United States       '
                     Environmental Protaction
                     Agency
                      Prevention, Pesticides
                      And Toxic Substances
                      (7508W)
EPA-738-F-93-026
December 1993
&EPA   R.E.D.   FACTS
          Pesticide
     Reregistration
Peroxy   Compounds

     All             or used in the United     must be         by
EPA, based on icienliflc studies showing that they can be used without
unreasonable     to people or the environment.  Because of advances in
scientific knowledge, the law requires  that pesticides which were first
registered years ago be reregistered to ensure that they meet today's more
stringent standards.
     In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human health
and environmental effects of each pesticide. The Agency imposes any regu-
latory controls that are needed to effectively manage each pesticide's risks,
EPA then reregisters pesticides that can be used without posing undue hazards
to human health or the environment.
     When a pesticide is eligible for reregistration, EPA announces this and
explains why in a Reregistration Eligibility Decision (RED) document.  This
feet sheet summarizes the information in the RED document for the Peroxy
Compounds, including hydrogen peroxide, peroxyacetic acid, and potassium
peraxymonosullate sulfate.
        Use Profile
     The peroxy compounds are microbiocides. When mixed with water and
applied by spraying, fogging or immersing, they kill bacteria, fungi  and
viruses on hard surfaces including equipment, floors and walls, indoors in
agricultural premises, food establishments, commercial/industrial locations,
hospital/medical  institutions, and bathrooms  in  residences.   Hydrogen
peroxide and peroxyacetic acid products are formulated as liquids, and the one
registered  product  that contains potassium peroxymonosulfate  sulfate is
formulated as a solid soluble concentrate.
        Regulatory       Hydrogen peroxide, peroxyacetic acid and potassium peroxymonosulfate
           History   sulfate products were first registered in the United States as pesticides as early
                     as 1977, 1985 and 1968 respectively, for use as disinfectants, sanitizers and
                     sterilants.   Currently,  23  products are registered which contain  peroxy
                     compounds as active ingredients; 11 products contain hydrogen peroxide, 11
                     products contain peroxyacetic  acid,  and one product contains
                     peroxymonosulfate sulfate.  Under a Memorandum of Understanding
                     by  EPA and the Food and Drug  Administration in June 1993, EPA has
                     primary regulatory jurisdiction over the peroxy compounds.

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Human Health   Human Toxtcity
   Assessment        The three peroxy compounds are oxidizing  agents.  They can react,
                    sometimes violently, with reducing agents, so in concentrated form they must
                    be handled with care.
                         These compounds are corrosive and severely irritating to the eyes, skin
                    and  mucous membranes.  They have been placed in Toxicity Category I,
                    indicating the greatest degree of acute toxicity, for eye and dermal irritation.
                    In contrast,  they are not extremely toxic by the oral route, and are placed in
                    Toxicity Category IE for acute  oral effects.   It is because of their very
                    reactive properties and moderately low oral toxicity that dilute concentrations
                    of peroxy  compounds  have  found wide  applications and safe  use  as
                    disinfectants.
                         Based on their chemical reactivity, the peroxy compounds are expected
                    to have biological activity, particularly with molecules.  Hydrogen peroxide,
                    for example, is known to be  mutagenic.
                    Dietary Exposure
                         Hydrogen peroxide and  peroxyacetic acid are used in  dairy/cheese
                    processing plants, on  food  processing equipment  and in pasteurizers  in
                    breweries, wineries and beverage plants.   Although food may come into
                    contact with treated equipment, only trace amounts of the  chemicals would
                    remain on equipment, since  both compounds degrade rapidly in air to form
                    oxygen and  water.  No residues of these pesticides are expected to remain in
                    food.
                         When potassium peroxymonosulfete sulfate is  used to disinfect poultry
                    bouses, hatcheries and processing plants, it does not come into direct contact
                    with animals or food.  The animals or meat/eggs  are removed before use,
                    which is followed by a potable water  rinse and drying time before the animals
                    or food are  reimroduced.  This is considered a non-food use  and no  dietary
                    exposure is expected to result.
                    Occupational  and Residential Exposure
                         Applicators/mixers  may  be  exposed  to hydrogen  peroxide and
                    peroxyacetic acid when these chemicals are applied as sprays, wipe/mop-on
                    or immersion  solutions,  to disinfect  industrial/commercial  floors,  food
                    processing  equipment,  pasteurizers,   medical   equipment  or residential
                    bathroom  surfaces.  When potassium peroxymonosulfate sulfate is applied in
                    poultry houses, hatcheries  and processing  plants by  spraying, misting  or
                    fogging, dermal and inhalation exposure of applicators  is expected.   These
                    exposures are of concern since  the peroxy  compounds are  corrosive and
                    severely irritating  to  the skin, eyes and mucous  membranes.  However,
                    product labels require the use of protective equipment including protective
                    clothing, rubber gloves, and  goggles, a  face shield or safety glasses.  Labels
                    also  recommend thorough washing (including clothing) with soap and water

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                        after handling.  These measures sufficiently minimize exposure and risk to
                        applicators/mixers.
                        Human Risk Assessment
                             Essentially no  dietary exposure  occurs  from  use of  the  peroxy
                        compounds, so no dietary or chronic risks are posed.  These chemicals are
                        corrosive and pose acute toxicity risks of severe eye and skin  irritation to
                        applicators and mixers.  These risks are minimized, however, through use of
                        protective equipment, as required by product labeling.  Therefore, the  risks
                        to humans are considered negligible.
     Environmental
       Assessment
Environmental Fate
     The peroxy compounds are registered for indoor     only.  No direct
environmental exposure is anticipated from their use as directed by product
labeling.
Ecological Effects
     Because of their indoor use patterns, and because they rapidly degrade
to oxygen, carbon dioxide, water or acetic acid,  avian and aquatic toxicity
studies were waived for hydrogen peroxide and peroxyacetic acid.
     Potassium peroxymonosulfate sulfate is corrosive and  is assumed to be
highly toxic to birds on an acute oral basis. Avian dietary  studies using the
bobwhite quail indicate  that the chemical is practically nontoxic to birds on
a dietary basis.  It is highly  toxic to rainbow trout and moderately toxic to
bluegill sunfish.
Ecological Effects Risk Assessment
     All use patterns tor the  three peroxy compounds are considered indoor,
Risks to wildlife ire considered minimal      exposure is extremely low or
nonexistent when the pesticides are      according to label directions.
   Additional Data        EPA is requiring product-specific data* including product chemistry and
           Required   acute toxicity studies, revised Confidential Statements of Formula (CSF), and
                        revised product labeling for reregistration of products  containing the peroxy
                        compounds.
  Product  Labeling        The labeling of all end-use products containing the peroxy compounds
Changes Required   must comPly w^ EPA's current pesticide labeling requirements.  In addition;
                        •  Personal Protective Equipment (PPE) Requirements
                             Labels of all end-use products for commercial, industrial and medical
                             uses must  require mixers and applicators to  use protective equipment
                             including protective clothing, rubber gloves, and goggles, a     shield
                             or safety          Labels also must recommend washing (including
                             clothing) with      and water after handling.these pesticides.-

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                   Dilution Water pH Requirement
                     Labels of products containing potassium peroxymonosulfate sulfate and
                     sodium chloride salts must specify the appropriate pH range of dilution
                     water, to ensure optimum and safe use.
 Regulatory
 Conclusion
     The use of registered products containing the peroxy compounds will not
pose unreasonable risks or adverse effects to humans or the environment.
Therefore, all uses of these  products are eligible for reregistration.  These
products  will  be  reregistered  once  the  required  product-specific  data,
Confidential Statements of Formula and revised  labeling are received and
accepted by EPA.  Products  also containing other active ingredients will be
reregistered  only  when the  other  active  ingredients  are  eligible for
reregistration.
   For More
Information
     EPA is  requesting public comments on the Reregistration  Eligibility
Decision (RED) document for the Peroxy Compounds during a 60-day time
period, as announced hi a Notice of Availability published  in the Federal
Register.  To obtain a copy of the RED document  or to submit written
comments, please contact the Pesticide Docket, Public Response and Program
Resources  Branch, Field Operations Division (7506C), Office of Pesticide
Programs (OPP), US EPA, Washington, DC 20460, telephone 703-305-5805.
     Following the comment period, the  Peroxy Compounds RED document
will be available from the National Technical Information Service (NTIS),
5285 Port Royal Road, Springfield, VA 22161, telephone 703^87^1650.
     For more information about EPA's pesticide reregistration program, the
Peroxy Compounds RED, or reregistration of individual products  containing
peroxy compounds,  please contact the  Special  Review and  Reregistration
Division (7508W), OPP, US EPA, Washington, DC 20460, telephone 703-
308-8000.
     For information about the health effects of ^>esticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact the
National Pesticides Telecommunications Network (NPTN). Call toll-free 1-
800-858-7378, 8:00  am to 6:00 pm Central Time, Monday through Friday.

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REREGISTRATION ELIGIBILITY DECISION
                   LISTD


                 CASE 4072
            ENVIRONMENTAL HIOTECTION AGENCY
             OFFICE OF PESTICIDE PROGRAMS
         SPECIAL REVIEW AND REREGISTRATION DIVISION

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                       TABLE OF CONTENTS


PEROXY COMPOUNDS REREGISTRATION ELIGIBILITY DECISION TEAM  .   i

GLOSSARY OF TERMS AND ABBREVIATIONS  	ii

EXECUTIVE SUMMARY	-. . . .   iv

I.    INTRODUCTION	   	   1

D.   CASE OVERVIEW	'	   2
     A.    Chemical Overview	   2
     E.    Use Profile	   3
     C.    Data Requirements	,	  12
     D.    Regulatory History ,	 .  12

m.  SCIENCE ASSESSMENT	  13
     A.    Physical Chemistry Assessment  	  13
     B.    Human Health Assessment		  14
           1.    Toxicology Assessment	.,..,,..  14
                a.    Acute Toxkity	  14
                b.    Other Toxic End points	  16
           2.    Exposure Assessment	  16
                a.    Dietary Exposure	  16
                b.    Occupational  and Residential	  17
           3.    Risk Assessment  	  17
     C.    Environmental Assessment  .	  18
           1.    Environmental Fate  Assessment	  18
                a.    Chemical Fate.	  18
                b.    Environmental Fate	  19
           2.    Ecological Effects 	  19

 IV. RISK MANAGEMENT AND REREGISTRATION	  20
     D.    Determination of Eligibility	  20
           1.    Eligibility Decision	  21
           2.    Eligible and Ineligible Uses  	  21
     E.    Regulatory Position	 .  21

IV.  ACTIONS REQUIRED BY REGISTRANTS	  22
     A.    Manufacturing-Use Products	  22
           1.    Additional Generic Data Requirements	  22
           2.    Labeling 	  22
     B.    End-Use Products	  22
           1.    Additional Product-Specific Data Requirements  	  22
           2.    Labeling Requirements for End-Use Products	  23

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      C.          Stocks	,	  24

V.   APPENDICES	  25
      APPENDIX A. Table of Use Patterns Subject to Reregistration	  27
      APPENDIX B. Table of the Generic Data Requirements and Studies Used
           to Make the Reregistration Decision	  71
      APPENDIX C. Citations Considered to be Part of the Data Base Supporting
           the Reregistration of Peroxy compounds	  83
      APPENDIX D. List of Available Related Documents	  89
      APPENDIX E	  93
           PR Notice  86-5	  95
           PR       91-2	 115
      APPENDIX F. Product Specific Data Call-In	121
           Attachment 1. Chemical Status Sheet	135
           Attachment 2. Product Specific Data Call-In Response Forms (Form
                 A inserts) Plus Instructions	137
           Attachment 3. Product Specific Requirement Status and Registrant's
                 Response Forms (Form B inserts) and Instructions  	141
           Attachment 4, EPA Batching of End-Use Products for Meeting Data
                 Requirements for Reregistration	147
           Attachment 5. EPA Acceptance Criteria  ................... 153
           Attachment 6. List of All Registrants Sent This Data Call-in (insert)
                 Notice ..................................... 167
           Attachment 7. Cost Share Data Compensation Form, and Confidential
                 Statement of Formula Form	 169

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PEROXY COMPOUNDS REREGISTRATION ELIGIBILITY DECISION TEAM

Office of Pesticide Programs:

Biological and Economic Analysis Division
Michele L. Pethel
Rafael Prieto

Environmental Fate and Effects Division

Laura A Dye
Silvia C. Termes
David M. Edelstein
Henry T. Craven
Concepcion Rodriguez
Biological Analysis Branch
Biological Analysis Branch
Science Analysis and Coordination Branch
Science Analysis and Corrdination Branch
Environmental Fate and Groondwater Branch
Ecological Effects Branch
Ecological Effects Branch
Health • Effects • Division

Jane S. Smith

Registration Division

Valdis Goncarovs
Ian D. Blackwell
Bipin C, Gindhi

Special Review and Reregistration Division

Rieman P. Rhinehart
Bruce Sidwell

Office of Compliance Monitoring

Phyllis Flaherty

Office of General Counsel
Chemical Coordination Branch
Antimicrobial Program Branch
Registration Support Branch
Registration Support Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
Pesticides Enforcement Policy Branch
Kevin Lee
Pesticides Branch

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                  GLOSSARY OF TERMS AND ABBREVIATIONS

a.i.          Active Ingredient

CAS         Chemical Abstracts Service

CSF         Confidential Statement of Formula

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

EP          End-Use Product

EPA         U.S. Environmental Protection Agency

FDA         Food and Drug Administration

FIFRA       Federal Insecticide, Fungicide, and Rodenticide Act

FFDCA      Federal Food, Drug,  and Cosmetic Act

GRAS        Generally Recognized As Safe as designated by FDA

HDT         Highest Dose Tested

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

LDlo         Lethal Dose-low. Lowest Dose at which lethality occurs

LEL         Lowest Effect Level

LOEL        Lowest Observed Effect Level

MP          Manufacturing-Use Product

MPI         Maximum Permissible Intake
LD
   W
                                         11

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                  GLOSSARY OF TERMS AND ABBREVIATIONS


MOE        Margin Of Exposure (PAD)

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

N/A         Not Applicable

NPDES      National Pollutant Discharge Elimination System

NOEL       No Observed Effect Level

OPP         Office of Pesticide Programs

PADI        Provisional Acceptable Daily Intake

ppm         Parts Per Million

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

RED         Reregistration Eligibility Decision

RfD         Reference Dose

RS          Registration Standard

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

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

TMRC       Theoretical Maximum Residue Contribution.
                                         111

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EXECUTIVE SUMMARY

       Hie Enviromental Protection Agency has determined that the uses of hydrogen peroxide,
peroxyacetic acid and potassium peroxymonosulfate sulfate as currently registered will not cause
unreasonable risk to humans or the environment and these uses are eligible for reregistration.

       Before reregistering the products containing hydrogen peroxide, peroxyacetic acid and
potassium peroxymonosulfate sulfate, the Agency is requiring that product specific data, revised
Confidential Statements of Formula, and revised labeling be submitted within eight months of
the issuance of this document. These data include product  chemistry 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 FIFRA, the Agency will  reregister a product.
Those  products which  contain other active ingredients will be eligible for reregistration only
when the other active ingredients are determined to be eligible for reregistration.

       Hydrogen peroxide,  peroxyacetic acid and potassium peroxymonosulfate sulfate are
microbiocides. When mixed with water and applied by spraying, fogging  or immersing, these
chemicals kill bacteria,  fungi and viruses on surfaces of treated materials. Currently, 23 products
are registered that contain one or more of these peroxy compounds as the active ingredients: 11
contain hydrogen  peroxide,  11  contain peroxyacetic acid, and  one  contains  potassium
peroxymonosulfate sulfate.
                                           IV

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I.      INTRODUCTION

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

       FIFRA  Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for registration" before calling
in  data on products and either reregistering products or taking  "other 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 hydrogen peroxide, peroxyacetic  acid and potassium peroxymonosulfate
sulfate, collectely referred to as "peroxy compounds". The  document consists of six sections.
Section I is the  introduction.  Section  II  describes these active ingredients, their uses, data
requirements and regulatory history. Section III discusses the human health and environmental
assessment based on the data available to the  Agency. Section IV presents  the reregistration
decision  for each active ingredient  and Section V discusses the reregistration requirements.
Finally, Section VI is the Appendices  which support this Reregistration Eligibility Decision.
Additional details concerning the Agency's review of applicable data  are available on request.

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H.    CASE OVERVIEW

      A.    Chemical Overview

            The following active ingredient(s) are covered by this Reregistration Eligibility
      Document:


      1.     Common Name;          Hydrogen Peroxide


            *    Chemical Name;          Hydrogen Peroxide


            »    CAS Registry Number:    7722-84-1


            •    OFF Chemical Code:      000595


            *    Empirical Formula:       H202



      2.     Common Name:          Peroxyacetic Acid


            •    Chemical Namei          Peroxyacetic Acid


            •    CAS Registry Numbers    79-21-0


            *    OPP Chemical Code:      063201


            *    Empirical Formula:       C2H4O3

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       3.
Common Name:
Potassium Peroxymonosulfate Sulfate;  Potassium
Peroxomonosulfate Sulfate.
                   Chemical Name:
                                Potassium Peroxymonosulfate Sulfate  (or
                                Potassium Peroxomonosulfate Sulfate; The
                                rales of chemical nomenclature state that
                                both of these  chemical names  would be
                                correct; however, peroxy is preferred).
                   CAS Registry Number:    37222-66-5


                   OPP Chemical Code:      63607


                   Empirical Formula:       (KHS05*KHS04*K2S04)
       B.     Use Profile

             The  following is  information on the current registered  uses of the peroxy
       compounds with an overview of use sites and application methods.  A detailed table of
       these uses of hydrogen peroxide, peroxyacetic acid and potassium peroxymonosulfate
       sulfate is in Appendix A.

For Hydrogen Peroxide:

TYPE OF PESTICIDE:

       Sterilant/Sporicide, Tuberculocide, Medical disinfectant, Broad spectrum disinfectant,
       Disinfectant (Bactericide/Germicide, General or Broad-Spectrum, Hospital or Medical),
       Sanitizer (Food and Non-food), Virucide, Fungicide.

USE SITES:
INDOOR FOOD:
      Agricultural/Farm Premises; Dairies/Cheese processing plant equipment and premises;
      Livestock,  including dairy cattle, dairy goats and poultry; Dairy farm milk handling

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       facilities and equipment, Dairy  farm milking equipment; Food handling and food
       processing establishments and equipment.
 INDOOR NON-FOOD:

       Animals  (Laboratory/Research);  Commercial/Institutional/Industrial  floors,  premises  and
       equipment; Eating Establishment Food Handling, Food Serving and Non-Food areas; Reverse
       osmosis water systems.

 INDOOR MEDICAL:

       Hospital  Critical Items  (Surgical  Instruments/Pacemakers);  Hospital  Semicritical  Items
       (Catheters/Inhalation  Equipment);    Hospital   Noncritical    Items   {Bedpans/Furniture);
       Hospitals/Medical  Institutions  Premises  (Human/Veterinary)  non-conductive  floors  and
       noncritical premises; Reverse osmosis water systems.
 INDOOR RESIDENTIAL:

       Bathroom Premises/Hard Surfaces


 PESTS:

 Bacteria:
 Mycobacterium tuberculosis and non-rnberculous mycobaeteria, Spore-forming bacteria, Pseudomonas
 spp., Salmonella spp., Streptococcus spp,,  Bacterial spores, Streptococcus pyogenes,  Streptococcus
faecalis, Streptococcus salivarius,  Corynebacterium diphtheriae, Salmonella choleraesuis, Salmonella
paratyphi,  Salmonella schottmuelleri,  Neisseria  elongata,  Acinetobacter  calcoaceticus,  Shigella
 dysenteriae, Enterobacter aerogenes, Escherichia coli, Proteus vulgaris, Proteus mirabilis, Pseudomonas
 aeruginosa, Pseudomonas cepacia, Klebsiellapneumoniae, Serratiamarcescens, Staphylococcusaureus,
 Staphylococcus  aureus (Penicillin Resistant),  Listeria  monocytogenes,  Salmonella  typhimurium,
 Pediococcus damnosus, Lactobacillus buchneri.

 Fungi:
 Trichophyton mentagrophytes, Candida albicans, Aspergillus niger, Saccharomyces cerevisiae,

 Viruses:
 Herpes simplex virus, Influenza A2 virus, Human immunodeficiency virus type i (HIV-1), Hepatitis B
 virus.

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FORMULATION TYPES REGISTERED:

TYPE: End Use

FORM: Liquid - Ready to Use, Soluble Concentrate/Liquid


METHODS AND RATES OF APPLICATION:

TYPES OF TREATMENT:

       Sterilant/disinfectant for dialyzers and dialysis equipment, Percutaneous Transluminal Coronary
       Angioplasty catheters, anesthesia equipment,  aseptic packaging and related surfaces in food
       processing  plants,  respiratory  equipment,  endoscopes, endotracheal tubes, dental  hand
       instruments and burs,  and  surgical instruments  -  dialyzer treatment, angioplasty  catheter
       treatment,  immersion  - 2000 to 50727 ppm a.i. by volume, 8000 to 60000 ppm a.i, by weight
       (sterilization); 160 to 2000 ppm a.i. by volume, 8000 to 60000 ppm a.i. by weight (disinfection).

       Disinfectant for reverse osmosis membranes and their associated distribution  systems (water
       related  surface systems) - 2000 ppm a.i. by volume.

       Disinfectant for hospital noncritical items made of plastic and stainless steel - immersion, mop,
       spray -  160 to 2000 ppm a.i.  by  volume, 8000 ppm a.i. by weight.

       Used as a disinfectant for hard  non-food contact surfaces  such as floors, counter surfaces,
       machine exteriors, and premises in hospitals and medical, surgical, and dental  offices and
       clinics,  and laboratories;  disinfectant/sanitizer for restrooras, pharmaceutical  manufacturers,
       medical product manufacturers,  electrical utility  companies, semiconductor  manufacturers,
       cosmetic manufacturers, and biotech companies - surface treatment, mop, brush-on, scrub, soak,
       sponge-on,  spray,  wipe-on - 755 to 6250 ppm a.i. by volume,  8000 ppm  a.i.  by weight
       (disinfection); 160 to  6250 ppm a.i. by volume (sanitation).

       Used as a  sanitizer of food-contact and non-food contact surfaces and equipment in dairies,
       breweries,  wineries, and  beverage plants - immersion,  closed circulation  system treatment,
       circulation method, premise treatment, spray - 118 ppm  a.i.  by volume (non-food use); 472 to
       849 ppm a.i. by volume (food use).

       Used as a  disinfectant of food-contact and non-food contact surfaces and equipment in
       areas, dairies, breweries, wineries, and beverage plants - spray, mop, sponge-on, soak, scrub,
       wipe-on, brush-on - 755 ppm a.i. by volume.

       Disinfection of  animal  life science  laboratories,  livestock premises,  dairy cattle and goat

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       premises, poultry premises, trucks, coops, and crates - premise treatment, transportation vehicle
       treatment, feeding and watering appliance treatment - 755 ppm a.i, by volume.

       Disinfection/sanitation of farm buildings and premises - brush-on, mop, premise treatment,
       sponge-on, spray, soak, scrub, wipe-on - 755 ppm a.i. by volume (disinfection); 118 ppm by
       volume (sanitation, non-food use).

EQUIPMENT:

       Mop,  sponge, brush, sprayer, mechanical sprayer, power sprayer, pump spray bottle, cloth,
       heated sterilizing tray, heating bath, automatic decontamination machine, and not specified.

TIMING:

       Not Specified.

RATE OF APPLICATION:


       See TYPES OF TREATMENT.


USE PRACTICES LIMITATIONS:

       Only a fresh solution should be used when employed  as a tuberculocide, cleaner, sanitizer, or
       hospital disinfectant (use-diluted).  Re-use as a sterilant and broad system disinfectant (undiluted)
       for 30 days. Those used exclusively as sterilants for dialyzer reprocessing systems may be used
       undiluted for seven days. Do not allow products to mix with alkaline substances such as bleach
       or other oxidizing  agents.   Use  AAMI  [Association  for  the  Advancement of Medical
       Instrumentation] Quality Water for Hemodialysis m making dilutions. Reuse of diluted products
       is not recommended.   Do not store instruments to be sterilized in solution for  more than 16
       hours.  Maintain temperature below 75 degrees Fahrenheit.  Avoid contact  with combustible
       materials.   Avoid contamination  from  any  source, including  metals, dust, etc.    Such
       contamination may cause rapid decomposition, generation of large quantities of oxygen gas, and
       high pressures.  Store product in original closed container-never tamper with the vent.   The
       material  of construction in some kidney machine parts may not be compatible  with the product.
       Do not use rubber hoses to dispense product.   The reverse osmosis membrane manufacturer
       should be consulted prior to use of some products to determine compatibility of the specific
       membranes.

