United States -
        Environmental Protection
        Agency  <	
           Prevention, Pesticides
           And Toxic Substances
           (7508W)	
EPA738-R-98-
October 1998
&EPA
Reregistration
Eligibility Decision (RED)

Methylisothiazolinone

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                 United States-
                 Environmental Protection
                 Agency	___^
                       Prevention/ Pesticides
                       And Toxic Substances
                       (7508C)
EPA-738-F-98-008
October 1998
                  R . E . D.   FACTS
     Pesticide
Reregistration
   Use Profile
Methylisothiazolinone
     All pesticides sold or distributed in the United States must be registered
by EPA, based on scientific studies showing that they can be used without
posing unreasonable risks to people or the environment.  Because of advances
in scientific knowledge, the law requires that pesticides which were first
registered before November 1, 1984, be reregistered to ensure that they meet
today's more stringent standards.
     In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human health
and environmental effects of each pesticide. The Agency develops any
mitigation measures or regulatory controls needed to effectively reduce each
pesticide's risks.  EPA then reregisters pesticides that can be used without
posing unreasonable risks to human health or the environment.
     When a pesticide is eligible for reregistration, EPA explains the basis
for its decision in a Reregistration Eligibility Decision (RED) document.  This
fact sheet summarizes the information in the RED document for reregistration
case 3092, methylisothiazolinone. The Reregistration Eligibility Decision
covers the two active ingredients 5-chloro-2-methyl-3(2H)-isothiazolone and
2-methyl-3(2H)-is.othiazoloiie. These two active ingredients occur together in
the currently registered products ^approximately a 3:1 ratio, respectively, and
are commonly referred to as methylisothiazolinone.

     .Methylisothiazolinone is used to control slime-forming bacteria, fungi,
and algae in pulp/paper mills, cooling water systems, oil field operations,
industrial process waters, and air washer systems and is incorporated into
adhesives, coatings, fuels, metal working fluids, resin emulsions, paints, and
yarious other speciality industrial products as a preservative. It is also used to .
control the growth of mold, mildew, and sapstain on wood products.
Formulations include soluble concentrated liquids and soluble concentrated
solids. Products containing methylisothiazolinone are added to systems and
industrial products using manual pouring and metered pumping methods, dip
tanks and sprayers. Use practice limitations include National Pollutant
Discharge Elimination System (NPDES) license restrictions.

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    Regulatory        Methylisothiazolinone was first registered in the U.S. in 1977 as an
         History  antimicrobial with various uses. There are currently 85 products registered
                    including one technical product.
                          In 1987 the Agency issued the Antimicrobial Data Call-In Notice to
                    registrants with pesticides containing methylisothiazolinone to obtain additional
                    chronic and subchronic toxicity data. A Phase 4 Data Call-In was issued on
                    November 3,1992, requiring additional toxicity and environmental fate data.

Human Health   Toxicity
  Assessment        In studies using laboratory  animals, methylisothiazolinone has been
                    shown to be of moderate acute toxicity  by the oral and inhalation routes. It is
                    highly acutely toxic when applied dermally or to the eye and is considered to be
                    corrosive.
                          In subchronic studies, the most significant toxicological effect was
                    microscopic lesions in the nasal turbinates from inhalation exposure.
                    Developmental and chronic feeding/carcinogenicity studies in rats resulted in
                    no significant effects and the Agency classified methylisothiazolinone as a
                    Group D chemical, not classifiable as to human carcinogenicity. Results from
                    mutagenicity studies were equivocal.
                    Dietary Exposure
                          Tolerances or residue limits are established for methylisothiazolinone in
                    adhesives, paper, and paper products which may contact food.  These uses are
                    regulated by the U.S. Food and Drug Administration (FDA). There are no
                    other registered food uses of methylisothiazolinone.
                    Occupational and Residential Exposure
                          Based on current use patterns, handlers may be exposed to
                    methylisothiazolhione during and after normal use of the liquid and solid
                    soluble concentrate formulations.  Persons in residential settings may be
                    exposed to products containing methylisothiazolinone. Therefore,, an exposure
                    assessment was conducted based on the toxicological endpoint of the
                    respiratory effect from the subchronic inhalation study.
                          The open-pouring application of methylisothiazolinone is considered the
                    worst-case inhalation exposure scenario for applicators.  The worst-case
                    scenario for persons exposed to methylisothiazolinone-treated products is the
                    paint application use.
                          Although exposures to workers in areas where products containing
                    methylisothiazolinone have recently been applied are expected, EPA believes
                    that these post-application exposures would be significantly less than those for
                    handlers applying the pesticide.

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                          There are no methy lisothiazolinone products labeled for homeowner use.
                    Exposures to homeowners may occur from products, such as adhesives, paints
                    or paper products, treated with methy lisothiazolinone. Again, the Agency
                    believes that these exposures would be minimal.
                    Human Risk Assessment
                          Methylisothiazolinone is moderately to highly acutely toxic in oral,
                    dermal, eye irritation, dermal irritation, and inhalation acute toxicity studies.
                          The use of methy lisothiazolinone in the manufacture of paper,
                    paperboard, and adhesives which may contact food is regulated by FDA.
                    There are no other registered food uses.
                          The Agency concluded that the risks of short-term and intermediate-term
                    occupational exposure to pesticide handlers are acceptable.  Margins of
                    Exposure (MOEs) for all uses were above 100.  An MOE of less than 100 is of
                    concern to the Agency.  Short-term risks of corrosivity can be adequately
                    managed through the use of personal protective equipment (PPE) and
                    monitoring, as "necessary. The Agency further believes risks from secondary
                    occupational exposures, residential exposures, and post-application exposures
                    are comparatively less and also acceptable. However, protective measures are
                    being imposed including additional product specific PPE (when appropriate),
                    and baseline PPE.
Environmental
   Assessment
, Environmental Fate
      Of the two chemicals (5 -chloro-2-methyl-3(2H)-isothiazolone and 2r
 methyl-3(2H)-isothiazolone) that compose methylisothiazolinone, only 5 -
 chloro-2-methyl-3(2H)-isothiazolone was susceptible to hydrolysis and only at
 alkaline pH. 5-Chlor6-2-methyl-3(2H)-isothiazolone was very mobile in most
 soils. The degradation profile observed in an aqueous availability study is
 similar to that observed in the hydrolysis studies.
 Ecological Effects
      Methylisothiazolinone is moderately to practically non-toxic to birds, and
 moderately to highly toxic to freshwater and estuarine/marine organisms.
 Ecological Effects Risk Assessment
      While the hazard to aquatic organisms from methylisothiazolinone has
 beeri 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 Agency currently requires
 that labels for all methylisothiazolinone products require that discharges to
 aquatic environments comply with an NPDES permit

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     Risk Mitigation
      To lessen the potential human health risks posed by
methylisothiazolinone, EPA is requiring the following risk mitigation measures.
      (1)   The Agency is establishing active-ingredient based minimum PPE
           for primary occupational handlers.  Since all the MOEs generated
           are based on units of exposure from the Pesticide Handlers
           Exposure Database in which handlers wore chemical resistant
           gloves, long-sleeve shirts, long pants, and shoes plus socks, these
           PPE are required for occupational handlers of
           methylisothiazolinone products.
      (2)   The acute dermal, inhalation and ocular toxicity of the end-use
           products will be used to determine appropriate protection from the
           corrosivity of methylisothiazolinone.
    Additional Data        EPA has required additional generic information describing the
            Required  hydrolysis of 5-chloro-2-methyl-3(2H)-isothiazolone at pH 9 to confirm its
                         regulatory assessments and conclusions.
                               The Agency also is requiring methylisothiazolinone product-specific data
                         including product chemistry and acute toxicity studies, revised Confidential
                         Statements of Formula (CSFs), and revised labeling for registration.

