United States Prevention, Pesticides EPA738-R-95-013
Environmental Protection And Toxic Substances April 1995
Agency (7508W)
&EPA Reregistration
Eligibility Decision (RED)
ALIPHATIC ALCOHOLS
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case aliphatic alcohols
which includes the active ingredients ethanol and isopropanol. The enclosed Reregistration
Eligibility Decision (RED) contains the Agency's evaluation of the data base of these
chemicals, its conclusions of the potential human health and environmental risks of the current
product uses, and its decisions and conditions under which these uses and products will be
eligible for reregistration. The RED includes the data and labeling requirements for products
for reregistration. It may also include requirements for additional data (generic) on the active
ingredients to confirm the risk assessments.
To assist you with a proper response, read the enclosed document entitled "Summary
of Instructions for Responding to the RED". This summary also refers to other enclosed
documents which include further instructions. You must follow all instructions and submit
complete and timely responses. The first set of required responses are due 90 days from
the date of this letter. The second set of required responses are due 8 months from the
date of this letter. Complete and timely responses will avoid the Agency taking the
enforcement action of suspension against your products.
If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregistration Division representative
Frank Rubis at (703) 308-8008. Address any questions on required generic data to the Special
Review and Reregistration Division representative Tom Myers at (703) 308-8074.
Sincerely yours,
Lois Rossi, Director
Special Review
and Reregistration Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1. DATA CALL-IN (PCI) OR "90-DAY RESPONSE" If generic data are required for
reregistration, a DCI letter will be enclosed describing such data. If product specific data
are required, another DCI letter will be enclosed listing such requirements. If both generic
and product specific data are required, a combined Generic and Product Specific letter will
be enclosed describing such data. Complete the two response forms provided with each DCI
letter (or four forms for the combined) by following the instructions provided. You must
submit the response forms for each product and for each DCI within 90 days of the date
of this letter (RED issuance date); otherwise, your product may be suspended.
2. TIME EXTENSIONS AND DATA WAIVER REQUESTS No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for data waivers must be submitted as part of the
90-day response. Requests for time extensions should be submitted in the 90-day response,
but certainly no later than the 8-month response date. All data waiver and time extension
requests must be accompanied by a full justification. All waivers and time extensions must be
granted by EPA in order to go into effect.
3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE" You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately. You may delete uses
which the RED says are ineligible for reregistration. For further labeling guidance, refer to
the labeling section of the EPA publication " General Information on Applying for Registration
in the U.S., Second Edition, August 1992" (available from the National Technical Information
Service, publication #PB92-221811; telephone number 703-487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's acceptance criteria (attached to the DCI).
d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard certified
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limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by the analysis
of five batches. If you choose the second option, you must submit or cite the data for the five
batches along with a certification statement as described in 40 CFR §158.175(e). A copy of
the CSF is enclosed; follow the instructions on its back.
e. Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.
4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5. WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS—EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILITY DECISION
ALIPHATIC ALCOHOLS
LISTD
CASE 4003
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
ALIPHATIC ALCOHOLS REREGISTRATION ELIGIBILITY DECISION TEAM . . . i
EXECUTIVE SUMMARY v
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Data Requirements 11
D. Regulatory History 11
III. SCIENCE ASSESSMENT 13
A. Physical Chemistry Assessment 13
B. Human Health Assessment 14
1. Toxicology Assessment 14
a. Acute Toxicity 14
b. Subchronic Toxicity 16
c. Chronic toxicity 17
d. Carcinogenicity 18
e. Developmental/Reproductive Toxicity 19
f. Mutagenicity 22
g. Metabolism 23
h. Reference Dose 23
2. Exposure Assessment 24
a. Dietary Exposure 24
b. Occupational and Residential 24
3. Risk Assessment 25
a. Dietary 25
b. Occupational and Residential 25
C. Environmental Assessment 25
1. Ecological Toxicity Data 25
a. Toxicity to Terrestrial Animals 26
b. Toxicity to Aquatic Animals 26
2. Environmental Fate 27
a. Environmental Fate Chemistry 27
b. Environmental Fate Assessment 27
3. Exposure and Risk Characterization 27
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 28
A. Determination of Eligibility 28
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B. Determination of Eligibility 28
1. Eligibility Decision 28
2. Eligible and Ineligible Uses 29
C. Regulatory Position 29
1. Labeling Rationale 29
V. ACTIONS REQUIRED BY REGISTRANTS 30
A. Manufacturing-Use Products 31
1. Additional Generic Data Requirements 31
2. Labeling Requirements for Manufacturing-Use Products 31
B. End-Use Products 31
1. Additional Product-Specific Data Requirements 31
2. Labeling Requirements for End-Use Products 32
C. Existing Stocks 32
VI. APPENDICES 35
APPENDIX A. Table of Use Patterns Subject to Reregistration 37
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 103
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of Aliphatic Alcohols 113
APPENDIX D. List of Available Related Documents 123
APPENDIX E 127
PR Notice 86-5 129
PR Notice 91-2 147
APPENDIX F. Product Specific Data Call-in 153
Attachment 1. Chemical Status Sheet 167
Attachment 2. Product Specific Data Call-in Response Forms (Form A
inserts) Plus Instructions 169
Attachment 3. Product Specific Requirement Status and Registrant's
Response Forms (Form B inserts) and Instructions 175
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 179
Attachment 5. EPA Acceptance Criteria 193
Attachment 6. List of All Registrants Sent This Data Call-in (insert) Notice
207
Attachment 7. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 209
APPENDIX G. FACT SHEET 219
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ALIPHATIC ALCOHOLS REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Ed Brandt
Rafael Prieto
Phyllis Johnson
Michelle Cottrill
Cynthia Szymanski
Environmental Fate and Effects Division
James Felkel
Harry Craven
Betsy Grim
Larry Liu
Health Effects Division
Arliene Aikens
Pat Mclaughlin
Winston Dang
Registration Division
Sami Malak
Wallace Powell
Lucy Markarian
Valdis Goncarovs
Special Review and Reregistration Division
Leonard Ryan
Tom Myers
Kathleen Depukat
Policy and Special Projects Staff
Jean Frane
Office of Compliance
Phyllis Flaherty
Economic Analysis Branch
Biological Analysis Branch
Biological Analysis Branch
Biological Analysis Branch
Biological Analysis Branch
Ecological Effects Branch
Ecological Effects Branch
Science Analysis and Coordination Staff
Environmental Fate and Groundwater Branch
Risk Characterization and Analysis Branch
Toxicology Branch
Occupational and Residential Exposure Branch
Registration Support Branch
Antimicrobial Branch
Registration Support Branch
Antimicrobial Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
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Office of General Counsel
Kevin Lee
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GLOSSARY OF TERMS AND ABBREVIATIONS
AE Acid Equivalent
a.i. Active Ingredient
ADI Acceptable Daily Intake. A now defunct term for reference dose (RfD).
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
CSF Confidential Statement of Formula
DFR Dislodgeable Foliar Residue
ORES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e. drinking
water) lifetime exposure at which adverse, non carcinogenic health effects are not anticipated to occur.
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
GLC Gas Liquid Chromatography
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory (HA) The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur.
HOT Highest Dose Tested
LC50 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/L, mg/kg or ppm.
LD50 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
LOG Level of Concern
LOD Limit of Detection
LOEL Lowest Observed Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
pg/g Micrograms Per Gram
mg/L Milligrams Per Liter
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MOE Margin of Exposure
NOEC No effect concentration
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
OP Organophosphate
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GLOSSARY OF TERMS AND ABBREVIATIONS
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
PPE Personal Protective Equipment
ppb Parts Per Billion
ppm Parts Per Million
PRN Pesticide Registration Notice
Q*j The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
SLN Special Local Need (Registrations Under Section 24 (c) of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
WP Wettable Powder
WPS Worker Protection Standard
IV
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EXECUTIVE SUMMARY
The Environmental Protection Agency has completed an assessment of the potential
human health and environmental risks associated with the pesticidal uses of aliphatic alcohols,
ethanol and isopropanol, in the United States.
Aliphatic alcohols are used as components of a variety of commercial and household
products including a sterilant, medical disinfectants, virucides, sanitizers, fungicides and plant
regulators (ripener). Ethanol is used with quaternary ammonium compounds for swimming
pool water systems. Isopropanol is used in conjunction with quaternary ammonium
compounds, phenolic compounds, glycols, methyl salicylate, and essential oils. It is also a
component, in combination with one or more of the following active ingredients d-limonene,
pyrethrins, piperonyl butoxide, d-cis trans phenothrin and oil of eucalyptus, for killing fleas
and ticks, and other household insects. Both of these active ingredients are well known
substances and have a wide range of human exposure uses. For example, ethanol is a
constituent of some beverages for human consumption and isopropanol is the major ingredient
in rubbing alcohol. The Agency has determined that ethanol and isopropanol as active
ingredients in pesticide products will not cause unreasonable risk to humans or the
environment and these uses are eligible for reregistration.
Before reregistering the products containing ethanol and isopropanol, the Agency is
requiring that product specific data on acute toxicology, chemistry, and efficacy, revised
Confidential Statements of Formula (CSF) and revised labeling be submitted within eight
months of the issuance of this document. 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.
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the reregistration of products with active ingredients registered prior to
November 1, 1984. The amended Act provides a schedule for the reregistration process to be
completed in nine years. There are five phases to the reregistration process. The first four
phases of the process focus on identification of data requirements to support the reregistration
of an active ingredient and the generation and submission of data to fulfill the requirements.
The fifth phase is a review by the U.S. Environmental Protection Agency (referred to as "the
Agency") of all data submitted to support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for reregistration" before
calling in data on products and either reregistering products or taking "other appropriate
regulatory action." Thus, reregistration involves a thorough review of the scientific data base
underlying a pesticide's registration. The purpose of the Agency's review is to reassess the
potential hazards arising from the currently registered uses of the pesticide; to determine the
need for additional data on health and environmental effects; and to determine whether the
pesticide meets the "no unreasonable adverse effects" criterion of FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of ethanol and isopropanol. The document consists of six sections. Section I
is the introduction. Section II describes ethanol and isopropanol, its 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
ethanol and isopropanol. Section V discusses the reregistration requirements for ethanol and
isopropanol. Finally, Section VI contains 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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II. CASE OVERVIEW
A. Chemical Overview
The following active ingredients are covered by this Reregistration Eligibility
Decision:
Common Name:
Chemical Name:
Chemical Family:
CAS Registry Number:
OPP Chemical Code:
Empirical Formula:
Common Name:
Chemical Name:
Chemical Family:
CAS Registry Number:
OPP Chemical Code:
Empirical Formula:
Ethanol
Ethyl Alcohol
Aliphatic Alcohol
64-17-5
001501
C2H5OH
Isopropanol
Isopropyl Alcohol
Aliphatic Alcohol
67-63-0
047501
C3H80
B.
Use Profile
The following is information on the currently registered uses with an overview
of use sites and application methods. A detailed table of the registered uses of ethanol
and isopropanol appears in Appendix A.
For ETHANOL:
Chemical Name:
Case Number:
Ethyl Alcohol
4003
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Chemical Code: 001501
CAS Reg Number: 64-17-5
Type of Pesticide:
Medical disinfectant, Virucide, Sanitizer, Algaecide, Microbiocide/microbiostat
(bacteria, fungi, and algae), Fungicide/fungistat, Fungicide (mold/mildew),
Tuberculocide (with other chemicals, particularly phenols), Plant regulator, component
of formaldehyde-based sterilant.
Use Sites:
Aquatic Non-Food Residential:
Domestic/Commercial Nonpotable Water (Waterbed Water) (whirlpools)
Indoor Food:
Citrus Fruits
Pear
Avocado
Banana
Papaya
Melons
Tomato
Grain/Cereal/Flour Bins - Empty
Grain/Cereal/Flour Elevators - Empty
*Poultry (Egg/Meat)
Egg Handling Equipment (Commercial)
Egg Handling Rooms (Commercial)
Egg Packing Plants (Commercial)
Household/Domestic Dwellings Indoor Food Handling Areas
Food Processing Plant Premises (Nonfood Contact)
Dairies/Cheese Processing Plant Premises (Nonfood Contact)
Feed Mills/ Feed Processing Plants
Meat Processing Plant Premises (Nonfood Contact)
Poultry Processing Plant Premises (Nonfood Contact)
Fish/Seafood Processing Plant Premises (Nonfood Contact)
Food Processing Plant Equipment (Food Contact)
Meat Processing Plant Equipment (Food Contact)
Poultry Processing Plant Equipment (Food Contact)
Eating Establishments Food Handling Areas (Food Contact)
Eating Establishments Food Serving Areas (Food Contact)
Eating Establishments Equipment/Utensils (Food Contact)
Food/Grocery/Marketing/Storage/Distribution Facility Premises
Food Dispensing Equipment/Vending Machines
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Food Stores/Markets/Supermarkets Premises
Food Marketing/Storage/Distribution Equipment/Utensils (Food Contact)
Indoor Non-Food:
Tobacco/Cigar/Cigar Wrapping
* Goats (wool/angora animal)
*Mink
* Nutria
* Rabbits
*Fox
*Specialized Animals (zoo animals)
*Dogs (Show/Military/Special)
Animal Kennels/Sleeping Quarters (Commercial)
* Donkeys
*Horses (Show/Race/Special/Ponies)
*Mules (Work)
*Animals (Laboratory/Research)
*Cats (Laboratory/Research)
*Rodents, Wild (Captured for Sale)
*Sheep
Commercial Transportation Facilities-Nonfeed/Nonfood
Tobacco Processing Plant Premises/Equipment
Eating Establishments Food Handling Areas (Nonfood Contact)
Eating Establishments Food Serving Areas (Nonfood Contact)
Commercial/Institutional/Industrial Premises/Equipment (Indoor)
Commercial/Institutional/Industrial Floors
Leather/Leather Products
Textiles/Textile Fibers/Cordage
Felt/Furs/Feathers/Felt Products
Laundry (Drycleaning)
Dust Mops/Cloths/Tool Covers/Dusters (Laundry/Dryclean)
Laundry (Commercial)
Diapers (Commercial Laundry)
Carpets (Commercial Sanitizer)
Laundry Equipment
Refuse/Solid Waste Transportation Facilites/Handling Equipment
Museum Collections (Preserved Animal/Plant Specimens)
Upholstery (Hospital/Commercial)
Indoor Medical:
Household Sickrooms Premises/Contents/Utensils
Hospitals/Medical Institutions Premises (Human/Veterinary)
Ambulances
Hospitals/Medical Institutions Critical Premises (Burn Wards)
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Hospitals/Medical Institutions Patient Premises
Hospitals/Medical Institutions Noncritical Premises
Hospital Critical Items (Surgical Instruments/Pacemakers)
Hospital Noncritical Items (Bedpans/Furniture)
Hospitals/Medical Institutions Nonconductive Floors
Barber/Beauty Shop Instruments (Shavers/Scissors)
Barber/Beauty Shop Equipment (Barber Chair/Cabinets)
Morgues/Mortuaries/Autopsy/Embalming Room Premises
Morgues/Mortuaries/Autopsy/Embalming Equipment
Morgues/Mortuaries/Autopsy/Embalming Instruments
Upholstery (Hospital/Commercial)
Carpets (Hospital Sanitizer)
Biological Specimens (Organs/Tissues/Milk Samples)
Cuspidors/Spittoons
Air Treatments (Hospital)
Indoor Residential:
*Cats (Adults/Kittens)
*Dogs/Canines (Adults/Puppies)
* Monkeys
*Birds
Pet Living/Sleeping Quarters
* Rodents (Guinea pigs/Hamsters/Gerbils/Mice/Rats)
* Rabbits
Fish (Aquaria)
*Amphibians
*Reptiles
Household/Domestic Dwellings Indoor Premises
Household/Domestic Dwellings Contents
Human Clothing (Insect and Mold/Mildew Control)
Human Face Gear
Human Footwear
Human Headgear
Human Dentures/Toothbrushes/Mouthpieces
Human Camping Equipment
Human Grooming Instruments (Brushes, Combs)
Laundry (Household/Coin-Operated)
Diapers (Household/Coin-Operated Laundry)
Carpets (Household Sanitizer)
Toilet Bowls (Interior Surfaces)
Toilet Tanks/Water Closets Water
Urinals (Interior Surfaces)
Bathroom Premises/Hard Surfaces
Portable/Chemical Toilets/Latrine Buckets
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Vehicular Holding Tanks
Diaper Pails (Empty)
Refuse/Solid Waste Containers (Garbage Cans)
Refuse/Solid Waste Transportation Facilities/Handling Equipment
Household Trash Compactor/Food Disposals
Incinerators
Air Treatments (Commercial/Household)
Terrestrial Non-Food Crop:
Refuse/solid Waste Sites (Outdoor)
*Premises of specified animal is the specific site on the label.
Target Pests:
Bacteria:
Odor-causing bacteria, Airborne bacteria, Staphylococcus aureus, Staphylococcus
aureus (penicillin resistant methicillin & gentamicin), Pseudomonas aeruginosa,
Pseudomonas cepacia, Pseudomonas putida, Mycobacterium tuberculosis,
Mycobacterium tuberculosis var. bovis, Mycobacterium smegmatis, Salmonella
choleraesuis, Salmonella schottmuelleri (paratyphoid B), Salmonella enteritidis,
Salmonella typhosa, Salmonella paratyphi, Escherichia coli, Shigella paradysenteriae,
Shigella dysenteriae, Shigella flexneri, Streptococcus pyogenes, Streptococcus
hemolyticus, Streptococcus salivarius, Streptococcus faecalis, Proteus mirabilis,
Proteus vulgaris, Neisseria gonorrhoeae, Neisseria elongata, Enterobacter aerogenes,
Klebsiella pneumoniae, Corynebacterium diphtheriae, Listeria monocytogenes,
Campylobacterjejuni, Serratia marcescens, Acinetobacter calcoaceticus, Chlamydia
psittaci
Fungi:
Mold and mildew, Penicillium glaucus, Aspergillus niger, Trichophyton
mentagrophytes, Candida albicans
Viruses:
Influenza A2/Hong Kong (myxovirus) and Japan 305/57, Influenza B (Hong Kong
5/72), Herpes Simplex Types 1 and 2, Adenovirus Types 2 and 5, Vaccinia (poxvirus),
Infectious Canine Hepatitis Virus, HIV-1 Virus, Canine Distemper, Canine Parvovirus
ATCC VR-2006, Poliovirus Type 1 (Mahoney Strain), Rhinovirus Type 39,
Respiratory Syncytial Virus, Echovirus Type 12, Rotavirus (Wa), Poliovirus Type 1,
Hepatitis A Virus, Parainfluenza Type 2, Cytomegalovirus, Influenza Type B, Adeno
Type 2, Coxsackie B3, Polio Type 2, Rhino Type 16, Parainfluenza Type 3, Influenza
A/J305, Parainfluenza 1 (Sendai), Influenza A2 (Aichi)
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Formulation Types Registered:
Type: End use, Manufacturing use.
Form: Pressurized liquid, Ready to use liquid, Soluble concentrate/liquid.
Methods and Rates of Application:
Types of Treatment:
Antimicrobials:
Spray, Surface treatment, Premise treatment, Water related surface treatment,
Transportation vehicle treatment, Immersion, Aerosol application.
Plant regulator:
Stored commodity fumigation as ripening agent (citrus fruits, pear, avocado, banana,
papaya, melons, tomato, flue-cured tobacco/cigar/cigar wrapping).
Equipment:
Antimicrobials:
Aerosol can, Sprayer, Pump spray bottle, Automatic aerosol dispenser, Hand held
sprayer.
Plant regulator:
Catalytic generator of ethylene gas (citrus fruits, pear, avocado, banana, papaya,
melons, tomato, tobacco/cigar/cigar wrapping).
Timing:
Antimicrobials:
Not specified.
Plant regulator:
Postharvest (citrus fruits, pear, avocado, banana, papaya, melons, tomato,
tobacco/cigar/cigar wrapping).
Rate of Application:
Antimicrobials:
For all surfaces (including food contact surfaces and upholstery), air treatments, and
water-related surface treatment: From 169200 to 820000 ppm active ingredient.
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Plant regulator (ethanol is converted to ethylene by dehydration in an ethylene
generator):
Produce ripening—one quart product used in a 4000 to 8000 cubic feet ripening room
produces 20-1200 ppm ethylene over a period of 16 hours.
Tobacco—use 2 quarts product in 1500-2500 cubic foot curing barn for 12 hours,
immediately after filling barn. Use an additional 2 quarts as required. [Label did not
state ethylene ppm to be expected.]
Use Practices Limitations:
Do not use on polished wood furniture or on rayon fabrics. Do not get product on
foods/drinks/feeds or surfaces that they may contact; protect polished wood furniture,
rayon fabrics, foods/drinks/feeds or surfaces during treatment by removing or covering
them. Any contaminated food/drink/feed contact surfaces should be washed with a
suitable cleaning product and rinsed with potable (drinking) water before using. Treat
food/drink/feed processing areas only when the facility is not in operation.
For ISOPROPANOL
Chemical Name: Isopropyl Alcohol
Case Number: 4003
Chemical Code: 047501
CAS Reg Number: 67-63-0
Type of Pesticide:
Disinfectant, Bacteriostat, Sanitizer, Microbiocide/microbiostat (bacteria and algae),
Fungicide, Fungicide/fungistat, Virucide, Tuberculocide, component of insecticides,
acaricides, and a repellent in combination with one or more of the following active
ingredients: d-limonene, pyrethrins, piperonyl butoxide, d-cis trans phenothrin and oil
of eucalyptus.
Use Sites:
Aquatic Non-Food Industrial:
Commercial/Industrial Water Cooling Systems
Outdoor Residential:
Pet Living/Sleeping Quarters
Indoor Food:
Eating Establishments Food Handling Areas (Food Contact)
Dairies/Cheese Processing Plant Equipment (Food Contact)
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Dairies/Cheese Processing Plant Premises (Nonfood Contact)
Eating Establishments Equipment/Utensils (Food Contact)
Eating Establishments Food Serving Areas (Food Contact)
Food Marketing/Storage/Distribution Equipment/Utensils (Food Contact)
Food Processing Plant Equipment (Food Contact)
Food Processing Plant Premises (Nonfood Contact)
Household/Domestic Dwellings Indoor Food Handling Areas
Indoor Non-Food:
Commercial Transportation Facilities-Nonfeed/Nonfood
Commercial/Institutional/Industrial Premises/Equipment (Indoor)
Commercial/Institutional/Industrial Floors
Laundry Equipment
Animal Kennels/Sleeping Quarters (Commercial)**
Eating Establishments Food Handling Areas (Nonfood Contact)
Eating Establishments Food Serving Areas (Nonfood Contact)
Eating Establishments Non-Food Areas (Nonfood Contact)
Indoor Medical:
Household Sickrooms Premises/Contents/Utensils:
Hospital/Medical Institutions Premises (Human/Veterinary)
Hospital Critical Items (Surgical Instruments/Pacemakers)
Hospital Semicritical Items (Catheters/Inhalation Equipment)
Hospital Noncritical Items (Bedpans/Furniture)
Hospital/Medical Institutions Non-Conductive Floors
Air treatments (Hospital)
Barber/Beauty Shop Instruments (Shavers/Scissors)
Hospital/Medical Institutions Critical Premises (Burn Wards)
Hospital/Medical Institutions Noncritical Premises
Hospital/Medical Institutions Patient Premises
Indoor Residential:
Cats (Adults/Kittens)*
Dogs/Canines (Adults/Puppies)*
Pet Living/Sleeping Quarters**
Household/Domestic Dwellings Indoor Premises**
Household/Domestic Dwellings Contents
Residential Floors
Human Bedding/Mattresses
Human Footwear
Toilet Bowls (Interior Surfaces)
Urinals (Interior Surfaces)
Bathroom Premises/Hard Surfaces
Diaper Pails (Empty)
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Refuse/Solid Waste Containers (Garbage Cans)
Air treatments (Commercial/Household)
Human Headgear
*Isopropanol is only a component of an insecticide/acaricide/repellent at this site.
*Isopropanol has antimicrobial activity as well as being a component of
insecticide/acaricide/repellent products at this site.
Pests:
Salmonella choleraesuis, Salmonella schottmuelleri, Salmonella typhosa,
Staphylococcus aureus, Pseudomonas aeruginosa, Trichophyton mentagrophytes
(Trichophyton interdigitale), Streptococcus spp., Escherichia coli, Klebsiella
pneumoniae, Shigella flexneri, Proteus vulgaris, Enterobacter aerogenes,
Mycobacterium tuberculosis, Candida albicans, Aspergillus niger, Mycobacteria,
Odor-causing bacteria, Slime-forming bacteria and fungi, Mold and mildew, Herpes
Simplex I Virus, Herpes Simplex II Virus, Influenza Al Virus (Hong Kong), Influenza
A2 Virus, Vaccinia Virus, HIV-1 (AIDS Virus), component of
insecticide/acaricide/repellent which act against ticks, fleas, roaches, bedbugs, ants,
silverfish, lice, sowbugs, centipedes, firebrats, and mites.
Formulation Types Registered:
Type: End use, Manufacturing use.
Form: Ready to use liquid, Pressurized liquid, Impregnated material, Soluble
concentrate/liquid.
Methods and Rates of Application:
Types of Treatment:
Spray, Mop, Sponge-on, Wipe-on, Surface treatment, Pour-on, Aerosol application,
Animal treatment (spray), Animal bedding/litter treatment, Enclosed premise
treatment, Indoor premise treatment, Wipe-on/wiper treatment, Immersion, Water
treatment (recirculating system).
Equipment:
Aerosol can, Pump spray bottle, Sprayer, Mop, Sponge, Mist sprayer, Cloth, Swab,
Atomizing type sprayer, Not specified.
Timing:
Not specified.
10
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Rate of Application:
Generally, for disinfection of hard and porous surfaces 242370 to 757100 ppm active
ingredient for ready to use and pressurized liquid products, and 2713 to 10606 ppm
active ingredient for the liquid/soluble concentrate product. For sanitizing air - 385000
to 600000 ppm active ingredient. For water cooling systems, 8.4 to 13 ppm active
ingredient (intermittent slug initial) and 2.8 to 4.2 ppm active ingredient (intermittent
slug subsequent).
Use Practices Limitations:
Not recommended for use on aluminum. Do not pour used solution back into the stock
bottle. Do not use on polished wood furniture or rayon fabrics. Avoid spraying
lacquered or shellacked surfaces.
C. Data Requirements
The data required to support the uses of ethanol and isopropanol are identified
in Appendix B. This includes all data requirements identified by the Agency for
currently registered uses.
D. Regulatory History
Ethanol and isopropanol were registered in the United States as early as 1948 as
active ingredients in indoor disinfectants. Currently, 73 ethanol and 67 isopropanol
products are registered for use as hard surface treatment disinfectants, sanitizers and
mildewcides. Ethanol products are also registered for use as a plant regulator
(ripener). There have not been any Data Call-Ins issued for these chemicals.
Ethanol and isopropanol can be considered to function as inert ingredients (40
CFR 153.139(a)). This determination is made on a case-by-case basis involving the
following four parameters. First, ethanol and isopropanol when present in multiple
active products (except products formulated with quaternary ammonium compounds) at
percentages lower than 30% are not considered to be active ingredients, but rather
inert. Second, ethanol and isopropanol when present in quaternary ammonium
compound products at percentages greater than 5% are considered to be active
ingredients. Third, ethanol and isopropanol when present in quaternary ammonium
compound products at percentages less than 5% are considered to be inert ingredients.
Fourth, all products which list only ethanol or isopropanol as active ingredients in the
ingredient statement, regardless of percentage, are considered to be active ingredients
and not inerts.
Historically, certain products containing ethanol or isopropanol, and certain
other liquid chemical germicides have been regulated both as pesticides under the
Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and as devices under the
Federal Food, Drug and Cosmetic Act (FFDCA). In an effort to resolve the confusion
11
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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), and
amended on June 20, 1994. The MOU has been mailed to registrants as an attachment
to Pesticide Regulation (PR) Notice 94-4, signed on June 30, 1994. 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 of 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 that 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, and describes how each
Agency will have primary jurisdiction over one of the two categories. All products
that 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 that
correspond to a high level disinfectant use pattern. These 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.
PR Notice 94-4 discusses the MOU in greater detail. The PR Notice contains
specific labeling statements that are also included in Part V of this RED.
The other three chemicals in the aliphatic alcohols case, methanol, propyl
alcohol, and tert-butyl alcohol are not being supported in reregistration. Products
containing these chemicals have been either voluntarily cancelled or the registrants
have been permitted to declare these alcohols as inert ingredients in formulations.
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These unsupported chemicals, when or if someone decides to support any one of them,
will be required to go through the registration process as new chemicals.
III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
The physical/chemical characteristics of ethanol and isopropanol are described
below:
Ethanol:
Chemical Structure:
Molecular Weight
Color
Physical State
Odor
Boiling point
Specific gravity
Solubility
Vapor pressure
Stability
H H
H - C - C- H
H OH
46.1 g/mole
Clear colorless
Liquid
Characteristic, alcoholic odor
78.5 °C
0.789 at 20 °C
miscible in water
43.9 mm Hg at 20 °C
Stable
Isopropanol:
Chemical Structure
Molecular Weight
Color
Physical State
Odor
Boiling point
Specific gravity
Solubility
Vapor pressure
Stability
H H H
H-C-C-C-H
H OH H
60.1 g/mole
Clear colorless
Liquid
Characteristic, alcoholic odor
82.5 °C
0.785 at 20 °C
miscible in water
96 mm Hg at 20 °C
Stable
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B.
Human Health Assessment
1. Toxicology Assessment
The toxicological data base for the aliphatic alcohols, ethanol and
ispropanol, is adequate and will support reregistration eligibility.
a. Acute Toxicity
Ethanol
Acute toxicity studies for ethanol are summarized in Table 1. No
dermal sensitization studies were available.
Table 1
STUDY
Acute oral
Rata
Mouse3
Acute inhalation
Rata
Mouse3
Primary eye
irritation - Rabbitb
Primary dermal irritation - Rabbitb
RESULT
LD50:
7060 mg/kg
7500 mg/kg
^^50-
38 mg/L (10 hr)
39 mg/L (4 hr)
Mild iritis, chemosis, redness
Nonirritating
CATEGORY
IV
IV
IV
IV
IV
IV
1 Sax and Lewis (1989a)
b Guess (1970)
In an acute neurotoxicity study, (Broxup et al., 1989) male
Sprague-Dawley rats were orally gavaged once with ethanol at 0, 0.2, 1,
or 5 ml/kg (0, 0.16, 0.79, or 3.95 mg/kg). During the FOB (Functional
Observational Battery), decreased incidence of rearing, flaccid body
tone, and reduced extensor thrust, toe pinch and tail pinch reflexes were
observed. At 5 mg/kg, motor activity was significantly decreased.
Isopropanol
Acute toxicity studies for isopropanol are summarized in Table 2.
No dermal sensitization studies were available.
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Table 2
STUDY
Acute oral
Rata
Mouseb
Acute dermaF
Acute inhalation
Ratd
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b. Subchronic Toxicity
Ethanol
In a 12-week oral study, male Sprague-Dawley rats were given
drinking water containing 3.26 M ethanol (Kager et al, 1974). During
the course of the study, the animals consumed an average of 10.2 g of
alcohol/kg/day. Compared to controls, treated animals showed
decreased mean body weights. A high degree of fatty degeneration
occurred in the livers of 10/12 treated animals. Other than the fatty
changes in the liver, no other gross or histopathological changes were
observed.
In a 21-day dermal study (Phillips et al., 1972), human
volunteers were continuously exposed to ethanol-saturated patches under
an occlusive dressing. No dermal irritation was noted through day 14,
very slight edema and erythema was noted from days 15 to 18, and well
defined edema and erythema was noted from days 19 to 21.
In a 90-day aerosol inhalation study, several species of animals
(rats, guinea pigs, rabbits, monkeys and dogs) were exposed
continuously to ethanol vapors at 86 mg/m3 (Coon et al., 1970). No
deaths or clinical signs of toxicity were observed during the study; all
hematology results were within normal limits. Histopathology findings
were negative also.
Isopropanol
In a subchronic inhalation study (Burleigh-Flayer et al. 1991,
1994), rats and mice were exposed to isopropanol vapors at
concentrations of 0 (air only), 100, 500, 1500, or 5000 ppm for 6
hr/day, 5 days/week, for 13 weeks. No treatment-related deaths
occurred. During the actual exposure, clinical signs in some 1500 and
5000 ppm rats and mice included ataxia, narcosis, and hypoactivity, and
lack of startle response was also present in 5000 ppm animals.
Following exposure at 500 or 1500 ppm, some rats showed perinasal
encrustations. At 5000 ppm, there were also periocular swelling, ataxia
and paresis. Following exposure at 5000 ppm, some mice showed
hypoactivity and ataxia. After an initial decrease in mean body weight
during Week 1, increases in body weight were observed at some dose
levels in rats and female mice. At 5000 ppm, increased absolute liver
weights were observed in male and female rats and female mice.
However, no histopathological changes were present, suggesting an
adaptive rather than toxic effect. Hyaline droplets were present in the
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kidneys of all male rats, and the severity of the lesion generally
increased with increasing dose. In a nine-day range-finding inhalation
exposure study in rats, hyaline droplet nephropathy was also observed in
male rats in the 1000 and 5000 ppm groups (Burleigh-Flayer et al.,
1990). Subsequent immunohistochemical evaluation of the kidneys did
not reveal any differences in the distribution of alpha2u-globulin,
suggesting that the accumulation of this protein is not associated with
hyaline droplet formation (Fowler and Martin, 1994). Based on these
results, the systemic NOEL was 500 ppm in rats and mice, and the
systemic LOEL was 1500 ppm in rats and mice.
In a subchronic inhalation neurotoxicity study (Burleigh-Flayer et
al., 1991, 1994), rats were exposed to isopropanol vapors at
concentrations of 0 (air only), 100, 500, 1500, or 5000 ppm for 6
hr/day, 5 days/week for 13 weeks. FOB, motor activity, and
neuropathology were evaluated. No treatment-related changes were
noted in the FOB or neuropathological evaluations. Motor activity was
increased in 5000 ppm female rats at 9 and 13 weeks, and full recovery
did not occur until 42 days post-treatment. In a subsequent inhalation
study (Burleigh-Flayer and Hurley, 1994), increased motor activity was
also observed in female rats exposed to 5000 ppm isopropanol for 13
weeks.
c. Chronic toxicity
Ethanol
In a chronic oral study (Boughton, 1944), male albino rats were
treated with 5% ethanol (2.1 ml/kg/day) in drinking water for 304 days.
No treatment related mortalities occurred during the study. Decreased
mean body weights were evident throughout the study. At Week 36, the
mean body weight of ethanol-treated animals was decreased by 30%,
compared to controls. Ethanol-treated animals showed decreased
activity and impaired maze learning ability.
In a chronic dermal toxicity study (Boughton, 1944), a 50%
aqueous solution of ethanol was applied to the facial area of male albino
rats for 187 days. No treatment-related effects were noted.
Isopropanol
In a chronic feeding study (Boughton, 1944), male albino rats
were treated with 5% isopropanol (1.87 ml/kg/day, 1470 mg/kg/day) in
drinking water for 304 days. No treatment-related mortalities occurred
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during the study. Decreased mean body weights were evident
throughout the study. At Week 36, the mean body weight of
isopropanol-treated animals was 29% lower than control animals.
Isopropanol-fed animals showed decreased activity and impaired maze
learning ability.
