United States        Office of Prevention, Pesticides EPA 738-R-94-002
           Environmental Protection   And Toxic Substances     February 1994
           Agency	(7508W)	

v>EPA  Reregistration

           Eligibility Decision  (RED)


           Methiocarb      738R94002
                                         Recycled/Recyclable
                                         Printed on paper that contains
                                         at least 50% recycled fiber
                                         SM-X3

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   *"* PRO*
                   UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

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

       I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case Methiocarb
which includes the active ingredients 4-methylthio-3,5-xylylmethylcarbamate.   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 reregistration.  The RED includes the data and labeling requirements for
products for reregistration.  It may also include requirements for additional data (generic) on
the active ingredient(s) to confirm  the risk assessments.

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

       If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregistration Division representative
Franklin  Gee at (703) 308-8008.  Address any questions on required generic data to the
Special Review and Reregistration Division representative Karen Jones at 703-308-8047 .
                                              Sincerely yours,
                                              Daniel M. Barolo, Director
                                              Special Review and
                                                Reregistration Division
Enclosures

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              SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
             THE TtFttF/lTSTRATION ELIGIBILITY DECISION
 1   DATA CALL-IN (PCD OR "90-DAY RESPONSE"-If generic data are required for
 reregistration, a DCI letter will be enclosed describing such data.  If product specific data
 are required, another DCI letter will be enclosed listing such  requirements. Complete the
 two response forms provided with  each DCI letter by following the instructions contained in
 each DCI.  You must submit the  response forms for each product and for each DCI
 within 90 days of the date you receive the RED; otherwise, your product may be
 suspended.

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

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

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

      b. Five copies of draft labeling which complies with the RED and current
 regulations and requirements.  Only make labeling changes which are required by the RED
 and current  regulations (40 CFR 156. 10) and policies. Submit any other amendments (such
 as formulation changes, or labeling changes not related to reregistration) separately.  You
 may delete uses which the RED says are ineligible for reregistration. For further labeling
 guidance, refer 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; 703-487-4650).

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

      d. Two copies of the Confidential Statement of Formula (CSF1 for each  hasir
 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

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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 Citation of Data. Complete and sign this form
(EPA form 8570-29) for each product. Cite-all is not a valid option for reregistration.

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 ALL PCI RESPONSES (90-DAY) AND APPLICATIONS  FOR
REREGISTRATION (8-MONTH RESPONSES)

Bv U.S. Mail;

      Document Processing Desk (RED-SRRD-0577)
      Office of Pesticide Programs (7504C)
      EPA, 401 M St. S.W.
      Washington, D.C.  20460-0001

Bv express;

      Document Processing Desk (RED-SRRD-0577)
      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 DOCUMENT

         METfflOCARB

             LIST A

            CASE 0577
      ENmONMENTAL-FROTECTION-AGENCY
        OFFICE-OF-FESnCEDE'FROGRAMS
   SPECIAL-REVIEW-AND-REREGISTRATION-DIVISION

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                         TABLE OF CONTENTS


METHIOCARB REREGISTRATION ELIGIBILITY TEAM	   i

GLOSSARY OF TERMS AND ABBREVIATIONS 	ii

EXECUTIVE SUMMARY	  iv

I.     INTRODUCTION	   1

II.    CASE OVERVIEW	   2
      A.   Chemical Overview	   2
      B.   Use Profile	   2
      C.   Data Requirements	   5
      D.   Regulatory History	   5

III.   SCIENCE ASSESSMENT	   6
      A.   Physical Chemistry Assessment  	   6
      B.   Human Health Assessment	   6
           1.    Toxicology Assessment  	   6
                 a.    Acute Toxicity	   6
                 b.    Subchronic Toxicity	   7
                 c.    Chronic toxicity	   8
                 d.    Carcinogenicity  	   9
                 e.    Developmental Toxicity 	   9
                 f.     Reproductive Toxicity  	  10
                 g.    Mutagenicity	  10
                 h.    Metabolism	  11
                 i.     Other Toxic Endpoints	  11
                 j.     Other Toxicological Considerations	  11
                 k.    Reference Dose	  12
           2.    Exposure Assessment  	  12
                 a.    Dietary	  12
                 b.    Occupational and Residential	  13
           3.    Risk Assessment  	  16
                 a.    Dietary	  16
                 b.    Occupational and Residential	  16
      C.   Environmental Assessment	  18
           1.    Environmental Fate	  18
                 a.    Environmental Chemistry, Fate and Transport  ......  18
                 b.    Environmental Fate Assessment	  19
           2.    Ecological Effects  	  20
                 a.    Ecological Effects Data	  20
                       (1)    Terrestrial Data	  20
                       (2)    Aquatic Data  	  21

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                        (3)    Non-Target Insects Data  	  21
                  b.    Ecological Effects Risk Assessment	  21
                        (1)    Risk to Terrestrial Organisms	  21
                        (2)    Risk to Aquatic Organisms	  23

IV.   RISK MANAGEMENT AND REREGISTRATION DECISION	  26
      A.    Determination of Eligibility	  26
            1.    Eligibility Decision	  27
            2.    Eligible and Ineligible Uses	  27
      B.    Regulatory Position	  27
            1.    Tolerance Reassessment	  28
            2.    Restricted Use Classification	  28
            3.    Endangered Species Statement	  28
            4.    Labeling Rationale	  29
                  a.    Postapplication/Reentry Requirements	  29
                  b.    Personal Protective Equipment (PPE) Requirements  ...  30
                  c.    Ecological Effects	  31
V.    ACTIONS REQUIRED BY REGISTRANTS	  31
      A.    Manufacturing-Use Products	  31
            1.    Additional Generic Data Requirements	  31
            2.    Labeling Requirements for Manufacturing-Use Products	  32
      B.    End-Use Products	  32
            1.    Additional Product-Specific Data Requirements 	  32
            2.    Labeling Requirements for End-Use Products	  33
                  a.    Compliance with the Worker Protection Standard  ....  33
                  b.    Entry Restrictions;  Labeling	  33
                  c.    Personal Protective Equipment Requirements;
                        Labeling	  35
                  d.    Other Labeling Requirements  	  37
      C.    Existing Stocks  	  39

VI.   APPENDICES	  41
      APPENDIX A. Table of Use Patterns Subject to Reregistration	  43
      APPENDIX B. Table of the Generic Data Requirements and Studies Used
                     to Make the Reregistration Decision	  51
      APPENDIX C. Citations Considered to be Part of the Data Base
                     Supporting the Reregistration of Methiocarb	  65
      APPENDIX D. List of Available Related Documents	  81
      APPENDIX E. PR Notice 91-2  	  85
      APPENDIX F. Combined Generic and Product Specific Data Call-in	  91
            Attachment 1. Chemical Status Sheet .	113
            Attachment 2. Combined Generic and Product Specific Data Call-In
                          Response Forms  (Form A inserts) Plus Instructions ...  117

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      Attachment 3. Generic and Product Specific Requirement Status
                   and Registrant's Response Forms (Form B inserts)
                   and Instructions	127
      Attachment 4. EPA Grouping of End-Use Products for Meeting
                   Data Requirements for Reregistration	149
      Attachment 5. EPA Acceptance Criteria  	153
      Attachment 6. List of All Registrants Sent This Data Call-In (insert)
                   Notice 	167
      Attachment 7. Confidential Statement of Formula, Cost  Share and
                   Data Compensation Forms   	171
APPENDIX G.  RED Fact Sheet	181

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METHIOCARB REREGISTRATION ELIGIBILITY TEAM

Office of Pesticide Programs:

Biological and Economic Analysis Division
William Gross             Biological Analysis Branch
Frank Hernandez           Economic Analysis Branch
Steve Jarboe               LUIS Staff, Biological Analysis Branch

Environmental Fate and Effects Division
Regina Hirsch             Ecological Effects Branch
James Hetrick             Environmental Fate and Groundwater Branch
Jean Holmes               Science Analysis and Coordination Staff

Health Effects Division
Nguyen Thoa              Chemical Coordination Branch
Karen Hammernik         Toxicology Branch I
Jeffrey Evans              Occupational and Residential Exposure Branch

Registration Division
Marilyn Mautz            Insecticide-Rodenticide Branch
Bipin Gandhi              Registration Support Branch
Joanne Hayes              Registration Support Branch

Special Review and Reregistration Division
Karen Jones               Reregistration Branch
Linda Propst               Reregistration Branch
Carol Stangel              Planning  and Reregistration Branch

Policy and Special Projects Staff
Jean Frane

Office of Compliance Monitoring

Beverly Updike            Pesticides Enforcement Policy Branch

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                  GLOSSARY OF TERMS AND ABBREVIATIONS

a.i.          Active Ingredient

CAS         Chemical Abstracts Service

CSF         Confidential Statement of Formula

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

EP          End-Use Product

EPA         U.S.  Environmental Protection Agency

FDA         Food and Drug Administration

FIFRA       Federal Insecticide, Fungicide, and Rodenticide Act

FFDCA      Federal Food, Drug, and Cosmetic Act

GRAS        Generally Recognized As Safe as designated by FDA

HDT         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.

LD10         Lethal Dose-low. Lowest Dose at which lethality occurs

LEL         Lowest Effect Level

LOEL        Lowest Observed Effect Level

MP          Manufacturing-Use Product

MPI         Maximum Permissible Intake
                                        11

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                  GLOSSARY OF TERMS AND ABBREVIATIONS


MOE        Margin Of Exposure (PAD)

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

N/A         Not Applicable

NPDES      National Pollutant Discharge Elimination System

NOEL       No Observed Effect Level

OPP         Office of Pesticide Programs

PADI        Provisional Acceptable Daily Intake

ppm         Parts  Per Million

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

RED         Reregistration Eligibility Decision

RfD         Reference Dose

RS          Registration Standard

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

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

TMRC       Theoretical Maximum Residue Contribution.
                                       111

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EXECUTIVE SUMMARY

       This Reregistration Eligibility Decision document (RED) addresses the reregistration
eligibility of the pesticide methiocarb, 4-methylthio-3,5-xylylmethylcarbamate.

       Methiocarb is a carbamate insecticide, acaricide, molluscicide, and avian repellent
produced by Miles, Inc.  Methiocarb is used to control slugs, snails, and other pests on
ornamentals, lawns, turf, and ginseng.  Ginseng is not considered a food use because current
methiocarb end-use labels bear the 12 months' preharvest interval.  The end-use formulations
of methiocarb are granular and pelleted/tableted, wettable powder, and pressurized liquid.
The registered products are applied by  broadcast, foliar spray, and soil-incorporation (spot
treatment).

       Methiocarb was initially registered as a pesticide in 1972.  A Registration Standard
was issued in March 1987 (NTIS# PB87-190898).  This Registration Standard summarized
available data supporting the registration of products containing methiocarb used as a bird
repellent in corn fields and  fruit orchards and for slug, snail, and other types of pest control
on ornamentals, lawns, turf and ginseng.  The Registration Standard also required additional
product chemistry, residue chemistry, ecological effects, environmental fate, toxicology and
occupational/residential exposure data.  The residue chemistry data requirements were
waived because of the deletion of the food uses from methiocarb product registration labels
in 1992. The technical producer is no  longer supporting commercial turf uses and support
from end-use registrants or amendment of their labels deleting the commercial turf use is
required.  However, this document addresses commercial turf uses because such uses are
currently still on labels.  The Agency has now completed its review of the methiocarb target
data base including data submitted in response to the  1987 Registration Standard.

       The Agency has classified  methiocarb as a Group D carcinogen (insufficient
information to evaluate the  chemical).  The Agency has determined that methiocarb is a
developmental toxicant based on a dermal developmental toxicity study in rabbits. The no
observed effect level (NOEL) for  developmental toxicity is 50 mg/kg/day.

       There may be a risk to workers tending to plants in greenhouses/nurseries, handlers
(mixer/loader/applicators), commercial turf workers,  and homeowners exposed to
methiocarb. The margins of exposure  (MOE) for the uses with the greatest potential for
occupational exposure indicate a level of concern. Specifically,  for handlers using the
wettable powder.formulation, the  MOE's are estimated to be less than 100, the commonly
accepted margin of exposure. In order to achieve an acceptable MOE, the Agency  is
imposing additional PPE.  The Agency is also concerned about workers entering  treated
areas following application of the  wettable powder and pressurized liquid formulations.    In
order to achieve an acceptable MOE for workers, the Agency is requiring a 25-day restricted
entry interval (REI) following foliar applications with the wettable powder formulation and
treatment of greenhouses with the pressurized liquid.  After 10 days workers may enter
treated areas to perform tasks, including hand labor tasks that involve contact with treated
                                           IV

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surfaces provided each worker spends no more than three hours in each 24-hour period
performing such tasks. PPE is not required during the 3 hour work period.  The Agency
has determined that the uses of the wettable powder and the pressurized liquid formulations
are eligible for reregistration.  Confirmatory data on estimation of dermal and inhalation
exposure to handlers for the wettable powder formulation is required.  The Agency is also
requiring an inhalation passive dosimetry study to better define exposure to workers
reentering treated greenhouses following application of the pressurized liquid.

       The Agency is requiring that coveralls be added to current Personal Protective
Equipment (PPE) requirements in order to provide  handlers of the wettable powder
formulation with adequate MOE's for all uses.   This PPE with modifications also applies to
early entry workers entering treated areas. The Agency is also requiring that a dust mask be
worn while mixing/loading the wettable powder formulation because the wettable powder is a
potentially high exposure route with respect to inhalation.  In addition, the Agency is
requiring that a respirator be worn by handlers during ventilation activities.

       With respect to homeowner uses of methiocarb, the Agency has determined that  there
is insufficient exposure data for the use of methiocarb by broadcast application on residential
lawns and turf and a reregistration eligibility decision cannot be made at this time.  The
Agency is unable to estimate the risk to homeowners and children from the broadcast
treatment of methiocarb granulars on residential lawns because of the numerous uncertainties
in  potential exposure levels. The only registered homeowner use is for the broadcast
application of the 1 % or 2% granular or pellet products on ornamentals and lawns. Data
relating to postapplication reentry will be derived from the turfgrass foliar dislodgeable
dissipation and dermal passive dosimetry  studies required at this time to support the
residential lawn uses. Registrants may prohibit  use on lawns and commercial turf while
maintaining uses on ornamentals and avoid generation of the foliar dissipation and passive
dosimetry studies. Exposure to homeowners using  methiocarb for applications to building
foundations is  expected to be low and additional data are not required to support this use.
The Agency is retaining the 24-hour REI for postapplication activities for the granular
formulation use on commercial or research production of turfgrass. The commercially
grown  turfgrass use is eligible for reregistration. Also, the use of the self-contained granular
shakers are eligible for reregistration except for the use on residential lawns and turf.

       Applications to ornamentals in residential situations, including application by
commercial applicators, is eligible for reregistration except for products marketed in
packages larger than the 2 Ib.  shaker cans (e.g.  20  - 25 Ib. bags) for use by homeowners.
The Agency is requiring data (soil dissipation and dermal exposure) to assess the exposure to
persons entering treated ornamental planting areas.   These data are considered confirmatory.
After the Agency reviews exposure data on ornamentals and residential lawns, the Agency
will determine if further marketing in packages  other than 2 Ib. shaker containers for use by
homeowners is appropriate.

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       The Agency has also determined that the use of methiocarb exceeds levels of concern
for endangered species for birds, mammals, non-target insects, and freshwater invertebrates
for all outdoor uses. Because of these concerns, the Agency is requiring label amendments
and confirmatory data, as well as negotiating with the registrants to maintain a production
cap in an effort to decrease the environmental risk of methiocarb.

       In addition, the Agency has classified methiocarb as a restricted use pesticide for all
outdoor uses except homeowner uses.

       In summary, the  Agency has determined that the following uses and formulations are
eligible for reregistration: 1) granular/pelleted formulations (1-2% a.i.) applied to
commercially grown turfgrass; to residential and commercially grown ornamentals except for
20 -  25 Ib.  bag products used by homeowners; in commercial greenhouses and nurseries; and
around building foundations.  2)  wettable powder formulation (75  % a.i.) used as a foliar
spray to nursery and greenhouse  grown ornamentals.  3) pressurized liquid formulation (1 %
a..i.)  applied as a total release spray in commercial greenhouses.

       Due to a lack of exposure information, a reregistration eligibility decision on the
granular and pelleted formulations for use on residential.lawns and turf by broadcast methods
cannot be made at this time.

       The Agency is requiring that additional generic data be submitted to confirm the risk
assessment done on the uses declared eligible in the reregistration review. These data
include the following:

              Estimation of dermal exposure - for wettable powder
                    formulation use in greenhouses and nurseries
              Estimation of inhalation exposure - for wettable powder
                    formulation use in greenhouses and nurseries
              Estimation of dermal exposure and soil dissipation - for granular formulations
                    used on ornamentals
              Inhalation passive dosimetry - for pressurized liquid formulation use in
                    greenhouses
              Aquatic and estuarine organisms - fish/mollusk/shrimp - required for  all
                    lawn and turf uses
              Aquatic invertebrate life cycle - required for all lawn and turf uses
              Fish early life stage - required for all lawn and turf uses
              Fish life cycle - required for all lawn and turf uses
              Hydrolysis - required for all outdoor uses
              Adsorption/desorption/leaching - required for all outdoor uses
              Terrestrial  field dissipation - required for all lawn and turf uses
              Outdoor usage data - specify pounds used per year by site
                                          VI

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       The following data are required to support the use of granular formulations of
methiocarb on residential lawns and turf:

              Foliar dislodgeable dissipation
              Dermal passive dosimetry

       Also,  data on acute and subchronic neurotoxicity, which are not part of the target data
base for methiocarb, are required because methiocarb is a carbamate pesticide.

       Accordingly, the Agency has determined that only the products containing methiocarb
as the sole active ingredient for the uses declared eligible for reregistration will be
reregistered when acceptable labeling and product specific data are submitted and/or cited.
Before reregistering each product, the Agency is requiring that product specific data (product
chemistry and acute toxicity) be submitted by the registrants within eight months of the
issuance of this document.   Additionally, in order to remain in compliance with FIFRA, it is
the Agency's position that revised labeling be submitted by the registrants within that same
time period.  After reviewing these data and revised labels, the Agency will determine
whether the conditions and requirements of FIFRA  3(c)(5) have been met for the
reregistration of these products.
                                           VII

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I.      INTRODUCTION

       In  1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the reregistration of products with active ingredients registered prior to
November 1, 1984.  The amended Act provides a schedule for the reregistration process to
be completed in nine years. There are five phases to the reregistration process.  The first
four phases of the process focus on identification of data requirements to support the
reregistration of an active ingredient and the generation and submission of data to fulfill the
requirements.  The fifth phase is a review by the U.S. Environmental Protection  Agency
(referred to as "the Agency") of all data submitted to support reregistration.

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

       This document presents the Agency's decision regarding the reregistration eligibility
of the registered uses of methiocarb.  The document consists of six sections. Section I is the
introduction.  Section II describes methiocarb, its uses, data requirements and regulatory
history. Section III discusses the human health and environmental  assessment based on the
data available to the Agency. Section IV presents the reregistration decision for methiocarb.
Section V discusses the reregistration requirements for methiocarb.  Finally, Section VI is
the Appendices which support this Reregistration Eligibility Decision document.  Additional
details concerning the Agency's review of applicable data are available on request.1
    'EPA's reviews of data on the set of registered uses considered for EPA's analysis may be
obtained from the OPP Public Docket, Field Operations Division (H7506C), Office of Pesticide
Programs, EPA, Washington, DC 20460.

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II.    CASE OVERVIEW

      A.    Chemical Overview

            The following active ingredient is covered by this Reregistration Eligibility
      Decision:

      •     Common Name:    methiocarb


      •     Chemical Name:    4-methylthio-3,5-xylylmethylcarbamate


      •     Chemical Family:          Carbamate


      •     CAS Registry Number:    2032-65-7


      •     OPP Chemical  Code:       100501


      •     Empirical Formula:        CnHi5NO2S
            Trade and Other Names:         Mercaptodimethur, Metmercapturnon,
                                            Mesurol, Methiocarbe, Bay 376344, and
                                            H-321
      •      Basic Manufacturer:       Miles, Inc.

      B.     Use Profile

             The following contains information on the current registered uses of
      methiocarb with an overview of use sites and application methods.  A detailed table of
      these uses of methiocarb is in Appendix A.

             For methiocarb:

             Type of Pesticide:  Molluscicide/Avian Repellent/Insecticide/Acaricide

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Use Sites:    Terrestrial Non-Food Crop: ornamental and/or shade trees,
             ornamental herbaceous plants, ginseng, ornamental non-
             flowering plants, ornamental woody shrubs and vines.

             Terrestrial Non-Food/Outdoor Residential: ornamental and/or
             shade trees, ornamental herbaceous plants, ornamental lawns
             and turf, ornamental non-flowering plants, ornamental woody
             shrubs and vines.

             Greenhouse Non-Food Crop: ornamental and/or shade trees,
             ornamental herbaceous plants, ornamental non-flowering plants,
             ornamental woody shrubs and vines.

             Outdoor Residential: household/domestic dwellings outdoor
             premises

Target Pests:        snails, slugs, sowbugs, millipedes, crickets, aphids,
                    centipedes, fall webworms, scales, spider mites, pillbugs,
                    moths, and whiteflies.
Formulation Types Registered:

Bait - Granular
(1.0% methiocarb plus other active ingredients, 2.0 % methiocarb)

Bait - Pelleted/Tableted
(2.0% methiocarb)

Wettable Powder
(75.0%  methiocarb)

Pressurized Liquid
(1.0% methiocarb)

Technical Grade
(95%  methiocarb, soluble concentrate/solid)

Manufacturing Use
(75%  methiocarb, form not identified/solid)

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Current Method and Rates of Application:

Granular: Water area to be treated before application.  Sprinkle one pound of
product directly from container or with spreader over 1000 square feet (for 2%
product this equals 0.87 Ibs ai/A). Scatter so that granules are hardly visible
in treated area. Special attention  should be given to treating areas around
flower beds, under greenhouse benches, and around building foundations.  Use
sites include ornamentals, border plantings, flower gardens (ornamental
gardens), shrubs, ornamental greenhouses, ornamental nurseries, lawns, turf,
ornamental ground covers,  around the home, around building foundations, and
ginseng gardens.

Pelleted/Tableted: Sprinkle one pound of pellets over 1000 square feet (0.87
Ibs ai/A). For best results  lightly water area to be treated before application.
Scatter bait so that it is visible on the ground.  Use sites include flower
gardens, ornamental greenhouses, around the home, and around building
foundations.

Wettable Powder: Apply up to two pounds product (1.5 Ibs ai/A) per acre in
50 gallons water using conventional ground spray equipment.  Spray plants
and foliage until thoroughly wet.  Maximum of four applications per season (8
pounds of product per acre equals 6.0 Ibs ai/A per season).  Use sites include
ornamental nurseries and ornamental greenhouses for use on shrubs, flowers,
and trees.

Pressurized Liquid (Total Release Aerosol): For best results, apply in early
evening when  foliage is dry and temperatures are between 60-80°F.  Shut off
all exhaust fans and close all windows, doors and ventilators.  Keep
greenhouse closed 2-4 hours after treatment. Maximum rate is 1 pound per
1500 square feet. Place container on ground or on bench depending on
location where plants are grown.  Press tab down to lock position  and leave
greenhouse.  Entire contents will release automatically.  Use site includes
commercial  greenhouses.

Current Limitations on Use Practices:

Granular: Do not use on or around plants grown for food.  Do not put
granules in piles.  Do not enter treated areas for 24 hours unless protective
clothing is worn.  This restriction is not applicable to the homeowner use of
granular formulations.

Pelleted/Tableted: Do not use on plants grown for food.  Do not put bait in
piles. Toxic to fish and highly toxic to birds.

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       Wettable Powder: Do not apply through any type of irrigation system. Do not
       apply with oil. Do not enter treated areas for 24 hours without protective
       clothing.  Do  not apply in conjunction with  foliar fertilizer applications.

       Pressurized Liquid: Do not remain in treated area and ventilate area after
       treatment.  Container must be at room temperature before use.  Test for
       phytotoxicity before use.  Toxic to fish.

C.    Data Requirements

       Data requested in the March  1987 Registration Standard for methiocarb
included studies on product chemistry, residue chemistry, ecological effects,
environmental fate, toxicology and occupational/residential exposure. These data
were required to support the uses listed in the Registration Standard.  Appendix  B
includes all data requirements identified by the Agency for currently registered uses
needed  to support reregistration.
D.     Regulatory History

       A Registration Standard was issued in March 1987 (NTIS #PB87-190898) for
all pesticide products containing the active ingredient, methiocarb.  This document
identified the additional generic data required to support the continued registration of
the use of methiocarb as a bird repellent,  insecticide, acaricide and molluscicide. The
use patterns registered at that time included terrestrial food and non-food, greenhouse
non-food and domestic outdoor.  This document also specified those product-specific
product chemistry and acute toxicity data  required for the manufacturing-use products.

       Additionally, the Registration  Standard restricted all outdoor agricultural and
commercial (non-domestic) uses of methiocarb for use by certified applicators or
workers  under their direct supervision on  an interim basis pending submittal and
evaluation of the required terrestrial field, avian repellency and aquatic residue
monitoring data.  The Registration  Standard further specified that no new permanent
tolerances would be granted pending submittal and evaluation  of data required to
ascertain and validate an appropriate analytical method for the enforcement of
tolerances for residues of methiocarb  and  any metabolites deemed to be of
lexicological concern.

       Consequently, in 1989,  Miles  Inc.  (technical producer) dropped all terrestrial
food uses of methiocarb and in 1992, the  end-use registrants either voluntarily
cancelled their product(s)  or amended their label(s) by deleting the food uses.
Therefore,  no residue chemistry data  requirements remain for  methiocarb.  The
technical producer also dropped their  support of all commercial turf and field grown
ornamental uses.  However, these uses remain on end-use product labels.  A

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       Reregistration Eligibility Decision document reflects a reassessment of all data which
       were submitted in response to the Registration Standard.
HI.   SCIENCE ASSESSMENT

      A.    Physical Chemistry Assessment

      The physical and chemical characteristics of methiocarb are described below:

      TGAI              Methiocarb
      Molecular weight   225.3
      Color              White
      Physical State      Crystalline solid
      Odor              Slightly mercaptan
      Melting Point      121°C
      Boiling Point       N/A
      Bulk Density       35-40 Ib/cu. ft (0.56 - 0.64 g/cc)
      Solubility           27 mg/1 in water, 80 g/1 in 2-propanol, 70 g/1 in toluene and 2
                          g/1 in n-hexane
      Vapor Pressure     8.8 x 10'7 mbar at 25°C (6.6 x 10'7 torr)
      Dissoc. Constant    N/A
      Oct./Water Part.  Coeff.   2200 at 20°C
      pH                 N/A
      Stability            Half life at 22°C is > 1 year at pH 4

      There are no further Product Chemistry data requirements for methiocarb technical.

      B.    Human Health Assessment

             1.      Toxicology Assessment

                    Adequate animal lexicological data on methiocarb are available and will
             support reregistration eligibility as a terrestrial non-food use pesticide.   The
             data are reported below.

                    a.     Acute Toxicity

                          Acute toxicity data for methiocarb technical are listed in the
                    table below.

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                                       Acute Toxicity
Test
Oral LD50 (rat)1-2
Dermal LD50 (rabbit)3
Inhalation LCSO (rat)4
Eye Irritation5
Dermal Irritation6
Delayed Neurotoxicity7'0
Result
30 mg/kg (both sexes)*
14 mg/kg (males)b
16 mg/kg (females)*
> 2000 mg/kg
0.585 mg/1 (males)
0.433 mg/1 (females)
Not an irritant
Not an irritant
Negative
Category
I
m
II
IV
IV
N/A
1-7 MRID numbers are 00036477, 00083437, 00036478, 4040420, 00055163, 00055163, and 00083438.
a  Test material in ethanol and propylene glycol vehicle.
b  Test material in polyethylene glycol 400 (Lutrol) vehicle.
c  Study available but not required for carbamates.
N/A Not applicable
                     b.     Subchronic Toxicity

                            Four dermal toxicity studies in rabbits are available.  The first
                     two, a six-day initial range-finding study and a 21-day repeated dermal
                     toxicity study (interrupted at day 14), were performed by the same
                     laboratory .  In the range-finding study, doses of 0 (saline vehicle),
                     15.7, 31.3, 62.5, 125, 250, 500, 1000, or 2000 mg/kg/day of
                     methiocarb technical were administered.  Death occurred in one out of
                     two females per group at doses of 250, 500, and  1000 mg/kg/day and
                     in both of the high dose females.  One out of two males per group died
                     at doses of 1000 mg/kg/day and above.  All deaths were ascribed to
                     treatment since no other explanation was provided in the study report.
                     Other clear-cut clinical signs of toxicity were noted at the two highest
                     doses.  The interrupted 21-day study, in which doses of 0 (saline
                     vehicle), 60, 150, or 375 mg/kg/day of methiocarb technical were
                     being administered, was stopped due to three accidental deaths at the
                     high dose. No treatment-related effects were observed by day 14 at the
                     lower doses.

                            The third and fourth dermal studies were 21-day studies which
                     were performed at later dates by a different laboratory.   The respective
                     doses of methiocarb technical used in the two studies  were 0 (saline

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vehicle), 60, 150, or 375 mg/kg/day and, 0 (saline vehicle) or 500
mg/kg/day.  No clear adverse findings were observed and a lowest
observed effect level (LOEL) could  not be established (MRIDs
40922301 and 41771701).

