United States       Prevention, Pesticides    EPA 738-R-94-032
        Environmental Protection   And Toxic Substances    September 1994
        Agency	(7508W)	
&EPA Reregistration
        Eligibility Decision (RED)

        Chloroxylenol

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         \        UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

         ^                           WASHINGTON, D.C. 20460


                                                                           OFFICE OF
                                                                     PREVENTION, PESTICIDES
                                                                      AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:

       I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case chloroxylenol
which includes the active ingredients chloroxylenol. The enclosed Reregistration Eligibility
Decision (RED) contains the Agency's evaluation of the data base of these chemicals, its
conclusions of the potential human health and environmental risks of the current product uses,
and its decisions and conditions under which these uses and products will be eligible for
reregistration. The RED includes the data and labeling requirements for products for
reregistration.

       To assist you with a proper response, read the enclosed document entitled "Summary
of Instructions for Responding to the RED". This summary also refers to other enclosed
documents which include further instructions.  You must follow all instructions and submit
complete and timely responses. The first set of required responses are  due 90 days from
the date of this letter.  The second set of required responses are due 8 months from the
date of this letter.  Complete and timely responses will avoid the Agency taking the
enforcement action of suspension against your products.

       If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and  Reregistration Division representative
Yvonne Brown  at (703) 308-8073.

                                                     Sincerely yours,
                                                     Peter Caulkins, Acting Director
                                                      Special Review
                                                      and Reregistration Division
Enclosures

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

1.  DATA CALL-IN (PCI) OR "90-DAY RESPONSE"  If generic data are required for
reregistration, a DCI letter will be enclosed describing such data.  If product specific data
are required, another DCI letter will be enclosed listing such requirements.  If both generic
and product specific data are required, a combined Generic and Product Specific letter will
be enclosed describing such data.  Complete the two response forms provided with each DCI
letter (or four forms for the combined) by following the instructions provided. You must
submit the response forms for each product and for each DCI within 90 days of the date
of this letter (RED issuance date); otherwise, your product may be suspended.

2.  TIME  EXTENSIONS AND DATA WAIVER REQUESTS No time extension requests
will be granted for the 90-day response.  Time extension requests may be submitted only with
respect to actual data submissions. Requests for data waivers must be submitted as part of the
90-day response. Requests  for time extensions should be submitted in the 90-day response,
but certainly no  later than the  8-month response  date.  All data waiver and time extension
requests must be accompanied by a full justification. All waivers and time extensions must be
granted by EPA in order to  go into effect.

3.  APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"  You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).

      a.  Application for Reregistration (EPA Form 8570-1).  Use only an original
application form. Mark it "Application for Reregistration."  Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.

      b.  Five copies of draft labeling which complies with the RED and current regulations
and requirements.  Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately. You may delete uses
which the RED says are ineligible for reregistration. For further labeling guidance,  refer to
the labeling section of the EPA publication " General Information on Applying for Registration
in  the U.S., Second Edition, August 1992" (available from the National Technical Information
Service, publication #PB92-221811;  telephone number 703-487-4650).

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

      d.  Two copies of the  Confidential Statement of Formula (CSF) for each basic and
each alternate formulation.  The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active  ingredient as the nominal
concentration.  You have two options for submitting a CSF:  (1) accept the standard certified

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limits (see 40 CFR 158.175) or (2) provide certified limits that are supported by the analysis
of five batches. If you choose the second option, you must submit or cite the data for the five
batches along with a certification statement as described in 40 CFR 158.175(e). A copy of
the CSF is enclosed; follow the instructions on its back.

      e. Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.

4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE  Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.

5. WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)

By U.S. Mail:

      Document Processing Desk (RED-SRRD-PRB)
      Office of Pesticide Programs (7504C)
      EPA, 401 M St. S.W.
      Washington, D.C.  20460-0001

By express:

   Document Processing Desk (RED-SRRD-PRB)
      Office of Pesticide Programs (7504C)
      Room 266A, Crystal Mall 2
      1921 Jefferson Davis Hwy.
      Arlington, VA 22202

6. EPA'S REVIEWSEPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days.  EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.

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REREGISTRATION ELIGIBILITY DECISION

            CHLOROXYLENOL

                  LISTC

                CASE 3045
          ENVIRONMENTAL PROTECTION AGENCY
            OFFICE OF PESTICIDE PROGRAMS
        SPECIAL REVIEW AND REREGISTRATION DIVISION

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                         TABLE OF CONTENTS
      CHLOROXYLENOL REREGISTRATION ELIGIBILITY DECISION TEAM  .  i


      EXECUTIVE SUMMARY 	  vi

I.     INTRODUCTION	1

II.    CASE OVERVIEW	2
      A.    Chemical Overview 	2
      B.    Use Profile 	2
      C.    Data Requirements	4
      D.    Regulatory History	4

III.   SCIENCE ASSESSMENT	5
      A.    Physical Chemistry Assessment	5
      B.    Human Health Assessment	6
           1.    Toxicology Assessment	6
                 a.    Acute Toxicity  	7
                 b.    Subchronic Toxicity	8
                 c.    Developmental Toxicity  	8
                 d.    Mutagenicity   	8
                 e.    Metabolism  	8
           2.    Exposure Assessment	9
                 a.    Dietary  	9
                 b.    Occupational and Residential  	9
           3.    Risk Assessment	9
                 a.    Dietary  	9
                 IV.   Occupational and Residential  	10
      A.    Environmental Assessment	10
           1.    Environmental Fate   	10
                 a.    Environmental Chemistry, Fate and Transport  	10
                 b.    Environmental Fate Assessment	10
           2.    Ecological Effects	10
                 a.    Ecological Effects Data	10
                 b.    Ecological Effects Risk Assessment	11

V.    RISK MANAGEMENT AND REREGISTRATION DECISION	12
      A.    Determination of Eligibility	12
      B.    Risk Management Decision   	13
           1.    Eligibility Decision  	13

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            2.     Eligible and Ineligible Uses   	13
      C.    Regulatory Position  	13
            1.     Labeling Rationale  	13

VI.   ACTIONS REQUIRED BY REGISTRANTS 	15
      A.    Manufacturing-Use Products	15
            1.     Additional Generic Data Requirements	15
            2.     Labeling Requirements for Manufacturing-Use Products	15
      B.    End-Use Products  	16
            1.     Additional Product-Specific Data Requirements	16
            2.     Labeling Requirements for End-Use Products	16
      C.    Existing Stocks  	17

VII.   APPENDICES  	19
      APPENDIX A. Table of Use Patterns Subject to Reregistration  	21
      APPENDIX B.  Table of the Generic Data Requirements and Studies Used to Make
            the Reregistration Decision   	29
      APPENDIX C.  Citations Considered to be Part of the Data Base Supporting the
            Reregistration of Chloroxylenol  	37
      APPENDIX D. List of Available Related Documents  	45
      APPENDIX E	49
            PR Notice 86-5	51
            PR Notice 91-2	69
      APPENDIX F. Product Specific Data Call-in	75
            Attachment 1. Chemical Status Sheet 	87
            Attachment  2.  Product Specific Data Call-in Response Forms (Form  A
                  inserts) Plus Instructions  	89
            Attachment  3.  Product Specific Requirement Status  and  Registrant's
                  Response Forms (Form B inserts) and Instructions	95
            Attachment  4.  EPA Batching of End-Use Products  for Meeting Data
                  Requirements for Reregistration	99
            Attachment 5. EPA Acceptance Criteria  	  105
            Attachment 6. List of All Registrants Sent This Data Call-in (insert) Notice
                    	  119
            Attachment 7. Cost Share Data Compensation Forms, Confidential Statement
                  of Formula Form and Instructions	  121
      APPENDIX G. FACT SHEET	  131

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CHLOROXYLENOL REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:

Biological and Economic Analysis Division

Cynthia Szymanski
Steven Nako

Environmental Fate and Effects Division

Jim Breithaupt
Ann Stavola
Betsy Grimm
Akiva Abramovitch
Andrew Bryceland

Health Effects Division

Winston Dang
Pat McLaughlin
Linda Kutney

Registration Division

Shyam Mathur
Barbara Pringle
Walter Francis
Mark Perry

Special Review and Reregistration Division

Yvonne  Brown
Virginia Dietrich

Office of General Counsel:

Kevin Lee

Office of Compliance:

Phyllis Flaherty
Biological Analysis Branch
Economic Analysis Branch
Environmental Fate and Groundwater Branch
Ecological Effects Branch
Science Analysis and Coordination Staff
Environmental Fate and Groundwater Branch
Ecological Effects Branch
Occupational and Residential Exposure Branch
Toxicology Branch II
Chemical Coordination Branch
Registration Support Branch
Antimicrobial Program Branch
Antimicrobial Program Branch
Registration Support Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
Pesticides Branch
 Agriculture Branch

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11

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          GLOSSARY OF TERMS AND ABBREVIATIONS


AE          Acid equivalent

a.i.          Active Ingredient

ARC         Anticipated Residue Contribution

CAS         Chemical Abstracts Service

CSF         Confidential Statement of Formula

DRES        Dietary Risk Evaluation System

DWEL       Drinking Water Equivalent Level  (DWEL)  The DWEL represents a medium
             specific (i.e. drinking water) lifetime exposure at which adverse, non carcinogenic
             health effects are not anticipated to  occur.

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

EP          End-Use Product

EPA         U.S. Environmental Protection Agency

FDA         Food and Drug Administration

FIFRA       Federal Insecticide, Fungicide, and Rodenticide Act

FFDCA      Federal Food, Drug, and Cosmetic Act

GLC         Gas Liquid Chromatography

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
                                        in

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          GLOSSARY OF TERMS AND ABBREVIATIONS
LD
   50
LDlo

LEL

LOG

LOEL

MCLG
mg/L

MP

MPI

MOE

MRID


N/A

NPDES

NOEL

OPP

PADI
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.

Lethal Dose-low. Lowest Dose at which lethality occurs

Lowest Effect Level

Level of Concern

Lowest Observed Effect Level

Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency
to regulate contaminants in drinking water under the Safe Drinking Water Act.

Micrograms Per Gram

Milligrams Per Liter

Manufacturing-Use Product

Maximum Permissible Intake

Margin Of Exposure

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

Not Applicable

National Pollutant Discharge Elimination System

No Observed Effect Level

Office of Pesticide Programs

Provisional Acceptable Daily Intake
                                       IV

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          GLOSSARY OF TERMS AND ABBREVIATIONS

PAM        Pesticide Analytical Method

PPE        Personal Protective Equipment

ppb         Parts Per Billion

ppm        Parts Per Million

PRN        Pesticide Registration Notice

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

RED        Reregistration Eligibility Decision

REI         Restricted Entry Interval

RfD        Reference Dose

RS         Registration Standard

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

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

TEP        Typical End-Use Product

TGAI       Technical Grade Active Ingredient

TMRC      Theoretical Maximum Residue Contribution

TLC        Thin Layer Chromatography

WPS        Worker Protection Standard

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EXECUTIVE SUMMARY

       The U.S. EPA has determined that the uses of chloroxylenol as currently registered will
not cause  unreasonable risk to humans  or the environment and  these uses are eligible for
reregistration.  Chloroxylenol is used as an antimicrobial for control  of bacteria, algae and fungi
in adhesives, emulsions,  paints and wash tanks.  It is also used to sanitize industrial and hospital
premises and pet living  quarters.

       Before reregistering the products containing chloroxylenol, 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. These data include product
chemistry for each registration and acute toxicity testing.  After reviewing these data and any
revised labels and finding them acceptable in accordance with Section 3(c)(5) of FIFRA, the
Agency will reregister a product. Those products which contain other active ingredients will be
eligible for reregistration only when the other active ingredients are determined to be eligible for
reregistration.
                                            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 chloroxlenol.   The document consists of six sections. Section I is  the
introduction. Section II describes chloroxylenol,  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 chloroxylenol. Section
V discusses the reregistration requirements for chloroxylenol.  Finally, Section VI contains  the
Appendices which support this Reregistration Eligibility Decision. Additional details concerning
the Agency's review of applicable data are available  on request.

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II.    CASE OVERVIEW
      A.     Chemical Overview
             The following active ingredient is  covered  by this Reregistration Eligibility
             Document:

             Common Name:    Chloro-m-xylenol or Chloroxylenol
             Chemical Name:    4-chloro-3,5-xylenol or p-chloro-m-xylenol
             CAS Registry
             Number:
      3-04-0
             OPP Chemical
             Code:
     086801
             Empirical
             Formula:
     CHQC10
             Basic
             Manufacturer:
      B.     Use Profile
     Nipa Laboratories Incorporated,
     Wilmington, Delaware.
             The following is information on the current registered uses with an overview of use
      sites and application methods.  A detailed table of these uses of chloroxylenol  is  in
      Appendix A.
Case:
Chemical Code:

Type of Pesticide:

Mechanism of Action:
3045

086801

Antimicrobial

denatures proteins, inactivates enzymes

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Use Sites:
              OUTDOOR  Pet living/sleeping quarters
           RESIDENTIAL

                INDOOR   Industrial adhesives, commercial/institutional/industrial premises/
              NONFOOD  equipment, resin/latex/polymer emulsions, latex (in-can) paints
                            and photographic wash tanks

                 INDOOR  Hospitals/medical institutions premises
               MEDICAL
                 INDOOR
                   FOOD
Industrial adhesives
                 INDOOR  Bathroom  premises/hard  surfaces,  diaper  pails   (empty),
           RESIDENTIAL  household/ domestic dwellings contents and  premises, human
                            bedding/  mattresses,  human  footwear,  pet  living/sleeping
                            quarters, refuse/ solid waste containers (garbage cans)
Target Pests:
Formulation Types
Registered:
Method and Rates of
Application:
Slime-forming   bacteria,   algae,   and   fungi;   Salmonella
choleraesuis;  Staphylococcus aureus; Pseudomonas aeruginosa;
Streptococcus   pyogenes;   pathogenic  fungi  (Trichophyton
mentagrophytes);  Viruses: Vaccinia,  Herpes  simplex Type 2,
Influenza A2 (Hong Kong); mold/mildew

Single Active Ingredient Products
       Soluble concentrate/liquid3%
       Technical formulation100%
       Formulation intermediate /solid98%

Multiple Active Ingredient (AI) Product
       Pressurized liquid-0.047 to  0.1% + 3 other AI

Soluble concentrate/liquid
       Directly treat equipment by squirt bottle (30,000 ppm),
       then dilute with water to 0.02 fl oz Al/gal (159 ppm).

Pressurized liquid
       Spray  5 to 6 seconds by aerosol can until thoroughly wet
       and allow 10 min contact time.

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                             Formulation intermediate/solid
                                    "During   manufacture   of  adhesives,   paints,  etc.,
                                    incorporate into product as a preservative at 0.05 to 0.5%
                                    AI of weight of product."

Use Practice Limitations:    Do not discharge effluent containing this chemical into lakes,
                             streams, ponds,  estuaries,  oceans,  or  public waters  unless
                             specifically identified and addressed in an NPDES permit.  Do
                             not discharge this chemical to  sewer systems without previously
                             notifying the sewage treatment plant authority.

       C.     Data Requirements

              Data requirements  for  reregistration apply to all  currently  registered uses.
       Appendix B includes all data  requirements  identified by  the Agency  for currently
       registered uses, including technical chemistry, toxicology,  and environmental fate and
       ecological effects.

       D.     Regulatory History

          Chloroxylenol was first registered in the United States in 1959, for use as
       a fungicide.   Products  used as disinfectants and sanitizers have  subsequently  been
       registered.  Currently, there are two manufacturing-use products  and five  end-use
       products registered for use in household and  domestic dwellings,  laundry equipment,
       bathroom premises, diaper pails, hospitals and related institutional areas and equipment,
       and human footwear.  Chloroxylenol may also be used in industrial processing water and
       aqueous systems such as adhesives/binders, latex paints, polymer  emulsions, coatings
       and photographic wash tanks.

              Chloroxylenol has FDA clearance for use as a preservative in food packaging
       adhesives under 21 CFR Section 175.105 (c)  (5).

              The antimicrobial Data Call-in Notice of March 1987 was issued by Registration
       Division  for  the  manufacturing-use product  for  Chloroxylenol  for  chronic and
       subchronic toxicity data on human exposure.

              Technical  Chemistry  data were called  in  by  the Special  Review and
       Reregistration Division under the Dioxin/Furan Data Call-In in 1988.

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III.   SCIENCE ASSESSMENT
      A.     Physical Chemistry Assessment

             The physical chemical properties for the technical grade active  ingredient
      chloroxylenol are described below.
      Color:
      Physical State:
White to Buff
Crystalline powder
      Chemical Structure:
                                           OH
                                     OH,
                                            a
      Odor:

      Molecular Weight:

      Melting Point:

      Boiling Point:

      Density:

      Vapor Pressure:

      Dissociation constant:

      pH:

      Stability:
      Corrosion
      characteristics:
Slight phenolic odor

156.65

112-116C

246C

0.89 g/ml at 20C

0.1 mmHgat20C

1.7xl010

6.45 at 20C (after dispersion in distilled water)

Chloroxylenol is stable when exposed to sunlight and humidity
from ambient storage over 24 hrs. It is also stable at elevated
temperatures (54C  2C).

At ambient temperature, a 25% solution of chloroxylenol in
isopropanol is not corrosive to stainless  steel or aluminum.
Brass is  slightly affected as is mild steel, but the latter is

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Solubility:
slightly affected by the isopropanol alone.

Solubilities of chloroxylenol in g/100 ml of different solvents
Name of the solvent
Water
Petroleum ether
Benzene
Acetone
Toluene
IMS
Chloroform
Isopropanol
IMNaOH
Glycerine
15C
0.03
0.5
6.0
58.0
7.0
55.0
6.2
38.0


25C





86.6

50.0
8.8
1.5
100C
0.5









Dioxins:

       Because of the chemistry of this compound, the Agency was concerned with the
potential formation of dioxins and  chlorinated dioxin impurities during the manufacture
of this chemical and the effect on human health and the environment.  The  registrant
submitted appropriate data to address this issue.  After reviewing these data the Agency
has concluded that the reaction conditions during manufacturing are not appropriate for
the creation of dioxin or chlorinated dioxins/dibenzofurans. Additionally, no chlorinated
dioxins were  found  at the stated limit of detection of 1 ppb. Therefore no additional
information or data are required for choroxylenol (MRID#s 40937401, 40725501).

       B.     Human Health Assessment

              1.     Toxicology Assessment
                    The toxicological data base  on chloroxylenol is  adequate and
              supports reregistration eligibility.

