United States       Prevention, Pesticides     EPA 738-R-95-003
         Environmental Protection    And Toxic Substances     March 1995
         Agency	(7508W)	
4>EPA  Re registration
         Eligibility Decision (RED)
         Linuron

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         \
                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                     WASHINGTON, D.C. 20460
                                                                          OFFICE OF
                                                                    PREVENTION, PESTICIDES
                                                                    AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:

       I am pleased to announce that the Environmental Protection Agency has completed its
reregi strati on eligibility review and decisions on the pesticide chemical case linuron which
includes the active ingredient 3-(3,4-dichlorophenyl)-l-methoxy-l-methylurea. The enclosed
Reregi strati on Eligibility Decision (RED) contains the Agency's evaluation of the data base of
these chemicals, its conclusions of the potential human health and environmental risks of the
current product uses, and its decisions and conditions under which these uses and products
will be eligible for reregi strati on. The RED includes the data and labeling requirements for
products for reregi strati on. It may also include requirements for additional data (generic) on
the active ingredients to confirm the risk assessments.

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

       If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregi strati on Division representative
C.P. Moran at (703) 308-8590.  Address any questions on required generic data to the Special
Review and Reregi strati on Division representative Karen Jones at (703) 308-8047.

                                                    Sincerely yours,
                                                    Peter Caulkins, Acting Director
                                                    Special Review
                                                     and Reregi strati on Division
Enclosures

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

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

2  TIME EXTENSIONS AND DATA WAIVER 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 REREGISTRATION OR "8-MONTH RESPONSE"-You
must submit the following items for each product within eight months of the date of this
letter (RED issuance date).

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

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

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

      d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation.  The labeling and CSF which you submit for each product must
comply with P.R. Notice  91-2 by declaring the active ingredient as the nominal
concentration.  You have two options for submitting a CSF: (1) accept the standard certified
limits (see 40 CFR §158.175) or (2) provide  certified limits that are supported by the analysis
of five batches.  If you choose the second option, you must submit or cite the data for the five

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batches along with a certification statement as described in 40 CFR §158.175(e).  A copy of
the CSF is enclosed; follow the instructions on its back.

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

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

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

By U.S. Mail:

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

By express:

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

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

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REREGISTRATION ELIGIBILITY DECISION

                  LINURON

                   LIST A

                  CASE 0047
           ENVIRONMENTAL PROTECTION AGENCY
             OFFICE OF PESTICIDE PROGRAMS
         SPECIAL REVIEW AND REREGISTRATION DIVISION

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                          TABLE OF CONTENTS



LINURON REREGISTRATION ELIGIBILITY DECISION TEAM                 i

EXECUTIVE SUMMARY                                                    vii

I.     INTRODUCTION                                                       1

II.    CASE OVERVIEW                                                     2
      A.    Chemical Overview	2
      B.    Use Profile                                                        2
      C.    Estimated Usage of Pesticide  	5
      D.    Data Requirements	6
      E.    Regulatory History 	6

III.   SCIENCE ASSESSMENT                                                7
      A.    Physical Chemistry Assessment	7
            1.     Description of Chemical  	7
            2.     Identification of Active Ingredient	8
      B.    Human Health Assessment	8
            1.     Toxicology Assessment  	8
                  a.     Acute Toxicity                                         8
                  b.     Subchronic Toxicity                                   9
                  c.     Chronic Toxicity and Carcinogenicity	10
                  d.     Developmental Toxicity	12
                  e.     Reproductive Toxicity                                 13
                  f.     Mutagenicity                                        14
                  g.     Metabolism	14
                  h.     Reference Dose (RfD) for Chronic Oral Exposure	15
                  i.     Dermal Absorption 	15
            2.     Exposure Assessment  	16
                  a.     Dietary Exposure                                    16
                  b.     Occupational and Residential                          21
            3.     Risk Assessment	24
                  a.     Dietary	24
                  b.     Occupational and Residential                          26
      C.    Environmental Assessment  	35
            1.     Environmental Fate	35
                  a.     Environmental Chemistry, Fate and Transport           35
                  b.     Environmental Fate Assessment	38
            2.     Ecological Effects                                           41
                  a.     Ecological Effects Data                                41

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                        (1)    Terrestrial Animal Data                         41
                        (2)    Aquatic Animal Data                           43
                        (3)    Non-Target Plants Data                         48
                  b.    Ecological Effects Risk Assessment                     48
                        (1)    Risk to Terrestrial Animals	48
                        (2)    Aquatic Risk                                  53
                        (3)    Plants   	56
                        (4)    Endangered Species                            56

IV.   RISK MANAGEMENT AND REREGISTRATION DECISION              56
      A.    Determination of Eligibility  	56
            1.     Eligibility Decision	57
            2.     Eligible and Ineligible Uses                                  58
      B.    Regulatory Position                                               58
            1.     Tolerance  Reassessment 	58
            2.     Restricted Use Classification	63
            3.     Risk Mitigation                                            63
            4.     Endangered Species Statement  	64
            5.     Labeling Rationale	64

V.    ACTIONS REQUIRED  BY REGISTRANTS                               68
      A.    Manufacturing-Use Products                                      68
            1.     Additional Generic Data Requirements                       68
            2.     Labeling Requirements for Manufacturing Use Products        69
      B.    End-Use Products                                                70
            1.     Additional Product-Specific Data Requirements                70
            2.     Labeling Requirements for End-Use Products                  70
                  a.    Worker Protection                                   70
                  (1)    Entry Restrictions; Labeling                           70
                  (2)    Personal Protective Equipment Requirements; Labeling  71
                  b.    Other Labeling Requirements                         71
      C.    Existing Stocks                                                   73

VI.  APPENDICES                                                          74
      APPENDIX A. Table of Use Patterns Subject to Reregistration              75
      APPENDIX B. Table of the Generic Data Requirements and Studies Used to
            Make the Reregistration Decision                                 103
      APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
            Reregistration of Linuron	119
      APPENDIX D. List of Available Related Documents                       141
      APPENDIX E	145
            PR Notice 86-5 	147
            PR Notice 91-2 	165
      APPENDIX F. Combined Generic  and Product Specific Data Call-In        171
            Attachment 1. Chemical Status Sheets                              189

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      Attachment 2. Combined Generic and Product Specific Data Call-In
            Response Forms (Form A inserts) Plus Instructions 	193
      Attachment 3. Generic and Product Specific Requirement Status and
            Registrant's Response Forms (Form B inserts) and Instructions
             	199
      Attachment 4. EPA Batching of End-Use Products for Meeting Data
            Requirements for Reregistration	207
      Attachment 5. EPA Acceptance Criteria  	213
      Attachment 6. List of All Registrants Sent This Data Call-in (insert) Notice
             	227
      Attachment 7. Cost Share, Data Compensation Forms, Confidential
            Statement of Formula Form and Instructions 	229
APPENDIX G. FACT SHEET                                           239

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LINURON REREGISTRATION ELIGIBILITY DECISION TEAM

Office of Pesticide Programs:

Biological and Economic Analysis Division

George Keitt                            Biological Analysis Branch
Arthur Grube                           Economic Analysis Branch

Environmental Fate and Effects Division

Betsy Grim                             Science Analysis and Coordination Staff
James Felkel                            Ecological Effects Branch
William Effland                         Environmental Fate and Groundwater Branch

Health Effects Division

John Redden                            Chemical Coordination Branch
Susan Makris                           Toxicology Branch II
Jeffrey Evans                           Occupational and Residential Exposure Branch
David Miller                            Reregi strati on Support Chemistry Branch

Registration Division

Terri Stowe                             Fungicide-Herbicide Branch
Mary Waller                            Registration Support Branch

Special Review and Reregi strati on Division

Karen Jones                            Reregi strati on Branch
Linda Propst                            Reregi strati on Branch
Carol Stangel                           Policy, Planning and Operations Branch

Policy and Special Projects Staff

Jean Frane                              Food Safety and Regulations Section

Office of Compliance

Steve Howie                            Agriculture and Ecosystem Division

Office of General Counsel
Jon Fleuchaus                          Pesticides and Toxic  Substances Division

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11

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          GLOSSARY OF TERMS AND ABBREVIATIONS


AE         Acid equivalent

a.i.          Active Ingredient

ARC        Anticipated Residue Contribution

CAS        Chemical Abstracts Service

CNS        Central Nervous System

CSF        Confidential Statement of Formula

DFR        Dislodgeable Foliar Residue

DRES       Dietary Risk Evaluation System

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

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

EP          End-Use Product

EPA        U.S. Environmental Protection Agency

FDA        Food and Drug Administration

FIFRA      Federal Insecticide, Fungicide, and Rodenticide Act

FFDCA     Federal Food, Drug, and Cosmetic Act

GLC        Gas Liquid Chromatography

GM        Geometric Mean

GRAS       Generally Recognized As Safe as designated by FDA
                                       in

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          GLOSSARY OF TERMS AND ABBREVIATIONS

HA         Health Advisory (HA) The HA values are used as informal guidance to
            municipalities and other organizations when emergency spills or contamination
            situations occur.

HOT        Highest Dose Tested

LC50        Median Lethal Concentration.  A statistically derived concentration of a
            substance that can be expected to cause death in 50% of test animals. It is
            usually expressed as the weight of substance per weight or volume of water, air
            or feed, e.g., mg/1, mg/kg or ppm.

LD50        Median Lethal Dose.  A statistically derived single dose that can be expected to
            cause death in 50% of the test animals when administered by the route
            indicated (oral, dermal, inhalation). It is expressed as a weight of substance per
            unit weight of animal, e.g., mg/kg.

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

LEL        Lowest Effect Level

LOG        Level of Concern

LOEL       Lowest Observed Effect Level

MATC      Maximum Acceptable Toxicant Concentration

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

Hg/g        Micrograms Per Gram

mg/L        Milligrams Per Liter

MP         Manufacturing-Use Product

MPI        Maximum Permissible Intake

MOE        Margin Of Exposure
                                        IV

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          GLOSSARY OF TERMS AND ABBREVIATIONS

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


OP         Organophosphate

OPP        Office of Pesticide Programs

PADI       Provisional Acceptable Daily Intake

PAM       Pesticide Analytical Method

PHED       Pesticide Handler's Exposure Data

PPE        Personal Protective Equipment

ppb         Parts Per Billion

ppm        Parts Per Million

PRN        Pesticide Registration Notice

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

RBC        Red Blood Cell

RED        Reregi strati on Eligibility Decision

REI        Restricted Entry Interval

RfD        Reference Dose

RS         Registration Standard
                                        v

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          GLOSSARY OF TERMS AND ABBREVIATIONS

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

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

TEP        Typical End-Use Product

TGAI       Technical Grade Active Ingredient

TMRC      Theoretical Maximum Residue Contribution

TLC        Thin Layer Chromatography

WP         Wettable Powder

WPS        Worker Protection Standard
                                      VI

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EXECUTIVE SUMMARY

Reregistration Decision

       This Reregistration Eligibility Decision document (RED) addresses the reregi strati on
eligibility of the pesticide linuron, 3-(3,4-dichlorophenyl)-l-methoxy-l-methylurea.

       Based on the reviews of the generic data for the active ingredient linuron, the Agency
has reviewed information on the health effects of linuron and on its potential for causing
adverse effects in fish and wildlife and the environment. Based on this information, the
Agency concludes that products containing linuron for most registered uses are eligible for
reregi strati on. However, the Agency is unable to make a reregi strati on decision for certain
uses. Because of the lack of key generic data, the Agency cannot complete an assessment on
the use of linuron on cotton, potato, non-cropland (rights-of-way), and sweet corn. At this
time, the Agency is unable to make a reregi strati on eligibility decision on the use of linuron
on potatoes because under current policies a tolerance under Section 409 of the Federal Food,
Drug and Cosmetic Act (FFDCA) is needed for this use, but such a tolerance may be barred
by the Delaney  clause in Section 409.

       The Agency has further determined based on information currently available that the
remaining uses  of linuron, as currently registered, will not cause unreasonable risk to humans
and the environment. However, the Agency is concerned with the potential for
postapplication/reentry exposure to workers and handlers (mixers/loaders/applicators)
exposure. In order to reduce the postapplication/reentry exposure  risks, the Agency is
establishing a 24 hour REI, requiring postapplication/reentry exposure data, and requiring
minimum handler personal protective equipment (PPE) for all end-use products containing
linuron.  The 24 hour REI is only for those uses in the scope of the Worker Protection
Standards.

       Linuron exceeds the Levels of Concern (LOCs) for ecological effects and groundwater
quality. The Agency is requiring additional ecological effects data, which include plant and
chronic aquatic studies needed to confirm the risk assessment for all uses of linuron. In
addition, the Agency has some moderate concerns for potential risks of linuron to surface
water source supply systems.

       Following discussions with the technical registrant, E.I. DuPont de Nemours and
Company, Inc., several risk mitigation measures were agreed upon. These measures include
the following:

       - prohibiting the aerial uses of linuron
       - prohibiting the use on sand or loamy sand soils
       - prohibiting the use on soils of <1% organic matter
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       - voluntarily cancelling the high application rate uses such as Hybrid poplar and Non-
             Cropland uses (Rights-of-way)
       - reducing the maximum use rate for soybeans (to 1.0 Ib ai/A), field corn (to 0.75 Ib
       ai/A), potatoes (to 1.5 Ibs ai/A), asparagus (to 2.0 Ibs ai/A)
       - limiting soybeans, field corn, potatoes to 1 application per year (pre-emergent use
       only)  and limit asparagus to 3  applications per year
       - adding a ground water label advisory
       - adding a surface water label advisory

       DuPont's risk mitigation measures would substantially reduce the amount of linuron
entering the environment. However, exposure does not get below all acute and chronic
LOCs. For example, using the new proposed rate for soybean use of 1 Ib ai/A to determine
the expected environmental concentration, small mammals remain at risk from acute and
chronic effects to linuron and birds still potentially remain at risk to chronic effects.
Reduction of the application rates for soybeans and asparagus may also improve the MOEs
for handlers.

       The main technical producer for linuron, DuPont, has agreed to voluntarily cancel the
Hybrid poplar and non-cropland (rights-of-way) uses of linuron as a risk mitigation measure.
DuPont has already voluntarily cancelled the cotton use. At this time, the Agency is  unable to
make a reregi strati on eligibility decision for the linuron use on cotton, rights-of-way, and
sweet corn because there is a lack of data to support these uses. Registrants are required to
either amend their product labels deleting these uses or submit the outstanding data to support
the cotton, rights-of-way, and sweet corn uses.

Background Information

       Linuron [3-(3,4-dichlorophenyl)-l-methoxy-l-methylurea] is a substituted urea
herbicide registered for use on asparagus, carrots, celery, corn (field and  sweet), cottonseed
(DuPont has voluntarily dropped use),  parsley, parsnips, potatoes, sorghum, soybeans, and
wheat (winter).  Linuron is registered for application  preplant, preemergence, postemergence,
or post-transplant using ground equipment.  The registered modes of application are band
treatment, directed spray, or broadcast  spray. The end-use formulations of linuron include
wettable powder (50% a.i.), flowable concentrate (40.6% a.L), water dispersible granules
(50% a.i.), and liquid suspensions.  There are currently 23 end-use products and 5 technical
products registered for linuron.

       Linuron was initially registered as a pesticide  in 1966. Technical linuron is currently
being produced in the United States by E.I. DuPont de Nemours and Company, Inc.,  Griffin
Corporation, and Drexel Chemical Company.  A Registration Standard for Linuron was
issued in June 1984 (NTIS# PB85-149011). The Registration Standard summarized  available
data supporting the registrations of products containing linuron. The Registration Standard
also  required the submission of product chemistry, residue chemistry, toxicology, ecological
                                         Vlll

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effects and environmental fate studies. In 1984, the Agency initiated a Special Review
because linuron exceeded the oncogenicity risk criteria.  The Agency was concerned about
applicator exposure and dermal penetration. The Special Review was concluded in 1988 and
in the Federal Register (dated 6/26/90), the Agency revised the toxicological classification of
linuron from a quantifiable Group C carcinogen to an unquantifiable Group C carcinogen.

       DuPont is no longer supporting the cotton use.  Reregi strati on support from end-use
registrants or amendment of their labels deleting the cotton use is required. This document
addresses the cotton use because this use currently exists on end-use product labels.

       A Data Call-In (DCI) was issued in May 1986 for linuron requiring product chemistry,
chronic toxicity, processing and cooking studies.  In September 1990, a second DCI was
issued requiring additional data on ecological effects, phytotoxicity and residue chemistry.
Most recently, in November  1993, a DCI was issued requiring cropfield trials replacement
data for studies generated by Craven Laboratories. This RED reflects a reassessment of all
data which were submitted in response to the Registration  Standard and the subsequent DCIs.

Supporting Rationales for Reregistration Decision

• Product Chemistry

       All of the registrants of linuron products must confirm the sources of linuron used for
their products. Registrants are also required to submit the product chemistry data for the
linuron technical products, and either certify that the suppliers of the starting materials and the
manufacturing process for the linuron TGAIs and  MPs have not changed since the last
comprehensive product chemistry review or submit a complete updated product chemistry
data package.

• Health Effects

       Linuron is classified as Category III for acute oral and dermal toxicity, Category III for
acute inhalation toxicity, Category III for primary eye  irritation, and Category IV for skin
irritation.  Linuron is also a nonsensitizer. The Agency classified linuron as a Group C
carcinogen based upon testicular effects in the rat  (interstitial cell hyperplasia and adenomas)
from a two-year feeding study.  Quantification of risk by unit risk is not recommended.

       The Reference Dose (RfD) is 0.008 mg/kg/day based on a one-year feeding study in
dogs in which  a No Observed Effect Level (NOEL)  of 0.77 mg/kg/day was demonstrated. An
uncertainty factor of 100 was used to account for inter-species extrapolation and intra-species
variability. Chronic dietary exposure to the general  population is expected to be 2% of the
Reference Dose. Of the standard subgroups routinely  analyzed by the Dietary Risk
Evaluation System (ORES), the two subgroups with the highest exposures are non-nursing
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infants less than 1 year old, with expected exposures of 6% of the RfD, and children 1
through 6 years old, with expected exposures 4% of the RfD.

       Acute, high-end, exposure to females 13 years of age or older (DRES approximation
of women of childbearing age) on any given day is expected to result in a MOE of 1667 for
developmental toxicity.

       The qualitative nature of linuron residue in plants, ruminants, and poultry is adequately
understood. The Agency is requiring residue data to establish tolerances for corn aspirated
grain fractions (grain dust). Field trial data are required for asparagus; sorghum, forage and
hay; soybeans forage and hay; sweet corn; and wheat forage as replacement for Craven data
and to confirm tolerances established on limited data for these crops. There are sufficient data
to indicate that significant linuron residue declines are not expected to occur in oilseeds/nuts,
leafy vegetables, root vegetables, and non-oily grains over short to intermediate storage
intervals. A cotton processing study is also  required.

       Food additive tolerances are needed for potato chips and granules, and feed additive
tolerances are needed for wet and dry peel waste.  However, such tolerances may be barred by
the Delaney clause of the FFDCA, which provides that a food additive regulation may not be
established for a pesticide which induces cancer in man or animals. The Agency is unable to
make a reregi strati on eligibility  decision as to this use because EPA is currently evaluating
legal challenges to its policies related to the coordination of actions under Section  409's
Delaney clause and FFDCA section  408 and FIFRA. But in the event that the Agency allows
the use of linuron on potatoes, additional data to upgrade an existing potato processing study
will be required. Furthermore, the established linuron tolerances for corn, popcorn, forage
and fodder; barley, oats, and rye forage, grain, hay and straw will be revoked since there are
no registered uses of linuron on these commodities. A tolerance reassessment is also included
in this document.

• Occupational and Residential Exposure

       Margins of Exposure (MOE's) for linuron were calculated  for all occupational
exposure scenarios for which data were available. Margins of exposure (MOE's) for certain
mixer/loader scenarios  are below 100 for both short-term and intermediate-term exposure.
Particularly low are those MOE's for mixer/loaders supporting the aerial applications.  For
those scenarios, MOE's are below 100 for intermediate-term exposure, even with the use of
closed  mixing/loading systems.

       Most applications of linuron are made early in the season,  before reentry tasks are
likely,  or applications are made  to crops that are mechanically harvested.  The notable
exception is asparagus where applications of linuron are made between asparagus  cuttings.
Because asparagus harvesting occurs over a long  period of time, the use of both the short-
term and the intermediate-term end-points are appropriate for addressing

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postapplication/reentry exposure.  The task specific MOE's for asparagus reentry workers: 1)
1000 for short term exposure; and 2) 100 for intermediate exposure.
       The Agency is requiring a restricted-entry interval (REI) of 24 hours for uses within
the scope of the WPS. For crops such as celery and carrots, where intermediate exposure is
likely, the 24 hour REI is required until worker exposure data [132-la Foliar Dislodgeable
Residues (carrots and celery), 132-lb Soil Dislodgeable Residues (carrots and celery), 133-3
Dermal Exposure (carrots and celery), and 133-4 Inhalation Exposure (carrots and celery)]  are
submitted by the registrant and evaluated by the Agency.

       Due to the short-term and intermediate-term endpoints based on maternal and
developmental concerns, the Agency is  requiring minimum handler personal protective
equipment requirements for any end-use product containing linuron. Products containing
linuron may contain more stringent PPE, but in no case may they require less stringent PPE
than the following: coveralls over long-sleeved shirt and long pants, chemical-resistant
gloves, chemical-resistant footwear, and chemical-resistant apron.

• Environmental Fate

       The environmental data base of only parent linuron is essentially complete. Linuron
appears to be moderately persistent and relatively immobile. Increased mobility of linuron
may occur under specific environmental conditions such as coarse textured soils and soils
with low organic matter levels. However, information on the persistence, mobility and
dissipation pathways of several primary degradates of linuron is not currently available;
therefore, the environmental fate assessment is considered incomplete and tentative.
Additional data are required on leaching/adsorption and desorption to assess the mobility of
the primary degradates of linuron; and field dissipation to assess the rates of dissipation of
parent linuron and its primary degradates.

       Linuron exceeds the Level of Concern (LOG) for groundwater quality. Linuron
exhibits some of the properties and characteristics associated with chemicals that have been
detected in groundwater.  Based on its persistence and possible mobility under certain
environmental conditions, linuron may have an impact on ground water quality. Furthermore,
the Agency has some moderate concerns for potential risks of linuron to surface water source
drinking water supply systems.

• Ecological Effects

       Levels of concern from linuron use have been exceeded for acute effects to birds,
mammals, fish, aquatic invertebrates, aquatic plants and endangered species. Risk to
terrestrial plants cannot be assessed due to the lack of adequate data. High risk to terrestrial
plants is likely, based on the herbicidal properties of linuron. In addition, levels of concern
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for chronic effects have been exceeded for birds and mammals.  Chronic effects to fish cannot
be fully evaluated since a NOEL was not determined.  Chronic effects to aquatic invertebrates
cannot be evaluated due to inconsistencies between acute and chronic testing.  The Agency is
requiring additional ecological effects data, which include plant and chronic aquatic studies,
needed to complete the ecological effects risk assessment for linuron.

       In summary, based on the information currently available to the Agency, all uses of
linuron are eligible for reregistration, with the exception of cotton, potato, non-cropland
(rights-of-way), and sweet corn. The Agency is unable to make a reregistration eligibility
decision for the use of linuron on cotton, non-cropland (rights-of-way), and sweet corn until
additional data are submitted and reviewed.  Also, the Agency is unable to make a
reregistration decision for the potato use of linuron until a decision on Delaney is made
regarding EPA's coordination policy. Furthermore, the Agency is requiring that additional
confirmatory data be submitted to fulfill the generic data requirements for reregistration of
linuron.

       Starting Materials and Manufacturing Process

       Foliar Dislodgeable Residues (Carrots/Celery)
       Soil Dislodgeable  Residues (Carrots/Celery)
       Dermal Exposure (Carrots/Celery)
       Inhalation Exposure (Carrots/Celery)

       Cropfield Trials - Asparagus; Corn Aspirated Fractions (Grain Dust); Sorghum, Forage
             and Fodder; and Wheat, Forage
       Cropfield Trials -  Soybeans Forage and Hay - required due to change in Agency policy
             on grazing  restrictions

       Acute Avian Dietary Toxicity w/TGAI - Quail  and Duck
       Acute Aquatic Invertebrate Toxicity
       Fish Early Life Stage - both Rainbow Trout and Sheepshead Minnow
       Aquatic Invertebrate Life Cycle - Mysid shrimp
       Leaching/Adsorption/Desorption
       Terrestrial Field Dissipation

       In order to support the use of linuron on cotton and sweet corn, the following residue
data are required:

       Cottonseed processing study
       Cropfield trials - sweet corn

       In order to support the use of linuron on non-cropland  (rights-of-way) uses, the
following data are required:
                                          xn

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       Acute Marine/Estuarine (TEP) - Sheepshead Minnow using DF Formulation for
             Rights-of-Ways

       Certain data are not part of the target database for linuron, but are also
required:

       Seed germination/seedling emergence -  10 species
       Vegetative vigor - 10 species
       Aquatic plant growth - 4 additional species

       Before reregistering the products containing linuron, the Agency is requiring that
product specific data, revised Confidential Statements of Formula (CSF) and revised labeling
be submitted within eight months of the issuance of this document for all products containing
linuron. The product specific  data include product chemistry for each registration and acute
toxicity testing. After reviewing all these data and any revised labels and finding them
acceptable in accordance with Section 3(c)(5) of FIFRA, the Agency will reregister a product.
However, those products which bear uses of this or any other active  ingredients which have
not been determined to be eligible for reregi strati on will be reregistered only when such uses
and active ingredients are determined to be eligible for reregi strati on.
                                         Xlll

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 I.     INTRODUCTION

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

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

This document presents the Agency's decision regarding the reregi strati on eligibility of the
registered uses of linuron. The document consists of six sections. Section I is the
introduction.  Section II  describes linuron,  its uses, data requirements and regulatory history.
Section III discusses the human health and environmental assessment based on the data
available to the Agency. Section IV presents the reregi strati on decision for linuron. Section V
discusses the reregi strati on requirements for linuron.  Finally, Section VI is the Appendices
which  support this Reregi strati on Eligibility Decision. Additional details concerning the
Agency's review of applicable data are available on request.

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II.    CASE OVERVIEW

      A.    Chemical Overview

            The following active ingredient(s) are covered by this Reregi strati on Eligibility
      Document:

      •     Common Name:    Linuron
            Chemical Name:    Linuron [3-(3,4-dichlorophenyl)-l-methoxy-l-
                               methylurea]
            Chemical Family:         Substituted urea


            CAS Registry Number:   330-55-2


            OPP Chemical Code:     035506


            Empirical Formula:        C9H10C12N2O2
            Trade and Other Names:  Lorox®, Lorox Plus®, Gemini®, Linex®,
                                     Linuron 4L®
      •     Basic U.S. Manufacturers: E.I. DuPont DeNemours Company, Inc., Griffin
                                     Corporation, and Drexel Chemical Company

      B.    Use Profile

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

            For linuron:

            Type of Pesticide:         Herbicide

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Mechanism of Action:     Photosynthesis inhibitor (Hill reaction)

Use Sites:    Terrestrial Food Crop:  asparagus, carrots, celery

             Terrestrial Food + Feed Crop: corn (field and sweet), cotton,
             parsnips, potatoes,  soybeans, and wheat.

             Terrestrial Non-Food and Feed Crop: ornamental bulb
             production (Calla lily, daffodil, Dutch iris, tulip), non-cropland
             (roadsides, fencerows, etc.),

             Forestry: hybrid poplar plantations (pulpwood source)
Target Pests:              Preemergence application: Florida beggarweed,
                          carpetweed, chickweed, common dayflower,
                          Florida pussley, galinsoga, lambsquarters,
                          mustards, nettleleaf goosefoot, pigweeds,
                          purslane, wild radish, common ragweed,
                          Pennsylvania smartweed, barnyardgrass,
                          canarygrass, crabgrass, foxtails,  goosegrass, fall
                          panicum.

                    Postemergence application: the above PLUS: annual
                    morningglory, cocklebur, dog fennel, fiddleneck,
                    groundsel, knawel, prickly sida, sesbania, sicklepod,
                    velvetleaf, wild buckwheat, annual ryegrass, broadleaf
                    signalgrass, rattail fescue, Texas panicum; NOT
                    galinsoga, chickweed, common ragweed, wild radish

Formulation Types Registered:

Single Active Ingredient (AI) Products
95% flake (technical)
92% flake (technical)
50% wettable powder
50% dispersible granules
50% liquid concentrate
41% liquid concentrate

Multiple Active Ingredient (AI) Products
56.9% linuron + chlorimuron
30.8% linuron + atrazine

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Current Method and Rates of Application:

ASPARAGUS (CA, MI, MN, NC, OR, WA)
      Direct seeded/newly planted crowns, applied by ground boom:
      Preemergence, 1-2 Ib ai/A, using band of activated charcoal over seed;
      postemergence, 1 or 2 applications at 0.5-1 Ib ai/A.
      Established, applied by ground boom: Preemergence, 1-2 Ib ai/A;
      postemergence, 1 to 4 applications at 0.5-1 Ib ai/A. Do not exceed 4 Ib
      ai/A per season. PHI = 1 day. Directed  postemergence application of
      2-4 Ib ai/A may be used to control  dudain melon.
BULBS, Calla lily, Daffodil, Dutch iris, Tulip (CA)
      After planting, during growing season, apply preemergence 1 Ib ai/A
      by ground boom.
CARROTS
      Preemergence (FL, MI, OH, WI):  0.5-1.5 Ib ai/A by ground boom.
      Postemergence applications  may be made later, but do not exceed a
      total of 4 Ib. ai/A per season.
      Postemergence (U.S.): 0.75-1.5 Ib ai/A by ground boom: if repeat
      applications are made do not exceed a total of 4 Ib.ai/A (west of Rocky
      Mountains, 3 Ib ai/A).  PHI = 14 days.
CELERY (East of Rocky Mountains only)
      Post-transplant ground boom application, 0.75-1.5  Ib ai/A, after celery
      is established but before it is 6 inches tall. In the Northeast, use only on
      celery grown on muck soils.
CORN, FIELD (East of Rocky Mountains only)
      Preemergence, after planting, before crop emerges, by ground boom,
      as tank mix with alachlor or atrazine: 0.33-1.5 Ib ai/A.
CORN, FIELD AND SWEET
      Directed postemergence, by ground boom: 0.63-1.5 Ib ai/A, after corn
      is 15 inches high.
COTTON (East of Rocky Mountains only)
      Directed postemergence, by ground boom: 0.5-0.75 Ib ai/A when
      cotton is 15 inches tall; a second application may be made 7 or more
      days later.  After cotton is 20 inches tall, a single application of 1-1.5 Ib
      ai/A may be made after last cultivation.
      Do not graze treated fields or feed forage or gin trash to livestock.
HYBRID POPLAR (Midwest)
      Before bud break, by ground boom: 1-2 Ib ai/A.  After bud break, by
      directed ground spray, 1-2 Ib ai/A. More than one application may be
      made but do not exceed 4 Ib ai/A per year.
PARSNIPS
      Preemergence, by ground boom, after planting, before crop emerges,
      0.75-1.5 Ib ai/A, single application.

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      POTATOES (East of Rocky Mountains)
             Preemergence, between planting and crop emergence, by ground boom
             or aerial spray: 0.75-2 Ib ai/A  (Wisconsin: 0.5 Ib ai/A on sands, 1 Ib
             ai/A on loamy  sands).
      SORGHUM
             Preemergence, between planting and crop emergence, in tank mix with
             another registered herbicide: 0.31-1 Ib ai/A, by ground boom.
             Postemergence, directed, after sorghum is 16 inches tall, 0.5-1 Ib ai/A.
             Livestock grazing/feeding restriction = 3 months.
      SOYBEANS
             Preemergence, between planting and crop emergence, by ground boom
             or aerial spray: 0.5-3 Ib ai/A. Do not use on sand or loamy sand.
             Postemergence, directed, by ground boom, after soybeans are 8  inches
             tall  (Midsouth) 0.25-0.5 Ib ai/A., or after soybeans are 12 inches tall
             (Midsouth,  Southeast), split application of 0.5 Ib ai/A each, at interval
             of 7 or more days. Do not exceed a total of 1 Ib ai/A per season
             postemergence. PHI = 60 days; do not graze forage or feed hay to
             livestock from  postemergence-treated fields.
      WHEAT, WINTER (Drill-planted; ID, OR, WA)
             Preemergence/early postemergence treatment, as soon as possible
             after planting (though crop may have emerged), by ground spray, West
             of Cascades: 1-1.75 Ib ai/A. East of Cascades, fall or winter treatment,
             0.5-0.75 Ib  ai/A; spring treatment, 0.5-0.62 Ib ai/A, as soon as growth
             starts.  Do not apply after ground has frozen in fall.
      NON-CROP SITES (e.g.  roadsides, fencerows)
             Preemergence/early postemergence treatment, just before weeds
             emerge or at early seedling stage, 1-3 Ib ai/A by ground spray.

      Current Limitations  on  Use Practices:

      •     Do  not apply directly to water, or to  areas where surface water is
             present, or to intertidal areas below the mean high water mark.
      •     Do  not apply aerially (DuPont only;  Griffin allows aerial application to
             potatoes and soybeans, before  crop emerges).
      •     Do  not apply through any type of irrigation system.

C.    Estimated Usage of Pesticide

      This section summarizes the best estimates available for the pesticide uses of
linuron.  These estimates are derived from a variety of published  and proprietary
sources available to the Agency.  The data, reported on an aggregate and site (crop)
basis, reflect annual fluctuations  in use patterns as well as the variability in using data
from various information sources.

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       The table below summarizes the pesticides use by site.

Table 1. Distribution of linuron usage by site
Crop
Soybeans
Cotton
Potatoes
Corn, field
Carrots
Asparagus
Celery
Sorghum
Total
States of
greatest usage
MI, OH, DE, IN, IL,
MN, MD
AR, LA, MS

MI, IN, OH, NC,
PA, WI
CA, FL
CA,MI
CA, FL, NY


Acres
planted
(000)
59,000
13,700
1,400
76,000
85
85
33
11,500

Acres
treated
(000)
2,500
110
55
140
65
15
10
10

Pounds
Active
Ingredients
(000)
1,400
80
80
95
90
15
10
10
1,780
Percent of
crop
treated
4
8
6
<1
77
18
30
<1

Percent
of
linuron
usage
79
4
4
5
5
1
1
1

D.     Data Requirements

       Data requested in the June 1984 Registration Standard for linuron included
submission of studies on product chemistry, ecological effects, environmental fate,
residue chemistry, and toxicology. These data were required to support the uses listed
in the Registration Standard. In May 1986, a Data Call-In was issued for linuron
requiring product chemistry, chronic toxicity,  processing and cooking studies.
Subsequent DCIs were issued in September 1990 and November 1993 requiring
additional data to address ecological effects, phytotoxicity, and residue chemistry data
gaps. Appendix B includes all data requirements identified by the Agency for
currently registered uses needed to support reregi strati on.

E.     Regulatory History

       Linuron was registered in the United States in 1966 as a substituted urea
herbicide for use on asparagus, barley, carrots, celery, corn (field and sweet),
cottonseed, forage, grain, hay, oats, parsley, parsnips, potatoes, rye, sorghum,
soybeans, straw, and wheat (winter).  A Registration Standard for Linuron was issued
in June 1984 (NTIS #PB 85-149011) which required the submission of product
chemistry, residue chemistry, toxicology, ecological effects and environmental fate

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       studies.  In 1984, the Agency initiated a Special Review because linuron exceeded the
       oncogenicity risk criteria.  The Agency was concerned about applicator exposure and
       dermal penetration. The Special Review was concluded in 1988 and in the Federal
       Register (dated 6/26/90), the Agency revised the toxicological classification of linuron
       from a quantifiable Group C carcinogen to an unquantifiable Group C carcinogen.

             In 1991, DuPont voluntarily cancelled uses on cotton.  However, other
       registrants have not deleted this use from their end-use product registration labels.
       Uses on barley, oats, rye, forage, grain, hay, and straw were also voluntarily cancelled
       and do not appear on any labels.

             Three Data Call-Ins were subsequently issued (May 1986, September 1990,
       and November 1993) requiring additional data on product chemistry, chronic toxicity,
       processing and cooking studies, ecological effects, phytotoxicity and cropfield trials
       replacement data for studies generated by Craven Laboratories.  This Reregi strati on
       Eligibility Decision reflects a reassessment of all data which were submitted in
       response to the Registration Standard and the subsequent DCIs.
III.    SCIENCE ASSESSMENT

       A.    Physical Chemistry Assessment

             1.     Description of Chemical

                    Linuron [3 -(3 ,4-dichlorophenyl)- 1 -methoxy- 1 -methylurea] :

                             ci    />,
               ,
H              3
                             Cl           N     N     CH

                                               CH
                                 Empirical Formula:  C9H10C12N2O2
                                 Molecular Weight: 249.1
                                 CAS Registry No.: 330-55-2
                                 ShaughnessyNo.: 035506

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       2.     Identification of Active Ingredient

             Technical linuron is an odorless, white crystalline flake or powder with
       a melting range of 86-91C. Linuron is soluble in water at 81 mg/L at 25 C, and
       is slightly soluble in aliphatic hydrocarbons and moderately soluble in ethanol
       and common aromatic solvents.

             Assessments as to whether the various sources of technical linuron are
       substantially similar have been an integral part of the scientific review of the
       product chemistry database submitted in support of reregi strati on. The Linuron
       Guidance Document dated 6/29/84 required that additional data concerning all
       product chemistry topics be submitted in support of the reregi strati on of
       linuron.  The Linuron Reregi strati on Standard Update, dated 6/20/90, required
       additional product chemistry data.  Because sources for the registered technical
       products have changed repeatedly since the Linuron Update, the data
       requirements have also changed.

