic use, have not shown any
 reason for concern over  continued  human  exposure to  lithium in a
pesticidal use scenario.

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Information on the effects to humans exposed to lithium not by natural
sources or by therapeutic treatment is also available.  One study looked
at the levels of lithium in the urine of people who had been swimming in
pools treated with lithium hypochlorite.  No indication was found that
these exposures led to significant lithium absorption (MRCD 240927).

A controlled study on dermal absorption was conducted with humans who
bathed in spas containing lithium chloride in the water.  The subjects were
exposed to  solutions containing 40 to  45  ppm lithium  ion  for 20
minutes/day, 4 days/week for two weeks.  Lithium levels in the serum of
the bathers were not increased above  normal serum  levels  (MRED
40746701).  This study demonstrates that there is no significant absorption
of h'thium through intact human  skin. Without significant  absorption,
there would not be intake or accumulation of lithium in the body by this
route and thus, no reason for particular concern  about long term dermal
exposure in  spas and swimming pools. There is no indication that intake
by accidental drinking of water while swimming would increase the serum
level of lithium nor increase intake over that ingested in ordinary food and
drink.   Certainly  any intake in  pools is not  significant compared to the
levels ingested in  drug use.

Exposure Assessment

a.     Dietary Exposure

       There are no direct food/feed uses for this chemical; consequently
there are no dietary exposure concerns and a dietary exposure assessment
was not performed.  Residues of lithium hypochlorite from the use of
products on food contact surfaces in food processing plants and eating
establishments  are limited  under the FFDCA regulations,  21  CFR
178.1010, to solutions containing no more  than 200  ppm of available
chlorine and 30 ppm of lithium.

b.     Occupational and Residential

       Workers who handle lithium hypochlorite may  be exposed to the
formulated soluble concentrate  or solid.  The potential for  dermal and
inhalation exposures of workers exists (such as  in  hand  washing  of
utensils).  Post-application exposure is considerably less and  is minimal,
as the exposure is to a diluted  material such  as dermal exposure to
swimmers.

There are no significant exposure concerns other than appropriate  label
precautions for eye and dermal  hand  protection for workers  who handle
                       8

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              concentrated or solid lithium hypochlorite.

       3.     Risk Assessment

              a.     Dietary

                    As stated  above there are no  direct food/feed uses for this
              chemical;  consequently there are no dietary exposure concerns and a
              dietary risk  assessment was not performed.  Regulations in 21 CFR
              178.1010 state that solutions of lithium hypochlorite used on food handling
              surfaces can be  considered  safe provided they do  not exceed  the
              concentration limits referenced above.

              b.     Occupational and Residential

                    Lithium hypochlorite is a Toxicity Category I eye and dermal
              irritant.   It  is  in Toxicity Category in for acute  oral and Toxicity
              Category IV for dermal toxicity.

              Because of the potential for eye and dermal exposure, appropriate label
              precautions are required.    The  current requirements for  protective
              clothing, including safety glasses or goggles and chemical-resistant gloves
              while using MP or end-use products must be continued to reduce exposure
              potential. Post-application exposure to the compound in swimming pools
              is expected to be minimal.  Because these exposures  are expected to  be
              low no human health risk of concern is expected.

C.     Environmental Assessment
       1.     Environmental Fate

             The Agency is relying on data available in the scientific literature to assess
       the environmental fate and transport of lithium hypochlorite used as a pesticidal
       compound.

             a.     Environmental Chemistry, Fate and Transport

                    Lithium hypochlorite,  like all  of the  other hypochlorite salts
             (sodium, potassium, calcium) form hypochlorous acid when dissolved in
             water.(1> 2> 3) Thus, lithium hypochlorite can be considered as a precursor
             to  hypochlorous  acid.   Hypochlorous acid is the chemical  species
             exhibiting actual pesticidal activity.  The pesticidal mode of action of
             hypochlorous acid is linked to its oxidizing effect on organic and inorganic

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contaminant sources. The environmental fate of lithium hypochlorite is
essentially that of  hypochlorous acid.   The advantage  of lithium
hypochlorite over calcium hypochlorite is that lithium hypochlorite can be
used in hard waters (that is, waters in which the concentrations of calcium
and magnesium ions are above 3 milliequivalents per liter (5)), where the
use of a calcium salt would be contraindicated.(1)

Hypochlorous acid is a weak acid; the pK^ of hypochlorous acid at 25 C
is  7.4.(4)   In  acidic  pH, the  predominant  species  is  undissociated
hypochlorous acid;  in  the neutral range small amounts of hypochlorite
anions are present  together with  hypochlorous  acid.   The acid is
completely dissociated into hypochlorite anions and hydronium ions only
at very high pH. The maximum decomposition rate of hypochlorous acid
occurs at pH 6.89.(4)  For swimming pool sanitation it is recommended
that the pH be maintained between 7.2 and 7.6, where hypochlorous acid
predominates together with hypochlorite anions.

The mechanisms and rates of decomposition of hypochlorous acid and
hypochlorite  anions are  not only  dependent  on  pH,  but also  on
concentration and temperature/1'2> 4)  Sunlight affects the decomposition
of hypochlorous acid/ hypochlorite as  these species absorb in the 292 to
380 nm region.(4)  The concentration and nature of organic and inorganic
matter present in the aqueous  media have an effect on the decomposition
of hypochlorous acid;  redox  reactions are involved in this  case.  The
oxidation state of chlorine in hypochlorous acid and hypochlorite is +1.

The oxidizing effect (and hence the sanitation properties)  can be either
associated with hypochlorous acid or with the hypochlorite anion,  but
rarely  to both species simultaneously.(1) In  disinfection by chlorination
operations it is  customary to use the expression "free residual chlorine"
to  define the sum  of the  concentrations  of  hypochlorous  acid and
hypochlorite anions;  "free residual chlorine" is often used as a measure
of the  effectiveness of  chlorination, which is also a measurement of the
available chlorine in solution.(5)

The aim in disinfection is to add sufficient chlorinating agent to achieve
"free residual chlorine."  The most common redox reactions are  (1) the
oxidation of iron(n), sulfide and organic matter, in which chlorine (+1)
is reduced to chlorine  (-1) (that is, to chloride).  This is followed by
formation of chloroamines and chloroorganic compounds, which are then
further oxidized by addition of sufficient disinfectant to achieve a "free
residual chlorine".  The recommended rates of application (in terms of
available chlorine by weight) for aquatic non-food  (residential) uses of
lithium hypochlorite varies from 1 to 13 ppm;  for indoor food handling
                      10

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                 establishment uses it varies from 43 ppm by  weight to  181 ppm by
                 volume.
                b.     Environmental Fate Assessment

                       Water sanitation with hypochlorite salts is widely used. Products
                containing lithium hypochlorite carry NPDES permit restrictions.  The
                major environmental/ecological concern would be if discharged effluent
                treated with hypochlorites show free residual chlorine concentrations that
                exceed those stipulated under the NPDES permits. Note that free residual
                chlorine  can be  independent  of the  source  of chlorination (lithium,
                sodium,  calcium,  potassium hypochlorites; chlorinated isocyanurates;
                chlorine gas) since all of these materials form hypochlorous acid in water.
                Thus, in cases where  free residual chlorine levels may  be found above
                recommended  levels,  it  may be  difficult  to trace  the  source  of
                contamination  considering that the counter cations (lithium,  sodium,
                calcium and potassium) are ubiquitous in nature.

                A fate model was used to determine the Tier lc2 estimated environmental
                concentration (EEC) for lithium hypochlorite from effluent discharge after
                lithium hypochlorite products are used in food processing plants and eating
                establishments.  A single EEC  was calculated to represent the milking
                equipment, food processing plants, and  eating establishment uses (Table
                1).  The EEC has been presented in several different representations for
                easy comparisons to hazard data. Although the primary use  of lithium
                hypochlorite is for swimming pools, no EEC was calculated for this use
                as discharge data are  not available for swimming pools.  However, it
                would be expected that the exposure from the swimming pool use pattern
                is small as discharges may  occur only once or twice a year should pools
                be drained.

                A  Tier lc  EEC provides  the maximum concentration  that  occurs
                immediately downstream from an industrial (point source) discharge site.
                The EECs calculated are those for a high exposure site with a return
                frequency  of 1 in 10 years.  The high exposure site represents a site that
                would be expected to produce larger EECs than 90% of all sites with the
                specified use pattern.  A one in 10 year EEC  has a 10% probability of
                being equalled or exceeded in any single year at a given site,  or, would
                be equalled or exceeded once every ten years at that site on a long term
                average.  This is similar to the  site and frequency assumptions that are
2 A tier lc EEC is a preliminary or lower exposure assessment for industrial biocides.