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                     a.     Acute Toxicity

ACUTE TOXICITY OF CHLOROXYLENOL
TEST
Acute Oral - rat
Acute Dermal - rat
Acute Inhalation - rat
Eye Irritation - rabbit
Skin Irritation - rabbit
Skin Sensitization - guinea
Pig
Skin Sensitization - human
RESULT
LDsn = 3. 83 g/kg
LDsn > 2.0 g/kg
LC50 >6.29 mg/L
corneal opacity, severe irritation
slight irritation
no Sensitization
no Sensitization
CATEGORY1
III
III
IV
I
IV

--
 1 Toxicity Category I: high acute toxicity
  Toxicity Category III: moderate acute toxicity
  Toxicity Category IV: low acute toxicity
                           Chloroxylenol has  moderate  to  low  oral, dermal,  and
                     inhalation acute toxicity.  In an acute oral toxicity study with rats
                     the LD50 was determined to be 3.83  g/kg (toxicity category III)
                     (MRID 40223120; guideline 81-1).  In another acute oral toxicity
                     study with rats, the LD50 was greater than 5 g/kg (MRID 00147438;
                     guideline 81-1). An acute dermal  toxicity study in rats resulted in
                     an LD50 greater  than 2.0 g/kg  (toxicity  category III) (MRID
                     00137439; guideline 81-2).  An acute inhalation toxicity study in
                     rats showed an LC50 greater than 6.29 mg/L (toxicity category IV)
                     (MRID 00137440; guideline 81-3).

                             Chloroxylenol is highly toxic (toxicity category I) in acute
                     irritation studies.  An eye irritation study in rabbits found mild to
                     severe corneal opacity  in unwashed  eyes,  with irritation  that
                     persisted for 14 days; eyes  washed after four seconds had mild to
                     moderate erythema, edema, and discharge without corneal damage,
                     all of which subsided in five days (MRID 00069585; guideline 81-
                     4).  Another rabbit eye  study, with a 30 percent solution,  found
                     marked corneal opacity that was not reversed in  72 hours (MRID
                     00092252; guideline 81-4). A third rabbit eye study concluded that
                     Chloroxylenol was corrosive (MRID 00137441; guideline 81-4).

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       Chloroxylenol does not appear to be a dermal irritant or
sensitizer.  A dermal irritation study with rabbits showed slight
irritation lasting less than 48 hours (toxicity category IV) (MRID
00137442; guideline 81-5).  Chloroxylenol did not produce dermal
sensitization in guinea pigs (MRID 41886601; guideline 81-6). A
repeated insult patch test with humans showed no skin sensitization
or irritation (MRID 40223125).

b.     Subchronic Toxicity

       A  subchronic  dermal study was conducted with albino
rabbits. Part of the animals at each dose were treated for 21 days
and  part for 90  days.   The  dose levels were  0,  18, or  180
mg/kg/day of  Chloroxylenol.   The  systemic NOEL  was  180
mg/kg/day and the NOEL for skin irritation was 18 mg/kg/day.
The  LOEL for skin effects was 180 mg/kg/day, where erythema,
coriaceous areas, and fissuring were found (guidelines 82-2, 82-3;
MRID 00066995).

c.     Developmental Toxicity

       A developmental toxicity study was conducted in Sprague
Dawley rats with dose levels of 0, 100, 500, or  1000 mg/kg given
by gavage  on gestation days 6-15.  The maternal  NOEL was 100
mg/kg/day.  The maternal LOEL was 500 mg/kg/day, based on
decreased weight gain and food consumption.  There were deaths
at the high dose. The NOEL for developmental toxicity was 1000
mg/kg/day, the highest dose (Guideline 83-3; MRID 42002702).

d.     Mutagenicity

       An  Ames  mutagenicity study in  Salmonella typhimurium
concluded Chloroxylenol was negative for  inducing reversion in the
standard strains, with and without activation (MRID 41310301). In
a test of unscheduled DNA synthesis in primary rat hepatocytes, the
chemical did not induce a genotoxic effect up to  cytotoxic  levels
(MRID 40704101). No evidence of mutagenicity or genetic toxicity
was  found in  an in vivo  mouse  micronucleus assay (MRID
41085301).  (These studieTfill guidelines 84.)

e.     Metabolism

       Tests of a 25 percent solution of Chloroxylenol with Sprague
Dawley  rats  demonstrated the chemical  was  practically  all
                   8

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       eliminated in the first 24  hours, mostly in the urine, with small
       amounts in feces, after oral or dermal exposure.  Following dermal
       exposure, about half of the  material was not absorbed.  High
       concentrations were found in the  tissues   of the  kidney, which
       indicates excretion in urine.  Concentrations in the  lungs indicates
       some  elimination in expired  air.   In another study, beagle  dogs
       dosed orally excreted virtually  all of the chloroxylenol in their urine
       within 24 hours.   A  small  amount  was  present in feces,  but
       essentially none remained in any tissue.  The chemical was excreted
       in conjugated form with little free  chloroxylenol (Guideline 85-1;
       MRID 40223102).

2.     Exposure Assessment

       a.     Dietary

             There are no food or animal feed uses of  chloroxylenol.
       Therefore, the Agency expects there to be no  dietary exposure.

       b.     Occupational and Residential

             Based  on the use  information, the potential dermal  and
       inhalation exposures to applicators,  mixers,  and  loaders can be
       significant, i.e., as a medical disinfectant using spray application
       methods, or as a preservative using the open pouring application
       method.  While  there may be some secondary  exposure, e.g., to
       residents, to chloroxylenol after application of end-use products, the
       Agency believes the likely exposures are significantly less than for
       mixers,  loaders and applicators, of products because of the use
       patterns.

3.     Risk Assessment

       a.     Dietary

             Since this chemical is  not applied to food or feed crops or
       in food handling establishments no  dietary risk is expected.

             One exception to this is the  use as a food packing adhesive
       under FDA purview under 21 CFR Section 175.105(c) (5).  The
       Agency defers to FDA regarding this use and any related exposure
       and risk.

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IV.    Occupational and Residential
                           Except for eye irritation, no  toxicological  endpoints of
                    concern for acute, short term or chronic exposure to chloroxylenol
                    through occupational or residential exposure have been identified.
                    Personal protective equipment requirements may be appropriate for
                    the end use products based on their acute toxicity.  At this time,
                    however the Agency does not believe additional personal protective
                    equipment requirements are necessary.
       A.    Environmental Assessment

             1.     Environmental Fate

                    The  Agency used information from the open chemical literature
             (Streitweiser and Heathcock, Introduction to Organic Chemistry, 2nd ed.,
             1981) to predict the fate of chloroxylenol in the environment.

                    a.     Environmental Chemistry, Fate and Transport

                           Chloroxylenol is hydrolytically stable, in the typical range
                    of environmental pH values, and is a weak acid, with a pKa value
                    of 9.0.

                    b.     Environmental Fate Assessment

                           The Agency does not anticipate significant environmental
                    exposure with chloroxylenol based on the limited outdoor usepet
                    living quarters.

             2.     Ecological Effects

                    a.     Ecological Effects Data

                                 The Agency has the minimum data base to assess the
                           potential ecotoxicity of chloroxylenol. The results of the
                           studies, described below,  suggest chloroxylenol has low to
                           high toxicity depending on the test species.
                                       10

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Ecological Effects Data For Chloroxylenol
Test Species
Bobwhite Quail
Mallard Duck
Bobwhite Quail
Rainbow Trout
Daphnia magna
Results
LD5n > 2250 mg/Kg
LC50 > 5620 ppm
LC50 > 5620 ppm
LC50 > 0.76 ppm
EC50 = 7.7 mg/1
MRID Number
00145647
00145646
00144377
41536903
00144380
Conclusions
practically nontoxic
practically nontoxic
practically nontoxic
highly toxic
moderately toxic
                           The results of a single avian acute oral toxicity study that
                    chloroxylenol study suggest that chloroxylenol is practically non-
                    toxic to Bobwhite Quail on an acute oral basis (MRID 00145647).
                    Results from two dietary studies on the bobwhite quail and  the
                    mallard duck revealed LC50 values greater than 5620 ppm.  Based
                    on the data chloroxylenol can be classified as practically non-toxic
                    to birds on a dietary basis. (MRIDs 00145646, 00144377).  From
                    an acute toxicity study with Rainbow trout, chloroxylenol can be
                    classified as highly toxic to freshwater fish.   (MRID 0041536903).
                    Chloroxylenol  can be classified as moderately toxic to aquatic
                    invertebrates, based on an acute toxicity study with Daphnia magna
                    (MRID 00144380).  Due to the use pattern, which is mostly indoor,
                    plants and non-target insects are not expected to be exposed to
                    chloroxylenol.

                    b.     Ecological Effects Risk Assessment

                            Although chloroxylenol is classified as practically nontoxic
                    to birds, highly toxic to fish, and moderately toxic to freshwater
                    invertebrates,  there are  mitigating  factors  which support  the
                    conclusion that exposure  to  terrestrial and aquatic  organisms is
                    extremely  minimal.    The  majority  of  registered   uses   of
                    chloroxylenol  being supported for reregistration  are mostly  for
                    indoor use.  The only current  outdoor use is  application to  pet
                    living quarters which would not result in significant environmental
                    exposure.  Therefore, when used according to label directions the
                    risk to terrestrial and aquatic organisms is minimal.
                                        11

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V.     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
       chloroxylenol 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 chloroxylenol. Appendix B identifies the
       generic data requirements that the Agency reviewed as part of its determination of
       reregistration eligibility of chloroxylenol,  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 chloroxylenol and to determine that chloroxylenol can
       be used without resulting in unreasonable adverse  effects to  humans  and the
       environment.  The Agency  therefore finds,  when used  as  directed  in this
       document, that all products containing chloroxylenol as the active ingredients are
       eligible for reregistration. The reregistration of particular products is addressed
       in Section V  of this  document.

              The Agency made  its reregistration eligibility determination based upon the
       target data base required for reregistration, the current guidelines for conducting
       acceptable studies to generate such data and  the  data identified in Appendix B.
       Although the Agency has found  that all uses of chloroxylenol 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 chloroxylenol, if new information comes to the
       Agency's attention or if the data requirements for registration (or the guidelines for
       generating such data) change.
                                        12

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B.     Risk Management Decision

       1.      Eligibility Decision

              Based on the reviews of the generic data for the active ingredients
       chloroxylenol, the Agency has sufficient information on the health effects
       of chloroxylenol and on its potential for causing adverse effects in fish and
       wildlife and  the environment.  Therefore, the Agency concludes  that
       products  containing   chloroxylenol  for  all  uses   are  eligible  for
       reregistration.

              The Agency has determined that chloroxylenol products, labeled
       and used as specified in this  Reregistration Eligibility Decision, are not
       expected pose an unreasonable risk or adverse effect to humans or the
       environment.
       2.      Eligible and Ineligible Uses

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

C.     Regulatory Position

       The following is a summary of the regulatory positions and rationales for
chloroxylenol.  Where labeling revisions are imposed, specific language is set forth
in Section V of this document.

       1.      Labeling Rationale

              a.     Discharge Limitations

                    Chloroxylenol  is  classified  as highly  toxic  to  fish and
              moderately toxic to freshwater invertebrates.  Although the Agency
              expects the exposure to aquatic organisms to be  extremely minimal
              it is requiring labelling language  to require discharge of effluent
              into bodies of water in accordance with the requirement of a  " Dis-
              charge Elimination System (NPDES) permit as described below."
              in section V. A. 2. and section V. B. 2.

              b.     Personal  Protective  Equipment   (PPE)  for  Handlers
              (Mixers/Loaders/Applicators)
                                 13

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       For each end-use product, PPE requirements for pesticide
handlers will be set during reregistration in one of two ways:

     If the Agency has no special concerns about the  acute or
       other adverse effects of an active ingredient, the  PPE for
       pesticide handlers will be based on the acute toxicity of the
       end-use product.

     If  the  Agency  has  special  concerns about  an  active
       ingredient due to very high acute toxicity or to certain other
       adverse effects, such as allergic effects or delayed effects
       (cancer, developmental toxicity, reproductive effects, etc.):

             In the RED for  the active ingredient, the Agency
              may  establish minimum or "baseline" handler PPE
              requirements that pertain to all or most occupational
              end-use products containing that active ingredient;

             These  minimum  PPE  requirements  must  be
              compared with the PPE that would be designated on
              the  basis  of the acute toxicity of  each  end-use
              product;

             The  more stringent choice for each type of PPE
              (e.g.,  bodywear,  hand  protection,  footwear,
              eyewear, etc.) must be placed on the label  of the
              end-use product.

       Because the Agency has no special concerns at this time for
the toxicity potential of the active ingredient there will  be  no
minimum baseline personal protective equipment, no new reentry
restrictions or any new labeling for mixers/loaders/applicators of
the chloroxylenol.

       Upon receipt and review of end-use product acute toxicity
data for the  current products or for new  proposed products
containing the subject active ingredient, the Agency may determine
that PPE is appropriate.

c.      Entry Restrictions for Occupational-Use Products (Non
       WPS uses)

       Exposure to the chloroxylenol from treated products, such
as emulsions,  latex paints, or  adhesives is expected to occur.
                   14

-------
                    However, the Agency believes that such exposure to  chloroxylenol
                    would be negligible because  of  dilution and  therefore  special
                    restrictions are not warranted.

                    d.     Formulation Type Identification

                           All products must specify their formulation type and percent
                    of active ingredient on their labels.
VI.    ACTIONS REQUIRED BY REGISTRANTS

       This section specifies the data requirements and responses  necessary for the
reregistration of both manufacturing-use and end-use products.

       A.    Manufacturing-Use Products

             1.     Additional Generic Data Requirements

                    The generic data base supporting the reregistration of chloroxylenol
             for the above eligible  uses has  been reviewed and  determined to be
             substantially complete.

             2.     Labeling Requirements for Manufacturing-Use Products

                    "This product is toxic to fish. Do not discharge effluent
                    containing this product into lakes, streams, ponds, estuaries,
                    oceans  or  other water unless in  accordance with  the
                    requirements of a National Pollutant Discharge Elimination
                    System (NPDES) permit and the permitting authority  has
                    been  notified in writing  prior  to discharge.   Do  not
                    discharge this product to sewer systems without previously
                    notifying the local sewage treatment plant  authority. For
                    guidance contact your State Water Board or Regional Office
                    of the EPA".

                    In addition products must specify their formulation type and percent
             of active ingredient on the label.
                                       15

-------
             All  affected  products  distributed  or sold  by registrants  and
       distributors (supplemental registrants) must bear the above labeling by
       October 1,  1995. All products distributed or sold by persons other than
       registrants or supplemental registrants after October 1,  1997 must bear the
       correct labeling. Refer to PR Notice 93-10 or 40 CFR 152.46(a)(l) for
       additional information.

B.     End-Use Products

       All  end-use products must specify their formulaton type  and percent of
active ingredient on their labels.
       1.     Additional Product-Specific Data Requirements

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

       2.     Labeling Requirements for End-Use Products

       End-Use Product Labeling Requirements for Products with Outdoor
       Use (pet living quarters)

             "This pesticide is toxic to fish.  Do not apply directly  to
             water.   Do  not  contaminate water  when  disposing  of
             equipment wash waters or rinsate."

       Labeling Requirements for Indoor Nonfood and/or Indoor Medical Use
       (non-residential)

             "This pesticide is toxic to fish.  Do not discharge effluent
             containing this product into lakes,  streams, ponds, estuaries,
             oceans  or  other  water  unless  in  accordance with the
             requirements of a National Pollutant Discharge Elimination
             System (NPDES)  permit and the permitting authority has
                                 16

-------
              been notified in writing prior to discharge.
              Do  not discharge  this product  to  sewer
              systems without  previously  notifying  the
              local sewage treatment plant authority.  For
              guidance contact your State Water Board or
              Regional Office of the EPA".

       Effluent Discharge Labeling Statements

              Refer to subsection  A.  above for applicable  due dates  for this
       labeling requirements for effluent discharge.
C.     Existing Stocks

       Registrants  may generally distribute  and sell  products bearing  old
labels/labeling for 26 months from the date of the issuance of this Reregistration
Eligibility  Decision (RED).  Persons other than the registrant may generally
distribute or sell such products for 50 months from the date of the issuance of this
RED.  However,  existing stocks time frames will be established case-by-case,
depending on the number of products involved, the number of label changes, and
other factors. Refer to  "Existing Stocks  of Pesticide  Products;  Statement  of
Policy"; Federal Register, Volume 56, No. 123, June 26, 1991.
       The  Agency has  determined that registrants  may distribute and  sell
chloroxylenol 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.
                                 17

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18

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VII.  APPENDICES
        19

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20

-------
APPENDIX A. Table of Use Patterns Subject to Reregistration
                           21

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22

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Date 08/11/94
                  Time 14:27
                                                      APPENDIX A
                                                                     CASE 3045,  [p-Chloro-m-xylenol] Chemical  086801  [4-Chloro-3,5-xylenol]
                                                                                                                                                                          Page 1
SITE Application Type, Application        Form(s)  Min. Appl.      Max. Appl. Soil Max. tt Apps Max. Dose  [(AI   Min.  Restr.      Geographic  Limitations       Use
  Timing, Application Equipment  -                 Rate  (AI un-      Rate  (AI Tex.  Max. Rate unless noted     Interv Entry   Allowed           Disallowed   Limitations
  Surface Type  (Antimicrobial only) & Effica-      less noted    unless noted Max. /crop /year otherwise)/A]    (days) Interv                                  Codes
  cy Influencing Factor  (Antimicrobial only)       otherwise)      otherwise) Dose cycle       /crop    /year          [day(s)]
USES ELIGIBLE FOR REREGISTRATION

NON- FOOD/NON- FEED
                                                                                               cycle
ADHESIVES,  INDUSTRIAL

Industrial preservative treatment., During   FM/S  W 490
manufacture.,  Not on label.,  Not
Applicable.,  Not applicable for this use.

Preservative treatment., During              FM/S  W 490
manufacture.,  Not on label.,  Not
Applicable.,  Not applicable for this use.

BATHROOM PREMISES/HARD SURFACES
   Use Group: INDOOR NON- FOOD

     W 5000     *  NS    NS
Spray., Not on label., Aerosol can., Hard.,  PRL
Not applicable for this use.
                                                   W 470
                                             PRL   W 1000

COMMERCIAL/INSTITUTIONAL/INDUSTRIAL PREMISES/EQUIP.  (INDOOR)

Equipment treatment., Not on label., Squirt  SC/L  V 159
bottle., Not Applicable., Not applicable for
this use.