       Although inconsistencies were noted in the data from the two
laboratories  and the quality of the data from the two completed 21-day
dermal studies exceeded that of the earlier studies, the deaths in the
dose ranging study cannot be ignored.  Therefore, based on all  of the
available information, a no observed effect level (NOEL) for
subchronic dermal toxicity could be established at 150 mg/kg/day (the
next lower dose tested from amongst the studies in which no treatment-
related effects were noted). The LOEL was 250 mg/kg/day based on
mortality in  females at doses of 250 mg/kg/day and above. (MRIDs
40922301 and 41771701).

       Since a subchronic NOEL could be established from the above
studies, the requirements for subchronic toxicity studies in rodents and
non-rodents  are formally satisfied by the availability of acceptable
chronic feeding studies (MRIDs 00115226, 00128939, and  00149362).

c.     Chronic toxicity

       In a chronic feeding study in rodents,  groups of rats (60/
sex/group) were fed diets containing 0, 67, 200, or 600 ppm of
methiocarb technical for two years.  The systemic NOEL was
determined to be 600 ppm (30 mg/kg/day). At this dose, in both sexes,
body weight decreases, relative to controls, were observed which were
considered to be a secondary effect of cholinesterase inhibition.  Both
erythrocyte and plasma cholinesterase inhibition  occurred at the high
dose. The LOEL for cholinesterase inhibition was judged to be 200
ppm (10 mg/kg/day), at which dose transitory erythrocyte
cholinesterase inhibition was observed.  The NOEL for cholinesterase
inhibition was set at 67 ppm (3.35 mg/kg/day).  Brain cholinesterase
was not affected (MRID 00115226 and 00128723)

       In a chronic feeding study in the non-rodent, groups of six-
month old pure bred beagle dogs (4/sex/group) were fed diets
containing 0, 5 (reduced from 15 ppm at study week three), 60, or 240
ppm of methiocarb technical in the diet for two years.  Effects which
appeared to be treatment-related were sporadic incidences of hind limb
weakness and tremor in the high  dose group animals fed 240 ppm (6
mg/kg/day) of test material and plasma cholinesterase inhibition of 30%
or greater, with respect to controls, at dose levels of 15 ppm (0.375
                       8

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mg/kg/day) and above. The NOEL for systemic effects was
determined to be 60 ppm (1.5 mg/kg/day) and the NOEL for plasma
cholinesterase inhibition was determined to be 5 ppm (0.125
mg/kg/day).  RBC and brain cholinesterase were not affected (MRIDs
00128939 and 00149362).

d.     Carcinogenicity

       Methiocarb technical was not found to be carcinogenic in a two-
year rat feeding/carcinogenicity study in which the highest dose tested
was 600 ppm (30 mg/kg/day) (MRID 00115226 and 00128723).

       The data presented in a two-year mouse carcinogenicity study
were not sufficient to fully evaluate the carcinogenic potential of the
test material  in the mouse.   An acceptable mouse carcinogenicity study
is no longer  required since the registrant dropped food-uses for the
chemical (MRIDs 00128723, 00133477, and 00133480)

e.     Developmental Toxicity

       In a developmental toxicity study in rats,  daily oral doses of
vehicle, 1, 3, or 10 mg/kg/day of methiocarb technical, were
administered to groups of 19 or 20 fertilized female FB-30 rats from
the sixth to the fifteenth day of pregnancy inclusive.  Although a
decrease in weight gain was noted in the high dose group compared to
controls, there was no evidence of developmental toxicity in the study.
The LOEL and NOEL for maternal toxicity were 10 mg/kg/day and 3
mg/kg/day, respectively. The NOEL for developmental effects was
greater than  10 mg/kg/day  (MRID 00124617).

       In an oral developmental toxicity study in rabbits,  groups of 17
New Zealand White rabbits were dosed orally with vehicle, 1, 3 or  10
mg/kg/day of methiocarb technical from day 6 to 18 inclusive of
gestation.  The maternal toxicity NOEL was 3 mg/kg/day and the
LOEL was 10 mg/kg/day based on cholinergic signs and body weight
loss.  There  was no evidence of developmental toxicity in the study.
The NOEL for developmental toxicity was greater than  10 mg/kg/day
(MRID 00143213).

       In a dermal developmental toxicity study in rabbits, methiocarb
technical was administered  by the dermal route to 16 Chinchilla rabbits
(CHbb:CH,  hybrids, SPF quality) per group during gestational days 6
through 18 at doses of 0 (1 %  Cremophor vehicle),  10, 50, or 250
mg/kg/day.  The NOEL for developmental toxicity is 50 mg/kg/day.

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The LEL for developmental toxicity is judged to be 250 mg/kg/day
based on a statistically significant increase in embryonic resorptions as
a percentage of implantation sites and incompletely ossified hind limb
phalanx at multiple sites.  The maternal NOEL/LEL was judged to be
50/250 mg/kg/day based on a slight body weight decrement in the main
study, confirmed by a definitive body weight decrement in the range-
finding study (MRIDs 42496401,  42931901).

f.     Reproductive Toxicity

      An acceptable reproduction study is not available.  There is no
requirement for a reproductive study since the registrant dropped food-
uses for the chemical.

g.    Mutagenicity

      The 1987 Methiocarb Registration Standard listed data gaps for
three categories of mutagenicity studies based on the 1982 Pesticide
Assessment Guidelines: I. Gene Mutation; n. Structural Chromosomal
Aberration; and HI.  Other Genotoxic Effects.  Three studies, the results
of which are summarized below, were submitted by the registrant to fill
the data gaps:

      Gene Mutation - Methiocarb was not mutagenic in the presence
      or absence of metabolic activation in the Salmonella
      typhimurium/mammalian microsome mutagenicity assay (MRID
      40508101).

      Structural Chromosomal Aberration - In a sister chromatid
      exchange  assay in Chinese hamster ovary (CHO) cells,
      methiocarb was not genotoxic. The guidance given under the
       1982 guidelines for mutagenicity was that a sister chromatid
      exchange  assay could be used to satisfy the requirement for a
      study in either Mutagenicity Study Category II or HI (MRID
      40508102).

      Other Genotoxic Effects - In an in vitro unscheduled DNA
      synthesis assay in primary rat hepatocytes,  methiocarb was not
      genotoxic up to and including cytotoxic concentrations (MRID
      40700801).

      The current mutagenicity guideline requirements (starting from
1991) for mutagenicity testing include an Ames  assay, a mammalian
cell gene mutation assay, and an in vivo cytogenetics assay.  According
                      10

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to this guidance, there would be two data gaps for methiocarb
mutagenicity testing. However, since the submitted studies are
acceptable and negative, and since food uses for methiocarb have been
withdrawn, no additional mutagenicity testing will be required at this
time.

h.    Metabolism

      A metabolism study was performed in rats. More than 80% of
the 14C-carbonyl label was eliminated in 48 hours. Radioactivity was
distributed in expired CO2, urine, feces, and body tissues. The study
was considered to be inadequate due to a number  of deficiencies (only
one dose level was tested, an insufficient number  of animals was used,
and a number of metabolites was not clearly identified). There is no
requirement for a metabolism study since the registrant dropped food-
uses for the chemical.

i.     Other Toxic  Endpoints

      Neurotoxicity Testing

      Both an acute and a subchronic  (90-day) neurotoxicity study in
rodents must be performed with methiocarb technical.  These studies
are now required for all carbamate pesticides.  They are not part of the
target data set for this reregistration review, but are required for the
continued registration of methiocarb.

      Ocular Toxicity Testing

      Ocular toxicity testing is not currently required for the
carbamate class of pesticides.

      Dermal Absorption

      A dermal absorption study is not required  at this time.

      Domestic Animal Safety

      A domestic animal safety study  is not required at this time.

j.     Other Toxicological Considerations

      When food uses existed for methiocarb,  an amendment to the
1987 Methiocarb Registration Standard Toxicology Chapter required
                       11

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       that a 30-day dog feeding study (including measurement of
       cholinesterase activities) be performed using methiocarb sulfoxide, a
       cholinesterase-inhibiting metabolite of methiocarb (Mesurol®).
       Methiocarb sulfoxide had been shown in some studies to be more
       acutely toxic than methiocarb and to comprise a much larger portion of
       certain post-application, non-removable residues than the parent
       compound.  The 30-day dog study was no longer required when food
       uses were dropped for methiocarb.

       k.    Reference Dose

             On February 25, 1993, the OPP RfD/Peer Review  Committee
       recommended that the RfD  for methiocarb (Mesurol®)  be  established at
       0.005 mg/kg/day.  This value was based on a NOEL of 1.5 mg/kg/day
       for tremors  and muscle weakness observed at 6 mg/kg/day in a long-
       term feeding study in dogs using an uncertainty factor (UF) of 100 to
       account for  inter-species extrapolation and intra-species variability.
       Even though a reproduction study is not required, the RfD Committee
       recommended that an additional UF of 3 be added to compensate for
       the lack of adequate reproduction data. Since methiocarb was shown to
       be a developmental toxicant in rabbits, when administered  by the
       dermal route, the Committee also expressed a concern for  acute risk
       from exposure to methiocarb.

             On November 18, 1993, the OPP RfD/Peer Review Committee
       reconsidered the NOEL/LOEL in light of the additional information
       submitted by the registrant on the dermal developmental toxicity study.
       The OPP RfD/Peer Review Committee reevaluated and changed the
       NOEL/LOEL from 10/50 mg/kg/day  to 50/250 mg/kg/day for the
       dermal toxicity study with methiocarb.

2.     Exposure Assessment

       a.     Dietary

             No dietary exposure is expected from use of methiocarb since
       there are no remaining food uses.  Ginseng is not considered a food use
       since current methiocarb end-use labels bear a 12 month-preharvest
       interval.

             Since all food uses for methiocarb  have been cancelled, there
       are no Residue Chemistry data requirements and no Codex
       harmonization issues to be resolved.  The Agency accordingly intends
       to revoke all tolerances for methiocarb (40 CFR 180.320).
                            12

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b.     Occupational and Residential

       Post-application/reentry data and mixer/loader/applicator data
are required by the Agency when both toxicity and exposure criteria are
met.  Methiocarb is a N-methyl carbamate pesticide used to control
snails, slugs and other pests on ornamental plants and turfgrass.
Methiocarb was previously  used on agricultural food crops, primarily
as a bird repellent.  The registrants however, are not supporting the
food uses and these uses have been deleted from all labels.

       Methiocarb end-use  products are formulated as granulars/pellets
(1 - 2% a.i.), wettable powder (75%  a.L), and pressurized liquids (1%
a.i.).  The granular/pelleted formulations are applied to residential and
commercially grown turfgrass; to residential and commercially grown
ornamentals; in commercial greenhouses; and around building
foundations.  A 75% wettable powder formulation is used as a foliar
spray to nursery and greenhouse grown ornamentals.  A pressurized
liquid formulation is applied as a total release spray in commercial
greenhouses.

       In the Methiocarb Registration Standard, the Agency imposed an
interim 24-hour, reentry interval.  The reentry interval was imposed for
labels containing directions  for applications to the then registered
agricultural food crops, commercially grown turfgrass, commercially
grown ornamentals, and greenhouses.  The reentry interval was
required  until postapplication/reentry  data were submitted and reviewed
by the Agency.

       The Worker Protection Standard (WPS) for Agricultural
Pesticides ~ 40 CFR Parts  156 and 170 --  converted the 24-hour
reentry interval (where reentry with protective clothing is allowed) to a
24-hour restricted-entry interval (where entry is prohibited except under
the limited circumstances allowed under the Worker Protection
Standards such  as exception for activities with no contact,  40  CFR
170.112  [b], short term activities,  40 CFR 170.112[c], exceptions for
agricultural emergencies, 40 CFR  170.112[d], and exceptions for
requiring Agency approval, 40 CFR 170.112[e]).

       Personal protective equipment (PPE) were required while
applying end use products containing  20 to 75% methiocarb.  These
PPE consisted of a long sleeve shirt,  long pants, shoes, socks, and
chemical-resistant gloves. There are  no current PPE requirements or
reentry intervals for the homeowner products. However, there are
certain labels containing directions for applications to greenhouses as

                      13

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well as residential turfgrass and building foundations that display the
reentry and PPE statements regardless of percent methiocarb.

       On March 2, 1993, the OPP's Toxicology Branch determined
that methiocarb is a developmental toxicant based on a dermal toxicity
study using rabbits.  The data, which were submitted to the Agency
under 6(a)(2), indicate a no observed effect level (NOEL) of 50
mg/kg/day. Because methiocarb is a developmental toxicant, it meets
the Agency's toxicity criteria for requiring postapplication/reentry and
mixer/loader/applicator exposure data.  In addition, methiocarb, a
cholinesterase inhibitor (reversible), is in Toxicity Category I for acute
oral toxicity (MRID 42496401).

 Mixer/Loader/Applicator Exposure (Handlers)

       There is a potential for exposure to methiocarb sprays and dusts
via the dermal and inhalation route, particularly during foliar applications
using low  pressure, hand sprayers.   Applicator exposure regarding  the
total release aerosol applications, .and self-contained granular shakers is
expected to be lower.

       There are no chemical-specific  mixer/loader/applicator exposure
data available for methiocarb. In the absence  of these data, the Agency
has reviewed  the Pesticide  Handlers Exposure Database (PHED)  for
application scenarios similar to those used to apply methiocarb.  The one
identified by  PHED with the greatest potential for exposure  is  the
application of wettable powder formulations using a low pressure hand
sprayer.

       Based on the available data in PHED, the exposure estimate for an
individual  mixing/loading and applying methiocarb  (while wearing  the
currently labeled PPE) is as follows:

       A mixer/loader/applicator applying a wettable powder (open bag)
       with a low pressure  hand wand,  is  exposed  to 8.6 mg/lb  ai
       (dermal).  Inhalation exposure is estimated to be 1 mg/lb ai per
       acre.  The Agency assumes  a mixer/loader/applicator treating 6
       acres per day (based on previous backpack sprayer assessment for
       maleic hydrazide).

       6 acres x 0.75 Ib ai/acre x 8.6 mg/lb. ai handled (dermal)

       6 acres x 0.75 Ib ai/acre x 1 mg/lb. ai  handled (inhalation)
                       14

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      Thus, the respective dermal and inhalation exposure estimates are 38.7
      mg/day and 4.5 mg/day for the wettable powder formulation.

            The mixer/loader/applicator exposure assessment was estimated
      using surrogate data and conservative exposure assumptions. The Agency
      is requiring mixer/loader/applicator exposure data to support reregistration
      of methiocarb for the following commercial uses:

      233  and  234  -  For commercial  application of  wettable  powder
      formulations to greenhouse/nursery grown ornamentals.

            These data will be considered confirmatory for scenarios  where
      margins of exposure  (MOE) are estimated to be greater than  100 with
      appropriate  personal   protective   equipment  (PPE)  (coveralls)  and
      appropriate restricted entry intervals.

Postappiication/Reentry Exposure (Worker and Residential)

            There is a potential for postapplication exposure following most of
      the methiocarb applications.  These include dermal exposure to residues
      on treated  lawns  and turf,  thatch  and  soil following the granular
      applications; and to the foliage of commercially grown ornamentals treated
      with  the wettable powder and pressurized liquid formulations.  There is
      also a potential  for inhalation exposure following the application  of the
      total  release  aerosols.

            Postapplication  exposure is expected to be  low  following the
      application of granular formulations beneath greenhouse benches, around
      building foundations, and in residential ornamental plantings other than
      lawns and turf.

            Postapplication inhalation monitoring data are required to support
      the reregistration of the pressurized liquid formulation.   These data are
      considered confirmatory:

            Inhalation passive dosimetry for entry  into greenhouses following
            an application using the pressurized liquid formulation (133-4).

            Postapplication/reentry  data  are  required  to  support  the
      reregistration of the granular formulations used  on ornamentals.   These
      data are considered confirmatory:

            Soil residue dissipation (132-lb)
            Dermal passive dosimetry exposure (133-3)
                            15

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              The following postapplication/reentry data are required to support
       homeowner lawn use:

              Foliar dislodgeable dissipation, lawns and turf (132-la), and
              Dermal passive dosimetry, lawns and turf (133-3)

       These studies must be conducted concurrently.

3.     Risk Assessment

       The data available on the lexicological effects of methiocarb are sufficient
for assessing human risks.

       In acute toxicity  studies in laboratory animals, methiocarb is highly toxic
by the oral route (Toxicity Category I), moderately toxic by the inhalation route
(Toxicity Category II), slightly toxic by the dermal route (Toxicity Category III),
but is not  a dermal or eye irritant.   In long-term studies, administration of
methiocarb have been observed to inhibit RBC and/or plasma cholinesterase but
not brain cholinesterase in both the rat and dog. In the latter species the enzyme
inhibition was associated with signs of muscular weakness and/or tremors at the
high dose.  Methiocarb  is not carcinogenic in  rats and does not appear to have
any mutagenicity potential.   Methiocarb  administered by the  dermal route is
associated with developmental toxicity in rabbits. Administered by the oral route,
it is associated only with maternal toxicity in both rats and rabbits.

       The OPP  RfD/Peer  Review Committee considered the carcinogenicity
study  in  rats  to be  acceptable  and  the doses  used to  be  adequate for
carcinogenicity testing.  There was no other carcinogenicity study available on
methiocarb.  On this basis the  OPP RfD/Peer Review Committee  classified
methiocarb as  a Group D  carcinogen  (insufficient information to  evaluate
chemical).

       The toxicology endpoint of concern is developmental toxicity.  Based on
the developmental  study  with the  most sensitive  species  (rabbits)  and the
appropriate developmental NOEL (NOEL =  50  mg/kg/day),  there may be a
potential for adverse developmental effects in exposed humans.

       a.    Dietary

             Dietary risk  from exposure is  not expected  since there are  no
       remaining food uses for methiocarb.

       b.    Occupational and Residential
                             16

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                          Workers and homeowners may be at risk for developmental effects
                    from exposure to methiocarb. The Agency has no chemical-specific data
                    for assessing potential exposure from the use of methiocarb. The margin
                    of exposure (MOE) may be estimated by the following equation:

                          MOE =  NOEL fmg/kg/day)
                                 Exposure (mg/kg/day)

                    where the NOEL = 50 mg/kg/day  based on  the dermal developmental
                    study in rabbits.  The MOE from use of the granular formulations cannot
                    be estimated at this time because we do not have actual or surrogate
                    exposure data. The MOEs from  the use  of the  wettable  powder
                    formulations are presented in the table below.

                                  Margin of Exposure
Wettable
Powder
Formulation
With current PPE
With coveralls
Exposure Rate
(mg/day)
Dermal Inhalation
38.70 4.50
7.74 2.25
Exposure Kate
(mg/kg/day)
Dermal Inhalation
0.645 0.072
0.129 0.072
MOE*
Dermal +
Inhalation
70
250
A ssurnpuons:
(1) A handler weighs 60 kg,
(2) Currently labeled-PPE are used, and
(3) maximum efficiencies achieved for coverall (80%).
                   The MOE is less than 100 for handlers (with PPE) of wettable powder
             formulations.  With risk  mitigation steps such as coveralls, the margins  of
             exposure are expected to be greater than 100 with a maximum efficiency of 80%
             for coveralls.

                   Restricted Entry Intervals (REIs)

                   The registrant submitted a foliar dissipation study measuring
             dislodgeable residues after a wettable powder formulation of methiocarb had
             been foliarly applied to grapes.  The dislodgeable residues declined in a linear
             fashion with residue decay equation  having an intercept of 2.95 and a slope of
             -0.064.  These data are considered supplementary and have been used to
             calculate a reentry interval for ornamental crops foliarly treated with
             methiocarb.  These data are not appropriate to calculate a reentry interval
             following the application of granular formulations to turfgrass due to  the
             differences in formulation type and method of application (MRID 40465901).
                                          17

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             Based on the data from MRID 40465901, an REI of 25 days is imposed
       following foliar applications of the wettable powder and the pressurized liquid
       (total release aerosol) formulations to ornamental plants. After 10 days
       workers may enter treated areas to perform tasks, including hand labor tasks
       that involve contact with treated surfaces provided each worker spends no
       more than 3 hours in each 24-hour period performing such tasks.  PPE is not
       required during the 3 hour work period.

             Personal Protective Equipment (PPE)

             Occupational Uses:   Although methiocarb has  been  classified as  a
       Toxicity Category  HI chemical for acute  dermal  toxicity and  skin  irritation
       potential,  the  Agency is requiring  personal protective equipment (PPE)  for
       applicators and other handlers as well as early entry workers consistent with the
       PPE level  (as established by 40 CFR Part 156, the Worker Protection Standard)
       required for pesticides classified as Toxicity Category II for acute dermal toxicity.
       In addition, the Agency is requiring that a respirator be worn by handlers during
       ventilation activities. The Agency is also requiring that a dust mask be worn
       while mixing/loading the wettable powder formulation because this is a potentially
       high exposure route with respect to inhalation.  These PPE requirements are  due
       to the known lexicological concerns for methiocarb, including its identification
       as a developmental toxicant.

             Homeowner Uses:  The Agency has determined that, at this time,  the
       personal protective  equipment discussed  in this section  need not  apply to
       homeowner users of methiocarb. The predicted frequency, duration, and degree
       of exposure by  homeowners should not warrant the risk mitigation measures being
       required for  occupationally exposed users.  No  data are available to support
       homeowner use by broadcast method.

C.     Environmental Assessment

       1.     Environmental Fate

             a.     Environmental Chemistry, Fate and Transport

                    Based on incomplete, supplemental and acceptable
             environmental fate data, methiocarb appears  to be moderately persistent
             and relatively immobile in soil. Methiocarb  degradation appears to be
             dependent on microbial-mediated (aerobic  soil metabolism - half-life =
             17  to  111 days); anaerobic soil metabolism (half-life = 64 days); and
             abiotic processes (photodegradation metabolism in water and on soil
             (half-life = 88 days). These data indicate that methiocarb degrades  in
             mineral soils and  anaerobic soil environments, and should photodegrade

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slowly in soil and slightly acidic aqueous environments. The major
degradates  are methiocarb sulfoxide, methiocarb sulfoxide phenol,
methiocarb phenol,  and methiocarb sulfone. Supplemental field
dissipation  studies suggest methiocarb residues (e.g., methiocarb,
methiocarb sulfone, and methiocarb sulfoxide) are moderately persistent
(half-life < 92 days) in surface soil (30 cm).  Methiocarb was also
detected in a single well in a New York well survey of 21,000 wells.

b.     Environmental Fate Assessment

       Methiocarb appears to be relatively immobile (K,, = 12.5) in
loam textured soil, but methiocarb degradates as well as parent
methiocarb were  found to be mobile in "aged" soil column leaching
studies.  The mobility of methiocarb and its degradates could not be
confirmed in field dissipation studies because of inadequate soil
sampling and/or nonspecific analytical methodologies.  Although
compounds similar to methiocarb (e.g., aldicarb) are mobile in soil and
have been found  in  groundwater,  the weight of evidence from
supplemental field dissipation data suggest that methiocarb, methiocarb
sulfoxide, and methiocarb sulfone are retained in the surface soil(0-30
cm).  The results of the screening model PATRIOT (Pesticides
Assessment Tool  for Rating Investigations of Transport), performed
over a range of soil textures for methiocarb reinforced  the conclusion
that  methiocarb per se is not likely to contaminate groundwater.
However, a full assessment will only be possible when the following
confirmatory data are provided.

       These studies are required for all outdoor uses:

       161-1 Hydrolysis
       163-1 Adsorption-Desorption/Leaching

       This study is required to support the lawns and turf uses of
       methiocarb:

       164-1 Terrestrial Field Dissipation

       The additional confirmatory data will help to define the rates
and routes  of methiocarb dissipation under typical use conditions.  The
additional hydrolysis data would provide information on abiotic
degradation of methiocarb in soil  and  aquatic environments.  Although
the unaged portion of the adsorption-desorption/leaching (GL 163-1)
study was previously fulfilled using a single soil type, additional batch
equilibrium data on parent  methiocarb would provide a more reliable
                       19

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       mobility classification in coarse textured soils (e.g., sand and loamy
       sands) with low organic matter.  Fine textured soil, which was used in
       the study, tends to decrease estimates of mobility.  In addition, parent
       methiocarb was detected in the leachate of aged-residue soil column
       studies and hence may be mobile in coarse textured soils.  The
       additional terrestrial field dissipation data are necessary with greater
       sampling depths and appropriate soil sampling increments to assess
       leaching of methiocarb below 30 cm.

             The Fish Accumulation (165-4) study is waived because
       methiocarb and its degradates in aquatic systems are likely to kill fish
       before the residues could accumulate to levels of concern in fish
       tissues.

2.     Ecological Effects

       a.    Ecological Effects Data

             There are enough ecotoxicological data submitted to characterize
       the toxicity of methiocarb to nontarget terrestrial and aquatic
       organisms when used  primarily on ornamentals and in greenhouses.
       The toxicity evaluation of methiocarb for lawns and turf use is based on
       limited available data.

              (1)    Terrestrial Data

                    Available data indicate that methiocarb is toxic to
             terrestrial mammals (acute oral  LD50 range from 14 to 30
             mg/kg) for males and females rats, respectively.

                    The avian toxicity of methiocarb was evaluated  from
             thirty-four studies.  The data indicate that the technical grade
              (TGAI) of methiocarb is very highly toxic to birds on an acute
             oral basis.  The LD50 s to passerine species tested ranged  as  low
             as 2.47 mg/kg, and the LD50 values to mallards (waterfowl)
              were determined to be 12.8 mg/kg.   The subacute dietary data
              using the TGAI indicate that methiocarb is practically non-toxic
              to upland game birds, LC50 of > 5000 ppm for ring-necked
              pheasants and  slightly toxic to waterfowl with an LC50  of 1071
              ppm for mallard ducks.  Because no feed consumption data  were
              provided, it can not be determined if the low dietary toxicity is
              attributable to  reduced feed consumption.  Also, pen studies
              with 2% bait and 4% bait suggest that these formulations may
              produce a repellent effect in bobwhite quail and pheasants,
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      respectively.  Avian reproduction studies indicate that no
      reproductive impairment is caused in the mallard duck at a
      dietary dose level of 100 ppm TGAI methiocarb or in bobwhite
      quail at a dietary dose level of 50 ppm.  Pen studies with 2%
      bait suggest that this formulation may produce a repellency
      effect in the bobwhite quail (MRIDs 00036482, 00036491,
      00128119, and GS0577006).

      (2)    Aquatic Data

             The available data indicate that the TGAI of methiocarb
      is highly toxic to coldwater (rainbow trout LC50 =0.436 ppm)
      and warmwater (bluegill LC50 = 0.734 ppm) fish. The
      freshwater fish acute toxicity data on formulated products
      indicate that the 75 % wettable powder formulation of
      methiocarb is moderately toxic to coldwater (rainbow trout LC50
      = 1.4 ppm) and warmwater (bluegill LC50 =1.9 ppm) fish.
      Data from a fish early life stage study using rainbow trout
      suggest that methiocarb is  highly toxic (the MATC of technical
      methiocarb to this  species  is 50 to 100 ppb).  The data indicate
      that methiocarb is very highly toxic to freshwater aquatic
      invertebrates  (48-hour EC50 for Daphnia magna was 0.019
      ppm); (48-hour EC50 for mayflies was 0.007 ppm). Data from
      an aquatic invertebrate life cycle test further support the very
      high toxicity of methiocarb to aquatic invertebrates (test using
      Daphnia magna suggest that the MATC of technical methiocarb
      to this species is 0.10-0.17 ppb). There are no estuarine data
      available on methiocarb. (MRIDs 0036484, 00127638,
      00150383, 00150628, 155967).

      (3)    Non-Target Insects Data

             There are sufficient data to characterize technical
      methiocarb as very highly toxic to honey bees (LD50 for honey
      bees is 0.375 ug/bee) (MRIDs 00001999, 00036935).

b.    Ecological Effects Risk Assessment

      (1)    Risk to Terrestrial Organisms

             Granular

             The level of concern to mammalian and avian  species,
      1/2  the LC50, is exceeded for all formulations of methiocarb for
                      21

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all outdoor uses of methiocarb.  The acute toxicity data of
methiocarb to rats indicate that a rat weighing 0.4 kg could
obtain an LDJO (14 to 30 mg/kg for male and females rats,
respectively) eating less than 10 of the 1% ( 0.6mg a.i./granule)
bait formulation granules.  Less than one granule of the 2% (1-2
mg per granule) bait formulation or 1 % bait formulation could
contain the LD50 for blackbirds (3.2 mg/kg).  Therefore, all of
the granular uses represent a hazard to blackbirds or other birds
of similar size and sensitivity to the toxicant.  After ingesting 10
to 20 granules of the 2% and 1% granular formulations,
respectively, the mallard duck would reach the  LD50 (12.8
mg/kg).  Repellency data demonstrated that it is not clear that
medium to large sized birds may be repelled from treated
granules; therefore, granular formulations could present a
hazard to medium and larger birds.

      Wettable Powder

      Methiocarb 75% wettable powder is applied indirectly to
avian food items as an insecticide. The chemical is applied as a
spray.  Therefore,  residues are expected to be available to birds
on a variety of food and forage items.  A model, explained in
the following paragraph, was used to estimate the maximum
residues expected after application on several different exposed
substrates,  for example, leaves, long grass, short grass, and
soil.  For all application rates,  except the lowest, residues on
short grass exceeded endangered species concern levels (1/10
LC50 for mallard duck, 107 ppm) from 1 to 3.5 times and
exceed the restricted use criteria (1/5 LC50 for mallard duck 214
ppm) by 1.5 times on  short grass at the highest application rate.

