United States
Environmental Protection
Agency	
Prevention, Pesticides
And Toxic Substances
(75O8W)

May 1998
Reregistrafion
Eligibility Decision (RED)

Butralin

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                 United States
                 Environmental Protection
                 Agency            ;
                       Prevention, Pesticides
                       And Toxic Substances
                       (7508W)
EPA-738-F-97-009
May 1998
                      .E.D.    FACTS
     Pesticide
Reregistration
                 Butralin
     All pesticides sold or distributed inthe UnitedStates must be
registered by EPA, based on scientific studies showing that they can be used
without posing unreasonable risks to people or the environment. Because of
advances in scientific knowledge, the law requires that pesticides which
were first registered before November 1, 1984, be reregistered to ensure
that they meet today's more stringent standards.
                 ^    In evaluating pesticides for reregistration, EPA obtains and reviews a
                 complete set of studies from pesticide producers, describing the human
                 health and environmental effects of each pesticide. To implement provisions
                 of the Food Quality Protection Act of 1996, EPA considers the special
                 sensitivity of infants and children to pesticides, as well as aggregate
                 exposure of the public to pesticide residues from all sources, and the
                 cumulative effects of pesticides and other compounds with common
                 mechanisms of toxicity. The Agency develops any mitigation measures or
                 regulatory controls needed to effectively reduce each pesticide's risks. EPA
                 then reregisters pesticides that meet the safety standard of the FQPA and can
                 be used without posing unreasonable risks to human health or the
                 environment.
   Use Profile
     When a pesticide is eligible for reregistration, EPA explains the basis
for its decision in a Reregistration Eligibility Decision (RED) document.
This fact sheet summarizes the information in the RED document for
reregistration case 2075, Butralin.

     Butralin is a dinitroaniline herbicide used as a plant growth regulator
on flue-cured and air-cured tobacco.  The one end use product formulation
is a ready-to-use solution. Tobacco use is considered to be a non food use.
   Regulatory
     Butralin was first registered as a pesticide in the U.S. in 1976. As
part of the re-registration process the Agency issued a Data Call-in (DCI)

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Human Health
  Assessment
 The DCI required additional data to support the turf grass uses registered at
 that time.  In addition, there were tolerances for food uses that were no
 longer on the label.  The food uses were not supported and the Agency is in
 the process of revoking the tolerances.

 Toxicity
      In studies using laboratory animals, butralin generally has been shown
 to be of low acute toxicity. It has. been placed in Toxicity Category III for
 effects via the oral route of exposure and eye irritation, and Toxicity
 Category IV  for the dermal and inhalation routes.  The carcinogenicity
 classification for butralin has been not determined.

 Dietary Exposure
      People  are not likely to be exposed to residues of butralin either
 through their diet or drinking water since there are no food or feed uses and
 groundwater  contamination from butralin.is unlikely.
 Occupational Exposure
      Workers can be exposed to this pesticide during mixing/loading and
 application to tobacco fields as well as from post application exposure.
      EPA is generally not concerned with occupational risk if MOEs
 (margins of exposures) are greater than 100.  For butralin, the calculation
 for intermediate term dermal risk show that MOEs are less than 100 for:
      1).   mixing/loading liquids for groundboom;
      2).   mixing/loading/applicators spraying with a backpack sprayer;
      3).   mixing/loading/applicators spraying with a low volume pressure
      hand wand; and,
      4).   by jug application.
 All of the above use scenarios have acceptable MOEs with the use of
 chemical resistant gloves.
 bther Considerations
      Because butralin has no food uses the specific determinations outlined
 in FQPA are  not required. There are no residential uses and exposure from
 drinking water is not expected.
      The Agency has not made a determination whether butralin and any
 other pesticide have a common mechanism of toxicity that would require a
 cumulative risk assessment. For the purposes of this RED, EPA has
 considered only the risks from butralin.  If required, cumulative risks will
be assessed when methodologies for deterniining common mechanism of
toxicity and for performing cumulative risk assessments are finalized.

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    Environmental
       Assessment
 Environmental Fate
      For the currently registered use of butralin, the Agency typically
 requires an abbreviated set of environmental fate data on hydrolysis,
 metabolism, and mobility.
      Based on existing data, butralin is likely to be moderately persistent to
 persistent and relatively immobile in terrestrial environments.  Butralin is
 stable to abiotic hydrolysis arid photodegradatibn on soil.  It does not exhibit
 fate and transport characteristics similar to chemicals that are known to
 leach to groundwater.                         *
   Risk Mitigation
  Additional Data
          Required
 Product Labeling
Changes Required
 Ecological Effects/Risk
      Calculated acute avian risks do not exceed the Level of Concern
 (LOG).  The acute LOG has been exceeded for small mammals such as the
 meadow vole and least shrew, but the Agency is not recommending a
 restricted userclassification since the actual exposure is expected to be
 reduced because of the directed spray application method .to the tobacco
 plant. The acute LOG to freshwater fish has not been exceeded although
 they have been for freshwater invertebrates. The acute LOG for estuarine
 and marine fish and shrimp have been slightly exceeded. The Agency
 concludes that the overall acute impact on freshwater and terrestrial non-,
 target organisms from the use of butralin on tobacco will be minimal. The
" Agency is requiring Tier 2 testing for terrestrial and,aquatic plants. The
 Agency cannot determine the impact of butralin to non-target plants but it
 can be assumed that the plant growth regulator will adversely affect non-
 target plants if they are exposed.

