United States Prevention, Pesticides EPA738-R-98-012
Environmental Protection And Toxic Substances October 1998
Agency (7508C)
&EPA Reregistration
Eligibility Decision (RED)
Methylisothiazolinone
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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, methylisothiazolinone
which includes the active ingredients 5-chloro-2-methyl-3(2H)-isothiazolone and 2-methyl-3(2H)-
isothiazolone. The enclosed Reregistration Eligibility Decision (RED), which was approved on
April 03,1996 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 is due 90 days from the receipt of this
letter. The second set of required responses is 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 Barbara
Briscoe at (703) 308-8177. Address any questions on required generic data to the Special
Review and Reregistration Division representative, Deanna Scher at (703) 308-7043.
Sincerely yours,
Lois Rossi, Division Director
Special Review
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and Reregi strati on 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
reregi strati on, a DCI letter will be enclosed describing such data. If product specific data are
required, a DCI letter will be enclosed listing such requirements. If both generic and product
specific data are required, a combined Generic and Product Specific DCI letter will be enclosed
describing such data. However, if you are an end-use product registrant only and have been
granted a generic data exemption (GDE) by EPA, you are being sent only the product specific
response forms (2 forms) with the RED. Registrants responsible for generic data are being sent
response forms for both generic and product specific data requirements (4 forms). You must
submit the appropriate response forms (following the instructions provided) within 90 days
of the receipt of this RED/DCI letter; otherwise, your product may be suspended.
2 TIME EXTENSIONS AND DATA WAIVER REOUESTS-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 time extensions for product specific data should
be submitted in the 90-day response. Requests for data waivers must be submitted as part of the
90-day response. 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 reregi strati on) separately. You may, but are not
required to, delete uses which the RED says are ineligible for reregi strati on. 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
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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 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 reregi strati on determination within 14 months after the RED has been
issued.
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REREGISTRATION ELIGIBILITY DECISION
Methylisothiazolinone
LISTC
CASE 3092
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
METHYLISOTHIAZOLINONE REREGISTRATION ELIGIBILITY DECISION TEAM
i
EXECUTIVE SUMMARY v
I. INTRODUCTION 1
II. CASE OVERVIEW 1
A. Chemical Overview 1
B. Use Profile 2
C. Data Requirements 6
D. Regulatory History 6
III. SCIENCE ASSESSMENT 6
A. Physical Chemistry Assessment 6
B. Human Health Assessment 8
1. Toxicology Assessment 8
a. Acute Toxicity 9
b. Subchronic Toxicity 9
c. Chronic Toxicity and Carcinogenicity 10
d. Developmental Toxicity 12
e. Mutagenicity 13
f. Toxicological Endpoints for Risk Assessment 14
2. Exposure Assessment 15
a. Occupational/Residential Exposure 15
b. Dietary Exposure 19
3. Risk Characterization 19
a. Occupational and Residential 19
b. Dietary 21
C. Environmental Assessment 21
1. Ecological Toxicity Data 21
a. Toxicity to Terrestrial Animals 21
b. Toxicity to Aquatic Animals 22
2. Environmental Fate 24
a. Environmental Fate Assessment 24
b. Environmental Fate and Transport 25
3. Exposure and Risk Characterization 28
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 29
A. Determination of Eligibility 29
B. Determination of Eligibility Decision 30
1. Eligibility Decision 30
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2. Eligible and Ineligible Uses 30
C. Regulatory Position 30
1. Endangered Species Statement 30
2. Labeling Rationale/Risk Mitigation 31
a. Occupational-Use Products 31
b. Homeowner-Use Products 32
c. Post-Application Safety Requirements 32
d. Other Labeling Requirements 32
V. ACTIONS REQUIRED OF REGISTRANTS 32
A. Additional Data Requirements 33
B. Labeling Requirements 33
C. Labeling Clarifications 36
1. Use Profile Clarifications 36
2. Use on Pilings 36
3. Water Treatment Systems 36
4. Clarification of Oil Drilling Mud Use 36
D. Existing Stocks 37
VI. APPENDICES 38
APPENDIX A. Table of Use Patterns Subject to Reregistration 39
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 87
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of Kathon® 91
APPENDIX D. Product Specific Data Call-In 99
Attachment 1. Chemical Status Sheets 113
Attachment 2. Product Specific Data Call-In Response Forms (Form A
inserts) Plus Instructions 114
Attachment 3. Product Specific Requirement Status and Registrant's
Response Forms (Form B inserts) and Instructions
116
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 123
Attachment 5. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 132
APPENDIX E. List of Available Related Documents 144
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METHYLISOTHIAZOLINONE REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Assessment
Michele Cottrill
Frank Hernandez
Margaret Cogdell
Environmental Fate and Effects Assessment
Joanne Edwards
Larry Liu
Karen Angulo
Health Effects Assessment
Kathleen Martin
Linda Taylor
Winston Dang
Registration Support
Marion Johnson
Valdis Goncarovs
Shy am B. Mathur
Risk Management
Kathy Davis
Bill Wooge
Deanna Scher
Office of General Counsel
Kevin Lee
Office of Enforcement and Compliance
Biological Analysis Branch
Economic Analysis Branch
Biological Analysis Branch
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Science Analysis and Coordination Staff
Risk Characterization and Analysis Branch
Toxicology Branch II
Occupational and Residential Exposure Branch
Antimicrobial Program Branch
Antimicrobial Program Branch
Registration Support Branch
Accelerated Reregi strati on Branch
Accelerated Reregi strati on Branch
Reregi strati on Branch I
Pesticides Branch
Rick Colbert
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. A now defunct term for reference dose (RfD).
AE Acid Equivalent
a.i. Active Ingredient
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 (D WEL) 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
FOB Functional Observation Battery
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/1, 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.
ug/g Micrograms Per Gram
mg/L Milligrams Per Liter
MOE Margin of Exposure
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
N/A Not Applicable
NOEC No effect concentration
NPDES National Pollutant Discharge Elimination System
ill
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GLOSSARY OF TERMS AND ABBREVIATIONS
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
OP Organophosphate
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
Q*! 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 © 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.
FAO/WHO Food and Agriculture Organization/World Health Organization
WP Wettable Powder
WPS Worker Protection Standard
IV
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EXECUTIVE SUMMARY
The U. S. Environmental Protection Agency has completed its reregi strati on eligibility decision
for the pesticide case methylisothiazolinone, which includes the active ingredients 5-chloro-2-methyl -
3(2H)-isothiazolone and 2-methyl-4-isothiazolin-3-one. This decision includes a comprehensive
reassessment of the required target data and the use patterns of currently registered products. The
Agency has concluded that all uses, as prescribed in this document, will not cause unreasonable risks
to humans or the environment and therefore, all products are eligible for reregi strati on. To mitigate
risks of potential inhalation and dermal toxicity to workers the Agency is requiring, among other
changes, the use of personal protective equipment. Additional data for hydrolysis for 5-chloro-2-
methyl-3(2H)-isothiazolone are required to be submitted to confirm the Agency's assessment and
conclusions.
Use Patterns
Methylisothiazolinone is an antimicrobial used to control slime-forming bacteria, fungi, and
algae in cooling water systems, fuel storage tanks, pulp and paper mill water systems, oil extraction
systems, and other industrial settings. It is also used to control the growth of mold, mildew, and
sapstain on wood products.
Human Health Assessment
From its review of the mammalian toxicology data, the Agency determined that
methylisothiazolinone is highly to very highly toxic, especially corrosive, by acute routes of exposure.
In subchronic studies with oral and inhalation dosing of rats, the most significant toxicological effect
was microscopic lesions in the nasal turbinates from inhalation exposure (NOEL of 0.34 //g/1), which
is a typical physiological response to a respiratory irritant. Developmental and
chronic/carcinogenicity studies resulted in no significant effects, with the Agency classifying
methylisothiazolinone as a group D carcinogen. Results from mutagenicity studies were equivocal.
The Agency selected the respiratory effect from the subchronic inhalation study as the
toxicological endpoint for risk assessment of short-term and intermediate occupational exposures.
The Agency concluded that the risks to workers in most situations are not of concern and short-term
risks of corrosivity can be adequately managed, as necessary. The Agency further believes risks from
secondary occupational exposures, residential exposures, and post-application exposures are
comparatively less and also not of concern.
Environmental Assessment
Methylisothiazolinone is moderately toxic to practically non-toxic to birds, and highly toxic
to freshwater and estuarine/marine organisms. While the hazard to aquatic organisms from
methylisothiazolinone has been characterized, a quantitative risk assessment has not been conducted
because the risks to aquatic environments from these uses are regulated under the NPDES permitting
program of EPA's Office of Water.
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Product Reregistration
Before reregistering the products containing methylisothiazolinone, the Agency is requiring
that product specific data, revised Confidential Statements of Formula (CSF) and revised labeling be
submitted within eight months of the issuance of this document. In addition, registrants must comply
with the generic data requirements as outlined in Section V of this document. These data include the
upgrading of an existing hydrolysis study. 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 that contain other active ingredients will be eligible for reregi strati on only
when the other active ingredients are determined to be eligible for reregistration.
VI
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended to
accelerate the reregi strati on of products with active ingredients registered prior to November 1,1984.
The amended Act provides a schedule for the reregi strati on 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 methylisothiazolinone. The document consists of six sections. Section I is the
introduction. Section II describes methylisothiazolinone, 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 methylisothiazolinone.
Section V discusses the reregistration requirements for methylisothiazolinone. Finally, Section VI
is the Appendices which support this Reregistration Eligibility Decision. Additional details
concerning the Agency's review of applicable data are available on request.
II. CASE OVERVIEW
A. Chemical Overview
This Reregistration Eligibility Decision covers the two active ingredients 5-chloro-2-
methyl-3(2H)-isothiazolone and2-methyl-3(2H)-isothiazolone. These two active ingredients
occur together in the currently registered products in approximately a 3:1 ratio, respectively,
and are commonly referred to as methylisothiazolinone. The Agency has permitted most
generic studies to be conducted on the formulation intermediate or on end-use products which
contain both active ingredients in equilibrium (-3:1 ratio).
! Chemical Names: 5-Chloro-2-methyl-3(2H)-isothiazolone
2-Methyl-3 (2H)-isothiazolone
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! Chemical Family: Thiazole, heterocyclic aromatic compound
! Trade and Other Names: Kathon®
! Basic Manufacturer: Rohm and Haas Company
1. 5-Chloro-2-methyl-3(2H)-isothiazolone
! CAS Registry Number: 26172-55-4
! OPP Chemical Code: 107103
! Empirical Formula: C4H4C1NOS
2. 2-Methyl-3(2H)-isothiazolone
! CAS Registry Number: 2682-20-4
! OPP Chemical Code: 107104
! Empirical Formula: C4H5NOS
B. Use Profile
The following is information on the currently registered uses with an overview of use
sites and application methods.
For Methylisothiazolinone:
(5-chloro-2-methyl-3(2H)-isothiazolone and 2-methyl-3(2H)-isothiazolone)
Type of Pesticide: Mi crobiocide/Microbiostat (slime-forming bacteria, fungi, and
algae), Fungicide (mold and mildew, sapstain)
Use Sites:
TERRESTRIAL NON-FOOD SITES:
Wood Protection Treatment To Forest Products (Seasoned)
Wood Pressure Treatment To Forest Products
Oil Recovery Drilling Muds/Packer Fluids*
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AQUATIC NON-FOOD INDUSTRIAL:
Air Washer Water Systems
Commercial/Industrial Water Cooling Systems
Evaporative condenser Water Systems
Heat Exchanger Water Systems
Industrial Processing Water
Industrial Scrubbing System
Oil Recovery Drilling Muds/Packer Fluids*
Pulp/Paper Mill Water Systems
Secondary Oil Recovery Injection Water
AQUATIC NON-FOOD OUTDOOR:
Wood Protection Treatment (unspecified)**
INDOOR FOOD
Adhesives and Coatings intended for Food Packaging
(regulated by FDA)
INDOOR NON-FOOD:
Adhesives, Industrial
Coatings, Industrial
Emulsions, Resin/Latex/Polymer
Fuels/Oil Storage Tank Bottom Water Additive
Metalworking Cutting Fluids
Oil Recovery Drilling Muds/Packer Fluids*
Paints, Latex (In-Can)
Pasteurizer/Warmer/Cannery Cooling Water Systems
Specialty Industrial Products
(e.g., cleaning fluids, hydraulic fluids, polishes, air fresheners,
carpet shampoos, detergents, waxes, photo plate processing
chemicals, conveyor lubricants)
* Registrants must specify on labels, as per Section V of this document, whether the product is used on off-shore
and/or terrestrial sites.
** One label has use directions for treatment to pilings. The registrant has agreed to clarify their label to specify
that these treated woods are not to be used in aquatic environments. For further details, see Section V.
* Registrants must specify on labels, as per Section V of this document, whether the product is used on off-shore
and/or terrestrial sites.
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Textiles/Textile Fibers/Cordage
Wet-End Additives/Industrial Processing Chemicals
Target Pests: Slime-forming bacteria, fungi, and algae; sulfate-reducing bacteria
Formulation Types Registered:
TYPE: End use, Manufacturing use
FORM: Soluble concentrate/liquid, Soluble concentrate/solid
Method and Rates of Application:
Types of Treatment - Industrial preservative treatment, Preservative
treatment, Water treatment, Water treatment
(recirculating system), Water treatment
(unspecified)**, Wood protection treatment by
pressure, Dip treatment, Non-soil contact non-
fumigation
Equipment - Chemical pump, Metering pump, Automatic dispensing
equipment, Dip tank, Sprayer, Not specified (Registrant must
specify on labeling).
Use Rate -
Use Rates for 5-Chloro-2-methyl-3(2H)-isothiazolone:
Terrestrial Non-Food Crop
Microbiocide for oil recovery drilling muds and packer fluids - 0.34
to 34 ppm active ingredient.
Fungicide (mold and mildew) for wood products - 1.7 to 37 ppm
active ingredient.
Fungicide (sapstain) for wood products - not able to calculate dosage.
Aquatic Non-Food Industrial
0.11 to 36 ppm active ingredient.
Aquatic Non-Food Outdoor
** See Section V for revisions to clarify this use site.
4
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1.7 to 37 ppm active ingredient.
Indoor Non-Food
0.29 to 115 ppm active ingredient.
Use Rates for 2-Methyl-3(2H)-isothiazolone:
Terrestrial Non-Food Crop
Microbiocide for oil recovery drilling muds and packer fluids - 0.1 to
10 ppm active ingredient.
Fungicide (mold and mildew) for wood products - 0.52 to 11 ppm
active ingredient, (wood protection treatment)
Fungicide (sapstain) for wood products - not able to calculate dosage.
(wood protection treatment)
Aquatic Non-Food Industrial
0.034 to 11 ppm active ingredient.
Aquatic Non-Food Outdoor
0.52 to 11 ppm active ingredient.
Indoor Non-Food
0.088 to 12 ppm active ingredient.
Timing - During manufacture, Continuous feed (initial), Continuous
feed (subsequent), Initial, Subsequent/maintenance,
Intermittent (slug)(initial), Intermittent (slug)(sub sequent),
Shock/slug, When needed, Not specified (Registrant must
specify on labeling).
Use Practice Limitations:
Preclean for heavily soiled areas. Do not discharge effluent containing this
pesticide into sewage systems without notifying the sewage treatment plant
authority. Do not apply in marine and/or estuarine oil fields. Do not
discharge effluent containing this product into lakes, streams, ponds, estuaries,
oceans, or public water (NPDES license restriction).
C. Data Requirements
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The Agency applied the data requirements specified in 40 CFR Section 158 and the
Phase II Requirements to active ingredients in this chemical case. Studies were generated and
submitted to the Agency. The data from these studies along with other available information
form the basis for the Agency's scientific assessment and regulatory decisions. Appendix B
includes all data requirements needed to support reregi strati on of currently registered uses.
D. Regulatory History
5-Chloro-2 methyl-3(2H)-isothiazolone and 2-methyl-3(2H)-isothiazolone were
registered in the United States as early as 1977 as active ingredients. Currently, 85 products
are registered for uses for incorporation into products such as adhesives, coatings, fuels,
metal working fluids, resin emulsions, paints and various other speciality industrial products
(as a preservative); and, as a microbiocide in pulp/paper mills, cooling water systems, oil field
operations, industrial process waters and air washers systems. The compound is also used
to treat wood products (seasoned/unseasoned forest products and various finished wood
products).
Two Data Call-Ins have been issued: The Antimicrobial Data Call-In of March 4,1987
and a Reregi strati on Phase 4 Data Call-In dated November 3, 1992 requiring additional
toxicity and environmental fate data.
III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
For methylisothiazolinone (5-chloro-2-methyl-3(2H)-isothiazolone and 2-methyl-
3(2H)-isothiazolone at 3:1 ratio):
Color: golden yellow at 25 °C
Physical State: clear liquid at 25 °C
Odor: pungent aromatic
Boiling Point: 101.1 ± 0.2°C at standard room pressure
Bulk Density: 1.296 g/ml at 25°C
pH: 1.90 at 23.8 °C
Vapor Pressure:
For 5-chloro-2-methyl-3(2H)-isothiazolone - 1.8x10"2 torr.
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For 2-methvl-3(2HVisothiazolone - 6.2xlO'4 torr.
Solubility:
For 5-chloro-2-methyl-3(2H)-isothiazolone
Solvent Solubility g/lOOml Solvent
Water Infinite
Ethyl Acetate > 4.31
Methanol > 4.40
Toluene > 4.07
Hexane > 0.28
For 2-methyl-3(2H)-isothiazolone
Solvent Solubility g/lOOml Solvent
Water Infinite
Ethyl Acetate > 0.19
Methanol > 1.52
Toluene > 0.08
Hexane > 0.03
Dissociation Constant: Does not dissociate into ions
Octanol/Water Partition Coefficient:
For 5-chloro-2-methyl-3(2H)-isothiazolone
Kow = 0.401 at 24°C in log For 2.519
For 2-methyl-3(2HVisothiazolone
Kow = 0.486 at 24°C in log P or 0.326
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Stability:
For 5-chloro-2-methyl-3(2H)-isothiazolone
Conditions Duration
54°C
Metal
(Mild steel)
Metal ion
(FeC13)
Sunlight
1 week
2 weeks
1 week
1 week
24 hours
48 hours
72 hours
% of Active Ingredient Remaining
98.0
96.0
97.0
85.0
99.0
99.0
99.0
For 2-methyl-3(2H)-isothiazolone
Conditions Duration
54°C
Metal
(Mild steel)
Metal ion
(FeC13)
Sunlight
1 week
2 weeks
1 week
1 week
24 hours
48 hours
72 hours
% of Active Ingredient Remaining
99.0
98.0
100.0
90.0
100.0
100.0
100.0
B. Human Health Assessment
1. Toxicology Assessment
At present, the toxicology data base for methylisothiazolinone meets the
requirements for antimicrobials. The data are adequate and will support a
reregi strati on eligibility determination for the currently registered non-food uses. All
food use of methylisothiazolinone is regulated by the U.S. Food and Drug
Administration. All data have been generated on a formulation intermediate or on an
end-use product. The formulation intermediate and all currently registered end-use
products are a combination of 5-chloro-2-methyl-3(2H)-isothiazolone and 2-methyl-
3(2H)-isothiazolone in an equilibrium ratio of approximately 3:1.