             All pertinent TGAI data requirements are satisfied for the DuPont
       linuron technical. Only the nominal concentrations of the product components
       remain outstanding for the MP requirements.  All of the registrants of linuron
       products must confirm the sources of linuron used for their products. The
       registrants are required to  submit the product chemistry data for the linuron
       technical products, and either certify that the suppliers of the starting materials
       and the manufacturing process for the linuron TGAIs and MPs have not
       changed since the last comprehensive product chemistry review or submit a
       complete updated product chemistry data package.

B.     Human Health Assessment

       1.     Toxicology Assessment

             The toxicological data base is adequate and will  support reregi strati on
       of linuron as a food and non-food use pesticide.

             a.    Acute Toxicity

                   Acute toxicity values and categories for linuron are summarized
             in the following table.

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TEST
Oral LD,0 - rat
Dermal LDW - rat
Inhalation LC,0 - rat
Eye Irritation - rabbit*
Dermal Irritation - rabbit*
Dermal Sensitization - guinea pig*
RESULTS
2600 mg/kg
> 2000 mg/kg
> 1.7mg/L
Slight conjunctival redness at 24
hrs; clear at 72 hrs
Not an irritant
Not a sensitizer
CATEGORY
III
III
III
III
IV
N/A
* Note: Data pertaining to acute eye irritation, dermal irritation, and dermal sensitization are not required to support
the reregistration of the TGAI. These data are presented for informational purposes.

                           In an acute oral toxicity study conducted in rats, the oral LD50
                    value for technical (96%) linuron was determined to be 2600 mg/kg
                    (Toxicity Category III).  In the same study, the dermal LD50 in rats was
                    established at >2000 mg/kg (Toxicity Category III). Inhalation
                    exposure of rats to 40.6% linuron resulted in a LC50 of >1.7 mg/L
                    (Toxicity Category III).  These acute oral, dermal, and inhalation studies
                    satisfy  Guidelines §81-1, §81-2, and §81-3, respectively. (MRIDs
                    00027625  and 00053769)

                           Application of 97.4% linuron to the rabbit eye resulted in slight
                    conjunctival redness at 24 hours, which was clear by 72 hours (Toxicity
                    Category III).  No corneal opacity or irritation of the iris was noted.  A
                    primary dermal irritation study in rabbits demonstrated that application
                    of 97.4% linuron produced no irritation (Toxicity Category IV). No
                    dermal sensitization occurred with 95% linuron in guinea pigs. The
                    primary eye and dermal studies and the guinea pig sensitization study
                    satisfy  Guidelines §81-4, §81-5, and §81-6, respectively. (MRIDs
                    00146868, 42849001, and 42849002)

                    b.     Subchronic  Toxicity

                           A 3-month subchronic study was conducted with linuron in rats
                    at dietary levels of 80, 400,  and 3000 ppm  (4, 20, and 150 mg/kg/day).
                    Observations of decreased red blood cell count and increased white
                    blood cell  count were noted at 400 ppm.  At the high-dose (3000 ppm)
                    growth was retarded. Based upon hematological findings, 400 ppm  (20
                    mg/kg/day) was established as the LOEL; the NOEL was 80 ppm (4
                    mg/kg/day) (US Government, 1963).

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       The requirement for a 90-day feeding study in dogs (§82-1) was
satisfied by the completion of two acceptable chronic studies conducted
with linuron in beagles.

c.      Chronic Toxicity and Carcinogenicity

       In a 1-year dog study 96.2% linuron was fed to groups of 4
beagles/sex/dose at dietary levels of 10, 25, 125, or 625 ppm (male:
0.29, 0.79, 4.17, or 18.6 mg/kg/day; females: 0.3, 0.77, 3.49, or 16.1
mg/kg/day, respectively); this study satisfies the §83-l(b) guideline
requirement for a chronic canine toxicity study. In a previous 2-year
dog study, linuron was administered in the diet to beagle dogs at 25,
125, or 625 ppm  (0.625, 3.13, or 15.63 mg/kg/day); an abnormal
pigment was observed in the blood of animals at all dose levels.
Decreased red blood cell count, hematocrit, and hemoglobin levels were
also  noted in males at 625 ppm.  Since the abnormal pigment was
postulated to be met- and sulfhemoglobin, assays for these substances
were conducted on the 1-year study. The presence of one or both
substances in the blood was confirmed for both sexes in the 125 and
625 ppm dose groups at all intervals tested (3, 6, 9, and 12 months).  At
625 ppm, evidence of red blood cell destruction was noted as increased
hemosiderin deposition on the Kupffer cells of the liver (male and
female), slight decreases in erythrocyte count, hemoglobin, and
hematocrit levels at all time periods tested, and a small increase in
erythropoietic activity in the bone marrow. Secondary hematological
changes at 625 ppm included increased platelet count, leukocyte count,
and serum cholesterol levels.  In addition, absolute liver weight was
increased in males at 625 ppm; relative liver weight was increased in
males at 125 and 625 ppm. Based upon hematology changes, the LOEL
for systemic toxicity was determined as 125 ppm  (4.17 mg/kg/day for
males; 3.49 mg/kg/day for females). The NOEL for systemic toxicity is
25 ppm (0.79 mg/kg/day for males;  0.77 mg/kg/day for females).
(MRIDs 40952601, 00018374, and 00018376)

       In a 2-year feeding/carcinogenicity study,  linuron (97%) was
administered to Crl:CD(SD)BR Sprague-Dawley rats at dietary levels of
50, 125, or 625 ppm (2.5, 6.25, or 31.25 mg/kg/day). Testicular
interstitial cell adenomas were observed at a significantly increased
incidence in mid- and high-dose males (125 and 625 ppm, respectively).
In addition, various indications of blood cell destruction and turnover
(increased mean corpuscular volume, decreased red blood cell count,
and possible reticulocytosis) were observed in both sexes at 125 and
625 ppm. Analysis of percent hemoglobin to evaluate hematotoxicity
                      10

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indicated that males were not affected, but percent hemoglobin was
decreased for females at 6 and 12 months for the high-dose group, and
at 12 months for the mid-dose group. Therefore, based upon
hematotoxicity, observed as a decrease in the percent hemoglobin, the
LOEL for systemic toxicity for females was 125 ppm (6.25 mg/kg/day).
The systemic NOEL for females was 50 ppm (2.5 mg/kg/day), and the
systemic NOEL for males was 625 ppm (31.25 mg/kg/day). The
requirements for chronic and oncogenicity testing in rodents [Guidelines
§83-l(a) and §83-2(a)] were satisfied by this study. (MRID 00029680)

      In another two-year rat feeding study, in which groups of albino
rats were treated with dietary linuron at levels of 25, 125, or 625 ppm
(1.25, 6.25, or 31.25 mg/kg/day), the systemic NOEL was determined to
be 125 ppm. At the LOEL of 625 ppm (31.25 mg/kg/day), growth
retardation was observed.  In addition, at that dietary level, hemosiderin
content of the spleen was increased for both sexes, marrow fat was
reduced for females, the ratio of myeloid-to-erythroid precursors was
reduced for males, and the incidence of endometrial hypoplasia was
increased for females.  These findings were considered to be indicative
of hemolysis (MRID 00018379).

      An 18-month feeding study was conducted in Crl:CD(SD)BR
rats to study the effects of linuron (94.5%) on methemoglobin and
sulfhemoglobin blood concentrations.  The dietary levels tested were
25,  125, or 625 ppm (1.25, 6.25, or 31.25 mg/kg/day). Based upon
significant changes noted in blood pigments in mid- and high-dose
female rats and in high-dose male rats, the LOEL was determined to be
625 ppm (31.25 mg/kg/day) and 125 ppm (6.25 mg/kg/day) for male
and female rats, respectively.  The corresponding NOELs for male and
female rats were 125 and 25 ppm (6.25 and 1.25 mg/kg/day). (MRID
00149883)

      In a two-year feeding/oncogenicity study in CD-I mice, linuron
was administered in the diet at levels of 50, 150, or 1500 ppm (12, 35,
or 455 mg/kg/day). This study satisfied the requirement for Guideline
§83-2(b) carcinogenicity study in a second rodent species.  A
statistically significant increase in the incidence of hepatocellular
adenomas was observed at 1500 ppm for female mice, and border-line
statistical significance was attained for hepatocellular adenomas at 50
ppm for male mice. At 1500 ppm, body weight and body weight gain
were decreased for both males and females throughout the study.
Methemoglobin values were increased at all dietary levels for both
sexes. Mean absolute and relative liver weights were increased for
                      11

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females at 1500 ppm. For both males and females at that level,
histopathological evaluation identified increased incidences of
hemosiderosis of the spleen and hepatocytomegaly, hepatocellular
cytoplasmic alteration, hepatocellular vacuolization, hemorrhage, and
necrosis of the liver. A NOEL was not established; the systemic toxicity
LOEL, based on increased methemoglobin values, was < 50 ppm (12
mg/kg/day). (MRID 00124195)

       Linuron was placed in Special Review for carcinogenesis in
1982. It was later classified as a Group C carcinogen with a Qt* of 2 x
10"5 on the basis of a dose-related increase in interstitial cell hyperplasia
and adenomas in a two-year rat feeding study and hepatocellular tumors
that appeared in low-dose male and high-dose female mice in a two-
year feeding study. Subsequent review by the OPP/HED Peer Review
Committee and the Science Advisory Panel resulted in the elimination
of the Qj*, since the weight of evidence suggested that the carcinogenic
potential of linuron in humans is weak and it should not be regulated
using a linearized multi-stage risk assessment model.  (MRIDs
00029680, 00124195, and U.S. EPA, 1989)

d.     Developmental Toxicity

       In a developmental toxicity study conducted with 97% linuron in
Sprague-Dawley rats, dietary doses of 50, 125, or 625 ppm (5.0, 12.1,
or 49.8 mg/kg/day, respectively) were administered on days 6-15 of
gestation; this study satisfied Guideline §83-3(a) requirement for a
developmental toxicity study in rodents.  The NOELs for maternal
systemic toxicity and developmental toxicity were 125 ppm (12.1
mg/kg/day). The LOEL of 625 ppm (49.8 mg/kg/day) for maternal
systemic toxic effects was based upon decreased body weight and food
consumption values. The developmental toxicity LOEL of 625 ppm
(49.8 mg/kg/day) was based on increases in postimplantation loss and
increases in the litter and fetal incidences of resorptions.  (MRID
00018167)

       When 96.2% linuron was administered by gavage to New
Zealand White rabbits  at doses of 5, 25, or 100 mg/kg/day on days 7
through 19 of gestation, a maternal systemic toxicity LOEL was
observed at the 25 mg/kg/day level, based upon reduced maternal body
weight, thereby  defining the NOEL as 5 mg/kg/day.  At the high-dose
level (100 mg/kg/day), maternal body weight, food consumption,
absolute liver weight, and liver-to-body weight ratios were decreased.
The developmental toxicity NOEL was determined to be 25 mg/kg/day,
                      12

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based upon an increased number of abortions, decreased mean number
of fetuses per litter, decreased fetal body weight, and increased
incidence of fetuses with skeletal variations of the skull at the 100
mg/kg/day level (the developmental toxicity LOEL). This study
satisfied Guideline §83-3(b) data requirements for a developmental
toxicity study in rabbits. (MRID 00153867)

e.      Reproductive Toxicity

       In a two-generation reproductive toxicity study in Sprague-
Dawley rats, dietary levels of 12.5, 100, or 625 ppm linuron (96.2%)
(males: 0.84, 6.8, or 44.75 mg/kg/day; females:  1.0, 8.3, or 54.1
mg/kg/day) were administered. This study satisfied the data
requirements for Guideline §83-4 for a multigeneration reproductive
toxicity study in rats. Since no evidence of adverse effects on fertility
or reproductive performance was noted, the reproductive toxicity LOEL
was undetermined, and the reproductive toxicity NOEL was estimated
to be greater than 625 ppm (44.75 and 54.1  mg/kg/day for males and
females, respectively).  The parental systemic toxicity NOEL was 12.5
ppm, and the systemic LOEL was 100 ppm, based upon decrements in
parental body weight gain. In addition, at the 625 ppm level, testicular
and epididymal abnormalities (testicular atrophy and intratubular
fibrosis; epididymal inflammatory response or oligospermia) and ocular
abnormalities (mineralization of the cornea; lens degeneration) were
observed at histopathological evaluation of the Fl adults.  Further
evaluation of reproductive organ weight and hormone data from the Fl
adults of this 2-generation study combined with an in vitro analysis of
the ability of linuron and its metabolites to compete for binding to the
androgen receptor resulted in the conclusion that linuron is a weak
androgen receptor antagonist.  These results support the hypothesis that
rats exposed to linuron  could develop interstitial cell hyperplasia and
subsequent adenomas (Leydig cell tumors) of the testicular tissue via a
mechanism of sustained hypersecretion of luteinizing hormone induced
by the  antiandrogenic potential of linuron. (MRID 41463401,
41864701,41630101)

       A three-generation reproductive toxicity  study in Sprague-
Dawley rats, was conducted with 94.5% linuron at dietary levels of 25,
125, or 625 ppm (approximately 1.25, 6.25, and 31.25  mg/kg/day).
Parental systemic effects observed included reduced premating body
weight in females of all three generations at 125 and 625 ppm, reduced
body weights at weaning for 125 ppm dams, and alopecia in both sexes
for the FO and Fib adults at 625 ppm. Based upon the findings at the
                      13

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mid-dose level, the systemic LOEL was determined to be 125 ppm (6.25
mg/kg/day), and the systemic NOEL was 25 ppm (1.25 mg/kg/day).
The reproductive toxicity NOEL was 25  ppm (1.25 mg/kg/day) and the
reproductive toxicity LOEL was determined to be 125 ppm (6.25
mg/kg/day), based on the following findings. Fertility was reduced in
generations at 625 ppm F2a through F3a. Pup survival was consistently
decreased for pups at 625 ppm, with most deaths occurring in the first
24 hours postpartum, and a trend for decreased viability from days 1-4.
Weanling body weights were decreased for Fib and F2b male and
female pups at 125 ppm and 625 ppm. Absolute liver and kidney
weights of weanlings (both sexes) were decreased, and histopathology
of the 625 ppm F2b weanlings identified a frequent incidence of liver
atrophy (decreased cytoplasmic clear spaces of hepatocytes).  This study
was flawed by  the lack of histopathological data on the adult animals;
however, the systemic study results are considered to be supportive of
those obtained  from the two-generation study on linuron.  (MRIDs
00146071 and  41463401)

f.      Mutagenicity

       Technical linuron did not produce gene mutation in an Ames
assay,  in which Salmonella typhimurium bacteria were tested without
activation up to 5.0 jig/plate and with activation up to 100 jig/plate. In
an in vitro assay using CHO cells, linuron did  not produce gene
mutations when tested up to 0.50 mM in a nonactivated system and up
to 1.0 mM in an S9-activated system. Similarly, linuron did not induce
bone marrow chromosome aberrations in vivo, and in other tests for
genotoxicity, linuron did not induce unscheduled DNA synthesis in
isolated rat  hepatocytes. These studies met the mutagenicity  testing
requirements for Guidelines §84-2(a), §84-2(b), and §84-4 (gene
mutation, structural chromosomal aberration, and other genotoxic
effects). (MRIDs 00131738, 00137152, 00137153, and 00132583)

g.     Metabolism

       The  metabolism and tissue distribution  of [phenyl-14C](U)
linuron was studied in male and female Sprague-Dawley rats. The
results of several metabolism studies and communications containing
supplemental information were combined to satisfy the requirements for
Guideline §85-1 metabolism study.  In the first study, labeled linuron
was administered as a single gavage dose to 2  rats/sex/dose at 24 mg/kg
and 400 mg/kg and also as  a single 400 mg/kg gavage dose following
dietary pretreatment at 100 ppm  (approximately 10 mg/kg) to 2
                      14

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rats/sex/dose. To further elucidate the metabolic pathway of linuron, a
second study was conducted in which a single oral dose of 400 mg/kg
of 14C-linuron was administered by gavage to five Sprague-Dawley rats
per sex. The results from these studies indicate that linuron was
extensively metabolized by male and female rats at both the low- (24
mg/kg) and high-dose (400 mg/kg) levels when administered by gavage.
The majority of the administered 14C-linuron was eliminated in the urine
and, to a lesser extent, in the feces, within 96-120 hours.  In general,
tissue and organ residues were very low (<1%) at both dose levels, and
there was no indication of accumulation or retention of linuron or its
metabolites. The major metabolites identified in the urine and feces
were hydroxy-norlinuron and norlinuron.  Approximately 4-5% and 6-
8% of the urinary and fecal metabolites, respectively, remained
unidentified. Exposure to linuron appears to induce mixed function
oxidative enzymes. (MRIDs 00146489, 40142401, 41960001,
42006801,42318701)

h.    Reference Dose (RfD) for Chronic Oral Exposure

      The RfD for linuron was determined to be 0.0077 (0.008) mg/kg
bodyweight per day. This was based on results of a one-year chronic
dog study in which hematological changes demonstrated LOELs of 4.17
and 3.49 mg/kg/day for males and females, and NOELs of 0.79 and
0.77 mg/kg/day. The RfD calculation was based upon the NOEL of
0.77 mg/kg/day and used an uncertainty factor of 100 to account for
inter-species extrapolation and intra-species variability. (MRID
40952601)

      There has been no WHO RfD determination yet.

i.     Dermal Absorption

      In a dermal absorption study rats were exposed to dose levels of
0.12, 0.87, and 7.4 mg of linuron, as a radiolabelled Lorax L
formulation, with both sexes at the low-dose level, and males only at the
mid- and high-dose levels.  Although the study was found to be
unacceptable by current Agency standards, a dermal absorption value
could be determined.  The potential dermal absorption of linuron to
humans is estimated to be approximately 2% per hour or 16% per 8-
hour workday. (Accession NO. 254943)
                      15

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2.     Exposure Assessment

       a.     Dietary Exposure

             Tolerances for residues of linuron in/on plant and animal
       commodities are expressed in terms of linuron per se [40 CFR
       §180.184(a) and (b)]. No food/feed additive tolerances have been
       established for linuron residues.  The established tolerances listed in 40
       CFR §180.184 range from 0.25 ppm to 3 ppm.  The Health Effects
       Division's Metabolism Committee has concluded that the residues of
       concern are linuron and its metabolites convertible to
       3,4-dichloroaniline, expressed as linuron; residues of
       3,4-dichloroaniline/>er se need not be regulated separately. The
       committee expressed concern that 3,4-DCA may be a carcinogen in
       light of the fact that p-chloroaniline is a quantifiable carcinogen.
       Because of the low levels found; however, the committee decided that
       3,4-DCA could pose no greater than a negligible risk in connection with
       the registered use of linuron. Adequate enforcement methods are
       available for the determination of linuron residues of concern in/on
       plant and animal tissues.  The current enforcement methods determine
       linuron and all metabolites hydrolyzable to 3,4-dichloroaniline.

             Plant Metabolism: The qualitative nature of the residue in plants
       is adequately understood. Metabolism studies with corn, soybeans, and
       potatoes indicate that linuron is absorbed from the soil and translocated
       (i.e., systemic).  The metabolic pathway involves demethylation to 3-
       (3,4-dichlorophenyl)-l-methoxyurea which is further metabolized to
       3,4-dichloroaniline; metabolism may also occur through
       demethoxylation of linuron. The terminal residues of concern are the
       parent and its metabolites which are convertible to 3,4-dichloroaniline.
       (MRIDs 00018173, 00018176, 00027624, 40084801, 42542101, and
       42548401).

             Animal Metabolism: The qualitative nature of the residue in
       ruminants and poultry is  adequately understood. An acceptable
       metabolism study with goats indicates that linuron is rapidly
       metabolized by demethylation, demethoxylation, and hydroxylation and
       is primarily eliminated by excretion.  The metabolism of linuron in
       poultry has been found to be consistent with the goat study. The
       terminal residues of concern are the parent and its metabolites which are
       convertible to 3,4-dichloroaniline.  (MRIDs 00029932, 42635401, and
       43245101).
                             16

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       Residue Analytical Methods - PI ants/Animals:  Adequate
enforcement methods are available for the determination of linuron in
plant and animal commodities. The Pesticide Analytical Manual (PAM)
Vol. II lists a colorimetric method (Method I, Bleidner et. al.) and a
paper chromatographic method (Method II). Residues of diuron may
interfere in Method I.  A modified version of Method I (H. L. Pease,
Journal of Agric. and Food Chem., 1962, Vol. 10, p. 279), which
includes a cellulose column step to separate linuron from diuron, is
currently the preferred method for the enforcement of tolerances.  Both
these methods determine linuron and all metabolites hydrolyzable to
3,4-dichloroaniline and have limits of detection of 0.05 ppm. A
GLC/ECD method for linuron residues in/on asparagus from the CA
Department of Food and Agriculture has been validated by the Agency
and sent to FDA to be published in PAM Vol. II as Method III. This
method determines residues of linuron per se and the limit of detection
is 0.05 ppm. However, this method is inadequate for tolerance
enforcement since it does not determine all the residues of concern. In
addition, this method uses benzene as the extraction solvent.  (MRIDs
00018087, 00018089,  00018127, and 00018176).

       The FDA Pestrak Database (PAM Vol. I) contains data
concerning the applicability of multiresidue methods D and E (fatty and
nonfatty foods) for recovery of linuron and its metabolites 3-(3,4-
dichlorophenyl)-1 -methoxyurea, 3 -(3,4-dichlorophenyl)-1 -methylurea,
3,4-dichlorophenyl urea and 3,4-dichloroaniline. Linuron is partially
recovered using Multiresidue Method E (fatty and nonfatty foods);
recovery using Method D is variable.  Linuron metabolites 3-(3,4-
dichlorophenyl)-1 -methoxyurea, 3 -(3,4-dichlorophenyl)-1 -methylurea,
and 3,4-dichlorophenyl urea are not recovered using Method E (fatty
and nonfatty foods); 3-(3,4-dichlorophenyl)-l-methylurea is recovered
using Method D but 3-(3,4-dichlorophenyl)-l-methoxyurea is not likely
to be recovered using this method. Linuron metabolite 3,4-
dichloroaniline is not recovered using Method E (nonfatty foods) and
has variable recovery using Method D.

       Storage Stability:  Residues of linuron in frozen analytical
samples of potatoes have been shown to be stable for a period of at least
12 months. Residues in/on  soybeans, sugar beet tops, carrots, and
asparagus have been shown to be stable for up to approximately two
years of storage at -20°C. The Agency will translate this data in
accordance wtih the Storage Stability Guidance Document (1/93)
concerning translation of crop stability to crop groupings. The Agency
concludes that linuron is stable in oilseeds/nuts, leafy vegetables, and
                      17

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root vegetables for a period of at least two years.  The conclusion
regarding this latter crop group assumes that the 18 month storage
interval data for the potato and processed potato commodity storage
stability study, currently in review, are found to be acceptable.

       Linuron has been shown to be stable in corn grain, corn oil,
sorghum grain, and sorghum starch for a period of at least 3 months.
The Agency concludes that linuron is stable on non-oily grain crops for
a period of at least one year, providing the 12-month storage stability
data, currently in review, are found to be acceptable.

       The Agency concludes that additional storage stability data will
not be necessary provided that storage intervals do not exceed one-year
for non-oily grains and two years for oilseeds/nuts, leafy vegetables, and
root crops:  the registrant has provided sufficient data to indicate that
significant linuron residue declines are not expected to occur in
oilseeds/nuts, leafy vegetables, root vegetables, and non-oily grains over
short to intermediate storage intervals. Since residues have been shown
to be stable in several  matrices, no additional storage stability data other
than the studies currently in review (discussed above) will be required,
provided that linuron is not registered for use on fruits, fruiting
vegetables, or citrus.  (MRIDs 00159802, 41716103, 42836701,
42836702, 43040001, 42913301, and 42974401).

       Magnitude of the Residue in Plants:  All data for magnitude of
the residue in carrots,  corn field, grain; corn field, forage and fodder;
celery, parsley, parsnips, potatoes, sorghum grain, soybeans, and wheat
grain and straw have been evaluated and deemed adequate to reassess
tolerances for these commodities.

       Field residue data remain outstanding for the following crops:
asparagus; corn, sweet (K + CWHR); corn, sweet, forage; sorghum
forage and fodder; soybeans forage and hay; and wheat forage. In
addition, aspirated grain fraction data remains outstanding for field corn.

       Sufficient data to reassess tolerances for these commodities are
not available at this time. Although sufficient field trial  data are not
available to reassess tolerances for all crops, sufficient data are available
to do a reliable exposure assessment. (MRIDs 00018067, 00018076,
00018087,00018089, 00018148, 00018171, 00018172, 00018175,
00018206,00018375, 00018382, 00018443, 00018450, 00027635,
00163267,40210901, 40537601, 41189801, 41377601, 41452601,
                      18

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41452701, 41501501, 41503401, 41569901, 42605901, 42948501,
43039101, and 43044101).

       Two additional field residue studies on corn and soybean raw
agricultural commodities have been submitted. However, data from
these submissions were not evaluated because they were generated by
Craven Laboratories. Replacement data for field corn commodities and
soybean grain were found to be adequate. Replacement data are still
needed for sweet corn raw agricultural commodities and soybean forage
and hay.  The existing feeding restriction prohibiting the feeding of
soybean forage and hay should be removed because the feeding
restriction is no longer considered practical (see Livestock Feeds Table,
6/94 Subdivision O. Residue Chemistry. Guidelines) (MRIDs 41510501,
41591801, 43039101, and 43044101).

       Processed Food/Feed:  All data for magnitude of the residue in
processed food/feed have been evaluated and deemed adequate except
that a full processing study is required for cottonseed and additional
data are required to upgrade an existing potato processing study.  In
1991, DuPont voluntarily deleted the linuron use on cotton. However,
other registrants have not deleted the cotton use from their end-use
product labels. Registrants are required to either submit the required
processing study for cottonseed or amend their labels deleting the cotton
use.  The tolerance for cottonseed will be revoked if no registrants
support this use.

       Outstanding potato processing data are required for chips,
granules, dry and wet peel waste; sufficient data are available to
reassess tolerances and estimate dietary exposure for potato processed
products. Because linuron is assessed as a Group C nonquantifiable
carcinogen, it is subject to the Delaney clause of the FFDCA. See
Section IV.B.l "Tolerance Reassessment." (MRIDs 00018206,
42462901, 42542102, and 42560001).

       Magnitude of the Residue in Meat. Milk. Poultry and Eggs: All
data for magnitude of the  residues in meat, milk, poultry, and eggs have
been evaluated and deemed adequate.  No tolerances are required for
poultry and eggs.  (MRIDs 00018209, 00018210, 00018375, 00018383,
00018450, 00018775, and 00029932).

       Recently the Agency received interim data from DuPont
indicating that residue levels of linuron in or on corn fodder exceeded
the 1 ppm tolerance.  Preliminary data from field trials on corn indicate
                      19

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a tolerance of 6 ppm will be required to cover residues resulting from
current registered uses. These data were submitted to the Agency under
6(A) (2) of FIFRA.  Since corn fodder is a major feed item for
ruminants throughout the U.S., a revision to the previously estimated
dietary burden to ruminants is required. The Residue Chemistry
Chapter (6/29/82) to the Linuron Registration Standard previously
estimated a "maximum plausible dietary load of 1.4 ppm."  This
estimate utilized the established tolerance of 1.0 ppm in or on corn
fodder. However, assuming residues are present at levels of
approximately 6 ppm (the level at which tolerances may be required
considering the currently available 6 (a)(2) data) a hypothetical diet
based on feeding 50% corn grain and 50% corn fodder would result in a
dietary burden of approximately 3.1 ppm.

      Based on available ruminant feeding studies, the Agency
concludes that established tolerances for meat and milk are adequate to
cover the increased dietary burden of 3.1 ppm.  It should be noted
however that the estimated residue level in ruminant liver (0.81 ppm)
and kidney (0.81 ppm) are approaching the established tolerances of 1.0
ppm.  Should the currently estimated ruminant dietary burden of 3.1
ppm be increased, established linuron tolerances for ruminant liver and
kidney will need to be reassessed.

      Confined/Field Rotational Crops:  All data for nature of the
residue in confined rotational crops have been evaluated and deemed
adequate.  The requirement for field rotational crop studies has been
waived. (MRIDs 40104101 and 40730101). The following are
rotational crop restrictions:

      "If initial seeding fails to produce a stand, crops
      registered for the rate of "name of product" that has been
      applied may be planted into the treated area."

      Unless otherwise directed, any crop may be planted after
      4 months except for cereals where only barley,  oats, rye,
      and wheat may be planted.

      Reduction of Residues:  All data for reduction of residues have
been evaluated and deemed adequate except that additional information
to upgrade existing potato and carrot cooking studies remains
outstanding. However, since there is not a dietary risk, the additional
information to upgrade the cooking studies will not be required.
(MRIDs 41241201, 42379901, 42397201, 42462901, and 42462902).
                      20

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       The asparagus cooking study shows washing with water reduces
residues by 40%.  Boiling removes an additional 25% of the residues,
while steaming had little or no effect on reducing residue levels in or on
asparagus.

       A carrot cooking study reviewed and found to be unacceptable
due to residues below the limit of quantitation does indicate that
cooking in boiling water does reduce overall residues.

       The potato cooking study shows that linuron residues
concentrate in or on oven baked potatoes (1.5X) and microwave baked
potatoes (1.6X), but are reduced in or on boiled potatoes (0.48X).

b.     Occupational and Residential

       Linuron is a substituted urea herbicide used to control
germinating and newly emerging grasses and broad-leaved weeds. It is
applied to agricultural crops, ornamental bulbs, and to poplar trees, for
use in shelterbelts, in the mid-west. Formulations include water
dispersable granules, wettable powders, flowable concentrates, and
emulsifiable concentrates.  Linuron is usually applied after the crop has
been planted, but before the weeds emerge. In some cases,  over-top
sprays are applied to newly emerging crops such as carrots and celery.
In asparagus, sprays may be applied between cuttings of newly
emerging spears for weed control during harvesting activities. Current
label directions allow for both ground and aerial applications.  Although
some registered uses are for crops  that may be grown in home gardens,
the Agency is not aware of any products that are labelled primarily for
home use.

       Postapplication/reentry and mixer/loader/applicator exposure
data are required when both toxicity and human exposure criteria are
met. The application methods (broadcast and directed) result in direct
exposure of mixer/loaders and applicators to the formulated product.
When workers enter treated areas to perform hand labor tasks, such as
thinning, cultivation, and harvesting, or to perform irrigation-related
tasks, they may be exposed to residues on the soil surface and to
residues on the foliage following post-emergence applications.
Therefore, linuron meets the Agency's human exposure criteria. The
OPP/HED Toxicology Endpoint Selection Committee identifies two
endpoints for assessing short-term and intermediate occupational
exposure to linuron.  Therefore, linuron meets the toxicity criteria.
                      21

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Mixer/Loader/Applicator Exposure (Handlers):

       In the Guidance for the Reregi strati on of Linuron (June 29,
1984), the following personal protective equipment were required for
mixer/loader/applicators handling linuron:

       One-piece overalls which have long sleeves and long
       pants constructed of finely woven fabric as specified in
       the USDA/WPA Guide for Commercial Applicators.

       Wide-brimmed hat and heavy-duty fabric work gloves.

       Instead of clothing and equipment specified above, the
       applicator can use an enclosed tractor cab which provides
       a filtered air supply.

       The PPE requirements were based on concerns for linuron as a
carcinogen, and that lifetime exposures for mixer/loader/applicators
resulted in an unacceptable risk, without those PPE. In a subsequent
OPP/HED Peer Review Committee and Science Advisory Panel, it was
determined that the carcinogenic potential of linuron in humans is weak,
and it should not be regulated using a linear multi-stage risk assessment
model.

       Since the  issuance of the Registration Standard in 1984, linuron
product labels have been modified in response to PR Notice 93-7, which
implemented the labelling requirements of the 1992 Worker Protection
Standard for Agricultural Pesticides.  These WPS-mandated label
modifications established personal protective equipment (PPE)
requirements on each end-use product depending on the acute toxicity
of the end-use product.  However,  if the existing labelling contained
PPE requirements more stringent than those that the WPS would
establish, the more stringent requirements would be retained.  Current
linuron labels, therefore, may contain a variety of PPE requirements,
depending on what other active ingredients and on what inert
ingredients are included in  a particular formulation.

       Mixer/loader/applicator (handler) exposure to linuron was
derived from data in the Pesticide Handlers Exposure Database (PHED).
Exposure for ground-boom and aerial applicators was addressed as well
as exposure for mixer/loaders using wettable powder and liquid
formulations.
                      22

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       The data in PHED are normalized by pounds of active ingredient
handled, and, are referred to as unit exposures.  Whenever possible,
surrogate unit exposures are chosen from studies having the same PPE
as required on the labelling of the chemical currently being evaluated.
When data are not available for certain clothing scenarios, existing data
points are adjusted using a protection factor based on the type of PPE
(eg. a 50% reduction to hand exposure for the use of gloves).  Although
a 90% protection factor for gloves has been used in the past, a
conservative 50% reduction was used in this assessment. The handler
assessment presented in this memorandum  assumes the use of long
sleeved shirt, long pants, gloves, and coveralls.  This double layer is an
upgrade to existing PPE.

Postapplication/Reentry Exposure (Workers):

       The potential for postapplication/reentry exposure is unlikely
following most applications of linuron. This is because most
applications are made early in the season before reentry tasks are likely
or are made to crops that are mechanically harvested.  The notable
exception is asparagus where applications of linuron are made between
asparagus cuttings.  Current labelling indicates a 24-hour reentry
interval, which was  established in the 1984 Registration Standard
Guidance Document. The 24-hour reentry  interval established by the
1984 Registration Standard Guidance Document was converted  into a
24-hour restricted-entry interval through modifications to the labelling
specified in PR Notice 93-7, which implemented the labelling
requirements of the  1992 Worker Protection Standard for Agricultural
Pesticides.

       To formally establish a REI, the registrant submitted a worker
exposure study addressing asparagus worker exposure "Exposure of
Asparagus Harvesters to Lorox® (Linuron) Herbicide in California,
1986." In the study,  the registrant measured exposures for three  worker
tasks; harvesters, sledders, and off-loaders. Harvesters cut the spears
and leave  them in bundles  at various locations in the field. Sledders
drive a tractor and wagon along the field and  pick up the bundles of
asparagus left by the harvesters. Off-loaders unload the asparagus from
the wagons at the packing  house. Because asparagus harvesting occurs
over a long period of time, the use of both the short-term and the
intermediate-term end-points are appropriate for addressing
postapplication/reentry exposure. (MRID 40341801)
                      23

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             The following confirmatory occupational exposure data are
      required:

             132-la Foliar Dislodgeable Residues (carrots and celery)
             132-lb Soil Dislodgeable Residues (carrots and celery)
             133-3  Dermal Exposure (carrots and celery)
             133-4  Inhalation Exposure (carrots and celery)

             The Agency requires that foliar and soil dislodgeable residue
      studies, and dermal and inhalation exposure studies be conducted
      concurrently.

3.    Risk Assessment

      a.     Dietary

             The acute dietary endpoint for one day was based on a
      developmental toxicity study in the rabbit.  When  96.2% linuron was
      administered by  gavage to New Zealand White rabbits at doses of 5, 25
      or 100 mg/kg/day on days 7 through 19 of gestation, a maternal
      systemic toxicity was observed at 25 mg/kg/day, based upon reduced
      maternal body weight. The developmental toxicity NOEL was
      determined to be 25 mg/kg/day based upon an increased number of
      abortions, decreased mean number of fetuses per litter, decreased fetal
      body weight, and increased  incidence of fetuses with skeletal variations
      of the skull at 100 mg/kg/day.  The endpoint and dose for use in risk
      assessment is a NOEL of 25 mg/kg/day (basis described above). (MRID
      00260064)

             The RfD  for linuron was determined to be  0.0077 (0.008) mg/kg
      bodyweight per day. This was based on results of a one-year chronic
      dog study in which hematological  changes demonstrated LOELs of 4.17
      and 3.49 mg/kg/day for males and females, and NOELs of 0.79 and
      0.77 mg/kg/day.  The RfD calculation was based upon the NOEL of
      0.77 mg/kg/day and used an uncertainty factor of  100 to account for
      inter-species extrapolation and intra-species variability. (MRID
      40952601)

             There has been no WHO RfD determination at this time.

             The Health Effects Division Metabolism Committee discussed
      the possible significance of 3,4-dichloroaniline residues in plants and
      animal tissues resulting from treatment with linuron.  The Committee
                            24

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expressed concern that 3,4-DCA may be a carcinogen in light of the fact
that p-chloroaniline is a quantifiable carcinogen.  3,4-DCA does not
pose dietary risks of concern. Nonetheless, the Agency still considers
linuron to be a chemical that "induces cancer" within the meaning of
section 409 of the FFDCA.

Residues

      Anticipated residues from the 1987 Special Review of Linuron
were used in the analysis of chronic exposure.

      Information on percent of crop treated was supplied by the
Biological and Economic Analysis Division, a table entitled "Typical
Annual Usage (1992) and Percentage of various U.S. Crops Treated
with Linuron".  For most crops, the estimate of percent crop treated is
the same as or lower than the 1989 estimates provided by BEAD.
However, no estimates were supplied for "small grains" in the 1993
table, whereas the estimate was "< 1%" in  1989.  In cases where no
estimates are supplied, Dietary Risk Evaluation System (ORES) policy
is to assume that 100% of the crop is treated. Thus, the percent of crop
treated value used in the ORES run went from 1% to 100% for barley,
oats, and rye. ORES believes that this is likely to be an overestimate,
and that the acutal (domestic) use on these crops may even be 0% since
there are no  registered products for these uses.  However, in the absence
of confirmation from BEAD, the default value of 100% was assumed.