  Product Labeling        All methylisothiazolinone end-use products must comply with EPA's
Changes Required  current pesticide product labeling requirements and with the following. Fora
                         comprehensive list of labeling requirements, please see the
                         methylisothiazolinone RED document.
                               Personal Protective (PPE) Requirements
                                    (1) EPA is establishing the following minimum, baseline PPE:
                                       Mixers, loaders, and others exposed to methylisothiazolinone
                                       products must wear:                      •
                                              — Long-sleeve shirt and long pants,
                                              — Chemical resistant gloves,
                                              — Shoes plus socks.
                                    (2) If the end-use product is classified as Toxicity Category I or II
                               for eye irritation potential, add to the above PPE:
                                              —Protective eyewear
                                    (3) If the end-use product is classified as Toxicity Category I or II
                                       for acute dermal toxicity or skin irritation potential, add:
                                              --Chemical-resistant apron

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      (4) If the end-use product is classified as Toxicity Category I or II
         for acute inhalation toxicity, add:
                -Respirator (the type must be specified; EPA will assist
                registrants in determining appropriate respirators during
                product reregistration).
Labeling Clarifications                           .
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 uses of products containing methylisothiazolinone in water
      treatment systems must  clearly specify recirculating water
      treatment systems.  The term "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 me 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."

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                            For use in both terrestrial and offshore oil drilling muds and packer
                            fluids, the following statement must be added:
                               "This product may be used for terrestrial and off-shore oil
                               drilling muds and packer fluids."
 Regulatory
Conclusion
Other Labeling Requirements
           The Agency is requiring the following labeling statements to be
    •  located on all end-use products containing methylisothiazolinone that are
      intended primarily for occupational use.
      (1)   Application Restrictions
           "Do not apply this product in a way that will contact
           workers or other persons."
      (2)   User Safety Requirements
           "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 there  are no such instructions for
           washables, use detergent and hot water. Keep and wash PPE
           separately from other laundry."
      (3)   User Safety Recommendations
           •   "Users should wash hands before eating, drinking, chewing
               gum, using tobacco, or using the toilet."
           •   "Users should remove clothing immediately if pesticide gets
               inside.  Then 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."
      (4)   Skin Sensitizer Statement
           "This product may cause skin sensitization reactions in
           some people."

      The use  of currently registered products containing
methylisothiazolinone in accordance with approved labeling and as described in
the Reregistration Eligibility Decision Document will not pose unreasonable
risks or adverse effects to humans or the environment.  Therefore, all uses of
these products are eligible for reregistration.

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   For More
Information
      Methylisothiazolinone products will be reregistered once the required
product-specific data, generic data, revised Confidential Statements of
Formula, and revised labeling are received and accepted by EPA.

      EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for methylisothiazolinone during a 60-day time
period, as announced in a Notice of Availability published in the Federal
Register. To obtain a copy of the RED document or to submit written
comments, please contact me Pesticide Docket, Public Response and Program
Resources Branch, Field Operations Division (7506C), Office of Pesticide
Programs (OPP), US EPA, Washington, DC 20460, telephone 703-305-58Q5.
      Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregistration Information System at
703-308-7224. They also are available on the Internet using ftp on
FTP.EPA.GOV, or using WWW (World Wide Web) on WWW.EPA.GOV.
      Printed copies of the RED and.fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH  45242-0419, telephone 513-
489-8190, fax 513-489-8695.
      Following the comment period, the methylisothiazolinone RED
document also will be available from the National Technical Information
Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161, telephone
703-487-4650.
      For more information about EPA's pesticide reregistration program, the
methylisothiazolinone RED, or reregistration of individual products containing
methylisothiazolinone, please contact the Special.Review and Reregistration
Division (7508C), OPP, US EPA, Washington, DC 20460, telephone 703-308-
8000.
.   ,  For information about the health effects of pesticides, or for assistance in
recognizing and managing pesticide poisoning symptoms, please contact the
National Pesticides Telecommunications Network (NPTN). Call toll-free 1-
800-858-7378, between 9:30 am and 7:30 pm Eastern Standard Time, Monday
through Friday.                              .

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                    UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                                       WASHINGTON, D.C. 20460
                                                                              OFFICE OF
                                                                        PREVENTION, PESTICIDES
                                                                         AND TOXIC SUBSTANCES
 CERTIFIED MAIL
NOV  12 1998 ,
 Dear Registrant:

        I am pleased to announce that the Environmental Protection Agency has completed its
 reregistratiqn 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
 me 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, Deanha Scher at (703) 308-7043.
                                                      Sincerely yours.
 Enclosures
                                                        Sis Rossi,,
                                                       Special
                                                      and Reregistration Division

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               SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
              THE REREGISTRATION ELIGIBILITY DECISION (RED)

1. DATA CALL-IN (DClVOR "90-DAY RESPONSE"-If generic data are required for
reregistration, a DCI letter will be enclosed describing such data. If product specific data are
required, 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 reregistration) separately. You may, but are not
required to, delete uses  which the RED says are ineligible for reregistration. For further labeling
guidance, refer to the labeling section of the EPA publication "General Information on Applying
for Registration in the U.S.,  Second Edition, August 1992" (available from the National
Technical Information Service, publication #PB92-221811; telephone number 703-487-4650).

       c. Generic or Product Specific Data. Submit all data in a format which complies with
PR Notice  86-5, and/or submit citations of data already submitted and give the EPA identifier
(MRID) numbers.  Before citing these studies,  you must make sure that they meet the
Agency's acceptance criteria (attached to the  DCI).
                          1  , -     .  ; .,  .     '•  •.''.'    j
       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 f8-MONTH RESPONSES^

Bv 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 tune extension requests within 60 days. EPA will also try to respond to all 8-month
submissions with a final reregistration determination within 14 months after the RED has been
issued.