                                     11

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generally being used for agricultural pesticides: EECs for a 50% (typical
site) at mean stream flow were also calculated.  These values are listed in
Table 1 on a lithium hypochlorite basis.
Table 1. Tier Ic EECs for Lithium Hypochlorite at Food Processing
Facilities
Chemical
Representation
LiOCl
as Cl, CT1, or
"available chlorine"
as O-JCL
High Exposure Case
88 mgL.!
53 mg-L-1
77 rag*!/1
Typical Exposure Case
0.300 jig*!/1
0.179 /ig'L-1
0.260 fig'U1
Following is a description of the Agency's method for estimating the
environmental concentrations. Two products, E-Z Chlor Litho Industrial
Sanitizer (EPA Reg. # 8791-51), manufactured by E-Z Chlor Systems,
Inc, and Lithco Lithium Hypochlorite (EPA Reg. # 7675-4), manufactured
by FMC Lithium Division, have uses for sterilizing milking equipment,
in food processing plants, and in eating establishments. All these uses are
represented  as Publicly Owned Treatment Works (POTW) (SIC Code
4952) as recommended by the Agency's, Office of Pollution Prevention
and Toxics (OPPT).  The concentration in the waste stream is assumed to
be  the  same as the application rate, 210 ppm; this  assumes  that no
degradation of the hypochlorite occurs in the processing stream.  The
concentration  in the  waste stream  is  then used to calculate  the
concentration in the receiving stream immediately downstream from the
discharge site.  Dilution factors  are taken from a compilation of dilution
factors compiled for the Agency(6).  All sites in the classification are then
ranked from best to worst based on the mean flow in water body receiving
the waste stream.  The typical  EEC is then calculated by  dividing the
waste stream concentration by the tabulated dilution factor for the mean
flow condition at the median site. The high exposure EEC is calculated by
using the dilution factor tabulated for the 90% site (90% of the sites had
greater mean stream flows) for the low flow condition at the site, which
is the seven day mean low flow that would be expected to occur once in
10 years.

Because Tier Ic EECs make many very conservative assumptions and do
not address the environmental fate of the pesticide, they may significantly
                      12

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       overestimate  the true exposure to the chemical.  A higher tier EEC
       calculation which more accurately reflects the fate and transport properties
       of hypochlorite would likely show that the risk is less than that reported
       in the Ecological Effects section below.   There is some evidence that
       hypochlorite  degrades within hours  in aquatic environments m which
       would significantly reduce the exposure. Waste water treatment prior to
       discharge, restriction on discharge during low flow periods and other
       methods which may be available through the NPDES permitting process
       may reduce EECs below the  level of concern at each site using  the
       pesticide.

2.     Ecological Effects
       a.     Ecological Effects Data
              (1)    Terrestrial Data

                    The acute toxicity of lithium hypochlorite to mallard ducks
              is classified as slightly toxic with an LD50 of 567.0 mg/kg active
              ingredient(MKID# 94673). The dietary toxicity to bobwhite quail
              is classified as almost nontoxic with an LC50 of greater than 5,000
              ppm(MRID# 104674).

              (2)    Aquatic Data

                    The 96-hour acute toxicity to rainbow trout was reported as
              an LC50 of 0.20 mg a.i./L.; thus, classifying lithium hypochlorite
              as highly toxic to cold water fish(MRID# 94672).  The 48-hour
              acute toxicity to Daphnia magna was reported as an EC50 of 23.0
              pg a.i./L;  thus, classifying lithium hypochlorite as very highly
              toxic to aquatic invertebrates(MEID# 94674).

      b.      Ecological Effects Risk Assessment

              (1)    Industrial Biocide Use Pattern

             Lithium  hypochlorite is considered slightly toxic to nontoxic to
      avian species.   Due to  hypochlorite's  reactivity,  any level of exposure
      would be expected to dissipate rapidly as contact is made with organic
      matter in the environment. In addition, it is not expected to be found in
      the environment at levels that are hazardous.   Therefore, risk to avian
      species is expected  to  be minimal.    Toxicity to  fish and aquatic
                             13

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invertebrates is considered very high.  The Agency determined a single
Tier  Ic  EECs,   as  documented above,  (estimated  environmental
concentration) to represent the aquatic residues  occurring immediately
downstream from the milking equipment, food  processing plants, and
eating establishment use discharges.

Toxicity to fish and aquatic invertebrates is considered extremely high. A
stream flow screening model was utilized by the  Agency to determine a
"high exposure case" and a "typical exposure case" EEC - these numbers
depict the highest value that could occur in these situations. The Agency
determined a single Tier Ic EEC (estimated environmental concentration),
as  documented above,  to represent the aquatic  residues  occurring
immediately downstream from the milking equipment, food processing
plants, and eating  establishment  use  discharges.   Even though  the
freshwater LOCs have been triggered for the high exposure scenario, there
is significant experience in the use and NPDES permitting of industrial
microbicidal uses of lithium hypochlorite to mitigate the aquatic risk. The
permitting system that is in place is the appropriate mechanism to set the
appropriate discharge limits based on the receiving body of water.

When the EEC is greater than or equal  to  1/2  the LC50, the level of
concern (LOG) for acute effects is exceeded.  As  the high level  of
exposure EEC of 88 ppm is greater than and the typical exposure EEC of
0.300 ppb is less than 1/2 the LC50 values for rainbow trout and Daphnia
magna (100 ppb and 11.5 ppb, respectively), LOC's for acute aquatic risk
are exceeded only for the high exposure scenario.  Therefore, aquatic
organisms may be at high risk from only the high use exposure, but not
from the typical use exposure.  However,  the Agency cannot state with
any degree of certainty whether there will be a significant risk under the
high exposure  scenario due to the use of lithium hypochlorite as  an
industrial biocide.

       (2)    Swimming Pool Use Pattern

The Agency could not calculate a Tier  Ic EEC for swimming  pools
because there  is no discharge and site data available on the receiving
water. At best, The Agency can only make an intuitive risk assessment
of the swimming pool use pattern. That is, there is no data to support any
risk assessment conclusion for the swimming pool use pattern. However,
there are mitigating factors in which the Agency may conclude that the
aquatic organism exposure resulting from swimming pool drainage is
minimized.  First, it is not customary to routinely empty and refill pools.
Swimming pools may be emptied at the end of the swimming season or
for maintenance.  It is not expected that these drainings would be very
                      14

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 frequent, at most, twice per year. Second, one would be unlikely to treat
 a  swimming pool  with lithium hypochlorite and then immediately
 discharge the water into a  lake or stream.  Third, direct discharge of
 swimming pool water into a lake or stream is probably not typical. Pools
 are most often  drained either directly into the  area immediately
 surrounding  the pool or into municipal sewage systems. In either case,
 the reactivity of hypochlorite ions with organic matter and the pathway to
 a natural body of water, as well as the organic matter in the receiving
 body of  water, greatly  reduces the  levels of hypochlorite available to
 aquatic organisms.

 The Ambient Water Quality Criteria for Chlorine - 1984 (Office of Water,
 EPA 440/5-84-030,  1985) is used to regulate the discharge of chlorine
 forming chemicals into receiving waters. The document states:

  "..except possibly -where a locally important species  is very sensitive,
freshwater aquatic organisms  and their uses should  not be affected
 unacceptable if the four-day average concentration  of total residual
 chlorine does not exceed 11  fig/1 (ppb) more than once every three years
 on the average and if the one-hour average concentration does not exceed
 19 ng/L (ppb) more than once every three years on the average.

 ....except possibly where a locally important species  is very sensitive,
 saltwater aquatic organisms and their  uses  should not be affected
 unacceptabfy if the  four-day average concentration of total residual
 chlorine produced oxidants does not exceed 7.5 pg/L (ppb) more than once
 every  three  years  on  the average and if the  one-hour  average
 concentration does not exceed 13 pg/L (ppb) more than once every three
years on the  average.

 The recommended exceedence frequency of three years is the Agency's best
scientific judgment of the average amount of time it mil take an unstressed
system to recover from a pollution event in which exposure to chlorine
exceeds the criterion.  Stressed systems, for example, one in which several
outfalls occur in a limited area, would be expected to require more time
for recover. The resilience of ecosystems and their ability to recover differ
greatly, however, and site-specific criteria may be established if adequate
justification is provided."

The EECs as determined by the Agency, exceed the Agency's Office of
Water Criteria for 'unacceptable exceedence' for  freshwater organisms.
The uses  for lithium  hypochlorite are covered under NPDES  permit
regulation; the exposure  and subsequent  risk to freshwater  organisms
should be included in the determination of acceptable regulatory levels for
                      15

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                    this permit.

                    .Endangered Species

                           When the EEC is greater than or equal to 1/20 the LC50, the LOG
                    for endangered species is exceeded. As the high exposure EEC of 88 ppm
                    is greater than and the typical exposure EEC of 0.300 ppb is less than
                    1/20 the LC50 values for rainbow trout and the Daphnia magna (10 ppb
                    and  1.15 ppb), LOC's for acute risk are exceeded only for the high
                    exposure scenario.  Therefore, endangered aquatic organisms may be at
                    high risk from only the high use exposure but not from the typical use
                    exposure.

                    Based  on the registered uses,  lithium hypochlorite is expected to be
                    discharged at a number of different sites; endangered species may be
                    present in these aquatic sites.   Based on these EEC screening values
                    effluent  containing lithium hypochlorite should not be discharged into
                    streams and other waterways where endangered aquatic  organisms are
                    known to frequent.

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

       A.    Determination of Eligibility

             Section 4(g)(2)(A) of FDFRA calls for the Agency to determine, after submission
       of relevant data concerning an active ingredient, whether products containing the active
       ingredients are eligible for reregistration.  The Agency has previously identified and
       required the  submission of the generic (i.e. active ingredient specific) data required to
       support reregistration of products containing  lithium hypochlorite.  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 lithium hypochlorite.  Those products
       which contain  other active ingredients will be eligible for reregistration only when the
       other active  ingredients  are determined to  be  eligible for reregistration.  Appendix B
                                          16

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      .identifies  the generic data requirements  that the Agency  reviewed as part of  its
       determination of reregistration eligibility of lithium hypochlorite, and lists the submitted
       studies that the Agency found acceptable.