      Although this ORES analysis uses anticipated residues and
percent of crop treated where available, a separate part of the analysis
uses tolerances to estimate theoretical maximum exposure. The
tolerance reassessment suggested that some tolerances  should be
revoked (barley, oats, rye, and popcorn) or that there were insufficient
data to support a tolerance (asparagus, sheep).  In these cases, the ORES
analysis used the existing tolerance rather than the reassessed tolerance.
The resulting Theoretical Maximum Residue Contribution (TMRC) is
thus likely to be higher than what would be expected if all of the
tolerances suggested in the tolerance reassessment were implemented.
(It is possible, however, that a reassessed tolerance for  asparagus and
sheep could  raise exposure above what is estimated in the  TMRC.)

      For the acute dietary exposure analysis, tolerance values were
used. Anticipated residues for acute analysis were not  provided.
Information  on percent of crop treated was not used.
                      25

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       Proposed tolerances for lettuce, ginger, and taro, and proposed
tolerance revisions for potatoes and meat byproducts, are not included
in this DRES analysis.

Results

       Chronic exposure: Exposure to the general population based
on anticipated residues is expected to be approximately 0.000185 mg/kg
body weight/day, or 2% of the Reference Dose. Of the standard
subgroups routinely analyzed by the Dietary Risk Evaluation System,
the two subgroups with the highest exposures are non-nursing infants
less than 1 year old, with expected exposures of 0.000485 mg/kg/day
(6% of the RfD), and children 1 through 6 years old, with expected
exposures of 0.000343 mg/kg/day (4% of the RfD).

       Acute exposure:  High-end exposure to females 13 years of age
or older (ORES' approximation of women of childbearing age) on any
given day is expected to be 0.015 mg/kg/day, or result in a MOE of
1667 for developmental toxicity. Mean exposure is expected to  be
0.003365 mg/kg/day, or 7400 times less than the NOEL for
developmental toxicity.
       The estimate of acute exposure is likely to be an overestimate
inasmuch as it assumes that consumers will eat tolerance levels of
linuron residue on all items simultaneously.  This is an unlikely
occurrence, given that less than 100% of any one crop is treated  with
linuron, and that residues are rarely at tolerance level on all fields that
are treated.

b.     Occupational and Residential

       Occupational and Residential risk

       The short term occupational or residential exposure for 1  to 7
days was based on a developmental toxicity study in the rat. Sprague-
Dawley rats were given dietary doses of 50, 125 or 625 ppm (equivalent
to 5.0,  12.1 or 49.8 mg/kg/day) on  days 6-15 of gestation. The maternal
and developmental NOEL is 12.1 mg/kg/day.  The LOEL is 49.8
mg/kg/day based upon decreased maternal body weight and food
consumption, and increased postimplantation loss and increased in litter
and fetal incidences of resorptions (maternal and developmental  effects,
respectively). The endpoint and  dose for use in risk assessment  is a
NOEL of 12.1 mg/kg/day as described above.  (MRID 00018167)
                      26

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       The intermediate term occupational or residential exposure (1
week to several months) was based on a three-generation reproduction
study in the rat. Sprague-Dawley rats were given dietary doses of 0, 25,
125 or 625 ppm linuron (equivalent to 0, 1.25, 6.25 or 31.25 mg/kg/day)
through three successive generations. Parental systemic effects
observed included reduced premating body weight in females of all
three generations at 125 and 625 ppm, reduced body weights at weaning
for 125 ppm dams, and alopecia in both sexes for the FO and Fib adults
at 625 ppm. Based upon the findings at the mid-dose level, the systemic
LOEL  was determined to be 125 ppm (6.25 mg/kg/day), and systemic
NOEL was 25 ppm (1.25 mg/kg/day). The reproductive NOEL was
also 25 ppm based upon reduced fertility in the F2a through F3a
generations at doses of 125 ppm or greater. The endpoint and dose for
use in risk assessment is a NOEL of 1.25 mg/kg/day based upon
reduced fertility at the LOEL of 6.25  mg/kg/day. (MRID 00146071)

       Table 3 gives the Margins of Exposure (MOE's) for applicator
and mixer/loader exposure scenarios. Information regarding the studies
from which the surrogate data were selected is provided in Table 4. For
all of the applicator scenarios, MOE's are greater than 100.  However,
MOE's for certain mixer/loader scenarios are below 100 for both short-
term and intermediate-term exposure.  Particularly low, are those MOE's
for mixer/loaders supporting the aerial applications. For those
scenarios, MOE's are below 100 for intermediate-term exposure, even
with the use of closed mixing/loading systems.

       MOE's are also low for handlers using open mixing/loading for
ground-boom applications. MOE's for closed mixing/loading systems
appear to be adequate.

Margins of exposure may be calculated from:

       MOE = NOEL
               exposure

•     The NOEL equals 12.1 mg/kg/day for short-term (1-7 days)
       exposure
•     The NOEL equals 1.25 mg/kg/day for intermediate (> 7 days)
       exposure
                      27

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             Postapplication/Reentry Exposure (Workers):

                          The study "Exposure of Asparagus Harvesters to Lorox®
                    (Linuron) Herbicide in California, 1986" (MRID 40341801) is
                    considered supplemental, and can be used to evaluate the current use of
                    linuron on asparagus. The sampling schedule was limited to 0 day, 1
                    day, and 3 days postapplication because of inclement weather.
                    Therefore, a dissipation curve could not be established. However, off-
                    loader exposure was measured on the first day of the study for workers
                    handling asparagus treated 14 days prior to the initiation of the study.
                    High winds and other complicating factors rendered the inhalation data
                    unacceptable.  The Agency decided to use these supplemental data
                    because the major route of exposure is via the dermal route. The task
                    specific worker MOE's are presented in the following table:

                         MOE's for Asparagus Reentry Workers
TASK
(DAT)



Harvest (1)
Sledder(l)
Off-Loader (1)
HOURLY
EXPOSURE
(mg/hour)


3.386
2.161
2 022
AVERAGE
DAILY
EXPOSURE
(ADE)
(mg/kg/day)
0.009
0.006
0.005
Short-Term
(1 - 7 days)

MOE

1344
2017
2420
Intermediate
( > 7 days)

MOE

138
208
250
DAT - Days After Treatment

ADE = hourly exposure x 2% x 8 hr (dermal absorption rate, MRID 00143622, Acc#254933)
       60 kg (body wt.)

             Restricted-Entry Interval (RED:

                    The Agency recommends a restricted-entry interval (REI) of 24 hours
             for all crops.  The REI is based on the MOE's calculated above. For crops such
             as celery and carrots, where intermediate exposure is likely, the 24 hour REI is
             required until worker exposure data are submitted by the registrant and
             evaluated by the Agency.

                    The early-entry personal protective equipment requirements established
             for the products containing linuron are coveralls, chemical-resistant gloves,
             shoes, and socks.
                                          28

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Personal Protective Equipment (PPE) Requirements:

       The personal protective equipment requirements for pesticide handlers
of products containing linuron should, in general, be established based on the
acute toxicity of the end-use product by route of entry as described in PR
Notice 93-7 or other EPA guidance. However, due to concerns for the short-
term and intermediate-term risks, the Agency establishes minimum handler
personal protective equipment requirements for any end-use product containing
linuron. Products containing linuron may contain more stringent PPE, but in
no case may they require less stringent PPE than the following: coveralls over
long-sleeved shirt and long pants, chemical-resistant gloves, chemical-resistant
footwear, and chemical-resistant apron.

       Since the Agency is unaware of any linuron end-use products that are
primarily intended for home-use, the Agency will not establish entry
restrictions or personal protective equipment requirements for home-use
products at this time.
                            29

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Table 3. Summary Exposure Values for Linurorr1
Exposure Scenario

Open Pour
Liquids (I)
Open Mix Wettable
Powder (II)
Open Pour
Liquids (I)
Open Mix Wettable
Powder (II)
Closed Mix (III)
Closed Mix (III)
Application Type

Aerial
Aerial
Ground-boom
Ground-boom
Ground-boom
Aerial
Application
Targets

Variable
Variable
Variable
Variable
Variable
Variable
Application
Timing
Treatment Rate
(Ib ai/acre)B
Daily
Maximum
Treated
(acres)0
Unit Dermal
Exposure
(mg/lb ai)
Unit Inhalation
Exposure
(mg/lb ai)
ADED
Combined
Systemic Dose
(mg/kg/day)
Short-term
exposure
MOE
1 to 7 days
Intermediate
exposure
MOE
7 days to several
months
Mixer Loader Exposure Levels
Variable
Variable
Variable
Variable
Variable
Variable
1 -2.5
1-2.5
1-2.5
1 -2.5
1 -2.5
1 -2.5
350
350
100
100
100
350
0.113
0.2
0.113
0.2
0.02
0.02
0.00057
0.0037
0.00057
0.0037
0.0003
0.0003
0.014-0.033
0.026 -0.065
0.004 - 0.008
0.008 -0.019
0.008 - 0.0019
0.003 - 0.0063
360 - 880
184 - 464
>1000
>500
>1000
> 1000
40-88
16-48
128-336
64 - 168
>500
>100
Applicator Exposure Levels
Ground-boom
Application (IV)
Ground-boom
Ground-boom
Ground-boom
Ground-boom
Ground-boom
Broadcast
Broadcast
Broadcast
Broadcast
Broadcast
Broadcast
Asparagus,
Direct Seeded or
newly planted
crowns
Asparagus,
Direct Seeded or
newly planted
crowns
Asparagus,
Established Beds
Asparagus,
Established Beds
Asparagus,
Established Beds
(fern stage)
Bulbs, (calla lily,
daffodil, tulip,
Dutch iris)
Preemergence
Postemergence
Preemergence
Postemergence,
before cutting
season or
immediately after
cutting
Directed
Postemergence
After Planting,
before plants
emerge
1 -2
Two Ib ai
per season
0.5-1
One to two
applications per
season
1-2
One application
0.5- 1
One to four
applications
2-4
One application
1
One application
50
50
50
50
50
25
0.014
0.014
0.014
0.014
0.014
0.014
0.0004
0.0004
0.0004
0.0004
0.0004
0.0004
0.002 - 0.004
0.001 - 0.002
0.002 - 0.004
0.001 - 0.002
0.004 - 0.004
0.001
> 1000
>1000
>1000
> 1000
> 1000
> 1000
>300
>500
>300
>500
>100
>1000
                                                                                                        30

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Table 3 (continued)
Exposure Scenario
Ground-boom

Ground-boom

Ground-boom



Ground-boom
Ground-boom

Ground-boom
Application Type
Broadcast

Broadcast

Broadcast



Broadcast
Broadcast

Broadcast
Application
Targets
Carrots, Florida

Carrots, Ohio
Michigan, and
Wisconsin
Carrots, East of
the Rocky
Mountains


Celery, East of
the Rocky
Mountains
Corn, East of the
Rocky Mountains
Corn (Field and
Sweet)
Application
Timing
Preemergence

Preemergence

Postern ergence,
Non-directed spray
after carrots are 3"
tall


Non-Directed
Spray After
Transplanting
Preemergence,
after planting
Postemergence,
directed spray after
corn is at least 15"
hish
Treatment Rate
(Ib ai/acre)B
0.5-1
No more than 2 Ib
ai per season
0.5-1.5
No more than 2 Ib
ai per season
0.75 - 1.5
A repeat
application may
be made. No
more than 2 Ib
ai/crop
0.75 - 1.5
One application
0.375 - 1.5
One application
0.625 - 1.5
One application
Daily
Maximum
Treated
(acres)0
100

60

15



100
100

100
Unit Dermal
Exposure
(mg/lb ai)
0.014

0.014

0.014



0.014
0.014

0.014
Unit Inhalation
Exposure
(mg/lb ai)
0.0004

0.0004

0.0004



0.0004
0.0004

0.0004
ADED
Combined
Systemic Dose
(mg/kg/day)
0.002 - 0.004

0.001 - 0.004

0.001



0.003 - 0.007
0.002 - 0.007

0.003 - 0.007
Short-term
exposure
MOE
1 to 7 days
>1000

>1000

> 1000



>1000
> 1000

>1000
Intermediate
exposure
MOE
7 days to several
months
>250

>250

>1000



> 150
>150

> 150
                                                                                                    31

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Table 3 (continued)

Exposure Scenario




Ground-boom


Ground-boom


Ground-boom



Ground-boom


Ground-boom



Ground-boom

Ground-boom


Ground-boom


Ground-boom


Ground-boom




Aerial (total
deposition) (V)


Application Type




Broadcast


Broadcast


Broadcast



Broadcast


Broadcast



Broadcast

Broadcast


Broadcast


Broadcast


Broadcast




Broadcast



Application
Targets



Parsley, Texas


Parsnips


Poplar
(Shelterbelt),
Midwest

Potatoes, East of
the Rocky
Mountains
Potatoes,
Wisconsin
(Central Sands
Area)
Sorghum

Sorghum


Soybeans,
Conventional
Tillage
Soybeans,
Minimum or No-
Tillage
Soybeans




Variable



Application
Timing



Preemergence,
after planting

Preemergence,
after planting

Directed spray
after bud break in
the spring

Preemergence,
after planting

Preemergence,
after planting


Preemergence

Postemergence,
Directed spray

Preemergence


Preemergence


Postemergence,
Directed spray



Variable (not
including directed
sprays)

Treatment Rate
(Ib ai/acre)B



1.5

One application
0.75 - 1.5

One application
1-2

No more than
4 Ib ai/year
0.75 - 2

One application
0.5- 1

One application

0.313 - 1
One application
0.5-1

One application
0.16-2.5

One application
0.375-2.5

One application
0.5-1

Up to two
applications not to
exceed 1 Ib ai
1-2.5


Daily
Maximum
Treated
(acres)0


25


15


25



100


100



100

100


100


100


100




350


Unit Dermal
Exposure
(mg/lb ai)



0.014


0.014


0.014



0.014


0.014



0.014

0.014


0.014


0.014


0.014




0.004


Unit Inhalation
Exposure
(mg/lb ai)



0.0004


0.0004


0.0004



0.0004


0.0004



0.0004

0.0004


0.0004


0.0004


0.0004




0.0002


ADED

Combined
Systemic Dose
(mg/kg/day)

0.002


0.0001


0.001 - 0.002



0.003 - 0.007


0.002 - 0.004



0.001 - 0.004

0.002 - 0.004


0.001 -0.01


0.001 -0.01


0.002 - 0.004




0.005 - 0.01


Short-term
exposure

MOE
1 to 7 days

> 1000


>1000


>1000



>1000


> 1000



>1000

>1000


> 1000


>1000


>1000




>1000


Intermediate
exposure

MOE
7 days to several
months
>700


>1000


>600



>150


>250



>300

>250


> 100


>100


>250




>100


           Liquid and wettable powder linuron formulations were chosen to represent best and worst case scenarios respectively.
                                                                                                               32

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A range of application rates are provided whenever the amount used is based on soil types, cropping systems, tank mixes, or weed species.

Daily maximum treated acres are based either on the amount acreage that can be treated in one day or based on average farm size. The average farm size is based on data presented in the 1987 Census of Agriculture.

The Average Daily Exposure (ADE) (mg/kg/day) = [(Exposure (mg/lb ai) * Appl. Rate (Ib ai/acre) * Acres Treated)/60 kg]. A 16% dermal absorption rate was assumed for dermal exposure and 100% absorption was assumed for inhalation
exposure.  Values presented in this column were rounded to the second decimal place for mixer/loaders and to the third decimal place for applicators. The  Margins of Exposure (MOE) were calculated using the unrounded values.

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Table 4. Exposure Scenario Descriptions for Linurorf
Exposure Scenario (Scene #)
Data
Source
Clothing
Scenario
Equipment
Formulations
Standard Assumptions (8-
hour work day)
Comments
Mixer/Loader Exposure Levels
Open Pour Liquids (I)
Open Mix Wettable Powders (II)
Closed Mix Liquids (III)
PHED
PHED
PHED
Long Pants,
Long-Sleeves,
No Gloves
Total Deposition
Total Deposition
Open System
Open System
Closed System
All Liquids
PHED Wettable
Powder Category
PHED Closed
System Category
For all liquid formulations
plus dry flowables such as
water dispersable
granulars
Wettable powder only
All closed systems
considered similar for this
assessment
Acceptable PHED grades, 14+ replicates, 50%
protection factor applied to hand exposure to
account for the use of chemical resistant gloves.
All PHED grades, 3 to 14 replicates, 50%
protection factor applied to dermal and to hand
exposure levels to account for the use of normal
work clothing and chemical resistant gloves.
PHED grades A/B/C, 13 replicates, 50%
protection factor applied to dermal and to hand
exposure levels to account for the use of normal
work clothing and chemical resistant gloves.
Applicator Exposure Levels
Ground-boom Application (IV)
Aerial (V)
PHED
PHED
Long Pants,
Long-Sleeves,
No Gloves
Long Pants,
Long-Sleeves,
No Gloves
PHED Ground-boom
Category /Open Cab
PHED Aerial Fixed Wing
Category
All Formulations
All Formulations
Tractor based ground-
boom
All fixed-wing aerial data
PHED grades A/B/C, 6+ replicates, 50%
protection factor applied to hand exposure to
account for the use of chemical resistant gloves,
and for the use of coveralls.
No helicopter data available, all PHED grades, 4
to 41 replicates, 50% protection factor applied to
hand exposure to account for the use of chemical
resistant gloves when entering and exiting
aircraft.
     All exposure levels presented in Appendix 1 reflect the current PPE requirements for linuron handlers.  Any exposure values which did not reflect the required clothing scenario were adjusted using protection
     factors (see comments). Unit dermal exposure was assumed to be 50 percent hand exposure and 50 percent remaining dermal exposure.  All dermal exposure values are the "best" fit mean.  The "best" fit mean is
     the composite total dermal exposure based on using the geometric mean for lognormal distributed data, arithmetic mean for normal distributed data, and the median for all other distribution types.
                                                                                               34

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C. Environmental Assessment

   1.     Environmental Fate

          At this time, two data requirements in the environmental fate guidelines are not
   fulfilled for linuron: leaching/adsorption/desorption (163-1) and terrestrial field
   dissipation (164-1). The environmental data base for only the parent linuron is
   essentially complete.  Information on the persistence, mobility, and dissipation
   pathways of several primary degradates of linuron is not currently available; therefore,
   the environmental fate assessment must be considered incomplete and tentative.

          a.      Environmental Chemistry, Fate and Transport

                 Hydrolysis

                 Phenyl-labeled [14C] linuron did not degrade via hydrolysis in sterile
          buffer solutions at pH 5, 7, or 9 and incubated in the dark at 25 ± 1 °C for 30
          days. The registrant calculated half-lives for linuron in the buffer solutions
          averaged 945 days.  (MRID 40916201)

                 Photodegradation in Water

                 Phenyl-labeled [14C] linuron degraded slowly with a half-life greater
          than 30 days (registrant-calculated half-life of 49 days) in sterile aqueous pH 5
          buffer solution irradiated with natural sunlight at 25° C. At 30 days
          posttreatment (total  light intensity = 196,006 Watt-hours/m2), linuron
          comprised 61.6% of the applied radioactivity;  volatiles totaled 10.2% of the
          applied and unidentified degradates (at least 8 separate peaks) each accounted
          for up to 5.1% of the applied.  In the dark control after 30 days, 92.1% of the
          recovered was undegraded parent linuron, suggesting the observed degradation
          was primarily photolytic rather than hydrolytic. The ultraviolet-visible light
          absorption spectrum for linuron at 18 ppm displayed absorption maxima at 210,
          245, and 280 nm with some overlap at greater than 290 nm, further supporting
          direct photolysis of  the parent linuron.  (MRID 40103601)

                 Photodegradation in Soil

                 Phenyl-labeled [14C] linuron degraded with a half-life greater than 15
          days on silt loam soil irradiated continuously with a Pyrex glass-filtered xenon
          arc light at 25° C. After 15 days of irradiation, the soil contained 78.8% of the
          recovered radioactivity as parent linuron. Minor degradates identified were
          norlinuron, desmethyl linuron, and 3,4-dichloroaniline (each less than  8.4% of
          the recovered). Unidentified polar compounds comprised less than 4% of the
          recovered, unextractable compounds were less than 2.5% of the recovered, and
          volatiles were  less than 0.1% of the recovered at all  sampling intervals. In the
          dark controls, parent linuron accounted for 96.5% of the recovered
          radioactivity after 15 days, suggesting  that degradation was primarily
          photolytic and not biologically-mediated. (MRID 40171711)
                                       35

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       Photodegradation in Air

       No studies were reviewed. The data requirement was waived because
the reported vapor pressure for linuron was 1.5 x 10"5 mm Hg at 24° C;
therefore, volatilization and subsequent photodegradation in air are not
considered probable routes of dissipation.

       Aerobic Soil Metabolism

       Linuron degraded with a half-life of 49 days in sandy loam soil that was
incubated in the dark at 25° C and 75% of 0.33 bar moisture content.  The
primary nonvolatile degradate was 3-(3,4-dichlorophenyl)-l-methylurea
(desmethoxy linuron; maximum  average concentration of 3.0% of the applied
at 120 days posttreatment, decreasing to 1.9% of the applied by 365 days);
other nonvolatile degradates were 3-(3,4-dichlorophenyl)-l-methoxyurea
(desmethyl linuron; maximum average concentration of 2.1% of the applied at
365 days posttreatment) and l-(3,4-dichlorophenyl)urea (norlinuron; maximum
average concentration of 1.9% of the applied at 28 days). By 12 months
posttreatment, unidentified polar [14C]residues increased to 4.7% (0.20 ppm) of
the applied and "other" unidentified [14C]residues comprised 1.8% (0.07 ppm).
At 12 months posttreatment, 14CO2 was the major degradate (totaled 69% of the
applied). (MRID 41625401)

       Anaerobic Soil Metabolism

       No studies were reviewed. The anaerobic aquatic metabolism study was
used to fulfill this data requirement. (MRID 40142501)

       Anaerobic Aquatic Metabolism

       Phenyl-labeled [14C] linuron degraded with a half-life of less than 3
weeks in nonsterile anaerobic silt loam and sand soil: water (1:1) systems
incubated in the dark at 24° C. Primary degradates were desmethoxy linuron,
desmethoxy monolinuron, and norlinuron.  Minor degradates were desmethyl
linuron and dichloroaniline. (MRID 40142501)

       Aerobic Aquatic Metabolism

       No studies were required  because there are no aquatic uses of linuron.

       Leaching and Adsorption/Desorption

       Based on the results of two studies reviewed by the Agency and
supplemental information from three peer-reviewed journal publications on
linuron mobility, linuron appears to be slightly mobile in coarse-textured soils
(Kads = 2.7-5.0 for sandy loams) and relatively immobile in fine-textured soils
(Kads = 7.2-7.7 for silt loams). Adsorption of linuron is probably related to the
                            36

-------
organic matter content with increased adsorption reported for soils with higher
organic matter content (Kads om less than 200 for two soils with greater than4 %
OM). The leaching/adsorption/ desorption (163-1) studies are partially
acceptable because information on the Kds for the primary linuron degradates
formed under anaerobic conditions (desmethoxy linuron, desmethoxy
monolinuron, norlinuron) is not currently available.  Adsorption coefficients
(Kds) may be determined using batch equilibrium test methodology.  A new
leaching/adsorption/ desorption study is required. The additional data
required will be used to assess the mobility of the primary degradates of linuron
and may be applied to complete computer simulation modeling for the fate and
transport of the primary degradates.(MRIDs 00148443 and 00146073)

       Volatility

      No studies were reviewed.  The data requirement was waived because
the reported  vapor pressure of linuron is 1.5 x 10"5 mm Hg at 24°C;  therefore,
volatilization is not considered a probable route of dissipation.

       Terrestrial Field Dissipation

       Additional data are required for the terrestrial field dissipation studies to
assess the rates and pathways of dissipation of parent linuron and its primary
degradates.  Three field studies were reviewed; (MRID# 41734201, 41734202)
which provided partially acceptable or supplemental information on the field
dissipation of linuron in California (1988 and 1989) and Delaware (1988). The
data requirement is not fulfilled because the patterns of formation and decline
of total linuron residues could not be assessed, and field test procedures and
analytical methodology were not completely described. The California (1988)
study may be upgradable if additional information on study methods and early
soil sample results can be provided; however, the Delaware and the 1989
California studies can not be upgraded because the consistent presence of
linuron in the control plot confounds accurate assessment of the pattern of
formation and  decline of total linuron residues.  A new study is needed to
satisfy the data requirement.  The 1988 California study may be upgraded.
(MRIDs 41734201, 41734202)

       Bioaccumulation in Fish

      Linuron residues accumulated in bluegill  sunfish during 28 days of
exposure to water treated at 0.1 and 1.0 ppm [14C] linuron. Maximum
bioconcentration factors were 49x for whole fish, 240x for viscera, 34x for
muscle and 39x for carcass tissues.  After 28 days of exposure,  linuron residues
in the viscera were identified as desmethyl linuron, norlinuron,  and glucuronide
conjugates.  The edible tissues were not analyzed for linuron residues.
Residues rapidly declined to approximately 10 % of maximum  levels after the
14-day depuration period. (Accession # 258300)
                            37

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       Droplet Size Spectrum and Drift Field Evaluation

       No studies were reviewed. The registrant is a participating member of
the Spray Drift Task Force. Information regarding spray drift of linuron must
be provided upon completion of the Spray Drift Task Force data base. These
studies may be required by the Agency when toxicological considerations are
indicated by either the Ecological Effects Branch and/or the Health Effects
Division. Information on spray drift of linuron for ground boom application
may be estimated from the forthcoming results of the Spray Drift Task Force.

b.     Environmental Fate Assessment

       The review of acceptable, partially acceptable and supplemental
information in the environmental fate data base, indicates that parent linuron
appears to be moderately persistent and relatively immobile. Increased
mobility of linuron may occur under specific environmental conditions such as
coarse textured soils and soils with low organic matter levels.

       Linuron dissipates principally by biotic processes such as microbial
degradation.  Degradation  of linuron by abiotic processes (hydrolysis,
photolysis, volatilization) does not appear to be a significant route of
dissipation.

       Partially acceptable and supplemental information on leaching and
adsorption/desorption suggests that linuron is primarily adsorbed to soil organic
matter with limited adsorption to the inorganic, mineral phase of soil. Linuron
would tend to be more mobile in  surface soils with low organic matter levels or
in subsoils exposed  on the land surface because of erosion. Decreased
adsorption in low organic matter  soil horizons may result in enhanced mobility
and increased leaching  potential of parent linuron.  For surface soils with
adequate organic matter levels, the combined processes of adsorption and
microbial degradation would limit the potential for linuron to migrate to ground
water.

       Transport of linuron dissolved in surface runoff and/or in suspended
sediment through runoff to surface water bodies (lakes, streams, etc.) could
result; however, based on degradation rates and by-products from anaerobic
aquatic metabolism  studies, fairly rapid degradation of parent linuron to three
primary metabolites (desmethoxy linuron, desmethoxy monolinuron,
norlinuron) would occur. Information on the mobility and persistence of these
primary degradates is not currently available from the studies submitted for the
environmental fate data base.

Ground Water. Linuron has been detected in ground water in four states
including Georgia, Missouri, Virginia, and Wisconsin at levels ranging up to
5.00 jUg/L (Hoheisel et  al., 1992). A review of the studies in which the ground
water detections were reported gave the following results:
                             38

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       1.  Georgia

       Detections in ground water were solely from STORET which did not
allow a detailed review. Concentrations of linuron ranged from 1 to 5 jUg/L
(ppb).  Recent information submitted by the State of Georgia indicates that this
data is suspect.

       2. Missouri

       Rural private wells in agricultural areas of Missouri were monitored for
pesticide residues.  Linuron was detected at concentrations ranging from 0.5 to
1.9 jUg/L (Sievers and Fulhage, 1989a and 1991). In another study conducted
in Missouri (Sievers and Fulhage, 1989b), linuron was also detected in ground
water in rural agricultural wells at levels ranging from 0.48 to 0.9 jUg/L.  The
study examined ground-water quality in eight major agricultural areas in the
state, without regard to the vulnerability of the soils to leaching, nor to areas of
high linuron use.

       Although there is indication that there were some interference problems
with the mass spectrometer detector due to sulfur and organic matter for linuron
detections below 1 Mg/L, results for detections reported above 1 /j-g/L appear
valid.  No information was provided about the wells, depth to ground water, or
detection limits.

       3. Virginia

       Eight monitoring wells and four household wells were sampled for a
suite of pesticides including linuron (Mostaghimi, 1992). There were no
indications of point-source contamination or problems with the wells during the
study.  Linuron was detected in 50 % of the monitoring wells (4 of 8 wells) at
levels ranging from 0.35 to 1.31 jUg/L.  The extensive QA/QC plan for the
sampling program and GC analysis provided a high degree of confidence for
these detections.

       4. Wisconsin

       In a Wisconsin study (Postle and Brey, 1991), monitoring wells were
located in areas that were highly vulnerable to ground-water contamination.
All detections were from areas with normal field use conditions. Linuron was
detected at one site at concentrations that ranged from 1.3 to 2.7 jUg/L.

       Linuron exhibits some of the properties and characteristics associated
with chemicals that have been detected in ground water. Linuron is a
moderately persistent chemical with an aerobic soil metabolism half-life that
ranges from  49 to 91 days.  In addition, its field dissipation half-life has been
reported to range from a minimum of 57 days to a maximum of 100 days («8 to
«14 weeks, respectively). Because linuron is sufficiently persistent and may be
                             39

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       mobile under certain environmental conditions, it has the potential to impact
       ground-water quality.

       Surface Water.  Linuron can be applied by ground spray and therefore could
contaminate surface waters by spray drift. Substantial quantities of linuron could be
available for runoff to surface waters for several weeks post-application
(photodegradation on soil half-life = approximately one month; aerobic soil half-life
=49 days; terrestrial field dissipation half-lives = 57 and 100 days). The moderately
low to intermediate soil/water partitioning of linuron (Kd = 2.7, 5.0, 7.7, and 7.2; Koc
from SCS database = 370) indicates that substantial fractions of linuron runoff could
occur as both dissolution in runoff water and adsorption to eroding soil.

       Resistance to abiotic hydrolysis coupled with only moderate susceptibility to
direct photolysis in water (half-life  =1-2 months) and aerobic biodegradation indicates
that linuron has the potential to be somewhat persistent in surface waters, particularly
those with low microbiological activities and long hydrological residence times. Its
reported half-life in an anaerobic aquatic metabolism study (less than 21  days)
indicates that it may be less persistent in water and sediment under anaerobic
conditions than under aerobic conditions. Based upon its relatively low to intermediate
soil and sediment to water partitioning, significant fractions of any linuron in water
could exist both dissolved  in the water column and adsorbed to suspended and bottom
sediment. The reported BCFs for linuron (ranging from 40x to 240x) indicate that the
bioconcentration potential  for linuron is relatively low.

       The available data on the major degradates of linuron are insufficient to assess
their runoff potential or persistence in surface water.

       Baker (1988) sampled 8 tributaries of Lake Erie from April 15 to  August 15 of
1983 through 1985. He reported April 15-August 15 time weighted mean
concentrations of linuron ranging from below the detection limit of 0.001 |ig/L to
0.860 |ig/L and an average April  15-August time weighted mean of 0.21  |ig/L. He
reported maximum concentrations ranging from below the detection limit to 10.9, 14.2
and 160 |ig/L and an average maximum of 8.8 |ig/L.  The USGS sampled 8 widely
spread locations within the Mississippi Basin at frequent intervals from April 1991 to
April 1992. Linuron was detected at a concentration of approximately 0.1 |ig/L in one
of the 46 samples collected from the White River. Linuron was not detected above a
detection limit of 0.01 |ig/L in any of the samples collected from the other 7 locations.

       The Agency has used the computer model PRZM to compare the  relative
leaching potential of linuron  and  12 other corn herbicides to that of atrazine. Based
upon that analysis, the Agency predicted that under the conditions modeled, the
percent of applied linuron  removed by runoff could be comparable to somewhat
greater than atrazine.

       Linuron is not currently regulated under the Safe Drinking Water Act (SDWA).
Therefore, no MCL has been established for it and water supply systems are not
required to sample and analyze for it. In addition, no drinking water health advisories
have been established for linuron. However, based upon the Reference Dose, the
                                   40

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Agency has (for screening purposes only) a low lifetime health advisory for linuron of
6.0 |ig/L.  Although the available data suggests that the average annual linuron
concentration will generally be well below 6 |ig/L, the available data do not
necessarily include those from watersheds that drain high linuron use areas. In
addition, the relatively low to intermediate soil to water partitioning of linuron
indicates that the primary treatment processes employed by most water supply systems
to remove suspended sediment may not always be completely effective in removing
linuron. Consequently, the Agency does have some moderate concerns for potential
risks of linuron to surface water source supply systems.

2.     Ecological Effects

       a.     Ecological Effects Data

             (1)    Terrestrial Animal Data

                    Avian Acute Toxicitv
Avian Acute Oral Toxicity Findings
Species
Bobwhite Quail
% Test
Material
(TGAI)
92.8
LDso
940 mg/kg
Conclusion
slightly toxic
                    These results show that linuron is slightly toxic to birds on an
             acute basis.  The guideline requirement for the avian acute oral LD50
             study is fulfilled.  (MRID 00150170)

                    Avian Subacute Dietary Toxicity

                    No acceptable avian dietary toxicity studies on technical linuron
             have been submitted for review.  However, the following data from the
             USFWS (United States Fish and Wildlife Service) using a 50%
             formulation were considered.  Some toxicity in formulation testing may
             be due to ingredients other than the active ingredient. Other
             formulations may be more or less toxic, depending on their ingredients.
             Technical testing allows prediction of the toxicity due to the active
             ingredient across all formulations. Therefore, tests with the technical
             material are still required.
                                   41

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Avian Subacute Dietary Toxicity Findings
Species
Mallard Duck
Japanese Quail
Ring-necked Pheasant
% Test
Material
50
50
50
LC50
3083 ppm
>5,000 ppm
3438 ppm
Conclusions
slightly toxic
practically nontoxic
slightly toxic
                    The USFWS extrapolation suggests that 100 precent active
             ingredient material would be considered "slightly toxic" to the mallard
             and ring-necked pheasant and "practically nontoxic" to the Japanese
             quail.  (MRID 00034769).

                    Avian Reproductive Toxicity

                    Avian reproduction studies are required when birds may be
             exposed repeatedly or continuously through persistence,
             bioaccumulation, or multiple applications, or if mammalian
             reproduction tests indicate reproductive hazard.  Because linuron is
             persistent and can be applied more than one time during a season these
             studies were required.
Avian Reproductive Toxicity
Species
Mallard Duck
Bobwhite Quail
% Test
Material
98.4
98.4
Results
NOEL = 100 ppm LOEL
= 300ppm(l)
NOEL= 100 ppm
LOEL = 300 ppm(2)
(1) Treatment-related effects in adult body weight, feed consumption, egg production, and eggshell
thickness.
(2) Treatment-related effects in egg production, hatchability, and offspring survival.

                    There are sufficient data to characterize the effects of linuron on
             avian reproduction.  The No Observable Effects Level for the mallard
             duck is 100 ppm and the Lowest Observable Effects Level is 300 ppm.
             (MRID 42541802)

                    The No Observable Effects Level for the bobwhite quail is 100
             ppm and the Lowest Observable Effects Level is 300 ppm. (MRID
             42541801)
                                    42

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       Toxicitv to Mammals
Mammalian Acute Oral Toxicity Findin
Species
Rat
LD50(mg/kg)
2100
?s
Conclusion
practically nontoxic
       The available data indicate that at a lowest acute oral LD50 of
2100 mg/kg, linuron is practically nontoxic to the rat.

       Toxicity to Insects

       The minimum data required to establish the acute toxicity to
honey bees is an acute contact LD50 study with the technical material.
Acute Toxicity to Insects
Species
Apis mellifera
% Test
Material
not reported
LDso
120.86 ug/bee
Conclusion
practically nontoxic
       There is sufficient information to characterize linuron as
practically non-toxic to bees. (MRID 00018842).

(2)    Aquatic Animal Data

       Freshwater Fish Toxicity

       Acute testing with the TGAI

       In order to establish the toxicity of a pesticide to freshwater fish,
the minimum data required on the technical grade of the active
ingredient are two freshwater fish toxicity studies.  One study should
use a coldwater species (preferably the rainbow trout), and the other
should use a warmwater species (preferably the bluegill sunfish).
                      43

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Freshwater Fish Acute Oral Toxicity
Species
Rainbow trout
Bluegill sunfish
% Test Material
(TGAI)
96.2
96.2
LC50
3 ppm
9.6 ppm
Conclusions
moderately toxic
moderately toxic
       The results of the 96-hour acute toxicity studies indicate that
linuron can be characterized as being moderately toxic to both cold and
warm water fish. (MRIDs 40445501 and 40354201).

       Acute testing with the formulated product

       Formulated product testing is specified if there is direct
application to an aquatic environment or if EECs are greater than or
equal to the LC50.  Linuron is registered for use on rights-of-way
(ROWs) which can result in a direct application to aquatic
environments.
Freshwater Fish Acute Testing with the Formulated Product
Species
Rainbow trout
Bluegill sunfish
Bluegill sunfish
% A.I.
Lorox 50 (WP)
Lorox 50 (WP)
Lorox 50 (DF)
Result LC50
16.4 ppm
16.2 ppm
9.2 ppm
Conclusions
slightly toxic
slightly toxic
moderately toxic
       The results of the 96-hour EC50 studies indicate that Lorox 50
WP (wettable powder) is slightly toxic to rainbow trout and bluegill
sunfish. Lorox 50 DF (dry flowable) is considered moderately toxic to
bluegill sunfish. (MRIDs 00018165, 00018165, and 00018198).