             Remove all poultry and feeds from premises, trucks, coops and crates.  Remove all litter
       and droppings from floors, walls and surfaces of facilities occupied or  traversed by poultry.
       Empty all troughs, racks and other feeding and watering appliances. Ventilate  buildings, coops,
       and other closed spaces.  Do not house poultry or employ equipment until treatment has been

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       absorbed, set or dried.  Thoroughly  scrub  treated  feed  racks, troughs, automatic feeders,
       fountains and waterers with a detergent.
FOR PEROXYACETIC ACID:
TYPE OF PESTICIDE:

       Tuberculocide, Sterilizer,  Disinfectant (Bactericide/ Germicide, General or Broad-Spectrum,
       Hospital or Medical), Sanitizer, Virucide, Fungicide/Fungistat.
USE SITES:

INDOOR FOOD:

       Agricultural/farm premises, buildings and equipment; Dairies/cheese processing plant equipment
       (food contact) and premises (nonfood contact); Livestock including poultry, dairy cattJe  and
       goats; (lactattng  or unspecified); Dairy  farm milk  handling  facilities/equipment; Eating
       establishment  equipment/utensils, food  handling  and  serving  areas  (Food Contact); Food
       dispensing equipment/Vending machines; Food marketing/storage/distribution equipment/utensils
       (Food Contact); Food processing plant equipment (food contact) and plant premises (Nonfood
       Contact).

INDOOR NON-FOOD:

       Animals  (Laboratory/Research);  Commercial/Institutional/Industrial  floors,  premises  and
       Equipment; Eating Establishment Food Handling, Food Serving and Non-Food areas; Reverse
       osmosis water systems.
INDOOR MEDICAL:

       Hospital/Medical  Institution  Premises  (Human/Veterinary);  Hospital/Medical  Institution
       Noncritical  Premises;  Hospital Critical Items (Surgical  Instruments/Pacemakers);  Hospital
       Semicritical   Items   (Catheters/Inhalation  equipment);   Hospital   Noncritical   Items
       (Bedpans/Furniture); Hospital/Medical  Institutions Non-conductive Floors; Reverse Osmosis
       Water Systems
INDOOR RESIDENTIAL:

       Bathroom Premises/Hard Surfaces

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PESTS:

Bacteria:
Mycobacterium tuberculosis and non-tuberculous mycobacteria, Spore-forming bacteria, Pseudomonas
spp,, Salmonella $pp., Streptococcus spp., Bacterial spores,  Streptococcus pyogenes, Streptococcus
faecatis,  Streptococcus salivarius,  Corynebacterium diphtheriae, Salmonella choleraesuis,  Salmonella
paratyphi,  Salmonella schottmuelleri,  Neisseria elongata,  Acinetobacter  calcoaceticus,  SMgella
dysenteriae, Enterobacteraerogenes, Escherichia coli, Proteus vulgaris, Proteus mirabilis, Pseudomonas
aeruginosa, Pseudomonas cepacia, KlebsieUapneumomae, Serratiamarcescens, Staphylococcus aureus,
Staphylococcus  aureus  (Penicillin Resistant),  Listeria monocytogenes,  Salmonella typhimurium,
Pediococcus damnoms, Lactobacillm buchneri,

Fungi:
Trichophyton mentagrophytes, Candida albicans, Aspergillus niger,  Saccharomyces cerevisiae.

Viruses:
Herpes simplex vims, Influenza Aa virus, Human immunodeficiency virus type 1 (HIV-1),  Hepatitis B
virus.
FORMULATION TYPES REGISTERED:

TYPE:  End use,

FORM:  Soluble concentrate/Liquid, Liquid-Ready to Use,


METHODS AND RATES OF APPLICATION:


TYPES OF TREATMENT:

       Sterilant/disinfectant for dialyzers and dialysis equipment, Percutaneous Transluminal Coronary
       Angioplasty catheters, anesthesia equipment,  aseptic packaging and  related surfaces  in food
       processing  plants,  respiratory  equipment,  endoscopes, endotracheal  tubes,  dental  hand
       instruments and  burs,  and surgical instruments  - dialyzer treatment,  angioplasty  catheter
       treatment, immersion - 400 to 8454 ppm a.i. by volume, 600 to 8500 ppm a.i. by weight
       (sterilization); 12 to 400 ppm a.i. by volume,  600 to 8500 ppm a.i. by weight (disinfection).

       Disinfectant for reverse osmosis membranes and their associated distribution systems (water
             surface          - 400     a.i. by volume.

       Disinfectant for hospital noncritical items made of plastic and stainless steel - immersion, mop,

                                             8

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       spray - 12 ppm to 600 ppm a.i. by volume, 600 ppm a.i. by weight.

       Used as a disinfectant  for hard non-food contact surfaces such as floors,  counter surfaces,
       machine exteriors, and premises in hospitals  and medical,  surgical, and dental offices and
       clinics, and laboratories; disinfectant/ sanitizer for rcstrooms,  pharmaceutical manufacturers,
       medical product manufacturers, electrical  utility companies,  semiconductor manufacturers,
       cosmetic manufacturers, and biotech companies - surface treatment, mop, brush-on, scrub, soak,
       sponge-on,  spray,  wipe-on - 100  to 400 ppm a.i.  by volume,  600 ppm  a.i.  by weight
       (disinfection); 12 to 1250 ppm a.i. by volume  (sanitation).

       Used as a sanitizer of food-contact and non-food contact surfaces  and  equipment in dairies,
       breweries, wineries, and  beverage  plants -  immersion, closed circulation system treatment,
       circulation method, premise treatment, spray - 26 ppm a.i. by  volume (non-food use); 103 to
       185 ppm a.i. by volume (food use).

       Used as a disinfectant of food-contact and non-food contact  surfaces and equipment in eating
       areas, dairies, breweries, wineries, and beverage plants - spray, mop, sponge-on, soak, scrub,
       wipe-on, brush-on - 164 ppm a.i, by volume.

       Disinfection  of animal life science laboratories, livestock  premises, dairy cattle and goat
       premises, poultry premises, trucks, coops, and crates - premise treatment, transportation vehicle
       treatment, feeding and watering appliance treatment - 164 ppm a.i.  by volume.

       Disinfection/sanitation  of  farm buildings and  premises - brush-on, mop, premise treatment,
       sponge-on, spray, soak, scrub, wipe-on - 164 ppm a.i. by volume  (disinfection); 26 ppm by
       volume (sanitation, non-food use).

EQUIPMENT:

       Cloth, mop, sponge, pump spray bottle, mechanical sprayer, power sprayer, brush.

TIMING:

       Not Specified,

RATE OF APPLICATION:

       See TYPES OF TREATMENT.


USE PRACTICE LIMITATIONS:

             Only  a  fresh solution  should  be used when employed as  a tuberculocide,  cleaner,
       sanitizer,  or hospital  disinfectant (use-diluted).   Re-use as  a  sterilant and broad system

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       disinfectant (undiluted) for 30  days.   Those used  exclusively  as sterilants for dialyzer
       reprocessing systems may be used undiluted for seven days. Do not allow products to mix with
       alkaline substances such as bleach or other oxidizing agents.  Use AAMI [Association for the
       Advancement of Medical Instrumentation] Quality Water for Hemodialysis in making dilutions.
       Reuse of diluted products is not recommended.   Maintain temperature below 75 degrees
       Fahrenheit. Do not store instruments to be sterilized in solution for more than 16 hours.  Avoid
       contact with combustible materials. Avoid contamination from any source, including metals,
       dust, etc.  Such contamination may cause rapid decomposition, generation of large quantities of
       oxygen gas, and high pressures.  Store product in original closed container-never tamper with
       the vent.  The  material of construction in some Wdney machine parts may not be compatible
       with the product.  Do not use rubber      to         product. The reverse        membrane
       manufacturer should  be consulted prior to use of      products to determine compatibility of
       the         membranes.

             Remove all poultry and feeds from premises, trucks, coops and crates. Remove all Utter
       and droppings from  floors, walls and surfaces of facilities occupied or traversed by poultry.
       Empty all troughs, racks and other feeding and watering appliances.  Ventilate buildings, coops,
       and other closed spaces.  Do not house poultry or employ equipment until treatment has been
       absorbed, set or  dried.  Thoroughly scrub treated  feed racks, troughs,  automatic feeders,
       fountains and waterers  with a detergent and rinse with potable water before reuse.

FOR POTASSIUM PEROXYMONOSULFATE SULFATE:

TYPE  OF PESTICIDE:

             This  active  ingredient  is  used  only  in  conjunction  with  sodium  chloride.
       Peroxymonosuifate sulfate oxidizes sodium chloride to hypochlorous acid.

       Air  sanitizer, broad  spectrum disinfectant for industrial inimal and agricultural  facilities,
       fungicide (mold/mildew), viracide
USE SITES:

INDOOR FOOD:
Poultry (Egg/Meat)
Poultry Processing Plant Premises (Nonfood Contact)

INDOOR NON-FOOD:
Egg Handling Equipment (Hatching)
Egg Handling Rooms (Hatching)
                                            10

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INDOOR RESIDENTIAL:
Air Treatments (Commercial/Household)
Bacteria:
Streptococcus pyogenes, Campyl0bacterpyloridas,:Klebsiella pneumonias, Escherichia coli, Salmonella
typhimurium, Salmonella choleraesuis, Pseudomonasaeruginosa, Staphylococcusaureus, Stapkylococcm
epidermidis, Mycoplasma gallisepticum

Fungi:
Aspergillus flavus, Aspergillus Jumigatus, Candida albicans

Viruses:
Newcastle         Virus, Infectious  Bronchitis  Vims, Infectious  Bur sal Disease  Vims,  Avian
Laryngotracheitis Vims, Avian Influenza Virus and Mirek's        Virus
FORMULATION TYPES REGISTERED:

TYPE: End use

FORM: Solid soluble concentrate

METHODS AND RATES OF APPLICATION:

TYPES OF TREATMENT:  Surface treatment, Spray, Fog, Feeding and watering appliance treatment

EQUIPMENT:  Fogger, Sprayer

TIMING:  Not specified

       OF APPLICATION;
       Indoor food:
            From 1,987 up to 4,128 ppm of active ingredient by weight
       Indoor non-food:
            From 1,987 up to 4,128 ppin of active ingredient by weight
       Indoor residential:
            From 1,987 up to 4,128 ppm of active ingredient by weight

USE             LIMITATIONS:

Remove animals and feed from premises before treatment.
                                          11

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C.     Data Requirements

       The Agency imposed the target data requirements for reregistration on the three active
ingredients for their currently registered uses. These target data requirements included Technical
Chemistry, Toxicology, and Environmental Fate and Ecological Effects. Appendix B includes
all data requirements identified by the Agency for currently registered uses needed to support
reregistration.
D.     Regulatory History

       Hydrogen peroxide, peroxyacetic acid and potassium peroxymonosulfate sulfate products
were  registered in  the  United  States as early  as 1977,  1985, and  1968 respectively as
disinfectants, sanitizers and sterilants. Currently, 23 products are registered for use in/on
agricultural premises, food establishments, commercial/industrial locations and hospital/medical
institutions on a variety of hard surfaces such  as equipment, floors and walls in indoor and
outdoor applications.

       Historically,   certain   hydrogen   peroxide,   peroxyaceUc   acid  and   potassium
peroxymonosulfate sulfate products and certain other liquid chemical germicides  have been
regulated both as pesticides and as devices.  In an effort to resolve  the confusion and burden of
dual regulation, a Memorandum of Understanding  (MOU) was signed on June 4,  1993 between
EPA and the Food  and Drug  Administration (FDA). The objectives of the MOU are to (1)
stimulate both Agencies to undertake rulemaking to permanently vest exclusive jurisdiction for
certain categories of chemical germicides in each Agency and  (2) serve as interim guidance
designed to minimize duplicative  regulatory requirements between the two Agencies until the
rulemaking is complete.

       The MOU separates the liquid chemical germicides into the following two categories
based on their  use patterns  and efficacy claims:  (1)  sterilants and (2) general purpose
disinfectants.  Sterilants, under this agreement, refer  to those chemical  germicides used to
reprocess reusable critical and semicritical devices as defined by the Centers  for Disease Control
(CDC). Critical devices are devices that are introduced directly into the  human body, either into
or in contact with the bloodstream or normally  sterile areas of the body.  Semicritical devices
are those which contact intact mucous membranes but which do  not ordinarily penetrate the
blood barrier or otherwise enter normally sterile areas of the body.  General disinfectants are
defined as all remaining types of public health liquid chemical germicides bearing non-sterilant
claims for use on non-critical surfaces.

       The MOU outlines the future separate regulation of liquid chemical germicides as either
pesticides under FIFRA or devices under FFDCA by granting each Agency primary jurisdiction
over one of the two categories.  All products which bear sterilant label claims and can be used
on critical or semicritical surfaces will be  regulated by FDA as devices.  In addition, many
sterilant products have  claims which correspond to a high level disinfectant use pattern.  These

                                       12

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       claims will also be regulated by FDA for the sterilant products,  EPA will regulate the general
       purpose disinfectants.

             Because the MOU does not change the statutory authority granted under FIFRA and
       FFDCA,  both Agencies will continue to have jurisdiction over all liquid chemical germicides
       and will continue registration and premarket approval until rulemaking has been completed.
       However, the MOU reduces the regulatory burden by stating that the required data to support
       efficacy claims and product performance need  only be submitted and reviewed by the Agency
       with primary jurisdiction as defined above.  In the case of these peroxy compound products,
       EPA has primary jurisdiction and the conditions of reregistration must be fulfilled and required
       data submitted as presented in Appendices F and G,
HI.    SCIENCE ASSESSMENT

       A.    Physical Chemistry Assessment

Hydrogen Peroxide

                    Hydrogen peroxide is a colorless, slightly pungent liquid with a density of 1.438
             at 20°C. It is infinitely soluble in water. It is an unstable corrosive liquid with strong
             oxidizing characteristics. This product is marketed generally at 3.1 to 35.0%  aqueous
             solution.

Peroxyacetic acid

                    Peroxyacetic acid is a colorless liquid. At low concentrations it is odorless, but
             has a strong pungent  odor wben present at 40%  or higher concentration. It boils  at
             103°C, probably with decomposition. It is a non-flammable, strong oxidizing,  unstable
             compound with a pH of 2 to 3. It has a density of 1.13.


Potassium peroxvmonosulfate sulfate

                    Potassium peroxymonosulfate sulfate is an odorless white granular powder with
             a density of 1.12 -  1,20 g/cm3. It melts at 235°C and it decomposes before boiling. It
             is a stable, non-flammable chemical with strong oxidizing characteristics.  It is 25.6%
             soluble in water at room temperature. The pH of this chemical is 2.3 for a 1%  aqueous
             solution.  In the one registered  product,  it occurs  as a triple  salt, i.e., potassium
             peroxymonosulfate  sulfate. Potassium peroxymonosulfate sulfate is registered  only for
             uses in conjunction with sodium chloride ions in water to produce  hypochlorous acid.
                                              13

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B.     Human Health Assessment

       1.     Toxicology Assessment

              The acute lexicological  data for hydrogen peroxide,  peroxyacetlc acid and
       potassium peroxymonosulfate sulfate are summarized below. The data available to the
       Agency are adequate and will support reregistration eligibility of these compounds.


              a.     Acute Toxicity

       Table I:            Acute Toxicity - Hydrogen Peroxide
Test
Acute Oral LDW
(mouse)
Acute Dermal LDW (rat)
Acute Inhalation LC^
(mouse)
Eye Irritation (rabbit)
Dermal Irritation (rabbit)
Skin Sensitization
Result*
2000 rag/kg
4060mg/kg
227 ul/L
severe irritation
corrosive
-
Category
ra
m
II
I
I
-
        SAX. Irving N. and Lena. Richard J., "Dangerous Properties erf Industrial Materials* Seventh edition. Van Nosfrand Rtinhdd, 1989, H1BQOQ.
                                         14

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      II:
                  Acute Toxicity - Peroxyacetic acid
            Test
                                   Result*
      Acute Oral
            (rat)
 Acute Dermal LDX (rabbit)
 Acute Inhalation LCJO (rat)
    Eye Irritation (rabbit)
  Dermal Irritation (rabbit)
      Skin Sensitization
                                1540 mg/kg

                                1410 mg/k§
                                0.450 mg/L
                               severe  irritation
                                  corrosive
Category
   III
   H
   n
    i
    i
SAX, Irving N. md Lewii, Richard I., *Dwvemu Propenia of Jnduorial
                                                 " Seventh ediuon. Vn Nanrnnd Reinhold. 1989, PCLSOO.
Table HI:
                Acute Toxicity - Potassium Peroxymonosulfate Sulfate
Test
Acute Oral LD^
(rat)1
Acute Dermal LD^ (rat)2
Acute Inhalation LC^ (rat)3
Eye Irritation (rabbit)4
Dermal Irritation (rabbit)5
Skin Sensitization (guinea
Pig)6
Result
1287 mg/kg (?)
1129 mg/kg ( 2000 mg/kg
> 5,0 mg/L
severe corneal
opacity
corrosive
negative
Category
III
in
IV
I
I
n/a1
1  81-1,  MRID 426074-01
2  81-2;  MRID 426074-02
3  81-3;  MRID 425912-01
4  81-4;  MRID 426074-03
5  81-5,  MRID 426074-04
6  81-6,  MRID 426074-05
7  n/a = not applicable
              Hydrogen peroxide, peroxyacetie acid, and potassium peroxymonosulfate
                                 15

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       sulfate are  oxidizing agents;   in  general, the organic  peroxides ire stronger
       oxidants  than  hydrogen  peroxide.   It  is  well  known that peroxides react
       (sometimes violently) with materials containing reducing agents, and concentrated
       materials are routinely bandied with care because of the potential for strong
       chemical reactions.  The  high reactivity  of  the peroxides are evident from the
       acute effects observed from exposure to these compounds by the dermal or ocular
       routes. They are corrosive,and severely  irritating to the eyes, skin and mucous
       membranes (Toxicity Category I). In contrast, exposure by the oral route appears
       to be moderately acutely toxic (Toxicity  Category HI),  Therefore, specifically
       because of these very reactive properties and moderately low oral toxicity, dilute
       concentrations of peroxides have found wide applications as disinfectants.
       b.    Other Toxic End points

             Based on the chemical reactivity of peroxides, these  compounds would
       be expected  to have biological activity, particularly  with macromolecules.
       Hydrogen peroxide, for example, is a known mutagenic compound with activity
       in such assays  as the Salmonella assay (Ames test),  aberrations and  sister
       chromatid exchanges in cultured mammalian cells, and for DNA damage and
       repair in cultured human fibroblasts.
2,     Exposure Assessment

       a.     Dietary Exposure

             Hydrogen  peroxide  and  peroxyacetie acid  are  used in dairy/cheese
       processing plants, on food processing equipment and in pasteurizers in breweries,
       wineries, and beverage plants.  Although some contact may occur between treated
       equipment and food, no residues are expected since  only trace amounts would
       come  in contact  with  food  having  contacted  treated  equipment and  both
       compounds degrade rapidly (in air) primarily to oxygen and water or oxygen and
       acetic  acid.  In addition, both of these compounds are generally recognized as
       safe (GRAB) according to the Food and Drug Administration (21 CFE §178.1010
       Sanitizing solutions)  when used on food-processing equipment, utensils, and other
       food-contact articles.  Dietary exposure is possible;  however,  these chemicals
       react instantly  upon        with materials  such as  food and are degraded to
       moieties which present no toxicological concern.

             Potassium peroxymonosulfate sulfate as a disinfectant is used in poultry
       houses, hatcheries and processing plants.  These      involve removal of the
       animals or meat/eggs before use,  followed by a potable water rinse and time for

                                16

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       drying before re-introducing the poultry.  In processing houses, the uses ire
       limited to floors, ceilings, and walls.  This active ingredient is not used directly
       on poultry/meat.  This is considered a non-food use and no dietary exposure is
       expected to occur as a result of pesiieidal/disinfeetant uses,

       b.     Occupational and Residential

              Hydrogen  peroxide and peroxyaeetic  acid, in the form of a soluble
       concentrate/liquid, are used for industrial/commercial floors, medical equipment,
       e.g., dialysis parts, catheters, surfaces, furniture, equipment, etc; and residential
       bathroom surfaces.  It is also      in diky/cheese processing plants on food
       processing equipment  and in pasteurizers in breweries, wineries, and beverage
       plants. Applications are primarily by immersion, mop, sponging or wipe-on, and
       spraying (dilutes, 1 % or less). There is a potential for applicator/mixer exposure.
       Considering these compounds are corrosive and severely irritating to the skin,
       eyes and mucous membranes (Toxicology Category I), exposure is a concern.
       Protective equipment  is  required on  the  labels including  protective  clothing,
       rubber gloves and goggles, face shield or safely glasses.  Thoroughly washing
       with soap and water after handling (including clothing) is recommended. The use
       of protective equipment sufficiently minimizes the exposure to applicators/mixers
       for these uses including the spray  applications which are  1 % concentration or
       less.

              Potassium   peroxymonosulfate  sulfate  in  the  form  of  a  soluble
       concentrate/liquid  is used in conjunction with sodium chloride to  produce
       hypochorous  acid.  Hypochlorous acid is a strong oxidizing agent; it is this
       oxidizing effect which imparts the disinfection/sanitation properties. The soluble
       concentrate/solid  is  diluted  for   spraying/misting/fogging   poultry  houses,
       hatcheries and processing plants,  Bised  on      uses dermal  nd  inhalation
       exposure to  applicators/mixers  is  expected.    Considering   this  chemical is
       corrosive  and  causes severe  eye,  skin  and  mucous  membrane  irritation
       (Toxicology Category  I) protective equipment is required on the labels including
       protective clothing, rubber gloves and goggles, face shield  or  safety glasses.
       Thoroughly washing with soap and water after handling (including clothing) is
       recommended.    Through  the  use  of protective  equipment, exposure to
       applicators/mixers is minimized.

              There is a potential for post-application exposure; however, based  on the
       current uses,  exposure is expected to be minimal.
3.     Risk Assessment

       The Agency has a concern for an acute risk based on Toxicology Category I for

                                 17

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       skin and eye irritation.   The  acute risk from occupational exposure to these  three
       corrosive compounds is minimized through the use of protective equipment.  There is
       essentially no dietary exposure  to these compounds based on these uses and their quick
       degradation;       therefore, no significant risk is associated with dietary or chronic
       exposure,        on      factors and the pesticidal use patterns, the  human  risks are
       considered to be negligible.  No additional hazard or exposure data  are required for
       reregistration eligibility for      compounds.
C.     Environmental Assessment

       1.     Environmental Fate Assessment

             a.     Chemical Fate.

                    Peroxy compounds are  highly reactive and short-lived          of the
             inherent instability of the peroxide bond (O-O bond). Instead of the usual oxygen
             oxidation number of -2, peroxide oxygen atoms have an oxidation number of -1
             due to the presence of two additional electrons. The peroxide bond is weak, and
             breaking it to form water and O2 is so highly favored thennodynamically that
             improperly stored quantities of highly concentrated peroxides may explode. A
             more positive aspect  of this instability,  however, is  that at typical  pesticidal
             concentrations, peroxides are not explosive, but do degrade rapidly.

                    Hydrogen peroxide is a strong oxidizing agent in both acidic  and basic
             solutions, but the reduction potentials (E°) vary as a function of pH.  Oxidation
             with hydrogen peroxide in acidic solutions  is slow,  but it  is rapid in basic
             solutions.  Hydrogen peroxide also behaves as a reducing agent (both in acidic
             and basic solutions) when it reacts with stronger oxidizing agents, such as with
             permanganate ions in an acidic solution.  Therefore, many redox systems and
             metal surfaces can serve as catalysts for peroxide decomposition.  The degradates
             of hydrogen peroxide  are water and oxygen.

                    Peroxyacetic acid is produced by the interaction of hydrogen peroxide and
             acetic acid. Peroxyacetic acid is an oxidizing agent, although it can act indirectly
             by decomposing  to acetic acid  and releasing a  hydrogen peroxide  molecule.
             Peroxyacetic  acid can  also provide a source of free radicals, which can attack C-
             H bonds in target molecules (e.g., the C-H bonds  in a microbia! cell membrane).
             The primary  degradates of peroxyacetic acid are acetic acid, water and oxygen.
             Acetic acid is rapidly metabolized by ambient aerobic microorganisms to carbon
             dioxide and water.
                    Potassium peroxymonosulfate sulfate is registered for use in conjunction


                                       18

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       with sodium chloride (NaCl).  The reaction of peroxymonosylfate sulfate with
       chloride anions generates hypochlorous acid, which is a well-known oxidizing
       agent. Both the oxidation reaction of peroxymonosulfate with chloride anions and
       the speciation of hypochlorous acid (which is a weak acid) are affected by the pH
       of the aqueous medium.  In addition, the rate and mechanism of decomposition
       of hypochlorous acid are also dependent  on temperature,  concentration and
       exposure to sunlight.       ;

             Because pH affect both the reaction of peroxymonosulfate       with
       chloride anions and the speeiation of hypochlorous acid, it is recommended that
       the pH of the dilution water     with this produces) be specified on the label(s)
       for optimum and     use of the product. The optimum sanitation potential and
       safe use of the product occurs in the pH range of 7.2 to 7,6.
       b.     Environmental Fate.