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REREGISTRATION ELIGIBILITY DECISION


             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.  v   Toxicology Assessment  . >...........'	'. 8
                  a.    Acute Toxicity	,	 9
                  b.    Subchrohic 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	 r..	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     ,
KarenAngulo

Health Effects Assessment

Kathleen Martin
Linda Taylor
Winston Dang

Registration Support

Marion Johnson
Valdis Goncarovs
Shyam B. Mathur

Risk Management

Kathy Davis
Bill Wooge
DeannaScher

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 Reregistration Branch
Accelerated Reregistration Branch
Reregistration Branch I
Pesticides Branch
                                      Rick Colbert

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11

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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 (DWEL) The DWEL represents a medium specific (i.e. drinking
                water) lifetime exposure at which adverse, non carcinogenic health effects are not anticipated to occur.
 EEC           Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
                such as a terrestrial ecosystem.                         .
 EP   ,         End-Use Product'                                                   • .     ,   "
 EPA           U.S. Environmental Protection Agency  ;
 FDA           Food and Drug Administration
 FIFRA         Federal Insecticide, Fungicide, and Rodenticide Act
 FFDCA         Federal Pood, 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.
               ; 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.    • .  ..           .
 LD,0           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     '                x                     ,                    -
 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
 NOEL          No Observed Effect Level
 NOAEL         No Observed Adverse Effect Level
LD-
   50
                                                 111

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            GLOSSARY OF TERMS AND ABBREVIATIONS
                                                     ".'">'•
OP            Qrganophosphate
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 reregistration 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
reregistration.  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-rhethyl-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
reregistration 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 reregistration of products with active ingredients registered prior to November 1,1984.
The amended Act provides a schedule for the reregistration process to be completed in nine years.
There are five phases to the reregistration process. The first four phases of the process focus on
identification of data requirements to support the reregistration of an active ingredient and the
generation and submission of data to fulfill the requirements. The fifth phase is a review by the U.S.
Environmental Protection Agency (referred to as "the Agency") of all data submitted to support
reregistration.                                               ;

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

       This document presents the Agency's decision regarding the reregistration eligibility of the
registered uses of 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
                                            1

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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:   Microbiocide/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*
                                  2

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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)**

                    INDOORFOOD

                            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
                       v    Specialty Industrial Products
* 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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                                  (e.g., cleaning fluids, hydraulic fluids, polishes, air fresheners,
                                  carpet shampoos, detergents, waxes, photo plate processing
                                  chemicals, conveyor lubricants)
                                  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.
** See Section V for revisions to clarify this use site.

                                           4

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              Aquatic Non-Food Industrial
              0.11 to 36 ppm active ingredient.

              Aquatic Non-Food Outdoor
              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 1.1 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
         1     0.088 to 12 ppm active ingredient.

       Timing -     During manufacture, Continuous feed (initial), Continuous
                    feed  .(subsequent),   Initial,   Subsequent/maintenance,
                    Intermittent (slug)(initial), Intermittent (slug)(subsequent),
                    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).

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       C.    Data Requirements
               11"            I          ;             '             |i'              ;'  ,
             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  reregistration 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).
                      v
             Two Data Call-ins have been issued: The Antimicrobial Data Call-In of March 4,
       1987 and a Reregistration Phase 4 Data Call-In dated November 3,1992 requiring additional
       toxicity and environmental fate data.
HI.    SCIENCE ASSESSMENT

       A.    Physical Chemistry Assessment

             For methylisothiazplinone (5-chloro-2-methyl-3(2H)-isothiazolone and 2-methyl-
             3C2HVisothiazolone at 3:1 ratio):
             Color:

             Physical State:

             Odor:

             Boiling Point:

             Bulk Density:

             PH:
golden yellow at 25 °C

clear liquid at 25 °C

pungent aromatic

101.1 ± 0.2°C at standard room pressure

1.296g/mlat25°C

1.90 at 23.8 °C
                                           6

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 Vapor Pressure:

       For5-chloro-2-methyl-3r2HVisothiazolone  - 1.8x1Q-2tnrr

       For 2-methyl-3(2H)-isothiazolone          - 6.2x1 O^torr.

 Solubility:

       For 5-chloro-2-methyl-3(2HVisothiazolone
       Solvent
       Water
       Ethyl Acetate
       Methanol
       Toluene .
       Hexane
Solubility g/lOOml Solvent
       Infinite
       a 4.31
       ^ 4:40
       £4.07  .
       sO.28
       For 2-methyl-3(2HVisothiazoIone
       Solvent
       Water
       Ethyl Acetate
       Methanol
       Toluene
       Hexane
Solubility g/lOOml Solvent
       Infinite
       ^0.19
       > 1.52
       ^0.08
       > 0.03
Dissociation Constant:       Does not dissociate into ions

Octanol/Water Partition Coefficient:

       For5-chloro-2-methvM(;2ffi-isothiazolone

             KQW = 0.401 at 24°C in log P or 2.519

       For 2-methvl-3r2HVisothiazoione

             ,KoW = 0.486 at 24°C in log P or 0.326
                             7

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       Stability:          -                   .

             For 5-chloro-2-methvl-3 C2H Visothiazolone
             Conditions    Duration
             54°C

             Metal
             (Mild steel)
             Metal ion
             (FeCIS)
             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-methvl-3f2HVisothiazolone
              Conditions    Duration
              54°C

              Metal
              (Mild steel)
              Metal ion
              (FeCIS)
              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
       reregistration 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-
       methy 1-3 (2H)-isothiazolone hi an equilibrium ratio of approximately 3:1.
                                    8

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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 LDso-rat
Dermal LD50--rabbit.
.
Inhalation LC50— rat
• • • '
- ' . • . • ' •
Eye irritation—rabbit1
Dermal irritation— rabbit1
Dermal sensitization— guinea pig'
Results
105mg/kg
200 mg/kg
0.33 mg/L
,: '; • "" ;.' , : -
,
corrosive
severely irritating
sensitizer
, Category
II
I
II >
I
I
~
MRID#
86091
86092 :
41963501 !
42360901 I
42360902 '
, 86092 j
86092 :
144880 i
  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 doselevels 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 toxicologically 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. toxicologically 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 pg/L   The LOEL is  1.15  vg/l, based  on
microscopic lesions in the nasal turbinates (rhinitis).  With the exception of
decreased body-weight gain, there were no toxicologically 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 #14841 8).                                       ,

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 DMgCl2 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  arid 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
                       12

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 of any fetal alteration (external, visceral or skeletal malformations, variations,
. or 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 hi the Ames assay in
 TA100  at concentrations as  low 95  0,0005 jj.l/plate without metabolic
 activation.  TA100 with activation and all other strains with and without
 metabolic activation were negative (GDLN 84-2(a); MRID #78827, 96692).

        In a second Ames assay using methylisothiazolinone manufactured
 by a different process than hi the previous study, methylisothiazolinone was
 positive, in TA100 without metabolic activation at concentrations as low as
 0.0005  (j.l/plate. TA100 with activation and all other strains with and without
 metabolic activation were negative (GDLN 84-2; MRID #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 ng ai/ml oral; 258
 ug 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;
 MRID #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 methylisothiazoiinone, 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
                             methylisothiazoiinone as a Group D carcinogen.  The Committee
                            . concluded   that  the   effects  observed  in   the  studies  on
                             methylisothiazoiinone  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 methylisothiazoiinone,  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 Methylisothiazoiinone
i Type of Exposure
  : Endpoint and Dose
j Acute Dietary
  • Because there, is no anticipated dietary exposure, this endpoint is
  ! not required for this active ingredient.
 Dermal Absorption
  ! Not available, because methylisothiazoiinone is corrosive and a
  ', human skin sensitizer.
 Short term Occupational
 or Residential Exposure
 (one to seven days)
 Intermediate Term Occupational
I or Residential Exposure
| (one week to several months)
  Dermal Exposure. The primary concern is acute exposure as this
  | chemical is corrosive.  There is no systemic lexicological endpoint
  for risk characterization.
  j Inhalation Exposure. The toxicological endpoint is the NOEL of
  10.34 fj.g/1 based on microscopic lesions in nasal turbinates observed
  i in the 90-day rat inhalation study (MRID 00148418).
 Chronic (noncancer)
  • 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 methylisothiazolinorie 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.