       Chronic Test-Early Life Stage

       The fish early life stage is required to support reregi strati on of a
chemical if exposure is expected to be continuous, recurrent or
persistent, and multiple applications of the chemical may occur.  The
minimum data required to establish chronic toxicity of linuron to fish is
the early life stage toxicity test based on survival offish embryos and
post-hatch larvae.
                      44

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Chronic Test-Early Life Cycle
Species
Rainbow trout
% A.I.
98.4
NOEC
< 0.042 ppm
       The Maximum Allowable Toxicant Concentration (MATC)
could not be determined for linuron since effects on fish length were
seen at the lowest test level. At present, the Agency does not know at
what level linuron will not have adverse effects on fish, since a NOEL
(No Observable Effects Level) was not determined in fish testing.
Submission of a core study will enable the Agency to determine this
level, and thus determine what maximum application rate of linuron
could be used without producing residues capable of causing the kinds
of chronic effects evaluated under current test protocols. Therefore,
additional testing is required. (MRID 42061804).

       Freshwater Invertebrate Toxicity

       Acute testing with the TGAI

       The minimum testing required to assess the hazard of a pesticide
is a freshwater aquatic invertebrate toxicity test, preferably using first
instar Daphnia magna or early instar amphipods, stoneflies, mayflies, or
midges.
Freshwater Invertebrate Toxicity Findings
Species
Daphnia magna
% Test
Material
(TGAI)
94.4
EC50
0.12 ppm
Conclusion
highly toxic
       There is sufficient information to characterize linuron as highly
toxic to aquatic invertebrates. (MRID 00142932).

       Acute testing with the formulated product

       The minimum data requirement to establish acute toxicity of the
formulated product to freshwater invertebrates is a 48-hour acute study.
                      45

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Acute Toxicity Findings on the End-Use Formulation
Species
Daphnia magna
% A.I. formulated
54
LC50
1.1 ppm
Conclusion
moderately toxic
       There is sufficient information to characterize the formulated
product of linuron as moderately toxic to freshwater aquatic
invertebrates.  (MRID 00018199).

       Chronic Test-life cycle

       The Daphnia Life Cycle is required to support reregi strati on if
the chemical's presence in water is likely to be continuous, recurrent or
persistent, and multiple applications of the chemical may occur.  The
minimum data required to establish chronic toxicity of linuron to
invertebrates is the Daphnia life cycle test based on reproduction,
growth and survival.
Chronic Test-Life Cycle
Species
Daphnia magna
% A.I.
98.4
Results
MATC>0.13
< 0.24 ppm
       Based on the data submitted, the MATC is greater than 0.13 and
less than 0.24 ppm. The Agency has chronic invertebrate data that
appear inconsistent with acute data: chronic effects were not seen until
levels higher than those causing acute effects. Also, invertebrates were
more sensitive than fish in acute tests, but appear considerably less
sensitive in the chronic test.  Therefore, additional testing is required
based on inconsistent results with the acute toxicity data. (MRID
42153401)

       Estuarine/Marine Toxicity

       Acute testing with the TGAI

       Acute toxicity testing with estuarine and marine organisms is
required when an end-use product is intended for direct application to
the marine/estuarine  environment or is expected to reach this
environment in significant concentrations.
                      46

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       The requirements under this category include a 96-hour LC50 for
an estuarine fish, a 96-hour LC50 for shrimp, and either a 48-hour
embryo-larvae study or a 96-hour shell deposition study with oysters.
Estuarine/Marine Acute Toxicity Findings
Species
Sheepshead minnow
Eastern oyster
Mysid shrimp
% Test
Material
(TGAI)
98.4
98.4
98.4
^C50
0.89ppm
5.4 ppm
3.3 ppm
Conclusions
highly toxic
moderately toxic
moderately toxic
       There is sufficient information to characterize the TGAI of
linuron as highly toxic to the sheepshead minnow and moderately toxic
to the eastern oyster and mysid shrimp. (MRIDs 42061801, 42061802,
and 42061803).

       Acute testing with the formulated product

       Marine and estuarine testing using the formulated products is
required due to the ROW (Rights-of-way) use.  ROWs could cross
virtually any habitat, including marine aquatic habitat such as salt
marshes.  Data are not currently available.  Testing is required with at
least the most sensitive species in acute testing (sheepshead minnow)
using the DF (dry flowable) formulation. A DF formulation was found
to be more toxic than expected based on active ingredient testing.
Because of the ROW (right-of-way) use, there could be direct exposure
to the aquatic environment by the formulated product.  TEP testing will
enable the Agency to assess the risk of specific formulation(s) actually
used on ROWs. Additional  species and/or formulations may also be
required.

       Chronic effects

       Chronic marine and estuarine testing are indicated based on the
same criteria as freshwater species.  In the case of linuron, these
indications include (1) LC50 value less than  1 mg/1, (2) EEC > 0.01
LC50 and (3) aquatic half-life of less than 4 days. Sheepshead minnow
and mysid shrimp should be tested.
                      47

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       (3)    Non-Target Plants Data

             Toxicity to Terrestrial Plants

             Data requirements for determining toxicity to terrestrial plants
       (Tier 2) remain outstanding.  These data are required for linuron
       because it is an herbicide registered for use on terrestrial food and
       nonfood sites and the vapor pressure is > 1.0 X 10"5. Labeling indicate
       that aerial application can be  used for soybeans, as well as ground boom
       spray for other crops. However, a plant risk assessment for linuron
       cannot be performed without the phytotoxicity data.

             Toxicity to Aquatic Plants

             Only one of the five required species for testing for toxicity to
       aquatic plants has been submitted.  Testing for Lemna gibba,
       Skeletonema costatum, Anabaenaflos-aquae., and a freshwater diatom
       remain outstanding.  These data are required for linuron as it is an
       herbicide registered for use on terrestrial food/nonfood sites, has a vapor
       pressure > 1.0 X 10"5 mm Hg, and a water  solubility greater than 10
       ppm. These data are required to conduct the plant risk assessment for
       linuron.
Aquatic Plant Toxicity
Species
Selenastrum capricornutum
% A.I.
100
EC50
5-day = 0.067 mg ai/1
             With a 5-day exposure of 0.067 mg active ingredient per liter of
       linuron, S. capricornutum can be expected to sustain a 50% reduction in
       density or number of cells. (MRID 42086801).

b.     Ecological Effects Risk Assessment

       (1)    Risk to Terrestrial Animals

             Nontarget insects

             Although honeybees  could be exposed to linuron, when used on
       corn and cotton specifically, minimal risk is expected as linuron is
       considered "practically nontoxic" (LD50 = 120.86 ug/bee) to honey bees.
                              48

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                           Avian and mammalian species

                           Avian and mammalian species may be exposed to linuron through
                    multiple routes, including dietary and dermal. The criterion for the
                    presumption of high risk from exposure for acute avian and mammalian
                    species is a value greater than or equal to 0.5 for the quotient of the
                    estimated environmental concentration (EEC) divided by the lowest LC50
                    value for birds and mammals—this is known as the risk quotient (RQ).

                           Acute RQ = EEC/LC50 > 0.5 for birds and mammals

                           Calculation of estimated environmental residues are based on the
                    work by Hoerger and Kenaga (1972).

                           Avian Acute/Subacute Risk

                           High Risk LOCs are not exceeded at any application rate for a single
                    application. Restricted Use Levels of Concern (LOG) are exceeded  on short
                    grass at the 3  and 4 Ibs a.i./A rates.  Endangered species LOG are exceeded
                    for all the rates evaluated.  Residues on insects would not exceed LOCs (see
                    Table 1).
Table 1. Avian Acute Risk Quotient and LOC exceedance for the maximum application rates of linuron by use site.
EEC for short grass = application rate (al ai/A) x 240 ppm/lb ai. EEC for insects = application rate x 58 ppm/lb ai.
Lowest avian LC50 = 3083 ppm (mallard duck)  Risk Quotient = EEC/LC50.
Use Site
Carrots, celery, sweet
corn, cottonseed, parsley,
parsnips, sorghum;
ornamental herbaceous
plants
Field corn
Winter wheat (drill
planted)
Application Rate
1.5 Ibs ai
1.54 Ibs ai
1.75 Ibs ai
Substrate
(EEC)
Short Grass
(360)
Insects
(87)
short grass
(370)
Insects
(89)
short grass
(420)
Insects
(101.5)
Risk Quotient
(EEC/LC50)
0.12
0.03
0.12
0.03
0.14
0.03
LOC
High Risk > 0.5
RU > 0.2
ES> 0.1
High Risk > 0.5
RU > 0.2
ES> 0.1
High Risk > 0.5
RU > 0.2
ES> 0.1
High Risk > 0.5
RU > 0.2
ES> 0.1
High Risk > 0.5
RU > 0.2
ES> 0.1
High Risk > 0.5
RU > 0.2
ES> 0.1
                                            49

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Use Site
Potatoes; poplar (forest/
shelterbelt)
Soybeans; non-ag.
ROW/fencerows/
hedgerows/ uncultiv.
areas/ soils
Asparagus
Application Rate
2.0 Ibs ai
3.0 Ibs ai
4.0 Ibs ai
Substrate
(EEC)
short grass
(480)
Insects
(116)
short grass
(720)
Insects
(174)
short grass
(960)
Insects
(232)
Risk Quotient
(EEC/LC50)
0.16
0.04
0.23
0.06
0.31
0.08
LOC
High Risk > 0.5
RU > 0.2
ES> 0.1
High Risk > 0.5
RU > 0.2
ES> 0.1
High Risk > 0.5
RU > 0.2
ES> 0.1
High Risk > 0.5
RU > 0.2
ES> 0.1
High Risk > 0.5
RU > 0.2
ES> 0.1
High Risk > 0.5
RU > 0.2
ES> 0.1
RU = Restricted Use ES = Endangered Species
                           Avian Chronic and Reproductive Risk

                           The avian reproduction NOEL is considered 100 ppm, with effects
                     seen at 300 ppm.  Both of these levels are below those residue levels that
                     could occur on short grass within the treated area at even the lowest of the
                     maximum application rates by crop, from a single application. Given this,
                     as well as the persistence of linuron described by the Agency, it appears
                     that chronic avian risk is present for all use sites.
Table 2. Avian Chronic Risk Quotient and LOC exceedance for the maximum application rates of linuron by use
site. (NOEL = 100 ppm). Table uses same EECs as Table 1. Risk Quotient = EEC/NOEL.
Use Site
Carrots, celery, sweet
corn, cottonseed, parsley,
parsnips, sorghum;
ornamental herbaceous
plants
Field corn
Application Rate
1.5 Ibs ai
1.54 Ibs ai
Substrate
(EEC)
Short Grass
(360)
Insects
(87)
short grass
(370)
Insects
(89)
Risk Quotient
(EEC/NOEL)
3.60
0.87
3.70
0.89
LOC
Chronic Risk* > 1
Chronic Risk* > 1
Chronic Risk* > 1
Chronic Risk* > 1
                                             50

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Use Site
Winter wheat (drill
planted)
Potatoes; poplar (forest/
shelterbelt)
Soybeans; non-ag.
ROW/fencerows/
hedgerows/ uncultiv.
areas/ soils
Asparagus
Application Rate
1.751bsai
2.0 Ibs ai
3.0 Ibs ai
4.0 Ibs ai
Substrate
(EEC)
short grass
(420)
Insects
(101.5)
short grass
(480)
Insects
(116)
short grass
(720)
Insects
(174)
short grass
(960)
Insects
(232)
Risk Quotient
(EEC/NOEL)
4.20
1.02
4.80
1.16
7.20
1.74
9.60
2.32
LOC
Chronic Risk* > 1
Chronic Risk* > 1
Chronic Risk* > 1
Chronic Risk* > 1
Chronic Risk* > 1
Chronic Risk* > 1
Chronic Risk* > 1
Chronic Risk* > 1
 "Chronic risk, endangered birds may be affected, restricted use recommended"
                            In addition to risk from direct application, there can be risk to birds
                     feeding in areas adjacent to treated fields, due to drift, particularly with
                     aerial application. The current Agecncy estimate is 5%.  This added risk,
                     based on this assumption, does not by itself exceed the LOC (see Table 3).
Table 3. Avian Chronic Risk Quotient and LOC exceedance ~ off-site exposure with soybeans. Off-site drift
estimate = 5% of EEC (from Table 1).
Use Site
Soybeans
Application Rate
3.0 Ibs ai
Substrate
short grass (36)
Insects (8.7)
Risk Quotient
(EEC/NOEL)
0.36
0.087
LOC
Chronic Risk* > 1
Chronic Risk* > 1
  "Chronic risk, endangered birds may be affected, restricted use recommended"
                            Risk to Mammals

                            Tables 4 and 5 show LD50s/sq. ft. for the use sites, for two small
                     mammals.  LD50s/sq. ft. will vary with the weight of the animal, since
                     LDSOs are expressed in mg/kg body weight (i.e., for a given LD50, a
                     smaller animal will require less toxicant to receive a lethal dose). For
                     linuron, all LOCs are exceeded for the small, carnivorous least shrew
                     whereas none are for the much heavier, omnivorous rat.
                                              51

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Table 4.  Mammalian Risk Quotient and LOC exceedance for the maximum application rates of linuron by use site.
(lowest LD50 = 2100 mg/kg; mammal body weight= 0.005 kg, least shrew).  Mg ai/sq. ft = Ib ai/A x 10.4 (conversion
factor).   Risk Quotient = LD 50/sq.ft. = mg ai/sq.ft./LD50 x animal weight).	
  Use Site
Risk Quotient
 LD50/sq. ft.
LOC
Carrots, celery, sweet
corn, cottonseed, parsley,
parsnips, sorghum;
ornamental herbaceous
plants
Field corn

Winter wheat (drill
planted)
Potatoes; poplar (forest/
shelterbelt)
Soybeans; non-ag.
ROW/fencerows/
hedgerows/ uncultiv.
areas/ soils
Asparagus

1.5 Ibs ai

1.541bsai

1.751bsai
2.0 Ibs ai
3.0 Ibs ai

4.0 Ibs ai

15.6

16.0

18.2
20.8
31.2

41.6

1.49

1.52

1.7
2.0
3.0

4.0

High Risk > 0.5
RU > 0.2
ES> 0.1

High Risk > 0.5
RU > 0.2
ES> 0.1
High Risk > 0.5
RU > 0.2
ES> 0.1
High Risk > 0.5
RU > 0.2
ES> 0.1
High Risk > 0.5
RU > 0.2
ES> 0.1
High Risk > 0.5
RU > 0.2
ES> 0.1
RU = Restricted Use ES = Endangered Species
Table 5.  Mammalian Risk Quotient and LOC exceedance for the maximum application rates of linuron by use site.
(lowest LD50 = 2100 mg/kg; mammal body weight= 0.3 kg, rat).
Use Site
Carrots, celery, sweet
corn, cottonseed, parsley,
parsnips, sorghum;
ornamental herbaceous
plants
Field corn
Winter wheat (drill
planted)
Potatoes; poplar (forest/
shelterbelt)
Application Rate
1.5 Ibs ai
1.54 Ibs ai
1.75 Ibs ai
2.0 Ibs ai
mg ai/sq. ft.
15.6
16.0
18.2
20.8
Risk Quotient
LD50/sq. ft.
0.02
0.03
0.03
0.03
LOC
High Risk > 0.5
RU > 0.2
ES> 0.1
High Risk > 0.5
RU > 0.2
ES> 0.1
High Risk > 0.5
RU > 0.2
ES> 0.1
High Risk > 0.5
RU > 0.2
ES> 0.1
                                                    52

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Use Site
Soybeans; non-ag.
ROW/fencerows/
hedgerows/ uncultiv.
areas/ soils
Asparagus
Application Rate
S.Olbsai
4.0 Ibs ai
mg ai/sq. ft.
31.2
41.6
Risk Quotient
LD50/sq. ft.
0.05
0.07
LOC
High Risk > 0.5
RU > 0.2
ES> 0.1
High Risk > 0.5
RU > 0.2
ES> 0.1
RU = Restricted Use ES = Endangered Species
                          Mammalian Chronic Risk

                          The lowest NOEL dietary concentration reported in submitted data
                    is 25 ppm, seen in a 1-year dog feeding study and in a 3-generation
                    reproduction study in rats. Oncogenic effects were reported in both mice
                    and rat studies. For mice,  "hepatocellular adenomas were significantly
                    increased in the high dose group [1500 ppm] and reached borderline
                    significance in the low dose group [50 ppm]".  For rats, "testicular
                    interstitial cell  adenomas increased in 125 and 625 ppm males" (submitted
                    data). Given the persistence of linuron in the field and the effects seen in
                    the lab at concentrations well below those expected  after initial application,
                    it appears that chronic effects in wild mammals are likely.

                    (2)    Aquatic Risk

                          Aquatic - Acute Risk

                          Acute risk to aquatic organisms has been estimated by comparing
                    EECs to the lowest available linuron technical LC50  or EC50 for fish and
                    aquatic invertebrates. EECs used were derived from two models, one
                    involving runoff to a 6' water body (A) and the second involving runoff to a
                    6" water body or wetland (B).  The latter is to be used for linuron only for
                    the ROW use.  Table 6 shows that fish restricted use LOCs are exceeded
                    under model B (ROWs).  Fish  endangered species LOCs are exceeded
                    under model B (ROWs) and also under model A for the 4 Ib ai/A rate.

                          Table 7 shows that the aquatic invertebrate high risk LOC is
                    exceeded with model B (ROWs). Aquatic invertebrate restricted use and
                    endangered species LOCs are exceeded for all sites  with both models.

                          Direct application to aquatic habitat could also potentially occur
                    with a ROW use. Direct application to 6" of water would result in 2202
                    ppb at a  3 Ib ai/A rate.  This would produce a risk quotient of 2,474 for fish
                    and 18,350 for aquatic  invertebrates, vastly exceeding all LOCs.
                                           53

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Table 6. Fish Risk Quotient and LOC exceedance for the maximum application rates of linuron by use site, (lowest
LC50 = 0.89 ppm). EEC for model A (runoff to 6' pond) = [application rate (Ib ai/A) x % runoff x 10 acre drainage
basin] x 61 ppb/lb ai. where % runoff = 2% (based on linuron water solubility of 81 ppm). EEC for model B (runoff
to 6" wetland) = [application rate (Ib ai/A x % runoff x 10 acre drainage basin] x 734 ppb/lb ai. with 2% runoff.
Risk Quotient = EEC/EC50 where fish LC  50 = 0.89 ppm (sheepshead minnow).
Use Site
Carrots, celery, sweet corn,
cottonseed, parsley,
parsnips, sorghum;
ornamental herbaceous
plants
Field corn
Winter wheat (drill
planted)
Potatoes; poplar (forest/
shelterbelt)
Soybeans; non-ag.
ROW/fencerows/
hedgerows/ uncultiv. areas/
soils
Asparagus
Application Rate
1.5 Ibs ai
1.541bsai
1.751bsai
2.0 Ibs ai
3.0 Ibs ai
4.0 Ibs ai
RQ
(EEC/EC50)
(model1)
0.021 (A)
0.021 (A)
0.024 (A)
0.027 (A)
0.041 (A)
0.49 (B) (ROW)
0.055(A)
LOC
High Risk > 0.5
RU> 0.1
ES > 0.05
High Risk > 0.5
RU> 0.1
ES > 0.05
High Risk > 0.5
RU> 0.1
ES > 0.05
High Risk > 0.5
RU> 0.1
ES > 0.05
High Risk > 0.5
RU> 0.1 (B)
ES > 0.05 (B)
High Risk > 0.5
RU> 0.1
ES > 0.05 (A)
RU = Restricted Use ES = Endangered Species
1.  model:  A =runoff to 6'pond; B = runoff to 6" wetland
Table 7. Aquatic Invertebrate Risk Quotient and LOC exceedance for the maximum application rates of linuron by
use site, (lowest EC50 = 0.12 ppm). EEC for model A (runoff to 6' pond) = [application rate (Ib ai/A) x % runoff x 10
acre drainage basin] x 61 ppb/lb ai. where % runoff = 2% (based on linuron water solubility of 81 ppm).EEC for
model B (runoff to 6" wetland) = [application rate (Ib ai/A x % runoff x 10 acre drainage basin] x 734 ppb/lb ai. with
2% runoff. Risk Quotient = EEC/LC50 where lowest aquatic invertebrate = 0.12 ppm/). Magna)
Use Site
Carrots, celery, sweet
corn, cottonseed, parsley,
parsnips, sorghum;
ornamental herbaceous
plants
Field corn
Application Rate
1.5 Ibs ai
1.54 Ibs ai
RQ
(EEC/EC50)
(model1)
0.1 5 (A)
0.1 57 (A)
LOC
High Risk > 0.5
RU> 0.1 (A)
ES > 0.05 (A)
High Risk > 0.5
RU> 0.1 (A)
ES > 0.05 (A)
                                                   54

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Use Site
Winter wheat (drill
planted)
Potatoes; poplar (forest/
shelterbelt)
Soybeans; non-ag.
ROW/fencerows/
hedgerows/ uncultiv.
areas/ soils
Asparagus
Application Rate
1.751bsai
2.0 Ibs ai
3.0 Ibs ai
4.0 Ibs ai
RQ
(EEC/EC50)
(model1)
0.178 (A)
0.203 (A)
0.305 (A)
3.67 (B)
(ROW)
0.4 (A)
LOC
High Risk > 0.5
RU> 0.1 (A)
ES > 0.05 (A)
High Risk > 0.5
RU> 0.1 (A)
ES > 0.05 (A)
High Risk > 0.5(B)
RU> 0.1 (A,B)
ES > 0.05 (A,B)
High Risk > 0.5
RU> 0.1 (A,B)
ES > 0.05 (A,B)
RU = Restricted Use ES = Endangered Species
1. model: A = runoff to 6'pond; B = runoff to 6" wetland
                          Aquatic - Chronic Risk
                          Chronic aquatic effects cannot be fully assessed at this time. Effects
                    on fish length were seen at the lowest concentration (0.042 ppm) with
                    rainbow trout in an early life stage test.  The "rough-cut" EECs used for the
                    above tables under model A exceed this effect level at the 4 Ib ai/A rate and
                    under model B at the 3 Ib ai rate (ROWs).  Since the NOEL for this study
                    was some untested level below 0.042 ppm, there would likely be further
                    exceedances of the NOEL and thus the chronic LOC (EEC/NOEL > 1).

                          Although the above comparisons were derived from "preliminary
                    qaulitative" EECs, available environmental fate information from EFED
                    (see above) indicates potential persistence in water.  There is little or no
                    effect of hydrolysis or photolysis (both half-lives greater than 30 days).
                    Microbial degradation is described by EFED; the anaerobic aquatic half-life
                    is reported as less than 21 days.  Three degradates of unknown toxicity
                    have been identified by EFED. Thus, the toxicity of the combined
                    degradates plus remaining parent linuron is also not known.

                          The chronic effect level for D. magna is reportedly 2x the LC50 seen
                    in a previous acute study, a major inconsistency. Also, invertebrates were
                    more sensitive than fish in acute tests, but appear considerably less sensitive
                    in the chronic test. Further testing with the acute would be necessary to
                    resolve this problem.
                                            55

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                    (3)    Plants

                          Valid data on the toxicity of linuron to nontarget plants is available
                    for only one of five aquatic plants, and not available at all for the ten
                    required terrestrial species. Exposure of nontarget terrestrial and aquatic
                    plants to linuron is expected primarily due to runoff from ground
                    applications (all use sites) and from runoff and drift for aerial applications
                    (certain soybean product labels).

                          No terrestrial plant risk assessment can be done due to the lack of
                    adequate data.

                          Only a preliminary aquatic plant risk assessment can be done since
                    adequate data are available for just one of five species. High risk and
                    endangered plant LOCs are exceeded for aquatic plants if the EEC/EC50 > 1.
                    Based on the EECs previously calculated to evaluate risk to aquatic
                    animals, and the one available EC50 (0.067 ppm), these LOCs are exceeded
                    under the runoff to wetland model (6") for ROWs, but not the runoff to 6'
                    pond model for all other uses.

                    (4)    Endangered Species

                          As  described in the above risk assessment sections, endangered
                    species LOCs are exceeded in some instances for acute effects to birds, wild
                    mammals, aquatic organisms and nontarget plants. Endangered species
                    LOCs are exceeded for chronic effects to birds, wild mammals, and aquatic
                    organisms.

                          The Endangered Species Protection Program is expected to become
                    final in 1995. Limitations on the use of linuron will be required to protect
                    endangered and threatened species, but these limitations  have not yet been
                    defined (and may be formulation specific).  OPP anticipates that
                    consultation with the Fish and Wildlife Service will be conducted in
                    accordance with the species-based priority approach described in the
                    Program. After completion of consultation, registrants will be informed if
                    any required label modifications are necessary.  Such modifications would
                    most likely consist of the generic label statement referring pesticide users to
                    use limitations contained in county bulletins.
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


                                            56

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containing linuron active ingredient. The Agency has completed its review of these generic data,
and has determined that based on the information currently available, there is data to support the
reregistration of all products containing linuron, with the exception of use on cotton, potato, non-
cropland (rights-of-way), and sweet corn. Appendix B identifies the generic data requirements
that the Agency reviewed as part of its determination of reregistration eligibility of linuron, 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 linuron and to determine that except for the cotton, potato, non-cropland, and sweet corn
uses, linuron can be used without resulting in unreasonable adverse effects to humans and the
environment.  To ensure that the potential risks of linuron are not unreasonable, the Agency is
requiring  the  registrant to implement certain risk mitigation measures.  Provided that these
measures  are implemented, as discussed below,  the Agency therefore finds that all products
containing linuron as the sole active ingredient with the exception of cotton, potato, non-cropland
(rights-of-way),  and sweet corn, are eligible for reregistration. The reregistration of particular
products is addressed in Section V of this document.

    The Agency made its reregistration eligibility determination based upon the target data base
required for reregistration, the current guidelines  for conducting acceptable studies to generate
such data and the data identified in Appendix B. The Agency has found that all uses of linuron,
except  for the cotton, potato, non-cropland (rights-of-way), and sweet corn uses, are eligible for
reregistration At this time, the Agency is unable to make a reregistration eligibility decision
on the  use of linuron on potatoes because under current policies tolerances  under Section
409 of  the Federal Food, Drug and Cosmetic Act (FFDCA) are needed for this use, but such
a tolerance may be barred by the Delaney clause in Section 409.  Refer to  the discussion
under  "Tolerance Reassessment."

    As a risk reduction measure for linuron, DuPont has agreed to voluntarily cancel the Hybrid
poplar and non-cropland  (rights-of-way) uses.  In  addition, DuPont has already voluntarily
cancelled the cotton use of linuron. However, data remain outstanding for the cotton, rights-of-
way, and sweet corn uses. Registrants must either amend their labels deleting these uses or
submit the required data.  Therefore, the Agency is unable to make a reregistration eligibility
decision for the use of linuron on cotton, rights-of-way, and sweet corn.

    It should be understood that the Agency may take appropriate regulatory action, and/or
require the  submission of additional data to support the  registration of products containing
linuron, if new  information comes to the Agency's attention or if the data requirements for
registration (or the guidelines for generating such data) change.

    1.     Eligibility Decision

          Based on the reviews of the generic data for the active ingredient linuron, the Agency
    has sufficient information on the health effects of linuron and on its potential for causing
    adverse effects in fish and wildlife and the environment.  Although levels of concern are
    exceeded for ecological effects and groundwater quality, the Agency concludes that most of
    the uses of products containing linuron, with the exception of cotton, potato, non-cropland
    (rights-of-way), and sweet corn, amended to reflect the risk mitigation measures imposed in
    this RED are eligible for reregistration.


                                         57

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          The Agency is unable to make a reregistration eligibility decision for the use of linuron
    on cotton, potato, non-cropland (rights-of-way), and sweet corn until additional generic data
    are submitted. The Agency is unable to make a reregistration eligibility decision on the use
    of linuron on potatoes because under current policies tolerances under Section 409 of the
    Federal Food, Drug and Cosmetic Act (FFDCA) are needed for this use, but such a tolerance
    may be barred by the Delaney clause in Section 409.

          The Agency  has determined that eligible linuron  products, labeled  and used as
    specified in this Reregistration Eligibility Decision, will not pose unreasonable risks or
    adverse effects to humans or the environment.

    2.     Eligible and Ineligible Uses

          The Agency has determined that all uses  of linuron, with the exception of cotton,
    potato, non-cropland (rights-of-way), and sweet corn, are eligible for reregistration.

B.  Regulatory Position

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

    1.     Tolerance Reassessment

          Tolerances Listed Under 40 CFR §180.184(a)

          The tolerances listed under 40 CFR §180.184(a) for residues of linuron in/on plant and
    animal commodities are expressed in terms of residues of linuron per se.  The tolerance
    expression under  40 CFR  §180.184(a) should  be revised as  follows:  "Tolerances are
    established for the combined  residues of the herbicide linuron (3-(3,4-dichlorophenyl)-l-
    methoxy-1-methylurea) and its metabolites convertible to 3,4-dichloroaniline, calculated as
    linuron,  in or on  the following  raw  agricultural commodities:".   A  summary of the
    reassessment of tolerances listed in 40 CFR §180.184(a) is presented in Table D.

          Sufficient data are available to support the established tolerances  for the following
    crops: carrots; corn, field, grain; corn, field, forage and fodder; celery; cottonseed; parsnips;
    potatoes; sorghum, grain;  soybeans; and wheat, grain and straw.

          Additional residue data are required if all registered uses of linuron  are to be covered
    under established tolerances for:  asparagus; corn,  sweet (K + CWHR); corn, sweet, forage;
    sorghum forage and fodder;  soybeans, forage and  hay; and wheat forage.  In addition,
    aspirated grain fraction data remain outstanding for field corn.

          A processing study remains outstanding  for cottonseed, if registrants  other than
    DuPont decide to support use on cotton. The tolerance for cottonseed must be revoked, if no
    registrant is supporting the cotton use.
                                         58

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       Food additive tolerance proposals are required for "potatoes, granules" at 0.8 ppm and
"potatoes, chips" at 0.6 ppm, and a feed additive tolerance proposal is required for "potatoes,
waste from processing" at 10 ppm.

       However, under the Delaney clause of the FFDCA, a food/feed additive regulation for
a processed food may not be established for a pesticide which induces cancer in man or
animals.  Linuron may meet this criterion (see discussion in Section III.B.l.c. of this
document).  The Ninth Circuit Court of Appeals has ruled that EPA must interpret this
provision strictly. EPA is in the process of revoking food additive tolerances that violate the
Delaney clause.

       Under current EPA policy, if a food/feed additive tolerance cannot be established due
to the Delaney clause, EPA will neither establish nor continue in effect a tolerance for the
associated raw agricultural commodity.

       At this time, the Agency is unable to make a reregi strati on eligibility decision on
potatoes because EPA is currently evaluating legal challenges to its policies related to the
coordination of actions under Section 409's Delaney clause and FFDCA Section 408 and
FIFRA. But in the event that the Agency will allow the use of linuron on potatoes, additional
data to upgrade the existing potato processing study will be required.

       The established tolerances for corn, grain (inc. pop); corn, pop, forage; corn, pop,
fodder; barley, oats, and rye forage, grain, hay, and straw will be revoked since there are no
registered uses of linuron on these commodities.  In addition, the established tolerances for
corn, sweet, fodder; parsnips, tops; and wheat, hay will be revoked since these commodities
are not listed as  raw  agricultural  commodities of  sweet corn, parsnips,  and wheat,
respectively.

       Tolerances have been proposed for lettuce at 0.1 ppm (PP#1E02486), and ginger and
taro at 1 ppm (PP#3E2920). Tolerance revisions have been proposed for potatoes at 0.2 ppm;
the meat, fat, and meat-by-product (except kidney and liver) of cattle, goats, hogs, horses, and
sheep at 0.1 ppm; and the liver and kidney of cattle, goats, hogs, horses, and sheep at 1.0 ppm
(PP#OF3832).

       A 6(a)(2) data submission indicates linuron residues in or on corn fodder will need to
be raised to cover residues up to 5.5 ppm in corn fodder.  The current tolerance is 1 ppm.

       Tolerances Listed Under 40 CFR §180.1840?;)

       The tolerance  listed  under 40 CFR §180.184(b) is with regional restriction and is
expressed in terms of residues of linuron per se.  The tolerance expression under 40 CFR
§180.184(b) should be revised  as follows:  "Tolerances are established for the combined
residues of the herbicide linuron (3-(3,4-dichlorophenyl)-l-methoxy-l-methylurea) and its
metabolites convertible to 3,4-dichloroaniline, calculated as linuron, in or on the following
raw agricultural commodities:". A summary of the reassessment of tolerances listed in 40
CFR §180.184(b) is presented in Table D.

       Sufficient data are available to support the established tolerance for parsley.


                                      59

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Table D.  Tolerance Reassessment Summary.
Commodity
Current Tolerance
(ppm)
Tolerance
Reassessment (ppm)
Comment/ Correct
Commodity Definition
Tolerances listed under 40 CFR 180.184(a):
Asparagus
Barley, forage
Barley, grain
Barley, hay
Barley, straw
Carrots
Cattle, fat
Cattle, mbyp
Cattle, meat
Celery
Corn, field, fodder
Corn, field, forage
Corn, fresh (inc. sweet
K + CWHR)
Corn, grain (inc. pop)
Corn, pop, fodder
Corn, pop, forage
Corn, sweet, fodder
Corn, sweet, forage
o
6
0.5
0.25
0.5
0.5
1
1
1
1
0.5
1
1
0.25
0.25
1
1
1
1
Reserved
Revoke
Revoke
Revoke
Revoke
1
0.1
1
0.1
0.1
0.5
Increase to 6
1
Reserved
0.1
Revoke
Revoke
Revoke
Reserved
Data are still needed for the
F1C. The current tolerance is
inadequate. Based on
available data, the tolerance
will need to be raised to 7
ppm.
No registered uses.
No registered uses.
No registered uses; not
regulated as a RAC.
No registered uses.
A 1 4-day PHI is required.
Proposed tolerance revision
O.lppm. PP#OF3832
Cattle, kidney
Cattle, liver
Cattle, mbyp (exc. liver and
kidney) /Proposed tolerance
revision 0.1 ppm. PP#OF3832
Proposed tolerance revision
0.1 ppm. PP#OF3832
The available data support use
west of the Rocky Mountains,
all labels must reflect this
restriction.
6(a)(2) data have been
submitted by DuPont
indicating a higher tolerance 6
ppm in/on fodder is required.

Corn, sweet (K + CWHR)
Additional data are required.
Corn, field, grain
Pop corn grain tolerance
should be deleted since there
are no registered uses.
No registered uses.
Not regulated as a RAC.
Additional data required.
                                        60

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Commodity
Cottonseed
Goats, fat
Goats, mbyp
Goats, meat
Hogs, fat
Hogs, mbyp
Hogs, meat
Horses, fat
Horses, mbyp
Horses, meat
Oats, forage
Oats, grain
Oats, hay
Oats, straw
Parsnips (with or without
tops)
Parsnips, tops
Current Tolerance
(ppm)
0.25
1
1
1
1
1
1
1
1
1
0.5
0.25
0.5
0.5
0.5
0.5
Tolerance
Reassessment (ppm)
Revoke
0.1
1
0.1
0.1
0.1
1
0.1
0.1
0.1
1
0.1
0.1
Revoke
Revoke
Revoke
Revoke
0.5
Revoke
Comment/ Correct
Commodity Definition
Cotton, seed
Use is not supported by
DuPont; If other registrants
support use, a processing
study is required. Otherwise,
use should be cancelled and
tolerance revoked.
Proposed tolerance revision to
0.1 ppm.
Goats, kidney
Goats, liver
Goats, mbyp (exc. liver and
kidney) /Proposed tolerance
revision to 0. 1 ppm.
PP#OF3832
Proposed tolerance revision to
0.1 ppm. PP#OF3832
Proposed tolerance revision to
O.lppm. PP#OF3832
Hogs, kidney
Hogs, liver
Hogs, mbyp (exc. liver and
kidney /Proposed tolerance
revision to 0. 1 ppm.
PP#OF3832
Proposed tolerance revision to
O.lppm. PP#OF3832
Proposed tolerance revision to
0.1 ppm. PP#OF3832
Horses, kidney
Horses, liver
Horses, mbyp (exc. liver and
kidney /Proposed tolerance
revision to 0. 1 ppm.
PP#OF3832
Proposed tolerance revision to
0.1 ppm. PP#OF3832
No registered uses.
No registered uses.
No registered uses; not
regulated as a RAC.
No registered uses.
Parsnips, roots
Not regulated as a RAC.
61

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Commodity
Potatoes
Rye, forage
Rye, grain
Rye, hay
Rye, straw
Sheep, fat
Sheep, mbyp
Sheep, meat
Sorghum, fodder
Sorghum, forage
Sorghum, grain (milo)
Soybeans, (dry or succulent)
Soybeans, forage
Soybeans, hay
Wheat, forage
Wheat, grain
Wheat, hay
Wheat, straw
Current Tolerance
(ppm)
1
0.5
0.25
0.5
0.5
1
1
1
1
1
0.25
1
1
1
0.5
0.25
0.5
0.5
Tolerance
Reassessment (ppm)
0.2*1
Revoke
Revoke
Revoke
Revoke
0.1
1
0.1
0.1
Reserved
Reserved
0.2
1
Reserved
Reserved
Reserved
0.1
Revoke
2.0
Comment/ Correct
Commodity Definition
Proposed revision to the
established tolerance. * - All
registrants must submit
revised labels prohibiting use
west of the Rocky Mountains.
No registered uses.
No registered uses.
No registered uses; not
regulated as a RAC.
No registered uses.
Proposed tolerance revision to
0.1 ppm. PP#OF3832
Sheep, kidney
Sheep, liver
Sheep, mbyp (exc. liver and
kidney) /Proposed tolerance
revision to 0. 1 ppm.
PP#OF3832
Proposed tolerance revision to
0.1 ppm. PP#OF3832


Sorghum, grain
Soybeans
Feeding restrictions prohibited
per June 1 994 document.
Additional data required.
Feeding restrictions prohibited
per June 94 document.
Additional data required.
Additional data required.