      Calculation of Exposure Levels

      The majority of the labels for methiocarb do not indicate
a maximum amount of active ingredient to be applied per season
nor time intervals between applications.  Therefore, the Agency
Fate Model for Accumulated Pesticide Residues for Multiple
Applications was run for a number of different  scenarios.  The
model looked at various application intervals (7, 20, 30 days)
and initial concentrations based on vegetative residue data
determined from a nomograph  developed by Hoerger and
Kenega.
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       The results indicate that the lowest level of active
ingredient applied per application to short grass would trigger
the endangered species concern (1/10 LC50 for mallard duck,
107 ppm) by 1.5 times by the second application no matter if
the interval was 7, 20, or 30 days.  In addition, by the third
application on short grass at either 7, 20, or 30 days the trigger
for restricted use concern would be exceeded (1/5 LC50 for
mallard duck 214 ppm) by <  1.5 times.

       Models for long grass residue indicate that at the 0.5 Ibs
a.i./A application rate triggers for both endangered species and
restricted use would be exceeded by the 2nd and 3rd
applications, respectively, at all interval times (7,  20, and 30
days).

       The last set of models looked at the residue on leaves
and leafy plants with the lowest amount of active ingredient per
application.  These results indicate that both endangered species
and restricted use triggers would be exceeded by the 3rd and 5th
application, respectively, at 7 and 20 day intervals. At the 30
day interval endangered species and restricted use  triggers were
exceeded at the 3rd and 8th application, respectively.  Special
Review trigger levels were exceeded for small mammals  (1 to 3
times the LD50) at the two highest application rates for short
grass.  These models were run on the lowest amount of active
ingredient per application; therefore, it is likely that the level of
concern would be exceeded for endangered species and
nontarget terrestrial organisms earlier for all other active
ingredient application levels.  In addition, the predicted EEC
values exceed  the NOEC levels for avian species with respect to
chronic effects for short grass.  Therefore, the use of
methiocarb 75% wettable powder may be expected to result in
hazard to exposed avian species both acutely and chronically.

(2)     Risk to Aquatic Organisms

       The level of concern for chronic fish and acute and
chronic aquatic invertebrate exposures is exceeded for all
formulations of methiocarb.  Refined EEC's were  modeled for
two methiocarb formulations, Mesurol® 2% Bait and Mesurol®
75% Wettable Powder for 1, 2, and 4 applications per year.
One application per year  with an occasional second application
is the typical use pattern for methiocarb.  The 75% Wettable
Powder may be applied up to four times a year. There are no
               23

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restrictions on the number of applications of the 2% bait, but 4
applications were modeled as the maximum number of uses for
this formulation also.  A New York turf farm was used for both
formulations, as it is a reasonable surrogate for scenarios with
significant turf coverage such as ornamentals and shade trees.
(Spagnoli, 1993).

      Results from the refined model on methiocarb in
Mesurol® Bait 2% indicated that fish endangered species
concern levels, 1/20 LC50, were exceeded by 2 to 7 times and
after 90 days the value was exceeded by 1 time, and restricted
use levels, 1/10 LC50> were exceeded by 1 to 4 times but after
90 days was not exceeded.  Aquatic invertebrate endangered
species concern levels, 1/20 LC50) were  exceeded by 50 to 168
times from the first to the fourth application and after 90 days
with just one application the 1/20 LC50 value was still exceeded
by 27 times.  In addition, restricted use concerns were exceeded
by 26 to 84 times and after 90 days the  value was exceeded by
13 times, and special review concerns, 1/5 LC50, were exceeded
by 5 to  17 times and after 90 days the value was exceeded by 3
times.

      Results from the refined model on methiocarb in
Mesurol® 75% Wettable Powder, indicated that fish endangered
species concern levels were exceeded by 3 to 8 times and after
90 days by 2 times, and restricted use levels were exceeded 1 to
4 times  but not exceeded after 90 days.  Aquatic invertebrate
endangered species concern level were exceeded by 57 to 185
times from the first to the fourth application and after 90 days
with just one application the endangered species concern level
was still exceeded by 29 times.  In addition, restricted use
concerns were exceeded by 29 to 93 times and after 90 days
1/10 LC50 value exceeded by 15 times.

       Conclusions

       The ecological effects risk assessment for methiocarb
indicates that for all the formulations used on all outdoor sites,
the acute and chronic levels of concern  are exceeded for avian
species, and the acute level of concern is exceeded for
mammalian  species and aquatic invertebrates.  The toxicity data
used in  the risk assessment suggest that the chronic level of
concern also is exceeded for aquatic organisms.
                24

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       Some of the factors considered in further evaluation of
the risk of methiocarb to nontarget organisms include: 1) refined
aquatic EEC's using typical number of applications, 2)
methiocarb production volume, and 3) the estimate of the
amount of methiocarb used for the use sites.

       When the aquatic EEC's were refined using maximum as
well as typical number of applications the level of concern was
still exceeded (ex. the level of concern for aquatic invertebrates
is exceeded by about nine times the typical number of
applications).  However, the typical number of applications
decreased the risk by about a factor of two.  The labels for
methiocarb should reflect the typical number of applications as
the maximum application rate. (2 Ibs 75% a.i. wettable powder
per 50 gallons of water applied up to 2, not 4,  times a year, bait
formulations should not be applied more than twice a year).

       The environmental fate and ecological risk assessments
are based on the estimate that 90% of methiocarb is used in
nursery and greenhouses and the other 10%  of methiocarb use
includes homeowner ornamentals,  as well as turf and lawn uses.

       Methiocarb outdoor use is likely to have adverse effects
on aquatic and terrestrial species.  Although the total volume of
methiocarb used is low relative to  other pesticides, it still could
have major impacts in localized  areas if there is concentrated
outdoor use.  At present the Agency is unable to estimate how
much of the use is outdoors.

       If the lawn and turf use of  methiocarb continues to be
supported, the following studies are required on a confirmatory
basis:

       72-3 (a)      Acute LC50 Estuarine/Marine Tox Fish

       72-3 (b)      Acute LC50 Estuarine/Marine Tox Mollusk

       72-3 (c)      Acute LC50 Estuarine/Marine Tox Shrimp

       72-4 (a)      Fish Early Life Stage
             (Data describing water temperatures in each test
             tank are required to  ensure that no significant
             variance of temperature occurred in any of these
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                                        tanks.  If this data is submitted the currently
                                        available study may be upgradable.)

                                 72-4 (b)       Aquatic Invertebrate Life-Cycle.
                                        (Study was submitted, however it was deemed
                                        supplemental because raw data were not
                                        available.)

                                 72-5          Fish Life-Cycle
IV.    RISK MANAGEMENT AND REREGISTRATION DECISION

       A.    Determination of Eligibility

             Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after
       submission of relevant data concerning an active ingredient, whether products
       containing the active ingredient are eligible for reregistration. The Agency has
       previously identified and required the submission, of the generic (i.e. active ingredient
       specific) data required to support reregistration of products containing  methiocarb
       active ingredient.  The Agency has completed its review of these generic data, and
       has determined that the data are sufficient to support reregistration of products
       containing methiocarb except for those products which are used on residential lawns
       and turf.  Appendix B identifies the generic data requirements that the Agency
       reviewed as part of its determination of reregistration eligibility of methiocarb, 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 methiocarb and to determine that methiocarb can be used
       without resulting in unreasonable adverse effects to humans and the environment only
       for greenhouses, homeowner use around  building  foundations and ornamentals,
       commercially grown turfgrass, and ginseng uses.  The Agency, therefore,  finds that
       products containing methiocarb as  the active ingredient used on ornamentals,
       greenhouses, homeowner use around building foundations, commercially grown
       turfgrass, and ginseng are eligible  for reregistration.  The reregistration of these
       particular products is  addressed in  Section V of this document.

             The Agency made its reregistration eligibility determination based upon the
       target data base required for reregistration, the current guidelines for conducting
       acceptable studies to generate  such data and the data identified in Appendix B.
       Although the Agency has found that the greenhouse, homeowner use around building
       foundations and ornamentals, commercially grown turfgrass, and ginseng uses of
       methiocarb are eligible for reregistration, it should be understood that the Agency
       may take appropriate regulatory action, and/or require the submission  of additional


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data to support the registration of products containing methiocarb, if new information
comes to the Agency's attention or if the data requirements for reregistxation (or the
guidelines for generating such data) change.

       1.      Eligibility Decision

              Based on the reviews of the generic data for the active ingredient
       methiocarb, the Agency has sufficient information on the health effects of
       methiocarb and on its potential for causing adverse effects in fish and wildlife
       and the environment to make a reregistration eligibility decision. The Agency
       has determined that granular and pelleted products containing methiocarb  for
       use on ornamentals in greenhouses, homeowner use around building
       foundations and ornamentals,  commercially grown turfgrass, ginseng, as well
       as the wettable powder and pressurized liquid products for use on ornamentals
       in greenhouses and nurseries are eligible for reregistration.

              The Agency has determined that methiocarb granular, pelleted, wettable
       powder, and pressurized liquid products, labeled and used as specified in  this
       Reregistration Eligibility Decision document, will not pose unreasonable risks
       or adverse effects to humans or the environment.

              There is insufficient exposure data for the use of methiocarb by
       broadcast application on residential lawn and turf and a reregistration
       eligibility decision for this use cannot be made until appropriate postapplication
       reentry exposure, ecological effects and environmental fate data are submitted
       and evaluated.

       2.      Eligible and Ineligible Uses

              The Agency has determined that methiocarb use on ornamentals in
       greenhouses,  homeowner use  around building foundations, ornamentals,
       commercially grown turfgrass, and ginseng are eligible for reregistration.

              The Agency has also determined that a reregistration eligibility decision
       for residential lawn and turf uses cannot be made at this time.

B.     Regulatory Position

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

       Since methiocarb is considered to be an important tool for control of slugs in
nurseries and greenhouses and the total use volume is relatively low, the Agency is


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declaring eligible for reregistration the nursery and greenhouse ornamental uses of
granular/pellet and pressurized liquid formulations.  However, in order to prevent the
use volume and hence the risk of impact on aquatic and terrestrial species from
increasing, the Agency is negotiating with the registrants to maintain a production
cap.

       1.     Tolerance Reassessment

             Since all food uses for methiocarb are cancelled, the Agency has
       determined  that all existing tolerances for methiocarb will be revoked.

       2.     Restricted Use Classification

             Based on the ecological effects risk assessment for methiocarb, a
       restricted use classification should be placed on all outdoor uses except
       homeowner uses.

       3.     Endangered Species Statement

             Methiocarb (a molluscicide, insecticide and avian repellent) may pose a
       hazard to many listed birds, mammals, insects, and aquatic organisms.  To
       date the Agency has one recorded incident, a wild bird kill, from the use of
       methiocarb. (Dec. 1983, Lima, Ohio - waterfowl (NWHR  1980- 1990).  The
       Agency requested consultation with the U.S. Fish and Wildlife Service
       (USFWS) in 1986 on, 1) blueberries and cherries, and 2) golf courses,
       cemeteries,  parkways, roadways, and industrial sites for certain birds, reptiles,
       fish, mussels, and insects.  The consultation was rejected because of lack of
       information.

             The  use of methiocarb exceeds triggers for endangered species for
       selected avian species, mammals, non-target insects, and freshwater organisms.
       These proposed outdoor uses cover the whole United States and are not
       restricted by boundaries.  Therefore to properly identify endangered species
       which may  utilize these areas, the U.S. Fish and Wildlife Service (USFWS)
       will be consulted. After identifying  the endangered species inhabiting these
       areas a formal Section 7 consultation with the USFWS may be requested.
       Based on current information, a generic label statement may be required when
       the Agency's Endangered Species Protection program is implemented.
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4.     Labeling Rationale

       a.    Postapplication/Reentry Requirements

       The Worker Protection Standard (WPS) for Agricultural Pesticides -
40 CFR Parts 156 and 170 — converted the 24-hour reentry interval (where
reentry with protective clothing is allowed) to a 24-hour restricted-entry
interval (where entry is prohibited except under the limited circumstances
allowed under the Worker Protection Standards such as exception for activities
with no contact, 40 CFR 170.112 [b], short term activities, 40 CFR
170.112[c],  exceptions for agricultural emergencies, 40 CFR 170.112[d], and
exceptions for requiring Agency approval, 40 CFR  170.112[e]).

       All methiocarb end-use products within the scope of the Worker
Protection Standard for Agricultural Pesticides (see  PR Notice 93-7) — must,
within the timeframes listed in PR Notice 93-7 and  93-11, revise their labeling
to be consistent with the WPS, as directed in those  notices and the
requirements of this RED.  The restricted-entry interval for methiocarb end-
use products are discussed below.

       (1) For Wettable Powder:

       For ornamental crops (nurseries and greenhouses) following foliar
application,  the Agency is requiring a 25-day restricted-entry interval (REI).
After 10 days workers may enter treated areas to perform tasks, including
hand labor tasks that involve contact with treated surfaces provided each
worker spends no more than three hours in each 24-hour period performing
such tasks.  PPE is not required during the 3 hour work period.  This REI
is supported by the foliar residue dissipation data presented in MRID
40465901.  These restricted entry intervals provide  margins of exposure of
approximately 100. The Agency generally considers 100 an acceptable margin
of exposure.  Mixer/loader/applicator exposure data (studies on estimation of
dermal exposure at indoor sites and  estimation of inhalation exposure at indoor
sites) are required to support reregistration of the wettable powder formulation
(these data are considered confirmatory).

       (2) For Granular Formulations:

       The Agency has determined that the use of methiocarb on non-
residential turfgrass (including turf grown for sod, turf grown to produce seed,
or turf grown for research purposes) is eligible for reregistration.  The Agency
is retaining the 24-hour restricted entry interval for  postapplication activities
because of the known lexicological concerns for methiocarb.
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       For turfgrass in residential situations, including application by
commercial applicators, the Agency determined that a reregistration eligibility
decision cannot be made until postapplication exposure data (foliar
dislodgeable dissipation and dermal passive dosimetry data) are submitted and
reviewed.

       Applications to ornamentals in residential situations, including
application by commercial applicators, is eligible for reregistration except for
products  marketed in packages larger than  the 2 Ib. shaker cans (e.g. 20 -
25 Ib. bags) for use by homeowners.  The Agency is requiring data (soil
dissipation and dermal exposure) to assess  the exposure to persons entering
treated ornamental planting areas. These data are considered confirmatory.
After the Agency reviews exposure data on ornamentals and residential lawns,
the Agency will determine if further marketing in packages other than 2 Ib.
shaker containers for use by homeowners is appropriate.

       The Agency has determined that, at this time, the entry restrictions
discussed in this section do NOT apply to  homeowner uses.

       (3) For the Pressurized Liquid Formulation:

       For ornamental crops in greenhouses, the Agency is requiring a 25-day
restricted-entry interval (REI). After 10 days workers may enter treated areas
to perform tasks,  including hand labor tasks that involve contact with treated
surfaces provided each worker spends no more than three hours in each 24-
hour period performing such tasks. PPE is not required during the 3 hour
work period.  This REI is supported by the foliar residue  dissipation data
presented in MRID 40465901. These restricted entry intervals provide
margins of exposure of approximately  100. The Agency generally considers
100 an acceptable margin of exposure.

       Postapplication inhalation monitoring data are required to  assess
inhalation exposure to workers following the use of the pressurized
formulation (these data are considered  confirmatory).

       b.     Personal Protective Equipment (PPE) Requirements

       Occupational Uses: Although methiocarb has been classified as a
Toxicity  Category III chemical for acute dermal toxicity and skin irritation
potential, the Agency  is requiring personal protective equipment (PPE) for
applicators and other handlers as well as early entry workers consistent  with
the PPE  level (as established by 40 CFR Part 156, the Worker Protection
Standard) required for pesticides classified as Toxicity Category II for acute
dermal toxicity.  In addition,  the Agency is requiring that a respirator be worn
                             30

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             by handlers during ventilation activities. The Agency is also requiring that a
             dust mask be worn while mixing/loading the wettable powder formulation
             because this is a potentially high exposure route with respect to inhalation.
             These PPE requirements are being imposed due to the known lexicological
             concerns for methiocarb, including its identification as a developmental
             toxicant.

                    Homeowner Uses:  The Agency has determined that, at this time, the
             personal protective equipment discussed in this section need not apply to
             homeowner users of methiocarb.

                    c.     Ecological Effects

                    The acute and chronic levels of concern are exceeded for avian species,
             the acute level of concern is exceeded for mammalian species and aquatic
             invertebrates, and the chronic level of concern is exceeded for aquatic
             organisms for all formulations of methiocarb. One means to further decrease
             the potential risk to the environment from the use of this toxic chemical would
             be to remove the turf and lawn site uses.  The Agency is requiring label
             amendments and confirmatory data, as well as negotiating with registrants  to
             maintain a production cap in an effort to decrease the environmental risk.

V.     ACTIONS REQUIRED BY REGISTRANTS

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

       A.    Manufacturing-Use Products

             1.     Additional Generic Data Requirements

                    The generic data base supporting the reregistration of methiocarb for
             the above eligible uses has been reviewed and determined to be substantially
             complete.  However, additional confirmatory data are needed to fulfill
             requirements for the studies listed below:

                    Estimation of dermal exposure - for wettable powder formulation use in
                          greenhouses and nurseries
                    Estimation of inhalation exposure - for wettable powder formulation use
                          in greenhouses and nurseries
                    Inhalation passive dosimetry - for pressurized liquid formulation use in
                          greenhouses
                    Estimation of dermal exposure and soil dissipation - for granular
                          formulations used on ornamentals

                                         31

-------
             Aquatic and estuarine organisms - fish/mollusk/shrimp - required for all
                    lawn and turf uses
             Aquatic invertebrate life cycle - required for all lawn and turf uses
             Fish early life stage - required for all lawn and turf uses
             Fish life cycle - required for all lawn and turf uses
             Hydrolysis - required for all outdoor uses
             Adsorption/desorption/leaching - required for all outdoor uses
             Terrestrial field dissipation - required for all lawn and  turf uses
             Outdoor usage  data - specify pounds used per year by site

             The following data are required to support the use of granular
       formulations of methiocarb on  residential lawns and turf:

             Foliar dislodgeable dissipation
             Dermal passive dosimetry

             Also, data on acute and subchronic neurotoxicity, which are not part of
       the reregistration target data base for methiocarb,  are required.

       2.     Labeling Requirements for Manufacturing-Use Products

                    The  Agency has determined that the current label precautions
             are still applicable and are required for product reregistration if the
             product is to remain in  compliance with  FIFRA.

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.
                                    32

-------
2.     Labeling Requirements for End-Use Products

       a.     Compliance with the Worker Protection Standard

             In order to remain in compliance with FIFRA, it is the
       Agency's position that any product whose labeling reasonably permits
       use in the production of an agricultural plant on any agricultural
       establishment (farm, forest, nursery, or greenhouse) must comply with
       the labeling requirements of EPA's labeling regulations for worker
       protection statements (40 CFR part 156, subpart K). These labeling
       revisions are necessary to implement the Worker Protection Standard
       for Agricultural Pesticides (40 CFR Part 170) and must be completed in
       accordance with the deadlines specified in the WPS, unless official
       EPA guidance  specifies otherwise.  EPA has issued PR Notice 93-7,
       "Labeling Revisions Required by the Worker Protection Standard
       (WPS),  and PR Notice 93-11, "Supplemental Guidance for PR Notice
       93-7," which contain specific instructions to registrants about how to
       complete the required WPS labeling changes and offer guidance and
       deadline-options for making those changes.  Unless otherwise
       specifically directed in this RED, all statements required  by the WPS
       (and reflected in PR Notices  93-7 and 93-11) are to be on the product
       labeling.

       -In order to remain in compliance with FIFRA, after April 21, 1994,
       except as otherwise provided in PR Notices 93-7 and 93-11, or other
       EPA guidance, all products within the scope of those notices must bear
       WPS PR-Notice-complying labeling when they are distributed or sold
       by the registrant or any supplementally registered distributor, or any
       repackager under the Agency's Bulk Repackaging  Policy.

       -In order to remain in compliance with FIFRA, after October 23,
       1995, except as otherwise provided in PR Notices 93-7 and 93-11 or
       other EPA guidance, all products within the scope of those notices must
       bear WPS PR-Notice-complying labeling when they are distributed or
       sold by  any person.

       b.    Entry Restrictions; Labeling

       •     Products NOT Primarily Intended for Home Use

       -Uses Within the Scope of the WPS:

       (1)   Wettable Powder Formulations: In order to remain in
       compliance with FIFRA,  a 25-day restricted entry interval  (REI)  as

                             33

-------
follows is required on all methiocarb end-use products formulated as a
wettable powder.

       Do not enter or allow worker entry in treated areas
       during the restricted entry interval (REI) of 25 days,
       except, after 10 days, workers may enter treated areas to
       perform tasks including hand labor tasks that involve
       contact with treated surfaces provided each worker
       spends no  more than 3 hours in each 24 hour period
       performing such tasks.

This REI should be inserted into the standardized REI statement
required by PR Notice 93-7.

       In order to remain in compliance with FTFRA, labels of sole-
active-ingredient end-use products that contain methiocarb must be
revised to adopt the entry restrictions set forth in this section.  Any
conflicting entry restrictions on current labeling must be removed.

(2)    Granular Formulations: In order to remain in compliance with
FIFRA, a 24-hour restricted entry interval (REI)  is required for all uses
within the scope of the WPS (see PR Notice 93-7) on all methiocarb
end-use products  formulated as a granular, except those products
intended primarily for home use (see tests in PR  Notice 93-7 and 93-
11).  This REI should be inserted into the standardized REI statement
required by PR Notice 93-7.

       In order to remain in  compliance with FIFRA, labels of sole-
active-ingredient end-use products that contain methiocarb must be
revised to adopt the entry restrictions set forth in this section.  Any
granular homewoner product that currently has a 24 hour REI must
retain that REI as specified on current labeling.  Any conflicting entry
restrictions on current labeling must be removed.

       In order to remain in  compliance with FIFRA, labels of
multiple-active-ingredient end-use products that contain methiocarb
must compare the entry  restrictions set forth in this section to the entry
restrictions on their current labeling and retain the more protective.  A
specific time-period in hours or days is considered more protective than
"sprays have dried" or "dusts have settled."

(3)    Pressurized Liquid Formulations: In order to remain in
compliance with  FIFRA, a 25-day restricted entry interval (REI) as
                       34

-------
follows is required on all methiocarb end-use products formulated as a
pressurized liquid.

       Do not enter or allow worker entry in treated areas
       during the restricted entry interval (REI) of 25 days,
       except, after 10 days, workers may enter treated areas to
       perform tasks including hand labor tasks that involve
       contact with treated surfaces provided each worker
       spends no more than 3 hours in each 24 hour period
       performing  such tasks.

These restrictions should be inserted into the labeling section pertaining
to REI's as required by PR Notice 93-7.  Early entry by handlers and
ventilation procedures must be in accordance with the WPS for
greenhouse workers,  40 CFR 170.110(c) and this RED.

c.     Personal Protective Equipment Requirements; Labeling

(1)     Handlers:

•     Products NOT Primarily Intended  for Home Use:  The
minimum personal protective equipment (PPE) requirement for
pesticide handlers on all methiocarb end-use products, except products
intended primarily  for home use (see tests in PR Notices 93-7 and 93-
11), is:

"Applicators and other handlers must wear:
-Coveralls over short-sleeved shirt and short pants
--Chemical-resistant or waterproof gloves (see * below)
—Chemical-resistant footwear plus socks
-Chemical-resistant headgear for overhead exposure
-Chemical-resistant apron when cleaning equipment, mixing,
       or loading (see ** below)

       In addition  to the above, handlers  must wear a respirator with
an organic vapor cartridge TC-23C during early entry to greenhouses
following  treatment with the  pressurized liquid for those tasks
associated with ventilating the greenhouse.

       A dust  mask must be  worn while mixing/loading the wettable
powder formulation.
                      35

-------
       * The glove statement for methiocarb is the statement
established through the instructions in Supplement Three of PR Notice
93-7.
       ** The words "mixing or loading" are not necessary  for the
granular and aerosol formulations.

       Producers of end-use products that contain methiocarb must
compare the personal protective equipment requirements set  forth in
this section to the personal protective equipment requirements, if any,
on their current labeling and retain the more protective. For guidance
in choosing which  requirement is more protective, see Supplement
Three of PR Notice 93-7.

•     Products Primarily Intended for Home Use:  For products
primarily intended for home use (see tests in PR Notice 93-7 and 93-
11), do not add any additional personal protective equipment for such
products, however, any personal protective equipment requirements on
the current product labeling must be retained.

(2)     PPE for Entry During the Restricted Period; Labeling

(i)     Wettable Powder Formulations. The personal protective
equipment for early entry is the PPE required for applicators of
methiocarb, except the applicator requirement for an apron is waived.
A dust mask must be worn while mixing/loading the wettable powder
formulation.  This PPE should be inserted into the standardized early
entry PPE statement required by PR Notice 93-7.

(ii)    Granulars Formulations.  The personal protective equipment
for early entry is the PPE required for applicators of methiocarb. This
PPE should be inserted into the standardized early entry PPE statement
required by PR Notice 93-7.

(iii)   Pressurized Liquid Formulations.  The personal protective
equipment for early entry by workers is the PPE required for
applicators of methiocarb.  This PPE should be inserted into the
standardized early entry PPE statement required by PR Notice
93-7.

       The personal protective equipment  for early entry by handlers
should be the PPE required for applicators of methiocarb.  Label
language for reentry to perform ventilation tasks is as follows.
                       36

-------
      Handlers entering a treated greenhouse must wear
      a respirator with an organic vapor cartridge TC-
      23C during early entry to a greenhouse following
      treatment with the pressurized liquid for those
      tasks associated with ventilating the greenhouse.

      This respirator requirement language must be included with the
standardized early entry PPE statement required by PR Notice 93-7.

(iv) Uses Not Within the Scope of the WPS:

      Do not add any additional entry restrictions for uses not within
      the scope of the WPS; however, any entry restrictions on the
      current product labeling for those uses must be retained.

•     Products Primarily Intended for Home Use:  For products
primarily intended for home use (see tests in PR Notice 93-7 and 93-
11), do not add any additional entry restrictions for such products;
however, any entry restrictions on the current product labeling must be
retained.

d.    Other Labeling Requirements

      (1)    Labeling for Lawn and Turf Uses.

      If a registrant chooses to support lawn and turf uses, he must
submit the data required in this Reregistration Eligibility Decision
document associated with the lawn and turf uses of methiocarb.  If a
registrant chooses to support the residential lawn uses only, he must
add the following exclusionary statement to his labels in order to
remove the use site from the scope of the WPS in accordance with  PR
Notice 93-11.

Exclusionary Statement:  All granular end-use products that contain
methiocarb must carry the  following statement located (1) on the front
panel of the label  in association with the product name or (2) near the
beginning of the Directions For Use section:

              "Not for use on turf being grown for sale
             or other commercial use as  sod, or for
             commercial  seed production, or for
             research purposes."
                      37

-------
       If registrant does not support the residential lawn uses, the
following statement must appear on his labels located (1) on the front
panel of the label in association with the product name or (2) near the
beginning of the Directions For Use section:

             "Do not use on turfgrass around residences
             or dwellings."

Also, if any lawn and turf uses are not being supported, the registrant
must amend his labels by deleting the lawn and turf uses in accordance
with the procedures in PR Notice 91-1.

       The labels and labeling of all products must comply with EPA's
current regulations and requirements as specified in 40 CFR §156.10.

       (2)  Restricted Use Labeling.

       The following statement must appear on all end-use labels for all
outdoor uses, except those products intended for homeowner uses.  If
your product is intended for use on sites that have been classified as
restricted use as well as sites which have not been restricted as such,
you  must separate the restricted use from the other uses by splitting the
one product label into two products and applying for a new registration
number for one or the other product.  Each of the labels must further
clarify the intended site of use.

       Restricted Use Pesticide

       Due to Toxicity to Fish, Birds, and Aquatic Organisms

       For retail sale to and use only by certified
       applicators or persons  under their direct
       supervision and only for those uses covered by
       the certified applicator's certification.

       (3)  Changes Relating to Label Rates and Number of
             Applications.

       The following typical number of applications must  appear as the
maximum application rate on  labels in the Directions for Use  section
for the specified uses of methiocarb in order to decrease the aquatic
risks.
                       38

-------
                    75% Wettable Powder

                    2 Ibs 75% wettable powder per 50
                    gallons of water applied up to 2
                    times a year.

                    Granular or Pelletized Bait

                    Should not be applied more than twice a year.

                    (4) Labeling for Fish and Wildlife Hazard.

             The following statements must appear on labeling for the following
             specified uses:

             End Use — Granular or Pelletized Bait for Molluscicide Use

             This pesticide is toxic to fish and very highly toxic to
             birds and mammals.  Do not apply directly to water,
             wetlands (swamps, bogs, marshes, and potholes).
             Runoff from treated area may be hazardous to aquatic
             organisms in adjacent aquatic sites. Do not contaminate
             water when disposing of equipment washwaters and
             rinsates.

                    End Use - 75% Wettable Powder

             This pesticide is toxic to fish and very highly toxic to
             birds and mammals.  Do not apply directly to water, or
             to areas below the mean high water mark.  Runoff from
             treated area may be hazardous to aquatic organisms in
             adjacent aquatic sites. Do not contaminate water when
             disposing of equipment washwaters and rinsates.

             This product is very highly toxic to honey bees exposed
             to direct  treatment or residues on blooming shrubs,
             flowers, weeds and trees.  Do not apply this  product or
             allow it to drift to blooming shrubs, flowers,  weeds, or
             trees if bees are visiting the treatment area.

