United States       Prevention, Pesticides    EPA-738-R-96-008
         Environmental Protection    And Toxic Substances    January 1997
         Agency	(7508W)	
&EPA  Reregistration
         Eligibility Decision (RED)

         p-Chloro-m-cresol

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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
reregi strati on eligibility review and decisions on the pesticide chemical case 3046 which
includes the active ingredient p-chloro-m-cresol. The enclosed Reregistration Eligibility
Decision (RED) contains the Agency's evaluation of the data base of this chemical, 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
reregi strati on. The RED  includes the data and labeling requirements for products for
reregi strati on. It may also include requirements for additional  data (generic) on the active
ingredient to confirm the risk assessments.

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

      Please note that this RED was finalized and signed prior to August 3, 1996. On that
date, the Food Quality Protection Act of 1996 ("FQPA") became effective, amending portions
of both the pesticide law (FIFRA) and the food and drug  law (FFDCA). This RED does not
address any issues raised by FQPA, and any tolerance-related statements in the RED did not
take into account any  changes in tolerance assessment procedures required under FQPA.  To
the extent that this RED indicates that a change in any tolerance is necessary, that
determination will be reassessed by the Agency under the standards set forth in FQPA before
a proposed tolerance is issued.  To the extent that the RED does not indicate that a change in a
tolerance is necessary, that tolerance too will be reassessed in the future pursuant to the
requirements of FQPA.

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       If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregi strati on Division representative,
Emily Mitchell at (703) 308-8583. Address any questions on required generic data to the
Special Review and Reregi strati on Division representative, Tom Luminello at (703) 308-
8075.

                                                     Sincerely yours,
                                                     Lois A. Rossi, Director
                                                     Special Review
                                                      and Reregi strati on Division
Enclosures

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

1  DATA CALL-IN (PCI) OR "90-DAY RESPONSE"-If generic data are required for
reregi strati on, a DCI letter will be enclosed describing such data.  If product specific data are
required, a DCI letter will be enclosed listing such requirements.  If both generic and
product specific data are required, a combined Generic and Product Specific DCI letter will
be enclosed describing such data.  However, if you are an end-use product registrant only and
have been granted a generic data exemption (GDE) by EPA, you are being sent only the
product specific response forms (2 forms) with the RED.  Registrants responsible for generic
data are being sent response forms for both generic and product specific data requirements (4
forms).  You must submit the appropriate response forms (following the instructions
provided) within 90 days of the receipt of this RED/DCI letter; otherwise, your product
may be suspended.

2. TIME EXTENSIONS AND DATA WAIVER 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 time extensions for product specific data
should be submitted in the 90-day  response.  Requests for data waivers must be submitted as
part of the 90-day response. All data waiver and time extension requests must be  accompanied
by a full justification. All waivers and time extensions must be granted by EPA in order to go
into effect.

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

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

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

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

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

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

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

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

By U.S. Mail:

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

By express:

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

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

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REREGISTRATION ELIGIBILITY DECISION

          P-CHLORO-M-CRESOL

                  LISTC

                 CASE 3046
           ENVIRONMENTAL PROTECTION AGENCY
             OFFICE OF PESTICIDE PROGRAMS
        SPECIAL REVIEW AND REREGISTRATION DIVISION

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                          TABLE OF CONTENTS



P-CHLORO-M-CRESOL REREGISTRATION ELIGIBILITY DECISION TEAM . . . i

EXECUTIVE SUMMARY                                                      v

I.     INTRODUCTION                                                       1

II.    CASE OVERVIEW                                                      2
      A.    Chemical Overview	2
      B.    Use Profile                                                        2
      C.    Data Requirements	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                                         6
                  b.     Subchronic Toxicity                                   7
                  c.     Chronic toxicity                                       7
                  d.     Carcinogenicity                                       8
                  e.     Developmental Toxicity	9
                  f.     Reproductive Toxicity                                  9
                  g.     Mutagenicity	10
                  h.     Metabolism                                          11
                  i.     Toxicological Endpoints of Concern	12
            2.     Exposure Assessment  	12
                  a.     Dietary Exposure                                    12
                  b.     Occupational and Residential Exposures                 13
            3.     Risk Assessment	16
                  a.     Dietary	16
                  b.     Occupational and Residential                          16
      C.    Environmental Assessment  	18
            1.     Ecological Toxicity Data                                    18
                  a.     Toxicity to Terrestrial Animals	18
                  b.     Toxicity to Aquatic Animals                            19
            2.     Environmental Fate                                        20
            3.     Exposure and Risk Characterization                          20

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IV.   RISK MANAGEMENT AND REREGISTRATION DECISION              21
      A.    Determination of Eligibility  	21
      B.    Determination of Eligibility Decision	22
            1.     Eligibility Decision                                         22
            2.     Eligible and Ineligible Uses                                  22
      C.    Regulatory Position                                               22
            1.     Occupational and Residential Labeling Rationale/Risk Mitigation
                  Measures; Personal Protective Equipment (PPE)/Engineering
                  Controls for Handlers	22
            2.     Reduction in Percentage of Active Ingredient  	23
            3.     Other Labeling Requirements 	23

V.    ACTIONS REQUIRED OF REGISTRANTS                               23
      A.    Manufacturing-Use Products	23
            1.     Additional Generic Data Requirements  	23
            2.     Labeling Requirements for Manufacturing-Use Products  	23
      B.    End-Use Products                                                24
            1.     Additional Product-Specific Data Requirements  	24
            2.     Labeling Requirements for p-Chloro-m-cresol Products  	24
      C.    Existing Stocks                                                   28

VI.   APPENDICES                                                         29
      APPENDIX  A.    Table of Use Patterns Subject to Reregistration          30
      APPENDIX  B.    Table of the Generic Data Requirements and Studies Used to
                        Make the Reregistration Decision	35
      APPENDIX  C.    Citations Considered to be Part of the Data Base Supporting
                        the Reregistration of p-Chloro-m-cresol 	41
      APPENDIX  D.    Product Specific Data Call-In                          47
            Attachment  1.     Chemical Status Sheets                         61
            Attachment  2.     Product Specific Data Call-In Response Forms (Form
                              A inserts) Plus Instructions 	63
            Attachment  3.     Product Specific Requirement Status and Registrant's
                              Response Forms (Form B inserts) and Instructions
                                	67
            Attachment  4.     EPA Batching of End-Use Products for Meeting Data
                              Requirements for Reregistration 	75
            Attachment  5.     List of All Registrants Sent This Data Call-In (insert)
                              Notice	77
            Attachment  6.     Cost Share, Data Compensation Forms, Confidential
                              Statement of Formula Form and Instructions	79
      APPENDIX  E.    List of Available Related Documents                    87

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P-CHLORO-M-CRESOL REREGISTRATION ELIGIBILITY DECISION TEAM

Office of Pesticide Programs:

Biological and Economic Assessment
Margaret Cogdell-Ervin
Tom Harris
Frank Hernandez
Rafael Prieto
Biological Analysis Branch
Biological Analysis Branch
Economic Analysis Branch
Biological Analysis Branch
Environmental Fate and Effects Assessment
Karen Angulo
Joanne Edwards
Hank Jacoby

Health Effects Assessment

Winston Dang
Pamela M. Hurley
Tom Myers

Registration Assessment

Marianne Clark
Tina Levine
Shyam Mathur

Risk Management

Kathy Davis
Tom Luminello
Emily Mitchell

Field Operations Division
Science Analysis and Coordination Staff
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Occupational and Residential Exposure Branch
Toxicology Branch I
Risk Characterization and Analysis Branch
Antimicrobial Program Branch
Registration Support Branch
Registration Support Branch
Accelerated Reregi strati on Branch
Accelerated Reregi strati on Branch
Planning and Reregi strati on Branch
Steve Shapiro

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11

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            GLOSSARY OF TERMS AND ABBREVIATIONS

ADI           Acceptable Daily Intake. A now defunct term for reference dose (RfD).
AE            Acid Equivalent
a.i.            Active Ingredient
ARC           Anticipated Residue Contribution
CAS           Chemical Abstracts Service
CI             Cation
CNS           Central Nervous System
CSF           Confidential Statement of Formula
DFR           Dislodgeable Foliar Residue
ORES          Dietary Risk Evaluation System
DWEL         Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e.
               drinking water) lifetime exposure at which adverse, non carcinogenic health effects are not
               anticipated to occur.
EEC           Estimated Environmental Concentration.  The estimated pesticide concentration in an
               environment, such as a terrestrial ecosystem.
EP            End-Use Product
EPA           U.S. Environmental Protection Agency
FAO/WHO     Food and Agriculture Organization/World Health Organization
FDA           Food and Drug Administration
FIFRA         Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA        Federal Food, Drug, and Cosmetic Act
FOB           Functional Observation Battery
GLC           Gas Liquid Chromatography
GM           Geometric Mean
GRAS          Generally Recognized as Safe as Designated by FDA
HA            Health Advisory (HA).  The HA values are used  as informal guidance to municipalities and
               other organizations when emergency spills or contamination situations occur.
HOT           Highest Dose Tested
LC50           Median Lethal Concentration.  A statistically derived concentration of a substance that can be
               expected to cause death in 50% of test animals.  It is usually expressed as the weight of
               substance per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LD50           Median Lethal Dose. A statistically derived single dose that can be expected to cause death in
               50% of the test animals when administered by the route indicated (oral, dermal, inhalation). It
               is expressed as a weight of substance per unit weight of animal,  e.g., mg/kg.
LDlo           Lethal Dose-low. Lowest Dose at which lethality occurs.
LEL           Lowest Effect Level
LOG           Level of Concern
LOD           Limit of Detection
LOEL          Lowest Observed Effect Level
MATC         Maximum Acceptable Toxicant Concentration
MCLG         Maximum Contaminant Level Goal (MCLG)  The MCLG is used by the Agency to regulate
               contaminants in drinking water under the Safe Drinking Water Act.
Hg/g           Micrograms Per Gram
mg/L           Milligrams Per Liter
MOE           Margin of Exposure
MP            Manufacturing-Use Product
MPI           Maximum Permissible Intake
MRID          Master Record Identification (number). EPA's system of recording and tracking studies
               submitted.
N/A           Not Applicable
                                                 111

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            GLOSSARY OF TERMS AND ABBREVIATIONS

NOEC         No effect concentration
NPDES        National Pollutant Discharge Elimination System
NOEL         No Observed Effect Level
NOAEL        No Observed Adverse Effect Level
OP            Organophosphate
OPP           Office of Pesticide Programs
PADI          Provisional Acceptable Daily Intake
PAG           Pesticide Assessment Guideline
PAM          Pesticide Analytical Method
PHED         Pesticide Handler's Exposure Data
PHI            Preharvest Interval
ppb            Parts Per Billion
PPE           Personal Protective Equipment
ppm           Parts Per Million
PRN           Pesticide Registration Notice
Q*!            The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC           Red Blood Cell
RED           Reregistration Eligibility Decision
REI            Restricted Entry Interval
RfD           Reference Dose
RS            Registration Standard
RUP           Restricted Use Pesticide
SLN           Special Local Need (Registrations Under Section 24 (c) of FIFRA)
TC            Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD            Toxic Dose. The dose at which a substance produces a toxic effect.
TEP           Typical End-Use Product
TGAI          Technical Grade Active Ingredient
TLC           Thin Layer Chromatography
TMRC         Theoretical Maximum Residue Contribution
torr            A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
ug/L           Micrograms per liter
WP            Wettable Powder
WPS           Worker Protection Standard
                                                IV

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EXECUTIVE SUMMARY

       The U. S. Environmental Protection Agency has completed its reregi strati on eligibility
decision (RED) for the pesticide p-chloro-m-cresol, case 3046, which includes the active
ingredient para-chloro-meta-cresol.  This decision includes a comprehensive reassessment of
the required target data and the use patterns of currently registered products. p-Chloro-m-
cresol is an antimicrobial preservative used to control bacteria and fungi in the formulation of
industrial materials.  The Agency has concluded that all uses, as described in this document,
will not cause unreasonable risks to humans or the environment and therefore, all  products are
eligible for reregi strati on.