Not regulated as a RAC.
PP#4F4293
Tolerances listed under 40 CFR 180.184(b):
Lettuce
Ginger
Parsley
Taro
--
--
0.25
--
0.1
1
0.25
1
Proposed tolerance.
PP#1E02486
Proposed tolerance.
PP#3E2920

Proposed tolerance.
PP#3E2920
Tolerances to be proposed under 40 CFR 185 and 186 :
Potatoes, chips
Potatoes, granules
Potatoes, waste from processing
—
—
--
0.6
0.8
10
Proposed tolerance.
Proposed tolerance.
Proposed tolerance.
Delaney issues may prevent the establishment of these tolerances.





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       CODEX HARMONIZATION

       No Codex MRLs have been established for linuron; therefore, issues of compatibility
between Codex MRLs and U.S. tolerances do not exist.

2.     Restricted Use Classification

       Linuron meets the proposed triggers for candidacy as a restricted use chemical for
groundwater concerns. The Agency will consider linuron as a candidate for classification as
a restricted use chemical after the groundwater restricted use rule is finalized.

3.     Risk Mitigation

       The Agency has determined that the current uses of linuron exceed levels of concern
for many  uses.  Several risk mitigation measures proposed  by the technical registrant,
DuPont, and accepted by the Agency are being required. These risk mitigation measures
include reducing application rates, cancellation of high application rate uses, prohibiting use
in certain vulnerable soil types, prohibiting aerial uses, adding groundwater and surface water
label advisories.  These risk mitigation measures are required for all linuron registrants.

       The technical registrant, DuPont, is reducing the application rates  of linuron on
soybeans to 1.0 Ib ai/A, corn field to 0.75 Ib ai/A, potatoes to 1.5 Ibs ai/A, and asparagus to
2.0 Ibs ai/A. DuPont is also limiting the use of linuron on soybeans, field corn, potatoes to
1 application per year (pre-emergent use only) and limiting the use of linuron on asparagus
to 3 applications per year.  Reduction of the application rates for soybeans and asparagus will
also improve the MOEs for handlers.

       DuPont has also  agreed to prohibit the aerial uses of linuron, prohibit the use of
linuron on sand or loamy sand, and on soils of <1% organic matter. Furthermore, DuPont has
agreed to voluntarily cancel the high application rate uses including Hybrid poplar and Non-
cropland uses (Rights-of-way).

       Groundwater Concerns:  Due to groundwater  quality concerns,  the following
mitigation steps are required:

       •     Linuron has been detected in groundwater. Therefore all product
             labels must carry a groundwater advisory.  The label language for
             this advisory can be found in Section V. of this document.

       Surface Water Concerns:

       Linuron can be  applied  by ground spray and therefore could contaminate surface
waters by spray drift.  The available data on the major degradates of linuron are insufficient
to assess their runoff potential  or persistence in surface water.  Linuron is not currently
regulated  under the  Safe Drinking Water Act (SDWA).  Therefore, no MCL has been
established for it and water supply systems are not required to sample and analyze for it. In
addition, no drinking water health advisories have been established for linuron. However,


                                     63

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based upon the Reference Dose, the Agency has (for screening purposes only) a low lifetime
health advisory for linuron of 6.0 ug/L.  Although the available data suggests that the average
annual linuron concentration will generally be well below 6 ug/L, the available data do not
necessarily include those from watersheds that drain high linuron use areas. In addition, the
relatively low to intermediate soil to water partitioning of linuron indicates that the primary
treatment processes employed by most water supply systems to remove suspended sediment
may not always be completely effective in removing linuron.  Consequently, the Agency does
have some moderate concerns for potential risks of linuron to surface water source supply
systems.

       Spray Drift Advisory: The potential for spray drift exists because linuron can also
be applied by ground spray. However, a spray drift labeling statement will not be imposed
until spray drift data is submitted and reviewed by the Agency.

4.     Endangered Species Statement

       The Agency has concerns about the exposure of threatened and endangered plant and
animal species to linuron. Based on the conclusions discussed in the preceding sections of
this risk assessment, endangered species LOCs are  exceeded in some instances for acute
effects to birds, wild mammals, aquatic organisms, and nontarget plants.  Endangered species
LOCs are also exceeded for chronic effects to birds, wild mammals, and aquatic organisms.

       Currently, the Agency is developing a program ("The Endangered Species Protection
Program") to identify all pesticides whose use may cause adverse impacts on endangered and
threatened species and to implement mitigation measures that will eliminate the adverse
impacts. The program would require use restrictions to protect endangered and threatened
species in the county.  Consultations with the Fish and Wildlife Service may be necessary to
assess  risks to newly listed species or from proposed new uses. In the future, the Agency
plans to publish in the Federal Register a description of the program and have available
enforceable county-specific bulletins. Because the Agency is taking this approach for
protecting endangered and threatened species, it is not imposing label modifications at this
time through the RED. Rather, any requirements for product use modifications will occur in
the future under the Endangered Species Protection Program.

5.     Labeling Rationale

             Worker Protection Standard

             Any product whose labeling reasonably permits use in the production of an
       agricultural plant on any farm, forest, nursery, or greenhouse must comply with the
       labeling requirements of 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 reflect the 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, and within the
       deadlines specified in, PR Notices 93-7 and  93-11. Unless otherwise specifically
                                     64

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             directed in this RED, all statements required by PR Notices 93-7 and 93-11 are to be
             on the product label exactly as instructed in those notices.

                    After April 21, 1994,  except as otherwise provided in PR Notices 93-7 and
             93-11, all  products within the scope of those notices must bear WPS PR Notice
             complying labeling when they  are distributed or sold by the primary registrant or any
             supplementally registered distributor.

                    After October 23, 1995, except as otherwise provided in PR Notices 93-7 and
             93-11, all  products within the scope of those notices must bear WPS PR Notice
             complying labeling when they are distributed or sold by any person.

                    Uses within the scope of the Worker Protection Standard

                    The 1992 Worker Protection  Standard for Agricultural Pesticides (WPS)
             established certain worker-protection requirements (personal protective equipment,
             restricted entry intervals, etc.) to be specified on the label of all products that contain
             uses within the scope of the  WPS.  Uses within the scope of the WPS include all
             commercial (non-homeowner) and research uses  on farms, forests, nurseries, and
             greenhouses to produce agricultural plants (including food, feed, and fiber plants,
             trees, turf  grass,  flowers, shrubs, ornamentals, and seedlings). Uses within scope
             include not only uses on plants, but also uses on the soil or planting medium the plants
             are (or will be) grown in.
Some of the registered uses of linuron are within the scope of the Worker Protection Standard for
Agricultural Pesticides (WPS) and some uses are outside the scope of the WPS. Those that are
outside the scope of the WPS include use:

                    •      on plants that are in ornamental gardens, parks, golf courses, and
                           public or private lawns and grounds and that are intended only for
                           decorative or environmental benefit.

                    •      in a manner not directly related to the production of agricultural plants,
                           including, for example, control of vegetation along rights-of-way and
                           shelterbelts.

                    Entry Restrictions

                    Entry Restrictions for Occupational-Use Products (WPS Uses)

                    Some registered uses of linuron are within the scope of the Worker Protection
             Standard for Agricultural Pesticides (WPS) and some are outside the scope of the
             WPS.

                    Restricted Entry Interval -- Under the Worker Protection Standard (WPS),
             interim restricted entry intervals (REI) for all uses within the scope of the WPS are
             based  on the acute toxicity of the active ingredient.  The toxicity categories of the


                                            65

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active ingredient for acute dermal toxicity, eye irritation potential, and skin irritation
potential are used to determine the interim WPS REI.  If one or more of the three
acute toxicity effects are in toxicity category I, the interim WPS REI is established at
48 hours. If none of the acute toxicity effects are in category I, but one or more of the
three is classified as category II, the interim WPS REI is established at 24 hours.  If
none of the three acute toxicity effects are in category I or II, the interim WPS REI is
established  at 12  hours.  A  48-hour REI is increased to 72 hours when an
organophosphate pesticide is applied outdoors in arid areas. In addition, the WPS
specifically  retains two types of REI's  established by  the Agency prior to the
promulgation of the WPS: (1) product-specific REI's established on the  basis of
adequate  data, and (2) interim REI's that are longer than those that would be
established under the WPS.

       For occupational end-use products containing linuron as an active ingredient,
the Agency  is establishing a 24-hour restricted-entry interval for each use of the
product that is within the scope of the Worker Protection Standard for Agricultural
Pesticides (WPS).  The basis of the 24-hour REI is a post-application risk assessment
using asparagus reentry  data and the toxicological  endpoint  for developmental
toxicity.

       The WPS  places very  specific restrictions on entry  during restricted-entry
intervals when that entry involves contact with treated surfaces. The Agency believes
that these  existing WPS  protections  are  sufficient  to  mitigate  post-application
exposures of workers who contact surfaces treated with linuron.

       Entry Restrictions for Occupational-Use Products (NonWPS Uses}

       Some registered uses of linuron are outside the scope of the Worker Protection
Standard for Agricultural Pesticides (WPS). The Agency is establishing the following
entry restrictions for all nonWPS occupational uses of linuron end-use products:

       For liquid applications:
       "Do not enter or allow others to enter the treated area until sprays have
       dried."

       Personal Protective Equipment (PPE) Requirements

       PPE for Handlers (Mixer/ Loader/Applicators}

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

1.      If EPA has no special concerns about the acute or other adverse effects of an
       active ingredient, the PPE for pesticide handlers will be based on the acute
       toxicity of the end-use  product. For occupational-use products, PPE will be
       established using the process described in PR Notice 93-7 or more recent EPA
       guidelines.

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

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

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

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

       There are special  toxicological concerns  about linuron  that warrant the
establishment of active-ingredient-based PPE requirements for handlers.  The MOE's
were calculated as being acceptable only when (1) a closed system is used for mixing
and  loading  to  support aerial  application  and (2) specified personal protective
equipment is worn by other mixers and loaders.

       Handler PPE for Occupational-Use Products

       Some of the registered uses  of linuron are within the scope of the Worker
Protection Standard for Agricultural Pesticides (WPS) and some are outside the scope
of the WPS. However, the minimum (baseline) PPE requirements for both the WPS
and nonWPS uses are the same, since the potential exposure to handlers is similar for
WPS and nonWPS uses.

       The minimum (baseline) PPE for mixers and loaders supporting  ground
equipment applications for all WPS and nonWPS uses of linuron end-use products is:
coveralls over long-sleeve shirt and long pants, chemical-resistant footwear, chemical-
resistant gloves,  and chemical-resistant apron.

       No minimum (baseline) PPE for applicators and other handlers (other than
mixers and loaders) is being established by the Agency through this RED.

       Early-Entry PPE

       The WPS establishes very specific restrictions on entry by workers to areas
that remain under a restricted-entry interval if the entry involves contact with treated
surfaces. Among those restrictions are a prohibition of routine entry to perform hand
labor tasks and requirement that personal protective equipment be worn. Personal
protective equipment requirements for persons who must enter areas that remain under
a restricted-entry interval are  based on the toxicity concerns  about the active
ingredient. The requirements are set  in one of two ways.
                              67

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              1.     If EPA has no special concerns about the acute or other adverse effects of an
                    active ingredient, it establishes the early-entry PPE requirements based on the
                    acute dermal toxicity, skin irritation potential, and eye irritation potential of the
                    active ingredient.

              2.     If EPA has special concerns about an active ingredient due to very high acute
                    toxicity or to certain other adverse effects, such as allergic effects, cancer,
                    developmental toxicity, or reproductive effects, it may establish early-entry
                    PPE requirements that are more stringent than would be established otherwise.

                    Since linuron is classified as category  III  for  eye irritation potential, skin
              irritation potential, and acute dermal toxicity,  the PPE required for early entry  is:
              coveralls, chemical-resistant gloves, shoes, and socks. EPA believes that the potential
              adverse  effects of linuron  will be mitigated with this attire, provided the entry
              limitations established by the WPS are complied with.

V. ACTIONS REQUIRED BY REGISTRANTS

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

   A.  Manufacturing-Use Products

       1.      Additional Generic Data Requirements

   In summary, all uses of linuron are eligible for reregistration,  with the exception of cotton, potato,
non-cropland  (rights-of-way), and sweet  corn.   The Agency is  unable to make a  reregistration
eligibility decision for the use of linuron on cotton, non-cropland (rights-of-way), and sweet corn
until additional data are submitted and evaluated. Also, a reregistration eligibility decision will not
be made on the potato use of linuron until a decision on EPA's Coordination Policy has been
made. Furthermore, the Agency is requiring that additional confirmatory data be submitted to fulfill
the generic data requirements for reregistration of linuron.

       Starting Materials and Manufacturing Process

       Foliar Dislodgeable Residues (Carrots/Celery)
       Soil Dislodgeable Residues (Carrots/Celery)
       Dermal Exposure (Carrots/Celery)
       Inhalation Exposure (Carrots/Celery)

       Cropfield Trials - Asparagus; Corn Aspirated Fractions,  Sorghum, Forage and Hay; and
              Wheat, Forage
       Cropfield Trials - Soybeans Forage and Hay - required due to change in Agency policy  on
              grazing restrictions

       Acute Avian Dietary Toxicity w/TGAI -  Quail and Duck
       Acute Aquatic Invertebrate Toxicity
       Fish Early Life Stage - both Rainbow Trout and Sheepshead Minnow

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       Aquatic Invertebrate Life Cycle - Mysid shrimp
       Leaching/Adsorption/Desorption
       Terrestrial Field Dissipation

   In order to support the use of linuron on cotton and sweet corn, the following residue data are
required:

       Cottonseed processing study
       Cropfield trials - sweet corn

   In order to support the use of linuron on and non-cropland (rights-of-way) uses, the following data
are required:

       Acute Marine/Estuarine (TEP) - Sheepshead Minnow using DF Formulation for
             Rights-of-Ways

   Certain data are not part of the target database for linuron, but are also  required:

       Seed germination/seedling emergence - 10 species
       Vegetative vigor - 10 species
       Aquatic plant growth - 4 additional species

       2.     Labeling Requirements for Manufacturing Use Products

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

             "Only for formulation into a herbicide for the following uses(s):	(fill
       blank only with  those uses that are being supported by MP registrant)."

             An MP registrant may, at his/her discretion, add one of the following statements
       to an MP label under "Directions for Use" to permit the reformulation of the product for
       a specific use or all additional uses supported by a formulator or user group:

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

       (b)    "This product may be used to formulate products for any additional use(s) not
             listed on the MP label if the formulator, user group, or grower has complied with
             U.S. EPA submission requirements regarding the support of such uses(s)."
                                           69

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B.  End-Use Products

    1.     Additional Product-Specific Data Requirements

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

          Registrants must review previous data submissions to ensure that they meet current
    EPA acceptance criteria (Appendix F; Attachment E) and if not, commit to conduct new
    studies. If a registrant believes that previously submitted data meet current testing standards,
    then study MRID numbers should be cited according to the instructions in the Requirement
    Status and Registrants Response Form provided for each product.

    2.     Labeling Requirements for End-Use Products

          a.     Worker Protection

                 (1)    Entry Restrictions; Labeling

                 Entry Restrictions for Occupational-Use Products (WPS Uses}

                 In order to be in compliance with FIFRA, a 24 hour  restricted  entry
          interval (REI) is required for all uses within the scope of the Worker Protection
          Standard. This REI must be inserted into the standardized REI statement specified in
          the  WPS as  explained by the EPA guidance in PR Notice 93-7.   The personal
          protective equipment for early entry must be the PPE required for handlers of linuron
          (see Section 2 below). This PPE must be inserted into the standardized REI statement
          specified by the WPS as explained in the EPA guidance in PR Notice 93-7.
                 In order to be in compliance with FIFRA, labels of sole active ingredient
          end-use products that contain linuron must be revised to adopt the entry restrictions
          set forth in this section.  Any conflicting entry restrictions on their current labeling
          must be removed.

                 In order to be  in compliance with FIFRA, labels of  multiple-active-
          ingredient end-use products that contain linuron must bear the more protective of
          either the entry restrictions set forth in this section or the entry restrictions on the
          current labeling.

                 Entry Restrictions for Occupational-Use Products (NonWPS Uses)

                 Some registered uses of linuron are outside the scope of the Worker Protection
          Standard for Agricultural Pesticides (WPS). The Agency is establishing the following
          entry restrictions for all nonWPS occupational uses of linuron end-use products:
                                        70

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             For liquid applications:
             "Do not enter or allow others to enter the treated area
             until sprays have dried."

       (2)    Personal Protective Equipment Requirements; Labeling

       Handler PPE for Occupational Use Products: For all uses of linuron, (includes
uses both within the scope of WPS and non-WPS uses) the minimum (baseline) PPE
requirements for pesticide handlers on all linuron end-use products are:

       •     coveralls over long-sleeve shirt and long pants
       •     chemical-resistant footwear
       •     chemical-resistant gloves
       •     chemical-resistant apron

       No minimum (baseline) PPE for applicators and other handlers (other than
mixers and loaders) is being established by the Agency through this RED.

       Early Entry PPE:  Since linuron is classified as category III for eye irritation
potential, skin irritation potential, and acute dermal toxicity, the PPE required for early
entry is: coveralls, chemical-resistant gloves, shoes, and socks.  EPA believes that
the potential adverse effects of linuron will be mitigated with this attire, provided the
entry limitations established by the WPS are complied with.

       Products containing linuron may contain more stringent PPE, but in no case
may they require less stringent PPE than the above requirements.

       Producers of end-use products that contain linuron must compare the PPE
requirements set forth in this  section to the  PPE requirements,  if any, on  current
labeling and retain the more protective. For guidance in choosing which requirement
is more protective, see supplement 3 of PR Notice 93-7.

b.     Other Labeling Requirements

       The Agency is requiring the following labeling statements to be located on all
end-use products containing linuron that are intended primarily for occupational use:

(1)    The labels of all linuron end-use products must be revised to bear the following
under the Environmental Hazard  Section:

Ground Water Advisory

       "This chemical is known to leach through soil into ground water under
       certain conditions as a result of agricultural use.  Use of this chemical
       in areas where  soils are permeable, particularly where the water table
       is shallow, may result in ground-water contamination."
                              71

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Surface Water Advisory

       "Linuron may contaminate surface water through spray drift or, under
       certain conditions, from surface runoff into adjacent surface water
       bodies (pond, lakes, streams, etc.)  For several weeks post-application,
       linuron has a high potential to runoff when applied to fields with any
       of the following conditions:  sloping land  draining into nearby surface
       waters;  very  poorly  to somewhat  poorly  drained  soils; areas with
       extremely shallow ground water; frequently flooded areas; fields with
       surface water canals  or ditches; and highly erodible  land cultivated
       with poor managment practices."

For terrestrial uses except rights-of-way

       "This pesticide is toxic to fish and aquatic invertebrates. Do not apply
       to water or to areas where surface water is present, or to intertidal areas
       below  the  mean high  water mark.  Do  not  apply  when  weather
       conditions favor drift from treated  areas. Do not contaminate water
       when disposing of equipment wash water or rinsate."

For rights-of-way

       If a registrant chooses  to support the rights-of-way use, he must submit the data
required in this RED  document associated with the rights-of-way use of linuron and
his labels must also bear the  following labeling statement:

       "This pesticide is toxic to fish and aquatic invertebrates.   Do not
       contaminate water when  disposing of equipment  washwaters or
       rinsate."

       However, if a registrant does not support the rights-of-way use, the registrant
must amend his product label  by deleting the rights-of-way use in accordance with the
procedures in PR Notice 91-1.

(2)    The labels of all linuron end-use products must be revised to bear the following
application restrictions under the Directions for Use Section:

       Application Restrictions:

       "Do not apply this product in a way that will  contact workers or
       other persons, either directly or through drift. Only protected
       handlers may be in the area during application."

       "Aerial application is prohibited."

       "Use on sand  or loamy sand is prohibited."

       "Use on soils  of <1% organic matter is prohibited."

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          (3)    The labels of all linuron end-use products must be revised to bear the following
          application rates under the Crop Uses Section for the respective crops:

          Application Rates

                 For linuron use on soybeans:
                 A maximum application rate of 1.0 Ib ai/A, with use limited to single
                 application (pre-emergent use only) per year.

                 For linuron use on corn, field:
                 A maximum application rate of 0.75 Ib ai/A, with use limited to single
                 application (pre-emergent use only) per year.

                 For linuron use on potatoes:
                 A maximum application rate  of 1.5 Ibs ai/A, with use limited to single
                 application (pre-emergent use only) per year.

                 For linuron use on asparagus:
                 A maximum application rate of 2.0 Ibs ai/A per year, with use limited
                 to 3 applications per year.

                 Do not exceed 2.0 Ibs total per acre  per year.

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

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

    The Agency has determined that registrants may  distribute and sell products bearing old
labels/labeling, i.e., labels absent the modifications specified in this RED document, except as
noted below,  for 26 months from the date of issuance of this  RED.  Persons other than the
registrant may distribute or sell such products for 50 months from  the date of the issuance of this
RED.  Registrants and persons other than registrants remain obligated to meet pre-existing
Agency imposed label changes and existing stocks requirements applicable to products they sell
or distribute.
                                        73

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VI.  APPENDICES
       74

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APPENDIX A.  Table of Use Patterns Subject to Reregistration
                            75

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76

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                                                                                                                                                        LUIS 2.0  )  Page

                                   4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
SITE Application Type, Application         Form(s)   Min.  Appl.      Max. Appl. Soil Max.  #  Apps  Max.  Dose [(AI   Min.  Restr.     Geographic Limitations       Use
  Timing, Application Equipment   )                  Rate  (AI un-      Rate  (AI Tex. @ Max.  Rate  unless noted    Interv Entry   Allowed            Disallowed   Limitations
  Surface Type  (Antimicrobial  only)  &  Effica-      less noted    unless noted Max. /crop /year  otherwise)/A]    (days)  Interv                                  Codes
  cy Influencing Factor  (Antimicrobial only)        otherwise)      otherwise) Dose cycle       /crop    /year         [day(s)]
                                                                                                 cycle
Note: All DuPont labels, except  for  package mixes with chlorimuron for soybeans only,  and  certain other manufacturers' labels, carry the following  limitations not captured in
codes; other labels lack one  or  both limitations:
     • E)  net u e  n HII^  r p  rn  I ern C iint^ ,  C alrf ornr H,  ^  ept a-paraju  nnd  nrr t^ when  H permrt ha-  ] een  obtained form the Agriculture Commission.
     • In the _clum] rn Fr^er EH_rn, u-e Lrnur  n  cnl^  rf the  r  p r-  ^prrnller rrrrgated.
                                                                                                                                                                                         the
-SEAF.AGUL'

Broadcast., Postemergence.,  Boom  sprayer.     DF
                                                    NA
DF    NA

DF    NA


DF    NA
                                              F1C   NA
                                              F1C   NA
                                              F1C   NA
                                              F1C   NA
1 Ib A


1 Ib A

1 Ib A


1 Ib A


1 Ib A


1 Ib A


1 Ib A


1 Ib A


1 Ib A


1 Ib A
                                                                                           NS

                                                                                           NS
4 Ib


4 Ib

4 Ib


4 Ib


4 Ib


4 Ib


4 Ib


4 Ib
                                                                                                    4  Ib

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                                                                                                                                                      LUIS 2.0   )   Page
SITE Application Type, Application
                                          Form(s)  Min. Appl.      Max. Appl.  Soil  Max.  #  Apps Max.  Dose [(AI   Min.   Restr.     Geographic Limitations      Use
  Timing, Application Equipment  )
  Surface Type  (Antimicrobial only) & Effica-
  cy Influencing Factor  (Antimicrobial only)
Rate  (AI un-      Rate  (AI Tex. @ Max. Rate unless  noted     Interv  Entry   Allowed
less noted    unless noted Max. /crop /year otherwise)/A]    (days)  Interv
otherwise)       otherwise) Dose cycle       /crop     /year          [day(s)]
                                            cycle
                                                                        2  Ib  A
                                                                                     1     NS
                                                                        2  Ib  A
                                                                                     1     NS
                                                                                                   4 Ib
                                              F1C   NA
                                                                        2  Ib  A
                                                                                     1     NS
                                              F1C   NA
                                              F1C   NA
                                              F1C   NA
                                             DF    NA
                                                                        4  Ib  A
                                                                                                   4 Ib
                                             DF    NA

                                             DF    NA
                    4 Ib A

                    4 Ib A
NS

NS
                                             DF    NA
                                                                        4  Ib  A
                                                                                                   4 Ib
                                                                        4  Ib  A
                                                                                                   4 Ib
                                              F1C   NA
                                                                        4  Ib  A
                                                                                                   4 Ib

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                                                                                                                                                       LUIS  2.0   )   Page
SITE Application Type, Application
                                          Form(s)  Min. Appl.       Max.  Appl.  Soil  Max.  # Apps Max.  Dose [(AI   Min.  Restr.     Geographic Limitations       Use
  Timing, Application Equipment  )
  Surface Type  (Antimicrobial only) & Effica-
  cy Influencing Factor  (Antimicrobial only)
      Rate  (AI un-      Rate  (AI Tex.  @ Max. Rate  unless  noted     Interv Entry   Allowed
      less noted    unless noted Max.  /crop  /year  otherwise)/A]    (days)  Interv
      otherwise)       otherwise) Dose  cycle        /crop     /year          [day(s)]
                                                   cycle
                                              F1C   NA
                                              F1C   NA
                                              F1C   NA
                                                                        4  Ib  A
                                                                        4  Ib  A
                                                                                                   4 Ib
Spray., Postemergence., Boom sprayer.


Spray., Preemergence.,  Boom sprayer.
F1C   NA


DF    NA

F1C   NA
1'AFFOT (INCLUDING TOES)

Spray., Postemergence., Boom sprayer.
                                              DF    NA


                                              DF    NA

                                              DF    NA

                                              F1C   NA

                                              F1C   NA
                                                                        4  Ib  A
                                                                        1  Ib  A
                                                                                                   4 Ib
                                                      2  Ib


                                                      2  Ib

                                                      2  Ib

                                                      2  Ib

                                                      2  Ib
 1    FL, MI,  OH, WI

 1

0.5

-------
SITE Application Type, Application
  Timing, Application Equipment  )
  Surface Type  (Antimicrobial only)  & Effica-
  cy Influencing Factor  (Antimicrobial only)
                                                                    APPENDIX A  )   CASE 0047,  [Linuron] Chemical 035506  [Linuron]
                                                                                     LUIS 2.0  )   Page
  Max. Appl. Soil Max. # Apps Max. Dose  [(AI   Min.   Restr.
    Rate  (AI Tex. @ Max. Rate unless  noted
unless noted Max. /crop /year otherwise)/A]
  otherwise) Dose cycle       /crop    /year
                              cycle
                                                                                                                                  Geographic Limitations
                                              F1C   NA


                                              F1C   NA


                                              F1C   NA


                                              WP    NA

                                              F1C   NA

                                              DF    NA


                                              DF    NA

                                              DF    NA

                                              DF    NA


                                              F1C   NA



                                              F1C   NA

                                              F1C   NA


                                              F1C   NA

                                              F1C   NA
                                                                                     TERRESTRIAL FOOD CROP  (con't)
    1.5 Ib A
    1.5 Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
Ib A
* N
* N
* N
* N
* N
* N
s
s
s
s
s
s
NS
NS
NS
NS
NS
NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
1
0.5
1 FL, MI, OH,
1 FL, MI, OH,
1 FL, MI, OH,
1 FL, MI, WI


WI
WI
WI

                                                             FL,  MI,  OH,  WI  013
        Ib A

        Ib A


        Ib A

        Ib A
NS

NS


NS

NS
0.5

 1    FL, MI, OH, WI
      FL, MI, OH, WI

      FL, MI, OH, WI

-------
                                                                                                                                                        LUIS 2.0  )  Page

                                   4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
SITE Application Type, Application         Form(s)   Min. Appl.      Max. Appl. Soil Max.  #  Apps Max.  Dose [(AI   Min.  Restr.      Geographic  Limitations      Use
  Timing, Application Equipment   )                  Rate  (AI un-      Rate  (AI Tex. @  Max.  Rate unless noted    Interv Entry   Allowed            Disallowed   Limitations
  Surface Type  (Antimicrobial  only)  &  Effica-      less noted    unless noted Max. /crop /year otherwise)/A]    (days) Interv                                  Codes
  cy Influencing Factor  (Antimicrobial only)        otherwise)      otherwise) Dose cycle       /crop    /year         [day(s)]
                                                                                                 cycle
                                              WP    NA

Spray., Preemergence., Ground.                DF    NA

CELERY

Spray., Posttransplant.,  Boom  sprayer.        DF    NA
    Use Group: TERRESTRIAL FOOD CROP  (con't)

1.5 Ib A   *  NS    NS       2 Ib       NS    NS      1    FL, MI, OH, WI

  1 Ib A   *  NS  1/1 yr       NS     1  Ib    NS      1    CA

    Use Group: TEFRESTRIAL FOOD CFOP
                                              F1C   NA
                                              F1C   NA
                                              F1C   NA
                                              F1C   NA

-------
                                                                                                                                                        LUIS 2.0  )  Page

                                   4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
SITE Application Type, Application         Form(s)   Min.  Appl.      Max. Appl. Soil Max.  #  Apps  Max.  Dose [(AI   Min.  Restr.     Geographic  Limitations       Use
  Timing, Application Equipment   )                  Rate  (AI un-      Rate  (AI Tex. @  Max.  Rate  unless noted    Interv Entry   Allowed            Disallowed   Limitations
  Surface Type  (Antimicrobial  only)  &  Effica-      less noted    unless noted Max. /crop /year  otherwise)/A]    (days) Interv                                  Codes
  cy Influencing Factor  (Antimicrobial only)        otherwise)      otherwise) Dose cycle       /crop    /year         [day(s)]
                                                                                                 cycle
CELERY  (con't)
                                              F1C   NA
                                                                          Use Group:  TERRESTRIAL FOOD CROP (con't)
COF1I, FIELD

Band treatment., Pcstemergence.,  EC  m
sprayer.
.5^4  Ib A   *   US  11 yr       IIS   . "^ It   NS      1
. :_4  Hi A   F
.400  Ib A   M
.154  Ib A   C
                                                                      .524 Ib A    *  NS   1/1  yr       NS  .77 Ib   NS     1
                                                                      .524 Ib A    F
                                                                      .400 Ib A    M
                                                                      .154 Ib A    C
Band treatment., Preemergence.,  Boom
sprayer.
                                                                                    NS   1/1  yr
Band treatment., Preemergence.,
Tractor-mounted sprayer.
                                                                                    NS   1/1  yr

-------
SITE Application Type, Application
  Timing, Application Equipment  )
  Surface Type  (Antimicrobial only)  & Effica-
  cy Influencing Factor  (Antimicrobial only)
                                                                                                                                                       LUIS  2.0   )   Page
  Max. Appl. Soil Max. # Apps Max. Dose  [(AI   Min.  Restr.
    Rate  (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
  otherwise) Dose cycle       /crop    /year
                              cycle
                                                                                                                                  Geographic Limitations
CORN, FIELD  (con't)
                                                                          Use Group:  TERRESTRIAL FOOD+FEED CROP (con't)
DF
DF
F1C
F1C
F1C
F1C
F1C
WP
WP


NA
NA
NA
NA
NA
NA
NA
NA
NA


1.5 Ib
1.5 Ib
1.5 Ib
1.5 Ib
1.5 Ib
1.5 Ib
1.5 Ib
1.5 Ib
1.54 Ib
1.54 Ib
1.232 Ib
A
A
A
A
A
A
A
A
A
A
A
* NS
* NS
* 1
* 1
* 1
* NS
* NS
* NS
* NS
F
M
NS
NS
NS
NS
NS
NS
NS
NS
1/1 yr


NS
NS
1.5 Ib
1.5 Ib
1.5 Ib
NS
NS
NS
NS


NS
NS
NS
NS
NS
NS
NS
NS
.77 Ib


NS
NS
NS
NS
NS
NS
NS
NS
NS


1
1
0.5
1
NS
1
1
1
1


                                                                     .493 Ib A
                                                                                 *   1    NS     1.5 Ib      NS   NS     1    013
                                                                                 F  Geo.013:  Apply East of the Rocky Mountains only.
                                                                                                                              013
                                                                                                                                                              C40,  C46,  C87

                                                                                                                                                              C46,  C87

                                                                                                                                                              C40,  C87

                                                                                                                                                              C40,  C46,  C92

                                                                                                                                                              C40,  C46,  CAD

                                                                                                                                                              C46,  C93,  CAG

                                                                                                                                                              C40,  C46,  C92

                                                                                                                                                              C46

                                                                                                                                                              C40,  C46,  CAD

-------
                                                                                                                                                       LUIS  2.0   )   Page
SITE Application Type, Application
  Timing, Application Equipment  )
  Surface Type  (Antimicrobial only)  & Effica-
  cy Influencing Factor  (Antimicrobial only)
                Max. Appl. Soil Max. # Apps Max. Dose  [(AI   Min.   Restr.      Geographic Limitations
Rate  (AI un-      Rate  (AI Tex. @ Max. Rate unless  noted     Interv  Entry   Allowed
less noted    unless noted Max. /crop /year otherwise)/A]    (days)  Interv
otherwise)       otherwise) Dose cycle       /crop    /year          [day(s)]
                                            cycle
CORN, FIELD  (con't)
                                                                          Use  Group:  TERRESTRIAL FOOD+FEED CROP (con't)
                                                                          Ib  A   *   NS    NS         NS
                                                                          Ib  A   F   Geo.013:  See above
                                                                          Ib  A   M
                                                                          Ib  A   C
                                                                                                                              013
                                              F1C   NA
                                                                          Ib  A   *    1    NS     1.5 Ib      NS   NS    0.5   013
                                                                          Ib  A   F   Geo.013:  Apply East of the Rocky Mountains only.
                                                                          Ib  A   M
                                                                          Ib  A   C
                                              F1C   NA
                                                                          Ib  A   *    1    NS     1.5 Ib      NS   NS     1    013
                                                                          Ib  A   F   Geo.013:  Apply East of the Rocky Mountains only.
                                                                          Ib  A   M
                                                                          Ib  A   C
                                              F1C   NA
                                                                          Ib  A   *    1    NS     1.5 Ib      NS   NS     NS   013
                                                                          Ib  A   F   Geo.013:  See above
                                                                          Ib  A   M
                                                                          Ib  A   C
                                              F1C   NA
                                              F1C   NA
                                                                          Ib  A   *   NS    NS         NS      NS   NS     1    013
                                                                          Ib  A   F   Geo.013:  Apply East of the Rocky Mountains.
                                                                          Ib  A   M
                                                                          Ib  A   C

-------
SITE Application Type, Application
  Timing, Application Equipment  )
  Surface Type  (Antimicrobial only)  & Effica-
  cy Influencing Factor  (Antimicrobial only)
                                                                                                                                                       LUIS  2.0   )   Page
  Max. Appl. Soil Max. # Apps Max. Dose  [(AI   Min.  Restr.
    Rate  (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
  otherwise) Dose cycle       /crop    /year
                              cycle
                                                                                                                                  Geographic Limitations
CORN, FIELD  (con't)
Spray., Preemergence., Tractor-mounted       WP    NA
sprayer.
PARSLEY

Broadcast., Preemergence., Boom sprayer.     DF    NA

PAFSNIE

Spray., Preemergence., Boom sprayer.         DF    NA

                                             DF    NA

                                             F1C   NA

                                             DF    NA

                                             DF    NA
                                                                          Use  Group:  TERRESTRIAL FOOD+FEED CROP (con't)

                                                                          Ib A   *   NS    NS         NS      NS   NS     1    013
                                                                          Ib A   F   Geo.013:  Apply East of the Rocky Mountains only
                                                                          Ib A   M
                                                                          Ib A   C
                                                                                        1/1
                                                                                                     NS
        Use Group: TERRESTRIAL FOOD CROP

          UC   *  NS  1/1 yr       NS

        Use Group: TEFRESTRIAL FOOD CFOP
                        NS

                        NS

                        NS

                        NS

                        NS
C40, C46, C92

C46, C92

C40, C87

C40, C46, C92

C46, C92

-------
SITE Application Type, Application
  Timing, Application Equipment  )
  Surface Type  (Antimicrobial only) & Effica-
  cy Influencing Factor  (Antimicrobial only)
                                                                                                                                                       LUIS  2.0   )   Page
  Max. Appl. Soil Max. # Apps Max. Dose  [(AI   Min.  Restr.
    Rate  (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
  otherwise) Dose cycle       /crop    /year
                              cycle
                                                                                                                                  Geographic Limitations
PARSNIP (con't)
                                                                          Use  Group:  TERRESTRIAL FOOD+FEED CROP (con't)
DF
DF
F1C
F1C
F1C
F1C
F1C
WP
NA
NA
NA
NA
NA
NA
NA
NA
1.5 Ib
1.5 Ib
1.5 Ib
1.5 Ib
1.5 Ib
1.5 Ib
1.5 Ib
1.5 Ib
A *
A *
A *
A *
A *
A *
A *
A *
Use Group:
DF
DF
DF
DF
F1C
F1C
F1C
F1C
NA
NA
NA
NA
NA
NA
NA
NA
1 Ib
1 Ib
1 Ib
1 Ib
1 Ib

1 Ib
1 Ib
A *
A *
A *
A *
A *
UC *
A *
A *
NS
NS
1
1
1
1
NS
NS
TERRE
1
NS
NS
NS
1
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
STRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
1.5 Ib
1.5 Ib
1.5 Ib
1.5 Ib
NS
NS
FOOD+FEED
NS
NS
NS
NS
1 Ib
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS 1
NS 1
NS 0.5
NS 1
NS 1
NS NS
NS 1
NS 1

NS 1
NS 1
NS 1
NS 1
NS 0.5
NS 1
NS 1
NS 1
                                                                                                                                                             040, 046, 087

                                                                                                                                                             046, 087

                                                                                                                                                             040, 087

                                                                                                                                                             040, 046, 092

                                                                                                                                                             040, 046, 092

                                                                                                                                                             040, 046, CAD

                                                                                                                                                             046, 093, CAG

                                                                                                                                                             046
                                              F1C   NA
                                                                        1  Ib  A

-------
                                                                                                                                                      LUIS 2.0   )   Page
SITE Application Type, Application
  Timing, Application Equipment  )
  Surface Type  (Antimicrobial only) & Effica-
  cy Influencing Factor  (Antimicrobial only)
  Max. Appl. Soil Max. # Apps Max. Dose  [(AI   Min.  Restr.
    Rate  (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
  otherwise) Dose cycle       /crop    /year
                              cycle
                                                                                                                                  Geographic Limitations
                                                                         Use  Group:  TERRESTRIAL FOOD+FEED CROP (con't)
                                             WP    NA

                                             F1C   NA

                                             DF    NA
                                                                        1  Ib A
                        NS

                        NS

                        NS
                                             DF    NA

                                             DF    NA
                                                                      1.5  Ib A
                        NS

                        NS
                                              F1C   NA
                                                                                                   1 Ib
                                              F1C   NA
                                                                                                   1 Ib
                                              F1C   NA
                                                                      1.5
                                                                        1
                                              F1C   NA
                                              F1C   NA

-------
                                                                                                                                                      LUIS 2.0   )   Page
SITE Application Type, Application
  Timing, Application Equipment  )
  Surface Type  (Antimicrobial only) & Effica-
  cy Influencing Factor  (Antimicrobial only)
  Max. Appl. Soil Max. # Apps Max. Dose  [(AI   Min.  Restr.
    Rate  (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
  otherwise) Dose cycle       /crop    /year
                              cycle
                                                                                                                                  Geographic Limitations
SOYBEANS (UNSPECIFIED)

Broadcast., Postemergence., Boom sprayer.
                                             F1C   NA
                                             DF    NA


                                             DF    NA

                                             DF    NA

                                             DF    NA

                                             DF    NA


                                             F1C   NA


                                             F1C   NA
                                                                         Use  Group:  TERRESTRIAL FOOD+FEED CROP (con't)

                                                                                          NS         NS      NS   NS     1
                                                                        1  Ib  A
                                                                        1  Ib  A
      1 Ib A
                        NS

                        NS

                        NS

                        NS
                                                                                                   1 Ib
                                                                                                   1 Ib
                                 1 Ib
                                                                                                   1 Ib
                                              F1C   NA
                                                                        1  Ib  A
                                                                                                   1 Ib

-------
SITE Application Type, Application        Form(s)  Min. Appl.
  Timing, Application Equipment  )                 Rate  (AI un-
  Surface Type  (Antimicrobial only) & Effica-      less noted
  cy Influencing Factor (Antimicrobial only)       otherwise)
                                                                   APPENDIX A   )  CASE
  Max. Appl. Soil Max. # Apps Max. Dose  [(AI   Min.  Restr.
    Rate  (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
  otherwise) Dose cycle       /crop    /year
                              cycle
                                                                                     LUIS  2.0   )   Page
                                                                                                                                  Geographic  Limitations
                                             F1C   NA
                                             F1C   NA
                                                                         Use Group: TERRESTRIAL  FOOD+FEED CROP  (con't)
                                                                       1 Ib A
                                                                       1 Ib A
                                                                                   NS    NS         NS      NS   NS     0.5    013                             C40,  C87,  HOI(60)
                                                                                     Geo.013:  In Midsouth  and Southeast apply when  soybeans  are  at  least 12  inches  tall  and when weeds do
                                                                                    not exceed 4 inches  in height.   In  Midsouth,  application may be made when  soybeans are  at least 8
                                                                                    inches tall and weeds  do not exceed 2  inches  in height.   Make a single application of  1 to 2 pints
                                                                                    per acre  (0.5  to  1 pint per acre on 8  inch soybeans).  Alternatively,  if  application  is  made to 12
                                                                                    inch soybeans, make  a  split application  of 1  pint  per  acre followed by a second application at same
                                                                                    rate after a week or later. Overall dosage not  to  exceed 2 pints per acre  per season,  for
                                                                                    postemergence  treatment.
                                                                                   NS
                                                                                         NS
                                                                                                    NS
                                                                                                            NS
                                                                                                                        NS
Soil incorporated treatment., Early
preplant., Boom sprayer.
                                             WP    NA

                                             DF    NA
                                                                       1 Ib A
                                                                                                   1  Ib
                                                                    .6401 Ib A
Spray., Early preplant., Boom sprayer.