C.     Existing Stocks

       Registrants may generally distribute and sell products bearing old
labels/labeling for 26 months from the date of the issuance of this Reregistration


                                   39

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

      The Agency has determined that registrants may distribute and sell methiocarb
products bearing old  labels/labeling for 26 months from the date of issuance of this
RED. Persons other than the registrant may distribute or sell  such products for 50
months from the date of the issuance of this RED.
                                     40

-------
VI.   APPENDICES
       41

-------

-------
APPENDIX A.  Table of Use Patterns Subject to
               Reregistration
                    43

-------

-------
The following table includes uses eligible/ineligible (or reregistration.  It also includes changes (maximum number of applications and REIs) that result from the RED review.
APPENDIX A Case 0577, [Methiocarb] Chemical 100501
S)T£ Application Typ*. Application Timing. A(.pjication Equipment
Fo.m

USES ELIGIBLE FOR REREGISTRATION
Minimum Application
Ret*
Maximum
Application Ral«
Max. «
Apo..
Max. i
Appa @
Max. R>u
Min. Intetval
Bdtwean Appe. @
Max. Rau
(O.y.l
Realiicled
Enl,V
Inlefval
(Daya)

Geogtaphtc
Li mint ion*
Allowed

DiMllowed
U»« Limitations


NONFOOD/NONFEED USES
Ornamental Herbaceous Plants Use Groups: Terrestrial Non-Food Crop and Outdoor Residential
Bait Application, Foliar Stage, Not on Label
Bait Application, Foliar Stage, Shaker Can
Bait Application, Foliar Stage, Spreader
B/S
B/S
B/S
na
na
na
.02 Ib Al per
1,000 sq. ft.
.02 Ib Al per
1 ,000 sq. ft.
.02 Ib Al per
1 ,000 sq. ft.
2 per
Vr.
2 per
yr.
2 per
y.
2 per
yr.
2 per
Vr-
2 per
yr.
not spec
not spec
not spec
24 hr.
24 hr.
24hr.









Ornamental Herbaceous Plants Use Group: Terrestrial Non-Food Crop Only
Bait Application, Nurserystock, Not on Label
Spray, Nurserystock, Ground
B/S
WP
na
na
.01 Ib Al per
1 ,000 sq. ft.
1.5lb Alper
Acre
2 per
vr-
2 per
Vr.
2 per
Vr.
2 per
yr.
not spec
not spec
24 hr.
•" See
REIat
end






Ornamental Herbaceous Plants Use Group: Greenhouse Non-Food Crop Only
Bait Application, Foliar Stage, Not on Label
Bait Application, Foliar Stage, Not on Label
Aerosol, fog, or fumigation Application, Foliar
Stage, Aerosol generator
Spray, Foliar Stage, Ground
B/S
B/S
or G
PRL
WP
na
na
na
na
.02 Ib Al per
1 ,000 sq. ft.
.02 Ib Al per
1 ,000 sq. ft.
.0067 Ib Al
per 1 ,000 sq.
ft.
1 .5 Ib Al per
Acre
2 per
Vr.
2 per
vr.
not
spec
2 per
V-
2 per
yr.
2 per
yr.
not
spec
2 per
vr.
not spec
not spec
not spec
not spec
24 hr.
24 hr.
"« See
REIat
end
»" See
REIat
end








•See
Limitation
at end



                                                                                  45

-------
APPENDIX A Case 0577, [Methiocarb] Chemical 100501
SITE Application Type, Application Timing, Aitplicnrion Equipment

Rale
Application Rate
Max. f
Appe
Max. *
Appa @
Max Rale
Min. tnleival
Between Appa. p
Max Rate
(Dayal
Rtntiicled
Entiy
httnval
lOeye)
Ornamental Lawns and Turf Use Groups; Terrestrial Non-Food Crop
Bait Application, Foliar Stage, Granule
Applicator
Bait Application, Foliar Stage, Not on Label
Bait Application, Foliar Stage, Shaker Can
Bait Application, Foliar Stage, Spreader
B/S
BIS
B/S
B/S
na
na
na
na
.02 Ib Al per
1 ,000 sq. ft.
.02 Ib Al per
1 ,000 sq. ft.
.02 Ib Al per
1 ,000 sq. ft.
.02 Ib Al per
1 ,000 sq. ft.
2 per
yr.
2 per
yr.
2 per
yr.
2 per
yr.
2 per
yr.
2 per
yr.
2 per
yr.
2 per
yr.
not spec
not spec
not spec
not spec
24 hr.
24 hr.
24 hr.
24 hr.
Geogfaphic
Ltmilationa
Allowed





Oieellowed





Uae limitationa






Ornamental arid/or Shade Trees Use Groups: Terrestrial Non-Food Crop and Outdoor Residential
Bait Application, Foliar Stage, Not on Label
Bait Application, Foliar Stage, Shaker Can
B/S
B/S
na
na
.02 Ib Al per
1 ,000 sq. ft.
.02 Ib Al per
1,000 sq.ft.
2 per
yr.
2 per
yr.
2 per
yr-
2 per
vr.
not spec
not spec
24 hr.
24 hr.






Ornamental and/or Shade Trees Use Group: Terrestrial Non-Food Crop Only
Bait Application, Nurserystock, Not on Label
Spray, Nurserystock, Ground
B/S
WP
na
na
.01 Ib Al per
1 ,000 sq. ft.
1 .5 Ib Al per
Acre
2 per
yr.
2 per
yr.
2 per
yr.
2 per
yr.
not spec
not spec
24 hr.
••See
REIat
end






Ornamental and/or Shade Trees Use Group: Greenhouse Non-Food Crop Only
Bait Application, Foliar Stage, Not on Label
Bait Application, Foliar Stage, Not on Label
Aerosol, fog, or fumigation Application, Foliar
Stage, Aerosol generator
B/S
B/S
or G
PRL
na
na
na
.02 Ib Al per
1 ,000 sq. ft.
.02 Ib Al per
1 ,000 sq. ft.
.0067 Ib Al
per 1 ,000 sq.
ft.
2 per
yr.
2 per
yr.
not
spec
2 per
yr.
2 per
yr-
not
spec
not spec
not spec
not spec
24 hr.
24 hr.
•• See
REIat
end






•See
Limitation
at end


46

-------
APPENDIX A- Case 0577, [Methiocarb] Chemical 100501
SITE Application lype. Application liming, Application Equipment
Spray, Foliar Stage, Ground

WP
Minimum Application
Rate
na
Application Rate
1 .5 Ib Al per
Acre
Ma*. >
Apps.
2 per
Vr.
Max. 1
Appt &
Max Rau
2 per
yr.
Min. Interval
Between Appe. @
Max. Rate
(Dayal
not spec
Realticted
Entry
Interval
(Oeye)
•" See
REIat
end
Gsogiflphic
Limit ntions
Allowed

DiMllowed

Use UmitBlion*

Ornamental Nonflowaring Plants (Inc. ferns) Use Groups; Terrestrial Non-Food Crop and Outdoor Residential
Bait Application, Foliar Stage, Not on Label
Bait Application, Foliar Stage, Shaker Can
B/S
B/S
na
na
.02 Ib Al per
1 ,000 sq. ft.
.02 Ib Al per
1 ,000 sq. ft.
2 per
Yr.
2 per
Yr.
2 per
yr-
2 per
yr.
not spec
not spec
24 hr.
24 hr.






Ornamental Nonflowerlng Plants Use Group: Terrestrial Non-Food Crop Only
Bait Application, Nurserystock, Not on Label
Spray, Nurserystock, Ground
B/S
WP
na
na
.01 Ib Al per
1 ,000 sq. ft.
1.5lb Alper
Acre
2 per
yr.
2 per
yr.
2 per
yr.
2 per
yr.
not spec
not spec
24 hr.
*" See
REIat
end






Ornamental Nonflowering Plants Use Group: Greenhouse Non-Food Crop Only
Bait Application, Foliar Stage, Not on Label
Bait Application, Foliar Stage, Not on Label
Aerosol, fog, or fumigation Application, Foliar
Stage, Aerosol generator
Spray, Foliar Stage, Ground
B/S
B/S
or G
PRL
WP
na
na
na
na
.02 Ib Al per
1 ,000 sq. ft.
.02 Ib Al per
1,000 sq. ft.
.0067 Ib Al
per 1 ,000 sq.
ft.
1 .5 Ib Al per
Acre
2 per
yr-
2 per
Yr.
not
spec
2 per
yr.
2 per
yr.
2 per
yr.
not
spec
2 per
yr.
not spec
not spec
not spec
not spec
24 hr.
24 hr.
"•See
REIat
end
•» See
REIat
end








* See
Limitation
at end



Ornamental Woody Shrubs and Vines Use Groups: Terrestrial Non-food Crop and Outdoor Residential
Bait Application, Foliar Stage, Not on Label
Bait Application, Foliar Stage, Shaker Can
B/S
B/S
na
na
.02 Ib Al per 2 per
1 ,000 sq. ft. 1 yr.
.02 Ib Al per 2 per
1 ,000 sq. ft. 1 yr.
2 per
yr.
2 per
yr.
not spec
not spec
24 hr.
24 hr.






47

-------
APPENDIX A- Case 0577, [Methiocarb] Chemical 100501
SITE Application Type. Application riming. Application Equipment
Fotm
Minimum Application
R.I.
Minimum II Max. >
Application Rale II Appa.
M>». «
Appa e>
Max. Rat*
Min. Mafval
fx.lw.en Appa. fl
Mo. D.M
(Oaya)
Raattictad
Entry
htafval
(D.y.l
Geogtaphic
Limitations
Allowed
Disallowed
U*e Limitation*
Ornamental Woody Shrubs and Vines Use Group: Terrestrial Non-Food Crop Only
Bait Application, Nurserystock, Not on Label
Spray, Nurserystock, Ground
BIS
WP
na
na
.01 Ib Al per
1 ,000 sq. ft.
1 .5 Ib Al per
Acre
2 per
vr.
2 per
yr.
2 per
yr.
2 per
yr.
not spec
not spec
24 hr.
*" See
REIat
end






Ornamental Woody Shrubs and Vines Use Group: Greenhouse Non-Food Crop Only
Bait Application, Foliar Stage, Not on Label
Bait Application, Foliar Stage, Not on Label
Aerosol, fog, or fumigation Application, Foliar
Stage, Aerosol generator
Spray, Foliar Stage, Ground
BIS
BIS
or G
PRL
WP
na
na
na
na
.02 Ib Al per
1 ,000 sq. ft.
.02 Ib Al per
1 ,000 sq. ft.
.0067 Ib Al
per 1 ,000 sq.
ft.
1.5 Ib Alper
Acre
2 per
Yr.
2 per
vr.
not
spec
2 per
yr.
2 per
yr.
2 per
yr. '
not
spec
2 per
yr.
not spec
not spec
not spec
not spec
24 hr.
24 hr.
••See
REIat
end
•• See
REIat
end








• See
Limitation
at end



Household/Domestic Dwellings Outdoor Premises Use Group: Outdoor Residential Only
Bait Application, When needed, Not on Label
BIS
or G
na
.02 Ib Al per I 2 per
1 ,000 sq. ft. || yr.
2 per
yr.
not spec
24 hr.



Ginseng (with 12 month Preharvest Interval) Use Group; Terrestrial Non-Food Crop
Bait Application, Spring, Ground
Bait Application, Spring, Hand-Held
BIS
BIS
na
na
.02 Ib Al per
1 ,000 sq. ft.
.02 Ib Al per
1 ,000 sq. ft.
2 per
Yr.
2 per
yr-
2 per
yr-
2 per
yr.
not spec
not spec
24 hr.
24 hr.




1 2 month
preharvest
interval
1 2 month
preharvest
interval
48

-------
APPENDIX A- Case 0577, [Methiocarb] Chemical 100501
SITE Application Type. Application liming. Application Equipment
Fo.m
Minimum Application
Rate
Maximum II Max. *
Application Rat* || Appt.
1
Max. *
Appa. @
Max. Rat*
Min. Interval
Batwe«n Appa. @
Max. Rata
(Daya)
Raatiictvd
Entry
(ntorval
(Oaya)
Gaogtaphic
Limitation*
Allowed
DiaallovMd
Ua* Limitation*
USES INELIGIBLE FOR REREGISTRATION: Includes Uses on Ornamental Lawns and Turf (Outdoor Residential Only) and all Food Crops including previously Registered Sites (Corn,
Avocado, and Citrus Fruits).
Abbreviations used
    Header:       max = maximum; min=minimum;apps = applications; not spec = not specified; na = not applicable
    Form :        G = Granular, BIS = Bait/Solid. WP = Wettable powder. PRL = Pressurized liquid

* Limitations for Greenhouse Use:
    Do not enter treated areas without protective clothing until 24 hours after application.

* * Restricted Entry Interval (RED:
    REI for Wettable Powder and Pressurized Liquid formulations:  Do not enter or allow worker entry in treated areas during the restricted entry interval (RED of 25 days, except after 10 days,
    workers may enter treated areas to perform tasks including hand labor tasks that involve contact with treated surfaces provided each worker spends no more than 3 hours in each 24 hour
    period performing such tasks.
                                                                                       49

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APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
                          51

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                                 GUIDE TO APPENDIX B

       Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case covered by this Reregistration Eligibility Decision Document. It
contains generic data requirements that apply to in all products, including data requirements for
which a "typical formulation" is the test  substance.

       The data table is organized in  the following format:

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

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

                          A     Terrestrial food
                          B     Terrestrial feed
                          C     Terrestrial non-food
                          D     Aquatic food
                          E     Aquatic non-food outdoor
                          F     Aquatic non-food industrial
                          G     Aquatic non-food residential
                          H     Greenhouse food
                          I      Greenhouse non-food
                          J      Forestry
                          K     Residential
                          L     Indoor food
                          M     Indoor non-food
                          N     Indoor medical
                          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.
                                             53

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                                       APPENDIX  B
           Data Supporting Guideline Requirements for the Reregistration of Methiocarb
REQUIREMENT
                                              USE PATTERN
             CITATION(S)
PRODUCT
61-1        Chemical Identity
61-2        Start. Mat. & Mnfg. Process
61-3        Formation of Impurities
62-1        Preliminary Analysis
62-2        Certification of Limits
62-3        Analtyical Method
63-2        Color
63-3        Physical State
63-4        Odor
63-5        Melting Point
63-6        Boiling Point
63-7        Density
63-8        Solubility
63-9        Vapor Pressure
63-10       Dissociation Constant
63-11       Octanol/Water Partition
63-12       pH
63-13       Stability
CIK
CIK
CIK
CIK
CIK
CIK
CIK
CIK
CIK
CIK
CIK
CIK
CIK
CIK
CIK
CIK
CIK
CIK
40686901
42389002
42389002
40619301, 40619302
40619301
40619301
40452101
40452101
40452101
40452101
N/A - TGAI is a solid at room temperature
40452101, 42389001
40452101
40452101
40452101
40452101
N/A - TGAI is not soluble enough in water
40452101, 42389001
                                                  55

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                                      APPENDIX  B
           Data Supporting Guideline Requirements for the Reregistration of Methiocarb
REQUIREMENT
                                  USE PATTERN
             CITATION(S)
64-1
Submittal of Samples
ECOLOGICAL EFFECTS
71-1A     Acute Avian Oral - Quail/Duck
71-2A     Avian Dietary (LCSO) - Quail
71-2B     Avian Dietary (LCSO) - Duck
71-3       Wild Mammal Toxicity
71-4A     Avian Reproduction - Quail
71-4B     Avian Reproduction - Duck
71-5A     Simulated Field Study
71-5B     Actual Field Study
72-1A     Fish Acute (LCSO) - Bluegill
72-1B     Fish Acute (LCSO) - Bluegill (TEP)
72-1C     Fish Acute (LCSO) - Rainbow Trout
72-1D     Fish Acute (LCSO) - Rainbow Trout
          (TEP)
72-2A     Aquatic Invertebrate (ECSO)
72-3A     Estuarine/Marme Toxicity - Fish
72-3B     Estuarine/Marine Toxicity -
          Mollusk
CIK
                                      CIK
                                      CIK
                                      CIK
                                       C
                                      CK
                                      CK
                                      CK
                                      CK
                                      CK
                                      CK
                                      CIK
                                      CIK

                                      CIK
                                      CK
                                      CK
RESERVED - If samples are required, the
Agency will request them
             GS0577006, 00036482
             00022923
             00022923
             N/A
             00128119
             00128119
             40560001
             40560001
             00150628
             00036484
             00150628
             00036484

             00127638, 00150383
             DATA GAP
             DATA GAP
                                                56

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                                       APPENDIX  B
           Data Supporting Guideline Requirements for the Reregistration of Methiocarb
REQUIREMENT
USE PATTERN
CITATION(S)
72-3C      Estuarine/Marine Toxicity -
           Shrimp
72-4A      Early Life Stage Fish
72-4B      Life Cycle Invertebrate
72-5        Life Cycle Fish
72-6        Aquatic Organism Accumulation
72-7A      Simulated Field - Aquatic
           Organisms
72-7B      Actual Field - Aquatic Organisms
70-A-SS    Special Test: Avian Repellency
70-B-SS    Special Test: Aquatic Residue
           Monitoring
141-1       Honey Bee Acute Contact Toxicity
141-2       Honey Bee Toxicity of Residues on
           Foliage
141-4       Honey Bee Subacute Feeding Study

141-5       Field Testing for Pollinators

142-1       Acute Toxicity to Aquatic Insects
    CK

    CK
    CK
    CK
     C
    CK
     C

     C
     C
DATA GAP

00155967 - DATA GAP
40628001 - DATA GAP
DATA GAP
N/A
RESERVED

RESERVED
40560001
WAIVED

0001999, 00036935
00060625

RESERVED - pending development of test
methodology.
N/A - data reviewed under RS does not
indicate need for this study.
RESERVED - pending Agency decision as to
whether data requirement should be
established.
                                                  57

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                                        APPENDIX B
            Data Supporting Guideline Requirements for the Reregistration of Methiocarb
REQUIREMENT
                                     USE PATTERN
CITATION(S)
142-2
142-3
143-1
thru
143-3
Aquatic Insect Life Cycle Study
Simulated or Actual Field Testing
for Aquatic Insects

NonTarget Insect Testing -
Predators and Parasites
RESERVED - pending Agency decision as to
whether data requirement should be
established.
RESERVED - pending Agency decision as to
whether data requirement should be
established.
RESERVED - pending Agency decision as to
whether data requirement should be
established.
TOXICOLOGY
81-1       Acute Oral Toxicity - Rat
81-2       Acute Dermal Toxicity -
           Rabbit/Rat
81-3       Acute Inhalation Toxicity - Rat
81-4       Eye Irritation
81-5       Dermal Irritation
81-6       Dermal Sensitization
81-7       Acute Delayed Neurotoxicity - Hen
82-1A      90-Day Feeding - Rodent
82-1B      90-Day Feeding - Non-rodent
                                         CIK
                                         CIK

                                         CIK
                                         CIK
                                         CIK
                                         CIK
                                         CIK
00036477, 00083437
00036478

40404201
0055163
0055163
N/A - Not required for technical methiocarb.
N/A - Methiocarb is not an organophosphate.
N/A - Adequate chronic studies are available.
N/A - Adequate chronic studies are available.
                                                   58

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                                         APPENDIX B
            Data Supporting Guideline Requirements for the Reregistration of Methiocarb
REQUIREMENT
                                                USE PATTERN
                                                       CITATION(S)
82-2
82-3

82-4
82-5A
82-5B
82-A-SS

83-1A
83-1B

83-2A
83-2B
83-3A
83-3B
83-4
84-2A
21-Day Dermal - Rabbit/Rat
CIK
90-Day Dermal - Rodent

90-Day Inhalation - Rat
90-Day Neurotoxicity - Hen
90-Day Neurotoxicity - Mammal
30-Day Feeding - Non - Rodent
(Dog)
Chronic Feeding Toxicity - Rodent
Chronic Feeding Toxicity - Non-
Rodent
Oncogenicity - Rat
Oncogenicity - Mouse
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
Gene Mutation (Ames Test)
CIK

CIK
CIK

CIK

CIK
CIK

CIK
41771701, 40922301 (Although these studies
were classified as supplemental, acceptable
chronic studies are available which satisfy this
guideline requirement.)
N/A - because of existing use patterns do not
result in repeated skin contact for an extended
period of time.
N/A - not required for current use patterns.
N/A - not required for current use patterns.
DATA GAP
N/A - not required for current use patterns.

00115226
00128939, 00149362

00115226
N/A - Not required for current use patterns.
00124617
00143213, 42496401, 42931901
N/A - Not required for current use patterns.
40508101
                                                    59

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                                APPENDIX B
         Data Supporting Guideline Requirements for the Reregistration of Methiocarb
REQUIREMENT
84-2 B Structural Chromosomal
Aberration
84-4 Other Genotoxic Effects
85-1 General Metabolism
85-2 Dermal Absorption
86-1 Domestic Animal Safety
REENTRY PROTECTION
132-1 A Foliar Residue Dissipation
132-1B Soil Residue Dissipation
133-3 Dermal Passive Dosimetry
Exposure
133-4 Inhalation Passive Dosimetry
Exposure
USE PATTERN CITATION(S)
CIK 40508102
CIK 40700801
N/A - Not required for current use patterns.
N/A - Not required for current use patterns.
N/A - Not required for current use patterns.

K DATA GAP
DATA GAP
K DATA GAP
I DATA GAP
ENVIRONMENTAL FATE
161-1     Hydrolysis
161-2     Photodegradation - Water
161-3     Photodegradation - Soil
CK
CI
C
DATA GAP
40624501
40622301
                                         60

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                                        APPENDIX B
            Data Supporting Guideline Requirements for the Reregistration of Methiocarb
REQUIREMENT
                                                USE PATTERN
              CITATION(S)
161-4      Photodegradation - Air

162-1      Aerobic Soil Metabolism
162-2      Anaerobic Soil Metabolism
162-3      Anaerobic Aquatic Metabolism

162-4      Aerobic Aquatic Metabolism

163-1      Leaching/Adsorption/
           Desorption
163-2      Volatility - Lab

163-3      Volatility - Field

164-1      Terrestrial Field Dissipation
164-2      Aquatic Field Dissipation

164-3      Forest Field Dissipation

164-4      Combination and Tank Mixes

164-5      Long-Term Soil Dissipation
CIK
CIK
CK
 CK
N/A - Not required based on low vapor
pressure of methiocarb.
41194601
41194601
N/A - Not required because of current use
patterns.
N/A - Not required because of current use
patterns.
40342201 - DATA GAP

N/A - Not required based on low vapor
pressure.
N/A - Not required based on low vapor
pressure.
DATA GAP
N/A - Not required because of current use
patterns.
N/A - Not required because of current use
patterns.
N/A - Not required because of current use
patterns.
RESERVED
                                                    61

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                                       APPENDIX B
           Data Supporting Guideline Requirements for the Reregistration of Methiocarb
REQUIREMENT USE PATTERN CITATION(S)
165-1
165-2
165-3
165-4
165-5
Confined Rotational Crop
Field Rotational Crop
Irrigated Crops
Bioaccumulatin in Fish
Bioaccumulation - Aquatic
WAIVED
RESERVED
N/A - Not required
patterns.
WAIVED
N/A - Not required


because of current use

because of current use
           Non-Target Organisms
201-1       Droplet Size Spectrum
202-1       Drift Field Evaluation
patterns.
N/A - Not required because of current use
patterns.
N/A - Not required because of current use
patterns.
RESIDUE CHEMISTRY
*A11 of the Residue Chemistry data requirements are waived due to the dropped food uses.  Residue Chemistry
references are listed in the Bibliography (Appendix C).
171-3      Directions for Use                                      *
171-4A    Nature of Residues - Plants                              *
171-4B    Nature of Residues - Livestock                            *
171-4C    Residue Analytical Method - Plants                        *
171-4D    Residue Analytical Method -                              *
          Animal
                                                  62

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                                      APPENDIX B
           Data Supporting Guideline Requirements for the Reregistration of Methiocarb
REQUIREMENT
                                             USE PATTERN
CITATION(S)
171-4E    Storage Stability

171-4J     Magnitude of Residues -
          Meat/ Milk/Poultry

171-4K    Cropfield Trials
                Agricultural Crops
                 (Preplant Application)
                Avocados
                Blueberries
                Cherries
                Corn, Field
                Cranberries
                Deciduous Fruit Trees
                 (Nonbearing)
                Grapefruit
                Lemons
                Oranges
                Peaches
                Peppers and Sunflowers
                Grown for Seed

171-4L    Processed Food
                Citrus Group

171-5      Reduction of Residues
                                                63

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APPENDIX C.  Citations Considered to be Part of the
Data Base Supporting the Reregistration of Methiocarb
                        65

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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


                                          67

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       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.

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.
                                   68

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                                BIBLIOGRAPHY
MRID
                   CITATION
00001999
00022923
00035520
00036477
00036478
00036482
Spagnoli, J. (1993) Typical Use of Methiocarb.  (Letter to Karen Farmer,
U.S. EPA, dated July 22, 1993; submitted by Miles, Inc., Kansas City, Mo.)

Atkins, L., Jr.;  Anderson, L.D. (1967) Toxicity of Pesticides and Other
Agricultural Chemicals to Honey Bees:  laboratory Studies.  (Unpublished
study received Jan 30,  1969 under 9G0802; prepared by Univ. of California-
Riverside, Dept. of Entomology, submitted by Hercules, Inc., Agricultural
Chemicals, Wilmington, Del.; CDL:093111-D)

Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary Toxicities
of Environmental Pollutants to Birds: Special Scientific Report-Wildlife No.
191. (U.S. Dept. of Interior, Fish and Wildlife Service, Patuxent Wildlife
Research Center; unpublished report)

Strankowski, K.J.; Stanley, C.W. (1978) Determination of Residues of
Mesurol® and Its Toxic Metabolites in Crops: Report No. 45089.
(Unpublished  study including report nos. 53015, 53701 and 62625, received
Jun 19, 1980 under OF2362; prepared in cooperation with International
Research & Development Corp. and others, submitted by Mobay Chemical
Corp., Kansas City, Mo.; CDL:099475-B)

Crawford, C.R.; Anderson, R.H. (1973) The Acute Oral Toxicity of Mesurol
Technical to Rats: Report No. 34008.  Rev.  (Unpublished study received Mar
26, 1975 under 5F1607; submitted by Mobay Chemical Corp., Kansas City,
Mo.; CDL:094391-T)

Crawford, C.R.; Anderson, R.H. (1972) The Dermal Toxicity of Mesurol
Technical and Mesurol 75% Wettable Powder to Rabbits: Report No. 34477.
(Unpublished study received Mar 26, 1975 under 5F1607; submitted by
Mobay Chemical Corp., Kansas City, Mo.; CDL:094391-U)

Schafer, E.W., Jr.; Brunton, ? (1973) Toxicity and Repellency Tests of 9
Materials from Bayer and Chemagro: Report No. S-225; Report  No.  36054.
(Unpublished study including report nos. S-223  and 36055, received Mar 26,
1975 under 5F1607; prepared in cooperation with U.S. Fish and Wildlife
Service,  Denver Wildlife Research Center, submitted by Mobay Chemical
Corp., Kansas City, Mo.; CDL:094391-Z)
                                        69

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                               BIBLIOGRAPHY
MRID
CITATION
00036484     Lamb, D.W.; Roney, D.J. (1973) Acute Toxicity of Mesurol 75% Wettable
             Powder to Bluegill and Rainbow Trout: Report No. 36612. (Unpublished study
             received Mar 26,  1975 under 5F1607; submitted by Mobay Chemical Corp.,
             Kansas City, Mo.; CDL:094391-AB)

00036491     Schafer, E.W., Jr.; Brunton, R.B.; Lockyer, N.F.; et al.  (1973) The Chronic
             Toxicity of Methiocarb to Crackles, Doves,  and Quail and Reproductive
             Effects in Quail: Report No. 39615.  (U.S. Fish and Wildlife Service, Denver
             Wildlife Research Center, unpublished study; CDL:094391-AJ)

00036496     Morgan, J.G.; Parton, K. (1974) Metabolism of Mesurol in Apples: Report
             No. 40208.  (Unpublished study received Mar 26, 1975 under 5F1607;
             submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:094391-AO)

00036935     Atkins, E.L.; Greywood,  E.A.; Macdonald, R.L. (1975) Toxicity of Pesticides
             and Other Agricultural chemicals to Honey Bees: Laboratory Studies.  By
             University of California, Dept. of Entomology.   ?: UC, Cooperative
             Extension.  (Leaflet 2287; published study)

00037132     Chemagro Corporation (1971) Synopsis of Mesurol: Analytical and Residue
             Information for Seed Treatment of Corn:  (Unpublished study  received Jul 2,
             1975 under  6F1652; CDL:094636-A)

00037822     Cunningham, D.; Schafer, E.W., Jr. (1968) [Toxicity Studies on Birds]:
             Report No.  23196.  (U.S. Fish and Wildlife Service, Denver Wildlife
             Research Center,  unpublished study; CDL: 094390-AP)

00046448     Mobay Chemical  Corporation (1978) Recovery of Mesurol from Blueberries
             and Grapes: Report No. 65401.  (Unpublished study received May 5,  1980
             under 3125-288; prepared in cooperation with International Research and
             Development Corp.; CDL:099423-B)

00046449     Mobay Chemical  Corporation (1978) The Effect of Frozen Storage at 0 to
             -10°=F on  Mesurol Residues in Various Crops:  Report No. 66101.
             (Unpublished study received may 5,  1980 under 3125288; CDL:099423-C)

00046450     Stanley, C.W.; Kottman, R.F.; Bingman, K.J.  (1979) Metabolism and
             Excretion of Mesurol by Poultry: Report No. 66777. (Unpublished study
                                        70