       To mitigate risks of potential toxicity to occupational handlers, the Agency is requiring
use of personal protective equipment and reductions of application concentrations of p-
chloro-m-cresol in the manufacture of paints.  The Agency is also requiring revisions to
product labels to clarify use sites, application instructions, and user safety recommendations.
Revised labeling, product chemistry, and acute toxicology studies must be submitted to
achieve product reregi strati on.
                                           v

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I.      INTRODUCTION

       In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the reregi strati on of products with active ingredients registered prior to
November 1, 1984. The amended Act provides a schedule for the reregi strati on process to be
completed in nine years. There are five phases to the reregi strati on process.  The first four
phases of the process focus on identification of data requirements to support the reregi strati on
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 reregi strati on.

       FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for reregi strati on" before
calling in data on products and either reregistering products or taking "other appropriate
regulatory action." Thus,  reregi strati on 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 reregi strati on eligibility of
the registered uses of p-chloro-m-cresol.  The document consists of six sections. Section I is
the introduction.  Section II describes  p-chloro-m-cresol, 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 reregi strati on decision for
p-chloro-m-cresol. Section V discusses the reregi strati on requirements for p-chloro-m-cresol.
Finally, Section VI is the Appendices  which support this Reregi strati on 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 Reregi strati on Eligibility
      Decision:

      •     Common Name:          p-chloro-m-cresol (PCMC)

      •     Chemical Name:          para-chloro-meta-cresol

      •     Chemical Family:         phenol

      •     CAS Registry Number:   59-50-7

      •     OPP Chemical Code:     064206

      •     Empirical Formula:       C7H7OC1

      •     Trade and Other Names:  Preventol

      •     Basic Manufacturer:      Bayer AG

      B.     Use Profile

             The following is information on the currently registered uses with an overview
      of use sites and application methods.  A detailed table of the uses of p-chloro-m-cresol
      is in Appendix A.

      Type of Pesticide:   Fungicide; Microbiocide/Microbiostat (Slime-Forming
      Bacteria); Microbiocide/Microbiostat (Slime Forming Fungi)

      Use Sites:    Terrestrial Non-food
                   Industrial Preservatives:
                   Oil Recovery Drilling Muds/Packer Fluids

                   Aquatic Non-Food Industrial
                   Industrial Preservatives:
                   Oil Recovery Drilling Muds/Packer Fluids

                   Indoor Non-Food
                   Industrial Preservatives:
                   Adhesives, Industrial

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             Coatings, Industrial
             Emulsions, Resin/Latex/Polymer
             Leather Processing Liquors
             Leather/Leather Products
             Metalworking Cutting Fluids
             Paints (In-Can)
             Specialty Industrial Products
             Wet-end Additives/Industrial Processing Chemicals

Target Pests:

      Bacteria:      Formaldehyde-resistant bacteria, Aeromonaspunctata, Bacillus
                    subtilis, Escherichia coli, Leuconostoc mesenteroides, Proteus
                    vulgaris, Pseudomonas aeruginosa, Pseudomonasfluorescens,
                    Staphylococcus aureus, Desulfovibrio desulfuricans

      Yeasts:       Candida albicans, Torula rubra

      Fungi:        Aspergillus flavus, Aspergillus niger,  Aureobasidiumpullulans,
                    Chaetomium globosum, Cladosporium herbarum, Coniophora
                   puteana, Paecilomyces variotti, Penicillium citrinum,
                    Penicillium glaucum, Trichophyton pedis, Trichoderma viride

Formulation Types Registered:   End use, manufacturing use; crystalline

Method and Rates of Application:

      Types of Treatment - Hides and skins treatment; Industrial preservative
                          treatment; Preservative treatment; Not on label (registrant
                          must specify on label)

      Equipment - Not on label (registrant must specify on label)

      Timing - During manufacture; Not on label (registrant must specify on label)

      Surface Type - Not Applicable

      Application Rate -

             Terrestrial non-food crop:  From 500 to 1998 ppm of active ingredient.

             Aquatic non-food industrial:  From 500 to 1998 ppm of active
             ingredient.

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             Indoor non-food: From 500 to 29970 ppm of active ingredient.

Use Practice Limitations:   (that apply to all uses on all products)

Do not discharge effluent containing this pesticide into sewage systems without
notifying the sewage treatment plant authority (POTW).

Do not discharge effluent containing this product into lakes, streams, ponds, estuaries,
oceans, or public water (NPDES license restriction).

C.    Data Requirements

      The Agency applied the data requirements specified in 40 CFR Section  158 and
the Phase II Requirements to active ingredients in this chemical case. Studies were
generated and submitted for these requirements to the Agency.  The data from these
studies along with other available information form the basis for the Agency's
scientific assessment and regulatory decisions.  Appendix B includes all data
requirements identified by the Agency needed to support reregi strati on for currently
registered uses.

D.    Regulatory History

      p-Chloro-m-cresol was initially registered as a pesticide in the United States in
1968 for use as an industrial preservative. There are currently three products
registered with p-chloro-m-cresol as an active ingredient. Each product is at least
99.9% p-chloro-m-cresol.

      Data to support the continued registration of p-chloro-m-cresol were required
under the Antimicrobial Data Call-In of 1987 and the Phase IV Data Call-In of 1991.
These data have been submitted and are part of the data base considered in this
Reregi strati on Eligibility Decision.

      Uses of p-chloro-m-cresol include application to systems which may result in
residues of p-chloro-m-cresol in paper coatings and adhesives. Tolerances for food
grade adhesives and paper coatings which may contact foods are cited in the 21 CFR.
The FDA has jurisdiction for establishing these tolerances.

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III.    SCIENCE ASSESSMENT

       A.     Physical Chemistry Assessment

       Chemical Name:  p-chloro-m-cresol

       Molecular Weight:  142.58

       Color: white/colorless

       Physical State:  crystalline solid

       Odor:  phenolic

       Melting Point:  63-65°C

       Boiling Point: approximately 239°C

       Bulk Density: 49.93 Ibs/ft3 (800 g/kg/m3)

       Solubility:   Water 4 g/L
                   Ethanol 500 g/L
                   Toluene 300 g/L
                   10% aqueous NaOH solution 320 g/L

       Vapor Pressure: 0.25 mm Hg at 25°C

       Dissociation constant: 9.4 ± 0.1 at 20°C

       Log K0/,/or log P):  3.02

       pH: 5.6 (saturated aqueous solution) at 20°C

       Flash Point: 244.4°F (118°C)

             p-Chloro-m-cresol is corrosive to metals and forms complex compounds with
       transition metal ions. Slow discoloration of the chemical occurs in the presence of
       sunlight.

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       B.
Human Health Assessment
             1.     Toxicology Assessment

                    At present, the toxicological data base for p-chloro-m-cresol meets the
             requirements for antimicrobial pesticides.  The data are adequate and will
             support a reregi strati on eligibility determination for the currently registered
             non-food uses.

                    a.     Acute Toxicity

                           Results of the acute toxicity studies conducted with technical p-
                    chloro-m-cresol are summarized below in Table 1:
Table 1. Acute Toxicity Values of Technical p-Chloro-m-cresol
Route
Oral
Dermal
Inhalation
Eye Irritation1
Skin Irritation1
Dermal Sensitization1
Species
Rat
Rat
Rat
Rabbit
Rabbit
Guinea Pig
Results
LD50:
Males 5129mg/kg
Females 3636 mg/kg
LD,0 >5000 mg/kg
Waived
Corrosive
Corrosive
Not a sensitizer
Toxicity Category
III
IV
..
I
I
N/A
 Not required for TGAI, however, presented here for informational purpose.
                           The acute oral LD50 in rats is 5129 mg/kg for males and 3636
                    mg/kg for females placing p-chloro-m-cresol in Toxicity Category III
                    (MRID 00071335).  The acute dermal LD50 in rats is >5000 mg/kg
                    placing p-chloro-m-cresol in Toxicity Category IV (MRID 00075492).

                           The rat acute inhalation study was waived because p-chloro-m-
                    cresol is a chunky solid and respirable particles will not be formed.

                           p-Chloro-m-cresol is a Toxicity Category I primary eye irritant
                    in rabbits. The study resulted in corneal cauterization, conjunctivitis,
                    conjunctival ulceration, iritis, and corneal opacity and ulceration.  The
                    results were not reversible in 21 days (MRIDs 00109649 and
                    00048548).  p-Chloro-m-cresol is a Toxicity Category I primary dermal
                    irritant in rabbits.  This study demonstrated that p-chloro-m-cresol was
                    very irritating and cauterizing at the site of administration (MRID

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00109649). However, p-chloro-m-cresol is not a skin sensitizer in
guinea pigs (MRID 00078837).

b.     Subchronic Toxicity

       Preventol CMK (technical 99.9% p-chloro-m-cresol) was tested
in a subchronic feeding study in 20/sex male and female Wistar rats at
dose levels of 0,  150, 500 or 1500 ppm for 13 weeks (0, 12, 41, or 120
mg/kg/day for  males and 0,  17, 54, or 167 mg/kg/day for females).
Clinical signs,  body weights, food consumption, clinical biochemistry,
urinalysis, organs weights, gross pathology and microscopic pathology
were examined.  At 500 and 1500 ppm, a decrease in body weight gain
was observed in males but not females (5-6% less than controls). No
other effects were observed. The decreases in body weight gain are not
of toxicological significance. The NOEL is greater than 1500 ppm
which was the  highest dose tested (MRID 124844).

       Preventol CMK (technical 99.9% p-chloro-m-cresol) was tested
in a 21-day dermal study in New Zealand White rabbits (10/sex/dose
group) at the following dose levels:  0, 10,  40 or 160 mg/kg/day. The
animals were dosed 5 days/week for a total of 15 applications.  It
appears that the test material was applied without a vehicle. Dermal
irritation was observed in all treated groups, which ranged from slight
erythema and very slight edema (10 mg/kg/day) to severe erythema and
slight edema (160 mg/kg/day). Other dermal effects included skin
thickening, scaling, blanching, raw areas, necrosis, brown scab-like
areas, and sloughing. Fissuring occurred in one mid-dose female and in
two high dose males. The NOEL for dermal irritation is less than 10
mg/kg/day lowest dose tested.  No systemic effects were observed at
either 10 mg/kg/day or 40 mg/kg/day. At 160 mg/kg/day, a compound-
related enhancing effect on nonsupporative pericholangitis (both sexes)
and bile duct proliferation (females) in the  liver were observed.  The
systemic NOEL is 40 mg/kg/day and the LOEL is  160 mg/kg/day based
on enhanced liver pathology in both sexes  (MRID  62905).

c.     Chronic toxicity

       Technical p-chloro-m-cresol (99.90 - 99.97%) was tested in a
chronic feeding/carcinogenicity study in male and female Wistar rats for
24 months. Fifty/sex were tested per dose  level with an additional
ten/sex scheduled to be sacrificed at 53 weeks. The following dose
levels were administered: 0, 400, 2000, or 10,000  ppm (0, 21.0, 103.1,

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or 558.9 mg/kg/day for males and 0, 27.7, 134.3, or 743.5 mg/kg/day
for females).

       At some intervals, the concentration analyses were somewhat
low for all dose groups.  At 10,000 ppm, the following systemic effects
were observed when compared to controls: an increase in the frequency
of poor general condition in females; a decrease in body weight (8%
males, 21% females, p < 0.01); a decrease in food efficiency in females
(29%); an increase in water intake (14% in males, 16% in females); a
decrease in urinary total protein in females (25-40%, p< 0.01); a
decrease in brain weight in females  (88.6-94.4%, p < 0.01); an increase
in relative kidney weights (both sexes 8%, p< 0.05);  an increase in
papillary necroses in males (eight vs. two in controls, p < 0.05  for
trend); an increase in cortical dilation and fibrosis in  the kidney of males
(p < 0.05); an increase in unilateral and combined unilateral and
bilateral degeneration of seminiferous tubules in males; an increase in
unilateral and combined unilateral and bilateral reduced spermatozoa in
epididymides in males and an increase in brain compression in females.
At 2000 ppm, the same effects in seminiferous tubules, epididymides
and brain were observed. At 400 ppm, the same effects were observed
in the brain.  The systemic NOEL is less than 400 ppm and the systemic
LOEL is 400 ppm based on poor general condition, decreased body
weight and food efficiency, increased water intake, decreased urinary
protein, changes in organ weights and histopathology of the kidney,
brain (400 ppm and above), testes and epididymides  (2000 ppm and
above) (MRID 42784801). Conclusions on carcinogenicity in this study
are reported below.

d.     Carcinogenicity

       From the above chronic toxicity study (MRID 42784801),
female rats had a statistically significant increase in pituitary adenomas
and adenomas and/or carcinomas combined in the mid-dose group
(2000 ppm, p=0.042) but not in the  high dose group in pairwise
comparisons with the control group. There was no significant increase
in the trend for these tumors.  In addition, the incidences  of these tumors
were within the historical control range.  A statistically significant
increase in pituitary adenomas was also observed in low dose males, but
not in the mid- or high dose males.  There  was a statistically significant
decreasing trend for these tumors (p <0.05).  Again, the incidences of
these tumors were within the historical control range.