       The data identified in Appendix B were sufficient to allow  the Agency to assess the
       registered uses of lithium hypochlorite and to determine that lithium hypochlorite can be
       used without resulting in unreasonable adverse effects to humans.  Conversely, the
       Agency has some concerns about possible adverse risks to aquatic species from discharge
       of effluent containing lithium hypochlorite.  Since this  discharge is regulated through the
       NPDES permitting program for specific  sites the  Agency defers to  that program to
       regulate the use of lithium hypochlorite products at specific sites.  Likewise, the Agency
       will incorporate in the future appropriate risk mitigation measures to minimize impacts
       on endangered species.  The Agency therefore finds that all products containing lithium
       hypochlorite as the active ingredients are eligible for reregistration.  The reregistration
       of particular products is addressed in Section V of this document.

       The Agency made its reregistration eligibility determination based upon the target data
       base required for reregistration, the current guidelines  for conducting acceptable studies
       to generate such data and the data identified in Appendix B.   Although the Agency has
       found that all uses of lithium hypochlorite are eligible for reregistration, it should be
       understood that the Agency may take appropriate regulatory action, and/or require the
       submission of additional data to support the registration of products containing lithium
       hypochlorite, if new information  comes  to  the  Agency's  attention or if  the  data
       requirements for registration (or the guidelines for generating such data) change.
              1.
Eligibility Decision
              Based on the reviews of the generic data for  the active ingredients lithium
       hypochlorite, the Agency has sufficient information on the  health effects of lithium
       hypochlorite and on its potential for causing adverse effects in fish and wildlife and the
       environment.   Therefore, the  Agency concludes that products containing lithium
       hypochlorite for all uses are eligible for reregistration.    The  Agency is requiring
       precautionary labeling on all registered products because lithium hypochlorite is highly
       toxic to fish and aquatic invertebrates.

              2.     Eligible and Ineligible Uses

                    The Agency has  determined that all uses  of  lithium hypochlorite  are
              eligible for reregistration.

V.     ACTIONS REQUIRED BY REGISTRANTS

       This section specifies the data requirements and responses necessary for the reregistration
of both manufacturing-use and end-use products.
                                           17

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A.     Manufacturing-Use Products

       1.    Additional Generic Data Requirements

             The generic data base supporting the reregistration of lithium hypochlorite
       for the above eligible uses has been reviewed and determined to be complete.  No
       additional generic data are  required at this time.

       2.    Labeling Requirements for Manufacturing-Use Products


                    Effluent Discharge Labeling Statements

             All manufacturing-use or end-use products that may be contained in an
       effluent discharged to the waters of the United States or municipal sewer systems
       must bear the following revised effluent discharge labeling statement.

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

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


B.     End-Use Products

       1.    Additional Product-Specific Data Requirements

             Section 4(g)(2)B) of FJPRA 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
                                   18

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       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

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

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

C.     Existing Stocks

       Registrants may generally distribute and sell products bearing old labels/labeling
for 26 months from the date of the issuance of this Reregistration Eligibility Decision
(RED). Persons other than the registrant may generally distribute or sell such products
for 50 months from the date of the issuance of this RED.  However, existing stocks time
frames will be established case-by-case, depending on the number of products involved,
the number of label changes, and other factors.  Refer to "Existing Stocks of Pesticide
Products;  State of Policy";  Federal Register. Volume 56, No. 123,  June 26, 1991.

       The Agency has determined  that registrants may distribute and sell lithium
hypochlorite products bearing old labels/labeling for 26 months from the date of issuance
of this RED.  Persons other than the registrant may distribute or sell such products for
50 months from the date of the issuance of this RED.
                                   19

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VI.   APPENDICES
       21

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APPENDIX A. Table of Use Patterns Subject to
               Reregistration
                    23

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-------
APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
                         27

-------

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

       The data table is organized in the following format:

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

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

                           A     Terrestrial food
                           B      Terrestrial feed
                           C      Terrestrial non-food
                           D      Aquatic food
                           E      Aquatic non-food outdoor
                           F      Aquatic non-food industrial
                           G      Aquatic non-food residential
                           H      Greenhouse food
                           I      Greenhouse non-food
                           J      Forestry
                           K      Residential
                           L      Indoor food
                           M     Indoor non-food
                           N      Indoor medical
                           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.
                                          29

-------

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-------
APPENDIX C.  Citations Considered to be Part of the
 Data Base Supporting the Reregistration of Lithium
                   Hypochlorite
                        33

-------

-------
                        GUIDE TO APPENDIX C

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

 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.

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

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

 a      Author.  Whenever the author could confidently be identified, the Agency has
       chosen to show a personal author. When no individual was identified, the
       Agency has shown an identifiable laboratory or testing facility as the author.
       When no author or laboratory could be identified, the Agency has shown the
       first submitter as the author.
b.
Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced
                                  35

-------
       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.

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

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

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

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

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

       (4)    Volume Identification (Accession Numbers).  The final element in the
             trailing parentheses identifies the EPA accession number of the volume
             in which the original submission of the study appears.  The six-digit
             accession number follows the symbol "CDL," which stands for
              "Company Data Library."  This accession number is in turn followed
             by an alphabetic suffix which shows the relative position of the study
             within the volume.
                                    36

-------
                                BIBLIOGRAPHY
 MRID
                                CITATION
 00234351     a. Acute Oral Toxicitv Study in Rats. (1977) Unpublished study prepared by
              Hazleton and submitted by Lithium Corp. of America. Study No. 668-103.
              b. Acute Dermal Toxicitv Study in Rabbits. (1977) Unpublished study
              prepared by Hazleton and submitted by Lithium Corp. of America. Study No
              668-104.
              c. Primary Skin Irritation Study in Rabbits. (1977) Unpublished study prepared
              by Hazleton and submitted by Lithium Corp. of America. Study No. 668-105.
              d. Acute Eve Irritation Potential Study in Rabbits. (1977) Unpublished study
              prepared by Hazleton and submitted by Lithium Corp. of America. Study No
              668-106.

              Nelli, J. R. The Build-up of Lithium Ion in Swimming Pool Waters and Its
              Effect on Swimmers.  (1964) Unpublished study submitted by Lithium Corp of
              America.

              Guinea Pig Maximization Test with Lithcoa Lithium Hvpochlorite (1984)
              Unpublished  study prepared by Hazleton. Study No. 668/115.

              Lithium Corporation of America (1969) Analysis of Lithium hypochlorite.
              Includes R & D method no. 210 dated Nov 1969.  (Unpublished study
              received Dec 29, 1972 under 7675-1;  CDL: 008072-A)

              Lithium Corporation of America (19??) Product Information:  LCA Lithium
              hypochlorite: Data Sheet 111-463. (Unpublished study received Aug 28, 1964
             under 7675-2; CDL:008073-A)

             Lithium Corporation of American (1977) Storage Stability Data for Lithcoa
             Lithium Hypochlorite.  (Unpublished study received Aug 24,  1979 under
             7675-4; CDL:246731-B)

             Buccafusco, RJ. (1978) Acute Toxicity of Lithcoa Lithium Hypochlorite to
             Rainbow Trout (n  -Salmo gairdneri, ): Report #BW-782-031.
             (Unpublished study received Apr 25, 1978 under 7675-4; prepared by EG  & G
             Bionomics, submitted by Lithium Corp. of America, Gastonia N C 
             CDL:246732-C)

00094673    Piccirillo, V.J.  (1977) Final Report: Acute Oral LDaj50-> Study in Mallard
             Ducks: Project No. 668-107.  (Unpublished study received Apr 25, 1978
240927



252294


00007257



00007258



00094669



00094672
                                        37

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                               BIBLIOGRAPHY
MRID
CITATION
             under 7675-4; prepared by Hazleton Laboratories America, Inc. and Truslow
             Farms, Inc., submitted by Lithium Corp. of America, Gastonia, N.C.;
             CDL:246732-D)

00094674    LeBlanc, G. A. (1978) Acute Toxicity of Lithcoa Lithium Hypochlorite to the
             Water Flea (n -Daphnia magna| ): Report #BW-78-2-032. (Unpublished
             study received Apr 25,  1978 under 7675-4; prepared by EG & G Bionomics,
             submitted by Lithium Corp. of America, Gastonia, N.C.; CDL:246732-E)

00104674    Piccirillo, VJ. (1977) Final Report: Subacute Dietary LCae50-> Study in
             Bobwbite Quail: Project No. 668-109. (Unpublished study received Apr 25,
             1978 under 7675-4; prepared by Hazleton Laboratories America, Inc. and
             Truslow Farms, Inc., submitted by Lithium Corp. of America, Gastonia,
             N.C.; CDL:246732-B)

40545701    Yang, L. (1988) CHO/HGPRT Mutation Assay: 11945 CLithium
             Hypochlorite  | : Study No. T5674.332005.  Unpublished study prepared by
             Microbiological Associates Inc. 30 p.

40545702    Batt, K. (1987) Salmonella/Mammalian-Microsome Plate Incorporation
             Mutagenicity Assay (Ames Test): Study No. 187-0975. Unpublished study
             prepared by FMC Corp., Genetic Toxicology Laboratory.  33 p.

40545703    Putman, D. (1988) Chromosome Aberrations in Chinese Hamster Ovary
             (CHO) Cells: 11945 CLithium Hypochlorite | : Study No. T5674. 337020.
             Unpublished study prepared by Microbiological Associates, Inc.  29 p.

40545704    Curren, R. (1988) Unscheduled DNA Synthesis in Rat Primary Hepatocytes:
             11945 CLithium Hypochlorite | : Final Report: T5674.380017. Unpublished
             study prepared by Microbiological Associates, Inc. 28 p.