             Hydrogen peroxide, peroxyacetic acid and potassium peroxymonosulfate
       sulfate (hi conjunction with sodium chloride) are registered exclusively for indoor
       use, with no direct exposure  to the environment when used according to the
       directions on the label.
2.     Ecological Effects

       The following four studies would normally be required  for labeling purposes
concerning non-target species:

       71-1 (a)  Acute Avim Oral, Quail/Duck
       71-2(b)  Acute AYim Dietary Duck
       ?2-l(e)  Acute Fish Toxicity Rainbow Trout
       72-2(a)  Acute Aquatic Invertebrate Toxicity

       a-     Hydrogen Peroxide and Peroxyacetic Acid

             For hydrogen peroxide and peroxyacetic acid, the two avian studies were
       waived because of their indoor use pattern and the corrosive nature of these
       chemicals. These chemicals are considered highly toxic on an acute basis.

             The  two aquatic  studies  were  waived for  hydrogen  peroxide  and
       peroxyacetic acid because of the indoor use pattern and because these chemicals
       readily degrade to oxygen or carbon dioxide and water.
                                19

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                   b.     Potassium Peroxvmonosulfate Sulfate

                         The acute avian oral study was waived for potassium peroxymonosulfate
                   sulfate because of its corrosive nature. This chemical is considered highly toxic
                   on an avian oral acute basis.

                         Avian dietary studies for the bobwhite quail (MRID No. 204057) and the
                   mallard duck (MRID No. 204058) were submitted to the Agency,  A preliminary
                   review of  the  studies indicates that these  studies  will fulfill  the guideline
                   requirements for potassium peroxymonosulfate sulfate. The studies indicate an
                   LC50 >5000  ppm for these species of birds.  The chemical is classified as
                   practically non-toxic to birds on a dietary basis.

                         Acute  fish  toxicity  studies  (MRID  No. 19852)  using  potassium
                   peroxymonosulfate sulfate as the test material and rainbow trout and  bluegill
                   sunfish as the test species were submitted to the Agency. A review of the studies
                   indicates that these studies will fulfill the guideline requirements.  The LC50 for
                   rainbow trout was 0.78 ing/I classifying the chemical as highly toxic.  The LC50
                   for the bluegill sunfish was 1.0 mg/1 classifying it as moderately toxic. The acute
                   aquatic invertebrate study was waived because of the indoor use pattern and the
                   high toxicity to aquatic organisms as indicated by the rainbow trout study.

                         All  of the use patterns  for the three  chemicals are  considered indoor
                   because of the potential for high volume use. A National Pollutant Discharge
                   Elimination System (NPDES) permit for products which are sold for industrial
                   or commercial  use may be required,
IV.  RISK MANAGEMENT AND REREGKTRATION DECISION

     D.     Determination of Eligibility

            Section 4(g)(2)(A) of FIFRA calls for the Agency to .determine, after submission of
     relevant data concerning an active ingredient, whether products containing the active ingredients
     are eligible for reregistration. The Agency has previously identified and required the submission
     of the generic (i.e. active ingredient specific) data required to support reregistration of products
     containing hydrogen peroxide, peroxyacetic acid and potassium peroxymonosulfate sulfate active
     ingredients. 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 one or more more of
     these active ingredients. Appendix B identifies the generic data requirements that the Agency
     reviewed as part of its determination of reregistration eligibility of these chemicals 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


                                             20

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registered     of hydrogen peroxide, proxyaeetie acid and potassium peroxymonosulfate sulfate
and to determine that they can be used without resulting in unreasonable adverse effects to
humans and the environment.  The Agency therefore finds that all products containing hydrogen
peroxide, peroxyacetic acid and potassium peroxymonosulfate sulfate 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 guideline!  for  conducting acceptable        to
generate     data and the data identified in Appendix B.  Although the Agency has found that
all usei of hydrogen peroxide, peroxyacetic acid and potasiium peroxymonosulfate sulfate 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 any  one  of these  active ingredients, 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 hydrogen peroxide, peroxyacetic acid
       and potassium  peroxymonosulfate sulfate, the Agency has  sufficient information to
       determine whether these chemicals  will cause unreasonable adverse effects to humans or
       the  environment.  The  Agency concludes that  products containing hydrogen peroxide,
       peroxyacetic acid and potassium peroxymonosulfate sulfate for all uses are eligible for
       reregistration and  as labeled and  used as specified  in this  Reregistration  Eligibility
       Decision,  will  not  pose unreasonable  risks  or adverse  effects to humans or the
       environment.
       2.     Eligible and Ineligible Uses

              The Agency has determined that all uses of Hydrogen peroxide, peroxyacetic acid
       and potassium peroxymonosulfate sulfate are eligible for reregistration.

£.     Regulatory Position

       In consideration of the above information about hydrogen peroxide, peroxyacetic acid,
and potassium peroxymonosulfate sulfate, the Agency finds no reason to impose new risk
reduction measures for currently registered uses. The Agency will however, assess the need for
product specific risk reduction measures upon receipt of data that are being required under the
Product Specific Data Call-in Notice appended to this document.  Where labeling revisions are
imposed,  specific language is set forth in Section V of this document.
                                        21

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IV.    ACTIONS             BY REGISTRANTS

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

             1.     Additional Generic Data Requirements

                    The  generic data base  supporting the reregistration of  Hydrogen  peroxide
             Peroxyaeetie acid and Potassium peroxymonosulfate sulfate for the above eligible use:
             has been reviewed and determined to be substantially complete.
             2.     Labeling

                    All manufacturing-use products containing any of these three active ingredients
             pesticides must have the following Environmental Hazard Statement on their labels:

             "this pesticide is toxic to birds, fish and aquatic invertebrates."

                    The following is required labeling for all manufacturing-use products:

                    "Do not discharge effluent containing      products into lakes,  streams, ponds,
             estuaries, oceans, or public waters unless these products are specifically identified and
             addressed in a NPDES permit. Do not discharge effluent containing these products to
             sewer  systems  without previously notifing the sewage plant authority. For guidance
             contact your State Water Board or Regional office of the U.S. Environmental Protection
             Agency,"


       B,    End-Use Products

             1.     Additional Product-Specific Data Requirements

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

                    Registrants must review  previous                  to  ensure that they meet
             current EPA acceptance criteria (Appendix F; Attachment 5)  and if not,        to
             conduct new studies. If a registrant believes that previously submitted data meet current


                                             22

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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  mil products must comply with EPA's  current
regulations and requirements as specified in 40 CFR §156.10,

       The following label statement is required for all end-use products containing
potassium peroxymonosulfate sulfate:

       "Because pH may affect both the  redox potential of the reaction and  the
       speeiitioE of the weak hypochlorous acid reaction product, the pH of the dilution
       water must be  specified  on the  labels of  products  containing potassium
       peroxymonosttlfate sulfate and sodium  chloride salts. The optimum sanitation
       potential and safe use of the product occurs in the pH range of 7.2 to 7.6,"

The following label statement is required for all end use products containing the active
ingredient potassium peroxymonosulfate sulfate, hydrogen peroxide or peroxyacetic acid:

       For end use products  having  an indoor  residential or medical (veterinary) use
       pattern,  the following environmental hazard statement should appear on the label:

       "This pesticide is toxic to birds, fish, and aquatic invertebrates. Caution should
       be used  when applying indoors because pets may be at risk."
       Precautionary Labeling

       For end-use products for industrial and commercial uses;

             All end-use product      for commercial/industriil uses and medical
       must include protective equipment including protective clothing,  rubber gloves
       and goggles, face shield or safety glasses.   Thorough washing with soap and
       water after handling (including clothing) should also be recommended.  These
       label requirements should  appear as appropriate  based on the end-use  product
       toxicity.

       For products which may have industrial/commercial applications:

              "Do not         effluent containing      products into lakes,  streams,
       ponds, estuaries, oceans, or public waters unless  these products are specifically
       identified and addressed in a NPDES permit. Do not discharge effluent containing


                                23

-------
             these products to sewers systems without previously notifing the sewage plant
             authority. For guidance contact your State Water Board or Regional office of the
             U.S. Environmental Protection Agency."
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 iell such products for 50        from the
     of the issuance of this RED, However,                time frames will be
case-by-case, depending on the number of products involved, the number of label changes, and
other factors. Refer to "Existing Stocks  of Pesticide Products; Statement of Policy"; Federal
         Volume 56,  No, 123, June 26, 1991.

       The Agency  has determined that registrants may distribute and sell hydrogen peroxide,
peroxyacetic acid  and  potassium peroxymonosulfaie 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  sucb products for 50 months from the date of the issuance of this RED.
                                       24

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V.  APPENDICES
       25

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26

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APPENDIX A.  Table of Use Patterns Subject to Reregistration
                           27

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28

-------
CASE 40 7? , {Prro»f
Chrmfcal 000595 (Hydrogen peroxide)
SITE Application Type, Application
Timing, Application Equipment
Surface Type & Efficacy Influen-
cing Factor (Antimicrobial only)
USgS ;Et[6t'8L:6::Wft:;ftER|W5f RAT JON
FOOD/FEED USES
AcsiMM^/r^i^^^^r:.:' ':.:•:;>
Brush-on., Not on label., Brush., Hard.,
Organic soi I (5K).
Mop., Not on label., Hop., Hard., Organic
soil (5%).
Premise treatment.. Not on label,. Mot on
label., Hard., Not applicable for this use.
Scrub., Not gn label., Mot on label., Hard.,
Organic soil (5%).
Soak., Not on label., Not on label., Hard.,
Organic soil (5%).
Sponge- on. , Not on label.. Sponge., Hard.,
Organic soi I CSX).
Spray., Not on label.. Mechanical sprayer.,
Hard., Organic soil (5X).
Spray., Wot on [abet., Power sprayer.,
Hard., Organic soil (5%).
Wipe-on., Not on label., Cloth., Hard.,
Organic soi 1 (5X}.
ABRJOULTUftAt/WliBii' StRMtUSES/BUROfNGS'' AW |i
Brush-on., Not on label,. Brush., Hard.,
Organic soil (5X),
Mop., Not on label,. Hop., Hard., Organic
soil (5%).
Premise treatment.. Not on label., dot on
label., Hard., Mot applicable for this use.
Scrub., Not on label., Mot on Label., Hard.,
Organic soi I (5X).
Soak., Not on label,. Not on label., Hard,,
Organic soi I (5%).
Sponge-on., Not on label., Sponge., Hard.,
Organic soi 1 (5%).
Form

SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L

SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
H i n i mtlti
Appl icat ion
Rate

V 755
V 755
V 118
V 755
V 755
V 755
V 755
V 755
V 755

V 755
V 755
V 118
V 755
V 755
V 755
Maximum Soil Hax. Haxiimjn Cose Hin, Restr. Geographic
Application Text Apps /crop cycle, tnterv Entry Allowed
Rates (Max 3 Max or /year (days) Interv
Dse) Rate (days)
:• -:;•: 	 ;*;•;:(&$ Gfoop: 1MJ30CK FOOD
V 755 * NS NS NS NS
V 755 * NS NS NS NS
V 118 * NS NS NS NS
V 755 * MS NS NS NS
V 755 * NS NS NS NS
V 755 * NS NS NS HS
V 755 * NS HS NS NS
V 755 * NS NS NS HS
V 755 * NS NS NS MS
;: m 	 -J^fiS* drdup; INDOOR FOOD
V 755 * NS MS NS NS
V 755 * NS NS NS NS
V 118 * NS NS NS NS
V 755 * NS NS NS NS
V 755 * NS NS NS NS
V 755 * NS NS NS NS
Geographic Use
Disallowed Limitations
Codes

A08, A13, A30,
A10(10J, A29{50P»
A08, A13, A30,
A10(10>, A29C5QO)
AOB, A13, AJO, ADS,
A2i(5), A29(500J
A08, AH, A30,
AIO(IO), A29<500)
A08, A13, A30,
AW10), A29C500I
AOB, A13, A30,
A1SK10), A29C500)
AD8, A13, A30,
A10OO), A29C500)
AOB, A13, A30,
A10(10), A29(500)
AOB, A13, A30,
AIO(IO), A29(500)

A08, A13, A30,
AIO(IO), A29C500)
A08, A13, A30,
A10{10), A29{500)
A08, A13, A30, AOB,
A25(S), A29C500)
A08, A13, A30,
AKK10), A29{500J
AOB, A13, A30,
A10<10>, A29<500}
A08,AI3,ft30,
A10S10), A29(500)

-------
Dote
                  Time
APPENDIX A  -  CASE 407?,  [Prro.y cmpdM  Chemical  000595  [Hydrogen peroxide:
                                                                                                                                                                        Page 2
SITE Application Type, Application Form
Timing, Application Equipment
Surface Type & Efficacy Influen-
cing Factor (Antimicrobial only)
If&S-ELiiHBtfr fW REliEGJSTHATJOW
FOOD/FEED USES (con't)
Mini mum
Appl icat ion
Rate

AGtt1fc^LtUSAL^A^H!Sfti^CtURES/8UltbINGS:ANO EQUIPMENT tcon't}
Spray., Not on label.. Mechanical sprayer., SC/L
Hard., Organic soil C5%).
Spray., Not on label., Power sprayer., SC/L
Hard., Organic soil C5S}.
Uipe-on., Mot on label., Cloth., Hard., SC/L
Organic so! I (5K).
TOtp»;ti^
Circulation method., Not on label.. Not on SC/L
label., Hard., Not applicable for this use.
Closed circulation system treatment., Not on SC/L
A33C5),
label., Hot on label., Hard., Not applicable
for this use.
Immersion., Not on label.. Not on label., SC/L
Hard., Not applicable for this use.
Spray., Not on label.. Sprayer., Hard., Not SC/L
applicable for this use.
mMis^HWsEsp;sScess:tNG ;-Mfe:ft^*fHfffiitobti.
Premise treatment.. Not on label., Not on SC/L
label., Hard., Not applicable for this use.
DAIRT CATTLE UACTATING OR UNSPECIFIED)
Premise treatment., Not on label.. Brush., SC/L
Hard., Organic soil (5X).
Premise treatment., Not on label.. Cloth., SC/L
Hard., Organic soil (5X).
Premise treatment., Not on label., SC/L
Mechanical sprayer.. Hard., Organic soil
Premise treatment., Not on label., Hop., SC/L
Hard., Organic soil (5%).
Premise treatment., Not on label., Not on SC/L
label., Hard,, Organic soil (5X).
V 755
V 755
V 755

V 472
V 543
V 472
V 472
CONTACT) ' -
,V 118

V 755
V 755
V 755
V 755
V 755
Maximum Soil
Appl ication Text
Rates (Max
Dse)

Use Group:
V 755 *
V 755 *
V 755 *
Use Gr6up:
V 849 *
V 644 *
V 849 •
V 849 *
USfr Sfoupt
V 118 *
Uie Group:
V 755 *
V 755 *
V 755 *
V 755 *
V 755 *
Max. Haxiimn Dose Min. Restr. Geographic
Apps /crop cycle, Interv Entry Allowed
3 Max or /year (days) Interv
Rate (days)

[NOOOfi FOOD (can't)
NS NS NS NS
NS NS NS NS
NS NS NS NS
INDOOR FOOD
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
INDOOR FOGG
NS HS NS NS
INDOOR FOOD
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
Geographic Use
Disallowed Limitations
Codes


AOB, A13, A30,
A10(10), AJ9<500)
A08, A13, A30,
A10(10), A29(500)
A08, A13, A30,
A10(10), AJ9(500)

AOB, AOB, A25C2), .
A»(500)
i
A08, A25<1>,
A34<40)
AOS, AOB, A25C2),
A29C500)
A08, AOB, A25f2>,
A29{500)

AOS, AOB, AOB,
AZ5<5>, A29(500)

A08, A13, A30,
AIO(IO), AZ9(500)
AOB, A13, A30,
A10{10), A29(500)
AOB, A13, A30,
AIO(IO), A29(500)
A08, A13, A30,
A10C10), A29{500)
AOS, A13, A30,
A10HO), A29{500)

-------
Date 12/09/93
                  Time 12:29
APPENDIX A  -  CASE 4072,  EPerony
Chemical 000595 [Hydrogen peroxide]
                                                                                                                                                                       Page 3
SITE Application Type, Application
Timing, Application Equipment
Surface Type & Efficacy Influen-
cing Factor (Antimicrobial only)
FOOD/FEED USES Ccon'tJ
DAIRY ;CAtJlE (IjAGfAfiMlSit UNSPECIFIED) tcon'
Premise treatment., Not on label., Power
sprayer., Hard,, Organic soil (5%).
Premise treatment., Sot on label.. Sponge,,
Hard., Organic soil (5X).
BM Rf "r. AM :» i iK '• f ASM | NO.;.: f AM t f t t es/iou i pfcNt
Circulation method., Not on label,, Not on
label.. Hard., Not applicable for this use.
Inraersion. , Not on label.. Not on Label.,
Hard., Not applicable for this use.
Spray., Not on label., Sprayer., Hard., Not
applicable for this use.
DAIRY FARM HILKING EQUIPMENT
Circulation method., Not on label.. Hot on
label., Hard., Not applicable for this use.
Immersion., Not on label.. Not on Label.,
Hard., Hot applicable for this use.
Spray., Not on label., Sprayer,, Hsrd., Hot
applicable for this use.
w!fet,Bosfs • csmATiKQ m uNsrccmw)- * ^T:
Premise treatment,, Not on label.. Brush.,
Hard., Organic soil (5%).
Premise treatment., Not on label., Clcith.,
Hard., Organic soil C5M.
Premise treatment.. Not on label.,
Mechanical sprayer., Hard., Organic soiL t
Premise treatment.. Not on label., Hop.,
Hard., Organic soil (5%).
Premise treatment,, Not on label., Not on
label.. Hard., Organic Soil <5X).
Form Minimuti
Application
Rate

t) ' '••• •' .:"';:i:|i?
SC/L V 755
SC/L V 755
:_.-::; 	 •' ' '\'\..,.£:.\ •*:*.
SC/L V 472
SC/L V 472
SC/L V 472

SC/L V 472
SC/L V 472
SC/t V 472

SC/L V 755
SC/t V 755
SC/L V 755
SC/L V 755
SC/L V 755
Maximum Soil
Application Text
Rates (Max
Dse>

;;:;;:: !;!; '••::••<< :'':U£ff Group!
V 755 *
V 755 *
^y^^nfm^
V 849 *
V 849 *
V 849 *
Use Group:
V 349 *
V 849 *
V 849 *
Use Croup:
V 755 *
V 755 *
V 755 *
V 755 *
V 755 *
Max. Maximum Dose Min, Restr, Geographic
Apps /crop cycle, Interv Entry AL lowed
9 Max or /year (daysj Interv
Rate {days)

UOOOfi FOOD (CQO'tj
NS KS NS HS
NS NS NS NS
'fNDOOR FOOD
NS NS NS NS
NS NS HS NS
NS NS NS NS
INDOOR FOOD
KS KS NS NS
NS NS MS NS
HS MS NS NS
INDOOR fOOO
NS HS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS HS
Geographic Use
Disallowed Limitations
Codes


A08, A13, A30,
A1CK10), A29(500)
AOS, A13, A30,
A10{10), A29C500)

AOB, AOS, A25(Z),
A29C500)
AQ3, A08, A25(2),
t
AOB, A01, A25{2),
A2°ISOO)

A08, AOS, AZ5{2>,
A29C500)
AQ8, AOS, A25C2),
A29CSOO)
AOB, AOS, A25C2).
A29(500)

AOS, A13, A30,
A10{10>, A29<500)
AOB, A13, A30,
AIO(IO), A29C500)
AOS, A13, A30,
A10(10), A29C500)
AOB, A13, A30,
A1Q<10), A29<500)
AB8, All, A30,
AIO(ID), A20(500)

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Date 12/09/95  ••  Time
APPENDIX A  -  CASE 4072,  [Peroxy cnpds) Chemical 000595 [Hydrogen peroxide]
                                                                                                                                                                         Page 4
SITE Application Type, Application
Timing, Application Equipment -
Surface Type & Efficacy Influen-
cing Factor {Antimicrobial only)
U'sfes-jf SEI Gi sit' J$K.. Wfeeei STfSAt i PM
FOCO/FKD USES (eon't)
Form
Minimum
Appl i cat ion
Rats
Maxirmjn Soil
Application Text
Rates (Max
Ose)
B* i RijitdWiylptJM: lifi ;6fe &fepEC i f ftS i 1 fed* f » :/-: - • '• ' : :' " :: : : :;:i!i il: - ; |f; If; i : usi ^ woup:
Premise treatment,, Not on label,, Power
sprayer.. Hard., Organic soil .
Sponge- on,, Not on label., Sponge,, Hard.,
Organic soil (55!}.
Spray., Not on label.. Mechanical sprayer.,
Hard., Organic soil (5%).
Spray,, Not on label., Powir sprayer,,
Hard., Organic soil (5%),
Uipe-on., Not on label., Cloth., Hard.,
Organic soi 1 (SXJ.
SC/L
SC/L
TO- CC5N
SC/L
SC/L
SC/t
SC/L
SC/L
SC/L
SC/L
SC/L
V
V
t/ft
V
V
V
V
V
V
V
V
755
755
755
755
755
755
755
755
755
755
V
V
V
V
V
V
V
V
¥
V
755 *
755 *
lii is HEMP'S
755 *
755 *
755 *
755 *
755 *
755 •
755 *
755 *
6AfiSt3 EStABLiif!(i!£Nf$'-FiSS3:K(JiiNbLiNG. AREAS (FdOd CONTACT). •;•••• .?;" :':•.•::..•. : ::' "" 'i'Uife GrBL|H
Brush -on,. Not on label., irysh,. Hard.,
Organic soil <5S).
Mop., Not on label., Hop., Hard., Organic
soil C5X).
Scrub., Mot on label. , Not on label., Hard.,
Organic sot! {51).
Soak., Not on label.. Not an label., Hard.,
Organic soi 1 (5X).
SC/L
SC/L
SC/L
SC/L
V
V
V
V
755
755
755
755
V
V
V
V
755 *
755 *
755 *
755 *
Hax. Haxinun Dose Kin. Restr. Geographic
Apps /crop cycle, Interv Entry Allowed
S Hax or /year (days) Interv
Rat* (days)
IKBOOS FOOD Ccwi'ti
NS MS NS NS
NS NS NS NS
imim FOOJ
NS NS MS NS
NS NS NS NS
NS ttS NS NS
NS MS NS NS
NS NS NS NS
NS NS NS NS
NS m NS NS
NS NS MS NS
tNDOOfi FOOD
NS MS NS MS
NS NS NS NS
NS NS NS NS
NS NS NS NS
Geographic Use
Disallowed Limitations
Codes

AOB, A13,
A10(1Q),
A08, A13,
A1Q<10),
AOB, A13,
A10(10),
A08, A13,
A1QC1Q),
AOB, A13,
A10OOJ,
A08, A13,
A1QUQ5,
AOS, A11,
A1QC10},
AOS, A1S,
A10{10),
AOI, A13,
A10C10),
AOS, A13,
A10(10),

AOI, A13,
A1QOO),
AOB, A13,
A10C10),
A08, At 3,
AIO(IO),
AOB, A13,
A1D(10>,

A30,
A29C500)
A30,
A29CS00J
A30,
A30,
129(500}
i
A30,
A29(500)
A30,
AZ9C5QO)
*30,
A29(500)
A30,
A29(500)
MO,
A2°C500>
A3Q,
A29(5005

MO,
129(500}
A3B,
A29(500)
AJO,
A2t(iOO}
A3Q,
A29{500)

-------
U.lte 12/09/93    lime
APPENDIX ft  -  CASE 407?,  |Pn o«y
Chemical 000595 [Hydrogen peroxide)
                                                                                                                                                                       Page  5
SITE Application Type. Application
Timing, Application Equipment -
Surface Type £ efficacy Influen-
cing Factor (Antimicrobial only)
OB
FOOD/FEED USES (con't)
EAtpQjsitoUsHrSNiS- FW; MMbUNS ARIA'S
Sponge -on.. Not on label.. Sponge., Bard.
Organic soil CSX).
Spray., Not on label.. Mechanical sprayer
Hard., Qrsuntc soil <5X>,
Spray., Not on label., PoHer sprayer.,
Hard,, Orginic soil .
Mop,, Not on label.. Mop., Hard., Organic
soil (5X>.
form
Miniimjn Ha xi nun soil Max. Max iimjn Dose Min. Restr. Geographic
Application Application Text Apps /crop cycle, Interv Entry Allowed
Rate Rates (Max 3 Max or /year (days5 Interv
Dse> Rate (days)
Geographic Use
Oisal Lowed Limitation*
Codes
(Food CONTACT) Ttc(*l't> " ' Use Groups INODOR FOOJ (eort'tji
, SC/L
., SC/L
SC/L
SC/L
V 755 V 755 * NS NS HS KS
V 755 V 755 * MS NS NS NS
V 755 V 755 * NS NS US NS
V 755 V 755 * NS NS NS NS
(fOOb CONTACT) Use Croup: INDOOR FOOD
SC/L
SC/L
Scrub., Mot on label., Mot on label., Hard., SC/L
Organic Soil <5X>,
Soak,, Not on label., Not on label., Hard
Organic soil (5%).
Sponge-on., Not on label., Sponge., Hard.
Organic soil (5S),
Spray., Hot on label., Mechanical sprayer
Hard., Organic soil (5X>.
Spray., Not on label.. Power sprayer.,
Hard., Organic soft C5%3.
yipe-on., Not on label., Cloth,, Hard,,
Organic sot 1 <5X).
FOOD' DtSPESSIfiG- EQyiPHEBf/l/eNPlNlj'ittWNE
flrush-on., Not on label., Brush., Hard.,
Organic sail (5%).
Hop,, Not on label,. Mop., Hard., Organic
soil (5X),
. , SC/L
SC/L
., SC/L
EC/L
SC/L
j - .--- .•
SC/L
SC/L
V 755 V 755 * NS NS MS NS
V 755 V 755 * NS NS NS NS
V 755 V 755 * NS NS NS NS
V 755 V 755 * NS NS NS NS
V 755 V 755 * NS NS NS NS
V 755 V 755 * NS NS NS NS
V 755 V 755 • NS NS NS NS
V 755 V 755 * NS NS NS NS
- : • :: : "" :':': :?: : : • ;:"; ;';. . ; • ;
-------
Date 12/09/93  -  T imc  12:29
APPENDIX ft  .   C*SE 40?,?,
Chemical 000595 [Hydrogen peroxide]
Page 6
SITE Application Type, Application
Timing, Application Equipment
Surface Type & Efficacy Influen-
cing Factor (Antimicrobial only)
FOOD/FEED (con't)