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       In addition to the pituitary tumors in females, male rats had a
significant increasing trend in testicular interstitial cell tumors (p <0.05).
 The incidences of these tumors, however, were within the historical
control range.  Therefore, the increased incidence of tumors seen in this
study were not related to treatment with p-chloro-m-cresol.  Based on
the Agency's conclusions of this study and because there is no mouse
study, the Agency has determined that p-chloro-m-cresol is not
classifiable as a human carcinogen, Group D. This determination is also
discussed in subsection], Toxicological Endpoints of Concern.

e.      Developmental Toxicity

       p-Chloro-m-cresol was tested by gavage in a developmental
toxicity study in rats at the following dose levels: 0, 30, 100, or 300
mg/kg/day during gestation days 6-15 inclusive. At 300 mg/kg, six
dams died. Treatment-related clinical  signs of toxicity included audible
breathing sounds, gasping breathing, reduced motility and high stepping
gait; and after dosing:  lying  on side, somnolence, abdominal position,
spastic convulsions, rough coat, sunken flanks and bloody muzzle.
Statistically  significant decreases in body weight gain were observed
during the dosing period and significant decreases in the corrected body
weight gain  were also  observed during the entire gestation period.  In
addition, the decreased food  consumption was also considered to be
biologically  significant. Finally, two dams totally resorbed their litters.
At 100 mg/kg/day, labored breathing was observed in two animals.
Statistically  significant decreases in body weight gain during the dosing
period were  observed in addition to significant decreases in the
corrected body weight gain during the entire gestation period.  The
NOEL for maternal toxicity is 30 mg/kg/day and the LOEL is  100
mg/kg/day based on clinical  signs of toxicity and decreases in body
weight gain  (100 mg/kg/day  and above) and death, decreases in food
consumption and increases in total resorptions (300 mg/kg/day). The
NOEL for developmental toxicity is 100 mg/kg/day and the LOEL is
300 mg/kg/day based on a significant decrease in the mean fetal weight
per litter at 300 mg/kg/day when compared to the control  group and a
slight increase in the number of microphthalmias or anophthalmias at
this dose level (MRID 42292901).

f.      Reproductive Toxicity

       A reproduction study  is required for antimicrobials if it is
determined that developmental toxicity and/or adverse effects  on the
reproductive organs were observed in a 90-day dermal or  inhalation

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study.  From the available subchronic studies (developmental, a 90-day
subchronic feeding, and 21-day dermal studies) no adverse effects on
the reproductive organs were observed in either of the 21-day dermal or
the 90-day feeding studies.  The developmental toxicity study indicated
that developmental effects in the rat were only observed at maternally
toxic levels. In addition, there was no indication of any mutagenic
effects for p-chloro-m-cresol under the conditions of the studies.
Although p-chloro-m-cresol was considered to have induced effects in
the testes and epididymides in the chronic feeding  study, a closer
examination of the data indicated that these effects appeared late in the
study in older rats at terminal sacrifice.  Therefore, it is unlikely that
these effects would be observed in a reproduction study, and one is not
required.

g.     Mutagenicity

       The four acceptable  studies satisfy the guideline requirements for
mutagenicity studies for p-chloro-m-cresol. All of these studies indicate
that p-chloro-m-cresol was not found to be mutagenic.

       Technical p-chloro-m-cresol was tested for  potential to induce
reverse mutations in Salmonella typhimurium strains TA 1535, TA
1537, TA 100 and TA 98.  Metabolic activation was provided by an S-9
mix prepared from the livers of adult male Sprague-Dawley rats,
induced with an injection of Aroclor 1254. Five dose levels,  ranging
from 20 to 12,500 jig/plate, were used.  All dose groups were tested
with S-9 mix; the highest dose was also tested in the absence of the S-9
mix. Endoxan® and Trypaflavin were used as positive controls. The
two highest dose levels, 2500  and 12,500 jig/plate  were toxic to the
cells.  p-Chloro-m-cresol failed to induce a mutagenic response at any
of the three lowest dose levels (20, 100, or 500 jig/plate) with all four
tester strains (MRID 00078838).

       Technical p-chloro-m-cresol was tested for  potential to induce
reverse mutations in Salmonella typhimurium strains TA1535, TA1537,
TA100 and TA98. Metabolic activation was provided by an S-9 mix
prepared from the livers of adult male rats, induced with an injection of
Aroclor 1254.  The initial assay was conducted with five dose levels
ranging from 8 to 5000 jig/plate, evaluated both with and without
metabolic activation. The repeat assay was conducted with six dose
levels ranging from 30  to 960 jig/plate, evaluation  both with and
without metabolic activation.  Positive control chemicals were sodium
azide, nitrofurantoin, 4-nitro-l,2-phenylene diamine and 2-
                      10

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aminoanthracene. In the initial assay, no revertant colonies were
observed on plates containing 5000 jig/plate with and without S-9.
Cytotoxicity was observed in all strains at 1000 jig/plate with and
without S-9. At the other dose levels, no increase in revertants were
observed. In the repeat assay, cytotoxicity was observed in all  strains at
960 jig/plate with and without activation.  Reduced bacterial
populations were observed for all strains at 480 jig/plate and  for strain
TA100 at 240 jig/plate with S-9.  p-Chloro-m-cresol was not found to
be mutagenic under the conditions of the assay (MRID 42199901).

       p-chloro-m-cresol was tested in a CHO-HGPRT assay for
potential to induce forward mutations.  The dose levels tested were 50,
100, 150, 200, 250,  or 300 |ig/ml, either with or without metabolic
activation.  Both the 250 and 300 |ig/ml doses were cytotoxic, with and
without activation. For the remaining dose levels, p-chloro-m-cresol did
not induce an increase in mutations over the controls, either with or
without metabolic activation (MRID 41548601).

       p-Chloro-m-cresol was tested for the potential to  induce
chromosomal aberrations in a micronucleus assay in the  mouse. It was
administered as a single i.p. injection at a dose level of 125 mg/kg.  The
animals were sacrificed and the bone marrow was isolated and  prepared
at 24, 48, and 72 hours after administration of the test chemical. No
increases in micronuclei in the polychromatic erythrocytes were
observed under the conditions of the study. In addition,  the ratio of
normochromatic and polychromatic erythrocytes were unaffected by
treatment at any time point. The positive control, cyclophosphamide,
induced a statistically significant positive response.  There were clear
signs of toxicity to the animals. Therefore, the dose level used  was
acceptable (MRID 41598101 or 42005201).

       p-Chloro-m-cresol was tested in a rat primary hepatocyte
unscheduled DNA synthesis (UDS) assay.  The following dose levels
were tested: 0.25, 0.5, 2.5, 7.5, 10 or 20 |ig/ml and 2.53, 5.06, 7.58,
10.1, 15.2 or 20.2 |ig/ml.  The positive control used was 2-
acetylaminofluorene (2-AAF).  p-Chloro-m-cresol did not cause any
DNA damage or inducible repair under the conditions of the  studies
(MRIDs 41548602 and 42163201).

h.     Metabolism

       A metabolism study is not required at this time for p-chloro-m-
cresol based on the Agency's requirements for antimicrobials.
                      11

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       Metabolism studies are required only if the Agency determines that
       additional information on the metabolism of the chemical is necessary
       to clarify unusual effects observed in chronic or reproduction studies or
       to clarify issues concerning structural activity relationships. For
       p-chloro-m-cresol, the Agency has not identified any such issues that
       warrant the need for metabolism data.

       i.     Toxicological Endpoints of Concern

             For short term (1 to 7 days) and intermediate term (one week to
       several months) occupational or residential exposure, the NOEL of 30
       mg/kg/day and the LOEL of 100 mg/kg/day for maternal toxicity
       (developmental toxicity study in the rat) is appropriate for risk
       assessment. For chronic occupational or residential exposures, a LOEL
       of 28 mg/kg/day for brain weight depression in females should be used
       for risk assessment. This LOEL was observed in the two-year feeding
       study in  rats (MRID 42784801). Due to the lack of dermal absorption
       data for p-chloro-m-cresol, 100% absorption is assumed for these risk
       assessments.

             The Agency (OPP's Health Effects Division's Carcinogenicity
       Peer Review Committee) has classified p-chloro-m-cresol as Group D,
       not classifiable as to human carcinogenicity.  This determination is
       further discussed in subsection d., Carcinogenicity, above.  In addition,
       there was no concern  for mutagenicity.   Several distant analogues tested
       negatively in NTP bioassays. p-Chloro-m-cresol was not tested in the
       mouse. However, since p-chloro-m-cresol is intended for non-food use,
       a mouse carcinogenicity study is not required.

2.     Exposure Assessment

       a.     Dietary Exposure

             p-Chloro-m-cresol current uses include applications to
       adhesives, glues, and  paper which can be used in food processing,
       packaging, and transportation. FDA has established tolerances for these
       uses, as specified above in Section II, and is responsible for assuring
       that any  potential dietary exposures  attributable to these uses are
       acceptable in terms of toxicological  risk. Therefore, EPA has not
       addressed dietary exposure.
                             12

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b.     Occupational and Residential Exposures

       All current product formulations contain 99.9% p-chloro-m-
cresol as a crystalline solid. As specified above in Section II and in
Appendix A, the use sites include industrial adhesives, general
preservatives for leather, paper products, textiles, fibers and cordage,
metal-working fluids, industrial oil drilling muds and packer fluids,
industrial coatings, paints, and resin/latex/polymer emulsions.  The
range of application rates for p-chloro-m-cresol is 0.05 to 2.0% in
adhesives, coatings, emulsions, dye pigments, and materials in the
paper, photo and textile industries and 0.02 to 5.0% in metal-working
fluids based on the total weight of product. All products containing p-
chloro-m-cresol are intended primarily for occupational use.  However,
people in residential settings may use or handle products, such as
adhesives, leather, or paper products, which have been treated with p-
chloro-m-cresol.

       An occupational and/or residential exposure assessment is
required for a pesticide if certain  toxicological criteria are triggered and
there is potential exposure to handlers (mixers, loaders, and/or
applicators) during use, or to persons entering treated sites after
application is complete.  As discussed above, the Agency believes there
are toxicological endpoints of concern for p-chloro-m-cresol and it is
reasonable to assume there is occupational and residential exposure
from the use of p-chloro-m-cresol products. Therefore, exposure
assessments are appropriate. To  estimate exposures of primary
occupational handlers (workers) to this chemical the Agency used the
CMA Antimicrobial Exposure Assessment Study (MRID 42587501)
and a complete set of product application rates for primary occupational
handler exposure. Because current p-chloro-m-cresol end-use  products
are formulated as solids, the pour-solid data from this study were used.
For secondary occupational handlers (painters) the Agency used the
Pesticide Handlers Exposure Data base (PHED) to estimate the
exposure.

Handler (Mixers. Loaders. Applicators) Exposures and Assumptions

       There are potential exposures from handling p-chloro-m-cresol
end-use products or products to which p-chloro-m-cresol has been
added in commercial, industrial, and residential settings. The Agency
calculated daily exposure estimates using the following formula:
                      13

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                      Actual Daily Exposure (ADE) (mg/kg/day)
                             = ADE (//g/day) - Body Weight (BW) (kg) X 1 mg/1000 //g

                      Where the body weight is 60 kg based on the average weight of an adult
                      female, since the selected toxicological endpoint is a developmental
                      effect, and dermal absorption is assumed to be 100%.

                      Occupational Handler Exposures

                      Primary Exposures to Occupational Handlers:  EPA estimated
                      exposures of p-chloro-m-cresol to handlers (mixers, loaders, and
                      applicators) who open-pour end use products into tanks of metal
                      working fluids and for other general industrial preservative uses. Short-
                      term and intermediate-term average daily doses for these handlers are
                      presented in Table 2.  These uses are considered reasonable worst-case
                      exposures.