In a chronic dermal toxicity study (Boughton, 1944), a 50%
aqueous solution of isopropanol was applied to the facial area of male
albino rats for 187 days. No treatment-related effects were noted.
d. Carcinogenicity
Ethanol
A 1982 review of the toxicity of ethanol did not reference any
studies pertaining to the carcinogenic potential of ethanol (Clayton and
Clayton, 1982). A literature search conducted in March 1994 of the
Registry of Toxic Effects of Chemical Substances indicated that ethanol
was an equivocal tumorigenic agent. An International Agency of
Research in Cancer review, conducted in 1988, concluded that the
animal data were inadequate to evaluate carcinogenic risk in man. The
Agency review of the literature indicates that carcinogenic effects are not
expected from the uses of ethanol.
Isopropanol
In a carcinogenicity study, rats were exposed to isopropanol
vapors at concentrations of 0 (filtered air), 500, 2500, or 5000 ppm for
6 hr/day, 5 days/week for 105 weeks (Burleigh-Flayer and Benson,
1994). Treatment-related gross pathological changes consisted of an
increased incidence of granular kidneys of mid- and high-dose males at
the interim sacrifice and mid-dose males at terminal sacrifice; no
treatment-related gross lesions were noted in female rats. Male rats,
which died or were sacrificed in extremis during the study, had increased
incidences of thickened stomachs, granular kidneys and color change of
the kidneys at 2500 and 5000 ppm. Female rats had increased
incidences of thickened stomachs at 5000 ppm and granular kidneys at
2500 and 5000 ppm. Histopathological examinations revealed an
increased incidence of nonneoplastic kidney lesions (mineralization,
tubular dilation, glomerulosclerosis, interstitial nephritis, interstitial
fibrosis, hydronephrosis and transitional cell hyperplasia) of 2500 and
5000 ppm males and females. A secondary effect of the renal lesions
was an increased incidence of mineralization observed in other tissues.
Neoplastic lesions consisted of interstitial cell adenomas, which were
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present at frequencies of 64.9, 77.3, 86.7 and 94.7% for the 0, 500,
2500 and 5000 ppm groups, respectively. This lesion was attributed to
marked hyperplasia rather than autonomous growth. Based on the
results of this study, the NOEL for systemic toxicity was 500 ppm in
males and females, and the LOEL for systemic toxicity was 2500 ppm in
males and females. Evidence of carcinogenicity was not found.
In a second carcinogenicity study, mice were exposed to
isopropanol vapors at concentrations of 0 (filtered air), 500, 2500, or
5000 ppm for 6 hr/day, 5 days/week for 78 weeks (Burleigh-Flayer and
Wagner, 1993). Gross examination revealed increased incidence of
abnormal stomach contents in all treated mice at the interim sacrifice.
At terminal sacrifice an increased incidence of seminal vesicle
enlargement was noted in 5000 ppm males. This lesion was also noted
in 2500 and 5000 ppm males that died or were sacrificed in extremis
during the study. Histopathological examination revealed dilation of the
seminal vesicles of 2500 and 5000 ppm males, and 5000 ppm females
showed increased incidence of renal tubular dilation. All treated mice
also showed an increased incidence of renal tubular proteinaceous
material. Other nonneoplastic lesions included mucosal cell hyperplasia
within the glandular portion of the stomach, congestion of the adrenal
gland and extramedullary hematopoiesis and hemosiderosis of the
spleen. The study indicated that none of these findings are of biological
significance. There were no increases in the frequencies of neoplastic
lesions. Based on the results of this study, the NOEL for systemic
toxicity was 500 ppm in males and females.
e. Developmental/Reproductive Toxicity
Ethanol
Ethanol is generally recognized as a human developmental
neurotoxicant (Rees et al. 1990). Jones and Smith (1973) and Jones et
al. (1973) initially described Fetal Alcohol Syndrome, that results from
the effects of chronic maternal alcohol consumption on the fetus. The
effects of this syndrome include altered prenatal growth and
morphogenesis, characterized, in part, by severe growth retardation,
mental retardation and microencephaly. Meyer and Riley (1986)
extensively reviewed the behavioral teratology of alcohol and describe
transient delays in development, such as age-dependent deficits in
activity, delays in maturational indices (eye opening, incisor eruption),
increased open field activity, and learning deficits. The effects listed
here are generally associated with high (grams/day, oral) maternal
consumption of ethanol. Given that OSHA has established the threshold
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limit value at 1000 ppm (10 hour, time weighted average), the human
risk to ethanol exposure in an industrial environment appear to be
minimal.
Isopropanol
Rats were orally gavaged with aqueous solutions of isopropanol,
at dosages of 0, 400, 800 or 1200 mg/kg/day, on days 6 through 15 of
gestation (Tyl et al., 1990a). Maternal toxicity consisted of two (8%)
deaths at 1200 mg/kg and one (4%) death at 800 mg/kg. At 800 and
1200 mg/kg, fetal body weights were significantly reduced. Based on
the results of this study the NOEL for systemic maternal toxicity was
400 mg/kg/day. The NOEL for developmental toxicity was 400
mg/kg/day.
In another developmental toxicity study, New Zealand White
rabbits were orally gavaged with isopropanol, at dosages of 0, 120, 240
or 480 mg/kg/day, on days 6-18 of gestation (Tyl et al., 1990b).
Maternal toxicity consisted of increased mortality (4/15, 26.7%) at 480
mg/kg/day, significantly decreased mean body weights during dosing,
and decreased corrected maternal body weight change. No other
treatment-related differences were noted. Based on the results of this
study, the NOEL was 240 mg/kg/day for systemic maternal toxicity and
480 mg/kg/day for developmental toxicity. The LOEL was 480
mg/kg/day for systemic toxicity, and greater than 480 mg/kg/day for
developmental toxicity.
In an inhalation developmental toxicity study, Sprague-Dawley
rats were exposed to high vapor concentrations of isopropanol (0, 3500,
7000, or 10000 ppm) 7 hr/day on gestation days 1-19 (Nelson etal,
1988). At 10000 ppm, the mean number of implants/dam and the
number of live implants/litter were significantly reduced, and there was
a significant increase in the number of resorptions/litter. At all
treatment levels, the mean fetal body weights were significantly reduced.
The incidence of total fetal (but not litter) skeletal malformations was
increased at 7000 and 10000 ppm. Based on the results of the study, a
NOEL for developmental toxicity was not obtained, since the lowest
dose (3500 ppm) produced slight decreases in the mean fetal body
weights.
In a developmental neurotoxicity study, timed-pregnant Sprague-
Dawley rats were orally gavaged with isopropanol at dosages of 0, 200,
700 or 1200 mg/kg/day from day 6 of gestation through postpartum day
21 (RTI, 1991). For maternal animals, one high-dose animal died.
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There were no other clinical signs of toxicity present. Maternal body
weight and food consumption were not altered by treatment. No
treatment-related differences in the litter indices or sexual maturation
were observed. Behavioral tests did not reveal any differences that
could be attributed to treatment. At necropsy, maternal and pup organ
weights and incidence of pup histological findings were comparable
between control and treatment groups. Based on these findings, the
NOEL for developmental neurotoxicity in rats was established at greater
than 1200 mg/kg/day.
In a two-generation reproduction study, rats were treated by oral
gavage with aqueous solutions of isopropanol at 0, 100, 500 or 1000
mg/kg/day (Exxon, 1992). For parental animals, no treatment-related
differences were noted in the incidence of clinical signs, mortality, body
weights or food consumption. High-dose, and to a lesser extent mid-
dose, parental animals showed increases in the absolute and/or relative
liver and/or kidney weights. No treatment-related histopathological
lesions were noted in parental females, and treated Pj and P2 males had
increased incidence of hyaline droplet nephropathy. During the first two
days postpartum, Fl offspring showed increased mortality compared to
controls, however, no clinical signs of toxicity were present. Gross
pathological examination on postnatal day 21 did not reveal any
biologically meaningful differences between control and treated
offspring from either generation. Based on the results of this study, the
NOEL for systemic toxicity was 500 mg/kg/day, and no reproductive
toxicity was noted at the highest dose tested (1000 mg/kg/day).
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f. Mutagenicity
Ethanol
A summary of mutagenicity study results for ethanol is presented
in Table 3.
Table 3
MUTAGENICITY TEST3
Rodent dominant lethal
Aspergillus-forward mutation; sister chromatid exchange-clonal assay
Cell transformation-RLV F344 rat embryo
In vitro cytogenetics- nonhuman; mammalian micronucleus
N. crassa-aneuploidy; histidine reversion
(Ames Test)
In vitro sister chromatid exchange-human lymphocytes
In vitro sister chromatid exchange-nonhuman; sperm morphology-mouse
RESULT
Positive
Negative
Negative
Negative
Negative
Negative
Negative
From USEPA Genetox Program 1988.
Isopropanol
A summary of mutagenicity study results for isopropanol is
presented in Table 4.
Table 4
MUTAGENICITY TEST
Cell transformation-SA7/SHE; N. crassaaneuploidy3
In vitro mouse micronucleus testb
CHO/HGPRT forward gene mutation assayc
RESULT
Negative
Negative
Negative
From USEPA Genetox Program 1988.
Young (1990)
Ivett (1991b)
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g. Metabolism
Ethanol
The metabolism of ethanol has been well described in the
literature. The first step, oxidation to acetaldehyde, may involve
various enzymes that act as mediators during alcohol metabolism.
Alcohol dehydrogenase is a soluble enzyme found in high concentrations
in the liver that appear to play the major role in alcohol metabolism.
NAD is the coenzyme, and the products are NADH and acetaldehyde.
A second enzyme capable of converting ethanol to acetaldehyde is
catalase which uses hydrogen peroxide to perform the oxidation. Since
there is very little peroxide available to support this reaction, it accounts
for no more than 10 percent of ethanol metabolism. A third enzyme is
the NADPH-dependent microsomal ethanol oxidizing system, that with
oxygen as a cosubstrate results in the oxidation of ethanol to
acetaldehyde. Acetaldehyde is further metabolized to acetate via a
NAD-dependent reaction with acetaldehyde dehydrogenase.
Isopropanol
The absorption, metabolism, tissue distribution, and excretion of
[14C]-isopropanol were studied in rats and mice (Slauter et al., 1994).
Animals were treated either intravenously or by inhalation. Rats were
also orally gavaged. In both rats and mice, no marked differences were
noted between sexes or route of administration. Total cumulative
excretion ranged from 78 to 97%, with exhaled volatile organic
compounds (unmetabolized isopropanol and acetone) and C02
accounting for most of the radioactivity. Small amounts of radioactivity
were found in the urine (3 - 8%) and feces (0.5 - 1.5%). Urinary
metabolites consisted of unmetabolized isopropanol, acetone and a
metabolite tentatively identified as the isopropyl glucuronic acid.
From pharmacokinetic analysis, the elimination half-life was 0.6
to 2 hr. At the high oral dose (3000 mg/kg) the half-lives ranged from
4.0 to 6.8 hr in females and males, respectively.
h. Reference Dose
There are registered food uses for ethanol and isopropanol as a
plant regulator (ripener). However, dietary exposure is not expected
from the use patterns of ethanol and isopropanol. Therefore, Reference
Doses (RfD) were not established for the active ingredients.
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2. Exposure Assessment
Aliphatic alcohols are used as components of a variety of
commercial and household products including a sterilant, medical
disinfectants, virucides, sanitizers, fungicides, and plant regulators.
Application sites include: indoor food, indoor nonfood, indoor
residential, and indoor medical sites (such as surfaces, equipment and
utensils in medical facilities, eating and food-handling/processing
establishments, veterinary institutions and kennels, and crack and crevice
treatment of home/commercial institutions or transportation facilities).
Isopropanol is a component used in combination with known
insecticidal/acaricidal or repellent activity, of products used as
insecticides/acaricides/repellent on cats and dogs and in and around
kennels and non-food areas of homes.
Concentrations of the active ingredients range from
approximately 5% to 92% in the various formulations. Antimicrobial
application methods include surface wipes, spray, mop, sponge-on,
wipe-on, pour-on, immersion, aerosol, and closed system uses for
commercial/industrial water cooling systems. Application equipment
includes surface swipes, pump spray bottle, aerosol sprays, power and
hand-held sprayers.
The uses of aliphatic alcohols may result in high dermal and
inhalation exposures; however, the risk from exposures to these active
ingredients is considered to be incidental when compared to the frequent
intentional human exposures. Therefore, an occupational/residential
exposure risk assessment is not required.
a. Dietary Exposure
Dietary exposure is not expected from the use patterns of ethanol
and isopropanol.
b. Occupational and Residential
The registered uses of aliphatic alcohols may result in high
dermal and inhalation exposures during mixer/loader and applicator use
of aliphatic alcohol products, especially when power sprays are used.
However, the risk from exposures to these active ingredients is
considered to be incidental when compared to the frequent intentional
human exposures.
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3. Risk Assessment
a. Dietary
Dietary exposure is not a concern for the aliphatic alcohols when
used as a plant regulator (ripener). Dietary exposure is not expected
from this use. A dietary risk assessment is not required.
b. Occupational and Residential
The Agency has determined that an occupational/residential
exposure risk assessment is required for active ingredients if: (1) certain
toxicological criteria are triggered and (2) there is an exposure risk for
handlers (mixers, loaders, applicators, etc.) during use or for persons
entering treated sites immediately after completion of product
applications, especially in the use of sanitizers.
Based on the acute toxicities and usage patterns for the active
ingredients in this reregistration case, the Agency has determined the
toxicological criteria are not triggered and that the exposure risk, from
the active ingredients, for handlers and reentry workers is not significant
when compared to the frequent intentional human exposures. (EPA's
OPP Less Than Lifetime Committee, November 2, 1994). Both active
ingredients in this reregistration case have a history of extensive human
exposure. Therefore, an occupational/residential exposure risk
assessment is not required for the uses of aliphatic alcohols in this
reregistration case.
The Agency review of the literature concluded that there is no
expectation of developmental or reproductive effects from the potential
dermal and inhalation exposures from the regstered uses of the aliphatic
alcohols as described in this reregistration case.
C. Environmental Assessment
1. Ecological Toxicity Data
The Agency relied on data available from its Toxicology Data Base and
published literature to review the toxicity of ethanol and isopropanol to
mammalian and aquatic species.
25
-------
Table 5
a. Toxicity to Terrestrial Animals
Species
Rat: ethanol
Rat: isopropanol
LD50
7060 mg/kg
4384 mg/kg
Source
Agency Toxicology Data Base
Agency Toxicology Data Base
Conclusion
practically non-toxic
practically non-toxic
These results demonstrate that ethanol and isopropanol are
practically non-toxic to the rat on an acute basis.
b. Toxicity to Aquatic Animals
(1) Acute Toxicity Data for Ethanol
Table 6
Species
rainbow trout
fathead minnow
Daphnia
Palaemonetes kadiakensis
%ai
100%
95%
unknown
100%
Results
LC50 = 13000 ppm
LC50 = 14200 ppm
LC50 > 100 ppm
LC50 > 250 ppm
MRID
MRID 40098001
Brooke, et al.2
Ewell, et al.3
MRID 40098001
Conclusion1
practically non-toxic
practically non-toxic
practically non-toxic
practically non-toxic
for material tested
Brooke, L.T., et al., Acute Toxicities of Organic Chemicals to Fathead Minnows, Center for Lake Superior Environmental Studies, University of
Wisconsin-Superior, 1994.
Information obtained secondarily from EPA's Office of Pollution Prevention and Toxics.
These results show that ethanol is practically non-toxic to the
rainbow trout, fathead minnow, Daphnia, and Palaemonetes kadiakensis
(glass shrimp).
(2) Aquatic Toxicity Data for Isopropanol.
Table 7
Species
fathead minnow
Daphnia
%ai
99.8%
unknown
Results
LC50 = 6550 ppm
EC50 = 2280 ppm
Author
Brooke, et al.2
Hermen3
Conclusion1
practically non-toxic
practically non-toxic
for material tested
Brooke, L.T., et al., Acute Toxicities of Organic Chemicals to Fathead Minnows, Center for Lake Superior Environmental Studies,
University of Wisconsin-Superior, 1994.
Information obtained secondarily from EPA's Office of Pollution Prevention and Toxics.
26
-------
These results show that isopropanol is practically non-toxic to the
fathead minnow and Daphnia.
2. Environmental Fate
The Agency relied on information from the open chemical literature to
characterize the environmental fate of ethanol and isopropanol.
a. Environmental Fate Chemistry
Aliphatic alcohols are organic chemical compounds in which the
carbon atoms are linked in open chains and that contain a hydroxyl (-
OH) group. There are two principal ways to manufacture the simple
alcohols: by hydration of alkenes obtained from the cracking of
petroleum and by fermentation of carbohydrates.
Ethanol and isopropanol are flammable liquids. Both chemicals
are miscible with water and with many organic solvents. The high
solubility of the chemicals in water is due to the hydrogen bond that can
exist between an alcohol molecule and a water molecule.
b. Environmental Fate Assessment
Ethanol and isopropanol are highly volatile liquids. They are
expected to be stable in water under typical use conditions. The Agency
does not anticipate significant exposure to the environment from the
remaining supported uses (mostly indoor except for pet living quarters;
and discharge of treated water from water beds and whirlpools; and
refuse/solid waste sites) of the aliphatic alcohols.
3. Exposure and Risk Characterization
Estimated environmental concentrations (EECs) were not established for
the use patterns for ethanol and isopropanol. Results from the Agency's
toxicology data base and the published literature show that these alcohols are
practically non-toxic to mammals and the aquatic species tested. The majority
of registered uses for ethanol and isopropanol being supported for reregistration
are mostly for indoor use. The only outdoor uses are for pet living quarters
(isopropanol) and refuse/solid waste sites (ethanol). In addition, both alcohols
are highly volatile, which supports the conclusion that exposure to terrestrial
organisms would be extremely minimal.
27
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IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after
submission of relevant data concerning an active ingredient, whether products
containing the active ingredient are eligible for 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 ethanol and
isopropanol as 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 ethanol and isopropanol. Appendix B identifies the generic data
requirements that the Agency reviewed as part of its determination of reregistration
eligibility of ethanol and isopropanol, and lists the submitted studies that the Agency
found acceptable.
The data identified in Appendix B were sufficient to allow the Agency to assess
the registered uses of ethanol and isopropanol and to determine that ethanol and
isopropanol can be used without resulting in unreasonable adverse effects to humans
and the environment. The Agency therefore finds that all products containing ethanol
and/or isopropanol as the active ingredients are eligible for reregistration. The
reregistration of particular products is addressed in Section V of this document.
The Agency based its reregistration eligibility determination upon the target
data base required for reregistration, the current guidelines for conducting acceptable
studies to generate such data, published scientific literature, and the data identified in
Appendix B. Although the Agency has found that all uses of ethanol and isopropanol
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 ethanol and isopropanol if new
information comes to the Agency's attention or if the data requirements for registration
(or the guidelines for generating such data) change.
B. Determination of Eligibility
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredients
ethanol and isopropanol, the Agency has sufficient information on the health
effects and on their potential for causing adverse effects in fish and wildlife and
the environment. The Agency has determined that ethanol and isopropanol
products, labeled and used as specified in this Reregistration Eligibility
Decision, will not pose unreasonable risks or adverse effects to humans or the
28
-------
environment. Therefore, the Agency concludes that products containing ethanol
and isopropanol for all uses are eligible for reregistration.
2. Eligible and Ineligible Uses
The Agency has determined that all uses of ethanol and isopropanol are
eligible for reregistration.
C. Regulatory Position
The following is a summary of the regulatory positions and rationales for
ethanol and isopropanol. Where labeling revisions are imposed, specific language is set
forth in Section V of this document.
1. Labeling Rationale
The registered uses of these aliphatic alcohols may result in high dermal
and inhalation exposures during mixer/loader and applicator use of aliphatic
alcohol products, especially when power sprays are used. However, the risk
from exposures to these active ingredients is considered to be incidental when
compared to the frequent intentional human exposures.
Mixer/loader/applicator PPE
For each end-use product, PPE requirements for pesticide handlers are
established during reregistration in one of two ways:
1. If EPA has no special concerns about the acute or other adverse effects of an
active ingredient, the PPE for pesticide handlers will be established based on
the acute toxicity of the end-use product. For occupational-use products, PPE
will be established using the process described in PR Notice 93-7 or more
recent EPA guidelines.
2. If EPA has special concerns about an active ingredient due to very high acute
toxicity or to certain other adverse effects, such as allergic effects or delayed
effects (cancer, developmental toxicity, reproductive effects, etc):
• In the RED for that active ingredient, EPA may establish minimum or
"baseline" handler PPE requirements that pertain to all or most
occupational end-use products containing that active ingredient.
• These minimum PPE requirements must be compared with the PPE that
would be designated on the basis of the acute toxicity of each end-use
product.
29
-------
• The more stringent choice for each type of PPE (i.e., bodywear, hand
protection, footwear, eyewear, etc.) must be placed on the label of the
end-use product.
The EPA concludes there are no specific acute toxic or adverse effects
from exposures to registered uses of aliphatic alcohols (ethanol and
isopropanol), for handlers which warrant the establishment of active-ingredient-
based minimum PPE.
Post-Application Exposures
There are several types of potential exposures to persons after
application is complete. These include:
1). Potential exposure, especially inhalation exposure, to
industrial/manufacturing workers immediately after aliphatic
alcohol use.
2). Potential exposure, especially inhalation exposure, to products
containing aliphatic alcohol immediately after such products are
used.
Post-application dermal exposures to aliphatic alcohols, excluding
ethanol used to generate ethylene, are expected to be minimal, because both
active ingredients evaporate rapidly.
Although there is potential inhalation exposure following applications of
the aliphatic alcohols in this reregistration case, the establishment of active-
ingredient-based post-application entry restrictions and personal protective
equipment specifications are not warranted. This conclusion is based on the
absence of toxicological concerns when the uses are compared to the frequent
intentional human exposures.
V. ACTIONS REQUIRED BY REGISTRANTS
This section specifies the data requirements and responses necessary for the
reregistration of both manufacturing-use and end-use products.
30
-------
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of ethanol and
isopropanol for the above eligible uses has been reviewed and determined to be
substantially complete.
2. Labeling Requirements for Manufacturing-Use Products
To remain in complaince with FIFRA, manufacturing use product (MP)
labeling must be revised to comply with all current EPA regulations, PR
Notices and applicable policies. The MP labeling must bear the following
statement under Directions for Use:
"Only for formulation into an [fill blank with Insecticide, Herbicide or the
applicable term which describes the type of pesticide use(s)] for the following
use (s) [fill blank only with those uses that are being supported by MP
registrant."
An MP registrant may, at his/her discretion, add one of the following
statements to an MP label under "Directions for Use" to permit the
reformulation of the product for a specific use or all additional uses supported
by a formulator or user group:
(a) "This product may be used to formulate products for
specific use(s) not listed on the MP label if the
formulator, user group, or grower has complied with
U.S. EPA submission requirements regarding support of
such use(s)."
(b) "This product may be used to formulate products for any
additional use(s) not listed on the MP label if the
formulator, user group, or grower has complied with
U.S. EPA submission requirements regarding support of
such use(s)."
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
31
-------
has been made. The product specific data requirements are listed in Appendix
G, the Product Specific Data Call-in Notice.
Registrants must review previous data submissions to ensure that they
meet current EPA acceptance criteria (Appendix F; Attachment E) and if not,
commit to conduct new studies. If a registrant believes that previously
submitted data meet current testing standards, then study MRID numbers should
be cited according to the instructions in the Requirement Status and Registrants
Response Form provided for each product.
Where new efficacy studies must be conducted, the registrant may refer
to Subdivision G of EPA's Pesticide Assessment Guidelines. Subdivision G is
available from National Technical Information Service (a fee will be charged);
the order number is PB83-153924.
2. Labeling Requirements for End-Use Products
In compliance with PR Notice 94-4, the following statement must be
added to the label of each product, except for sterilants, that is registered for
treatment of any medical device or medical equipment surface:
"This product is not to be used as a terminal sterilant/high level
disinfectant on any surface or instrument that (1) is introduced directly
into the human body, either into or in contact with the bloodstream or
normally sterile areas of the body, or (2) contacts intact mucous
membranes but which does not ordinarily penetrate the blood barrier or
otherwise enter normally sterile areas of the body. This product may be
used to preclean or decontaminate critical or semi-critical medical
devices prior to sterilization or high level disinfection."
C. Existing Stocks
Registrants may generally distribute and sell products bearing old
labels/labeling for 26 months from the date of the issuance of this Reregistration
Eligibility Decision (RED). Persons other than the registrant may generally distribute
or sell such products for 50 months from the date of the issuance of this RED.
However, existing stocks time frames will be established case-by-case, depending on
the number of products involved, the number of label changes, and other factors. Refer
to "Existing Stocks of Pesticide Products; Statement of Policy"; Federal Register,
Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell ethanol and
isopropanol products bearing old labels/labeling for 26 months from the date of
issuance of this RED. Persons other than the registrant may distribute or sell such
32
-------
products for 50 months from the date of the issuance of this RED. Registrants and
persons other than registrants remain obligated to meet pre-existing Agency imposed
label changes and existing stocks requirements applicable to products they sell or
distribute.
33
-------
34
-------
VI. APPENDICES
35
-------
36
-------
APPENDIX A. Table of Use Patterns Subject to Reregistration
37
-------
38
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page 1
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES
AVOCADO
Stored commodity fumigation., Postharvest., RTU
Catalytic generator.
Stored commodity fumigation., Postharvest., RTU NA
Catalytic generator.
CITRUS FRUITS
Stored commodity fumigation., Postharvest., RTU NA
Catalytic generator.
DAIRIES/CHEESE PROCESSING PLANT PREMISES (NONFOOD CONTACT)
Spray., Not on label., Not on label., Hard., RTU W 660000
Not applicable for this use.
EATING ESTABLISHMENTS EQUIPMENT/UTENSILS (FOOD CONTACT)
Spray., Not on label., Aerosol can., Hard., PRL W 527880
Not applicable for this use.
PRL W 534600
Spray., Not on label., Sprayer., Hard., Not RTU W 668250
applicable for this use.
EATING ESTABLISHMENTS FOOD HANDLING AREAS (FOOD CONTACT)
Spray., Not on label., Aerosol can., Hard., PRL W 527880
Not applicable for this use.
Use Group: INDOOR FOOD
UC * NS NS
Use Group: INDOOR FOOD
UC * NS NS
Use Group: INDOOR FOOD
UC * NS NS
Use Group: INDOOR FOOD
W 660000 * NS NS
Use Group: INDOOR FOOD
W 527880 * NS NS
W 534600 * NS NS
W 668250
NS NS
Use Group: INDOOR FOOD
W 527880 * NS NS
W 534600 * NS NS
NS NS NS NS
A08, AIO(IO),
A35(68)
A08, A25(10)
A06, A08, AIO(IO),
C17
A06, A08, AIO(IO),
C17
A08, A25(10)
A06, A08, AIO(IO),
C17
Spray., Not on label., Sprayer., Hard., Not RTU W 668250
applicable for this use.
EATING ESTABLISHMENTS FOOD SERVING AREAS (FOOD CONTACT)
Spray., Not on label., Aerosol can., Hard., PRL W 527880
Not applicable for this use.
W 668250 * NS NS
Use Group: INDOOR FOOD
W 527880 * NS NS
W 534600 * NS NS
NS NS NS NS
NS NS NS
NS NS NS
A06, A08, AIO(IO),
C17
A08, A25(10)
A06, A08, AIO(IO),
C17
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
EATING ESTABLISHMENTS FOOD SERVING AREAS (FOOD CONTACT) (con't)
Spray., Not on label., Sprayer., Hard., Not RTU W 668250
applicable for this use.
EGG HANDLING EQUIPMENT (COMMERCIAL)
Spray., Not on label., Not on label., Hard., RTU W 660000
Not applicable for this use.
EGG HANDLING ROOMS (COMMERCIAL)
Spray., Not on label., Not on label., Hard., RTU W 660000
Not applicable for this use.
EGG PACKING PLANTS (COMMERCIAL)
Spray., Not on label., Not on label., Hard., RTU W 660000
Not applicable for this use.
FEED MILLS/FEED PROCESSING PLANTS
Spray., Not on label., Not on label., Hard., RTU
Not applicable for this use.
W 660000
FISH/SEAFOOD PROCESSING PLANT PREMISES (NONFOOD CONTACT)
Spray., Not on label., Not on label., Hard., RTU W 660000
Not applicable for this use.
FOOD DISPENSING EQUIPMENT/VENDING MACHINES
Spray., Not on label., Aerosol can., Hard., PRL W 530000
Not applicable for this use.
Spray., Not on label., Not on label., Hard., RTU W 660000
Not applicable for this use.
Use Group: INDOOR FOOD (con't)
W 668250 * NS NS NS
Use Group: INDOOR FOOD
W 660000 * NS NS NS
Use Group: INDOOR FOOD
W 660000 * NS NS NS
Use Group: INDOOR FOOD
W 660000 * NS NS NS
Use Group: INDOOR FOOD
W 660000 * NS NS NS
Use Group: INDOOR FOOD
W 660000 * NS NS NS
Use Group: INDOOR FOOD
W 530000 * NS NS NS
W 660000 * NS NS NS
FOOD MARKETING/STORAGE/DISTRIBUTION EQUIPMENT/UTENSILS (FOOD CONTACT) Use Group: INDOOR FOOD
W 527880 * NS NS
Spray., Not on label., Aerosol can., Hard., PRL W 527880
Not applicable for this use.
Spray., Not on label., Sprayer., Hard., Not RTU W 668250
applicable for this use.
W 534600 * NS NS
A06, A08, AIO(IO),
C17
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO),
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, A25(10)
A06, A08, AIO(IO),
C17
A06, A08, AIO(IO),
C17
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page 3
SITE Application Type, Application Form(s)
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
FOOD PROCESSING PLANT EQUIPMENT (FOOD CONTACT)
Spray., Not on label., Aerosol can., Hard., PRL W 527880
Not applicable for this use.
FOOD PROCESSING PLANT PREMISES (NONFOOD CONTACT)
Spray., Not on label., Aerosol can., Hard., PRL W 527880
Not applicable for this use.
PRL W 530000
Use Group: INDOOR FOOD
W 527880 * NS NS
Use Group: INDOOR FOOD
W 527880 * NS NS
W 530000
NS NS
NS NS
NS
A08, A25(10)
A08, A25(10)
A08, AIO(IO),
A35(68)
PRL W 530880
Spray., Not on label., Not on label., Hard., RTU W 660000
Not applicable for this use.
FOOD STORES/MARKETS/SUPERMARKETS PREMISES
Spray., Not on label., Aerosol can., Hard., PRL W 530000
Not applicable for this use.
Spray., Not on label., Not on label., Hard., RTU W 660000
Not applicable for this use.
FOOD/GROCERY/MARKETING/STORAGE/DISTRIBUTION FACILITY PREMISE
Spray., Not on label., Aerosol can., Hard., PRL W 527880
Not applicable for this use.
PRL W 530000
W 530880 * NS NS
W 660000 * NS NS
Use Group: INDOOR FOOD
W 530000 * NS NS
W 660000 * NS NS
Use Group: INDOOR FOOD
W 527880 * NS NS
W 530000 * NS NS
NS
NS
NS NS NS
NS NS NS
A08, AIO(IO)
A08, AIO(IO),
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, A25(10)
A08, AIO(IO),
A35(68)
NS NS NS NS
A06, A08, AIO(IO),
C17
Spray., Not on label., Not on label., Hard., RTU W 660000
Not applicable for this use.
Spray., Not on label., Sprayer., Hard., Not RTU W 668250
applicable for this use.
GRAIN/CEREAL/FLOUR BINS-EMPTY
Spray., Not on label., Not on label., Hard., RTU W 660000
Not applicable for this use.
W 660000 * NS NS
NS NS NS NS
W 668250
NS NS
Use Group: INDOOR FOOD
W 660000 * NS NS
A08, AIO(IO),
A35(68)
A06, A08, AIO(IO),
C17
A08, AIO(IO),
A35(68)
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page 4
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
GRAIN/CEREAL/FLOUR ELEVATORS-EMPTY
Spray., Not on label., Not on label., Hard., RTU
Not applicable for this use.
W 660000
HOUSEHOLD/DOMESTIC DWELLINGS INDOOR FOOD HANDLING AREAS
W 442500
Spray., Not on label., Aerosol can., Hard., PRL
Not applicable for this use.
PRL
PRL
PRL
MEAT PROCESSING PLANT EQUIPMENT (FOOD CONTACT)
Spray., Not on label., Aerosol can., Hard., PRL
Not applicable for this use.
Spray., Not on label., Sprayer., Hard., Not RTU
applicable for this use.
MEAT PROCESSING PLANT PREMISES (NONFOOD CONTACT)
Spray., Not on label., Aerosol can., Hard., PRL
Not applicable for this use.
Spray., Not on label., Not on label., Hard., RTU
Not applicable for this use.
Spray., Not on label., Sprayer., Hard., Not RTU
applicable for this use.
Stored commodity fumigation., Postharvest., RTU
Catalytic generator.
Stored commodity fumigation., Postharvest., RTU
Catalytic generator.
W 534600
W 560000
W 685000
W 530000
W 534600
W 660000
W 668250
Use Group: INDOOR FOOD
W 660000 * NS NS
Use Group: INDOOR FOOD
W 442500 * NS NS
W 534600 * NS NS
W 560000 * NS NS
W 685000 * NS NS
Use Group: INDOOR FOOD
W 534600 * NS NS
W 668250 * NS
NS
Use Group: INDOOR FOOD
W 530000 * NS NS
W 534600 * NS NS
W 660000 * NS NS
W 668250
NS NS
Use Group: INDOOR FOOD
UC * NS NS
Use Group: INDOOR FOOD
UC * NS NS
NS
NS
NS
NS
NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS
NS
NS
NS
NS NS NS
NS NS NS
NS
A08, AIO(IO),
A35(68)
A06, A08, A25(10)
A08
A08, AIO(IO)
A08, AIO(IO)
A06, A08, AIO(IO),
C17
A06, A08, AIO(IO),
C17
A08, AIO(IO),
A35(68)
A08, AIO(IO) , C17
A08, AIO(IO),
A35(68)
A08, AIO(IO) , C17
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page 5
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
))))))
PEAR
Stored commodity fumigation., Postharvest., RTU NA
Catalytic generator.
POULTRY (EGG/MEAT)
Premise treatment., Not on label., Not on RTU W 660000
label., Hard., Not applicable for this use.
POULTRY PROCESSING PLANT EQUIPMENT (FOOD CONTACT)
Spray., Not on label., Aerosol can., Hard., PRL W 534600
Not applicable for this use.
Spray., Not on label., Sprayer., Hard., Not RTU W 668250
applicable for this use.
POULTRY PROCESSING PLANT PREMISES (NONFOOD CONTACT)
Spray., Not on label., Aerosol can., Hard., PRL W 530000
Not applicable for this use.
Spray., Not on label., Not on label., Hard., RTU W 660000
Not applicable for this use.
Spray., Not on label., Sprayer., Hard., Not RTU W 668250
applicable for this use.
Stored commodity fumigation., Postharvest., RTU NA
Catalytic generator.