              Iii 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.
                      16

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Table 3 -Inhalation Exposure Estimates and Risks to Workers for Methylisothiazolinone Application
Scenarios
                         < Calculation of Pounds A.I. Used Per Day i    Calculations of Worker Exposure and MOE
\ Application Site/Product
t

-
Oil Well Injection Fluid
/Liquid
Cooling Tower
/Liquid
Paint Manufacturing ^
/Liquid
Metal Fluid,
/Liquid
Pulp and Papermill
/Liquid '
Drilling Mud
/Solid

Product Used i Volume
Per Vol. Treated Per
Treated' , Day2
•
Ibai' [ UE
used/day3 | (u.g/lbai)4
Primary Exposure Scenarios (Open-Pouring Applic
1010.51bs : 1000 barrels
42,000 gal I (42,000 gal)
15.1
SS \ 20'000gal i 2M
^ iflSIX,
(119gal) <83"»>s)
SS l *»*
0.02
•
0.04
LflbS ! 100 tons 1 2.25
ton :
• ' i •/
m!Ii.lbSi ' 1000 barrels
1000 barrels |
1.2
•.
1.22 I 1.7
:
A J. Inhaled5
(fig/day)
ations)
18.12
2.69
. 0.025 .
0.049
i - : •• "i
' ADE MOE7 ;
• (mg/kg/ . 1 v • . i • t
1 Product Used Per Vol. Treated = The use rate of methylisothiazolinone. The concentration of the product, for all settings is 1.5% a.j.
(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 (jig/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
= 70kg.                                             -                    '                      •
7 MOE = 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.
                                    i          -          ,          .,            *                      .
                                            The   Agency   considers   exposures   while   handling
                                     methylisothiazolinone-containing paint  to  represent a reasonable

                                                     17                        '     .'.''•'

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 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 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 metal working 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.

                18 .

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              The   -Agency   believes   that   the   concentration   in   a
              methylisothiazolinorie-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.

       b.     Dietary Exposure

              Administrative guidelines are established for methylisothiazolinpne
       uses (in adhesives and as slimicides) in food contact through food packaging.
       These uses of methylisothiazolhione 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
                                                                   s
              (1)    Application Exposure  Scenarios
                                   -        '                ' -           i
                        l   '   ,          • •
                    Intermediate-Term Risks

                    Based on the Agency's  assessment of the available tbxicity
           .   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.
                             19

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       Acute Risks

       However,  even though the MQEs  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:

       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.
                20

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                           The Agency has'also considered the potential formaldehyde
                    exposure from products containing memylisothiazolinone (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-
                    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).    .

                                 -   21       ."•-'.-         '   '

-------
                                   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)

                            (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 IMetary Toxicity Findings
Species
Mallard1
'II;II:^;:;%;A.L:.
1 14.17%
	 1 — —
LCjo ppm *
717
MRID No.
41719503
Toxicity Category i
i • 	 1
moderately toxic i
Bobwhite Quail1
                           14.17%
2200
t	—„.—           ,   	-   |    __—           41719502       practically non-toxic      j
 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
                                                    i            i
                            (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 . f %A.I. •
Rainbow trout 14.17% j
Rainbow trout1 14.17% i
, 	 : .... , • I
lAoppm j
0.19 |
0.07 |
MRID Toxicity Category
41718802 Highly toxic
41963503 Highly toxic
                                                                    ! Highly toxic
 Study is considered to be supplemental because the results were based on a 14-day exposure period.

                                           22

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                                  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.   (MRIDs  #41718802  and  #41718801,
                           respectively)

                           (2)    Freshwater Fish, Chronic Toxicity

                                  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.
                                          i                   •        •       .
                                  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
i % AX |
j 1.5%r i
1 i
| 14.17% |
	 ! 	 : 	
LCSO ppm | MRID #
0.20
; 0.18
42358701
41718803
j Toxicity Category ',
! highly toxic j
.1 "i
! highly toxic I
 '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.
                                           23

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                                  In a freshwater invertebrate chronic toxicity study conducted
                           using Daphnia, 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

                                  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 copepod Acartia tonsa'
Pink Shrimp
Fiddler Crab Uca pugilator'
Eastern Oyster Embryo-larvae
% A.I.
13.9%
unspecified purity
13.9%
.13.9%
13.9%
LC50/ECso(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. (MRID #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.
                                          24

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       5-Chloro-2-methyl-3(2H)-isothiazolbne 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-Chiofo-2-methyl-3(2H)-isothiazolone was found to be readily
degradable in a sandy loam soil (pH 4.9) under aerobic conditions (haif-
life=5 hours). Because of the low adsorption coefficient (K^O. 1-4.9; or
Koc=30-310),  the chemical is expected to be very mobile in soil.   No
information is 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 l.SxlO"2 torr  and  the  vapor pressure for
methyl-3(2H)-isothiazolone is 6.2x1 Q-4 torr.

       Because of the low octanol/water partition coefficients (Kow=0.4 for
5-chloro-2-methyl-3(2H)-isothiazolone and 1^=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 metiiylisothiazolinone. 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-]Viethyl-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.
                       25

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       The 5-chloro-2-methyl-3(2H)-isothiazplone 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 at 0 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,
       formaldehyde.  During the study, material balances ranged
       from 100.2-107.7%. (MRID #42681301)

       (b)     Methyl-3(2H)-IsothiazoIone

              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][rnethyl-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 240-26°C for 64 days, and 75%
       of field moisture capacity.   The  parent  was  the  only
               26

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       compound extracted, from the soil, and averaged 107.4% of
       the applied radioactivity immediately posttreatment, 8.1.0% 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
       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/Leachabffity

       (a)    Leaching-Adsorption/Desorption

             The submitted study on the adsorption and desorption
       of  5-chloro-2-methyl-3(2H)-isothiazolone  in  soil  is
       acceptable.

             m 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 K^ values of 0.1-1.5, and in sandy loam sediment
       with a Freundlich Kads value of 4.9. K^ 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 rriethyl 3(2H)-isothiazolone from pressure-
       treated wood was evaluated. This study is acceptable. No
       additional data are required.       ;

             The folio whig summarizes the results of the study. :
       The   active    ingredients,    5-chloro-2-methyl-3(2H)-
               27

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                     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.

                            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-rnethyl-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.