Table 2. Exposure Estimates for Short-  and  Intermediate-Term Worker Exposures for
p-Chloro-m-cresol
Use Scenario
Metal-working
Fluids

Mineral Oil based
(cone.)3
Non-Mineral Oil
based (cutting
fluids)4
General
Preservative5
UE1
(Hg/lb ai)
479
479

479

Ib/ai
used
5
6.5

3

Actual Daily
Exposure
(Hg/kg/day)
40.00
52

24.00

MOE2
751.00
578

1,253.00

'UE = Unit Exposure (dermal and inhalation) was derived from CMA Study. All handlers in these exposure studies
wore chemical-resistant gloves, long sleeves, and long pants.
2  Margin of Exposure (MOE) for short and intermediate term exposures.
3  Exposure calculation for metal-working fluid (mineral oil) tank side additives. Preventol CMK Preservative (EPA
Reg. 39967-12, 99.9% a.i.), is added at concentrations of approximately 0.5 pounds of preservative per gallon of
mineral oil. Assuming 10 gallons of mineral oil are treated before further dilution then, a total of 5 pounds of active
ingredient is used by handler per day.
4  Exposure calculation for metal-working fluids (non-mineral oil) tank side additives. Preventol CMK Preservative
(EPA Reg. 39967-12, 99.9% a.i.), is added at concentrations of approximately 1.3 pounds of preservative per gallon
of substrate.  Assuming 5 gallons of mineral oil are treated everyday then, a total of 6.5 Ibs of active ingredient is
used by handler per day.
5  Exposure calculation for the general preservative use of p-chloro-m-cresol in adhesives.
1000 pounds of the material being treated at a labeled maximum rate of 0.3% by weight. Assuming 1000 pounds is
treated then, a total of 3 pounds of active ingredient is used by handler per day.
                                              14

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             Secondary Occupational and Residential Exposures: Based on the
             use patterns, the Agency has identified three secondary exposure
             scenarios for occupational handlers likely to represent reasonable worst-
             case scenarios.  These are exposures while handling paints, adhesives
             and metal-working fluids treated with p-chloro-m-cresol.

                    The Pesticide Handler's Exposure Database (PHED) was used to
             calculate risks to painters using p-chloro-m-cresol treated paints at the
             currently labeled range of concentration (0.05 to 0.40%).  Exposures to
             homeowners using paints are expected to be of short or intermediate
             term, but are not expected to be significant bcause of infrequent use.
             Commercial painters, however, may experience significant short and
             intermediate term and chronic exposures.

                    Currently, the Agency has no specific data upon which to
             estimate exposures from adhesive and metal-working/cutting fluids.
             However, the Agency assumes that such secondary occupational
             exposures, whether occupational or residential, are not greater than
             primary occupational exposures (open-pouring the 99.9% p-chloro-m-
             cresol product). EPA makes this assumption of relatively low exposure
             because: 1) p-chloro-m-cresol  is in a diluted concentration (0.02 to
             5.0%) in treated products like adhesive paper coatings, textiles and
             leather; and 2) the length of contact time with treated products in
             residential settings is usually of short duration.

                    Secondary occupational handler exposures and risks to
             machinists handling metal-working/cutting fluids containing p-chloro-
             m-cresol are not addressed in detail in this document.  Agency
             representatives continue to discuss with the Occupational Safety and
             Health Administration (OSHA) the roles and responsibilities of
             regulating the uses of metal-working fluids, and other products in
             industrial settings. Currently, OSHA is responsible for regulating
             machinists safety and exposure. EPA has made available this document
             to OSHA for their regulatory use.
Post-Application Exposures
                    Primary and Secondary Occupational Post-Application
             Exposures: Based on the use patterns, the Agency has identified two
             reasonable worst-case primary occupational post-application exposure
             scenarios: (1) exposures following applications of p-chloro-m-cresol to
             open vats of liquids, such as adhesives, coatings, paints, or emulsions in
             a commercial/industrial setting, and (2) exposures to persons
                                   15

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       maintaining equipment, such as industrial equipment, which contains
       product treated with p-chloro-m-cresol. Exposures to persons
       occupying work areas where p-chloro-m-cresol containing adhesives
       have recently been applied, exposures in areas where p-chloro-m-cresol
       containing products are being manufactured, and exposures to p-chloro-
       m-cresol treated products are secondary occupational post-application
       exposure. These exposures include both dermal and inhalation
       exposures.

             Primary and Secondary Residential Post-Application
       Exposures: Because currently there are no end-use products containing
       p-chloro-m-cresol intended for residential use, any exposures in these
       settings would be limited to those after application of a p-chloro-m-
       cresol treated product.  Reasonable worst-case secondary residential
       post-application exposure scenarios are exposures while occupying
       areas where p-chloro-m-cresol containing adhesives and paints have
       recently been applied and exposures to p-chloro-m-cresol treated
       products, such as leather, paper or textile products. For the reasons
       stated above, the Agency assumes secondary post-application exposures
       in residential settings would be lower than primary exposures to
       workers in industrial settings.

3.     Risk Assessment

       a.     Dietary

             The Agency did not conduct a dietary risk assessment for p-
       chloro-m-cresol because of the non-food use patterns of current
       products and FDA's responsibility for the tolerances for food-grade
       adhesives and paper, as explained above.

       b.     Occupational and Residential

             The Margin of Exposure (MOE) is a measure of how closely the
       estimated exposure is to the NOEL (NOEL/exposure = MOE).  For
       substances whose NOEL is based on  animal studies,  the Agency's
       policy has been that MOEs of  100 or greater represent a negligible risk
       from that toxicological endpoint, that is, there is an adequate margin of
       the exposure from the toxicological endpoint. However, for p-chloro-
       m-cresol an additional  factor of 3  is included in the margin of exposure
       for chronic exposure to account for a lack of an NOEL from the chronic
       rat study. For reasons given in subsection l.j, Toxicological Endpoints
       of Concern, 30 mg/kg/day is the selected toxicological  endpoint
                             16

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(NOEL) for short- and intermediate-term risk assessments of
occupational exposures. For chronic risk assessment, the toxicological
endpoint is the LOEL (no NOEL) of 28 mg/kg/day from the chronic rat
study.  This increases the MOE threshold for chronic risk assessment
from 100 to 300 because of the additional uncertainty factor of 3. For
the exposure component the Agency used the calculated ADEs (Table 2
above) to calculate the MOEs for the primary occupational scenarios.

Risk from Occupational Handler Exposures

Primary Occupational Handler Exposures: The Agency estimated
risks (MOEs) to occupational handlers who have primary exposures of
short- and/or intermediate-term duration to p-chloro-m-cresol from the
application of p-chloro-m-cresol  products to metal-working/ cutting
fluids and as general preservatives.  In addition, the chronic risk was
estimated for the primary occupational exposures from the general
preservative use of p-chloro-m-cresol.  The results (for the short- and
intermediate-term exposures) are presented in Table 2, above. MOEs
for chronic exposure would be similar to those calculated for short- and
intermediate-term exposure since the LOEL (no NOEL) selected for
chronic risk assessment is 28 mg/kg/day (brain weight depression in
female rats) versus a NOEL of 30 mg/kg/day for short-  and
intermediate-term risks. MOEs are greater than 300 for all use settings
and thus are not of concern to the Agency.

Secondary Occupational Handler Exposures: The Agency believes
that exposures to painters using p-chloro-m-cresol treated paints
represents one of the worst-case  scenarios for secondary occupational
handlers.  To estimate these exposures, the Agency used the maximum
application concentration of 0.40% and assumed that 5  gallons of paint
are applied per day.  In the  absence of dermal absorption data, 100 %
dermal absorption is assumed. Using the PHED exposure database, the
short- and intermediate-term NOEL of 30 mg/kg/day, and the chronic
LOEL of 28 mg/kg/day resulted in low MOEs of approximately  30 for
the three terms of exposures. These compare against the Agency's
acceptable risk level of 100 (300 for p-chloro-m-cresol  chronic
exposure as explained above). However, using the lowest application
concentration (0.05%) the estimated MOEs are 247 for  short- and
intermediate-term and 269 for chronic exposure. While the chronic
MOE for painters is 269 as compared to the Agency's regulatory
standard of 300, the Agency is comfortable with this MOE because this
risk estimate includes conservative assumptions. These conservative
assumptions include 100%  dermal absorption of p-chloro-m-cresol,
                      17

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             chronic exposure to occupational painters, and that all paint is treated
             with p-chloro-m-cresol.  Therefore, this MOE may actually be greater
             than 269.

                    The Agency has assumed that secondary occupational handler
             exposures from handling adhesives containing p-chloro-m-cresol are not
             greater than the exposures of the primary occupational handler from
             open pouring the solid formulation of p-chloro-m-cresol in the industrial
             preservative use scenario. Therefore, the risks from secondary
             occupational exposures are assumed to be equal to or less (MOE >
             1,253) than that for primary occupational exposure in the industrial
             preservative use.

                    Using the assumption of 100% dermal absorption and the
             potentially worst-case dermal and inhalation exposures to machinists
             handling metal-working fluids containing p-chloro-m-cresol, the
             Agency has some risk concerns  for these secondary occupational
             handlers.  Metal-working machinists may experience high exposure
             from splashing of the metal-working cutting fluids.  The Agency will
             notify OSHA of its concerns and will provide that Agency with a copy
             of this document and supporting information.

             Risk for All Other Occupational and Residential Scenarios

                    As discussed above, the Agency assumes that all other primary
             and secondary exposures in occupational and residential settings, as
             described  above, including post-application exposures, are expected to
             be no greater than, and more likely less than, estimated exposures
             associated with the general preservative use (Table 2).  Thus, the risks
             associated with the other exposure scenarios are likely to be no greater,
             or less, than those estimated, for the general preservative use (MOE =
             1,253).

C.     Environmental Assessment

       1.     Ecological Toxicity Data

             a.     Toxicity to Terrestrial Animals

                    (1)   Acute Toxicity to Birds

                    In  order to establish the acute toxicity of p-chloro-m-cresol to
             birds, the following test was performed using the technical grade
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                    material: one avian single-dose oral (LD50) study on one species of
                    waterfowl or upland game bird (preferably mallard duck or bobwhite
                    quail).
TABLE 3: Avian Acute Oral Toxicity Findings
Species
Bobwhite Quail
% A.I.
99.97%
LD50 (ppm)
1,540
MRID
42692401
Toxicity Category
Slightly toxic
                          There is sufficient information to characterize p-chloro-m-cresol
                    as slightly toxic to avian species on an acute oral basis (Table 3). The
                    guideline requirement is satisfied (MRID 42692401).

                          (2)    Subacute Toxicity to Birds

                          In order to establish the subacute toxicity of p-chloro-m-cresol to
                    birds, the following test was performed using the technical grade
                    material: one avian dietary study (LC50) on one species of waterfowl or
                    upland game bird (preferably the mallard duck or bobwhite quail).
TABLE 4: Avian Subacute Dietary Toxicity Findings
Species
Bobwhite Quail
% A.I.
99.97%
LC50(ppm)
>3,180
MRID
42692402
Toxicity Category
Slightly toxic
                          There is sufficient information to characterize p-chloro-m-cresol
                    as slightly toxic to practically non-toxic to avian species on a subacute
                    dietary basis (Table 4).  The guideline requirement is satisfied (MRID
                    42692402).

                    b.    Toxicity to Aquatic Animals

                          (1)    Freshwater Fish

                          In order to establish the toxicity of p-chloro-m-cresol to
                    freshwater fish, the minimum data required on the technical grade of the
                    active ingredient is a single 96-hour LC50 fish toxicity study using either
                    a warmwater fish (preferably bluegill sunfish) or a  coldwater fish
                    (preferably rainbow trout).
                                          19

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TABLE 5: Freshwater Fish Acute Toxicity Findings
Species
Rainbow trout
% A.I.
99.97%
LC50 (ppm)
0.9
MRID
42692403
Toxicity Category
Highly toxic
                          There is sufficient information to characterize p-chloro-m-cresol
                    as highly toxic to freshwater fish (Table 5). The guideline requirement
                    for freshwater fish acute toxicity is fulfilled (MRID 42692403).

                          (2)    Freshwater Invertebrates

                          The minimum testing required to assess the acute toxicity of p-
                    chloro-m-cresol to freshwater invertebrates is a single 48-hour LC50 test.