Form

TOdO: ti I S'f'Etl 5 1 HE : MUl MiEW/VEKB r HG llACH ! NE S ( con < t »
Scrub., Not on label., Not on label.. Hard., SC/L
Organic soil <5X).
Soak., Not on label., Not on label., Hard.,
Organic soi I (5XJ,
Sponge - on. , Not on label., Sponge., Hard.,
Organic soil (5%),
Spray., Mot on label.. Mechanical sprayer.,
Hard., Organic soil (5XJ.
Spray., Not on label., PoHer sprayer.,
Hard., Organic soil (5%),
Wipe- on.. Not on label., Cloth., Hard.,
Organic soil (5%5,
f^^^^m^^^^^n^^m^
Brush-on., Not on label., Brush., Hard.,
Organic soil (5K>.
Mop., Not on label., Mop., Hard., Organic
soil CSX),
Scrub., Not on label.. Not an label., Hard. ,
Organic soil (5%).
Soak., Not on label., Not on label.. Hard.,
Organic soil (5%>.
Sponge-on., Not on label.. Sponge., Hard,,
Organic soi 1 C5%).
Spray., Not on label., Mechanical, spriyer.,
Hard., Organic soft (5%).
Spray., Not on label., Power sprayer.,
Hard., Organic soil (5X).
Wipe-on., Not on label., Cloth., Hard.,
Organic soil {5SJ.
SC/L
SC/L
SC/L
SC/L
SC/L
FyrUTEN
SC/L
SC/L
SC/L
SC/L
SC/L.
SC/L
SC/L
SC/L
Minimum Maximum Soil
Application Application text
Rate Rates (Max
Ose}
V 755
V 755
V 755
V 755
V 755
V 755
sltsaiNx
V 755
V 755
V 755
V 755
V 755
V 755
V 755
V 755
TO'^-xlM^sg^-BrSup:
V 755 *
V 755 *
V ?55 *
V 755 *
V 755 *
V 755 *
%;cplrAeft:f:u'^'fira*:
V 755 *
V 755 *
V 755 *
V 755 *
V 755 *
V 755 *
V 755 *
V 755 *
Max. Haximsi Dose Hin. Restr, Geographic
AF^S /crop cycle, Interv Entry Allowed
S Max or /year (days) Interv
Rate (days)
INDOOR FOCO
NS
NS
NS
NS
NS
NS
INDOOR FOOD
NS
NS
NS
NS
NS
NS
NS
MS
NS NS NS
MS NS MS
NS NS NS
MS NS NS
NS NS NS
MS NS NS

KS NS NS
NS NS NS
SS NS NS
NS NS NS
NS NS MS
NS NS NS
NS NS NS
NS NS NS
Etographie Use
Disallowed Limitations
Codes
A08, A1S, A30,
A10(10), A29C500)
A08, A13, A30,
A10(10», A29CSOOJ
AOB, *13, AJO,
A10(tO), A29(500>
A08, A13, A30,
AIO(IO), A2°(500)
A08, A13, A3D,
AIQOO}, A29J500)'
AOS, A13, AM,
AIO(IO), A29{500>

A08, AT 3, A30,
A10(10), A29C500)
AOI, A13, A30,
A10C10), A29C800)
AOB, A13, A30,
A1Q<10>, A29C50D)
AOS, A13, A30,
A10{10>, A29(500)
A08t A13, A30,
A10(10), A29C500J
AOB, A13, A30,
A10C10), A29{500)
A08, A13, A30,
A10C103. A29C500)
AOB, A13, A30,
A10{10), A29{50DJ

-------
Dote 12/09/9-i
                   'Time  12:2'}
                                                             APPENDIX A
CASE in;?,  \ff.,r,,v
Chrmkal 000595  [Hydrogen peroxide]
                                                                                                                                                                              Page 7
SITE Application type. Application
Timing, Application Equipment -
Surface Type & Efficacy Influen-
cing Factor (Antimicrobial only)
USES; EL i G J B1E;:: : f. qH :REREG t StSAti ON
FOOD/FEED USES (con't)

Form

FDOD:PRf>tESSiNO:::PLANT EOUJPMEHT CFDOO CONTACT) :
Brush-on., Not on label., Brush., Hard.,
Organic soi L (5X).
Circulation method.. Not on label.. Not on
label., Hard., Not applicable for this use-
Closed circulation system treatment., Not on
A33(5),
label.. Not on label., Hard., Not applicable
for this use.
[rmersion. , Not on Label., Not on label.,
Hard., Not applicable for this use.
Scrub., Not on label.. Not on label., Hard.,
Organic soi I (5%) .
Soak., Not on label., Not on label., Hard.,
Organic soil (5%).
Sponge-on., Not on label., Sponge., Hard.,
Organic soil (5%).
Spray,, Not on label., Mechanical sprayer.,
Hard., Organic soil (5%).
Spray., Not on label.. Power Sprayer.,
Hard., Organic soil (5%).
Spray., Not on label., Sprayer., Hard., Not
applicable for this use.
Uipe-on., Not on label.. Cloth., Hard,,
Organic sci I (5%).
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
Minimum Maxinun Soil Max. HaxinunQose Bin. Restr. Geographic
Application Application Text Apps /crop cycle, Interv Entry Allowed
Rate Rates (Max a Max or /year (days) Interv
Ose> Rate (days)
: Use Groups
V
V
V
V
V
V
V
V
V
V
V
755
472
543
472
755
755
755
755
755
472
755
V
V
V
V
V
V
V
V
V
V
V
755 *
849 *
644 *
849 *
755 *
755 *
755 *
755 *
755 *
849 *
755 *
Fix>ti;>Ro'CESSING PtANT.x.PREHlSES;-(Nt)N'Fo6o MHfActjT' H' :'" '• O;li- iPNN ;? ^ u^' ^HaJp:
Brush-on., Not on Label., Brush., Hard.,
Organic soi L (5%) .
Mop., Not on label., Hop,, Hard., Organic
soil '(5S).
Premise treatment., Not on label., Not on
label., Hard., Not applicable for this use.
Scrub., Not on label., Not on label,. Hard.,
SC/L
SC/L
SC/L
SC/L
V
V
V
V
755
755
118
755
V
V
V
V
755 *
755 *
118 *
755 *
INDOOR FOOD
NS NS NS NS
NS NS NS NS
NS HS NS NS
NS NS HS HS
NS NS NS NS
NS NS NS NS
NS HS MS NS
NS NS NS NS
NS NS NS HS
NS NS NS NS
NS NS NS NS
: INDOOR FOOD
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
Geographic Use
Disallowed Limitations
Codes

A08, A13
A10(10),
AOB, A13

, A30,
A29<500(
, A30, AOB,
A29<500)
A08, A25C1),
A34(40)
A08, A13
AOS, A13
A10(1D),
A08, A13
AlOdO),
AOB, A13
AlOdO),
AOB, A13
AlOdO},
A08, A13
A10{10),
AOS, A 13
A25{2),
AOS, A13
A10{10),

AOS, A13
A10(10),
AOB, A13
AlOdO},
AOB, A13
A25(5),
AOS, A13
, A30, AOB,
A29(500>
i
, A30,
A29(500)
, A30,
A29(500)
, A30,
A29(500>
, A30,
AZ9(500)
, A30,
A29(500)
, A30, AOB,
A29(500)
, A30,
A29(500)

, A30,
A29(500)
'A29(500)
, A30, AOB.
AZ9(500>
, A30,

-------
Date 12/09/93
                  Time  12:29
                                                            APPENDIX A
                                                                           CASE 407?,
                     rmpdi]  chemical 000595 [Hydrogen peroxide]
                                                                                                                                                                         Page 8
SITE Application Type, Application Form
Timing, Application Equipment -
Surface Type S Efficacy Influen-
cing Factor (Ant imicrobiil only}
FOOD/FEED USES (can't)
Fo^Mjijejii f p'fpffi i p«i»i rill . t NON f=p ;" etirafer >
Soak., Wot on label.. Not on label., Hard., SC/L
Organic soil {5SS.
Sponge -on.. Not on label,, Sponge., Hard., SC/L
Organic soil (5X).
Spray., Not on label.. Mechanical sprayer., SC/L
Hard., Organic soil (5X).
Spray., Not on label.. Power sprayer., SC/L
Hard., Organic soil (5X).
Wipe-on., Mot on label.. Cloth., Hard., SC/L
Organic soil (5X>.
UVESTDOC
Premise treatment.. Mot on label.. Brush., SC/L
Hard., Organic soil (5X).
Premise treatment.. Not on label,. Cloth., * SC/L
Hard., Organic soil <5%).
Premise treatment.. Not on label., SC/l
Mechanical sprayer., Hard,, Organic soil
(5%).
Premise treatment.. Hot on label.. Hop., SC/L
Hard., Organic soil CSX).
Premise treatment.. Not on label.. Not on SC/L
label., Hard., Organic soil (556).
Premise treatment.. Not on label.. Power SC/L
sprayer.. Herd,, Organic soil (5%).
Premise treatment., Not on label., Sponge., SC/L
Hard., Organic soil <5%),
Minimum
Application
Rate

(cbo'tf '.ili'fif
V 755
V 755
V 755
V 751
V 755

V 755
V 755
V 755
,V 755
V 755
V 755
V 755
Maximum Soil
Application Text
Rates (Max
Ose)

m:-m^m^t
V 755 *
V 755 *
V 755 *
V 755 *
V 755 *
Use iGroupi
V 755 *
¥ ?SS *
V 755 *
V 755 «
V 755 *
V 755 *
V 755 *
Max. Max iirum Dose Hjn. Restr. Geographic
Apps /crop cycle, Interv Entry Allowed
3 Max or /year (days) Interv
Sale (days)

INDOOR F000 teon'ti
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS US NS NS
NS NS MS NS
INDOOR fOOD
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS MS NS NS
NS NS NS NS
NS NS NS NS
Geographic Use
Disallowed Limitations
Codes
t

ADB, A13, A30,
AIQ(IO), A39(5005
AD8, A13, A30,
A10t10), A29{500)
A08, A13, A30,
A10<10), A29(500)
A08, A13, A30,
AIO(IO), A29(50Q>
A08, A13, *30,
AIO(IO), A29(500)'

ADB, A13, A30,
AIO(IQ), A29{500)
AOS, A1S, A30,
A10(10J, A29(500)
A08, A 13, A30,
A10C10), A29(500}
A08, A13, A30,
A1CK1Q), A29C5QO)
A08, A13, A30,
A10(10), AZ9(5QO)
A08, All, A30,
AIOOO), *2t(500)
AOB, A13, A30,
A10(10), A29{500>
POtlLTP              .

Feeding and Metering appliinee treatment.,    SC/L  V 755
Not on label., Not on  label.,  Hard., Organic
soil (5W.
     Group: INDOOR FOOD

V 755   *    NS
                               NS NS     NS
AOB, A08,  C04,  C25,
C27, A10C10),
A29<500)

-------
Date 12/09/93  -  Time
SITE Application Type, Application

  Timing, Application Equipment
  Surface Type & Efficacy Influen-
  cing Factor (Antimicrobial only)
                                                           APPENDIX A  -  CASE  40?2,  [Peroxy  cnpd-sj Chemical 000595  [Hydrogen peroxide]
                                             form1  Minimum
                                                                      Maximun  Soil  Ma*.   Maximum Dose  Win.   Restr. Geographic
                                                   Application    Application  Text   Apps    /crop cycle,   Interv Entry  Allowed
                                                   Rate                 Rates  (Max   8 Hax      or /year   (days) Interv
                                                                               Dse)   Rate                        (days)
Geographic

Disallowed
                                                                                                                                                                        Page 9
Use

Limitations
Codes
USES; RltfifRUr!.q

FOOD/FEED USES (con't)
Premise treatment.. Hot on label..  Not on   SC/L  V 755
label., Hard., Organic soil (5X) ,
Transportation vehicle treatment..  Not on   SC/L  V 755
label,. Mot on label., Hard., Organic soil
CSX).

NQN- FOOD/TON-FEED
                                                                         USS Groups  INDOOR  FOOD  CcOfl'tS

                                                                        V 755   *    NS               NS  NS      MS
                                                                        V 755   *    NS
                                                                                                       MS NS      MS
                  A08,  *Q8,  C04,  C25,
                  C27,  A10CIO),   •'
                  A29C500)

                  A08,  AOB,  C04,  C25,
                  C27,  A10C10),
                  A2W500)

A'*M^si l^^^^f MAi(iiCH '
Premise treatment.. Not on label.. Brush., SC/L V 755
Hard,, Organic soil (5X).
Premise treatment., Not on label., Cloth., SC/L V 755
Hard., Organic soil (5X).
Premise treatment.. Not on label,, SC/l V 755
Mechanical sprayer.. Hard., Organic soil
CSt).
Premise treatment,, Not on label.. Mop., SC/l V 755
Hard., Organic soil (5X).
Premise treatment,, Not on label.. Not on SC/L V 755
label., Hard,, Organic soil (5%).
Premise treatment.. Not on label.. Power SC/L V 755
sprayer.. Hard., Organic soil (5%).
Premise treatment.. Not on label.. Sponge,, SC/L V 755
Hard., Organic soil (SX).
:;.;;;;,;;.;: ;: ,: :: ; ; ; *'•;.* f:m
Brush-on., Mot on label., Brush., Hard., SC/L V 755
Organic soil (5%).
Mop,, Not on label., Hop., Hard., Hot SC/L V 6250
applicable for this use.
SC/L V 160
Hop., Not on label.. Hop., Hard., Organic SC/L V 755
soil <5S),

Use Group;
V 755 *
V 755 *
V 755 *
V 755 *
V 755 *
V 755 *
V 755 *
: •:;";: :;•• y. y^g jrSUp;
V 755 *
V 6250 *
V 160 *
V 755 *

INDOOR HON-fOOt)
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS KS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
INDOOR RESIOiMTlKL
N5 NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS


A08, A13, A30, '
A10OO), A29(500>
AOB, A13, A3D,
A10C10), A29C50Q)
AOB, A13, A30,
A10(10», A29000)
A08, A13, A30,
AlOflO), A29{500)
A08, A13, A30,
A10(1Q>, A29(500)
A08, A13, A30,
A10HO), A29C500}
AOB, A13, A JO,
A10C105, A29C500)

A08, *13, A30,
A10(10>, A29(500)
AOB, A10{10), A06
AOfl, A10(5)
AOB, A13, A30,
A10(10), A29(500)

-------
Date 12/09/93  -  Time
APPENDIX A  -  CASE 4072,  [Pcroxy cn^ris]  Chemical  000595 [Hydrogen peroxide]
Page 10
SITE Application Type, Application
Timing, Application Equipment
Surface Type K Efficacy Influen-
cing Factor (Antimicrobial only)
NON-FOOO/MON-FEED tcon't)
Mt mm ;*Rl*isWpiiiJ*; SOR r ACES i&n < t i :. ; ' : ; : • .
Scrub., Not on label.. Not on tabel., Hard.,
Organic soi I (5%).
Soak., Not on label., Not on label., Hard.,
Organic soil (5%).
Sponge-on., Hot on label., Sponge., Hard.,
Not applicable for this use.

Sponge- on. , Not on label., Sponge., Hard.,
Organic soi I (5X).
Spray., Hot on label., Mechanicat sprayer.,
Hard., Organic soil (5%).
Spray., Hot on label.. Power sprayer.,
Hard., Organic soil (5%).
Spray., Not on label.. Pump spray bottle..
Hard., Not applicable for this use.

Uipe-on., Not on label.. Cloth., Hard., Hot
applicable for this use.

Wipe-on. , Not on label., Cloth., Hard.,
Organic soil (5K).
K^ERCtAt/iNST^TUTJDNAL/iNDUSTREAl flQQHS
Brush-on., Not on label., Brush., Hard.,
Organic soi I (5%).
Hop., Not on label.. Mop., Hard., Not '
applicable for this use.
Bop., Hot on label.. Mop., Hard., Organic
soil (55!).
Scrub., Not on label., Not on label., Hard.,
Organic soi I (5%).
Form
Minimum
Appl ication
Rate
Maximum Soil
Application Text
Rates (Max
Dse)
::h .:.. ••• • :: ' . fee. .droup;
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
V
V
V
V
V
V
V
U
V
V
V
V
V
V
V
V
755
755
6250
160
755
755
755
aooo
2000
6250
160
755
755
6250
755
755
V
V
V
V
V
V
V
W
V
V
V
V
;,;* •*•*•;• 'I
V
V
V
V
755 *
755 *
6250 •
160 *
755 *
755 *
755 *
8000 *
2000 *
6250 *
160 *
755 *
Jse Croup:
755 *
6250 *
755 *
755 *
Max. Maximum Dose
Apps /crop cycle,
3 Max or /year
Rate
Min. Restr. Geographic Geographic Use
Interv Entry Allowed Oi sal towed Limitations
(days) Interv Codes
(days)
INDOOR RESIDENTIAL tewiilfeii!
NS
NS
NS
NS
HS
NS
NS
NS
NS
NS
NS
NS
INDOOR HOH-FOOO
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
HS
NS
NS
NS
HS
NS
NS
HS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
HS
NS
NS
NS
HS
NS
NS
NS
NS
NS
HS
NS
NS
A08, A13, A30,
A1D(10), A29(500)
A08, A13, A30,
AlOdO), A29(500)
AOB, AIO(IO), A06
AOB, A1U(5)
AOB, A13, HO,
AIO(IO), A29(5QO>
A08, A13, A30,
AlOnO), A29(500)
AOfl, A13, A30,
AlOdO), A29(500)
AOB, AIO(O.S)
AlOdO)
AOB, AIO(IO), AD6
AOB, A10(5)
A08, A13, A30,
AIO(IO), A29C500)
AOB, A13, A30,
AIO(IO), A29(500)
AOB, A10(10), A06
AOB, A13, A30,
A10C10), A29(500)
AOB, A13, A30,
AlOdO), A29(500)

-------
Date 12/09/93  --  Time
APPENDIX A  -  CASE 4072,
cnfxft]  Chemical  000595 [Hydrogen peroxide}
                                                                                                                                                                       Page 11
SITE Appl i cat ion Type, Application
Timing, Application Equipment -
Surface Type 8 Efficacy Influen-
cing Factor (Antimicrobial only)
: It |fl |L% *flft : f t « At 1 0'N
NGN- FOOD/HON- FEED ( con't}
a^MWW^m***,*****
Soak., Not on label.. Mot on label., Hard.,
Organic soil £5%).
Sponge-on., Not on label., Sponge,, Hard,,
Not applicable for this use.
Sponge-on., Not on label.. Sponge., Hard.,
organic soi 1 (5%),
Spray., Not on label.. Mechanical sprayer,,
Hard., Organic soil (5%).
Spray., Not on label.. Power sprayer.,
Hard., Organic soil <5X).
Spray., Hot on label., Pimp spray bottle.,
Hard., Not applicable for this use.
Uipe-on,, Not on label.. Cloth., Hard., Not
applicable for this use.
Hipe-on,, Not on label.. Cloth., Hard.,
Organic iol I (5%).
Form Minimum Maxirrur Soil Max. Max imuBi Dose Min. Restr. Geographic
Application Application Text Apps /crop cycle, Interv Entry Allowed
Rate Rates (Max 3 Max or /year (days) Interv
Ose} Rate {days)
;6h*t> ' Use Srtjup: INDOOR NON-FOCO (earv'tii
SC/L V 755 V 755 * HS MS NS NS
SC/L V 6250 V 6250 * NS MS NS NS
SC/t V 755 V 755 * NS NS NS NS
SC/L V 755 V 755 * MS NS NS NS
SE/L V 755 V 755 * NS NS NS NS
SC/L V 2000 V 2000 * NS NS NS NS
SC/L V 6250 V 6250 * HS NS NS NS
SC/L V 755 V 755 * NS NS NS NS
Geographic Use
Disallowed Limitations
Codes

AQS, *13, A30,
A1D(10), A29(500)
AOB, A10C10), ACI6
AM, *13, A30,
A10(10), A2W500J
AM, A13, A30,
A10C10), A2°{5QQ)
AOB, A13, A30,
A10C10), A29C500}'
A10C10)
A08, A10(10), ADA
AOI, A13, A30,
A10(10), A29{500)
coMMlBtit My. i ttST i Yijt i (ttfAi/'i pustii i A L ':f>BeS i SES'/ESU \'Pi'--\i m&^^m'<: ;!;/; f !y 1 Uie-: ti j-bups i toots NON - toots
Brush-on., Not on label., Brush., Hard.,
Organic soil (5%).
Hop., Not on label. , Mop., Hard., Not
applicable for this use.
Mop., Hot on label.. Mop., Hard., Organic
soil <5X). -
Scrub., Not on label.. Not on label., Hard.,
Organic soi I (5X).
Soak., Not on label., Not on label.. Hard.,
Organic soil (5X).
Sponge-on., Not on label., Sponge., Hard.,
Not applicable for this use.
Sponge- on., Hot on label., Sponge., Hard.,
Organic soi I C5%).
SC/L V 755 V 755 * NS MS NS NS
SC/L V 6250 V 6250 * NS MS NS NS
SC/L V 755 V 755 * NS MS NS NS
SC/L V 755 V 755 * MS NS NS NS
BC/L V 755 V 755 * NS NS NS NS
SC/L V 6?50 V 625D * NS MS NS NS
SC/L V 755 V 755 * HS NS NS NS
AOfl, A13, A30,
A10(10>, A29C500)
A08, A10C10), A06
AOB, A13, A30,
A10(10>, A29(5
-------
Date 1Z/CW/93
                  lime
SITE Application Type, Application

  Timing, Application Equipment  -
  Surface Type S Efficacy Influen-
  cing Factor (Antimicrobial only)
                                                           APPENDIX A  -   CASE
                                .  (Peroxy cmpds] Chemical 000595 [Hydrogen peroxide]
                                             Form 'Minimum
                   Maxinun  Soil   Max.   Maximum Dose  Min.   Restr. Geographic
Application    Application  Text   Apps   /crop cycle,  Interv Entry  Allowed
Rate                 Rates  (Max   S Max      or /year  (days) Interv
                            Dse)   Rate                        (days)
Geograph i c

Disallowed
                                                                                                                                                                      Page
Use

Limitations
Codes
NDN-FOOD/NON-FEED (con't)
c^ERciAt/lNsriWtbiMAL/iKDiijitSiiiiii: PS^tsi
Spray., Not on label., Mechanical sprayer.
Hard., Organic soil C5X).
Spray., Not on label.. Power sprayer.,
Hard., Organic soil (5X).
Spray., Not on label., Puip spray bottle.,
Hard., Not applicable for this use.
Wipe-on., Not on label.. Cloth., Hard., No
applicable for this use.
Wipe-on., Not on label.. Cloth., Hard.,
Organic soi I (5S).
EATIWSEETAaLlSHHEWTE: FOOD HANDLING AREAS:
Brush-on., Not on label., Brush., Hard,,
Organic soil (5X).
Hop., Not on label.. Mop., Hard., Organic
soil (5%).
Scrub., Not on label.. Not On label.. Hard
Organic soil (5X).
Soak., Not on label-. Not on label., Hard.
Organic soi I (5K).
Sponge-on., Mot on'labet., Sponge., Hard.,
Organic soil (5S).
Spray., Mot on label., Mechanical sprayer.
Hard., Organic soil (5%),
Spray., Hat on label.. Power sprayer.,
Hard., Organic soil (5%).
Wipe-on., Not on label., Cloth., Hard.,
Organic soi t (5X).
feATJHG^StA8i;U.HHENlS:.fC
A08, A13, A30,
A10{10), A29{500)
A08, A13, A30,
AIO(IO), AZ9(500)
A08, A13, A30,
A10OO), A29(500)
A08, A13, A30,
AIO(IO)-, A29{500J

AOB, A13, A30,
A10(10), A29(500)

-------
Date 1Z/Q9/93  -   Time
APPENDIX ft  -  CftSE 4072, fcproiy cnpetel  Chewiest         [Hydrogen peroxide]
                                                                                                                                                                       Page 13
SITE Application Type, Application
Timing, Application Equipment
Surface Type & Efficacy Influen-
cing Factor (Antimicrobial only)
NQN - FOOD/ NQN- FEED Ccon't)
EBTIHG 6STA^i!3!iffiBW:top6;.S|RV^Nfi')i^AS: ti<6>
Mop., Not on label,. Hop., Hard., Organic
soil (5X).
Scrub., Not on label., Not on label., Hard.,
Organic soi I (5X).
Soak., Mot on label.. Not on label., HarcJ. ,
Organic soi I <5X),
Sponge- on.. Not on label., Sponge., Nard.,
Organic soil (5X),
Spray., Mot on label.. Mechanical sprayer.,
Hard., Organic soil (5%).
Spray., Not on label., Power sprayer.,
Hard., Organic soil (5%).
Wipe-on., Not on label.. Cloth., Hard.,
Organic soi I (5X).
EAttNd : SstfcStlSfflp II;;;' NO)) pOp;. AREAS:: < NOKFOOj
Brush-on., Not on label., Brysh., Hard.,
Organic sail (5X).
Mop., Not on label.. Mop., Hard., Organic
soil (5X).
Scrub., Not on label., Not on label., Hard.,
Organic soil {5%).
Soak., Not on label.. Not on label., Hard.,
Organic soft <5%).
Sponge - on. , Not on label., Sponge., Hard.,
Organic soil (5%).
Spray., Mot on label., Mechanical sprayer.,
Hard., Organic soil (5%).
Spray., Not on label., Power- sprayer.,
Hard., Organic soil CM).
Wipe- on.. Hot on label,, Cloth., Hard,,
Organic soi I (5%).
Form Minimum
Appt ication
Rate
ifbOD CONfACt) |, A29C500)
A08, A13, A30,
A1QOD), A29(500)
A08, A13, A30,
A10(10), A29{500}
AOB, A13, A30,
A10(19), A29{500)
A08, A13, A30,
A 10(10), A29{500)
A08, A13, A30,
AID(IO), A29(500>

-------
Date
                  limn
                                                           APPENDIX A
                                                                          CASF
                                                                                      (P«-r..f
                                                                                                    Chemical 000595 [Hydrogen peroxide]
           Page  14
SITE Application Type, Application
Timing, Application Equipment —
Surface Type 8 Efficacy Influen-
cing Factor (Antimicrobial only)
LtSESHHlGietE^R^EG^RATIOrt
NON-FOCO/NOH-FEED (con't)
Form



Minimum
Application
Rate


iidsp t wii/cSif iiiistft tiMs • -itsuRiS j 'ovl : :Nsf RU«ENT s/ipACEiwicERS >
Angioplasty catheter treatment.. Not on
label.. Not on label., Not Applicable., Not
applicable for this use.
Dialyzer treatment., Not on label., Not on
label.. Not Applicable., Not applicable for
this use.