                             28

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                     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;          ''.;.-.
              (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
                     leachability 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 reregistration. The Agency has previously identified and required
       the submission of the generic (i.e. active ingredient specific) data required to support
       reregistration of products containing methylisothiazplinone active ingredients. The Agency
       has completed its review of these generic data, and has determined that the data are sufficient
       to support reregistration of all products containing methylisothiazolinone.  Appendix B
       identifies the generic data requirements that the Agency reviewed as part of its determination
       of reregistration 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
       reregistration of particular products is addressed hi Section V of this document.
                                           29

-------
       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 conies to the
Agency's attention or if the data requirements for registration (or the guidelines for
generating such data) change.

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 tb humans or the environment.
       Therefore, the Agency concludes that products containing methylisothiazolinone for
       all uses are eligible for reregistration.

       2.      Eligible and Ineligible Uses

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

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

                                    30

-------
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 reregistration, the Agency considers handler safety requirements for
occupational and  residential  uses.   The Agency establishes handler safety
requirements 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 methylisothiazolhione.

                    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.

                             31

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                     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
                            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
                           tune.

                    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 reregistration
Of both manufacturing-use and end-use products.

                                          32

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A.   ,  Additional Data Requirements

       Generic Data Requirements:  The generic data base supporting the reregistration
       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
      , 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.                                    J

B.     Labeling Requirements
             -                     .                            '
       The following chart summarizes the label changes that must be made on all
       manufacturing and end-use products.
                                    33

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"This chemical is toxic to terrestrial and aquatic plants, fish and aquatic invertebrates.
containing this product into lakes, streams, ponds estuaries, oceans or other waters unl
requirements of a National Pollutant Discharge Elimination System (NPDES) permit a
been notified in writing prior to discharge. Do not discharge effluent containing this p
without previously notifying the local sewage treatment plant authority. For guidance
or Regional Office of the EPA."


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C.     Labeling Clarifications

              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."     .   "
                                     36

-------
             For use in both terrestrial and offshore oil drilling muds and packer fluids, the
       following statement must be added:
             "This product may be used for terrestrial and off-sho're 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 Reregistration Eligibility Decision (RED).
Persons other than the registrant may generally distribute or sell such products for 50 months
from the date of the issuance of this RED. However, existing stocks time frames will be
established case-by-case, depending on the number of products involved, the number of label
changes, and other factors. Refer to "Existing Stocks of Pesticide Products; Statement of
Policy"; Federal Register. Volume 56, No, 123, June 26,1991.

       The  Agency  has  determined  .that  registrants   may  distribute  and  sell
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

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PRO Report Date:
Case 3092 [Methylisothiazolin
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                                GUIDE TO APPENDIX B                ,
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case methylisothiazolinone covered by this Reregistration 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

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                 APPENDIXB

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
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
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
41741401
41741401
41741401
41741401
41741401
41741401
41741401
41741401
41741401
41741401
41741401
41741401
41741401,.
41741401
41741401
ECOLOGICAL EFFECTS
71-1A
71-2A
71-2B.
72-1A
72-1C
72-2A
72-3A

Acute Avian Oral - Quail/Duck
Avian Dietary - Quail
Avian Dietary - Duck
Fish Toxicity Bluegill
Fish Toxicity Rainbow trout
Invertebrate Toxicity
Estuarine/Marine Toxicity - Fish
88
C,E,F
C,E,F
C,E,F
C,E,F
C,E,F
C,E,F
C,E,F

41719501
41719502
41719503
41718801
41718802,41963503
41718803,42358701
00042556
. - • ' - .

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    Data Supporting Guideline Requirements for the Reregistration of
                            Methylisothiazolinone               	
 REQUIREMENT    "  ''
USE PATTERN
                       CITATIONfS)
 72-3B      Estuarine/Marine Toxicity -
            Mollusk
 72-3 C      Estuarine/Marine Toxicity -
            Shrimp
 72-4A      Early Life Stage Fish
 72-4B      Life Cycle Invertebrate
 TOXICOLOGY                 ,
 81-1        Acute Oral Toxicity - Rat
 81-2        Acute Dermal Toxicity -
            Rabbit/Rat
 81 -3        Acute Inhalation Toxicity - Rat

 81-4        Primary Eye Irritation - Rabbit
 81-5        Primary Dermal Irritation -
            Rabbit
         '               •      '    i
 81-6        Dermal Sensitization - Guinea
            Pig   .
 82-1A      90-Day Feeding - Rodent
 82-4        90-Day Inhalation - Rat
 83-1A      Chronic Feeding Toxicity -
            Rodent
 83-3A      Developmental Toxicity - Rat
 83-3B       Developmental Toxicity - Rabbit
 83-5        Combined Chronic Toxicity /
            Carcinogenicity
84-2A      Gene Mutation (Ames Test)
   C,E,F      00042558
     /  ,           •         •  -
   C,E,F      00042559,00042557

   C,E?F      42012201
   C,E,F      41963502

    All       00086091
    All       00086092

    All       41963501,42360901,
              42360902
    All       00086092
    All       00086092

    All       00144880
All
All
All
All
All
All
42810101
00148418
43140701
00078831
42311701
43140701
    All       00078827,00096692,
      •'• ..    00096693,00105044
                                      89

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   Data Supporting Guideline Requirements for the Reregistration of
  	              Methylisothiazolinone
                                                              CITATION(S)
REQUIREMENT
                                        USE PATTERN
84-2B    "  Structural Chromosomal
           Aberration
84-4    •  Other Genotoxic Effects
ENVIRONMENTAL FATE
160-5      Chemical Identity
161-1      Hydrolysis
162-1      Aerobic Soil Metabolism
163-1      Leaching/Adsorption/Desorption
168-1-SS    Aqueous Availability
                                            All       42538001

                                            All       00130751,41875502

                                            All       41741401
                                            All       42578401,42681301
                                             C        42086901
                                                      i • •    .     ,
                                           ,C,E,F      42086902
                                            C,E       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 Reregistration Eligibility Document.  Primary sources for studies in this bibliography
       have been the body of data submitted to EPA and its predecessor agencies in support of past
       regulatory decisions.  Selections from other sources including the published literature, in
       those instances where they have been considered, are included.

2.     UNITS OF ENTRY. The unit of entry in this bibliography is called a "study".  In the case
       of published materials, this corresponds closely to an article. In the case of unpublished
       materials submitted to the Agency, the Agency has sought to identify documents at a level
       parallel to the published article from within the typically larger volumes in which they were
       submitted. The resulting "studies" generally have a distinct title (or at least a single subject),
       can stand alone for purposes of review and can be described with a conventional
       bibliographic citation.   The Agency has also  attempted to unite basic documents and
       commentaries upon tihem, treating them as a single study.

3f     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

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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.