TABLE 6: Freshwater Invertebrate Acute Toxicity Findings
Species
Daphnid (Daphnia magna)
% A.I.
99.97%
LC50 (ppm)
2.3
MRID
42692404
Toxicity Category
Moderately toxic
             2.
       There is sufficient information to characterize p-chloro-m-cresol
as moderately toxic to freshwater invertebrates (Table 6). The guideline
requirement is satisfied (MRID 42692404).

Environmental Fate
                    The Agency has not required data on the dissipation of p-chloro-m-
             cresol in the environment. However, the currently registered uses are of such a
             nature that little or no environmental exposure is likely to occur and no further
             information is currently necessary.  Based on the very limited information
             available,  it appears that this chemical may be relatively stable in the
             environment.  Eventual degradation would depend on the solubilization of the
             chemical and microbial-aided degradation. Solubility in water is reported in
             the Ninth Edition of The Merck Index as 1 gram of p-chloro-m-cresol in 260
             milliliters  of water at 20° C with solubility increasing with temperature.

             3.     Exposure and Risk Characterization

                    Acceptable laboratory studies demonstrate that p-chloro-m-cresol is
             slightly toxic to birds, highly toxic to fish, and moderately toxic to aquatic
             invertebrates.  The oil recovery drilling mud (aquatic and terrestrial) uses are
             expected to result in minimal to no exposure if proper procedures are employed
             in the disposal of contaminated drilling muds.
                                          20

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                    While the hazard to aquatic organisms from p-chloro-m-cresol has been
             characterized, a quantitative risk assessment has not been conducted.  The risks
             to aquatic environments from this use are regulated under the NPDES
             permitting program of EPA's Office of Water.  The labels for all p-chloro-m-
             cresol products must require that discharges to aquatic environments comply
             with an NPDES permit.

IV.    RISK MANAGEMENT AND REREGISTRATION DECISION

       A.    Determination of Eligibility

             Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after
       submission of relevant data concerning an active ingredient, whether products
       containing the active ingredients are eligible for reregi strati on. The Agency has
       previously identified and required the submission of the generic (i.e. active ingredient
       specific) data required to support reregi strati on of products containing p-chloro-m-
       cresol active ingredients. The Agency has completed its review of these generic data,
       and has determined that the data are sufficient to support reregi strati on of all current
       products containing p-chloro-m-cresol. Appendix B identifies the generic data
       requirements that the Agency reviewed as part of its determination of reregi strati on
       eligibility of p-chloro-m-cresol, 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 p-chloro-m-cresol and to determine that p-chloro-m-cresol can
       be used without resulting in unreasonable adverse effects to humans and the
       environment. The Agency therefore finds that all products containing p-chloro-m-
       cresol as the active ingredient, and as  specified in this document, are eligible for
       reregi strati on.  The reregi strati on of particular products is addressed in Section V of
       this document.

             The Agency made its reregi strati on eligibility determination based upon the
       target data base required for reregistration, the current guidelines for conducting
       acceptable studies to generate such data, published scientific literature, etc. and the
       data identified in Appendix B.  Although the  Agency has found that all uses of p-
       chloro-m-cresol 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 p-chloro-m-cresol, if new
       information comes to the Agency's attention or if the data requirements for registration
       (or the guidelines for generating such data) change.
                                          21

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B.     Determination of Eligibility Decision

       1.     Eligibility Decision

             Based on the reviews of the generic data for the active ingredients p-
       chloro-m-cresol, the Agency has sufficient information on the health effects of
       p-chloro-m-cresol and on its potential for causing adverse effects in fish and
       wildlife and the environment.  The Agency has determined that p-chloro-m-
       cresol products, labeled and used as specified in this Reregi strati on Eligibility
       Decision, will not pose unreasonable risks or adverse effects to humans or the
       environment. Therefore, the Agency concludes that products containing p-
       chloro-m-cresol for all uses are eligible for reregi strati on.

       2.     Eligible and Ineligible Uses

             The Agency has determined that all uses of p-chloro-m-cresol are
       eligible for reregi strati on.

C.     Regulatory Position

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

       1.     Occupational and Residential Labeling Rationale/Risk Mitigation
       Measures; Personal Protective Equipment (PPE)/Engineering Controls for
       Handlers

       Occupational-Use Products

             The Agency has determined that regulatory action regarding the
       establishment of active-ingredient-based minimum PPE requirements for
       primary occupational  handlers is necessary for products containing p-chloro-m-
       cresol. Because data from the CMA study were collected with the handlers
       wearing long sleeved  shirt, long pants, shoes, socks and chemical-resistant
       gloves, the Agency is requiring these PPE as active-ingredient based minimum
       (baseline) PPE for primary handlers of p-chloro-m-cresol.

             The Agency has determined that for the other occupational and
       residential exposure scenarios (except machinists using p-chloro-m-cresol
       treated metal-working fluids and painters using p-chloro-m-cresol treated
       paint), including post-application exposure, concerns for toxicological risks are
       unwarranted. For this reason, active ingredient-based minimum PPE
                                   22

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             requirements, or entry restrictions are not being imposed.  The Agency notes,
             however, that there are possible concerns about secondary occupational
             handlers who are machinists handling p-chloro-m-cresol treated metal-working
             fluids. These concerns will be conveyed to OSHA for their consideration of
             regulatory measures to protect these workers.

             2.     Reduction in Percentage of Active Ingredient

                    Also the Agency notes that short- and intermediate- term and chronic
             toxicity risks to painters may be unacceptable when paints are formulated at
             higher application concentration of p-chloro-m-cresol. At the lowest
             application concentrations (0.05%) these risks are significantly reduced.  The
             sole registrant with products for use in paint, Bayer, has agreed to reduce the
             concentration to 0.05% in paints.

             3.     Other Labeling Requirements

                    The Agency is also requiring other use and safety information to be
             placed on the labeling of all end-use products containing p-chloro-m-cresol.
             For the specific labeling statements, refer to Section V of this document.

V.    ACTIONS REQUIRED OF REGISTRANTS

      This section specifies the data requirements and responses necessary for the
reregi strati on of all p-chloro-m-cresol products.

      A.    Manufacturing-Use Products

             1.     Additional Generic Data Requirements

                    The generic data base supporting the reregi strati on of p-chloro-m-cresol
             for the above eligible uses has been reviewed and determined to be
             substantially complete.

             2.     Labeling Requirements for Manufacturing-Use Products

                    To remain in compliance with FIFRA, manufacturing use product (MP)
             labeling must be revised to comply with all current EPA regulations, PR
             Notices and applicable policies. The MP labeling must bear the following
             statement under Directions for Use:

             "Only for formulation into a microbiocide for the following use(s): industrial
             adhesives, general preservatives for leather, paper products, textiles, fibers and
                                         23

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       cordage, metalworking (cutting) fluids, industrial oil/ gas drilling muds and
       packer fluids, industrial coatings, and resin/latex/ polymer emulsions."
       An MP registrant may, at his/her discretion, add one of the following
       statements to an MP label under:

             "Directions for Use" to permit the reformulation of the product
             for a specific use or all additional uses supported by a formulator
             or user group:

             (a)    "This product may be used to formulate products for specific
                    use(s) not listed on the MP label if the formulator, user  group, or
                    grower has complied with U.S. EPA submission requirements
                    regarding support of such use(s)."

             (b)    "This product may be used to formulate products for any
                    additional use(s) not listed on the MP label if the
                    formulator, user group, or grower has complied with U.S.
                    EPA submission requirements regarding support of such
                    use(s)."

B.     End-Use Products

       1.     Additional Product-Specific Data Requirements

             Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
       product-specific data regarding the pesticide after a determination of eligibility
       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 p-Chloro-m-cresol Products

             a.     Environmental Hazards

                    The following statement is required to appear in the
             Environmental Hazards section of the label, in accordance with 40 CFR
             156.10:
                                   24

-------
"This pesticide is highly toxic to fish."

b.     Directions for Use Clarification

       Registrants must specify on labeling the complete directions for
use for each use pattern: site of application, type of application, timing
of application, equipment used for application, and the rate of
application (dosage).

       The labeling must be amended to specify a maximum application
rate to achieve a concentration of 0.05% of p-chloro-m-cresol in paints.

The following statement must be added to the precautionary labeling:

       "Do not apply in marine and/or estuarine oil fields."

       The following statement must be added to the labels for aquatic
non-food industrial oil drilling muds and packer fluids:

       "For use in offshore wells only."

       For use in both terrestrial and offshore oil drilling muds and
packer fluids, the following statement must be added:

       "This product may be used for terrestrial and off-shore oil/gas
       drilling muds and packer fluids."

Clarification of Oil Drilling Mud Use

       To clarify the intent of the oil recovery drilling muds/packer
fluids use (as an  aquatic or terrestiral non-food use pattern), the
following statement must be added to the labels for terrestrial non-food
oil drilling muds and packer fluids:

       "For use in terrestrial wells only."

c.     Worker Protection Labeling

PPE/Engineering Control Requirements for Pesticide Handlers

       For sole active-ingredient end-use products that contain p-
chloro-m-cresol, the product labeling must be revised to adopt the
handler personal protective equipment/engineering control requirements
                      25

-------
set forth in this section.  Any conflicting PPE requirements on the
current labeling must be removed.

      For multiple active-ingredient end-use products that contain p-
chloro-m-cresol, the handler personal protective equipment/engineering
control requirements set forth in this section must be compared to the
requirements on the current labeling and the more protective must be
retained. For guidance on which requirements are considered more
protective, see PR Notice 93-7.

Minimum (Baseline) PPE/Engineering Control Requirements

      The Agency is establishing active-ingredient-based minimum
(baseline) PPE/engineering control requirements for p-chloro-m-cresol
end-use products that are intended primarily for  occupational use. The
minimum (baseline) PPE for all occupational uses of p-chloro-m-cresol
end-use products is:

Applicators and other handlers must wear:

—long-sleeved shirt, long pants, socks and shoes, and
—chemical-resistant gloves.

For the glove statement, use the statement established through the
instructions in Supplement Three of PR Notice 93-7.  Although this  PR
Notice addresses products within the scope Worker Protection Standard
(WPS),  that is products are generally of agricultural use, the certain
parts of the guidance are applicable to all pesticide products.

Determining PPE Requirements for End-use Product Labels

1. Any  necessary PPE for each p-chloro-m-cresol  occupational end-use
product will be established on the basis of the end-use product's acute
toxicity  category. NOTE: All end-use products will also be required to
specify minimum work attire for all handlers. If the end-use product is
classified as toxicity category I or II for eye irritation potential,
protective eyewear is also required for all handlers. If the end-use
product is classified as toxicity category I or II for  skin irritation
potential or acute dermal toxicity, a chemical-resistant apron is also
required for all handlers.

2. The PPE that would be established on the basis of the acute toxicity
category of the end-use product must be compared to the active
                      26

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ingredient-based minimum (baseline) personal protective equipment
specified above. The more protective PPE must be placed on the
product labeling. For guidance on which PPE is considered more
protective, see PR Notice 93-7.

Placement in Labeling

       The personal protective equipment requirements must be placed
on the end-use product labeling in the location specified in PR Notice
93-7, and the format and language of the PPE requirements must be the
same as is specified in PR Notice 93-7.

d.     Other Labeling Requirements

       The Agency is requiring the following labeling statements to be
located on all end-use products containing p-chloro-m-cresol:

Application Restrictions

"Do not apply this product in a way that will  contact workers or other
persons."

User Safety Requirements

Add the following statement to all end-use product labeling:

"Follow manufacturer's instructions for cleaning/maintaining personal
protection equipment (PPE).  If no such instructions for washables, use
detergent and hot water. Keep and wash PPE separately from other
laundry."

User Safety Recommendations

•      "Users should wash hands  before eating, drinking, chewing gum,
       using tobacco, or using the toilet."

•      "Users should remove clothing immediately if pesticide gets
       inside. Then wash thoroughly and put on clean clothing."