-------
SITE Application Type, Application
  Timing, Application Equipment  )
  Surface Type  (Antimicrobial only) & Effica-
  cy Influencing Factor  (Antimicrobial only)
                                                                                                                                                      LUIS 2.0   )   Page
  Max. Appl. Soil Max. # Apps Max. Dose  [(AI   Min.  Restr.
    Rate  (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
  otherwise) Dose cycle       /crop    /year
                              cycle
                                                                                                                                  Geographic Limitations
SOYBEANS (UNSPECIFIED) (con't)

Spray., Preemergence., Aircraft.
                                                                         Use  Group:  TERRESTRIAL FOOD+FEED CROP (con't)
                                             DF    NA

                                             DF    NA

                                             F1C   NA
                        NS

                        NS

                        NS
                                              F1C   NA
                                             DF    NA

                                             DF    NA
                                                                      1.5  Ib A
                        NS

                        NS

-------
                                                                                                                                                      LUIS 2.0   )   Page
SITE Application Type, Application
  Timing, Application Equipment  )
  Surface Type  (Antimicrobial only) & Effica-
  cy Influencing Factor  (Antimicrobial only)
  Max. Appl. Soil Max. # Apps Max. Dose  [(AI   Min.  Restr.
    Rate  (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
  otherwise) Dose cycle       /crop    /year
                              cycle
                                                                                                                                  Geographic Limitations
                                                                         Use  Group:  TERRESTRIAL FOOD+FEED CROP (con't)
                                              F1C   NA
                                                                                                   3 Ib
                                              F1C   NA
                                              F1C   NA
                                              F1C   NA
                                              F1C   NA

-------
SITE Application Type, Application
  Timing, Application Equipment  )
  Surface Type  (Antimicrobial only)  & Effica-
  cy Influencing Factor  (Antimicrobial only)
                                                                    APPENDIX A  )   CASE 0047,  [Linuron]  Chemical 035506  [Linuron]
                                                                                     LUIS 2.0  )   Page
  Max. Appl. Soil Max. # Apps Max. Dose  [(AI   Min.  Restr.
    Rate  (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
  otherwise) Dose cycle       /crop    /year
                              cycle
                                                                                                                                  Geographic Limitations
WHEAT

Spray., Fall., Boom sprayer.
                                             F1C   NA


                                             F1C   NA

                                             F1C   NA


                                             F1C   NA

                                             F1C   NA

                                             F1C   NA



                                             F1C   NA

                                             F1C   NA


                                             F1C   NA





                                             F1C   NA

                                             F1C   NA
                                                                                     TERRESTRIAL FOOD+FEED CROP
        Ib A

        Ib A
        Ib A

        Ib A


   .625 Ib A
        Ib A

        Ib A
                                                                                                     NS
                                                                                                             NS
                                                                                                                              013
                                   NS
                                           NS
                                                             ID, OR, WA
                                                             ID, OR, WA
                                                             ID, OR, WA
                                                             013
                  NS
                        NS
                                   NS
                                           NS
                                                             ID, OR, WA
                                                                                    NS     NS         NS      NS   NS     1    ID, OR, WA      013
                                                                                    Geo.013:   Extracted data refers to area east of Cascade Range and where
                                                                                    Average Annual rainfall exceeds 16 inches; however in areas east of Cascade Range, with  an
                                                                                    average rainfall of 10 to 20 inches the dosage is reduced to 0.5 pint and as a tank mixture
                                                                                    with another herbicide.

-------
                                                                    APPENDIX A  )   CASE 0047, [Linuron] Chemical 035506  [Linuron]
                                                                                     LUIS 2.0  )  Page
SITE Application Type, Application
  Timing, Application Equipment  )
  Surface Type  (Antimicrobial only)  & Effica-
  cy Influencing Factor  (Antimicrobial only)
  Max. Appl. Soil Max. # Apps Max. Dose  [(AI   Min.  Restr.
    Rate  (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
  otherwise) Dose cycle       /crop    /year
                              cycle
                                                                                                                                  Geographic Limitations
WHEAT  (con't)

Spray., Winter., Boom sprayer.
                                              F1C   NA
                                                                                 Use Group:  TERRESTRIAL FOOD+FEED CROP (con't)
                                              F1C   NA

                                              F1C   NA
                                                                                                                              ID, OR, WA

-------
                                                                                                                                                       LUIS 2.0   )   Page
SITE Application Type, Application
  Timing, Application Equipment   )
  Surface Type  (Antimicrobial only)  s  Effica-
  cy Influencing Factor  (Antimicrobial  only)
  Max. Appl. Soil Max. # Apps Max.  Dose  [(AI    Min.   Restr.
    Rate  (AI Tex. @ Max. Rate unless  noted
unless noted Max. /crop /year otherwise)/A]
  otherwise) Dose cycle       /crop   /year
                              cycle
                                                                                                                                   Geographic Limitations
NOITAGPICULTUKAL UNCULTIVATED APEAS/SOILS

Spray.,  When needed., Boom sprayer.
OP1IAME1TTAL HEPEACEOUS PLANTS

Spray.,  Preemergence., Boom sprayer.
DF
DF
DF
DF
F1C
F1C
F1C
F1C
F1C
WP

DF
DF
F1C
F1C
WP
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA

NA
NA
NA
NA
NA
3 Ib
3 Ib
3 Ib
3 Ib

3 Ib
3 Ib
3 Ib
3 Ib
3 Ib
U?
1 Ib
1 Ib
1 Ib
1 Ib
1 Ib
A
A
A
A
UC
A
A
A
A
A

A
A
A
A
A
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
jup : TEF F.E
* 1
* 1
* 1
* 1
* 1
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
STF.IAL
NS
NS
NS
NS
NS
N
N
N
N
N
N
N
N
N
N
s
s
s
s
s
s
s
s
s
s
NON-FOOD
1 Ib
N
s
1 Ib
1 Ib
N
s
N
N
N
N
N
N
N
N
N
N
OF OP
N
N
N
N
N
S
s
s
s
s
s
s
s
s
s

s
s
s
s
s
NS 1
NS 1
NS 1
NS 1
NS 0.5
NS 1
NS 1
NS 1
NS NS
NS 1

NS 1
NS 1
NS 1
NS 1
NS 1
                                                                                            C40, C46, C87

                                                                                            C40, C46, C92

                                                                                            C46, C87

                                                                                            C46, C92

                                                                                            C40, C87

                                                                                            C40, C46, C92

                                                                                            C46, C93, CA6

                                                                                            C40, C46, C92

                                                                                            C40, C46, CAD

                                                                                            C46



                                                                                            C46, C92

                                                                                            C46, C87

                                                                                            C40, C46, C47, CAD

                                                                                            C46, C93, CA6

                                                                                            C46

-------
                                                                                                                                                      LUIS 2.0  )  Page
SITE Application Type, Application
  Timing, Application Equipment  )
  Surface Type  (Antimicrobial only) & Effica-
  cy Influencing Factor (Antimicrobial only)
                      Max. Appl. Soil Max. # Apps Max. Dose  [(AI   Min.  Restr.     Geographic Limitations
      Rate  (AI un-      Rate  (AI Tex. @ Max. Rate unless noted    Interv Entry   Allowed
      less noted    unless noted Max. /crop /year otherwise)/A]   (days) Interv
      otherwise)       otherwise) Dose cycle       /crop    /year          [day(s)]
                                                  cycle
POPLAR (FOREST/SHELTERBELT)

Spray., Spring., Boom sprayer.
       Before bud break
  (Use Directed Spray after
       bud break.)
DF    NA


DF    NA

DF    NA
013


013

013
                                             F1C   NA
                                             F1C   NA
                                             F1C   NA
                                                                                                                              013
                                                                                                                              013
                                                                                                                              013
                                                                                                                              013

-------
SITE Application Type, Application
  Timing, Application Equipment  )
  Surface Type  (Antimicrobial only)  s Effica-
  cy Influencing Factor  (Antimicrobial only)
                                                                                                                                                      LUIS  2.0   )   Page
  Max. Appl. Soil Max. # Apps Max. Dose  [(AI   Min.  Restr.
    Rate  (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
  otherwise) Dose cycle       /crop    /year
                              cycle
                                                                                                                                  Geographic Limitations
CORN, SWEET

DF
DF
DF
DF
F1C
F1C
F1C
F1C
F1C
WP

DF

NA
NA
NA
NA
NA
NA
NA
NA
NA
NA

NA
Use
1.5 Ib
1.5 Ib
.625 Ib
1.5 Ib
1.5 Ib
1.5 Ib
1.5 Ib
1.5 Ib
1.5 Ib
1.5 Ib
Use
1.5 Ib
Group :
A *
A *
A *
A *
A *
A *
A *
A *
A *
A *
Group :
A *
TERRE
1
1
NS
NS
1
1
1
NS
NS
NS
TERRE
NS
STRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
STRIAL
NS
FOOD+FEED
1.5 Ib
NS
NS
NS
1.5 Ib
1.5 Ib
1.5 Ib
NS
NS
NS
FOOD+FEED
NS
CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
CROP
NS

NS 1
NS 1
NS 1
NS 1
NS 0.5
NS 1
NS NS
NS 1
NS 1
NS 1

NS 1
                                              F1C   NA
                                              F1C   NA
                                                                                                                              013
                                                                      1.5  Ib  A
                                                                      1.5  Ib  A
                                                                      1.5  Ib  A
                  NS    NS         NS      NS   NS     0.5    013

                  Geo.013:  Apply East of the Rocky Mountains  only.

                  NS    NS         NS      NS   NS      1     013

                  Geo.013:  Use east of Rocky Mountains.
                                                                                                                                                             040, 046, 092

                                                                                                                                                             046, 092

                                                                                                                                                             040, 046, 087

                                                                                                                                                             046, 087

                                                                                                                                                             040, 087

                                                                                                                                                             040, 046, 092

                                                                                                                                                             040, 046, CAD

                                                                                                                                                             046, 093, CAG

                                                                                                                                                             040, 046, 092

                                                                                                                                                             046

-------
SITE Application Type, Application
  Timing, Application Equipment  )
  Surface Type  (Antimicrobial only) & Effica-
  cy Influencing Factor (Antimicrobial only)
                                                                                                                                                      LUIS 2.0  )  Page
                      Max. Appl. Soil Max. # Apps Max. Dose  [(AI   Min.  Restr.
                        Rate  (AI Tex. @ Max. Rate unless noted
                    unless noted Max. /crop /year otherwise)/A]
                      otherwise) Dose cycle       /crop    /year
                                                  cycle
                                                                                                                                  Geographic Limitations
                                                                         Use Group: TERRESTRIAL  FOOD+FEED  CROP  (con't)
                                             F1C   NA
                                             F1C   NA
                                             F1C   NA
                                   *  NS    NS         NS      NS   NS      1     013

                                      Geo.013:  Apply East of the Rocky Mountains  only.

                        1.5 Ib A   *  NS    NS         NS      NS   NS      1     013

                                      Geo.013:   Apply East of the Rocky Mountains only.
POTATO, TTHITE/IFISH

Spray., Postplant., Boom sprayer.


Spray., Preemergence.,  Aircraft.
F1C   NA


DF    NA

DF    NA


F1C   NA

DF    NA
                                                                                   NS
                                                                                         NS
                                                                                                     NS
                                                                                                             NS
                                                                                     1    NS        2  Ib       NS    NS      1     013                             C40,  C46,  C92
                                                                                   Geo.013:  Apply extracted dosages  East  of  the  Rocky Mountains.  In Wisconsin -  Central Sands
                                                                                   Area, apply  1  pound  product  per acre  on sands  and 2 pounds per  acre on loamy sands.  In
                                                                                   Northeast, apply  2 pounds per acre   on coarse soils with 3  to 5 percent organic matter.
                                                                                   Apply 2.5 pounds  of  product   on medium  soils with 3  to 5 percent organic matter.

-------
  APPENDIX A  )  CASE 0047,  [Linuron] Chemical 035506  [Linuron]
                                                                                                                                                      LUIS  2.0   )   Page
SITE Application Type, Application
  Timing, Application Equipment  )
  Surface Type  (Antimicrobial only)  & Effica-
  cy Influencing Factor (Antimicrobial only)
  Max. Appl. Soil Max. # Apps Max. Dose  [(AI   Min.  Restr.
    Rate  (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
  otherwise) Dose cycle       /crop    /year
                              cycle
                                                                                                                                 Geographic Limitations
POTATO, WHITE/IRISH (con't)
                                                                         Use Group: TERRESTRIAL FOOD+FEED CROP  (con't)

                                                                                *  NS    NS         NS      NS   NS     1    013                            C40, C46, 087
                                                                                F  Geo.013:  Apply extracted dosages  East of the Rocky mountains.  In Wisconsin - Central Sands
                                                                                M  Area, apply 1 pound product per acre on sands and 2 pounds per  acre  on  loamy sands.  In  the
                                                                                C  Northeast, apply 2 pounds per acre on coarse soils with  3 percent to 5  percent  organic
                                                                                   matter.  Apply 2.5 pounds of product per acre on medium  soils with 3 percent to 5 percent
                                                                                   organic matter.
                                             F1C   NA
                                             F1C   NA
                                                                       2 Ib A   *   1    NS       2 Ib      NS   NS     1    013                            C40, C46, C92
                                                                       2 Ib A   F  Geo.013:  Apply extracted dosages East of the Rocky Mountains.  In Wisconsin - Central Sands
                                                                       2 Ib A   M  Area, apply 1 pint of product per acre on sands and 2 pints per acre  on  loamy sands. In
                                                                    1.25 Ib A   C  Northeast, apply 2 pints  per acre  on coarse soils with  3  to  5 percent organic matter.
                                                                                   Apply 2.5 pints of product  on medium soils with 3  to  5  percent organic matter.
                                                                                                            NS
                                                                                                                        NS
                                                                                                                             013
                                             F1C   NA
                                                                       2 Ib A   *  NS    NS         NS      NS   NS    0.5   013                            C40, C87
                                                                       2 Ib A   F  Geo.013: Apply extracted dosages East of Rocky mountain, whereas,  in Wisconsin  apply  dosages
                                                               Ib A   M  according to soil type specified.
                                                                    1.25 Ib A   C
                                             F1C   NA
                                             F1C   NA
               *  NS    NS         NS      NS   NS     1    013                            C46, C93, CAG
                  Geo.013:  Apply extracted dosages East of the Rocky Mountains. In Wisconsin - Central Sands
                  Area, apply 1 pint product per acre on sands and 2 pints per  acre on  loamy sands.  In the
                  Northeast, apply 2 pints per acre on coarse soils with  3 percentr to  5 percent  organic
                  matter.  Apply 2.5 pints of product per acre on medium  soils with 3 percent to  5 percent
                  organic matter.

      2 Ib A   *  NS    NS         NS      NS   NS     1    013             013            C40, C46, C92
      2 Ib A   F  Geo.013:  " Do not use on any crop in Kern County,  California. Apply  extracted  dosages East
      2 Ib A   M  of the Rocky mountains. Do not apply in Kern County, CA.
   1.25 Ib A   C

-------
                                                                                                                                                        LUIS 2.0   )   Page
SITE Application Type, Application
  Timing, Application Equipment   )
  Surface Type  (Antimicrobial  only)  &  Effica-
  cy Influencing Factor  (Antimicrobial only)
  Max. Appl. Soil Max.  # Apps  Max.  Dose [(AI   Min.  Restr.
    Rate  (AI Tex. @ Max. Rate  unless noted
unless noted Max. /crop /year  otherwise)/A]
  otherwise) Dose cycle        /crop    /year
                               cycle
                                                                                                                                    Geographic Limitations
POTATO, WHITE/IRISH  (con't)
                                                                          Use  Group:  TERRESTRIAL FOOD+FEED CROP  (con't)
                                                                     1.25  Ib A
 1011-FO' 'D II'jlI-FEED
 1O1TKPICULTIIRAL Fl
2 Ib A
2 Ib A
1.25 Ib A
,F' 'TJ
E'F
DF
DF
DF
F1C
F1C
F1C
F1C
F1C
WP

II-
NA
NA
NA
NA
NA
NA
NA
NA
NA
Us
' Ib
3 Ib
3 Ib
3 Ib

3 Ib
3 Ib
3 Ib
3 Ib
3 Ib
F Geo.013: Apply East of the Rocky Mountains. In Wisconsin - Central Sands Area, apply 1
M pound product per acre on sands and 2 pounds per acre on loamy sands. In the Northeast,
C apply 2 pounds per acre on coarse soils with 3 percent to 5 percent organic matter. Ap
H.rj i cun 1 of pr du t en me lium soils with 3 percent to 5 percent organic matter.
e Gr up: TEFFE, TFI-L H'"'1I-F'J' 'E'
A
A
A
A
UC
A
A
A
A
A
4 113
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
1,^
NS
NS
NS
NS
NS
NS
NS
NS
NS
113
NS
NS
NS
NS
NS
NS
NS
NS
NS
' FL'E
113
NS
NS
NS
NS
NS
NS
NS
NS
NS

NS 1
NS 1
NS 1
NS 1
NS 0.5
NS 1
NS 1
NS 1
NS NS
NS 1

040,
C40,
046,
C46,
040,
C40,
046,
C40,
040,
C46

046,
C46,
087
C92
087
C46,
093,
C46,
046,


C87
092



092
CAG
C92
CAD


-------
                                                                   APPENDIX A   )  CASE  0047,  [Linuron]  Chemical  035506  [Linuron]
LUIS 2.0  )  Page
                                                                                                                                                                                       100
LEGEND
444444
  HEADER ABBREVIATIONS
  Min. Appl.  Rate (AI unless :  Minimum dose for a single application to a single site.  System calculated.  Microbial claims  only.
  noted otherwise)
  Max. Appl.  Rate (AI unless :  Maximum dose for a single application to a single site.  System calculated.
  noted otherwise)
  Soil Tex.  Max.Dose        :  Maximum dose for a single application to a single site as related to  soil texture  (Herbicide claims  only).
  Max. # Apps @ Max. Rate    :  Maximum number of Applications at Maximum Dosage Rate.  Example: "4 applications per year"  is  expressed  as  "4/1  yr";  "4  applications  per  3
                               years" is expressed as "4/3 yr"
  Max. Dose  [(AI unless      :  Maximum dose applied to a site over a single crop cycle or year.  System calculated.
  noted otherwise)/A]
  Min. Interv (days)         :  Minimum Interval between Applications (days)
  Restr. Entry Interv  (days) :  Restricted Entry Interval (days)
  PRO Report Date            :  LUIS contains all products that were active or suspended  (and that were available  from OPP  Document  Center)  as of  this date.   Some  products
                               registered after this date may have data included in this report, but LUIS does not guarantee  that all products  registered after  this date have
                               data that has been captured.
  SOIL TEXTURE FOR MAX APP. RATE
  *       :  Non-specific
  C       :  Coarse
  M       :  Medium
  F       :  Fine
  O       :  Others

  FORMULATION CODES
  DF      :  WATER DISPERSIBLE GRANULES (DRY FLOWABLE)
  F1C     :  FLOWABLE CONCENTRATE
  WP      :  WETTABLE POWDER
  ABBREVIATIONS
  AN      :  As Needed
  NA      :  Not Applicable
  NS      :  Not Specified (on label)
  UC      :  Unconverted due to lack of data  (on label), or with one of following units: bag, bait, bait block, bait pack, bait  station, bait  station (s),  block,  briquet,
            briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop, eartag, grains,  lure, pack,  packet,  packets,  pad,  part,
            parts, pellets,  piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick,  strip, tab,  tablet, tablets,  tag,  tape, towelette,  tray,  unit,  --

  APPLICATION RATE
            Dosage Can Not be Calculated
            No Calculation can be made
            PPM calculated by weight
            PPM Calculated by volume
            Unknown whether PPM is given by weight or by volume
            Hundred Weight
            nn times  (10 power -xx); for instance,  "1.234E-04" is equivalent to ".0001234"

  USEuSE LIMITATIONS CODES
  C14 :  Grown for seed only.
  C40 :  Do not apply by aircraft.
  C46 :  Do not apply through any type of irrigation system.
  C47 :  Do not enter treated areas without protective clothing until 24 hours after application.
  C87 :  Do not apply directly to water or wetlands, or where runoff is likely to occur.
  C92 :  For terrestrial uses, do not apply directly to water or to areas where surface water is present or to  intertidal  areas  below the mean  high water  mark.
  C93 :  Do not apply directly to water.
  CAA :  Do not apply to any body of water.
  CAD :  Do not apply directly to water or wetlands.
  CAG :  Do not apply where runoff is likely to occur.
  CCA :  Application rates are for crops established 1 year or more.  For newly seeded or transplanted crop, maximum dose  per  application is 2  Ib  ai/A  preemergence  and  1  Ib
posetemregence; and per crop cycle is 2 Ib ai/A.
  G01 :  	 day(s)  pregrazing interval.
  G03 :  Do not graze livestock in treated areas.
  G14 :  Do not feed gin trash or treated foliage to livestock.
  G28 :  Do not feed gin trash or treated foliage to dairy animals.
  G63 :  No parts of treated plants may be used as food or feed.
  G74 :  Do not feed treated foliage to livestock or graze treated areas.
                                ai/A

-------
                                                                 APPENDIX A  )  CASE  0047,  [Linuron] Chemical  035506  [Linuron]
                                                                                                                                           LUIS  2.0   )   Page
                                                                                                                                                                                     101
not feed tre
not feed or
not graze li
not feed tre
not graze or
not graze or
not feed liv
not use seed
not graze or
not feed for
day (s)  preha
IN PARENTHES
                     ated forage or hay to livestock.
                     graze animals on treated areas .
                       stock in treated areas or harvest for forage.
                     ated forage to livestock.
                      forage crop grown in treated soil or cut for hay or silage.
                      harvest for forage or hay.
                     estock on treated plant parts.
                      for food, feed or oil purposes.
                      feed forage, silage or fodder  ( stubble) from treated fields to dairy animals .
                     age to livestock or allow livestock to graze in treated areas.
                     rvest interval.
                     ES REPRESENTS THE NUMBER OF TIME UNITS  (HOURS, DAYS, ETC.)  DESCRIBED IN THE LIMITATION.
GEOGRAPHIC CODES
    :  Other
    :  California
    :  Delaware
    :  Florida
    :  Idaho
    :  Maryland
    :  Michigan
    :  Minnesota
    :  North Carolina
    :  Ohio
    :  Oregon
    :  Pennsylvania
    :  Texas
    :  Virginia
    :  Washington
    :  Wisconsin
    :  West Virginia

-------
102

-------
APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
                         103

-------
104

-------
                              GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregi strati on for active
ingredients within the case Linuron covered by this Reregi strati on Eligibility Decision
Document. It contains generic data requirements that apply to Linuron 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.
                                         105

-------
106

-------
                                       APPENDIX B
             Data Supporting Guideline Requirements for the Reregistration of Linuron
REQUIREMENT
                                              USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-1        Chemical Identity

61-2A      Start. Mat. & Mnfg. Process

61-2B      Formation of Impurities

62-1        Preliminary Analysis

62-2        Certification of limits

62-3        Analytical 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
00162140, 42927301, 42927302, 42927303,
42959301
00162140, 42927301, 42927302, 42927303,
42959301 -DATA GAP
00162140, 42927301, 42927302, 42927303,
42959301
00162140, 42927301, 42927302, 42927303,
42959301
42493101, 42927301, 42927302, 42927303,
42959301
00162140,42213301
00162140,42213301
00162140,42213301
00162140,42213301
00162140,42213301
N/A - Not applicable
00162140,42213301
00162140,42213301
00162140,42213303
00162140,42213302
                                                 107

-------
             Data Supporting Guideline Requirements for the Reregistration of Linuron
REQUIREMENT
                                                USE PATTERN
                CITATION(S)
63-11      Octanol/Water Partition
63-12      pH
63-13      Stability
63-14      Oxidizing/Reducing Action
63-15      Flammability
63-16      Explodability
63-17      Storage stability
63-18      Viscosity
63-19      Miscibility
63-20      Corrosion characteristics
63-21      Dielectric breakdown volt
64-1       Submittal of Samples
ECOLOGICAL EFFECTS
71-1A      Acute Avian Oral - Quail/Duck

71-1B      Acute Avian Oral - Quail/Duck
           TEP
71-2A      Avian Dietary - Quail
71-2B      Avian Dietary - Duck
71-3       Wild Mammal Toxicity
71-4A      Avian Reproduction - Quail
71-4B      Avian Reproduction - Duck
A,C,E,J,K

A,C,E,J,K

A,C,E,J,K
A,C,E,J,K
00162140,42213302
00162140,42213301
00162140,42213301
00162140,42213301
N/A - Not applicable
00162140
00162140
N/A
N/A
00162140
N/A
N/A

00150170

00150170

00034769 - DATA GAP
00034769 - DATA GAP
N/A - Not applicable
N/A
N/A
                                                   108

-------
              Data Supporting Guideline Requirements for the Reregistration of Linuron
REQUIREMENT
                                                 USE PATTERN
                 CITATION(S)
71-5A      Simulated Field Study
71-5B      Actual Field Study
72-1A      Fish Toxicity Bluegill
72-1B      Fish Toxicity Bluegill - TEP
72-1C      Fish Toxicity Rainbow Trout
72-1D      Fish Toxicity Rainbow Trout- TEP
72-2A      Invertebrate Toxicity
72-2B      Invertebrate Toxicity - TEP
72-3A      Estuarine/Marine Toxicity - Fish
72-3B      Estuarine/Marine Toxicity -
           Mollusk
72-3C      Estuarine/Marine Toxicity -
           Shrimp
72-3D      Estuarine/Marine Toxicity Fish-
           TEP
72-3E      Estuarine/Marine Toxicity
           Mollusk - TEP
72-3F      Estuarine/Marine Toxicity Shrimp
           -TEP
72-4A      Early Life Stage Fish
72-4B      Life Cycle Invertebrate
72-5       Life Cycle Fish
72-6       Aquatic Organism Accumulation
A,C,E,J,K
A,C,E,J,K
A,C,E,J,K
A,C,E,J,K
A,C,E,J,K
A,C,E,J,K
A,C,E,J,K
A,C,E,J,K
A,C,E,J,K
A,C,E,J,K

A,C,E,J,K

A,C,E,J,K

A,C,E,J,K

A,C,E,J,K

A,C,E,J,K
A,C,E,J,K
A,C,E,J,K
A,C,E,J,K
Reserved
Reserved
40354201
00018165,00018198
40445501
00018165
00142932-DATA GAP
00018199
42061801
42061802

42061803

DATA GAP

DATA GAP

DATA GAP

42061804-DATA GAP
42153401 -DATA GAP
Reserved
Reserved
                                                     109

-------
Data Supporting Guideline Requirements for the Reregistration of Linuron
REQUIREMENT
72-7A
72-7B
122-1A
122-1B
122-2
123-1A
123-1B
123-2
124-1
124-2
141-1
141-2
141-5
TOXICOI
81-1
81-2
81-3
81-4
Simulated Field - Aquatic
Organisms
Actual Field - Aquatic Organisms
Seed Germination/Seedling
Emergence
Vegetative Vigor
Aquatic Plant Growth
Seed Germination/Seedling
Emergence
Vegetative Vigor
Aquatic Plant Growth
Terrestrial Field
Aquatic Field
Honey Bee Acute Contact
Honey Bee Residue on Foliage
Field Test for Pollinators
.OGY
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
USE PATTERN
A,C,E,J,K
A,C,E,J,K
A,C,E,J,K
A,C,E,J,K
A,C,E,J,K
A,C,E,J,K
A,C,E,J,K
A,C,E,J,K


A,C,E,J,K



A,B
A,B
A,B
A,B
CITATION(S)
Reserved
Reserved
Reserved
Reserved
Reserved
DATA GAP
DATA GAP
42086801 -DATA GAP
N/A
N/A
00018842
N/A
N/A

00027625,05016511
00027625
00018181
00018178, 00018183, 00018179, 00018196
                                 110

-------
            Data Supporting Guideline Requirements for the Reregistration of Linuron
REQUIREMENT
81-5
81-6
81-7
82-1A
82-1B
82-2
82-3
82-4
82-5A
82-5B
83-1A
83-1B
83-2A
83-2B
83-3A
83-3B
83-4
Primary Dermal Irritation -
Rabbit
Dermal Sensitization - Guinea Pig
Acute Delayed Neurotoxicity - Hen
90-Day Feeding - Rodent
90-Day Feeding - Non-rodent
21-Day Dermal - Rabbit/Rat
90-Day Dermal - Rodent
90-Day Inhalation - Rat
90-Day Neurotoxicity - Hen
90-Day Neurotoxicity - Mammal
Chronic Feeding Toxicity - Rodent
Chronic Feeding Toxicity -
Non-Rodent
Oncogenicity - Rat
Oncogenicity - Mouse
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
USE PATTERN
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
CITATION(S)
00018180
GS00047-0001, 40187601
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
00018374, 00029680, 00029679, 00164093,
00164117
00018374, 00029680, 00029679, 40952601
00029679, 00029680, 00124195,
00029679, 00029680, 00124195,
00018167,00018170
00018167, 00018170, 40437201
00018169, 00146071, 00159846, 41463401,
84-2A
Gene Mutation (Ames Test)
A,B
41630101,41864701
00029933,00131738
                                               111

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             Data Supporting Guideline Requirements for the Reregistration of Linuron
REQUIREMENT
                                               USE PATTERN
             CITATION(S)
84-2B      Structural Chromosomal
           Aberration
84-4        Other Genotoxic Effects
85-1        General Metabolism
85-2        Dermal Penetration
86-1        Domestic Animal Safety
OCCUPATIONAL/RESIDENTIAL EXPOSURE
132-1A     Foliar Residue Dissipation
132-1B     Soil Residue Dissipation
133-3       Dermal Passive Dosimetry
           Exposure
133-4       Inhalation Passive Dosimetry
           Exposure
231        Estimation of Dermal Exposure at
           Outdoor Sites
232        Estimation of Inhalation Exposure
           at Outdoor Sites
233        Estimation of Dermal Exposure at
           Indoor Sites
234        Estimation of Inhalation Exposure
           at Indoor Sites
ENVIRONMENTAL FATE
160-5       Chemical Identity
A,B

A,B
A,B

AB
00029933, 00132583, 00137153

00137152
00146489,05016511,40142401,41960001,
42086801,42318701
00163837
N/A
             40341801, 00163268 - DATA GAP
             40341801 -DATA GAP
             40341801, 00163268 - DATA GAP

             40341801, 00163268 - DATA GAP

             N/A

             N/A

             N/A

             N/A
                                                  112

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              Data Supporting Guideline Requirements for the Reregistration of Linuron
REQUIREMENT
                                                USE PATTERN
               CITATION(S)
161-1      Hydrolysis
161-2      Photodegradation - Water
161-3      Photodegradation - Soil
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
165-1      Confined Rotational Crop
165-2      Field Rotational Crop
165-3      Accumulation - Irrigated Crop
165-4      Bioaccumulation in Fish
A,B,G
A,B,G
 A,G
  A
A,B,G
  A
  G

A,B,G

  A
  A
 A,B
  A
  A

A,B,G
40916201
40103601
00144569,40171701
WAIVED
00125244,41625401
40142501
40142501
N/A
00148443,000146073,05016640, 05019500 -
DATA GAP
WAIVED
WAIVED
41734201, 41734202, 42422801 - DATA GAP
N/A
N/A
N/A
Reserved
40104101,40730101
WAIVED
N/A
00142933
                                                   113

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             Data Supporting Guideline Requirements for the Reregistration of Linuron
REQUIREMENT
                                               USE PATTERN
CITATION(S)
165-5      Bioaccumulation - Aquatic
           NonTarget
166-1      Ground Water - Small Prospective
166-2      Ground Water - Small
           Retrospective
166-3      Ground Water - Irrigated
           Retrospective
201-1      Droplet Size Spectrum
202-1      Drift Field Evaluation
N/A

N/A
N/A

N/A

Reserved
Reserved
RESIDUE CHEMISTRY
171-4A     Nature of Residue - Plants
171-4B     Nature of Residue - Livestock
171-4C     Residue Analytical Method -
           Plants
171-4D     Residue Analytical Method -
           Animal
171-4E     Storage Stability
171-4F     Magnitude of Residues - Potable
           H2O
171-4G     Magnitude of Residues in Fish
00018173, 00018176, 00027624, 40084801,
42542101,42548401
00029932, 42635401, 43245101
00018087, 00018089, 00018176

00018127

00159802,41716103, 42836701, 42836702,
42913301,42974401,43040001,43104401,
43288301,43288302
N/A

N/A
                                                  114

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             Data Supporting Guideline Requirements for the Reregistration of Linuron
REQUIREMENT
                                               USE PATTERN
CITATION(S)
171-4H     Magnitude of Residues - Irrigated
           Crop
171-41      Magnitude of Residues - Food
           Handling
171-4J      Magnitude of Residues-
           Meat/Milk/Poultry/Egg
171-4K     Magnitude of Residues in Plants
           Root and Tuber Vegetable Group
           - Carrots

           - Parsnips, and
            Parsnips, tops
           - Potatoes
           Leafy Vegetables Group
           - Celery
           - Parsley
           Legume Vegetables Group
           - Soybeans

           Foliage of Legume Vegetables
           Group
           - Soybean forage and hay
N/A

N/A

00018209, 00018210, 00018375, 00018383,
00018450, 00018775, 00029932
00018172, 00027635, 00163267, 40210901,
40537601,41503401
00018171
00027635, 00163267, 40210901, 41452701

00018443, 40537601, 41501501
41189801
00018076, 00018206, 00027635, 00163267,
40210901,43039101
00018076, 00018206, 00027635 - DATA GAP
                                                  115

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             Data Supporting Guideline Requirements for the Reregistration of Linuron
REQUIREMENT
                                               USE PATTERN
CITATION(S)
           Cereal Grains Group
           - Barley, grain
           - Corn, field, grain

           - Corn, pop, grain
           - Corn, sweet (K + CWHR)

           - Sorghum, grain
           - Wheat, grain
           - Oats, grain
           - Rye, grain
USE DELETED
00018171, 00018206, 00018375, 00018382,
00018450, 00163267, 40210901, 40537601,
42948501
USE DELETED
00018171, 00018206, 00018375, 00018382,
00018450-DATA GAP
00018171,00018148,40537601, 41377601
00018171, 00018175, 42605901, 40537601
USE DELETED
USE DELETED
           Forage. Fodder, and Straw of
           Cereal Grains Group
           - Barley, forage, hay and straw
           - Corn, field, forage and fodder
           - Corn, pop, forage and fodder
           - Corn, sweet, fodder
           - Corn, sweet, forage
USE DELETED
00018171, 00018206, 00018375, 00018382,
00018450, 00163267, 40210901, 40537601 -
DATA GAP
N/A
N/A
00018171, 00018206, 00018375, 00018382,
00018450, 00163267, 40210901, 40537601 -
DATA GAP
                                                  116

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               Data Supporting Guideline Requirements for the Reregistration of Linuron
 REQUIREMENT
                                                  USE PATTERN
                                                        CITATION(S)
 171-4L
 171-5
 - Oats, forage, hay and straw
 - Rye, forage, hay and straw
 - Sorghum forage and fodder
 - Wheat forage and straw
 - Wheat, hay

Miscellaneous Commodities
 - Asparagus

 - Cotton, seed
Processed Food
 - Corn, field
 - Cotton, seed
 - Potatoes
 - Sorghum, grain
 - Soybeans
 - Wheat, grain
Reduction of Residues
                                                                    USE DELETED
                                                                    USE DELETED
                                                                    00018171, 00018148, 40537601
                                                                    00018171, 40537601, 42605901 - DATA GAP
                                                                    N/A - No longer a raw agricultural commodity
                                                                    for linuron
                                                                    00018087, 00018089, 00163267, 40210901,
                                                                    41452601 -DATA GAP
                                                                    00018067, 41569901 - DATA GAP
42560001
DATA GAP
See Footnote1
42542102
00018206, 41241202, 42462901
WAIVED
42462901, 42462902
   1 At this time, the Agency is unable to make a reregi strati on eligibility decision on the use of linuron on potatoes because EPA
is currently evaluating legal challenges to its policies related to coordination of actions under Section 409's Delaney clause and the
Federal Food, Drug and Cosmetic Act (FFDCA) section 408 and FIFRA. But in the event that the Agency allows the use of
linuron on potatoes, additional data to upgrade an existing potato processing study will be required.
                                                     117

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	Data Supporting Guideline Requirements for the Reregistration of Linuron
 REQUIREMENT                               USE PATTERN      CITATION(S)
 171-6      Proposed Tolerance                                   N/A
 171-7      Support for Tolerance                                 N/A
 171-13     Analtyical Reference Standard                          N/A
                                                118

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APPENDIX C. Citations Considered to be Part of the Data
      Base Supporting the Reregistration of Linuron
                         119

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120

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                              GUIDE TO APPENDIX C

1.      CONTENTS OF BIBLIOGRAPHY.  This bibliography contains citations of all studies
       considered relevant by EPA in arriving at the positions and conclusions stated
       elsewhere in the Reregi strati on Eligibility Document. Primary sources for studies in
       this bibliography have been the body of data submitted to EPA and its predecessor
       agencies in support of past regulatory decisions. Selections from other sources
       including the published literature, in those instances where they have been considered,
       are included.