Gas sterilization treatment., Not on label..
Automatic decontamination machine., Hard.,
Not applicable for this use.
Inversion., Not on label., Heated
sterilizing tray.. Hard., Not applicable for
this use.
Iitmersion., Not on label., Heating bath.,
Hard., Not applicable for this use.
Imnersion. , Not on label., Not on label.,
Hard,, Not applicable for this use.




RTU
SC/L
SC/L
SC/L
SC/L
SC/L
RTU
RTU
RTU
RTU
RTU
SC/L
SC/L
SC/L
U 8000
No Calc
V 2000
V 2000
V 42272
V 50727
No Calc
U 60000
U 60000
W 60000
W 60000
V 160
U 8000
U BOOO
Maximum Soi 1
Application Tent
Rates (Max
Ose)


Uee Croup:
W 8000 *
No Calc *
V 2000 *
V 2000 *
V i2272 *
V 50727 *
No Calc *
U 60000 *
W 60000 *
W 60000 *
W 60000 *
V 160 *
W BOOO *
U BOOO *
Max.
Apps
3 Max
Rate


IKDOOB
HS
NS
N5
NS
NS
HS
NS
NS
NS
NS
NS
NS
HS
HS
Maiinun Dose Hin.
/crop cycle, Interv
or /year (days)


MEDICAL
HS NS
HS NS
NS MS
NS KS
NS NS
NS NS
HS NS
NS HS
NS NS
NS NS
HS NS
HS NS
NS NS
NS NS
Restr. Geographic
Entry Allowed
Interv
(days)



HS
NS
NS
NS
NS
HS
NS
NS
NS
HS
NS
NS
NS
NS
Geographic Use
Disallowed Limitations
Codes



1
A08
A08, A10(10), A16
AOB, A1U11), A16,
A32(75)
'

ADS, A08
AOB, A10(10), A16,
A36(50)
AOB, A10(10), A16,
A36(50)
A08, AIO(IO), A16
AOB, A1H6), A16
A08, AIO(IO), A06,
A36(20)
A08, A1U5.5), A16,
A36{20)
A08, A25(10)1
A36(20)
 Inmersion., Not on  label..  Not  on label..
 Not Applicable., Not applicable for this
 use.
                                              SC/L   U  8000
                                                                       U  BOOO    -     NS
                                                                                                       NS NS
                                                                                                                 NS
A08, A10(10),  A06,
A36C20)
                                              SC/L   V   2000
                                                                       V  2000
                                                                                      NS
                                                                                                       NS NS
                                                                                                                 NS
A08, A10(10),  A16

-------
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-------
Date 12/09/93
                  Time 12:29'
APPENDIX A  -  CASE 407?,
                                               ciipcM Chemical 000595 [Hydrogen peroxide}
SHE Application Type,  Application

  Timing, Application Equipment  —
  Surface Type & Efficacy Influen-
  cing Factor (Antimicrobial only)
Form  Minimum

      AppL icat ion
      Rate
                                                                                                                                                                      Page 17
           Maximum  Soil   Max.    Maximm Dose  Min.   Restr. Geographic        Geographic        Use

       Application  Text   Apps    /crop cycle,  Interv Entry  Allowed           Disallowed        Limitations
             Rates  {Max   3 Max     or /year  (days) Interv                                    Codes
                    Dse)   Rate                        {days}
USES ; • Eti BJ BL;£: • foit

NON-FOQD/NON-FEED tcon't)
Uater related surface treatment.,  Not on     SC/L  V 2000
Label., Not on label., Not Applicable., Mot
applicable for this use.

Water treatment., Not on label.. Not on      SC/L  V 2000
label.. Not Applicable., Not applicable for
this use.
Hater related surface treatment.,  Not on     SC/L  V 2000
label,, Not on label., Not Applicable., Not
applicable for this use.

Uater treatment.. Not on  label..  Mot on      SC/L  V 2000
label., Not Applicable.,  Not  applicable for
this use.
                                                                         Use Group:  AQUATIC NON-FOOD IHOUETRJAL

                                                                      V 2000    *     NS                HS NS     NS
                         V 2000    *     NS
                         V 2000    *     NS
                                                         NS HS     NS
                                                                         Use Group:  INDOOR MEDICAL

                                                                      V 2000    *     NS                NS NS     NS
                                                         HS NS     NS
                                                                                                             A08, A10C10)
                                                                                                A08, A10C10)
                                                                                                             A08, A10C10)
                                                                                                AOB, AIO(IO)

-------
Date 12/09/93  -   lime 1?;?9                              APPENDIX A     CASE MU?, tP
-------
Date 12/09/93  -  Time 12:56                               APPENDIX A  -  CASE  4072,  (Pernxy rnpdsl  Chemical 063201 CPeroxyacetie acid]       '                           Page 1

SITE Application Type, Application           Form  Miniiun            Maximum  Soil   Max.    Haxiimm  Dose  Min.   Restr. Geographic        Geographic        Use

  Timing, Application Equipment  —                 Application    Application  Text   Apps    /crop cycle,  Interv Entry  Allowed           Disallowed        Limitations
  Surface Type & Efficacy  influen-                 Rate                 Rates  (Max   a Max      or /year  (days) Interv                                     Codes
  eing Factor (Antimicrobial only)                                             Ose)   Rate                        tdiys)

-------

-------
USES ELIGIBLE  FQ» REREGfSTKATlOK




FOOD/FEED USES
«R»m»AtiW:«EmsEih.,--:-- :••••
Brush-on., Not on label., Brush., Hard.,
Organic soi I (5JS).
Hop., Not on label., Mop., Hard., Organic
soil (55i).
Premise treatment.. Wot on label., Mot on
label.. Hard., Not applicable for this use.
Scrub., Not on tabet., Not on Label., Hard.
Organic soil (5S).
Soak., Not on label.. Not on label.. Bard.,
Organic soil (5%).
Sponge-on., Mot on label.. Sponge., Hard.,
Organic soi 1 (5%).
Spray., Not on label.. Mechanical sprayer.,
Hard., Oriinic soi! <5X).
Spray., Not on label., Power sprayer,,
Hard., Organic soil <5S).
Ufpe-on., Not on label.. Cloth., Hard.,
Organic soil (5%).
Res i OTL-MAt/ fill ' ¥f IdpijiSi s / iui tci NOS ' AM> *
Brush-on., Not on label.. Brush., Hard.,
Organic soi t (550,
Mop., Wot on label., Mop., Hard., Organic
soil (52).
Premise treatment.. Mot on label., Not on
label., Hard., Not applicable for this use.
Scrub., Not on label.. Not on label.. Hard.
Organic soil (551).
Soak., Not on label.. Not on label., Hard.,
Organic soil (5X).
Sponge-on., Not on label., Sponge., Hard.,
Organic soil (5SS,

SC/L
SC/L
SC/L
, SC/L
SC/L

SC/L
SC/L
SC/L
SC/L

V
V
V
V
V

V
V
V
V

164
164
26
164
164

164
164
164
164
:H-V :::?: :.;; ;|t
¥
V
¥
V
¥

V
V
¥
¥

164
164
26
164
164

164
164
164
164
*«lp; INOOOR FOOD
* NS NS m NS
* NS NS NS NS
* NS iS NS NS
* NS NS NS NS
* NS NS NS NS

* NS MS NS NS
* NS NS NS NS
* NS NS NS NS
* NS NS NS NS

A08, A13
AIO(IO),
A08, A13
A10C10),
A08, A13
A2SCS),
A08, A13
AIO(IO),
A08, A15
A10C1Q),
A08, A13
A10(10>,
A08, A13
A08, A13
A10(10),
A08, A13
A10C10),

*A29(500)
, A30,
A29C500)
, A30, *OB,
A29(500>
, A30,
A29C500)
A30,
'*29(SOOJ
, A30,
A29C500)
, A30,
A29(500J ,
, A30, '
A29(500)
, A30,
A29[SOOJ
tOU 1 PNlNf S - :-V* ' .';.J •,'::,-:- SvE 5 ff '^Ift ^ FUUfK I NDODR FOOD
SC/l
SC/L
SC/L
, SC/L
SC/L
SC/L
t
V
V
¥
¥
¥
V
164
164
26
164
164
164
¥
¥
¥
V
¥
V
164
164
26
164
164
164
* NS NS NS NS
* NS NS NS NS
* NS N§ NS NS
* MS NS NS NS
* NS m NS NS
* NS NS NS NS
A08, A13
A1QOO),
A08, A13
A10OQ),
*0§, A13
A25{5J,
A08, A13
ANXIO),
A08, A 13
A10C1Q),
AOB, A13
A10«10),
, A30,
A29(500)
, A3D,
A29(500)
, A30, A08,
A29(500)
, *30,
A29(500)
'A29C500)
, A30,
A29(500)

-------
Date 12/09/93     Time 13:56
APPENDIX A  -  CASE 4072,  [Peroxy cupdsl  Chemical  063201  rPeroxyacetic acfd]
                                                                                                                                                                        Page 2
SITE Application Typp, Application Form' Minimum
Timing, Application Equipment - Application
Surface Type & Efficacy Influen- Rate
cirii Factor (Antimicrobial only)
tStS "ftf ifUff- F.f r:«ERE6'j SflATIGM
FOOD/FEED USES (con't)
AtiiitdUlfiJKAt/FAiiK; stmjoTUR£s/eLiii:t>fi«;s AND EDMIPHENT tcon'tJ
Spray., Not on label., Mechanical sprayer., SC/L V 164
Hard., Organic soil (5%).
Spray., Not on label.. Power sprayer., SC/L V 164
Hard., Organic soil (5%).
Wipe- on., Not on label.. Cloth., Hird., SC/l V 164
Organic soil CSX).
fifctSt5WciE6ii--!|d(i£^^ tFoofi cGMtACtllf ;i»:ll;?
Circulation method., Not on label., Not on SC/L V 103
label.. Hard., Not applicable for this use.
Closed circulation system treatment,, Not on SC/L V 128
A33<5),
label., Not on label., Hard., Not applicable
for this use.
[nmersidn.. Not on label.. Not on label,, SC/L V 103
Hard., Not applicable for this use.
Spray., Not on label.. Sprayer., Hard., Not SC/L V 105
applicible for this use.
pAiRf es/triffisr psocessins ^fcAHir-fiisii.^* (NONhoob .CONTAW s;:; ;•;•:;;
Premise treatment., Not on label., Not on SC/L V 26
label., l(a'rd., Not applicable for this use.
DAjft :cAt|ie;;tLAeTATiHe; OR e«$F*gmH»
Premise treatment.. Not on label., Brush., SC/L V 164
Hard., Organic soil (5%).
Premise treatment.. Hot on label., Cloth., SC/L V 164
Hard., Organic soil (5%J.
Premise treatment.. Not on label., SC/L V 164
Mechanical sprayer.. Hard., Organic soil
(5%).
Premise treatment., Not on label., Hop., SC/L V 164
Hard., Organic soil C5%).
Premise treatment.. Not on label., Not on SC/L V 164
label., Hard., Organic soil (5X),
Naximjn Soil Max. Han imun Cose Hin. Rtstr. Geographic
Application Text Apps /crop cycle, Interv Entry Allowed
Rates (Max S) Han or /year (days! Interv
Dse) Rate (days)


Use Group- INDOOR FOOD Ccon't)
V 164 * NS NS NS NS
V 164 * NS NS NS NS
V 164 * NS NS NS NS
fcffi\ ..:.;. ••"x-.U»B: SroUpi; jtHIXXit FOOD
V 185 * NS NS NS NS
V 151 * NS NS NS NS
V tSS * NS NS NS NS
V 185 * NS NS NS NS
:;:;|:|rf';TLJsti'Srtiup: INDoon FOOD
V 26 * NS NS NS NS
U&$ Group: INDOOR FOOD
V 164 * NS NS NS NS
V 164 * NS NS NS NS
V 164 * NS NS NS NS
V 164 * NS US BS NS
V 164 * MS NS NS NS
Geographic Use
Disallowed Limitations
Codes



AW, A13, A30,
A1fl(10), A29{500J
A08, A13, A30,
A10C103, A29C5QO)
ADS, A13, A30,
AIO(IO), A29(500)

AOfl, ADfl, A25{Z),
A29C50Q)
A08, A25C1),
AW (40)
ABB, A08, A25(2),
AiiliOO)
AOB, AOJ, A25{2},
A2f(SOO)

Aoa, AOB, AOS,
A25{5), A29C500)

A08, A13, A30,
A10{101, A29(5QO>
AOI, A13, A30,
A10(10), A29C500)
AOI, S13, A30,
A10C10H A29{500)
AOS, A13, A30,
A1B(10), A29<500)
AOB, A13, A30,
A10(10J, A29C500)

-------
Date 12/09/93
                  Time 12:56
APPENDIX A  -  CflSE 4073,
cnixhl Chemical 063201 [Perexyatetic  acid]
Page 3
SITE Application Type, Application Form Hinimum
Timing, Application Equipment — Application
Surface Type 4 Efficacy Influen- Rate
cing Factor (Antimicrobial orily)
OSes ; ;EU US 3 IBs POT Rf R861 STf* Af 1 0«
FOOD/FEED USES Ccon't)
MtRy-:CATfL|/ti:AtfAfiSiB:.'61^SWMjHED^^eoft't)'. ;: ; ' ' :••;: :;;i-
Premise treatment.. Not on label., Power SC/L V 164
sprayer., Hard,, Organic soil 15%).
Premise treatment.. Not on label., Sponge., SC/L V 164
Hard., Organic soil (5%).
Mjf!/F.AHjfi fl|XK:HAfct.iBf:iRiii|l;bi:tfBSj'MiiS'WSiNT
Circulation method., Not on label., Mot on SC/L V 103
label.. Hard., Not applicable for this use.
Immersion., Not on label., lot on label., SC/L V 103
Hard., Not applicable for this use.
Spray., Not on label.. Spray er., Hard., Not SC/L V 103
applicable for this use.
OAi fit: : rMS- :^'i:u INB ecw i PMENT
Circulation method.. Not on label., Not on SC/L V 103
label., Hard., Not applicable for this use.'
Imnersion., Mot on label.. Mot on label., SC/L V 103
Hard., Not applicable for this use.
Spray., Not on 1 abet.. Sprayer., Hard., Not SC/L V 103
applicable for this Use,
OAtRrttHfS UACTAUNG OR UNSPECIFIED
Premise treatment.. Not on label.. Brush., SC/L V 164
Hard., Organic soil (5X>.
Premise treatment.. Not on label., Cloth., SC/L V 164
Hard., Organic soil (513,
Premise treatment.. Not on libel,, SC/L V 164
Mechanical sprayer., Hard., Organic soil
?5X>.
Premise treatment,, Not on libel,. Mop,, SC/L V 164
Hard., Organic soil (5%),
Premise treatment.. Not on label,. Mot on SC/L V 164
label.. Hard., Organic soil (5%),
Maximum Soil
Application Text
Rates (Max
Dsc)


:::;:;;:;«HtiteiS:'^ir8, MB, A25C2),
A08, A08, A2S{2),
A29C500)

A08, AOS, A25<2>,
A29C5QO)
AD8, A08, A2SC2),
AOS, A08, A25C2),
A29C500)

AOS, A13, A3Q,
A1DC10), A29<500)
ACS, A13, A30,
A10C10J, A29C500)
MB, A13, A30,
A10OQ), A29(500)
MB, A13, A30,
AIO(IO), A29(500)
A08, A13, A30,
A10(10), A29C500)

-------
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-------
Date 12/09/93  -  Time 12:56
                                                           APPENDIX A
CASE 407?,  (Pprony cnpdil  Chemical  063201  (Peroxyacetic  acid)
                                                                                                                                                                        Page 6
SITE Application Type, Application
Timing, Application Equipment -
Surface Type & Efficacy Influen-
cing Factor C Antimicrobial only)
FOOD/FEED USES Ccon't)
loo!' ::B i; sp*p'!lw:m|f f mm NG ! HACH i NESJ
Scrub,, Not on label., Not on label., Hard,
Organic soil (5%).
Soak., Not on label., Not on label., Hard.,
Organic soil (53!).
Sponge-on., Not on label.. Sponge,, Hard.,
Organic soil (5X).
Spray,, Not on label,. Mechanical sprayer.,
Hard,, Organic soil CSX).
Spray., Not on label., Power sprayer.,
Hard., Organic soil (5%).
Wipe-on., Mot on label.. Cloth., Hard.,
Organic soil <5X).
Form Minimum
Application
Rate

(con'-iji
, SC/L V 164
SC/L V 164
SC/t V 164
SC/L V 164
SC/L V 164
SC/L V 164
8B^;;H/Lj&$$f»]p^  COM
Brush-on., Not on label.. Brush., Hard.,
Organic soil C5%).
Mop., Not on label.. Mop., Hard., Organic
soil C5X).
Scrub., Not on label.. Not on label., Hard.
Organic soil (5X).
Soak., Not on label.. Not on Label., Hard.,
Organic soil (5X).
Sponge-on., Not on label.. Sponge., Hard.,
Organic soil (5%).
Spray., Mot on label., Mechanical sprayer.,
Hard., Organic soil (5XJ.
Spray,, Not on label., Power sprayer.,
Hard.1, organic soil {51).
Wipe-on., Not on label., Cloth., Hard.,
Organic soil (55{>.
SC/L V 164
SC/L V 164
, SC/L V 164
SC/L V 164
SC/L V 164
SC/L V 164
SC/L V 164
SC/L V 164
Naxirmm Soil
Application Text
Rates (Max
Dse)

Use Croup:
V 164 *
V 164 *
V 164 *
V 164 *
V 164 *
V 164 *
TACT) US* Grotfp:;
V 164 »
V 164 *
V 164 *
V 164 *
V 164 *
V 164 *
V 164 *
V 164 *
Kax.
Apps
a Max
Rate

INDOOR
NS
NS
NS
NS
NS
NS
INDOOR
NS
NS
NS
NS
NS
NS
NS
NS
Hsximum Dose Hin.
/crop cycle, Interv
or /year {days)

FOOD (can't)
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
fOOO
NS NS
NS NS
NS MS
NS NS
NS NS
NS NS
NS NS
NS NS
Restr. Geographic
Entry Allowed
Interv
(days)


HS
NS
NS
NS
NS
KS

NS
NS
NS
m
MS
NS
NS
HS
Geographic Use
Disallowed Limitations
Codes


AOB, A13, A30,
A10C10), A29C50Q)
MB, A13, A30,
A10C10), A2°(SOO)
AOB, A1J, «30,
A10OO), A29C500)
A08, A13, A30,
AIO(IO), A29CSOO)
A08, A13, A30,
A10(10), A29C500)1
A08, A13, A30,
A10£10), A29C500)

A08, All, A30,
410(10), A29C500)
A08, A13, A30,
A10(105, A29(500)
AOB, A13, A30,
A10{10), AZ9(500)
AOB, A13, A30,
AIO(IO), A29C500J
AOfl, A13, A30,
A1Q[10), A?9(500)
A08, A13, A30,
AIO(IO), A29C500)
*08, A13, A30,
*10(10)i A29<500)
A08, A13, A30,
«10(10), A29{500)

-------
1P/Q9/9.5  -  time-
APPENDIX A  -  CASE 4Q<7,  (Peroxy  cmpds]  Chemical  065201 (Peroxyacetic acid]
                                                                                                                                                                      Page 7
SITE Application Type, Application
Timing, Application Equipment -
Surface Type E Efficacy Influen-
cing Factor {Antimicrobial only)
USES El J GI BL.E 	 FOR SEREG I STRAT I QN
FOOD/FEED USES (con't)

Brush-on., Not on label., Brush., Hard.,
Organic soi I (5X) .
Circulation method., Not on label., Not on
label., Hard., Not applicable for this use.
Closed circulation system treatment.. Not on
label., Not on label.. Hard., Not applicable
for this use.
Immersion., Not on label.. Not on label..
Hard., Not applicable for this use.
Scrub., Not on label.. Not on label., Hard.,
Organic soi 1 <5X).
Soak., Not on label., Hot on label., Hard.,
Organic soi I (5%).
Sponge-on., Not on label.. Sponge., Ha-d.,
Organic soi I C5%).
Spray., Not on label,. Mechanical sprayer,.
Hard., Organic soil (5%).
Spray., Not on label.. Power sprayer.,
Hard., Organic soil (5%).
Spray., Not on label., Sprayer., Hard., Not
applicable for this use.
Wipe-on., Not on label.. Cloth., Hard.,
Organic soi I (511).
Form
FJ:-- ' :
SC/L
SC/L
SC/L

SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
FOOD PRpCESSfNG PLANT : PfiEMlSES CNONFDQD CONTACT)
Brush-on., Not on label., Brush., Hard.,
Organic soi t C5%) .
Hop., Not on label., Hop., Hard., Organic
soil (5%).
Premise treatment., Not on label.. Not on
label., Hard., Not applicable for this use.
Scrub., Not on label.. Not on label.. Hard.,
SC/L
SC/L
SC/L
SC/L
Minimum Maximum Soil Max. Maximum Dose Min. Restr. Geographic
Application Application Text Apps /crop cycle, Interv Entry Allowed
Rate Rates (Max Q Max or /year (days) Interv
Dse) Rate (days)

•:'..-.:..-.- ....:..::..::::::•:. ::.:''.::. :::;llSB:::Cf OUpJ INDOOR FOOD
V 164 V 164 * NS HS NS NS
V 103 V 185 * NS HS HS HS
V 128 V 151 * NS HS NS NS

V 103 V 185 * NS HS NS HS
V 164 V 164 * NS NS NS NS
V 164 V 164 * NS NS NS NS
V 164 V 164 * NS NS NS NS
V 164 V 164 * NS NS NS NS
V 164 V 164 * NS NS NS NS
V 103 V 185 * NS NS NS NS
V 164 V 164 * NS NS NS NS
: :-:;-:::; ;:;::: USE; Group: INDOOR FOOD
V 164 V 164 * NS NS NS NS
V 164 V 164 * NS NS NS NS
V 26 V 26 * NS NS NS NS
V 164 V 164 * NS HS NS NS
Geographic Use
Di sallowed Limitations
Codes
A08, A13, A30,
A10(10), A29(500>
A08, A13, A30, A08,
A25(2), A29C500)
A08, A25(1),
A34C40)
A08, A13, A30, AOB,
A25(2), A29(530)
t
A08, A13, A30,
AIO(IO), A29(500)
A08, A13, A30,
A10(10), A29(500)
A08, A13, A30,
AlOdO), A29(500>
AOB, A13, A30,
AIO(IO), A29C500)
A08, A13, A30,
A10{10), A29(500)
A08, A13, A30, A08,
A25(2), A29(500)
AOB, A13, A30,
A10C10), A29(500)
A08, A13, A30,
A10(10), A29C500)
AOB, A13, A30,
A10{10), A29(500)
A08, A13, A30, A08,
A25(5), A29(500)
A08, A13, A30,