NON- FOOD/NON- FEED
Use Group: INDOOR FOOD
UC * NS NS
Use Group: INDOOR FOOD
W 660000 * NS NS
W 668250 * NS NS
Use Group: INDOOR FOOD
W 530000 * NS NS
W 534600 * NS NS
W 660000 * NS NS
W 668250
NS NS
NS
Use Group: INDOOR FOOD
W 534600 * NS NS NS
NS
NS
NS
NS
Use Group: INDOOR FOOD
UC * NS NS NS
NS NS
NS NS
NS NS
NS NS
NS
NS
A08, AIO(IO),
A35(68)
A06, A08, AIO(IO),
C17
A06, A08, AIO(IO),
C17
A08, AIO(IO),
A35(68)
A08, AIO(IO) , C17
A08, AIO(IO),
A35(68)
A08, AIO(IO) , C17
AIR TREATMENTS (COMMERCIAL/HOUSEHOLD)
Aerosol application., Not on label., Aerosol PRL W 169200
can., Not Applicable., Not applicable for
this use.
Use Group: INDOOR RESIDENTIAL
W 169200 * NS NS NS
NS NS NS
PRL W 321000
PRL W 370000
W 321000 * NS NS NS
W 370000 * NS NS NS
NS NS NS
NS NS NS
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page
SITE Application Type, Application Form(s)
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
AIR TREATMENTS (COMMERCIAL/HOUSEHOLD) (con't)
PRL
PRL
Aerosol application., Not on label.,
Automatic aerosol dispenser., Not
Applicable., Not applicable for this use.
Aerosol application., Not on label., Hand PRL
held sprayer., Not Applicable., Not
applicable for this use.
AIR TREATMENTS (HOSPITAL)
Aerosol application., Not on label., Aerosol PRL
can., Not Applicable., Not applicable for
this use.
PRL
PRL
Aerosol application., Not on label.,
Automatic aerosol dispenser., Not
Applicable., Not applicable for this use.
Aerosol application., Not on label., Hand PRL
held sprayer., Not Applicable., Not
applicable for this use.
AMBULANCES
Spray., Not on label., Aerosol can., Hard., PRL
Not applicable for this use.
Spray., Not on label., Sprayer., Hard., Not RTU
applicable for this use.
AMPHIBIANS
Premise treatment., Not on label., Not on RTU
label., Hard., Not applicable for this use.
ANIMAL KENNELS/SLEEPING QUARTERS (COMMERCIAL)
Spray., Not on label., Aerosol can., Hard., PRL
Not applicable for this use.
W 627400
W 301480
W 627400
W 301480
Use Group: INDOOR RESIDENTIAL (con't)
W 627400 * NS NS NS NS NS NS
W 301480 * NS NS NS NS NS NS
W 301480 * NS NS NS NS NS NS
Use Group: INDOOR MEDICAL
W 169200 * NS NS NS NS NS NS
W 627400 * NS NS
W 301480 * NS NS
NS
NS
Use Group: INDOOR MEDICAL
W 680000 * NS NS NS
W 680000 * NS NS
NS
Use Group: INDOOR RESIDENTIAL
W 660000 * NS NS NS
Use Group: INDOOR NON-FOOD
W 527880 * NS NS NS
W 530000
NS NS
NS
NS NS
NS NS
NS
NS
A08, A25(10)
A08, AIO(IO),
A35(68)
A08, A25(10)
A08, AIO(IO) ,
A35(68)
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page 7
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
ANIMAL KENNELS/SLEEPING QUARTERS (COMMERCIAL) (con't)
PRL W 534600
PRL
PRL
RTU
Spray., Not on label., Aerosol can., Hard., RTU
Organic soil (5%) .
Spray., Not on label., Not on label., Hard., RTU
Not applicable for this use.
W 696230
W 790000
W 820000
W 820000
W 660000
Spray., Not on label., Sprayer., Hard., Not RTU W 668250
applicable for this use.
ANIMALS (LABORATORY/RESEARCH)
Premise treatment., Not on label., Not on RTU W 660000
label., Hard., Not applicable for this use.
BARBER/BEAUTY SHOP EQUIPMENT (BARBER CHAIR/CABINETS)
Spray., Not on label., Aerosol can., Hard., PRL W 530000
Not applicable for this use.
Spray., Not on label., Not on label., Hard., RTU W 660000
Not applicable for this use.
BARBER/BEAUTY SHOP INSTRUMENTS (SHAVERS/SCISSORS)
Spray., Not on label., Aerosol can., Hard., PRL W 530000
Not applicable for this use.
Spray., Not on label., Not on label., Hard., RTU W 660000
Not applicable for this use.
BATHROOM PREMISES/HARD SURFACES
Spray., Not on label., Aerosol can., Hard., PRL W 242380
Not applicable for this use.
PRL W 242380
PRL W 242380
Use Group: INDOOR NON-FOOD (con't)
W 534600 * NS NS NS NS NS
W 696230 * NS NS NS NS NS
W 790000 * NS NS NS NS NS
W 820000 * NS NS NS NS NS
W 820000 * NS NS NS NS NS
W 660000 * NS NS
W 668250
NS NS
NS
NS
W 660000 * NS NS
NS
W 660000 * NS NS
NS
Use Group: INDOOR RESIDENTIAL
W 242380 * NS NS NS
W 242380 * NS NS
W 242380 * NS NS
NS
NS
NS NS
NS NS
Use Group: INDOOR NON-FOOD
W 660000 * NS NS NS NS NS
Use Group: INDOOR MEDICAL
W 530000 * NS NS NS NS NS
NS NS
Use Group: INDOOR MEDICAL
W 530000 * NS NS NS NS NS
NS NS
NS NS
NS NS
NS NS
NS
NS
NS
NS
NS
NS
NS
A08, AIO(IO)
A08, AIO(IO)
A08, AIO(IO) , A38
A08, AIO(IO)
A08, AIO(IO)
A08, AIO(IO),
A35(68)
A08, AIO(IO)
A08, AIO(IO),
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, A37
A30, A37
A3 7
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
BATHROOM PREMISES/HARD SURFACES (con't)
Use Group: INDOOR RESIDENTIAL (con't)
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
370000
370000
442500
499500
511480
527880
530000
530000
530880
534600
534600
534600
537200
560000
570000
625600
627400
640000
666000
666000
680000
685000
691000
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
370000
370000
442500
499500
511480
527880
530000
530000
530880
534600
534600
534600
537200
560000
570000
625600
627400
640000
666000
666000
680000
685000
691000
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
A08
A08, A25(10)
A08, A25(10)
A08, AIO(IO)
A08, A25(10)
A08, AIO(IO),
A35(68)
A08, C17
A08, AIO(IO)
A08
A08, AIO(IO)
A08, A25(10)
A25(10) , A30
A08, AIO(IO)
A08
A08, AIO(IO)
A08, AIO(IO)
A08, AIO(IO)
A08, A25(10)
A08, AIO(IO)
A08
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page 9
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
BATHROOM PREMISES/HARD SURFACES (con't)
Use Group: INDOOR RESIDENTIAL (con't)
Spray., Not on label., Aerosol can., Hard.,
Organic soil (5%).
Spray., Not on label., Aerosol can., Hard., PRL W 785000
Organic soil.
Spray., Not on label., Not on label., Hard., RTU W 660000
Not applicable for this use.
Spray., Not on label., Sprayer., Hard., Not RTU W 668250
applicable for this use.
RTU W 680000
RTU W 693000
BIOLOGICAL SPECIMENS (ORGANS/TISSUES/MILK SAMPLES)
Spray., Not on label., Aerosol can., Not PRL W 527880
Applicable., Not applicable for this use.
Spray., Not on label., Not on label., Not RTU W 660000
Applicable., Not applicable for this use.
Premise treatment., Not on label., Not on RTU W 660000
label., Hard., Not applicable for this use.
PRL
PRL
PRL
PRL
PRL
RTU
RTU
RTU
W
W
W
W
W
W
W
W
696230
790000
790000
790000
790000
820000
820000
820000
W
W
W
W
W
W
W
W
696230
790000
790000
790000
790000
820000
820000
820000
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
W 785000 * NS
W 668250 * NS NS
NS
W 680000 * NS NS NS
W 693000 * NS NS NS
Use Group: INDOOR MEDICAL
W 527880 * NS NS NS
W 530000 * NS NS
W 660000
NS NS
NS
NS
Use Group: INDOOR RESIDENTIAL
W 660000 * NS NS NS
NS NS
NS NS
NS NS
NS
NS
A08, AIO(IO)
A08
A08, AIO(O.S), A38
A08, AIO(IO)
A08, AIO(IO) , A38
A08, AIO(O.S)
A08, AIO(IO)
A08, AIO(IO)
A08, AIO(IO)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO)
A08, A25(10)
A08
A08, A25(10)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO),
A35(68)
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page 10
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
CARPETS (COMMERCIAL SANITIZER)
Spray., Not on label., Not on label.,
Porous., Not applicable for this use.
CARPETS (HOSPITAL SANITIZER)
Spray., Not on label., Not on label.,
Porous., Not applicable for this use.
CARPETS (HOUSEHOLD SANITIZER)
Spray., Not on label., Not on label.,
Porous., Not applicable for this use.
CATS (ADULTS/KITTENS)
Premise treatment., Not on label., Not on
label., Hard., Not applicable for this use.
CATS (LABORATORY/RESEARCH)
Premise treatment., Not on label., Not on
label., Hard., Not applicable for this use.
RTU
COMMERCIAL TRANSPORTATION FACILITIES-NONFEED/NONFOOD
Spray., Not on label., Aerosol can., Hard., PRL W
Not applicable for this use.
Spray., Not on label., Aerosol can., Not
Applicable., Not applicable for this use.
Spray., Not on label., Aerosol can., Not
Applicable., Organic soil (5%).
Spray., Not on label., Aerosol can.,
Porous., Not applicable for this use.
PRL
PRL
PRL
RTU
RTU
PRL
790000
790000
820000
820000
Transportation vehicle treatment., Not on PRL
label., Aerosol can., Hard., Not applicable
for this use.
Use Group: INDOOR NON-FOOD
W 660000 * NS NS NS
Use Group: INDOOR MEDICAL
W 660000 * NS NS NS
Use Group: INDOOR RESIDENTIAL
W 660000 * NS NS NS
Use Group: INDOOR RESIDENTIAL
W 660000 * NS NS NS
Use Group: INDOOR NON-FOOD
W 660000 * NS NS NS
Use Group: INDOOR NON-FOOD
W 790000 * NS NS NS
W 691000
NS
NS
W 790000 * NS NS
W 790000 * NS NS
W 820000 * NS NS
W 820000 * NS NS
NS
NS
NS
NS
NS
W 790000
NS NS
W 530000 * NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS
NS
NS
NS
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO)
A08
A08, AIO(IO)
A08, AIO(IO) , A38
A08, AIO(IO)
A08, AIO(IO)
A08, AIO(IO)
A08, AIO(IO),
A35(68)
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page 11
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
COMMERCIAL TRANSPORTATION FACILITIES-NONFEED/NONFOOD (con't)
Transportation vehicle treatment., Not on RTU W 660000
label., Not on label., Hard., Not applicable
for this use.
COMMERCIAL/INSTITUTIONAL/INDUSTRIAL FLOORS
Spray., Not on label., Aerosol can., Hard., PRL W 242380
Not applicable for this use.
COMMERCIAL/INSTITUTIONAL/INDUSTRIAL PREMISES/EQUIP. (INDOOR)
Spray., Not on label., Aerosol can., Hard., PRL
Not applicable for this use.
Use Group: INDOOR NON-FOOD (con't)
W 660000 * NS NS NS NS NS
Use Group: INDOOR NON-FOOD
W 242380 * NS NS NS NS NS
PRL
PRL
'EQUII
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
W
W
D
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
242380
242380
(INDOOR)
242380
242380
242380
499500
511480
527880
530000
530000
530880
534600
534600
537200
560000
625600
627400
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
242380 *
242380 *
Use Group
242380 *
242380 *
242380 *
499500 *
511480 *
527880 *
530000 *
530000 *
530880 *
534600 *
534600 *
537200 *
560000 *
625600 *
627400 *
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: INDOOR NON- FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
A08, AIO(IO) ,
A35(68)
A08, A37
A30, A37
A3 7
A08, A37
A30, A37
A3 7
A08, A25(10)
A08, AIO(IO)
A08, A25(10)
A08, AIO(IO) ,
A35(68)
A08, C17
A08, AIO(IO)
A08, AIO(IO)
A08, A25(10)
A25(10) , A30
A08, AIO(IO)
A08, AIO(IO)
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page 12
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
COMMERCIAL/INSTITUTIONAL/INDUSTRIAL PREMISES/EQUIP
Spray., Not on label., Aerosol can., Hard.,
Organic soil (5%) .
Spray., Not on label., Aerosol can.,
Porous., Not applicable for this use.
Spray., Not on label., Aerosol can.,
Porous., Organic soil (5%) .
Spray., Not on label., Not on label., Hard., RTU
Not applicable for this use.
Spray., Not on label., Sprayer., Hard., Not RTU
applicable for this use.
Spray., Not on label., Sprayer., Porous.,
Not applicable for this use.
Transportation vehicle treatment., Not on
label., Aerosol can., Hard., Not applicable
for this use.
'EQUIP. (INDOOR) (con't)
PRL
PRL
PRL
PRL
PRL
RTU
PRL
RTU
PRL
PRL
PRL
PRL
RTU
PRL
RTU
RTU
RTU
RTU
RTU
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
640000
680000
691000
696230
790000
820000
530960
820000
499500
534600
691000
790000
820000
530000
820000
660000
668250
680000
668250
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
Use Group: INDOOR NON- FOOD (con'
640000
680000
691000
696230
790000
820000
530960
820000
499500
534600
691000
790000
820000
530000
820000
660000
668250
680000
668250
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
t)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
A08, AIO(IO)
A08, A25(10)
A08
A08, AIO(IO)
A08, AIO(IO) , A38
A08, AIO(IO)
A08, AIO(IO), A30
A08, AIO(IO)
A08
A08
A08
A08, A38
A08
A08, A10(5) ,
A08, AIO(IO)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO)
A08, A25(10)
A08
A08, AIO(IO)
ASS(72)
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page 13
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
CUSPIDORS/SPITTOONS
Spray., Not on label., Aerosol can., Hard.
Not applicable for this use.
Spray., Not on label., Aerosol can., Not
Applicable., Not applicable for this use.
Spray., Not on label., Aerosol can., Not
Applicable., Organic soil (5%).
Spray., Not on label., Not on label., Hard.
Not applicable for this use.
DIAPER PAILS (EMPTY)
Spray., Not on label., Aerosol can., Hard.,
Not applicable for this use.
PRL W 530000
PRL W 790000
RTU W 820000
RTU W 820000
RTU W 660000
PRL W 370000
Use Group: INDOOR MEDICAL
W 530000 * NS NS NS
W 790000 * NS NS
W 820000 * NS NS
W 820000 * NS NS
W 660000 * NS NS
NS
NS
NS
NS
Use Group: INDOOR RESIDENTIAL
W 370000 * NS NS NS
NS NS
NS NS
NS NS
NS NS
NS
NS
Spray., Not on label., Aerosol can., Hard.,
Organic soil (5%) .
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
RTU
RTU
W
W
W
W
W
W
W
W
W
W
W
W
W
370000
442500
530000
534600
534600
534600
560000
627400
691000
790000
790000
820000
820000
W
W
W
W
W
W
W
W
W
W
W
W
W
370000
442500
530000
534600
534600
534600
560000
627400
691000
790000
790000
820000
820000
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
A08, AIO(IO),
A35(68)
A08, AIO(IO) , A38
A08, AIO(IO)
A08, AIO(IO)
A08, AIO(IO) ,
A35(68)
A08
A08, A25(10)
A08, AIO(IO) ,
A35(68)
A08
A08, AIO(IO)
A08, A25(10)
A08, AIO(IO)
A08, AIO(IO)
A08
A08, AIO(IO)
A08, AIO(IO) , A38
A08, AIO(IO)
A08, AIO(IO)
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page 14
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
DIAPER PAILS (EMPTY) (con't)
Spray., Not on label., Not on label., Hard.,
Not applicable for this use.
DIAPERS (COMMERCIAL LAUNDRY)
Spray., Not on label., Not on label.,
Porous., Not applicable for this use.
DIAPERS (HOUSEHOLD/COIN-OPERATED LAUNDRY)
Spray., Not on label., Not on label.,
Porous., Not applicable for this use.
DOGS (SHOW/MILITARY/SPECIAL)
Premise treatment., Not on label., Not on
label., Hard., Not applicable for this use.
DOGS/CANINES (ADULTS/PUPPIES)
Premise treatment., Not on label., Not on
label., Hard., Not applicable for this use.
RTU
W 660000
DOMESTIC/COMMERCIAL NONPOTABLE WATER (WATERBED WATER)
Water related surface treatment., Not on PRL W 790000
label., Aerosol can., Hard., Not applicable
for this use.
Use Group: INDOOR RESIDENTIAL (con't)
W 660000 * NS NS NS NS NS
Use Group: INDOOR NON-FOOD
W 660000 * NS NS NS NS NS
Use Group: INDOOR RESIDENTIAL
W 660000 * NS NS NS NS NS
Use Group: INDOOR NON-FOOD
W 660000 * NS NS NS NS NS
Use Group: INDOOR RESIDENTIAL
W 660000 * NS NS NS
NS
NS
Use Group: AQUATIC NON-FOOD RESIDENTIAL
W 790000 * NS NS NS NS NS
A08, AIO(IO),
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO), A38
Water related surface treatment., Not on
label., Aerosol can., Hard., Organic soil
(5%) .
RTU
RTU
W 820000
W 820000
W 820000 * NS NS NS NS NS NS
W 820000 * NS NS NS NS NS NS
A08, AIO(IO)
A08, AIO(IO)
DONKEYS
Premise treatment., Not on label., Not on
label., Hard., Not applicable for this use.
RTU
W 660000
DUST MOPS/CLOTHS/TOOL COVERS/DUSTERS (LAUNDRY/DRYCLEAN)
Spray., Not on label., Not on label., RTU W 660000
Porous., Not applicable for this use.
Use Group: INDOOR NON-FOOD
W 660000 * NS NS NS
Use Group: INDOOR NON-FOOD
W 660000 * NS NS NS
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page 15
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
EATING ESTABLISHMENTS FOOD HANDLING AREAS (NONFOOD CONTACT)
Spray., Not on label., Aerosol can., Hard., PRL W 499500
Not applicable for this use.
Use Group: INDOOR NON-FOOD
W 499500 * NS NS NS
Spray., Not on label., Aerosol can., Hard., RTU W 820000
Organic soil (5%).
Spray., Not on label., Not on label., Hard., RTU W 660000
Not applicable for this use.
EATING ESTABLISHMENTS FOOD SERVING AREAS (NONFOOD CONTACT)
Spray., Not on label., Aerosol can., Hard., PRL W 499500
Not applicable for this use.
PRL W 527880
PRL W 530000
PRL W 537200
PRL W 790000
RTU W 820000
Spray., Not on label., Aerosol can., Hard., RTU W 820000
Organic soil (5%).
Spray., Not on label., Not on label., Hard., RTU W 660000
Not applicable for this use.
FELT/FURS/FEATHERS/FELT PRODUCTS
Spray., Not on label., Not on label., RTU W 660000
Porous., Not applicable for this use.
W
W
W
W
W
W
W
W
W
W
W
W
537200 *
790000 *
820000 *
820000 *
660000 *
Use Group
499500 *
527880 *
530000 *
537200 *
790000 *
820000 *
820000 *
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: INDOOR NON- FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
W 660000 * NS
NS
NS
Use Group: INDOOR NON-FOOD
W 660000 * NS NS NS
A08, A25(10)
A08, A25(10)
A08, AIO(IO) ,
A35(68)
A25(10) , A30
A08, AIO(IO), A38
A08, AIO(IO)
A08, AIO(IO)
A08, AIO(IO),
A35(68)
A08, A25(10)
A08, A25(10)
A08, AIO(IO) ,
A35(68)
A25(10) , A30
A08, AIO(IO), A38
A08, AIO(IO)
A08, AIO(IO)
A08, AIO(IO),
A35(68)
A08, AIO(IO),
A35(68)
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page 16
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
FILTERS (AIR/AIR CONDITIONER/FURNACE)/AIR DUCTS
Spray., Not on label., Aerosol can., Hard., PRL
Not applicable for this use.
FISH
Premise treatment., Not on label., Not on RTU
label., Hard., Not applicable for this use.
Premise treatment., Not on label., Not on
label., Hard., Not applicable for this use.
GOATS (WOOL/ANGORA ANIMAL)
Premise treatment., Not on label., Not on
label., Hard., Not applicable for this use.
HORSES (SHOW/RACE/SPECIAL/PONIES)
Premise treatment., Not on label., Not on
label., Hard., Not applicable for this use.
RTU
W 660000
HOSPITAL CRITICAL ITEMS (SURGICAL INSTRUMENTS/PACEMAKERS)
W 723800
Immersion., Not on label., Not on label., RTU
Hard., Not applicable for this use.
Spray., Not on label., Not on label., Hard., RTU
Not applicable for this use.
Surface treatment., Not on label., Package RTU
applicator., Hard., Not applicable for this
use.
W 660000
Use Group: INDOOR RESIDENTIAL
W 530000 * NS NS NS
Use Group: INDOOR RESIDENTIAL
W 660000 * NS NS NS
Use Group: INDOOR NON-FOOD
W 660000 * NS NS NS
Use Group: INDOOR NON-FOOD
W 660000 * NS NS NS
Use Group: INDOOR NON-FOOD
W 660000 * NS NS NS
Use Group: INDOOR MEDICAL
W 723800 * NS NS NS
W 660000
NS NS
NS
W 660000 * NS NS
A08, C17
A08, AIO(IO),
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, A25(10) ,
A35(68)
HOSPITAL NONCRITICAL ITEMS (BEDPANS/FURNITURE)
Spray., Not on label., Aerosol can., Hard., PRL
Not applicable for this use.
Use Group: INDOOR MEDICAL
W 242380 * NS NS NS
PRL
PRL
PRL
PRL
W 242380
W 242380
W 370000
W 442500
W 242380
W 242380
W 370000
W 442500
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
A08, A37
A30, A37
A3 7
A08
A08, A25(10)
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page 17
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
HOSPITAL NONCRITICAL ITEMS (BEDPANS/FURNITURE) (con't)
Use Group: INDOOR MEDICAL (con't)
Spray., Not on label., Aerosol can., Hard.,
Organic soil (5%) .
Spray., Not on label., Aerosol can., Hard.,
Organic soil.
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
RTU
PRL
RTU
PRL
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
499500
511480
527880
530000
530000
530880
534600
534600
537200
570000
625600
627400
640000
666000
680000
685000
696230
790000
820000
530960
820000
785000
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
499500
511480
527880
530000
530000
530880
534600
534600
537200
570000
625600
627400
640000
666000
680000
685000
696230
790000
820000
530960
820000
785000
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
A08, A25(10)
A08, AIO(IO)
A08, A25(10)
A08, AIO(IO) ,
A35(68)
A08, C17
A08, AIO(IO)
A08
A08, AIO(IO)
A25(10) , A30
A08
A08, AIO(IO)
A08, AIO(IO)
A08, A25(10)
A08, AIO(IO)
A08, AIO(IO)
A08, AIO(IO) , A38
A08, AIO(IO)
A08, AIO(IO), A30
A08, AIO(IO)
A08, AIO(IO)
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page 18
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
HOSPITAL NONCRITICAL ITEMS (BEDPANS/FURNITURE) (con't)
Spray., Not on label., Aerosol can., PRL W 499500
Porous., Not applicable for this use.
Use Group: INDOOR MEDICAL (con't)
W 499500 * NS NS NS NS NS
Spray., Not on label., Aerosol can.,
Porous., Organic soil (5%).
Spray., Not on label., Not on label., Hard., RTU
Not applicable for this use.
Spray., Not on label., Sprayer., Hard., Not RTU
applicable for this use.
Spray., Not on label., Sprayer., Porous.,
Not applicable for this use.
HOSPITAL/MEDICAL INSTITUTIONS NON-CONDUCTIVE FLOORS
Spray., Not on label., Aerosol can., Hard., PRL W
Not applicable for this use.
PRL
PRL
RTU
PRL
RTU
RTU
RTU
RTU
RTU
W
W
W
W
W
W
W
W
W
534600
790000
820000
530960
820000
660000
668250
680000
668250
W
W
W
W
W
W
W
W
W
534600
790000
820000
530960
820000
660000
668250
680000
668250
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Spray., Not on label., Aerosol can., Hard., PRL
Organic soil.
HOSPITALS/MEDICAL INSTITUTIONS CRITICAL PREMISES (BURN WARDS
Mop., Not on label., Mop., Hard., Not RTU W 648000
applicable for this use.
Use Group: INDOOR MEDICAL
W 242380 * NS NS NS
PRL
PRL
PRL
PRL
PRL
W 242380
W 242380
W 370000
W 442500
W 785000
W 242380
W 242380
W 370000
W 442500
W 785000
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Use Group: INDOOR MEDICAL
W 648000 * NS NS NS
A08
A08
A08, A38
A08
A08, AIO(IO) , A30
A08, AIO(IO)
A08, AIO(IO),
A35(68)
A08, AIO(IO)
A08, A25(10)
A08
A08, A37
A30, A37
A3 7
A08
A08, A25(10)
A08, AIO(IO)
A08, A10(5)
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page 19
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
HOSPITALS/MEDICAL INSTITUTIONS CRITICAL PREMISES (BURN WARDS
W 648000
Sponge-on., Not on label., Sponge., Hard., RTU
Not applicable for this use.
Spray., Not on label., Aerosol can., Hard., PRL
Not applicable for this use.
(con't) Use Group: INDOOR MEDICAL (con't)
W 648000 * NS NS NS
W 530000
Spray., Not on label., Aerosol can., Hard., RTU
Organic soil (5%) .
Spray., Not on label., Not on label., Hard., RTU W 660000
Not applicable for this use.
Spray., Not on label., Pump spray bottle., RTU W 648000
Hard., Not applicable for this use.
Wipe-on/wiper treatment., Not on label., RTU W 648000
Cloth., Hard., Not applicable for this use.
HOSPITALS/MEDICAL INSTITUTIONS NONCRITICAL PREMISES
Spray., Not on label., Aerosol can., Hard., PRL W 530000
Not applicable for this use.
PRL W 790000
RTU W 820000
Spray., Not on label., Aerosol can., Hard., RTU W 820000
Organic soil (5%).
Spray., Not on label., Not on label., Hard., RTU W 660000
Not applicable for this use.
W 530000 * NS
NS
W 648000 * NS NS
NS
PRL
PRL
PRL
PRL
PRL
RTU
RTU
W
W
W
W
W
W
W
530880
666000
666000
685000
790000
820000
820000
W
W
W
W
W
W
W
530880
666000
666000
685000
790000
820000
820000
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Use Group: INDOOR MEDICAL
W 530000 * NS NS NS
W 790000 * NS NS NS
W 820000 * NS NS NS
W 820000 * NS NS NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
W 660000
NS NS
NS
A08, A10(5)
A08, AIO(IO),
A35(68)
A08, AIO(IO)
A08, AIO(IO)
A08, AIO(IO)
A08, AIO(IO) , A38
A08, AIO(IO)
A08, AIO(IO)
A08, AIO(IO),
A35(68)
A08, A10(5)
A08, A10(5)
A08, AIO(IO),
A35(68)
A08, AIO(IO), A38
A08, AIO(IO)
A08, AIO(IO)
A08, AIO(IO),
A35(68)
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page 20
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
HOSPITALS/MEDICAL INSTITUTIONS PATIENT PREMISES
Mop., Not on label., Mop., Hard., Not RTU W 648000
applicable for this use.
Sponge-on., Not on label., Sponge., Hard., RTU W 648000
Not applicable for this use.
Spray., Not on label., Aerosol can., Hard., PRL W 511480
Not applicable for this use.
PRL W 530000
Use Group: INDOOR MEDICAL
Spray., Not on label., Aerosol can., Hard.,
Organic soil (5%) .
Spray., Not on label., Not on label., Hard., RTU
Not applicable for this use.
Spray., Not on label., Pump spray bottle.,
Hard., Not applicable for this use.
Spray., Not on label., Sprayer., Hard., Not RTU
applicable for this use.
Wipe-on/wiper treatment., Not on label.,
Cloth., Hard., Not applicable for this use.
HOSPITALS/MEDICAL INSTITUTIONS PREMISES (HUMAN/VETERINARY)
Mop., Not on label., Mop., Hard., Not RTU W 648000
applicable for this use.
PRL
PRL
PRL
PRL
PRL
PRL
PRL
RTU
RTU
RTU
RTU
RTU
RTU
W
W
W
W
W
W
W
W
W
W
W
W
W
530880
534600
666000
666000
680000
696230
790000
820000
820000
660000
648000
680000
648000
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
648000
648000
511480
530000
530880
534600
666000
666000
680000
696230
790000
820000
820000
660000
648000
680000
648000
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Use Group: INDOOR MEDICAL
W 648000 * NS NS NS
A08, A10(5)
A08, A10(5)
A08, AIO(IO)
A08, AIO(IO),
A35(68)
A08, AIO(IO)
A08, A25(10)
A08, AIO(IO)
A08
A08, AIO(IO)
A08, AIO(IO) , A38
A08, AIO(IO)
A08, AIO(IO)
A08, AIO(IO),
A35(68)
A08, A10(5)
A08, A25(10)
A08, A10(5)
A08, A10(5)
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page 21
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
HOSPITALS/MEDICAL INSTITUTIONS PREMISES (HUMAN/VETERINARY) (con't)
Sponge-on., Not on label., Sponge., Hard., RTU W 648000
Not applicable for this use.
Spray., Not on label., Aerosol can., Hard., PRL W 242380
Not applicable for this use.
Use Group: INDOOR MEDICAL (con't)
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
242380
242380
370000
442500
499500
511480
527880
530000
530000
534600
534600
534600
537200
560000
570000
625600
627400
640000
666000
666000
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
242380
242380
370000
442500
499500
511480
527880
530000
530000
534600
534600
534600
537200
560000
570000
625600
627400
640000
666000
666000
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
A08, A10(5)
A08, A37
A30, A37
A3 7
A08
A08, A25(10)
A08, A25(10)
A08, AIO(IO)
A08, A25(10)
A08, AIO(IO),
A35(68)
A08, C17
A08
A08, AIO(IO)
A08, A25(10)
A25(10) , A30
A08, AIO(IO)
A08
A08, AIO(IO)
A08, AIO(IO)
A08, AIO(IO)
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page 22
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
HOSPITALS/MEDICAL INSTITUTIONS PREMISES (HUMAN/VETERINARY) (con't)
Use Group: INDOOR MEDICAL (con't)
Spray., Not on label., Aerosol can., Hard.,
Organic soil (5%) .
Spray., Not on label., Aerosol can., Hard.,
Organic soil.
Spray., Not on label., Not on label., Hard., RTU W 660000
Not applicable for this use.
Spray., Not on label., Pump spray bottle., RTU W 648000
Hard., Not applicable for this use.
Spray., Not on label., Sprayer., Hard., Not RTU W 668250
applicable for this use.
Transportation vehicle treatment., Not on
label., Aerosol can., Hard., Not applicable
for this use.
PRL
PRL
PRL
PRL
RTU
PRL
RTU
PRL
W
W
W
W
W
W
W
W
680000
685000
696230
790000
820000
530960
820000
785000
W
W
W
W
W
W
W
W
680000
685000
696230
790000
820000
530960
820000
785000
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
W 648000 * NS NS
NS NS NS
NS NS NS
Transportation vehicle treatment., Not on
label., Aerosol can., Hard., Organic soil
(5%) .
RTU
PRL
PRL
PRL
PRL
PRL
RTU
RTU
W
W
W
W
W
W
W
W
680000
530000
534600
537200
696230
790000
820000
820000
W
W
W
W
W
W
W
W
680000
530000
534600
537200
696230
790000
820000
820000
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
A08, A25(10)
A08, AIO(IO)
A08, AIO(IO)
A08, AIO(IO) , A38
A08, AIO(IO)
A08, AIO(IO), A30
A08, AIO(IO)
A08, AIO(IO)
A08, AIO(IO),
A35(68)
A08, A10(5)
A08, AIO(IO)
A08, A25(10)
A08, AIO(IO),
A35(68)
A08, AIO(IO)
A25(10) , A30
A08, AIO(IO)
A08, AIO(IO) , A38
A08, AIO(IO)
A08, AIO(IO)
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page 23
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
HOSPITALS/MEDICAL INSTITUTIONS PREMISES (HUMAN/VETERINARY) (con't)
Transportation vehicle treatment., Not on RTU W 660000
label., Not on label., Hard., Not applicable
for this use.
Transportation vehicle treatment., Not on
label., Sprayer., Hard., Not applicable for
this use.
RTU
Use Group: INDOOR MEDICAL (con't)
W 660000 * NS NS NS NS NS
A08, AIO(IO),
A35(68)
A08, AIO(IO)
Wipe-on/wiper treatment., Not on label.,
Cloth., Hard., Not applicable for this use.
RTU
RTU
HOUSEHOLD SICKROOMS PREMISES/CONTENTS/UTENSILS
Spray., Not on label., Aerosol can., Hard., PRL
Not applicable for this use.
Spray., Not on label., Aerosol can., Hard.,
Organic soil (5%) .
Spray., Not on label., Not on label., Hard., RTU
Not applicable for this use.
Spray., Not on label., Sprayer., Hard., Not
applicable for this use.
HOUSEHOLD TRASH COMPACTOR/FOOD DISPOSALSS
Spray., Not on label., Aerosol can., Hard.,
Not applicable for this use.
Spray., Not on label., Not on label., Hard.,
Not applicable for this use.
W 680000
W 648000
W 680000
W 648000
NS
NS
NS
NS
NS
NS
Use Group: INDOOR MEDICAL
W 530000 * NS NS NS
W 693000
NS NS
NS
Use Group: INDOOR RESIDENTIAL
W 530000 * NS NS NS
W 660000
NS NS
NS
NS NS
NS NS
NS
NS
PRL
PRL
PRL
RTU
PRL
RTU
RTU
W
W
W
W
W
W
W
534600
790000
790000
820000
530960
820000
660000
W
W
W
W
W
W
W
534600
790000
790000
820000
530960
820000
660000
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
A08, A25(10)
A08, A10(5)
A08, AIO(IO) ,
A35(68)
A08
A08, AIO(IO)
A08, AIO(IO) , A38
A08, AIO(IO)
A08, AIO(IO), A30
A08, AIO(IO)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page 24
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
HOUSEHOLD/DOMESTIC DWELLINGS CONTENTS
Spray., Not on label., Aerosol can., Hard., PRL W 442500
Not applicable for this use.
Use Group: INDOOR RESIDENTIAL
W 442500 * NS NS NS
Spray., Not on label., Aerosol can., Hard.,
Organic soil (5%) .
Spray., Not on label., Aerosol can.,
Porous., Not applicable for this use.
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
RTU
PRL
RTU
PRL
PRL
PRL
PRL
PRL
PRL
RTU
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
499500
527880
530000
530880
534600
534600
685000
691000
790000
790000
820000
530960
820000
499500
530000
534600
691000
790000
790000
820000
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
499500
527880
530000
530880
534600
534600
685000
691000
790000
790000
820000
530960
820000
499500
530000
534600
691000
790000
790000
820000
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
A08, A25(10)
A08, A25(10)
A08, A25(10)
A08, AIO(IO),
A35(68)
A08, AIO(IO)
A08
A08, AIO(IO)
A08, AIO(IO)
A08
A08, AIO(IO)
A08, AIO(IO) , A38
A08, AIO(IO)
A08, AIO(IO), A30
A08, AIO(IO)
A08
A08, AIO(IO),
A35(68)
A08
A08
A08
A08, A38
A08
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page 25
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
HOUSEHOLD/DOMESTIC DWELLINGS CONTENTS (con't)
Spray., Not on label., Aerosol can.,
Porous., Organic soil (5%).