Spray., Not on label., Aerosol can., Hard.,  PRL   W 470
Not applicable for this use.

DIAPER PAILS (EMPTY)

Spray., Not on label., Aerosol can., Hard.,  PRL   W 1000
Not applicable for this use.

EMULSIONS, RESIN/LATEX/POLYMER

Preservative treatment., During              FM/S  W 490
manufacture.,  Not on label., Not
Applicable.,  Not applicable for this use.

HOSPITALS/MEDICAL INSTITUTIONS PREMISES  (HUMAN/VETERINARY)

Spray., Not on label., Aerosol can., Hard.,  PRL   W 470
Not applicable for this use.

HOUSEHOLD/DOMESTIC DWELLINGS CONTENTS

Spray., Not on label., Aerosol can., Hard.,  PRL   W 1000
Not applicable for this use.
   Use Group: INDOOR RESIDENTIAL

W 470      *  NS    NS         NS


    W 1000     *  NS    NS

   Use Group: INDOOR NON- FOOD

V 30,000   *  NS    NS         NS
W 470
           *  NS    NS
                               NS
   Use Group: INDOOR RESIDENTIAL

W 1000     *  NS    NS         NS


   Use Group: INDOOR NON-FOOD

W 5000     *  NS    NS         NS



   Use Group: INDOOR MEDICAL

W 470      *  NS    NS         NS


   Use Group: INDOOR RESIDENTIAL

W 1000     *  NS    NS         NS
     CIS,  C24



CIS, C24





A08, AIO(IO)


    AIO(IO), A30



A08



A06, A08,  AIO(IO)




AIO(IO),  A30




CIS, C24





A08, AIO(IO)




AIO(IO),  A30

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Date 08/11/94
                  Time 14:27
                                                      APPENDIX A
                                                                     CASE 3045,  [p-Chloro-m-xylenol]  Chemical  086801  [4-Chloro-3,5-xylenol]
                                                                                                                                                                          Page
SITE Application Type, Application
  Timing, Application Equipment
  Surface Type  (Antimicrobial only) & Effica-
  cy Influencing Factor  (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED  (con't)
Form(s)   Min. Appl.       Max. Appl.  Soil Max. tt Apps Max. Dose  [(AI   Min.  Restr.     Geographic Limitations      Use
         Rate (AI un-      Rate (AI Tex. @ Max. Rate unless noted    Interv Entry   Allowed           Disallowed   Limitations
         less noted    unless noted Max. /crop /year otherwise)/A]    (days) Interv
         otherwise)       otherwise) Dose cycle       /crop    /year          [day(s)]
                                                     cycle
                                                                                                                                                              Codes
HOUSEHOLD/DOMESTIC DWELLINGS INDOOR PREMISES

Spray., Not on label., Aerosol can., Hard.,  PRL   W 1000
Not applicable for this use.

HUMAN FOOTWEAR

Spray., Not on label., Aerosol can.,         PRL   W 1000
Porous., Not applicable for this use.

PAINTS, LATEX (IN-CAN)

Preservative treatment., During              FM/S  W 980
manufacture.,  Not on label., Not
Applicable.,  Not applicable for this use.

PET LIVING/SLEEPING QUARTERS

Spray., Not on label., Aerosol can., Hard.,  PRL   W 1000
Not applicable for this use.

PET LIVING/SLEEPING QUARTERS

Spray., Not on label., Aerosol can., Not     PRL   W 1000
Applicable.,  Not applicable for this use.

REFUSE/SOLID WASTE CONTAINERS  (GARBAGE CANS)

Spray., Not on label., Aerosol can., Hard.,  PRL   W 1000
Not applicable for this use.
                               Use Group: INDOOR RESIDENTIAL

                            W 1000    *  NS   NS          NS


                               Use Group: INDOOR RESIDENTIAL

                            W 1000    *  NS    NS         NS


                               Use Group: INDOOR NON-FOOD

                            W 5000    *  NS    NS         NS



                               Use Group: INDOOR RESIDENTIAL

                             W 1000   *  NS    NS         NS


                               Use Group: OUTDOOR RESIDENTIAL

                             W 1000   *  NS    NS         NS


                               Use Group: INDOOR RESIDENTIAL

                             W 1000   *  NS    NS         NS
NS   NS     NS
NS   NS     NS
NS   NS     NS
                                                 AIO(IO), A30
                                                 AIO(IO), A30
                                                 CIS, C24
                                                 AIO(IO), A30
                                                 AIO(IO), A30
                                                                                                                   AIO(IO), A30

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Date 08/11/94  -  Time 14:27
                                                      APPENDIX A  -  CASE 3045,  [p-Chloro-m-xylenol] Chemical 086801  [4-Chloro-3,5-xylenol]
                                                                                                                                                            LUIS  1.5   -   Page  3
  HEADER ABBREVIATIONS
  Min. Appl.  Rate  (AI unless :  Minimum dose for a single application to a single site.  System calculated.  Microbial claims only.
  noted otherwise)
  Max. Appl.  Rate  (AI unless :  Maximum dose for a single application to a single site.  System calculated.
  noted otherwise)
  Soil Tex. Max. Dose        :  Maximum dose for a single application to a single site as related to soil texture  (Herbicide claims only).
  Max. # Apps  Max. Rate    :  Maximum number of Applications at Maximum Dosage Rate.  Example: "4 applications per year" is expressed as  "4/1 yr";  "4 applications per 3
                               years" is expressed as "4/3 yr"
  Max. Dose  [(AI unless      :  Maximum dose applied to a site over a single crop cycle or year.  System calculated.
  noted otherwise)/A]
  Min. Interv (days)         :  Minimum Interval between Applications (days)
  Restr. Entry Interv (days) :  Restricted Entry Interval (days)

  SOIL TEXTURE FOR MAX APP.  RATE
  *        : Non-specific
  C        : Coarse
  M        : Medium
  F        : Fine
  O        : Others

  FORMULATION CODES
  FM/S     : FORM NOT IDENTIFIED/SOLID
  PRL      : PRESSURIZED LIQUID
  SC/L     : SOLUBLE CONCENTRATE/LIQUID
  ABBREVIATIONS
  AN      :  As Needed
  NA      :  Not Applicable
  NS      :  Not Specified  (on label)
  UC      :  Unconverted due to lack of data  (on label), or with one of following units: bag, bait, bait block, bait pack, bait station, bait station(s), block, briquet,
            briquets,  bursts,  cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop, eartag, grains,  lure, pack, packet, packets, pad, part,
            parts, pellets, piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape, towelette, tray, unit,  --

  APPLICATION RATE
  DCNC
  No Calc
  W
  V
  cwt
  nnE-xx
Dosage Can Not be Calculated
No Calculation can be made
PPM calculated by weight
PPM Calculated by volume
Hundred Weight
nn times (10 power -xx); for instance,
                                                    "1.234E-04" is equivalent to ".0001234"
  USE LIMITATIONS CODES
  A06 :  Potable water rinse  (non-residual claim).
  A08 :  Preclean claim.
  A10 :  	 minute(s) contact time.
  CIS :  Do not discharge effluent containing this pesticide into sewage systems without notifying the sewage treatment plant authority.
  C24 :  Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or public water.   (NPDES  license  restriction)
  * NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS  (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
cy Influencing Factor  (Antimicrobial only)       otherwise)      otherwise) Dose cycle       /crop    /year
                                                                                               cycle
                                                                                                         [day(s)]
USES ELIGIBLE FOR REREGISTRATION

NON-FOOD/NON-FEED
ADHESIVES,  INDUSTRIAL

Industrial preservative treatment.,  During   FM/S  W 490
manufacture.,  Not on label.,  Not
Applicable.,  Not applicable for this use.

Preservative treatment.,  During              FM/S  W 490
manufacture.,  Not on label.,  Not
Applicable.,  Not applicable for this use.

BATHROOM PREMISES/HARD SURFACES

Spray.,  Not on label.,  Aerosol can.,  Hard.,   PRL   W 470
                                                             Use Group: INDOOR NON-FOOD

                                                               W 5000     *  NS    NS



                                                          W 5000     *  NS    NS
CIS,  C24
                                                                                         NS      NS   NS     NS
                                                             Use Group: INDOOR RESIDENTIAL

                                                          W 470      *  NS    NS         NS      NS   NS     NS
                                                                                                                                                  CIS, C24
                                                                                                                                                  A08, AIO(IO)

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Not applicable for this use.

                                             PRL   W 1000

COMMERCIAL/INSTITUTIONAL/INDUSTRIAL PREMISES/EQUIP.  (INDOOR)

Equipment treatment., Not on label., Squirt  SC/L  V 159
bottle., Not Applicable., Not applicable for
this use.

Spray., Not on label., Aerosol can., Hard.,  PRL   W 470
Not applicable for this use.

DIAPER PAILS (EMPTY)

Spray., Not on label., Aerosol can., Hard.,  PRL   W 1000
Not applicable for this use.
EMULSIONS, RESIN/LATEX/POLYMER

Preservative treatment., During
manufacture.,  Not on label.,  Not
Applicable.,  Not applicable for this use.
FM/S  W 490
HOSPITALS/MEDICAL INSTITUTIONS PREMISES  (HUMAN/VETERINARY)

Spray., Not on label., Aerosol can., Hard.,  PRL   W 470
Not applicable for this use.

HOUSEHOLD/DOMESTIC DWELLINGS CONTENTS

Spray., Not on label., Aerosol can., Hard.,  PRL   W 1000
Not applicable for this use.
                             W 1000     *  NS    NS

                            Use Group: INDOOR NON-FOOD

                         V 30,000   *  NS    NS         NS
                         W 470
                                       NS    NS
                                                        NS
   Use Group: INDOOR RESIDENTIAL

W 1000     *  NS    NS         NS


   Use Group: INDOOR NON-FOOD

W 5000     *  NS    NS         NS



   Use Group: INDOOR MEDICAL

W 470      *  NS    NS         NS


   Use Group: INDOOR RESIDENTIAL

W 1000     *  NS    NS         NS
                                                                                                                     AIO(IO), A30
                                                                                                                 A06, A08, AIO(IO)
                                                                                                                 AIO(IO), A30
                                                                                                                 CIS, C24
                                                                                                                 A08, AIO(IO)
                                                                                                                 AIO(IO), A30

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Date 08/11/94
                  Time 14:27
                                                      APPENDIX A
                                                                     CASE 3045,  [p-Chloro-m-xylenol]  Chemical  086801  [4-Chloro-3,5-xylenol]
                                                                                                                                                                          Page
SITE Application Type, Application
  Timing, Application Equipment
Form(s)   Min. Appl.
         Rate (AI un-
  Surface Type  (Antimicrobial only) & Effica-
  cy Influencing Factor  (Antimicrobial only)
         less noted
         otherwise)
  Max. Appl. Soil Max. tt Apps Max. Dose  [(AI   Min.  Restr.     Geographic Limitations      Use
    Rate (AI Tex. @ Max. Rate unless noted    Interv Entry   Allowed           Disallowed   Limitations
unless noted Max. /crop /year otherwise)/A]    (days) Interv
  otherwise) Dose cycle       /crop    /year          [day(s)]
                              cycle
                                                                                                                                                              Codes
USES ELIGIBLE FOR REREGISTRATION

NON-FOOD/NON-FEED (con't)
HOUSEHOLD/DOMESTIC DWELLINGS INDOOR PREMISES

Spray., Not on label., Aerosol can., Hard.,  PRL   W 1000
Not applicable for this use.

HUMAN FOOTWEAR

Spray., Not on label., Aerosol can.,         PRL   W 1000
Porous., Not applicable for this use.

PAINTS, LATEX (IN-CAN)

Preservative treatment., During              FM/S  W 980
manufacture.,  Not on label., Not
Applicable.,  Not applicable for this use.

PET LIVING/SLEEPING QUARTERS

Spray., Not on label., Aerosol can., Hard.,  PRL   W 1000
Not applicable for this use.

PET LIVING/SLEEPING QUARTERS

Spray., Not on label., Aerosol can., Not     PRL   W 1000
Applicable.,  Not applicable for this use.

REFUSE/SOLID WASTE CONTAINERS  (GARBAGE CANS)

Spray., Not on label., Aerosol can., Hard.,  PRL   W 1000
Not applicable for this use.
                               Use Group: INDOOR RESIDENTIAL

                            W 1000    *  NS   NS          NS


                               Use Group: INDOOR RESIDENTIAL

                            W 1000    *  NS    NS         NS


                               Use Group: INDOOR NON-FOOD

                            W 5000    *  NS    NS         NS



                               Use Group: INDOOR RESIDENTIAL

                             W 1000   *  NS    NS         NS


                               Use Group: OUTDOOR RESIDENTIAL

                             W 1000   *  NS    NS         NS


                               Use Group: INDOOR RESIDENTIAL

                             W 1000   *  NS    NS         NS
                                           NS   NS     NS
                                           NS   NS     NS
                                           NS   NS     NS
                                                                                            AIO(IO), A30
                                                                                            AIO(IO), A30
                                                                                            CIS, C24
                                                                                            AIO(IO), A30
                                                                                            AIO(IO), A30
                                                                                                                   AIO(IO), A30

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Date 08/11/94  -  Time 14:27                          APPENDIX A  -  CASE 3045,  [p-Chloro-m-xylenol] Chemical 086801  [4-Chloro-3,5-xylenol]                 LUIS  1.5   -  Page 3
  HEADER ABBREVIATIONS
  Min. Appl.  Rate (AI unless :  Minimum dose for a single application to a single site.  System calculated.  Microbial claims only.
  noted otherwise)
  Max. Appl.  Rate (AI unless :  Maximum dose for a single application to a single site.  System calculated.
  noted otherwise)
  Soil Tex. Max. Dose        :  Maximum dose for a single application to a single site as related to soil texture  (Herbicide claims only).
  Max. # Apps  Max. Rate    :  Maximum number of Applications at Maximum Dosage Rate.  Example: "4 applications per year" is expressed as  "4/1 yr";  "4 applications per 3
                               years" is expressed as "4/3 yr"
  Max. Dose  [(AI unless      :  Maximum dose applied to a site over a single crop cycle or year.  System calculated.
  noted otherwise)/A]
  Min. Interv (days)         :  Minimum Interval between Applications (days)
  Restr. Entry Interv (days) :  Restricted Entry Interval (days)

  SOIL TEXTURE FOR MAX APP.  RATE
  *        : Non-specific
  C        : Coarse
  M        : Medium
  F        : Fine
  O        : Others

  FORMULATION CODES
  FM/S     : FORM NOT IDENTIFIED/SOLID
  PRL      : PRESSURIZED LIQUID
  SC/L     : SOLUBLE CONCENTRATE/LIQUID

  ABBREVIATIONS
  AN       : As Needed
  NA       : Not Applicable
  NS       : Not Specified (on label)
  UC       : Unconverted due to lack of data (on label),  or with one of following units: bag, bait, bait block, bait pack, bait station, bait station(s), block, briquet,
            briquets, bursts,  cake, can, canister, capsule, cartridges,  coil,  collar, container, dispenser, drop, eartag, grains, lure, pack, packet, packets, pad, part,
            parts, pellets,  piece, pieces, pill, pumps,  sec, sec burst,  sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape, towelette, tray, unit, --

  APPLICATION RATE
  DCNC     : Dosage Can Not be Calculated
  No Calc  : No Calculation can be made
  W        : PPM calculated by weight
  V        : PPM Calculated by volume
  cwt      : Hundred Weight
  nnE-xx   : nn times (10 power -xx); for instance,  "1.234E-04" is equivalent to ".0001234"

  USE LIMITATIONS CODES
  A06 :  Potable water rinse (non-residual claim).
  A08 :  Preclean claim.
  A10 :  	 minute(s) contact time.
  CIS :  Do not discharge effluent containing this pesticide into sewage systems without notifying the sewage treatment plant authority.
  C24 :  Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or public water.   (NPDES license  restriction)
  * NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS  (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.

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APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
                          29

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30

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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  covered by this Reregistration Eligibility Decision Document. It
contains generic data requirements that apply to  in all products,  including data requirements
for which a "typical formulation" is the test substance.

       The data table is organized in the following format:

       1.  Data Requirement (Column 1).  The data requirements are listed in the order in
which they appear in 40 CFR Part 158. the reference numbers accompanying each test refer
to the test protocols set in the Pesticide Assessment Guidelines, which are available from the
National Technical Information Service, 5285 Port Royal Road,  Springfield, VA 22161 (703)
487-4650.

       2.  Use Pattern  (Column 2).  This  column indicates the use patterns for which the data
requirements apply.  The following letter  designations are used for the given use patterns:

                           A      Terrestrial food
                           B      Terrestrial feed
                           C      Terrestrial non-food
                           D      Aquatic food
                           E      Aquatic non-food outdoor
                           F      Aquatic non-food industrial
                           G      Aquatic non-food residential
                           H      Greenhouse food
                           I       Greenhouse non-food
                           J       Forestry
                           K      Residential
                           L      Indoor food
                           M     Indoor non-food
                           N      Indoor medical
                           0      Indoor residential

       3.  Bibliographic citation (Column 3).  If the Agency has acceptable data in its files,
this column lists the identifying number of each study.  This normally is the Master Record
Identification (MRID) number, but may be a "GS" number if no MRID number has been
assigned.  Refer to the  Bibliography appendix for a complete citation of the study.
                                          31

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32

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                     APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Chloroxylenol
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-1
61-2A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-12
63-13
63-17
Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
PH
Stability
Storage stability
MNO
MNO
MNO
MNO
MNO
MNO
MNO
MNO
MNO
MNO

MNO
MNO
MNO
MNO
MNO
MNO
MNO
40725501, 40937401
40725501, 40973401
40725501
40725501
40725501, 40937401
40725501
40725501
40725501
40725501
43322201, 40725501
N/A
43322202, 40725501
43322203, 40725501
43322204
43322205, 40725501
43322206
40725501, 43294801
40725501
                             33

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Data Supporting Guideline Requirements for the Reregistration of Chloroxylenol
REQUIREMENT
63-20
Corrosion characterist
USE PATTERN
MNO
CITATION(S)
40725501
ECOLOGICAL EFFECTS
71-1A
71-2A
71-2B
72-1A
72-1C
72-2A
Acute Avian Oral - Quail/Duck
Avian Dietary - Quail
Avian Dietary - Duck
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
MNO
MNO
MNO
MNO
MNO
MNO
00145647
00144377
00145646
41670403
41536903
00144380
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
82-1A
82-2
82-3
83-3A
84-2A
Acute Oral Toxicity - Rat
Acute Dermal Toxicity - Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization - Guinea Pig
90-Day Feeding - Rodent
21 -Day Dermal - Rabbit/Rat
90-Day Dermal - Rodent
Developmental Toxicity - Rat
Gene Mutation (Ames Test)
MNO
MNO
MNO
MNO
MNO
MNO
MNO
MNO
MNO
MNO
MNO
402231209, 00137438
00137439
00137440
00137441, 00092252, 00069585
00137442
41886601
00141330
00066995
00066995
42002702
41310301
                                    34

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         Data Supporting Guideline Requirements for the Reregistration of Chloroxylenol
REQUIREMENT
USE PATTERN
CITATION(S)
84-2B      Structural Chromosomal Aberration          MNO
84-4       Other Genotoxic Effects                   MNO
85-1       General Metabolism                      MNO
OCCUPATIONAL/RESIDENTIAL EXPOSURE
160-5      Chemical Identity                        MNO
161-1      Hydrolysis                              MNO
                                          41085301
                                          41085301
                                          00063125

                                          40937401
                                       SATISFIED
                                             35

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36

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APPENDIX C.  Citations Considered to be Part of the Data
   Base Supporting the Reregistration of Chloroxylenol
                          37

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38

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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 them, treating them as a
       single study.