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a. Acute Toxicity
The acute toxicity values and categories for Kathon 886, a formulation
intermediate, are summarized in Table 1.
Table 1 - Acute Toxicity Data for Methylisothiazolinone
GDLN#
81-1
81-2
81-3
81-4
81-5
81-6
Test
Oral LD50~rat
Dermal LD50~rabbit
Inhalation LC50~rat
Eye irritation-rabbit1
Dermal irritation— rabbit1
Dermal sensitization-guinea pig1
Results
105 mg/kg
200 mg/kg
0.33 mg/L
corrosive
severely irritating
sensitizer
Category
II
I
II
I
I
-
MRID#
86091
86092
41963501
42360901
42360902
86092
86092
144880
1 This study is a requirement for manufacturing-use and end-use products (40 CFR Section 158). For
methylisothiazolinone, data have been generated on the formulation intermediate and are presented here for
informational purposes.
b. Subchronic Toxicity
Exposure of Charles River COBS CD(SD)BR rats to
methylisothiazolinone (15.5% a.i.) via the drinking water at dose levels of 25,
75, or 225 ppm (males 2.4, 6.3, or 16.3 mg/kg/day; females 4.1, 10.8, or 24.7
mg/kg/day) for three months resulted in a slight decrease (96% of control) in
body weight in the high-dose males during weeks 1 and 2 and decreases in
body-weight gain in both sexes (males 82-89% and females 82-85% of
control) at the high-dose level during the first two weeks of the study. The
mid- (90-91% of control) and low-dose (86-88% of control) females also
displayed decreases in body-weight gains compared to the controls during
weeks 1 and 2, but there was no dose response.
A dose-related decrease in food consumption was observed in males
during weeks 1 through 3, which was statistically significant at all dose levels
during weeks 1 and 3. Females displayed a dose-related decrease in food
consumption during the first two weeks, which was statistically significant at
the high dose during week 1 and at the mid- and high-dose levels during week
2. There was a dose-related decrease in water consumption throughout most
of the study at all dose levels in males and females at the high-dose level.
Females at all dose levels displayed a significant decrease in water
consumption during the first week. This decrease in water consumption may
have been due to a palatability problem.
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No adverse effects were observed on hepatic mixed function oxidase
activity in either sex. Although differences in several parameters were
observed (decreased cholesterol in females, increased SGOT in females,
decreased BUN, foci of erosion and focal blunting of the superficial
epithelium of the glandular mucosa of the stomach in both sexes), there were
no lexicologically significant effects observed in either sex. The NOEL is 75
ppm (males 6.3 mg/kg/day; females 10.8 mg/kg/day). The LOEL is 225 ppm
(males 16.3 mg/kg/day; females 24.7 mg/kg/day), based on microscopic
findings (focal blunting) in the stomach in both sexes. Although there were
no lexicologically significant effects observed in either sex, the corrosive
properties of methylisothiazolinone impose limitations on the dose levels
tested for any duration (GDLN 82-1; MRID #42810101).
In a subchronic inhalation toxicity study, the exposure of 16
Crl:CD(SD)BR rats/sex/group to methylisothiazolinone (14% a.i.) at dose
levels of 0.34, 1.15, or 2.64 mg/m3 via inhalation for 90 days resulted in
decreased body weight in the high-dose males (-90% of control) and
decreased body-weight gains in both sexes (males «84%; females «89%) at
the high-dose level. There were no treatment-related deaths, and no effects
were observed in the hematology, clinical chemistry, ophthalmoscopic, and
gross pathology parameters monitored that could be attributed to treatment.
Treatment-related lesions in the nasal turbinate were observed at the
mid- and high-dose levels, which consisted of eosinophilic droplets in the
anterior respiratory mucosa (2.64 mg/m3) and rhinitis in the lining of the
anterior portion of the nasal cavity (1.15 and 2.64 mg/m3). These are
consistent with a normal physiological response to a respiratory irritant.
The NOEL is 0.34//g/1. The LOEL is 1.15/^g/1, based on microscopic
lesions in the nasal turbinates (rhinitis). With the exception of decreased
body-weight gain, there were no lexicologically significant effects observed
in either sex, but the corrosive properties of methylisothiazolinone imposed
limitations on the dose levels tested for any duration (GDLN 82-4; MRID
#148418).
c. Chronic Toxicity and Carcinogenicity
Although chronic data are not typically required for indoor non-food
use patterns, these data were submitted. A discussion of the results is
included here.
Exposure of 90 male and 80 female Crl:CD®BR rats per group to
methylisothiazolinone (14.2% a.i.) via the drinking water at dose levels of 30
10
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(males 2.0 mg/kg; females 3.1 mg/kg), 100 (males 6.6 mg/kg; females 9.8
mg/kg), or 300 ppm (males 17.2 mg/kg; females 25.7 mg/kg), or to tap water
or 0.5% salt solution [MgCl2 and Mg(NO3)2] vehicles for 24 months resulted
in a dose-related decrease in drinking water consumption at all dose levels in
both sexes throughout the study.
Decreased body weight (95-98% of control) and body weight gain
(87% of control at week one, from 91-98% thereafter) were observed in the
high-dose males, although statistical significance was not always attained.
Females displayed an equivocal decrease in body weight throughout the study,
with the mid- (93-96% of control) and high-dose (87-96% of control) groups
showing comparable decreases that were not always dose-related.
During the second year, body-weight gains of the high-dose females
were significantly decreased (83-88% of control). High-dose males displayed
a significant decrease (91-98% of control) in food consumption compared to
the control groups throughout most of the study, and females at all dose levels
displayed significant decreases in food intake but a dose response was not
always evident.
Hematology and clinical chemistry parameters were comparable
among the groups of both sexes, as were the organ weights and eyes. During
the first six months of the study, the specific gravity of the urine was increased
in both sexes, which may be attributed to the decrease in water consumption.
With the exception of the stomach, none of the gross and non-
neoplastic lesions observed could be attributed to treatment. An increased
incidence in hyperplasia and hyperkeratosis of the squamous mucosa of the
stomach was observed at the mid- and high-dose levels in both sexes, which
correlated with the finding of prominence of the limiting ridge and/or
thickened non-glandular mucosa of the forestomach on gross examination.
Additionally, there was an increased incidence of necrosis of the glandular
mucosa in the mid-dose females and in both sexes at the high-dose level.
There was no treatment-related increase in the incidence of any tumor
in either sex. The corrosive properties of methylisothiazolinone imposed
limitations on the dose levels tested. The NOEL is 30 ppm (males 2.0
mg/kg/day; females 3.1 mg/kg/day). The LOEL is 100 ppm (males 6.6
mg/kg/day; females 9.8 mg/kg/day), based on microscopic lesions
(hyperplasia/hyperkeratosis in both sexes, necrosis of glandular mucosa in
females) in the stomach (GDLN 83-l(a), 83-5; MRID #43140701).
11
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Based on the results of the chronic drinking water study in rats and
considering the corrosive nature and lethality of the test material in addition
to the absence of another carcinogenicity study in a second species, the Office
of Pesticide Program's Health Effects Division RfD Peer Review Committee
determined that methylisothiazolinone should be classified as a Group D, not
classifiable as to human carcinogenicity. This is further discussed below in
subsection f, Toxicological Endpoints for Risk Assessment.
d. Developmental Toxicity
Exposure of Sprague-Dawley CR® rats (25 dams/group) to
methylisothiazolinone (14% a.i.) via gavage (days 6-15 of gestation) at dose
levels of 0 (distilled H2O), 10, 30, or 100 mg/kg/day resulted in a dose-related
decrease in maternal body-weight gains (62% of control at mid-dose and 41 %
of control at high-dose level) during treatment and a dose-related increase in
maternal death (control 0/25, low 1/25, mid 2/25, high 3/25).
There were no effects on pregnancy rate, numbers of corpora lutea,
implantations, resorptions, and/or live fetuses; pup weights, sex ratios, and
crown-rump length were comparable among the groups. There were no
adverse findings from the visceral or skeletal examinations of the fetuses that
could be attributed to treatment.
Methylisothiazolinone was not found to be fetotoxic, embryotoxic, or
teratogenic in rats. The maternal toxicity NOEL is 10 mg/kg/day. The
maternal LOEL is 30 mg/kg/day, based on decreased body-weight gains, with
support from the dose-related increase in deaths. The NOEL for
developmental toxicity was 100 mg/kg/day, the highest dose tested (GDLN
83-3(a);MRID #78831).
In a second developmental toxicity study, dose levels of 0.5, 2, 8, or
20 mg methylisothiazolinone (13.4% a.i.)/kg body weight per day to
presumed-pregnant New Zealand white rabbits (16/group) during days 7
through 19 of gestation resulted in: (1) death and gross pathological lesions
of the stomach at the highest dose (all animals either died or were sacrificed
moribund by day 15 of gestation); (2) scant or no feces and diarrhea at the 8
and 20 mg/kg/day dose levels; and (3) decreased overall body-weight gain
(70% of control), corrected body weight (92% of control), and food
consumption at the 8 mg/kg/day dose level.
The numbers of implantations, live fetuses, resorptions, dead
implants, and dead fetuses per doe were comparable among the groups, and
fetal body weight (combined and per sex) was comparable among the groups.
Although there were no statistically significant differences in the incidence of
any fetal alteration (external, visceral or skeletal malformations, variations, or
12
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retarded development), there was a tendency for these to occur to a greater
degree at the 8 mg/kg/day dose level than in the control or other treatment
groups. The maternal toxicity NOEL is 2 mg/kg/day.
The maternal toxicity LOEL is 8 mg/kg/day, based on decreased body-
weight gain, corrected body weight, food consumption, and scant/no feces
and diarrhea. The developmental toxicity NOEL is 2 mg/kg/day. The
developmental toxicity LOEL is 8 mg/kg/day, based on the slight increase in
fetal alterations (GDLN 83-3(b); MRID #42311701).
e. Mutagenicity
Methylisothiazolinone (14% a.i.) was positive in the Ames assay in
TA100 at concentrations as low as 0.0005 jil/plate without metabolic
activation. TA100 with activation and all other strains with and without
metabolic activation were negative (GDLN 84-2(a); MRTD #78827, 96692).
In a second Ames assay using methylisothiazolinone manufactured by
a different process than in the previous study, methylisothiazolinone was
positive in TA100 without metabolic activation at concentrations as low as
0.0005 |il/plate. TA100 with activation and all other strains with and without
metabolic activation were negative (GDLN 84-2; MRTD #105044).
Methylisothiazolinone was positive in the mouse lymphoma gene
mutation assay at dose levels as low as 1 nl/ml without metabolic activation
and at 1.22 nl/ml with metabolic activation (GDLN 84-2(a); MRID #96693).
Negative results were observed in the Drosophila sex-linked recessive
lethal assay up to the highest dose tested (dose levels 86 jig ai/ml oral; 258 jig
ai/ml injection) (GDLN 84-4; MRID #130751).
Methylisothiazolinone did not cause a significant increase in the
frequency of structural chromosome aberrations in mouse bone marrow cells
at oral doses of 3, 15, or 30 mg ai/kg, which were considered sufficiently high
dose levels (GDLN 84-2; MRID #42538001).
Methylisothiazolinone did not induce unscheduled DNA synthesis in
primary rat hepatocytes at dose levels that were sufficiently high to adequately
assess the mutagenic potential of the test material (GDLN 84-4; MRTD
#41875502).
13
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f. Toxicological Endpoints for Risk Assessment
(1) Reference Dose
An RfD was not established for this chemical because it is
currently registered for non-food use applications only, outside the
FDA regulated uses in paper and adhesives which may contact food.
Also, chemicals such as methylisothiazolinone, used as disinfectants,
microbiocides, microbiostats, and sanitizer have not been reviewed by
the FAO/WHO Joint Meeting on Pesticide Residues (JMPR).
(2) Carcinogenicity Classification
The Agency's Office of Pesticide Program Health Effects
Division RfD Peer Review Committee classified methylisothiazolinone
as a Group D carcinogen. The Committee concluded that the effects
observed in the studies on methylisothiazolinone result from a contact
phenomenon, and observed that doses adequate to produce systemic
toxicity are not possible because of its corrosive nature. In addition,
the results of the mutagenicity studies are equivocal.
(3) Other Toxicological Endpoints
Based on the review of the toxicology database and
information on the use patterns for methylisothiazolinone, the
Agency's Office of Pesticide Program Health Effects Division Toxicity
Endpoint Selection Committee established endpoints to be used in the
occupational and residential risk characterization; they are listed in
Table 2.
Table 2 - Toxicological Endpoints for Methylisothiazolinone
Type of Exposure
Acute Dietary
Dermal Absorption
Short term Occupational
or Residential Exposure
(one to seven days)
Intermediate Term Occupational
or Residential Exposure
(one week to several months)
Chronic (noncancer)
Endpoint and Dose
Because there is no anticipated dietary exposure, this endpoint is
not required for this active ingredient.
Not available, because methylisothiazolinone is corrosive and a
human skin sensitizer.
Dermal Exposure. The primary concern is acute exposure as this
chemical is corrosive. There is no systemic toxicological endpoint
for risk characterization.
Inhalation Exposure. The toxicolosical endpoint is the NOEL of
0.34 ,ag/l based on microscopic lesions in nasal turbinates observed
in the 90-day rat inhalation study (MRID 00148418).
Not applicable.
14
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The Committee concluded that for methylisothiazolinone,
occupational and residential risk should be characterized via the
inhalation route of exposure. Occupational and/or residential
exposure to methylisothiazolinone would occur over weeks or months
(i.e., intermediate-term). Dermal exposure would tend to occur only
in the short-term (i.e., acute) as methylisothiazolinone is corrosive.
Thus, the inhalation route is appropriate for intermediate term risk
characterization.
The Committee did not identify a chronic toxicological
endpoint because methylisothiazolinone is so corrosive that an
adequately high dose cannot be administered to observe systemic
effects.
2. Exposure Assessment
a. Occupational/Residential Exposure
An occupational and/or residential exposure assessment is required for
an active ingredient if there are applicable toxicological endpoints and if there
is potential exposure to handlers (mixers, loaders, applicators, etc.) during use
or to persons entering treated sites after application is complete, or to persons
in residential settings. The Agency has identified short-term and intermediate-
term toxicological endpoints (inhalation effects) for methylisothiazolinone
and recognizes that there is occupational and residential exposure from the
use of methylisothiazolinone products. Therefore, an exposure assessment is
appropriate.
In addition to methylisothiazolinone, the Agency had concerns that
individuals may be exposed to formaldehyde as this pesticide is a putative
formaldehyde generator based on its chemical structure. However, hydrolysis
studies do not suggest that formaldehyde will be formed.
The following exposure and risk characterization addresses both
primary and secondary exposure for occupational and residential
methylisothiazolinone application and post-application scenarios. As noted
earlier, the risk for methylisothiazolinone is characterized via the inhalation
route.
Exposure to the registered end-use products of methylisothiazolinone
is considered primary exposure and it may occur to handlers during
application or post-application. Primary application exposure scenarios
include those where persons handle the methylisothiazolinone end-use
15
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products; for example, exposures which occur as the handler pours end-use
product into a vat. During handling, workers may experience both acute
(dermal and inhalation) and intermediate (inhalation) effects.
Primary post-application exposure scenarios include those where
persons are in or near areas where methylisothiazolinone end-use products are
being or have recently been applied; for example, exposures to a handler
working near a vat containing water treated with methylisothiazolinone.
Because methylisothiazolinone is an industrial pesticide, primary exposures
will only occur in an occupational setting; no primary residential exposure is
expected.
Exposure to a product that is not a pesticide but happens to contain
one is considered secondary exposure and again, it may occur during
application or post-application. Secondary application scenarios include those
where persons, either people in a residential setting or handlers in an
occupational setting, handle products such as paints and adhesives to which
methylisothiazolinone has been added. Secondary post-application exposure
scenarios include those where persons are in or near areas where products
such as methylisothiazolinone-treated paints or adhesives are being used or
have recently been used. Because methylisothiazolinone-containing products
may be used in either industrial-use or residential-use products, secondary
exposure is possible in both occupational and residential settings.
(1) Application Exposure Scenarios
Primary Exposures to Occupational Handlers
Primary occupational handler exposure scenarios include open-
pouring the soluble liquid or the soluble solid formulation product into
receiving vessels, applications of the soluble liquid by metering pumps,
automatic dispensers, dip tanks, and spraying.
Of these scenarios, the Agency considers the open-pouring of
a soluble concentrate liquid formulation to represent a reasonable
worst-case inhalation exposure scenario for primary occupational
handlers. Provided in Table 3 are exposure estimates based on for five
open-pour liquid applications (oil well injection fluid, cooling tower,
paint manufacturing, metal-working fluid, and pulp and papermill) and
one open-mixing solid application (drilling mud). These estimates
were derived from the Pesticide Handlers Exposure Database, Agency
knowledge of industry practice, and pesticide labels.
Table 3 -Inhalation Exposure Estimates and Risks to Workers for Methylisothiazolinone Application
Scenarios
16
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Application Site/Product
Calculation of Pounds A.I. Used Per Day
Product Used
Per Vol.
Treated1
Volume
Treated Per
Day2
Ibai
used/day3
Calculations of Worker Exposure and MOE
UE
(ug/lb ai)4
A.I. Inhaled5
(ug/day)
ADE
(mg/kg/day)6
MOE7
Primary Exposure Scenarios (Open-Pouring Applications)
Oil Well Injection Fluid
/Liquid
Cooling Tower
/Liquid
Paint Manufacturing
/Liquid
Metal Fluid
/Liquid
Pulp and Papermill
/Liquid
Drilling Mud
/Solid
Paint
Application
1010.5 Ibs
42,000 gal
7.46 Ibs
1000 gal
1.65 Ib
1000 Ib
(119 gal)
9.94 Ibs
1000 gal
1.5 Ibs
ton
17.5 Ibs
1000 barrels
1000 barrels
(42,000 gal)
20,000 gal
100 gal
(833.7 Ibs)
300 gal
100 tons
1000 barrels
15.1
2.24
0.02
0.04
2.25
1.22
1.2
1.7
18.12
2.69
0.025
0.049
2.73
2.074
2.6xlO'4
3.84xlO'5
3.5xlO-7
7.0xlO-7
3.9xlO'5
3.0xlO'5
189
1,300
139,000
70,000
1,300
1,655
Secondary Exposure Scenarios
Occupational
Residential
1675 pprn
1 gal paint
5 gal
Igal
0.0013
0.00025
570
0.741
0.143
l.lxlO'5
2.0xlO-6
4,896
24,480
1 Product Used Per Vol. Treated = The use rate of methylisothiazolinone. The concentration of the product, for all settings is 1.5% a.i.
(except Drilling Mud @ 6.98 %a.i.) This was obtained from the following pesticide labels: EPA Reg. Nos. 10445-66, 10707-13,1577-
73, 1448-348, and 1757-79.