Spray., Not on label., Not on label., Hard.,
Not applicable for this use.
Spray., Not on label., Not on label.,
Porous., Not applicable for this use.
Spray., Not on label., Sprayer., Hard., Not
applicable for this use.
Spray., Not on label., Sprayer., Porous.,
Not applicable for this use.
HOUSEHOLD/DOMESTIC DWELLINGS INDOOR PREMISES
Spray., Not on label., Aerosol can., Hard.,
Not applicable for this use.
PRL
RTU
RTU
RTU
W 530960
W 820000
W 660000
W 660000
Use Group: INDOOR RESIDENTIAL (con't)
W 530960 * NS NS NS NS NS
W 820000 * NS
W 660000 * NS
W 660000 * NS
W 693000 * NS
NS
NS
NS
NS
W 693000
NS
NS
NS
Use Group: INDOOR RESIDENTIAL
W 370000 * NS NS NS
NS
NS
NS
NS
NS
NS
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
W
W
W
W
W
W
W
W
W
W
W
W
442500
499500
527880
530000
530880
534600
534600
560000
685000
691000
790000
790000
W
W
W
W
W
W
W
W
W
W
W
W
442500
499500
527880
530000
530880
534600
534600
560000
685000
691000
790000
790000
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
A08, AIO(IO) , A30
A08, AIO(IO)
A08, AIO(IO),
A35(68)
A08, AIO(IO) ,
A35(68)
A08, A25(10)
A08, A25(10)
A08, A25(10)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO)
A08
A08, AIO(IO)
A08, AIO(IO)
A08, AIO(IO)
A08
A08, AIO(IO)
A08, AIO(IO) , A38
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page 26
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
HOUSEHOLD/DOMESTIC DWELLINGS INDOOR PREMISES (con
RTU
Spray., Not on label., Aerosol can., Hard., PRL
Organic soil (5%) .
Spray., Not on label., Not on label., Hard., RTU
Not applicable for this use.
Spray., Not on label., Sprayer., Hard., Not RTU
applicable for this use.
HUMAN CAMPING EQUIPMENT
Spray., Not on label., Not on label., Hard., RTU
Not applicable for this use.
HUMAN CLOTHING (INSECT AND MOLD/MILDEW CONTROL)
Spray., Not on label., Not on label., RTU
Porous., Not applicable for this use.
HUMAN DENTURES/TOOTHBRUSHES/MOUTHPIECES
Spray., Not on label., Not on label., Hard., RTU
Not applicable for this use.
HUMAN FACE GEAR
Spray., Not on label., Aerosol can., Hard., PRL
Not applicable for this use.
Spray., Not on label., Not on label., Hard., RTU
Not applicable for this use.
HUMAN FOOTWEAR
Spray., Not on label., Aerosol can., Hard., PRL
Not applicable for this use.
Spray., Not on label., Aerosol can., PRL
Porous., Not applicable for this use.
PRL
PRL
t)
w
w
w
w
Use Group: INDOOR RESIDENTIAL (con't)
820000
530960
820000
660000
W
W
W
W
820000
530960
820000
660000
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
W 499500
W 534600
W 534600
W 693000
NS NS
NS
Use Group: INDOOR RESIDENTIAL
W 660000 * NS NS NS
Use Group: INDOOR RESIDENTIAL
W 660000 * NS NS NS
Use Group: INDOOR RESIDENTIAL
W 660000 * NS NS NS
Use Group: INDOOR RESIDENTIAL
W 530000 * NS NS NS
W 660000 * NS NS
NS
Use Group: INDOOR RESIDENTIAL
W 242380 * NS NS NS
W 499500 * NS NS
W 534600
W 534600
NS NS
NS NS
NS
NS
NS
NS NS
NS
NS NS NS
NS NS NS
A08, AIO(IO)
A08, AIO(IO), A30
A08, AIO(IO)
A08, AIO(IO),
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08
A08
A08, A25(10)
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page 27
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
HUMAN FOOTWEAR (con't)
Spray., Not on label., Aerosol can.,
Porous., Organic soil (5%).
Spray., Not on label., Sprayer., Porous.,
Not applicable for this use.
HUMAN GROOMING INSTRUMENTS (BRUSHES,COMBS)
Spray., Not on label., Aerosol can., Hard.,
Not applicable for this use.
Spray., Not on label., Not on label., Hard.
Not applicable for this use.
HUMAN HEADGEAR
Spray., Not on label., Aerosol can., Hard.,
Not applicable for this use.
Spray., Not on label., Not on label., Hard.
Not applicable for this use.
INCINERATORS
Spray., Not on label., Not on label., Hard.
Not applicable for this use.
LAUNDRY (COMMERCIAL)
Spray., Not on label., Not on label.,
Porous., Not applicable for this use.
LAUNDRY (DRYCLEANING)
Spray., Not on label., Not on label.,
Porous., Not applicable for this use.
LAUNDRY (HOUSEHOLD/COIN-OPERATED)
Spray., Not on label., Not on label.,
Porous., Not applicable for this use.
PRL
PRL
RTU
W 625600
W 530000
W 693000
Use Group: INDOOR RESIDENTIAL (con't)
W 625600 * NS NS NS NS NS NS
W 530000 * NS NS NS NS NS NS
NS NS
ASS(72)
W 693000
NS
NS
NS
Use Group: INDOOR RESIDENTIAL
W 530000 * NS NS NS
W 660000 * NS NS
NS
Use Group: INDOOR RESIDENTIAL
W 530000 * NS NS NS
W 660000 * NS NS
NS
Use Group: INDOOR RESIDENTIAL
W 660000 * NS NS NS
Use Group: INDOOR NON-FOOD
W 660000 * NS NS NS
Use Group: INDOOR NON-FOOD
W 660000 * NS NS NS
Use Group: INDOOR RESIDENTIAL
W 660000 * NS NS NS
NS
NS
A08, A10(5) ,
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
LAUNDRY EQUIPMENT
Use Group: INDOOR NON-FOOD
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page 28
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
LAUNDRY EQUIPMENT (con't)
Spray., Not on label., Aerosol can., Hard., PRL W 442500
Not applicable for this use.
Use Group: INDOOR NON-FOOD (con't)
W 442500 * NS NS NS NS NS
Spray., Not on label., Aerosol can., Hard.,
Organic soil (5%).
Spray., Not on label., Aerosol can., Hard.,
Organic soil.
Spray., Not on label., Not on label., Hard.,
Not applicable for this use.
Spray., Not on label., Sprayer., Hard., Not
applicable for this use.
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
511480
527880
530000
530000
530880
534600
534600
537200
570000
666000
680000
691000
696230
790000
530960
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
511480
527880
530000
530000
530880
534600
534600
537200
570000
666000
680000
691000
696230
790000
530960
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
W 785000 * NS
W 660000 * NS NS
W 668250 * NS NS
A08, A25(10)
A08, AIO(IO)
A08, A25(10)
A08, AIO(IO),
A35(68)
A08, C17
A08, AIO(IO)
A08
A08, AIO(IO)
A25(10) , A30
A08
A08, A25(10)
A08
A08, AIO(IO)
A08, AIO(IO)
A08, AIO(IO) , A30
A08, AIO(IO)
A08, AIO(IO),
A35(68)
A08, AIO(IO)
A08, A25(10)
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page 29
SITE Application Type, Application Form(s)
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
LEATHER/LEATHER PRODUCTS
Spray., Not on label., Not on label.,
Porous., Not applicable for this use.
Premise treatment., Not on label., Not on
label., Hard., Not applicable for this use.
Premise treatment., Not on label., Not on RTU W f
label., Hard., Not applicable for this use.
MORGUES/MORTUARIES/AUTOPSY/EMBALMING EQUIPMENT
Spray., Not on label., Aerosol can., Hard., PRL W E
Not applicable for this use.
Spray., Not on label., Not on label., Hard., RTU W f
Not applicable for this use.
MORGUES/MORTUARIES/AUTOPSY/EMBALMING INSTRUMENTS
Spray., Not on label., Aerosol can., Hard., PRL W E
Not applicable for this use.
Spray., Not on label., Not on label., Hard., RTU W f
Not applicable for this use.
MORGUES/MORTUARIES/AUTOPSY/EMBALMING ROOM PREMISES
Spray., Not on label., Aerosol can., Hard., PRL W E
Not applicable for this use.
Spray., Not on label., Not on label., Hard., RTU W f
Not applicable for this use.
MULES (WORK)
Premise treatment., Not on label., Not on RTU W f
label., Hard., Not applicable for this use.
MUSEUM COLLECTIONS (PRESERVED ANIMAL/PLANT SPECIMENS)
Spray., Not on label., Not on label., Hard., RTU W f
Not applicable for this use.
Use Group: INDOOR NON-FOOD
W 660000 * NS NS NS
Use Group: INDOOR NON-FOOD
W 660000 * NS NS NS
Use Group: INDOOR RESIDENTIAL
W 660000 * NS NS NS
Use Group: INDOOR MEDICAL
W 530000 * NS NS NS
W 660000
NS NS
NS
Use Group: INDOOR MEDICAL
W 530000 * NS NS NS
W 660000
NS NS
NS
Use Group: INDOOR MEDICAL
W 530000 * NS NS NS
W 660000
NS NS
NS
Use Group: INDOOR NON-FOOD
W 660000 * NS NS NS
Use Group: INDOOR NON-FOOD
W 660000 * NS NS NS
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page 30
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
NUTRIA
Premise treatment., Not on label., Not on RTU
label., Hard., Not applicable for this use.
PET LIVING/SLEEPING QUARTERS
Spray., Not on label., Aerosol can., Hard., PRL
Not applicable for this use.
Spray., Not on label., Not on label., Hard.,
Not applicable for this use.
Spray., Not on label., Sprayer., Hard., Not
applicable for this use.
Surface treatment., Not on label., Aerosol
can., Hard., Not applicable for this use.
Surface treatment., Not on label., Aerosol
can., Hard., Organic soil (5%).
PORTABLE/CHEMICAL TOILETS/LATRINE BUCKETS
Spray., Not on label., Aerosol can., Hard.,
Not applicable for this use.
Spray., Not on label., Not on label., Hard.,
Not applicable for this use.
PRL
RTU
RTU
W 790000
W 820000
W 820000
Use Group: INDOOR NON-FOOD
W 660000 * NS NS NS
Use Group: INDOOR RESIDENTIAL
W 370000 * NS NS NS
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
RTU
W
W
W
W
W
W
W
W
W
442500
527880
530000
534600
560000
685000
691000
790000
660000
W
W
W
W
W
W
W
W
W
442500
527880
530000
534600
560000
685000
691000
790000
660000
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
W 790000 * NS NS
W 820000 * NS NS
W 820000 * NS NS
NS
NS
Use Group: INDOOR RESIDENTIAL
W 530000 * NS NS NS
NS NS
NS NS
NS NS
NS
NS
W 660000
NS NS
NS
A08, AIO(IO),
A35(68)
A08, A25(10)
A08, A25(10)
A08, AIO(IO),
A35(68)
A08, AIO(IO)
A08, AIO(IO)
A08, AIO(IO)
A08
A08, AIO(IO)
A08, AIO(IO),
A35(68)
A08, AIO(IO), A38
A08, AIO(IO)
A08, AIO(IO)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page 31
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
RABBITS
Premise treatment., Not on label., Not on RTU W 660000
label., Hard., Not applicable for this use.
Premise treatment., Not on label., Not on RTU
label., Hard., Not applicable for this use.
REFUSE/SOLID WASTE CONTAINERS (GARBAGE CANS)
Spray., Not on label., Aerosol can., Hard., PRL
Not applicable for this use.
Use Group: INDOOR NON-FOOD
W 660000 * NS NS NS
Use Group: INDOOR RESIDENTIAL
W 660000 * NS NS NS
Use Group: INDOOR RESIDENTIAL
W 242380 * NS NS NS
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
242380
242380
370000
442500
499500
511480
527880
530000
530000
530880
534600
534600
534600
560000
570000
625600
680000
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
242380
242380
370000
442500
499500
511480
527880
530000
530000
530880
534600
534600
534600
560000
570000
625600
680000
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, A37
A30, A37
A3 7
A08, A25(10)
A08, A25(10)
A08, AIO(IO)
A08, A25(10)
A08, AIO(IO) ,
A35(68)
A08, C17
A08, AIO(IO)
A08
A08, AIO(IO)
A08, A25(10)
A08, AIO(IO)
A08
A08, A25(10)
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page 32
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
REFUSE/SOLID WASTE CONTAINERS (GARBAGE CANS) (con't)
Use Group: INDOOR RESIDENTIAL (con't)
Spray., Not on label., Aerosol can., Hard.,
Organic soil (5%) .
Spray., Not on label., Aerosol can., Hard.,
Organic soil.
Spray., Not on label., Not on label., Hard., RTU
Not applicable for this use.
Spray., Not on label., Sprayer., Hard., Not RTU
applicable for this use.
RTU
RTU
REFUSE/SOLID WASTE SITES (OUTDOOR)
PRL
PRL
PRL
PRL
RTU
PRL
RTU
PRL
W
W
W
W
W
W
W
W
685000
691000
790000
790000
820000
530960
820000
785000
W
W
W
W
W
W
W
W
685000
691000
790000
790000
820000
530960
820000
785000
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
W 668250
W 680000
W 693000
Spray., Not on label., Not on label., Not RTU W 660000
Applicable., Not applicable for this use.
REFUSE/SOLID WASTE TRANSPORTATION FACILITIES/HANDLING EQUIP.
Spray., Not on label., Not on label., Hard., RTU W 660000
Not applicable for this use.
Spray., Not on label., Aerosol can., Hard., PRL W 530000
Not applicable for this use.
Spray., Not on label., Not on label., Hard., RTU W 660000
Not applicable for this use.
W 668250 * NS NS
NS
NS NS
W 680000 * NS NS NS NS NS
W 693000 * NS NS NS NS NS
Use Group: TERRESTRIAL NON-FOOD CROP
W 660000 * NS NS NS NS NS
Use Group: INDOOR NON-FOOD
W 660000 * NS NS NS NS NS
Use Group: INDOOR RESIDENTIAL
W 530000 * NS NS NS NS NS
NS
NS
W 660000 * NS NS
NS
NS NS
A08, AIO(IO)
A08
A08, AIO(IO)
A08, AIO(IO) , A38
A08, AIO(IO)
A08, AIO(IO), A30
A08, AIO(IO)
A08, AIO(IO)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO)
A08, A25(10)
A08
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page 33
SITE Application Type, Application Form(s)
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
REPTILES
Premise treatment., Not on label., Not on RTU
label., Hard., Not applicable for this use.
RODENTS (GUINEA PIGS/HAMSTERS/GERBILS/MICE/RATS)
Premise treatment., Not on label., Not on RTU
label., Hard., Not applicable for this use.
RODENTS, WILD (CAPTURED FOR SALE)
Premise treatment., Not on label., Not on RTU
label., Hard., Not applicable for this use.
Premise treatment., Not on label., Not on
label., Hard., Not applicable for this use.
SPECIALIZED ANIMALS
Premise treatment., Not on label., Aerosol
can., Hard., Not applicable for this use.
Premise treatment., Not on label., Not on RTU
label., Hard., Not applicable for this use.
TEXTILES/TEXTILE FIBERS/CORDAGE
Spray., Not on label., Not on label., RTU
Porous., Not applicable for this use.
TOBACCO PROCESSING PLANT PREMISES/EQUIPMENT
Spray., Not on label., Not on label., Hard., RTU
Not applicable for this use.
TOBACCO/CIGAR/CIGAR WRAPPING
Stored commodity fumigation., Postharvest., RTU
Catalytic generator.
W 530000
W 537200
W 660000
Use Group: INDOOR RESIDENTIAL
W 660000 * NS NS NS
Use Group: INDOOR RESIDENTIAL
W 660000 * NS NS NS
Use Group: INDOOR NON-FOOD
W 660000 * NS NS NS
Use Group: INDOOR NON-FOOD
W 660000 * NS NS NS
Use Group: INDOOR NON-FOOD
W 527880 * NS NS NS
W 530000 * NS NS
W 537200 * NS NS
W 660000 * NS NS
NS
NS
NS
Use Group: INDOOR NON-FOOD
W 660000 * NS NS NS
Use Group: INDOOR NON-FOOD
W 660000 * NS NS NS
Use Group: INDOOR NON-FOOD
UC * NS NS NS
NS NS
NS NS
NS NS
NS
NS
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, A25(10)
A08, AIO(IO),
A35(68)
A25(10) , A30
A08, AIO(IO),
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
-------
Date 12/13/94 ) Time 15:17
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol]
LUIS 1.6 ) Page 34
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
TOILET BOWLS (INTERIOR SURFACES)
Spray., Not on label., Aerosol can., Hard., PRL
Not applicable for this use.
Spray., Not on label., Not on label., Hard., RTU
Not applicable for this use.
TOILET TANKS/WATER CLOSETS WATER
Spray., Not on label., Aerosol can., Hard., PRL
Not applicable for this use.
UPHOLSTERY (HOSPITAL/COMMERCIAL)
Spray., Not on label., Aerosol can., Not PRL
Applicable., Not applicable for this use.
Spray., Not on label., Not on label., RTU W 660000
Porous., Not applicable for this use.
URINALS (INTERIOR SURFACES)
Spray., Not on label., Aerosol can., Hard., PRL W 442500
Not applicable for this use.
Spray., Not on label., Not on label., Hard., RTU W 660000
Not applicable for this use.
VEHICULAR HOLDING TANKS
Spray., Not on label., Not on label., Hard., RTU W 660000
Not applicable for this use.
Use Group: INDOOR RESIDENTIAL
W 530000 * NS NS NS
W 660000 * NS NS
NS
Use Group: INDOOR RESIDENTIAL
W 530000 * NS NS NS
Use Group: INDOOR MEDICAL
W 627400 * NS NS NS
Use Group: INDOOR NON-FOOD
W 660000 * NS NS NS
Use Group: INDOOR RESIDENTIAL
W 442500 * NS NS NS
W 530000
NS NS
W 660000 * NS NS
NS NS NS
NS NS NS
NS
Use Group: INDOOR RESIDENTIAL
W 660000 * NS NS NS NS NS NS
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
AIO(IO)
A08, AIO(IO),
A35(68)
A08, A25(10)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
A08, AIO(IO) ,
A35(68)
-------
Date 12/13/94 ) Time 15:17 APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 001501 [Ethyl alcohol] LUIS 1.6 ) Page 35
44444444
LEGEND
444444
HEADER ABBREVIATIONS
Min. Appl. Rate (AI unless : Minimum dose for a single application to a single site. System calculated. Microbial claims only.
noted otherwise)
Max. Appl. Rate (AI unless : Maximum dose for a single application to a single site. System calculated.
noted otherwise)
Soil Tex. Max. Dose : Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).
Max. # Apps ® Max. Rate : Maximum number of Applications at Maximum Dosage Rate. Example: "4 applications per year" is expressed as "4/1 yr"; "4 applications per 3
years" is expressed as "4/3 yr"
Max. Dose [(AI unless : Maximum dose applied to a site over a single crop cycle or year. System calculated.
noted otherwise)/A]
Min. Interv (days) : Minimum Interval between Applications (days)
Restr. Entry Interv (days) : Restricted Entry Interval (days)
SOIL TEXTURE FOR MAX APP. RATE
* : Non-specific
C : Coarse
M : Medium
F : Fine
O : Others
FORMULATION CODES
PRL : PRESSURIZED LIQUID
RTU : LIQUID-READY TO USE
ABBREVIATIONS
AN : As Needed
NA : Not Applicable
NS : Not Specified (on label)
UC : Unconverted due to lack of data (on label), or with one of following units: bag, bait, bait block, bait pack, bait station, bait station(s), block, briquet,
briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop, eartag, grains, lure, pack, packet, packets, pad, part,
parts, pellets, piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape, towelette, tray, unit, --
APPLICATION RATE
DCNC : Dosage Can Not be Calculated
No Calc : No Calculation can be made
W : PPM calculated by weight
V : PPM Calculated by volume
cwt : Hundred Weight
nnE-xx : nn times (10 power -xx); for instance, "1.234E-04" is equivalent to ".0001234"
USE LIMITATIONS CODES
A06 : Potable water rinse (non-residual claim).
A08 : Preclean claim.
A10 : minute(s) contact time.
A25 : minute(s) contact time (minimum).
A30 : Preclean for heavily soiled areas.
A37 : Residual bacteriostatic activity.
A38 : Do not use on any surface or instruments that (1) is introduced directly into the human body, either into or in contact with the bloodstream or normally sterile areas of the
body, or (2) contacts intact mucous membranes but which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body.
C17 : Remove or carefully protect food products and food packaging.
* NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
-------
Date 12/14/94 ) Time 10:43
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemial 047501 [Isopropanol]
LUIS 1.6 ) Page 1
SITE Application Type, Application Form(s) Min. Appl.
Timing, Application Equipment ) Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES
)))))))))))))))»:
DAIRIES/CHEESE PROCESSING PLANT EQUIPMENT (FOOD CONTACT)
Mop., Not on label., Mop., Hard., Not
applicable for this use.
RTU
Sponge-on., Not on label., Sponge., Hard., RTU
Not applicable for this use.
Spray., Not on label., Mechanical sprayer., RTU
Hard., Not applicable for this use.
Spray., Not on label., Pump-up sprayer., RTU
Hard., Not applicable for this use.
IMPR W 80000
Wipe-on/wiper treatment., Not on label.,
Cloth., Hard., Not applicable for this use.
DAIRIES/CHEESE PROCESSING PLANT PREMISES (NONFOOD CONTACT)
Mop., Not on label., Mop., Hard., Not
applicable for this use.
Sponge-on., Not on label., Sponge., Hard.,
Not applicable for this use.
Spray., Not on label., Mechanical sprayer.,
Hard., Not applicable for this use.
Spray., Not on label., Pump-up sprayer.,
Hard., Not applicable for this use.
Wipe-on/wiper treatment., Not on label.,
Cloth., Hard., Not applicable for this use.
Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min.
Rate (AI Tex. &dOD@ Max. Rate&d@ unless noted
unless noted Max. /crop /year &dODotherwise)/A] &ds
otherwise) Dose cycle /crop /year
cycle
Use Group: INDOOR FOOD
W 80000 * NS NS NS NS NS
W 80000 * NS NS
W 80000 * NS NS
NS
NS NS
Restr. &dOD Geographic Limitations &d@ Use
Interv Entry Allowed Disallowed Limitations
(days) Interv Codes
[day(s)]
IMPR
IMPR
RTU
W
W
W
80000
80000
80000
W
W
W
IFOOD CONTACT)
RTU
RTU
RTU
RTU
RTU
RTU
RTU
RTU
IMPR
W
W
W
W
W
W
W
W
W
80000
80000
80000
80000
80000
80000
80000
80000
80000
W
W
W
W
W
W
W
W
W
80000 *
80000 *
80000 *
Use Group
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
NS
NS
NS
NS
NS
NS
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
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
A06, AIO(IO) , A30
A06, AIO(IO), A30
A06, AIO(IO), A30
A06, AIO(IO), A30
A06, A10(5), A30
A10(5)
A25(0.5), A26(10)
A06, AIO(IO), A30
AIO(IO), A13, A30
AIO(IO) , A30
AIO(IO), A13, A30
AIO(IO) , A30
AIO(IO), A13, A30
AIO(IO) , A30
AIO(IO), A13, A30
AIO(IO) , A30
A10(5)
IMPR W 80000
A10(5), A13, A30
-------
Date 12/14/94 ) Time 10:43
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 047501 [Isopropanol]
LUIS 1.6 ) Page
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
Form(s) Min. Appl.
Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. &dOD Geographic Limitations
Rate (AI un- Rate (AI Tex. &dOD@ Max. Rate&d@ unless noted
less noted unless noted Max. /crop /year &dODotherwise)/A]
otherwise) otherwise) Dose cycle /crop /year
cycle
Interv Entry Allowed
(days) Interv
[day(s) ]
Disallowed Limitations
Codes
DAIRIES/CHEESE PROCESSING PLANT PREMISES (NONFOOD CONTACT) (con't)
IMPR W 80000
IMPR W 80000
RTU W 80000
RTU W 80000
EATING ESTABLISHMENTS EQUIPMENT/UTENSILS (FOOD CONTACT)
RTU W 80000
Mop., Not on label., Mop., Hard., Not
applicable for this use.
Sponge-on., Not on label., Sponge., Hard.,
Not applicable for this use.
RTU
W 80000
Spray., Not on label., Mechanical sprayer., RTU W 80000
Hard., Not applicable for this use.
Spray., Not on label., Pump-up sprayer., RTU W 80000
Hard., Not applicable for this use.
Wipe-on/wiper treatment., Not on label., IMPR W 80000
Cloth., Hard., Not applicable for this use.
IMPR W 80000
IMPR W 80000
RTU W 80000
EATING ESTABLISHMENTS FOOD HANDLING AREAS (FOOD CONTACT)
Mop., Not on label., Mop., Hard., Not RTU
applicable for this use.
Sponge-on., Not on label., Sponge., Hard., RTU
Not applicable for this use.
Spray., Not on label., Aerosol can., Hard., PRL
Not applicable for this use.
Spray., Not on label., Mechanical sprayer., RTU
Hard., Not applicable for this use.
Spray., Not on label., Pump-up sprayer., RTU
Hard., Not applicable for this use.
W 80000
Use Group: INDOOR FOOD (con't)
W 80000 * NS NS
W 80000 * NS NS
W 80000 * NS NS
W 80000 * NS NS
Use Group: INDOOR FOOD
W 80000 * NS NS
W 80000
NS NS
W 80000 * NS NS
W 80000 * NS NS
W 80000 * NS NS
W 80000 * NS NS
W 80000 * NS NS
Use Group: INDOOR FOOD
W 80000 * NS NS
W 80000 * NS
NS
W 675000 * NS NS
W 80000 * NS NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
A13
A25(0.5), A26(10)
AIO(IO), A13, A30
AIO(IO) , A30
A06, AIO(IO) , A30
A06, AIO(IO), A30
A06, AIO(IO), A30
A06, AIO(IO), A30
A06, A10(5), A30
A10(5)
A25(0.5), A26(10)
A06, AIO(IO), A30
A06, AIO(IO), A30
A06, AIO(IO), A30
A06
A06, AIO(IO) , A30
A06, AIO(IO), A30
-------
Date 12/14/94 ) Time 10:43
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 047501 [Isopropanol]
LUIS 1.6 ) Page 3
SITE Application Type, Application Form(s)
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. &dOD Geographic Limitations &d@ Use
Rate (AI un- Rate (AI Tex. &dOD@ Max. Rate&d@ unless noted Interv Entry Allowed Disallowed Limitations
less noted unless noted Max. /crop /year &dODotherwise)/A] &d@ (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
EATING ESTABLISHMENTS FOOD HANDLING AREAS (FOOD CONTACT) (con't)
Wipe-on/wiper treatment., Not on label., IMPR W 80000
Cloth., Hard., Not applicable for this use.
IMPR W 80000
IMPR W 80000
RTU W 80000
EATING ESTABLISHMENTS FOOD SERVING AREAS (FOOD CONTACT)
Mop., Not on label., Mop., Hard., Not RTU W 80000
applicable for this use.
Sponge-on., Not on label., Sponge., Hard., RTU W 80000
Not applicable for this use.
Spray., Not on label., Mechanical sprayer., RTU W 80000
Hard., Not applicable for this use.
Spray., Not on label., Pump-up sprayer., RTU W 80000
Hard., Not applicable for this use.
Wipe-on/wiper treatment., Not on label., IMPR W 80000
Use Group: INDOOR FOOD (con't)
W 80000 * NS NS NS
W 80000 * NS NS
W 80000 * NS NS
W 80000 * NS NS
Use Group: INDOOR FOOD
W 80000 * NS NS
W 80000
Mop., Not on label., Mop., Hard., Not
applicable for this use.
Sponge-on., Not on label., Sponge., Hard.,
Not applicable for this use.
Spray., Not on label., Mechanical sprayer.,
Hard., Not applicable for this use.
Spray., Not on label., Pump-up sprayer.,
Hard., Not applicable for this use.
RTU
W 80000
NS NS
W 80000 * NS NS
W 80000 * NS NS
Cloth., Hard., Not applicable for this use.
IMPR W 80000
IMPR W 80000
RTU W 80000
FOOD MARKETING/STORAGE/DISTRIBUTION EQUIPMENT/UTENSILS (FOOD CONTACT)
RTU W 80000
W 80000 * NS
W 80000 * NS
W 80000 * NS
NS
NS
NS
Use Group: INDOOR FOOD
W 80000 * NS NS
W 80000 * NS
NS
NS
NS
NS
NS
NS
NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS
NS
NS
NS
NS
NS
W 80000 * NS NS
A06, A10(5) , A30
A10(5)
A25(0.5), A26(10)
A06, AIO(IO), A30
A06, AIO(IO), A30
A06, AIO(IO), A30
A06, AIO(IO), A30
A06, AIO(IO), A30
A06, A10(5), A30
A10(5)
A25(0.5), A26(10)
A06, AIO(IO), A30
A06, AIO(IO), A30
A06, AIO(IO), A30
A06, AIO(IO), A30
A06, AIO(IO), A30
-------
Date 12/14/94 ) Time 10:43
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 047501 [Isopropanol]
LUIS 1.6 ) Page 4
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. &dOD Geographic Limitations &d@ Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. &dOD@ Max. Rate&d@ unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year &dODotherwise)/A] &d@ (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
FOOD MARKETING/STORAGE/DISTRIBUTION EQUIPMENT/UTENSILS (FOOD CONTACT)
Wipe-on/wiper treatment., Not on label., IMPR W 80000
Cloth., Hard., Not applicable for this use.
IMPR W 80000
IMPR W 80000
Use Group: INDOOR FOOD (con't)
W 80000 * NS NS NS
RTU W 80000
FOOD PROCESSING PLANT EQUIPMENT (FOOD CONTACT)
Mop., Not on label., Mop., Hard., Not RTU W 80000
applicable for this use.
Sponge-on., Not on label., Sponge., Hard., RTU W 80000
Not applicable for this use.
Spray., Not on label., Mechanical sprayer., RTU W 80000
Hard., Not applicable for this use.
Spray., Not on label., Pump-up sprayer., RTU W 80000
Hard., Not applicable for this use.
Wipe-on/wiper treatment., Not on label., IMPR W 80000
Cloth., Hard., Not applicable for this use.
FOOD PROCESSING PLANT PREMISES (NONFOOD CONTACT)
Mop., Not on label., Mop., Hard., Not
applicable for this use.
Sponge-on., Not on label., Sponge., Hard.,
Not applicable for this use.
Spray., Not on label., Mechanical sprayer.,
Hard., Not applicable for this use.
W 80000 * NS NS
W 80000 * NS NS
W 80000 * NS NS
Use Group: INDOOR FOOD
W 80000 * NS NS
NS
NS
NS
W 80000
NS NS
W 80000 * NS NS
W 80000 * NS
NS NS
NS NS
NS NS
NS NS
NS
NS
NS
IMPR
IMPR
RTU
iCT)
RTU
RTU
RTU
RTU
RTU
W
W
W
W
W
W
W
W
80000
80000
80000
80000
80000
80000
80000
80000
W
W
W
W
W
W
W
W
80000 *
80000 *
80000 *
Use Group
80000 *
80000 *
80000 *
80000 *
80000 *
NS
NS
NS
NS
NS
NS
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
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
A06, A10(5) , A30
A10(5)
A25(0.5), A26(10)
A06, AIO(IO), A30
A06, AIO(IO), A30
A06, AIO(IO), A30
A06, AIO(IO), A30
A06, AIO(IO), A30
A06, A10(5), A30
A10(5)
A25(0.5), A26(10)
A06, AIO(IO), A30
AIO(IO), A13, A30
AIO(IO) , A30
AIO(IO), A13, A30
AIO(IO) , A30
AIO(IO), A13, A30
-------
Date 12/14/94 ) Time 10:43
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 047501 [Isopropanol]
LUIS 1.6 ) Page 5
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. &dOD Geographic Limitations &d@ Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. &dOD@ Max. Rate&d@ unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year &dODotherwise)/A] &d@ (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
FOOD PROCESSING PLANT PREMISES (NONFOOD CONTACT) (con't)
Spray., Not on label., Pump-up sprayer.,
Hard., Not applicable for this use.
Wipe-on/wiper treatment., Not on label., IMPR W 80000
Cloth., Hard., Not applicable for this use.
Use Group: INDOOR FOOD (con't)
HOUSEHOLD/DOMESTIC DWELLINGS
Mop., Not on label., Mop., Hard., Not
applicable for this use.
Sponge-on., Not on label., Sponge., Hard., RTU W 80000
Not applicable for this use.
Spray., Not on label., Mechanical sprayer., RTU W 80000
Hard., Not applicable for this use.
Spray., Not on label., Pump-up sprayer.,
Hard., Not applicable for this use.
Wipe-on/wiper treatment., Not on label., IMPR W 80000
Cloth., Hard., Not applicable for this use.
RTU
RTU
RTU
IMPR
IMPR
IMPR
IMPR
RTU
RTU
RTU
RTU
RTU
RTU
RTU
RTU
RTU
RTU
IMPR
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
80000
80000
80000
80000
80000
80000
80000
80000
80000
80000
80000
80000
80000
80000
80000
80000
80000
80000
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
Use Group
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
NS
NS
NS
NS
NS
NS
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
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
AIO(IO) , A30
AIO(IO), A13, A30
AIO(IO) , A30
A10(5)
A10(5), A13, A30
A13
A25(0.5), A26(10)
AIO(IO), A13, A30
AIO(IO) , A30
AIO(IO), A13, A30
AIO(IO) , A30
AIO(IO), A13, A30
AIO(IO) , A30
AIO(IO), A13, A30
AIO(IO) , A30
AIO(IO), A13, A30
AIO(IO) , A30
A10(5)
IMPR W 80000
A10(5), A13, A30
-------
Date 12/14/94 ) Time 10:43
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 047501 [Isopropanol]
LUIS 1.6 ) Page
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [ (AI Min. Restr. &dOD Geographic Limitations &d@ Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. &dOD@ Max. Rate&d@ unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year &dODotherwise)/A] &d@ (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES (con't)
HOUSEHOLD/DOMESTIC DWELLINGS (con't)
IMPR
IMPR
RTU
RTU
NON- FOOD/NON- FEED
)))))))))))))))))))))
AIR TREATMENTS (COMMERCIAL/HOUSEHOLD)
Aerosol application., Not on label., Aerosol I
can., Not Applicable., Not applicable for
this use.
AIR TREATMENTS (HOSPITAL)
Aerosol application., Not on label., Aerosol I
can., Not Applicable., Not applicable for
this use.
Spray., Not on label., Atomizing type !
sprayer., Not Applicable., Not applicable
for this use.
ANIMAL KENNELS/SLEEPING QUARTERS (COMMERCIAL)
Enclosed premise treatment., When needed., !
Mist sprayer.
Spray., Not on label., Aerosol can., Hard., I
Not applicable for this use.
BATHROOM PREMISES/HARD SURFACES
Mop., Not on label., Mop., Hard., Not
applicable for this use.
Sponge-on., Not on label., Sponge., Hard.,
Not applicable for this use.