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

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

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

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

       b.     Document date. The date of the study is taken directly from the document.
             When the date is followed by  a question mark, the bibliographer has deduced
                                         121

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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.
                                  122

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                               BIBLIOGRAPHY
MRID
CITATION
00018067
00018087
00018089
Hoheisel, C.; Karrie, J.; Lees, S.; Davies-Hillard, L.; Hannon, P.; Bingham, R.;
Behl, E.; Wells, D. and E. Waldman.  1992. Pesticides in Ground Water
Database - A Compilation of Monitoring Studies:  1971-1991, EPA 734-12-92-
001, September, 1992.

Mostaghimi, S. 1992. Watershed/Water Quality Monitoring for Evaluating
BMP Effectiveness, Virginia Polytechnic Institute  and State University.

Postle, J.K. and K.M. Brey. 1991. Results of the WDATCP Groundwater
Monitoring for Pesticides.  Wisconsin Department of Agriculture.  Madison,
WI.

Sievers, D.M. and C.D. Fulhage.  1989a. Quality of Missouri's Agricultural
Groundwater Region II Sampling. University of Missouri.

Sievers, D.M. and C.D. Fulhage.  1989b.  Quality of Rural Well Water, North
Missouri.  Special Report 402.  University of Missouri at Columbia.
September 1989.

Sievers, D.M. and C.D. Fulhage.  1991.  Quality of Missouri's Agricultural
Groundwater Region II Sampling.  Missouri Department of Natural Resources.

U.S. EPA (1989)  Linuron: Conclusion of the Special Review.  [OPP-
30000/41C] (FRL-3510-3) Federal Register 54(17):4072.

E.I. du Pont de Nemours & Company (1961) Residue
Data—Linuron-Sweetcorn. (Unpublished study received Apr 8, 1963 under
unknown admin, no.; CDL:124702-B)

California. Department of Food and Agriculture (19??) Determination of
Linuron Residues on Asparagus. Undated method. (Unpublished
study/received Mar 20, 1973 under 3E1373; CDL:093663-B)

California. Department of Agriculture (1974) Linuron Recoveries from
Asparagus by Alkaline Hydrolysis (200 gram samples). Method dated Jul 31,
1974.  (Unpublished study received on unknown date under 3E1373;
CDL:093662-B)
                                        123

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                              BIBLIOGRAPHY
MRID
CITATION
00018127    E.I. du Pont de Nemours and Company (1962) Determination of
            3-(3,4Dichlorophenyl)-l-methoxy-l-methylurea (Linuron) in Soils and Plant
            Tissue.  (Unpublished study received Nov 8, 1962 under 352-270;
            CDL:026676-D)

00018148    E.I. du Pont de Nemours & Company (1970) Residue Data: Table A.
            (Unpublished study received Sep 16, 1971 under 352-270; CDL:  125817-A)

00018165    Sleight, B.H., III (1973) Acute Toxicity of H-7952,MR-581 to Bluegill
            (Lepomis macrochirus) and Rainbow Trout (Salmo gairdneri).  (Unpublished
            study received Dec 28, 1973 under 352-270; prepared by Bionomics, Inc.,
            submitted by E.I. du Pont de Nemours & Co., Wilmington, Del.;
            CDL:008908-A)

00018167    E.I. du Pont de Nemours & Company (1978) Teratogenicity Study of
            3(3,4-Dichlorophenyl)-l-methoxy-l-methylurea in Rats: Haskell Laboratory
            Report No.  33-79.  (Unpublished study received Sep 13, 1979 under 352-270;
            CDL:240982-B)

00018169    Hodge, H.C.; Downs, W.L.; Maynard, E.A. (1963) Second Reproduction Study
            of Rats Fed Linuron. (Unpublished study received Oct 5, 1966 under 7F0542;
            prepared by Univ.  of Rochester, Dept.  of Pharmacology, submitted by E.I. du
            Pont de Nemours & Co., Inc., Wilmington, Del.; CDL:090665-A)

00018170    Powers, M.B. (1965) Reproduction Study-Rabbits. (Unpublished study
            received Oct 5, 1966 under 7F0542; prepared by Hazleton Laboratories, Inc.,
            submitted by E.I. du Pont de Nemours & Co., Inc., Wilmington, Del.;
            CDL:090665-B)

00018171    E.I. du Pont de Nemours & Company, Incorporated (1966) Results of Tests on
            the Amount of Residue in Crops Grown on Treated Soil. (Unpublished study
            received Oct 5, 1966 under 7F0542; CDL: 090665-C)

00018172    E.I. du Pont de Nemours & Company, Incorporated (1963) Residue Data:
            Linuron—Carrots: Pre-emergence Treatment.  (Unpublished study received Oct
            5, 1966 under 7F0542; CDL:090665-D)
                                       124

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                               BIBLIOGRAPHY
MRID
CITATION
00018173    Belasco, IJ. (1967) Absence of Tetrachloroazobenzene in Soils Treated with
             Diuron and Linuron.  (Unpublished study received on unknown date under
             7F0542; submitted by E.I. du Pont de Nemours & Co., Inc., Wilmington, Del.;
             CDL:092830-A)

00018175    E.I. du Pont de Nemours and Company (19??) Residue Data: Linuron-Diuron:
             Cereal Grains. (Unpublished study received Oct 14, 1966 under 7F0542;
             CDL:092830-D)

00018176    Reasons, K.M.; Furtick, W.R.; Atkeson, G.A.; et al. (1966) Additional Data in
             Support of Petition. (Unpublished study received Oct 14, 1966 under 7F0542;
             submitted by E.I. du Pont de Nemours & Co., Inc., Wilmington, Del.;
             CDL:092830-G)

00018178    Kapp, R.W. (1975) Final Report: Acute Eye Irritation Potential Study in
             Rabbits: Project No. 915-104.  (Unpublished study received Dec 19, 1977
             under 33660-11; prepared by Hazleton Laboratories America, Inc., submitted
             by Industria Prodotti Chimici s.p.a., Novate Milanese, Italy; CDL:232505-B)

00018179    Reno, F.E. (1976) Final Report: Acute Eye Irritation Study in Rabbits: Project
             No. 915-118.  (Unpublished study received Dec 19, 1977 under 33660-11;
             prepared by Hazleton Laboratories America, Inc., submitted by Industria
             Prodotti Chimici s.p.a., Novate Milanese, Italy; CDL:232505-C)

00018180    Kapp, R.W. (1975) Final Report: Primary Skin Irritation  Study in Rabbits:
             Project No. 915-105. (Unpublished study received Dec 19, 1977 under
             33660-11; prepared by Hazleton Laboratories America, Inc., submitted by
             Industria Prodotti Chimici s.p.a., Novate Milanese, Italy; CDL:232505-D)

00018181    Kapp, R.W. (1975) Final Report: Acute Inhalation Toxicity Study in Rats:
             Project No. M915-103.  (Unpublished study received Dec 19, 1977 under
             33660-11; prepared by Hazleton Laboratories America, Inc., submitted by
             Industria Prodotti Chimici s.p.a., Novate Milanese, Italy; CDL:232505-E)

00018182    Seaman, L.; Doyle, P.E. (1979) Primary Dermal Irritation: Laboratory No.
             9E-4149. (Unpublished study received Mar 14, 1979 under 1812-245;
             prepared by Cannon Laboratories, Inc., submitted by Griffin Corp., Valdosta,
             Ga.; CDL:237806-A)
                                        125

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                              BIBLIOGRAPHY
MRID
CITATION
00018183    Seaman, L.; Doyle, P.E. (1979) Primary Eye Irritation: Laboratory No.
            9E-4148. (Unpublished study received Mar 14, 1979 under 1812-245;
            prepared by Cannon Laboratories, Inc., submitted by Griffin Corp., Valdosta,
            Ga.; CDL:237806-B)

00018196    Edwards, D.F. (1979) Eye Irritation in Rabbits-EPA Pesticide Registration:
            Haskell Laboratory Report No. 2-79.  (Unpublished study received lun 21,
            1979 under 352-394; submitted by E.I. du Pont de Nemours & Co.,
            Wilmington, Del.; CDL:238656-D)

00018198    Zihal, A.J. (1979) 96-Hour LC50 to Bluegill Sunfish: Haskell Laboratory
            Report No. 41-79. (Unpublished study received lun 21, 1979 under 352-394;
            submitted by E.I. du Pont de Nemours & Co., Wilmington, Del.;
            CDL:238656-F)

00018199    Goodman, N.C. (1979) 48-Hour LC50 to Daphnia magna: Haskell Laboratory
            Report No. 50-79. (Unpublished study received lun 21, 1979 under 352-394;
            submitted by E.I. du Pont de Nemours & Co., Wilmington, Del.;
            CDL:238656-G)

00018206    E.I. du Pont de Nemours and Company (1962) Results of Tests on the Amount
            of Residue in Crops Grown on Treated Soil: Linuron. (Unpublished study
            received Apr 13,  1963 under PP0356;  CDL: 092640-E)

00018209    E.I. du Pont de Nemours & Company, Incorporated (1954?) Feeding Study at 1
            PPM in Corn Fodder.  (Unpublished study received Apr 13, 1963 under
            PP0356; CDL:092640-I)

00018210    E.I. du Pont de Nemours & Company, Incorporated (1954?) Feeding Study at
            50 PPM in Total Daily Diet.  (Unpublished study received Apr 13, 1963  under
            PP0356; CDL:092640-J)

00018374    Hodge, H.C.; Downs, W.L.; Maynard, E.A. (1963) Chronic Feeding Studies of
            Linuron (Herbicide 326) in Dogs.  (Unpublished study received Feb 7, 1963
            under PP0356; prepared by Univ. of Rochester, Dept. of Pharmacology,
            submitted by E.I. du Pont de Nemours & Co., Inc., Wilmington, Del.;
            CDL:090386-A)
                                       126

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                               BIBLIOGRAPHY
MRID
CITATION
00018375    E.I. du Pont de Nemours and Company (1962) Linuron Livestock Feeding
            Studies: Milk and Meat. (Unpublished study received Feb 7, 1963 under
            PP0356; CDL:090386-B)

00018382    E.I. du Pont de Nemours & Company (1962) Residue Data:
            Linuron-Sweetcorn—1962.  (Unpublished study received Apr 13, 1962 under
            352-270; CDL:090385-D)

00018383    E.I. du Pont de Nemours and Company (1963) Linuron: Poultry Feeding
            Studies: Residue Data—Tissues and Eggs. (Unpublished study received Apr
            13, 1962 under 352-270; CDL:090385-E)

00018443    E.I. du Pont de Nemours & Company, Incorporated (1970) The Results of
            Tests on the Amount of Linuron Residue Remaining on or in Celery including
            a Description of the Analytical Method Used. (Unpublished  study received Apr
            18, 1971 under 1E1148; submitted by Interregional Research Project No. 4,
            New Brunswick, N.J.; CDL:090935-A)

00018444    IR-4 Project at Rutgers, the State University (19??) Annual Weeds Controlled
            at Rates of 0.5 to 2 Pounds Actual Linuron per Acre. (Unpublished study
            received Apr  18, 1971 under 1E1148; CDL: 090935-B)

00018446    Agamalian, H.; Ries, S.K.; Boyd, W.I.; et al.  (1969) Weed Control Record
            Sheet: Celery.  (Unpublished study received Apr 18, 1971 under 1E1148;
            prepared by Univ. of Calif, Agricultural Extension Service in cooperation with
            Michigan State Univ., Barker Chemical Co. and Univ. of Florida, Everglades
            Experiment Station, submitted by Interregional Research Project No. 4, New
            Brunswick, N.J.; CDL:090935-D)

00018447    Orsenigo, J.R. (1966) Posternergence Herbicides for Celery  Seedbeds. Pages
            159-165, In Proceedings of the Florida State Horticultural Society; Oct 24-27,
            1966, Miami, Fla. N.P. (Also In unpublished submission received Apr 18,
            1971 under 1E1148; submitted by Interregional Research Project No. 4, New
            Brunswick, N.J.; CDL:090935-E)

00018450    E.I. du Pont de Nemours and Company, Incorporated (1961) Du Pont
            Herbicide 326—Corn.  (Unpublished  study received on unknown date under
            PP0356; CDL:098656-A)
                                       127

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                               BIBLIOGRAPHY
MRID
CITATION
00018775    E.I. du Pont de Nemours and Company, Incorporated (1961)
            Linuron-Livestock Feeding Studies. (Unpublished study received on unknown
            dateunderPP0356; CDL:098656-B)

00018842    Atkins, E.L., Jr.; Anderson, L.D.; Greywood, E.A. (1969) Effect of Pesticides
            on Apiculture: Project No. 1499; Research Report CF-7501. (Unpublished
            study received May 8, 1971 under 1F1174; prepared by Univ. of California--
            Riverside, Dept. of Entomology, submitted by Ciba Agrochemical Co.,
            Summit, N.J.; CDL: 090973-8)

00027624    E.I. du Pont de Nemours and Company (1966) Name, Chemical Identity, and
            Composition: Linuron. (Unpublished study received Oct 14, 1966 under
            7F0542; CDL:092830-E)

00027625    Consultox Laboratories, Limited (1974) Linuron: Acute Oral and Dermal
            Toxicity Evaluation: CL74 : 46 : 996G. (Unpublished study received Dec 19,
            1977 under 33660-11; submitted by Industrial Prodotti Chimici s.p.a., Novate
            Milanese, Italy; CDL:232505-A)

00027635    E.I. du Pont de Nemours & Company, Incorporated (1963)  Results of Tests on
            the Amount of Residue in Crops Grown on Treated Soil: Linuron.
            (Unpublished study received Feb 18, 1963 under PP0413; CDL:090447-B)

00029679    Everett, R.M.; Graepel, G.J.; Blanchfield, T.F.; et al. (1980) 3(3,
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00029680    Kaplan, A.M.; McAlack, J.W.; Hall, C.L.; et al. (1980) Long-Term Feeding
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00029932    Belasco, IJ. (1979) The Metabolism of 14C-Phenyl Labeled Linuron in the
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00029933     Shirasu, Y.; Moriya, M.; Watanabe, Y. (1976?) Mutagenicity Testing on
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00034769     Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary Toxicities of
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00124195     Wood, C.; Rickard, R.; Hall, C.; et al. (1982) Long-term Feeding Study with ...
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             249256)

00125244     Dulka, J. (1977) Microbial Degradation of 14C-phenyl-labeled Linuron in Soil:
             Document No. AMR-19-80. (Unpublished study received Jan 13, 1983 under
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00131738     Russell, J. (1983) Mutagenicity Evaluation in Salmonella typhimurium: Haskell
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00132583     Chromey, N.; Horst, A.; McCooey, K. (1983) Unscheduled DNA Synthesis/Rat
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                                        129

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00137152   McCooey, K. (1983) CHO/HGPRT Assay for Gene Mutation: Linuron:
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00137153   Farrow, M.; Cortina, T.; Padilla-Nash, H. (1983) In vivo Bone Marrow
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00142932   Hall, C. (1985) 48-Hour EC50 to Daphia magna: Linuron: Haskell Laboratory
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00142933   Kasprzak, D.  (1985) Laboratory Studies of Phenyl-Radiolabeled Carbon(u)
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00143622   Anderson, J. (19??) Dermal Adsorption of Carbon-14 Linuron in the Lorox L
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00144569   Venzon, E. (19??) Photodegradation of Phenyl-radiolabeled carbon (U)-linuron
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00146071   Pastoor, T. (1984) Multigeneration Reproduction Study in Rats with
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00146073   Chrzanowski, R. (19??) Soil Column Adsorption Studies with Lorox Linuron
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                                       130

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00148443    Priester, T.  (19??) Batch Equilibrium (Adsorption/Desorption) and Soil
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00150170    Beavers, J.  (1985) An Acute Oral Toxicity Study with the Bobwhite: HI 5,651:
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00159802    E.I. du Pont de Nemours & Co., Inc. (1978) Linuron Freezer Storage Study on
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00159846    Pastoor, T.  (1985) Cross-mating Study in Rats with INZ-326: Report No.
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00162140    Industria Prodotti Chimici S.p.A. (1986) Linuron Technical: Product Chemistry
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00163267    E. I. du Pont de Nemours & Co., Inc. (1986) Linuron Residue Study: Response
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00163268    Baugher, D. (1986) Field Study Assessing Exposure of Workers Who
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             149 p.

00163837    Anderson, J. (1984) Dermal Absorption of Carbon 14 Linuron in the Lorox L
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00164093    Pastoor, T.  (1986) Biomedical and Pathological Effects of Linuron on  Selected
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                                       131

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00164117    Carakostas, M. (1986) Letter sent to T.Pastoor dated Aug 13, 1986: Evaluation
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40084801    Ferguson, E. (1986) Metabolism of [Carbon 14]-Linuron by Corn Plants:
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40103601    Buchta, R. (1986) Photodegradation of [Phenyl-carbon 14 (U)] Linuron in
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             E.I. du Pont de Nemours and Co., Inc. 31 p.

40104101    Erbes, D. (1986) Confined Accumulation Study of [Phenyl(U)-[carbon 14]]
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40142401    Cater, L. (1985) Metabolism of [Phenyl-[carbon 14](U)] Linuron by  Male and
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40142501    Monson, K. (1986) Anaerobic  Aquatic Metabolism of [Phenyl(U)-[Carbon 14]
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40171701    Brown, A. (1986) Photodegradation of [Phenyl(U)-[Carbon 14]]-Linuron on
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40187601    Henry, J. (1987) Dermal Sensitization Study with INZ-326-118 in Guinea Pigs:
             Haskell Laboratory Report No. 152-87.  Unpublished study prepared by
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40210901    E.I. du Pont de Nemours & Co. (1987) Linuron Residue Study: Supplement:
             Response to Special Review/Reregi strati on Guidance Document: Lab Project
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40341801     Baugher, D. (1987) Exposure of Asparagus Harvesters to Lorax (Linuron)
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             study prepared by Orius Associates, Inc. in cooperation with Cambridge
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40354201     Wetzel, I. (1986) Static Acute 96-hour LC50 of Linuron (IN Z-326118) to
             Bluegill Sunfish (Lepomis macrochirus): Rept. No.  52786. Unpublished study
             prepared by E.I. du Pont de Nemours and Co., Inc.  14 p.

40437201     Christian, M.; Hoberman, A. (1985) Supplement to: Developmental Toxicity
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             Laboratory Project ID: MR 7560-001; HLO 609-85. Unpublished study
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40445501     Wetzel, I. (1986) Static Acute 96-hour LC50 of Linuron (INZ-326118) to
             Rainbow Trout (Salmo gairdneri): Rept. No. HLR 525-86. Unpublished study
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40537601     E. I. du Pont de Nemours & Co., Inc. (1988) Linuron Residue Study: Response
             to Special Review/Reregi strati on: Du Pont EPA Case No. 47.  Unpublished
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40730101     Erbes, D. (1988) Supplement to: Confined Accumulation Study of Phenyl(U)-
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             609-86. Unpublished study prepared by E. I. du Pont de Nemours and Co., Inc.
             85 p.

40916201     Stevenson, I. (1988) Hydrolysis of Phenyl(U)- Carbon HLinuron in Water
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40952601     Malley, L. (1988) Chronic Toxicity Study with IN Z326-118: One-Year
             Feeding Study in Dogs: Report No. 181-88; Medical Research Project No.
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             Inc.  660 p.
                                       133

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41189801     Baron, J. (1989) Linuron: Magnitude of Residue on Parsley: Project ID: IR-4
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41241202     Guinivan, R. (1989) Magnitude of Residues of Linuron in Soybeans and
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41377601     Eble, J. (1989) Magnitude of Lorox L and Lorox DF Herbicide Residues in
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41452601     Elbe, J. (1990) Magnitude of Lorox L and Lorox DF Herbicide Residues in
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41452701     Elbe, J. (1990) Magnitude of Lorox L Herbicide Residues in Potatoes : Lab
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41463401     Mullin, L. (1990) Reproductive and Fertility Effects with IN Z326-118
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41501501     Eble, J. (1989) Magnitude of Lorox L and Lorox DF Herbicide Residues in
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41503401     Eble, J. (1990) Magnitude of Lorox L and Lorox DF Herbicide Residues in
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41569901     Eble, J. (1990) Magnitude of Lorox L and Lorox DF Herbicide Residues in
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                                        134

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41625401     Schneiders, G. (1990) Aerobic Soil Metabolism of Phenyl(U)- Carbon
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41630101     Cook, J. (1990) Investigation of a Mechanism for Leydig Cell Tumorigenesis
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41734201     Eble, J. (1990) Field Soil Dissipation of Linuron Herbicide: Lab Project
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41734202     Eble, J. (1990) Field Soil Dissipation of Linuron Herbicide in California Soil:
             Lab Project Number: AMR-1466-89.  Unpublished study prepared by E.I. du
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41716103     E.I. du Pont de Nemours and Co.  (1990) Supplement No. 1 to: Linuron Residue
             Study: Supplement: Response to Special Review/Reregitration Guidance
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41864701     Stula, E. (1990) Reproductive and Fertility Effects with IN Z326118
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41960001     Hundley, S.  (1991) Metabolism of Phenyl-Carbon-14(U)Linuron by the
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42061801     Ward, T.; Boeri,  R. (1991) Static  Acute Toxicity of DPX-Z326-198 (Linuron)
             to the Sheepshead Minnow, Cyprinodon variegatus: Lab Project Number:
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             Envirosystems, Inc. in coop, with Dupont Haskell Labs.  32 p.
                                       135

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            9129-DU. Unpublished study prepared by EnviroSystems, Inc. in coop, with
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42086801    Douglas, M.; Handley, J. (1988) The Algistatic Activity of Linuron Technical
            (DPX-Z326): Lab Project Number: DPT 171R/88602. Unpublished study
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42153401    Baer, K. (1991) Chronic Toxicity of DPX-Z326-198 (Linuron) to Daphnia
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42213301    Hogg, A. (1992) Linuron: Determination of Physico-Chemical Properties: Lab
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42213302    Hogg, A. (1992) Linuron: Determination of Dissociation Constant and Partition
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42213303    Taylor, N. (1992) Linuron: Determination of Vapor Pressure by Balance
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42318701    Brown, A. (1992) Supplement No. 2  to: Metabolism of carbon 14 (U)-Phenyl
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42422801    Tomic, D. (1992) Freezer Storage Stability of Linuron in Soil: Lab Project
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42462901    McClory, J.; Jones, W.; Sund, R. et al. (1992) Residues of Lorox Herbicide in
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                                       136

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42493101   I.pi.ci. Industria Prodotti Chimici SpA. (1992) Linuron Technical Product
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42542102   McClory, J.; Devine, P. (1992) Residues of Lorox Herbicide  in Grain Sorghum
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42560001   McClory, J.; Tomic, D. (1992) Residues of Lorox Herbicide in Field Corn
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42605901   McClory, J.; Tomic, D. (1992) Residues of Linuron in Wheat and Wheat Straw
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            2136-92: LOR-2136-92. Unpublished study prepared by E. I. du Pont de
            Nemours and Co. and The Texas A&M University System.  59 p.

42635401   Hawkins, D.; Elsom, L.; Dighton, M.; et al. (1993) The Metabolism of (carbon
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            AMR-2200-91. Unpublished study prepared by Huntingdon  Research Centre
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42836701   McClory, J.; Jones, W.; Tomic, D. (1993) Freezer Storage Stability of Linuron
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42836702   McClory, J.; Jones, W.; Tomic, D. (1993) Freezer Storage Stability of Linuron
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                                       137

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42927303    Castles, M.; Lomax, N. (1993) Supplement #1 to: Determination of TCAB,
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43039101    McClory, J.; Tomic, D. (1993) Residues of Linuron in Soybean Seed
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                                       138

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43104401
43245101
43288301
43288302
05016511
05016640
05019500
GS000470001
ACC#258300
McClory, J.; Jones, W.; Tomic, D. (1994) Freezer Storage Stability of Linuron
on Soybean Processed Fractions: Lab Project Number: AMR/2501/92.
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Microfilms, Ann Arbor, MI; 73-9861.

      E.I. DuPont de Nemours & Co., Inc.  (1961) Skin Sensitization/
      Irritation: Guinea Pig (Unpublished study received Oct.  1961 Under
      unknown admin,  no.; submitted by Haskell Laboratory; CDL:114108)

      Butler, L.D. 1985. Laboratory studies of phenyl-14C Linuron
      Bioconcentration in Bluegill Sunfish.  Unpublished study received June
       14, 1985 under 352-326. Submitted by E.I. DuPont de Nemours and
      Company, Inc. Wilmington, DE.
                                        139

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140

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APPENDIX D. List of Available Related Documents
                      141

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142

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       The following is a list of available documents related to Linuron. 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 Linuron 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.     Linuron RED Fact Sheet

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

       5.     PR Notice 91-2  (included in this appendix) pertains to the Label Ingredient
             Statement
                                        143

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144

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APPENDIX E. PR Notices 86-5 and 91-2
                   145

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146

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PR Notice 86-5
      147

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148

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             UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

    Pno                         WASHINGTON, B.C. 20460

                                   July 29, 1986

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

          NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS
                          AND REGISTRANTS

Attention:      Perspns  responsible for Federal registration of
                pesticides.

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

I.    Purpose

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

II.   Applicability

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

III. Effective  Date

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

IV.   Background

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

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


                                149

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

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

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

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

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

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

VI.  Format Requirements

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

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

B.   Transmittal Document	   4       11

C.   Individual Studies  	   4

     C. 1  Special Considerations for Identifying Studies   .  .   5

D.   Organization of each Study Volume   	   6       17

     D. 1  Study Title Page	   7       12


                                    150

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

E.   Reference to Previously Submitted Data  	   9

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

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

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

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

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

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

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

B.   Transmittal Document

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

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

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


                                151

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

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

C.   Individual Studies

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

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

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

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

C.1  Special Considerations for Identifying Studies

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

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

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

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

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

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


                                152

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

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

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

Study Title Page

Statement of Data
Confidentiality
Claims

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

Cover Sheet to Confi-
dential Attachment
                    When Required                  Example

                    Always                         Page 12

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

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

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

                    Always  -  with an  English language
                    translation if  required.

                    At submitter's  option

                    If CBI  is claimed under FIFRA
                    §10 (d) (1) (A),  (B), or  (C)
CBI Attachment
Supplemental Statement
of Data Confidentiality
Claims
                     If  CBI  is  claimed  under  FIFRA
                     §10(d) (1)(A),  (B),  or  (C)      Page 15
                     Only  if  confidentiality  is
                     claimed  on  a basis  other than
                     FIFRA §10(d)(1)(A),  (B),  or  (C!
Page 14
                                153

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D.I. Title Page

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

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

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

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

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

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

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

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


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

     Each submitted study must be accompanied by one of the tv\ro
alternative forms of the statement of Data Confidentiality Claims
specified in the proposed regulation in §158.33  (b)  and (c)    (See
Attachment 3).  These statements apply  only to claims of data
confidentiality based on FIFRA §10(d)(1)(A),  (B), or  (C).   Use
the appropriate alternative form of the statement either to
assert a claim of §10(d)(1) data confidentiality (§158.33(b)) or
to waive such a claim (§158.33(c)).  In either case,  the
statement must be signed and dated, and must include the typed
name and title of the official who signs it.  Do not make CBI
                                154

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claims with respect to analytical methods associated with pet-
itions for tolerances or emergency exemptions  (see NOTE Pg 13) .

D.3. Confidential Attachment

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

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

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

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

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

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

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

D.5. Good Laboratory Practice Compliance Statement

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

E.    Reference to Previously Submitted Data

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

F.    Physical Format Requirements

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


                                155

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disassembly for microfilming.  Check with EPA for special
instructions before submitting data in any medium other than
paper, such as film or magnetic media.

Please be particularly attentive to the following points:

     •    Do not include frayed or torn pages.

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

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

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

     •    Do not bind any documents with glue or binding tapes.

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

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

G.   Special Requirements for Submitting Data to the Docket

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

     •    Remove the "Supplemental Statement of Data
          Confidentiality Claims".

     •    Remove the "Confidential Attachment".

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

     •    Mark the fourth copy plainly on both its cover and its
          title page with the phrase  "Public Docket Material -
          contains no information claimed as confidential".
                                156

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V.    For Further Information

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

                          James W. Akerman
                          Acting Director,
                          Registration Division
Attachment 1.   Sample  Transmittal  Document
Attachment 2.   Sample  Title  Page  for  a Newly  Submitted  Study
Attachment 3.   Statements  of Data  Confidentiality  Claims
Attachment 4.   Supplemental  Statement of  Data Confidentiality
                Claims
Attachment 5.   Samples of  Confidential Attachments
Attachment 6.   Sample  Good Laboratory Practice Statements
Attachment 7.   Format  Diagrams  for Submittal  Packages and  Studies
                                157

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                           ATTACHMENT 1

       ELEMENTS  TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*

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

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



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

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

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

3.   Transmittal date

4.   List of submitted studies

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

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

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

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

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


Company Official:   	 	
                     Name                 Signature

Company Name        	

Company Contact:    	 	
                     Name                 Phone
                                158

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                   ATTACHMENT  2
SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY
                     Study  Title
   (Chemical  name)  -  Magnitude  of  Residue  on  Corn
                  Data Requirement
                   Guideline  171-4
                       Author
                   John C. Davis
                 Study Completed On
                   January  5, 1979
               Performing  Laboratory
           ABC Agricultural Laboratories
                 940  West  Bay Drive
                Wilmington, CA 39897
               Laboratory  Project  ID
                      ABC 47-79
                     Page  1  of X
   (X is the total number of pages in the study)
                         159

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                             ATTACHMENT 3

             STATEMENTS OF DATA  CONFIDENTIALITY  CLAIMS

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

        STATEMENT OF  NO DATA CONFIDENTIALITY CLAIMS
   No claim of confidentiality is made  for any information contained in this
   study on the basis of its falling within the scope of FIFRA
   6§10(d)(1)(A), (B),  or (C).


   Company 	


   Company Agent: 	Typed Name	 Date :	


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


    Company:  	


    Company Agent:   	Typed Name	 Date :	


   	Title	 Signature 	
              STATEMENT  OF DATA CONFIDENTIALITY CLAIMS

NOTE: Applicants for permanent or temporary tolerances  should
note  that it is OPP policy that no permanent tolerance,  temporary
tolerance,  or request  for an emergency exemption incorporating an
analytical  method, can  be approved unless the applicant waives
all claims  of confidentiality for the  analytical method.  These
analytical  methods are  published in  the FDA Pesticide Analytical
Methods  Manual, and therefore cannot be claimed as  confidential.
OPP implements this policy by returning submitted analytical
methods,  for which confidentiality claims have been made,  to the
submitter,  to obtain the confidentiality waiver before  they can
be processed.
                                  160

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                           ATTACHMENT 4

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

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

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

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

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

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

     •    Enclose copies of any pertinent determinations of
          confidentiality made by EPA,  other Federal agencies, of
          courts concerning this information.

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

     •    If you assert that the informatipn in voluntarily sub-
          mitted, indicate whether you  believe disclosure of this
          information might tend to lessen the availability to
          EPA of similar information in the future, and if so,
          how.
                                161

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                                    ATTACHMENT 5

              EXAMPLES  OF SEVERAL  CONFIDENTIAL ATTACHMENTS

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

 PAGES       REASON FOR THE DELETION               FIFRA REFERENCE
 35-41.         Description of product manufacturing process             § 10(d)(l)(A)
                                          162

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                               ATTACHMENT 6.

             SAMPLE GOOD LABORATORY PRACTICE STATEMENTS

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

           Submitter 	

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

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

          Submitter
                                      163

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                              ATTACHMENT 7.
                     FORMAT OF THE SUBMITTAL PACKAGE
                       Transmittal Document

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

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

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

                      Statement of Confidentiality Claims.

                          . GLP and flagging*  statements - as appropriate.

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

                      Documents submitted at submitter's option.
                 	'
                                       164

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PR Notice  91-2
      165

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166

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

II.  BACKGROUND

     For some time the Agency has accepted  two  different methods
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
certified limits required for each active ingredient  are intended
to encompass any such "good manufacturing practice" variations 40
CFR 158.175(c) (3).

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

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


                                 167

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

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

III. REQUIREMENTS

     As described below under Unit V. "  COMPLIANCE SCHEDULE,"  all
currently registered products as well as all applications for new
registration must comply with this Notice by specifying the
nominal 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. Cppies 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 1, 1997, all  pesticide  ingredient Statements must
be changed to nominal concentration.

IV. PRODUCTS THAT REQUIRE EFFICACY DATA

     All pesticides are required to be efficacious. Therefore,
the certified lower limits may not be lower then the minimum
level to achieve efficacy.  This is extremely important for
products which are intended to 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.
                                168

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

      (3)  All other products/applications that are not  subject to
           (1) and  (2) 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.


                                    /s/
                         Anne  E.  Lindsay,  Director
                         Registration Division  (H-7505C)
                                169

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170

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APPENDIX F. Combined Generic and Product Specific
                   Data Call-In
                       171

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172

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                        GENERIC AND PRODUCT SPECIFIC
                              DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:

       This Notice requires you and other registrants of pesticide products containing the
active ingredient identified in Attachment 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 III-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).

       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:
                                         173

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       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 Reregi strati on
       5 -    EPA Acceptance  Criteria
       6 -    List of Registrants Receiving This Notice
       7 -    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 II. 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.

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].
                                        174

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

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

SECTION III.      COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE

      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).

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.
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       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 Form(s). If you
choose this option, these are the only forms that you are required to complete.

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

       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
Response Form. Generic Data Exemption cannot be selected as  an option for responding to
product specific data requirements.

                                         176

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       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 III-C.l. 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
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

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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 Reregi strati on 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.

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)
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       (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
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 lab oratory (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
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       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, 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.
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       To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly Met:

       a.     You must certify at the time that the existing study is submitted that the raw
             data and specimens from the study are available for audit and review and you
             must identify where they are available. This must be done in accordance with
             the requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR
             Part 160. As stated in 40 CFR 160.3 'Raw data' means any laboratory
             worksheets, records, memoranda, notes, or exact copies thereof, that are the
             result of original observations and activities of a study and are necessary for the
             reconstruction and evaluation of the report of that study. In the event that exact
             transcripts of raw data have been prepared (e.g., tapes which have been
             transcribed verbatim, dated, and verified accurate by signature), the exact copy
             or exact transcript may be substituted for the original source as raw data. 'Raw
             data' may  include photographs, microfilm or microfiche copies,  computer
             printouts,  magnetic media, including dictated observations, and recorded data
             from automated instruments." The term "specimens", according  to 40 CFR
             160.3, 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
             Reregi strati on Phase 3 Technical Guidance and that the study has been
             conducted according to the Pesticide Assessment Guidelines (PAG) or meets
             the purpose of the PAG (both available from NTIS). A study not conducted
             according to the PAG may be submitted to the Agency for consideration if the
             registrant  believes that the study clearly meets the purpose of the PAG. The
             registrant  is referred to 40 CFR 158.70 which states the Agency's policy
             regarding  acceptable protocols. If you wish to submit the study,  you must, in
             addition to certifying that the purposes of the PAG are met by the study, clearly
             articulate the rationale why you believe the study meets the purpose of the
             PAG, including copies  of any supporting information or data. It has been the
             Agency's experience that studies completed prior to January 1970 rarely
             satisfied the purpose of the PAG and that necessary raw data 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.