2 Volume Treated Per Day = EPA assumption based on knowledge of industrial practices.
3 Ib ai used/day = Product Used per Vol. Treated x volume treated/day x % ai. For paint, 1 gallon of paint = 10 Ibs.
4 UE = Unit Exposure, which was derived from Pesticide Handlers Exposure Database (Version 1.1, 1995), based on 29 1/min as an
inhalation rate.
5 Amount Inhaled (ug/day) = UE x Ib ai used/day.
6 ADE = Actual Daily Exposure (by the inhalation route). Calculated as: ADE (mg/kg/day) = (Amount Inhaled/BW)/1000; where BW
= 70 kg.
7MOE = NOEL/ADE (inhalation dose), where NOEL = 0.00034 mg/L (0.049 mg/kg/day) with a daily inhalation rate of 10 m3.
Secondary Exposures to Occupational Handlers
Secondary occupational handler exposure scenarios include
exposures while handling methylisothiazolinone-containing paint,
adhesives, wood/forestry products, and metalworking fluids.
The Agency considers exposures while handling
methylisothiazolinone-containing paint to represent a reasonable
worst-case inhalation exposure scenario for secondary occupational
handlers. Exposures to handlers from methylisothiazolinone in paints,
adhesives, wood products, and textiles are expected to be smaller than
17
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those for primary handlers, since the dilution rate is usually far greater
than one percent. Provided in Table 3 (as Paint Application) is the
exposure estimate for this scenario.
For exposure to methylisothiazolinone-containing metal
working fluids, the assessment of occupational exposure addresses
only the potential exposures to pesticide handlers who are loading
methylisothiazolinone products as an active ingredient into metal
working fluids. The Agency continues to discuss with Occupational
Safety and Health Administration (OSHA) and National Institute for
Occupational Safety Health (NIOSH) the roles and responsibilities of
regulating the uses of metalworking fluids, paints and other products
in the industrial setting. Because OSHA is responsible for regulating
machinists' safety and exposure, these exposures will not be addressed
in detail in this document.
Primary Exposures to Residential Handlers
Because methylisothiazolinone products are currently intended
for occupational use, there are no primary residential scenarios.
Secondary Exposures to Residential Handlers
Secondary residential handler exposure scenarios include
exposures while handling methylisothiazolinone-treated paint,
adhesives, paper products, wood products, and fabrics.
The Agency believes that exposures from handling
methylisothiazolinone-containing paint represent a reasonable worst-
case inhalation exposure scenario for secondary residential handlers.
The Table 3 - Paint Application provides the exposure estimate for
this scenario.
(2) Post-Application Exposure Scenarios
There are no data available to estimate the exposures from
these types of post-application scenarios described above. However,
the Agency assumes that the application exposures from primary and
secondary scenarios are much higher than post-application exposures.
The Agency believes that the concentration in a
methylisothiazolinone-treated product, such as paint or wood
products, is significantly reduced from that concentration an individual
would be exposed to during application of the end-use product.
18
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b. Dietary Exposure
Administrative guidelines are established for methylisothiazolinone
uses (in adhesives and as slimicides) in food contact through food packaging.
These uses of methylisothiazolinone in the manufacture of paper, paperboard
(21 CFR §176.170 and 21 CFR §175.300) and adhesives (21 CFR§175.105)
which may contact food are regulated under the jurisdiction of the United
States Food and Drug Administration. These guidelines are not directly
regulated by EPA. There are no other registered food uses of
methylisothiazolinone.
3. Risk Characterization
a. Occupational and Residential
(1) Application Exposure Scenarios
Intermediate-Term Risks
Based on the Agency's assessment of the available toxicity
data and described exposure scenarios for methylisothiazolinone, the
Agency has determined that quantitative risk characterizations are
appropriate for occupational and residential handlers. Because of the
selected toxicity endpoint from the 90-day inhalation study for
methylisothiazolinone, the Agency is characterizing the intermediate-
term risks by margins of exposure (MOE), that is, by the ratio of the
NOEL to the exposure estimates.
Provided in Table 3 are the MOEs for the
methylisothiazolinone application scenarios. For
methylisothiazolinone, all the application exposure MOEs are greater
than 100. The occupational scenario MOEs range from nearly 200 for
open-pouring oil well injection fluid to 139,000 for open-pouring
during paint manufacturing; the residential scenario (painting) MOE
is -25,000. The Agency generally is not concerned about the risk if
MOEs are greater than 100.
Acute Risks
However, even though the MOEs for intermediate term
exposure are not of concern, EPA is concerned with potential adverse
effects resulting from acute dermal and inhalation exposures to
methylisothiazolinone for the following reasons:
19
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Technical methylisothiazolinone is corrosive and a skin
sensitizer. In acute toxicity tests, methylisothiazolinone (14%
a.i.) was shown to be in Toxicity Category I for: dermal
toxicity with rabbits, dermal irritation with rabbits and primary
eye irritation with rabbits. In a dermal sensitization study in
guinea pigs, methylisothiazolinone produced delayed contact
hypersensitivity. In an acute inhalation study with rats,
methylisothiazolinone showed Category II toxicity. Finally,
methylisothiazolinone is volatile.
Methylisothiazolinone may be used indoors as well as
outdoors and is often applied to systems by open pouring. For
example, handlers may openly pour methylisothiazolinone into
cooling towers, vats of paint during the manufacturing
process, and into metal cutting fluids. During such operations
the pesticide may volatilize and cause inhalation irritation or
it may splash onto skin, causing dermal irritation. Even under
closed-metering conditions, workers may experience acute
dermal and inhalation exposure during coupling operations.
Indoor use may result in greater acute inhalation exposure
than outdoor use as the pesticide most likely would not
dissipate from the vicinity of the workers as quickly as it
would outdoors.
(2) Post-Application Exposure Scenarios
As previously discussed, the Agency does not have data to
directly assess post-application exposure to methylisothiazolinone in
occupational or residential settings. However, the Agency believes
that exposures following application are likely to be less than
exposures during application, and therefore risks will be less (i.e.,
higher MOE values). Further, the Agency believes that post-
application dermal risks will be minimal because the concentrations
that individuals would be exposed to would be much lower than the
amount of methylisothiazolinone workers are exposed to during
application. Thus, a quantified characterization of the dermal post-
application exposure risks is unnecessary.
The Agency has also considered the potential formaldehyde
exposure from products containing methylisothiazolinone (based on
methylisothiazolinone's chemical structure). Supported by hydrolysis
studies, EPA believes that exposure to formaldehyde from
methylisothiazolinone is unlikely (no formaldehyde release was
observed). Even if some formaldehyde were generated, the post-
20
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application exposure in the workplace would be governed by the
Occupational Safety and Health Administration (OSHA).
In May 1992 OSHA published a comprehensive workplace
standard for the protection of workers in the industrial setting due to
formaldehyde-release in the workplace. The standard set a permissible
exposure level (PEL) of 0.75 ppm and prescribes that certain actions
should be taken if monitoring shows levels of 0.50 ppm. Further, it
requires monitoring before workers enter the premises following use
of formaldehyde or when potential ambient formaldehyde is generated
from other chemicals.
b. Dietary
The potential dietary exposure to methylisothiazolinone from food
uses in food-grade paper, paperboard, and adhesives is regulated by the Food
and Drug Administration.
C. Environmental Assessment
1. Ecological Toxicity Data
Ecological effects toxicity testing was performed using a formulation
intermediate (Kathon® 886F, 14.17%), or end-use formulations (Kathon® WT,
Kathon® OM, or Kathon® WT, 1.5%). Testing of the formulation intermediate and
end-use products is sufficient to fulfill guideline data requirements where ecological
effects testing of the technical grade is indicated, due to the inherent instability of the
active ingredients at higher percentages.
a. Toxicity to Terrestrial Animals
(1) Birds, Acute Toxicity
In order to establish the acute toxicity of methylisothiazolinone
to birds, the following test is required using the technical grade
material: one avian single-dose oral (LD50) study on one species of
waterfowl or upland game bird (preferably mallard duck or bobwhite
quail).
In an acute oral toxicity study conducted using bobwhite quail,
methylisothiazolinone (14.17% a.i.) gave an LD50 of 62.7 mg/kg. This
is sufficient information to characterize methylisothiazolinone as
moderately toxic to avian species on an acute oral basis. The
guideline requirement is fulfilled. (MRID #41719501)
21
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(2) Birds, Subacute Toxicity
In order to establish the subacute toxicity of
methylisothiazolinone to birds, the following test is required using the
technical grade material: one subacute dietary study (LC50) on one
species of waterfowl or upland game bird (preferably the mallard duck
or bobwhite quail).
TABLE 4 - Avian Subacute Dietary Toxicity Findings
Species
Mallard1
Bobwhite Quail1
% A.I.
14.17%
14.17%
LCSO ppm
717
2200
MRID No.
41719503
41719502
Toxicity Category
moderately toxic
practically non-toxic
Study is considered to be supplemental because the analytical methodology may not have followed GLP procedures.
There is sufficient information to characterize
methylisothiazolinone as moderately toxic to practically non-toxic to
avian species on an subacute dietary basis (Table 4). Both avian
subacute dietary toxicity studies are considered to be supplemental
because GLP compliance was not evident. However, the guideline
requirement is considered fulfilled. (MRID #41719502 and
#41719503)
b. Toxicity to Aquatic Animals
(1) Freshwater Fish, Acute Toxicity
In order to establish the toxicity of methylisothiazolinone to
freshwater fish, the minimum data required on the technical grade of
the active ingredient is a single 96-hour LC50 fish toxicity study using
either a warmwater fish (preferably bluegill sunfish) or a coldwater
fish (preferably rainbow trout).
TABLE 5 - Freshwater Fish Acute Toxicity Findings
Species
Rainbow trout
Rainbow trout1
Bluegill sunfish
% A.I.
14.17%
14.17%
14.17%
LC50 ppm
0.19
0.07
0.30
MRID
41718802
41963503
41718801
Toxicity Category
Highly toxic
Highly toxic
Highly toxic
1 Study is considered to be supplemental because the results were based on a 14-day exposure period.
There is sufficient information to characterize
methylisothiazolinone as highly toxic to both cold and warmwater fish
(Table 5). The guideline requirements for freshwater fish acute
toxicity are fulfilled. (MRTDs #41718802 and #41718801,
respectively)
(2) Freshwater Fish, Chronic Toxicity
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In order to establish the chronic toxicity of
methylisothiazolinone to freshwater fish, the minimum data required
on the technical grade of the active ingredient is a single fish early life
stage study using the technical material.
In a chronic toxicity study conducted using fathead minnows,
methylisothiazolinone (14.17% a.i.) gave an Maximum Allowable
Toxicant Concentration (MATC) of 0.035 ppm. The MATC (the
geometric mean of the NOEL and LOEL), based on significantly
reduced weight at 0.06 mg a.i./L, was >0.02 and <0.06 ppm. The
guideline requirement for freshwater fish chronic toxicity is fulfilled.
(MRID #42012201)
(3) Freshwater Invertebrates, Acute Toxicity
The minimum testing required to assess the acute toxicity of
methylisothiazolinone to freshwater invertebrates is a single 48-hour
LC50 test. Two studies were reviewed.
Table 6 - Freshwater Invertebrate Acute Toxicity Findings
Species
Daphnid Ceriodaphnia
Daphnid Daphnia
% A.I.
1.5%'
14.17%
LCSO ppm
0.20
0.18
MRID#
42358701
41718803
Toxicity Category
highly toxic
highly toxic
'Adjusted to 100% a.i.
There is sufficient information to characterize
methylisothiazolinone as highly toxic to freshwater invertebrates
(Table 6). The guideline requirement for freshwater invertebrate
acute toxicity is fulfilled. (MRIDs #42358701 and #41718803)
(4) Freshwater Invertebrates, Chronic Toxicity
In order to establish the chronic toxicity of
methylisothiazolinone to freshwater invertebrates, the minimum data
required on the technical grade of the active ingredient is an
invertebrate life cycle study using the technical material.
In a freshwater invertebrate chronic toxicity study conducted
usingDaphnia, methylisothiazolinone (14.17% a.i.) gave an MATC of
0.13 ppm. The MATC, based on survival, was >0.10 and <0.18 ppm.
The guideline requirement for freshwater invertebrate chronic toxicity
is fulfilled. (MRID #41963502)
(5) Estuarine and Marine Animals, Acute Toxicity
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The minimum data required to evaluate acute toxicity to
estuarine/marine species are a fish 96-hour LC50 test using either a
marine or estuarine species, a mollusc 96-hour EC50 shell deposition
study or 48-hour EC50 on oyster embryo/larvae, and a shrimp 96-hour
LC50 test using either a marine or estuarine species.
Table 7 - Estuarine/Marine Acute Toxicity Findings
Species
Sheepshead Minnow
Marine copepodAcartia tonsa1
Pink Shrimp
Fiddler Crab Uca pugilator1
Eastern Oyster Embryo-larvae
% A.I.
13.9%
unspecified purity
13.9%
13.9%
13.9%
LC5o/EC5o (ppm)
0.36
0.056
2.3
59.0
0.028
MRID#
00042556
42840301
00042559
00042557
00042558
Toxicity Category
highly toxic
highly toxic
moderately toxic
moderately toxic
highly toxic
Study is considered to be supplemental because a test organism was used that is not recommended.
There is sufficient information to characterize
methylisothiazolinone as moderately toxic to highly toxic to
estuarine/marine species (Table 7). Certain studies are considered to
be supplemental because test organisms were used that are not
recommended, nevertheless, these studies are considered to have
satisfied the guideline requirements. The guideline requirements for
estuarine/marine acute toxicity are fulfilled. (MRTD #00042556,
#42840301, #00042559, #00042557, and #00042558)
2.
Environmental Fate
a.
Environmental Fate Assessment
Although only hydrolysis and aqueous availability data were required
for both chemicals, the registrant also submitted aerobic soil metabolism and
leaching-adsorption/desorption studies for 5-chloro-2-methyl-3(2H)-
isothiazolone. The additional studies were reviewed in order to gain a better
understanding of the fate of methylisothiazolinone in the environment.
5-Chloro-2-methyl-3(2H)-isothiazolone is susceptible to hydrolysis at
alkaline pH (half-life=22 days) but stable at acidic and neutral pHs. Methyl-
3(2H)-isothiazolone is not susceptible to hydrolysis at acidic, neutral, and
alkaline pHs.
5-Chloro-2-methyl-3(2H)-isothiazolone was found to be readily
degradable in a sandy loam soil (pH 4.9) under aerobic conditions (half-life=5
hours). Because of the low adsorption coefficient (Kads=0.1-4.9; or Koc=30-
310), the chemical is expected to be very mobile in soil. No information is
24
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available on the metabolism and mobility of methyl-3(2H)-isothiazolone in
soil.
Both chemicals are very volatile: the vapor pressure for 5-chloro-2-
methyl-3 (2H)-isothiazolone is 1. 8x 10"2 torr and the vapor pressure for methyl-
3(2H)-isothiazolone is 6.2xlO"4 torr.
Because of the low octanol/water partition coefficients (Kow=0.4 for
5-chloro-2-methyl-3(2H)-isothiazolone and Kow=0.5 for methyl-3(2H)-
isothiazolone), the chemicals are unlikely to accumulate in fish at a significant
level upon exposure.
An aqueous availability study was required because of the wood
preservation uses of methylisothiazolinone. The results from the aqueous
availability study indicate that both chemicals are readily released from the
treated wood to the aqueous environment. Approximately 84% of the
chemicals leached out of the treated woods within 28 days under non-stirred
conditions. Of the amount leached, 55% leached out within first 5 days.
b. Environmental Fate and Transport
(1) Degradation: Hydrolysis
(a) 5-Chloro-2-Methyl-3(2H)-Isothiazolone
The submitted study on the hydrolysis of 5-chloro-2-
methyl-3(2H)-isothiazolone is unacceptable because
degradates detected in the pH 9 solution were not identified.
The study must be upgraded by providing information on the
identity of the degradates.
In this hydrolysis study, ring-labeled [4,5-14C][5-
chloro-2-methyl-3(2H)-isothiazolone], at 10.9-11.4 ppm, did
not hydrolyze in sterile pH 5 and 7 aqueous buffered solutions
that were incubated in the dark at 25.0° + 0.5°C for 30 days.
The 5-chloro-2-methyl-3(2H)-isothiazolone degraded with a
half-life of 22 days in pH 9 buffered solutions when incubated
under similar conditions. The parent compound comprised
97.0-97.7% of the applied atO day posttreatment, 53.6-60.8%
at 10 days, 46.9-48.4% at 18 days, and 26.8-51.8% at 30
days. Three degradates, "A" (maximum of 46.4% of the
applied), "B" (maximum of 10.6%), and "other" (maximum of
23.8%) were detected in the pH 9 solution. They were only
partially identified. None these degradates were, however,
25
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formaldehyde. During the study, material balances ranged
from 100.2-107.7%. (MRID #42681301)
(b) Methyl-3(2H)-Isothiazolone
The submitted study on the hydrolysis of methyl-
3(2H)-isothiazolone is acceptable. No additional data are
required.
The following summarizes the results of the hydrolysis
study. Ring-labeled [4,5-14C][methyl-3(2H)-isothiazolone], at
9.9-13.3 ppm, that were incubated in the dark at 24-25 C for
30 days were stable in sterile aqueous buffered solutions (pH
5, 7, and 9). Throughout the study, methyl-3(2H)-
isothiazolone comprised 87.1-108.3% of the applied
radioactivity in the pH 5 buffered solution, 88.2-103.3% in the
pH 7 buffered solution, and 96.8-101.6% in the pH 9 buffered
solution. The material balances ranged from 90.6-108.3%.
(MRID #42578401)
(2) Degradation: Metabolism
(a) Aerobic Soil Metabolism
The submitted study on the metabolism of 5-chloro-2-
methyl-3(2H)-isothiazolone in soil under aerobic conditions is
acceptable.
The following summarizes the results of the aerobic
soil metabolism study. At 1 ppm, [14C][5-chloro-2-methyl-
3(2H)-isothiazolone], ring-labeled at the 4 and 5 carbons,
degraded with a half-life of 5.4 hours in sandy loam soil that
was incubated in the dark at 24°-26°C for 64 days, and 75%
of field moisture capacity. The parent was the only compound
extracted from the soil, and averaged 107.4% of the applied
radioactivity immediately posttreatment, 81.0% at 1 hour,
102.1% at 2 hours, 46.3% at 4 hours, 55.1% at 6 hours,
10.9% at 48 hours, and 4.8% at 64 days. Unextracted soil
residues increased from an average of 1.6% of the applied
immediately posttreatment to a maximum of 76.5% at 48
hours, and was 58.7-59.1% at 30 and 64 days. At 64 days,
12.4-12.6% of the applied radioactivity was in the humin
fraction, 17.3-17.7% was humic acid, and 28.4-29.0% was
26
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fulvic acid. The only volatile compound was CO2, which
increased from 0.8-1.7% of the applied at 4-6 hours to 9.9-
12.8% at 48 hours, 16.7-17.7% at 30 days, and 27.0-27.3%
at 64 days. Material balances ranged from 91-113%. (MRID
#42086901)
(3) Mobility/Leachability
(a) Leaching-Adsorption/Desorption
The submitted study on the adsorption and desorption
of 5-chloro-2-methyl-3(2H)-isothiazolone in soil is acceptable.