RTU
RTU
RTU
W 80000
W 80000
W 80000
W 80000
W 80000
W 80000
W 80000
Use Group: INDOOR FOOD (con't)
W 80000 * NS NS NS
W 80000 * NS NS NS
W 80000 * NS NS NS
W 80000 * NS NS NS
))))))))))))))))))))))))))))))))))))
Use Group: INDOOR RESIDENTIAL
W 385000 * NS NS NS
Use Group: INDOOR MEDICAL
W 385000 * NS NS NS
Use Group: INDOOR NON-FOOD
UC * NS NS NS
W 432200 * NS NS
NS
Use Group: INDOOR RESIDENTIAL
W 80000 * NS NS NS
W 80000 * NS NS
W 80000 * NS NS
NS
NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS
NS
NS
NS
NS
NS NS NS
NS NS NS
A13
A25(0.5), A26(10)
AIO(IO), A13, A30
AIO(IO) , A30
AIO(IO), A30
AIO(IO), A13, A30
AIO(IO) , A30
AIO(IO), A13, A30
RTU
W 80000
W 80000
NS NS
NS NS
NS
AIO(IO) , A30
-------
Date 12/14/94 ) Time 10:43
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 047501 [Isopropanol]
LUIS 1.6 ) Page 7
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. &dOD Geographic Limitations &d@ Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. &dOD@ Max. Rate&d@ unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year &dODotherwise)/A] &d@ (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
BATHROOM PREMISES/HARD SURFACES (con't)
Spray., Not on label., Aerosol can., Hard.
Not applicable for this use.
PRL W 242370
Use Group: INDOOR RESIDENTIAL (con't)
W 242370 * NS NS NS NS NS
Spray., Not on label., Mechanical sprayer.
Hard., Not applicable for this use.
Spray., Not on label., Pump spray bottle.,
Hard., Not applicable for this use.
Spray., Not on label., Pump-up sprayer.,
Hard., Not applicable for this use.
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
RTU
RTU
RTU
RTU
RTU
RTU
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
242370
242370
343900
432200
507000
530000
530000
530000
530000
530000
570000
591600
675000
603900
80000
80000
400000
757100
80000
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
242370
242370
343900
432200
507000
530000
530000
530000
530000
530000
570000
591600
675000
603900
80000
W 80000
W
W
W
400000
757100
80000
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
A08, A37
A30, A37
A3 7
A08, AIO(IO)
A08
A08, AIO(IO)
A08
A08, AIO(IO)
A08, CIS, C24
AIO(IO)
A08
AIO(IO) , A30
AIO(IO)
AIO(IO) , A30
AIO(IO), A13, A30
AIO(IO) , A30
A08, AIO(IO), C23
A08, AIO(IO)
AIO(IO), A13, A30
RTU W 80000
AIO(IO) , A30
-------
Date 12/14/94 ) Time 10:43
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 047501 [Isopropanol]
LUIS 1.6 ) Page
SITE Application Type, Application Form(s)
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. &dOD Geographic Limitations &d@ Use
Rate (AI un- Rate (AI Tex. &dOD@ Max. Rate&d@ unless noted Interv Entry Allowed Disallowed Limitations
less noted unless noted Max. /crop /year &dODotherwise)/A] &d@ (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
BATHROOM PREMISES/HARD SURFACES (con't)
Spray., Not on label., Sprayer., Hard., Not RTU W 600000
applicable for this use.
Surface treatment., Not on label., Not on
label., Hard., Not applicable for this use.
Wipe-on/wiper treatment., Not on label.,
Cloth., Hard., Not applicable for this use.
RTU W 600000
SC/L V 5385
IMPR W 80000
IMPR W 80000
IMPR W 80000
IMPR W 80000
CATS (ADULTS/KITTENS)
Animal treatment (spray)., When needed.,
Pump spray bottle.
RTU
RTU
RTU
W 80000
W 80000
NA
RTU NA
COMMERCIAL TRANSPORTATION FACILITIES-NONFEED/NONFOOD
Spray., Not on label., Aerosol can., Hard., PRL W 432200
Not applicable for this use.
COMMERCIAL/INDUSTRIAL WATER COOLING SYSTEMS
Water treatment (recirculating system)., SC/L W 8.4
Intermittent (slug)(initial)., Not on
label., Not Applicable., Not applicable for
this use.
Water treatment (recirculating system)., SC/L W 2.8
Intermittent (slug)(subsequent)., Not on
label., Not Applicable., Not applicable for
this use.
Use Group: INDOOR RESIDENTIAL (con't)
W 600000 * NS NS NS NS NS
W 600000
V 5385
W 80000
NS
NS
NS
NS
NS
NS
NS
NS
NS
W 80000 * NS NS NS
W 80000 * NS NS NS
W 80000 * NS NS NS
W 80000 * NS NS NS
W 80000 * NS NS NS
Use Group: INDOOR RESIDENTIAL
UC * NS NS NS
NS
NS
NS
NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS 2
UC * NS NS NS NS NS
Use Group: INDOOR NON-FOOD
W 432200 * NS NS NS NS NS
Use Group: AQUATIC NON-FOOD INDUSTRIAL
W 13 * NS NS NS NS NS
NS
NS
NS
NS
NS
NS
NS
A08
A08, A25(10)
A08
A06, A10(5) , A30
AIO(IO)
A10(5)
A25(0.5), A26(10)
AIO(IO), A13, A30
AIO(IO) , A30
-------
Date 12/14/94 ) Time 10:43
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 047501 [Isopropanol]
LUIS 1.6 ) Page 9
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. &dOD Geographic Limitations &d@ Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. &dOD@ Max. Rate&d@ unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year &dODotherwise)/A] &d@ (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
COMMERCIAL/INSTITUTIONAL/INDUSTRIAL FLOORS
Spray., Not on label., Aerosol can., Hard., PRL
Not applicable for this use.
Use Group: INDOOR NON-FOOD
W 242370 * NS NS NS
Spray., Not on label., Pump spray bottle., RTU
Hard., Not applicable for this use.
COMMERCIAL/INSTITUTIONAL/INDUSTRIAL PREMISES/EQUIP
Mop., Not on label., Mop., Hard., Not
applicable for this use.
Sponge-on., Not on label., Sponge., Hard., RTU
Not applicable for this use.
Spray., Not on label., Aerosol can., Hard., PRL
Not applicable for this use.
PRL
PRL
PRL
PRL
PRL
PRL
PRL
RTU
RTU
'EQUII
RTU
RTU
RTU
RTU
PRL
PRL
PRL
PRL
PRL
PRL
W
W
W
W
W
W
W
W
W
D _
W
W
W
W
W
W
W
W
W
W
242370
242370
507000
530000
530000
530000
530000
400000
757100
(INDOOR)
80000
80000
80000
80000
242370
242370
242370
507000
530000
530000
W
W
W
W
W
W
W
W
W
242370 *
242370 *
507000 *
530000 *
530000 *
530000 *
530000 *
400000 *
757100 *
Use Group
W 80000 *
W
W
80000 *
80000 *
W 80000 *
W
W
W
W
W
W
242370 *
242370 *
242370 *
507000 *
530000 *
530000 *
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: INDOOR NON- FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
A08, A37
A30, A37
A3 7
A08, AIO(IO)
A08
A08, AIO(IO)
AIO(IO)
A08, AIO(IO), C23
A08, AIO(IO)
AIO(IO), A13, A30
AIO(IO) , A30
AIO(IO), A13, A30
AIO(IO) , A30
A08, A37
A30, A37
A3 7
A08, AIO(IO)
-------
Date 12/14/94 ) Time 10:43
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 047501 [Isopropanol]
LUIS 1.6 ) Page 10
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. &dOD Geographic Limitations &d@ Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. &dOD@ Max. Rate&d@ unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year &dODotherwise)/A] &d@ (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
COMMERCIAL/INSTITUTIONAL/INDUSTRIAL PREMISES/EQUIP
Spray., Not on label., Aerosol can., Not
Applicable., Not applicable for this use.
Spray., Not on label., Mechanical sprayer.,
Hard., Not applicable for this use.
Spray., Not on label., Pump spray bottle.,
Hard., Not applicable for this use.
Spray., Not on label., Pump-up sprayer.,
Hard., Not applicable for this use.
Spray., Not on label., Sprayer., Hard., Not RTU
applicable for this use.
Surface treatment., Not on label., Not on
label., Hard., Not applicable for this use.
Wipe-on/wiper treatment., Not on label.,
Cloth., Hard., Not applicable for this use.
'EQUIP. (INDOOR) (con't) Use Group: INDOOR NON- FOOD (con'
PRL
PRL
PRL
PRL
RTU
PRL
RTU
RTU
RTU
RTU
RTU
RTU
RTU
RTU
SC/L
SC/L
IMPR
IMPR
IMPR
IMPR
W
W
W
W
W
W
W
W
W
W
W
W
W
W
V
V
W
W
W
W
530000
530000
530000
675000
603900
570000
80000
80000
400000
757100
80000
80000
600000
600000
2713
5385
80000
80000
80000
80000
W 530000
W 530000
W 530000
W 675000
W 603900
W 570000
W 80000
W 80000
W 400000
W 757100
W 80000
W 80000
W 600000
W 600000
V 2713
V 5385
W 80000
W 80000
W 80000
W 80000
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
t)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
A08, AIO(IO)
A08, CIS, C24
AIO(IO)
AIO(IO)
AIO(IO) , A30
A08
AIO(IO), A13, A30
AIO(IO) , A30
A08, AIO(IO), C23
A08, AIO(IO)
AIO(IO), A13, A30
AIO(IO) , A30
A08
A08, A25(10)
A08
A08
A06, A10(5) , A30
AIO(IO)
A10(5)
A13
-------
Date 12/14/94 ) Time 10:43
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 047501 [Isopropanol]
LUIS 1.6 ) Page 11
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. &dOD Geographic Limitations &d@ Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. &dOD@ Max. Rate&d@ unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year &dODotherwise)/A] &d@ (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
COMMERCIAL/INSTITUTIONAL/INDUSTRIAL PREMISES/EQUIP
DIAPER PAILS (EMPTY)
Spray., Not on label., Aerosol can., Hard., PRL
Not applicable for this use.
Surface treatment., Not on label., Not on
label., Hard., Not applicable for this use.
DOGS/CANINES (ADULTS/PUPPIES)
Animal treatment (spray)., When needed., RTU
Pump spray bottle.
RTU
EATING ESTABLISHMENTS FOOD HANDLING AREAS (NONFOOD
RTU
'EQUIP. (INDOOR) (con't) Use Group
IMPR
RTU
RTU
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
SC/L
W
W
W
W
W
W
W
W
W
W
W
V
80000
80000
80000
343900
432200
530000
530000
530000
530000
530000
591600
5385
W 80000 *
W 80000 *
W 80000 *
Use Group
W 343900 *
W 432200 *
W 530000 *
W 530000 *
W 530000 *
W 530000 *
W 530000 *
W 591600 *
V 5385 *
: INDOOR
NS
NS
NS
NS
NS
NS
: INDOOR
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NON- FOOD (con'
NS
NS
NS
RESIDENTIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
t)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Mop., Not on label., Mop., Hard., Not
applicable for this use.
RTU
Sponge-on., Not on label., Sponge., Hard., RTU
Not applicable for this use.
NA
NA
CONTACT)
W 80000
W 80000
W 80000
Use Group: INDOOR RESIDENTIAL
UC * NS NS NS
UC * NS NS NS
Use Group: INDOOR NON-FOOD
W 80000 * NS NS NS
W 80000 * NS NS
W 80000 * NS NS
NS
NS
NS
NS
NS
NS
NS
NS
A25(0.5), A26(10)
AIO(IO), A13, A30
AIO(IO) , A30
A08, AIO(IO)
A08
A08, AIO(IO)
A08, CIS, C24
AIO(IO)
AIO(IO) , A30
A08
AIO(IO), A13, A30
AIO(IO) , A30
AIO(IO), A13, A30
W 80000
W 80000 * NS NS
AIO(IO) , A30
-------
Date 12/14/94 ) Time 10:43
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 047501 [Isopropanol]
LUIS 1.6 ) Page 12
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [ (AI Min. Restr. &dOD Geographic Limitations &d@ Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. &dOD@ Max. Rate&d@ unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year &dODotherwise)/A] &d@ (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
EATING ESTABLISHMENTS FOOD HANDLING AREAS (NONFOOD CONTACT) (con't)
Spray., Not on label., Mechanical sprayer., RTU W 80000
Hard., Not applicable for this use.
RTU W 80000
Spray., Not on label., Pump-up sprayer., RTU W 80000
Hard., Not applicable for this use.
RTU W 80000
Wipe-on/wiper treatment., Not on label., IMPR W 80000
Cloth., Hard., Not applicable for this use.
IMPR W 80000
IMPR W 80000
IMPR W 80000
IMPR W 80000
RTU W 80000
RTU W 80000
EATING ESTABLISHMENTS FOOD SERVING AREAS (NONFOOD CONTACT)
Mop., Not on label., Mop., Hard., Not RTU W 80000
applicable for this use.
RTU W 80000
Sponge-on., Not on label., Sponge., Hard., RTU W 80000
Not applicable for this use.
RTU W 80000
Spray., Not on label., Mechanical sprayer., RTU W 80000
Hard., Not applicable for this use.
RTU W 80000
Spray., Not on label., Pump-up sprayer., RTU W 80000
Hard., Not applicable for this use.
Use Group: INDOOR NON-FOOD (con't)
W 80000 * NS NS NS NS NS
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
Use Group
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: INDOOR NON- FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
AIO(IO), A13, A30
AIO(IO) , A30
AIO(IO), A13, A30
AIO(IO) , A30
A06, A10(5) , A30
AIO(IO)
A10(5)
A13
A25(0.5), A26(10)
AIO(IO), A13, A30
AIO(IO) , A30
AIO(IO), A13, A30
AIO(IO) , A30
AIO(IO), A13, A30
AIO(IO) , A30
AIO(IO), A13, A30
AIO(IO) , A30
AIO(IO), A13, A30
RTU W 80000
W 80000 * NS NS
AIO(IO) , A30
-------
Date 12/14/94 ) Time 10:43
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 047501 [Isopropanol]
LUIS 1.6 ) Page 13
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. &dOD Geographic Limitations &d@ Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. &dOD@ Max. Rate&d@ unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year &dODotherwise)/A] &d@ (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
EATING ESTABLISHMENTS FOOD SERVING AREAS (NONFOOD CONTACT) (con't)
IMPR W 80000
Wipe-on/wiper treatment., Not on label.,
Cloth., Hard., Not applicable for this use.
EATING ESTABLISHMENTS NON-FOOD AREAS (NONFOOD CONTACT)
Mop., Not on label., Mop., Hard., Not
applicable for this use.
Sponge-on., Not on label., Sponge., Hard.,
Not applicable for this use.
Spray., Not on label., Mechanical sprayer.,
Hard., Not applicable for this use.
Spray., Not on label., Pump-up sprayer.,
Hard., Not applicable for this use.
Wipe-on/wiper treatment., Not on label.,
Cloth., Hard., Not applicable for this use.
Use Group: INDOOR NON-FOOD (con't)
W 80000 * NS NS NS NS NS
IMPR
IMPR
IMPR
IMPR
RTU
RTU
W
W
W
W
W
W
80000
80000
80000
80000
80000
80000
W
W
W
W
W
W
) CONTACT)
RTU
RTU
RTU
RTU
RTU
RTU
RTU
RTU
IMPR
IMPR
IMPR
IMPR
IMPR
W
W
W
W
W
W
W
W
W
W
W
W
W
80000
80000
80000
80000
80000
80000
80000
80000
80000
80000
80000
80000
80000
W
W
W
W
W
W
W
W
W
W
W
W
W
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
Use Group
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: INDOOR NON- FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
A06, A10(5) , A30
AIO(IO)
A10(5)
A13
A25(0.5), A26(10)
AIO(IO), A13, A30
AIO(IO) , A30
AIO(IO), A13, A30
AIO(IO) , A30
AIO(IO), A13, A30
AIO(IO) , A30
AIO(IO), A13, A30
AIO(IO) , A30
AIO(IO), A13, A30
AIO(IO) , A30
A06, A10(5) , A30
AIO(IO)
A10(5)
A13
A25(0.5), A26(10)
-------
Date 12/14/94 ) Time 10:43
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 047501 [Isopropanol]
LUIS 1.6 ) Page 14
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. &dOD Geographic Limitations &d@ Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. &dOD@ Max. Rate&d@ unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year &dODotherwise)/A] &d@ (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
EATING ESTABLISHMENTS NON-FOOD AREAS (NONFOOD CONTACT) (con't)
RTU W 80000
RTU W 80000
HOSPITAL CRITICAL ITEMS (SURGICAL INSTRUMENTS/PACEMAKERS)
RTU W 153000
Immersion., Not on label., Not on label.,
Hard., Not applicable for this use.
Soak., Not on label., Not on label., Hard.
Not applicable for this use.
RTU
RTU
RTU
HOSPITAL NONCRITICAL ITEMS (BEDPANS/FURNITURE)
Mop., Not on label., Mop., Hard., Not RTU
applicable for this use.
Sponge-on., Not on label., Sponge., Hard.,
Not applicable for this use.
Spray., Not on label., Aerosol can., Hard.,
Not applicable for this use.
W 500000
W 600000
W 80000
Use Group: INDOOR NON-FOOD (con't)
W 80000 * NS NS NS NS NS
W 80000 * NS NS NS NS NS
Use Group: INDOOR MEDICAL
W 153000 * NS NS NS NS NS
W 500000 * NS NS
W 600000 * NS NS
W 80000 * NS NS
NS NS NS
NS NS NS
NS NS NS
Use Group: INDOOR MEDICAL
W 80000 * NS NS NS
NS
NS
NS
NS
NS
RTU
RTU
RTU
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
W
W
W
W
W
W
W
W
W
W
W
W
700000
80000
700000
242370
242370
242370
432200
507000
530000
530000
530000
530000
W
W
W
W
W
W
W
W
W
W
W
W
700000
80000
700000
242370
242370
242370
432200
507000
530000
530000
530000
530000
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
AIO(IO), A13, A30
AIO(IO) , A30
A06, A08, AIO(IO)
A08, A25(15)
A08, A16, A25(30)
AIO(IO), A30,
A33 (20)
AIO(IO), A30
AIO(IO) , A30
AIO(IO), A30
AIO(IO) , A30
A08, A37
A30, A37
A3 7
A08
A08, AIO(IO)
A08
A08, AIO(IO)
A08, CIS, C24
-------
Date 12/14/94 ) Time 10:43
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 047501 [Isopropanol]
LUIS 1.6 ) Page 15
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. &dOD Geographic Limitations &d@ Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. &dOD@ Max. Rate&d@ unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year &dODotherwise)/A] &d@ (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
HOSPITAL NONCRITICAL ITEMS (BEDPANS/FURNITURE) (con't)
Use Group: INDOOR MEDICAL (con't)
Spray., Not on label., Mechanical sprayer.,
Hard., Not applicable for this use.
Spray., Not on label., Pump spray bottle.,
Hard., Not applicable for this use.
Spray., Not on label., Pump-up sprayer.,
Hard., Not applicable for this use.
Spray., Not on label., Sprayer., Hard., Not RTU
applicable for this use.
Wipe-on/wiper treatment., Not on label.,
Cloth., Hard., Not applicable for this use.
HOSPITAL SEMICRITICAL ITEMS (CATHETERS/INHALATION EQUIPMENT)
Immersion., Not on label., Not on label., RTU W 153000
Hard., Not applicable for this use.
PRL
PRL
PRL
RTU
RTU
RTU
RTU
RTU
RTU
RTU
RTU
IMPR
IMPR
IMPR
IMPR
RTU
RTU
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
530000
570000
675000
80000
700000
400000
757100
80000
153000
600000
600000
80000
80000
80000
80000
80000
700000
W 530000
W 570000
W 675000
W 80000
W 700000
W 400000
W 757100
W 80000
W 153000
W 600000
W 600000
W 80000
W 80000
W 80000
W 80000
W 80000
W 700000
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Use Group: INDOOR MEDICAL
W 153000 * NS NS NS
W 500000
NS
NS
NS
AIO(IO)
A08
AIO(IO)
AIO(IO), A30
AIO(IO) , A30
A08, AIO(IO), C23
A08, AIO(IO)
AIO(IO), A30
A08
A08
A08, A25(10)
A06, A10(5), A30
AIO(IO)
A10(5)
A25(0.5), A26(10)
AIO(IO) , A30
AIO(IO) , A30
A06, A08, AIO(IO)
A08, A25(15)
-------
Date 12/14/94 ) Time 10:43
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 047501 [Isopropanol]
LUIS 1.6 ) Page 16
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. &dOD Geographic Limitations &d@ Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. &dOD@ Max. Rate&d@ unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year &dODotherwise)/A] &d@ (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
HOSPITAL SEMICRITICAL ITEMS (CATHETERS/INHALATION EQUIPMENT)
Mop., Not on label., Mop., Hard., Not RTU W 80000
applicable for this use.
Sponge-on., Not on label., Sponge., Hard., RTU W 80000
Not applicable for this use.
Spray., Not on label., Mechanical sprayer., RTU W 80000
Hard., Not applicable for this use.
Spray., Not on label., Pump-up sprayer., RTU W 80000
Hard., Not applicable for this use.
Wipe-on/wiper treatment., Not on label., IMPR W 80000
Cloth., Hard., Not applicable for this use.
IMPR W 80000
IMPR W 80000
IMPR W 80000
RTU W 80000
HOSPITAL/MEDICAL INSTITUTIONS NON-CONDUCTIVE FLOORS
Spray., Not on label., Aerosol can., Hard.,
Not applicable for this use.
Spray., Not on label., Pump spray bottle.,
Hard., Not applicable for this use.
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
RTU
W 242370
W 242370
W 242370
W 507000
W 530000
W 530000
W 530000
W 530000
W 400000
W 80000 *
W 80000 *
W 80000 *
W 80000 *
W 80000 *
W 80000 *
W 80000 *
W 80000 *
W 80000 *
Use Group
W 242370 *
W 242370 *
W 242370 *
W 507000 *
W 530000 *
W 530000 *
W 530000 *
W 530000 *
W 400000 *
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: INDOOR MEDICAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
AIO(IO), A30
AIO(IO), A30
AIO(IO), A30
AIO(IO), A30
A06, A10(5), A30
AIO(IO)
A10(5)
A25(0.5), A26(10)
AIO(IO) , A30
A08, A37
A30, A37
A3 7
A08, AIO(IO)
A08
A08, AIO(IO)
AIO(IO)
A08, AIO(IO), C23
RTU
W 757100
W 757100 * NS
A08, AIO(IO)
-------
Date 12/14/94 ) Time 10:43
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 047501 [Isopropanol]
LUIS 1.6 ) Page 17
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. &dOD Geographic Limitations &d@ Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. &dOD@ Max. Rate&d@ unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year &dODotherwise)/A] &d@ (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
HOSPITAL/MEDICAL INSTITUTIONS NON-CONDUCTIVE FLOORS (con't)
Surface treatment., Not on label., Not on SC/L V 5385
label., Hard., Not applicable for this use.
Surface treatment., Not on label., Not on SC/L V 10606
label., Porous., Not applicable for this
use.
HOSPITALS/MEDICAL INSTITUTIONS CRITICAL PREMISES (BURN WARDS
Mop., Not on label., Mop., Hard., Not RTU W 80000
applicable for this use.
Sponge-on., Not on label., Sponge., Hard., RTU W 80000
Not applicable for this use.
Spray., Not on label., Mechanical sprayer., RTU W 80000
Hard., Not applicable for this use.
Spray., Not on label., Pump-up sprayer., RTU W 80000
Hard., Not applicable for this use.
Spray., Not on label., Sprayer., Hard., Not RTU W 153000
applicable for this use.
Wipe-on/wiper treatment., Not on label., IMPR W 80000
Cloth., Hard., Not applicable for this use.
IMPR W 80000
IMPR W 80000
IMPR W 80000
IMPR W 632500
IMPR W 632500
IMPR W 632500
RTU W 80000
HOSPITALS/MEDICAL INSTITUTIONS NONCRITICAL PREMISES
Mop., Not on label., Mop., Hard., Not RTU W 80000
applicable for this use.
Use Group: INDOOR MEDICAL (con't)
V 5385 * NS NS NS NS NS
V 10606 * NS NS
Use Group: INDOOR MEDICAL
NS
NS NS
W
W
W
W
W
W
W
W
W
W
W
W
W
80000
80000
80000
80000
153000
80000
80000
80000
80000
632500
632500
632500
80000
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Use Group: INDOOR MEDICAL
AIO(IO), A30
AIO(IO), A30
AIO(IO), A30
AIO(IO), A30
A08
A06, A10(5) , A30
AIO(IO)
A10(5)
A25(0.5), A26(10)
A08, A10(l)
A08, A10(4)
A08, A10(6)
AIO(IO) , A30
AIO(IO), A30
-------
Date 12/14/94 ) Time 10:43
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 047501 [Isopropanol]
LUIS 1.6 ) Page 18
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. &dOD Geographic Limitations &d@ Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. &dOD@ Max. Rate&d@ unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year &dODotherwise)/A] &d@ (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
HOSPITALS/MEDICAL INSTITUTIONS NONCRITICAL PREMISES (con't)
Sponge-on., Not on label., Sponge., Hard., RTU W 80000
Not applicable for this use.
Spray., Not on label., Mechanical sprayer., RTU W 80000
Hard., Not applicable for this use.
Spray., Not on label., Pump-up sprayer., RTU W 80000
Hard., Not applicable for this use.
Wipe-on/wiper treatment., Not on label., IMPR W 80000
Cloth., Hard., Not applicable for this use.
IMPR W 80000
IMPR W 80000
IMPR W 80000
IMPR W 632500
IMPR W 632500
IMPR W 632500
RTU W 80000
HOSPITALS/MEDICAL INSTITUTIONS PATIENT PREMISES
Spray., Not on label., Sprayer., Hard., Not RTU W 153000
applicable for this use.
HOSPITALS/MEDICAL INSTITUTIONS PREMISES (HUMAN/VETERINARY)
Use Group: INDOOR MEDICAL (con't)
Mop., Not on label., Mop., Hard., Not
applicable for this use.
Sponge-on., Not on label., Sponge., Hard.,
Not applicable for this use.
Spray., Not on label., Aerosol can., Hard.,
Not applicable for this use.
RTU
RTU
RTU
RTU
PRL
W 80000
W 700000
W 80000
W 700000
W 242370
W
W
W
W
W
W
W
W
W
W
W
80000
80000
80000
80000
80000
80000
80000
632500
632500
632500
80000
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Use Group: INDOOR MEDICAL
W 153000 * NS NS
NS
Use Group: INDOOR MEDICAL
W 80000 * NS NS NS
W 700000 * NS NS
W 80000 * NS NS
W 700000 * NS NS
W 242370 * NS NS
NS
NS
NS
NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS
NS
NS
NS
AIO(IO), A30
AIO(IO), A30
AIO(IO), A30
A06, A10(5), A30
AIO(IO)
A10(5)
A25(0.5), A26(10)
A08, A10(l)
A08, A10(4)
A08, A10(6)
AIO(IO) , A30
AIO(IO), A30
AIO(IO) , A30
AIO(IO), A30
AIO(IO) , A30
A08, A37
PRL
W 242370
W 242370
NS NS
NS NS
A30, A37
-------
Date 12/14/94 ) Time 10:43
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 047501 [Isopropanol]
LUIS 1.6 ) Page 19
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. &dOD Geographic Limitations &d@ Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. &dOD@ Max. Rate&d@ unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year &dODotherwise)/A] &d@ (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
HOSPITALS/MEDICAL INSTITUTIONS PREMISES (HUMAN/VETERINARY) (con'
Spray., Not on label., Mechanical sprayer.,
Hard., Not applicable for this use.
Spray., Not on label., Pump spray bottle.,
Hard., Not applicable for this use.
Spray., Not on label., Pump-up sprayer.,
Hard., Not applicable for this use.
Spray., Not on label., Sprayer., Hard., Not
applicable for this use.
Surface treatment., Not on label., Not on
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
RTU
RTU
RTU
RTU
RTU
RTU
RTU
RTU
SC/L
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
V
242370
432200
507000
530000
530000
530000
530000
530000
570000
675000
80000
700000
400000
757100
80000
153000
600000
600000
5385
t)
W
W
W
W
W
W
W
W
W
W
Use Group: INDOOR MEDICAL (con't)
242370
432200
507000
530000
530000
530000
530000
530000
570000
675000
W 80000
W
W
W
700000
400000
757100
W 80000
W
W
W
153000
600000
600000
V 5385
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
label., Hard., Not applicable for this use.
Surface treatment., Not on label., Not on
label., Porous., Not applicable for this
use.
SC/L V 10606
V 10606 * NS NS
A3 7
A08
A08, AIO(IO)
A08
A08, AIO(IO)
A08, CIS, C24
AIO(IO)
A08
AIO(IO)
AIO(IO), A30
AIO(IO) , A30
A08, AIO(IO), C23
A08, AIO(IO)
AIO(IO), A30
A08
A08
A08, A25(10)
A08
A08
-------
Date 12/14/94 ) Time 10:43
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 047501 [Isopropanol]
LUIS 1.6 ) Page 20
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
Form(s) Min. Appl.
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. &dOD Geographic Limitations
Rate (AI un- Rate (AI Tex. &dOD@ Max. Rate&d@ unless noted
less noted unless noted Max. /crop /year &dODotherwise)/A]
otherwise) otherwise) Dose cycle /crop /year
cycle
Interv Entry Allowed
(days) Interv
[day(s)]
Disallowed Limitations
Codes
HOSPITALS/MEDICAL INSTITUTIONS PREMISES (HUMAN/VETERINARY) (con't)
Wipe-on/wiper treatment., Not on label.,
Cloth., Hard., Not applicable for this use.
IMPR W 80000
HOUSEHOLD SICKROOMS PREMISES/CONTENTS/UTENSILS
RTU
Mop., Not on label., Mop., Hard., Not
applicable for this use.
Sponge-on., Not on label., Sponge., Hard.,
Not applicable for this use.
Spray., Not on label., Aerosol can., Hard.,
Not applicable for this use.
Spray., Not on label., Mechanical sprayer.,
Hard., Not applicable for this use.
Spray., Not on label., Pump-up sprayer.,
Hard., Not applicable for this use.
Wipe-on/wiper treatment., Not on label.,
Cloth., Hard., Not applicable for this use.
RTU
PRL
PRL
RTU
RTU
W 343900
W 432200
W 80000
W 80000
IMPR W 80000
IMPR W 80000
IMPR W 80000
IMPR W 80000
Use Group: INDOOR MEDICAL (con't)
W 80000 * NS NS NS NS NS
IMPR
IMPR
IMPR
IMPR
IMPR
IMPR
RTU
RTU
W
W
W
W
W
W
W
W
80000
80000
80000
632500
632500
632500
80000
700000
W
W
W
W
W
W
W
W
80000
80000
80000
632500
632500
632500
80000
700000
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Use Group: INDOOR MEDICAL
W 80000 * NS NS
W 80000 * NS
NS
W 343900
NS NS
W 432200 * NS NS
W 80000 * NS NS
NS
NS
W 80000
NS NS
W 80000 * NS NS
W 80000 * NS NS
W 80000 * NS NS
W 80000 * NS NS
NS
NS
NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS
NS
NS
NS
NS
A06, A10(5) , A30
AIO(IO)
A10(5)
A25(0.5), A26(10)
A08, A10(l)
A08, A10(4)
A08, A10(6)
AIO(IO) , A30
AIO(IO) , A30
AIO(IO), A30
AIO(IO), A30
A08, AIO(IO)
A08
AIO(IO), A30
AIO(IO), A30
AIO(IO)
A10(5)
A10(5), A13, A30
A25(0.5), A26(10)
-------
Date 12/14/94 ) Time 10:43
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 047501 [Isopropanol]
LUIS 1.6 ) Page 21
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. &dOD Geographic Limitations &d@ Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. &dOD@ Max. Rate&d@ unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year &dODotherwise)/A] &d@ (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
HOUSEHOLD SICKROOMS PREMISES/CONTENTS/UTENSILS (con't)
RTU W 80000
HOUSEHOLD/DOMESTIC DWELLINGS
Mop., Not on label., Mop., Hard., Not RTU W 80000
applicable for this use.
Sponge-on., Not on label., Sponge., Hard., RTU W 80000
Not applicable for this use.
Spray., Not on label., Mechanical sprayer., RTU W 80000
Hard., Not applicable for this use.
Spray., Not on label., Pump-up sprayer.,
Hard., Not applicable for this use.
Wipe-on/wiper treatment., Not on label., IMPR W 80000
Cloth., Hard., Not applicable for this use.
HOUSEHOLD/DOMESTIC DWELLINGS CONTENTS
Spray., Not on label., Aerosol can., Hard., PRL W 343900
Not applicable for this use.
Use Group: INDOOR MEDICAL (con't)
W 80000 * NS NS NS NS NS
Use Group: INDOOR RESIDENTIAL
W 80000 * NS NS NS NS NS
RTU
RTU
RTU
RTU
RTU
RTU
RTU
IMPR
IMPR
IMPR
IMPR
RTU
RTU
PRL
PRL
PRL
PRL
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
80000
80000
80000
80000
80000
80000
80000
80000
80000
80000
80000
80000
80000
343900
432200
507000
530000
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
Use Group
343900 *
432200 *
507000 *
530000 *
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: INDOOR
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
RESIDENTIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
AIO(IO) , A30
AIO(IO), A13, A30
AIO(IO) , A30
AIO(IO), A13, A30
AIO(IO) , A30
AIO(IO), A13, A30
AIO(IO) , A30
AIO(IO), A13, A30
AIO(IO) , A30
AIO(IO)
A10(5)
A10(5), A13, A30
A25(0.5), A26(10)
AIO(IO), A13, A30
AIO(IO) , A30
A08, AIO(IO)
A08
A08, AIO(IO)
-------
Date 12/14/94 ) Time 10:43
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 047501 [Isopropanol]
LUIS 1.6 ) Page 22
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [ (AI Min. Restr. &dOD Geographic Limitations &d@ Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. &dOD@ Max. Rate&d@ unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year &dODotherwise)/A] &d@ (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
HOUSEHOLD/DOMESTIC DWELLINGS CONTENTS (con't)
Use Group: INDOOR RESIDENTIAL (con't)
Spray., Not on label., Aerosol can.,
Porous., Not applicable for this use.
Spray., Not on label., Pump spray bottle.
Hard., Not applicable for this use.
HOUSEHOLD/DOMESTIC DWELLINGS INDOOR PREMISES
Indoor premise treatment., When needed.,
Mist sprayer.
Spray., Not on label., Aerosol can., Hard.,
Not applicable for this use.
Spray., Not on label., Pump spray bottle.,
Hard., Not applicable for this use.
PRL
PRL
PRL
PRL
PRL
PRL
RTU
RTU
RTU
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
RTU
RTU
W
W
W
W
W
W
W
W
NA
W
W
W
W
W
W
W
W
W
W
W
530000
530000
530000
570000
591600
432200
400000
757100
343900
432200
507000
530000
530000
530000
530000
570000
591600
603900
400000
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
530000 *
530000 *
530000 *
570000 *
591600 *
432200 *
400000 *
757100 *
Use Group
UC *
343900 *
432200 *
507000 *
530000 *
530000 *
530000 *
530000 *
570000 *
591600 *
603900 *
400000 *
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: INDOOR
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
RESIDENTIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
A08
A08, AIO(IO)
AIO(IO)
A08
AIO(IO) , A30
A08
A08, AIO(IO), C23
A08, AIO(IO)
AIO(IO), A30
A08, AIO(IO)
A08
A08, AIO(IO)
A08
A08, AIO(IO)
AIO(IO)
A08
AIO(IO) , A30
AIO(IO) , A30
A08, AIO(IO), C23
-------
Date 12/14/94 ) Time 10:43
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 047501 [Isopropanol]
LUIS 1.6 ) Page 23
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. &dOD Geographic Limitations &d@ Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. &dOD@ Max. Rate&d@ unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year &dODotherwise)/A] &d@ (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
HOUSEHOLD/DOMESTIC DWELLINGS INDOOR PREMISES (con't)
RTU W 757100
HUMAN BEDDING/MATTRESSES
Spray., Not on label., Aerosol can., Hard.,
Not applicable for this use.