3.      IDENTIFICATION OF ENTRIES.  The entries in this bibliography are sorted
       numerically by Master Record Identifier, or "MRID number".  This  number is unique
       to the citation, and should be used whenever a specific reference is required.  It is not
       related  to the six-digit "Accession Number" which has been used to identify volumes of
       submitted studies (see paragraph 4 (d) (4) below for further explanation).  In a few
       cases, entries added to the bibliography late in the review may be preceded by  a nine
       character temporary identifier. These  entries are listed after all MRID entries.  This
       temporary identifying number is also to be used whenever specific reference is needed.

4.      FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
       consists of a citation containing standard elements followed,  in the case of material
       submitted to  EPA, by a description of the earliest known submission. Bibliographic
       conventions used reflect the standard of the American National Standards Institute
       (ANSI), expanded to provide for certain special needs.

       a     Author.  Whenever the author could confidently be identified, the Agency has
             chosen to show a personal author.  When no individual was identified, the
             Agency has shown an identifiable laboratory or testing facility as the  author.
             When no author or laboratory could be identified, the Agency has shown the
             first submitter as the author.

       b.     Document date.  The date of the study is taken directly from the document.
             When the date is followed by a question mark, the bibliographer has deduced
             the date from the evidence contained in the document.  When the date appears


                                           39

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       as (19??), the Agency was unable to determine or estimate the date of the
       document.

c.      Title.  In some cases, it has been necessary for the Agency bibliographers to
       create or enhance a document title.  Any such editorial insertions are contained
       between square brackets.

d.      Trailing parentheses. For studies submitted to the Agency in the past, the
       trailing parentheses include (in addition to any self-explanatory text) the
       following elements describing the earliest known submission:

       (1)    Submission date.  The date of the earliest known submission appears
             immediately following the word "received."

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

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

       (4)    Volume Identification (Accession Numbers).  The final element in the
             trailing parentheses identifies the EPA accession number of the volume
             in which the original submission  of the study appears.  The six-digit
             accession number follows the symbol "CDL," which stands for
             "Company Data Library." This accession number is in turn followed by
             an alphabetic suffix which shows the relative position of the study within
             the volume.
                                    40

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                                BIBLIOGRAPHY
MRID
CITATION
00137438     Cummins, H.; Gardner, J. (1983) 4-Chloro-3.5-xylenol (PCMX): Acute Oral
             Toxicity in the Rat: LSR Report No. 83/BTP024/244.  (Unpublished study
             received Dec 27, 1983 under 49403-1; prepared by Life Science Research,
             Eng., submitted by Nipa Laboratories, Inc., Wilmington, DE; CDL:252039-A)

00137439     Cummins, H.; Gardner, J. (1983) 4 Chloro-3.5-xylenol (PCMX): Acute
             Percutaneous Toxicity in the Rat: LSR Report No. 83/BTP025/245.
             (Unpublished study received Dec 27,  1983 under 49403-1; prepared by Life
             Science Research, Eng., submitted by Nipa Laboratories, Inc., Wilmington,
             DE; CDL:252039-B)

00137440     Cummins, H.; Bannerman, M.  (1983) 4 Chloro-3.5-xylenol (PCMX): Acute
             Inhalation Toxicity in the Rat: LSR Report No. 83/BTP029/ 356.
             (Unpublished study received Dec 27,  1983 under 49403-1; prepared by Life
             Science Research, Eng., submitted by Nipa Laboratories, Inc., Wilmington,
             DE; CDL:252039-C)

00137441     Cummins, H.; Gardner, J. (1983) 4-Chloro-3.5-xylenol (PCMX): Acute Eye
             Irritation/Corrosion Test in Rabbits: LSR Report No. 837 BPT027/247.
             (Unpublished study received Dec 27,  1983 under 49403-1; prepared by Life
             Science Research, Eng., submitted by Nipa Laboratories, Inc., Wilmington,
             DE; CDL:252039-D)

00137442     Cummins, H.; Gardner, J. (1983) 4 Chloro-3.5-xylenol (PCMX): Acute
             Dermal Irritation/Corrosivity Test in Rabbits: LSR Report No.
             83/BTP026/246. (Unpublished study received Dec 27, 1983 under 49403-1;
             prepared by Life Science Research, Eng., submitted by Nipa Laboratories,
             Inc., Wilmington, DE; CDL:252039-E)

00141330     Hunter, B.;  Bridges, J.; Heywood, R.; et al.  (1973) RBA 666 Toxicity to Rats
             in Oral Administration for 13 Weeks: RKT46/73744. Unpublished study
             prepared by Huntingdon Research Centre. 88 p.

00144377     Beavers, J. (1984) A Dietary LC50 Study in the Bobwhite with Nipacide MX:
             Final Report: Project No. 189-104. Unpublished study prepared by Wildlife
             International Ltd. 14 p.

00144380     Hoberg, J. (1984) Acute Toxicity of Nipacide MX to Daphnids (Daphnia
             magna): Bionomics Report #BW-84-9-1623: Bionomics Study

                                        41

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                                BIBLIOGRAPHY
MRID
CITATION
             #10829-0584-6100-110.  Unpublished study prepared by Springborn
             Bionomics, Inc.  12 p.

00145646     Beavers, J. (1984) A Dietary LC50 Study in the Mallard with Nipacide MX:
             Final Report: Project No. 189-105. Unpublished study prepared by Wildlife
             International Ltd. 14 p.
00145647     Beavers, J. (1984) An Acute Oral Toxicity Study in the Bobwhite with Nipacide
             MX: Final Report: Project No. 189-106.  Unpublished study prepared by
             Wildlife International Ltd. 18 p.

00063125     Havler, M.E.; Jordan, B.J.; Malam, S.; et al. (1974) Sectional Laboratory
             Report: Metabolism Studies of PCMX: Report No. 5389/2.  (Unpublished study
             received Aug 2,  1978 under 4026-4; prepared by Reckitt & Colman, submitted
             by Ottawa Chemical Div., Toledo, Ohio; CDL:235214-F)

00066995     Doyle, R.L.; Elsea, J.R.  (1965) Subacute and Chronic Dermal Application of
             Ottasept Extra to Rabbits: P-13. (Unpublished study received  Oct 8,  1966
             under 4026-4; prepared by Hill Top Research, Inc., submitted by Ottawa
             Chemical Div., Toledo, Ohio;  CDL:100252-B)

00069585     Estep, C.L.; Teske, R.H. (1968) Acute Application of Ottasept Tech to the
             Eyes of Rabbits: R-550.   (Unpublished study received Sep 23,  1976 under
             10145-EX-2; prepared by Hill Top Research, Inc., submitted by Blumberg Co.,
             Inc., Peabody, Mass.; CDL:226150-F)

00092252     Doyle, R.L.; Elsea, J.R.  (1965) Acute Eye Application of Ottasept Extra to
             Albino Rabbits: P-12B.  (Unpublished study received Sep 23,  1976 under
             10145-EX-2; prepared by Hill Top Research, Inc., submitted by Blumberg Co.,
             Inc., Peabody, Mass.; CDL:235329-E)

40223109     Cappetti, N. (1976)  30-day Subacute Toxicity of PCMX in Rats: Summary
             Interim Report: Experiment SON.  Unpublished study prepared by Pennwalt
             Corp. 48 p.

40223114     Green, D.; Preece, J.  (1974) Technical Memorandum No. 25: Dermal
             Exposure of Rats to Dettol. Unpublished study prepared by Reckitt and
             Colman.  9 p.

                                         42

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                                BIBLIOGRAPHY
MRID
CITATION
40223115     Preece, J.  (1975) Technical Memorandum No. 30: Dermal Exposure of Rats to
             Dettol. Unpublished study prepared by Reckitt and Colman.  6 p.

40725501     Clark, J. (1988) Product Chemistry: Nipacide CMX (4 Chloro 3,5 Xylenenol):
             Study I.D. RE-C2-10.  Unpublished study prepared by Nipa Laboratories, Inc.
             20 p.

40937401     Clark, J. (1988) Product Chemistry: Nipacide MX
             (4-Chloro-3,5dimethylphenol): Study I.D. RE-T2-88. Unpublished study
             prepared by Nipa Laboratories in cooperation with Salford University Industrial
             Centre Ltd.  23 p.
41085301     Ivett, J.  (1989) Mutagenicity Test on Chloroxylenol in the in vivo Mouse
             Micronucleus Assay: Final Report:  Project ID: HLA Study No.: 10555-0-455.
             Unpublished study prepared by Hazleton Laboratories America, Inc.  21 p.

41310301     May, K. (1989) Nipacide MX (Parachlorometaxylenol): Assessment of
             Mutagenic Potential in Histidine Auxotrophs of Salmonella Typhmurium: Lab
             Project Number: 89/0690: NIPA/1989/8. Unpublished study prepared by Life
             Science Research Ltd.  32 p.

41536903     Leblanc, G.  (1980) Acute Toxicity  of Ottasept to Rainbow Trout (Salmo
             gairdneri): Lab Project Number:  BW-80-10-756.  Unpublished study prepared
             by EG & G, Bionomics.  12 p.

41670403     LeBlanc, G. (1990) Acute Toxicity of Ottasept to  Bluegill
             (Lepomismacrochirus): Lab Project Number: BW/80/10/755.  Unpublished
             study prepared by EG&G Bionomics.  13 p.

41886601     Blaszcak, D. (1991) A Close-Patch Repeated Insult Dermal Sensitization Study
             in Guinea Pigs with Ottasept Technical (chloro-3,5 xylenol)  (Buehler Method):
             Lab Project Number: 5933-90. Unpublished study prepared by Bio/dynamics,
             Inc.  21  p.

42002702     Siglin, J. (1991) 4 Chloro 3,5 Xylenol (PCMX): Teratology Study in Rats.
             Unpublished study prepared by Springborn Laboratories, Inc.  266 p.

43294801     Ellison,  F. (1994) Physical and Chemical Characteristics of Nipacide PX:

                                         43

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                                BIBLIOGRAPHY
MRID
CITATION
             Stability: Lab Project Number: 520-05. Unpublished study prepared by Case
             Consulting Labs., Inc.  25 p.

43322201     Nipa Labs, Inc. (19??) Melting Point: Supplement to "Product Chemistry:
             Nipacide CMX (4-Chloro-3, 5-Xylenol)": Lab Project Number: 1994-1S:
             RE-02-10.  Unpublished study. 8 p.

43322202     OECD (1981) Density of Liquids and Solids: Supplement to "Product
             Chemistry Nipacide CMX (4 Chloro 3, 5 Xylenol)": Lab Project Number:
             1994-1S: RE-02-10.  Unpublished study.  14 p.

43322203     Nipa Labs Inc.  (1994) Solubility: Supplement to "Product Chemistry Nipacide
             CMX (4-Chloro-3, 5 Xyleneol)": Lab Project Number:  1994-1S: 1994-1S.
             Unpublished study.  5 p.

43322204     OECD (1981) Vapour Pressure Curve: Supplement to "Product Chemistry
             Nipacide CMX (4Chloro-3,  5-Xylenol)": Lab Project Number: 1994-1S,
             1994-1S.  Unpublished study.  24  p.

43322205     Clark, J.; Cunliffe, A. (1972) Rapid Spectrophotometric Measurement of
             lonisation Constants in Aqueous Solution. Chemistry and Industry (Mar. 17,
             '93):291-293.

43322206     Clark, J.; Cunliffe, A. (1988) Discussion of pH of Nipacide CMX in Aqueous
             Solution: Lab Project Number: 1994/1S: RE-02-10. Unpublished study
             prepared by Nipa Labs, Inc and University of Salford. 4 p.
                                        44

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APPENDIX D.  List of Available Related Documents
                     45

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46

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       The following is a list of available documents related to chloroxylenol.  It's purpose is
to provide a path to more detailed information if it is needed. These accompanying documents
are part of the Administrative Record for chloroxylenol and are included in the EPA's Office
of Pesticide  Programs Public Docket.

       1.      Health and Environmental Effects Science  Chapters for chloroxylenol

       2.      Detailed Label Usage Information System  (LUIS) Report for chloroxylenol

       3.      RED Fact Sheet for chloroxylenol

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

       5.      PR Notice 91-2  (included in this appendix) pertains to the Label Ingredient
              Statement
                                          47

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48

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APPENDIX E.  PR Notices 86-5 and 91-2
                  49

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50

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PR Notice  86-5
      51

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52

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              UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

   tpno1                        WASHINGTON, D.C. 20460

                                  July 29, 1986

                                                            OFFICE OF
                             PR NOTICE 86-5           PREVENTION, PESTICIDES
                                                     AND TOXIC SUBSTANCES


          NOTICE TO PRODUCERS,  FORMULATORS, DISTRIBUTORS
                         AND REGISTRANTS

Attention:      Pers9ns responsible for Federal  registration  of
                pesticides.

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

I.    Purpose

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

II.   Applicability

     This PR Notice applies to all data that are submitted to EPA
to satisfy data requirements for granting  or maintaining
pesticide registrations, experimental  use  permits, tolerances,
and related approvals under certain provisions  of FIFRA  and
FFDCA.  These data are defined in FIFRA 10(d)(1).  This Notice
does not apply  to commercial, financial, or production
information, which are, and must continue  to be, submitted
differently under separate  cover.

Ill.  Effective  Date

     This notice is effective on November  1, 1986. Data  formatted
according to this notice may be submitted  prior to the effective
date.  As of the effective  date, submitted data packages that do
not conform to  these requirements may  be returned to the
submitter for necessary revision.

IV.   Background

     On September 26, 1984, EPA published  proposed regulations  in
the Federal Register (49 FR 37956) which include Requirements for
Data Submission (40 CFR 158.32), and  Procedures for Claims  of
Confidentiality of Data (40 CFR 158.33).  These regulations
specify the format for data submitted  to EPA under Section 3 of
FIFRA and Sections 408 and  409 of FFDCA, and procedures  which
must be followed to make and substantiate  claims of confiden-
tiality.  No entitlements to data confidentiality are changed,
either by the proposed regulation or by this notice.

     OPP is making these requirements  mandatory through  this
Notice to gain  resource-saving benefits from their use before the


                                53

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entire proposed regulation becomes final.  Adequate lead time is
being provided for submitters to comply with the new
requirements.

V.   Relationship of this Notice to Other OPP Policy and Guidance

     While this Notice contains requirements for organizing and
formatting submittals of supporting data,  it does not address the
substance of test reports themselves.  "Data reporting" guidance
is now under development in OPP, and will specify how the study
objectives, protocol, observations, findings, and conclusions are
organized and presented within the study report. The data
reporting guidance will be C9mpatible with submittal format
requirements described in this Notice.

     OPP has also promulgated a policy (PR Notice 86-4 dated
April 15, 1986) that provides for early screening of certain
applications for registration under FIFRA 3.  The objective of
the screen is to avoid the additional C9sts and prolonged delays
associated with handling significantly incomplete application
packages.  As of the effective date of this Notice,  the screen
will include in its criteria for acceptance of applicati9n
packages the data formatting requirements described herein.

     OPP has also established a public docket which imposes
deadlines for inserting int9 the docket documents submitted in
connection with Special Reviews and Registration Standards  (see
40 CFR 154.15 and 155.32).  To meet these deadlines, OPP is
requiring an additional copy of any data submitted to the docket.
Please refer to Page 10 for more information about this
requirement.

     For several years, OPP has required that each application
for registration or other action include a list 9f all applicable
data requirements and an indication of how each is satisfied--the
statement of the method of support f9r the application.
Typically, many requirements are satisfied by reference to data
previously submitted--either by the applicant or by another
party.  That requirement is not altered by this notice, which
applies only to data submitted with an application.

VI.   Format Requirements

     A more detailed discussion of these format requirements
foll9ws the index on the next page, and samples of some of the
requirements are attached.  Except for the language 9f the two
alternative forms of the Statement of Data Confidentiality Claims
(shown in Attachment 3) which cannot be altered, these samples
are illustrative.  As long as the required information is
included and clearly identifiable, the form of the samples may be
altered to reflect the submitter's preference.

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

B.   Transmittal Document	4      11

C.   Individual Studies 	  4

     C. 1  Special Considerations for Identifying Studies  .  .  5

D.   Organization of each Study Volume	6      17

     D. 1  Study Title Page	7      12


                                   54

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     D. 2  Statement of Data Confidentiality Claims
                   (based on FIFRA 10 (d) (1)1   	8      13
     D. 3  Confidential Attachment	8      15
     D. 4  Supplemental Statement of Data Confidentiality
            Claims  (other than those based on FIFRA 10(d)(1) )  8      14
     D. 5  Good Laboratory Practice Compliance Statement   .  .  9      16

E.   Reference to Previously Submitted Data 	  9

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

G.   Special Requirements for Submitting Data to the Docket   10
A.   Organization of Submittal Package

     A "submittal package" consists of all studies submitted at
the same time f9r review in support of a single regulatory
action, along with a transmittal document and other related
administrative material  (e.g. the method of support statement,
EPA Forms 8570-1, 8570-4, 8570-20, etc.) as appropriate.

     Data submitters must organize each submittal package as
described in this Notice.  The transmittal and any other admin-
istrative material must be grouped together in the first physical
volume.  Each study included in the submittal package must then
be bound separately.

     Submitters sometimes provide additional materials that are
intended to clarify, emphasize, or otherwise comment to help
Product Managers and reviewers better understand the submittal.

        If such materials relate to one study, they should be
     included as an appendix to that study.