In an aerobic soil metabolism study, ring-labeled [4,5-
14C] [5-chloro-2-methyl-3 (2H)-isothiazolone] was very mobile
in sandy loam, silt loam, clay loam, and sand soils with
Freundlich Kads values of 0.1-1.5, and in sandy loam sediment
with a Freundlich Kads value of 4.9. Koc values were 30-144
for the soils and 310 for the sediment. No degradation of the
parent compound was noted during the course of the
experiment. Material balances were greater than 99%.
(MRID #42086902)
(b) Aqueous Availability
The registrant has submitted a study in which the
aqueous availability of 5-chloro-2-methyl-3(2H)-isothiazolone
and methyl 3(2H)-isothiazolone from pressure-treated wood
was evaluated. This study is acceptable. No additional data
are required.
The following summarizes the results of the study.
The active ingredients, 5-chloro-2-methyl-3(2H)-isothiazolone
and methyl-3(2H)-isothiazolone, leached from the pressure-
treated Southern yellow pine wood blocks when incubated in
artificial sea water; deionized water; and pH 5, 7, and 9
aqueous buffered solutions at room temperature under non-
stirred conditions. Approximately 84% of the chemicals in the
wood leached out of the treated woods within 28 days. Of the
amount leached, about 55% leached out within first 5 days of
the study.
27
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The degradation profile observed in the aqueous
availability study is similar to the one observed in the
hydrolysis. The released 5-chloro-2-methyl-3(2H)-
isothiazolone and methyl-3(2H)-isothiazolone appear to be
stable at acidic and neutral pHs, 5-chloro-2-methyl-3(2H)-
isothiazolone is susceptible to hydrolysis at alkaline pH. The
recovery of the parent compounds, based on the analysis of
treated wood and solutions at the end of the study, ranged
from 100-135% for deionized water, sea water, and pH 5 and
7 buffer solutions. However, the recovery was only 23% in
the pH 9 solution. The low recovery in the pH 9 buffer
solution was apparently caused by the hydrolysis of 5-chloro-
2-methyl-3(2H)-isothiazolone. (MRTD #43478401)
3. Exposure and Risk Characterization
Methylisothiazolinone is moderately toxic to practically nontoxic to avian
species, but highly toxic to freshwater fish and invertebrates and moderately toxic to
highly toxic to marine/estuarine species.
While the hazard to aquatic organisms from methylisothiazolinone has been
characterized, a quantitative risk assessment has not been conducted. The risks to
aquatic environments from this use are regulated under the NPDES permitting
program of EPA's Office of Water. The labels for all methylisothiazolinone products
must require that discharges to aquatic environments comply with an NPDES permit.
The jet fuel use (indoor non-food) of methylisothiazolinone may be associated
with periodic releases into the environment from the purging of storage tanks. This
terrestrial use is expected to result in minimal to no exposure. The oil-related aquatic
uses (oil recovery drilling muds/packer fluids, secondary oil recovery injection water)
are expected to result in minimal to no exposure if proper procedures are employed
in the disposal of the contaminated materials.
Based on the environmental fate assessment, wildlife are not expected to be
significantly exposed to methylisothiazolinone from its wood preservative uses,
therefore, there is little likelihood of adverse effects occurring to wildlife.
Although the aqueous availability study shows that these two chemicals are
readily released from the treated wood under laboratory conditions, their potential for
exposure to aquatic or terrestrial organisms under actual use conditions is relatively
low. This is because:
(1) 5-chloro-2-methyl-3(2H)-isothiazolone and methyl-3(2H)-isothiazolone are
highly volatile and expected to dissipate from the wood surface quickly;
(2) The major active ingredient, 5-chloro-2-methyl-3(2H)-isothiazolone,
hydrolyzes at pH 9 and degrades very rapidly in soil under aerobic conditions;
28
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(3) The areas where the treated wood is used are relatively small, and mainly in
residential areas;
(4) It is not anticipated that methylisothiazolinone will be applied to wood that
will be placed in aquatic environments because the label specifies that it be
applied to soft woods only (such as pine) and the wood preservation
protection will last 12 weeks; and
(5) The use of water repellents and sealers on treated wood further decreases the
teachability of the chemicals from the wood. As a result, the risk of exposure
would likely be reduced.
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
ingredients are eligible for reregi strati on. The Agency has previously identified and required
the submission of the generic (i.e. active ingredient specific) data required to support
reregi strati on of products containing methylisothiazolinone active ingredients. The Agency
has completed its review of these generic data, and has determined that the data are sufficient
to support reregi strati on of all products containing methylisothiazolinone. Appendix B
identifies the generic data requirements that the Agency reviewed as part of its determination
of reregi strati on eligibility of methylisothiazolinone, 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 methylisothiazolinone and to determine that methylisothiazolinone can be
used as specified in this document without resulting in unreasonable adverse effects to humans
and the environment. The Agency therefore finds that all products containing
methylisothiazolinone as the active ingredients are eligible for reregistration. The
reregi strati on of particular products is addressed in Section V of this document.
The Agency made its reregistration eligibility determination based upon the target data
base required for reregistration, the current guidelines for conducting acceptable studies to
generate such data, published scientific literature, etc. and the data identified in Appendix B.
Although the Agency has found that all uses of methylisothiazolinone as specified in this
document 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 methylisothiazolinone, if new information comes to the
Agency's attention or if the data requirements for registration (or the guidelines for generating
such data) change.
29
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B. Determination of Eligibility Decision
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredients in the case
methylisothiazolinone, the Agency has sufficient information on the health effects of
methylisothiazolinone and on its potential for causing adverse effects in fish, wildlife,
and the environment. The Agency has determined that methylisothiazolinone
products, labeled and used as specified in this Document, will not pose unreasonable
risks or adverse effects to humans or the environment. Therefore, the Agency
concludes that products containing methylisothiazolinone for all uses are eligible for
reregi strati on.
2. Eligible and Ineligible Uses
The Agency has determined that all uses of methylisothiazolinone are eligible
for reregi strati on.
C. Regulatory Position
The following is a summary of the regulatory positions and rationales for
methylisothiazolinone. Where labeling revisions are imposed, specific language is set forth
in Section V of this document.
1. Endangered Species Statement
Currently, the Agency is developing a program ("The Endangered Species
Protection Program") to identify all pesticides whose use may cause adverse impacts
on endangered and threatened species and to implement mitigation measures that will
eliminate the adverse impacts. The program would require use restrictions to protect
endangered and threatened species at the county level. Consultations with the Fish
and Wildlife Service may be necessary to assess risks to newly listed species or from
proposed new uses. In the future, the Agency plans to publish a description of the
Endangered Species Program in the Federal Register and have available voluntary
county-specific bulletins. Because the Agency is taking this approach for protecting
endangered and threatened species, it is not imposing label modifications at this time
through the RED. Rather, any requirements for product use modifications will occur
in the future under the Endangered Species Protection Program.
2. Labeling Rationale/Risk Mitigation
During reregi strati on, the Agency considers handler safely requirements for
occupational and residential uses. The Agency establishes handler safety requirements
30
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when risk assessments or general concerns suggest such requirements are appropriate.
If the Agency determines that no specific handler requirements are warranted based
on the potential acute or other adverse effects of the active ingredient, the handler
safety requirements will be based on the acute toxicity characteristics of the end-use
product.
a. Occupational-Use Products
Primary Occupational Handlers. The Agency has
determined that regulatory action regarding the establishment of
active-ingredient-based minimum PPE requirements for occupational
handlers must be taken for methylisothiazolinone.
Even though the estimated risks for intermediate-term
inhalation exposures are considered low to very low (MOEs well
above 100), the Agency is concerned with short-term inhalation
exposure to methylisothiazolinone because the material is volatile,
corrosive, and used primarily indoors. Hence, the Agency believes
that there may be some circumstances in the industrial/commercial
setting where risks from inhalation exposures may be of concern.
Respirator requirements based on the end-use product toxicity and
vapor pressure are being required to mitigate these risks.
Acute dermal and eye irritation risks from end-use products containing
methylisothiazolinone will be addressed based on the acute inhalation
toxicity of the end-use products.
Secondary Occupational Handlers. At this time, the
Agency believes that risks from inhalation exposures and skin/eye
corrosivity would be not of concern for secondary occupational
handlers, since the methylisothiazolinone in such products as paint,
adhesives, metal-working fluids, wood products, and textiles is very
diluted, usually far less than one percent.
b. Homeowner-Use Products
Primary Homeowner Handlers. All methylisothiazolinone
end-use pesticide products are intended primarily for occupational
use. There are no primary homeowner uses of methylisothiazolinone
that would result in homeowner primary exposure.
Secondary Homeowner Handlers. At this time, the Agency
believes that risks from inhalation exposures and skin/eye corrosivity
would be acceptable for secondary occupational handlers, since the
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methylisothiazolinone in such products as paint, adhesives, metal-
cutting fluids, wood products, and textiles is very diluted.
c. Post-Application Safety Requirements
Primary Occupational Post-Application Workers. The
Agency is not establishing entry restrictions based on the corrosivity
concerns about methylisothiazolinone because the anticipated
frequency, duration, and degree of dermal/eye exposure following
occupational applications do not warrant special risk mitigation
measures at this time.
Secondary Occupational Post-Application Workers. The
Agency has determined that no regulatory action regarding the
establishment of active-ingredient-based minimum PPE requirements
for secondary occupational post-application workers must be taken
for methylisothiazolinone, since the anticipated frequency, duration,
and degree of exposure following secondary occupational applications
do not warrant special risk mitigation measures at this time.
d. Other Labeling Requirements
The Agency is also requiring other use and safety information to be
placed on the labeling of all end-use products containing
methylisothiazolinone. For the specific labeling statements, refer to Section
V of this document.
V. ACTIONS REQUIRED OF REGISTRANTS
This section specifies the data requirements and responses necessary for the reregi strati on of
both manufacturing-use and end-use products.
A. Additional Data Requirements
Generic Data Requirements: The generic data base supporting the reregi strati on
of methylisothiazolinone for the above eligible uses has been reviewed and determined
to be substantially complete, with the exception of the hydrolysis study. Additional
data to characterize the hydrolysis at pH 9 for 5-chloro-2-methyl-3(2H)-isothiazolone
are required by November 16, 1998 to upgrade the existing study.
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
32
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determination of eligibility has been made. The product specific data requirements are
listed in Appendix G, the Product Specific Data Call-In Notice.
Registrants must review previous data submissions to ensure that they meet
current EPA acceptance criteria (Appendix F; Attachment E) and if not, commit to
conduct new studies. If a registrant believes that previously submitted data meet
current testing standards, then study MRID numbers should be cited according to the
instructions in the Requirement Status and Registrants Response Form provided for
each product.
B. Labeling Requirements
The following chart summarizes the label changes that must be made on all
manufacturing and end-use products.
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Table 8: Summary of Labeling Requirements for Methylisothiazolinone
Description
Required Labeling
Placement on Label
Manufacturing Use
The following language must be added to
MP labeling to allow reformulation of the
product for a specific use or all additional
uses supported by a formulator or user
group
The following language may be added to an
MP label at the discretion of an MP
registrant to permit the reformulation of the
product for a specific use or all additional
uses supported by a formulator or user
group:
Environmental Hazards Statements
"Only for formulation into a microbiocide for the following use(s) [fill blank only with those uses that are
being supported by MP registrant]."
"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)."
"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
suchuse(s)."
"This chemical is toxic to terrestrial and aquatic plants, fish and aquatic invertebrates. Do not discharge
effluent containing this product into lakes, streams, ponds estuaries, oceans or other waters unless in
accordance with the requirements of a National Pollutant Discharge Elimination System (NPDES) permit and
the permitting authority has been notified in writing prior to discharge. Do not discharge effluent containing
this product to sewer systems without previously notifying the local sewage treatment plant authority. For
guidance contact your state Water Board or Regional Office of the EPA."
Directions for Use
Precautionary
Statements: Hazards
to Humans and
Domestic Animals
End Use Products Intended for Occupational Use1
Baseline PPE requirements: The following
language must be placed on each product:
"Mixers, loaders, and others exposed to methylisothiazolinone products must wear:
- long-sleeve shirt and long pants
-chemical-resistant gloves2
- shoes plus socks."
Precautionary
Statements: Hazards
to Humans and
Domestic Animals
1 For sole-active-ingredient end-use products that contain methylisothiazolinone, the product labeling must be revised to adopt the handler personal protective
equipment requirements set forth in this section. Any conflicting PPE requirements on the current labeling must be removed. For multiple-active-ingredient
end-use products that contain methylisothiazolinone, the handler personal protective equipment set forth in this section must be compared to the requirements
on the current labeling and the more protective must be retained.
For the glove statement, use the statement established through the instructions in Supplement Three of PR Notice 93-7. In addition, the corrosiveness and
penetration of methylisothiazolinone itself must be considered and appropriate chemical-resistant materials must be listed on the product labeling.
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Additional PPE requirements: The PPE
established on the basis of the acute toxicity
category of the end-use product must be
compared to the active-ingredient-based
minimum (baseline) personal protective
equipment specified above. The more
protective PPE must be placed on the
product labeling.
"Protective eyewear" must be added to the above list if the end-use product is classified as Toxicity Category I
or II for eye irritation potential.
"Chemical-resistant apron" must be added if the end-use product is classified as toxicity category I or II for
acute dermal toxicity or skin irritation potential.
A respirator requirement must be added if the end-use product is classified as toxicity category I or II for acute
inhalation toxicity. The type of respirator must be specified in the statement and is based on the acute toxicity
category and the vapor pressure. EPA will assist registrants in determining the appropriate type of respirator
during the end-use product phase of reregistration.
Precautionary
Statements: Hazards
to Humans and
Domestic Animals
User Safety Requirements
The following wording is required on all products intended primarily for occupational use.
"Discard clothing or other absorbent materials that have been drenched or heavily contaminated with this
product's concentrate. Do not reuse them. Follow manufacturer's instructions for cleaning/maintaining PPE.
If no such instructions for washables exist, use detergent and hot water. Keep and wash PPE separately from
other laundry."
Precautionary
Statements: Hazards
to Humans and
Domestic Animals
immediately
following the PPE
requirements
Application Restrictions
The following wording is required on all products intended primarily for occupational use.
"Do not apply this product in a way that will contact workers or other persons."
Directions for Use
User safety Recommendations
The following wording is required on all products intended primarily for occupational use.
"Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet."
"Users should remove clothing immediately if pesticide gets inside. Them wash thoroughly and put on clean
clothing."
"Users should remove PPE immediately after handling this product. Wash the outside of gloves before
removing. As soon as possible, wash thoroughly."
Precautionary
Statement: Hazards
to Humans and
Domestic Animals
Skin Sensitizer Statement
"This product may cause skin sensitization reactions in some people."
Precautionary
Statement: Hazards
to Humans and
Domestic Animals
Environmental Hazards
"This chemical is toxic to terrestrial and aquatic plants, fish and aquatic invertebrates. Do not discharge
effluent containing this product into lakes, streams, ponds estuaries, oceans or other waters unless in
accordance with the requirements of a National Pollutant Discharge Elimination System (NPDES) permit and
the permitting authority has been notified in writing prior to discharge. Do not discharge effluent containing
this product to sewer systems without previously notifying the local sewage treatment plant authority. For
guidance contact your state Water Board or Regional Office of the EPA."
Precautionary
Statements under
Environmental
Hazards
C. Labeling Clarifications
35
-------
The following clarifications must be made on all end-use products labels, where
applicable.
1. Use Profile Clarifications
Registrants must specify on labeling of products containing
methylisothiazolinone the complete directions for use for each use pattern: site of
application, type of application, timing of application, equipment used for application,
and the rate of application (dosage).
2. Use on Pilings
Methylisothiazolinone is to be used only on terrestrial-use pilings not aquatic-
use pilings. The phrase "terrestrial-use pilings" must be used when referring to any
type of piling.
3. Water Treatment Systems
All use of products containing methylisothiazolinone in water treatment
systems must clearly specify recirculating water treatment systems. The word
"recirculating" must be added before all references to water treatment systems (e.g.,
water treatment, cooling towers, etc.).
4. Clarification of Oil Drilling Mud Use
To clarify the intent of the oil recovery drilling muds/packer fluids use (as an
aquatic or terrestrial non-food use pattern), the following statement must be added to
the labels for terrestrial non-food oil drilling muds and packer fluids:
"For use in terrestrial wells only."
And the following statement must be added to the precautionary labeling:
"Do not apply in marine and/or estuarine oil fields."
The following statement must be added to the labels for aquatic non-food
industrial oil drilling muds and packer fluids:
"For use in offshore wells only."
For use in both terrestrial and offshore oil drilling muds and packer fluids, the
following statement must be added:
36
-------
"This product may be used for terrestrial and off-shore oil drilling muds and
packer fluids."
D. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for
26 months from the date of the issuance of this Reregi strati on 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
methylisothiazolinone products bearing old labels/labeling for 26 months from the date of
issuance of this RED. Persons other than the registrant may distribute or sell such products
for 50 months from the date of the issuance of this RED. 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.