HUMAN FOOTWEAR
Spray., Not on label., Aerosol can., Hard.,
Not applicable for this use.
Spray., Not on label., Aerosol can.,
Porous., Not applicable for this use.
HUMAN HEADGEAR
Mop., Not on label., Mop., Hard., Not
applicable for this use.
Sponge-on., Not on label., Sponge., Hard.,
Not applicable for this use.
Spray., Not on label., Mechanical sprayer.,
Hard., Not applicable for this use.
Spray., Not on label., Pump-up sprayer.,
Hard., Not applicable for this use.
Wipe-on/wiper treatment., Not on label.,
Cloth., Hard., Not applicable for this use.
RTU W 603900
PRL W 242370
PRL W 432200
Use Group: INDOOR RESIDENTIAL (con't)
W 757100 * NS NS NS NS NS
Use Group: INDOOR RESIDENTIAL
W 603900 * NS NS NS NS NS
Use Group: INDOOR RESIDENTIAL
W 242370 * NS NS NS NS NS
W 432200
NS
NS
NS
NS NS
PRL
PRL
RTU
RTU
RTU
RTU
RTU
RTU
RTU
RTU
IMPR
IMPR
IMPR
W
W
W
W
W
W
W
W
W
W
W
W
W
530000
591600
80000
80000
80000
80000
80000
80000
80000
80000
80000
80000
80000
W
W
W
W
W
W
W
W
W
W
W
W
W
530000 *
591600 *
Use Group
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
80000 *
NS
NS
NS
NS
: INDOOR
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
RESIDENTIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
A08, AIO(IO)
AIO(IO), A30
A08
A08, CIS, C24
AIO(IO) , A30
AIO(IO), A13, A30
AIO(IO) , A30
AIO(IO), A13, A30
AIO(IO) , A30
AIO(IO), A13, A30
AIO(IO) , A30
AIO(IO), A13, A30
AIO(IO) , A30
A06, A10(5) , A30
AIO(IO)
A10(5)
-------
Date 12/14/94 ) Time 10:43
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 047501 [Isopropanol]
LUIS 1.6 ) Page 24
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. &dOD Geographic Limitations &d@ Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. &dOD@ Max. Rate&d@ unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year &dODotherwise)/A] &d@ (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
HUMAN HEADGEAR (con't)
Use Group: INDOOR RESIDENTIAL (con't)
LAUNDRY EQUIPMENT
Mop., Not on label., Mop., Hard., Not
applicable for this use.
Sponge-on., Not on label., Sponge., Hard.,
Not applicable for this use.
Spray., Not on label., Aerosol can., Hard.
Not applicable for this use.
Spray., Not on label., Aerosol can., Not on
the Label., Not applicable for this use.
Spray., Not on label., Mechanical sprayer.,
Hard., Not applicable for this use.
Spray., Not on label., Pump spray bottle.,
Not on the Label., Not applicable for this
use.
Spray., Not on label., Pump-up sprayer.,
Hard., Not applicable for this use.
IMPR
RTU
RTU
RTU
RTU
RTU
RTU
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
RTU
RTU
RTU
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
80000
80000
80000
80000
80000
80000
80000
530000
530000
530000
432200
507000
530000
530000
570000
80000
80000
757100
W 80000 *
W 80000 *
W 80000 *
Use Group
W 80000 *
W 80000 *
W 80000 *
W 80000 *
W 530000 *
W 530000 *
W 530000 *
W 432200 *
W 507000 *
W 530000 *
W 530000 *
W 570000 *
W 80000 *
W 80000 *
W 757100 *
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: INDOOR NON- FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
RTU W 80000
A25(0.5), A26(10)
AIO(IO), A13, A30
AIO(IO) , A30
AIO(IO), A13, A30
AIO(IO) , A30
AIO(IO), A13, A30
AIO(IO) , A30
A08
A08, AIO(IO)
A08
A08, AIO(IO)
A08, AIO(IO)
AIO(IO)
A08
AIO(IO), A13, A30
AIO(IO) , A30
A08, AIO(IO)
AIO(IO), A13, A30
-------
Date 12/14/94 ) Time 10:43
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 047501 [Isopropanol]
LUIS 1.6 ) Page 25
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. &dOD Geographic Limitations &d@ Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. &dOD@ Max. Rate&d@ unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year &dODotherwise)/A] &d@ (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
LAUNDRY EQUIPMENT (con't)
Spray., Not on label., Sprayer., Not on the
Label., Not applicable for this use.
Wipe-on/wiper treatment., Not on label.,
Cloth., Hard., Not applicable for this use.
Use Group: INDOOR NON-FOOD (con't)
RTU
RTU
RTU
IMPR
IMPR
IMPR
IMPR
IMPR
RTU
RTU
W
W
W
W
W
W
W
W
W
W
80000
600000
600000
80000
80000
80000
80000
80000
80000
80000
W
W
W
W
W
W
W
W
W
W
80000
600000
600000
80000
80000
80000
80000
80000
80000
80000
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
PET LIVING/SLEEPING QUARTERS
Animal bedding/litter treatment., When
needed., Pump spray bottle.
Enclosed premise treatment., When needed.,
Mist sprayer.
Indoor premise treatment., When needed.,
Pump spray bottle.
Spray., Not on label., Aerosol can., Hard.,
Not applicable for this use.
PRL W 343900
PRL W 432200
PRL W 591600
Spray., Not on label., Aerosol can., Not PRL W 591600
Applicable., Not applicable for this use.
Use Group: INDOOR RESIDENTIAL
UC * NS NS NS
UC
* NS
W 343900 * NS
NS
NS
NS
NS
W 432200 * NS NS NS
W 591600 * NS NS NS
Use Group: OUTDOOR RESIDENTIAL
W 591600 * NS NS NS
NS NS
NS NS
NS NS
NS
NS
AIO(IO) , A30
A08
A08, A25(10)
A06, A10(5), A30
AIO(IO)
A10(5)
A13
A25(0.5), A26(10)
AIO(IO), A13, A30
AIO(IO) , A30
AIO(IO), A30
A08, AIO(IO)
A08
AIO(IO) , A30
AIO(IO), A30
-------
Date 12/14/94 ) Time 10:43
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 047501 [Isopropanol]
LUIS 1.6 ) Page 26
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. &dOD Geographic Limitations &d@ Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. &dOD@ Max. Rate&d@ unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year &dODotherwise)/A] &d@ (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
REFUSE/SOLID WASTE CONTAINERS (GARBAGE CANS)
Spray., Not on label., Aerosol can., Hard.,
Not applicable for this use.
Use Group: INDOOR RESIDENTIAL
W 242370 * NS NS NS
Spray., Not on label., Pump spray bottle.,
Hard., Not applicable for this use.
Spray., Not on label., Sprayer., Hard., Not
applicable for this use.
Surface treatment., Not on label., Not on
label., Hard., Not applicable for this use.
RESIDENTIAL FLOORS (ANTIMICROBIALS ONLY)
Spray., Not on label., Aerosol can., Hard.,
Not applicable for this use.
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
PRL
RTU
RTU
RTU
RTU
SC/L
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
V
242370
242370
343900
432200
507000
530000
530000
530000
530000
570000
591600
675000
400000
757100
600000
600000
5385
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
242370
242370
343900
432200
507000
530000
530000
530000
530000
570000
591600
675000
400000
757100
600000
600000
V 5385
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Use Group: INDOOR RESIDENTIAL
W 507000 * NS NS NS
A08, A37
A30, A37
A3 7
A08, AIO(IO)
A08
A08, AIO(IO)
A08, AIO(IO)
A08, CIS, C24
AIO(IO)
A08
AIO(IO) , A30
AIO(IO)
A08, AIO(IO), C23
A08, AIO(IO)
A08
A08, A25(10)
A08
A08, AIO(IO)
W 530000 * NS NS
NS
-------
Date 12/14/94 ) Time 10:43
APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 047501 [Isopropanol]
LUIS 1.6 ) Page 27
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. &dOD Geographic Limitations &d@ Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. &dOD@ Max. Rate&d@ unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year &dODotherwise)/A] &d@ (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
RESIDENTIAL FLOORS (ANTIMICROBIALS ONLY) (con't)
PRL
PRL
PRL
RTU
Spray., Not on label., Pump spray bottle.,
Hard., Not applicable for this use.
TOILET BOWLS (INTERIOR SURFACES)
Pour-on., Not on label., Swab., Hard., Not
applicable for this use.
URINALS (INTERIOR SURFACES)
Pour-on., Not on label., Swab., Hard., Not
applicable for this use.
RTU
W 530000
W 530000
W 530000
W 400000
W 757100
SC/L V 7143
SC/L W 350000
Use Group: INDOOR RESIDENTIAL (con't)
W 530000 * NS NS NS NS NS
W 530000 * NS NS NS NS NS
W 530000 * NS NS NS NS NS
W 400000 * NS NS NS NS NS
W 757100 * NS NS NS NS NS
Use Group: INDOOR RESIDENTIAL
V 7143 * NS NS NS NS NS
Use Group: INDOOR RESIDENTIAL
W 350000 * NS NS NS NS NS
NS
NS
NS
NS
A08
A08, AIO(IO)
AIO(IO)
A08, AIO(IO), C23
A08, AIO(IO)
-------
Date 12/14/94 ) Time 10:43 APPENDIX A ) CASE 4003, [Aliphatic alcohols, C1-C5] Chemical 047501 [Isopropanol] LUIS 1.6 ) Page 28
44444444
LEGEND
444444
HEADER ABBREVIATIONS
Min. Appl. Rate (AI unless : Minimum dose for a single application to a single site. System calculated. Microbial claims only.
noted otherwise)
Max. Appl. Rate (AI unless : Maximum dose for a single application to a single site. System calculated.
noted otherwise)
Soil Tex. Max. Dose : Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).
Max. # Apps ® Max. Rate : Maximum number of Applications at Maximum Dosage Rate. Example: "4 applications per year" is expressed as "4/1 yr"; "4 applications per 3
years" is expressed as "4/3 yr"
Max. Dose [(AI unless : Maximum dose applied to a site over a single crop cycle or year. System calculated.
noted otherwise)/A]
Min. Interv (days) : Minimum Interval between Applications (days)
Restr. Entry Interv (days) : Restricted Entry Interval (days)
SOIL TEXTURE FOR MAX APP. RATE
* : Non-specific
C : Coarse
M : Medium
F : Fine
O : Others
FORMULATION CODES
IMPR : IMPREGNATED MATERIAL
PRL : PRESSURIZED LIQUID
RTU : LIQUID-READY TO USE
SC/L : SOLUBLE CONCENTRATE/LIQUID
ABBREVIATIONS
AN : As Needed
NA : Not Applicable
NS : Not Specified (on label)
UC : Unconverted due to lack of data (on label), or with one of following units: bag, bait, bait block, bait pack, bait station, bait station(s), block, briquet,
briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop, eartag, grains, lure, pack, packet, packets, pad, part,
parts, pellets, piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape, towelette, tray, unit, --
APPLICATION RATE
DCNC : Dosage Can Not be Calculated
No Calc : No Calculation can be made
W : PPM calculated by weight
V : PPM Calculated by volume
cwt : Hundred Weight
nnE-xx : nn times (10 power -xx); for instance, "1.234E-04" is equivalent to ".0001234"
USE LIMITATIONS CODES
A06 : Potable water rinse (non-residual claim) .
A08 : Preclean claim.
A10 : minute(s) contact time.
A13 : One-step cleaner.
A16 : Sterile water rinse.
A25 : minute(s) contact time (minimum).
A30 : Preclean for heavily soiled areas.
A37 : Residual bacteriostatic activity.
CIS : Do not discharge effluent containing this pesticide into sewage systems without notifying the sewage treatment plant authority.
C24 : Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or public water. (NPDES license restriction)
* NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
-------
102
-------
APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
103
-------
104
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case Aliphatic Alcohols covered by this Reregistration Eligibility
Decision Document. It contains generic data requirements that apply to Aliphatic Alcohols 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
0 Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files,
this column lists the identifying number of each study. This normally is the Master Record
Identification (MRID) number, but may be a "GS" number if no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
105
-------
106
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Ethanol
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-1
61-2A
61-2B
62-2
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Certification of limits
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition
PH
Stability
Oxidizing/Reducing Action
Flammability
Explodability
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
42705601
42705601
42705601
42705602
42705603
42705603
42705603
42705603
42705603
42705603
42705603
42705603
42705603
Waived
42705603
42705603
42705603
42705603
42705603
107
-------
Data Supporting Guideline Requirements for the Reregistration of Ethanol
REQUIREMENT
63-17
63-18
63-19
63-20
Storage stability
Viscosity
Miscibility
Corrosion characteristics
USE PATTERN
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CITATION(S)
Waived
42705603
42705603
42705603
ECOLOGICAL EFFECTS
72-1A
72-1C
72-2A
72-3A
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
Esturine/Marine Toxicity Fish
CGLMNO
CGLMNO
CGLMNO
CGLMNO
40098001
40098001
*
*
TOXICOLOGY
81-1
81-3
81-4
81-5
82-1A
82-2
82-4
83-1A
83-3A
84-2A
Acute Oral Toxicity - Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
90 Day Feeding - Rodent
21 Day Dermal
90 Day Inhalation
Chronic Feeding Toxicity - Rodent
Developmental Toxicity - Rat
Gene Mutation (Ames Test)
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
*
*
*
*
*
*
*
00031038
*
*
108
-------
Data Supporting Guideline Requirements for the Reregistration of Ethanol
REQUIREMENT USE PATTERN CITATION(S)
84-2B Structural Chromosomal CGLMNO *
Aberration
84-4 Other Genotoxic Effects CGLMNO *
85-1 General Metabolism CGLMNO *
* These guidelines were satisfied by studies in the open literature.
109
-------
Data Supporting Guideline Requirements for the Reregistration of Isoproponal
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-1
61-2A
61-2B
62-2
62-3
63-2
63-3
63-4
63-6
63-7
63-8
63-9
63-11
63-12
63-13
Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Certification of limits
Analytical Methods
Color
Physical State
Odor
Boiling Point
Density
Solubility
Vapor Pressure
Octanol/Water Partition
PH
Stability
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
42478901
42478901
42478901
*
42478901
42705603
42705603
42705603
42705603
42705603
42705603
42705603
*
*
42478901
ECOLOGICAL EFFECTS
72-2A
72-3A
Invertebrate Toxicity
Esturine/Marine Toxicity Fish
CGLMNO
CGLMNO
*
*
TOXICOLOGY
81-1
Acute Oral Toxicity - Rat
CGLMNO
110
*
-------
Data Supporting Guideline Requirements for the Reregistration of Isoproponal
REQUIREMENT
81-2
81-3
81-4
81-5
83-1A
83-3A
84-2A
84-2B
84-4
85-1
* These
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Chronic Feeding Toxicity - Rodent
Developmental Toxicity - Rat
Gene Mutation (Ames Test)
Structural Chromosomal
Aberration
Other Genotoxic Effects
General Metabolism
guidelines were satisfied by studies in the
USE PATTERN
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
CGLMNO
open literature.
CITATION(S)
0050951
42478902
*
*
00031038
42873501
*
*
*
*
111
-------
112
-------
APPENDIX C. Citations Considered to be Part of the Data
Base Supporting the Reregistration of Aliphatic Alcohols
113
-------
114
-------
GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere in the Reregistration Eligibility Document. Primary sources for studies in
this bibliography have been the body of data submitted to EPA and its predecessor
agencies in support of past regulatory decisions. Selections from other sources
including 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 least a single subject), can stand alone for purposes of review and
can be described with a conventional bibliographic citation. The Agency has also
attempted to unite basic documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically 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 (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the
Agency has shown an identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the
first submitter as the author.
b. Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced
the date from the evidence contained in the document. When the date appears
115
-------
as (19??), the Agency was unable to determine or estimate the date of the
document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are contained
between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the
trailing parentheses include (in addition to any self-explanatory text) the
following elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the
word "under" is the registration number, experimental use permit
number, petition number, or other administrative number associated
with the earliest known submission.
(3) Submitter. The 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 study within
the volume.
116
-------
BIBLIOGRAPHY
MRID
CITATION
00031038 Boughton, L.L. (1944) The relative toxicity of Ethyl and Isopropyl alcohols as
determined by long term rat feeding and external application. Journal of the
American Pharmaceutical Association 33:111-113. (Also In unpublished
submission received Apr 23, 1980 under 10279-7; submitted by Purdue
Frederick Co., Norwalk, Conn.; CDL:242321-F)
00050951 Union Carbide Corporation (1967) Toxicology Studies: Isopropanol. Rev.
(Unpublished study received Sep 6, 1977 under 9480-3; submitted by
Professional Disposables, Inc., Mount Vernon, N.Y.; CDL:231846-E)
00131196 Nixon, G.; Tyson, C.; Wertz, W. (1975) Interspecies comparisons of skin
irritancy. Toxicology and Applied Pharmacology 31:481-490. (Also In
unpublished submission received Sep 19, 1983 under 49199-1; submitted by
Isotex, Inc., Framingham, MA; CDL: 251341-C)
42478902 Gill, M.; Hurley, J. (1992) Isopropanol Single Exposure Vapor Inhalation
Neurotoxicity Study in Rats to Fulfill Requirement for Acute Inhalation LC50
for Isopropanol: Lab Project Number: 53-554. Unpublished study prepared by
Union Carbide Co., Bushy Run Research Center. 294 p.
42873501 Tyl, R.W., Marr, M.C., and Meyers, C.B. (1990a). Developmental Toxicity
Evaluation of Isopropanol Administered by Gavage to CD (Sprague-Dawley)
Rats, RTI Project No. 311C-4557, Research Triangle Institute, Research
Triangle Park, NC.
Andrews, L.S. and Snyder, R. (1991). Toxic Effects of Solvents and Vapors.
In Amdur, M.O., Doull, J. and Klaassen, C.D. (Eds.), Casarett and Doull's
Toxicology, The Basic Science of Poisons, 4th Edition, Pergamon Press, New
York, pp 698-699.
BASF Corp. (1989). Bericht uber die Bestimmung der akuten
Inhalationstoxizitat LC50 von Isopropanol, 99.7% (MERCK AG) als
Flussigkeits-Aerosol bei 4stundiger Exposition an Sprague-Dawley-Ratten.
(USEPA/OTS Doc. No.: 86-890000188, NTIS/OTS No. 0516725)
Broxup, B, Robinson, K., Losos, G. and Beyrouty, P. (1989). Correlation
between Behavioral and Pathological Changes in the Evaluation of
Neurotoxicity. Toxicol. Appl. Pharmacol. 101, 510-520.
117
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BIBLIOGRAPHY
MRID CITATION
Burleigh-Flayer, H.D. and Benson, C.L. (1994). Isopropanol Vapor Inhalation
Oncogenicity Study in Fischer 344 Rats. BRRC Report 91N0133, Bushy Run
Research Center, Export, PA.
Burleigh-Flayer, H.D., Chun, J.S., and Kintigh, W.J. (1991). Isopropanol
Fourteen-Week Vapor Inhalation Study in Rats and Mice with Neurotoxicity
Evaluation in Rats. BRRC Report 53-589, Bushy Run Research Center,
Export, PA.
Burleigh-Flayer, H.D., Gill, M.W. and Kintigh, W.J. (1990). Isopropanol
Nine-Day Probe Vapor Inhalation Study on Rats and Mice. BRRC Report 53-
514, Bushy Run Research Center, Export, PA.
Burleigh-Flayer, H.D., Gill, M.W., Strother, D.E., Masten, L.W., McKee,
R.H., Tyler, T.R., and Gardiner, T. (1994). Isopropanol 13-week Vapor
Inhalation Study in Rats and Mice with Neurotoxicity Evaluation in Rats,
Fundam. Appl. Pharmacol. 23, 421-428.
Burleigh-Flayer, H.D. and Hurley, J.M. (1994). Isopropanol: Ninety-Day
Vapor Inhalation Neurotoxicity Study in Female Fischer 344 Rats. BRRC
Report 93N1245, Bushy Run Research Center, Export, PA.
Burleigh-Flayer, H.D. and Wagner, C.L. (1993). Isopropanol Vapor
Inhalation Oncogenicity Study in CD-I Mice. BRRC Report 91 NO 132, Bushy
Run Research Center, Export, PA.
Clayton, G. D. and Clayton, F. E., eds., (1982). Patty's Industrial Hygiene
and Toxicology, vol 2C, Third Revised Edition, John Wiley and Sons, pp.
4564-4565.
Coon, R.A., Jones, R.A. Jenkins, L.J., Jr., and Siegle, R.E. (1970). Animal
Inhalation Studies on Ammonia, Ethylene Glycol, Formaldehyde,
Dimethylamine, and Ethanol. Toxicol. Appl. Pharmacol. 16, 646-655
Exxon (1992). Multi-Generational Rat Reproduction Study with Isopropanol,
Project No. 259835, Exxon Biomedical Sciences, Inc., East Millstone, NJ.
Fowler, E.H. and Martin, C. (1994). Immunohistochemical Evaluation of
Alpha2u-globulin in Kidneys of Fischer 344 Rats from the Isopropanol Nine-Day
118
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BIBLIOGRAPHY
MRID CITATION
Vapor Inhalation Study. BRRC Report 93N1229, Bushy Run Research Center,
Export, PA.
Griffith, J., Nixon, G., Bruce, R., Reer, P., and Bannan, E. (1980). Dose-
Response Studies with Chemical Irritants in the Albino Rabbit Eye as a Basis
for Selecting Optimum Testing Conditions for Predicting Hazard to the Human
Eye, Toxicol. Appl. Pharmacol. 55, 501-513.
Guess, W.L. (1970). Tissue Reactions to 2-Chloroethanol in Rabbits. Toxicol.
Appl. Pharmacol. 16, 382-390
Ivett, J.L. (199la). Single Acute Exposure Dose Selection Study of
Isopropanol. HLA Study No.: 12005-0-459-IP. Hazelton Laboratories
America, Inc., Rockville, MD.
Ivett, J.L. (1991b). Mutagenicity Test of Isopropanol in vitro Mouse
Micronucleous Assay, HLA Study No.: 12005-0-455, Hazelton Laboratories
America, Inc., Rockville, MD.
Jones, K.L. and Smith, D.W. (1973). Recognition of the Fetal Alcohol
Syndrome in Early Infancy. Lancet 2: 999-1001.
Jones, K.L. Smith, D.W., Ulleland, C.N. and Streissguth, A.P. (1973).
Pattern of Malformation in Offspring of Chronic Alcoholic Mothers, Lancet 1:
1267-1271.
Kager, L. and Ericsson, J.L.E. (1974). Long Term Toxicity Study with
Alcohol and 4-Methylpyrazole in Rat. Acta Pathol. Microbiol. Scand., Sect A,
82, 534-538.
Kennah, H.E., II, Hignet, S., Laux, P.E., Dorko, J.D. and Barrow, C.S.
(1989). An Objective Procedure for Quantitative Eye Irritation Based upon
Changes of Corneal Thickness. Fundam. Appl. Toxicol. 12, 258-268.
Laham, S., Potvin, M., Schrader, K., and Marino, I. (1980). Studied on
Inhalation Toxicity of 2-Propanol. Drug Chem. Tox. 3, 343-360.
119
-------
BIBLIOGRAPHY
MRID CITATION
Meyer, L.S. and Riley, E.P. (1986). Behavioral Teratology of Alcohol, In:
Handbook of Behavioral Teratololgy, Riley, E.P. and Vorhees, C.V., Eds.,
New York, Plenum Press, pp 101-140.
Nelson, B.K, Brightwell, W.S., MacKenzie-Taylor, D.R., Khan, A., Burg,
J.R., Weigel, W.W., and Goad, P.T. (1988). Teratogenicity of n-Propanol
and Isopropanol Administered at High Concentrations to Rats, Fd. Chem.
Toxic. 26, 247-254.
Phillips, L., II, Steinberg, M., Maibach, H.I. and Akers, W.A. (1972). A
Comparison of Rabbit and Human Skin Response to Certain Irritants. Toxicol.
Appl. Pharmacol. 21, 369-382.
Rees, D.C., Francis, E.Z. and Kimmel, C.A. (1990). Scientific and
Regulatory Issues Relevant to Assessing Risk for Developmental Neurotoxicity:
An Overview. Neurotoxicol. Teratol. 12, 175-181.
RTI (1991). Developmental Neurotoxicity Evaluation of Isopropanol (CAS 67-
63-0) Administered by Gavage to Timed-Mated CD Rats on Gestational Day 6
Through Postnatal Day 21, RTI Study Code: RT89-ISDN, Research Triangle
Institute, Research Triangle Park, NC.
Sax, N.I. and Lewis R.J., Sr. (1989a). Dangerous Properties of Industrial
Materials, Vol II, 7th ed., New York, Van Nostrand Reinhold, p. 1595.
Sax, N.I. and Lewis R.J., Sr. (1989b). Dangerous Properties of Industrial
Materials, Vol II, 7th ed., New York, Van Nostrand Reinhold, p. 2045.
Slauter, R.W., Coleman, D.P., Gaudette, N.F., McKee, R.H., Masten, L.W.,
Gardiner, T.H., Strother, D.E., Tyler, T.R., and Jeffcoat, A.R. (1994).
Disposition and Pharmacokinetics of Isopropanol in F-344 Rats and B6C3F1
Mice. Fundam. Appl. Toxicol. 23, 407-420.
Tyl, R.W., Marr, M.C., and Meyers, C.B. (1990b). Developmental Toxicity
Evaluation of Isopropanol Administered by Gavage to New Zealand White
Rabbits, RTI Project No. 311C-4557, Research Triangle Institute, Research
Triangle Park, NC.
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BIBLIOGRAPHY
MRID CITATION
Young, R.R. (1990). Mutagenicity Test on Isopropanol in the CHO/HGPRT
Forward Mutation Assay with Independent Repeat. HLA Study No.: 12005-0-
435, Hazelton Laboratories America, Inc., Kensington, MD.
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122
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APPENDIX D. List of Available Related Documents
123
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124
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The following is a list of available documents related to Aliphatic Alcohols. 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 Aliphatic Alcohols 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. Aliphatic Alcohols 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
125
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126
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APPENDIX E. PR Notices 86-5 and 91-2
127
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128
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PR Notice 86-5
129
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130
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
tPROl WASHINGTON, D.C. 20460
July 29, 1986
OFFICE OF
PR NOTICE 86-5 PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
NOTICE TO PRODUCERS, FORMULATORS, 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)(l). 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 1, 1986. Data formatted according to this notice
may be submitted prior to the effective date. As of the effective date, submitted data packages
that do not conform to these requirements may be returned to the submitter for necessary
revision.
IV. Background
On September 26, 1984, EPA published proposed regulations in the Federal Register
(49 FR 37956) which include Requirements for Data Submission (40 CFR §158.32), and
Procedures for Claims of Confidentiality of Data (40 CFR §158.33). These regulations
specify the format for data submitted to EPA under Section 3 of FIFRA and Sections 408 and
4139 of FFDCA, and procedures which must be followed to make and substantiate claims of
confidentiality. 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.
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V. Relationship of this Notice to Other OPP Policy and Guidance
While this Notice contains requirements for organizing and formatting submittals of
supporting data, it does not address the substance of test reports themselves. "Data reporting"
guidance is now under development in OPP, and will specify how the study objectives,
protocol, observations, findings, and conclusions are organized and presented within the study
report. The data reporting guidance will be compatible with submittal format requirements
described in this Notice.
OPP has also promulgated a policy (PR Notice 86-4 dated April 15, 1986) that
provides for early screening of certain applications for registration under FIFRA §3. The
objective of the screen is to avoid the additional costs and prolonged delays associated with
handling significantly incomplete application packages. As of the effective date of this Notice,
the screen will include in its criteria for acceptance of application packages the data formatting
requirements described herein.
OPP has also established a public docket which imposes deadlines for inserting into the
docket documents submitted in connection with Special Reviews and Registration Standards
(see 40 CFR §154.15 and §155.32). To meet these deadlines, OPP is requiring an additional
copy of any data submitted to the docket. Please refer to Page 10 for more information about
this requirement.
For several years, OPP has required that each application for registration or other
action include a list of all applicable data requirements and an indication of how each is
satisfied—the statement of the method of support for the application. Typically, many
requirements are satisfied by reference to data previously submitted—either by the applicant or
by another party. That requirement is not altered by this notice, 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.
- INDEX-
Text Example
Page Page
A. Organization of the Submittal Package 3 17
B. Transmittal Document 4 11
C. Individual Studies 4
C. 1 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
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Claims (other than those based on FIFRA §10(d)(l)) 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. Organization of Submittal Package
A "submittal package" consists of all studies submitted at the same time for review in
support of a single regulatory action, along with a transmittal document and other related
administrative material (e.g. the method of support statement, EPA Forms 8570-1, 8570-4,
8570-20, etc.) as appropriate.
Data submitters must organize each submittal package as described in this Notice. The
transmittal and any other administrative 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).
B. Transmittal Document
The first item in each submittal package must be a transmittal 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)(2j(B) data call-in, §6(aj(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.
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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 or the studies. Within
these two groups of studies follow the instructions above.
C. Individual Studies
A study is the report of a single scientific investigation, including all supporting
analyses required for logical completeness. 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 Guideline requirement for supporting data, with some
exceptions discussed 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.
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.I 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 associated 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.
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Note particularly that product chemistry studies are likely to contain Confidential
Business Information as defined in FIFRA §10(d)(l)(A), (B), or (C), and if so must be
handled as described in section D.3. of this notice.
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 investigation 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
Always
One of the two alternative
forms of this statement
is always required
If study reports laboratory
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
, (B),or(C)
Example
Page 12
Page 13
Page 16
CBI Attachment
Supplemental Statement
of Data Confidentiality
Claims
If CBI is claimed under FIFRA
(B),or©
Only if confidentiality is
claimed on a basis other than
FIFRA§10(d)(l)(A), (B), or (C)
Page 15
Page 14
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D.I. Title 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 INCLUDE CBI ON
THE TITLE PAGE. An example of an acceptable title page is on page 12 of this notice.
The following information must appear on the title page:
a. Study title. The study title should be as descriptive as possible It must clearly identify
the substance (s) tested and correspond to the name of the data requirement as it appears in the
Guidelines.
b. Data requirement addressed. Include on the title page the Guideline number (s) of the
specific requirement (s) addressed by the study.
c. Author (s). Cite only individuals with primary intellectual responsibility for the content
of the study. Identify them plainly as authors, to distinguish them from the performing
laboratory, study sponsor, or other names that may also appear on the title page.
d. Study Date. The title page must include a single date for the study. If parts of the
study were performed at different times, use only the date of the latest element in the study.
e. Performing Laboratory Identification. If the study reports work done by one or more
laboratories, include on the title page the name and address of the performing laboratory or
laboratories, and the laboratory's internal project number (s) for the work. Clearly distinguish
the laboratory's project identifier from any other reference numbers provided by the study
sponsor or submitter.
f. Supplemental Submissions. If the study is a commentary on or supplement to another
previously submitted study, or it 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 published document, identity on the
title page all relevant tacts of publication, such as the journal title, volume, issue, inclusive
page numbers, and publication date.
D.2. Statements of Data Confidentiality Claims Under FIFRA §10(d)(l).
Each submitted study must be accompanied by one of the two alternative forms of the
statement of Data Confidentiality Claims specified in the proposed regulation in §158.33 (b)
and (c) (See Attachment 3). These statements apply only to claims of data confidentiality
based on FIFRA §10(d)(l)(A), (B), or (C). Use the appropriate alternative form of the
statement either to assert a claim of §10(d)(l) data confidentiality (§158.33(b)) or to waive
such a claim (§158.33(c)). In either case, the statement must be signed and dated, and must
include the typed name and title of the official who signs it. Do not make CBI claims with
respect to analytical methods associated with pet-itions for tolerances or emergency
exemptions (see NOTE Pg 13).
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D.3. Confidential Attachment
If the claim is made that a study includes confidential business information as defined
by the criteria of FIFRA §10(D)(1)(A), (B), or (C) (as described in D.2. above) all such
information must be excised from the body of the study and confined to a separate
study-specific Confidential Attachment. Each passage of CBI so isolated must be identified by
a reference number cited within the body of the study at the point from which the passage was
excised (See Attachment 5).
The Confidential Attachment to a study must be identified by a cover sheet fully
identifying the parent study, and must be clearly marked "Confidential Attachment." An
appropriately annotated photocopy of the parent study title page may be used as this cover
sheet. Paginate the Confidential Attachment separately from the body of the study, beginning
with page 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(s) in the main body of the study
on which it is cited, and with a reference to the applicable passage(s) of FIFRA §10(d)(l) on
which the confidentiality claim is based.
D.4. Supplemental Statement of Data Confidentiality Claims (See
Attachment 4)
If you wish to make a claim of confidentiality for any portion of a submitted study
other than described by FIFRA §10(d) (1)(A), (B), or (C), the following provisions apply:
- The specific information to which the claim applies must be clearly marked in the
body or the study as subject to a claim of confidentiality.
- A Supplemental Statement of Data Confidentiality Claims must be submitted,
identifying each passage claimed confidential 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.
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. Samples of these statements are shown in Attachment
6.
E. Reference to Previously Submitted Data
DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED
FOR ANOTHER PURPOSE unless EPA specifically requests it. A copy of the title page
plus the MRID number (if known) is sufficient to allow us to retrieve the study immediately
for review. This prevents duplicate entries in the Agency files, and saves you
the cost of sending more copies of the study. References to previously submitted studies
should not be included in the transmittal document, but should be incorporated into the
statemenTof 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
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microfilming. Check with EPA for special instructions before submitting data in any medium
other than paper, such as film or magnetic media.
Please be particularly attentive to the following points:
• Do not include frayed or torn pages.
• Do not include carbon copies, or copies in other than black ink.
• Make sure that photocopies are clear, complete, and fully readable.
• Do not include oversize computer printouts or fold-out pages.
• Do not bind any documents with glue or binding tapes.
• Make sure that all pages of each study, including any attachments or
appendices, are present and in correct sequence.
Number of Copies 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.)
G. Special Requirements for Submitting Data to the Docket
Data submittal packages associated with a Registration Standard 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 or an RS or SR are claimed as
CBI, the first three copies will include the CBI material as provided in section D of this
notice. The following special preparation is required for the fourth copy.
• Remove the "Supplemental Statement of Data Confidentiality Claims".
• Remove the "Confidential Attachment".
• Excise from the body of the study any information you claim as confidential,
even if it does not fall within the scope of FIFRA §10(d)(l)(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 phi
"Public Docket Material - contains no information claimed as confidential".
ihrase
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V. For Further Information
For further information contact John Carley, Chief, Information Services Branch,
Program Management and Support Division, (703) 305-5240.