40648101    Lochry, E. (1988) Developmental Toxicity (Embro/Fetal Toxicity and
             Teratogenic Potential) Study of Lithium Hypochlorite Administered Orally via
             Gavage to Crl:CD(SD)BR Presumed Pregnant Rats: Sponsor's Study No.
             187-0978. Unpublished study prepared by Argus Research Laboratories, Inc.
             236 p.

40746701    McCarty, J.; Carter, S.; Fletcher, M.; et al. (1988) Study of Lithium
             Absorption by Users of Spas Treated with Lithium Ion: Study No. 187-0981.

                                        38

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                                BIBLIOGRAPHY
 MRID
                    CITATION
             Unpublished study prepared by FMC Toxicology Dept. 225 p.
 40803901



 40907500


 41367401
42940801
42967001
42967002
42967003
42991801
93138001
 Freeman, C. (1988) Lithium Hypochlorite: Acute Oral Toxicity Study in Rats:
 Study No. 187-0982. Unpublished study prepared by FMC Toxicology
 Laboratory. 47 p.

 Lithium Corporation of America (1988) Submission of Toxicity Data in
 Support of Lithium Hypochlorite Products.  Transmittal of 1 study.

 Todhunter, J.; Mandava, N. (1990) Supplemental Data and Documentation in
 Support of Data Waiver Requests filed by Lithium Corporation of America
 dated November 24, 1989: FMC Study No. 190-1108.  Unpublished study
 prepared by SRS International. 1424 p.

 Hatch, H. (1993) Beginning Materials and Manufacturing Process: FIFRA
 Reregistration of Lithium Hypochlorite: Product Class-C: Data Gaps in Phase
 HE Submission. Unpublished study.  18 p.

 Hatch, H. (1993) FIFRA Reregistration of Lithium Hypochlorite, Product
 Class-C:  (Response to) Data Gaps in Phase m Submission: Solubility.
 Unpublished study prepared by FMC Corp.  7 p.

 Hatch, H. (1993) FIFRA Reregistration of Lithium Hypochlorite, Product
 Class-C:  (Response to) Data Gaps in Phase m Submission: Vapor Pressure.
 Unpublished study prepared by FMC Corp.  4 p.

 Hatch, H. (1993) FIFRA Reregistration of Lithium Hypochlorite, Product
 Class-C:  (Response to) Data Gaps in Phase m Submission: Dissociation
 Constant.  Unpublished study prepared by FMC Corp.  10 p.

 Eschbach, J. (1993) Method Validation and Determination of Lithco Lithium
 Hypochlorite for Swimming Pool/Spa Sanitation and Algea (sic) Control.
 Final Report: Lab Project Number:  93/9078: P93/0035.  Unpublished study
prepared by Pharmaco-LSR. 55 p.

 Cinq-Mars, R. (1990) Lithium Corporation of America Phase 3 Summary of
MRID 00051222 and Related MRIDs 00007258, 00031511,  00094670,
00007261, 00094669, 00094670. Chemical and Physical Properties of Lithium
Hypochlorite. 34 p.
                                        39

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                               BIBLIOGRAPHY
MRID
CITATION
                                  REFERENCES

1. Greenwood, N.N. and Earnshaw, A. The Chemistry of the Elements. 1984, Pergamon Press,
Oxford, UK. pp. 988-1013.

2. Cotton, A.F.  and Wilkinson, G. Advanced Inorganic Chemistry. Fifth Edition, 1988, John
Wiley and Sons, New York, pp. 560-570.

3. Wojtowicz, J.A.,  "Chlorine Monoxide,  Hypochlorous  Acid and the Hypochlorites" in
Kirk-Othmer Encyclopedia of Chemical Technology. Third Edition, Vol. 5, Wiley-Interscience,
New York, pp. 580-611.

4. Adam, L.C., Fabian, I., Suzuki, K. and Gordon, G. "Hypochlorous Acid Decomposition in
the pH 5-8 Region", Inorganic Chemistry.  1992, vol.31, pp. 3534-3541.

5. Tchobanoglous,  G.  and  Schroeder,  E.D.  Water  Quality-Characteristics:  Modeling:
Modification. 1985, Addison-Wesley Publishing Company, Reading, MA, pp. 92; 560-571.

6. Office  of Prevention and  Toxic Substances. 1992. Summary of Stream Dilution  Factor
Program (SDFP) Outputs for 40 Industrial Categories (Updated January, 1991, 1Q10 & 3Q5
Added October,  1992.

7. Jolley, R. L. 1983. A review of the chemistry and environmental fate of reactive oxidant
species in chlorinated water, in Water Chlorination: Environmental Impact and Health Effects
vol. 4. pp. 3-47.
                                        40

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APPENDIX D.  List of Available Related Documents
                     41

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-------
       The following is a list of available documents related to Lithium Hypochlorite.  It's
purpose is to provide a path to more detailed information if it is needed. These
accompanying documents are part of the Administrative Record for Lithium Hypochlorite and
are included in the EPA's Office of Pesticide Programs Public Docket.
       1.

       2.

       3.

       4.

       5.
Health and Environmental Effects Science Chapters

Detailed Label Usage Information System (LUIS) Report

Lithium HypochloriteRED Fact Sheet

PR Notice 86-5 (included in this appendix)

PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
                                         43

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-------
APPENDIX E. PR Notices 86-5 and 91-2
                 45

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PR Notice  86-5
      47

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

                             WASHINGTON, D.C. 20460

                                  July 29, 1986
                             PR NOTICE 86-5
                                                       OFFICE OF

                                                 PREVENTION, PESTICIDES

                                                 AND TOXIC SUBSTANCES
 Attention:
 Subject:
     NOTICE TO PRODUCERS,  FORMULATORS, DISTRIBUTORS
                    AND REGISTRANTS

          Persons responsible for Federal  registration of
          pesticides.

          Standard format for data submitted under the
          Federal Insecticide, Fungicide,  and Rodenticide
          Act  (FIFRA) and certain provisions of  the Federal
          Food, Drug, and Cosmetic Act  (FFDCA) .
 I.
Purpose
      To require data to be submitted to the Environmental
 Protection Agency (EPA)  in a standard format. This Notice also
 provides additional  guidance about,  and illustrations of  the
 required formats.

 II.   Applicability

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

 III.  Effective  Date

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

 IV.   Background

      On  September  26, 1984,  EPA published proposed regulations in
 the Federal  Register (49 FR  37956) which  include  Requirements for
DatatSubmission (40  CFR 158.32), and Procedures  for Claims  of
Confidentiality of Data  (40  CFR 158.33).  These  regulations
                                49

-------
specify the format for data submitted to EPA under Section 3 of
FIFRA and Sections 408 and 409 of FFDCA, and procedures which
must be followed to make and substantiate claims of confiden-
tiality.  No entitlements to data confidentiality are changed,
either by the proposed regulation or by this notice.

     OPP is making these requirements mandatory through this
Notice to gain resource-saving benefits from their use before_the
entire proposed regulation becomes final. Adequate lead time is
being provided for submitters to comply with the new
requirements.

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

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

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

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

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

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

                                 50

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                             - INDEX-
A.

B.

C.




D.
E.

F.

G.
      Organization of the Submittal Package  	   3

      Transmittal Document 	   4

      Individual Studies 	       4

      C.  1  Special Considerations for Identifying Studies  .  .   5

      Organization of each Study Volume  	   6

      D.  1  Study Title Page	7
      D.  2  Statement of Data Confidentiality Claims
                   (based on FIFRA 10 (d) (1) )   	         8
      D.  3  Confidential Attachment	'....!!"   8
      D.  4  Supplemental Statement of Data Confidentiality
             Claims (other than those based on FIFRA 10(d)(l))  8
      D.  5  Good Laboratory Practice Compliance Statement   .  .   9

      Reference  to Previously Submitted Data	9

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

      Special Requirements  for Submitting  Data  to  the Docket   10

                              **************

A-    Organization of Submittal Package

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

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

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

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

     - If such materials relate to more than one study (as  for
     example a summary of all studies in a discipline)  or to the
     submittal in general,  they must be included in the submittal
     package as a separate study  (with title page and statement
     of confidentiality claims).
Text Example
Page   Page
          17
          11
                                                                      17

                                                                      12

                                                                      13
                                                                      15

                                                                      14
                                                                      16
                               51

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B.   Transmittal Document

     The first item in each submittal package must be a trans-
mittal document.  This document identifies the submitter_ or all
joint submitters; the regulatory action in support of which the
package is being submitted--i.e.,  a registration application,
petition, experimental use permit (EUP) ,  3(c)(2).(B)  data
call-in, 6(a)(2) submittal, or a special review; the transmxttal
date; and a list of all individual studies included in the
package in the order of their appearance, showing (usually by
Guideline reference number) the data requirement(s)  addressed by
each one.  The EPA-assigned number for the regulatory action
 (e.g. the registration, EUP, or tolerance petition number) should
be included in the transmittal document as well, if it is known
to the submitter.  See Attachment 1 for an example of an
acceptable transmittal document.

     The list of included studies in the transmittal of a data
submittal package supporting a registration application should be
subdivided by discipline, reflecting the order in which .data
requirements appear in 40 CFR 158.

     The list of included studies in the transmittal of a data
submittal package supporting a petition for tolerance or an
application for an EUP should be subdivided into sections A, B,
C,	 of the petition or application, as defined in 40 CFR 180.7
and 158.125,  (petitions) or Pesticide Assessment Guidelines,
Subdivision I  (EUPs) as appropriate.

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

C.   Individual Studies

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

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

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

      -  Include a company name or  mark  and study number  on each
     page of  the study, e  g , Company  Name-1986-23 .   Never reuse
     a  study  number  for marking the  pages of  subsequent  studies.