      The Agency is requiring the use of chemical resistant gloves and a 12
 hour re-entry interval. The Agency js also establishing the nunimum
 Worker Protection Standard (WPS) Personal Protective Equipment (PPE) of
 coveralls, chemical-resistant gloves, shoes and socks for early re-entry.     '

      EPA is requiring product-specific data including product chemistry
 and acute toxieity studies, and revised labeling for reregistratipn.  Some
 additional ecological effects and environmental fate data are being required
 for confirmatory purposes.

      All butralin end-use products must comply with EPA's current
 pesticide product labeling requirements and the chemical resistant glove
 requirement, the 12 hour restricted entry interval.,1 the early entry PPE

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                 requirements and the user safety recommendations below. The following
                 labeling changes are required.

                 User Safety Recommendations
                      •   "Users should wash hands before eating, drinking, chewing
                           gum, using tobacco, or using the toilet."
                      •   "Users should remove clothing immediately if pesticide gets
                           inside. Then wash thoroughly and put on clean clothing."
                      •   "Users should remove protective clothing and equipment
                           immediately after handling this product.  Wash the outside of
                           gloves before removing.  Keep and wash protective clothing and
                           equipment separately from other laundry."

 Regulatory        The use of currently registered products containing butralin in
Conclusion   accordance with changes specified in this document will not pose
                 unreasonable risks of adverse effects to humans or the environment.
                 Therefore, all uses of these products are eligible for reregistration.

                      Butralin products will be reregistered once the required product-
                 specific data, any required confirmatory generic data, product specific data,
                 CSFs, and revised labeling are received and accepted by EPA.
   For More
Information
     EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for butralin 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 Information and Records Integrity
Branch, Information Resources and Services Division (7502C), Office of
Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone
703-305-5805.
     Electronic copies of the RED and this fact sheet are available on the
Internet.  See http://www.epa.gov/oppsrrdl/REDs/.
     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 45242-2419, phone 1-800-
490-9198; fax 513-489-8695.
     Following the comment period, the butralin RED document also will
be available from the National Technical Information Service (NTIS), 5285
Port Royal Road, Springfield, VA 22161, phone 703-605-6000;

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     For more information about JEPA' s pesticide reregistration program,
the butralin RED, or reregistration of individual products containing
butralin, please contact the Special Review and Reregistration Division
(7508W), OPP, US EPA, Washington, DC 20460, phone 703-308-8000.
     For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms^ please contact
the National Pesticides Telecommunications Network (NPTN).  Call toll-
free 1-800-858-7378, from 6:30 am to 4:30 pm Pacific Time, of 9:30 am to
7:30 pm Eastern Standard Time, seven days a week.

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                   UNITED STATES ENyiRONMENTAL PROTECTION AGENCY

                      ,        '         WASHINGTON, D.C. ^20460
                                                                          .  QEEICE OF '
                                                                     PREVENTION, PESTICIDES
                                                                     AND TOXIC SUBSTANCES
 CERTIFIED MAIL
 Richard J4 Often, Agent
         ..                ,          ,     .             ...   .        MAY 2 1 1998
 5 116 Wood Valley Dr.
 Raleigh,N.C.  27613                                                       .

 Dear Registrant:;      ,

       I am pleased to announce that the Environmental Protection Agency has completed its
 reregistration eligibility review and decisions on the pesticide chemical case butralin which
 includes the active ingredient butralin.  The enclosed Reregistration Eligibility Decision
 (RED), which was approved on September 29, 1997, contains the Agency's evaluation of the
 data base of these chemicals, its conclusions of the potential human health and environmental
 risks of the current product uses, and its decisions and conditions under which these uses and
 products will be eligible for reregistration.  The RED includes the data and labeling
 requirements for products for reregistration. .It may also include requirements for additional
 data (generic) on the active ingredients to confirm the risk assessments.