37
-------
VI. APPENDICES
38
-------
) Time 10:37
LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107103 [5-Chloro-2-methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry
unless noted Max. /crop /year otherwise)/AI (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED
Water treatment (recirculating system),
Continuous feed (initial), Not on label,
Not Applicable, Not applicable for this
use
Water treatment (recirculating system),
Continuous feed (subsequent), Not on
label, Not Applicable, Not applicable for
this use
W 1. 7
W .41
W 35 * NS NS
W 19 * NS NS
W 19 * NS NS
W 19 * NS NS
W 20 * NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
39
-------
LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107103 [5-Chloro-2-methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/AI (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
Water treatment (recirculating system),
Intermittent (slug)(initial), Not on
label, Not Applicable, Not applicable for
this use
Water treatment (recirculating system),
Intermittent (slug)(subsequent), Not on
label, Not Applicable, Not applicable for
this use
W .41
W .41
W .58
W .41
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, CIS, C24
A08, C23
C24
A08, C23
40
-------
LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107103 [5-Chloro-2-methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Geographic Limitations
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/A] (days) Intv.
otherwise) Dose cycle /crop /year
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
Water treatment, Initial, Automatic SC/L
dispensing equipment, Not Applicable, Not
applicable for this use
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W 10 * NS NS NS NS NS NS
W 2 . 6 * NS NS NS NS NS NS
NS NS NS
NS NS NS
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, 023
A30, 023
A30, 024
A08, 023
A08, 018, 024
41
-------
LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107103 [5-Chloro-2-methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/AI (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
Water treatment, Not on label, Not on
label, Not Applicable, Not applicable for
this use
COATINGS, INDUSTRIAL
Industrial preservative treatment, During
manufacture, Not on label, Not
Applicable, Not applicable for this use
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W 2 . 6 * NS NS NS NS NS NS
W 2 . 6 * NS NS NS NS NS NS
W 10 * NS NS NS NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
CIS, C24
C23
C24
C24
CIS, C24
CIS, C24
COMMERCIAL/INDUSTRIAL WATER COOLING SYSTEMS
42
-------
) Time 10:38
LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107103 [5-Chloro-2-methyl-3(2H)-isothiazoline]
4444444
Form(s
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry
unless noted Max. /crop /year otherwise)/A] (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
COMMERCIAL/INDUSTRIAL WATER COOLING SYSTEMS (con't)
Water treatment (recirculating system), SC/L
Initial, Automatic dispensing equipment,
Not Applicable, Not applicable for this
use
Water treatment (recirculating system),
Initial, Not on label, Not Applicable,
Not applicable for this use
SC/L
Water treatment (recirculating system),
Intermittent (slug) (initial), Not on
label, Not Applicable, Not applicable for
this use
Water treatment (recirculating system),
Intermittent (slug)(subsequent), Not on
label, Not Applicable, Not applicable for
this use
W 1.2
W .58
A08, C23
A30, CIS, C24
A30, C23
A30, C24
A08, CIS, C24
A08, C23
A30, CIS, C24
C22, C24
43
-------
LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107103 [5-Chloro-2-methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/A] (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
COMMERCIAL/INDUSTRIAL WATER COOLING SYSTEMS (con't)
Water treatment (recirculating system),
Not on label, Not on label, Not
Applicable, Not applicable for this use
Water treatment (recirculating system),
Subsequent/maintenance, Automatic
dispensing equipment, Not Applicable, Not
applicable for this use
Water treatment, Intermittent
(slug) (initial), Not on label, Not
Applicable, Not applicable for this use
W 1. 7
w
w
w
w
w
w
w
w
w
.41
.41
.41
.41
1.7
1.7
1.7
1.8
3.4
W 2
W 2
W 2
W 2
W 2
W 2
W 2
W 2
W
. 6
. 6
. 6
. 6
. 6
. 6
. 6
. 6
10
A08, C23
A30, CIS, C24
A30, C23
A30, C24
A08, CIS, C24
A08, C23
A30, CIS, C24
A08, C23
A08, C23
44
-------
LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107103 [5-Chloro-2-methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/AI (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
EMULSIONS, RESIN/LATEX/POLYMER
Water treatment (recirculating system),
Initial, Not on label, Not Applicable,
Not applicable for this use
Water treatment (recirculating system),
Intermittent (slug)(initial), Not on
label, Not Applicable, Not applicable for
this use
Water treatment (recirculating system),
Intermittent (slug)(subsequent), Not on
label, Not Applicable, Not applicable for
this use
W 12 * NS NS NS
W 19 * NS NS NS
W 38 * NS NS NS
W 38 * NS NS NS
W 38 * NS NS NS
W 38 * NS NS NS
W 39 * NS NS NS
Use Group: AQUATIC NON-FOOD INDUSTRIAL
W 10 * NS NS NS NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
CIS, C24
CIS, C24
CIS, C24
C23
C24
C24
CIS, C24
45
-------
LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107103 [5-Chloro-2-methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/AI (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
FUELS/OIL STORAGE TANK BOTTOM WATER ADDITIVE
46
-------
LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107103 [5-Chloro-2-methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/A] (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
FUELS/OIL STORAGE TANK BOTTOM WATER ADDITIVE (con't)
SC/L V 1.1
SC/L V 4.6
HEAT EXCHANGER WATER SYSTEMS
INDUSTRIAL PROCESSING WATER
Water treatment (once-through system),
Initial, Not on label, Not Applicable,
Not applicable for this use
Water treatment (recirculating system),
Initial, Not on label, Not Applicable,
Not applicable for this use
Use Group: INDOOR NON-FOOD (con't)
V 4 . 6 * NS NS NS NS NS NS
V 4 . 6 * NS NS NS NS NS NS
Use Group: AQUATIC NON-FOOD INDUSTRIAL
W 10 * NS NS NS NS NS NS
47
-------
LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107103 [5-Chloro-2-methyl-3(2H)-isothiazoline]
4444444
Form(s
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry
unless noted Max. /crop /year otherwise)/A] (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
INDUSTRIAL PROCESSING WATER
Water treatment, Continuous feed SC/L
(initial), Chemical pump, Not Applicable,
Not applicable for this use
Water treatment, Initial, Automatic SC/L
dispensing equipment, Not Applicable, Not
applicable for this use
Water treatment, Initial, Not on label,
Not Applicable, Not applicable for this
use
48
-------
LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107103 [5-Chloro-2-methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/AI (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
INDUSTRIAL PROCESSING WATER (con't)
Water treatment (recirculating system),
Initial, Not on label, Not Applicable,
Not applicable for this use
METALWORKING CUTTING FLUIDS
Industrial preservative treatment, During SC/L
manufacture, Not on label, Not
Applicable, Not applicable for this use
Preservative treatment, Initial, Not on
label, Not Applicable, Not applicable for
this use
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W 5. 9 * NS NS NS NS NS NS
Use Group: AQUATIC NON-FOOD INDUSTRIAL
W 10 * NS NS NS NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
49
-------
LUIS 5.1 - Page: 12
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107103 [5-Chloro-2-methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/AI (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
METALWORKING CUTTING FLUIDS
Preservative treatment,
Subsequent/maintenance, Automatic
dispensing equipment, Not Applicable, Not
applicable for this use
Preservative treatment,
Subsequent/maintenance, Metering pump,
Not Applicable, Not applicable for this
use
Use Group: INDOOR NON-FOOD (con't)
W 13 * NS NS NS NS NS NS
W 27 * NS NS NS NS NS NS
W 2.36 * NS NS NS NS NS NS
11
NS NS NS
NS NS NS
NS NS NS
NS NS NS
50
-------
LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107103 [5-Chloro-2-methyl-3(2H)-isothiazoline]
4444444
Form(s
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry
unless noted Max. /crop /year otherwise)/AI (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
METALWORKING CUTTING FLUIDS (con't)
OIL RECOVERY DRILLING MUDS/PACKER FLUIDS
Use Group: INDOOR NON-FOOD (con't)
W 27 * NS NS NS NS NS NS
Use Group: AQUATIC NON-FOOD INDUSTRIAL
V 34 * NS NS NS NS NS NS
W 27 * NS NS NS NS NS NS
Use Group: TERRESTRIAL NON-FOOD CROP
V 34 * NS NS NS NS NS NS
51
-------
LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107103 [5-Chloro-2-methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/AI (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
OIL RECOVERY DRILLING MUDS/PACKER FLUIDS (con't)
Industrial preservative treatment, During SC/L
manufacture, Not on label, Not
Applicable, Not applicable for this use
PASTEURIZER/WARMER/CANNERY COOLING WATER SYSTEMS
Water treatment, Initial, Automatic SC/L
dispensing equipment, Not Applicable, Not
applicable for this use
W 19 * NS NS NS
W 19 * NS NS NS
W 20 * NS NS NS
Use Group: INDOOR NON-FOOD
W 10 * NS NS NS
52
-------
LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107103 [5-Chloro-2-methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/A] (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
PASTEURIZER/WARMER/CANNERY COOLING WATER SYSTEMS
Water treatment, Initial, Not on label,
Not Applicable, Not applicable for this
use
Water treatment, When needed, Not on SC/L
label, Not Applicable, Not applicable for
this use
PULP/PAPER MILL WATER SYSTEMS
W 4.8
W 2.5
53
-------
LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107103 [5-Chloro-2-methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/AI (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
PULP/PAPER MILL WATER SYSTEMS (con't)
Water treatment, During manufacture,
Automatic dispensing equipment, Not
Applicable, Not applicable for this use
Water treatment, Intermittent
(slug)(initial), Not on label, Not
Applicable, Not applicable for this use
Water treatment, Not on label, Not on SC/L
label, Not Applicable, Not applicable for
this use
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
A08, C23
A30, C18, C24
A30, C24
CIS, C24
A08, C23
54
-------
LUIS 5.1 - Page: 17
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107103 [5-Chloro-2-methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/AI (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
PULP/PAPER MILL WATER SYSTEMS (con't)
SECONDARY OIL RECOVERY INJECTION WATER
Water treatment, Initial, Not on label,
Not Applicable, Not applicable for this
use
Water treatment, Intermittent
(slug)(initial), Not on label, Not
Applicable, Not applicable for this use
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W 8 . 7 * NS NS NS NS NS NS
Use Group: AQUATIC NON-FOOD INDUSTRIAL
W 4 . 4 * NS NS NS NS NS NS
W 4.5
W 2.2
W 2.2
W 2.3
W 1.1
W 4.5
W 3.8
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
A08, CIS, C24
CIS, C24
C22, C23
C23
CIS, C24
55
-------
LUIS 5.1 - Page: 18
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107103 [5-Chloro-2-methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/AI (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
SECONDARY OIL RECOVERY INJECTION WATER (con't)
SC/L
SPECIALITY INDUSTRIAL PRODUCTS
Industrial preservative treatment, During SC/L
manufacture, Metering pump, Not
Applicable, Not applicable for this use
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W 3. 8 * NS NS NS NS NS NS
W 2 .2 * NS NS NS NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
W 1. 9 * NS NS NS
W 1. 9 * NS NS NS
W 1. 9 * NS NS NS
W 1. 9 * NS NS NS
Use Group: INDOOR NON-FOOD
UC * NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
C23
A08, CIS, C24
CIS, C24
C22, C23
56
-------
LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107103 [5-Chloro-2-methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/AI (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
SPECIALITY INDUSTRIAL PRODUCTS (con't)
Industrial preservative treatment,
Initial, Not on label, Not Applicable,
Not applicable for this use
Preservative treatment, Initial, Metering SC/L
pump, Not Applicable, No longer used
NS NS NS
NS NS NS
NS NS NS
NS NS NS
C18, C24
C23
C18, C24
A08, C18, C24
57
-------
LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107103 [5-Chloro-2-methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Geographic Limitations
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/A] (days) Intv.
otherwise) Dose cycle /crop /year
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
SPECIALITY INDUSTRIAL PRODUCTS (con't)
Preservative treatment, Initial, Not on
label, Not Applicable, Not applicable for
this use
Preservative treatment,
Subsequent/maintenance, Metering pump,
Not Applicable, Not applicable for this
use
Use Group: INDOOR NON-FOOD (con't)
V 19 * NS NS NS NS NS NS
V 21 * NS NS NS NS NS NS
V 11 * NS NS NS NS NS NS
V 12
V 16
NS NS NS
NS NS NS
NS NS NS
NS NS NS
58
-------
LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107103 [5-Chloro-2-methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Geographic Limitations
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/A] (days) Intv.
otherwise) Dose cycle /crop /year
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
TEXTILES/TEXTILE FIBERS/CORDAGE
WET-END ADDITIVES/INDUSTRIAL PROCESSING CHEMICALS
Industrial preservative treatment, During SC/L
manufacture, Not on label, Not
Applicable, Not applicable for this use
W 17 * NS NS NS
Use Group: INDOOR NON-FOOD
W 5.31 * NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
CIS, C24
C18, C24
CIS, C24
CIS, C24
C23
C24
C24
CIS, C24
CIS, C24
59
-------
LUIS 5.1 - Page: 22
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107103 [5-Chloro-2-methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/AI (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
WOOD PRESSURE TREATMENT TO FOREST PRODUCTS
SC/L V 2.4
WOOD PROTECTION TREATMENT TO AQUATIC STRUCTURES/ITEMS
V 1.7
SC/L V 2.4
WOOD PROTECTION TREATMENT TO FOREST PRODUCTS (SEASONED)
SC/L NA
NA
V 37 * NS NS NS NS NS NS
Use Group: AQUATIC NON-FOOD OUTDOOR
V 11 * NS NS NS NS NS NS
V 37 * NS NS NS NS NS NS
Use Group: TERRESTRIAL NON-FOOD CROP
* NS NS NS NS NS NS
NS
NS
60
-------
LUIS 5.1 - Page: 23
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107103 [5-Chloro-2-methyl-3(2H)-isothiazoline]
4444444
LEGEND
444444
Sort: Uses Eligible or Ineligible for Re-registration, Food/Feed or Non-Food/Non-Feed Uses, Alpha Site Name, Use Group Name, Alpha Application Type/Timing/Equipment
Description, Formulation, Maximum Application Rate Unit/Area Quantity, Minimum Application Rate
HEADER ABBREVIATIONS
Min. Appl. Rate (AI unless : Minimum dose for a single application to a single site. System calculated. Antimicrobial claims only.
noted otherwise)
Max. Appl. Rate (AI unless : Maximum dose for a single application to a single site. System calculated.
noted otherwise)
: Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).
: 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"
: Maximum dose applied to a site over a single crop cycle or year. System calculated.
Max. Dose [(AI unless
noted otherwise)/A]
Min. Interv (days)
Re-Entry Intv.
PRO Report Date
Minimum Interval between Applications (days)
Reentry Intervals
LUIS contains all products that were active or suspended (and that were available from OPP Document Center) as of this date. Some products
registered after this date may have data included in this report, but LUIS does not guarantee that all products registered after this date have
data that has been captured.
SOIL TEXTURE FOR MAX APP. RATE
* : Non-specific
C : Coarse
M : Medium
F : Fine
O : Others
SC/L : SOLUBLE CONCENTRATE/LIQUID
SC/S : SOLUBLE CONCENTRATE/SOLID
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
U : Unknown whether PPM is given by weight or by volume
61
-------
LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107103 [5-Chloro-2-methyl-3(2H)-isothiazoline]
USE LIMITATIONS CODES
Do not apply in marine and/or estuarine oil fields.
* NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
62
-------
) Time 10:44
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APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107104 [2-Methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry
unless noted Max. /crop /year otherwise)/AI (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED
Water treatment (recirculating system),
Continuous feed (initial), Not on label,
Not Applicable, Not applicable for this
use
Water treatment (recirculating system),
Continuous feed (subsequent), Not on
label, Not Applicable, Not applicable for
this use
W .35
W 1.5
W 1.5
W 1.5
W 1.6
W .13
W .53
W 11 * NS NS
W 5. 8 * NS NS
W 5. 8 * NS NS
W 5. 8 * NS NS
W 6 * NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
63
-------
LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107104 [2-Methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/AI (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
Water treatment (recirculating system),
Intermittent (slug)(initial), Not on
label, Not Applicable, Not applicable for
this use
Water treatment (recirculating system),
Intermittent (slug)(subsequent), Not on
label, Not Applicable, Not applicable for
this use
W .13
W .53
W .53
W .53
W .53
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, CIS, C24
A08, C23
C24
A08, C23
64
-------
LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107104 [2-Methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Geographic Limitations
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/A] (days) Intv.
otherwise) Dose cycle /crop /year
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
Water treatment, Initial, Automatic SC/L
dispensing equipment, Not Applicable, Not
applicable for this use
W .13
W .13
W .13
W .53
W .58
W .53
W .53
W .53
W 1
W .13
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W 3. 1 * NS NS NS NS NS NS
W .78 * NS NS NS NS NS NS
NS NS NS
NS NS NS
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, 023
A30, 023
A30, 024
A08, 023
A08, CIS, 024
65
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LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107104 [2-Methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/AI (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
Water treatment, Not on label, Not on
label, Not Applicable, Not applicable for
this use
COATINGS, INDUSTRIAL
Industrial preservative treatment, During SC/L
manufacture, Not on label, Not
Applicable, Not applicable for this use
COMMERCIAL/INDUSTRIAL WATER COOLING SYSTEMS
Water treatment (recirculating system), SC/L
Initial, Automatic dispensing equipment,
Not Applicable, Not applicable for this
use
W .13
W .53
W .12
W 1.5
W 1.5
W 1.5
W 1.6
W 1.5
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W .78 * NS NS NS NS NS NS
W .78 * NS NS NS NS NS NS
W 3. 1 * NS NS NS NS NS NS
W 5.8
W 5.8
W 5.8
W 6
W 5.8
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
66
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LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107104 [2-Methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Geographic Limitations
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/A] (days) Intv.