     - If such materials relate to more than one study  (as for
     example a summary of all studies in a discipline) or to the
     submittal in general, they must be included in the submittal
     package as a separate study  (with title page and statement
     of confidentiality claims).

B.   Transmittal Document

     The first item in each submittal package must be a trans-
mittal document.  This document identifies the submitter or all
joint submitters; the regulatory action in support of which the
package is being submitted--!.e., a registration application,
petition, experimental use permit (EUPT, 3(c)(2)(B) data
call-in,  6(a)(2) submittal, 9r a special review; the transmittal
date; and a list of all individual studies included in the
 gackage in the order of their appearance, showing (usually by
 uideline reference number)  the data requirement(s)  addressed by
each one.  The EPA-assigned number for the regulatory action
(e.g. the registration, EUP, or tolerance petition number) should
be included in the transmittal document as well, if it is known
to the submitter.  See Attachment 1 for an example of an
acceptable transmittal document.

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

     The list of included studies in the transmittal of a data
submittal package supporting a petition for tolerance or an


                                55

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application for an EUP should be subdivided into sections A, B,
C,....  of the petition or application,  as defined in 40 CFR 180.7
and 158.125, (petitions)  or Pesticide Assessment Guidelines,
Subdivision I (EUPs)  as appropriate.

     When a submittal package supports a tolerance petiti9n and
an application for a registration or an EUP, list the petition
studies first,  then the balance of the studies.  Within these two
groups of studies follow the instructions above.

C.   Individual Studies

     A study is the report of a single scientific investigation,
including all supporting analyses required for logical complete-
ness.   A study should be identifiable and distinguishable by a
C9nventional bibliographic citation including author, date, and
title.   Studies generally correspond in scope to a single Guide-
line requirement for supporting data, with 39016 exceptions dis-
cussed in section C.I.  Each study included in a submittal
 Eackage must be bound as a separate entity.  (See comments on
 inding studies on page 9.)

     Each study must be consecutively paginated, beginning from
the title page as page 1.  The total number of pages in the com-
plete study must be shown on the study title page.  In addition
(to ensure that inadvertently separated pages can be reassociated
with the proper study during handling or review) use either of
the following:

     - Include the total number of pages in the complete study on
     each page (i.e., 1 of 250, 2 of 250,  ...250 of 250).

     - Include a company name or mark and study number on each
     page of the study, e g ,  Company Name-1986-23.    Never reuse
     a study number for marking the pages of subsequent studies.
     When a single study is extremely long, binding it in mul-
tiple V9lumes is permissible so long as the entire study is pag-
inated in a single series,  and each volume is plainly identified
by the study title and its position in the multi-volume sequence.

C.1  Special Considerations for Identifying Studies

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

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

     Extensive supplemental reports of pathology reviews, feed
analyses, historical C9ntrol data, and the like are often assoc-
iated with safety studies.   Whenever possible these should be
submitted with primary reports of the study, and bound with the
primary study as appendices.  When such supplemental reports are
submitted independently of the primary report,  take care to fully
identify the primary report to which they pertain.

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

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

     Product chemistry data submitted in support of a technical
product, other manufacturing-use product, an experimental use
permit, an import tolerance petition, or an end-use product


                                56

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produced from unregistered source ingredients, should be bound as
a single study for each Guideline series  (61, 62, and 63) for
C9nventional pesticides, or for the equivalent subject range for
biorational pesticides.  The first of the three studies in a
complete product chemistry submittal for a biochemical pesticide
would cover Guidelines 151-10,  151-11,  and 151-12; the second
would cover Guidelines 151-13,  151-15,  and 151-16; the third
would cover Guideline 151-17. The first study for a microbial
pesticide would cover Guidelines 151-20, 151-21,  and 151-22; the
second W9uld cover Guidelines 151-23 and 151-25;  the third would
cover Guideline 151-26.

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

     c.   Residue Chemistry Studies.   Guidelines 171-4, 153-3,
and 153-4 are extremely broad in scope; studies addressing
residue chemistry requirements must thus be defined at a level
below that of the Guideline code.  The general principle,
h9wever, of limiting a study to the report of a single inves-
tigation still applies fully.  Data should be treated as a single
study and bound separately for each analytical method, each
report of the nature of the residue in a single crop or animal
species, and for each report of the magnitude of residues
resulting from treatment of a single crop or from processing a
single crop.  When more than one commodity is derived from a
single crop  (such as beet tops and beet roots) residue data on
all such C9mmodities should be reported as a single study.  When
multiple field trials are associated with a single crop, all such
trials should be reported as a single study.
D.
Organization of Each Study Volume
     Each complete study must include all applicable elements in
the list below, in the order indicated.  (Also see Page 17.)
Several of these elements are further explained in the following
paragraphs.   Entries in the column headed "example" cite the
page number of this notice where the element is illustrated.
Element

Study Title Page

Statement of Data
Confidentiality
Claims

Certification of Good
Laboratory Practice
Flagging statements
Body of Study
Study Appendices

Cover Sheet to Confi-
dential Attachment
                    When Required                 Example

                    Always                        Page 12

                    One of the two alternative    Page 13
                    forms of this statement
                    is always required

                    If study reports Iaborat9ry   Page 16
                    work subject to GLP require-
                    ments

                    For certain t9xicology studies (When
                    flagging requirements are finalized.)

                    Always - with an English language
                    translation if required.

                    At submitter's option

                    If CBI is claimed under FIFRA
                    10 (d) (1) (A) ,  (B) ,  or (C)
CBI Attachment
Supplemental Statement
of Data Confidentiality
Claims
                    If CBI is claimed under FIFRA
                    10 (d) (1) (A) ,  (B) ,  or (C)      Page 15

                    Only if confidentiality is    Page 14
                    claimed on a basis other than
                    FIFRA 10(d)(1)(A),  (B),  or (C)
                                57

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D.I. Title Page

     A title page is always required for each submitted study,
published or unpublished.  The title page must always be freely
releasable to requestors; DO NOT INCLUDE CBI ON THE TITLE PAGE.
An example of an acceptable title page is on page 12 of this
notice.  The following information must appear on the title page:

a.   Study title.  The study title should be as descriptive as
possible It must clearly identify the substance(s) tested and
correspond to the name of the data requirement as it appears in
the Guidelines.

b.   Data requirement addressed.  Include on the title page the
Guideline number(s)  of the specific requirement(s) addressed by
the study.

c.   Author(s).  Cite only individuals with primary intellectual
responsibility for the C9ntent 9f the study.  Identify them
plainly as authors,  to distinguish them from the performing
laboratory, study sponsor, or other names that may also appear on
the title page.

d.   Study Date.  The title page must include a single date for
the study.  If parts of the study were performed at different
times, use only the date of the latest element in the study.

e.   Performing Laboratory IdentificatJ9n.   If the study reports
work done by one or more laboratories,Include on the title page
the name and address of the performing laboratory or
laboratories, and the laboratory's internal project number(s) for
the work.  Clearly distinguish the laboratory's project
identifier from any other reference numbers provided by the study
sponsor or submitter.

f.   Supplemental Submissions.  If the study is a commentary on
or supplement to another previously submitted study, or if it
responds to EPA questions raised with respect to an earlier
study, include 9n the title page elements a. through d. for the
previ9usly submitted study, along with the EPA Master Record
Identifier (MRID) or Accession number of the earlier study if you
know these numbers.   (Supplements submitted in the same submittal
package as the primary study should be appended to and bound with
the primary stuay.  Do not include supplements to more than one
study under a single title page).

g.    Facts of Publication.  If the study is a reprint of a pub-
lished d9cument, identity on the title page all relevant facts of
publication,  such as the J9urnal title, volume, issue, inclusive
page numbers, and publication date.


D.2. Statements of Data Confidentiality Claims Under FIFRA
10(d) (1) .

     Each submitted study must be accompanied by one of the two
alternative forms of the statement of Data Confidentiality Claims
specified in the proposed regulation in 158.33 (b) and (c)    (See
Attachment 3).   These statements apply only to claims of data
confidentiality based on FIFRA 10(d)(1)(A), (B),  or  (C).   Use
the appropriate alternative form of the statement either to
assert a claim of 10(d)(l) data confidentiality  (158.33(b)) or
to waive such a claim (158.33(c)).  In either case, the
statement must be signed and dated, and must include the typed
name and title of the official who signs it.  09 not make CBI
claims with respect to analytical methods associated with pet-


                                58

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itions for tolerances or emergency exemptions  (see NOTE Pg 13).

D.3. Confidential Attachment

     If the claim is made that a study includes confidential
business information as defined by the criteria of FIFRA
10(D)(1)(A),   (B),  or (C) (as described in D.2. above) all such
information must be excised from the body 9f the study and
confined to a separate study-specific Confidential Attachment.
Each passage of CBI so isolated must be identified by a reference
number cited within the body of the study at the point from which
the passage was excised  (See Attachment 5).

     The Confidential Attachment to a study must be identified by
a cover sheet fully identifying the parent study, and must be
clearly marked "Confidential Attachment."  An appropriately
annotated photocopy of the parent study title page may be used as
this cover sheet.  Paginate the Confidential Attachment
separately from the body of the study, beginning with page 1 of X
on the title page.   Each passage confined t9 the Confidential
Attachment must be associated with a specific cross reference to
the page(s) in the main body of the study on which it is cited,
and with a reference to the applicable passage(s) of FIFRA
10(d)(1)  on which the confidentiality claim is based.

D.4. Supplemental Statement of Data Confidentiality Claims (See
     Attachment 4)

     If you wish to make a claim of confidentiality for any
portion of a submitted study other than described by FIFRA 10(d)
(1)(A), (B),  or  (C),  the following provisions apply:

     - The specific information to which the claim applies must
     be clearly marked in the body of the study as subject to a
     claim of confidentiality.

     - A Supplemental Statement 9f Data Confidentiality Claims
     must be submitted,  identifying each passage claimed confi-
     dential and describing in detail the basis for the claim.
     A list of the points to address in such a statement is
     included in Attachment 4 on Pg 14.

     - The Supplemental Statement of Data Confidentiality Claims
     must be signed and dated and must include the typed name and
     title of the official who signed it.

D.5. Good Laboratory Practice Compliance Statement

     This statement is required if the study contains laboratory
work subject to GLP requirements specified in 40 CFR 160.  Sam-
ples of these statements are shown in Attachment 6.

E.    Reference to Previously Submitted Data

     DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED
FOR ANOTHER PURPOSE unless EPA specifically requests it.   A copy
of the title page plus the MRID number (if known) is sufficient
to allow us t9 retrieve the study immediately for review.  This
prevents duplicate entries in the Agency files, and saves you
the cost of sending more copies of the study.  References to pre-
viously submitted studies smpuld not be included in the transmit-
tal document,  but should be incorporated into the statement of
the method of support for the application.

F.    Physical Format Requirements

     All elements in the data submittal package must be on
uniform 8 1/2 by 11 inch white paper, printed 9n one side only in
black  ink,  with high contrast and good res9lution.  Bindings for
individual studies must be secure, but easily removable to permit
disassembly for microfilming.  Check with EPA for special


                                59

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instructions bef9re submitting data in any medium other than
paper, such as film or magnetic media.

Please be particularly attentive to the following points:

         Do not include frayed or torn pages.

         Do not include carbon copies, or copies in other than
          black ink.

         Make sure that photocopies are clear,  complete, and
          fully readable.

         Do not include oversize computer printouts or fold-out
          pages.

         Do not bind any documents with glue or binding tapes.

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

     Number of Copies Required - All submittal packages except
those associated with a Registration Standard or Special Review
(See Part G below)  must be provided In three complete,  identical
copies.  (The prop9sed regulati9ns specified two copies; three
are now being required to expedite and reduce the cost of
processing data into the OPP Pesticide Document Management System
and getting it into review.)

G.   Special Requirements for Submitting Data to the Docket

     Data submittal packages associated with a Registration Stan-
dard 9r Special Review must be provided in four C9pies, fr9m one
of which all material claimed as CBI has been excised.   This
fourth copy will become part of the public docket for the RS or
SR case.  If no claims of confidentiality are made for the study,
the fourth copy should be identical to the other three.  When
portions of a study submitted in support of an RS or SR are
claimed as CBI, the first three copies will include the CBI
material as provided in section D of this notice.  The following
special preparation is required for the fourth copy.

         Remove the "Supplemental Statement of Data
          Confidentiality Claims".

         Remove the "Confidential Attachment".

         Excise from the body of the study any information you
          claim as confidential, even if it does not fall within
          the scope of FIFRA 10(d)(1)(A), (B),  or  (C).  Do not
          close up or paraphrase text remaining after this
          excision.

         Mark the fourth copy plainly on both its cover and its
          title page with the phrase "Public Docket Material -
          contains no information claimed as confidential".
                                60

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V.    For Further Information

     For further information contact John Carley, Chief,
Information Services Branch, Program Management and Support
Division, (703) 305-5240.
                              /S/

                         James W. Akerman
                         Acting Director,
                         Registration Division
Attachment 1.   Sample Transmittal Document
Attachment 2.   Sample Title Page for a Newly Submitted Study
Attachment 3.   Statements of Data Confidentiality Claims
Attachment 4.   Supplemental Statement of Data Confidentiality
               Claims
Attachment 5.   Samples of Confidential Attachments
Attachment 6.   Sample G9od Laboratory Practice Statements
Attachment 7.   Format Diagrams for Submittal Packages and Studies
                                61

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                          ATTACHMENT 1

       ELEMENTS  TO  BE  INCLUDED  IN THE  TRANSMITTAL  DOCUMENT*

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

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



"Smith Chemical  Corp will  act as  sole  agent  for all submitters.

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

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

3.   Transmittal date

4.   List of submitted studies

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

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

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

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

     *    Indicate which of the J9int submitters is empowered to
          act on behalf of all joint submitters in any matter
          concerning data compensation or subsequent use or
          release of the data.


Company Official: 	
                    Name                Signature

Company Name       	

Company Contact:  	 	
                    Name                Phone
                                62

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                   ATTACHMENT 2
SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY
                    Study Title
   (Chemical name)  - Magnitude  of  Residue  on  Corn
                  Data  Requirement
                  Guideline 171-4
                       Author
                   John C. Davis
                 Study  Completed On
                  January 5, 1979
               Performing Laboratory
           ABC Agricultural Laboratories
                 940 West  Bay Drive
               Wilmington,  CA  39897
               Laboratory Project ID
                     ABC 47-79
                    Page 1 of X
   (X is the total number of pages in the study)
                         63

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                            ATTACHMENT 3

             STATEMENTS  OF DATA CONFIDENTIALITY CLAIMS

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

        STATEMENT OF NO  DATA CONFIDENTIALITY CLAIMS
   No  claim of  confidentiality is made for any information contained  in this
   study on the basis of  its falling within the scope of FIFRA
   610(d)(1)(A),  (B),  or (C).


   Company 	


   Company Agent: 	Typed Name	 Date:	


   	Title	  	Signature	
2. Claim of confidentiality under FIFRA 10(d)(1)(A),  (B),  or (C).
   Information  claimed confidential on the basis of its falling within the
   scope of FIFRA 10(d)(1)(A),  (B), or (C) has been removed to a
   confidential appendix, and is  cited by cross-reference number in the body
   of  the study.


    Company: 	


    Company Agent: 	Typed Name	 Date:	


   	Title	  Signature 	
             STATEMENT OF DATA  CONFIDENTIALITY  CLAIMS

NOTE: Applicants for  permanent or temporary tolerances  should
note that  it is OPP policy that no permanent tolerance,  temporary
tolerance,  or request for an emergency  exemption incorporating an
analytical  method, can be approved unless the applicant  waives
all claims  of confidentiality for the analytical method.   These
analytical  methods are published in the FDA Pesticide Analytical
Meth9ds  Manual, and therefore cannot be claimed as confidential.
OPP implements this policy by returning submitted analytical
methods,  for which confidentiality claims have been  made,  to the
submitter,  to obtain  the  confidentiality waiver before  they can
be processed.
                                  64

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                          ATTACHMENT 4

      SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
     For any portion of a submitted study that is not described
by FIFRA 10(d)(1)(A), (B),  or (C),  but for which y9u claim
C9nfidential treatment 9n another basis, the following informa-
tion must be included within a Supplemental Statement of Data
Confidentiality Claims:

         Identify specifically by page and line number(s) each
          portion of the study for which you claim
          confidentiality.

         Cite the reasons why the cited passage qualifies for
          confidential treatment.

         Indicate the length of time--until a specific date or
          event,  or permanently--for which the information should
          be treated as confidential.

         Identify the measures taken to guard against undesired
          disclosure of this information.

         Describe the extent to which the information has been
          disclosed, and what precautions have been taken in con-
          nection with those disclosures.

         Encl9se C9pies of any pertinent determinations of
          confidentiality made by EPA, other Federal agencies, of
          courts concerning this information.

         If y9u assert that disclosure of this information would
          be likely to result in substantial harmful effects to
          you, describe th9se harmful effects and explain why
          they should be viewed as substantial.

         If you assert that the informati9n in voluntarily sub-
          mitted, indicate whether you believe disclosure of this
          information might tend to lessen the availability to
          EPA of similar information in the future, and if so,
          how.
                                65

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                                   ATTACHMENT 5

              EXAMPLES OF SEVERAL  CONFIDENTIAL ATTACHMENTS

Example  1.  (Confidential  word or phrase  that has  been  deleted
from  the study)
    CROSS REFERENCE NUMBER 1       This cross reference number is used in the study in place of the
                                     following paragraph (s) at the indicated volume and page
                                     references.
    DELETED WORDS OR PHRASE:              Ethylene Glycol
    PAGE         LINES  REASON FOR THE DELETION                      FIFRA
    REFERENCE
     6            14     Identity of Inert Ingredient                           10(d)(C)
    28           25
    100           19
Example 2. (Confidential paragraph(s) that have been deleted from the study)
 CROSS REFERENCE NUMBER 5       This cross reference number is used in the study in place of the
                                   following paragraph (s) at the indicated volume and page
                                   references.
  DELETED PARAGRAPH(S) :
        (                                                                   )
        (       Reproduce the deleted paragraph (s) here                              )
 PAGE         LINES REASON FOR THE DELETION               FIFRA REFERENCE
  20.           2-17   Description of the quality control process           1 0 (d) ( 1) (C)
Example 3. (Confidential pages that have been deleted from the study)
 CROSS REFERENCE NUMBER 7      This cross reference number is used in the study in place of the
                                  following paragraph (s) at the indicated volume and page
                                  references.
 DELETED PAGES(S): are attached immediately behind this page

 PAGES        REASON FOR THE DELETION               FIFRA REFERENCE
 35-41.        Description of product manufacturing process             10 (d) (1) (A)
                                           66

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                             ATTACHMENT 6.