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                               BIBLIOGRAPHY
MRID
CITATION
            received May 5, 1980 under 3125-288; submitted by Mobay Chemical Corp.,
            Kansas City, Mo.; CDL:099423-D)

00046451    Stanley, C.W.; Kottman, R.F.; Bingman, KJ.  (1979) Radioactive Residues of
            [14C]Mesurol in Poultry: Report No. 66778. Rev.  (Unpublished study
            received May 5, 1980 under 3125-288; submitted by Mobay Chemical Corp.,
            Kansas City, Mo.; CDL:099423-E)

00046453    Becker, B.D. (1979) Recovery of Mesurol from Grape Must: Report No.
            68215.  (Unpublished study received May 5, 1980 under 3125-288; prepared
            in cooperation with International Research & Development Corp., submitted
            by Mobay Chemical Corp., Kansas City, Mo.;  CDL:099423-H)

00055163    Crawford, C.R.; Anderson, R.H. (1970) The Skin and Eye Irritating
            Properties of Bay 37344 Technical to Rabbits: Report  No. 28304.
            (Unpublished study received May 20,  1971  under 3125-258; submitted by
            Mobay Chemical Corp., Kansas City, Mo.; CDL:229102-A)

00056044    Mobay Chemical Corporation (1976) Synopsis of Mesurol Residue Chemistry
            on Citrus.  Summary of studies 095325-B through 095325-D.  (Unpublished
            study received Oct  15, 1976 under 3125234; CDL:095325-A)

00056045    Strankowski, K.J.;  Stanley, C.W.  (1975) Determination of Residues of
            Mesurol and Its Toxic Metabolites in Crops: Report No. 45089.  Method dated
            Nov 21, 1975.  (Unpublished study received Oct 15, 1976 under 3125-234;
            submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:095325-B)

00056047    Chemonics (1976) The Effect of Frozen Storage at 0 to -10° on Mesurol
            Residues in Orange Peel and Pulp: Report No.  49580. (Unpublished study
            received 3125-234; submitted by Mobay Chemical Corp., Kansas City,  Mo.;
            CDL:095325-D)

00060625    Johansen, C.; Hutt, R. (1962) Bee Poisoning Investigations,  1962: Report No.
             10617.  (Unpublished study received Mar 27, 1974 under 4F1485; prepared by
            Washington State Univ.,  submitted by Chemagro Corp., Kansas City, Mo.;
             CDL:092011-E)

00060635     Shellenberger, T.E. (1970) Letter sent to D.W. Lamb dated Dec 10,  1970:
            Toxicological evaluations of three Chemagro chemicals with fish: GSRI

                                        71

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                               BIBLIOGRAPHY
MRID
CITATION
            Project No. NC-413; Report No. 29003.  (Unpublished study received Mar
            27, 1974 under 4F1485; prepared by Gulf South Research Institute, submitted
            by Chemagro Corp., Kansas City, Mo.; CDL:092011-T)

00083437    Lamb, D.W.; Matzkanin, C.S. (1977) A Comparison of the Acute Oral
            Toxicities of Mesurol Technical to Fasted and Non-fasted Rats: 51420.
            (Unpublished study received Aug 30, 1979 under 3125-234; submitted by
            Mobay Chemical Corp., Kansas City, Mo.; CDL:098990-A)

00083438    Thyssen, J.; Schilde, B. (1978) H 321 (Mesurol Active Ingredient):
            Neurotoxicity Studies on Hens: Report No. 7637; 66482.  (Unpublished study
            received Aug 30, 1979 under 3125-234; prepared by Bayer AG, West
            Germany, submitted by Mobay Chemical Corp., Kansas City, Mo.;
            CDL:098990-B)

00115224    Mobay Chemical Corp. (1982) Addition No. 2 to the Brochure Entitled:
            Mesurol Residue Chemistry on Grapes: Document No. AS 821702.
            (Compilation; unpublished study received Oct 4, 1982 under 3125-288;
            CDL:071113-A)

00115226    Kroetlinger, F.; Loeser, E.; Vogel,  O. (1981) H 321: (..., the Active
            Ingredient of MESUROL)~Chronic  Toxicity Study on Rats-(2-year Feeding
            Experiment): Bayer Report No. 10039; Mobay ACD Report No. 69844.
            (Unpublished study received Oct 4,  1982 under  3125-288; prepared by Bayer
            AG., W. Ger., submitted by Mobay Chemical Corp., Kansas City, MO;
            CDL:071114-B)

00116555    Mobay Chemical Corp. (1970) Mesurol (Bay 37344): Metabolic, Analytical,
            Residue, and Flavor Information (Apples and Pears).  (Compilation;
            unpublished study received Sep 9, 1971 under 1G1030;  CDL:091909-A;
            091907)

00123980    Mobay Chemical Corp. (1974) Mesurol:  Metabolic, Analytical, Residue and
            Flavor Information  for Foliar Spray Applications on Apples, Cherries, Peaches
            and Pears.  (Compilation; unpublished study received Mar 26, 1975 under
            5F1607; CDL:094388-A; 094387; 094386)

00124617    Lorke, D. (1971) Mesurol Active Ingredient (Bay 37  344): Studies on Rats for
            Embryotoxic and Teratogenic Effects: Report No. 3133; 32142.  (Unpublished

                                       72

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                               BIBLIOGRAPHY
MRID
                               CITATION
             study received Mar 26, 1975 under 5F1607; prepared by Farbenfabriken
             Bayer, AG, W. Ger., submitted by Mobay Chemical Corp., Kansas City, MO;
             CDL: 094389-L)

00124968     Abdel-Wahab, A.; Kuhr, R.; Casida, J. (1966) Fate of C14-carbonyllabeled
             aryl methylcarbamate insecticide chemicals in and on bean plants. J. Agr.
             Food Chem. 14(3):290-297. (Submitter 18274; also  In unpublished
             submission received Jul 15, 1976 under 3125-EX-135; submitted by Mobay
             Chemical Corp., Kansas City, MO; CDL:227756-E)

00125528     Mobay Chemical Corp. (1977) Addition No. 1, Mesurol Residue Chemistry on
             Apples, Cherries, Peaches and Pears, to Brochure Entitled:
             Mesurol-Metabolic, Analytical, Residue and Flavor Information for Foliar
             Spray Applications  on Apples, Cherries, Peaches and Pears: Document No.
             AS77-1086.  (Compilation; unpublished study received Jul 20, 1977 under
             3125-288; CDL: 096264-A)

             Mobay Chemical Corp. (1977) Mesurol: Residue Chemistry on Cole Crops:
             Document No. AS77-559.  (Compilation; unpublished study received May 5,
             1977 under 3125-234; CDL:096118-A)

             Mobay Chemical Corp. (1971) [Mesurol: Analytical and Residue Information
             for Seed Treatment of Corn].  (Compilation; unpublished study received Feb
             14, 1973 under unknown admin, no.; CDL: 126889-A)

             Pfipharmecs (1957) Study of the Efficacy of Tetracycline and Terramycin on
             Fish. (Compilation; unpublished study received Dec  5, 1956 under PP0111;
             CDL092391-B).

             Mobay Chemical Corp. (1977) Addition No.  1 to Brochure Entitled:
             Mesurol-Residue Chemistry on Berries: Document No. AS77-259.
             (Compilation; unpublished study received Feb 25, 1977 under 3125-EX-139-
             CDL:096002-A)

00127630     Mobay Chemical Corp. (1977) Mesurol: Residue Chemistry on Grapes:
             Document No. AS77-337.  (Compilation; unpublished study received Mar 4,
             1977 under 3125-EX-140; CDL:096017-A)
00125530
00125532
00125537
00127628
                                       73

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                               BIBLIOGRAPHY
MRID
CITATION
00127634     Mobay Chemical Corp. (1976) Mesurol: Residue Chemistry on Beans:
             Document No. AS77-565. (Compilation; unpublished study received May 5,
             1977 under 3125-234; CDL:096117-A)

00127635     Mobay Chemical Corp. (1978) Addition No. 2 to Brochure Entitled: Mesurol:
             Residue Chemistry on Berries (Dated Dec 1, 1976): AS19-1643.
             (Compilation; unpublished study received Sep 14, 1979 under 3125-288;
             CDL:098964-A)

00127638     Nelson, D.; Roney, D. (1979) Acute Toxicity of Mesurol Technical to
             Daphnia magna: Report No.  67264.  (Unpublished study received Sep 14,
             1979 under 3125-288; submitted by Mobay Chemical Corp., Kansas City,
             MO; CDL-.098965-D)

00128119     Lamb, D.; Carsel, M.; Mallicoat, D.; et al. (1982) Methiocarb Reproduction
             Study with Bobwhite Quail: 82400. (Unpublished  study received Feb 10, 1983
             under 3125-234;  submitted by Mobay Chemical Corp.,  Kansas City, MO;
             CDL:071396-A)

00128121     Carlisle, L; Carsel, M.; Lamb, D.; et al. (1982) A Laboratory Study
             Exposing Bobwhite Quail to  Mesurol 2% Bait: 82399.  (Unpublished study
             received Feb  10, 1983 under 3125-234; submitted by Mobay Chemical Corp.,
             Kansas City,  MO; CDL:071396-C)

00128122     Carlisle, J.; Toll, P.; Lamb, D.; et al. (1982) Small Pen Field Study of
             Mesurol 2% Bait Toxicity To Bobwhite Quail: 82674. (Unpublished study
             received Feb  10, 1983 under 3125-234; submitted  by Mobay Chemical Corp.,
             Kansas City,  MO; CDL:071396-D)

00128723     Mobay Chemical Corp. (19??) Summary of the Incidence of Nonneoplastic
             Lesions in Male and Female Rats (Gross and Microscopic Observations):
             Addendum to Bayer Report No. 10039: 69844.  (Unpublished study received
             Jun 22, 1983 under unknown admin, no.; CDL:250526-A)

00128939     Hoffman, K.; Schilde, B. (1980) H 321 (Mesurol  Active Ingredient-
             Mercaptodimethur):  Chronic Toxicity Study on Dogs (Two-year Feeding
             Experiment): Report No. 9626;  69364. (Unpublished study received Jun 15,
             1983 under unknown admin, no.; prepared by Bayer AG, W. Ger., submitted
             by Mobay Chemical Corp.,  Kansas City, MO; CDL:250497-A)

                                        74

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                                 BIBLIOGRAPHY
 MRID
                    CITATION
 00133477
 00133480
 00141660
 00143213
00145802



00149362


00150383


00150628



00154537
 Mobay Chemical Corp. (1983) Synopsis of Mesurol Toxicology: [Rats, Dogs
 and Mice].  (Unpublished study received Dec 12, 1983 under OF2356;
 CDL:072227-A)

 Kroetlinger; Janda; Blass; et al. (1983) H 321 (Mercaptodimethur, the Active
 Ingredient of Mesurol): Chronic Toxicity Study on Mice (Two-year Feeding
 Experiment): Report No. 11908; 85950. (Unpublished study received Dec 12,
 1983 under OF2356; prepared by Bayer AG, W. Ger., submitted by Mobay
 Chemical Corp., Kansas City,  MO; CDL:072227-D)

 Maddy, K.; Schneider, F.; Lowe, J.; et al. (1982) A Study of the Degradation
 of Mesurol When Applied as a Foliar Spray to Grape Vineyards in Fresno and
 San Luis Obispo Counties,  California during August of 1981: HS-964.
 Unpublished study prepared by California Dept. of Food and Agriculture,
 Worker Health and Safety Unit.  6 p.
Tesh, J.; Ross, F.; Seeker, R. et al. (1981) H 321 : Effects of Oral
Administration upon Pregnancy in the Rabbit: 2. Main Study:
81/BAG013/598.  Unpublished study prepared by Life Science Research.
P-
                                                                               60
Atwell, S.; Murphy, J. (1978) Soil Absorption and Desorption of FCarbon
14cr Mesurol: Mobay report No. 66145.  Unpublished study prepared by
Mobay Chemical Corp. 14 p.

Mobay Chemical Corporation (1985)  pChronic Toxicity Study on Dogscr:
Report No. 69364: Addendum.  Unpublished study. 42 p.

Marking, L.; Chandler, J. (1981) Toxicity of six bird control chemicals to
aquatic organisms.  Bull.  Environm. Contam. Toxicol. (26):705-716.

Lamb, D. (1981) Acute Toxicity of Technical Methiocarb (Mesurol) to
Bluegill and  Rainbow Trout: Study Nos. 81-066-03 and 80-066-12: Mobay
Report No. 69407. Unpublished study prepared by Mobay Chemical Co.  9 p.

Mobay Chemical Corp. (1982) Mesurol: Residue Chemistry on Pecans.
Unpublished  compilation.  92 p.
                                        75

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                               BIBLIOGRAPHY
MRID
CITATION
00155042    Mobay Chemical Corporation (1981) Residue Data for Mesurol. Unpublished
            compilation.  1059 p.

00155046    Strankowski, K.; Parker, G. (1981) Carbon-14 MESUROL® Rotational Crop
            Study. Unpublished Mobay report 69270.  15 p.

00155055    Strankowski, K. (1979) Metabolism of MESUROL® in Rice: Report No.
            66776.  Unpublished study prepared by Mobay Chemical Corporation. 46 p.

00155057    Mobay Chemical Corporation (1981) Residue Data for MESUROL®.
            Unpublished compilation.  793 p.

00155967    Carlisle, J. (1985) Toxicity of Methiocarb (Mesurol) Technical to Early Life
            Stages of Rainbow Trout:  Study No. 85-666-02: 90579. Unpublished study
            prepared by Mobay  Chemical Corp. 19 p.

00157781    Borderland Products Inc. (1986)  Residue Data on Methiocarb in Paddy Canal
            and Receiving Waters.  Unpublished study prepared in cooperation with
            Craven Laboratories, Inc. and Morse Laboratories,  Inc.  71 p.

00157782    Borderland Products Inc. (1986)  Aquatic Field Dissipation in Water.
            Unpublished compilation prepared in cooperation with Craven Laboratories
            Inc. and Morse Laboratories Inc. 74 p.

00158770     Mobay Chemical Corp. (1986) Mesurol: Residue Chemistry on Blueberries
             and Cherries;  March 13, 1986: Brochure No. 1444.  Unpublished compilation.
             280 p.

40342201     Ridlen, R. (1987) Soil Leaching of Aged  Residues  of Mesurol. Unpublished
             Mobay Report 94872 prepared by Mobay Corp., Stanley Research Center.  40
             P-

40404201     Shiotsuka, R. (1987) Acute Four-hour Inhalation Toxicity Study with Mesurol
             Technical in Rats: Study No. 86-041-25;  94635. Unpublished study prepared
             by Mobay Corp.  34 p.

40452101    Talbott, T. (1987) Product Chemistry  of Mesurol Technical: Mobay Reports:
             69950, 86787. Unpublished compilation  prepared  by Mobay Corp.  60 p.
                                         76

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                               BIBLIOGRAPHY
MRID
CITATION
40508101     Herbold, B. (1986) H 321 c.n. Mercaptodimethur Salmonella/Microsome Test
             to Evaluate for Point Mutagenic Effect: Report No.  14205.  Unpublished
             Mobay Study No. 91775 prepared by Bayer Ag, Germany . 33 p.

40508102     Putman,  D. (1986) Sister Chromatid Exchange Assay in Chinese Hamster
             Ovary (CHO) Cells: Laboratory Study No. T4522.334. Unpublished Mobay
             Study No.  91334 prepared by Mocrobiological Associates, Inc. 25 p.

40560001     Dolbeer, R.; Avery, M.;  Tobin, M. (1988) Assessment of Field Hazards to
             Birds and Mammals from Methiocarb Applications to Fruit Crops: Report No.
             87266. Unpublished compilation.  1198 p .

40615001     Greig-Smith, P.; Hardy, A.; Brown, P. et al. (1981) Assessment of the
             Hazard to Wildlife from the Use of Methiocarb To Protect Ripening Cherries:
             Project No. C/88/0127.  Unpublished study prepared by ADAS Tolworth
             Laboratory.  214 p.

40619301     Talbott, T. (1988) Product Chemistry of Mesurol Technical: 86256: 95644.
             Unpublished study prepared by Mobay  Corp.  214 p.

40619302     Talbott, T. (1988) Product Chemistry of Mesurol 75%  Concentrate: 88839:
             95644. Unpublished study prepared by Mobay Corp.  213 p.

40622201     Carlisle, J. (1985) Supplemental Submission to EPA Accession No. 262626:
             Toxicity of Methiocarb (Mesurol) Technical to Early Life Stages of Rainbow
             Trout: Study Report No.  85-666-02. Unpublished Mobay report No. 90579-1.
             6 p.

40622301     Jackson, S.; Kesterson, A.; Lawrence,  L.  (1988) Soil Surface Photolysis of
             [Carbon 14]Mesurol in Natural Sunlight: Report No. 1148: Project No. 220.
             Unpublished study prepared by Pharmacology and Toxicology Research
             Laboratory.  71  p.

40624501     Kesterson, A.; Marsh, J.; Lawrence, B.; et al. (1988) Photochemical
             Degradation of [Carbon 14]Mesurol in  Aqueous Solutions: Project No. 214;
             Report No. 1147.  Unpublished study prepared by Pharmacology and
             Toxicology Research Laboratory.  78 p.
                                        77

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                                BIBLIOGRAPHY
MRID
CITATION
40624502     Saakvitne, J.; Gustafson, D.; Wilkes, L.; et al. (1981) Mesurol Hydrolysis in
             Sterile Buffers: Proj. No. 443.  Unpublished Mobay study 69272 prepared by
             Analytical Development Corp.  32 p.

40628001     Forbis, A. (1988) Chronic Toxicity of [Carbon 14]-Mesurol to Daphnia magna
             Under Flow-through Test Conditions: Final Report No. 35249. Unpublished
             Mobay study no. 96731 prepared by Analytical Bio-Chemistry Laboratories,
             Inc.  34 p.

40686901     Talbott, T. (1988) Supplement 1: Product Chemistry of Mesurol Technical:
             Doc. Reg. No. 2017.  Unpublished study prepared by Mobay Corp.  10 p.

40700801     Curren, R. (1988) Unscheduled DNA Synthesis in Rat Primary Hepatocytes:
             Test Article Mesurol: Study No. T5391.380. Unpublished study prepared by
             Microbiological Associates, Inc. 41 p.

40922301     Procter, B. (1988) A 21-Day Dermal Toxicity Study of Mesurol Technical in
             Albino Rabbits: Bio-Research Laboratory 51901.  Unpublished Mobay report
             no. 98369 prepared  by Bio-Research Laboratories, Ltd.  259 p.

40994801     Murphy, J. (1989) Field Dissipation of Mesurol in Sand and Sandy Loam:
             Proj. ID ME092101. Unpublished Mobay report no. 98512 prepared in
             cooperation with Wilbur-Ellis Co., and EPL BioAnalytical Services,  Inc. 300
             P-

41015101     Gronberg, R.; Lemke, V. (1989) Validation of the Analytical Residue Method
             for Methiocarb and  Metabolites Using Field Weathered Residues in [Carbon
             14] Mesurol 75 WP Treated Cherries: Report No. 98524.  Unpublished study
             prepared by Mobay  Corporation. 71 p.

41015102     Gronberg, R.; Lemke, V. (1989) Validation of the Analytical Residue Method
             for Methiocarb and  Metabolites Using Greenhouse Weathered Residues in
             [Carbon 14] Mesurol 75 WP Treated Blueberries: Report No. 98525.
             Unpublished  study prepared by Mobay Corp. 70 p.

41194601     Minor, R.; Freeseman, P. (1989) Fate of Methiocarb  under Aerobic and
             Anaerobic Soil Conditions: Project ID 99206. Unpublished study prepared by
             Mobay Corp. 71 p.
                                        78

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                               BIBLIOGRAPHY
MRID
CITATION
41771701     Procter, B. (1989) A 21-Day Dermal Toxicity Study of Mesurol Technical in
             Albino Rabbits: Lab Project Number: 51925. Unpublished Study prepared by
             Bio-Research Laboratories Ltd. 190 p.

42389001     Fontaine,  L.  (1992) Supplement to MRID 40452101: Product Chemistry of
             Mesurol Technical: Lab Project Number: 34049: BR1807. Unpublished study
             prepared by Miles Inc.  18 p.

42389002     Fontaine,  L.  (1992) Supplement to MRID 40404401: Product Chemistry of
             Mesurol Technical: Lab Project Number: PN 97210-00: BR 1806.
             Unpublished  study prepared by Miles Inc. 14 p.

42481001     Proctor, B. (1992) A 21-day Dermal Toxicity Study of Mesurol Technical in
             Albino Rabbits: [Supplement to MRID 41771701]: Lab Project Number:
             98369.  Unpublished study prepared by Bio-Research Labs, Ltd.  59 p.

42496401     Dotti, A.; Biedermann, K. (1992) Embryotoxicity Study (Including
             Teratogenicity) with H 321 (c.n. Methiocarb) in the Rabbit (Dermal
             Application): Lab Project Number: 103271. Unpublished  study prepared by
             RCC, Research and Consulting Co. Ltd. 294 p.

42758401     Dotti, A.  (1993) Embryotoxicity Study  (Including Teratogenicity) with H 321
             (c.n. Methiocarb) in the Rabbit (Dermal Application): First Amendment to
             Report: Lab Project Number: 297900: 297898: 103271-1. Unpublished study
             prepared by Research and Consulting Co. Ltd. 99 p.

42931901     Dotti, A.  (1993) Embryotoxicity Study  (Including Teratogenicity) with H 321
             (c. n. Methiocarb) in the Rabbit (Dermal Application): Supplement to: Second
             Amendment to: Lab Project Number: 297900: 297898: R 5627. Unpublished
             study prepared by RCC, Research and Consulting Co., Ltd.  15 p.

GS0577001   Watts, R.R.  (1975) Method Trial for Mesurol on Corn Grain.  Located in
             Section D of PP# 6F1652.

GS0577002   Mahijani, G.P. (1977) Results of Method Tryout for Mesurol and its Sulfoxide
             Metabolite in Milk and Beef Liver. Submitted under PP# 7F1988.
GS0577003   Mobay Chemical Corp. (1978) Chemagro Agricultural Division Experiment:
             661-1609-77D.  Report No. 66573. Located in Section D of PP# OF2362.

                                         79

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                              BIBLIOGRAPHY
MRID
CITATION
GS0577004   Mobay Chemical Corp. (1981) Addition No. 2 to "Mesurol, the Effects on the
            Environment - Environmental Chemistry"; Vol. I. Received May 29, 1981
            under PP# OF2362. (EPA Accession Number 070111).

GS0577005   Mobay Chemical Corp. (1981) Addition No. 2 to "Mesurol, the Effects on the
            Environment - Environmental Chemistry"; Vol. II. Received May 29, 1981
            under PP# OF2362.  (EPA Accession Number 070112).

GS0577006   Hudson, R.H.; Tucker, R.K.; Haegele, M.A. (1984) Handbook of Toxicity of
            Pesticides to Wildlife. USDI Publication 153,  Washington, D.C.
                                      80

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APPENDIX D.  List of Available Related Documents
                      81

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

       1.     Health and Environmental Effects Science Chapters

      2.     Detailed Label Usage Information System (LUIS) Report

      3.     Methiocarb RED Fact Sheet (included in this RED)

      4.     PR Notice 91-2 (included in this RED) pertains to the Label Ingredient
             Statement

      Federal publications on methiocarb are available and may be purchased from the
National Technical Information Service (NTIS), 5825 Port Royal Road, Springfield, VA
22161.

       1.    Guidance for the Reregistration of Pesticide Products Containing Methiocarb
             as the Active Ingredient (The 1987 Registration Standard): NTIS Stock No.
             PB87-190898

       2.    Pesticide Fact Sheet (No. 120) for Methiocarb: NTIS Stock No.  PB87-191920
                                          83

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APPENDIX E. PR Notice 91-2
            85

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              UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

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

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

ATTENTION: Persons Responsible for Federal Registration  of
Pesticide Products.

SUBJECT: Accuracy of Stated Percentages for  Ingredients
Statement

I. PURPOSE:

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

II. BACKGROUND

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

     Current regulations  require that the percentage listed  in
the active ingredient statement be as precise as possible
reflecting good manufacturing practices 40 CFR  156.10(g)(5). The
                                87

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certified limits required for each active ingredient are intended
to encompass any such "good manufacturing practice" variations 40
CFR 158.175(C)(3).

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

     The nominal concentration would in fact state the greatest
degree of accuracy that is warranted with respect to actual
product composition because the nominal concentration would be
the amount of active ingredient typically found in the product.

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

III. REQUIREMENTS

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

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

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

IV. PRODUCTS THAT REQUIRE EFFICACY DATA

     All pesticides are required to be efficacious. Therefore,
the certified lower limits may not be lower then the minimum

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level to achieve efficacy. This is extremely important for
products which are intended to control pests which threaten the
public health, e.g., certain antimicrobial and rodenticide
products. Refer to 40 CFR 153.640.

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

V. COMPLIANCE SCHEDULE

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

      (1)  Beginning July 1, 1991, all new product registrations
          submitted to the Agency are to comply with the
          requirements of this Notice.

      (2)  Registrants having products subject to reregistration
          under FIFRA section 4(a) are to comply with the
          requirements of this Notice when specific products are
          called in by the Agency under Phase V of the
          Reregistration Program.

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

VI. FOR FURTHER INFORMATION

Contact Tyrone Aiken for  information or questions concerning
this  notice on  (703) 308-7031.
                                  Ann* E.  tiftdaay,  Director
                                  Registration  Division  (H-7505
                                89

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APPENDIX F.  Combined Generic and Product Specific
                  Data Call-In
                       91

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                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                               WASHINGTON, D.C. 20460

                        GENERIC AND PRODUCT SPECIFIC
                              DATA CALL-IN NOTICE
CERTIFIED MAIL
                                                                           OFFICE OF
                                                                    PREVENTION, PESTICIDES AND
                                                                        TOXIC SUBSTANCES
Dear Sir or Madam:

       This Notice requires you and other registrants of pesticide products containing the
active ingredient identified in Attachment A of this Notice, the Data Call-in Chemical Status
Sheet,  to submit certain 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  7; or

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

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

       If you do not respond to this Notice, or if you do not satisfy EPA that you will
comply with its requirements or should be exempt or excused from doing so, then the
registration of your product(s) subject to this Notice will be subject to suspension. We have*
provided a list of all  of your products subject to this Notice in Attachment 2.  All products
are listed on both the generic and product specific Data Call-In Response Forms.   Also
included is 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 3-31-96).
                                                                   Recycled/Recyclable
                                                                   Printed with Soy/Canola Ink on paper that
                                                                   contains at toast 50% recycled fiber

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

Section I     -      Why You are Receiving this Notice
Section II    -      Data Required by this Notice
Section III    -      Compliance with Requirements of this Notice
Section IV    -      Consequences of Failure to Comply with this Notice
Section V           -      Registrants' Obligation to Report Possible Unreasonable
                          Adverse Effects
Section VI    -      Inquiries and Responses to this Notice

       The Attachments to this Notice are:

       1  -    Data Call-In Chemical Status Sheet
       2  -    Generic Data  Call-In and Product Specific Data Call-In Response Forms with
             Instructions
       3  -    Generic Data  Call-In and Product Specific Data Call-In Requirements Status
             and Registrant's Response Forms with Instructions
       4  -    EPA Grouping of End-Use Products for Meeting Acute Toxicology Data
             Requirements for Reregistration
       5  -    EPA Acceptance Criteria
       6  -    List of Registrants Receiving This Notice
       7  -    Confidential Statement of Formula. Cost Share and Data Compensation Forms
SECTION I.  WHY YOU ARE RECEIVING THIS NOTICE

       The Agency has reviewed existing data for this active ingredient(s) and reevaluated
the data needed to support continued registration of the subject active ingredient(s). This
reevaluation identified additional data necessary to assess the health and safety of the
continued use of products containing this active ingredient(s). You have been sent this Notice
because you have product(s) containing the subject active ingredients.
SECTION H. DATA REQUIRED BY THIS NOTICE

II-A. DATA REQUIRED

       The data required by this Notice are specified in the Requirements Status and
Registrant's Response Forms: Attachment 3 (for both generic and product specific data
requirements).  Depending on the results of the studies required in this Notice, additional
studies/testing may be required.
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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 the Requirements Status and Registrant's Response Forms (Attachment 3) within
the timeframes 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 (Telephone
number: 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],
II-D.   REGISTRANTS RECEIVING PREVIOUS SECTION 3(cV2^ NOTICES ISSUED
       BY THE AGENCY

       Unless otherwise noted herein, this Data Call-In does not in any way supersede or
change the requirements of any previous Data Call-Inte). 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 ffl.      COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE

       You must use the correct forms and instructions when completing your response to
this Notice.  The type of Data Call-in you must comply with (Generic or Product Specific) is
specified in item number 3 on the four Data Call-In forms (Attachments 2  and 3).
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III-A.  SCHEDULE FOR RESPONDING TO THE AGENCY

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

III-B.  OPTIONS FOR RESPONDING TO THE AGENCY

       1. Generic Data Requirements

       The options for responding to this Notice for generic data requirements are: (a)
voluntary cancellation, (b) delete use(s), (c) claim generic data exemption, (d) agree to
satisfy  the generic data requirements imposed by this Notice or (e) request a data waiver(s).

       A discussion of how to respond if you choose the Voluntary Cancellation option,  the
Delete  Use(s) option or the Generic Data Exemption option is presented below. A discussion
of the various options available for satisfying the generic 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.