-------
Date 12/09/93  -  Time 12:56
                                                           APPENDIX A
CASE 4072, [Pcrony cnpck)  Chemical  063201  [Peroxyacetfc acidl
                                                                                                                                                                        Page
SHE Application Type, Application Form Minimum
Timing, Application Equipment ~
Surface Type & Efficacy Influen-
cing Factor {Antimicrobial only)
FOOD/fEEB USES (con't}
lcOOO:^i!ft^SS{'^sPtWJT:;':J'Rl«isES -{NONFOOD .eojracti:.
Soak., Not on label.. Hot on label., Hard., SC/L
Organic sail C55S).
Sponge- on,, Not on label., Sponge., Hard., SC/L
Organic soi I (5X>.
Spray., Not on label.. Mechanical sprayer., SC/L
Hard., Organic soil (558).
Spray., Not on label,, Power sprayer., SC/L
Hard., Organic soil (5X),
Wipe-on., Not on Label., Cloth., Hard., SC/L
Organic soi I (5%).
LIVESTOCK
Premise treatment.. Not on label., Brush., SC/L
Hard., Organic soil CSX}.
Premise treatment.. Not on label,. Cloth., SC/l
Hard., Organic soil CSX).
Premise treatment,. Not on label., SC/l
Mechanical sprayer.. Hard., Organic suit
<5X>.
Premise treatment,. Not on label.. Hop,, SC/l
Hard., Organic soil (5%).
Premise treatment'., Not on label.. Not on SC/L
label., Hard., Organic soil (5%).
Premise treatment.. Hot on label., Power SC/l
sprayer., Hard., Organic soil (5%).
Premise treatment.. Not on label., Sponge., SC/l
Hard,, Orgnoic sofl 
AOi, A 13, A30,
A10C10), A29(500)
A08, A13, A30,
AKKtO), A29<500)
A08, A13, A30,
A10(tD3, A29(500>'

A08, A13, A30,
AlOnQ), A29(500>
AOi, A 13, A30,
A10{10), A29<500)
AOS, A13, A30,
A10(10), A29J500)

A08, A13, A30,
A10(10), A29<500)
AOB, A13, A30,
AIO(IO), A29(5QOJ
AOB, A13, A30,
A10(10), A29{500)
ADI, A13, A30,
AIO(IO), A29{500>
Feeding and watering appliance  treatment.,   SC/L  V  164
Not on label., Mot on  label.. Hard.,  Organic
Soil <5X>.
                                                                         Use Group:  INDOOR FOOD

                                                                        V  164   *    NS
                             N5 NS     NS
AOfl,  AOB,  C04,  C25,
C2F,  A10(10),
A29C500)

-------
Pate 12/09/95  •-  Time 12:56
APPENDIX ft  •   CASE  W?,  tP>rn(y
                                                                                                            063201  tPeroxyacetic acid]
                                                                                                            Page 9
SITE Application Type, Application
Timing, Application Equipment -
Surface Type & Efficacy Influen-
cing Factor {Antimicrobial only)
list s • iiO! 6ilil;;-:f 3ft ftlf 16 j sTili ioS
FOOD/FEED USES Cconrt)
mm^m^^y
Premise treatment.. Not on label., Not on
label., Hard., Organic soil <5X),
Transportation vehicle treatment., Not on
label., Not on label., Hard., Organic soil
NON-FQOO/NQN-FEEO
AltMLS;:<£ASSSMia|#j«(iffiSeAiic«>;:i:: ::i: :;ii: I "' ;v '"'' '"•••••
Premise treatment., Not on label., Brush.,
Hard,, Organic soil (5X).
Premise treatment.. Not on label,, Cloth.,
Hard., Organic soil (5K).
Premise treatment., Not on label.,
Mechanical sprayer.. Hard., Organic soil
(5%),
Premise treatment., Not on label,, Mop.,
Hard., Organic soil {5X>_
Premise treatment.. Not on label., Not on
label., Hard,, Organic soil (5SJ.
Premise treatment., Not on label,, Power
sprayer.. Hard., Organic soil (51).
Premise treatment.. Not on label,, Sponge.,
Hard., Organic soil (5%).
mW** KWSEf «4*fi. SUMACES
Brush-on,, Not on label.. Brush., Hard.,
Organic soil (55).
Hop., Not on label., Hop., Hard., Not
applicable for this use.

Hop., Mot on label., Mop., Hard., Organic
soil (5K).
Form Minimum ttaxifwn Soil Ma*. Km (mm Dose Win, Restr. Gtographic
Application Application Text Apps /crop cycle, Interv Entry Allowed
Rate Rates (Max a Max or /year (days) Interv
Dse5 Rate (days)


use : Cirwjfi: INDOOR FOOD (ton'tj
SC/L V 164 V 164 * NS NS NS NS
SC/L ¥ 164 V 164 * NS NS NS NS

SC/L V 164 V 164 * NS NS MS NS
SC/L V 164 V 164 * NS NS NS NS
SC/L V 164 V 164 * NS NS NS NS
SC/L V 164 V 164 * NS NS NS NS
SC/L V 164 V 164 * NS NS NS NS
SC/L V 164 V 164 * NS NS NS NS
**
SC/L V 164 V 164 * NS NS NS NS
USB Croup: IKDOOR RESIDENTIAL
SC/l V 164 V 164 * NS NS NS NS
SC/L V 1250 V 1250 * NS NS NS NS
SC/L V 12 V 12 » NS NS NS NS
SC/L V 164 V 164 * NS NS NS NS
Geograc*i S C Use
Disallowed Limitations
Codes


t
A08, AOB, C04, C25,
C2F, A10C10), ,
AZ9(500)
SOB, A08, CQ4, C25,
car, Aiocio>,
A29(5QO)

AOB, A13, A30, i
A1IK18), AE9C500)
A08, A«, WO,
A10C10), AW500)
ADB, A13, A30,
AIO(IO), A29(500)
A08, A 13, AM,
A10(10», A29(5DO>
A08, A13, A3Q,
A10OO), A29{500)
A08, A13, A30,
A 10(10}, A29(500)
AOB, All, A30,
A10HO), A29{500>

AQB, A13, AID,
A10<10>, A29(500)
ACS, A1Q<10>, A06
AOS, A10C5)
A08, A13, A3Q,
A10(10>, A29E500)

-------
Date 12/09/9-5  -  Time 12:56
APPENDIX A  -  CASE 4072,  (P«?ro»y
Chcroical 063201  tPeroxyacet ic acid]
                                                                                                                                                                          Page 10
SITE Application Type, Application
Timing, Application Equipment -
Surface Type I Efficacy Influen-
cing Factor (Antimicrobial only)
pli :lif Silp : |p "s MEG j sTBXti ON
NQN-FQQO/NON-FEED (con'tj
lit iBSSf MlPli slifpRO -JiiSMCis teon« t )
Scryb, , Not on label., Not on label., Hard.,
Organic soi I (SS).
Soak., Not on label., Not on label., Hard.,
Organic soi I CSS),
Spongo-on., Not on label., Sponge., Hard.,
Not applicable for this use.

Sponge- on., Not on label.. Sponge., Hard.,
Organic soil C5%).
Spray., Not on label., Mechanical sprayer.,
Hard., Organic soil C5%).
Spray., Not on label., Power sprayer.,
Hard., Organic soil CSS).
Spray., Not on label.. Pump spray bottle., •
Hard., Not applicable for this yse.

yipe-en,, Not on label.. Cloth., Hard., Not
applicable for this use.

Wipe-on., Not on label., Cloth., Hard.,
Organic soil C5X}.
Brush-on., Nat on label., Brush., Hard.,
Organic soi I CSS) ,
Kop. , Not on label.. Hop., Hard., Not
applicable for this use.
Mop,, Not on label.. Hop., Hard., Orsanic
soil CSX).
Scrub., Not on label., Not on label.. Hard.,
Organic soil (5?!).
Form

SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
Mini mum
Appl icat ion
Rate

V
V
V
V
V
V
V
w
V
V
V
V

V
V
V
V

164
164
1250
12
164
164
164
600
400
1250
12
164

164
1250
164
164
Maximum Soil Max. Maxinun Dose Htn. Restr. Geographic
Application Text Apps /crop cycle, Interv Entry Allowed
Rates {Hax a Max or /year Cdays) Interv
Dse) Rate (days)
;;;.";::':.f:p
V
V
V
V
V
V
V
u
V
V
¥
V
:!":O;-1
V
V
V
V
let ifroup:
164 *
164 *
1250 *
12 *
164 *
164 *
164 *
600 *
400 «
1250 *
12 *
164 *
164 *
1250 *
164 *
164 *
i^ fciioeitiAUWi
HS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS HS NS
NS NS NS NS
NS MS NS NS
NS NS NS MS
NS NS NS NS
NS NS NS NS
NS NS NS NS
r INDOOR NON-FOOD
NS NS NS NS
N5 NS NS NS
NS NS NS NS
NS NS NS NS
Geographic Use
Disallowed Limitations
Codes

AOB, A13, A30,
A WOO). A29(500)
AQB, A13, A30,
A1QC10), A29C500)
AOB, A10C10), A06
AOB, A10(5)
AOB, A13, A30,
A10C10), A29C500)
AOfl, At3, A30,
A10C10), AZ9(500)
A08, A13, A30,
A10(10>, A29(500)
AOS, A10C0.5)
AIO(IO)
AOB, AIO(IO), A06
AOB, A1DI5J
A08, A13, A30,
A10<10), A29(500)
A08, A13, A30,
A10<10), A29C500)
A08, A10C10), A06
A08, At3, A30,
A10(10>, A29C500)
A08, A13, A30,
AIO(IO), A29C50Q)

-------
Date 12/QV/V3  •   Time 12:56
APPENDIX A  -  CASE 4072, [Peroxy cmpdsj  Chemical 063201 CPeroxyacetic acid]
Page 11
SITE Application Type, Application
Timing, Application Equipment -
Surface Type & Efficacy Influen-
cing Factor (Antimicrobial only}
NQN - FOOT /NON- FEED (can't)

(^iRgMlpip'i^ <:«
Soak., Not on label.. Not on label., Hard.,
Organic soil (5%).
Sponge-on., Hot on label.. Sponge., Hard.,
Not applicable for this use.
Sponge -on.. Not on label.. Sponge., Hard,,
Organic soil (5%),
Spray., Not on label., Mechanical sprayer.,
Hard,, Organic soil (5X>.
Spray., Not on label., Power sprayer.,
Hard,, Organic soil (55!) .
Spray., Not on label,, Punp spray bottle,,
Hard,, Not applicabla for this use.
Uipe-on., Not on label.. Cloth., Hard., Not
applicable for this use.
Wipe-on., Not on label., Cloth., Hard.,
Organic soil (5%).
Form Minimum
Application
Rate
Maximum Soil Max. Max imji Dose Hin. Restr. ieographie
Application Text Apps /crop cycle, Interv Entry Allowed
Rates (Max 3 Max or /year (days) Interv
Dse) Rate (days}
Geographic Use
Disallowed Limitations
Codes
?bn'i>; u&e Groups twboos NON-FOOT icoS'ti
SC/L V 164
SC/L V 1250
SC/L V 164
SC/L V 164
SC/L V 164
SC/L V 400
SC/t V 1250
SC/L V 164
V 164
V 1250
V 164
V 164
V 164
V 400
V 1250
U 164
CMH|ficMiiNs*nalIli*ppousf R i AL'WM i S| S/IQU fl* , ' ;< 'i TOWW ' ; ; s; ,
Sponge-on., Not on label.. Sponge., Hard.,
Mot applicible for this use.
Sponge-on., Not on label,. Sponge., Hard.,
Organic soil (5%).
SC/t V 164
SC/L V 1250
SC/L V 164
SC/L V 164
SC/L V 164
SC/L V 1250
SC/L V 164
V 164
V 1250
V 164
V 164
V 164
v 1250
V 164
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
oup: INDOOR HOM-fDQD
* MS
* NS
* NS
* NS
* NS
* NS
* NS
NS NS NS
NS NS NS
NS NS NS
NS NS MS
NS NS NS
NS NS NS
NS NS NS
NS NS NS

NS NS «S
NS NS NS
NS NS NS
NS NS NS
MS MS NS
NS NS NS
NS NS NS
A08, A15, A35,
AIO(IO), A29(500)
A08, A 10(10), A06
A08, A13, A30,
A10{10}, A29C500J
ADfl, A13, AJO,
A10OB), *29(500>
A08, A13, A30,
A1QC1Q), A29{SOO),
A10(10)
A09, A10(10), A06
AOB, A13, A30,
A10C10), A29C500)

AOB, A13, A30,
A10C10), A2°(500>
A08, A10C10J, A06
AOB, A13, A30,
A10C10), A29(SOO>
ADS, A13, A30,
A10(1Q), A29<500)
AOB, A13, AJO,
AlOdO), «9(500>
A08, A10(10), A06
*08, All, A30,
A10HQ), A29(500J

-------
APPENDIX A  -  CASE 4072,  IPeroxy cnpd*] Chemical  063201  (Pernxyacetic  acid!
Page
SITE Application Type, Application
Timing, Application Equipment
Surface Type & Efficacy Influen-
cing Factor (Antimicrobial only}
WON -FQQD/NQN- FEED (can't)
Form


Minimum
Appt ication
Rate

t^EtCjA t/T^Stl TOt t W
Spray,, Not on label.. Mechanical sprayer
Hard., Organic soil (5X).
Spray., Not on label., Power sprayer.,
Hard., Organic soil (5%).
Spray., Not on label., Pump spray bottle.
Hard., Not applicable for this use.
. , SC/L
SC/L
SC/L
Wipe- on.. Hot on label.. Cloth., Hard., Not SC/L
applicable for this use.
Uipe-on., Not on label.. Cloth., Hard.,
Organic soil (5%).
fi*ri tr :F.0C6;- JANDL t(f \
Brush-on., Not on label.. Brush., Hard.,
Organic soil (5%).
Mop., Not on label.. Hop., Hard., Organic
soil (5X3.
SC/L
'• fpNFOQi
SC/L
SC/L
Scrub., Not on label., Not on label,. Hard,, SC/L
Orgenic soil (5%).
Soak., Not on label.. Not on label., Hard
Organic soil (5X).
Sponge- on.. Not on label., Sponge., Hard.
Organic soil {5%).
Spray., Not on label.. Mechanical sprayer
Hard., Organic soil <535>.
Spray,, Not on label,. Power sprayer.,
Herd., Orgainit soil (5%).
Wipe-on., Not on label., Ctoth., Hard.,
Organic soi I (5%).
EATtNtTEstABLlSHHENfS FOOT SERVINfi AREAS
Brush -on., Not on label.. Brush,, Bard.,
Organic soi 1 C5X),
. , SC/L
SC/L
. , SC/L
SC/L
SC/L
(NONFOOD
SC/L
V 164
V 164
V 400
V 1250
V 164
•aanmm^
V 164
V 164
V 164
V 164
V 164
V 164
V 164
V 164
CONTACT J i :
V 164
Maximum Soi I
Application Text
Rates (Max
Cse)

n't) UM>«*
V 164 *
V 164 *
V 400 *
V 1250 *
V 164 *
;;ilfi7::ps«-::Broup:
V 164 *
V 164 *
V 164 «
V 164 *
V 164 *
V 164 *
V 164 *
V 164 »
:V :;. ::' '•'''• USB HfOt^!
V 164 *
Max. Kaiimm Oose Hin.
Apps /crop cycle, Interv
3 Max or /year (days)
Rate

INDOOR NON-FOCb (Con'tJ
NS NS NS
NS NS MS
NS NS NS
NS NS NS
NS NS NS
[ 4 DOOR NQN-rOOD
NS NS KS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
INDOOR NOW -FOOD
NS NS NS
Restr. Geographic
Entry Allowed
Interv
(days)


NS
NS
NS
NS
NS

NS
NS
NS
NS
HS
NS
NS
NS

NS
Geographic Use
Disal loved Limitations
Codes


AOB, A13, A3B,
A10C10), AE9(iOO)
AOB, A13, A30,
A10C10), A29{500)
A10C10)
AOfl, A10{10), A06
A08, A13, A30,
A10(10), A29(500)'

A08, A13, A30,
A10C10), A29(500)
ADB, A13, A30,
M0{10), A29C5QQJ
A08, A13, A30,
A10{10), A29(500)
AOfl, At3, A30,
AIO(IO), A29C500)
W8, A13, A30,
AIO(IO), A29(iOO)
AOfl, A13, A10,
A10(10), A29C500)
ADB, A 13, A30,
M0(10), AWSOO)
A08, A13, «0,
A10C10), A29C500)

A08, A13, A30,
A10(10), A29(500>

-------
APPENDIX A  -   CASE  407?,  IPt-rony [-mod-;] Chemical  065201  [Peroxyacetic acid]
Page 13
SITE Application Type, Application Form Minimum
Timing, Application Equipment - Application
Surface Type & Efficacy Influen- Rate
cing Factor (Antimicrobial only)
liSESJyjjI B lit •'•? OR:: .;« IKSSl SIR AT ] ON
NON-FOOD/NON-FEED (con't)
£*fi&& £$if AJillsipHtS JFtibb:: SERVING AREAS .(NONFOOD. CONTACT) (con'
Mop., Not on label., Mop., Hard., Organic SC/L V 164
soil (5%),
Scrub., Hot on label., Not on label., Hard., SC/L V 164
Organic soil (55E).
Soak., Not on label., Not on label., Hard., SC/L V 164
Organic soil (5%).
Sponge-on., Hot on label.. Sponge., Hard., SC/L V 164
Organic soil (5%).
Spray., Not on label., Mechanical sprayer., SC/L V 164
Hard., Organic soil (55E).
Spray., Not on label., Power sprayer., SC/L V 164
Hard., Organic soi I (5!S) .
Wipe-on., Not on label., Cloth., Hard., SC/L V 164
Organic soil (5%).
EATtNB^fitA&tiSSMEN'rSjNQU^fO^ Afi^S: (NONFOOD •;CC*TACt:i - '
Brush-on., Not on label.. Brush., Hard., SC/L V 164
Organic soil (5%).
Mop., Not on label., Mop., Hard., Organic SC/L V 164
soil (5X).
Scrub., Not oo label., Not on label., Hard., SC/L V 164
Organic soil (5%).
Soak., Not on label., Not on label., Hard., SC/L V 164
Organic soil (5X).
Sponge-on., Not on label., Sponge., Hard., SC/L V 164
Organic soi I (5S).
Spray., Not on label., Mechanical sprayer., SC/L V 164
Hard., Organic soil (5%).
Spray., Hot on label., Power sprayer., SC/L V 164
Hard., Organic soil (5X).
Uipe-on., Not on label., Cloth., Hard., SC/L V 164
Organic soi I (55).
Maximum
Application
Rates
Soil Max. Haiinuii Dose Kin. Restr. Geographic
Text Apps /crop cycle, Interv Entry Allowed
(Max 3 Max or /year (days) Interv
Dse) Rate (days)
Geographic Use
Disallowed Limitations
Codes
» . Use Group) INDOOR NON-FOOD [COM.**
V 164
V 164
V 164
V 164
V 164
V 164
V 164
Use Si
V 164
V 164
V 164
V 164
V 164
V 164
V 164
V 164
* NS HS NS NS
* NS HS NS NS
* NS NS NS NS
* NS NS NS NS
* NS HS NS NS
* NS HS NS NS
* NS HS NS NS
•bup: INDOOR NON-FOOD
* NS NS HS NS
* NS NS NS NS
* NS NS HS NS
* NS NS HS NS
* NS NS NS NS
* NS NS HS HS
* NS NS NS NS
* NS NS NS NS
A08, A13, A30,
A10(10), A29(500)
AQB, A13, A30,
A10C10), A29(500)
AOB, A13, A30,
A10MO), A29(500)
AOB, A13, A30,
AIO(IO), AZ9(500)
A08, A13, A30,
AIO(IO), A29(500).
A08, A13, A30,
A10(10), A29(500)
AOB, A13, A30,
AlOdOJ, A29(500)

AOB, A13, A30,
A10HO), A29(500)
AOB, A13, A30,
AlOdO). A29(500)
AOB, A13, A30,
AIO(IO), A29(500)
AOS, A13, A30,
AIO(IO), A29<500>
AOB, A13, A30,
AKK10), A29(500>
A08, A13, A30,
A10<10), A29{500)
AOB, A13, A30,
A10(10), A29(5CO)
AOB, A13, A30,
AIO(IC), A29(500)

-------
              APPENDIX A  -  CASE  40??,  (Prrony  rmxkl Chpmital 063201 [Peroxyacetic acid]
           Page
SITE Application Type, Application
Timing, Application Equipment -
Surface Type & Efficacy Influen-
cing Factor (Antimicrobial only)
uses: :itlij(ii;E:-,Rm. fcERg&i'sfMt ibN
NQN-FOCO/NON-FEEO (con't)
tfOSPpAl :C*itJCAL. itfe*S.;(5'lil*tii;CAl iHSTRUMENT
Angioplasty catheter treatment.. Not on
label., Mot on label.. Not Applicable., Mot
applicable for this use.
Dialyier treatment.. Wot on label,. Not en
label., Not Applicable., Not applicable for
this use.



Inversion., Not on label.. Not on label.,
Hard., Not applicable for this use.



Irmersion., Not on label.. Not on label.,
Mot Applicable., Mot applicable for this
use.


form Minimum
Application
Rate


S/PAC£HA*:ER5)
RTU M 600
SC/L No Calc
SC/L V 400
SC/L V 400
SC/L V 8*54
SC/L V 2000
SC/L V 12
SC/L y 600
SC/l U 600
SC/L U 600
SC/L V 400
SC/L V 400
Maximum Soil
Application Text
Rates CMax
Dse)


Uee Group;
y 600 *
No Calc *
V €00 *
V 400 *
V 8454 *
V 2000 *
V 12 *
y 600 *
y 600 *
U 600 *
V 4DO *
V 400 •
MS*.
a Max
Rate


INBOOS
NS
NS
NS
NS
NS
NS
WS
NS
NS
NS
NS
NS
Maximum Dose Hin.
/crop cycle, Interv
or /year (days)


KEDICAl
NS NS
NS NS
NS NS
MS NS
MS NS
MS NS
MS NS
NS NS
MS MS
HS MS
NS MS
NS NS
Restr. Geographic
Entry Allowed
Interv
{days)



NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Geographic Use
Disallowed Limitations
Codes




AOS
A08, A10(10), A16
AOS, A1K11), A16,
A3ZC75)
'
AOS
AIM, A1Q(1Q}, A06,
AMC20)
AOB, A11C5.5), A16',
AMI 20)
AM, A2S(10),
A36(20)
A08, AIO(IO), A06,
AS6(20>
AOB, AIO(IO), A16
AOS, A11(11), A16,
SC/L  No Calc
HOSPITAI HOtlCSinCAl-lTEHS tBebPANS/fUfcHIiURE) :

lirniersion., Wot on label., Not on  label.,    SC/L  V 1?
Hard., Not applicable for this use.

                                             SC/L  V 12
                         No Calc   *    NS
                                                         NS NS      NS
                         V 400
                         V 12
                                     :  INDOOR MEDICAL

                                        WS               NS HS     NS
ADI,  A11(5.S», AW,
                                        tiS
                                                         NS NS      NS
A08,  AIO(IO), A16
AD8,  A25(10), A06,

-------
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£ ;O.-; L. x o c
Q.*' ^:. m o
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? k ^3" « ° ti
CL. O -:*— . • CL sc O
•*^ ::*-i:-: »* O Z
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-------
                                                           APPENDIX ft     CASE 407?,  IPoroxy cnpds] Chemical  063IOt [Peroxyacetic acid]
                                                                                              Page 16
SITE Application Type, Application
Timing, Application Equipment -
Surface Type 1 Efficacy Influen-
cing Factor (Antimicrobial only)
UpS 1U8| III V W: 'R E« RS ! S TR AT '1 ON
MQN-FOOO/NON-FEED (con't)
HO^!TAWi*lCi|tAt?-t'MSTlTUTi:dNS FINISES (HU*
Sponge- on., Not on label.. Sponge,, Hard.,
Organic soil (5%).
Spray., Not on label., Mechanical sprayer..
Hard., Organic soi I (5X).
Spray., Not on label., Power sprayer.,
Hard., Organic soil (5X).
Spray., Not on label., Pump spray bottle.,
Hard., Not applicable for thfs ute.

Surface treatment,. Not on label., Not on
label.. Hard., Mot applicable for this use.