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

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 MRID
                    BIBLIOGRAPHY

                    CITATION
 00042556
 00042557
00042558
00042559
00078827
00078831
00086091
00086092
 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)                    ,   '
              r-                                       (
 Heitmuller, T. (1980) Acute Toxicity of Kathon WT to Fiddler Crabs, Ucapugilator:
 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)

 Hollister, T.A. (1980) Acute Toxicity of Kathone WT to EmbryoXarvae 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)

 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)

 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)

 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)

 Rohm and Haas  Company (1977)  Toxicity Data: Kathon 886 All-magnesium
 Formulation: Report No. 77-38. (Unpublished study received on unknown date
under 707-129; CDL:233075-B)

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: LBI Project No. 20989; Report No.
             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 NAR Process;
             Microbial Mutagen Test: Report No. 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
             ill.GuineaPigs: Report No. 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 hi Rats; Report No. 82R-245.   Unpublished  study prepared by
             Rohm and Haas Co. 267 p.

4^718801     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.
                                        94

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                                BIBLIOGRAPHY
 MRID
                                CITATION
 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.

             Derbyshire, R. (1990) Product Chemistry (of) Kathon 886F Microbiocide: Lab
             Project Number: 1770.02.  Unpublished study prepared by Rohm and Haas Co
             518 p.                                        '   '                 .

             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.

             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.

             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.

             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 Project 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 mykiss--14 Day Prolonged Test: Lab Project
             Number: 9006-RH: 89RC-0348.   Unpublished study prepared by Resource
             Analysts, Inc.  306 p.                      . '    .
41741401
41719501
41719502
41719503
41875502
                                        95

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                               BIBLIOGRAPHY
MRH)
                   CITATION
42086902
42311701
42358701
42360901
42360902
42538001
42578401
42681301
42810101
Wang, W. (1991) Adsorption and Desorption of carbon 14 |-RH-651 in Four Soils
and One Sediment: Lab Project Number: XBL 90024: RPTt)046: RH TECH.
34-91-09. Unpublished study prepared by XenoBiotics Labs, Inc.  86 p.

Thomas, T.; Solomon, EL; 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.

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 hi
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.

Marx, M.; Castle, S.; Shepler, K. (1992) Hydrolysis of (carbon 14)-RH-573 atpH
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.

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.

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
fept.  (Unpublished study received Aug 23, 1983 under 707-130; submitted by
Rohm & Haas Co., Philadelphia, PA; CDL:251098-A)
                                        96

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                               BIBLIOGRAPHY
MRID
CITATION
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.

43140701    Quinn, D.; O'Hara, G.; Brown, W. (1994) Kathon Biocide: 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.
                                       97

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98

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     . PRQ1
       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.
       2.
How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 6; or                              -

Why you believe you are exempt from the requirements listed in this Notice and in
Attachments, Requirements Status and Registrant's Response Form, (see section
             Why you believe EPA should not require your submission of product specific data
             in the manner specified by this Notice (see section III-D).
                                          99

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       If you do not respond to this Notice, or if you do not satisfy EPA that you will comply with
its requirements or should be exempt or excused from doing so, then the registration of your
product(s) subject to this Notice will be subject to suspension. We have provided a list of all of
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).
    •  •     • •  !'!'    "         "•""",,   •  . •    • ' '  -  '        '   j
       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 VI-   Inquiries And Responses To This Notice

The Attachments to this Notice are:

       1 -   Data Call-In Chemical Status Sheet
       2 -   Product-Specific Data Call-in Response Form
       3 -   Requirements Status and Registrant's Response Form
       4 -   EPA  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 I. WHY YOU ARE RECEIVING THIS NOTICE

       The Agency has reviewed existing data for this active ingredient and reevaluated the data
needed to support continued registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product specific data. No additional generic
data requirements are being imposed. You have been sent this Notice because you have product(s)
containing the subject active ingredient.
                           •  •: :  •   '   :"' ,.,'..     '••'.' .,••'•• T
SECTION II. DATA REQUIRED BY THIS NOTICE

II-A.  DATA REQUIRED
                                          100

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

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

 II-C. TESTING PROTOCOL                   ,

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

       These EPA Guidelines are available from the National Technical Information Service
 (NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).

       Protocols approved by the Organization for Economic Cooperation and Development
 (OECD) are also acceptable if the OECD-recommended test standards conform to those specified
 in the Pesticide Data Requirements regulation (40 CFR §  158.70),  When using the OECD
 protocols, they should be modified as appropriate so that the data generated by the study will
 satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend deadlines for
 complying with data requirements when the studies were not conducted in accordance with
 acceptable standards. The OECD protocols are available from OECD, 2001 L Street, N.W.,
 Washington., D-C. 20036 (Telephone number 202-785-6323; pax 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 3rcV2¥B^ NOTICES
     ISSUED BY THE AGENCY

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

 SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE

 III-A. SCHEDULE FOR RESPONDING TO THE AGENCY

       The appropriate responses initially required by this Notice for product specific data must
 be submitted to the Agency within 90 days after your receipt of this Notice.  Failure to adequately
                                          101

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respond to this Notice within 90 days of your receipt will be a basis for issuing a Notice of Intent
to Suspend (NOIS) affecting your products. This and other bases for issuance of NOIS due to
failure to comply with this Notice are presented in Section IV-A and IV-B.

III-B.  OPTIONS FOR RESPONDING TO THE AGENCY

       The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice or
(c) request a data waiver(s).

       A discussion of how to respond if you chose the Voluntary Cancellation option is presented
below. A discussion of the various options available for satisfying the product specific data
requirements of this Notice is contained in Section III-C.  A discussion of options relating to
requests for data waivers is contained in Section III-D.

       There are two forms that accompany this Notice of which, depending upon your response,
one or both must be used in your response to the Agency. These forms are the Data-Call-in
Response Form, and the Requirements Status and Registrant's Response Form. Attachment 2 and
Attachment 3. The Data Call-In  Response Form must be submitted as part of every response to this
Notice. In addition, one copy 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 me 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
                                           102

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 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
 as well as any other information/data pertaining to the option chosen to address the data
 requirement.                           x

 III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE                 ,
  '         •             s                                       •
,  ,     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 he 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 (4Q 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).
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       If you cannot submit the data/reports to the Agency in the time required by this Notice and
intend to seek additional time to meet the requirements(s), you must submit a request to the
Agency which includes: (1) a detailed description of the expected difficulty and (2) a proposed
schedule including alternative dates for meeting such requirements on a step-by-step basis. You
must explain any technical or laboratory difficulties and provide documentation from the
laboratory performing the testing.  While EPA is considering your request, the original deadline
remains. The Agency will respond to your request in writing.  If EPA does not grant your request,
the original deadline remains. Normally, extensions can be requested only in cases of
extraordinary testing problems beyond the expectation or control of the registrant.  Extensions will
not be given in submitting the 90-day responses. Extensions will not be considered if the request
for extension is not made in a timely fashion; in no event shall an extension request be considered
if it is submitted at or after the lapse of the subject deadline.

       Option 2. Agreement to Share in Cost to Develop Data  — Registrants may only choose this
option for acute toxicity data and certain efficacy data and only if EPA has indicated in the
attached data tables that your product and at least one other product are similar for purposes of
depending on the same data. If this is the case, data may be generated for just pne
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 agreement to be bound by binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii) and
 must not qualify this offer.  The other registrant must also inform EPA of its election of an option
 to develop and submit the data required by this Notice by submitting a Data Call-In Response
-Form and a Requirements Status and Registrant's Response Form committing to develop and
 submit the data required by this Notice.