•      "Users should remove PPE immediately after handling this
       product.  Wash the outside of gloves before removing."
                     27

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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 RED. Persons other than
the registrant may generally distribute or sell such products for 50 months from the
data 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 p-chloro-m-
cresol 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 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 your products.
                                   28

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VI. APPENDICES
       29

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30

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Report Run Date: 03/14/96  )  Time 11:20                                                                                                                           LUIS 3.0 - Page:
PRD Report Date: 06/07/95
                                           APPENDIX A REPORT
Case 3046[p-Chloro-m-cresol] Chemical 064206[4-Chloro-m-cresol]
44444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444,
SITE Application Type, Application        Form(s)   Min.  Appl.      Max. Appl.  Soil Max. # Apps Max. Dose  [(AI   Min.  Restr.     Geographic Limitations      Use
  Timing, Application Equipment  )                 Rate (AI un-       Rate  (AI  Tex. @ Max. Rate unless noted    Interv Entry   Allowed           Disallowed   Limitations
  Surface Type  (Antimicrobial only)  & Effica-       less noted     unless noted  Max. /crop /year otherwise)/A]    (days) Interv                                 Codes
  cy Influencing Factor (Antimicrobial only)       otherwise)      otherwise)  Dose cycle       /crop    /year         [day(s)]
                                                                                               cycle
                                                                                              ))))))
The uses  in Appendix A were evaluated  for  reregistration.  These do  NOT include changes in application rates,  deletion of uses,  frequency  or  timing of applications, restricted entry intervals,
etc. that may have been mandated in  this document.

NON- FOOD/NON- FEED
ADHESIVES, INDUSTRIAL

Industrial preservative treatment,  During P/T
manufacture, Not on label,  Not
Applicable, Not applicable for this use

COATINGS, INDUSTRIAL

Industrial preservative treatment,  During P/T
manufacture, Not on label,  Not
Applicable, Not applicable for this use

EMULSIONS, RESIN/LATEX/POLYMER

Industrial preservative treatment,  During P/T
manufacture, Not on label,  Not
Applicable, Not applicable for this use

LEATHER PROCESSING LIQUORS

Preservative treatment, Not on label,  Not P/T
on label, Not Applicable,  Not applicable
for this use
W 500
W 500
   Use Group: INDOOR NON-FOOD

W 19980   *  NS    NS         NS



   Use Group: INDOOR NON-FOOD

 W 3996   *  NS    NS         NS



   Use Group: INDOOR NON-FOOD

 W 1998   *  NS    NS         NS



   Use Group: INDOOR NON-FOOD

 W 2498   *  NS    NS         NS
                                                                                                        CIS, C24
                                                                                                        CIS, C24
                                                                                                        CIS, C24
                                                                                                        CIS, C24
LEATHER/LEATHER PRODUCTS

Hides and skins treatment,  Not on label,   P/T
Not on label, Not Applicable,  Not
applicable for this use

METALWORKING CUTTING FLUIDS

Preservative treatment, Not on label,  Not P/T
on label, Not Applicable,  Not  applicable
for this use

OIL RECOVERY DRILLING MUDS/PACKER FLUIDS

Preservative treatment, Not on label,  Not P/T
on label, Not Applicable,  Not  applicable
for this use
W 500
W 500
   Use Group: INDOOR NON-FOOD

 W 3996   *  NS    NS         NS      NS   NS     NS



   Use Group: INDOOR NON-FOOD

W 29970   *  NS    NS         NS      NS   NS     NS



   Use Group: AQUATIC NON-FOOD INDUSTRIAL

 W 1998   *  NS    NS         NS      NS   NS     NS
                                                                                                        CIS, C24
                                                                                                        CIS, C24
                                                                                                        CIS, C24
Preservative treatment,  Not on label,  Not P/T
on label, Not Applicable,  Not applicable
for this use
                                                                      W 1998    *  NS    NS
                                                                                                   NS      NS   NS     NS
                                                                                                                                                           CIS, C24
OIL RECOVERY DRILLING MUDS/PACKER FLUIDS

Preservative treatment,  Not on label,  Not P/T
on label, Not Applicable,  Not applicable
for this use
W 500
                      Use Group:  TERRESTRIAL NON-FOOD CROP

                    W 1998   *  NS    NS         NS      NS    NS     NS
                                                                                                        CIS, C24

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Report Run Date: 03/14/96  )  Time 11:20
PRD Report Date: 06/07/95
                                           APPENDIX A  REPORT
Case 3046[p-Chloro-m-cresol] Chemical 064206[4-Chloro-m-cresol]
                                          1444444,
SITE Application Type, Application        Form(s)  Min. Appl.
  Timing, Application Equipment  )                 Rate  (AI un-
  Surface Type  (Antimicrobial only) & Effica-      less noted
  cy Influencing Factor  (Antimicrobial only)       otherwise)
                                                                                                                                                                     LUIS 3.0  - Page:
                                                                   Max. Appl.  Soil Max.  # 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                                  Codes
                                                                   otherwise)  Dose cycle      /crop   /year          [day(s)]
                                                                                                cycle
The uses in Appendix A were evaluated for reregistration.  These do NOT include changes in application rates, deletion of uses, frequency or timing of applications, restricted entry intervals,
etc. that may have been mandated in this document.

NON-FOOD/NON-FEED  (continued)
OIL RECOVERY DRILLING MUDS/PACKER FLUIDS  (continued)

Preservative treatment, Not on label, Not P/T      W
on label, Not Applicable, Not applicable
for this use
PAINTS  (IN-CAN)

Industrial preservative treatment, During P/T
manufacture, Not on label, Not
Applicable, Not applicable for this use

SPECIALITY INDUSTRIAL PRODUCTS

Industrial preservative treatment, During P/T
manufacture, Not on label, Not
Applicable, Not applicable for this use

WET-END ADDITIVES/INDUSTRIAL PROCESSING CHEMICALS

Industrial preservative treatment, During P/T
manufacture, Not on label, Not
Applicable, Not applicable for this use
                                                   W 500
                                                   W 500
   Use Group: TERRESTRIAL NON-FOOD CROP

 W 1998   *  NS    NS         NS      NS   NS     NS



   Use Group: INDOOR NON-FOOD

 W 3996   *  NS    NS         NS      NS   NS     NS



   Use Group: INDOOR NON-FOOD

W 19980   *  NS    NS         NS      NS   NS     NS



   Use Group: INDOOR NON-FOOD

 W 2997   *  NS    NS         NS      NS   NS     NS
                                                                                                                                                             CIS,  C24
                                                                                                                                                             CIS,  C24
                                                                                                                                                             CIS,  C24
                                                                                                                                                             CIS,  C24
                                                                                            32

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Report Run Date: 03/14/96  )  Time 11:20
PRD Report Date: 06/07/95
                                           APPENDIX A REPORT
Case 3046[p-Chloro-m-cresol] Chemical 064206[4-Chloro-m-cresol]
LUIS 3.0 - Page:
LEGEND
444444


  Sort: Uses Eligible or Ineligible for Re-registration, Food/Feed or Non-Food/Non-Feed Uses, Alpha Site Name, Use Group Name, Alpha Application Type/Timing/Equipment
        Description, Formulation, Maximum Application Rate Unit/Area Quantity, Minimum Application Rate, Maximum Number of Applications at Maximum Rate, Maximum Dose per Crop
        Cycle or per Year, Minimum Interval Between Applications  (Days), Restricted Entry Interval  (Days), Allowed/Disallowed Geographical Areas, Use Limitations Codes.

  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)
  PRD Report Date            :  LUIS contains all products that were active or suspended (and that were available from OPP Document Center) as of this date.  Some products
                               registered after this date may have data included in this report, but LUIS does not guarantee that all products registered  after this date have
                               data that has been captured.

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

  FORMULATION CODES
  P/T     : PELLETED/TABLETED

  ABBREVIATIONS
  AN      : As Needed
  NA      : Not Applicable
  NS      : Not Specified (on label)
  UC      : Unconverted due to lack of data (on label), or with one of following units: bag, bait, bait block, bait pack, bait station, bait station(s), block, briquet,
            briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop, eartag, grains, lure, pack, packet, packets,  pad, part,
            parts, pellets,  piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape, towelette, tray, unit,  --
  APPLICATION RATE
  DCNC    :  Dosage Can Not be Calculated
  No Calc :  No Calculation can be made
  W       :  PPM calculated by weight
  V       :  PPM Calculated by volume
  U       :  Unknown whether PPM is given by weight or by volume
  cwt     :  Hundred Weight
  nnE-xx  :  nn times (10 power -xx); for instance,  "1.234E-04" is equivalent to ".0001234"
  USE LIMITATIONS CODES
  CIS :  Do not discharge effluent containing this pesticide into sewage systems without notifying the sewage treatment plant authority  (POTW).
  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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34

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                              GUIDE TO APPENDIX B

       Appendix B contains listings of data requirements which support the reregi strati on for
active ingredients within the case p-Chloro-m-cresol covered by this Reregi strati on Eligibility
Decision Document. It contains generic data requirements that apply to p-Chloro-m-cresol in
all products, including data requirements for which a "typical formulation" is the test
substance.

       The data table is organized in the following format:

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

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

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

       3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files,
this column lists the identifying number of each study.  This normally is the Master Record
Identification (MRID) number, but may be a "GS" number if no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
                                         35

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36

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                        APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of p-Choloro-m-cresol
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
63-11
63-12
63-13
63-14
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
Octanol/Water Partition
pH
Stability
Oxidizing/Reducing Action
C,F,M
C,F,M
C,F,M
C,F,M
C,F,M
C,F,M
C,F,M
C,F,M
C,F,M
C,F,M
C,F,M
C,F,M
C,F,M
C,F,M
C,F,M
C,F,M
C,F,M
C,F,M

41962601
41962601
41962601
41962601
41962601
41962601
41962601
41962601
41962601
41962601
41962601
41962601
41962601
41962601
41962601
41962601
41962601
41962601

                                 37

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Data Supporting Guideline Requirements for the Reregistration of p-Choloro-m-cresol
REQUIREMENT USE PATTERN
63-15
63-16
63-17
63-18
63-19
63-20
63-21
64-1
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion characteristics
Dielectric breakdown volt
Submittal of Samples
CITATION(S)








ECOLOGICAL EFFECTS
71-1A
71-2A
72-1C
72-2A
Acute Avian Oral - Quail/Duck C,F,M
Avian Dietary - Quail C,F,M
Fish Toxicity Rainbow Trout C,F,M
Invertebrate Toxicity C,F,M
42692401
42692402
42692403
42692404
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6

Acute Oral Toxicity - Rat C,F,M
Acute Dermal Toxicity - C,F,M
Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit C,F,M
Primary Dermal Irritation - C,F,M
Rabbit
Dermal Sensitization - Guinea Pig C,F,M
38
71335
75492

48548, 109649
48548, 109649
78837


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       Data Supporting Guideline Requirements for the Reregistration of p-Choloro-m-cresol
REQUIREMENT
82-1A
82-2
83-1A
83-2A
83-3A
84-2A
84-2B
90-Day Feeding - Rodent
21-Day Dermal - Rabbit/Rat
Chronic Feeding Toxicity - Rodent
Oncogenicity - Rat
Developmental Toxicity - Rat
Gene Mutation (Ames Test)
Structural Chromosomal
USE PATTERN
C,F,M
C,F,M
C,F,M
C,F,M
C,F,M
C,F,M
C,F,M
CITATION(S)
124844
62905
42784801
42784801
42292901
42199901,41548601
42005201,41598101
84-4
Aberration

Other Genotoxic Effects
C,F,M
OCCUPATIONAL/RESIDENTIAL EXPOSURE
233


234
Estimation of Dermal Exposure at
Indoor Sites

Estimation of Inhalation Exposure
at Indoor Sites
C,F,M


C,F,M
42163201,41548602
41412201,42587501
41412201,42587501
                                               39

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40

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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
             as (19??), the Agency was unable to determine or estimate the date of the
             document.
                                           41

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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.
                                   42

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                               BIBLIOGRAPHY
MRID
CITATION
00062905    Rutter, H.A., Jr.; Dewey, J.M.; Wolfe, G.W.; et al. (1980) Subchronic Dermal
            Study in Rabbits: Preventol CMK: Toxicology Report No. 109. Rev. final rept.
            (Unpublished study received Dec 4, 1980 under 39967-1; prepared by Hazleton
            Laboratories Ameriknown admin, no.; CDL:223571-A)

00048548    Lamb, D.W.; Matzkanin, C.S. (1976) The Eye and Dermal Irritancy of Mobay
            Sample, p-Chloro-m-cresol: Report No. 50847. (Unpublished study received
            Jan 24,  1977 under 39967-1; submitted by Mobay Chemical Corp., Pittsburgh,
            Pa.; CDL:227654-C)