Wipe-on., Not on label.. Cloth., Hard.,
Form Minimum
Application
Rate


AN/VETERlNWOp¥
SC/t V 164
SC/L V 164
SC/L V 164
SC/L y 600
SC/L ¥ 400
SC/L V 200
SC/L v 200
SC/L V 164
Maximum Soil
Application Text
Rates (Max
Dse5


t} Use Sraupt
V 164 *
V 164 *
V 164 «
U 600 *
V 400 *
V 400 *
V 200 *
V 164 *
Hax.
Apps
a Hax
Rate


INDOOR
NS
NS
NS
NS
NS
MS
NS
NS
Maximum Dose Hin.
/crop cycle, tnterv
or /year (days)


NIOICAL (cbrrtii
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
Restr. Geographic
Entry Allowed
Interv
Ways)



NS
NS
NS
NS
NS
NS
NS
Ni
Geographic Use
Disallowed Limitations
Codes

1

AOB, AW, A30,
AIO(IO), A29(500j
AOB, A15, AM,
A1DC10), A29(SOO)
AOB, A13, A30,
A10(10), AZ9(500)
AOB, A10CD.5)
A10C10), A06

AOB
A08, A13, AM,
Organic soft (5X),
                      sirs TEW
Water related surface treatment., Mot on     SC/L  V 400
label,, Mot on label.. Mot Applicable.,  Not
applicable for this use.

yater treatment..  Not on label., Mot on      SC/L V 400
label.. Mot Applicable., Not applicable for         ,
this use.
Mater related surface treatment., Not on     SC/L  V 400
label., Wot on label.. Not Applicable.,  Not
applicable for this use.

yater treatment..  Mot on label.. Not on      SC/L  V 400
label,. Not Applicable., Not applicable for
this use.
 Use Croup;  AQUATIC KW-FDOO

V 400   *    NS                NS  NS     NS
V 400
             NS
                               NS NS     NS
 U*e Group: INDOOR MEDICAL

V 4QO   *    NS                NS  NS     NS
V 400   *    NS
                               NS  NS     NS
                                                                                  A10C10), A29C500)
AOS, A10<10)
AOB, AtQOQJ
ADS,  A1QC1Q)
AOS, A10(10)

-------
Date 12/09/95  -  Time 12:56
                                                  APPENDIX A  -  CSSE 407?, (Pproxy cnpds]  Chemical  063201  IPeroxyacetic acid]
Page 17
LEGEND
  HEADER ABBREVIATIONS
  Max. Apps a Max Rate       : Maximum number of Applications at Maximum Dosage Sate
  Min. Interv (days)         : Minimum Interval  between Applications  
-------

-------
Date 12/09/93  - lime 13:18
APPENDIX A     CASE  40?2,  [Peroxy
                       Chemical 063604 tPotassiun peroxymoncsutf ate] '
Page 1
SITE Application Type, Appl i cat ion Form HinimLm Maximum Soil Max. Haxinun Dose Min. Restr. Geographic
Timing, Application Equipment - Application Application Tent Apps /crop cycle, Interv Entry Allowed
Surface Type & Efficacy Influen- Rate Rates (Max a Max or /year (days) Interv
cing Factor (Antimicrobial only) Qse) fiate (days)
FOOD /FEED USES
POULTRY (teS/WEAT) .."."" Uaa Groupi INDOOR FOOD
Feeding and watering appliance treatment., SC/S W 1987 W 4128 * NS MS NS NS
Not on label.. Not on label.. Hard., Organic
soi I.
Surface treatment.. Not on label., Fogger., SC/S U 1987 W 1987 * NS NS NS NS
Hard., Organic soil.
F^LTRt;::PfcOCESSyie::pANt: PREMISES : -(KCWWDb pDJffACt) Use Group: INW30R FOOD
Spray., Not on label.. Sprayer., Hard., SC/S W 1987 U 1987 * NS NS NS NS
Organic soil.
NON-FOCO/NON-FEED

Geographic Use
Disallowed Limitations
Codes
A03, C25, C27,
AIO(IO), A06
A03, C25, C27,
AIO(IO), A06
A03

Fog., Not on label.,  Fogger.,  Not            SC/S  W 1987
Applicable., Not applicable for this use.

EGG HANDLING fOJtPKENT (HATCHING)

Surface treatment., Not on label.,  Not on    SC/S  W 1987
label., Hard., Organic soil.
Surface treatment.. Not on label.,  Mot on    SC/S  U 1987
label,. Hard., Organic soil.
  Use Croup;  INDOOR RESIDENTIAL

U 4128   *    MS               NS NS     NS


  Use Group:  (HDOOR NON-FOOD

U 4128   *    NS               NS NS     NS


  Use Group:  tNOOOR N ON-FOOD

U 4128   *    NS               NS HS     NS
                                                                                                                                                          A03
                                                                                                    A03
                                                                                                                                                          A03

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Date 12/09/93
                  Time  13:18
                                          APPENDIX  A  -  CASE 4072, IPeroxy cmpd'jl Chemical  063604  [Potassium peroxymonosulfstel
Page 2
LEGEND
  HEADER ABBREVIATIONS
  Hex, Apps 3 Max Rate
  Mir», Interv (days)
  lestr. Entry Interv Cdays)
                   Maximum rentier cf Applieitions at  Maximum Dosage Rate
                   MinimuR Interval  between Applications  (days)
                   Restricted Entry  Interval (days)
  SOIL TEXTURE FOR MAX APP. RATE
            Won-spec i f ic
  C         Coarse
  N         Median
  I         Fine
  0         Others

  fQRMULAT OH COOES
  SC/S      SOLUBLE COMCEMTRATE/SDLID
  ABBREVIATIONS
  AN
  NA
  NS
  uc
As Needed
Mot Applicable
Not Specified ;  for
                              instance,  "I.234E-Q4"  is equivalent  to ".0001254"
  USE LIMITATIONS COOES
  AQ3 ; Hard watsr activity.
  A10 : 	 mioute(s) contact time.
  CZ5 : Remove animals prior to treatment.
  C2? ; Remove feed and water prior  to treatment,
  "        IN PARENTHESES REPRESENTS THE        OF TIME UNITS (HOURS,DATS, ETC.) DESCRIBED IN THE LIMITATION.

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APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
                          71

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72

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                              GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case Peroxy compounds covered by mis Reregistration Eligibility
Decision Document.  It contains generic data requirements that apply to Peroxy compounds 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.  Bibliographicjgitation (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.
                                          73

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74

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                       APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Hydrogen peroxide
REQUIREMENT
USE PATTERN
crrATioN(S)
PRODUCT CHEMISTRY ALL DATA REQUIREMENTS HAVE BEEN WAIVED
ECOLOGICAL EFFECTS
71-1A
71-2B
72-1C
72-2A
Acute Avian Oral - Quail/Duck
Avian Dietary - Duck
Fish Toxieity Rainbow Trout
Invertebrate Toxicity
ALL
ALL
ALL
ALL
WAIVED
WAIVED
WAIVED
WAIVED
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
82-3
82-4
83-3A
83-3B
83-4
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization - Guinea Pig
90-Day Dermal - Rodent
90-Day Inhalation - Rat
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2- Generation Reproduction - Rat
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
                               75

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      Data Supporting Guideline Requirements for the Reregistration of Hydrogen peroxide
REQUIREMENT	USE PATTERN	     CITATION^)
84-2A     Gene Mutation (Ames Test)             ALL        WAIVED
84-2B     Structural Chromosomal               ALL        WAIVED
         Aberration
84-4      Other Genotoxic Effects               ALL        WAIVED
OCCUPATIONAL/RESIDENTIAL EXPOSURE   ALL DATA REQUIREMENTS WAIVED
ENVIRONMENTAL FATE                    ALL DATA REQUIREMENTS WAIVED
                                        76

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                       APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Peroxyacetic Acid
REQUIREMENT
PRODUCT CHEMISTRY ALL
USE PATTERN
CITATION(S)
DATA REQUIREMENTS WAIVED
ECOLOGICAL EFFECTS
71-1A
71-2B
72-1C
72-2A
Acute Avian Oral - Quail/Duck
Avian Dietary - Duck
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
ALL
ALL
ALL
ALL
WAIVED
WAIVED
WAIVED
WAIVED
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
, 82-3
82-4
83-3B
83^1
84-2A
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization - Guinea Pig
90-Day Dermal - Rodent
90-Day Inhalation - Rat
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
Gene Mutation (Ames Test)
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
                               77

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      Data Supporting Guideline Requirements for the Re registration of Peroxyacetic Acid
REQUIREMENT
          USE PATTERN
                     crrATiON(S)
84-2B     Structural Chromosomal
         Aberration
84-4      Other Genotoxic Effects
OCCUPATIONAL/REi
ENVIRONMENTAL FATE
             ALL
WAIVED
             ALL        WAIVED
  EXPOSURE   ALL DATA REQUIREMENTS WAIVED
ALL DATA REQUIREMENTS WAIVED
                                         78

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                     APPENDIX B

Data Supporting Guideline Requirements for the Rercgistration of Potassium
                    pcroxymonosulfatesulfate
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY ALL DATA REQUIREMENTS WAIVED
ECOLOGICAL EFFECTS
71-IA
71-2A
71-2B
72- 1A
72-1C
72-2A
Acute Avian Oral - Quail/Duck
Avian Dietary - Quail
Avian Dietary - Duck
Fish Toxicily Bluegill
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
ALL
ALL
ALL
ALL
ALL
ALL
WAIVED
204057
204058
19852
19852
WAIVED
TOXICOLOGY
8i-i
81-2
81-3
81-4
81-5
81-6
82-1A
82-3
83-3A
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization - Guinea Pig
90-Day Feeding - Rodent
90-Day Dermal - Rodent
Developmental Toxicity - Rat
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL

42607402
42591201
42607403
42607401
WAIVED
WAIVED
WAIVED
WAIVED
                             79

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Data Supporting Guideline Requirements for the Reregistration of Potassium
                        peroxymonosulfatesulfate
REQUIREMENT USE PATTERN CITATION(S)
83-3B Developmental Toxicity - Rabbit
83-4 2-Generation Reproduction - Rat
84-2A Gene Mutation (Ames Test)
84-2B Structural Chromosomal
Aberration
84-4 Other Genotoxic Effects
OCCUPATIONAL/RESIDENTIAL EXPOSURE
ENVIRONMENTAL FATE
ALL WAIVED
ALL WAIVED
ALL WAIVED
ALL WAIVED
ALL WAIVED
ALL DATA REQUIREMENTS WAIVED
ALL DATA REQUIREMENTS WAIVED
                                   80

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82

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APPENDIX C. Citations Considered to be Part of the
  Data Base Supporting the Reregistration of Peroxy
                   compounds
                       83

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84

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                              GUIDE TO APPENDIX C

1.     CONTENTS OF BIBLIOGRAPHY.  This                             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
               in support of     regulatory decisions.  Selections from other sources
       including the published literature, in  those instances where they have been considered,
       are included.

2.     UNITS OF ENTRY.  The unit of entry 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     i single subject), can           for  purposes of review and
       can be described with a conventional bibliographic citation. The Agency has also
       attempted to unite basic documents and commentaries upon them, treating them as a
       single study.

3.     IDENTIFICATION OF ENTRIES.  The entries in  this bibliography are
       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.

4.     FORM OF ENTRY.  In addition to the Master Record Identifier (MRED), 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
                    to     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


                                          85

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       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            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
             immediately following the word "received."

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

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

       (4)    Volume Identification (Accession Numbers).  The final element 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
             within the volume.
                                   86

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                              BIBLIOGRAPHY

MRID                       CITATION
            Bard, A.J., Parsons, R. and Jordan, J. 1985. Standard
            Potentials in Aqueous Solutions. .IUPAC, Physical and
            Analytical Chemistry Divisions, Commissions on
            Electrochemistry and Electroanalytical Chemistry; Marcel
            Dekker, Inc., New York, NY; pp. 57-58.

            Cotton, F.A., and G, Wilkinson. 1988. Advanced Inorganic Chemistry. John
            Wiley and Sons, New York. pp. 456^60,

            Greenwood, N,N and Eamshaw, A. 1984, Chemistry of the Elements:
            Pergamon Press, Oxford, UK; pp. 834-854; 742-748.

            Mortimer, C.E. 1975. Chemistry: AConceptual Approach. D.Van Nostrand
            Company, New York. pp. 233-234.

            Turk, A., H. Meislich, F. Brescia, J.  Arents. 1968. Introduction to
            Chemisjry. Academic Press, New York. pp.401-402.
                                       87

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APPENDIX D.  List of Available Related Documents
                      89

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90

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       The following is a list of available documents related to Peroxy compounds. 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 Peroxy compounds and
are included in the EPA's Office of Pesticide Programs Public Docket.

       1,     Health and Environmental Effects Science Chapters

       2.     Detailed Label Usage Information System (LUIS) Report

       3,     Peroxy compounds RED Fact Sheet

       4.     PR Notice 86-5 (included in this appendix)

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

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92

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APPENDIX E.  PR Notices 86-5 and 91-2
                  93

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94

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PR Notice  86-5
       95

-------
96

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               UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                            WASHINGTON, D.C, 20460

                                 July 29, 198i

                                                            OFFICE OF
                            PRNOTICE 86-5            PREVENTION, PESTICIDES
                                                      AND TOXIC SUBSTANCES

          NOTICE TO PRODUCERS,  FQRMULATORS, DISTRIBUTORS
                         AND REGISTRANTS

Attention:     Persons responsible for Federal registration of
               pesticides.

Subject:       Standard format  for data submitted under  the
               Federal Insecticide,  Fungicide, and Rodenticide
               Act  (FIFRA)  and  certain provisions of the Federal
               Food, Drug,  and  Cosmetic Act  (FFDCA).

I.    Purpose

     To require data to be  submitted to the  Environmental
Protection Agency  (EPA) in  a standard  format. This Notice also
provides additional guidance about,  and illustrations of,  the
required formats.

II.   Applicability

     This PR Notice applies to  all data that are  submitted to EPA
to satisfy data requirements for granting or maintaining
pesticide registrations, experimental  use permits,  tolerances,
and related approvals under certain  provisions of FIFRA  and
FFDCA.  These data are defined  in FIFRA §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 I, 1966.  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, 19B4, EPA published proposed regulations  in
the Federal Register {49 FR 37956} which  include  Requirements for
Data Submission  (40 CFR §158.32), and  Procedures  for Claims of
Confidentiality of Data  (40 CFR §158,33).  These regulations


                                97

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specify the format for data submitted to EPA under Section 3 of
PIFRA 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 CPR §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, which
applies only to data submitted with an application.

VI.   Format Requirements

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

                                98

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                             -  INDEX-
                                                            Text Example
                                                            Page   Page
A.   Organization of the Submittal Package	  3      17

B.   Transraittal Document	,  .  4      11

C.   Individual Studies ...................  4

     C. l  Special Considerations for Identifying Studies  .  .  5

D,   Organization of each Study Volume	6      17

     D. 1  Study Title Page	, ,	7      12
     D. 2  Statement of Data Confidentiality Claims
                  (based on FIFRA §10(d)(l})   	  8      13
     D. 3  Confidential Attachment	8      15
     D. 4  Supplemental Statement of Data Confidentiality
            Claims {other than those based on  FIFRA §10(d)(1)} 8      14
     D, 5  Good Laboratory Practice Compliance Statement   .  .  9      16

E.   Reference to Previously Submitted Data  ... 	  9

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

G.   Special Requirements for Submitting Data  to the Docket   10



A.   Organizationof SubmittalPackage

     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,
    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).

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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 transmittal
date,- and a list of all individual studies included in the
package in the order of their appearance, showing (usually by
Guideline reference number) the data requirement(s)  addressed by
each one.  The EPA-assigned number' for the regulatory action
{e.g. the registration, EUP, or tolerance petition number) should
be included in the transmittal document as well, if it is known
to the submitter.  See Attachment 1 for an example of an
acceptable transmittal document.

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

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

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

C.   Individua1	S tudi e s

     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--except ions 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.

                               100

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

C.1  Special Considerations for Identifying Studies

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

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

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

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

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

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

     Note particularly that product chemistry studies are likely
to contain Confidential Business Information as defined in ,FIFRA
§10(d)(1)(A),  (B), or  (C), and if so must be handled as described
in section D.3.  of this notice.
                               101

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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)
                               102

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D.l. Titie Page

     A title page is always required for each submitted study,
published or unpublished.  The title page must always be freely
releasable to requestors; DO NOT INCLtJDE 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).

g.    Facts of Publication.  If the study is a reprint of a pub-
lished document,  identity on the title page all relevant facts of
publication,  such as the journal title, volume, issue, inclusive
page numbers, and publication date.
                                103

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D.2. Statements of Data Confidentiality Claims Under FIFRA
     §10(d)(i).

     Each eubmitted 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 §lQ(d)(1) 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
510(D)(1)(A),  (B), or  (C)   (as described in D.2. above) all  such
information must be excised from the body of the study and
confined to a separate study-specific Confidential Attachment.
Each passage of CBI so isolated must be identified by a reference
number cited within the body of the study at the point from which
the passage was excised (See Attachment 5).

     The Confidential Attachment to a study must be identified by
a cover sheet fully identifying the parent study, and-must  be
clearly marked "Confidential Attachment,"  An appropriately
annotated photocopy of the parent study title page may be used as
this cover sheet.  Paginate the Confidential Attachment
separately from the body of the study, beginning with page  1 of X
on the title page.  Each passage confined to the Confidential
Attachment must be associated with a specific cross reference to
the page(e) 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 otherthan described by FIFRA  §10(d)
{1} (A) ,  (B), or  (C), the following provisions apply:

     - The specific information Co 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.

                               104

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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 HOT 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 glu'e or binding tapes.

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

     Number of Copies Required - All submittal packages except
those associated with a Registration Standard or Special Review
(See Part G below)  must be provided In three complete, identical
copies.   (The proposed regulations specified two copies; three
are now being required to expedite and reduce the cost of
processing data into the OPP Pesticide Document Management System
and getting it into review.)
                               105

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G.
Special Requirements forSubmitting 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 FIPRA  §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.
                           9 V,  Aktnun
                       Acting airvctor.
                       ft*gittr*bLon 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
                                106

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                          ATTACHMENT 1

       ELEMENTS  TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*  '

1.   Name and address of submitter  (or all joint submitters**)

''"Smith Chemical Corporation              Jones Chemical Company
 1234 West Smith Street       -and-      5678 Wilson Blvd
 Cincinnati, OH 98765         -•          Covington, KY 56789



+Smith Chemical Corp will act as sole agent for all submitters,

2.   Regulatory action in support of which this package is
     submitted

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

3.   Transmittal date

4.   List of submitted studies

     Vol 1.     Administrative materials - forms, previous corres-
               pondence with Project Managers, and so forth.

     Vol 2.     Title of first study in the submittal  (Guideline
               No.)

     Vol n     Title of nth study in the submittal (Guideline
               No.)

     *    Applicants commonly provide this information in a tran-
          smit tal letter.  This remains an acceptable practice so
          long as all four elements are included.

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

Company Name:	
Company Contact:  	   	
                    Name                Phone
                               107

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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 l of X
   (X is the total number of pages in the study)

                       .108

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                           ATTACHMENT 3

            STATEMENTS OF DATA CONFIDENTIALITY CLAIMS

1. No claim of confidentiality under FIFRA  §10(d)(1)(A),(B) , or
(C) .

       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 6§10 (d) <1) (A)-',  (B) , or  (C) .
  Company
  Company Agent: 	Typed Name	 Date:.

         Title	  	Signature
2. Claim of confidentiality under FIFRA §lo(d) (1)(A) ,  (B) , or
(C) .

             STATEMENT OF DATA CONFIDENTIALITY CLAIMS
  Information claimed confidential on the basis of  its  falling
  within the scope of FIFRA §10(d)(1)(A),  (B), or  (C) has been
  removed to a confidential appendix, and is  cited  by
  cross-reference number in the body of  the study.
  Company:
  Company Agent:	Typed Name	 Date:.

  	Title		  	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.
                                109

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                          ATTACHMENT 4

      SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
     For any portion of a submitted study that "ia not described
by FIFRA §10(d)(1)(A), (B),  or (C),  but for which you claim
confidential treatment on another •'ba.sis, 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.
                               110

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                                            5

             EXAMPLES OF  SEVERAL CONFIDENTIAL ATTACHMENTS

Example  1.  . {Confidential  word or phrase that has  been  deleted
from the study)
   CROSS REFERENCE HUMBIR 1  This crofls reference number is used in the  study
                            in place of the following words or phrase at  the
                            indicated volume and page ref erencee .

   DELETED WORDS OR PHRASE:
   PAGE     LINE  REASON FOR THE DELETION                   FIFRA REFERENCE

      fi     14    Identity of  Inert Ingredient              iiQ(d) (l) (C)
     12     25                "                                   "
    100     19                "                                   "
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);
      <               .                                                )
      (     Reproduce  the deleted paragraph's) here                    >
      (                                                               }

 PAGE       LINES REASON FOR THE DELETION                   FIFRA REFERENCE
  20.       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 KUMBER 2, 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(Si;   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)
                                     111

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                                 ATTACHMENT 6.

                  SAMPLE GOOD LABORATORY PRACTICE STATEMENTS

Example i.	
     This study meets the requirements for 40 CFR Part 160

           Submitter  ——	

           Sponsor    	—	r
           Study Director
Example 2.
    This study does not neet the requirements of 40 CFR Part 160, and differs
    in the following ways r
    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 wfaetner  it has  been conducted  in
    accordance with 40 CFR Part 160.

          Submitter
                                      112

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                                    7.
                 FORMAT OP fHI SUSMITTAL PACKAGE
                   Transmittal Doeunent.
                       Related Administrative M«t*rial»
                       l«.g., Method of Support  Stat«mentf «tc»)
                             Other materials  about  th* submittal
                             (a.fl.j •uau&ari«8 of  group* of  studies
                             to aid In thair  review).
                                             «uboitt*d  •*  unlqu*
                                    physical •ntlti««/  according
                                    to tha format below.
                   FORMAT Of SUBMITTED STUDIES
LEGEND
                  title  paget

               Statement of Confidentiality Claims,

                   CLP  and flagging*  statements  - as appropriate.

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

                            Appendices to the study*
                                 Titl* f*9* Of th* Confidential
                                 Att*chm«nt.

                                      Confidantial Attachment.
                                                       Stat*OH»nt
                                          of Confidentiality Claim*,
                                      * Wh«n flagging raquir*»*nt8
                                        ara fintlitcd.
                Documents  which must be submitted am
                appropriate  to meet ettet>lish«d requirements.

                                •ubnitted at submitter'a option.
                             113

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114

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PR Notice  91-2
      115

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116

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I
        g       UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
        T
                            WASHINGTON, D.C. 20460
                                                          UWi OF
                                                        FREKNT1DN, PESTICIDES
                                                        UiD TOXIC SUiSTMKES
                          PR NOTICE 91-2

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

ATTENTION: Persons Responsible for Federal Registration of
Pesticide Products.

SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement

I. PURPOSE:

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

II. BACKGROUND

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

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

                                117

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CFR 158.175(c) (3) .

     The upper and lower certified limits, which must be proposed
in connection with a product's registration, represent the
amounts of an ingredient that may legally be present 40 CFR
158.175. The lower certified limit is used as the enforceable
lower limit for the product composition according to FIFRA
section 12(a)(1)(C) , while the nominal concentration appearing on
the label would be the routinely achieved concentration used 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.
                                118

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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:

     (!)  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.
                               119

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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. tindaay, Director
                                 Registration Division (H-7505
                               120

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APPENDIX F. Product Specific Data Call-In
                  121

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122

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

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

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

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

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

       The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U,S,C. section l36a(c)(2)(B).  Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107
(expiration date 12-31-92).
     This Notice is divided into six sections and seven Attachments.  The Notice itself contains

                                          123

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

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

    The Attachments to this Notice are:

       1  -   Data Call-In Chemical Status Sheet
       2 -   Product-Specific Data Call-in Response Form
       3  -   Requirements Status and Registrant's Response Form
       4 -   EPA  Grouping of  End-Use Products for Meeting  Acute JToxicoiogv  Data
             Requirements for Reregisiration
       5  -   FJA Acceptance Criteria
       6 -   List of Registrants Receiving This Notice
       7  -   Cost Share and Data Compensation Forms, and Product Specific Data Report
             Form
SECTION I.  WHY YOU ARE RECEIVING THIS NOTICE

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

SECTION II.  DATA REQUIRED BY THIS NOTICE

II-A.  DATA REQUIRED

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

II-B.  SCHEDULE FOR SUBMISSION OF DATA

    You are required to  submit the data or otherwise satisfy the data requirements specified in
Attachment 3, Requirements Status and  Registrant's Response Form, within the time frames
provided.
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II-C.  TESTING PROTOCOL

    All studies required under this Notice must be conducted hi 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), Ann: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703^87^650).

      Protocols approved by the Organization for  Economic Cooperation  and  Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those specified
m the Pesticide  Data  Requirements regulation  (40 CFR § 158,70).   When using the OECD
protocols, they should be modified as appropriate so that the data generated by the study will satisfy
the requirements of 40 CFR § 158.  Normally, the Agency will not extend deadlines for complying
with data requirements when the studies were  not  conducted in accordance with acceptable
standards.  The OECD protocols are available from OECD, 1750 Pennsylvania Avenue N.W.,
Washington, D.C. 20006.