            SAMPLE GOOD LABORATORY PRACTICE STATEMENTS

Example 1.
     This  study meets the requirements for 40 CFR Part  160

           Submitter 	

           Sponsor   	
Example 2.
    This study does not meet the  requirements of 40  CFR  Part 160, and
    differs  in the following ways:

    1.	

    2.	

    3.	

          Submitter	

          Sponsor	
          Study Director_
Example 3.
    The submitter of this study was neither the sponsor of this study nor
    conducted  it, and does not  know whether it has  been conducted in
    accordance with 40 CFR Part 160.

          Submitter
                                    67

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                              ATTACHMENT  7.
                     FORMAT OF THE SUBMITTAL PACKAGE
                       Transmittal Document

                            Related Administrative Materials
                            (e.g. Method of Support Statement, etc.)

                                   Other materials about the submittal
                                   (e.g., summaries of groups of studies
                                   to aid in their review).

                                           Studies submitted as unique
                                           to the format below.
                      FORMAT OF SUBMITTED STUDIES
                 Study title page.

                      Statement of Confidentiality Claims.

                           GLP and flagging* statements - as appropriate.

                                 Body of the study, with English
                                 language translation if required.
                                     Appendices to the study.
                                          Title Page of the Confidential
                                          Attachment.
                                             Confidential Attachment.
                                               Supplemental Statement
                                               of Confidentiality Claims
                                      When flagging requirements
                                      are finalised.
                 Documents which must be submitted as
                 appropriate to meet established requirements.

                      Documents submitted at submitter's option.
LEGEND
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PR Notice 91-2
      69

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              UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                             WASHINGTON, B.C. 20460
                                                         OFFICE OF
                                                     PREVENTION, PESTICIDES
                                                     AND TOXIC SUBSTANCES
                          PR NOTICE 91-2

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

ATTENTION: Persons Responsible for Federal Registration of
Pesticide Products.

SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement

I.  PURPOSE:

     The purpose of this notice is to clarify the Office of
Pesticide P^gram's P9licy with respect to the statement of
percentages in a pesticide's label's ingredient statement.
Specifically, the amount  (percent by weight) of ingredient(s)
specified in the ingredient statement on the label must be stated
as the nominal concentration of such ingredient(s), as that  term
is defined in 40 CFR 158.153(1). Accordingly, the Agency has
established the nominal concentration as the only acceptable
label claim for the amount of active ingredient in the product.

II.  BACKGROUND

     For some time the Agency has accepted two different methods
9f identifying on the label what percentage is claimed for the
ingredient(s) contained in a pesticide. Some applicants claimed a
percentage which represented a level between the upper and the
lower certified limits. This was referred to as the nominal
concentration. Other applicants claimed the lower limit as the
percentage of the ingredient(s) that would be expected to be
present in their product at the end of the product's shelf-life.
Unfortunately, this led to a great deal of confusion among the
regulated industry, the regulators, and the consumers as to
exactly how much of a given ingredient was in a given product.
The Agency has established the nominal concentration as the  only
acceptable label claim for the amount of active ingredient in the
product.

     Current regulations require that the percentage listed  in
the active ingredient statement be as precise as possible
reflecting go9d manufacturing practices 40 CFR 156.10(g)(5). The
certified limits required for each active ingredient are intended
to encompass any such "good manufacturing practice" variations 40
CFR 158.175 (c) (3) .

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

     The nominal concentration would in fact state the greatest
degree of accuracy that is warranted with respect to actual


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product compositi9n because the nominal concentration would be
the amount of active ingredient typically found in the product.

     It is imp9rtant for registrants to note that certified
limits for active ingredients are not considered to be trade
secret information under FIFRA section 10(b).  In this respect the
certified limits will be routinely provided by EPA to States for
enforcement purposes, since the nominal concentration appearing
on the label may not represent the enforceable composition for
purposes of section 12(a)(1)(C).

III. REQUIREMENTS

     As described below under Unit V. " COMPLIANCE SCHEDULE," all
currently registered products as well as all applications for new
registration must comply with this Notice by specifying the
nominal C9ncentrati9n expressed as a percentage by weight as the
label claim in the ingredient(s)  statement and equivalence
statements if applicable (e.g., elemental arsenic, metallic zinc,
salt of an acid).  In addition, the requirement for performing
sample analyses of five or more representative samples must be
fulfilled. C9pies of the raw analytical data must be submitted
with the nominal ingredient label claim. Further information
about the analysis requirement may be found in the 40 CFR
158.170. All products are required to pr9vide certified limits
for each active, inert ingredient, impurities of toxicological
significance(i.e.,  upper limit(s) 9nly) and on a case by case
basis as specified by EPA.  These limits are to be set based on
representative sampling and chemical analysis(i.e., quality
control) of the product.

     The format of the ingredient statement must conform to 40
CFR 156-Labeling Requirements For Pesticides and Devices.

     After July 1,  1997, all pesticide ingredient Statements must
be changed to nominal concentration.

IV. PRODUCTS THAT REQUIRE EFFICACY DATA

     All pesticides are required to be efficacious. Therefore,
the certified lower limits may not be lower then the minimum
level to achieve efficacy.  This is extremely important for
products which are intended to C9ntrol pests which threaten the
public health, e.g., certain antimicrobial and rodenticide
products. Refer to 40 CFR 153.640.

     In those cases where efficacy limits have been established,
the Agency will not accept certified lower limits which are below
that level for the shelf life of the product.

V. COMPLIANCE SCHEDULE

     As described earlier,  the purpose of this Notice is to make
the registration process more uniform and more manageable for
both the agency and the regulated community. It is the Agency's
intention to implement the requirements of this notice as
smoothly as possible so as not to disrupt or delay the Agency's
high priority programs,  i.e.,  reregistration,  new chemical, or
fast track (FIFRA section 3(c)(3)(B). Therefore,
applicants/registrants are expected to comply with the
requirements of this Notice as follows:

     (1)  Beginning July 1, 1991, all new product registrations
          submitted to the Agency are to comply with the
          requirements of this Notice.
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     (2)  Registrants having products subject to reregistration
          under FIFRA section 4(a) are to comply with the
          requirements of this Notice when specific products are
          called in by the Agency under Phase V of the
          Reregistration Program.

     (3)  All other products/applications that are not subject to
          (1) and  (2) ab9ve will have until July 1, 1997, to
          comply with this Notice. Such applications should note
          "Conversion to Nominal Concentrations on the
          application form. These types Or amendments will not be
          handled as "Fast Track" applications but will be
          handled as routine requests.

VI. FOR FURTHER INFORMATION

Contact Tyrone Aiken for information or questions concerning
this notice on (703) 308-7031.


                                   /s/
                         Anne E. Lindsay, Director
                         Registration Division (H-7505C)
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APPENDIX F. Product Specific Data Call-in
                  75

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                               DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:


This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment 1 of this Notice, the Data Call-in Chemical Status Sheet,
to submit certain product specific data as noted herein to the U.S. Environmental Protection
Agency (EPA, the Agency).  These data are necessary to maintain the continued registration
ofyour product(s) containing this active ingredient. Within 90 days after you receive this
Notice you must respond as set forth in Section III below. Your response must state:

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

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

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

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

       The authority for this Notice is section 3(c)(2)(B)  of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 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 (expiration date 12-31-92).
    This Notice is divided into six sections and seven Attachments.  The Notice itself
contains information and instructions applicable to all Data Call-In Notices.  The Attachments
contain specific chemical information and instructions.  The six sections of the Notice are:

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

   The Attachments to this Notice are:


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       1  -    Data Call-in Chemical Status Sheet
       2  -    Product-Specific Data Call-in Response Form
       3  -    Requirements Status and Registrant's Response Form
       4  -    EPA Grouping or End-Use Products tor Meeting Acute Toxicology Data
             Requirements tor Reregistration
             EPA
      5  -    EPA Acceptance Criteria
      6  -    List or Registrants Receiving This Notice
      7  -    Cost Share and Data Compensation Forms, and Product Specific Data Report
             Form


SECTION I.  WHY YOU ARE RECEIVING THIS NOTICE

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

SECTION II. DATA REQUIRED BY THIS NOTICE

II-A.  DATA REQUIRED

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

II-B.  SCHEDULE FOR SUBMISSION OF DATA
   You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment 3, Requirements Status and Registrant's Response Form, within the time frames
provided.


II-C.  TESTING PROTOCOL

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

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

       Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those
specified in the Pesticide Data Requirements regulation (40 CFR  158.70). When using the
C"ECD protocols, they should be  modified as appropriate so that the data generated by the
study will satisfy the requirements of 40 CFR   158.  Normally, the Agency will not extend
deadlines for complying with data requirements when  the studies were not conducted in
accordance with acceptable  standards. The  OECD protocols are available from OECD, 1750
Pennsylvania Avenue N.W., Washington, D.C.  20006.

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

II-D.  REGISTRANTS RECEIVING  PREVIOUS SECTION 3(c)(2)(B) NOTICES
     ISSUED BY THE AGENCY -
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     Unless otherwise noted herein, this Data Call-in does not in any way supersede or
change the  requirements of any previous Data Call-in (s), or any other agreements entered
into with the Agency pertaining to such prior Notice.  Registrants must comply with the
requirements of all Notices to avoid issuance of a Notice of Intent to Suspend their affected
products.

SECTION  III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE

III-A.  SCHEDULE FOR  RESPONDING TO THE AGENCY

       The appropriate responses initially required by this Notice for product specific data
must be submitted to the Agency within 90 days after your receipt of this Notice. Failure to
adequately  respond to this  Notice within 90 days of your receipt will be a basis for issuing a
Notice of Intent to Suspend (NOIS) affecting your products. This and other bases for issuance
of NOIS due to failure to comply with this Notice are  presented in Section IV-A and IV-B.

III-B.  OPTIONS FOR RESPONDING TO THE AGENCY

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

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

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

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


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Data Call-in Response Form. Deletion of a use(s) and the low volume/minor use option are
not valid options tor fulfilling product specific data requirements.

       3. Request for Product Specific Data Waivers.  Waivers for product specific data are
discussed in section 111-JJ of this Notice and are covered by ojition 7 on the Requirements
Status and Registrant's Response Form.  If you choose one of these options, you must submit
both forms as well as any other information/data pertaining to the option chosen to address
the data requirement.

III-C  SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE

       If you acknowledge on the Data Call-In Response Form that you agree to satisfy the
product specific data requirements (i.e. you select item number 7a or 7b), then you must
select one of the six options on the Requirements Status and Registrant's Response Form
related to data production for each data requirement.  Your option selection should be entered
under item number 9, "Registrant Response."  The  six options related to data production are
the first six options discussed under item 9 in the instructions for completing the
Requirements Status and Registrant's Response Form.  These six options are listed
immediately below with information in parentheses to guide registrants to additional
instructions provided in this Section.  The options are:

       (1)     I will generate and submit data within the specified time frame (Developing
              Data)
       (2)     I have entered into an agreement with one or more registrants to develop data
             jointly (Cost Sharing)
             I have made offers to cost-share  (Offers to Cost Share)
              I am submitting an existing study that has not been submitted previously to the
              Agency by anyone (Submitting an Existing Study)
       (5)     I am submitting or citing data to upgrade a study classified by EPA as partially
              acceptable and upgradeable (Upgrading a Study)
       (6)     I am citing an existing study that EPA has classified as acceptable  or an
              existing study that has  been submitted but not reviewed by the Agency (Citing
              an Existing Study)

       Option 1  Developing Data   If you choose  to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced herein
and in the attachments.  All data  generated and submitted must comply with the Good
Laboratory Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide
Assessment Guidelines  (PAG), and be in conformance with the requirements of PR Notice
86-5.

       The time frames in the Requirements Status  and Registrant's Response Form are the
time frames that the Agency is allowing for the submission of completed study reports. The
noted deadlines run from the date of the receipt of this Notice by the registrant.  If the data
are not submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to
Suspend the affected registration(s).

       If you cannot submit the data/reports to the Agency in the time required by this Notice
and intend to seek additional time to meet the requirements (s), you must submit a request to
the Agency which includes:  (1) a detailed description of the expected difficulty and (2) a
proposed schedule including alternative dates for meeting such requirements on a step-by-step
basis.  You must explain any technical or laboratory difficulties and provide documentation
from the laboratory performing the testing.  While EPA is considering your request, the
original deadline remains.  The Agency will respond to your request in writing.  If EPA does
not grant your request, the original deadline remains. Normally, extensions can  be requested
only in cases of 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
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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 tor acute toxicity data and certain efficacy data and only if EPA has
indicated in the attached data tables that your product and at least one other product are
similar for purposes of depending on the same data. If this is the case,  data may be generated
for just one of the products in  the group. The registration number of the product for which
data will be submitted must be noted in the agreement to cost share by the registrant selecting
this option.  If you  choose to enter into an agreement to share in  the cost of producing the
required data but will not be submitting the data yourself, you must provide the name of the
registrant who will  be submitting the data.  You must also provide EPA with documentary
evidence that an agreement has been formed. Such evidence may be your letter offering to
join in an agreement and the other registrant's acceptance of your offer, or a written
statement by the parties that an agreement exists.  The agreement to produce the data need
not specify all of the terms of the final arrangement between the parties or the mechanism to
resolve the terms.  Section 3(c)(2)(B) provides that if the parties  cannot resolve the terms  of
the agreement they  may resolve their differences through binding arbitration.

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

       In order for  you to avoid suspension under this option, you may not withdraw  your
offer to share in the burdens of developing the data. In addition, the other registrant must
fulfill its commitment to develop and submit the data as required by this Notice. If the other
registrant fails to develop the data or for some other reason is subject to suspension, your
registration as well  as that of the other registrant will normally be subject to initiation of
suspension proceedings, unless you commit to submit, and do submit the required data in the
specified time 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).
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       You should be aware that if the Agency determines that the study is not acceptable,
the Agency will require you to comply with this Notice, normally without an extension of the
required date of submission.  The Agency may determine at any time that a study is not valid
and needs to be repeated.

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

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

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

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


       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.
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       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 articulatedTationale
of how the  deficiencies have been remedied or corrected and why the study should  be rated as
acceptable to EPA.  Your submission must also specify the MRID number (s) of the study
which you are attempting to upgrade and must be in conformance with PR Notice 86-5.

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

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

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

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

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

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

III-D  REQUESTS FOR DATA WAIVERS

              If you request a waiver for product specific data because you believe it is
inappropriate,  you must attach a complete Justification for the request, including technical
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
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should also be aware that submitting a waiver request will not automatically extend the due
date for the study in question.  Waiver requests submitted
without adequate supporting rationale will be denied and the original due date will remain in
force.

IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE

IV-A NOTICE OF INTENT TO SUSPEND

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS

       EPA has statutory authority to  permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or cancelled if doing so would be
consistent with the purposes of the Act.

       The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section  3 (c) (2) (B) data  request is outstanding would generally
not be consistent with the Act's purposes.  Accordingly, the Agency anticipates granting
registrants permission to sell, distribute, or use existing stocks of suspended product(s) only
in exceptional  circumstances. If you believe such disposition of existing stocks of your
product(s) which may be suspended for failure to comply with this Notice should be
permitted, you have the burden of clearly demonstrating to EPA that granting such
permission would be consistent with the Act. You must also explain why an existing stocks"
provision is necessary, including a statement of the quantity of existing stocks and your
estimate of the time required for their  sale, distribution, and use. Unless you meet this
burden the Agency will not consider any request pertaining to the continued sale, distribution,
or use of your existing stocks after suspension.

       If you request a voluntary cancellation  of your product(s) as a response to this Notice
and your product is in full compliance with all Agency requirements, you will have,  under
most circumstances, one year from the date your  90 day response to this Notice is due, to
sell, distribute, or use existing  stocks.  Normally, the Agency will allow persons other than
the 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


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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,  oefore EPA
will consider granting an existing stocks provision.

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

       Registrants are reminded that FIFRA section 6 (a) (2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the  registrant shall submit the
information to the Agency.  Registrants must notify the Agency of  any factual information
they have, from whatever source, including but not limited to interim or preliminary results
of studies, regarding unreasonable adverse effects on man or the environment.  This
requirement continues as long as the products are registered by the  Agency.

SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE

       If you have any questions regarding the requirements and procedures established by
this Notice, call the  contact person(sj listed in Attachment 1, the Data Call-In Chemical
Status Sheet.
       All responses to this Notice (other than voluntary cancellation requests and generic
      cemption claims)  must include a completed Data Call-in Response Form and c
completed Requirements Status and Registrant's Response Form (Attachment 2 and
data exemption claims) must include a completed Data Call-in Response Form and a
completed Requirements Status and Registrant's Response Form (Attachment 2 and
Attachment 3 for product specific data) and any other documents required by this Notice, and
should be submitted to the contact person(s) identified in Attachment 1. If the voluntary
cancellation or generic data exemption option is chosen, only the Data Call-In Response Form
need be submitted.

       The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this
Notice.

                                       Sincerely yours,
                                       Peter Caulkins, Acting Director
                                       Special Review and
                                         Reregistration Division
Attachments

       1  -
       2  -
       3  -
       4  -

       5  -
       6  -
       7  -
             Data Call-In Chemical Status Sheet
             Product-Specific Data Call-in Response Form
             Requirements Status and Registrant's Response Form
             EPA Grouping; ot End- Use Products tor Meeting Acute Toxicology Data
             Requirements tor Reregistration
             EPA
     Acceptance Criteria
List of Registrants Receiving This Notice
Cost Share and Data Compensation Forms, and Product Specific Data Report
Form
                                           86

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Attachment 1. Chemical Status Sheet
                87

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 DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

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

       This Product Specific Data Call-In Chemical Status Sheet contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of
chloroxylenol.  This attachment is to be used in conjunction with (1) the Product Specific Data
Call-In Notice, (2) the Product Specific Data Call-In Response Form  (Attachment 2), (3) the
Requirements Status and Registrant's Form (Attachment 3),  (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA
Acceptance Criteria (Attachment 5), (o) a list of registrants receiving this DCI (Attachment 6)
and (7) the Cost Share and Data Compensation Forms in replying to this 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  are contained in the
Requirements Status and Registrant's Response, Attachment  3.  The Agency has concluded that
additional data on are needed for specific products. These data are required to be submitted to
the Agency within the time frame listed.  These data are needed to fully complete the
reregistration of all eligible products.