                                52

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

 C-1  Special Considerations for Identifying  Studies

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

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

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

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

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

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

     Note particularly that  product chemistry studies are likely
to contain Confidential Business Information  as defined in FIFRA
 10 (d) (l) (A),  (B), or  (C), and if so must be  handled as described
in section D.3. of this notice.
                               53

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     c   Residue Chemistry Studies.   Guidelines 171-4, 153-3,
and 153-4 are extremely broad in scope; studies addressing
residue chemistry requirements must thus be defined at a level
below that of the Guideline code.  The general principle,
however, of limiting a study to the report of a single inves-
tigation still applies fully.  Data should be treated as a single
study and bound separately for each analytical method, each
report of the nature of the residue in a single crop or animal.
species, and for each report of the magnitude of residues_
resulting from treatment of a single crop or from processing a
single crop.  When more than one commodity is derived from a
single crop  (such as beet tops and beet roots) residue data on
all such commodities should be reported as a single study.  When
multiple field trials are associated with a single crop, all such
trials should be reported as a single study.

D.   Organization of Each Study Volume

     Each complete study must include all applicable elements in
the list below, in the order indicated.   (Also see Page  17..)  _
Several of these elements are further explained in the .following
paragraphs.   Entries in the column headed  "example" cite the
page number  of this notice where the element  is illustrated.
Element

Study Title Page

Statement of Data
Confidentiality
Claims

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

 Cover Sheet to Confi-
 dential Attachment
When Required                 Example

Always                        Page 12

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

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

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

Always  - with an English language
translation if required.

At submitter's option

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

 Only if confidentiality is    Page 14
 claimed on a basis other than
 FIFRA 10 (d) (1) (A) ,  (B) ,  or (C)
                                 54

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D.I. Title Page

      A title page is always required for each submitted study,
 publxshed or unpublished.  The title page must always.be freely
 releasable to requestors; DO NOT INCLUDE CBI ON THE TITLE PAGE.
 An example of an acceptable title page is on page 12 of this
 notice.  The following information must appear on the title page:

 a.  _Study title.  The study title should be as descriptive as
 possible It must clearly identify the substance(s)  tested and
 correspond to the name of the data requirement as it appears in
 the Guidelines.

 b-   Data requirement addressed.   Include on the title page the
 Guideline number(s)  of the specific requirement(s)  addressed by
 the study.                                                     *

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

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

 e-   Performing Laboratory Identification.   if the  study reports
 work done by one or  more laboratories,  include on the title page
 the name  and address of the performing laboratory or
 laboratories, and the laboratory's  internal  project number(s)  for
 the work.   Clearly distinguish the  laboratory's project
 identifier  from any  other reference numbers  provided by the study
 sponsor or  submitter.                                           *

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

?: ,_  Facts of Publication.  If the study is  a reprint of a pub-
lished document, identity on the title page  all relevant facts of
publication, such as the  journal title, volume, issue, inclusive
page numbers, and publication date.
                                55

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D.2. Statements of Data Confidentiality Claims Under FIFRA
     Each submitted study must be accompanied by one of the two
alternative forms of the statement of Data Confidentiality Claims
specified in the proposed regulation in 158.33 (b) and (c)  (See
Attachment 3) .  These statements apply only to claims of data
confidentiality based on FIFRA 10 (d) (1) (A), (B) ,  or (C) .   Use
the appropriate alternative form of the statement either to
assert a claim of 10(d)(l) data confidentiality (158. 33 (b) )  or
to waive such a claim  (158.33 (c) ).  In either case, the
statement must be signed and dated, and must include the typed
name and title of the official who signs it.  Do not make CBI
claims with respect to analytical methods associated with pet-
itions for tolerances or emergency exemptions  (see NOTE Pg 13) .

D.3. Confidential Attachment

     If the claim is made that a study includes confidential
business information as defined by the criteria of FIFRA
10 (D) (1) (A),  (B) , or  (C)  (as described in D.2. above) all such
information must be excised from the body of the study and
confined to a separate study- specific Confidential Attachment.
Each passage of CBI so isolated must be identified by a reference
number cited within the body of the study at the point from which
the passage was excised  (See Attachment 5) .

     The Confidential Attachment to a study must be identified by
a cover sheet fully identifying the parent study, and must be
clearly marked "Confidential Attachment."  An appropriately
annotated photocopy of the parent  study title page may be used as
this cover sheet.  Paginate the Confidential Attachment
separately from the body of the study, beginning with page_l of X
on the title page.  Each passage confined to the Confidential
Attachment must be associated with a specific cross reference to
the page(s) in the main body of the study on which  it is cited,
and with a reference to the applicable passage (s) of FIFRA
10 (d) (1) on which the confidentiality claim is based.

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

     If you wish to make a claim of confidentiality for any
portion of a submitted study other than described by FIFRA 10 (d)
 (1) (A) ,  (B) , or  (C) , the following provisions apply:

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

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

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

                                56

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 D.5. Good Laboratory Practice Compliance Statement

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

 E-   Reference. to Previously Submitted Data

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

 F-   Physical Format Requirements

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

 Please  be particularly attentive to the following points:

          Do not include frayed or  torn pages.

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

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

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

          Do not bind any documents with  glue or binding tapes.

          Make sure  that  all  pages of each study, including any
          attachments or  appendices, are  present and  in  correct
          sequence .
Number of Copies
                               - All submittal packages except
those associated with a Registration Standard or Special Review
(See Part G below) must be provided In three complete, identical
copies.  (The proposed regulations specified two copies; three
are now being required to expedite and reduce the cost of
processing data into the OPP Pesticide Document Management System
and getting it into review.)
                                57

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G.   Special Requirements for Submitting Data to the Docket

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

         Remove the "Supplemental Statement of Data
          Confidentiality Claims".

         Remove the "Confidential Attachment".

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

         Mark the fourth copy plainly on both its cover and its
          title page with the phrase "Public Docket Material -
          contains no information claimed as confidential".
V.
For Further Information
     For further information contact John Carley, Chief,
Information Services Branch, Program Management and Support
Division,  (703) 305-5240.
                      /ACtine Sirtctor,
                     "'JtegiatratLon Division
Attachment 1.
Attachment 2.
Attachment 3,
Attachment 4.

Attachment 5.
Attachment 6.
Attachment 7.
         Sample Transmittal Document
         Sample Title Page for a Newly Submitted Study
         Statements of Data Confidentiality Claims
         Supplemental Statement of Data Confidentiality
         Claims
         Samples of Confidential Attachments
         Sample Good Laboratory Practice Statements
         Format Diagrams for Submittal Packages and Studies
                                58

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                           ATTACHMENT 1

       ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*

 1-    Name and address of submitter (or all joint submitters**)
 +Smith Chemical Corporation
  1234 West Smith Street
  Cincinnati,  OH 98765
                -and-
Jones Chemical Company
5678 Wilson Blvd
Covington, KY 56789
 +Smith Chemical  Corp will act as sole agent  for all  submitters.

 2    Regulatory  action in support  of which this package is
      submitted

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

 3.    Transmittal date

 4.    List  of submitted studies

      Vol 1.
     Vol 2.


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

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

Title of nth study in the submittal (Guideline
No.)
          Applicants commonly provide this information in a tran-
          smittal letter.  This remains an acceptable practice so
          long as all four elements are included.

          Indicate which of the joint submitters is empowered to
          act on behalf of all joint submitters in any matter
          concerning data compensation or subsequent use or
          release of the data.
Company Official:.
Company Name:.
Company Contact:
                    Name
                         Signature
                    Name
                         Phone
                               59

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                   ATTACHMENT 2

SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY

                    Study Title

   (Chemical name)  - Magnitude  of  Residue on Corn

                  Data Requirement

                  Guideline 171-4

                       Author

                   John C. Davis

                 Study Completed On

                  January 5, 1979

               Performing Laboratory

           ABC Agricultural Laboratories
                 940 West Bay Drive
                Wilmington,  CA  39897

               Laboratory Project  ID

                     ABC 47-79
                     Page 1 of X
    (X is -the  total number of pages  in the study)

                          60

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                            ATTACHMENT 3

             STATEMENTS OF DATA CONFIDENTIALITY CLAIMS

 1. No claim of confidentiality under FIFRA 10 (d) (1) (A), (B) , or
 \ ^ / *


        STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS
   No claim of confidentiality is made for any information
   contained in this study on the basis of its falling within
   the scope of FIFRA 610(d) (1) (A) ,  (B), or  (C).
   Company
   Company Agent:

  	Title
 Typed Name
Date:
                                                Signature
 2.  Claim of confidentiality under FIFRA 10 (d) (1) (A), (B) , or


             STATEMENT OF DATA CONFIDENTIALITY CLAIMS
   Information claimed confidential on the basis of its falling
   within the scope of FIFRA 10(d)(l)(A), (B),  or (C)  has been
   removed to a confidential appendix, and is cited by
   cross-reference number in the body of the study.
   Company:
   Company Agent:

  	Title
Typed Name
                          Date:
                                                Signature
NOTE: Applicants for permanent or temporary tolerances  should
note that it is OPP policy that no permanent tolerance,  temporary
tolerance, or request  for  an emergency exemption incorporating an
analytical method, can be  approved unless  the applicant waives
all claims of confidentiality for the  analytical method.   These'
analytical methods are published in the FDA Pesticide Analytical
Methods Manual, and therefore cannot be claimed  as  confidential.
OPP implements this policy by returning submitted analytical
methods, for which confidentiality claims  have been made,  to the
submitter, to obtain the confidentiality waiver  before  they can
be processed.                                              *
                                61

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                          ATTACHMENT 4