00071335    Hixson, E.J.; Lamb, D.W.; English, T.D.; et al. (1981) Acute Oral Toxicity of
            PCMC (p-Chloro-m-cresol) to Rats: Study No. 80-011-14.  (Unpublished study
            received Jan 26,  1981 under 39967-1; submitted by Mobay Chemical Corp.,
            Pittsburgh, Pa.; CDL:244164-A)

00075492    Hazleton Laboratories America, Incorporated (1979) Final Report: Acute
            Dermal Administration in Male and Female Rabbits: Project No. 339-108.
            (Unpublished study received Mar 16, 1981 under 39967-1;  submitted by
            Mobay Chemical Corp., Pittsburgh, Pa.; CDL:244849-A)

00078837    Bomhard, E.; Loeser, E.; Lorke, D. (1981) Preventol CMK: Evaluation To
            Determine the  Sensitization Effect by Means of the Open Epicutaneous Test:
            Report # 9447. A translation of: Preventol CMK: Untersuchungen auf
            sensibilisierende Wirkung im  offenen Epikutan-Test.  (Unpublished study,
            including  German text, received Jul 1, 1981 under 39967-1; prepared by Bayer,
            AG, West Germany, submitted by Mobay Chemical Corp., Pittsburgh, Pa.;
            CDL: 245551-B)

00078838    Herbold, B.; Lorke, D. (1980) Preventol CMK: Salmonella/Microsome Test for
            Detection of Point Mutagenic Effects: Report No. 9122. A translation of:
            Preventol  CMK:  Salmonella/Mikrosomen-test zur Untersuchung auf
            Punktmutagen Wirkung. (Unpublished study, including German text, received
            Jul 1, 1981 under 39967-1; prepared by Bayer, AG, West Germany, submitted
            by Mobay Chemical Corp., Pittsburgh, Pa.; CDL:245551-C)

00109649    Thyssen, J. (1978) Tests Regarding Skin and Mucosa Tolerance: Preventol
            CMK. (Unpublished study received Jun 13, 1979 under 39967-1; Submitted by
            Mobay Chemical Corp., Pittsburgh, PA; CDL: 238740-E) 00124844 Eiben,
            R.; Bomhard, E.; Loeser, E.; et al. 1981 (Preventol CMK: Subchronic
            Toxicological Tests on Rats:  3-month Feeding Test: Report # 10283.
            (Unpublished study received Sep 20, 1982 under 39967-1; prepared by Bayer
            Toxicological Institute, W Ger., submitted by Mobay Chem. Corp. Pittsburgh,
            PA. CDL: 248361-A)
                                        43

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                              BIBLIOGRAPHY
MRID
CITATION
41548601    Lehn, H. (1989) Parachlorometacresol (Preventol CMK): Mutagenicity Study
            for the Detection of Induced Forward Mutations in the CHO-HGPRT Assay in
            vitro: Lab Report No.: T1029785; 17755. Unpublished study prepared by
            Bayer AG, Dept. of Toxicology. 36 p.

41548602    Cifone, M. (1988) Parachlorometacresol (Preventol CMK) in the Rat Primary
            Hepatocyte Unscheduled DNA Synthesis Assay: HLA Study No.:
            10285-0-447: Sponsor Study No.: T3027707. Unpublished study prepared by
            Hazleton Laboratories America, Inc.  30 p.

41598101    Herbold, B. (1990) Preventol CMK: Micronucleus Test on the Mouse:  Lab
            Project Number: T 3033061. Unpublished study prepared by Bayer Ag. 45 p.

42005201    Herbold, B. (1991) Preventol CMK: Micronucleus Test on the Mouse:
            Supplement to: Lab Proj ect Number: 18686A: T 3033061. Unpublished study
            prepared by Bayer Ag.  12 p.

42163201    Van Goethem, D. (1991) Mutagenicity Test on Preventol CMK in the in the
            Rat Primary Hepatocyte Unscheduled DNA Synthesis Assay: Lab Project
            Number: 10285-0-447: T3027707. Unpublished study prepared by Hazleton
            Labs America, Inc.  6 p.

42199901    Herbold, B. (1991) Preventol CMK: Salmonella/Microsome Test:  Lab Project
            Number: T 4038030. Unpublished study prepared by Bayer AG. 45 p.

42292901    Bartman, K. (1991) Parachlorometacresol (Preventol CMK); Study for
            Embryonic Effects in the Rats after Oral Administration:  Lab Project Number:
            T3038066: 20869. Unpublished study prepared by Bayer AG, Wuppertal. 250
            P-

42587501    Popendorf, W.; Selim, M. Kross, B. (1992) Chemical Manufacturers
            Association Antimicrobial Exposure Assessment Study:  Second Replacement
            to MRID 41761201: Lab Project Number: Q626. Unpublished  study prepared
            by the University of Iowa. 316 p.

42692401    Hancock, G. (1993) Preventol CMK: An Acute Oral LD50 with  Bobwhite
            Quail: Lab Proj ect Number: PR711701:  105005. Unpublished study prepared
            by Miles Inc.  24 p.

42692402    Hancock, G. (1993) Preventol CMK: A Subacute Dietary LC50  with Bobwhite
            Quail: Lab Proj ect Number: PR721701:  105006. Unpublished study prepared
            by Miles Inc.  44 p.
                                       44

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                               BIBLIOGRAPHY
MRID
CITATION
42692403    Gagliano, G.; Bowers, L. (1993) Acute Toxicity of Preventol CMK Technical
            to the Rainbow Trout (Oncorhynchus mykiss) Under Static Renewal
            Conditions: Lab Project Number: PR812201: 105020.  Unpublished study
            prepared by Miles Inc.  48 p.

42692404    Gagliano, G.; Bowers, L. (1993) Acute Toxicity of Preventol CMK Technical
            to the Waterflea (Daphnia magna) Under Static Conditions: Lab Project
            Number: PR820701: 105021.  Unpublished study prepared by Miles Inc. 45 p.

42784801    Leser, K. (1993) Preventol CMK: Chronic Toxicity and Carcinogenicity Study
            in Wistar Rats: Lab Project Number: T9030673: 22168. Unpublished study
            prepared by Bayer Ag Institute of Industrial Toxicology. 1359 p.

The Merck Index. Ninth Edition
                                       45

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46

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                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                     WASHINGTON, D.C. 20460
                                                                         OFFICE OF
                                                                   PREVENTION, PESTICIDES
                                                                   AND TOXIC SUBSTANCES
                              DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:

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

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

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

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

       If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s)  subject to this Notice will be subject to suspension. We have provided a list

                                         47

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of all of your products subject to this Notice in Attachment 2, Data Call-In Response Form, as
well as a list of all registrants who were sent this Notice (Attachment 6).

       The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B).  Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-
0107 and 2070-0057 (expiration date 03-31-99).

       This Notice is divided into six sections and six Attachments. The Notice itself
contains information and instructions applicable to all Data Call-In Notices. The Attachments
contain specific chemical information and instructions.  The six sections of the Notice are:

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

The Attachments to this Notice are:

       1  -    Data Call-In Chemical Status Sheet
       2  -    Product-Specific Data Call-In Response Form
       3  -    Requirements Status and Registrant's Response Form
       4  -    EPA Batching of End-Use Products for Meeting Acute Toxicology Data
             Requirements for Reregi strati on
       5  -    List of Registrants Receiving This Notice
       6  -    Cost Share and Data Compensation Forms

SECTION! WHY YOU ARE RECEIVING THIS NOTICE

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

SECTION II. DATA REQUIRED BY THIS NOTICE

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.

                                          48

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II-B. SCHEDULE FOR SUBMISSION OF DATA

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

II-C. TESTING PROTOCOL

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

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

      Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those
specified in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the
OECD protocols, they should be modified as appropriate so that the data generated by the study
will satisfy the requirements of 40  CFR § 158.  Normally, the Agency will not extend deadlines
for complying with data requirements  when the studies were  not conducted in accordance with
acceptable standards.  The OECD protocols are available from OECD, 2001 L Street, N.W.,
Washington, D.C. 20036 (Telephone number 202-785-6323;  Fax telephone number 202-785-
0350).

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

II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICESISSUED BY
THE AGENCY

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

SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE

III-A. SCHEDULE FOR RESPONDING TO THE AGENCY

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

                                          49

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III-B. OPTIONS FOR RESPONDING TO THE AGENCY

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

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

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

       1. Voluntary Cancellation  - You may avoid the requirements of this Notice by requesting
voluntary cancellation of your product(s) containing the active ingredient that is the subject of
this Notice.  If you wish to voluntarily cancel your product, you must submit a completed Data
Call-In Response Form, indicating your election of this option.  Voluntary cancellation is item
number 5 on the Data Call-In Response Form. If you choose this option, this is the only form
that you are required to complete.

       If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.

       2. Satisfying the Product Specific Data Requirements of this Notice There are various
options available to satisfy the product specific data requirements of this Notice. These options
are discussed in Section III-C of this Notice and comprise options 1 through 6 on the
Requirements Status and Registrant's Response Form and item  numbers 7a and 7b on the Data
Call-in Response Form. Deletion  of a use(s) and the low volume/minor use option are  not valid
options for fulfilling product specific data requirements.
                                           50

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

III-C  SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE

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

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

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

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

       If you cannot submit the data/reports to the Agency in the time required by this Notice
and intend to seek additional time to meet the requirements(s), you must submit a request to the
Agency which includes:  (1) a detailed description of the expected difficulty and (2) a proposed

                                           51

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schedule including alternative dates for meeting such requirements on a step-by-step basis. You
must explain any technical or laboratory difficulties and provide documentation from the
laboratory performing the testing.  While EPA is considering your request, the original deadline
remains. The Agency will respond to your request in writing. If EPA does not grant your
request, the original deadline remains. Normally, extensions can be requested only in cases of
extraordinary testing problems beyond the expectation or control of the registrant. Extensions
will not be given in submitting the 90-day responses.  Extensions will not be considered if the
request for extension is not made in a timely fashion; in no event shall an extension request be
considered if it is submitted at or after the lapse of the subject deadline.

       Option 2. Agreement to Share in Cost to Develop Data — Registrants may only choose
this option for acute toxicity data and certain efficacy data and only if EPA has indicated in the
attached data tables that your product and at least one other product are similar for purposes of
depending on the same data. If this is the case, data may be generated for just one of the
products in the group.  The registration number of the product for which data will be submitted
must be noted in the agreement to cost share by the registrant selecting this option. If you
choose to enter into an agreement to share in the  cost of producing the required data but will not
be submitting the data yourself, you must provide the name of the registrant who will be
submitting the data. You must also provide EPA with documentary evidence that an agreement
has been formed.  Such evidence may be your letter offering to join in an agreement and the
other registrant's acceptance of your offer, or a written statement by the parties that an agreement
exists.  The agreement to produce the data need not specify all of the terms of the final
arrangement between the parties or the mechanism to resolve the terms.  Section 3(c)(2)(B)
provides that if the parties  cannot resolve the terms of the agreement they may resolve their
differences through binding arbitration.

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

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inform EPA of its election of an option to develop and submit the data required by this Notice by
submitting a Data Call-In Response Form and a Requirements Status and Registrant's Response
Form committing to develop and submit the data required by this Notice.

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

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

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

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

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

       b.      Health and safety studies completed after May 1984 must also contain all GLP-
              required quality assurance  and quality control information, pursuant to the

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

       If you submit an existing study, you must certify that the study meets all requirements of
the criteria outlined above.

       If you know of a study pertaining to any requirement in this Notice which does not meet
the criteria outlined above but does contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study. If such study is in the Agency's  files, you
need only  cite it along with the notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.

       Option 5. Upgrading a Study — If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study. The Agency will review the data
submitted  and determine if the requirement is satisfied. If the Agency decides the requirement is
not satisfied, you may still be required to submit new data normally  without any time extension.
Deficient,  but upgradeable studies will normally be classified as supplemental.  However, it is
important  to note that not all  studies classified as supplemental are upgradeable. If you have
questions regarding the classification of a study or whether a study may be upgraded,  call or
write the contact person listed in Attachment 1.  If you submit  data to upgrade an existing study
you must satisfy  or supply information to correct all deficiencies in the study identified by EPA.
You must  provide a clearly articulated rationale of how the deficiencies have been remedied or
corrected and why the study should be rated as acceptable to EPA. Your submission must also
specify the MRID number(s) of the study which you are attempting  to upgrade and must be in
conformance with PR Notice 86-5.