       Two forms apply to generic data requirements,  one or both of which must be used in
responding to the Agency, depending upon your response.  These two forms are the
Data-Call-in Response Form, and the Requirements Status and Registrant's Response Form.
(contained in Attachments 2 and 3, respectively).

       The Data Call-In Response Forms must be submitted as part of every response to this
Notice. The Requirements Status and  Registrant's Response Forms also must be submitted if
you do not qualify for a Generic Data Exemption or are not requesting voluntary cancellation
of your registration(s). Please note that the company's authorized  representative is required
to sign the first page of both Data Call-In Response Forms and the Requirements Status and
Registrant's Response Forms (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.

       a.      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 completed Generic and Product Specific
Data Call-In Response Forms (Attachment 2), indicating your election of this option.
Voluntary cancellation is item number 5 on both Data Call-In Response Formfsl If you
choose this option, these are the only forms  that you are required to complete.
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       If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice, which are contained in Section IV-C.

       b.     Use Deletion -

       You may avoid the requirements of this Notice by eliminating the uses of your
product to which the  requirements apply. If you wish to amend your registration to delete
uses, you must submit the Requirements Status and Registrant's Response Form (Attachment
3), a completed application for amendment, a copy of your proposed amended labeling, and
all other information  required for processing the application.  Use deletion is option number
7 under item 9 in the instructions for the Requirements Status and Registrant's Response
Forms. You must also complete a Data Call-in Response Form by signing the certification,
item number 8.  Application forms for amending registrations may be obtained from the
Registration Support  Branch, Registration Division, Office of Pesticide Programs, EPA, by
calling (703) 308-8358.

       If you choose to delete the use(s) subject to this Notice or uses subject to specific data
requirements, further sale, distribution, or use of your product after one year from the due
date of your 90 day response, is allowed only if the product bears an amended label.

       c.     Generic Data Exemption -

       Under section 3(c)(2)(D) of FIFRA, an applicant for registration of a product is
exempt from the requirement to submit or cite generic data concerning an active ingredient if
the active ingredient  in the product is derived exclusively from purchased, registered
pesticide products containing the active ingredient. EPA has concluded, as an exercise of its
discretion, that it normally will not suspend the registration of a product which would qualify
and continue to qualify for the generic data exemption in section  3(c)(2)(D)  of FIFRA. To
qualify, all of the following requirements must be met:

       (i). The  active ingredient in your registered product must be present solely because
       of incorporation of another registered  product which contains the subject active
       ingredient and is purchased  from a source not connected with you;

       (ii).  Every registrant who is the ultimate source of the active ingredient in your
       product subject to this DCI  must be in compliance  with the requirements of this
       Notice and  must remain in compliance; and

       (iii). You must have provided  to EPA an accurate and current  "Confidential
       Statement of Formula" for each of your products to which this Notice applies.

       To apply for  the Generic  Data Exemption you must submit a completed Data Call-in
Response Form. Attachment 2 and all  supporting documentation. The Generic Data
Exemption is item  number 6a on the Data Call-In Response Form. If you claim a generic
data exemption you are not required to complete the Requirements Status and Registrant's
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Response Form. Generic Data Exemption cannot be selected as an option for responding to
product specific data requirements.

       If you are granted a Generic Data Exemption, you rely on the efforts of other persons
to provide the Agency with the required data. If the registrant(s)  who have committed to
generate and submit the required data fail to take appropriate steps to meet requirements or
are  no longer in compliance with this Data Call-in Notice, the Agency will consider that both
they and you are not compliance and will normally initiate proceedings to suspend the
registrations of both your and their product(s), unless you commit to submit and do submit
the  required data within the specified time. In such cases the Agency generally will not grant
a time extension for submitting the data.

       d.      Satisfying the Generic Data Requirements of this Notice

       There are various options available to satisfy the generic data requirements of this
Notice. These options are discussed in Section HI-C.1.  of this Notice and comprise options 1
through 6 of item 9 in the instructions for the Requirements Status and Registrant's Response
Form and item 6b on the Data Call-In Response Form.  If you choose item 6b (agree to
satisfy the generic data requirements),  you  must submit the Data  Call-In  Response Form and
the  Requirements Status and Registrant's Response Form as well  as any other
information/data pertaining to the option  chosen to address the data requirement.  Your
response must be on  the forms marked "GENERIC" in item  number 3.

       e.      Request for Generic Data Waivers.

       Waivers for generic data are discussed in Section III-D.l. of this  Notice and are
covered by options 8 and 9 of item 9  in the instructions for 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.

       2. Product Specific Data Requirements

       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 choose 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.2.  A discussion of
options relating to requests for data waivers is contained in Section III-D.2.

       Two forms apply to the product specific data requirements one or both of which must
be used in responding to the Agency, depending upon your response. These forms are the
Data-Call-in Response Form,  and the Requirements Status and Registrant's Response Form.
for  product specific data (contained in Attachments 2 and 3,  respectively).  The Data Call-In
Response Form must be submitted as part of every response to this Notice.  In addition, one

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copy of the Requirements Status and Registrant's Response Form also must be submitted for
each product listed on the Data Call-In Response Form unless the voluntary cancellation
option is selected.  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.

      a.     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
both the Generic and Product Specific Data Call-In Response Forms. If you choose this
option,  you must complete both Data Call-In response forms.  These are the only forms that
you are  required to complete.

      If you choose 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.

      b.     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.2. of this Notice  and comprise
options  1 through 6 of item 9 in the instructions for the product specific Requirements Status
and Registrant's Response Form and item numbers 7a and 7b (agree to satisfy the product
specific data requirements  for an MUP or EUP as applicable) on the product specific Data
Call-In  Response Form. Note that the options available for addressing product specific data
requirements differ slightly from those options for fulfilling generic data requirements.
Deletion of a use(s) and the low volume/minor use option are not valid options for fulfilling
product specific data requirements. It is important to ensure that you are using the correct
forms and instructions when completing your response to the Reregistration Eligibility
Decision document.

      c.     Request for Product Specific Data Waivers.

       Waivers for product specific data are discussed in Section III-D.2.  of this Notice and
are covered by  option 7 of item 9 in the instructions for  the Requirements Status and
Registrant's Response Form.  If you choose this option,  you must submit  the Data Call-In
Response Form and the Requirements Status and Registrant's Response Form as well as any
other information/data pertaining to the option chosen to address the data  requirement.  Your
response must be on the forms marked "PRODUCT SPECIFIC" in item number 3.
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III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE

       1.     Generic Data

       If you acknowledge on the Generic Data Call-in Response Form that you agree to
satisfy  the generic data requirements (i.e. you select item number 6b), then you must select
one of the six options on the Generic 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 you to additional instructions
provided in this Section. The options are:

       (1)    I  will generate and submit data within the specified timeframe (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. In addition, certain studies
require Agency  approval of test protocols in advance of study initiation. Those studies for
which a protocol must be submitted have been identified in  the Requirements  Status and
Registrant's  Response Form and/or footnotes to the form. If you wish to use a protocol
which differs from the options discussed in Section II-C of this Notice, you must submit a
detailed description of the proposed protocol and your reason for wishing to use it. The
Agency may choose to reject a protocol not specified in Section II-C. If the Agency rejects
your protocol you will be notified in writing, however, you should be aware that rejection of
a proposed protocol will not be  a basis for extending the deadline for submission of data.

       A progress report must be submitted for each study within 90 days from the date you
are required to commit to generate or undertake some other means to address that study
requirement, such as making an offer to cost share or agreeing to share in the cost of

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developing that study.  This 90-day progress report must include the date the study was or
will be initiated and, for studies to be started within 12 months of commitment, the name and
address of the laboratory(ies) or individuals who are or will be conducting the study.

      In addition, if the time frame for submission of a final report is more than 1 year,
interim reports must be submitted at  12 month intervals from the date you are required to
commit to generate or otherwise address the requirement for the study. In addition to the
other information specified in the preceding paragraph, at a minimum, a brief description of
current activity on and the status of the study must be included as well as a full
description of any problems encountered since the last progress report.

      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 or
protocols. The noted deadlines run from the date of the receipt of this Notice by the
registrant. If the data are not submitted by the deadline, each registrant is subject to receipt
of a Notice of Intent to Suspend the affected registration(s).

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

       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

       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,

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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 the 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 to or, failing agreement, to be
bound by binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii) and  must not
qualify this offer. The other registrant must also inform EPA of its election of an option to
develop and submit the data required  by this  Notice by submitting a Data Call-in Response
Form  and a  Requirements Status and Registrant's Response Form committing  to develop and
submit the data required by this Notice.

      In order for you to avoid suspension under this option,  you  may not withdraw your
offer to share in the burden 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 normally will 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:
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      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 "'[r]aw 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, means "any material derived from a test system for examination or
             analysis."

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

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

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

Option 5. Upgrading a Study

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

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

       This option also should 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 ecological effects studies, the
classification  generally would be a rating of "core." 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.
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       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.

       2. Product Specific Data

       If you acknowledge on the product specific Data Call-In Response Form that you
agree to satisfy the product specific data requirements (i.e. you  select option 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 ~ The requirements  for developing  product specific data are the
same as those described for generic data (see Section HI.C.I, Option 1) except that normally
no protocols or progress reports are required.

Option 2. Agree to Share in Cost to Develop Data — If you enter into an agreement to cost
share, the same requirements  apply to product specific data as to generic data (see Section
III.C.I, Option 2). However, 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.

Option 3. Offer to Share in the Cost of Data Development —The same requirements for
generic data (Section IH.C.I., Option 3) apply to this option. This option only applies to
acute toxicity and certain efficacy data as described in option 2  above.

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Option 4. Submitting an Existing Study - The same requirements described for generic data
(see Section III.C.l., Option 4) apply to this option for product specific data.

Option 5. Upgrading a Study — The same requirements described for generic data (see
Section III.C.L, Option 5) apply to this option for product specific data.

Option 6. Citing Existing Studies ~ The same requirements described for generic data (see
Section III.C.l., Option 6) apply to this option for product specific data.

      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, and in the generic data requirements
section (III.C.L), as appropriate.
III-D REQUESTS FOR DATA WAIVERS

       1.     Generic Data

       There are two types of data waiver responses to this Notice. The first is a request for
a low volume/minor use waiver and the second is a waiver request based on your belief that
the data requirement(s) are not appropriate for your product.

       a.     Low Volume/Minor Use Waiver

             Option 8 under item 9 on the Requirements Status and Registrant's Response
       Form. Section 3(c)(2)(A) of FIFRA requires EPA to consider the appropriateness of
       requiring data for low volume, minor use pesticides. In implementing this provision,
       EPA  considers low volume pesticides to be only those active ingredients whose total
       production volume for all pesticide registrants is small. In determining whether to
       grant a low volume, minor use waiver, the Agency will consider the extent, pattern
       and volume of use, the economic incentive to conduct the testing, the importance of
       the pesticide, and the exposure and risk from use of the pesticide. If an active
       ingredient is used for both high volume and low volume uses, a low volume
       exemption will not be approved. If all uses of an active ingredient are low volume
       and the combined volumes for all uses are also low, then an exemption may be
       granted, depending on  review of other information outlined below. An exemption will
       not be granted  if any registrant of the active ingredient elects to conduct the testing.
       Any registrant receiving a low volume minor use waiver must remain within the sales
       figures in their forecast supporting the waiver request in order to remain qualified for
       such  waiver. If granted a waiver, a registrant will be required,  as a condition of the
       waiver, to submit annual sales reports. The Agency will respond to requests for
       waivers in writing.

             To  apply for a low volume, minor use waiver, you must submit the following
       information, as applicable to your product(s), as part of your 90-day response to this
       Notice:

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       (i).  Total company sales (pounds and dollars) of all registered product(s)
containing the active ingredient. If applicable to the active ingredient, include foreign
sales for those products that are not registered in this country but are applied to sugar
(cane or beet), coffee, bananas, cocoa, and other such crops. Present the above
information by year for each of the past five years.

       (ii)  Provide an estimate of the sales (pounds and dollars) of the active
ingredient for each major use site. Present the above information by year for each of
the past five years.

       (iii)  Total direct production cost of product(s) containing the active ingredient
by year for the past five years. Include information on raw material cost, direct labor
cost, advertising, sales and marketing, and any other significant costs listed
separately.

       (iv) Total indirect production cost (e.g. plant overhead, amortized  plant and
equipment) charged to product(s) containing the active ingredient by year for the past
five years. Exclude all non-recurring costs that were directly related to the active
ingredient, such as costs of initial registration  and any data development.

       (v)  A list of each data requirement for which you seek a waiver. Indicate the
type of waiver sought and the estimated cost to you (listed separately for each data
requirement and associated test) of conducting the testing  needed to fulfill each of
these data requirements.

       (vi)  A list of each data requirement for which you are not seeking  any waiver
and the estimated cost to you (listed separately for each data requirement and
associated test) of conducting the testing needed to fulfill  each of these data
requirements.

       (vii)  For each of the next ten years, a year-by-year forecast of company sales
(pounds and dollars) of the active ingredient, direct production costs of product(s)
containing the active ingredient (following the parameters in item 2 above), indirect
production costs of product(s) containing the active ingredient (following the
parameters in item 3 above), and costs of data development pertaining to the active
ingredient.

       (viii)  A description of the importance  and unique  benefits of the active
ingredient to users. Discuss the use patterns and the effectiveness of the active
ingredient relative to  registered alternative chemicals and  non-chemical  control
strategies. Focus on benefits unique to the active ingredient, providing information
that is as quantitative as possible.  If you do not have quantitative data upon which to
base your estimates, then present the reasoning used to derive your estimates. To
assist the Agency in determining the degree of importance of the active ingredient in
terms of its benefits,  you should provide information on any of the following  factors,
as applicable to your product(s):  (a) documentation of the usefulness of the active
ingredient in Integrated Pest Management, (b) description of the beneficial impacts on

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the environment of use of the active ingredient, as opposed to its registered
alternatives, (c) information on the breakdown of the active ingredient after use and
on its persistence in the environment, and (d) description of its usefulness against a
pest(s) of public health significance.

       Failure to submit sufficient information for the Agency to make a
determination regarding a request for a low volume/minor  use waiver will result in
denial of the request for a waiver.

b.     Request for Waiver of Data

       Option 9,  under Item 9, on the Requirements Status and Registrant's Response
Form.  This option may be used if you believe that a particular data requirement
should not  apply because the requirement is inappropriate.  You must submit a
rationale explaining why you believe the data requirements should not  apply. You also
must submit the current label(s) of your product(s) and, if  a current copy of your
Confidential Statement of Formula is not already on file you must submit a current
copy.

       You will be informed of the Agency's decision in writing. If the Agency
determines that the data requirements of this Notice  are not appropriate to your
product(s), you will not be required to supply the data pursuant to section 3(c)(2)(B).
If EPA determines that the data are required for your product(s). you must choose a
method of  meeting the requirements of this Notice within the time frame provided by
this Notice. Within 30 days of your receipt of the Agency's written decision, you
must submit a revised Requirements Status and Registrant's Response Form indicating
the option  chosen.

2. Product Specific Data

       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 product specific
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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SECTION 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 EI-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:

              i.  Inform EPA of intent to develop and submit the data required by this
              Notice on a Data Call-In Response  Form and a Requirements Status and
              Registrant's Response Form.
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             ii. Fulfill the commitment to develop and submit the data as required by this
             Notice; or

             iii.  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 generally
would not be consistent with the Act's purposes. Accordingly, the Agency anticipates

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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 also must explain why an "existing stocks"
provision is necessary, including a statement of the quantity of existing stocks and your
estimate of the time required for their sale, distribution, and use. Unless you meet this
burden,  the Agency will not consider any request pertaining to the continued sale,
distribution,  or use of your existing stocks after suspension.

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

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

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

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

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       All responses to this Notice must include completed Data Call-in Response Forms
(Attachment 2)and completed Requirements Status and Registrant's Response Forms
(Attachment 3), for both (generic and 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 Generic and Product Specific Data Call-in Response Forms need be  submitted.

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

                                       Sincerely yours,
                                      Daniel M. Barolo, Director
                                      Special Review and
                                        Reregistration Division
Attachments
      The Attachments to this Notice are:

      1 -    Data Call-in Chemical Status Sheet
      2 -    Generic Data Call-In and Product Specific Data Call-In Response Forms with
             Instructions
      3 -    Generic Data Call-In and Product Specific Data Call-In Requirements Status
             and Registrant's Response Forms with Instructions
      4 -    EPA Grouping of End-Use Products for Meeting Acute Toxicology Data
             Requirements for Reregistration
      5 -    EPA Acceptance Criteria
      6 -    List of Registrants Receiving This Notice
      7 -    Confidential Statement of Formula. Cost Share and Data Compensation Forms
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Attachment 1. Chemical Status Sheet
                113

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                       Generic and Product Specific Data Call-In

                                Chemical Status Sheet
                                        for
                                     Methiocarb
INTRODUCTION

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

       This combined Generic and Product Specific Data Call-In Chemical Status Sheet
contains an overview of data required by  this combined notice, and points of contact for
inquiries pertaining to the reregistration of methiocarb.  This attachment is to be used in
conjunction with:

       •     The Combined Generic and Product Specific Data Call-In Notice (Appendix
             E),
       •     The Generic Data Call-In and Product Specific Data Call-In Response Forms
             with Instructions (Attachment 2)
       •     The Generic Data Call-In and Product Specific Data Call-In Requirements
             Status and Registrant's Response Forms with Instructions (Attachment 3),
       •     EPA's Grouping of End-Use Products for Meeting Acute Toxicology Data
             Requirements for Reregistration (Attachment 4),
       •     The EPA Acceptance Criteria (Attachment 5),
       •     List of registrants receiving this combined DCI (Attachment 6), and
       •     The Confidential Statement of Formulat, Cost Share and Data Compensation
             Forms (Attachment 7)

Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE

       The additional data requirements needed to complete the data base for methiocarb are
contained in the Requirements Status and  Registrant's Response Forms. (Attachment 3).
The Agency has concluded that additional data on methiocarb are needed for specific
products.  These data are required to be submitted to the Agency within the time frame
listed.  These data are needed to fully complete the reregistration of all eligible methiocarb
products.
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INQUIRIES AND RESPONSES TO THIS NOTICE

       If you have any questions regarding the generic database of methiocarb, please contact
Ms. Karen Jones at (703) 308-8047.

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

       Ms.  Karen Jones, Chemical Review Manager
       Reregistration Branch
       Special Review and Reregistration Division (7508W)
       Office of Pesticide Programs
       U.S.  Environmental Protection Agency
       Washington, DC  20460

       RE:    Methiocarb

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

       All responses to this Notice for the product specific data requirements should be
submitted to:

       Ms.  Emily Mitchell
       Special Review and Reregistration Division (7508W)
       Office of Pesticide Programs
       U.S.  Environmental Protection Agency
       Washington, D.C.  20460

       RE:  Methiocarb
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Attachment 2. Combined Generic and Product Specific
  Data Call-In Response Forms (Form A inserts) Plus
                    Instructions
                        117

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                             Instructions For Completing
                                        The
                            "Data Call-In Response Forms"
                   For The Generic And Product Specific Data Call-In
INTRODUCTION
      These instructions apply to the Generic and Product Specific "Data Call-In Response
Forms" and are to be used by registrants to respond to generic and product specific Data
Call-Ins as part of EPA's Reregistration Program under the Federal Insecticide, Fungicide,
and Rodenticide Act. The type of data call-in (generic or product specific) is indicated in
item number 3 ("Date and Type of DCI") on each form. BOTH "Data Call-In Response"
forms must be completed.

      Although the form is the same for both generic and product  specific data, instructions
for completing these forms are different.  Please read these instructions carefully before
filling out the forms.

      EPA has developed these forms individually  for each registrant, and has preprinted
these forms with a number of items.  DO NOT use  these forms for any other active
ingredient.

      Items 1 through 4 have been preprinted on the form.  Items  5 through 7 must be
completed by the registrant as appropriate. Items 8 through 11 must be completed by the
registrant before submitting  a response to the Agency.

      The 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,  Mail Code 2136, U.S. Environmental Protection Agency, 401  M
St.,  S.W., Washington, D.C. 20460; and to the Office of Management and Budget,
Paperwork Reduction Project 2070-0107, Washington,  D.C. 20503.
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-In
Item 1.       ON BOTH FORMS:  This item identifies your company name, number and
             address.

Item 2.       ON BOTH FORMS:  This item identifies the case number, case name, EPA
             chemical number and chemical name.

Item 3.       ON BOTH FORMS:  This item identifies the type of Data Call-In. The date
             of issuance is date stamped.

Item 4.       ON BOTH FORMS:  This item identifies the EPA product registrations
             relevant to the data call-in. Please note that you are also responsible for
             informing the Agency of your response regarding any product that you believe
             may be covered by this Data Call-in but that is not listed by the Agency in
             Item 4. You must bring any such apparent omission to the Agency's attention
             within the period required for submission  of this response form.

Item 5.       ON BOTH FORMS:  Check this item for each product registration you wish
             to cancel voluntarily. If a registration number is listed for a product for which
             you previously requested voluntary cancellation, indicate in Item 5 the date of
             that request. Since this Data Call-In requires both generic and product specific
             data, you must complete item 5 on both Data Call-In  response forms.  You do
             not need to complete any item on the Requirements Status and Registrant's
             Response Forms.

Item 6a.      ON THE GENERIC DATA FORM: Check this Item if the Data Call-In is
             for generic data as indicated in Item 3 and you are eligible  for a Generic Data
             Exemption for the chemical listed in Item 2 and used  in the subject product.
             By electing this exemption, you agree to the terms and conditions of a Generic
             Data Exemption as explained in the Data Call-In Notice.

             If you are eligible for or claim a Generic Data Exemption,  enter the EPA
             registration Number of each registered source of that  active ingredient that you
             use in  your product.

             Typically, if you purchase an EPA-registered product from one or more other
             producers (who, with respect to the incorporated product, are in compliance
             with this and any other outstanding Data Call-In Notice), and
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-In
             incorporate that product into all your products, you may complete this item for
             all products listed on this form. If, however, you produce the active ingredient
             yourself, or use any unregistered product (regardless of the fact that some of
             your sources are registered), you may not claim a Generic Data Exemption
             and you may not select this item.

Item 6b.      ON THE GENERIC DATA FORM:  Check this  Item if the Data Call-In is
             for generic data as indicated in Item 3 and if you are agreeing to satisfy the
             generic data requirements of this Data Call-In. Attach the Requirements Status
             and Registrant's Response Form that indicates how you will satisfy those
             requirements.

             NOTE:  Item 6a and 6b are not applicable for Product Specific Data.

Item 7a.      ON THE PRODUCT SPECIFIC DATA FORM: 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."

             FOR BOTH MUP and EUP products

             You should also respond "yes" to this item (7a for MUP's and 7b for EUP's)
             if your product is identical to another product and  you qualify for a data
             exemption.   You  must provide the EPA registration numbers of your
             source(s); do 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.

             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.

             NOTE: Item 7a and 7b are not applicable  for Generic Data.
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-In
Item 8.      ON BOTH FORMS:  This certification statement must be signed by an
            authorized representative of your company and the person signing must include
            his/her title. Additional pages used in your response must be initialled and
            dated in the space provided for the certification.

Item 9.      ON BOTH FORMS:  Enter the date of signature.

Item 10.     ON BOTH FORMS:  Enter the name of the person EPA should contact with
            questions regarding your response.

Item 11.     ON BOTH FORMS:  Enter the phone number of your company contact.
Note:  You may provide additional information that does not fit on this form in a signed
      letter that accompanies your response.  For example, you may wish to report that
      your product has already been transferred to another company or that you have
      already voluntarily cancelled this product. For these cases,  please supply all relevant
      details so that EPA can ensure that its records are correct.
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DRAFT
COPY
                                                                                        Page 1 of  1
United States Environmental Protection Agency
Washington, D.C. 20460
DATA CALL-IN RESPONSE

INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested
Use additional sheet(s) if necessary
1. Comnany name and Address 2. Case # and Name
SAMPLE COMPANY 0577 Methiocarb
NO STREET ADDRESS Chemical # and Name 100501
NO CITY, XX 00000 Methiocarb
4. EPA Product
Registration
NNNNNN-NN'NNN
5. I wish to
cancel this
product regis-
tration volun-
tarily

6. Generic Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
N.A.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
N.A.
Form Approved
OMB No. 2070-0107
2070-0057
Approval Expires 03-31-96
on this form.
3. Date and Type of DCI
GENERIC
7. Product Specific Data
7a. My product is an HUP and
1 agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."

8. Certification
I certify that the statements made on this form and all attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
10. Name of Company Contact

7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."

9. Date
11.
Phone Number
                                            123

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DRAFT   COPY
Page  1 of   1
United States Environmental Protection Agency Form Approved
Washington, D. C. 20460
^ ' OMB Mo. 2070-0107
DATA CALL-IN RESPONSE 2070-0057
Approval Expires 03-31-96
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company name and Address 2. Case # and Name 3. Date and Type of DC I
SAMPLE COMPANY 0577 Methiocarb PRODUCT SPECIFIC
NO STREET ADDRESS
NO CITY, XX 00000
4. EPA Product
Registration
NNNNNN-NNNNN
5. I wish to
cancel this
product regis-
tration volun-
tarily.

6. Generic Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
N.A.

6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
N.A.
7. Product Specific Data
7a. My product is a HUP and
I agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."


7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."

8. Certification 9. Date
I certify that the statements made on this form and all attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
10. Name of Company Contact 11. Phone Number
                                        125

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Attachment 3. Generic and Product Specific Requirement
Status and Registrant's Response Forms (Form B inserts)
                   and Instructions
                          127

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                              Instructions For Completing
                                         The
                 "Requirements Status and Registrant's Response Forms"
                   For The Generic and Product Specific Data Call-In
INTRODUCTION

      These instructions apply to the Generic and Product Specific "Requirements Status
and Registrant's Response Forms" and are to be used by registrants to respond to generic and
product specific Data Call-in's as part of EPA's reregistration program under the Federal
Insecticide, Fungicide, and Rodenticide Act. The type of Data Call-In (generic or product
specific) is indicated in item number 3 ("Date and Type of DCI")  on each form. Both
"Requirements Status and Registrant's Response" forms must be completed.

      Although the form is the same for both product specific and generic data, instructions
for completing the forms differ slightly. Specifically, options for satisfying product specific
data requirements do not include (1) deletion of uses or (2) request for a low volume/minor
use waiver.  Please read these instructions carefully before filling out the forms.

      EPA has developed these forms individually for each registrant, and has preprinted
these forms to include certain information  unique to this chemical. DO NOT use these forms
for any other active ingredient.

      Items 1 through 8 have been preprinted on the form. Item 9 must be completed by
the registrant as appropriate.   Items 10 through  13 must be completed by the registrant
before submitting a response to the  Agency.

      The public reporting burden  for this collection of information  is estimated to average
30 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, Mail Code 2136, U.S. Environmental Protection Agency, 401 M
St., S.W., Washington, D.C. 20460; and  to the Office of Management and Budget,
Paperwork Reduction Project 2070-0107, Washington, D.C. 20503.
                                         129

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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-In
Item 1.      ON BOTH FORMS:  This item identifies your company name, number and
            address.

Item 2.      ON THE GENERIC DATA FORM: This item identifies the case number,
            case name, EPA chemical number and chemical name.

            ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the
            case number, case name, and the EPA Registration Number of the product for
            which the Agency is requesting product specific data.

Item 3.      ON THE GENERIC DATA FORM: This item identifies the type of Data
            Call-In. The date of issuance is date stamped.

            ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the
            type of Data Call-In.  The date of issuance is also date stamped.  Note the
            unique identifier number (ID#) assigned by the Agency. This ID number must
            be used in the transmittal document for any data submissions in response to
            this Data Call-In Notice.

Item 4.      ON BOTH FORMS:  This item identifies the guideline reference number of
            studies required. These guidelines,  in addition to the requirements specified in
            the Data Call-In 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.      ON BOTH FORMS:  This item identifies the study title associated with the
            guideline reference number and whether protocols and 1, 2, or 3-year progress
            reports are required to be submitted in connection with the study.  As noted in
            Section III of the Data Call-In Notice, 90-day progress reports are required for
            all studies.

            If an asterisk appears in Item 5, EPA has attached information relevant to this
            guideline reference number to the Requirements Status and Registrant's
            Response Form.
                                      130

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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-In

Item 6.       ON BOTH FORMS:  This item identifies the code associated with the use
             pattern of the pesticide.  In the case of efficacy data (product specific
             requirement), the required study only pertains to products which have the use
             sites and/or pests indicated.  A brief description of each code follows:

             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 crop
             J      Forestry
             K     Residential
             L     Indoor food
             M    Indoor non-food
             N     Indoor medical
             O     Indoor residential

Item 7.      ON BOTH FORMS:  This item identifies the code assigned to the substance
             that must be used for testing. A brief description of each code follows:

             EUP               End-Use Product
             MP                Manufacturing-Use Product
             MP/TGAI          Manufacturing-Use Product and Technical
                                      Grade Active Ingredient
             PAI                Pure Active Ingredient
             PAI/M             Pure Active Ingredient and Metabolites
             PAI/PAIRA         Pure Active Indredient or Pute Active
                                      Ingredient Radiolabelled
             PAIRA             Pure Active Ingredient Radiolabelled
             PAIRA/M          Pure Active Ingredient Radiolabelled
                                      and    Metabolites
             PAIRA/PM         Pure Active Ingredient Radiolabelled
                                      and Plant Metabolites
             TEP               Typical End-Use Product
             TEP	%          Typical End-Use Product, Percent
                                      Active Ingredient Specified


                                        131

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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-In
            TEP/MET          Typical End-Use Product and Metabolites
            TEP/PAI/M         Typical End-Use Product or Pure Active
        Ingredient and Metabolites
            TGAI              Technical Grade Active Ingredient
            TGAI/PAI          Technical Grade Active Ingredient or
                                     Pure Active Ingredient
            TGAI/PAIRA       Technical Grade Active Ingredient or
                                     Pure Active Ingredient
                                           Radiolabelled
            TGAI/TEP          Technical Grade Active Ingredient or
                                     Typical End-Use Product
            MET              Metabolites
            IMP               Impurities
            DEGR                   Degradates
            *                  See: guideline comment

Item 8.      This item completed by the Agency identifies the time frame allowed for
            submission of the study or protocol identified in  item 5.