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

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

       You should be aware that if the Agency determines that the study is not acceptable, the
 Agency will require you to comply with this Notice, normally without an extension of the required
 date of submission. The Agency may determine at any time that a study is not valid and needs to
 be repeated.

       To meet the requirements of the DCI Notice for submitting an existing study,  all of the
 following three criteria must be clearly met:

       a.     You must certify at the time that the existing'study  is submitted that the raw data
              and specimens from the study are available for audit and review and you must
              identify where they are available. This must be done in accordance  with the
              requirements of the Good Laboratory Practice (GLP) regulation, 40  CFR Part 160.
              As stated in 40 CFR 160.3(j) " 'raw data' means any laboratory worksheets, records,
              memoranda, notes, or exact copies thereof, that are the result of original
              observations and activities of a study and are necessary for the reconstruction and
              evaluation of the report of that study. In the event that exact transcripts of raw data
              have been prepared (e.g., tapes which have been transcribed verbatim, dated, and
              verified accurate by signature), the exact copy or exact transcript may  be substituted
              for the original source as raw data. 'Raw data' may include photographs, microfilm
              or microfiche copies, computer printouts, magnetic media, including dictated  ,
              observations, and recorded data from automated instruments." The term
              "specimens", according to 40 CFR 160.3(k), means "any material derived from a  >
              test system for examination or analysis."
                                           105

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

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

       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.
                                           106

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        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.
                                         1 '                   "           -              •
        Option 6. Citing Existing Studies -- If you choose to cite a study that has been previously
 submitted to EPA, that study must have been previously classified by EPA as acceptable or it must
 be a study which has not yet been reviewed by the Agency. Acceptable toxicology studies
 generally will have been classified as "core-guideline" or "core minimum." For all other
 disciplines the classification would be "acceptable." With respect to any studies for which you
 wish to select this option you must provide the MRID number of the study you are citing and, if
 the study has been reviewed by the Agency, you must provide the Agency's classification of the
 study.

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

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

 III-D REQUESTS FOR DATA WAIVERS

              If you request a waiver for product specific data because you believe it is
 inappropriate, you must attach a complete justification for the request, including technical 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.
                                           107

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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.
       2.
       3.
       4.
       5.
       7.

       8.
Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.

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

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

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

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

Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section III-C of this Notice.

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

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
                                           108

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       9.
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.

Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
 IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
 UNACCEPTABLE

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

       1. EPA requirements specified.™ 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
                                           109

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 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.
!,"             |l j,',!1' '         ' ' ' '• '"     '", 'II, '"•„,' i  '',„  ' ,    , ' .    ,'' ,    i
               "ill I      '       , '       ' ! '•',""     I,   ' , «  '  ,' ,' '   I ,
        If you request a voluntary cancellation of your product(s) as a response to this Notice and
 your product is in full compliance with all Agency requirements, you will have, under most
 circumstances, one year from the date your 90 day response to this Notice is due, to sell, distribute,
 or use existing stocks. Normally, the Agency will allow persons other than the registrant such as
 independent distributors, retailers and end users to sell, distribute or use such existing stocks until
 the stocks are exhausted.  Any sale, distribution or use of stocks of voluntarily cancelled products
 containing an active ingredient for which the Agency has particular risk concerns will be
 determined on case-by-case basis.

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

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

        Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
 pesticide is registered a registrant has additional factual information regarding unreasonable
 adverse effects on the environment J>y 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 pn 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.
                                            110

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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 he 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,
                                          SisA. Ro/si,pirecto?
                                        'Special Review and
                                         Reregistration Divisifc
Attachments

       1  -
      .2  -
       3  -
       4  -

       5  -
       6  -
Data Call-In Chemical Status Sheet
Product-Specific Data Call-in Response Form
Requirements Status and Registrant's Response Form
EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
List of Registrants Receiving This Notice
Cost Share and Data Compensation Forms and the Confidential Statement of
Formula Form
                                         111

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112

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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 rnntaing an ™,^,Hy rf data
 required by this notice, and point of contact for inquiries pertaining to the reregistration 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 Respnn.^ 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
 folly complete the reregistration of all eligible methylisothiazolinone products.

INQUIRIES AND RESPONSES TO THIS NQTTCF.

      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 Reregistration Branch
             Special Review and Reregistration Branch 7508C
             Office of Pesticide Programs
             U.S. Environmental Protection Agency
             Washington, D.C. 20460

             RE: Methylisothiazolinone
                                        113

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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.
                                          114

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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 transmittat document  for any data
             submissions hi 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.
             >fpte that series,61 and 62 in product chemistry are now listed under 40 CFR 158.155
             through 158.180, Subpart C.

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

Item 6.       The use 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 hi 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
                                         116

-------
5.
  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).

  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 HI-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).

 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).

 By the specified due date, I will submit or cite data to upgrade a study  classified by
 the Agency as partially acceptable and upgradable (Upgrading a Study). I will
 submit evidence of the Agency's review indicating that the study may be upgraded
 and what information is required to do so.  I will provide the MRID or Accession
number of the study at the due date.  I understand that the conditions for this option
outlined Option 5 in the Data  Call-In Notice (Section III-C.L) apply.  By the
specified due date, I will also submit: (1) a completed "Certification  With Respect
                                  117

-------
            To Data Compensation Requirements" form (EPA Form 8570-29) and (2) two
            completed and signed copies of the Confidential Statement of Formula (EPA
            Form 8570-4).

      6.    By the specified due date, I will cite an existing study that the Agency has classified
            as acceptable or an existing study that has been submitted but not reviewed by the
            Agency (Citing an Existing Study).  If I am citing another registrant's study, I
            understand that this option is available only for acute toxicity or certain efficacy data
            and only if the cited study was conducted on my product, an identical product or a
            product which EPA has "grouped" with one or more other products for purposes of
            depending on the same data.  I may also choose this option if I am citing my own
            data.  In either case, I will provide the MRID or Accession number(s) for the cited
            data on a "Product Specific  Data Report" form or in a similar format.  By the
            specified due date, I will also submit: (1) a completed "Certification With Respect
            to Data Compensation Requirements" form (EPA Form 8570-29) and (2) two
            completed and signed copies of the  Confidential Statement of Formula (EPA
            Form 8570-4).

      7.    I request a waiver for this study because it is inappropriate for my product (Waiver
            Request). I am attaching a complete justification for this request, including technical
            reasons, data and references to relevant EPA regulations, guidelines or policies.
             [ISfote: 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
             f>y 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.
                                         118

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  EPA'S  BATCHING   OF  METHYLISOTHIAZOLINONE  (5-Chloro-2-methyI-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  ,and  2-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, wetfable 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

                                           123

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Existing Study (Option 6). If a registrant depends on another's data, he/she must choose among: Cost
Sharing (Option 2); Offers to Cost Share (Option 3); or, Citing an Existing Study (Option 6). If a
registrant does not want to participate hi 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 methylisothiazolmone (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 hi 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 methylisothiazolmone as the, active ingredient produce irreversible destruction of
ocular tissue or cornea! 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 folio whig 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.

n.  The registrants with products hi 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.
                                           124

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 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.