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

II-D.  REGISTRANTS RECEIVING PREVIOUS SECTION 3(cK2)fB) NOTICES
     ISSUED BY THE AGENCY

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

SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE

ni-A. SCHEDULE FOR RESPONDING TO THE AGENCY
                                                             "-,
       The appropriate responses initially required by this Notice  for product specific data must
be submitted to the Agency widiin 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,

III-B. OPTIONS FOR RESPONDING TO THE AGENCY

      The options for responding to this Notice  for product  specific data are:  (a)  voluntary
cancellation, 
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requirements of this Notice is contained in Section ni-C.  A discussion of options relating to
requests for data waivers is contained in Section ni-D.

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

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

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

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

III-C  SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE

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

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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 hi 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 uppide a study classified by EPA  as partially
              acceptable and upgradeable (Uppading a Study)
       (6)     I am citing an existing study that EPA has          as acceptable or an existing
              study dial  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 §6-5.

       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     additional time to meet the requirements(s), you      submit i request to the Agency
which includes:  (1)  a detailed description of the expected difficulty and (2) i 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           if the        for extension is not      in a
timely fashion; in no event     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

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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
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 hut will not be submitting the data
yourself, you must provide the name of the registrant who will be submitting the data.  You must
also provide EPA with documentary evidence that an agreement has been formed.  Such evidence
may be your letter offering to join in an agreement and the other registrant's acceptance of your
offer, or a written statement by the parties that an agreement exists. The agreement to produce the
data need  not specify all of the terms of the final arrangement between the parties or the mechanism
to resolve the terms.  Section 3(c)(2)(B) provides that if the parties cannot resolve the terms of the
agreement they may  resolve their differences through binding arbitration.

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

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

       Option 4. Submitting  an Existing Study — If you choose to submit an existing study in
response to this Notice, you must determine that the  study satisfies the  requirements imposed by
this Notice.  You may only submit a study that has not been previously submitted to the Agency
or previously cited by anyone.  Existing  studies are studies which predate issuance of this Notice.

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Do not use this option if you are submitting     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) replation, 40 CFR Part  160. As       in
              40  CFR   160,30)   "  'raw  data'  means  any  laboratory worksheets, records,
              memoranda,  notes, or  exact copies thereof, that  are  the  result of  original
              observations and activities of a study and are necessary for the reconstruction and
              evaluation of the report of that study. In the event that exact transcripts of raw data
              have been prepared (e.g.,      which have      transcribed verbatim, dated, and
              verified accurate by signature), the exact copy or exact transcript may be substituted
              for the original source as raw data.  'Raw data' may include  photographs, microfilm
              or  microfiche  copies,  computer printouts,  magnetic media, including  dictated
              observations,  and  recorded  data  from automated  instruments."    The  term
              "specimens", according to 40 CFR 160.3(k), means "any material derived from a
              test system for examination or analysis."

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

       c.      You must certify that each study fulfills the acceptance  criteria for  the Guideline
              relevant to the study provided in the  FIFRA Accelerated  Reregistration Phase 3
              Technical Guidance and that the study has been conducted according to the Pesticide
              Assessment Guidelines (PAG) or meets the purpose of the PAG (both available from
              NTIS),  A study not                     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 Of  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.

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

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

       Option 5. Upgrading a Study — If a study has been classified as partially acceptable and
upgradeable, you may submit data to  upgrade that study.  The  Agency will  review the  data
submitted and determine  if the requirement is satisfied.  If the Agency decides the requirement is
not satisfied, you may still be required to submit new data  normally without any time extension.
Deficient, but upgradeable studies  will normally be classified as supplemental.  However,  it  is
important to  note that not all studies classified as  supplemental are upgradeable.   If you have
questions regarding the classification of a study or whether a study may be upgraded, call or write
the contact person listed in Attachment 1. If you submit data to upgrade an existing study you must
satisfy or supply information to correct all deficiencies in the study identified by EPA. You must
provide a clearly articulated rationale of how the deficiencies have been remedied  or corrected and
why the study should be rated as acceptable to EPA.  Your submission must also specify the MR1D
number(s) of the study which you are attempting to upgrade and must be in conformance with PR
Notice 86-5.

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

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

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

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

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

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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.

ni-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 FTFRA. 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.

IV.  CONSEQUENCES OF FAILURE TO COMPLY WITH  THIS NOTICE

IV-A NOTICE  OF INTENT TO SUSPEND

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

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

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

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

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

       5.     Failure to take a required  action or submit adequate information pertaiuing 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 III-C of this Notice.

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

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

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

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

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

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

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

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

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

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

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

       EPA haa atatutory authority to pemit 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      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          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 PO 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         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
UNREASONABLE

       Registrants are reminded that FIPRA  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 ire
         by the  Agency.

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SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE

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

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

       The Office of  Compliance Monitoring (OCM) of the Office  of Pesticides  and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in        to this Notice.
                                       Sincerely yours,
                                      Daniel M. Barolo, Director
                                      Special Review and
                                        Reregistration Division
Attachments
       1  -    Data Call-In Chemical Status Sheet
       2  -    Product-Specific Data Call-In Response Form
       3  -    RequirementsStates...and Registrant's Response Form
       4  -    EPA  Grouping  of End-Use  Products  for  Meeting  Acute Toxicology  Data
             Requirements for Reregistration
       5  -    EPA Acceptance Criteria
       6  -    List of Registrants Receiving This Notice
       7  -    Cost Share and Data Compensation Forms, and Product Specific Data Report Form
                                         134

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Attachment 1. Chemical Status Sheet
                135

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PEROXY COMPOUNDS DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

       You have been sent this Product Specific Data Call-In Notice because you have
product(s) containing peroxy compounds.

       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
peroxy compounds.  This attachment is to be used in conjunction with (1) the Product Specific
Data Call-In Notice, (2) the Product Specific Data Call-In Response Form (Attachment 2), (3)
the Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA
Acceptance Criteria (Attachment 5), (6) a list of registrants receiving this DCI (Attachment 6)
and (7) the Cost Share and Data Compensation Forms in replying to this peroxy compounds
Product Specific Data Call-In (Attachment 7).  Instructions and guidance accompany each form.

DATA REQUIRED BY THIS NOTICE

       The additional data requirements needed to complete the database for peroxy compounds
are contained in the Requirements Status; and Registrant's Response. Attachment 3. The
Agency has concluded that additional data on peroxy compounds 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 peroxy compounds
products.

INQUIRIES  AND RESPONSES TO THIS NOTICE

       If you have any  questions regarding the generic database of peroxy compounds, please
contact Rieman Rhinehart at (703) 308-8584.

      If you have any  questions regarding the product specific data requirements and
procedures established by this Notice,  please  contact Frank Rubis (703) 308-8184
      All responses to this  Notice for the Product Specific data requirements should be
      submitted to:                                              --

             Accelerated Reregistration Branch,  Chemical Review Manager Team 8J
             Product Reregistration Branch
             Special Review and Reregistration Branch 7508W
             Office of Pesticide Programs
             U.S. Environmental Protection Agency
             Washington, D.C.  20460

             RE: Peroxy compounds
                                          136

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Attachment 2. Product Specific Data Call-In Response
      Forms (Form A inserts) Plus Instructions
                        137

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138

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

Item 1-4.     Already completed by EPA.

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

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

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

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

Items 8-11.   Self-explanatory.

       Note: You may provide additional information that does not fit on this form  in a signed  letter
       that accompanies this form.  For example, you may wish to  report that your product has
       already been transferred to another that you have already voluntarily cancelled this product.
       For these cases, please supply all relevant details so that EPA can ensure that  its records
       are correct.
                                           139

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140

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Attachment 3. Product Specific Requirement Status and
  Registrant's Response Forms (Form B inserts) and
                    Instructions
                        141

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142

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

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

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

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

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

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

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

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

             1.    I will generate and submit     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 rny product is  similar.   Enough to
             another  product to qualify for  this option.   1  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).

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

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

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

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

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

                              144

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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        my waiver request, I must        a method of
             meeting the data requirements of this Notice by the due date      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.
                                           145

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146

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Attachment 4. EPA Batching of End-Use Products for
   Meeting Data Requirements for Reregistration
                       147

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148

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EPA'S   BATCHING   OF  PRODUCTS  CONTAINING   HYDROGEN   PEROXIDE.
PEROXY ACETIC ACID OR POTASSIUM PEROXYMONOSULFATE AS THE ACTIVE
INGREDIENTS  FOR  MEETING ACUTE  TOXICITY DATA REQUIREMENTS FOR
REREGISTMATION

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

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

    Registrants of products within a batch may choose to cooperatively generate, submit or
cite a single battery of six acute toxicological studies to represent all the products within that
batch.  It is the registrants* option to participate in the process with all other registrants,
only some of the  other registrants, or only their own products within a batch, or to generate
all the required acute toxicological studies for each of their own products.   If a registrant
chooses to generate the data for a batch, he/she must use one of the products within the batch
as the test material.  If a registrant chooses to rely upon previously submitted acute toxicity
data,  he/she may  do  so provided that the data base is complete and valid by today's standards
(see acceptance criteria attached), the formulation       is considered by EPA to be similar
for acute toxicity, and the formulation has not been significantly altered since submission and
acceptance of the  acute toxicity data.   Regardless of whether new data is generated or
existing data is referenced, registrants must clearly identify the test material by EPA
Registration Number. If more than one confidential statment 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     of receipt. The first form, "Data Call-In Response,"     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 on someone
else to do so.  If  a registrant supplies the data to support a batch of products, he/she must

                                         149

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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 1 displays the batches for the active ingredients hydrogen peroxide, peroxyacetic acid
and potassium peroxymonosulfate.

Table 1.
Batch
1
2
EPA Refl, No.
1677-129
5Z252-1
52258-4
5Z252-5
52252-6
65402- 1
5ZH52-2
52252-3
52252-7
Active Ingredient (s>
Hydrogen peroxide ... 27. 5X
Peroxyacetic acid ... 5.8S
Hydrogen peroxide ... 27, OX
Peroxyacetic acid — 5. OX
Hydrogen peroxide ... 22.11
Peroxyacetic acid — t.S!
Hydrogen peroxide ... 22. OX
Peroxyacette acid ... 4.5X
Hydrogen peroxide ... 22.0%
Peroxyacetic acid ... 4.5%
Hydrogen peroxide ... 21.7%
Peroxyieetic acid ... 5, IX
Hydrogen peroxide — D.92S
Perpxyacetic acid ... 0.08%
Hydrogen peroxide — 0.92%
Peroxyacetic acid ... Q.Q8X
Hydrogen peroxide 	 0.929C
Peraxyaeet fc acid ... 0, 08S
Formulation Type
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
Table 2  lists  those  products  the Agency  was unable  to batch.
These products were  either considered not to  be similar  to other
products  for purposes of  acute toxicity  or the Agency lacked
sufficient information  for decision making.    Registrants of
these products are responsible for  meeting the acute toxicity
data requirements for each product.
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Table 2.
EPA Reg, No.
675-39
875-107
5749-7
58779-1
62432-1
Active IngPidlentCi)
Hydrogen peroxide ... 6.002
Phosphoric acid ... O.S5X
Peroxyacetic acid ... 15. OS
Hydrogen peroxide ... 31.0%
Peroxyacetic acid ... 35. OX
Petassiun peroxynnnosulfete ... 20. 4X
Sodium chloride ... 1.5%
Formulation Type
liquid
liquid
liquid
liquid
solid
                                 151

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152

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Attachment 5. EPA Acceptance Criteria
                 153

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154

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                                  SUBDIVISION D
Guideline           Study Title

Series 61           Product Identity and Composition
Series 62           Analysis and Certification of Product Ingredients
Series 63           Physical and Chemical Characteristics
                                        155

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                                  61 Product Identity and Composition
ACCEPTANCE CRITERIA
Does your study meet the following aceeptance'criterla?

1 , _    Name of technical maieriil 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 lexicologically significant impurities (e.g., dioxirts,  nitrosamines) present at
          <0.1%.

4, _    Purpose of each active ingredient and      intentionally-added inert.

5. _    Chemical name from Chemical Abstracts index of Nomenclature and Chemical Abstracts Service (CAS)
          Registry Number for each active ingredient and, if available, for each intentionally-added inert,

6. _    Molecular, structural, and empirical formulas, molecular weight or weight range, and any company
          assigned experimental or internal code numbers for each active ingredient.

7. _    Description of each beginning material in the manufacturing process.
          _  EPA Registration Number if registered; for other beginning materials,       the     following:

          _  Name and address of manufacturer or supplier.
          _  Brand name, trade name or commercial designation.
          _  Technical specifications or daia sheets by which manufacturer or supplier describes composition,
                properties or
8. _ Description of manufacturing process.
          ___  Statement of whether batch or continuous process.
          _  Relative amounts of beginning materials and order in which they are added.
          _  Description of equipment.
          _ __  Description of physical conditions (temperature, pressure, humidity) controlled in each step and
                the parameters that are maintained.
          ___  Statement of whether process involves intended chemical reactions.
          _  Flow chair with chemical equations for each intended chenucaTreaction.
          _  Duration of each step of process.
          _____   Description of purification procedures.
          _  Description of measures taken to assure quality of final product.

9. _    Discussion of formation of impurities based on established chemical theory addressing (1) each impurity
          which may  be present at  >_ 0.1% or was found at >_ 0.1% by  product  analyses and (2)  certain
          toxicologicaliy significant impurities (see #3).
                                                  156

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                          61 Analysis and Certification of Product Ingredients


                                       ACCEPTANCE CRITERIA

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

Does your study meet the  following acceptance criteria?

 1.	  Five or more representative samples (batches in case of batch process) analyzed for each active ingredient
         and all impurities present at >_ 0.1%.
 2.	  Degree of accountability or closure _>_ ca 98%.
 3.	  Analyses conducted for certain trace toxic impurities at lower than 0.1% (examples, nitrosammes in ihe
         case of products  containing dinitroanilines or containing secondary or tertiary amines/alkanolamines plus
         nitrites; polyhalogenated dibenzodioxins and dibenzofurans). [Note  that in the case of nitrosamines both
         fresh and stored  samples must be analyzed.].
 4.	  Complete and detailed description of each step in analytical  method used to analyze ahove samples.
 5,	  Statement of precision and accuracy of analytical meihod used m analyze above samplei,
 6,	  Identities and quantities (including  mean and standard deviation) provided for each analyied ingredient.
 7.	  Upper and lower certified limits proposed for each active ingredient and intentionally added inert along
         with explanation of how ihe limits  were  determined.
 8.	  Upper certified  limit proposed  for each impurity present at  >_ 0.1% and  for certain lexicologically
         sipificant impurities at  <0.1% along with explanation of how limit determined.
 9.	  Analytical methods to verify certified Limits of each active ingredient and impurities (latter not required
         if exempt from requirement of tolerance or if generally recognized as safe by FDA) are fully described.
10,	  Analytical methods  (as discussed in #9) to verify  certified limits validated as to their precision and
         accuracy.
                                                  157

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                                63 Physical and Chemical Characteristics

                                       ACCEPTANCE CRITERIA


The following criteria apply to the technical grade of (he 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 Mwnsell 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

     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 produces 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 iu
          formulations and analytical methods for the pesticide
          Measured ai 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 (tonj or other conventional units

63-10 Dissociation Constant
   _  Experimental method described
   _  Temperature of measurement specified (preferably about
          20-25 °C)
                                                  158

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63~l 1 Qctanol/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 it about 20-25° C
    	   Measured following dilution or dispersion in distilled water

63-13 Stability
    	   Sensitivity to metaJ ions and metaJ determined
    	   Stability at normal and elevated temperatures
    	   Sensitivity to sunlight determined
                                                  159

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                                          SUBDIVISION F
Guideline          Study Title

 81-1          Acute Oral Taxieity in the Hat
 81-2          Acute Dennal Toxicity in the Rat, Rabbit or Guinea Pig
 81-3          Acute Inhalation Toxicity to the Rat
 81-4          Primary Eye Irritation in the Rabbit
 81-5          Primary Dermal Irritation Study
 81-6          Dermal Sensitiiauon in the Guinea Pig
                                               160

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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 toxieity category or a limit dose (5000 ing/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 ind nwy not be required for every study.
                                                   161

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                      81*2  Acute Dermal toxicity in the Rat, Rabbit or Guinea Fig


                                       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 nonirritaiing cover to retain lest 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,
                                                  162

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                               81-3 Acute Inhalation toxicity in the Rat


                                       ACCEPTANCE CRITERIA
Does your study meet lire following acceptance criteria?

 1.	Identify material tested (technical, end-use product, etc).
 2,__	Product is a gas, a solid wMch may produce a significant vapor hazard based oo toxicity and expected use
        or contains particles of inhalable size for man (aerodynamic diameter  15 jun or less).
 3,	At least 5 young adult rats/sexy group.
 4.	Dosing, at least 4 hours by inhalation.
 5.	 Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content.
 6.	Chamber temperature, 22° C (±2°), relative humidity 40-60%.
 7.	Monitor race of air flow.
 g,	Monitor actual concentrations of test material in breathing zone.
 9,	Monitor aerodynamic particle size for aerosols.
10.	  Doses tested, sufficient to determine a toxitiry category or a limit dose (5  mg/L actual concentration of
        respirable substance),
11.	  Individual observations at least once a day.
12.	  Observation period 10 last  at  least  14 days.
13.	  Individual body weights.
14.	  Gross necropsy on all animals.
                                                 163

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

 1.	Identify material tested (technical, end-use product, etc).
 2.	Study not required if material is corrosive, causes severe
        dermal irritation or has a pH of <2 or _>11.5.
 3.	6 adult rabbits.
 4.	Dosing, instillation into the conjunctival sac of one eye
        per animal,
 5.	Dose, 0.1 ml if a liquid; 0,1 ml or not more than 100 mg if a. solid, paste or paniculate 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 wiih an * »re supplement*! and mav not be required far even' siudv.
                                                  164

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                                 81-5  Primary Derma! Irritation Study

                                       ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

 1,_	Identify material tested (technical, end-use product, etc).
 2.	Study not required if material is corrosive or has a pH of <2 or ,>.! 1,5.
 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 cm5.
 8.	Application site covered with a gauze patch held in place with nonkriiating 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 wifli an * are supplemental and may not be required for every snidy.
                                                  165

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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
      pH of <2 or .Ml.5.
3.	One of the following methods is utilized:
      	Freund's complete adjuvant test
      	Guinea pig maximization test
      	Split adjuvant technique
      	Buebler 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.
                                                  166

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Attachment 6. List of All Registrants Sent This Data Call-In (insert)
                              Notice
                               167

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168

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Attachment 7. Cost Share Data Compensation Form, and Confidential
                  Statement of Formula Form
                             169

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170

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   Confidential Business Information: Does Not Conttin National Security Information (E. 0, 12065)     Form Approval OMB No 2070-ooeo  Approve Exptes 2f2a94i
Unit«4 Si*'"* £ nvkcj rime mil Prolftction Agency
_ OlliMrt P«tticid«P«>orim»(TS-767|
£LC D/V withim***. ocjtMeo
Vy C r A\ Confidential Statement of Formula
1 . Name and Address gf Applicam/RagiStrenl {Include ZIP Code;
3 Product Njrm
EPA USE ONLY








10. Component! in Formulation /List ti tttuttly mtroduttd
into f/?4 fotfnulHiofl. Grvf tommoniy Kct^tfd ctttrrictt
ntmff. tffda ntme. tndCAS nvmtot 1







'
A. 	
1— 1 Batic Formuiltion
LJ AJt«n«l* Formuiltion
a
P.B»
ol
S«« Inttoctiont en Bjcl
1, Name and Addf ess of Producoi {lncfud« HP Ccxto)
4 Rsflislrition No./Fita Symbol
7. PmintH/Qtl or Sulk Dwiiity
1 1 . Supplier Nanw & Mdrmi








5 EPA Product Mm /Team No.
9 pH
17 EPA Rag. No.








16. Typed Name ol Approving Olliciil
18. S>flfiaiuf* ot Approving Official
13. EaOi Compcnsnt
In For mutation
i.Amouni b. %ti«fcg)«








17. Total
19. Till*
Weight








100%
6 Countiy Wtiw « f OdtiulUBd
9, Flaih Point/Flams Eirtniion
14. Gcnihwl Unill
KbyWiignt
i Unw Ltn* b L»*«r Lnm
















IS. Purpot4 pn
F^mutantrk

j







20. Ption* Ho. (Include Am Codrj
2) Date
EPA Form  (570-4  (Rav.  12-90)    Previou* edition* »r« obsolete.   If jrouean phrtocopy tws, pleaw submit an addiltonal copy.White-  EPA File Copy  (original)      Yelow- Apptwani copy

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172

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Instructions for Completing the Confidential Statement of Formula

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

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

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

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

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

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

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

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

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

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

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

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

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

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

                                                   173

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174

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

OMB No, 3070-0IBS
        2B70-OOS7
Approval Ezpira* 3-31-94
 Public reporting burden (orthis colaction of information Is estimated to average 15 minutes per response, including
 time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
 completing and reviewing the collection of Information.  Send comments regarding the burden estimate or any other
 aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
 Branch, PM-223. U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
 of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503,

 Ploase fill In blanks below.
C'limfnu n XMM
Product > aiw
Company Nwnkar
WA H*g, "Vfl,
 ! Certify that:

 My company is willing to develop and submit the data required by EPA under the authority of ttie Federal
 Insecticide, Fungicide and Rodentteide Ac! (FIFHA), If nscassary.  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){iil) of FIFRA if final agreement on  all
 terms could not be reached otherwise.  This offer was made to the following flrm(s} on the  following
 date(s);
  Warn* of Firm(a)
                                                  Bat* of Offer
Certification:
I certify !hat! am duly authorized to represent the company named above, and that the statements that I  have made on
thte term and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Slgni(ur» of Comp»ny'
Mama and Htlt (Plait*
» Authored R»pr»«»nt*llv«
D»t«
Typ« or Print)
 EPA Form 8570-32 (SOT)   RtflaCfaLfA Form 8S80, wUek ii ttfamlcto
                                               175

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176

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untied StatM Environmental Proitctlon Agency
js^ f"|^J% Washington, DC 20480
W**^FMr^U CERTIFICATION WITH RESPECT TO
^r •« * m DATA COMPENSATION REQUIREMENTS
Pubic reporting bunlen for this collection of informal on is estimated to average IS mhuiM
time tar reviewing hsitudlons, searching existing dau sources, fathering and mawawng t
completing and reviewing the ooflecUon of Information. Send comments regarding the bund
aspect of this ooUeabn or information, induing suggestions for reducing this burden, to C
Branch. PM-223, U,S< Environmental Pmwdton Agency, 401 M St., S.W., WasNnglon, DC
of Miiugimni and Budg«, Papenwik Reduction Prajtd (2070-0108), WuMnown. DC
Please fill In blanks below.
OHa M*, JOTO-010T
]Qi»«ie«7
«Mr«nl Itflra* W1-*
per reaper**, ineluding
he data needed, and
en estimate or any other
Net, Information Policy
204W;andieirieOflee
20503,
DwtplAp MB** Cofflp.ny NMiJMr
rrodoct HUM HA tef . Ha.
1 CflftBy that
1 . For ••en atudy ot»d in mppon of tvetstration or rertgistntion under the Fedenl tnsecfx
RodenficiJe Aa (FIFRA) that is an eiekBive use study, I am the original data submitter, o
wrtten permission ef the original data submiaer » die IM study.
2. That lor each study eHed in support ol registration or nregiitr atton under PlFRA that k N
study, I am the original data submMer. or I have obtained the wrtnen permission of the o^
have notified In wrting the oompeny(ies) thai submttttd daia 1 have ded and nave ofltrr
oompensatiem tor those itta ki accortance wBh sections 3{c) (1)(D) and J(e){l)(D) of fm
neyoikeion w oeternwie wncn oiu are suufea re lie uunipensaiic«i requv*mefi or nr
oompeniatoft due, f any. The companies I have notified are: (eheekone}
1 1 The companies who have submitted the studies tsted on me back ol this form or ai
stweti, or irdicaied on the atrtctied flequinrmnis Status and Regijirarat' Rtspe
3, That i have previously oompDed wfth saaton 3(c)(i)(D) of RFRA for me studies i have at
mgtttniion or rent^striUon under FiFRA.
ade, Fungicide and
r 1 have obtained the
OT an exclusive use
Jioel djfla subminer, or 1
no; (a) Piy
IA: and (b) Commence
RA «nd the amount of
Bached
me Faun,"
ed in suppofl of
Sigrauv* ' *****
NMif IM flu* {|>MJM« Typ* er Prtnl)
GENERAL OFFER TO PAY: 1 hereby offer and agree to pay compensation to other persons, wflh regard to me
regictralion or reregijtruon of my products, 10 the extent required by FIFRA sections 3(0(1)(D) and 3(c)[2](Dj
itenatuit j^v
Nam* mrf Tin* (»lfM« Typ* mr Prini]
fPA  f»tm  SI70-H (4.SO)
                                                   177

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