       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.

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

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

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

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

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

III-D  REQUESTS FOR DATA WAIVERS

             If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies. (Note: any
supplemental data must be submitted in the format required by PR Notice 86-5). This will be the
only opportunity to state the reasons or provide information in support of your request.  If the
Agency approves your waiver request, you will not be required to supply the data pursuant to
section 3(c)(2)(B) of FIFRA.  If the  Agency denies your waiver request, you must choose an
option for meeting the data requirements of this Notice within 30 days of the receipt of the
Agency's decision.  You must indicate and submit the option chosen on the Requirements Status
and Registrant's Response Form. Product specific data requirements for product chemistry,
acute toxicity and efficacy (where appropriate) are required for all products and the Agency
would grant a waiver only under extraordinary circumstances. You should also be aware that
submitting a waiver request will not automatically extend the due date for the study in question.
Waiver requests submitted without adequate supporting rationale will be denied and the original
due date will remain in force.
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IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE

IV-A NOTICE OF INTENT TO SUSPEND

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

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

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

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

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

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

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

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

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

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

             b.     fulfill the commitment to develop and submit the data as required by this
                   Notice; or
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             c.      otherwise take appropriate steps to meet the requirements stated in this
                    Notice, unless you commit to submit and do submit the required data in the
                    specified time frame.

       9.     Failure to take any required or appropriate steps, not mentioned above, at any time
             following the issuance of this Notice.

IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS UNACCEPTABLE

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

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

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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 your registration
six months before a 3 year study is scheduled to be submitted,  all progress reports and other
information necessary to establish  that you have been conducting the study in  an acceptable and
good faith manner must have been submitted to the Agency, before EPA will consider granting
an existing stocks provision.

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

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

SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE

       If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status  Sheet.

       All responses to this Notice (other than voluntary  cancellation requests and generic data
exemption  claims) must include a completed Data Call-In Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment 2 and Attachment 3 for
product specific data) and any other documents required by this Notice, and should be submitted
to the contact person(s) identified in Attachment 1. If the voluntary cancellation or generic data
exemption  option is chosen, only the Data Call-In Response Form need be submitted.
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      The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this Notice.

                                      Sincerely yours,
                                      Lois Rossi, Division Director
                                      Special Review and
                                       Reregi strati on Division
Attachments
       1  -    Data Call-In Chemical Status Sheet
       2  -    Product-Specific Data Call-In Response Form
       3  -    Requirements Status and Registrant's Response Form
       4  -    EPA Batching of End-Use Products for Meeting Acute Toxicology Data
             Requirements for Reregi strati on
       5  -    List of Registrants Receiving This Notice
       6  -    Cost Share and Data Compensation Forms and the Confidential Statement of
             Formula Form
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P-CHLORO-M-CRESOL DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

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

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

INQUIRIES AND RESPONSES TO THIS NOTICE

      If you have any questions regarding this product specific data requirements and
procedures established by this Notice, please contact Emily Mitchell at (703) 308-8583.

      All responses to this Notice for the Product Specific data requirements should be
      submitted to:

             Emily Mitchell
             Chemical Review Manager Team 81
             Product Reregi strati on Branch
             Special Review and Reregi strati on Branch 7508W
             Office of Pesticide Programs
             U.S. Environmental Protection Agency
             Washington, D.C. 20460

             RE: p-Chloro-m-cresol
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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, Subpart C.

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

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

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

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

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

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


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      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 "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

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             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 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
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have already voluntarily canceled this product. For these cases, please supply all
relevant details so that EPA can ensure that its records are correct.
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EPA'S BATCHING OF P-CHLORO-M-CRESOL 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 reregi strati on of products containing p-chloro-m-cresol as
the active ingredient, the Agency has batched products which can be considered similar for
purposes of acute toxicity. Factors considered in the sorting process include each product's active
and inert ingredients (identity, percent composition and biological activity), type of formulation
(e.g., emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g.,
signal word, use classification, precautionary labeling, etc.).  Note that the Agency is not
describing batched products as "substantially similar" since some products within a batch may
not be considered chemically similar or have identical use patterns.

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

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

      In deciding how to meet the product specific data requirements, registrants must follow
the directions given in the Data Call-In Notice and its attachments appended to the RED. The
DCI Notice contains two response forms which are to be completed and submitted to the Agency
within 90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant
will meet the data requirements for each product. The second form, "Requirements Status and
Registrant's Response," lists the product specific data required for each product, including the
standard six acute toxicity tests. A registrant who wishes to participate in a batch must decide
whether he/she will provide the data or depend on someone else to do so. If a registrant supplies
the data to support a batch of products, he/she must select one of the following options:
Developing Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing
Study (Option 5) or Citing an Existing Study (Option 6). If a registrant depends on another's
data, he/she must choose among: Cost Sharing (Option 2), Offers to Cost Share (Option 3) or
Citing an Existing Study (Option 6). If a registrant does not want to participate in a batch, the

                                           75

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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.

       Three active products containing p-chloro-m-cresol have been identified, Registration
Nos. 39967-8, 39967-12 and 49403-19. All three products contain greater than 99% p-chloro-
m-cresol; two are identified as technicals and one is identified as a ready-to-use solution.  They
are all considered to be in the same batch.  The data reviewed and considered acceptable in the
RED chapter will support all three products.  However, as noted in the chapter, and acute
inhalation study, or an acceptable  data waiver request is still required.

Table 1
Batch
1
EPA Reg. No.
13808-7
35975-4
35978-8
39508-2
46779-1
56228-22
% Active Ingredient
1.0
1.0
1.0
1.0
1.0
1.0
Formulation Type
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
       The following table lists a product that was either considered not to be similar or the
Agency lacked sufficient information for decision making and were not placed in any batch. The
registrant of this product is responsible for meeting the acute toxicity data requirements
separately.

Table 2  (No Batch)
EPA Reg. No.
56228-26
% Active Ingredient
90.0
Formulation Type
Solid
                                            76

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Attachment  5.     List of All Registrants Sent This Data Call-In (insert) Notice
                                          77

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78

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Instructions for Completing the Confidential Statement of Formula

The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed
copies of the form are required.  Following are basic instructions:

      a.     All the blocks on the form must be filled in and answered completely.

      b.     If any block is not applicable, mark it N/A.

      c.     The CSF must be signed,  dated and the telephone number of the responsible party
             must be provided.

      d.     All applicable information which is on the product specific data submission must
             also be reported on the CSF.

      e.     All weights reported under item 7 must be in pounds per gallon for liquids and
             pounds per cubic feet for  solids.

      f     Flashpoint must be in degrees Fahrenheit and flame extension in inches.

      g.     For all active ingredients, the EPA Registration Numbers for the currently
             registered source products must be reported under column 12.

      h.     The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all
             common names for the trade names must be reported.

      i.     For the active ingredients, the percent purity of the source products must be
             reported under column 10 and must be exactly the same as on the source product's
             label.
      j.     All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or
             grams. In no case will volumes be accepted. Do not mix English and metric
             system units (i.e., pounds and kilograms).

      k.     All the items under column  13.b. must total 100 percent.

      1.     All items under columns 14.a. and 14.b. for the active ingredients must represent
             pure active form.

      m.     The upper and lower certified limits for ail active and inert ingredients must
             follow the 40 CFR 158.175  instructions. An explanation must be provided if the
             proposed limits are different than standard certified limits.

      n.     When new CSFs are submitted and approved, all previously submitted CSFs
             become obsolete for that specific formulation.
                                          79

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80

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81

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82

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                        United States Environmental Protection Agency
                                     Washington, B.C. 20460
                                 Certification of Offer to Cost
                             Share in the Development of Data
   Form Approved
 OMB No. 2070-0106,
     2070-0057
  Approval Expires
       3-31-99
 Public reporting burden for this collection of information is estimated to average  15 minutes per response, including
 time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
 completing and reviewing the collection of information.  Send comments regarding the burden estimate or any other
 aspect of this collection of information, including suggestions for reducing this burden to, Chief Information Policy
 Branch, PM-233, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office of
 Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.

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

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

 My firm has offered in writing to enter into such an agreement.  That offer was irrevocable and included an
 an offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all
 terms could not be reached otherwise. This offer was made to  the following firms on the following
 date(s):
 Name of Firm (s)
                                                                                        Date of Offer
 Certification:

 I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
 this form and all attachments therein are true, accurate, and complete.  I acknowledge that any knowingly false or
 misleading statement may be punishable by fine or imprisonment or both under applicable law.
 Signature of Company's Authorized Representative
                                                                                        Date
 Name and Title (Please Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA form 8580 which is obselete
                                                      83

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84

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                         United States Environmental Protection Agency
                                     Washington, DC 20460
                          CERTIFICATION WITH RESPECT TO
                       DATA COMPENSATION REQUIREMENTS
3J


\
                                                                                  SB
\
 Ul
 O
                    Form Approved
                    OMB No. 2070-0107,
                    2070-0057
                    Approval Expires
                    3-31-99
  Public reporting burden for this collection of information is estimated to average 15 minutes per response, including time for
  reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the
  collection of information.  Send comments regarding the burden estimate or any other aspect of this collection of information,
  including suggestions for reducing this burden to, Chief Information Policy Branch, PM-233, U.S. Environmental Protection
  Agency, 401 M St., S.W., Washington, DC 20460; and to the Office of Management and Budget, Paperwork Reduction Project
  (2070-0106), Washington, DC 20503.

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

  1.    For each study cited in support of registration or reregistratiion under the Federal Insecticide, Fungicide and Rodenticide Act
  (FIFRA) that is an exclusive use study, I am the original data submitter, or I  have obtained the written permission of the original
  data submitter to cite that study.

  2.    That for each study cited in support of registration or reregistration under  FIFRA that is NOT an exclusive use study, I am the
  original data submitter, or I have obtained the written permission of the original data submitter, or I have notified in writing the
  company(ies) that submitted data I  have cited and have offered to: (a) Pay compensation for those data in accordance with sections
  3(c)(1 )(F) and 3(c)(2)(D) of FIFRA;  and (b) Commence negotiation to determine which data  are subject to the compensation
  requirement of FIFRA and the amount of compensation due, if any. The companies I have notified are. (check one)

   [  ] The companies who have submitted the studies listed on the back of this form or attached sheets,  or indicated on the attached
  "Requirements Status and Registrants' Response Form,"

  3.    That I  have previously complied with section 3(c)(1)(F) of FIFRA for the studies I have  cited in support of registration or
  reregistration under FIFRA.
Signature
Date
  Name and Title (Please Type or Print)
  GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the registration or
  reregistration of my products, to the extent required by FIFRA section 3(c)(1)(F) and 3(c)(2)(D).
Signature
Date
  Name and Title (Please Type or Print)
EPA Form 8570-31 (4-96)
                                                           85

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86

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    The following is a list of available documents for p-Chloro-m-cresol that my further assist
you in responding to this Reregi strati on Eligibility Decision document.  These documents
may be obtained by the following methods:

Electronic
File format:   Portable Document Format (.PDF) Requires Adobe® Acrobat or compatible
             reader. Electronic copies can be downloaded from the Pesticide Special
             Review and Reregi strati on Information System at 703-308-7224. They also are
             available on the Internet on EPA's gopher server, GOPHER.EPA.GOV, or
             using ftp on FTP.EPA.GOV, or using WWW (World Wide Web) on
             WWW.EPA.GOV., or contact Emily Mitchell at (703)-308-8583.

             1.     PR Notice 86-5.

             2.     PR Notice 91-2 (pertains to the Label Ingredient Statement).

             3.     A full copy of this RED document.

             4.     A copy of the fact sheet for p-Chloro-m-cresol.

    The following documents are part of the Administrative Record for p-Chloro-m-cresol
and may included in the EPA's Office of Pesticide Programs Public Docket. Copies of these
documents are not available  electronically, but may be obtained by contacting the person
listed on the Chemical Status Sheet.

    1.        Health and Environmental Effects Science Chapters.

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

    The following Agency reference documents are not available electronically, but may be
obtained by contacting the person listed on the Chemical Status Sheet of this RED document.

    1.        The Label Review Manual.

    2.        EPA Acceptance Criteria
                                         87

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