 -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 bv 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).                                   ;
                                           125

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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).
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
1 , I , , , , ' " • ' , i ; ' ^ , ' , , , „ , , ' ' t
Batch
2
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
% 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
Formulation Type
Liquid
Liquid
Liquid
Liquid,
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
                                           126

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Batch
3
EPA Reg. No.
707-220
1706-170
6836-257
45017-42
45017-44
% Active Ingredient
2.69% 5-Chloro-2-methyl
0,81% 2-Methyl
3. 1 1% 5-Chloro-2-methyl
0.94% 2-Methyl
,3:69%5-Chloro-2-metiiyl
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
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
% Active Ingredient
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
1.1 1% 5-Chloro-2-methyl
0.39% 2-Methyl
1.11% 5rChloro-2-methyl
0.39% 2-Methyl
1.11% 5-Chloro-2-methyl
0.39% 2-Methyl
1.1 1% 5-Chloro-2-methyl
.0.39% 2-Methyl
1 . 1 5% 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
Formulation Type
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
127

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Batch

4
EPA Reg. No.
1757-67
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
% 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
1.15% 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
1.1 1% 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
1.11% 5-Chloro-2-methyl
0.39% 2-Methyl
1 . 1 5% 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 . 1 5% 5-Chloro-2-methyl
0.35% 2-Methyl
1 . 1 5% 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
1.1% 5-Chloro-2-methyl
0.4% 2-Methyl
1.1% 5-Chloro-2-methyl
0.4% 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

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Batch

4
EPA Reg. No.
67071-10
67071-11
67071-12
67071-13
67071-14
68329-17
68708-1
% Active. Ingredient
1.11% 5rChloro-2-methyl
0.44% 2-Methyl'
1.1 1% 5-Chloro-2-methyl ,
0.44% 2-Methyl
1.1 1% 5-Chloro-2-methyl
0.44% 2-Methyl '
1 . 1 1 % 5-Chloro-2-methyl
0.44% 2-Methyl
1.11% 5-Chloro-2-methy 1
, 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
Liquid
Batch ,
4a
EPA Reg. No.
707-166
707-218
6836-241
% Active Ingredient
1.11% 5-Chloro-2-methyl
0.39% 2-Methyl
1.11% 5-Chloro-2-methyl
0.39% 2-Methyl
1 . 1 8% 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-MethyI
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.
707T198
% Active Ingredient
1 J 1 1 % 5-Chloro-2-methyl
0.39% 2-Methyl .
Formulation Type
Liquid
129

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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-Pfopynyl Butyl Carbamate
0.06% 5-Chloro-2-methyl
0.02% 2-Methyl
31.94% 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-l,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-l,3-diol
0.28% 5-Chloro-2-methyl
0.10% 2-Methyl
8.80%2-Bromo-2-nitropropane-l,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

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Batch
EPA Reg. No.
                                          % Active Ingredient
                                                                 Formulation Type
  12
               1448-397
              1448-398
                           1.04% 5-Chloro-2-methyl
                             - 0.37%2-Methyl
                    12.0% Polyfoxyethylene (dimethyliminio)
                  ethylene(dimethyliminio)ethylene]dichloride
                           0.52% 5-Chloro-2-methyl
                               0.18%2-Methyl
                    6.0% Polyfoxyethylene (dimethyliminio)
                  ethylene(dimethyliminio)ethylene] dichloride
                                                                                 , 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% 1 ,2-dibromo-2,4-dicyanobutane
Formulation Type
Liquid
                                            131

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 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
              niust be provided.

       d.     All applicable information which is on the product specific data submission must
              also be reported on the CSF.
                                                              I
       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.
n,' '•     i       n'?!'     ',    . .   :  ,   'i  .',,:•    •   ,. ' •  . ' ' '  ,    /•, •   |
       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:


I Certify that:
Company Number ,
\
EPA Reg. No.

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 develooina
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):
NameofFirm(s)
                                                                                Date of Offer
Certification:

 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.

Name and Title (Please

Date

 i Form 8570-32 .(5/91) Replaces EPA form 8580 which is obselete
                                               135

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136

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                                                                                                             Form Approved OMB No. 2070-0060
                                        UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                                                 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 1.25 hours per response for
 registration and 0.25 hours per response for reregistration arid special review activities, including time for reading the instructions and completinq 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 Ingredients) and/or representative test compound(s)
General Use Pattern(s) (list all those claimed for this product using 40 CFR Part 1 58)
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).       '
        Dl 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).
D
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]

   J   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
       .. ' 9®^that tnis aPP|lcat'°n 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
 dentical 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.                                                                    t
                                                                                                 -                 ^

 ^ •   ., .i06^trtat for.eacn exclusive use study cited in support of this registration or reregistration, that I am the original data submitter .or that I have
obtained the wntten 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; (D) 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
 lave offered (I) to pay compensation to the extent required by sections 3(c)(1)(F) and/or 3(c)(2)(B) of FIFRA; and (if) to commence negotiations to determin.
 he 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 sucW
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'       I
conformity with FIFRA.                                 '                                                                                    II

         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
   Form 8570-34 (9-97) Electronic and Paper versions available. Submit only Paper version.

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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 begn sent by entering sufficient information in the attached matrix (photocopy and attach additional pages as necessary). Complete
Alt 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
for the Guideline Reference Number, Guideline Study Name, and MRID Number columns after the 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 ingredients) in this product for which data are cited.  The active ingredients) 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 methocJ is used for all data supporting this particular ingredient, enter "CITE-ALL" in the Guideline Reference Number I
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 I
Record Identification (MRID) Number listed in the Pesticide Document Management System (PDMS).  Enter only one MRID Number on I
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,
e,nter the MRID Numbers) for the study(ies).

Submitfen Using the mosl 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
riot 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.

                I have  obtained the permission of the Original Data  Submitter to use this study in support of this application.

                The study was submitted more than 1 5 years ago and all periods of compensation have expired.

                The study is in the public literature.

                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 for the use of the study(ies).
           '    ;•  "     if*:- ••    ,:< ••  •  ' ' -. ......  "; ', ''" ',-,;;» •;!':.  .,'.-.• . , .'} ;..'"- i . ..: .•}.•''.,.   }     •>  '              •        .'''",'
                This Guideline data requirement is a data gap as defined in 40 CFR sections 152.83(a) and 152.96.

                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.

                If additional explanation is heeded, enter a footnote number in this column and  attach the corresponding explanation.
PER:

OLD:

PL:

PAY:
GAP:

FOR:
                                                         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)
A 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 Reregistration Eligibility Decision document. These documents may be
 obtained by the following methods:
;«rf.	   J   . ,	       V, . . . 	         .,,...      ,....,'.
                               i                  'I             "*                      ' '
 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.     PRNotice86-5.

       2.     PR Notice 91-2 (pertauis 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.
                                          144

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