/S/
James W. Akerman
Acting Director,
Registration Division
Attachment 1. Sample Transmittal Document
Attachment 2. Sample Title Page for a Newly Submitted Study
Attachment 3. Statements of Data Confidentiality Claims
Attachment 4. Supplemental Statement of Data Confidentiality Claims
Attachment 5. Samples of Confidential Attachments
Attachment 6. Sample Good Laboratory Practice Statements
Attachment 7. Format Diagrams for Submittal Packages and Studies
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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-smittal letter. This
remains an acceptable practice so long as all four elements are included.
* Indicate which of the joint submitters is empowered to act on behalf of all joint
submitters in any matter concerning data compensation or subsequent use or
release of the data.
Company Official:
Name Signature
Company Name
Company Contact:
Name Phone
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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
Januarys, 1979
Performing Laboratory
ABC Agricultural Laboratories
940 West Bay Drive
Wilmington, CA 39897
Laboratory Project ID
ABC 47-79
Page 1 of X
(X is the total number of pages in the study)
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ATTACHMENT 3
STATEMENTS OF DATA CONFIDENTIALITY CLAIMS
1. No claim of confidentiality under FIFRA §10(d)(l)(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 §10(d)(l)(A), (B), or (C).
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
STATEMENT OF DATA CONFIDENTIALITY CLAIMS
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.
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ATTACHMENT 4
SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
For any portion of a submitted study that is not described by FIFRA §10(d)(l)(A), (B),
or (C), but for which you claim confidential treatment on another basis, the following
information 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 connection 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 submitted, 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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ATTACHMENT 5
EXAMPLES OF SEVERAL CONFIDENTIAL ATTACHMENTS
Example 1. (Confidential word or phrase that has been deleted from the study)
CROSS REFERENCE NUMBER 1 This cross reference number is used in the study in place of the
following paragraph (s) at the indicated volume and page
references.
DELETED WORDS OR PHRASED Ethylene Glycol
PAGE LINES REASON FOR THE DELETION FIFRA
REFERENCE
6 14 Identity of Inert Ingredient §10(d)(C)
28 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 NUMBER 7 This cross reference number is used in the study in place of the
following paragraph (s) at the indicated volume and page
references.
DELETED PAGES(S): are attached immediately behind this page
PAGES REASON FOR THE DELETION FIFRA REFERENCE
35-41. Description of product manufacturing process § 10 (d) (1) (A)
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Example 1.
ATTACHMENT 6.
SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
This study meets the requirements for 40 CFR Part 160
Submitter
Sponsor
Example 2.
This study does not meet the requirements of 40 CFR Part 160, and
differs in the following ways:
1.
2 .
3.
Submitter_
Sponsor
Study Director_
Example 3.
The submitter of this study was neither the sponsor of this study nor
conducted it, and does not know whether it has been conducted in
accordance with 40 CFR Part 160.
Submitter
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ATTACHMENT 7.
FORMAT OF THE SUBMITTAL PACKAGE
Transmittal Document
Related Administrative Materials
(e.g. Method of Support Statement, etc.)
Other materials about the submittal
(e.g., summaries of groups of studies
to aid in their review).
Studies submitted as unique
to the format below.
FORMAT OF SUBMITTED STUDIES
- Study title page.
Statement of Confidentiality Claims.
. GLP and flagging* statements - as appropriate.
Body of the study, with English
language translation if required.
Appendices to the study.
Title Page of the Confidential
Attachment.
Confidential Attachment.
Supplemental Statement
of Confidentiality Claims
• ' * When flagging requirements
are finalised.
Documents which must be submitted as
appropriate to meet established requirements.
Documents submitted at submitter's option.
LEGEND
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PR Notice 91-2
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, B.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
PR NOTICE 91 -2
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,
AND REGISTRANTS OF PESTICIDES
ATTENTION: Persons Responsible for Federal Registration of Pesticide Products.
SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement
I. PURPOSE:
The purpose of this notice is to clarify the Office of Pesticide Program's policy with
respect to the statement of percentages in a pesticide's label's ingredient statement.
Specifically, the amount (percent by weight) of ingredient(s) specified in the ingredient
statement on the label must be stated as the nominal concentration of such ingredient(s), as that
term is defined in 40 CFR 158.153(i). Accordingly, the Agency has established the nominal
concentration as the only acceptable label claim for the amount of active ingredient in the
product.
II. BACKGROUND
For some time the Agency has accepted two different methods of identifying on the
label what percentage is claimed for the ingredient (s) contained in a pesticide. Some applicants
claimed a percentage which represented a level between the upper and the lower certified
limits. This was referred to as the nominal concentration. Other applicants claimed the lower
limit as the percentage of the ingredient(s) that would be expected to be present in their
product at the end or the product's shelf-life. Unfortunately, this led to a great deal of
confusion among the regulated industry, the regulators, and the consumers as to exactly how
much of a given ingredient was in a given product. The Agency has established the nominal
concentration as the only acceptable label claim for the amount of active ingredient in the
product.
Current regulations require that the percentage listed in the active ingredient statement
be as precise as possible reflecting good manufacturing practices 40 CFR 156.10(g)(5). The
certified limits required for each active ingredient are intended to encompass any such "good
manufacturing practice" variations 40 CFR 158.175(c)(3).
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 158.1/5. The lower certified limit is used as the enforceable lower limit for the product
composition according to FIFRA section 12(a)(l)(C), while the nominal concentration
appearing on the label would be the routinely achieved concentration used for calculation of
dosages and dilutions.
The nominal concentration would in fact state the greatest degree of accuracy that is
warranted with respect to actual product composition because the nominal concentration would
be the amount of active ingredient typically found in the product.
It is important for registrants to note that certified limits for active ingredients are not
considered to be trade secret information under FIFRA section 10 (b). In this respect the
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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 or section 12(a)(l)(C).
III. REQUIREMENTS
As described below under Unit V. " COMPLIANCE SCHEDULE," all currently
registered products as well as all applications for new registration must comply with this
Notice by specifying the nominal concentration expressed as a percentage by weight as the
label claim in the ingredient(s) statement and equivalence statements if applicable (e.g.,
elemental 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.
IV. PRODUCTS THAT REQUIRE EFFICACY DATA
All pesticides are required to be efficacious. Therefore, the certified lower limits may
not be lower then the minimum level to achieve efficacy. This is extremely important for
products which are intended to control pests which threaten the public health, e.g., certain
antimicrobial and rodenticide products. Refer to 40 CFR 153.640.
In those cases where efficacy limits have been established, the Agency will not accept
certified lower limits which are below that level for the shelf life of the product.
V. COMPLIANCE SCHEDULE
As described earlier, the purpose of this Notice is to make the registration process
more uniform and more manageable for both the agency and the regulated community. It is
the Agency's intention to implement the requirements of this notice as smoothly as possible so
as not to disrupt or delay the Agency's high priority programs, i.e., reregistration, new
chemical, or fast track (FIFRA section 3(c)(3)(B). Therefore, applicants/registrants are
expected to comply with the requirements of this Notice as follows:
(1) Beginning July 1, 1991, all new product registrations submitted to the Agency
are to comply with the requirements of this Notice.
(2) Registrants having products subject to reregistration under FIFRA section 4 (a)
are to comply with the requirements of this Notice when specific products are
called in by the Agency under Phase V of the Reregistration Program.
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(3) All other products/applications that are not subject to (1) and (2) above will
have until July 1, 1557, 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.
/s/
Anne E. Lindsay, Director
Registration Division (H-7505C)
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APPENDIX F. Product Specific Data Call-in
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-
0
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION. PESTICIDES
AND TOXIC SUBSTANCES
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet, to
submit certain product specific data as noted herein to the U.S. Environmental Protection
Agency (EPA, the Agency). These data are necessary to maintain the continued registration
ofyour 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, (see
section III-B); or
3. Why you believe EPA should not require your submission of product specific
data in the manner specified by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this Notice will be subject to suspension. We have provided a list
of all ofyour 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), 1 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-
0107 (expiration date 12-31-92).
This Notice is divided into six sections and seven Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
Section III - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable
Adverse Effects
Section VI - Inquiries And Responses To This Notice
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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 Batching or End-Use Products tor Meeting Acute Toxicology Data
Requirements tor Reregistration
5 - EPA Acceptance Criteria
6 - List or 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.
II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the OECD
protocols, they should be modified as appropriate so that the data generated by the study will
satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend deadlines for
complying with data requirements when the studies were not conducted in accordance with
acceptable standards. The OECD protocols are available from OECD, 1750 Pennsylvania
Avenue N.W., Washington, D.C. 20006.
All new studies and proposed protocols submitted in response to this Data Call-In Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
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II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in any way supersede or change
the requirements of any previous Data Call-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
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for product specific data must
be submitted to the Agency within 90 days after your receipt of this Notice. Failure to
adequately respond to this Notice within 90 days of your receipt will be a basis for issuing a
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, (b) agree to satisfy the product specific data requirements imposed by this notice or
(c) request a data waiver (s).
A discussion of how to respond if you chose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product specific
data requirements of this Notice is contained in Section III-C. A discussion of options relating to
requests for data waivers is contained in Section III-D.
There are two forms that accompany this Notice of which, depending upon your response,
one or both must be used in your response to the Agency. These forms are the Data-Call-in
Response Form and the Requirements Status and Registrant's Response Form, Attachment 2 and
Attachment 3. The Data Call-in Response Form must be submitted as part of every response to
this Notice. In addition, one copy or the Requirements Status and Registrant's Response Form
must be submitted for each product listed on the Data Call-In Response Form unless the
voluntary cancellation option is selected or unless the product is identical to another (refer to the
instructions for completing the Data Call-In Response Form in Attachment 2). Please note that
the company's authorized representative is required to sign the first page of the Data Call-In
Response Form and Requirements Status and Registrant's Response Form (if this form is
required) and initial any subsequent pages. The forms contain separate detailed instructions on the
response options. Do not alter the printed material. If you have questions or need assistance in
preparing your response, call or write the contact person (s) identified in Attachment 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
b on the Data Calf-In Response Form. If you choose this option, this is the only form that you
are required to complete.
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If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
2. Satisfying the Product Specific Data Requirements of this Notice There are various
options available to satisfy the product specific data requirements of 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 Response Form. Deletion of a use(s) and the iow 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 111-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 six options on the Requirements Status and Registrant's Response Form related to data
production for each data requirement. Your option selection should be entered under item
number 9, "Registrant Response." The six options related to data production are the first six
options discussed under item 9 in the instructions for completing the Requirements Status and
Registrant's Response Form. These six options are listed immediately below with information in
parentheses to guide registrants to additional instructions provided in this Section. The options
are:
1) I will generate and submit data within the specified time frame (Developing Data)
2) I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
3) I have made offers to cost-share (Offers to Cost Share)
4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agency (Citing an Existing
Study)
Option 1 Developing Data — If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced herein
and in the attachments. All data generated and submitted must comply with the Good Laboratory
Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide Assessment
Guidelines (PAG), and be in conformance with the requirements of PR Notice 86-5.
The time frames in the Requirements Status and Registrant's Response Form are the time
frames that the Agency is allowing for the submission of completed study reports. The noted
deadlines run from the date of the receipt of this Notice by the registrant. If the data are not
submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the
affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by this Notice
and intend to seek additional time to meet the requirements(s), you must submit a request to the
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Agency which includes: (1) a detailed description of the expected difficulty and (2) a proposed
schedule including alternative dates for meeting such requirements on a step-by-step basis. You
must explain any technical or laboratory difficulties and provide documentation from the
laboratory performing the testing. While EPA is considering your request, the original deadline
remains. The Agency will respond to your request in writing. If EPA does not grant your
request, the original deadline remains. Normally, extensions can be requested only in cases of
extraordinary testing problems beyond the expectation or control of the registrant. Extensions
will not be given in submitting the 90-day responses. Extensions will not be considered if the
request for extension is not made in a timely fashion; in no event shall an extension request be
considered if it is submitted at or after the lapse of the subject deadline.
Option 2, Agreement to Share in Cost to Develop Data — Registrants may only choose
this option for acute toxicity data and certain efficacy data and only if EPA has indicated in the
attached data tables that your product and at least one other product are similar for purposes of
depending on the same data. If this is the case, data may be generated for just one of the
products in the group. The registration number of the product for which data will be submitted
must be noted in the agreement to cost share by the registrant selecting this option. If you choose
to enter into an agreement to share in the cost of producing the required data but will not be
submitting the data yourself, you must provide the name of the registrant who will be submitting
the data. You must also provide EPA with documentary evidence that an agreement has been
formed. Such evidence may be your letter offering to join in an agreement and the other
registrant's acceptance of your offer, or a written statement by the parties that an agreement
exists. The agreement to produce the data need not specify all of the terms of the final
arrangement between the parties or the mechanism to resolve the terms. Section 3(c)(2)(B)
provides that if the parties cannot resolve the terms of the agreement they may resolve their
differences through binding arbitration.
Option 3, Offer to Share in the Cost of Data Development — This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an offer
to pay in an attempt to enter into an agreement or amend an existing agreement to meet the
requirements of this Notice and have been unsuccessful, you may request EPA (by selecting this
option) to exercise its discretion not to suspend your registration^), although you do not comply
with the data submission requirements of this Notice. EPA has determined that as a general
policy, absent other relevant considerations, it will not suspend the registration of a product of a
registrant who has in good faith sought and continues to seek to enter into a joint data
development/cost sharing program, but the other registrant(s) developing the data has refused to
accept your offer. To qualify for this option, you must submit documentation to the Agency
proving that you have made an offer to another registrant (who has an obligation to submit data)
to share in the burden of developing that data. You must also submit to the Agency a completed
EPA Form 8570-32, Certification of Offer to Cost Share in the Development of Data,
Attachment 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
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frame. In such cases, the Agency generally will not grant a time extension for submitting the
data.
Option 4, Submitting an Existing Study — If you choose to submit an existing study in
response to this Notice, you must determine that the study satisfies the requirements imposed by
this Notice. You may only submit a study that has not been previously submitted to the Agency
or previously cited by anyone. Existing studies are studies which predate issuance of this Notice.
Do not use this option if you are submitting data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the
required date of submission. The Agency may determine at any time that a study is not valid and
needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data
and specimens from the study are available for audit and review and you must
identify where they are available. This must be done in accordance with the
requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR Part
160. As stated in 40 CFR 160.3(j) " 'raw data' means any laboratory worksheets,
records, memoranda, notes, or exact copies thereof, that are the result of original
observations and activities of a study and are necessary for the reconstruction and
evaluation of the report of that study. In the event that exact transcripts of raw
data have been prepared (e.g., tapes which have been transcribed verbatim, dated,
and verified accurate by signature), the exact copy or exact transcript may be
substituted for the original source as raw data. Raw data' may include
photographs, microfilm or microfiche copies, computer printouts, magnetic media,
including dictated observations, and recorded data from automated instruments."
The term "specimens", according to 40 CFR 160.3(k), means "any material
derived from a test system for examination or analysis."
b. Health and safety studies completed after May 1984 must also contain all GLP-
required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants must also certify at the time of
submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study
signed by an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the
Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both
available from NTIS). A study not conducted according to the PAG may be
submitted to the Agency for consideration if the registrant believes that the study
clearly meets the purpose of the PAG. The registrant is referred to 40 CFR
158.70 which states the Agency's policy regarding acceptable protocols. If you
wish to submit the study, you must, in addition to certifying that the purposes of
the PAG are met by the study, clearly articulate the rationale why you believe the
study meets the purpose of the PAG, including copies of any supporting
information or data. It has been the Agency's experience that studies completed
prior to January 1970 rarely satisfied the purpose of the PAG and that necessary
raw data are usually not available for such studies.
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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 in the Agency's files, you
need only cite it along with the notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.
Option 5, Upgrading a Study — If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study. The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the requirement is
not satisfied, you may still be required to submit new data normally without any time extension.
Deficient, but upgradeable studies will normally be classified as supplemental. However, it is
important to note that not all studies classified as supplemental are upgradeable. If you have
questions regarding the classification of a study or whether a study may be upgraded, call or
write the contact person listed in Attachment 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 MRID number (s) of the study which you are attempting to upgrade and must be in
conformance with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
This option should also be used to cite data that has been previously submitted to upgrade
a study, but has not yet been reviewed by the Agency. You must provide the MRID number of
the data submission as well as the MRID number of the study 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.
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-in Response Form and the
Requirements Status and Registrant's Response Form, as appropriate.
III-D REQUESTS FOR DATA WAIVERS
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request, including technical
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reasons, data and references to relevant EPA regulations, guidelines or policies. (Note: any
supplemental data must be submitted in the format required by PR Notice 86-5). This will be the
only opportunity to state the reasons or provide information in support of your request. If the
Agency approves your waiver request, you will not be required to supply the data pursuant to
section 3(c)(2)(B) of FIFRA. If the Agency denies your waiver request, you must choose an
option for meeting the data requirements of this Notice within 30 days of the receipt of the
Agency's decision. You must indicate and submit the option chosen on the Requirements Status
and Registrant's Response Form. Product specific data requirements for product chemistry,
acute toxicity and efficacy (where appropriate) are required for all products and the Agency
would grant a waiver only under extraordinary circumstances. You should also be aware that
submitting a waiver request will not automatically extend the due date for the study in question.
Waiver requests submitted withouTadequate 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 pertaining to any
option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task
Forces, failure to comply with the terms of an agreement or arbitration concerning
joint data development or failure to comply with any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost of
developing data and provided proof of the registrant's receipt of such offer or
failure of a registrant on whom you rely for a generic data exemption either to:
a. inform EPA of intent to develop and submit the data required by this
Notice on a Data Call-In Response Form and a Requirements Status and
Registrant's Response Form;
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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
UNACCEP TABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds
for suspension include, but are not limited to, failure to meet any of the following:
1. EPA requirements specified in the Data Call-In Notice or other documents
incorporated by reference (including, as applicable, EPA Pesticide Assessment
Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test Guidelines)
regarding the design, conduct, and reporting of required studies. Such requirements
include, but are not limited to, those relating to test material, test procedures, selection of
species, number of animals, sex and distribution of animals, dose and effect levels to be
tested or attained, duration of test, and, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation
of any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting,
the completeness of results, and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or included in this Notice or
contained in PR 86-5. All studies must be submitted in the form of a final report; a
preliminary report will not be considered to fulfill the submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or cancelled if doing so would be
consistent with the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not
be consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may
be suspended for failure to comply with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be consistent with the Act.
You must also explain why an "existing stocks" provision is necessary, including a statement of
the quantity of existing stocks and your estimate of the time required for their sale, distribution,
and use. Unless you meet this burden the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
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registrant such as independent distributors, retailers and end users to sell, distribute or use such
existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily cancelled products containing an active ingredient for which the Agency has particular
risk concerns will be determined on case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result in the Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due unless you demonstrate
to the Agency that you are in full compliance with all Agency requirements, including the
requirements of this Notice. For example, if you decide to voluntarily cancel your registration
six months before a 3 year study is scheduled to be submitted, all progress reports and other
information necessary to establish that you have been conducting the study in an acceptable and
good faith manner must have been submitted to the Agency, before EPA will consider granting
an existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6 (a) (2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information to
the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies, regarding
unreasonable adverse effects on man or the environment. This requirement continues as long as
the products are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status Sheet.
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All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data CalHn Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment Z 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 response to this Notice.
Sincerely yours,
Lois Rossi, Division Director
Special Review and
Reregistration Division
Attachments
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 Batching of End-Use Products tor Meeting Acute Toxicology Data
Requirements tor 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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ALIPHATIC ALCOHOLS DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing aliphatic alcohols.
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
aliphatic alcohols. 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), (o) a list of registrants receiving this DCI (Attachment 6)
and (7) the Cost Share and Data Compensation Forms in replying to this aliphatic alcohols
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 aliphatic alcohols
are contained in the Requirements Status and Registrant's Response, Attachment 3. The Agency
has concluded that additional data on aliphatic alcohols 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 aliphatic alcohols products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of aliphatic alcohols, please
contact Leonard Ryan at (703) 308-8067.
If you have any questions regarding the product specific data requirements and procedures
established by this Notice, please contact Bruce Kapner at (703) 308-8013.
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Bruce Kapner
Chemical Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Aliphatic Alcohols
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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 RESPONSE FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. If you wish to voluntarily cancel your product, answer "yes." If you choose this
option, you will not have to provide the data required by the Data Call-In Notice and
you will not have to complete any other forms. Further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing
Stocks provision of the Data Call-In Notice (Section IV-C).
Item 6. Not applicable since this form calls in product specific data only. However, if your
product is identical to another product and you qualify for a data exemption, you
must respond with "yes" to Item 7a (MUP) or 7B (EUP) on this form, provide the
EPA registration numbers of your source(s); you would not complete the
"Requirements Status and Registrant's Response" form. Examples of such products
include repackaged products and Special Local Needs (Section 24c) products which
are identical to federally registered products.
Item 7a. For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding "yes."
Item 7b. For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes. If you are
requesting a data waiver, answer yes" here; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with Option
7 (Waiver Request) for each study for which you are requesting a waiver. See Item
6 with regard to identical products and data exemptions.
Items 8-11. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already
voluntarily canceled this product. For these cases, please supply all relevant details
so that EPA can ensure that its records are correct.
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INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORM FOR PRODUCT SPECIFIC DATA
Item 1-3 Completed by EPA. Note the unique identifier number assigned by EPA in Item
3. This number must be used in the transmittal document for any data
submissions in response to this Data Call-In Notice.
Item 4. The guideline reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the requirements
specified in the Notice, govern the conduct of the required studies. Note that series
61 and 62 in product chemistry are now listed under 40 CFR 158.155 through
158.180, SubpartC.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use pattern(s) of the pesticide associated with the product specific requirements
is (are) identified. For most product specific data requirements, all use patterns are
covered by the data requirements. In the case of efficacy data, the required studies
only pertain to products which have the use sites and/or pests indicated.
Item 7. The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in rare
cases.
Item 8. The due date for submission of each study is identified. It is normally based on 8
months after issuance of the Reregistration Eligibility Document 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 me Data Call-In Notice.
1. I will generate and submit data by the specified due date (Developing Data). By
indicating that I have chosen this option, I certify that I will comply with all the
requirements pertainingto the conditions for submittal of this study as outlined in the
Data Call-In Notice. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form (EPA
Form 8570-29) and (2) two completed and signed copies of the Confidential
Statement of Formula (EPA Form 8570-4).
2. I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing). I am submitting a copy of this agreement. I understand that this
option is available only for acute toxicity or certain efficacy data and only if EPA
indicates in an attachment to this Notice that my product is similar enough to another
product to qualify for this option. I certify that another party in the agreement is
committing to submit or provide the required data; if the required study is not
submitted on time, my product may be subject to suspension. By the specified due
date, I will also submit: (1) a completed "Certification With Respect To Data
Compensation Requirements" form (EPA Form 8570-29) and (2) two completed
and signed copies of the Confidential Statement of Formula (EPA Form 8570-4).
3. I have made offers to share in the cost to develop data (Offers to Cost Share). I
understand that this option is available only for acute toxicity or certain efficacy data
and only if EPA indicates in an attachment to this Data Call-In Notice that my product
is similar enough to another product to qualify for this option. I am submitting
evidence that I have made an offer to another registrant (who has an obligation to
submit data) to share in the cost of that data. I am also submitting a completed
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"Certification of Offer to Cost Share in the Development Data" form. I am
including a copy of my offer and proof of the other registrant's receipt of that offer.
I am identifying the party which is committing to submit or provide the required data;
if the required study is not submitted on time, my product may be subject to
suspension. I understand that other terms under Option 3 in the Data Call-in Notice
(Section III-C.l.) apply as well. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
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. By the specified due date, I will also submit a completed "Certification With
Respect To Data Compensation Requirements" form (EPA Form 8570-29) to
show what data compensation option I have chosen. By the specified due date, I will
also submit: (1) a completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed copies
of the Confidential Statement of Formula (EPA Form 8570-4).
5. By the specified due date, I will submit or cite data to upgrade a study classified by
the Agency as partially acceptable and upgradable (Upgrading a Study). I will
submit evidence of the Agency's review indicating that the study may be upgraded
and what information is required to do so. I will provide the MRID or Accession
number of the study at the due date. I understand that the conditions for this option
outlined Option 5 in the Data Call-In Notice (Section III-C.l.) apply. By the
specified due date, I will also submit: (1) a completed "Certification With Respect
To Data Compensation Requirements" form (EPA Form 8570-29) and (2) two
completed and signed copies of the Confidential Statement of Formula (EPA Form
8570-4).
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) for the cited
data on a "Product Specific Data Report" form or in a similar format. By the
specified due date, I will also submit: (1) a completed "Certification With Respect
To Data Compensation Requirements" form (EPA Form 8570-29) and (2) two
completed and signed copies of the Confidential Statement of Formula (EPA Form
8570-4).
7. I request a waiver for this study because it is inappropriate for my product (Waiver
Request). I am attaching a complete justification for this request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies.
[Note: any supplemental data must be submitted in the format required by P.R. Notice
86-5]. I understand that this is my only opportunity to state the reasons or provide
information in support of my request. If the Agency approves my waiver request, I
will not be required to supply the data pursuant to Section 3(c) (2) (B) of FIFRA. If
the Agency denies my waiver request, I must choose a method of meeting the data
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requirements of this Notice by the due date stated by this Notice. In this case, I must,
within 30 days of my receipt of the Agency's written decision, submit a revised
"Requirements Status and Registrant's Response" Form indicating the option chosen.
I also understand that the deadline for submission of data as specified by the original
data call-in notice will not change. By the specified due date, I will also submit: (1)
a completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
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 canceled 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 associated with the guideline reference number is identified.
Item 6. The use patters (s) of the pesticide associated with the product specific
requirements is (are) identified. For most product specific data requirements, all
use patterns are covered by the data requirements. In the case of efficacy data, the
required studies only pertain to products which have the use sites and/ or pests
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 data by the specified due date (Developing
Data). By indicating that I have chosen this option, I certify that I will comply
with all the requirements pertaining to the conditions for submittal of this study as
outlined in the Data Call-in Notice.
2. I have entered into an agreement with one or more registrants to develop
data jointly (Cost Sharing). I am submitting a copy of this agreement. I
understand that this option is available on for acute toxicity or certain efficacy data
and only if EPA indicates in an attachment to this notice that my product is
similar. Enough to another product to qualify for this option. I certify that
another party in the agreement is committing to submit or provide the required
data; if the required study is not submitted on time, my product my be subject to
suspension.
3. I have made offers to share in the cost to develop data (Offers to Cost
Share). 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
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subject to suspension. I understand that other terms under Option 3 in the Data
Call-in Notice (Section III-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 request, I will not be require to supply the data
pursuant to Section 3(c) (2) (B) of FIFRA. If the Agency denies my waiver
request, I must choose a method of meeting the data requirements of this Notice by
the due date stated by this Notice. In this case, I must, within 30 days of my
receipt of the Agency's written decision, submit a revised "Requirements Status
chosen. I also understand that the deadline for submission of data as specified by
the original data cal-in notice will not change.
Items 10-13. Self-explanatory.
NOTE:You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your product has
already been transferred to another company or that you have already voluntarily cancelled this
product. For these cases, please supply all relevant details so that EPA can ensure that its
records are correct.
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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 ALIPHATIC ALCOHOL PRODUCTS FOR MEETING ACUTE
TOXICITY DATA REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the
acute toxicity data requirements for reregistration of products containing aliphatic alcohols as the
active ingredient, the Agency has batched products which can be considered similar for purposes
of acute toxicity. Factors considered in the sorting process include each product's active and inert
ingredients (identity, percent composition and biological activity), type of formulation (e.g.,
emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., signal
word, use classification, precautionary labeling, etc.). Note that the Agency is not describing
batched products as "substantially similar" since some products within a batch may not be
considered chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described in
the preceding paragraph. Notwith-standing 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 tested is considered by EPA to be similar for acute toxicity,
and the formulation has not been significantly altered since submission and acceptance of the
acute toxicity data. Regardless of whether new data is generated or existing data is referenced,
registrants must clearly identify the test material by EPA Registration Number. If more than one
confidential statement of formula (CSF) exists for a product, the registrant must indicate the
formulation actually tested by identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow
the directions given in the Data Call-In Notice and its attachments appended to the RED. The
DCI Notice contains two response forms which are to be completed and submitted to the Agency
within 90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant
will meet the data requirements for each product. The second form, "Requirements Status and
Registrant's Response," lists the product specific data required for each product, including the
standard six acute toxicity tests. A registrant who wishes to participate in a batch must decide
whether he/she will provide the data or depend on someone else to do so. If a registrant supplies
the data to support a batch of products, he/she must select one of the following options:
Developing Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing
Study (Option 5) or Citing an Existing Study (Option 6). If a registrant depends on another's
data, he/she must choose among: Cost Sharing (Option 2), Offers to Cost Share (Option 3) or
Citing an Existing Study (Option 6). If a registrant does not want to participate in a batch, the
choices are Options 1, 4, 5 or 6. However, a registrant should know that choosing not to
participate in a batch does not preclude other registrants in the batch from citing his/her studies
and offering to cost share (Option 3) those studies.
One hundred thirty eight products were found which contain aliphatic alcohols as the
active ingredient. Seventy of these contain ethanol, sixty five contain isopropanol, and three
contain both ethanol and isopropanol. The products containing ethanol have been placed into 10
batches, the products containing isopropanol have been placed in 6 batches, and the products
containing both alcohols have been placed in in alist under no batch in accordance with the active
and inert ingredients, type of formulation and current labeling. Table 1 identifies the products in
each of the ethanol batches, table 2 does the same for the isopropanol batches. The last list in
each table is for products that cannot be batched in any group.
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Table 1
Batch
1
2
3
4
5
EPA Reg. No.
334-214
334-312
334-313
334-317
334-318
334-385
1839-68
1839-71
47371-22
1839-31
6836-186
6836-183
47371-16
9157-10
47000-29
36341-1
34282-6
% Active Ingredient
ETOH52.7,
p-tert-amyl phenol 0.047
o-phenyl phenol 0.200
ETOH 53.959
p-tert-amyl phenol 0.050
o-phenyl phenol 0.176
ETOH 53.298
p-tert-amyl phenol 0.050
o-phenyl phenol 0.201
ETOH 53.460
p-tert-amyl phenol 0.044
o-phenyl phenol 0.176
ETOH 53.267
p-tert-amyl phenol 0.048
o-phenyl phenol 0.201
ETOH 53.268
p-tert-amyl phenol 0.048
o-phenyl phenol 0.201
ETOH 20.0
Alkyl dimethyl benzyl
ammonium chloride
(C14 50 %, C12 40 %,
C16 10 %) 80
ETOH 20.0
Alkyl dimethyl benzyl
ammonium chloride
(C1460%, C1630%,
CIS 5 %, C12 5 %) 80
ETOH 20.0
Alkyl dimethyl benzyl
ammonium chloride
(C1460%, C1630%,
CIS 5 %, C12 5 %) 80
ETOH 10.0
Alkyldimethyl benzyl ammonium chloride
(C14 60%,C12 25%, C16 15%) 80.0
ETOH 10.60
Alkyldimethyl benzyl ammonium chloride
(C14 50%,C12 40%, C16 10%) 80.0
ETOH 10.0
Alkyldimethyl benzyl ammonium chloride
(C14 60%,C12 25%,C16 15%) 50.0
ETOH 10.0
Alkyldimethyl benzyl ammonium chloride
(C14 60%,C16 30%, CIS 5%, C12 5 %)50.0
ETOH 3.20
Alkyldimethyl benzyl ammonium chloride
(C14 60%,C12 25%,C16 15%) 16.0
ETOH 2.50
Alkyldimethyl benzyl ammonium chloride
(C14 60%,C16 30%, CIS 5%, C12 5 %) 10.0
ETOH 2.0
Alkyldimethyl benzyl ammonium chloride
(C14 60%,C16 30%, CIS 5%, C12 5 %) 10.0
" " " " "
Formulation Type
pressurized liquid
liquid concentrate
technical liquid
formulation inter-
mediate
Inter-
mediate
Liquid
pool algicide
concentrate
pool algicide ready to
use
soluble concentrate
solution
182
-------
Table 1
Batch
6
7
8
9
10
EPA Reg. No.
1839-70
1839-69
10807-100
47371-13
1839-34
1839-54
11525-30
11525-31
777-74
777-53
675-25
211-32
56392-4
56392-2
56392-6
67346-1
58502-1
% Active Ingredient
ETOH 20.0
Alkyldimethyl benzyl ammonium chloride
(C14 60%,C12 25%, C16 15%) 40.0
Alkyldimethyl ethylbenzyl
Ammonium chloride
(C12 50%, C14 30%, C16
17%, CIS 3%40.0
ETOH 20.0
Alkyldimethyl benzyl ammonium chloride
(C14 60%,C12 25%, C16 15%) 40.0
Alkyldimethyl ethylbenzyl
Ammonium chloride
(C12 68%, C14 32%) 40.0
ETOH 12.5
Alkyldimethyl benzyl ammonium chloride
(C14 60%,C12 25%, C16 15%) 40.0
Alkyldimethyl ethylbenzyl
Ammonium chloride
(C12 50%, C14 30%, C16
17%,C18 3%)40.0
ETOH 50.088
Alkyldimethyl benzyl ammonium chloride
(C14 60%,C16 30%,C18 5%, C12 5 %) 0.072
Alkyldimethyl ethylbenzyl
Ammonium chloride
(C12 68%, C14 32%) 0.072
ETOH 79.646
o-phenyl phenolO.078
EtOH 79.0
O-phenyl phenol 0.1 00
ETOH 78.5
O-phenyl phenol 0.1 360
ETOH 73.49
O-phenyl phenol 0.214
ETOH 69.1
O-phenyl phenol 0.12
ETOH 69.1
O-phenyl phenol 0.13
ETOH 66.6
O-phenyl phenol 0.12
ETOH 92.46
" " " " "
Formulation Type
Liquid concentrate
formulation
inter-mediate
Soluble concentrate
Liquid concentrate
Formulation
inter-mediate
Pressurized Liquid
pressurized Liquid
Ethylene fluid
Solution
183
-------
Batch
EPA Reg. No.
Table 2
% Active Ingredient
Formulation Type
No batch
7405-51
ETOH 53.72
p-tert amyl phenol 0.03 o-phenyl ohenol 0.10
pressurized liquid
No batch
3862-99
1270-237
706-69
5197-50
334-417
ETOH 53.78
p-tert amyl phenol 0.02 o-phenyl phenolO.t
ETOH 67.6
p-tert amyl phenol 0.055 o-phenyl phenol
ETOH 52.580
p-tert amyl phenol 0.055 o-phenyl phenol
ETOH 56.99
p-tert amyl Phenol 0.050
O-phenyl phenol 0.10
ETOH 66.5860
p-tert amyl phenol 0.060 o-phenyl phenol
0.251
Liquid
No batch
64039-1
42964-17
1270-192
15035-1
4822-55
ETOH 76.0
Alkyl dimethyl benzyl ammonium chloride
(C14 50 %, C12 40 %, C16 10 %) 0.16
ETOH 62.74
Alkyl dimethyl benzyl ammonium chloride
(C14 60 %, C16 30 %, C12 5 %,C18 5 %)
0.15
Alkyl dimethyl ethyl benzyl ammonium
chloride
(C1268%, C1432%)0.15
ETOH 53.00
Alkyl dimethyl benzyl ammonium chloride
(C14 60 %, C16 30 %, C12 5 %,C18 5 %)
0.100
Alkyl dimethyl ethyl benzyl ammonium
chloride
(C1268%, C1432%)0.100
ETOH 3.5,
Alkyl dimethyl benzyl ammonium chloride
(C14 60 %, C16 30 %, C12 5 %,C18 5 %)
7.00
Alkyl dimethyl ethyl benzyl ammonium
chloride
(C12 68 %, C14 32 %)7.00
ETOH 62.56,
Alkyl dimethyl benzyl ammonium chloride
(C14 60 %, C16 30 %, C12 5 %,C18 5 %)
0.065
Alkyl dimethyl ethyl benzyl ammonium
chloride
(C12 60 %, C164 30%,
CIS 5%, C12 5%) 0.065
pump spray
Pressurized spray
liquid concentrate
pressurized liquid
No batch
4822-94
ETOH 37.00,
Alkyl dimethyl benzyl ammonium chloride
(C14 60 %, C16 30 %, C12 5 %,C18 5 %)
0.05
Alkyl dimethyl ethyl benzyl ammonium
chloride
(C12 60 %, C164 30%,
CIS 5%, C12 5%) 0.05
184
-------
Batch
EPA Reg. No.