otherwise) Dose cycle /crop /year
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
COMMERCIAL/INDUSTRIAL WATER COOLING SYSTEMS (con't)
Water treatment (recirculating system), SC/L I
Initial, Not on label, Not Applicable,
Not applicable for this use
Water treatment (recirculating system),
Intermittent (slug)(initial), Not on
label, Not Applicable, Not applicable for
this use
Water treatment (recirculating system),
Intermittent (slug)(subsequent), Not on
label, Not Applicable, Not applicable for
this use
Water treatment (recirculating system),
Not on label, Not on label, Not
Applicable, Not applicable for this use
W .53
W .53
W .53
W .53
W 1
W 1
W 1
W .18
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, C23
A30, C18, C24
A30, C23
A30, C24
A08, CIS, C24
A08, C23
A30, CIS, C24
C22, C24
67
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LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107104 [2-Methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/AI (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
COMMERCIAL/INDUSTRIAL WATER COOLING SYSTEMS (con't)
Water treatment (recirculating system),
Subsequent/maintenance, Automatic
dispensing equipment, Not Applicable, Not
applicable for this use
Water treatment, Intermittent
(slug)(initial), Not on label, Not
Applicable, Not applicable for this use
EMULSIONS, RESIN/LATEX/POLYMER
Industrial preservative treatment, During SC/L
manufacture, Not on label, Not
Applicable, Not applicable for this use
W .13
W .1
A08, 023
A30, 018, 024
A30, 023
A30, 024
A08, 018, 024
A08, 023
A30, 018, 024
A08, 023
68
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LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107104 [2-Methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry
unless noted Max. /crop /year otherwise)/AI (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
EMULSIONS, RESIN/LATEX/POLYMER (con't)
Water treatment (recirculating system),
Intermittent (slug)(initial), Not on
label, Not Applicable, Not applicable for
this use
Water treatment (recirculating system),
Intermittent (slug)(subsequent), Not on
label, Not Applicable, Not applicable for
this use
W .35
W 1.4
W 1.5
W 1.5
W 1.5
W 1.6
W 3. 5 * NS NS NS
W 5. 8 * NS NS NS
W 12 * NS NS NS
W 12 * NS NS NS
W 12 * NS NS NS
W 12 * NS NS NS
Use Group: AQUATIC NON-FOOD INDUSTRIAL
W 3. 1 * NS NS NS NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
69
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LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107104 [2-Methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/AI (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
FUELS/OIL STORAGE TANK BOTTOM WATER ADDITIVE
V .52
V 1.4
70
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LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107104 [2-Methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry
unless noted Max. /crop /year otherwise)/A] (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
HEAT EXCHANGER WATER SYSTEMS
Water treatment (recirculating system),
Initial, Not on label, Not Applicable,
Not applicable for this use
71
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) Time 10:47
LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107104 [2-Methyl-3(2H)-isothiazoline]
4444444
Form(s
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry
unless noted Max. /crop /year otherwise)/A] (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
INDUSTRIAL PROCESSING WATER (con't)
INDUSTRIAL SCRUBBING SYSTEM
Water treatment (recirculating system),
Initial, Not on label, Not Applicable,
Not applicable for this use
Water treatment, Initial, Automatic SC/L
dispensing equipment, Not Applicable, Not
applicable for this use
Water treatment, Initial, Not on label,
Not Applicable, Not applicable for this
use
Water treatment, Intermittent
(slug) (initial), Not on label, Not
Applicable, Not applicable for this use
W 1.8 * NS NS NS NS NS NS
Use Group: AQUATIC NON-FOOD INDUSTRIAL
W 3.1 * NS NS NS NS NS NS
72
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) Time 10:47
LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107104 [2-Methyl-3(2H)-isothiazoline]
4444444
Form(s
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry
unless noted Max. /crop /year otherwise)/AI (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
INDUSTRIAL SCRUBBING SYSTEM (con't)
METALWORKING CUTTING FLUIDS
Industrial preservative treatment, During SC/L
manufacture, Not on label, Not
Applicable, Not applicable for this use
Preservative treatment, Initial, Not on
label, Not Applicable, Not applicable for
this use
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
73
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) Time 10:47
LUIS 5.1 - Page: 12
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107104 [2-Methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry
unless noted Max. /crop /year otherwise)/AI (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
METALWORKING CUTTING FLUIDS
Preservative treatment,
Subsequent/maintenance, Automatic
dispensing equipment, Not Applicable, Not
applicable for this use
Preservative treatment,
Subsequent/maintenance, Metering pump,
Not Applicable, Not applicable for this
use
OIL RECOVERY DRILLING MUDS/PACKER FLUIDS
.7875 * NS NS
W 4 . 2 * NS NS
W 4 .2 * NS NS
W 8 . 3 * NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
74
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) Time 10:47
LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107104 [2-Methyl-3(2H)-isothiazoline]
SITE Application Type, Application Form
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry
unless noted Max. /crop /year otherwise)/AI (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
OIL RECOVERY DRILLING MUDS/PACKER FLUIDS (con't)
SC/L
W 8 . 1 * NS NS NS NS NS NS
Use Group: TERRESTRIAL NON-FOOD CROP
V 10 * NS NS NS NS NS NS
75
-------
LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107104 [2-Methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/AI (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
PASTEURIZER/WARMER/CANNERY COOLING WATER SYSTEMS
Water treatment (recirculating system), SC/L
Initial, Not on label, Not Applicable,
Not applicable for this use
Water treatment, Initial, Automatic SC/L
dispensing equipment, Not Applicable, Not
applicable for this use
Water treatment, Initial, Not on label,
Not Applicable, Not applicable for this
use
W .53
W . 088
W 5. 8 * NS NS NS
W 5. 8 * NS NS NS
W 6 * NS NS NS
Use Group: INDOOR NON-FOOD
W 3. 1 * NS NS NS
W 3.1
W .35
76
-------
LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107104 [2-Methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/AI (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
PASTEURIZER/WARMER/CANNERY COOLING WATER SYSTEMS
Water treatment, When needed, Not on SC/L
label, Not Applicable, Not applicable for
this use
PULP/PAPER MILL WATER SYSTEMS
W 1.5
W .41
W 2.1
W 2.8
77
-------
LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107104 [2-Methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/AI (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
PULP/PAPER MILL WATER SYSTEMS (con't)
Water treatment, Intermittent
(slug)(initial), Not on label, Not
Applicable, Not applicable for this use
Water treatment, Not on label, Not on SC/L
label, Not Applicable, Not applicable for
this use
W 5. 9
W 2.6
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
A08, C23
A30, C18, C24
A30, C24
CIS, C24
A08, C23
A30, C24
78
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LUIS 5.1 - Page: 17
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107104 [2-Methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/AI (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
SECONDARY OIL RECOVERY INJECTION WATER
Water treatment, Initial, Not on label,
Not Applicable, Not applicable for this
use
Water treatment, Intermittent
(slug)(initial), Not on label, Not
Applicable, Not applicable for this use
W .34
W .58
W .58
W .1
W 1.2
W 1.2
W 1.2
W 1.2
W 1.3
* NS
* NS
* NS
* NS
* NS
N:
N:
N:
N:
N:
NS NS NS
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, CIS, C24
CIS, C24
C22, C23
C23
CIS, C24
79
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LUIS 5.1 - Page: 18
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107104 [2-Methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Geographic Limitations
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/A] (days) Intv.
otherwise) Dose cycle /crop /year
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
SECONDARY OIL RECOVERY INJECTION WATER (con't)
SC/L
SC/L
SC/L
SPECIALITY INDUSTRIAL PRODUCTS
Industrial preservative treatment, During SC/L
manufacture, Metering pump, Not
Applicable, Not applicable for this use
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W .69 * NS NS NS NS NS NS
W .58 * NS NS NS NS NS NS
W .58 * NS NS NS NS NS NS
V 1.215 * NS NS NS NS NS NS
W .58 * NS NS NS
W .58 * NS NS NS
W .58 * NS NS NS
W .59 * NS NS NS
Use Group: INDOOR NON-FOOD
UC * NS NS NS
W 5.8
W 5.2
W 35
NS NS NS
NS NS NS
NS NS NS
NS NS NS
80
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LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107104 [2-Methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/A] (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
SPECIALITY INDUSTRIAL PRODUCTS (con't)
Industrial preservative treatment,
Initial, Not on label, Not Applicable,
Not applicable for this use
W 5.2
V 5.1
SC/L
Preservative treatment, Initial, Metering SC/L
pump, Not Applicable, Not applicable for
this use
Preservative treatment, Initial, Not on SC/L
label, Not Applicable, Not applicable for
this use
SC/L
81
-------
LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107104 [2-Methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/AI (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
SPECIALITY INDUSTRIAL PRODUCTS (con't)
Preservative treatment,
Subsequent/maintenance, Metering pump,
Not Applicable, Not applicable for this
use
TEXTILES/TEXTILE FIBERS/CORDAGE
Industrial preservative treatment, During SC/L
manufacture, Not on label, Not
Applicable, Not applicable for this use
SC/L
Use Group: INDOOR NON-FOOD (con't)
V 6. 8 * NS NS NS NS NS NS
V 8 . 1 * NS NS NS NS NS NS
V 3 * NS NS NS NS NS NS
V 2 . 9 * NS NS NS
V 2 . 9 * NS NS NS
V 3. 5 * NS NS NS
Use Group: INDOOR NON-FOOD
W 5.2 * NS NS NS
82
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LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107104 [2-Methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/AI (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
TEXTILES/TEXTILE FIBERS/CORDAGE (con't)
WOOD PRESSURE TREATMENT TO FOREST PRODUCTS
Dip treatment, Not on label, Not on SC/L
label, Not Applicable, Not applicable for
this use
.35
1.4
1.5
1.5
1.5
1.6
1.5
W 5.2 * NS NS NS
Use Group: INDOOR NON-FOOD
W 1.62 * NS NS NS
W
W
W
W
W
W 7
5.8
5.8
5.8
5.8
W 6
5.8
* NS
* NS
* NS
* NS
* NS
* NS
* NS
N:
N:
N:
N:
N:
N:
N:
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
CIS, 024
018, 024
018, 024
023
024
018, 024
018, 024
83
-------
LUIS 5.1 - Page: 22
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107104 [2-Methyl-3(2H)-isothiazoline]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Re-
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
unless noted Max. /crop /year otherwise)/AI (days) Intv.
otherwise) Dose cycle /crop /year
cycle
Geographic Limitations
Disallowed
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
WOOD PROTECTION TREATMENT TO AQUATIC STRUCTURES/ITEMS
V .52
SC/L V .71
WOOD PROTECTION TREATMENT TO FOREST PRODUCTS (SEASONED)
V 11 * NS NS NS NS NS NS
Use Group: TERRESTRIAL NON-FOOD CROP
NS NS NS NS
84
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LUIS 5.1 - Page: 23
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107104 [2-Methyl-3(2H)-isothiazoline]
4444444
LEGEND
444444
Sort: Uses Eligible or Ineligible for Re-registration, Food/Feed or Non-Food/Non-Feed Uses, Alpha Site Name, Use Group Name, Alpha Application Type/Timing/Equipment
Description, Formulation, Maximum Application Rate Unit/Area Quantity, Minimum Application Rate
HEADER ABBREVIATIONS
Min. Appl. Rate (AI unless : Minimum dose for a single application to a single site. System calculated. Antimicrobial claims only.
noted otherwise)
Max. Appl. Rate (AI unless : Maximum dose for a single application to a single site. System calculated.
noted otherwise)
: Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).
: 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"
: Maximum dose applied to a site over a single crop cycle or year. System calculated.
Max. Dose [(AI unless
noted otherwise)/A]
Min. Interv (days)
Re-Entry Intv.
PRO Report Date
Minimum Interval between Applications (days)
Reentry Intervals
LUIS contains all products that were active or suspended (and that were available from OPP Document Center) as of this date. Some products
registered after this date may have data included in this report, but LUIS does not guarantee that all products registered after this date have
data that has been captured.
SOIL TEXTURE FOR MAX APP. RATE
* : Non-specific
C : Coarse
M : Medium
F : Fine
O : Others
SC/L : SOLUBLE CONCENTRATE/LIQUID
SC/S : SOLUBLE CONCENTRATE/SOLID
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
U : Unknown whether PPM is given by weight or by volume
85
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LUIS 5.1 - Page:
APPENDIX A REPORT
Case 3092 [Methylisothiazolinone] Chemical 107104 [2-Methyl-3(2H)-isothiazoline]
USE LIMITATIONS CODES
Do not apply in marine and/or estuarine oil fields.
NPDES license restriction.
* NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
UNIT DESCRIPTIONS
gal : gallon
Ib : pound
86
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregi strati on for active
ingredients within the case methylisothiazolinone covered by this Reregi strati on Eligibility Decision
Document. It contains generic data requirements that apply to methylisothiazolinone in all products,
including data requirements for which a "typical formulation" is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in which they
appear in 40 CFR Part 158. the reference numbers accompanying each test refer to the test protocols
set in the Pesticide Assessment Guidelines, which are available from the National Technical
Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files, this
column lists the identifying number of each study. This normally is the Master Record Identification
(MRID) number, but may be a "GS" number if no MRID number has been assigned. Refer to the
Bibliography appendix for a complete citation of the study.
87
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of
Methylisothiazolinone
REQUIREMENT
USE PATTERN CITATION(S)
PRODUCT CHEMISTRY
61-1
6 1-2 A
61-2B
62-1
62-3
63-2
63-3
63-4
63-6
63-7
63-8
63-9
63-11
63-12
63-13
ECOL
71-1A
7 1-2 A
71-2B
72-1 A
72- 1C
72-2A
72-3A
Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Analytical Method
Color
Physical State
Odor
Boiling Point
Density
Solubility
Vapor Pressure
Octanol/Water Partition
pH
Stability
,OGICAL EFFECTS
Acute Avian Oral - Quail/Duck
Avian Dietary - Quail
Avian Dietary - Duck
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
Estuarine/Marine Toxicity - Fish
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
C,E,F
C,E,F
C,E,F
C,E,F
C,E,F
C,E,F
C,E,F
41741401
41741401
41741401
41741401
41741401
41741401
41741401
41741401
41741401
41741401
41741401
41741401
41741401
41741401
41741401
41719501
41719502
41719503
41718801
41718802,41963503
41718803,42358701
00042556
88
-------
Data Supporting Guideline Requirements for the Reregistration of
Methylisothiazolinone
REQUIREMENT USE PATTERN CITATION(S)
72-3B
72-3C
72-4A
72-4B
TOXICOI
81-1
81-2
81-3
81-4
81-5
81-6
82-1A
82-4
83-1A
83-3A
83-3B
83-5
Estuarine/Marine Toxicity -
Mollusk
Estuarine/Marine Toxicity -
Shrimp
Early Life Stage Fish
Life Cycle Invertebrate
OGY
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation -
Rabbit
Dermal Sensitization - Guinea
Pig
90-Day Feeding - Rodent
90-Day Inhalation - Rat
Chronic Feeding Toxicity -
Rodent
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
Combined Chronic Toxicity /
C,E,F
C,E,F
C,E,F
C,E,F
All
All
All
All
All
All
All
All
All
All
All
All
00042558
00042559, 00042557
42012201
41963502
00086091
00086092
41963501, 42360901,
42360902
00086092
00086092
00144880
42810101
00148418
43140701
00078831
42311701
43140701
Carcinogenicity
84-2A Gene Mutation (Ames Test)
84-2B Structural Chromosomal
Aberration
All 00078827, 00096692,
00096693, 00105044
All 42538001
89
-------
Data Supporting Guideline Requirements for the Reregistration of
Methylisothiazolinone
REQUIREMENT
USE PATTERN
CITATION(S)
84-4 Other Genotoxic Effects All
ENVIRONMENTAL FATE
160-5 Chemical Identity All
161-1 Hydrolysis All
162-1 Aerobic Soil Metabolism C
163-1 Leaching/ Adsorption/Desorpti on C,E,F
168-1-SS Aqueous Availability C,E
00130751,41875502
41741401
42578401, 42681301
42086901
42086902
43478401
90
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GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere in
the Reregi strati on 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 as (19??), the Agency
was unable to determine or estimate the date of the document.
91
-------
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.
92
-------
BIBLIOGRAPHY
MRID
CITATION
00042556 Heitmuller, T. (1980) Acute Toxicity of Kathon WT to Sheepshead Minnows,
Cyprinodon variegatus: Report No. BP-80-3-53. (Unpublished study received Aug
28,1980 under 707-128; prepared by EG&G, Bionomics, submitted by Rohm & Haas
Co., Philadelphia, Pa.; CDL:243239-A)
00042557 Heitmuller, T. (1980) Acute Toxicity of Kathon WT to Fiddler Crabs, Uca pugilator:
Report No. BP-80-3-52. (Unpublished study received Aug 28, 1980 under 707-128;
prepared by EG&G, Bionomics, submitted by Rohm & Haas Co., Philadelphia, Pa.;
CDL: 243238-A)
00042558 Hollister, T.A. (1980) Acute Toxicity of Kathone WT to Embryo Larvae of Eastern
Oysters, Crassostrea virginica: Report No. BP-80-5-85. (Unpublished study received
Aug 28, 1980 under 707-128; prepared by EG&G, Bionomics, submitted by Rohm
& Haas Co., Philadelphia, Pa.; CDL:243237-A)
00042559 Heitmuller, T. (1980) Acute Toxicity of Kathon WT to Pink Shrimp, Penaeus
duorarum: Report No. BP-80-3-51. (Unpublished study received Aug 28,1980 under
707-128; prepared by EG&G, Bionomics, submitted by Rohm & Haas Co.,
Philadelphia, Pa.; CDL:243240-A)
00078827 Scribner, H.E.; Melly, J.G; Lohse, K.L. (1981) Kathon 886 MW; Microbial Mutagen
Test: Report No. 81R-96. (Unpublished study received Jul 8, 1981 under 707-166;
submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:245555-C)
00078831 Weatherholtz, W.M.; Hoberman, A.; Durloo, R.S. (1980) Teratogenicity Study in
Rats: Kathon 886: Project No. 417-399. Final rept. (Unpublished study received Jul
8, 1981 under 707-166; prepared by Hazleton Laboratories America, Inc., submitted
by Rohm & Haas Co., Philadelphia, Pa.; CDL:245555-G)
00086091 Rohm and Haas Company (1977) Toxicity Data: Kathon 886 All-magnesium
Formulation: Report No. 77-3 8. (Unpublished study received on unknown date under
707-129; CDL:233075-B)
00086092 Rohm and Haas Company (1976) Toxicity Data: F, MF or CT All-magnesium
Formulation: Report No. 76-56. (Unpublished study received Aug 8, 1977 under
707-129; CDL:233075-C)
93
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BIBLIOGRAPHY
MRID
CITATION
00096692 Scribner, H.E.; Melly, J.G.; Lohse, K.L. (1981) Kathon 886 MW; Microbial Mutagen
Test: Report No. 81R-96. (Unpublished study received Mar 17,1982 under 707-166;
submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:247017-C)
00096693 Cifone, M.A.; Fisher, J. (1981) Mutagenicity Evaluation of TD-81-155 in the Mouse
Lymphoma Forward Mutation Assay: LBIProjectNo. 20989; ReportNo. 81RC-153.
Final rept. (Unpublished study received Mar 17, 1982 under 707-166; prepared by
Litton Bionetics, Inc., submitted by Rohm & Haas Co., Philadelphia, Pa.;
CDL:247017-E)
00105044 Scribner, H.E.; Melly, J.G.; Lohse, K.L. (1981) Kathon 886 NARProcess; Microbial
Mutagen Test: ReportNo. 81R-97. (Unpublished study received Mar 17,1982 under
707-166; submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:247017-D)
00130751 Valencia, R. (1983) Drosophila Sex-linked Recessive Lethal Test on Kathon Biocide:
Laboratory Project No. 100; Rohm & Haas Project No. 82P-152. Final rept.
(Unpublished study received Aug 23, 1983 under 707-130; prepared by Univ. of
Wisconsin, Zoology Dept, submitted by Rohm & Haas Co., Philadelphia, PA; CDL:
251100-A)
00144880 Parsons, R. (1982) Delayed Contact Hypersensitivity Test of RH-573 and RH-886
in Guinea Pigs: ReportNo. 79R-195. Unpublished study prepared by Rohm and Haas
Co. 52 p.
00148418 Hagan, J.; Baldwin, R. (1984) Kathon 886 MMPA Process: 13-Week Inhalation
Toxicity Study in Rats: ReportNo. 82R-245. Unpublished study prepared by Rohm
and Haas Co. 267 p.
41718801 Ward, T.; Boeri, R. (1990) Acute Flow Through Toxicity of Kathon 886 F Biocide
to the Bluegill Sunfish, Lepomis machcrochirus: Lab Project Number: 9002-RH:
89RC-0342. Unpublished study prepared by Resource Analysts Inc., Envirosystems
Div. 287 p.
41718802 Ward, T.; Boeri, R. (1990) Acute Flow Through of Kathon 886 Biocide to the
Rainbow Trout, Oncorhynchus mykiss: Lab Project Number: 9003-RH: 89RC-0343.
Unpublished study prepared by Resource Analysts Inc., Envirosystems Div. 250 p.
41718803 Ward, T.; Boeri, R. (1990) Acute Flow Through of Kathon 886 Biocide to the
Rainbow Trout, Oncorhynchus mykiss: Lab Project Number: 9001-RH: 89RC-0345.
Unpublished study prepared by Resource Analysts Inc., Envirosystems Div. 209 p.
94
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BIBLIOGRAPHY
MRID
CITATION
41741401 Derbyshire, R. (1990) Product Chemistry (of) Kathon 886F Microbiocide: Lab
Project Number: 1770.02. Unpublished study prepared by Rohm and Haas Co. 518
P-
41719501 Pedersen, C. (1990) Kathon 886 Biocide: 21-Day Acute Oral LD50 Study in
Bobwhite Quail: Lab Project Number: 90 QD148: 89RC-0339 Unpublished study
prepared by Bio-Life Associates, Ltd. 45 p.