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

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

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

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

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

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

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

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

         If you assert that the information in voluntarily sub-
          mitted, indicate whether you believe disclosure of this
          information might tend to lessen the availability to
          EPA of similar  information in the future, and if so,
          how.
                                62

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                                ATTACHMENT 5

             EXAMPLES  OF SEVERAL  CONFIDENTIAL ATTACHMENTS

 Example l.  (Confidential word or phrase  that has been deleted
 from the study)
    CROSS  REFERENCE NOMBER 1  This cross reference  number is used in the study
                             in place of the following words or phrase at the
                             indicated volume and  page references.
    DELETED WORDS OR PHRASE:.
                                          Kt-Ky-1c.no
       6
     12
    100
14
25
19
REASON FOR THE DELETION

Identity of Inert  Ingredient
FIFRA REFERENCE

10 (d) (1) (C) .
Example 2.  (Confidential paragraph(s)  that have been deleted from the study)
  CROSS REFERENCE NUMBER 5 This cross reference number is used in the study
                           in place  of the following paragraph (s)  at the
                           indicated volume and page references.
   DELETED PARAGRAPH (S):
 PAGE
  20.
            Reproduce the deleted paragraph(s) here
LINES REASON FOR THE  DELETION                   FIFRA REFERENCE

2-17  Description of  the quality control process   10 (d) (1) (C)
Example 3.  (Confidential pages that have been deleted from the study)
 CROSS REFERENCE NOMBER 7 This cross reference number noted on a place-
                         holder page is used in place of the  following
                         whole pages at the indicated volume  and page
                         references.

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

  PAGE LINES      REASON FOR THE DELETION                   FIFRA REFERENCE

  20.  2-17 Description of the product manufacturing process   10 (d) (1) (A)
                                     63

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                                ATTACHMENT 6.

                  SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
Example 1.
     This study meets the requirements for 40 CFR Part 160

           Submitter 		

           Sponsor   		
           Study Director
Example 2.
    This study does not meet the requirements of 40 CFR Part 160, and differs
    in the following ways:
    1.
    3.
          Submitter_

          Sponsor	
          Study Director_
Example 3.
    The submitter of this  study was neither the sponsor of this study nor
    conducted  it,  and  does not  know whether  it has  been conducted  in
    accordance with 40 CFR Part 160.

          Submitter		
                                      64

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LEGEND
                             ATTACHMENT 7.

                    ^FORMAT OF THE SUBMITTAL PACKAGE
                      Transmittal Document.
                           Qp SUBMITTED STUDIES
                         and
                   title page.

                 Statement of Conridertciality dates
                               of tn
                                                       .ppropcfate
                  -r
                    U
                        i
1 ^^-Appndice to the tudy.

 1
   r

 ~J"~'1       Confidential Attachment.
    .->l
           1
         ^ J
**"^wn"M* Statement
of Confidentiality Claims.
                     *
                     finalized.
            ^j     Documents submitted at fEmitter's option.
                            65

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PR Notice  91-2
      67

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tSR
               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(1).  Accordingly,  the Agency has
 established the nominal concentration as the only acceptable
 label claim for the amount  of  active  ingredient in the product.

 II. BACKGROUND

    _ For some time the Agency  has accepted two different methods
 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

                                69

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CFR 158.175(0)(3).

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

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

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

III. REQUIREMENTS

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

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

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

VI. FOR FURTHER INFORMATION

Contact Tyrone Aiken for information or questions concerning
this notice on (703) 308-7031.
                                 Ann* fi. fcindaay, Director
                                 Registration Division (H-75O3
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APPENDIX F. Product Specific Data Call-in
                   73

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                               DATA CALL-IN NQTTCR
  CER'llblBD 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 Sh* to
 submit certain product specific data  as noted herein to the U.S. Environmental Protection
 Agency (EPA, the Agency). These data are necessary to maintain the continued registration of
 your produces) containing this active ingredient.  Within 90 days after you receive this Notice
 you must respond as set forth in Section JH 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

              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 m-B); or                                                   '

              Why you believe EPA should not require your submission  of product specific
              data in the manner specified by this Notice (see section HI-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 yourproducts subject to this Notice in Attachment B, Data Call-in Response Form as well
as a list of all  registrants who were sent this Notice (Attachment F).

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

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information and instructions applicable to all Data Call-in Notices.  The Attachments contain
specific chemical infonnation and instructions.  The six sections of the Notice are:

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

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

5
7
8
SECTIONI.  WHY YOU ARE RECEIVING THIS NOTICE

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

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

H-B. SfTHBHTTT Jj FOR SUBMISSION OF DATA

    You are required to  submit the data or otherwise satisfy the data requirements specified ii
Attachment C,  Requirements Status and Registrant's Response Form,  within the time frames
provided.
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 H-C.  TESTING PROTOCOL

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

        These EPA Guidelines are available from the National Technical  Information Service
 (NTIS), 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
 hi the  Pesticide Data Requirements regulation (40 CFR  158.70).   When using the  QECD
 protocols, they should be modified as appropriate so that the data generated by the study will satisfy
 the requirements of 40 CFR  158.  Normally, the Agency will not extend deadlines for complying
 with data  requirements  when the studies were not  conducted  in  accordance with acceptable
 standards.   The OECD protocols are available from OECD,  1750 Pennsylvania Avenue N W
 Washington, D.C. 20006.                                                           "  "'

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

 n-D- REGISTRANTS RECEIVING PREVIOUS SECTION 3(cV2)(E) NOTICES
     ISSUED BY THE AGENCY

     Unless otherwise noted herein, this Data Call-in does not in anv wav supersede or change the
 requirements of any previous Data Call-InCsV 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 m.  COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE

 HI-A.  SCTranTTT.T; 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.

 m-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

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requirements of this Notice is contained in Section m-C.
requests for data waivers is contained in Section ni-D.
A discussion of options relating
      There are two forms that accompany this Notice of which, depending upon your respons
one or both must be used in your response to the Agency.   These forms are the
Response Form, and the Requirements Status and Registrant's Response Form. Attachment B an(|
Attachment C. The Data Call-In Response Form must be submitted as part of every response to
Notice.  In addition,  one copy of the Requirements Status and Registrant's Response Form mus
be submitted for each product listed on the Data Call-in Response Form unless the voluntai
cancellation option is  selected or unless the product is identical to another (refer to the instructior
for completing the Data Call-in Response Form in Attachment B). Please note that the company'!
authorized representative is required to sign the first page of the Data Call-in Response Form anJ
Requirements Status  and Registrant's Response Form (if this form  is required) and initial anj
subsequent pages. The forms contain separate detailed instructions on the response options. Do nc
alter the printed material. If you have questions or need assistance in preparing your response, ca
or write the contact person(s) identified in Attachment A.

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

      If you chose to voluntarily cancel  your product, further sale and distribution of your produc
after the effective date of cancellation must be in accordance with the Existing Stocks provision|
of this Notice which are contained in Section IV-C.
       2.  Satisfying the Product Specific Data Requirements of this Notice There are varioul
options available to satisfy the product specific data requirements of this Notice. These options
discussed in Section M-C of this Notice and comprise options 1 through 6 on the
Status and Registrant's Response Form and item numbers 7a and 7b on the Data Call-in
Form.  Deletion of a use(s) and the low volume/minor use option are not valid options for fulfilling
product specific data requirements.

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

TTT-f. SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE

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

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

        (1)    I will generate and submit data within the specified time frame (Developing Data)
        (2)    I have entered 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 Agency
 which includes:  (1) a detailed description of the expected difficulty and  (2) a proposed schedule
 including alternative dates for meeting such requirements on a step-by-step basis. You must explain
 any technical or laboratory difficulties and provide documentation from the laboratory performing
 the testing.  While EPA is considering your request, the original deadline remains.  The Agency
 will respond to your request in writing.  If EPA does not grant your request, the original deadline
 remains.  Normally,  extensions can be requested only in cases of extraordinary testing problems
 beyond the expectation or control of the registrant. Extensions will not be given in submitting the
 90-day responses. Extensions will not be considered if the request for extension is not made in a
timely fashion; in no event shall an extension request be considered if it is submitted at or after the
lapse of the  subject deadline.

      Option 2, Agreement to Share in Cost to Develop Data  - Registrants may only choose this
option for acute toxicity data and certain efficacy data and only if EPA has indicated in the attached
data tables that your product and at least one other product are similar for purposes of depending

                                           79

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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 I
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 hi 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 I
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.                      I

       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, I
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 8570-32,1
Certification  of Offer to Cost Share  hi the Development of Data, Attachment G.  In addition, you!
must demonstrate that the other registrant to whom the offer was made has not accepted your offer!
to enter imxra  cost sharing  agreement by including a copy of your offer and proof of the other!
registrant's receipt of that offer (such as a certified mail receipt).  Your offer must, in addition to!
anything else, offer to share in the burden of producing the data upon terms to be agreed or failing!
agreement to be bound by binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii) and must!
not qualify this offer.  The other registrant must also inform EPA of its election of an option to!
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.                                                             I

       In order for you to avoid suspension under this option, you may not withdraw your offerl
to share in the burdens of developing the data.  In addition, the other registrant must fulfill itsl
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 asl
that of the other registrant will normally be subject to initiation of suspension proceedings, unlessl
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.                  I

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

       You should be aware that if the Agency determines that the study is not acceptable  the
Agency will require you to comply with this Notice, normally without an extension of the required
date of submission.  The Agency may determine at any 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)  "  'raw  data' means any laboratory  worksheets,  records,
             memoranda,  notes, or  exact  copies thereof, that are the  result of original
             observations and activities of a study and are necessary for  the reconstruction and
             evaluation of the report of that study.  In the event that exact transcripts of raw data
             have been prepared  (e.g., tapes which have been transcribed verbatim, dated, and
             verified accurate by signature), the exact copy or exact transcript may be substituted
             for the original source as raw  data.  'Raw data' may include photographs, microfilm
             or  microfiche copies, computer printouts,  magnetic media,  including dictated
             observations,  and  recorded data from  automated instruments."    The  term
             "specimens", according to 40 CFR 160.3(k), means "any material derived from a
             test  system for examination or analysis."

