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.
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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
-------
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
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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
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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)
-------
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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-------
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
-------
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.
-------
APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
71
-------
72
-------
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
-------
74
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
-------
82
-------
APPENDIX C. Citations Considered to be Part of the
Data Base Supporting the Reregistration of Peroxy
compounds
83
-------
84
-------
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
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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.
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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.
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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)
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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
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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.
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PR Notice 91-2
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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
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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.
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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.
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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
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APPENDIX F. Product Specific Data Call-In
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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
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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
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Attachment 1. Chemical Status Sheet
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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
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Attachment 2. Product Specific Data Call-In Response
Forms (Form A inserts) Plus Instructions
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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.
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Attachment 3. Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and
Instructions
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA
Item 1-3. Completed by EPA. Note the unique identifier number assigned by EPA in item 3.
This number must be used in the transmittal document for any data submissions in
response to this Data Call-in Notice,
Item 4. The 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
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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.
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Attachment 4. EPA Batching of End-Use Products for
Meeting Data Requirements for Reregistration
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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
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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
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Attachment 5. EPA Acceptance Criteria
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SUBDIVISION D
Guideline Study Title
Series 61 Product Identity and Composition
Series 62 Analysis and Certification of Product Ingredients
Series 63 Physical and Chemical Characteristics
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61 Product Identity and Composition
ACCEPTANCE CRITERIA
Does your study meet the following 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).
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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.
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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
-------
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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