41719502 Pedersen, C. (1990) Kathon 886 Biocide: 8-Day Acute Oral LC50 Study in Bobwhite
Quail: Lab Project Number: 90 QC148: 89RC- 0340. Unpublished study prepared
by Bio-life Associates, Ltd. 45 p.
41719503 Pedersen, C. (1990) Kathon 886 Biocide: 8-Day Acute Dietary LC50 Study in
Mallard Ducklings: Lab Project Number: 90 DC 145: 89RC-0341. Unpublished study
prepared by Bio-Life Associates, Ltd. 61. p.
41875502 Pant, K. (1990) Test for Chemical Induction of Unscheduled DNA Synthesis in Rat
Primary Hepatocyte Cultures by Autoradiography: Kathon 886 MW Biocide: Final
Report: Lab Proj ect No: 0159/5100:90RC/168. Unpublished study prepared by Sitek
Research Labs. 29 p.
41963501 Wanner, F.; Hagan, J. (1991) Kathon 886F Biocide: Acute Inhalation Toxicity Study
in Rats: Lab Project Number: 91R-018: PROTOCOL No. 91P-018. Unpublished
study prepared by Rohm and Haas Co. 85 p.
41963502 Ward, T.; Boeri, R. (1991) Chronic Toxicity of Kathon 886 Biocide to the Daphnid,
Daphnia magna: Lab Project Number: 9005-RH: 89RC-0346. Unpublished study
prepared by Resource Analysts, Inc. 507 p.
41963503 Ward, T.; Boeri, R. (1991) Acute Flow Through Toxicity of Kathon 886 Biocide to
the Rainbow Trout, Oncorhynchus my kiss—14 Day Prolonged Test: Lab Project
Number: 9006-RH: 89RC-0348. Unpublished study prepared by Resource Analysts,
Inc. 306 p.
42086902 Wang, W. (1991) Adsorption and Desorption of carbon 14*-RH-651 in Four Soils
and One Sediment: Lab Project Number: XBL 90024: RPT 0046: RH TECH.
34-91-09. Unpublished study prepared by XenoBiotics Labs, Inc. 86 p.
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BIBLIOGRAPHY
MRID
CITATION
42360901
42360902
42538001
42311701 Thomas, T.; Solomon, H.; and O'Hara, G. (1992) Kathon Biocide: Oral (Gavage)
Developmental Toxicity Study in Rabbits: Lab Project Number: 91P-074.
Unpublished study prepared by Rohm and Haas Co. 206 p.
42358701 Jop, K. (1992) Kathon WT 1.5 Percent Biocide-Acute Toxicity to Cerlodaphnia
dubia under Static Conditions: Final Report: Lab Project Number: 92-404209:
91RC-0196: 86.0392-6152.132. Unpublished study prepared by Springborn Labs,
Inc. 36 p.
Wanner, F.; Hagan, J. (1991) Kathon 886F Biocide Acute Inhalation Toxicity Study
in Rats: A Supplement: Lab Project Number: 91R-018A. Unpublished study prepared
by Rohm and Haas Co. 5 p.
Bernacki, H.; Hagan, J. (1992) Kathon 886F Biocide Acute Inhalation Toxicity Study
in Rats: A Supplement: Lab Project Number: 91R-018B. Unpublished study prepared
by Rohm and Haas Co. 5 p.
Gudi, R. (1992) Acute Test for Chemical Induction of Chromosome Aberation in
Mouse Bone Marrow Cells in Vivo: Kathon 886 MW Biocide: Lab Project Number:
0202-1541: 92RC-0054. Unpublished study prepared by SITEK Research Lab. 65
P-
42578401 Marx, M.; Castle, S.; Shepler, K. (1992) Hydrolysis of (carbon 14)-RH-573 at pH 5,
7 and 9: Lab Project Number: 223W-1: 223W: 34-92-63. Unpublished study
prepared by Pharmacology and Toxicology Research Laboratory-West. 69 p.
42681301 Jalali-Araghi, K.; Shepler, K. (1993) Hydrolysis of (carbon 14)-RH-651 (the major
component of RH-886) at pH 5, 7 and 9: Lab Project Number: 225W-1: 225W:
34P-90-06: 34-93-07. Unpublished study prepared by Pharmacology and Toxicology
Research Laboratory-West. 134 p.
42810101 O'Hara, G.; DiDonato, L. (1982) Kathon 886 NAR: Three Month Rat Drinking Water
Study and One Generation Reproduction Study: Report No. 81R-162. Final rept.
(Unpublished study received Aug 23, 1983 under 707-130; submitted by Rohm &
Haas Co., Philadelphia, PA; CDL:251098-A)
42840301 Weideborg, M. (1993) Toxicity Test Results with Acartia tonsa for the chemical
Kathon OM: Lab Project Number: 0-93007: 93-028: 93RC-1011. Unpublished study
prepared by Aquateam-Norwegian Water Technology Centre A/S. 27 p.
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BIBLIOGRAPHY
MRID CITATION
43140701 Quinn, D.; O'Hara, G.; Brown, W. (1994)KathonBiocide: 24-Month Drinking Water
Chronic/Oncogenic Study in Rats: Final Report: Lab Project Number: 90P/149:
90R/149. Unpublished study prepared by Rohm and Haas Company Toxicology
Department. 5150 p.
43478401 Doshi, D. (1994) Aqueous Availability of Kathon WT from Treated Southern Yellow
Pine: Lab Project Number: 3122.00. Unpublished study prepared by Rohm and Haas
Co. and Hickson Corp. 325 p.
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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 of your
product(s) containing this active ingredient. Within 90 days after you receive this Notice you must
respond as set forth in Section III below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 6; 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
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product(s) subject to this Notice will be subject to suspension. We have provided a list of all of
your products subject to this Notice in Attachment 2, Data Call-In Response Form, as well as a list
of all registrants who were sent this Notice (Attachment 6).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide and
Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107
and 2070-0057 (expiration date 03-31-99).
This Notice is divided into six sections and six 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 VT - Inquiries And Responses To This Notice
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-In Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - List of Registrants Receiving This Notice
6 - Cost Share and Data Compensation Forms
SECTION! 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
H-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
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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, 2001 L Street, N.W.,
Washington, D.C. 20036 (Telephone number 202-785-6323; Fax telephone number 202-785-
0350).
All new studies and proposed protocols submitted in response to this Data Call-In Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(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(sX 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 HI. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
HI-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.
m-B. OPTIONS FOR RESPONDING TO THE AGENCY
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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 of the Requirements Status and Registrant's Response Form must be
submitted for each product listed on the Data Call-In Response Form unless the voluntary
cancellation option is selected or unless the product is identical to another (refer to the instructions
for completing the Data Call-In Response Form in Attachment 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 5
on the Data Call-In Response Form. If you choose this option, this is the only form that you are
required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
2. Satisfying the Product Specific Data Requirements of this Notice There are various
options available to satisfy the product specific data requirements of 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 low volume/minor use option are not valid
options for fulfilling product specific data requirements.
3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section III-D of this Notice and are covered by option 7 on the Requirements Status
and Registrant's Response Form. If you choose one of these options, you must submit both forms
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as well as any other information/data pertaining to the option chosen to address the data
requirement.
m-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
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
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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(s), although you do not comply
with the data submission requirements of this Notice. EPA has determined that as a general
policy, absent other relevant considerations, it will not suspend the registration of a product of a
registrant who has in good faith sought and continues to seek to enter into a joint data
development/cost sharing program, but the other registrant(s) developing the data has refused to
accept your offer. To qualify for this option, you must submit documentation to the Agency
proving that you have made an offer to another registrant (who has an obligation to submit data) to
share in the burden of developing that data. You must also submit to the Agency a completed EPA
Form 8570-32, Certification of Offer to Cost Share in the Development of Data, Attachment 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
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to develop the data or for some other reason is subject to suspension, your registration as well as
that of the other registrant will normally be subject to initiation of suspension proceedings, unless
you commit to submit, and do submit the required data in the specified time frame. In such cases,
the Agency generally will not grant a time extension for submitting the data.
Option 4. Submitting an Existing Study ~ If you choose to submit an existing study in
response to this Notice, you must determine that the study satisfies the requirements imposed by
this Notice. You may only submit a study that has not been previously submitted to the Agency or
previously cited by anyone. Existing studies are studies which predate issuance of this Notice. Do
not use this option if you are submitting data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the required
date of submission. The Agency may determine at any time that a study is not valid and needs to
be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data
and specimens from the study are available for audit and review and you must
identify where they are available. This must be done in accordance with the
requirements of the Good Laboratory Practice (GLP) regulation, 40 CFRPart 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
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available from NTIS). A study not conducted according to the PAG may be
submitted to the Agency for consideration if the registrant believes that the study
clearly meets the purpose of the PAG. The registrant is referred to 40 CFR 158.70
which states the Agency's policy regarding acceptable protocols. If you wish to
submit the study, you must, in addition to certifying that the purposes of the PAG
are met by the study, clearly articulate the rationale why you believe the study
meets the purpose of the PAG, including copies of any supporting information or
data. It has been the Agency's experience that studies completed prior to January
1970 rarely satisfied the purpose of the PAG and that necessary raw data are usually
not available for such studies.
If you submit an existing study, you must certify that the study meets all requirements of
the criteria outlined above.
If you know of a study pertaining to any requirement in this Notice which does not meet
the criteria outlined above but does contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study. If such study 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.
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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.
HI-D REQUESTS FOR DATA WAIVERS
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request, including technical reasons,
data and references to relevant EPA regulations, guidelines or policies. (Note: any supplemental
data must be submitted in the format required by PR Notice 86-5). This will be the only
opportunity to state the reasons or provide information in support of your request. If the Agency
approves your waiver request, you will not be required to supply the data pursuant to section
3(c)(2)(B) of FIFRA. If the Agency denies your waiver request, you must choose an option for
meeting the data requirements of this Notice within 30 days of the receipt of the Agency's
decision. You must indicate and submit the option chosen on the Requirements Status and
Registrant's Response Form. Product specific data requirements for product chemistry, acute
toxicity and efficacy (where appropriate) are required for all products and the Agency would grant
a waiver only under extraordinary circumstances. You should also be aware that submitting a
waiver request will not automatically extend the due date for the study in question. Waiver
requests submitted without adequate supporting rationale will be denied and the original due date
will remain in force.
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.
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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:
b. fulfill the commitment to develop and submit the data as required by this
Notice; or
c. otherwise take appropriate steps to meet the requirements stated in this
Notice, unless you commit to submit and do submit the required data in the
specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds for
suspension include, but are not limited to, failure to meet any of the following:
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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 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.
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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 Call-In Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment 2 and Attachment 3 for product
specific data) and any other documents required by this Notice, and should be submitted to the
contact person(s) identified in Attachment 1. If the voluntary cancellation or generic data
exemption option is chosen, only the Data Call-In Response Form need be submitted.
The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
Lois A. Rossi, 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 for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - List of Registrants Receiving This Notice
6 - Cost Share and Data Compensation Forms and the Confidential Statement of
Formula Form
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METHYLISOTHIAZOLINONE DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing methylisothiazolinone.
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 reregi strati on of
methylisothiazolinone. This attachment is to be used in conjunction with (1) the Product Specific
Data Call-In Notice, (2) the Product Specific Data Call-In Response Form (Attachment 2), (3) the
Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA Acceptance
Criteria (Attachment 5), (6) a list of registrants receiving this DCI (Attachment 6) and (7) the Cost
Share and Data Compensation Forms in replying to this Methylisothiazolinone 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 methylisothiazolinone
are contained in the Requirements Status and Registrant's Response. Attachment 3. The Agency has
concluded that additional data on methylisothiazolinone 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 reregi strati on of all eligible methylisothiazolinone products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding this product specific data requirements and procedures
established by this Notice, please contact Barbara Briscoe at (703) 308-8177.
All responses to this Notice for the Product Specific data requirements should be submitted
to:
Barbara Briscoe
Chemical Review Manager Team 81
Product Reregi strati on Branch
Special Review and Reregi strati on Branch 7508C
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Methylisothiazolinone
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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 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. 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
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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 "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. 1.) apply. By the specified
due date, I will also submit: (1) a completed "Certification With Respect To Data
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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
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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EPA'S BATCHING OF METHYLISOTHIAZOLINONE (5-Chloro-2-methyl-3(2H)-
isothiazolone and 2-Methyl-3(2H)-isothiazolone) 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 methylisothiazolinone (approximately a
3:1 ratio of 5-Chloro-2-methyl-3(2H)-isothiazolone and2-Methyl-3(2H)-isothiazolone, respectively)
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. Notwithstanding the batching process, the Agency reserves the right to require,
at any time, acute toxicity data for an individual product, should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite a single
battery of six acute toxicological studies to represent all the products within that batch. It is the
registrants' option to participate in the process with all other registrants, only some of the other
registrants, or only their own products within a batch, or to generate all the required acute
toxicological studies for each of their own products. If a registrant chooses to generate the data for
a batch, he/she must use one of the products within the batch as the test material. If a registrant
chooses to rely upon previously submitted acute toxicity data, he/she may do so provided that the
data base is complete and valid by today's standards (see acceptance criteria attached), the
formulation 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 are generated or existing data are 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 (DCI) 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
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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.
Eighty-three (83) products were found which contain methylisothiazolinone (5-Chloro-2-methyl-
3(2H)-isothiazolone and 2-Methyl-3(2H)-isothiazolone) as the active ingredient, plus two (2)
products which contain only 2-Methyl-3(2H)-isothiazolone as the active ingredient. These products
have been placed into eighteen batches in accordance with the active and inert ingredients and type
of formulation.
Results from studies available to the Agency indicate that products containing (a wide range of
percentages) of methylisothiazolinone as the active ingredient produce irreversible destruction of
ocular tissue or corneal involvement/irritation lasting for more than 21 days. Therefore, all products
containing this active ingredient will be classified as Toxicity Category I. However, if the registrant
does not agree with this classification, new studies must be submitted/cited to fulfill the primary eye
irritation data requirement.
Studies assessing skin sensitization are not required, because the existing data for the Technical (SF-
886 Technical Industrial Microbicide) indicate that the active ingredients are skin sensitizers, and
therefore, all products (including the End Use Products) would be considered positive for skin
sensitization. However, if the registrant does not agree with this classification, new studies must be
submitted/cited to fulfill the skin sensitization data requirement.
The following summarizes acute data requirements by batch:
• The registrant with the product in Batch 1 must cite/submit all acute data (except for the
primary eye irritation and the skin sensitization data).
The products in Batch la may be supported by citing/submitting the acute data from Batch
1. Data from EPA Reg. No. 707-256 may not be used to support EPA Reg. No. 707-255.
I. The registrants with products in Batch 2 need to cite/submit all acute data (except for the primary
eye irritation and skin sensitization data) on one of the subject products.
II. The registrants with products in Batch 3 need to cite/submit all acute data (except for the primary
eye irritation and skin sensitization data) on one of the subject products.
III. The registrants with products in Batch 3a may cite/submit all acute data (except for the primary
eye irritation and skin sensitization data) on one of the subject products. Products in Batch 3a may
also be supported by data from products in Batch 3.
IV. The registrants with products in Batch 4 need to cite/submit all acute data (except for the
primary eye irritation and skin sensitization data) on one of the subject products.
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V. The registrants with products in Batch 4a may cite/submit all acute data (except for the primary
eye irritation and skin sensitization data) on one of the subject products. Products in Batch 4a may
be supported by data from products in Batch 4.
VI. The registrants with products in Batch 5 need to cite/submit all acute data (except for the
primary eye irritation and skin sensitization data).
The registrants with products in Batch 5a may cite/submit all acute data (except for the
primary eye irritation and skin sensitization data) on one of the subject products. Products
in Batch 5a may be supported by data from products in Batch 5.
VII. The registrant with the product in Batch 6 needs to cite/submit all acute data (except for the
primary eye irritation and skin sensitization data).
VIII. The registrant with the product in Batch 7 needs to cite/submit all acute data (except for the
primary eye irritation and skin sensitization data). The product in Batch 7 may also be supported by
data from the products in Batch 4.
IX. The registrants with products in Batch 8 need to cite/submit all acute data (except for the
primary eye irritation and skin sensitization data) on one of the subject products.
X. The registrants with products in Batch 9 need to cite/submit all acute data (except for the primary
eye irritation and skin sensitization data) on one of the subject products.
XL The registrant with the product in Batch 10 needs to cite/submit all acute data (except for the
primary eye irritation and skin sensitization data).
XII.The registrants with products in Batch lOa need to cite/submit all acute data (except for the
primary eye irritation and skin sensitization data). EPA Reg. No. 68708-9 may be supported by data
from EPA Reg. No. 67071-16.
XIII. The registrant with the product in Batch 11 needs to cite/submit all acute data (except for the
primary eye irritation and skin sensitization data).
XIV. The registrants with products in Batch 12 need to cite/submit all acute data (except for the
primary eye irritation and skin sensitization data). EPA Reg. No. 1448-398 may be supported by data
from EPA Reg. No. 1448-397.
XV. The registrant with the product in Batch 13 needs to cite/submit all acute data (except for the
primary eye irritation and skin sensitization data).
XVI. The Registrant with the product in Batch 14 needs to cite/submit all acute data (except for the
primary eye irritation and skin sensitization data).
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NOTE: The technical acute toxicity values included in this document are for informational purposes
only. The data supporting these values may or may not meet the current acceptance criteria.
[Under "% Active Ingredient", the 5-Chloro-2-methyl-3(2H)-isothiazolone is listed as
"5-Chloro-2-methyl", and the 2-Methyl-3(2H)-isothiazolone is listed as "2-Methyl".]
Batch
1
EPA Reg. No.
707-234
% Active Ingredient
70.1% 5-Chloro-2-methyl
26.0% 2-Methyl
Formulation Type
Liquid
Batch
la
EPA Reg. No.
707-255
707-256
% Active Ingredient
93. 8% 2-Methyl
50.0% 2-Methyl
Formulation Type
Liquid
Liquid
Batch
2
Batch
3
EPA Reg. No.
707-128
707-129
707-130
707-132
707-194
707-217
6836-238
6836-239
6836-240
49403-24
67071-5
67071-9
EPA Reg. No.
707-220
% Active Ingredient
10.4% 5-Chloro-2-methyl
3. 7% 2-Methyl
10.4% 5-Chloro-2-methyl
3. 7% 2-Methyl
10.4% 5-Chloro-2-methyl
3. 7% 2-Methyl
10.4% 5-Chloro-2-methyl
3. 7% 2-Methyl
10.4% 5-Chloro-2-methyl
3. 7% 2-Methyl
10.4% 5-Chloro-2-methyl
3. 7% 2-Methyl
10.8% 5-Chloro-2-methyl
3. 83% 2-Methyl
10.8% 5-Chloro-2-methyl
3. 83% 2-Methyl
10.8% 5-Chloro-2-methyl
3. 83% 2-Methyl
8.6% 5-Chloro-2-methyl
2.6% 2-Methyl
10.2% 5-Chloro-2-methyl
4.0% 2-Methyl
10.2% 5-Chloro-2-methyl
4.0% 2-Methyl
% Active Ingredient
2.69% 5-Chloro-2-methyl
0.81% 2-Methyl
Formulation Type
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Formulation Type
Liquid
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Batch
EPA Reg. No.