INQUIRIES AND RESPONSES TO THIS NOTICE

       If you have any questions regarding the product specific data requirements and procedures
established by this Notice, please contact Franklin Gee at  (703) 308-8008.

       All responses to this Notice for the Product Specific data requirements should be
submitted to:
             Emily Mitchell
             Chemical Review Manager Team 81
             Product Reregistration Branch
             Special Review and Reregistration Branch 7508W
             Office of Pesticide Programs
             U.S. Environmental Protection Agency
             Washington, D.C. 20460

             RE: CHLOROXYLENOL
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Attachment 2.  Product Specific Data Call-In Response
       Forms  (Form A inserts) Plus Instructions
                         89

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90

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   INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR
                             PRODUCT SPECIFIC DATA

Item 1-4.     Already completed by EPA.

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

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

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

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

Items 8-11.  Self-explanatory.

NOTE:       You may provide additional information that does not fit on this form in a signed
             letter that accompanies this form.  For example,  you may wish to report that your
             product has already been  transferred to another company or that you have already
             voluntarily canceled this product. For these cases, please supply all relevant details
             so that EPA can ensure that its records are correct.
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       INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
         REGISTRANT'S RESPONSE FORM FOR PRODUCT SPECIFIC DATA

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

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

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

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

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

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

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

       1.     I  will generate and submit data by the specified due date  (Developing Data).  By
             indicating that I have chosen  this  option, I certify that I will comply with all the
             requirements pertainingto the conditions for submittal of this study as outlined in the
             Data Call-In Notice.  By the specified due date, I will also submit: (1) a completed
             "Certification With Respect To Data Compensation  Requirements" form (EPA
             Form  8570-29) and (2)  two  completed and  signed  copies of the Confidential
             Statement of Formula (EPA Form 8570-4).

       2.     I  have entered into an agreement with one or more registrants to develop data jointly
             (Cost Sharing).  I  am submitting a copy of this agreement.  I understand  that this
             option is  available only for acute toxicity or certain efficacy data and only if EPA
             indicates in an attachment to this Notice that my product is similar enough to another
             product to qualify for this option.  I certify that another party in the agreement is
             committing to submit or provide  the required data; if the required study is  not
             submitted  on time,  my product may be subject to suspension. By the specified due
             date,  I will also submit:  (1)  a completed "Certification  With Respect To Data
             Compensation Requirements" form (EPA Form 8570-29) and (2)  two  completed
             and signed copies of the Confidential Statement of Formula (EPA Form 8570-4).

       3.     I  have made offers to share in the  cost to develop data (Offers to Cost  Share).  I
             understand that this option is available only for acute toxicity or certain efficacy data
             and only if EPA indicates in an attachment to this Data Call-In Notice that my product
             is similar enough to another product to qualify for  this option.  I  am submitting
             evidence that I have made an offer to another registrant (who has an obligation to
             submit data) to share in the cost of that data.  I  am also submitting  a  completed


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       "Certification of Offer to  Cost Share in the Development Data" form.  I am
       including a copy of my offer and proof of the other registrant's receipt of that offer.
       I am identifying the party which is committing to submit or provide the required data;
       if the required study  is not submitted on time, my product may be subject to
       suspension.  I understand that other terms under Option 3 in the Data Call-in Notice
       (Section III-C.l.) apply as well.  By the specified due date, I will also submit: (1) a
       completed "Certification With Respect To Data Compensation Requirements"
       form  (EPA Form 8570-29)  and  (2) two completed and signed copies of the
       Confidential Statement of Formula (EPA Form 8570-4).

4.      By the specified due date, I will submit an existing study that has not been submitted
       previously to the Agency by anyone (Submitting an Existing Study).  I certify that
       this  study  will meet all the requirements for submittal of existing data outlined in
       Option 4 in the Data Call-in Notice (Section III-C.l.) and will meet the  attached
       acceptance criteria (for acute toxicity and product chemistry data).  I will attach the
       needed supporting information along with this response.  I also certify that I have
       determined that this study will fill the data requirement for which I have indicated this
       choice. By the specified due date, I will also submit a completed "Certification With
       Respect To Data Compensation  Requirements" form (EPA Form 8570-29) to
       show what data compensation option I have chosen. By the specified due date, I will
       also submit: (1) a completed "Certification With Respect To Data Compensation
       Requirements" form (EPA Form 8570-29) and (2) two completed and signed copies
       of the Confidential Statement of Formula (EPA Form 8570-4).

5.      By the specified due date,  I will submit or cite data to upgrade a study classified by
       the Agency as partially acceptable and upgradable  (Upgrading a Study).  I will
       submit evidence of the Agency's review indicating that the study  may be upgraded
       and what information is required to do so.  I will provide the MRID or Accession
       number of the study at the due  date. I understand that the conditions for this option
       outlined Option  5  in the Data  Call-In Notice (Section III-C.l.) apply.   By the
       specified due date, I will also submit: (1) a completed "Certification With  Respect
       To Data Compensation Requirements"  form (EPA Form 8570-29) and (2) two
       completed and signed copies of the Confidential Statement of Formula (EPA Form
       8570-4).

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

7.      I request a waiver for this study because it is inappropriate for  my product  (Waiver
       Request).  I am attaching a complete justification for this request, including technical
       reasons, data and references to  relevant  EPA regulations, guidelines or  policies.
       [Note: any supplemental data must be submitted in the format required by P.R. Notice
       86-5]. I understand that this is my only opportunity to state the reasons or provide
       information in support of my request.  If the Agency approves my waiver request, I
       will not be required to supply the data pursuant to Section 3(c) (2) (B) of FIFRA.  If
       the Agency denies my waiver request, I must choose a method of meeting the data


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             requirements of this Notice by the due date stated by this Notice.  In this case, I must,
             within 30 days of my receipt of the Agency's written decision, submit a revised
             "Requirements Status and Registrant's Response" Form indicating the option chosen.
             I also understand that the deadline for submission of data as specified by the original
             data call-in notice will not change.  By the specified due date, I will also submit:  (1)
             a completed "Certification With Respect To Data Compensation Requirements"
             form (EPA  Form 8570-29)  and (2)  two completed  and signed  copies of the
             Confidential Statement of Formula (EPA Form 8570-4).

Items 10-13.  Self-explanatory.

NOTE:      You may provide additional information that does not fit on  this form in a signed
             letter that accompanies this form.  For example, you may wish to report that your
             product has already been transferred to another company or that you have already
             voluntarily canceled this product.  For these cases, please supply all relevant details
             so that EPA can ensure that its records are correct.
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Attachment 3. Product Specific Requirement Status and
   Registrant's Response Forms (Form B inserts) and
                    Instructions
                         95

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96

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

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

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

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

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

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

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

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

             1.     I will generate and submit data by the specified due  date (Developing Data).
             By  indicating that I have  chosen this option, I certify that I will comply with all the
             requirements pertaining to the conditions for submittal of this study as outlined in the
             Data Call-In Notice.

             2.     I have entered into an agreement with one or more registrants to develop data
             jointly (Cost Sharing).  I am submitting a copy of this agreement.  I understand that
             this option is available on for acute toxicity or certain efficacy  data and only if EPA
             indicates in an attachment to this notice that my product is similar. Enough to another
             product to qualify for this option. I certify that another party in the agreement is
             committing  to submit or provide the required data;  if the required study is not
             submitted on time, my product my be  subject to suspension.

             3.     I have made offers to share in the cost to develop data (Offers to Cost Share).
             I understand that this option is available only for acute toxicity or certain efficacy data
             and only if EPA indicates in an attachment to this Data Call-In Notice that my product
             is similar enough to another product to  qualify for this option.   I am submitting
             evidence that I have made an  offer to another  registrant (who has an obligation to
             submit data) to share in the cost of that data.  I am also submitting a completed "
             Certification of offer to Cost Share in the Development Data" form. I am including
             a copy of my offer and proof of the  other registrant's receipt of that offer.   I am
             identifying the party which is committing to submit or provide the require data; if the
             required study is not submitted on time, my product may be subject to suspension.
             I understand that other terms under Option 3 in the Data Call-in Notice (Section III-
             C.l.) apply as well.
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              4.      By the specified due date, I will submit an existing study that has not been
              submitted previously to the Agency by anyone  (submitting an Existing Study).   I
              certify that this study will meet all the requirements for submittal of existing data
              outlined in option 4 in the Data Call-in Notice (Section III-C.l.) and will meet the
              attached acceptance criteria  (for acute toxicity and product chemistry  data).  I will
              attach the needed supporting information along with this response. I also certify that
              I have  determined that this  study  will fill the data requirement for which I have
              indicated this choice.

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

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

              7.      I request a  waiver  for this study because it is inappropriate for my product
              (Waiver Request). I am attaching a complete justification for this request, including
              technical reasons,  data and references to relevant EPA  regulations, guidelines or
              policies. [Note: any supplemental data must be submitted in the format required by
              P.R.  Notice 86-5].  I understand that this is my only opportunity to state the reasons
              or provide information in support of my request.  If the Agency approves my waiver
              request, I will not be require to supply the data  pursuant to Section 3(c)  (2) (B) of
              FIFRA. If the Agency denies my waiver request, I must choose a method of meeting
              the data requirements  of this Notice by the due  date stated by this Notice.  In this
              case, I must, within 30 days of my  receipt of the Agency's written decision, submit
              a  revised  "Requirements Status chosen.  I also understand that the  deadline for
              submission of data  as specified by the original data cal-in notice will not change.

Items 10-13.   Self-explanatory.

       NOTE:You may provide additional information that does not fit on this form in a signed letter
that accompanies this form.  For example, you may wish to report that your product has already been
transferred to another company or that you have already voluntarily cancelled this product.  For
these cases, please supply all relevant details so that EPA can ensure that its records are correct.
                                             98

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Attachment 4. EPA Batching of End-Use Products for
   Meeting Data Requirements for Reregistration
                       99

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100

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EPA'S  BATCHING  OF 4-CHLORO-3,5-XYLENOL 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 4-chloro-3,5-xylenol as the active
ingredient, the Agency has batched products which can be considered similar for purposes of acute
toxicity. Factors considered in the sorting process include each product's active and inert ingredients
(identity, percent  composition and biological  activity),  type  of formulation  (e.g., emulsifiable
concentrate,  aerosol,  wettable powder,  granular,  etc.),  and  labeling (e.g.,  signal word,  use
classification, precautionary labeling, etc.). Note that the Agency is not describing batched products
as "substantially similar" since some products within a batch may not be considered chemically
similar or have identical use patterns.

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

       Registrants of products within a batch may choose to cooperatively generate,  submit or cite
a single battery of six acute toxicological studies to represent all the products within that batch. It
is the registrants' option to participate in the process with all other registrants, only some of the other
registrants,  or  only their own products within  a  batch, or to generate all  the required acute
toxicological studies for each of their own products.  If a registrant chooses to generate the data for
a batch,  he/she  must use one of the products within the batch as the test material.   If a registrant
chooses to rely upon previously submitted acute toxicity data, he/she may do so provided that the
data base  is complete  and valid by  today's  standards (see  acceptance criteria  attached), the
formulation tested is considered by EPA to be similar for acute toxicity, and the formulation has not
been significantly altered since submission and acceptance of the acute toxicity  data.  Regardless of
whether new data is generated or existing data is referenced, registrants must clearly identify the test
material by EPA Registration Number. If more than one confidential statement of formula (CSF)
exists for a product, the registrant must indicate the formulation actually tested by identifying the
corresponding CSF.

       In deciding  how to meet the product specific data requirements,  registrants must follow the
directions given in the Data Call-In Notice and its attachments appended to the RED.  The DCI
Notice contains two response forms which are to be completed and submitted to the Agency within
90 days of receipt.  The first form, "Data Call-In Response," asks whether the registrant will meet
the data requirements for each product. The  second form,  "Requirements Status and Registrant's
Response,"  lists the product specific data required for each product, including the standard six acute
toxicity tests. A registrant who wishes to  participate in a batch must decide whether he/she will
provide the data or depend on someone else to do so.  If a registrant supplies the data to support a
batch of products, he/she must select one of the following options: Developing Data (Option 1),
Submitting  an Existing Study (Option 4),  Upgrading an Existing Study (Option 5) or Citing an
Existing Study (Option 6). If a registrant depends on another's data, he/she must choose among: Cost
Sharing (Option z), Offers to Cost Share (Option 3) or Citing an Existing Study (Option  6). If a
registrant does not want to participate in a batch, the choices are Options 1,  4, 5 or 6. However,
a registrant should know that choosing not to participate in a batch does not preclude other registrants
in the batch from citing his/her studies and  offering to cost share (Option 3) those studies.

       Seven products were found which contain 4-chloro-3,5-xylenol as the active ingredient.  The
products have been placed into two batches and a "no batch"  category in accordance with the active
and inert ingredients, type of formulation and current labeling. Table I identifies the products in each
batch. Table 2 lists the products which have been placed in the "no batch" category.
                                            101

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Table 1
Batch
1
2
EPA Reg. No.
49403-1
49403-12
49403-22
1270-232
1270-233
% Active Ingredient
4-chloro-3,5-xylenol 98.0
4-chloro-3,5-xylenol 98.0
4-chloro-3,5-xylenol 100
4-chloro-3,5-xylenol 0.047
o-phenylphenol 0.089
p-tert amylphenol 0.06
o-benzyl-p-chloro-phenol 0.095
4-chloro-3,5-xylenol 0.047
o-phenylphenol 0.089
p-tert amylphenol 0.06
o-benzyl-p-chloro-phenol 0.095
Formulation
Type
Solid
Solid
Solid
Liquid
Liquid
                                      102

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       The following table lists products that were either considered not to be similar or the Agency
lacked sufficient information for decision making and were not placed in any batch. Registrants of
these products are responsible for meeting the acute toxicity data requirements separately for each
product.
Table ?. (No Ratr
EPA Reg. No.
4584-53
48963-2
\\\
% Active Ingredient
4-chloro-3,5-xylenol 0.1
Isopropanol 59.16
Orthophenylphenol 0.1
Orthobenzyl para-chloro phenol 0.1
4-chloro-3,5-xylenol 3.0
Formulation
Liquid
Liquid
                                            103

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104

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Attachment 5. EPA Acceptance Criteria
                 105

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106

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                                    SUBDIVISION D
Guideline            Study Title

Series 61            Product Identity and Composition
Series 62            Analysis and Certification of Product Ingredients
Series 63            Physical and Chemical Characteristics
                                          107

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                                    61 Product Identity and Composition


ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

1.	    Name of technical material tested (include product name and trade name, if appropriate).

2.	    Name, nominal concentration, and certified limits (upper and lower) for each active ingredient and each
          intentionally-added inert ingredient.

3.	    Name and upper certified limit for each impurity or each group of impurities present at _>_ 0.1% by weight and
          for certain lexicologically significant impurities (e.g., dioxins, nitrosamines)  present "af < 0.1%.

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

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

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

7.	    Description of each beginning material in the manufacturing process.
          	  EPA Registration Number if registered;
                 for other beginning materials, the following:
          	  Name and address of manufacturer or supplier.
          	  Brand name, trade name or commercial designation.
          	  Technical specifications or data  sheets by which manufacturer or supplier describes composition,
                 properties  or toxicity.

8.	Description of manufacturing process.
          	  Statement of whether batch or continuous process.
          	  Relative amounts of beginning materials and order in which they are added.
          	  Description of equipment.
          	  Description of physical conditions (temperature, pressure, humidity)  controlled in each step and the
                 parameters that are maintained.
          	  Statement of whether process involves intended chemical reactions.
          	  Flow chart with chemical equations for each intended chemical reaction.
          	  Duration of each step of process.
          	  Description of purification procedures.
          	  Description of measures taken to assure quality of final product.

9.	    Discussion of formation of impurities based on established chemical theory addressing (1) each impurity which
          may be present at _>_ 0.1% or was found at _>_ 0.1% by product analyses and (2) certain lexicologically
          significant impurities~(see #3).
                                                    108

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                              62 Analysis and Certification of Product Ingredients


                                          ACCEPTANCE CRITERIA

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

Does your study meet the following acceptance criteria?

 1.	  Five or more representative samples (batches in case of batch process) analyzed for each active ingredient and
         all impurities present at > 0.1%.
 2.	  Degree of accountability!^ closure _>_ ca 98%.
 3.	  Analyses conducted for certain trace toxiclmpurities at lower than 0.1% (examples, nitrosamines in the case of
         products  containing dinitroanilines or containing  secondary or  tertiary amines/alkanolamines plus nitrites;
         polyhalogenated dibenzodioxins and dibenzofurans). [Note that in the case of nitrosamines both fresh and stored
         samples must be analyzed.].
 4.	  Complete and detailed description of each step in analytical method used to analyze above samples.
 5.	  Statement of precision and accuracy of analytical method used to analyze above samples.
 6.	  Identities and quantities (including mean and standard deviation)  provided for each analyzed ingredient.
 7.	  Upper and lower certified limits proposed for each active ingredient and intentionally added inert along with
         explanation of how the limits were determined.
 8.	  Upper certified limit proposed for each impurity present at > 0.1% and for certain lexicologically significant
         impurities at < 0.1% along with explanation of how limit determined.
 9.	  Analytical methods to verify certified limits of each active ingredient and impurities (latter not required if exempt
         from requirement of tolerance or if generally recognized as safe by FDA) are fully described.
10.	Analytical methods (as discussed in 19) to verify certified limits validated as to their precision and accuracy.
                                                     109

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                                   63 Physical and Chemical Characteristics

                                          ACCEPTANCE CRITERIA


The following criteria apply to the technical grade of the active ingredient being reregistered.

Does your study meet the following acceptance criteria?

63-2 Color
   	  Verbal description of coloration (or lack of it)
   	  Any intentional coloration also reported in terms of Munsell color system

63-3 Physical State
   	  Verbal description of physical state provided using terms such as "solid, granular, volatile liquid"
   	  Based on visual inspection at about 20-25  C

63-4 Odor
   	  Verbal description of  odor (or lack of  it) using  terms such as  "garlic-like,  characteristic  of aromatic
          compounds"
   	  Observed at room temperature

63-5 Melting Point
   	  Reported in  C
   	  Any observed decomposition reported

63-6 Boiling Point
   	  Reported in  C
   	  Pressure under which B.P. measured reported
   	  Any observed decomposition reported

63-7 Density, Bulk Density, Specific Gravity
   	  Measured at about 20-25 C
   	  Density of technical grade active ingredient reported in g/ml or the specific gravity of liquids reported with
          reference to water at  20  C. [Note: Bulk density of registered products may be reported  in lbs/ft3 or
          Ibs/gallon.]