Table 2
% Active Ingredient
Formulation Type
4822-158
ETOH 19.736
#Alkyl dimethyl benzyl ammonium chloride
(C14 60 %, C16 30 %, C12 5 %,C18 5 %)
0.0875
#Alkyl dimethyl ethyl benzyl ammonium
chloride
(C12 60 %. C164 30%,
CIS 5 %, C12 5 % ) #Combined# 0.0875
Liquid
No Batch
1270-47
5813-26
777-55
11694-99
11694-98
43222-6
3743-1
10801-1
66288-1
4822-329
2230-43
10648-1
5741-22
1270-243
7405-34
6836-162
777-72
ETOH 0.05
Alkyl dimethyl benzyl ammonium chloride
(C14 60 %, C16 30 %, C12 5 %,C18 5 %)
0.025
Alkyl dimethyl ethyl benzyl ammonium
chloride
(C12 60 %, C163030%, CIS 5 %, C12 5
%)0.025
ETOH 3.00
Alkyl dimethyl benzyl ammonium chloride
(C14 60 %, C16 30 %, C12 5 %,C18 5 %)
1.5
Alkyl dimethyl ethyl benzyl ammonium
chloride
(C12 60 %, C163030%, CIS 5 %, C12 5
ETOH 82.965
o-phenyl ohenol 0.108
ETOH 68.00
o-phenyl ohenol 0.192
ETOH 68.00
o-phenyl ohenol 0.190
ETOH 14.91
o-phenyl ohenol 0.071
ETOH 86
ETOH 75.101
ETOH 58.60
ETOH 56.0
ETOH 0.11
Hydrogen Chloride 10
Alkyl dimethyl benzyl ammonium chloride
(C14 50 %, C12 40 %, C16 10 % 0.42
ETOH 82.19
Formaldehyde 0.043
ETOH 64.0
2-benzyl chlorophenol 0.275
o-pnenyl phenolO.051
ETOH 53.46
2-benzyl chlorophenol 0.08
o-phenyl phenol 0.10
ETOH 32.10
diisobutylphenoxy ethoxy dimethyl benzyl
ammonium chloride 0.10
(hyamine 1622)
Triethylene glycol 4.5
ETOH 80
Alkyl dimethyl ammonium chloride (C14 58
%, C16 28 %,C12 14 %) 20
solution
solution
liquid
pressurized liquid
liquid
pressurized liquid
liquid
Pump spray
liquid
Pressurized liquid
soluble concentrate
solution
Pressurized liquid
Pressurized liquid
Concentrate liquid
ETOH 79.646
Alkyl dimethyl ammonium chloride (C14 50
%, C12 40 %,C16 10 %) 1.06
Pressurized liquid
185
-------
Table 2
Batch
EPA Reg. No.
1043-19
33176-5
257-295
4822-88
11715-116
323-28
% Active Ingredient
ETOH 53.09
o-benzyl chlorophenol 0.077
p-tert-amyl phenol 0.072
o.phenyl phenol 0.041
BTC 2125 0.085
ETOH 44.26
o-phenyl ohenol 0.255
n-alkyl dimethyl benzyl ammonium chloride
0.33
ETOH 37.00
alkyldimethyl benzyl ammonium chloride
(C14 60 %, C16 30 %,
CIS 5 %,C12 5 %)0.05
Alkyl dimethyl ethyl benzyl ammonium
chloride
(C12 68 %, C14 38 %) 0.05
3.4',5-dibromosalicylanalide 0.0067
Triethylene glycol 8.00
ETOH 37.00
Alkyl dimethyl benzyl ammonium chloride
(C14 60%,C16 30 %, CIS 5%, C12 5 %)0.05
alkyl dimetyl ethylbenzyl ammonium chloride
(C12 50 %, C14 30 %, C 16 17 %,C 18 3 %)
0.05
Triethylene glycol 8.00
ETOH 30. 148
Alkyl dimethyl benzyl ammonium chloride
(C12 61 %, C14 23 %,C16
11 %,C185%) 0.192
Propanol,oxy bis 3.84
Essential oils 0.96
ETOH 16.92
1,2 propanediol 2.5
alkyl dimethyl benzyl ammonium chloride
(C14 60 %, C16 30 %, CIS
5 %, C12 5%) 0.05
Formulation Type
pressurized liquid
186
-------
Table 3
Batch
1
2
3
4
5
6
EPA Reg. No.
8133-17
4482-15
48815-1
1769-187
1769-47
8047-34
1182-21
5680-14
6658-39
10806-21
11623-24
33176-24
9852-54
5197-30
5197-40
6836-176
11715-114
% Active Ingredient
Isopropanol 4.0
didecyl dimethyl ammonium chloride 10.0
Isopropanol 3.0
didecyl dimethyl ammonium chloride 7.50
Isopropanol 3.0
didecyl dimethyl ammonium chloride 7.5
Isoproanol 30.66
1,2 propanediol 4.62
methyl dodecylbenzyl trimethyl ammonium
chlorideO.042
Triethylene glycol 4.94
Isopropanol 27.30
1,2 propanediol 4.40
methyl dodecylbenzyl trimethyl ammonium
chloride 0.16
Triethylene glycol 4.70
Isopropanol 4.750
pine oil 3.95
Alkyl dimethyl benzyl ammonium chloride
(C14 58 %, C16 28 %, C12 14 %) 1.97
isopropanol 53.0
Alkyl dimethyl benzyl ammonium chloride
(C1460%, C1630%,C18
5%, C12 5%) 0.1
Alkyl dimethyl ethyl benzyl ammonium
chloride
(C1268%, C1432%) 0.10
Isopropanol 60.0
4-tert-amylphenol 0.05
o-phenyl pnenol 0.10
Isopropanol 63.79
4-tert amyl phenolO.053
O-phenyl pnenol 0.105
Isopropanol 43.22
Alkyl dimethyl oenzyl ammonium chloride
(C14 50%,C16 28 %,
C12 14%)0.25
Isopropanol 43.22
Alkyl dimethyl oenzyl ammonium chloride
(C14 50%,C16 28 %,
C12 14%)0.25
Formulation Type
Solution
Soluble concentrate
Liquid dip
Solution
Solution
Soluble concentrate
Pressurized liquid
solution
Pressurized liquid
187
-------
Table 4
Batch
EPA Reg. No.
%active ingredient
Formulation Type
No Batch
68329-5
8540-13
60142-1
Isopropanol 20.0
didecyl dimethyl ammonium chloride 50.0
solution
Isopropanol 10.0
didecyl dimethyl ammonium chloride 25.0
soluble concentrate
Isopropanol 70.0
solution
3150-1
Isopropanol 13.0
Alkyl dimethyl benzyl ammonium chloride
(C12 50 %,C14 30 %,
C16 17 %, CIS 3%)6.5
cetyl dimethyl ammonium bromide 6.5
solution
No
Batch
3150-3
11715-128
4758-143
6768-8
283-3
6836-191
9601-5
8047-22
421-16
402-113
1270-24
Isopropanol 13.0
Alkyl dimethyl benzyl ammonium chloride
(C12 50 %,C14 30 %,
C16 17 %, CIS 3%)6.5
cetyl dimethyl ammonium bromide 6.5
Pressurized liquid
Isopropanol 15.7
Triethylene glycolS.O
Isopropanol 89.5
d-limonene 10.0
pyrethrins 0.25
piperonyl butoxide 0.25
solution
Isopropanol 25.0
diisobutyl phenoxyethoxy ethyldimethyl
ammonium chloride 0.69
o-phenylphenol 0.21
bromine 0.04
pyrethrins 0.1
solution
Isopropanol 60
Alkyl dimethyl benzyl ammonium chloride
(C1261%, C1423%,C16 11%
CIS 5%) 0.13
solution
Isopropanol 6.049
Alkyl dimethyl benzyl ammonium chloride
(C12 67 %, CI4 25 %, CIS 1 %, CIO 1 % C8
1 %)51.74
Formulation
inter-
mediate
Isopropanol 2.00
Alkyl dimethyl benzyl ammonium chloride
(C14 60 %, C16 30 %, CIS 5 %,C12 5 %)
0.65
Alkyl dimethyl ethyl benzyl ammonium
chloride
(C12 68 %, C14 28 %) 0.65
Tetrasodium ethylenetriamine
triacetate 5.0
Liquid concentrate
Isopropanol 1.00
Alkyl dimethyl benzyl ammonium chloride
(C14 58 %, C16 28 %, C12 14%) 2.00
Essential oils 0.25
Soluble concentrate
Isopropanol 24.23
Essential oils 0.50
2-benzyl chlorophenol 4.92
0-phenyl phenol 0.75
Methyl salicilate 1.222
Soap 15.38
Isopropanol 23.23
Essential oils 2.00
2-benzylchlorophenol 3.16
O-phenylphenol 2.02
tert-amyl phenol 2.03
Emulsify-able
concentrate
Isopropanol 21.3
2-benzyl chlorophenol 6.7
Soluble concentrate
188
-------
Table 4
Batch
EPA Reg. No.
402-96
5747-2
10807-95
1275-28
10807-111
1130-6
12192-2
11715-30
1839-82
1839-85
44446-20
4000-42
%active ingredient
Isopropanol 13.13
pine oil 10.0
soap 15.79
nonyl phenoxypolyethoxy
ethanol 5.47
Isopropanol 5.00
Pine oil 75.0
soap 10.0
Isopropanol 0.050
Pine oil 80.0
Isoprpanol 7.560
Pine oil 7.04
Alkyl dimethyl 3,4-dichlorobenzyl ammonium
chloride 3.00
Isopropanol 4.75
pine oil 3.95
alkyl dimethyl benzyl ammonium chloride
(C 14 58 %, C16 28 %,
C12 14%) 1.97
Isopropanol 8.08
alkyl dimethyl benzyl ammonium chloride
(C 14 60 %, C16 30 %,
C185%,C12 5%) 0.14
alkyldimethyl ethylbenzyl
ammonium chloride
(C1268%, C1432%) 0.14
Isopropanol 5.0
alkyl dimethyl benzyl ammonium chloride
(C 14 60 %, C16 30 %,
C185 %,C12 5 %) 6.00
alkyldimethyl ethylbenzyl
ammonium chloride
(C12 68%, C14 32%) 6.00
Isopropanol 53.0
Essential oils 0.500
alkyl dimethyl benzyl ammonium chloride
(C 14 60 %, C16 30 %,
C185%,C12 5%) 0.10
alkyldimethyl ethylbenzyl
ammonium chloride
(C1268%, C1432%) 0.10
Isopropanol 75.14
alkyl dimethyl benzyl ammonium chloride
(C 14 60 %, C16 30 %,
C185%,C12 5%) 0.14
alkyldimethyl ethylbenzyl
ammonium chloride
(C1268%, C1432%) 0.14
isopropanol 53.0
alkyl dimethyl benzyl ammonium chloride
(C 14 60 %, C16 30 %,
C185%,C12 5%) 0.10
alkyldimethyl ethylbenzyl
ammonium chloride
(C1268%, C1432%) 0.10
Isopropanol 50.70
alkyl dimethyl benzyl ammonium chloride
(C 14 60 %, C16 30 %,
C185%,C12 5%) 0.10
alkyldimethyl ethylbenzyl
ammonium chloride
(C1268%, C1432%) 0.10
isopropanol 86.6
o-phenyl phenol 0.20
Formulation Type
Soluble Concentrate
Impregnated cloth
solution
Pressurized Liquid
Liquid
Pressurized liquid
189
-------
Batch
EPA Reg. No.
Table 4
%active ingredient
Formulation Type
421-21
1769-25
1769-201
954-10
8370-8
8047-25
48920-1
8654-1
8047-31
397-13
58369-2
58369-3
38526-1
10770-10
10770-8
875-137
45447-10
6836-188
Isopropanol 28.46
triethylene glycol 10.80
propylene glycol 3.0
p-diisobutyl pnenoxy ethoxyethylbenzyl
dimethyl ammonium chloride 0.24
propylene glycol 3.00
Isopropanol 38.5
1,2 prparendiol 8.12
Triethylene glycol 12.17
Isopropanol 57.0
tert-amyl phenol 0.02
o-phenyl pnenol 0.080
Isopropanol 11.0
0-phenylphenol 0.25
Isopropanol 35.0
Alkyl dimethyl benzyl ammonium chloride
(C14 50%,C12 40%, C16 10%) 3.00
Isopropanol 1.50
Alkyl dimethyl benzyl ammonium chloride
(C14 50%,C12 40%, C16 10%) 2.0
essential oils 0.80
Isopropanol 40.41
Alkyl dimethyl oenzyl ammonium chloride
(C14 58%,, C16 28%, C12
14%) 4.0
Isopropanol 50.0
alkyl dimethyl benzyl ammonium chloride
(C14 58%,C16 28%,C12 14%)
0.183
Isopropanol 4.00
alkyl dimethyl benzyl ammonium chloride
(C14 58%,C16 28%,C12 14%)
4.00
Isopropanol 60.9
sumitnrin 0.22
Alkyl dimethylbenzyl ammonium chloride
(C14 50%,C12 40%,C16 10%)
with
didecyl dimethyl ammonium chloride 0.199
Isopropanol 37.5
Eucaliptus oil 12.5
Isopropanol 18.75
Eucliptus oil 6.25
Quarternium-15 0.3
Isopropanol 15.3
diisobutylphenoxyethoxy ethyl dimethylbenzyl
ammonium chloride 0.25
solution
Pressurized liquid
Soluble concentrate
Soluble concentrate
solution
Emulsi-fyable
concentrate
solution
Isopropanol 15.3 diisobutylphenoxyethoxy
ethyl dimethylbenzyl ammonium chloride 0.25
Isopropanol 14.85 diisobutylphenoxyethoxy
ethyl dimethylbenzyl ammonium chloride 0.25
Pressurized liquid
Isobutanol 10.0
Phosphoric acid 72.0
Dodecyl benzene sulfonic acid 4.5
soluble concentrate
Isopropanol 8.5
Phosphoric acid 5/.0 Dodecyl benzene sulfonic
acid 15.5
Isopropanol 3.00
Alkyl diethylbenzyl ammonium Chloride 50.0
(C14 58%,C16 28%, C12 14%)
Benzyl chloride 16.363
Formulation
inter-mediate liquid
190
-------
Table 4
Batch
No Batch
No
Batch
EPA Reg. No.
6836-189
10492-4
4822-120
1839-42
9807-4
%active ingredient
Isopropanol 5.0
Alkyl dimethyl benzyl ammonium chloride
33.75
(C14 58%,C16 28%, C12 14%)
Benzyl chloride 18.36
Isopropanol 63.25
Alkyl dimethyl benzyl ammonium chloride
(C1460%, C1630%,C185%,C12 5%) 0.120
Alkyl dimethyl ethyl benzyl ammonium
chloride
(C1268%, C1432%) 0.1200
Isopropanol 24.238
ETOH 24.238
Alkyl dimethyl benzyl ammonium chloride
(C14 60%, C16 30 %,C18 5%,C12 5%) 0.065
Alkyl dimethyl ethyl benzyl ammonium
chloride
(C12 50%, C14 30 %,
C16 17%, CIS 3%) 0.065
Isopropanol 6.0
ETOH 5.0
Alkyl dimethyl benzyl ammonium chloride
(C14 60%, C16 30 %,C18 5%,C12 5%) 13.0
Alkyl dimethyl ethyl benzyl ammonium
chloride
(C12 50%, C14 30 %,
C16 17%, CIS 3%) 13.0
Isopropanol 3.00
ETOH 1.00
Alkyl dimethyl ethyl benzyl ammonium
chloride
(C14 50%, C12 40 %,
C16 10 %) 5.00
Formulation Type
Towelette
Pressurized liquid
Flowable Concentrate
soluble concentrate
191
-------
192
-------
Attachment 5. EPA Acceptance Criteria
193
-------
194
-------
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
195
-------
61 Product Identity and Composition
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Name of technical material tested (include product name and trade name, if appropriate).
2. Name, nominal concentration, and certified limits (upper and lower) for each active ingredient and each
intentionally-added inert ingredient.
3. Name and upper certified limit for each impurity or each group of impurities present at _>_ 0.1% by weight and
for certain lexicologically significant impurities (e.g., dioxins, nitrosamines) present "af < 0.1%.
4. Purpose of each active ingredient and each intentionally-added inert.
5. Chemical name from Chemical Abstracts index of Nomenclature and Chemical Abstracts Service (CAS)
Registry Number for each active ingredient and, if available, for each intentionally-added inert.
6. Molecular, structural, and empirical formulas, molecular weight or weight range, and any company assigned
experimental or internal code numbers for each active ingredient.
7. Description of each beginning material in the manufacturing process.
EPA Registration Number if registered;
for other beginning materials, the following:
Name and address of manufacturer or supplier.
Brand name, trade name or commercial designation.
Technical specifications or data sheets by which manufacturer or supplier describes composition,
properties or toxicity.
8. Description of manufacturing process.
Statement of whether batch or continuous process.
Relative amounts of beginning materials and order in which they are added.
Description of equipment.
Description of physical conditions (temperature, pressure, humidity) controlled in each step and the
parameters that are maintained.
Statement of whether process involves intended chemical reactions.
Flow chart with chemical equations for each intended chemical reaction.
Duration of each step of process.
Description of purification procedures.
Description of measures taken to assure quality of final product.
9. Discussion of formation of impurities based on established chemical theory addressing (1) each impurity which
may be present at _>_ 0.1% or was found at _>_ 0.1% by product analyses and (2) certain lexicologically
significant impurities~(see #3).
196
-------
62 Analysis and Certification of Product Ingredients
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered. Use a table to present the
information in items 6, Y, 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!^ closure _>_ ca 98%.
3. Analyses conducted for certain trace toxiclmpurities at lower than 0.1% (examples, nitrosamines in the case of
products containing dinitroanilines or containing secondary or tertiary amines/alkanolamines plus nitrites;
polyhalogenated dibenzodioxins and dibenzofurans). [Note that in the case of nitrosamines both fresh and stored
samples must be analyzed.].
4. Complete and detailed description of each step in analytical method used to analyze above samples.
5. Statement of precision and accuracy of analytical method used to analyze above samples.
6. Identities and quantities (including mean and standard deviation) provided for each analyzed ingredient.
7. Upper and lower certified limits proposed for each active ingredient and intentionally added inert along with
explanation of how the limits were determined.
8. Upper certified limit proposed for each impurity present at > 0.1% and for certain lexicologically significant
impurities at < 0.1% along with explanation of how limit determined.
9. Analytical methods to verify certified limits of each active ingredient and impurities (latter not required if exempt
from requirement of tolerance or if generally recognized as safe by FDA) are fully described.
10. Analytical methods (as discussed in 19) to verify certified limits validated as to their precision and accuracy.
197
-------
63 Physical and Chemical Characteristics
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered.
Does your study meet the following acceptance criteria?
63-2 Color
Verbal description of coloration (or lack of it)
Any intentional coloration also reported in terms of Munsell color system
63-3 Physical State
Verbal description of physical state provided using terms such as "solid, granular, volatile liquid"
Based on visual inspection at about 20-25° C
63-4 Odor
Verbal description of odor (or lack of it) using terms such as "garlic-like, characteristic of aromatic
compounds"
Observed at room temperature
63-5 Melting Point
Reported in ° C
Any observed decomposition reported
63-6 Boiling Point
Reported in ° C
Pressure under which B.P. measured reported
Any observed decomposition reported
63-7 Density, Bulk Density, Specific Gravity
Measured at about 20-25° C
Density of technical grade active ingredient reported in g/ml or the specific gravity of liquids reported with
reference to water at 20° C. [Note: Bulk density of registered products may be reported in lbs/ft3 or
Ibs/gallon.]
63-8 Solubility
Determined in distilled water and representative polar and non-polar solvents, including those used in
formulations and analytical methods for the pesticide
Measured at about 20-25° C
Reported in g/100 ml (other units like ppm acceptable if sparingly soluble)
63-9 Vapor Pressure
Measured at 25° C (or calculated by extrapolation from measurements made at higher temperature if pressure
too low to measure at 25° C)
Experimental procedure described
Reported in mm Hg (torr) or other conventional units
63-10 Dissociation Constant
Experimental method described
Temperature of measurement specified (preferably about
20-25 °C)
63-11 Octanol/water Partition Coefficient
Measured at about 20-25° C
Experimentally determined and description of procedure provided (preferred method-45 Fed. Register 77350)
Data supporting reported value provided
63-12 pH
Measured at about 20-25° C
Measured following dilution or dispersion in distilled water
63-13 Stability
Sensitivity to metal ions and metal determined
Stability at normal and elevated temperatures
Sensitivity to sunlight determined
198
-------
SUBDIVISION F
Guideline Study Tide
81-1 Acute Oral Toxicity in the Rat
81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
81-3 Acute Inhalation Toxicity in the Rat
81-4 Primary Eye Irritation in the Rabbit
81-5 Primary Dermal Irritation Study
81-6 Dermal Sensitization in the Guinea Pig
199
-------
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.r Dosing, single oral may be administered over 24 hrs.
4.*^ Vehicle control if other than water.
5. Doses tested, sufficient to determine a toxicity category or a limit dose (5000 mg/kg).
6. Individual observations at least once a day.
7. Observation period to last at least 14 days, or until all test animals appear normal whichever is longer.
8. Individual daily observations.
9. Individual body weights.
10. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
Lj\j\j
-------
81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. 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 oefore dosing.
9. Application site at least 10% of body surface area.
10. Application site covered with a porous nonirritating cover to retain test material and to prevent
ingestion.
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
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81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Product is a gas, a solid which may produce a significant vapor hazard based on toxicity and expected use or
contains particles of inhalable size for man (aerodynamic diameter 15 pm or less).
3. At least 5 young adult rats/sex/group.
4. Dosing, at least 4 hours by inhalation.
5. Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content.
6. Chamber temperature, 22° C (+_2°), relative humidity 40-60%.
7. Monitor rate of air flow.
8. Monitor actual concentrations of test material in breathing zone.
9. Monitor aerodynamic particle size for aerosols.
10. Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration of respirable
substance).
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
202
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81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive, causes severe
dermal irritation or has a pH of < 2 or > 11.5.
3. 6 adult rabbits.
4. Dosing, instillation into the conjunctival sac of one eye
per animal.
5. Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if a solid, paste or particulate substance.
6. Solid or granular test material ground to a fine dust.
7. Eyes not washed for at least 24 hours.
8. Eyes examined and graded for irritation before dosing and
at 1, 24, 48 and 72 hr, then daily until eyes are normal
or 21 days (whichever is shorter).
9.^ Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
LJ L/O
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81-5 Primary Dermal Irritation Study
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a pH of < 2 or > 11.5.
3. 6 adult animals.
4. Dosing, single dermal.
5. Dosing duration 4 hours.
6. Application site shaved or clipped at least 24 hours prior to dosing.
7. Application site approximately 6 cm2.
8. Application site covered with a gauze patch held in place with nonirritating tape.
9. Material removed, washed with water, without trauma to application site.
10. Application site examined and graded for irritation at 1, 24, 48 and 72 hr, then daily until normal or 14 days
(whichever is shorter).
11.^ Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
Lj L/T
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81-6 Dermal Sensitization in the Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a
pHof <2or >11.5.
3. One offhe following methods is utilized:
Freund's complete adjuvant test
Guinea pig maximization test
Split adjuvant technique
Buehler test
Open epicutaneous test
Mauer optimization test
Footpad technique in guinea pig.
4. Complete description of test.
5.^ Reference for test.
6.~ Test followed essentially as described in reference document.
7. Positive control included (may provide historical data conducted within the last 6 months).
Criteria marked with an * are supplemental and may not be required for every study.
205
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206
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Attachment 6. List of All Registrants Sent This Data Call-In (insert) Notice
207
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208
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Attachment 7. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions
209
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210
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed copies of the form are
required. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of the responsible party must be provided.
d. All applicable information which is on the product specific data submission must also be reported on the
CSF.
e. All weights reported under item 7 must be in pounds per gallon for liquids and pounds per cubic feet
for solids.
f. Flashpoint must be in degrees Fahrenheit and flame extension in inches.
g. For all active ingredients, the EPA Registration Numbers for the currently registered source products
must be reported under column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all common names for
the trade names must be reported.
i. For the active ingredients, the percent purity of the source products must be reported under column 10
and must be exactly the same as on the source product's label.
j. All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or 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.
213
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214
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&EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
2070-0057
Approval Expires 3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please fill in blanks below.
Company Maine
Product Name
Company Number
EPA Reg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Name of Firm(s)
Date of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Representative
Date
Name and Title (Please Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA Form 8580, which is obsolete
215
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216
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United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
Form Approved
OMB No. 2070-0107,
2070-0057
Approval Expires
3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. SencTcomments 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-233, U.S. Environmental Protection
Agency, 401 M St., S.W., Washington, DC 20460; and to the Office of Management and Budget, Paperwork Reduction Project
(2070-0106), Washington, DC 20503.
Please fill in blanks below.
Company Name
Product Name
Company Number
EPA Reg. No.
I Certify that:
1. For each study cited in support of registration or reregistratiion under the Federal Insecticide, Fungicide and Rodentipide Act
(FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the written permission of the original
data submitter to cite that study.
2. That for each study cited in support of registration or reregistration under FIFRA that is NOT an exclusive use study, I am the
original data submitter, or I have obtained the written permission of the original data submitter, or I have notified in writing the
company(ies) that submitted data I have cited and have offered to: (a) Pay cpmpensation for those data in accordance with sections
3(c)(1)(F) and 3(c)(2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation
requirement of FlFRA and the amount of compensation due, if any. The companies I have notified are. (check one)
[ ] The companies who have submitted the studies listed on the back of this form or attached sheets, or indicated on the attached
"Requirements Status and Registrants' Response Form,"
3. That I have previously complied with section 3(c)(1)(F) of FIFRA for the studies I have cited in support of registration or
reregistration under FIFRA.
Signature
Date
Name and Title (Please Type or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, wi
reregistration of my products, to the extent required by FIFRA section 3(c)(1)(F) and 3(c)(2)(D).
with regard to the registration or
Signature
Date
Name and Title (Please Type or Print)
EPA Form 8570-31 (4-96)
217
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218
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APPENDIX G. FACT SHEET
219
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220
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United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-95-012
April 1995
R.E.D. FACTS
Pesticide
Reregistration
Use Profile
Aliphatic Alcohols
All pesticides sold or distributed in the United States must be
registered by EPA, based on scientific studies showing that they can be used
without posing unreasonable risks to people or the environment. Because of
advances in scientific knowledge, the law requires that pesticides which
were first registered years ago be reregistered to ensure that they meet
today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency imposes
any regulatory controls that are needed to effectively manage each
pesticide's risks. EPA then reregisters pesticides that can be used without
posing unreasonable risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this and
explains why in a Reregistration Eligibility Decision (RED) document. This
fact sheet summarizes the information in the RED document for
reregistration case 4003, aliphatic alcohols, which contains the active
ingredients ethanol and isopropanol.
Aliphatic alcohols are registered for uses which include hard surface
treatment disinfectants, sanitizers, a sterilant, virucides, fungicides, and
mildewcides. Ethanol also is registered for use as a plant growth regulator
(a ripener), and is used with quaternary ammonium compounds in
swimming pool water systems. Isopropanol also is used in combination with
other pesticide active ingredients to kill fleas, ticks, and other household
insects. Both ethanol and isopropanol are well known substances and have a
wide range of human uses. For example, ethanol is contained in some
beverages, and isopropanol is the major ingredient in rubbing alcohol.
Aliphatic alcohols are applied as surface wipes, sprays, mop-on,
sponge-on, wipe-on or pour-on treatments, by immersion, and through
closed systems (for commercial/industrial water cooling systems).
Use practice limitations for ethanol include cautions not to use the
product on polished wood furniture or rayon fabrics, and not to get the
product on foods, drinks, feeds, or surfaces they may contact. Isopropanol
is not recommended for use on aluminum, should not be used on polished
wood furniture or rayon fabrics, and should not be sprayed on lacquered or
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shellacked surfaces. Used solution should not be poured back into the
bottle.
Regulatory
History
Human Health
Assessment
Aliphatic alcohols were first registered as indoor disinfectants in the
U.S. as early as 1948. Currently, 73 ethanol and 67 isopropanol pesticide
products are registered. Ethanol and isopropanol are considered inert
ingredients in some pesticide formulations; a determination is made on a
case-by-case basis.
Historically, aliphatic alcohols have been regulated both as pesticides
under EPA's jurisdiction and as devices under the Food and Drug
Administration (FDA)'s purview. This regulatory burden has been reduced
by a 1993/94 Memorandum of Understanding (MOU) which divides liquid
chemical germicides into two categories: sterilants (which FDA will
regulate) and general purpose disinfectants (which EPA will regulate). Both
Agencies will continue to have jurisdiction over all liquid chemical
germicides until rulemaking has been completed, but product performance
and efficacy data need only be reviewed by the Agency with primary
jurisdiction.
The case aliphatic alcohols contains three other active ingredients—
methanol, propyl alcohol, and tert-butyl alcohol—which are not being
supported for reregistration.
Toxicity
In studies using laboratory animals, aliphatic alcohols have been
shown to be of low acute toxicity. Ethanol has been placed in Toxicity
Category IV (indicating the lowest degree of acute toxicity) for all effects
tested including acute oral and inhalation toxicity, and primary eye and skin
irritation. Isopropanol also has been placed in Toxicity Category IV for all
effects except acute oral toxicity, for which it is placed in Toxicity Category
III. In an acute neurotoxicity study using rats, isopropanol vapors caused
decreased motor activity and effects on nervous system functions at the
higher dose levels.
In a subchronic toxicity study using rats, ethanol caused decreased
body weights and fatty degeneration in the livers of treated animals. In a
study using human volunteers, ethanol-saturated patches caused skin
irritation at 19-21 days of exposure. An inhalation study using rats, guinea
pigs, rabbits, monkeys, and dogs resulted in no signs of toxicity.
In a subchronic inhalation study using rats and mice, isopropanol
caused some clinical signs including ataxia, narcosis, hypoactivity, and lack
of startle response, as well as kidney lesions. In a subchronic inhalation
study using rats, no treatment-related changes were noted but motor activity
was increased at the highest dose level.
In a chronic toxicity study using rats, ethanol caused decreased mean
body weights, decreased activity, and impaired maze learning ability. In a
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Environmental
Assessment
chronic dermal toxicity study, no treatment-related effects were noted. Two
similar studies with isopropanol caused similar results.
EPA's review of the scientific literature indicates that carcinogenic
effects are not expected from the uses of ethanol. In a carcinogenicity study
using rats, isopropanol caused an increased incidence of granular kidneys,
thickened stomachs, and kidney lesions. A second study using mice also
caused increased incidence of stomach and kidney lesions, which were
determined not to be of biological significance.
Ethanol is generally recognized as a human developmental
neurotoxicant, causing Fetal Alcohol Syndrome in the offspring of mothers
who chronically consume high amounts of ethyl alcohol. However, the risk
in an industrial environment appears to be minimal.
Developmental toxicity studies using rats and rabbits show that
isopropanol causes reduced fetal body weights, decreased maternal body
weights, and increases in liver or kidney weights.
Ethanol was negative for mutagenicity effects in six out of seven
studies, while isopropanol was negative in all three studies available.
Dietary Exposure
Dietary exposure is not expected to result from the approved uses of
ethanol and isopropanol, including the plant regulator (ripener) use.
Occupational and Residential Exposure
Use of aliphatic alcohols may result in high dermal and inhalation
exposure of mixers, loaders and applicators, especially when power sprays
are used. However, the risk from exposure to these active ingredients is
considered to be incidental, considering the frequent intentional human
exposures to these substances.
Human Risk Assessment
Aliphatic alcohols are of low acute toxicity. No dietary exposure is
expected from their use as pesticides. EPA does not expect developmental
or reproductive effects to occur from the potential dermal and inhalation
exposures that may result from the registered pesticidal uses of ethanol and
isopropanol.
Environmental Fate
Aliphatic alcohols are organic chemical compounds. They are
flammable liquids and are highly soluble in water and many organic
solvents. Highly volatile liquids, they are stable in water under typical use
conditions. EPA does not anticipate significant exposure to the environment
from their uses.
Ecological Effects
Ethanol and isopropanol are practically non-toxic to mammals, fish,
and aquatic invertebrates.
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Ecological Effects Risk Assessment
Aliphatic alcohols are practically non-toxic to all species tested. They
are used primarily indoors. Both are highly volatile. Exposure to
terrestrial organisms would be extremely minimal.
Additional Data EPA is requiring product-specific data including product chemistry,
acute toxicity, and efficacy studies, revised Confidential Statements of
Formula (CSFs), and revised labeling for reregistration.
Required
Product Labeling
Changes Required
Regulatory
Conclusion
For More
Information
All aliphatic alcohol end-use products must comply with EPA's
current pesticide product labeling requirements. In addition, the following
statement must be added to the label of each product, except sterilant
products, that is registered for treatment of any medical device or medical
equipment surface:
"This product is not to be used as a terminal sterilant/high level
disinfectant on any surface or instrument that (1) is introduced directly
into the human body, either into or in contact with the bloodstream or
normally sterile areas of the body, or (2) contacts intact mucous
membranes but which does not ordinarily penetrate the blood barrier
or otherwise enter normally sterile areas of the body. This product
may be used to preclean or decontaminate critical or semi-critical
medical devices prior to sterilization or high level disinfection."
The use of currently registered products containing aliphatic alcohols
(ethanol and isopropanol) in accordance with approved labeling will not
pose unreasonable risks or adverse effects to humans or the environment.
Therefore, all uses of these products are eligible for reregistration.
Aliphatic alcohol products will be reregistered once the required
product-specific data, revised Confidential Statements of Formula, and
revised labeling are received and accepted by EPA.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for aliphatic alcohols during a 60-day time
period, as announced in a Notice of Availability published in the Federal
Register. To obtain a copy of the RED 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.
Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregistration Information System at
703-308-7224. They also are available on the Internet on EPA's gopher
server, GOPHER.EPA.GOV, or using ftp on FTP.EPA.GOV, or using
WWW (World Wide Web) on WWW.EPA.GOV.
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Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone
513-489-8190, fax 513-489-8695.
Following the comment period, the aliphatic alcohols RED document
also will be available from the National Technical Information Service
(NTIS), 5285 Port Royal Road, Springfield, VA 22161, telephone 703-487-
4650.
For more information about EPA's pesticide reregistration program,
the aliphatic alcohols RED, or reregistration of individual products
containing aliphatic alcohols, 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 pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN). Call toll-
free 1-800-858-7378, between 8:00 am and 8:00 pm Eastern Standard
Time, Monday through Friday.
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