            ON THE GENERIC DATA FORM:  The time frame runs from the date of
            your receipt of the Data Call-In notice.

            ON THE PRODUCT SPECIFIC DATA FORM: The due date for
            submission of product specific  studies begins from the date stamped on the
            letter transmitting the Reregistration Eligibility Decision document, and not
            from the date of receipt. However, your response to the Data Call-In itself is
            due 90 days from the date of receipt.

Item 9.      ON BOTH FORMS:  Enter the appropriate Response Code or Codes to show
            how you intend to comply with each data requirement. Brief descriptions of
            each code follow. The Data  Call-In Notice contains a fuller description of each
            of these options.

      Option 1.     ON BOTH FORMS: (Developing Data^ I will conduct a new study
                   and submit it within the time frames specified in item 8 above. 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 and that I will provide
                   the protocols and progress reports required in item 5 above.

                                       132

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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANTS RESPONSE FORMS"
Generic and Product Specific Data Call-In
      Option 2.    ON BOTH FORMS: (Agreement to Cost Share) I have entered into
                   an agreement with one or more registrants to develop data jointly. By
                   indicating that I have chosen this option, I certify that I will comply
                   with all the requirements pertaining to sharing in the cost of developing
                   data as outlined in the Data Call-in Notice.

                          However, for Product Specific Data, I understand that this
                   option is available for acute toxicity or certain efficacy data ONLY if
                   the Agency 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.

      Option 3.    ON BOTH FORMS: (Offer to Cost Share) I have made an offer to
                   enter into an agreement with one or more registrants to develop data
                   jointly. I am also submitting a completed "Certification of offer to
                   Cost Share in the Development of Data" form.  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
                   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 apply as well.

                          However, for Product Specific Data,  I understand that this
                   option is available only for acute toxicity or certain efficacy data and
                   only if the Agency indicates in an attachment to this Data Call-In
                   Notice that my product is similar enough to another product to qualify
                   for this option.

      Option 4.    ON BOTH FORMS: (Submitting Existing Data)  I will submit an
                   existing study by the specified due date that has never before been
                   submitted to EPA.  By indicating that I have chosen this option, I
                   certify that this study meets all the requirements pertaining to the
                   conditions for submittal of
                                         133

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INSTRUCTIONS FOR COMPLETING THE "REOUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-In
                   existing data outlined in the Data Call-In Notice and I have attached the
                   needed supporting information along with this response.

      Option 5.     ON BOTH FORMS:  (Upgrading a Study) I will submit by the
                   specified due date, or will cite data to upgrade a study that EPA has
                   classified as partially acceptable and potentially  upgradeable.  By
                   indicating that I have chosen this option, I certify that I have met all
                   the requirements pertaining to the conditions for submitting or citing
                   existing data to upgrade a study described in the Data Call-In Notice. I
                   am indicating on attached correspondence the Master Record
                   Identification Number (MRID) that EPA has assigned to the data that I
                   am citing as well as the MRID of the study I am attempting to upgrade.

      Option 6.     ON BOTH FORMS:  (Citing a Study) I am citing an existing study
                   that has been previously classified by EPA as acceptable, core, core
                   minimum,  or a study that has not yet been reviewed by the Agency. If
                   reviewed, I am providing the Agency's classification of the study.

                         However, for Product Specific Data,  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 the
                   Agency 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). If I cite another registrant's data, I will submit
                   a completed "Certification With Respect To Data Compensation
                   Requirements" form.

      FOR THE GENERIC DATA  FORM ONLY;  The following three options
      (Numbers 7, 8, and 9) are responses that apply only to the "Requirements Status
      and Registrant's Response Form" for generic data.
      Option 7.     (Deleting Uses)  I am attaching an application for amendment to my
                   registration deleting the uses for which the data are required.
                                        134

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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-In
      Option 8.    (Low Volume/Minor Use Waiver Request) I have read the statements
                   concerning low volume-minor use data waivers in the Data Call-In
                   Notice and I request a low-volume minor use waiver of the data
                   requirement. I am attaching a detailed justification to support this
                   waiver request including, among other things, all information required
                   to support the request. I understand that, unless modified by the
                   Agency in writing, the data requirement as stated in the Notice
                   governs.

      Option 9.    (Request for Waiver of Data) I have read the statements concerning
                   data waivers other than lowvolume minor-use data waivers in the Data
                   Call-In Notice and I request a waiver of the data requirement. I am
                   attaching a rationale explaining why I believe the data requirements do
                   not apply. I am also submitting a copy of my current labels. (You  must
                   also submit a copy of your Confidential Statement of Formula if not
                   already on file with EPA). I understand that, unless modified by the
                   Agency in writing, the data requirement as stated  in the Notice
                   governs.

      FOR PRODUCT SPECIFIC DATA;  The following option (number 7) is a
      response that applies to the "Requirements Status and Registrant's Response
      Form" for product specific data.

      Option 7.    (Waiver Request) I request a waiver for this study because it is
                   inappropriate for my product. 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"
                   form specifying 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.


                                        135

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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-In
Item 10.     ON BOTH FORMS:
Item 11.     ON BOTH FORMS:
Item 12.     ON BOTH FORMS:
Item 13.     ON BOTH FORMS:
This item must be signed by an authorized
representative of your company. The person
signing must include his/her title, and must initial
and date all other pages of this form.

Enter the date of signature.

Enter the name of the person EPA should contact
with questions regarding your response.

Enter the phone number of your company contact.
NOTE:      You may provide additional information that does not fit on this form in a
            signed letter that accompanies this your response. For example, you may wish
            to report that your product has already been transferred to another company or
            that you have already voluntarily cancelled this product. For these cases,
            please supply all relevant details so that the Agency can ensure that its records
            are correct.
                                       136

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DRAFT
COPY
Page 1 of
United States Environmental Protection Agency
Washington, D.C. 20460

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested
Use additional sheet(s) if necessary
1 . Comoanv name 'and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
it. Guideline
Requi rement
Number
72-3 (a) *
72-3 (b) *
72-3 (C) *
72-4(a) *
72-4 (b) *
72-5 *
82-5(b) *
132-1 (a) *
132-l(b) *
133-3 *
133-4 *
161-1 *
163-1 *
164-1 *
233 *
234 *
81-8-SS *

5. Study Title


Estu/mari tox. fish
Estu/marl tox. mollusk
Estu/mari tox. shrimp
Early life stage fish
Life cycle invertebrate
Life cycle fish
90-day neurotox-mammal
Foliar residue dissipation
Soil residue dissipation
Dermal passive dosimetry expo
Inhal. passive dosimetry expo
Hydrolysis
Leach/adsorp/desorpt i on
Terrestrial field dissipation
Estimation of Dermal Exposure at Indo
Estimation of Inhalation Exposure at
Acute Neurotoxicity - Rat

6
I
f

















/
2. Case # and Name
0577 Methiocarb
Chemical # and Name 100501
Methiocarb
Progress
Reports

1





Y
Y
Y
Y
Y
Y


Y




2


















3


















6. Use
Pattern

CK
CK
CK
CK
CK
CK
CIK
K
CIK
CIK
I
CK
CK
CK


CIK

7. Test
Substance

TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TEP
TEP
TEP
TEP
TGAI/PAIRA
TGAI
TEP
TEP
TEP
TGAI

10. Certification
I certify that the statements made on this form and all attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
12. Name of Company Contact
8.




Form Approved
OMB No. 2070-0107
2070-0057
Approval Expires 03-31-96
on this form.

3. Date and Type of DCI
GENERIC


Time
Frame

12
12
12
12
12
24
24
24
24
24
24
12
12
24
12
12
12
3
11.




13.

mos.
mos.
mos.
mos.
mos.
mos.
mos.
mos.
mos.
mos.
mos.
mos.
mos.
mos.
mos.
mos.
mos.
fflos —
9. Registrant
Response















'


:
Date




Phone Number
                                       137

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DRAFT
COPY
                                                                             Page 2 of 2
United States Environmental Protection Agency
Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested
Use additional sheet(s) if necessary
1. Company name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requi rement
Number
90-1-SS *
5. Study Title
Usage Data
I

2. Case n and Name
0577 Methiocarb
Chemical # and Name 100501
Methiocarb
Progress
Reports
1

2

3

6. Use
Pattern
CK
Initial to indicate certification as to information on this page
(full text of certification is on page one).
7. Test
Substance
TGAI
Form Approved
OMB No. 2070-0107
2070-0057
Approval Expires 03-31-96
on this form.
3. Date and Type of DCI
GENERIC
8. Time
Frame
3
mos.
9. Registrant
Response

Date
                                           138

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                                                                                        Page 1 of 4
                           United States Environmental Protection Agency
                                       Washington,  D.C.  20460

                              * COMMENTS FOR GUIDELINE REQUIREMENTS
Case it and Name
0577  Methiocarb
Chemical # and Name
100501  Methiocarb
GUIDELINE
COMMENT
72-3(a)The Agency  reviewed  the  estuarine/marine organisms data (MRIDs 155937,  155970)  submitted
         by the  registrant  in response  to  the Registration Standard for methiocarb.  These data
         contained summary  information  only  and therefore are classified as unacceptable for use
         in the  ecological  risk assessment for methiocarb. Testing of technical  methiocarb on
         estuarine/marine species is  required since methiocarb is registered for use on lawns and
         turf  in coastal counties.  The 96-hour LC50 study on an estuarine/marine species of fish
         should  be performed  using technical methiocarb.   These data are considered confirmatory
         for supporting the lawns and turf uses of methiocarb.

72-3(b)  The 48-hour EC50 study with  oyster  embryolarvae  or a 96-hour EC50 oyster shell
         disposition study  should be  performed using technical methiocarb.  See  comment for
         guideline for  72-3(a).

72-3(c)  The 96-hour LC50 study on an estuarine/marine species of shrimp should  be performed
         using technical methiocarb.  See  comment for guideline 72-3(a).

72-4(a)  The submitted  data (MRID 00155967)  partially satisfies this guideline requirement
         because of  a technical problem in the control tank had occurred.  The Agency is
         requiring data which describes the  water temperature in each tank to ensure that no
         significant variance of  temperature occurred in  any of the tanks.  If these data are
         submitted,  the study (MRID 00155967)  may be upgraded to fulfill this guideline
         requirement. These data  are  considered confirmatory to support the reregistration of
         methiocarb  for lawn  and  turf uses.

72-4(b)  The submitted  data (MRID 40628001)  was deemed supplemental because raw data was not
         available.   The Agency is requiring this study to support the reregistration of
         methiocarb  on  lawns  and  turf.   These data are considered confirmatory.
                                             139

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                                                                                         Page  2  of  4
                            United  States Environmental Protection Agency
                                       Washington, D.C.  20460

                              * COMMENTS FOR GUIDELINE REQUIREMENTS
Case # and Name
0577  Methiocarb
Chemical # and Name
100501  Methiocarb
GUIDELINE
          COMMENT
72-5      Data from fish life cycle tests are required to support the reregistration of an end-use
          product that is expected to be transported to water from the intended use site when any
          of the following conditions apply:

          *    If the estimated EEC is > 1/10 of the no effect level in the fish early life stage
          or invertebrate life cycle test.

          *    If studies of other organisms indicate that the reproductive physiology of the fish
          may be affected.

          The Agency is requiring this study based on the fish early life stage study results.
          These data are considered confirmatory for supporting the lawns and turf uses of
          methiocarb.

82-5(b)   The acute and neurotoxicity studies are now required for all carbamate pesticides.
          These studies are not part of the target data set for this reregistration review;
          however,  the Agency is requiring these studies because methiocarb is a carbamate.  These
          studies must be performed with the methiocarb technical in order to support the
          continued registration of methiocarb.

132-1(a)  The Agency is requiring postapplication/reentry data on foliar residue dissipation to
          support the  homeowner use of methiocarb on lawns and turf.   This study must be conducted
          concurrently with the dermal passive dosimetry study (GL 133-3).

132-1(b)  The Agency is requiring the soil residue dissipation study to support the granular
          formulation  use of methiocarb on ornamentals.  This study is required to assess the
          exposure  to  persons entering treated ornamental planting areas.   This study is
          considered confirmatory.
                                               140

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                                                                                        Page 3 of 4
                           United States Environmental Protection Agency
                                       Washington,  D.C. 20460

                              * COMMENTS FOR GUIDELINE REQUIREMENTS
Case # and Name
0577  Methiocarb
Chemical # and Name
100501  Methiocarb
GUIDELINE
         COMMENT
133-3
133-4
The Agency is requiring postapplication/reentry data on dermal passive dosimetry
exposure to support the homeowner use of methiocarb on lawns and turf.  This study must
be conducted concurrently with the foliar dislodgeable residue dissipation study  (GL
132-la).  The dermal passive dosimetry study is also required to support the granular
formulation use of methiocarb on ornamentals.  This study is considered confirmatory for
the granular formulation use on ornamentals.

There is a potential for inhalation exposure following the application of the
pressurized liquid formulation of methiocarb.  The Agency is retaining the 24-hour
reentry interval and ventilation requirements for entering greenhouses following  an
application using the pressurized liquid formulation. The Agency is also requiring
postapplication inhalation monitoring data in order to support the reregistration of the
pressurized liquid formulation of methiocarb.  These data are considered confirmatory.
161-1    The Agency is requiring this study because it is the baseline used to assess abiotic
         degradation of methiocarb in soil and aquatic environments.  This study is required for
         all outdoor uses and it will be considered confirmatory data.

163-1    The unaged portion of this study was previously satisfied using a single loam textured
         soil.   The Agency believes that additional batch equilibrium are necessary on 3 soils
         with different textures to assess more completely the mobility of methiocarb.  As per
         Subdivision N guidelines,  one of the test soils should have a sand or loamy sand texture
         with a low organic matter coontent (<1% OM).   Also, the batch equilibrium data on any
         single soil (e.g.,  loam)  may not adequately represent pesticide partitioning in other-
         soils  (e.g.,  sand and loamy sand).  This study is required for all outdoor uses and it
         will be considered confirmatory data.
                                              141

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                                                                                        Page 4 of  4
                            United  States  Environmental Protection Agency
                                       Washington, D.C. 20460

                              * COMMENTS FOR GUIDELINE REQUIREMENTS
Case # and Name
0577  Methiocarb
Chemical # and Name
100501  Methiocarb
GUIDELINE     COMMENT
164-1     The  submitted data (MRIDs 00155781,  00155782, and 40994801) were found unacceptable
          because sampling depth increments were too broad (or wide) across soil depth; broad
          sampling increments may dilute soil  pesticide concentrations and hence mask possible
          detection of pesticide movement.   At this time the field dissipation data cannot be used
          to assess leaching at soil depths greater than 30 cm.  The Agency is requiring
          additional field studies with greater sampling depths and appropriate soil sampling
          increments to assess leaching of  methiocarb below 30 cm.  This study is required on a
          confirmatory basis to support the lawns and turf uses.

233       The  Agency is requiring this study to support the reregistration of methiocarb for
          commercial application of the wettable powder formulation to greenhouse/nursery grown
          ornamentals.

234       See  comment for guideline 233.

81-8-SS   See  comment for guideline 82-5(b).

90-1-SS   The  Agency has determined that the outdoor uses of methiocarb is likely to have adverse
          effects on aquatic and terrestrial species.  The Agency is requiring usage data to
          estimate how much of methiocarb's use is outdoors and the geographical areas of the
          outdoor uses.
                                               142

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DRAFT COPY
Page 1 of 2
United States Environmental Protection Agency
Washington, D. C. 20460


REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

INSTRUCTIONS: Please type or print in ink. Please read carefully
Use additional sheet(s) if necessary.
1 . Company name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requi rement
Number


61-1
61-2 (a)


61-2 (b)

62-1
62-2
62-3
63-3
63-7
63-12
63-13
63-14
63-15
5. Study Title



Prod Gum - Regular Chemcal
Product identity & composition (1)
Desert ptn starting materials, (1,2)
productn & formulatn
process
Discussion of formation of (1,3)
impurities
Preliminary analysis (1,4)
Certification of limits (1,5)
Analytical method (1)
Physical state :
Density
pH (9)
Stability
Oxidiiinfl or reducing action (10)
Flammability (11)
10. Certification

Form Approved

OMB No. 2070-0107
2070-0057
Approval Expires 03-31-96
the attached instructions and supply the information requested on this form.

2. Case # and Name 3. Date and Type of DC I
0577 Methiocarb PRODUCT SPECIFIC
ID# NNNNNN-RD-NNNN
EPA Reg. NO. NNNNNN-NNNNN




















|
5
Q
n
















Progress
Reports

1

















2

















3
















6. Use
Pattern



ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO


ABCDEFGHIJKLMNO

ABCDEFGHIJKLMNO
ABCDEffGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
7. Test
Substance



MP/EP
MP/EP and TGAI


MP/EP and TGAI

TGAI
MP/EP
TGAI
MP/EP and TGAI
MP/EP and TGAI
MP/EP and TGAI
MP/EP
MP/EP
MP/EP
8. Time
Frame



8 mos.
8 mos.


8 mos.

8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
9. Registrant
Response


















11. Date
I certify that the statements made on this form and all attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may
or both under applicable law.
Signature and Title of Company's Authorized Representative
12. Name of Company Contact
be punishable by fine, imprisonment


13. Phone Number
144

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DRAFT COPY


Page 2 of 2
United States Environmental Protection Agency
Washington, D. C. 20460




REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

INSTRUCTIONS: Please type or print in ink. Please read carefully
Use additional sheet(s) if necessary.
1 . Company name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number

63-16
63-17
63-18
63-19
63-20
63-21

81-1
81-2

81-3
81-4
81-5
81-6


the attached instructions and supply the information requested

2. Case # and Name
0577 Methiocarb





EPA Reg. No. NNNNNN-NNNNN
5. Study Title
ExplodabHity (12)
Storage stability (50)
Viscosity (15)
Miscibility (14)
Corrosion characteristics
Dielectric breakdown voltage (15)
Acute Toxic - Regular Chemical
Acute oral toxi city- rat (1,37)
Acute dermal (1,2,3?)
toxicity-rabbit/rat
Acute inhalation toxi city- rat (3)
Primary eye irri tat ion- rabbit (2)
Primary dermal irritation (1,2)
Dermal sensitization (4)














k
I
C
?














Progress
Reports

1















2















3














6. Use
Pattern



ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO


ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO


ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
Initial to indicate certification as to information on this page
(full text of certification is on page one).
7. Test

Form Approved

OMB No. 2070-0107
2070-0057
Approval Expires 03-31-96
on this form.

3. Date and Type of DCI
PRODUCT SPECIFIC
ID# NNNNNN-RD-NNNN


Substance


MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP

MP/EP
MP/EP

MP/EP
MP/EP
MP/EP
MP/EP









and TGAI
and TGAI

and TGAI

V

8. Time
Frame


8 mos*
8 mos.
8 inos.
8 mos.
8 mos.
8 mos.

8 mos.
8 mos.

8 mos*
8 mos.
8 raos.
8 mos.
9. Registrant
Response
















Date
145

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           DRAFT    COPY	Page   1 of    2
                                           United  States  Environmental  Protection Agency
                                                            Washington,  D.  C.   20460
                                  FOOTNOTES  AND KEY  DEFINATIONS  FOR  GUIDELINE  REQUIREMENTS
                                                    Case t and  Name:  0577    Methiocarb
Key: MP - manufacturing-use product; EP « end-use product; provided formulators purchase their active ingredient(s) from a registered source, they need not submit or  cite
data pertaining to the purchased product.[NOTE:  If a product is a 100 percent repackage of  another registered product that is purchased, and any use for the product does
not differ from those of the purchased and registered source, users are not subject to any  data requirements identified in the tables.]; TEP = typical end-use product;
TGAI = technical grade of the active ingredient;  PAI = "pure" active ingredient; PAIRA = "pure" active ingredient, radiolabeled.
Use Categories Key:
  A - Terrestrial food crop       B - Terrestrial food feed crop     C - Terrestrial nonfood crop     D - Aquatic food crop           E - Aquatic nonfood outdoor
  F - Aquatic nonfood Industrial  G - Aquatic nonfood residential    H - Greenhouse food crop         I - Greenhouse nonfood crop     J - Forestry
  K - Residential outdoor         L - Indoor food                   M - Indoor nonfood              N - Indoor Medical              0 - Indoor residential

Footnotes:  [The following notes are referenced in column two (5. Study Title) of the REQUIREMENTS STATUS AND REGISTRANT'S  RESPONSE form.]


Prod Qum - Regular Cheaical

 1  Requirements pertaining to product identity,  composition, analysis, and certification of ingredients are detailed further in  the following sections:  *158.155 for
    product identity and composition (61-1);  *158.160, 158.162, and 158.165 for description of starting materials and manufacturing process (61-2); "158.167 for
    discussion of formation of impurities (61-3); *158.170 for preliminary analysis (62-1); *158.175 for certification of limits (62-2); and  *158.180 for enforcement
    analytical methods (62-3).
 2  A schematic diagram and/or brief description of the production process will suffice if  the pesticide is not already under full scale production and an experimental
    use permit is being sought.
 3  If the pesticide is not already under full scale production and an experimental use permit is sought, a discussion of unintentional ingredients shall be submitted to
    the extent this information is available.
 4  To support registration of an MP or EP, whether produced by an integrated system or not, the technical grade of Active Ingredient must be analyzed.  If the technical
    grade of Active Ingredient cannot be isolated, a statement of composition of the practical equivalent of the technical grade  of Active Ingredient must be submitted.
    Data on EPs or MPs will be required on a case-by-case basis.
 5  Certified  limits are not required for inert ingredients in products proposed for experimental use.
 9  Required if test substances are dispersible with water.
10  Required if product contains an oxidizing or reducing agent.
11  Required if product contains combustible liquids.
12  Required if product is potentially explosive.
13  Required if product is a liquid.
H  Required if product is an emulsifiable liquid and is to be diluted with petroleum solvents.
15  Required if end-use product is liquid and is to be used around electrical equipment.
50  Required but need not be submitted unless requested.


Acute Toxic - Regular CheMical

 1  Not required if test material is a gas or highly volatile.
 2  Not required if test material is corrosive to skin or has pH  less than 2 or greater than 11.5; such a product will be classified as Toxicity Category I on the basis
    of potential eye and dermal irritation effects.
 3  Required if the product consists of, or under conditions of use will  result in, an inhalable material (e. g., gas, volatile substances, or aerosol/particulate).
 4  Required unless repeated dermal exposure does not occur under conditions of use.



                                                                            Ufi

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	DRAFT   COPY	Page  2  of   2

                                  United  States Environmental Protection  Agency
                                               Washington,  D.  C.  20460

                           FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS

                                         Case # and  Name:  0577   Nethiocarb


 Footnotes (cont.):


 37  Testing of the EP dilution is required if it can be reasonably anticipated that the results of such testing may meet the criteria for restriction to use by certified
    applicators specified in 40 CFR 152.170(b) or the criteria for initiation of special review specified in 40 CFR 154.7 (a)(1).
                                                          147

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Attachment 4. EPA Grouping of End-Use Products for
    Meeting Data Requirements for Reregistration
                        149

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    EPA'S DECISION ON BATCHING PRODUCTS CONTAINING METHIOCARB FOR
       PURPOSES OF MEETING ACUTE TOXICITY DATA REQUIREMENTS FOR
                                   REREGISTRATION

       In an effort to reduce the time, resources and number of animals needed to fulfill the
acute toxicity data requirements for reregistration of products containing the active ingredient
Methiocarb, the Agency considered batching products. This process involves grouping similar
products 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.

       Batching has been accomplished using the information described above as available.
Acute toxicity data on individual products has been found to be incomplete. Notwithstanding
the batching process, the Agency reserves the right to require, at any time, acute toxicity data
for an  individual product should the need arise.

       Registrants of products within a batch may choose to cooperatively generate, submit or
cite a single battery of six acute toxicological studies to represent all the products within that
batch.   It is the registrants' option to participate in the process with all other registrants, only
some of the other registrants, or only their own products within a batch, or to generate all the
required acute toxicological studies for each of their own products.  If a registrant chooses to
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 cited, the registrant must clearly identify the
material tested by its EPA registration number.

       In deciding how to meet the product specific data requirements, registrants must follow
the directions given in the Data Call-In Notice and its attachments appended to the RED.  The
DCI Notice contains two response forms which are to be completed and submitted to the
Agency within 90 days of receipt. The first form, "Data Call-In Response", asks whether the
registrant will meet the data requirements  for each product.  The second form, "Requirements
Status and Registrant's Response", lists the product specific data required for each product,
including the standard  six acute toxicity tests.  A registrant who wishes to  participate in a batch
 must decide whether he/she will provide the data or depend on someone else to do  so. If a
 registrant supplies the  data to support a batch of products, he/she must select one of the
 following options:  Developing Data (Option 1), Submitting an Existing Study (Option 4),
 Upgrading an Existing Study (Option 5), or Citing an Existing Study (Option 6). If a registrant
 depends on another's data, he/she must choose among:  Cost  Sharing (Option 2), Offers to
 Cost Share (Option 3)  or  Citing an  Existing Study (Option 6). If a registrant does  not want to
 participate in  a batch,  the choices are Options 1, 4, 5 or 6.  However, a registrant  should know
 that choosing not to participate in a batch does not preclude other registrants in the batch from
 citing  his/her studies and  offering to cost share (Option  3) those studies.
                                            151

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       Table I lists 5 batches containing a total of 14 products.
Table I.
Batch No.
1



2



3

4

5

EPA Reg. No.
70-247
2393-241
NC86000300
WI92000400
3125-234
3125-387
7401-342
56644-20
5481-189
5481-333
5481-195
5481-332
802-500
802-566
% of Methiocarb
& other Active ingredients
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
1.0
2.0 Meta Metaldehyde
1.0
2.0 Meta Metaldehyde
2.0
2.0
Formulation
Type
granular
pellet
pellet
pellet
granular
pellet
granular
pellet
granular
granular
granular
granular
pellet
granular
       Table II lists the products which could not be batched.  These products were not
considered similar for purposes of acute toxicity. The registrants of these products are
responsible for meeting the acute toxicity data requirements specified in the data matrix for end-
use products.

Table II
EPA Reg. No.
239-2416
499-276
3125-258
7001-283
769-706
769-707
3125-288
3125-257
WI92000300
% of Methiocarb
2.0
1.0
95.0
2.0
2.0
2.0
75.0
75.0
2.0
Formulation Type |
granular
liquid !
technical
granular
pellet
granular
wetable powder
powder
pellet
                                             152

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Attachment 5. EPA Acceptance Criteria
                 153

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                                  SUBDIVISION D
Guideline           Study Title

Series 61           Product Identity and Composition
Series 62           Analysis and Certification of Product Ingredients
Series 63           Physical and Chemical Characteristics
                                         155

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                                 61 Product Identity and Composition


                                      ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

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

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

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


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

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

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

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

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

 9.	    Discussion of formation of impurities based on established chemical theory addressing (1) each impurity
          which may be present at  .>. 0.1 %  or was  found  at  J>.  0.1 %  by  product analyses and  (2) certain
          lexicologically significant impurities (see #3).
                                                  156

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                           62 Analysis and Certification of Product Ingredients


                                       ACCEPTANCE CRITERIA

The following criteria apply to the technical grade of the active ingredient bebg reregistered. Use a table to present
the information in items 6, 7,  and 8.
Does your study meet the following acceptance criteria?
 1.	  Five or more representative samples (batches in case of batch process) analyzed for each active ingredient
         and all  impurities present at > 0.1%.
 2.	  Degree of accountability or closure >_ ca 98 %.
 3.	  Analyses conducted for certain trace toxic impurities at lower than 0.1% (examples, nitrosamines in the
         case of products containing dinitroanilines or containing secondary or tertiary arnines/alkanolamines plus
         nitrites; polyhalogenated dibenzodioxins and dibenzofurans). [Note that in the case of nitrosamines both
         fresh and  stored samples must be analyzed.].
 4.	  Complete and detailed description of each step in analytical method used to analyze above samples.
 5.	  Statement of precision and accuracy of analytical method used to analyze above samples.
 6.	  Identities  and quantities (including mean and standard deviation) provided for each analyzed ingredient.
 7.	  Upper and lower certified limits proposed for each active ingredient and intentionally added inert along
         with explanation of how the limits were determined.
 8.	  Upper  certified limit proposed for each impurity  present at J>. 0.1% and for certain lexicologically
         significant impurities at <0.1% along with explanation of how limit determined.
 9.	  Analytical methods to verify certified limits of each active ingredient and impurities (latter not required
         if exempt from requirement of tolerance or if generally recognized as safe by FDA) are fully described.
 10.	 Analytical methods  (as discussed in #9) to verify certified limits validated  as to their precision and
         accuracy.
                                                   157

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                                63 Physical and Chemical Characteristics

                                       ACCEPTANCE CRITERIA


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

Does your study meet the following acceptance criteria?