1706-170
6836-257
45017-42
45017-44
% Active Ingredient
3.11%5-Chloro-2-methyl
0.94% 2-Methyl
3.69% 5-Chloro-2-methyl
1.31% 2-Methyl
2.8% 5-Chloro-2-methyl
1.0% 2-Methyl
2.30% 5-Chloro-2-methyl
0.70% 2-Methyl
Formulation Type
Liquid
Liquid
Liquid
Liquid
Batch
3a
EPA Reg. No.
707-171
10707-44
% Active Ingredient
4.3% 5-Chloro-2-methyl
1.3% 2-Methyl
5.36% 5-Chloro-2-methyl
1.62% 2-Methyl
Formulation Type
Solid
Solid
Batch
4
EPA Reg. No.
527-105
707-133
707-134
707-196
707-209
707-216
707-219
707-260
1448-348
1553-126
1706-153
1706-158
1706-183
1757-67
% Active Ingredient
1.15%5-Chloro-2-methyl
0.35% 2-Methyl
l.ll%5-Chloro-2-methyl
0.39% 2-Methyl
l.ll%5-Chloro-2-methyl
0.39% 2-Methyl
l.ll%5-Chloro-2-methyl
0.39% 2-Methyl
1.11% 5-Chloro-2-methyl
0.39% 2-Methyl
1.11% 5-Chloro-2-methyl
0.39% 2-Methyl
1.11% 5-Chloro-2-methyl
0.39% 2-Methyl
1.11% 5-Chloro-2-methyl
0.39% 2-Methyl
1.15%5-Chloro-2-methyl
0.35% 2-Methyl
1.15%5-Chloro-2-methyl
0.35% 2-Methyl
1.15%5-Chloro-2-methyl
0.35% 2-Methyl
1.15%5-Chloro-2-methyl
0.35% 2-Methyl
1.12% 5-Chloro-2-methyl
0.40% 2-Methyl
1.15% 5-Chloro-2-methyl
0.35% 2-Methyl
Formulation Type
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
127
-------
Batch
4
EPA Reg. No.
1757-79
3635-271
3876-143
3876-156
3931-7
6836-258
6836-259
8540-23
8591-34
9386-38
10445-66
10445-69
10707-38
11529-12
15300-24
33355-12
45017-34
48301-9
49403-25
67071-01
67071-08
67071-10
% Active Ingredient
1.15%5-Chloro-2-methyl
0.35% 2-Methyl
1.15%5-Chloro-2-methyl
0.35% 2-Methyl
1.15%5-Chloro-2-methyl
0.35% 2-Methyl
1.15%5-Chloro-2-methyl
0.35% 2-Methyl
1.11% 5-Chloro-2-methyl
0.39% 2-Methyl
1.11% 5-Chloro-2-methyl
0.39% 2-Methyl
1.11% 5-Chloro-2-methyl
0.39% 2-Methyl
1.15% 5-Chloro-2-methyl
0.35% 2-Methyl
1.15%5-Chloro-2-methyl
0.35% 2-Methyl
l.ll%5-Chloro-2-methyl
0.39% 2-Methyl
1.15%5-Chloro-2-methyl
0.35% 2-Methyl
1.15%5-Chloro-2-methyl
0.35% 2-Methyl
1.15% 5-Chloro-2-methyl
0.35% 2-Methyl
1.15% 5-Chloro-2-methyl
0.35% 2-Methyl
1.15% 5-Chloro-2-methyl
0.35% 2-Methyl
1.15% 5-Chloro-2-methyl
0.35% 2-Methyl
1.15%5-Chloro-2-methyl
0.35% 2-Methyl
1.15%5-Chloro-2-methyl
0.35% 2-Methyl
1.15%5-Chloro-2-methyl
0.35% 2-Methyl
l.l%5-Chloro-2-methyl
0.4% 2-Methyl
1.1% 5-Chloro-2-methyl
0.4% 2-Methyl
1.11% 5-Chloro-2-methyl
0.44% 2-Methyl
Formulation Type
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
128
-------
Batch
EPA Reg. No.
67071-11
67071-12
67071-13
67071-14
68329-17
68708-1
% Active Ingredient
l.ll%5-Chloro-2-methyl
0.44% 2-Methyl
l.ll%5-Chloro-2-methyl
0.44% 2-Methyl
l.ll%5-Chloro-2-methyl
0.44% 2-Methyl
l.ll%5-Chloro-2-methyl
0.44% 2-Methyl
1.11% 5-Chloro-2-methyl
0.39% 2-Methyl
1.15% 5-Chloro-2-methyl
0.35% 2-Methyl
Formulation Type
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Batch
4a
EPA Reg. No.
707-166
707-218
6836-241
% Active Ingredient
l.ll%5-Chloro-2-methyl
0.39% 2-Methyl
l.ll%5-Chloro-2-methyl
0.39% 2-Methyl
1.18% 5-Chloro-2-methyl
0.40% 2-Methyl
Formulation Type
Liquid
Liquid
Liquid
Batch
5
EPA Reg. No.
707-168
10707-13
% Active Ingredient
1.15% 5-Chloro-2-methyl
0.35% 2-Methyl
1.15% 5-Chloro-2-methyl
0.35% 2-Methyl
Formulation Type
Liquid
Liquid
Batch
5a
EPA Reg. No.
707-167
101-169
% Active Ingredient
1.15%5-Chloro-2-methyl
0.35% 2-Methyl
1.15%5-Chloro-2-methyl
0.35% 2-Methyl
Formulation Type
Liquid
Liquid
Batch
6
EPA Reg. No.
707-198
% Active Ingredient
1.11% 5-Chloro-2-methyl
0.39% 2-Methyl
Formulation Type
Liquid
129
-------
Batch
7
EPA Reg. No.
1757-74
% Active Ingredient
0.575% 5-Chloro-2-methyl
0.175%2-Methyl
Formulation Type
Liquid
Batch
8
EPA Reg. No.
48301-16
69838-1
% Active Ingredient
0.7% 5-Chloro-2-methyl
0.2% 2-Methyl
0.8% 5-Chloro-2-methyl
0.3% 2-Methyl
Formulation Type
Liquid
Liquid
Batch
9
EPA Reg. No.
60061-78
60061-93
% Active Ingredient
0.06% 5-Chloro-2-methyl
0.02% 2-Methyl
64.34% Didecyl Dimethyl Ammonium Chloride
7.55% 3-Iodo-2-Propynyl Butyl Carbamate
0.06% 5-Chloro-2-methyl
0.02% 2-Methyl
3 1.94% Didecyl Dimethyl Ammonium Chloride
3.75% 3-Iodo-2-Propynyl Butyl Carbamate
Formulation Type
Liquid
Liquid
Batch
10
EPA Reg. No.
3876-151
% Active Ingredient
1.6%5-Chloro-2-methyl
0.5% 2-Methyl
5.3% 2-Bromo-2-nitropropane- 1 ,3 -diol
Formulation Type
Liquid
Batch
lOa
EPA Reg. No.
67071-16
68708-9
% Active Ingredient
0.84% 5-Chloro-2-methyl
0.33% 2-Methyl
8.80% 2-Bromo-2-nitropropane- 1,3 -diol
0.28% 5-Chloro-2-methyl
0.10% 2-Methyl
8. 80% 2-Bromo-2-nitropropane- 1 ,3 -diol
Formulation Type
Liquid
Liquid
Batch
11
EPA Reg. No.
1448-396
% Active Ingredient
1.04% 5-Chloro-2-methyl
0.37% 2-Methyl
1.0% 2-Bromo-2-nitropropane- 1 ,3 -diol
12.0% Poly[oxyethylene (dimethyliminio)
ethylene(dimethyliminio)ethylene] dichloride
Formulation Type
Liquid
130
-------
Batch
12
EPA Reg. No.
1448-397
1448-398
% Active Ingredient
1.04% 5-Chloro-2-methyl
0.37% 2-Methyl
12.0% Poly[oxyethylene (dimethyliminio)
ethylene(dimethyliminio)ethylene] dichloride
0.52% 5-Chloro-2-methyl
0.18% 2-Methyl
6.0% Poly[oxyethylene (dimethyliminio)
ethylene(dimethyliminio)ethylene] dichloride
Formulation Type
Liquid
Liquid
Batch
13
EPA Reg. No.
3876-157
% Active Ingredient
1.41% 5-Chloro-2-methyl
0.47% 2-Methyl
7.5% Glutaraldehyde
Formulation Type
Liquid
Batch
14
EPA Reg. No.
10445-89
% Active Ingredient
0.059% 5-Chloro-2-methyl
0.018% 2-Methyl
23.725% l,2-dibromo-2,4-dicyanobutane
Formulation Type
Liquid
131
-------
Cost Share, Data Compensation Forms, Confidential Statement of Formula Form and
Instructions
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 aT -1 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.
132
-------
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United States Environmental Protection Agency
Washington, D.C. 20460
Certification of Offer to Cost
Share in the Development of Data
Form Approved
OMB No. 2070-0106,
2070-0057
Approval Expires
3-31-99
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-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
Company Number
Product Name
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
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 firms 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 obselete
135
-------
136
-------
Form Approved OMB No. 2070-0060
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
W\ M Street, S.W.
WASHINGTON, D.C. 20460
Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 1.25 hours per response for registration
and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send
comments regarding burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE
Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460.
Do not send the completed form to this address.
Certification with Respect to Citation of Data
Applicant's/Registrant's Name, Address, and Telephone Number
Active Ingredient(s) and/or representative test compound(s)
General Use Pattern(s) (list all those claimed for this product using 40 CFR Part 158)
EPA Registration
Number/File Symbol
Date
Product Name
NOTE: If your product is a 100% repackaging of another purchased EPA-registered product labeled for all the same uses on your label, you do not need to
submit this form. You must submit the Formulator's Exemption Statement (EPA Form 8570-27).
I am responding to a Data-Call-in Notice, and have included with this form a list of companies sent offers of compensation (the Data Matrix form should
be used for this purpose).
SECTION I: METHOD OF DATA SUPPORT (Check one method only)
I am using the cite-all method of support, and have included with this form
a list of companies sent offers of compensation (the Data Matrix form
should be used for this purpose).
I am using the selective method of support (or cite-all option
under the selective method), and have included with this form a
completed list of data requirements (the Data Matrix form must be
used).
SECTION II: GENERAL OFFER TO PAY
[Required if using the cite-all method or when using the cite-all option under the selective method to satisfy one or more data requirements]
I hereby offer and agree to pay compensation, to other persons, with regard to the approval of this application, to the extent required by FIFRA.
SECTION III: CERTIFICATION
I certify that this application for registration, this form for reregistration, or this Data-Call-in response is supported by all data submitted or cited in the
application for registration, the form for reregistration, or the Data-Call-in response. In addition, if the cite-all option or cite-all option under the selective method is
indicated in Section I, this application is supported by all data in the Agency's files that (1) concern the properties or effects of this product or an identical or
substantially similar product, or one or more of the ingredients in this product; and (2) is a type of data that would be required to be submitted under the data
requirements in effect on the date of approval of this application if the application sought the initial registration of a product of identical or similar composition and
uses.
I certify that for each exclusive use study cited in support of this registration or reregistration, that I am the original data submitter or that I have obtained
the written permission of the original data submitter to cite that study.
I certify that for each study cited in support of this registration or reregistration that is not an exclusive use study, either: (a) I am the original data
submitter; (b) I have obtained the permission of the original data submitter to use the study in support of this application; (c) all periods of eligibility for
compensation have expired for the study; (d) the study is in the public literature; or (e) I have notified in writing the company that submitted the study and have
offered (I) to pay compensation to the extent required by sections 3(c)(1)(F) and/or 3(c)(2)(B) of FIFRA; and (ii) to commence negotiations to determine the
amount and terms of compensation, if any, to be paid for the use of the study.
I certify that in all instances where an offer of compensation is required, copies of all offers to pay compensation and evidence of their delivery in
accordance with sections 3(c)(1)(F) and/or 3(c)(2)(B) of FIFRA are available and will be submitted to the Agency upon request. Should I fail to produce such
evidence to the Agency upon request, I understand that the Agency may initiate action to deny, cancel or suspend the registration of my product in conformity with
FIFRA.
I certify that the statements I have made on this form and all attachments to it 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
Date
Typed or Printed Name and Title
EPA Form 8570-34 (9-97) Electronic and Paper versions available. Submit only Paper version.
137
-------
138
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
401 M Street, S.W.
WASHINGTON, D.C. 20460
Form Approved OMB No. 2070-0060
Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for
reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of
information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460. Do not
send the form to this address.
DATA MATRIX
Date
EPA Reg No./File Symbol
Page of
Applicant's/Registrant's Name & Address
Product
Ingredient
Guideline Reference Number
Note
Guideline Study Name
EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version.
Public File Cop\
139
-------
140
-------
Form Approved OMB No. 2070-0060
/X\ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
^^J 401 M Street, S.W.
WASHINGTON, D.C. 20460
Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for
reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of
information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC
20460. Do not send the form to this address.
DATA MATRIX
Date
Applicant's/Registrant's Name & Address
EPA Reg No./File Symbol
Page of
Product
Ingredient
Guideline Reference Number
Guideline Study Name
MRID Number
Signature
Submitter
Status
Name and Title
Note
Date
EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version.
Agency Internal Use Copy
141
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INSTRUCTIONS FOR DATA MATRIX
INSTRUCTIONS: Identify all data submitted or cited and all submitters from whom permission has been received or to whom offers to
pay have been sent by entering sufficient information in the attached matrix (photocopy and attach additional pages as necessary).
Complete all columns; omission of essential information will delay approval of the registration/reregistration. On each page enter the
date, Applicant's/Registrant's name, EPA Registration Number or application file symbol of the product, ingredient, page number, and
total number of pages.
The Data Compensation Form entitled "Certification with Respect to Citation of Data" and the Data Matrix will be publicly available, except
forthe Guideline Reference Number, Guideline Study Name, and MRID Number columns afterthe registration/reregistration of this product
has been granted or once this form is received in response to a Data-Call-in Notice. However, the information in the Guideline Reference
Number, Guideline Study Name, and MRID Number columns is available through the Freedom of Information Act in association with the
EPA Registration Number.
Ingredient: Identify the active ingredient(s) in this product for which data are cited. The active ingredient(s) are to be identified by
entering the chemical name and the CAS registry number. Begin a new page for each separate active ingredient for which data are cited.
If bridging data from a related chemical or representative test compound are cited, enter the identity of that chemical/representative test
compound including the EPA Registration Number/File Symbol if appropriate.
If the cite-all method is usedforall data supporting this particular ingredient, enter "CITE-ALL" in the Guideline Reference Number
column and leave the Guideline Study Name column blank. If the cite-all method is used for a particular Guideline Reference Number
enter "CITE-ALL" in the MRID Number column on the line for that Guideline Reference Number. In either case, enter all submitters to
whom offers to pay have been sent on subsequent lines. [Note: if the selective method of support is used and written authorization (letter
of permission) is provided, the individual Guideline Reference Number, Guideline Study Name, and MRID Number columns must still be
completed.] Otherwise:
Guideline Reference Number: Enter on separate lines in numerical order the Guideline Reference Numbers from 40 CFR Part 158 for
all studies cited to support the registration/reregistration for this ingredient.
Guideline Study Name: For each Guideline Reference Number cited, enter the corresponding Guideline Study Name.
MRID Number: For each individual study cited in support of a Guideline Reference Number and Guideline Study Name, enter the Master
Record Identification (MRID) Number listed in the Pesticide Document Management System (PDMS). Enter only one MRID Number on
each line. Note that more than one MRID Number may be required per Guideline Reference Number. Note: Occasionally a study
required to maintain a registration/reregistration is not associated with a Guideline Reference Number and Guideline Study Name. In such
case, enter the MRID Number(s) for the study(ies).
Submitter: Using the most recent Data Submitters List, identify the Original Data Submitter with their current address for each study
cited. The EPA assigned company number or other abbreviation may be used. Clearly explain any variations (alternate addresses, data
owners not on the Data Submitters List, etc.) in footnotes to this table.
Status: Enter one of the following codes for each study cited, as appropriate:
OWN: I am the Original Data Submitter for this study.
EXC: I have obtained written permission of the Original Data Submitter to cite this exclusive-use study in support of this
application.
PER: I have obtained the permission of the Original Data Submitter to use this study in support of this application.
OLD: The study was submitted more than 15 years ago and all periods of compensation have expired.
PL: The study is in the public literature.
PAY: I have notified in writing the Original Data Submitter or, if the cite-all method is used, all companies listed in the most
current Data Submitters List for this ingredient, and have offered (a) to pay compensation in accordance with FIFRA
sections 3(c)(1)(F) and/or 3(c)(2)(B), and (b) to commence negotiations to determine the amount and terms of
compensation, if any, to be paid forthe use of the study(ies).
GAP: This Guideline data requirement is a data gap as defined in 40 CFR sections 152.83(a) and 152.96.
FOR: I am taking the formulator's exemption for this ingredient only. Other columns of this line should be marked "NA".
However, if this product is to be registered/reregistered for additional uses for which the purchased EPA registered
ingredient is not supported, additional data must be submitted or cited here to support those uses.
Note: If additional explanation is needed, enter a footnote number in this column and attach the corresponding explanation.
142
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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
3-31-99
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, Regulatory Information Division, Mail Code 2137, 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 reregistration under the Federal Insecticide, Fungicide and Rodenticide 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 compensation for those data in accordance with sections
3(c)(l)(F) and 3(c)(2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation
requirement of FIFRA and the amount of compensation due, 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)(l)(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, with regard to the registration or
reregistration of my products, to the extent required by FIFRA section 3(c)(l)(F) and 3(c)(2)(D).
Signature
Date
Name and Title (Please Type or Print)
EPA Form 8570-31 (4-96)
143
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List of Available Related Documents
The following is a list of available documents for methylisothiazolinone that my further assist
you in responding to this Reregi strati on Eligibility Decision document. These documents may be
obtained by the following methods:
Electronic
File format: Portable Document Format (.PDF) requires Adobe® Acrobat or compatible reader.
Electronic copies can be downloaded from the Pesticide Special Review and
Reregistration Information System at 703-308-7224. They also are available on the
Internet using WWW (World Wide Web) on WWW.EPA.GOV., or contact Venus
Eagle at (703)-308-8045.
1. PR Notice 86-5.
2. PR Notice 91-2 (pertains to the Label Ingredient Statement).
3. A full copy of this RED document.
4. A copy of the fact sheet for methylisothiazolinone.
The following documents are part of the Administrative Record for methylisothiazolinone and
may included in the EPA's Office of Pesticide Programs Public Docket. Copies of these documents
are not available electronically, but may be obtained by contacting the person listed on the Chemical
Status Sheet.
1. Health and Environmental Effects Science Chapters.
2. Detailed Label Usage Information System (LUIS) Report.
The following Agency reference documents are not available electronically, but may be
obtained by contacting the person listed on the Chemical Status Sheet of this RED document.
1. The Label Review Manual.
2. EPA Acceptance Criteria.
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