63-8 Solubility
   	  Determined  in  distilled water and  representative polar and non-polar solvents, including those  used in
          formulations and analytical methods for the pesticide
   	  Measured at about 20-25 C
   	  Reported in g/100 ml (other units like ppm acceptable if sparingly soluble)

63-9 Vapor Pressure
   	  Measured at 25 C (or calculated by extrapolation from measurements made at higher temperature if pressure
          too low to measure at 25 C)
   	  Experimental procedure described
   	  Reported in mm Hg (torr) or other conventional units

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

63-11 Octanol/water Partition Coefficient
          Measured at about 20-25 C
   	  Experimentally determined and description of procedure provided (preferred method-45 Fed. Register 77350)
   	  Data supporting reported value provided

63-12 pH
   	  Measured at about 20-25 C
   	  Measured following dilution or dispersion in distilled water

63-13 Stability
   	  Sensitivity to metal ions and metal determined
   	  Stability at normal and elevated temperatures
   	  Sensitivity to sunlight determined
                                                     110

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                                             SUBDIVISION F
Guideline         Study Tide

 81-1           Acute Oral Toxicity in the Rat
 81-2           Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
 81-3           Acute Inhalation Toxicity in the Rat
 81-4           Primary Eye Irritation in the Rabbit
 81-5           Primary Dermal Irritation Study
 81-6           Dermal Sensitization in the Guinea Pig
                                                   111

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                                      81-1  Acute Oral Toxicity in the Rat


                                         ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

 1.	Identify material tested (technical, end-use product, etc).
 2.	At least 5 young adult rats/sex/group.
 3.r	Dosing, single oral may be administered over 24 hrs.
 4.*^	Vehicle control if other than water.
 5.	Doses tested, sufficient to determine a toxicity category or a limit dose (5000 mg/kg).
 6.	Individual observations at least once a day.
 7.	Observation period to last at least 14 days, or  until all test animals appear normal whichever is longer.
 8.	Individual daily observations.
 9.	Individual body weights.
10.	Gross necropsy on all animals.
                       Criteria marked with an * are supplemental and may not be required for every study.

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                         81-2  Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig


                                          ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

 1.	Identify material tested (technical, end-use product, etc).
 2.	At least 5 animals/sex/group.
 3.*	Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-450 gm.
 4.	Dosing, single dermal.
 5.	Dosing duration at least 24 hours.
 6.^	Vehicle control, only if toxicity of vehicle is unknown.
 7.~	Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg).
 8.	Application site clipped or shaved at least 24 hours oefore dosing.
 9.	Application site at least 10% of body surface area.
10.	Application site covered with a porous nonirritating cover to retain test material and to prevent
      ingestion.
11.	Individual observations at least once a day.
12.	Observation period to last at least 14 days.
13.	Individual body weights.
14.	Gross necropsy on all animals.
                       Criteria marked with an * are supplemental and may not be required for every study.

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                                   81-3 Acute Inhalation Toxicity in the Rat


                                          ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

 1.	Identify material tested (technical, end-use product, etc).
 2.	Product is a gas, a solid which may produce a significant vapor hazard based on toxicity and expected use  or
        contains particles of inhalable size for man (aerodynamic diameter 15 pm or less).
 3.	At least 5 young adult rats/sex/group.
 4.	Dosing, at least 4 hours by inhalation.
 5.	Chamber air flow dynamic, at least  10 air changes/hour, at least 19% oxygen content.
 6.	Chamber temperature, 22 C (+_2), relative humidity 40-60%.
 7.	Monitor rate of air flow.
 8.	Monitor actual concentrations of test material in breathing zone.
 9.	Monitor aerodynamic particle size for aerosols.
10.	Doses tested, sufficient to determine a toxicity category or a limit dose (5  mg/L actual concentration of respirable
        substance).
11.	Individual observations at least once a day.
12.	Observation period to last at least 14 days.
13.	Individual body weights.
14.	Gross necropsy on all animals.
                                                    114

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                                   81-4 Primary Eye Irritation in the Rabbit


                                          ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

 1.	Identify material tested (technical, end-use product, etc).
 2.	Study not required if material is corrosive, causes severe
        dermal irritation or has a pH of < 2 or > 11.5.
 3.	6 adult rabbits.
 4.	Dosing, instillation into the conjunctival sac of one eye
        per animal.
 5.	Dose, 0.1 ml if a liquid;  0.1 ml or not more than 100 mg if a solid,  paste or particulate substance.
 6.	Solid or granular test material ground to a fine dust.
 7.	Eyes not washed for at least 24 hours.
 8.	Eyes examined and graded for irritation before dosing and
        at 1, 24, 48 and 72 hr, then daily until eyes are normal
        or 21 days (whichever is shorter).
 9.^	Individual daily observations.
                       Criteria marked with an * are supplemental and may not be required for every study.

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                                    81-5  Primary Dermal Irritation Study

                                          ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

 1.	Identify material tested (technical, end-use product, etc).
 2.	Study not required if material is corrosive or has a pH of < 2 or > 11.5.
 3.	6 adult animals.
 4.	Dosing, single dermal.
 5.	Dosing duration 4 hours.
 6.	Application site shaved or clipped at least 24 hours prior to dosing.
 7.	Application site approximately 6 cm2.
 8.	Application site covered with a gauze patch held in place with nonirritating tape.
 9.	Material removed, washed with water, without trauma to application site.
10.	Application site examined and graded for irritation at 1, 24, 48 and 72 hr, then daily until normal or 14 days
        (whichever is shorter).
11.^	Individual daily observations.
                       Criteria marked with an * are supplemental and may not be required for every study.

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                                 81-6  Dermal Sensitization in the Guinea Pig

                                          ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

1.	Identify material tested (technical,  end-use product, etc).
2.	Study not required if material is corrosive or has a
      pHof <2or  >11.5.
3.	One offhe following methods is utilized:
      	Freund's complete adjuvant test
      	Guinea pig maximization test
      	Split adjuvant technique
      	Buehler test
      	Open epicutaneous test
      	Mauer optimization test
      	Footpad technique in guinea pig.
4.	Complete description of test.
5.^	Reference for  test.
6.~	Test followed  essentially as described in reference document.
7.	Positive control included (may provide historical data conducted within the last 6 months).
                       Criteria marked with an * are supplemental and may not be required for every study.

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118

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Attachment 6. List of All Registrants Sent This Data Call-In (insert) Notice
                                  119

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120

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Attachment 7. Cost Share Data Compensation Forms, Confidential
         Statement of Formula Form and Instructions
                           121

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122

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124

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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed copies of the form are
required.  Following are basic instructions:
     a. All the blocks on the form must be filled in and answered completely.
     b.       If any block is not applicable, mark it N/A.
     c.       The CSF must be signed, dated and the telephone number of the responsible party must be provided.
     d.       All applicable information which is on the product specific data submission must also be reported on the
              CSF.
     e.       All weights reported under item 7 must be in pounds  per gallon for liquids and pounds per cubic feet for
              solids.
     f.       Flashpoint must be in degrees Fahrenheit and flame extension in inches.
     g.       For all active ingredients, the EPA Registration Numbers for the currently registered source products
              must  be reported under column 12.
     h.       The Chemical Abstracts Service (CAS) Numbers for  all actives and inerts and all common names for the
              trade  names must be  reported.
     i.       For the active ingredients, the percent purity of the  source products must be reported under column 10
              and must be exactly the same as on the source product's laoel.
     j.       All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or grams. In no case will
              volumes be accepted. Do not mix English and metric system units (i.e., pounds and kilograms).
     k.       All the items under column 13.b. must total 100 percent.
     1.       All items under columns 14.a.  and 14.b. for the active ingredients must represent pure active  form.
     m.      The upper and lower certified limits for ail active and inert ingredients must follow the 40 CFR  158.175
              instructions. An explanation must be provided if the proposed limits are different than standard certified
              limits.
     n.       When new CSFs are  submitted and approved, all previously submitted CSFs become obsolete for that
              specific formulation.
                                                   125

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126

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

OMB No.  2070-0106
         2070-0057

Approval  Expires 3-31-96
 Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
 time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
 completing and reviewing the collection of information.  Send comments regarding the burden estimate or any other
 aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
 Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
 of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.

 Please fill in  blanks below.
Company Name
Product Name
Company Number
EPA Reg. No.
 I Certify that:

 My company is willing to develop and submit the data required by EPA under the authority of the Federal
 Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary.  However, my company would prefer to
 enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
 data.

 My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included  an
 offer  to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on  all
 terms could not be reached otherwise. This offer was made to the following firm(s) on the following
 date(s):
  Name of Firm(s)
                                                                             Date of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I  have made on
this form and all attachments therein are true, accurate, and complete.  I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
 Signature of Company's Authorized Representative
                                                                            Date
 Name and Title (Please Type or Print)
 EPA Form 8570-32 (5/91)    Replaces EPA Form 8580, which is obsolete
                                                 127

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128

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United States Environmental Protection Agency
^\ ^^5/\ Washington, DC 20460
^J^r^rT^ CERTIFICATION WITH RESPECT TO
^r -. m m DATA COMPENSATION REQUIREMENTS
Pom Appao<
OKI NO. 2070-0107
2070-0037
Approval Esplroo 3 31 96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection o( information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223. U.S. Environmental Protection Agency. 401 M St., S.W.. Washington, DC 20460: and to the Office
of Management and Budget. Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please fill In blanks below.
Company Namo
Product NM
Company Number
EPA R*?. No.
 I Certify that:

1.  For each study cited in support of registration or reregistration under the Federal Insecticide, Fungicide and
    Rodent'cide 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)(1)(D) 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(0(1 )(D) of FIFRA for the studies I have tiled in support of
    registration or reregistration under FIFRA.
Signature
Date
Nano and TIM* (Ploaao Typo 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 sections 3(C)(1)(D) and 3(c)(2)(D).
Signature
Date
Namo and Tltlo (Ploaao Typo or Print)
EPA  Form 1570-31  (4-90)
                                                     129

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130

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APPENDIX G. FACT SHEET
          131

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132

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                  United States
                  Environmental Protection
                  Agency	
                       Prevention, Pesticides
                       And Toxic Substances
                       (7508W)	
EPA-738-F-94-028
September 1994
                  R.E.D.   FACTS
      Pesticide
Reregistration
                  Chloroxylenol
     All pesticides sold or distributed in the United States must be registered
by EPA, based on scientific studies showing that they can be used without
posing unreasonable risks to people or the environment.  Because of advances
in scientific knowledge, the law requires that pesticides which were first
registered years ago be reregistered to ensure that they meet today's more
stringent standards.
     In evaluating pesticides for reregi strati on, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human health
and environmental effects of each pesticide. The Agency imposes any
regulatory controls that are needed to effectively manage each pesticide's
risks. EPA then reregisters pesticides that can be used without posing
unreasonable risks to human health or the environment.
     When a pesticide is eligible for reregi strati on, EPA announces this and
explains why in a Reregistration Eligibility Decision (RED) document. This
fact sheet summarizes the information in the RED document for reregi strati on
case 3045, chloroxylenol or chloro-m-xylenol.
    Use Profile
    Regulatory
        History
     Chloroxylenol is an antimicrobial used to control bacteria, algae and
fungi in adhesives, emulsions, paints and wash tanks.  It also is used to
sanitize bathroom premises, diaper pails, laundry equipment, human bedding
and pet living quarters in households, hospitals and other institutions.
Formulations include a soluble concentrate/liquid (applied using a squirt
bottle) and a pressurized liquid (aerosol), as well as a technical formulation
and a formulation intermediate.
     Use practice limitations include a prohibition against discharging
effluent containing the pesticide into lakes, streams, ponds, estuaries, oceans
or public waters unless specifically addressed in an NPDES permit, and a
warning not to discharge the pesticide to sewer systems without previously
notifying the sewage treatment plant authority.

     Chloroxylenol was first registered as a pesticide in the U.S. in 1959, for
use as a fungicide. Products used as disinfectants and sanitizers have
subsequently been registered.  EPA issued an antimicrobial Data Call-In
Notice in March 1987 to obtain chronic and subchronic toxicity data for the
chloroxylenol manufacturing use product.  Technical chemistry data were
obtained through a Dioxin/Furan Data Call-In issued in 1988. Currently, two

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       Physical
     Chemistry
 Assessment
Human Health
  Assessment
manufacturing use products and five end use products containing this active
ingredient are registered.

     EPA was concerned with the potential formation of dioxins and
chlorinated dioxin impurities during the manufacture of chloroxylenol, and
with the effect of these impurities on human health and the environment. The
Agency has required the registrant to fully satisfy technical chemistry data
requirements addressing this concern.  These data have been submitted and do
not suggest that dioxins or chlorinated dioxin impurities are present in
technical chloroxylenol.

Toxicity
     Chloroxylenol generally is of moderate to low acute toxicity, but causes
severe eye irritation and has been placed in Toxicity Category I (indicating
the greatest degree of acute toxicity) for eye irritation effects. Chloroxylenol
is of low acute toxicity via the inhalation route and causes only slight skin
irritation, so it has been placed in Toxicity Category IV (the lowest of four
categories) for these effects. It is slightly toxic by the oral and dermal routes,
and has been placed in Toxicity Category III for acute oral and dermal effects.
     In a subchronic dermal study using rabbits,  chloroxylenol caused
redness, toughness and cracking of the skin at the highest dose level. In a
developmental toxicity study using rats, chloroxylenol caused maternal effects
including decreased weight gain and food consumption. Deaths occurred at
the highest dose. The No Observed Effect Level was the highest dose
administered.  Chloroxylenol is not mutagenic.
Dietary  Exposure
     Since no food or feed uses are registered, the Agency anticipates no
dietary exposure to chloroxylenol.  A food additive tolerance has been
established by the Food and Drug Administration (FDA) allowing use of
chloroxylenol as a preservative in food packaging adhesives (please see 21
CFR 175.105(c)(5)). However the safety of that use is under FDA's
regulatory purview.
Occupational and Residential Exposure
     Based on current use patterns, the potential  dermal and inhalation
exposures to applicators, mixers and loaders may  be significant when
chloroxylenol is applied as a medical disinfectant using spray application
methods, or as a preservative using the open pouring application method.
Secondary exposure of residents and others to chloroxylenol after application
of end-use products is significantly less than workers' exposure.
Human  Risk Assessment
     Since chloroxylenol is not applied to food or feed crops and is not used
in  food handling establishments, no dietary risk is expected.  FDA regulates
the use of this pesticide as a food packaging adhesive.

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     Environmental
       Assessment
    Additional Data
            Required
     No toxicological endpoints of concern have been identified for
chloroxylenol except eye irritation. Personal protective equipment (PPE) may
be required for some end-use products on a case-by-case basis, but is not
required for all chloroxylenol products at this time.

Environmental Fate and Assessment
     Chloroxylenol is hydrologically stable and is a weak acid. EPA does
not anticipate significant environmental exposure to this pesticide  since it has
only one  limited outdoor use, on pet living quarters.
Ecological Effects
     Chloroxylenol's toxic effects range from low to high, depending on the
species.  The pesticide is practically non-toxic to bobwhite quail on an acute
oral basis and to birds on a dietary basis. However, it is highly toxic to
freshwater fish and moderately toxic to aquatic invertebrates on an acute
basis. Plants and non-target insects are not expected to be exposed to
chloroxylenol since it is used mostly indoors.
Ecological Effects Risk Assessment
     Chloroxylenol is practically non-toxic to birds, moderately toxic to
freshwater invertebrates and highly toxic to fish.  However, exposure to
terrestrial and aquatic organisms is extremely minimal since chloroxylenol
has almost all indoor uses. The sole outdoor use, on pet living quarters, will
not result in significant environmental exposure.  Therefore, when used
according to label directions, chloroxylenol poses only a minimal  risk to
terrestrial and aquatic organisms.

     No additional generic data for chloroxylenol  is required at this time.
The Agency is requiring product-specific data including product chemistry
and acute toxicity studies, revised Confidential Statements of Formula (CSFs)
and revised labeling for reregi strati on.
  Product Labeling
Changes Required
     All chloroxylenol end-use products must comply with EPA's current
pesticide product labeling requirements, and with the following:
Products with the Outdoor Use - Products with the pet living quarters use
on their labeling must bear the following statement:
     "This pesticide is toxic to fish. Do not apply directly to water.  Do not
     contaminate water when disposing of equipment wash waters or
     rinsate."
Non-Residential Products with Indoor Nonfood and/or Medical Uses -
Must bear the following statement:
     "This pesticide is toxic to fish. Do not discharge effluent containing
     this product into lakes, streams, ponds, estuaries, oceans or other water
     unless in accordance with the requirements of a National Pollutant

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                      Discharge Elimination System (NPDES) permit and the permitting
                      authority has been notified in writing prior to discharge.  Do not
                      discharge this product to sewer systems without previously notifying the
                      local sewage treatment plant authority. For guidance contact your State
                      Water Board or Regional Office of the EPA."
 Regulatory
Conclusion
All end-use products must specify their formulaton type and percent of active
ingredient on their labels.

     The use of currently registered pesticide products containing
chloroxylenol in accordance with approved labeling is not expected to pose
unreasonable risks or adverse effects to humans or the environment.
Therefore, all uses of these products are eligible for reregi strati on.
   For More
Information
     Products containing chloroxylenol will be reregistered once the product-
specific data, revised Confidential Statements of Formula and revised labeling
are received and accepted by EPA.  Products containing chloroxylenol and
other active ingredients will be reregistered only after the other active
ingredients also are eligible for reregi strati on.

     EPA is requesting public comments on the Reregi strati on Eligibility
Decision (RED) document for chloroxylenol during a 60-day time period, as
announced in a Notice of Availability published in the Federal Register.  To
obtain a copy of the RED document or to  submit written comments, please
contact the Pesticide Docket, Public Response and Program Resources
Branch, Field Operations Division (7506C), Office of Pesticide Programs
(OPP), US EPA, Washington, DC 20460,  telephone 703-305-5805.
     Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregi strati on Information System at
703-308-7224, and also can be reached on the Internet via FEDWORLD.GOV
and EPAs gopher server, EARTHl.EPA.GOV.
     Following the comment period, the  chloroxylenol RED document 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 reregi strati on program, the
chloroxylenol RED, or reregi strati on of individual products containing
chloroxylenol,  please contact the Special Review and Reregi strati on Division
(7508W), OPP, US EPA, Washington, DC 20460, telephone 703-308-8000.
     For information about the health effects of pesticides, or for assistance
in recognizing  and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN). Call toll-free
1-800-858-7378, between 8:00 am and 6:00 pm Central Time, Monday
through Friday.

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