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

      If a study has been classified as partially acceptable and upgradeable, you may submit
data to upgrade that study. The Agency will review the data submitted and determine if the
requirement is satisfied. If the Agency decides the requirement is not satisfied, you may still
be required to submit new data normally without any time extension. Deficient, but
upgradeable studies will normally be classified as supplemental. However, it is important to
note that not all studies classified as supplemental are upgradeable. If you have questions
regarding the classification of a study or whether a study may be upgraded, call or write the
contact person listed in Attachment 1. If you submit data to upgrade an existing study you
must satisfy or supply information to correct all deficiencies in the study identified by EPA.
You must provide a clearly 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.

      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)

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       (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 III.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 III.C.L, Option 3) apply to this option. This option only applies to acute
toxicity and certain efficacy data as described in  option 2 above.

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

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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:

       (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.
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       (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 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 III-C of this Notice.

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

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

             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.

             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.
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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 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

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


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

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


SECTION VI.      INQUIRIES AND RESPONSES TO THIS NOTICE

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

      All responses to this Notice 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 (OC) of the Office of Enforcement and Compliance
Assurance (OECA), EPA, will be monitoring the data being generated in response to this
Notice.

                                 Sincerely yours,
                                Peter Caulkins, Acting Director
                                Special Review and
                                 Reregi strati on 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 Reregi strati on
       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 Sheets
                189

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190

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LINURON DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

      You have been sent this Generic Data Call-In Notice because you have product(s)
containing linuron.

      This Generic Data Call-In Chemical Status Sheet, contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregi strati on of
linuron.  This attachment is to be used in conjunction with (1) the Generic Data Call-In
Notice, (2) the Generic Data Call-In Response Form (Attachment 2), (3) the Requirements
Status and Registrant's Form (Attachment  2), (4) a list of registrants receiving this DCI
(Attachment 4), (5) the EPA Acceptance Criteria (Attachment 5), and (6) the Cost Share and
Data Compensation Forms in replying to this linuron Generic Data Callln (Attachment F).
Instructions and guidance  accompany each form.

DATA REQUIRED BY THIS NOTICE
      The additional data requirements needed to complete the generic database for linuron
are contained in the Requirements Status and Registrant's Response. Attachment C.  The
Agency has concluded that additional product chemistry data on  linuron are needed. These
data are needed to fully complete the reregi strati on of all eligible linuron products.

INQUIRIES AND RESPONSES TO THIS NOTICE

      If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Karen Jones at (703) 308-8047.

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

             Karen Jones, Chemical Review Manager
             Reregi strati on Branch
             Special Review and Registration Division (H7508W)
             Office of Pesticide Programs
             U.S. Environmental Protection Agency
             Washington, D.C. 20460
             RE: Linuron
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LINURON DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

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

      This Product Specific Data Call-In Chemical Status Sheet, contains an overview of
data required by this notice,  and point of contact for inquiries pertaining to the reregi strati on
of linuron. This attachment  is to be used in conjunction with (1) the Product Specific Data
Call-In Notice, (2) the Product Specific Data Call-In Response Form (Attachment 2), (3) the
Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use
Products for Meeting Acute  Toxicology Data Requirement (Attachment 4), (5) the EPA
Acceptance Criteria (Attachment 5), (6) a list of registrants receiving this DCI (Attachment 6)
and (7) the Cost Share and Data Compensation Forms in replying to this linuron Product
Specific Data Call-In (Attachment 7).  Instructions and guidance accompany each form.

DATA REQUIRED BY THIS NOTICE

      The additional data requirements needed to complete the database for linuron are
contained in the Requirements Status and Registrant's Response. Attachment 3. The Agency
has concluded that additional data on linuron are needed for specific products. These data are
required to be submitted to the Agency within the  time frame listed. These data are  needed to
fully complete the reregi strati on of all eligible linuron products.

INQUIRIES AND RESPONSES TO THIS NOTICE

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

      If you  have any questions regarding the product specific data requirements and
procedures established by  this Notice, please contact C.P.  Moran at (703) 308-8590.

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

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

             RE: Linuron
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Attachment 2. Combined Generic and Product Specific
  Data Call-In Response Forms (Form A inserts) Plus
                   Instructions
                       193

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194

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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 Reregi strati on 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 l.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


    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.


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  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.


    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.
                                          197

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198

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Attachment 3. Generic and Product Specific Requirement
Status and Registrant's Response Forms (Form B inserts)
                  and Instructions
                         199

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200

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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 reregi strati on 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.
                                         201

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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.

ItemS.       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.
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


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Item 7.
Item 8.
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

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
             MP
             MP/TGAI

             PAI
             PAI/M
             PAI/PAIRA

             PAIRA
             PAIRA/M
             PAIRA/PM

             TEP
             TEP    %
             TEP/MET
             TEP/PAI/M

             TGAI
             TGAI/PAI

             TGAI/PAIRA

             TGAI/TEP

             MET
             IMP
             DEGR
             *
                   End-Use Product
                   Manufacturing-Use Product
                   Manufacturing-Use Product and Technical       Grade
                   Active Ingredient
                   Pure Active Ingredient
                   Pure Active Ingredient and Metabolites
                   Pure Active Indredient or Pute Active
                   Ingredient Radiolabelled
                   Pure Active Ingredient Radiolabelled
                   Pure Active Ingredient Radiolabelled and Metabolites
                   Pure Active Ingredient Radiolabelled and Plant
                   Metabolites
                   Typical End-Use Product
                   Typical End-Use Product, Percent Active Ingredient
                   Specified
                   Typical End-Use Product and Metabolites
                   Typical End-Use Product or Pure Active Ingredient and
                   Metabolites
                   Technical Grade Active Ingredient
                   Technical Grade Active Ingredient or Pure Active
                   Ingredient
                   Technical Grade Active Ingredient or Pure Active
                   Ingredient    Radiolabelled
                   Technical Grade Active Ingredient or Typical End-Use
                   Product
                   Metabolites
                   Impurities
                   Degradates
                   See: guideline comment
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.
                                        203

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             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 Reregi strati on 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.

       Option 2.     ON BOTH FORMS:  (Agreement to Cost Shared 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 snaring 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:  fOffer to  Cost Shared 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:  rSubmitting 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


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             submittal of 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:  fCiting 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.

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.
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       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.

Item 10.      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.

Item 11.      ON BOTH FORMS: Enter the date of signature.

Item 12.      ON BOTH FORMS: Enter the name of the person EPA should contact with
             questions regarding your response.

Item 13.      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 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
                                          206

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Attachment 4. EPA Batching of End-Use Products for
   Meeting Data Requirements for Reregistration
                       207

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208

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EPA'S BATCHING OF LINURON PRODUCTS FOR MEETING ACUTE TOXICITY
DATA REQUIREMENTS FOR REREGISTRATION

   In an effort to reduce the time, resources and number of animals needed to fulfill the acute
toxicity data requirements for reregistration of products containing the active ingredient Linuron,
the Agency has batched products which can be considered similar for purposes of acute toxicity.
Factors  considered in the sorting process include each product's active and inert ingredients
(identity, percent composition and biological activity), type of formulation (e.g.,  emulsifiable
concentrate,  aerosol,  wettable  powder, granular, etc.), and labeling (e.g.,  signal word,  use
classification, precautionary labeling, etc.). Note that the Agency is not describing batched
products as "substantially similar" since some products within a batch may not be considered
chemically similar or have identical use patterns.

   Batching has been accomplished using the readily available information described above,  and
frequently  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 lexicological studies to represent all the products within that batch.
It is the registrants' option to participate in the process with all other registrants, only some of the
other registrants, or only their own products within a batch, or to generate all the required acute
toxicological studies for each of their own  products.  If a registrant chooses to generate the data
for a batch, he/she must use one of the  products within the  batch as the test material.   If a
registrant chooses to  rely upon previously submitted acute  toxicity data, he/she may do so
provided that the data base is complete and valid by today's standards (see acceptance criteria
attached), the formulation tested is considered by EPA to be similar for acute toxicity, and the
formulation has not been significantly altered since  submission and acceptance  of the acute
toxicity data.  Regardless of whether  new data is generated  or existing data is referenced,
registrants must clearly identify the test material by EPA Registration Number.

   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.

      Tables 1 and  2 below  show the products which were batched together in batches
numbered one through four.
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Table 1
BATCH
NO.
1
2












EPA REG.
NO.
352-391
1812-245
19713-97
34704-703
51036-78
352-270
352-394
352-562
1812-320
1812-356
19713-251
CA 820042
OR 9400 18
TX 920021
WA 900017
WA 940040
WI 940004
WI 940005
% of Linuron
40.7% - Linuron
40.6% - Lmuon
41.0% - Linuron
40.7% - Linuron
40.6% - Linuron
50.0% - Linuron
50.0% - Linuron
50.0% - Linuron
50.0% - Linuron
50.0% - Linuron
50.0% - Linuron
50.0% - Linuron
50.0% - Linuron
50.0% - Linuron
50.0% - Linuron
50.0% - Linuron
50.0% - Linuron
50.0% - Linuron
Formulation Type
Flowable Concentrate
Flowable Concentrate
Flowable Concentrate
Flowable Concentrate
Flowable Concentrate
Wettable Powder
Water Dispersible Granules
Water Dispersible Granules
Water Dispersible Granules
Water Dispersible Granules
Water Dispersible Granules
Water Dispersible Granules
Water Dispersible Granules
Water Dispersible Granules
Water Dispersible Granules
Water Dispersible Granules
Water Dispersible Granules
Water Dispersible Granules
Table 2
BATCH
NO.
3

4




EPA REG.
NO.
352-543
352-544
352-326
1812-270
19713-158
19713-367
19713-368
% of Linuron &
Other Active Ingredients
56.5% - Linuron
3.5% - Chlorimuron Ethyl
55.4% - Linuron
4.6% - Chlorimuron Ethyl
92.0% - Linuron
95.0% - Linuron
95.0% - Linuron
92.0% - Linuron
95.0% - Linuron
Formulation Type
Water Dispersible Granules
Water Dispersible Granules
Technical
Technical
Technical
Technical
Technical
  210

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       Table 3 below shows the two remaining products which were not batched. These products
were considered either not similar for purposes of acute toxicity or insufficient information
existed to make a determination concerning similarity.  The registrant of these  products is
responsible for meeting the acute toxicity data requirements specified in the data matrix.
                                        Table 3
EPA REG. NO.
352-451
19713-79
% of Fenamiphos &
Other Active Ingredients
56.9% - Lmuron
3.1%- Chlorimuron Ethyl
30.8% - Lmuron
29.3% - Atrazine
Formulation Type
Water Dispersible Granules
Wettable Powder
                                          211

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212

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Attachment 5. EPA Acceptance Criteria
                21:

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214

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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
                                                 215

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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 <0.1%.

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

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

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

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

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

9.	    Discussion of formation of impurities based on established chemical theory addressing (1) each impurity
          which  may be  present at > 0.1% or was found at >  0.1%  by  product analyses  and (2)  certain
          lexicologically significant impurities (see #3).
                                                  216

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                           62 Analysis and Certification of Product Ingredients


                                       ACCEPTANCE CRITERIA

The following criteria apply to the technical grade of the active ingredient being reregistered.  Use a table to present
the information in items 6, 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 ammes/alkanolamines plus
         nitrites; polyhalogenated dibenzodioxins and dibenzofurans). [Note  that in the case of nitrosamines both
         fresh and stored samples must be analyzed.].
 4.	  Complete and detailed description  of each step in analytical method used to analyze above samples.
 5.	  Statement of precision and accuracy of analytical method used to analyze above samples.
 6.	  Identities and quantities (including mean and standard deviation) provided for each analyzed ingredient.
 7.	  Upper and lower certified limits proposed for each active ingredient and intentionally added inert along
         with explanation of how the limits were determined.
 8.	  Upper certified limit  proposed for each  impurity  present at > 0.1% and  for certain lexicologically
         significant impurities at <0.1%  along with explanation of how limit determined.
 9.	  Analytical methods to  verify  certified limits of each active ingredient and impurities (latter not required
         if exempt from requirement of tolerance or if generally recognized as safe by  FDA) are fully described.
10.	  Analytical methods (as discussed in #9)  to verify  certified limits validated as to their precision and
         accuracy.
                                                  217

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                                63 Physical and Chemical Characteristics

                                       ACCEPTANCE CRITERIA


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

Does your study meet the following acceptance criteria?

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

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

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

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

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

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

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

63-9 Vapor Pressure
   	  Measured  at 25° C (or calculated by extrapolation from measurements made at higher temperature if
          pressure too low to measure at 25°  C)
   	  Experimental procedure described
   	  Reported in mm Hg (torr)  or other conventional units
63-10 Dissociation Constant
   	  Experimental method described
   	  Temperature of measurement specified (preferably about
          20-25°C)

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

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

63-13 Stability
   	  Sensitivity to metal ions and metal determined
   	  Stability at normal and elevated temperatures
   	  Sensitivity to sunlight determined
                                                  218

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                                           SUBDIVISION F
Guideline        Study Title
 81-1           Acute Oral Toxicity in the Rat
 81-2           Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
 81-3           Acute Inhalation Toxicity in the Rat
 81-4           Primary Eye Irritation in the Rabbit
 81-5           Primary Dermal Irritation Study
 81-6           Dermal Sensitization in the Guinea Pig
                                                 219

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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/grqup.
 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.

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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.
 6.1      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.	Individuafobservations at least once a day.
12.	Observation period to last at least 14 days.
13.	Individual body weights.
14.	Gross necropsy on all animals.
                      Criteria marked with an * are supplemental and may not be required for every study.

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                                81-3 Acute Inhalation Toxicity in the Rat


                                       ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

 1.	 Identify material tested (technical, end-use product, etc).
 2.	 Product is a gas, a solid which may produce a significant vapor hazard based on toxicity and expected use
        or contains particles of inhalable size for man (aerodynamic diameter 15 (im 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.
                                                  222

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                                81-4  Primary Eye Irritation in the Rabbit


                                        ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

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

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                                  81-5  Primary Dermal Irritation Study

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

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                               81-6 Dermal Sensitization in the Guinea Pig

                                        ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

1.	 Identify material tested (technical, end-use product, etc).
2.	 Study not required if material is corrosive or has a
      pHof <2or>11.5.
3.	One 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.^7  Reference for test.
6.	Test followed essentially as described in reference  document.
1.	Positive control included (may provide historical data conducted within the last 6 months).
                      Criteria marked with an * are supplemental and may not be required for every study.

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226

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Attachment 6. List of All Registrants Sent This Data Call-In (insert)
                            Notice
                              227

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228

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Attachment 7. Cost Share, Data Compensation Forms, Confidential
          Statement of Formula Form and Instructions
                            229

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230

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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.
                                                 233

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234

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

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

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

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

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236

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United States Environmental Protection Agency ~rto STA>
Washington, DC 20460 
-------
238

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APPENDIX G. FACT SHEET
          239

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240

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United States
Environr
Anpnrw
                   nvironmental Protection
                       Preyention.P,esticides
                       And Toxic Substances
                                                                 A-73-95-003
EPA-738-F-
IvTarch 1995
                  R.E.D.   FACTS
                  Linuron
      Pesticide
Reregistration
    Use Profile
     All pesticides sold or distributed in the United States must be
registered by EPA, based on scientific studies showing that they can be
used without posing unreasonable risks to people or the environment.
Because of advances in scientific knowledge, the law requires that
pesticides which were first registered years ago be reregistered to ensure
that they meet today's more stringent standards.
     In evaluating pesticides for 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 document for
reregistration case 0047, 3-(3,4-dichlorophenyl)-l-methoxy-l-methylurea,
commonly known as linuron.

     Linuron is a herbicide used to control germinating and newly
emerging grasses and broad-leafed weeds.  It is applied to agricultural
crops, ornamental bulbs, and poplar trees for use in shelterbelts in the mid-
west. Most of the linuron applied in the U.S. is to soybean  crops.
Formulations include water dispersable granules, wettable powders,
flowable concentrates,  and emulsifiable concentrates/liquid suspensions.
     Linuron usually is applied after a crop has been planted but before
weeds emerge, using ground or aerial equipment.  In some crops, such as
carrots and celery, linuron is applied to newly emerging plants as an over-
top spray. In asparagus, linuron is applied between cuttings of newly
emerging spears for weed control during harvest.
     Use practice limitations include prohibitions against applying linuron
directly to water, or to areas where surface water is present, or to intertidal
areas below the mean high water mark; applying linuron aerially (DuPont
only; Griffin allows aerial application to potatoes and soybeans before crop
emerges); and applying linuron through any type of irrigation system.

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    Regulatory
         History
Human Health
  Assessment
     Linuron was first registered as a pesticide in the U.S. in 1966. EPA
issued a Registration Standard for Linuron in June 1984 (NTIS #PB85-
149011). From 1984 through 1988, linuron was the subject of a Special
Review because it exceeded oncogenicity risk criteria. However, the
weight of evidence suggested that its cancer-causing potential in humans is
weak. EPA concluded that no regulatory action was warranted, and
reduced linuron's cancer classification from a quantifiable to an
unquantifiable Group C carcinogen (that is, a possible human carcinogen
for which there is limited animal evidence).
     EPA issued Data Call-In notices (DCIs) in May 1986, September
1990 and November 1993, requiring additional studies on product
chemistry, chronic toxicity, processing and cooking, ecological effects,
phytotoxicity, and residue chemistry, as well as cropfield trials replacement
data for studies generated by Craven Laboratories.  Currently, 23 linuron
end-use products and 5 technical products are registered.

Toxicity
     Linuron is of relatively low acute toxicity. It is slightly toxic by the
oral, dermal and inhalation routes, and has been placed in Toxicity
Category III (the second-to-lowest of four categories) for these effects. It
causes slight eye irritation in rabbits (Toxicity Category III), and is not a
skin irritant (Toxicity Category IV) or sensitizer.
     A subchronic toxicity study using rats resulted in changes in blood
cell counts, and retarded growth at the high dose level.
     In a chronic toxicity and carcinogenicity study using beagle dogs,
linuron caused changes in blood, including red blood cell  destruction, and
in liver weight. A study  using rats resulted in testicular tumors and blood
cell destruction.  Another rat study showed growth retardation and
destruction of red blood cells. A third rat study showed significant changes
in blood pigments.  An oncogenicity study using mice caused a statistically
significant increase in liver tumors, as well as decreased body weight and
body weight gain, increased liver weights, and other liver effects. As a
result of the Agency's Special Review, linuron remains classified as an
unquantifiable Group C carcinogen (that is, a possible human carcinogen
for which there is limited animal evidence).
     In a developmental toxicity study using rats, the highest dose level
caused maternal toxic effects including decreased body weight gain and
food consumption, as well  as increases in postimplantation loss and fetal
resorptions. In a study using rabbits, linuron caused decreases in maternal
body weight, food consumption and liver weight, as well as more abortions,
fewer fetuses per litter, decreased fetal body weight, and an increased
incidence of fetuses with skeletal  skull variations.
                                          242

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     In a 2-generation reproductive toxicity study using rats, linuron
caused effects on the parents including decreased body weight gain and
abnormalities in the eyes and testes. Linuron was shown to interfere with
the transmission of male hormones. Rats exposed to linuron could develop
cell tumors in testicular tissue.  A 3-generation study using rats showed
reduced body weights and fertility, decreased pup survival, and decreased
weanling body, liver and kidney weights, as well as liver atrophy. Linuron
does not appear to be mutagenic.
Dietary Exposure
     People may be exposed to residues of linuron through the diet.
Tolerances or maximum residue limits have been established for linuron in
many vegetables, grain crops, meat, milk, and other agricultural
commodities (please see 40 CFR 180.184(a) and (b)). EPA has reassessed
these tolerances and found that sufficient data are available to support the
established tolerances for carrots; field corn grain; field corn forage and
fodder; celery; cottonseed; parsnips; potatoes; sorghum grain; wheat grain
and straw; meat and milk.  Additional residue data are required for
asparagus; sweet corn; sweet corn forage; sorghum forage and fodder;
soybean forage and hay; wheat forage; and field corn grain dust.  Several
existing tolerances for barley, oats, and rye, forage, grain, hay, and straw;
and corn, popcorn, forage and fodder will be revoked since there are no
registered uses of linuron on these commodities. New tolerances have been
proposed for lettuce, ginger and taro; several tolerance  revisions  have been
proposed; and a tolerance for corn fodder needs to be raised.
     Food and feed additive tolerance proposals are required for potato
granules, chips, and processing waste.  Under the Delaney clause of the
Federal Food, Drug, and Cosmetic Act (FFDCA), however, food and feed
additive tolerances may not be established for pesticides that induce cancer
in man or animals.  Although its cancer-causing  potential in humans is
weak, EPA still considers linuron to be a chemical that "induces cancer"
within the meaning of the Delaney clause.  Therefore, under current policy,
EPA would not issue these food and feed additive tolerances, and would not
continue in effect the tolerance for the associated raw agricultural
commodity, potatoes.
     EPA currently is evaluating legal challenges to its policies regarding
pesticide tolerances, registrations and the Delaney clause.  Because of these
issues,  the Agency is unable to make a reregi strati on eligibility decision at
this time regarding the use of linuron on potatoes.
     Although the basic manufacturer of linuron deleted the cotton use in
1991, cotton still exists on linuron end-use product labels.  Registrants of
these end-use products must now either submit a required cottonseed
processing  study or delete the cotton use  from their labels.
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     EPA has assessed the dietary risk posed by linuron. For the overall
U.S. population, chronic exposure from all existing linuron tolerances
represents 2% of the Reference Dose (RfD), or amount believed not to
cause adverse effects if consumed daily over a 70-year lifetime. The two
most highly exposed subgroups are non-nursing infants (less than 1 year
old), whose exposure represents 6% of the RfD, and children age 1  to 6
years old, with exposures representing 4% of the RfD.  Therefore, chronic
dietary risk appears to be minimal.
     Acute exposure to the subgroup of greatest concern, women of
childbearing age, results in a Margin of Exposure (MOE) of 1,667 for
developmental toxicity.  This is likely to be an overestimate due to the
conservative assumptions used. Thus, acute dietary risk also appears to be
minimal.
Occupational and Residential Exposure
     Based on current use patterns, workers may be exposed to linuron
during and  after applications to agricultural crops, ornamental bulbs and
poplar trees.  The Agency is not aware of any linuron products intended for
home use.
     Margins of Exposure (MOEs) were estimated for applicators and
mixer/loaders of linuron. While most MOEs are greater than 100 (the
margin generally considered acceptable), exposure of mixer/loaders during
aerial applications is of concern, as is exposure of handlers using open
mixing/loading methods.
     Post-application/reentry worker exposure to linuron is unlikely,
except during asparagus harvesting where linuron is applied between
cuttings. However, a supplemental worker exposure study indicates that all
the MOEs for asparagus harvesters are over 100.  A 24-hour reentry
interval required for this use was converted to a 24-hour restricted entry
interval (REI) by the Worker Protection Standard (WPS). EPA is requiring
a 24-hour REI for all linuron  uses within the scope of the WPS, based on
the asparagus reentry data.
     Personal protective equipment (PPE) requirements for workers should
be based on the acute toxicity of end-use products. However, due to
concerns about worker risks, EPA is establishing minimum handler PPE
requirements for any end-use product containing linuron. Such products
may have more stringent PPE, but in no case may have less stringent PPE
than: coveralls over long-sleeved shirt and long pants, chemical-resistant
gloves, chemical-resistant footwear, and chemical-resistant apron.
Human Risk Assessment
     Linuron is of relatively  low acute toxicity, but is classified as  an
unquantifiable Group C carcinogen (that is, a possible human carcinogen
for which there is limited animal evidence), and shows some evidence of
developmental and reproductive toxicity.
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                          Although people may be exposed to residues of linuron in a number
                     of food commodities, acute and chronic dietary risks appear to be minimal.
                     Handler and post-application worker risks are of concern, but are being
                     mitigated by requiring a 24-hour REI and minimum PPE for all agricultural
                     uses of linuron.
Environmental
   Assessment
Environmental Fate
     Although the environmental fate data base for parent linuron is
essentially complete, two environmental fate data requirements
(leaching/adsorption/desorption and terrestrial field dissipation studies) are
not fulfilled. The environmental fate assessment for linuron is incomplete
and tentative because information on the persistence, mobility and
dissipation pathways of several degradates of linuron is not available.
     Parent linuron appears to be moderately persistent and relatively
immobile. Increased mobility may occur under specific environmental
conditions such as in coarse textured soils and soils with low levels of
organic matter. Linuron dissipates principally by biotic processes such as
microbial degradation. In surface soils with adequate organic matter, the
combined processes of adsorption and microbial degradation would limit
linuron's potential to migrate to ground water. Linuron could runoff to
surface water bodies. In that case, it would degrade fairly rapidly to three
primary metabolites. However, information on the persistence and mobility
of these degradates is not currently available.
     Linuron exhibits some of the properties and characteristics of
chemicals that have been detected in ground water, and linuron itself has
been detected in ground water in four states (Georgia, Missouri, Virginia
and Wisconsin).  Linuron is moderately persistent with an aerobic soil
metabolism half-life ranging from 57 to 100 days. Because linuron is
sufficiently persistent and may be mobile under certain environmental
conditions, it has the potential to impact ground water quality.
     Linuron can be applied by ground spray and therefore could
contaminate surface waters through spray drift. It has the potential to be
somewhat persistent in surface waters, particularly those with low
microbiological activity and long hydrological residence times. It may be
less persistent in water and sediment under anaerobic conditions than under
aerobic conditions.  Its bioconcentration potential is relatively low.
     Linuron is not currently regulated under the Safe Drinking Water Act,
and water supply systems are not required to sample and analyze for it. No
Maximum Contaminant Level (MCL) or drinking water health advisories
have been established for linuron. The primary treatment processes
employed by most water systems may not always be completely effective in
removing linuron.  As a result, the Agency does have some moderate
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concerns regarding potential risks of linuron to surface water source supply
systems.
Ecological Effects
     Linuron is practically nontoxic to mammals on an acute basis, and
practically nontoxic to honey bees. Linuron is slightly toxic to birds on an
acute basis.  Though studies are not available, US Fish and Wildlife Service
extrapolation suggests that linuron would be slightly toxic to practically
nontoxic to birds on a subacute dietary basis.  However, linuron causes
reproductive effects in birds.
     In acute oral toxicity studies, linuron is moderately toxic to both cold
and warm water fish.  Acute testing using a formulated product indicates
that linuron is slightly toxic to  moderately toxic to fish.  In a fish early life
stage chronic study, linuron caused effects on fish length even at the lowest
dose level, so additional testing is required.
     Linuron is highly toxic to aquatic invertebrates, while the formulated
product is moderately toxic to  freshwater aquatic invertebrates.  A life cycle
chronic test produced inconsistent results so additional testing is required.
In estuarine/marine acute toxicity studies, linuron is highly toxic to the
sheepshead minnow and moderately toxic to the eastern oyster and mysid
shrimp.
     A number of additional studies are required.
Ecological Effects Risk Assessment
     Linuron poses minimal risk to honeybees. However, chronic risk to
birds is posed at all use sites. Restricted use levels of concern are exceeded
for birds on  short grass, and endangered species levels of concern are
exceeded for all uses evaluated.
     Regarding mammals, the smaller the animal, the greater the level of
concern for acute effects from  exposure to linuron. For example, levels of
concern are exceeded for the least shrew but not for the rat. Chronic effects
in wild mammals are likely.
     Regarding aquatic risks,  restricted use and endangered species levels
of concern are exceeded for fish from  exposure to linuron in rights of way
(ROW), and for aquatic invertebrates at all use sites evaluated.  Chronic
effects cannot be fully assessed without further testing.
     Although further data on the toxicity of linuron to nontarget plants is
needed, a preliminary aquatic plant risk assessment indicates that high risk
and endangered plant levels of concern are exceeded for aquatic plants.
The risk to terrestrial plants cannot be assessed without further data.
      Endangered species levels of concern are exceeded in some
circumstances for acute and chronic effects to birds, wild mammals and
aquatic organisms, and for acute effects to nontarget plants. When the
Endangered Species Protection Program goes into effect, limitations on the
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                      use of linuron will be required to protect endangered and threatened
                      species.

 Risk Mitigation        Since the current uses of linuron exceed ecological effects levels of
                      concern in many circumstances, EPA is requiring the following risk
                      mitigation measures proposed by the technical registrant, DuPont:
                            • Reduce application rates for use of linuron on soybeans, field corn,
                            potatoes and asparagus.
                            • Limit the maximum number of applications to 1 per year (pre-
                            emergent use only) for soybeans, field corn, and potatoes, and to 3 per
                            year for asparagus.
                            • Prohibit aerial applications.
                            • Prohibit use on sand or loamy sand, and on soils of less than 1%
                            organic matter.
                            • Voluntarily cancel the high application rate uses including hybrid
                            poplar and non-cropland (rights-of-way) uses.
                            • Add a ground water advisory  to all product labels.
                            • Add a surface water advisory  to all product labels.
                            Since it meets the proposed triggers, EPA will consider linuron as a
                      candidate for classification as a restricted use pesticide due to ground water
                      concerns, once the ground water restricted use rule is finalized.  Also, the
                      potential for spray drift exists when linuron is applied by ground spray.
                      Once pertinent data are submitted and reviewed, EPA will  decide whether
                      spray drift labeling statements are required for linuron.

Additional Data        EPA is requiring the following generic studies for linuron to confirm
                      its regulatory assessments  and conclusions:
                            Starting Materials and Manufacturing Process;
                            Foliar Dislodgeable Residues (Carrots/Celery);
                            Soil Dislodgeable Residues (Carrots/Celery);
                            Dermal Exposure (Carrots/Celery);
                            Inhalation Exposure  (Carrots/Celery);
                            Cropfield Trials - Asparagus, Corn Aspirated Fractions (Grain Dust),
                            Sorghum Forage and Fodder and Wheat;
                            Cropfield Trials - Soybean Forage and Hay;
                            Acute Avian Dietary Toxicity with TGAI - Quail and Duck;
                            Acute Aquatic Invertebrate Toxicity;
                            Fish Early Life Stage - Both Rainbow Trout and Sheepshead
                            Minnow;
                            Aquatic Invertebrate Life Cycle - Mysid Shrimp;
                            Leaching/Adsorption/Desorption;

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 Product Labeling
Changes Required
     Terrestrial Field Dissipation;
     Cottonseed Processing Study - To support use on cotton;
     Cropfield Trials - Sweet corn - To support use on sweet corn;
     Acute Marine/Estuarine (TEP) - Sheepshead Minnow using DF
     formulation for rights-of-way.
     The following studies also are required, though they are not part of
the target data base:
     Seed Germination/Seedling Emergence - 10 Species;
     Vegetative Vigor - 10 Species;
     Aquatic Plant Growth - 4 Additional Species.
     The Agency also is requiring product-specific data including product
chemistry and acute toxicity studies, revised  Confidential Statements of
Formula (CSFs) and revised labeling for reregi strati on.

     All linuron end-use products must comply with EPA's current
pesticide product labeling requirements, and  with the following:
Worker Protection Standard
Entry Restrictions
     WPS Uses - A 24-hour restricted entry  interval (REI) is required for
all uses within the scope of the Worker Protection  Standard (WPS).  The
personal protective equipment (PPE) required for early entry must be the
PPE required for handlers of linuron (see below). Labels of multiple active
ingredient products that contain linuron must bear the more protective of
either these entry restrictions or those on current labeling.
     Non-WPS Uses - Labels of products with uses outside the scope of
the WPS must bear the following statement:
     For liquid applications: "Do not enter or allow others to enter the
     treated area until sprays have dried."
Personal Protective Equipment Requirements
     Products containing linuron may contain more stringent PPE, but in
no case may require less stringent PPE than the following requirements.
Producers must compare the PPE requirements in this section with those on
current labeling and retain the more protective.
     Handler PPE  for Occupational Use Products  - For all uses of linuron,
both within and outside the scope of the WPS, the minimum or baseline
PPE requirements for pesticide handlers (mixers and loaders) are:
          ° coveralls over long-sleeved shirt and long pants,
          ° chemical-resistant footwear,
          ° chemical-resistant gloves, and
          o chemical-resistant apron.
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     Early Entry PPE - Since linuron is in Toxicity Category III for eye
and skin irritation potential and acute dermal toxicity, the PPE required for
early entry is coveralls, chemical-resistant gloves, shoes and socks.
Other Labeling Requirements
Environmental Hazard Section - The labels of all linuron end-use products
must be revised to bear the following statements under this section:
     Ground Water Advisory
     "This chemical is known to leach through soil into ground water
     under certain conditions as a result of agricultural use.  Use of this
     chemical in areas where soils are permeable, particularly where the
     water table is shallow, may result in ground-water contamination."
     Surface Water Advisory
     "Linuron may contaminate surface water through spray drift or, under
     certain conditions, from surface runoff into adjacent surface water
     bodies (ponds, lakes, streams, etc.). For several weeks post-
     application, linuron has a high potential to runoff when applied to
     fields with any of the following conditions: sloping land draining into
     nearby surface waters; very poorly to somewhat poorly drained soils;
     areas with extremely shallow ground water; frequently flooded areas;
     fields with surface water canals or ditches; and highly erodible land
     cultivated with poor management practices."
     For Terrestrial Uses Except Rights-of-Way
     "This pesticide is toxic to fish and aquatic invertebrates. Do not apply
     to water or to areas where surface water is present, or to intertidal
     areas below the mean high water mark. Do not apply when weather
     conditions favor drift from treated areas. Do not contaminate water
     when disposing of equipment wash water or rinsate."
     For Rights-of-Way - If a registrant chooses to support the rights-of-
way use, he must submit the data required in this RED document and his
labels must bear the following  statement:
     "This pesticide is toxic to fish and aquatic invertebrates. Do not
     contaminate water when  disposing of equipment washwaters or
     rinsate."
If a registrant does not support the rights-of-way use, he must amend his
labels to delete this use.
Directions for Use Section - The labels of all linuron end-use products
must be revised to bear the following statements under this section:
     Application Restrictions:
     "Do not apply this product in a way that will contact workers or other
     persons, either directly or through spray drift.  Only protected
     handlers may be in the area during application."
     "Aerial application is prohibited."

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                      "Use on sand or loamy sand is prohibited."
                      "Use on soils of <1% organic matter is prohibited."
                 Crop Uses Section - The labels of all linuron end-use products must be
                 revised to bear the following application rates for the respective crops,
                 under this section:
                      Application Rates:
                      For use on soybeans: A maximum application rate of 1.0 Ib ai/A,
                 with use limited to single application (pre-emergent use only) per year.
                      For use on corn, field: A maximum application rate of 0.75 Ib ai/A,
                 with use limited to single application (pre-emergent use only) per year.
                      For use on potatoes: A maximum application rate of 1.5 Ibs ai/A,
                 with use limited to single application (pre-emergent use only) per year.
                      For use on asparagus:  A maximum application rate of 2.0 Ibs ai/A per
                 year, with use limited to 3 applications per year.
                      Do not exceed 2.0 Ibs total per acre per year.
 Regulatory
Conclusion
     Although levels of concern are exceeded for ecological effects and
ground water quality, most uses of currently registered products containing
linuron, amended to reflect the risk mitigation measures imposed in this
RED, will not pose unreasonable risks or adverse effects to humans or the
environment. Therefore, products  containing linuron for all registered uses
except use on cotton, non-cropland (rights-of-way), sweet corn, and
potatoes are eligible for reregi strati on.
     EPA is unable to make a reregi strati on eligibility decision for use of
linuron on cotton, non-cropland (rights-of-way) and sweet corn because the
Agency does not have key generic data to support these uses. The basic
manufacturer, DuPont, has voluntarily cancelled or plans to cancel these
uses, so end-use product registrants must either delete the uses from their
labels or submit the required data.
     EPA also is unable to make a reregi strati on eligibility decision
regarding  the use of linuron on potatoes because, under current policy, the
food additive tolerances needed to support this use appear to be barred by
the Delaney clause in the FFDCA.
     Linuron products with eligible uses will be reregistered once the
required product-specific data, revised Confidential Statements of Formula,
and revised labeling are received and accepted by EPA.
   For More
Information
     EPA is requesting public comments on the Reregi strati on Eligibility
Decision (RED) document for linuron 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
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Branch, Field Operations Division (7506C), Office of Pesticide Programs
(OPP), US EPA, Washington, DC 20460, telephone 703-305-5805.
     Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregi strati on Information System
at 703-308-7224. They also are available on the Internet on EPA's gopher
server, GOPHER.EPA.GOV, or using ftp on FTP.EPA.GOV, or using
WWW (World Wide Web) on  WWW.EPA.GOV.
     Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH  45242-0419, telephone
513-489-8190, fax 513-489-8695.
     Following the comment period, the linuron RED document also will
be available from the National  Technical Information Service (NTIS), 5285
Port Royal Road, Springfield, VA 22161, telephone 703-487-4650.
     For more information about EPA's pesticide reregi strati on program,
the linuron RED, or reregi strati on of individual products containing linuron,
please contact the Special Review and Reregi strati on Division (7508W),
OPP, US EPA, Washington, DC 20460, telephone 703-308-8000.
     For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN).  Call toll-
free 1-800-858-7378, between  8:00 am and 6:00 pm Central Time, Monday
through Friday.
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