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

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

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

       Option 5. Upgrading a Study - If a study has been classified as partially acceptable anc
upgradable,  you may submit data to upgrade that study.   The Agency  will review the date
submitted and determine if the requirement is satisfied. If the Agency decides the requirement i
not satisfied,  you may still be required to submit new data normally without any time extension]
Deficient, but upgradable  studies will normally be classified as supplemental.  However, it ij
important to  note that not all studies classified as supplemental are upgradable.  If you havd
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 yoi
must satisfy or supply information to correct all deficiencies in the study identified by EPA. Yoi
must provide a clearly articulated rationale of how the deficiencies have been remedied or correc
and why the study should be rated as acceptable to EPA. Your submission must also specify
MRID number(s) of the study which you are attempting to upgrade and must be in conformanc
with PR Notice 86-5.

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

       This option should also be used to cite data that has been previously submitted to upgrade!
a study, but has not yet been reviewed by the Agency.  You  must provide the MRID number o|
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
data submissions intended to upgrade studies. Additionally your submission of data intended
upgrade studies must be accompanied by  a certification that you comply with each of those criteri^
as well as a certification regarding protocol compliance with Agency requirements.

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

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

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

 m-D  REQUESTS FOR DATA WAIVERS

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

 TV-  CONSEQUENCES OP FAILURE TO COMPLY WITH THIS NQTTra

IV-A NOTICE OF INTENT TO SUSPEND

       The Agency may issue a Notice of Intent to Suspend products subject to this Notice due to
failure by a registrant to comply with the requirements of this Data Call-in Notice, pursuant to
FIFRA section 3(c)(2)(B).  Events which may be the basis  for issuance of a Notice of Intent to
Suspend include, but  are not limited to, the following:
       1.


       2.


       3.


       4.

       5.
Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.

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.

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

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

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

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

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

      8.     Failure of the registrant to whom you have tendered an offer to share in the cost
             developing data and provided proof of the registrant's receipt of such offer or fail
             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 Notic
                   on a Data Call-In Response Form and a Requirements Status and Regist
                   Response Form:

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

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

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

IV-B.  BASIS FOR DETERMINATION THAT SUBMT1THD STUDY IS
UNACCEPTABLE

      The Agency  may determine that a study (even if submitted within the required time)
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds foi]
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  incorporat
      by reference (including, as  applicable,  EPA Pesticide  Assessment  Guidelines,  Da
      Reporting Guidelines, and GeneTox Health Effects Test Guidelines) regarding the designj
      conduct, and reporting of required studies.  Such requirements include, but are not limite
      to, those relating to test material, test procedures,  selection of species, number of animalsJ
      sex and distribution of animals,  dose and effect levels to be tested or attained, duration oij
      test,  and, as  applicable, Good Laboratory Practices.

      2.  EPA requirements regarding the submission of protocols, including the incorporation 01
      any changes  required by the Agency following review.

      3.  EPA requirements regarding the reporting of data, including the manner of reporting J
      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 containe
      in  PR 86-5.  All studies must be submitted  in the form of a final report; a prelii
      report will not be considered to fulfill the submission requirement.
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 IV-C EXISTING STOCKS OF SUSPENDED OR CANCELED PRODUCTS

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

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

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

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

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

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

                                           85

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SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE

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

      All responses to this Notice  (other than voluntary cancellation requests and generic dat
exemption claims) must include a  completed Data Call-In Response Form and a complete
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, anJ
should be submitted to the contact person(s)  identified in Attachment A.  If the volunt?
cancellation or generic data exemption option is chosen, only the Data Call-in Response Form ne
be submitted.

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

                   Sincerely yours,
                   Daniel M. Barolo, Director
                   Special Review and
                     Reregistration Division
Attachments"
       2
       3
       4

       5
       6
       7
Data Call-in Chemical Status Sheet
Product-Specific Data Call-In Response Form
Requirements Status and Registrant's Response Form
EPA  Grouping  of End-Use  Products for Meeting  Acute Toxicology  Dat
Requirements for Reregistration
EPA Acceptance Criteria
List of Registrants Receiving This Notice
Cost Share and Data Compensation Forms, and Product Specific Data Report Fc
                                          86

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Attachment 1. Chemical Status Sheet
               87

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uraiuM HYPOCHLOETTE DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

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

      This Product Specific Data Call-In Chemical Status Sheet, contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of
Lithium Hypochlorite.  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 Requirement (Attachment D), (5) the
EPA Acceptance Criteria (Attachment E), (6) a list of registrants receiving this DCI
(Attachment F) and (7) the Cost Share and Data Compensation Forms in replying to this
Lithium Hypochlorite Product Specific Data Call[-]In (Attachment G).  Instructions and
guidance accompany each form.

DATA REQUIRED BY THIS NOTICE

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

INQUIRIES AND RESPONSES TO THIS NOTICE

      If you have any questions regarding the generic database  of Lithium Hypochlorite, please |
contact Ron Kendall at (703) 308-8068.

      If you have any questions regarding the product specific data requirements and
procedures established by this Notice, please contact Veronica Dutch (703) 308-8585. All
responses to this Notice for the Product Specific data requirements should be submitted to:

            ARE, Product Manager Team 52
            Special Review and Reregistration Branch 7508W
            Office of Pesticide Programs
            U.S. Environmental Protection Agency
            Washington, D.C.  20460

            RE: Lithium Hypochlorite

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Attachment 2. Product Specific Data Call-in Response
      Forms (Form A inserts) Plus Instructions
                       89

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

 ItemS.
Item 6.
              Already completed by EPA.

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

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

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

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

Items 8-11.   Self-explanatory.

      Note: You may provide additional information that does not fit on this form in a signed  letter
      that accompanies this form. For example, you may wish to report that your product has
      already been transferred to another that you have already voluntarily cancelled this product.
      For these cases, please supply all relevant details so that EPA can ensure that its records
      are correct.
Item 7a.


Item 7b.
                                          91

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Attachment 3. Product Specific Requirement Status and
  Registrant's Response Forms (Form B inserts) and
                    Instructions
                        93

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

 Item 6.
Item 7.
Item 8.
Item 9.
 Completed by EPA.  Note the unique identifier number assigned by EPA in item 3.
 This number must be used in the transmittal document for any data submissions in
 response to this Data Call-In Notice.

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

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

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

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

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

 Enter Only one of the following response codes for each data requirement to show
 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 toxicity or certain efficacy data and only if EPA
 indicates in an attachment to this notice that my product is similar.  Enough to
 another product to  qualify for this  option.  I certify that another party in the
 agreement is committing to submit or provide the required data; if the required study
 is not submitted on time, my product my be subject to suspension.

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

                              95

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

4.     By the specified  due date, I will submit an existing study that has not beel
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 datl
outlined in option 4 in the Data Call-In Notice (Section m-C.l.) and will meet thl
attached acceptance criteria (for acute toxicity and product chemistry data). I wil
attach the needed supporting information along with this response.  I also certify th J
I have determined that this study will fill the data requirement for which I  havl
indicated this choice.                                                       I

5.     By the specified due date, I will submit or cite data to upgrade a  studl
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 bl
upgraded and what information is required to do so.  I will provide the MRID ol
Accession number of the study at the due date.  I understand that the conditions fol
this Option outlined  Option 5 in the Data Call-in Notice (Section m-C.l.) apply.I

6.     By the specified  due date, I will cite an existing study that the Agency hal
classified as acceptable or an existing study that has been submitted but not reviewel
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 efficaci
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 fol
purposes of depending on the same data.  I may also choose this option if I am citinl
my own data.  In either case, I will provide the MRID or Accession number (a
number (s) for the cited data on a "Product Specific Data Report" form  or in I
similar format.  If I cite another registratrant's data, I will submit a completel
"Certification With Respect To Data Compensation Requirements" form.        I

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

                               96

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

Items 10-13.  Self-explanatory.

       NOTE:You may provide additional information that does not fit on this form in a signed
letter that accompanies this  form.  For example, you may wish to report that your product has
already been transferred to another company  or that  you have already voluntarily cancelled this
product. For these cases, please supply all relevant details so that EPA can ensure that its records
are correct.
                                           97

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Attachment 4. EPA Batching of End-Use Products for
   Meeting Data Requirements for Reregistration
                       99

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 EPA'S DECISION ONBATCHING PRODUCTS CONTA1MNGIITHIUMHYPOCHLORITE
 FOR PURPOSES OF MEETING  ACUTE TOXICITY DATA  REQUIREMENTS  FOR
 REREGISTRATTON

        In an effort to reduce the time, resources and number of animals needed to fulfill the
 acute toxicity data requirements for reregistration of products containing the active ingredient
 lithium hypochlorite, the Agency considered batching 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.).  Note that the
 Agency is not describing batched products as "substantially similar" since some products within
 a batch may not be considered chemically similar or have identical use patterns.

        Using available information, batching has been accomplished by the process described
 above. Acute toxicity data on individual products has frequently been found to be incomplete.
 Notwithstanding the batching process, the Agency reserves the right to require, at any time,
 acute toxicity data for an individual product should the need arise.