63-2 Color
   	  Verbal description of coloration (or lack of it)
   	  Any intentional coloration also reported in terms of Munsell color system
63-3 Physical State
   	  Verbal description of physical state provided using terms such as "solid, granular, volatile liquid"
   	  Based on visual inspection at about 20-25° C

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

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

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

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

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

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

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

                                                  158

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

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

63-13 Stability
   	  Sensitivity to metal ions and metal determined
   	  Stability at normal and elevated temperatures
   	  Sensitivity to sunlight determined
                                                   159

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                                          SUBDIVISION F
Guideline           Study Title

 81-1          Acute Oral Toxicity in the Rat
 81-2          Acute Dennal Toxicity in the Rat, Rabbit or Guinea Pig
 81-3          Acute Inhalation Toxicity in the Rat
 81-4          Primary Eye Irritation in the Rabbit
 81-5          Primary Dermal Irritation Study
 81-6          Dermal Sensitization in the Guinea Pig
                                                 160

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                                   81-1  Acute Oral Toxicity in the Rat
                                        ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?

 1.	Identify material tested (technical, end-use product, etc).
 2.	At least 5 young adult rats/sex/group.
 3.	Dosing, single oral may be administered over 24 hrs.
 4."	Vehicle control if other than water.
 5.	Doses tested, sufficient to determine a toxicity category or a limit dose (5000 mg/kg).
 6.	Individual observations at least once a day.
 7.	Observation period to last at least 14 days, or until all test animals appear normal whichever is longer.
 8.	Individual daily observations.
 9.	Individual body weights.
10.	Gross necropsy on all animals.
                      Criteria marked with an * are supplemental and may not be required for every study.
                                                    161

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                      81-2  Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig
                                       ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?

 1.	Identify material tested (technical, end-use product, etc).
 2.	At least 5 animals/sex/group.
 3.*	Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-450 gm.
 4.	Dosing, single dermal.
 5.	Dosing duration at least 24 hours.
 6.*	Vehicle control, only if toxicity of vehicle is unknown.
 7.	Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg).
 8.	Application site clipped or shaved at least 24 hours before dosing.
 9.	Application site at least 10% of body surface area.
10.	Application site covered with a porous nonirritating cover to retain test material and to prevent
ingestion.
11.	Individual observations at least once a day.
12.	Observation period to last at least 14 days.
13.	Individual body weights.
14.	Gross necropsy on all animals.
                     Criteria marked with an * are supplemental and may not be required for every study.
                                                   162

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                                81-3 Acute Inhalation Toxicity in the Rat


                                       ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
 1.	Identify material tested (technical, end-use product, etc).
 2.	Product is a gas, a solid which may produce a significant vapor hazard based on toxicity and expected use
        or contains particles of inhalable size for man (aerodynamic diameter 15 jam or less).
 3.	At least 5 young adult rats/sex/group.
 4.	Dosing, at least 4 hours by inhalation.
 5.	Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content.
 6.	Chamber temperature, 22° C (±2°), relative humidity 40-60%.
 7.	Monitor rate of air flow.
 8.	Monitor actual concentrations of test material in breathing zone.
 9.	Monitor aerodynamic particle size for aerosols.
 10.	  Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration of
        respirable substance).
 11.	  Individual observations at least once a day.
 12.	  Observation period to last at least 14 days.
 13.	  Individual body weights.
 14.	  Gross necropsy on all animals.
                                                   163

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                                81-4 Primary Eye Irritation in the Rabbit
                                        ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?

 1.	Identify material tested (technical, end-use product, etc).
 2.	 Study not required if material is corrosive,  causes severe
        dermal irritation or has a pH of <2 or ^.11.5.
 3.	6 adult rabbits.
 4.	 Dosing, instillation into the conjunctival sac of one eye
        per animal.
 5.	 Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if a solid, paste or paniculate substance.
 6.	Solid or granular test material ground to a fine dust.
 7.	Eyes not washed for at least 24 hours.
 8.	Eyes examined and graded for irritation before dosing and
        at 1, 24, 48 and 72 hr, then daily until eyes are normal
        or 21 days (whichever is shorter).
 9.*	Individual daily observations.
                     Criteria marked with an * are supplemental and may not be required for every study.
                                                   164

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                                 81-5  Primary Dermal Irritation Study

                                       ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?

 1.	 Identify material tested (technical, end-use product, etc).
 2.	 Study not required if material is corrosive or has a pH of <2 or >11.S.
 3.	6 adult animals.
 4.	Dosing, single dermal.
 5.	Dosing duration 4 hours.
 6.	Application site shaved or clipped at least 24 hours prior to dosing.
 7.	Application site approximately 6 cm2.
 8.	Application site covered with a gauze patch held in place with noninitating tape.
 9.	Material removed, washed with water, without trauma to application site.
 10.	  Application site examined and graded for irritation at 1, 24, 48 and 72 hr, then daily until normal or 14
        days (whichever is shorter).
 11 .*	  Individual daily observations.
                      Criteria marked with an * are supplemental and may not be required for every study.
                                                   165

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                              81-6 Dermal Sensitization in the Guinea Pig

                                       ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?

1.	 Identify material tested (technical, end-use product, etc).
2.	 Study not required if material is corrosive or has a
      pHof <2or >.11.5.
3.	 One of the following methods is utilized:
      	Freund's complete adjuvant test
      	Guinea pig maximization test
      	Split adjuvant technique
      	Buehler test
      	Open epicutaneous test
      	Mauer optimization test
      	Footpad technique in guinea pig.
4.	 Complete description of test.
5.*	Reference for test.
6.	Test followed essentially as described in reference document.
7.	Positive control included (may provide historical data conducted within the last 6 months).
                     Criteria marked with an * are supplemental and may not be required for every study.
                                                  166

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Attachment 6. List of All Registrants Sent This Data Call-In (insert) Notice
                                   167

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                              List  of  All Registrants  Sent This  Data  Call-in  Notice
Case # and Name
0577    Methiocarb
Chemical # and Name
100501   Methylthio)-3,5-xylyl  methylcarbamate
Company Number   Company Name
                                               Additional Name
                                                                               Address
                                                                                                City & State
                                                                                             Zip
000070
000239
000499
000769
000802
002393
003125
005481
007001
007401
WILBUR-ELLIS COMPANY
SOLARIS GROUP. THE
WHITNIRE RESEARCH LABORATORIES, IN
H.R. MCLANE, INC.
CHAS H. LILLY CO.
HACO, INC
MILES INC
AMVAC CHEMICAL CORP
J.R. SIMPLOT CO.
VOLUNTARY PURCHASING  GROUP,  INC.
A D1V OF THE AGRICULTURAL GROUP OF
AGENT FOR: SURECO,  INC.
AGRICULTURE DIVISION
BOX 16458
BOX 5006
3568 TREE CT  INDUSTRIAL BLVD
7210 RED ROAD, SUITE  206
7737 N.E. KILLINGSWORTH
BOX 7190
8400 HAUTHORN RD BOX  4913
4100 EAST WASHINGTON  BLVD
BOX 198
P. 0. BOX 460
FRESNO CA
SAN RAMON CA
ST LOUIS MO
MIAMI FL
PORTLAND OR
MADISON WI
KANSAS CITY MO
LOS ANGELES CA
LATHROPE CA
BONHAM TX
93755
94583
63122
33143
97218
53707
64120
90023
95330
75418
                                                                   169

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Attachment 7. Confidential Statement of Formula, Cost Share and
                 Data Compensation Forms
                            171

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Confidential Business In formation: Does Not Contain National Security Information (E.O. 12065)
United Stele* Environmental Protection Agency A. __.
Office of Pesticide Programs (TS-767) LJ Basic Formulation
f\ e~ pj yy Washmgttn, DC 20460 r— ,
*& El IT f\ Confidential Statement of Formula L-l Alternate Formulation
i . Name and Address of Applicam/Reflistrant (Include ZIP Code) 2. Nama and Address of Producer
3. Product Mams
EPA USE ONLY








10. Components in Formulation ILut u actutlly introduced
into r/M formulation. Gift commonlf tcctpttd ctttmictt
ritmt. trtatnamt. indCAS numbtt.)








4. Registration No./File Symbol
7. Pounds/Gal or Bulk Density
1 1 . Supplier Name & Address



-




Form Approved OMB No 2070-0060. Approval Expires 2/28/941
Page
ol
See nfitruciions on Back

5 EPA Product Mgr/Team No
8.pH
12. EPA Reg No.








16. Typed Name of Approving Official
18. Signature of Approving Official
in Formulation
S. Amount <>.%hrWiitii








1 7. Total
19. Title
EPA Form 8670-4 (Rev. 12-90) Previous editions are obsolete. If you can photocopy this, please submit an additional copy. White • EPA
Weight








100%

9. Flash Point/flame Extension
%br Weight
UM*r Li"M b Icwtr Imit
















formulation









i 20. Phone No. jlnclude Area Cede)
21- Date


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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.

                                          175

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

OMB No.  2070-0106
         2070-0057

Approve! Expires 3-31-96
Public reporting burden for this coflection 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 bunlen estimate or any other
aspect of this collection of Information, Including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223. U.S. Environmental Protection Agency, 401 M St., S.W.. Washington, DC 20460; and to the Office
of Management and Budget. Paperwork Reduction Project (2070-0106). Washington, DC 20503.

Please fill In blanks below.
Company Name
Product >«nc
Company Number
KPA Kff. No.
!  Certify that:

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

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

I certify that 1 am duly authorized to represent the company named above, and that the statements that I have made on
this form and afl 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
Mama and
of Company's Authorized Reprwentiflve
D»le
TUI« (Please Type or Print)
 EPA Form 8570-32 (5/91)   Replaces EPA Form 8580. which is ubuilctc
                                               177

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United State* Environmental Protection Agency FW» tmnvu
^\ P^nji Washington, DC 20480
^VHK/A CERTIFICATION WITH RESPECT TO "" "* SSSffi
^^ •"> * » DATA COMPENSATION REQUIREMENTS AW**** am*. "«•*
Public reporting burden for this colection 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 reflection of information. Send comments regarding the burden estimate or any other
aspect of this coilection of information, inducing suggestions for reducing this burden, to Chid. Information Policy
Branch. PM-223, U.S. Environmental Protection Agency. 401 M St., S.W., Washington, DC 20460: and to the Office
of Management and Budget, Papeiworic Reduction Project (2070-0106), Washington. DC 20503.
Please fill In blanks below.
Company Name
Product M«M
1 Certify that:
1. For each study cited in support of registration or registration under the Federal In
Rodentfcjde Aa (FIFRA) that is an exclusive use study, 1 am the original data submit
written permission of the original data submitter to cite that study.
2. That for each study died in support of registration or reregistration under FIFRA tha
study. 1 am the original data submitter, or I have obtained the wrtten permission el tt
have notified in writing the companyfies} that submtted data 1 have died and have c
compensation for those data In accordance with sections 3(c)(l)(D] and 3(c){2)(D) o
negotiation w oewrnvne wncn ana ere subject to tne compensation recjwremeni c
compensation due, I any. The companies 1 have notified are: (check one)
ine companies wno nave submitted tne stuoes listed on the back of tras term
sheets, or irxficaied on the attached "Requirements Status and Registrants' F
3. That i nave prevwusJyconplitdwttwctJon3(cHlXD) of FIFRA for the studies I ha
registration or wtgtttrnon unotf r IFRA.
Signature
Nam w* Tin* (PIMM Tree «r Print)
GENERAL OFFER TO PAY: 1 hereby offer and agree to pay compensation to other pi
registration or reregistration of my products, to the extent required by RFRA sections i
Signature
HUM and TUto (PtMM TyM «r Prinl)
Coffipuny Number
KPA X*g. MO.
sedicide, Fungicide and
ner. or I have obtained the
t is NOT an exclusive use
» original data submitter, or 1
iHeredio: (a) Pay
1 F1FRA; and (b) Commence
rf FIFRA and the amount of
or attached
Response Form,"
ve cited in support of
l>a»

irsons. wRh regard o the
KcKi)(D)and3(0(2)(0).
Datr

EPA Form U70>n
                                               179

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APPENDIX G.  RED Fact Sheet
            181

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                 United States              Prevention. Pesticides        EPA-738-F-94-002
                 Environmental Protection      And Toxic Substances        February 1994
                 Agency	(7508W)	

                 R.E.D.    FACTS
                 Methiocarb
     Pesticide       AU pesticides sold or distributed in the United States must be
Reregistration  registered by EPA, based on scientific studies showing that they can be
                 used without posing unreasonable risks to people or the environment.
                 Because of advances in scientific knowledge, the law requires that
                 pesticides which were first registered years ago be reregistered to ensure
                 that they meet today's more stringent standards.
                      In evaluating pesticides for reregistration, EPA obtains and reviews a
                 complete set of studies from pesticide producers, describing the human
                 health and environmental effects of each pesticide.  The Agency  imposes
                 any regulatory controls that are needed to effectively manage each
                 pesticide's risks.  EPA then reregisters pesticides that can be used without
                 posing unreasonable risks to human health or the environment.
                      When a pesticide is eligible for reregistration, EPA announces this
                 and explains why in a Reregistration Eligibility Decision (RED)  document.
                 This fact sheet summarizes the information in the RED for methiocarb.

   Use Profile       Methiocarb is an insecticide, acaricide and molluscicide. It is used to
                 control snails, slugs,  spider mites and insects  on lawns, turf and
                 ornamentals, around building foundations, and in ginseng gardens.
                 Methiocarb has no remaining food uses;  the use on ginseng has  a 12-month
                 preharvest interval and therefore is not considered a food use.
                      Methiocarb end-use products formulated as granulars and
                 pellets/tablets are used on residential and commercially grown lawns,
                 turfgrass and ornamentals, in commercial greenhouses and nurseries,
                 around building foundations, and in ginseng gardens. A wettable powder
                 formulation is used as a foliar spray for nursery and greenhouse
                 ornamentals.  A pressurized liquid is applied as a total release aerosol
                 spray in commercial greenhouses.
                      Although the total volume of use is relatively low, methiocarb is
                 considered an important tool for controlling slugs and snails in nurseries
                 and greenhouses.
                                      183

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     Regulatory         Methiocarb was first registered as a pesticide in the U.S. in 1972.
         History   EPA issued a Registration Standard for methiocarb in March 1987 (NTIS
                    #PB87-190898), requiring additional product chemistry, residue chemistry,
                    ecological effects, environmental fete, toxicology, and occupational and
                    residential exposure data.  The methiocarb producers deleted all food uses
                    from  their product labels between  1989-92, so residue chemistry studies
                    are no longer required.  The technical producer is no longer supporting the
                    commercial turf use of methiocarb. If end-use registrants do not support
                    this use,  it will have to be removed from product labels.
                          Currently, 22 pesticide products are registered which contain the
                    active ingredient methiocarb.   All methiocarb products for outdoor use
                    except products with homeowner uses are classified as Restricted Use
                    Pesticides,  and may be applied only by or under the  direct supervision  of
                    certified  applicators.

Human Health   Toxicity
   Assessment         Methiocarb is among the carbamate family of chemicals;  that is,  it
                    has the ability to inhibit the body's production of cholinesterase, an enzyme
                    necessary for accurate transmission of nerve impulses.
                          In  acute toxicity studies using laboratory animals, methiocarb has
                    been shown to be highly toxic by the oral route and has been placed  in
                    Toxicity  Category I (the highest of four levels) for acute oral effects.  It is
                    moderately toxic by the inhalation  route and slightly  toxic by the dermal
                    route, and has been placed in Toxicity Categories n and ffl for these
                    effects.  Methiocarb is not an eye or skin irritant, and it does not cause
                    delayed neurotoxicity.
                          Subchronic dermal toxicity studies using rabbits showed inconsistent
                    results, but the range-finding study resulted in treatment-related deaths at
                    the higher doses. In chronic feeding studies using  rats and beagle dogs,
                    methiocarb caused inhibition of red blood cell and  plasma cholinesterase,
                    but not brain cholinesterase.  In the dog study, hind limb weakness and
                    tremor occurred in the high dose group. Methiocarb is not carcinogenic in
                    rats, and does not appear to have any mutagenicity  potential.  Administered
                    by the dermal route, methiocarb is associated with  developmental toxicity
                    in rabbits.  By the oral route, it is  associated only with maternal toxicity in
                    both rats and rabbits.
                          Although they are not part of the target data base for reregistration,
                    acute and chronic neurotoxicity studies in rodents, now required for all
                    carbamate pesticides, must be performed for methiocarb.
                    Dietary  Exposure
                          Dietary exposure to methiocarb is not expected to occur  since there
                    are no remaining food uses.  Ginseng is not considered a food use since
                    current methiocarb labels require a 12-month preharvest interval.  The

                                              184

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Agency will revoke all existing methiocarb tolerances (maximum food
residue limits) set forth in 40 CFR 180.320.
Occupational and Residential Exposure
     Methiocarb wettable powder products applied as foliar sprays can
result in dermal and inhalation exposure to mixers, loaders and applicators.
Use of the granular and total release aerosol products is expected to result
in less applicator exposure than use of the foliar sprays.
     Post-application exposure also may occur following most methiocarb
applications. Examples include dermal exposure to residues on treated
lawns, turf and soil following the granular applications, dermal exposure to
foliage of commercially grown ornamentals following the wettable powder
and pressurized liquid formulations, and inhalation exposure following
application of total release aerosol sprays.
     Methiocarb meets both the toxicity and the exposure criteria requiring
mixer/loader/applicator exposure data and post-application reentry data.
These  studies will be required for reregistration of the commercial use of
the wettable powder formulation to greenhouse- and nursery-grown
ornamentals.
     The Worker Protection Standard (WPS) converted the previous 24-
hour worker reentry  interval (where reentry with protective clothing is
allowed) to  a 24-hour restricted entry interval or REI (where entry is
limited to performance of short term activities as defined in the WPS).
Considering the  lexicological concerns with methiocarb, EPA considers
these additional protections essential to its decision that REIs will
sufficiently  mitigate risks to workers.
Human  Risk Assessment
      Since no food uses are registered, methiocarb poses no human dietary
risks.  Regarding acute toxicity, methiocarb is extremely toxic by the oral
route but is moderately to slightly toxic by other routes of exposure.
Methiocarb is a  developmental toxicant, and workers and  homeowners may
be at risk for developmental effects from exposure to methiocarb during or
after application.
      For handlers of the wettable powder/foliar spray formulation of
methiocarb using currently-required personal protective equipment (PPE),
the estimated margin of exposure (MOE) for dermal and inhalation toxicity
is estimated to be less  than  100, the commonly accepted margin.
However, with the use of additional PPE (coveralls), the MOE increases to
well over 100. To achieve an acceptable MOE, therefore, EPA is
requiring use of additional  PPE.
       EPA also is concerned about workers entering treated areas following
application of methiocarb.  To protect workers, the Agency is requiring a
25-day restricted entry interval (REI) following foliar applications of the
wettable powder and pressurized liquid (total release aerosol) formulations

                          185

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                     to ornamental plants.  After 10 days, workers may enter treated areas to
                     perform tasks, including hand labor tasks that involve contact with treated
                     surfaces, provided each worker spends no more than 3 hours in each 24-
                     hour period performing such tasks.  PPE is not required during the 3-hour
                     work period.
                          Because methiocarb has been identified as a developmental toxicant,
                     EPA is requiring use of extra PPE by all applicators, handlers and early
                     entry workers.  These PPE requirements will not  apply to homeowner
                     users of methiocarb since their frequency and duration of exposure is less
                     than that of occupationally exposed users.


  Environmental   Environmental Fate
   Assessment         Methiocarb appears to be moderately persistent and relatively
                     immobile in soil, and is not likely to contaminate ground water.  A full
                     assessment will be possible only when confirmatory hydrolysis, adsorption-
                     desorption/leaching and terrestrial field dissipation studies are submitted.
                     Ecological Effects
                          Methiocarb is toxic to terrestrial mammals.  It is very highly toxic to
                     birds on an acute oral basis. In subacute studies,  it is slightly toxic to
                     waterfowl and practically non-toxic to upland game birds.  Methiocarb is
                     highly toxic to coldwater and warmwater fish, and very highly toxic to
                     aquatic invertebrates.  It also is very highly toxic to honey bees.
                     Ecological Effects Risk Assessment
                          Outdoor use of methiocarb is likely to have  adverse effects on aquatic
                     and terrestrial species.   For all formulations of methiocarb used on all
                     outdoor sites, acute and/or chronic levels of concern are exceeded for avian
                     and mammalian species, aquatic invertebrates and other aquatic organisms.
                     Although methiocarb is used in low volumes compared to other pesticides,
                     it still could have major impacts in areas where there is concentrated
                     outdoor use.
                          Methiocarb may pose a hazard to endangered species including many
                     listed birds, mammals, insects, and aquatic organisms.  The U.S. Fish and
                     Wildlife Service will be consulted and a generic label statement may be
                     required when EPA's Endangered Species Program is implemented.
                          EPA is requiring additional use precautions  and maximum application
                     rates on product labels,  requiring additional confirmatory data, and
                     negotiating with the registrants to maintain a production cap in an effort to
                     decrease the environmental risks of methiocarb.

Additional  Data        EPA is requiring the following additional generic data to confirm its
        Required   risk assessment for methiocarb: estimation of dermal exposure for
                     wettable powder formulation use in greenhouses and nurseries; estimation
                     of inhalation exposure for wettable powder formulation use in greenhouses

                                               186

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                        and nurseries; inhalation passive dosimetry for pressurized liquid
                        formulation use in greenhouses; estimation of dermal exposure and soil
                        dissipation for granular formulations used on ornamentals; aquatic and
                        estuarine organisms (fish/mollusk/shrimp) for all lawn and turf uses;
                        aquatic invertebrate life cycle for all lawn and turf uses; fish early life
                        stage for all lawn and turf uses; fish life cycle for all lawn and turf uses;
                        hydrolysis for all outdoor uses; adsorption/desorption/leaching for all
                        outdoor uses; terrestrial field dissipation for all lawn and turf uses; outdoor
                        usage data (pounds used per year by site); foliar dislodgeable dissipation
                        and dermal passive dosimetry for residential lawns and turf; and acute and
                        subchronic neurotoxicity data (which are not part of the target data base for
                        reregistration).
                             EPA is requiring product-specific data including product chemistry
                        and acute toxicity studies, as well as revised labeling,  for reregistration of
                        pesticide products containing methiocarb.

  Product  Labeling        All methiocarb end-use products must comply with EPA's current
Changes Required   pesticide product labeling requirements.  In addition:
                        Worker Protection Standard (WPS) -  Any product whose labeling
                        permits use in the production of an agricultural plant on any agricultural
                        establishment (farm, forest, nursery or greenhouse)  must comply with the
                        labeling requirements of EPA's Worker Protection Standard (WPS).  See
                        PR Notice 93-7, "Labeling Revisions Required by the Worker Protection
                        Standard (WPS)," and PR Notice 93-11, "Supplemental Guidance for PR
                        Notice 93-7."  Unless specifically directed in the RED, all statements
                        required by the WPS and reflected in these two PR Notices must be
                        included on product labeling.
                        Entry Restrictions - [See the RED for  detailed instructions.]  For uses
                        within the scope of the WPS and products not primarily intended for home
                        use:
                        •  Wettable Powder Formulations - A 25-day restricted entry interval (REI)
                        is required:
                              "Do not enter or allow worker entry in treated areas during the
                              restricted  entry interval (REI) of 25 days, except, after 10 days,
                              workers may enter treated areas to perform tasks including
                              hand labor tasks that involve contact with treated surfaces
                              provided each worker spends no more than 3 hours in each 24
                              hour period performing such tasks."
                        •  Pressurized Liquid Formulations - A 25-day REI is required:  (see
                        statement above).
                        •  Granular Formulations - A 24-hour REI is  required, except for products
                        intended primarily for home use.
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Personal Protective Equipment (PPE) Requirements
[See the RED for detailed instructions.]
•  For Products Not Primarily Intended for Home Use - The minimum
PPE requirement is:
      "Applicators and other handlers must wear:
      -Coveralls over short-sleeved shirt and short pants
      -Chemical-resistant or waterproof gloves...
      —Chemical-resistant footwear plus socks
      -Chemical-resistant headgear for overhead exposure
      -Chemical-resistant apron when cleaning equipment, mixing, or
      loading..."
In addition, handlers must wear a respirator with an organic vapor
cartridge TC-23C during early entry to greenhouses following treatment
with the pressurized liquid for those tasks associated with ventilating the
greenhouse.  A dust mask must be worn while mixing/loading the wettable
powder formulation.
Compare the PPE requirements set forth in the RED to the PPE
requirements, if any, on current labeling and retain the more protective.
•  For Products Intended for Home Use - Do not add any additional PPE
requirements but retain any requirements already on current product
labeling.
•  For Entry During the Restricted Entry Period - See the RED for
detailed instructions.
•  For Uses Not Within the  Scope of the WPS, and For Products Primarily
Intended for Home Use - Do not add any new entry restrictions but retain
any on current product labeling.
Lawn and Turf Uses
•  If a registrant chooses to  support lawn and turf uses, he must submit the
data required in the RED.
•  If a registrant chooses to  support the residential lawn uses only, he must
add the following  statement to his product labels to remove the site from
the scope of the WPS:
      "Not for use on turf being grown for  sale or other commercial
      use as sod, or for commercial seed production, or for research
      purposes."
•  If a registrant does not support the residential lawn uses, he must delete
the use from the product label and add the following statement:
      "Do not use on turfgrass around residences or dwellings."
Restricted Use Pesticide - The following statement must appear on the
labels of all end-use products for outdoor uses except products intended for
use by homeowners:
                          188

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                     "Restricted Use Pesticide
                     Due to Toxicity to Fish,  Birds, and Aquatic Organisms
                     For retail sale to and use only by certified applicators or
                     persons under their direct supervision and only for those uses
                     covered by the certified applicator's certification."
               Use Kates and Number of Applications - The following number of
               applications must appear as the maximum application rate in the Directions
               for Use section of the label, to decrease aquatic risks:
               •  75% Wetteble Powder -
                     "2 Ibs 75 % wettable powder per 50 gallons of water applied up
                     to 2 times a  year."
               •  Granular or Pelletized Bait  -
                     "Should not  be applied more than twice a year."
               Rsh and Wildlife Protection  -  The following statements must appear on
               products for  the following uses:
               •  Granular or Pelletized Bait  for Snails and Slugs -
                     "This product is toxic to fish and very highly toxic to birds and
                     mammals. Do not apply directly to water, wetlands (swamps,
                     bogs, marshes, and potholes). Runoff from treated area may be
                     hazardous to aquatic organisms in adjacent aquatic sites.  Do
                     not contaminate water when disposing of equipment washwaters
                     and rinsates."
               •  75% Wettable Powder Formulation -
                     "This pesticide is toxic to fish and very highly toxic to birds
                     and mammals. Do  not apply directly to  water, or to areas
                     below the mean high water mark.  Runoff from treated  area
                     may be hazardous to aquatic organisms in adjacent aquatic
                     sites.  Do not contaminate water when disposing of equipment
                     washwaters and rinsates.
                     "This product  is very highly toxic to honey bees exposed to
                     direct treatment or residues on blooming shrubs, flowers,
                     weeds  and trees.   Do not apply  this product or allow it to drift
                     to blooming shrubs, flowers, weeds, or trees if bees are visiting
                     the treatment area."

Regulatory        The use of most currently registered pesticide products  containing
Conclusion   methiocarb in accordance with approved labeling, except the  use of
               granular and pelletized  formulations on residential lawns and turf, and
               except products for use by homeowners on ornamentals marketed in 20-25
               pound bags,  will not pose unreasonable risks or adverse effects to humans
               or the environment.  Therefore,  uses of methiocarb on residential and
               commercial ornamentals (except large size products for use by homeowners

                                           189

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                on ornamentals), by homeowners around building foundations, in
                greenhouses, on commercially grown turfgrass, and on ginseng are eligible
                for reregistration.
                     These products will be reregistered once the required confirmatory
                generic data, product specific data and revised labeling are received and
                accepted by EPA.  Products which also contain other active ingredients
                will be reregistered after the other active ingredients are determined to be
                eligible for reregistration.
                     EPA cannot make a reregistration eligibility decision regarding the
                residential lawn and turf use of methiocarb until appropriate postapplication
                reentry exposure, ecological effects and environmental fate data are
                submitted and evaluated.
                     The Agency similarly cannot make a reregistration eligibility decision
                regarding large size methiocarb products for use by homeowners on
                ornamentals, marketed  in 20-25 pound bags, until soil dissipation and
                dermal exposure data are received and evaluated.

   For More        EPA is requesting public comments on the Reregistration Eligibility
Information   Decision (RED) document for methiocarb during a 60-day time period, as
                announced in a Notice  of Availability  published in the Federal Register.
                To obtain a copy of the RED document or to submit written comments,
                please contact the Pesticide Docket, Public Response and  Program
                Resources Branch, Field Operations Division (7506C), Office of Pesticide
                Programs (OPP), US EPA, Washington, DC 20460, telephone
                703-305-5805.
                     Following the comment period,  the methiocarb RED document will
                be available from the National Technical Information Service (NTTS), 5285
                Port Royal Road, Springfield, VA 22161,  telephone 703-487-4650.
                     For more information about EPA's pesticide reregistration program,
                the methiocarb RED, or reregistration of individual products containing
                methiocarb, please contact the Special Review and Reregistration Division
                (7508W), OPP, US EPA, Vfashington, DC 20460, telephone
                703-308-8000.
                     For information about the health effects of pesticides, or for
                assistance in recognizing and managing pesticide poisoning symptoms,
                please contact the National Pesticides Telecommunications Network
                (NPTN). Call toll-free 1-800-858-7378, from 8:00 am to 6:00 pm Central
                Time, Monday through Friday.
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