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

       In deciding how to meet the product specific data requirements, registrants must follow
the directions given in the Data Call-In Notice and its attachments appended to the RED. The
DCI Notice contains two response forms which are to be completed and submitted to the Agency
within 90  days of receipt. The first form, "Data Call-In Response", asks whether the registrant
will meet the data  requirements for each product.  The second form,  "Requirements Status and
Registrant's Response", lists the product specific data required for each  product, including the
standard six acute toxicity tests.  A registrant who wishes to participate in a batch must decide
whether he/she will provide the data or depend
                                          101

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on someone else to do so. If a registrant supplies the data to support a batch of products, he/she
must select one of the following options:
       Developing Data (Option 1),
       Submitting an Existing Study (Option 4),
       Upgrading an Existing Study (Option 5),
       or Citing an Existing Study (Option 6).

If a registrant depends on another's data, he/she must choose among:
       Cost  Sharing (Option 2),
       Offers to Cost Share (Option 3),
       or Citing an Existing Study (Option 6).

If a registrant does not want to participate in a batch, the choices are Options 1, 4, 5 or 6.
However, a registrant should know that choosing not to participate in a batch does not preclude
other registrants in the batch from citing his/her studies and offering to cost share
(Option 3) those studies.
       Table I lists 3 batches of lithium hypochlorite products.
Table I.
Batch
1

















EPA Reg. No.
3525-33
3525-96
7152-15
7152-19
7368-68
7675-1
7675-4
8791-51
5185-384
5185-385
7368-75
7675-5
7675-7
7675-8
7675-9
12014-31
24310-1 '
45309-13
% of Lithium
hypochlorite
29.0
ft
tt
ft
Tt
tf
If
If
n
tt

n
tt
n
tt
H
n
tr
Formulation
Type
granules
n
n
H
n
"
n

R
tt
n
ti
n
n
tt
ft
tt
H
                                          102

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                                           Table I (cont.)
                              3432-56
                              3432-57
                               6809-6
                              5185-323
                              5185-336
                              5185-340
                              5185-419
                              5185-431
                              6284-50
                              7124-84
                              7124-88
                              7675-6
                              8791-34
                             42177-15
                             42177^9
                             42177-54
                             42177-55
                             45309-5
                             45309-58
                             57787-14
       Table H lists the products which could not be batched. For the purposes of acute toxicity
batching, these products were not considered similar, or their similarity could not be determined
using the information available.  The registrants of these products are responsible for meeting
the acute toxicity data requirements specified in the data matrix for end-use products.
Table H.
          EPA Reg. No.
            ==
            1258-1194
            =====
            5185-369
             "-~
             10079-4
of Lithium Hypochlorite
       	
       65.0
       __
       27.0
       
       29.0
                                             103

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Attachment 5. EPA Acceptance Criteria
                105

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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
                                       107

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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


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.
          Description of each beginning material hi 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.

       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 hi each step and
                the parameters that are maintained.
          	 Statement of whether process involves intended chemical reactions.
                Flow chart with chemical equations for each intended chemical reaction.
          	 Duration of each step of process.
          	 Description of purification procedures.
          	 Description of measures taken to assure quality of final product.

          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).
                                                  108

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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?

 L	  Five or more representative samples (batches in case of batch process) analyzed for each active ingredient
         and all impurities present at  >_ 0.1 %.
         Degree of accountability or closure .>. ca 98 %.
         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.].
         Complete and detailed description of each step in analytical method used to analyze above samples.
         Statement of precision and accuracy of analytical method used to  analyze above samples
         Identities and quantities (including mean and standard deviation) provided for each analyzed ingredient
         Upper and lower certified limits proposed for each active ingredient and intentionally added inert along
         with explanation of how the limits were determined.
         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.
         Analytical methods to verify certified limits of each active ingredient and impurities  flatter not required
         if exempt from requirement of tolerance or if generally recognized as safe by FDA) are fully described
         Analytical methods (as discussed in #9) to verify certified limits validated as to their precision and
         accuracy.
 2.
 3."
 4.
 5."
 6."
 7."
 8.
 9.
10.
                                                 109

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                                63 Physical and Chemical Characteristics

                                       ACCEPTANCE CRITERIA


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

Does your study meet the following acceptance criteria?

63-2 Color
    	  Verbal description of coloration (or lack of it)
          Any intentional coloration also reported in terms of Munsell color system
63-3 Physical State
    	  Verbal description of physical state provided using terms such as "solid, granular, volatile liquid"
    	  Based on visual inspection at about 20-25 C

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

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

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

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

63-8 Solubility
    	  Determined in distilled water and representative polar and non-polar solvents, including those used hi
          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
           20-25C)
                                                   110

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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
                                                 111

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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
                                                112

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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 an * are supplemental and may not be required for every study.

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


                                       ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?

 1.	Identify material tested (technical, end-use product, etc).
 2.	At least 5 animals/sex/group.
 3.*	Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-450 gm.
 4.	Dosing, single dermal.
 5.	Dosing duration at least 24 hours.
 6.*	Vehicle control, only if toxicity of vehicle is unknown.
 7.	Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg).
 8.	Application site clipped or shaved at least 24 hours before dosing.
 9.	Application site at least 10% of body surface area.
10.	Application site covered with a porous nonirritating cover to retain test material and to prevent
        ingestion.
11.	Individual observations at least once a day.
12.	Observation period to last at least 14 days.
13.	Individual body weights.
14.	Gross necropsy on all animals.
                     Criteria marked with an * are supplemental and may not be required for every study.
                                                   114

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                                 81-3 Acute Inhalation Toxicity in the Rat
                                        ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
 1.
3.
4."
5."
6-]
7.
        Identify material tested (technical, end-use product, etc).
        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 /tm or less).
        At least 5 young adult rats/sex/group.
        Dosing, at least 4 hours by inhalation.
        Chamber ah- flow dynamic, at least 10 air changes/hour, at least 19% oxygen content.
        Chamber temperature, 22 C (2), relative humidity 40-60%.
        Monitor rate of air flow.
        Monitor actual  concentrations of test material in breathing zone.
        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.
9.
                                                 115

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                               81-4  Primary Eye Irritation in the Rabbit


                                       ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?

 1.	Identify material tested (technical, end-use product, etc).
 2.	Study not required if material is corrosive, causes severe
        dermal irritation or has a pH of <2 or >11.S.
 3.	6 adult rabbits.
 4,_	Dosing, instillation into the conjunctival sac of one eye
        per animal.
 5.	Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if a solid, paste or particulate substance.
 6.	Solid or granular test material ground to a fine dust.
 7.	Eyes not washed for at least 24 hours.
 8.      Eyes examined and graded for irritation before dosing and
        at 1, 24, 48 and 72 hr, then daily until eyes are normal
        or 21 days (whichever is shorter).
 9.*	Individual daily observations.
                     Criteria marked with an * are supplemental and may not be required for every study.
                                                   116

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                                  81-5 Primary Dermal Irritation Study

                                        ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

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

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                              81-6 Dermal Sensitization in the Guinea Pig

                                       ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?

1.	Identify material tested (technical, end-use product, etc).
2.	Study not required if material is corrosive or has a
      pHof.<2or >.11.5.
3.	One 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 an * are supplemental and may not be required for every study.
                                                   118

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Attachment 6. List of All Registrants Sent This Data Call-in (insert)
                              Notice
                               119

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Attachment 7. Cost Share Data Compensation Form, and Confidential
                  Statement of Formula Form
                            121

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tractions 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.


            d.


            e.


            f.

            g-


            h.


            i.
           k.

           1.



           m.




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

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

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

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

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

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

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

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

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

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

When new CSFs are submitted  and approved, all previously submitted CSFs
become obsolete for that specific formulation.
                                               125

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


OMB No. 2070-D106
        2070-0057

Approval Expires 3-31-96
  Public reporting burden for this coBection 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 buiden estimate or any other
  aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Poficy
  Branch. PM-223. U.S. Environmental Protection Agency, 401 M St., S.W.. Washington, DC 20460; and to Jhe Office
  of Management and Budget, Paperwork Reduction Project {2070-0106), Washington, DC 20503.

  Please fill In blanks below.


Company INmnber
KPA Kff.Xn.
 J  Certify that:

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

 My firm has offered in writing to enter into such an agreement.  That offer was irrevocable and included an
 offer to be bound  by arbitration decision under section 3(c}(2}(B)(iu) of FIFRA if final agreement on all
 terms could not be reached otherwise. This offer was made to the following firm(s) on the following
 date(s):
  Nam* of Flrm(>
                                                                          Date of Offer
Certification:
I certify that 3 am duly authorized to represent the company named above, and that the statements that I  have made on
this form and an attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fme or imprisonment or both under applicable law.
Signature ef Company'* Authorized Rpra*ntaHv
Maim and Title (P1a Typo or Print}
Dal*

                                             127

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                          United States Environmental Protection Agency
                                      Washington, DC 20460
                             CERTIFICATION WITH RESPECT TO
OIU M*. 3070-0101
        2070-MS7
                             	  '-* nun  ncor Cv I  Iw
  	DATA COMPENSATION  REQUIREMENTS;  w.. ww,








   Please nil In blanks below.
  iCertSytnat:
  "

  a'
  
    IJ  TT companies who hav* submitted the
        shwts. or mdica.d on tne ait^tHM -Requirement

               rereglstration under FIFRA.
 Ni we Tlti* (PIMM Type er
           feregBtntcn o ny products, to tntem required ^
                         Mat)
EPA Fwm U70-31 (4-eO)
                                            129

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