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

       Please note that the Food Quality Protection Act of 1996 (FQPA) became effective on
 August 3, 1996, amending portions of both:pesticide law (FIFRA) and the food and drug law
 (FFDCA). This RED takes into account, to the extent currently possible, the new safety
 standard set by FQPA to consider aggregate risk.  However, it should be noted that in
 continuing to make reregistration determinations during the early stages of FQPA
 implementation, EPA recognizes that it will be necessary to make decisions relating to FQPA
 before the implementation process is complete. In making these early case-by-case decisions,
 EPA does not intend to set broad precedents for the application of FQPA. Rather, these early
 determinatiqhs will be made on a, case-by-case basis and will not bind EPA as it proceeds with
 further policy development and any rulemaking that may be required.

       If EPA determines, as a result of this later implementation process, that any of the
 determinations described in this RED are no longer appropriate, the Agency will pursue
 whatever action may be appropriate, including but not limited to reconsideration of any
 portion of this RED.

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       If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregistration Division representative
C.P. Moran (703) 308-8590. Address any questions on required generic data to the Special
Review and Reregistration Division representative Tom Luminello at (703) 308-8075.
                                                      Sincerely yours,
Enclosures
                                                       Sis A. Rossi, ijirector
                                                      Special Review and
                                                       Reregistration Division

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

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

 2. TIME EXTENSIONS AND DATA WAIVED REQUESTS-No time extension requests
 will be granted for the 90-day response.  Time extension requests may be submitted only with
 respect to actual data submissions.  Requests for time  extensions for product specific data
 should be submitted in the 90-day response. Requests for data waivers must be submitted as
 part of the ,90^day response. All data waiver and time extension requests must be accompanied
by a full justification.  All waivers and time extensions must be granted by EPA in order to go
into effect.                                •
                •     '-'ป.--...•  ' _ •          't '  _  .   - -       ,    -      "-.-"-,

 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).
         1 •    '   ' "         -'''/.                ' '    •      ' '     f '        '*"   ' •
      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 hi b-e below) to the address listed in item 5.

      b. Five copies of  draft labeling which complies with the RED and current regulations
and requirements.  Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately. You may, but are not
required to, delete uses which the RED says are ineligible for reregistration. For further
labeling guidance, refer to the labeling section of the EPA publication "General Information
on Applying for Registration hi 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 thai they meet
the Agency's acceptance  criteria (attached to the DCI).

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      d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation.  The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard certified
limits (see 40 CFR ง158.175) or (2) provide certified limits that are supported by the analysis
of five batches. If you choose the second option, you must submit or cite the data for the five
batches along with a certification statement as described in 40 CFR ง158.175(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 NOHCE-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
      Attn:  P.P. Moran

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
      Attn:  C.P. Moran

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-
mpnth submissions with a final reregistration determination within 14 months after the RED
has been issued.

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REREGISTRATION ELIGIBILITY DECISION

 ; •'..";;' '••;".      BUTRALIN    '  ''  •'.  '  •  \  '

   :   :•'   ;."-.    ,  '-'LISTS -   ••..  .'.'   • ':;-:;;.-\

'   :'".' :   '    .. .'    CASE 2075           :'.'•'''  '   .-'
             ENVIRONMENTAL PROTECTIOI? AGENCY
               OFFICE OX.TESTIC1DE PROGRAMS   .  .
         SPECIAL REVIEW AND REREGISTRATION DIVISION

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                        TABLE OF CONTENTS
 B17TRALIN REREGISTRATION ELIGIBILITY DECISION TEAM ... . . ..'. ....  .  i

 ABSTRACT.^. . .-.'-.;.'. ...^ ...... . .  ... ..  ;.;;.., . . . ; . ...... ; .   v

 L    INTRODUCTIpN ... ,:   .  . . . ...... :./,'. ... . !.^ .....       i

 IL    CASE OVERVIEW .  . . . . '. . ; ... . . .... ..... ... ... ...;...  . .   .2
      A.   Chemical Overview  .. ^ ................................. 2
      B.   UseProfile . .  .	 ...         *                -•••••
-,   ..'  ,  •   -    • .      .   ;  .     T   ""•*••-•ป""•ป••ป•••• •Kซ.ปป*-vtf1ซปB.fc7
      C.  'DataRequirements .... . ..-.-> ..............". ... '. . . . ... ....... 4
      D.   Regulatory History . . . .................. ; . . . ; . ... ....    5

 m.   SCIENCE ASSESSMENT . . . .... , . . .......... ... . .      .      ... 5
      A.   Physical Chemistry Assessment. ..\. .\ .................       5,
      B.   Human Health Assessment. . ..... ....... .......  . . . . . .  . .... 6
           1.   Toxicology Assessment ./....................,....... .6
                a.   Acute Toxicity  ...................  . . . . . ...... 6
                "*. ;  Subchronic Toxicity . . ... ... .... . . ...  . . ... .  . ,-". . .6
                c.   Chronic Toxicity . . . . . . . .-.'-. . : . ......  .......... 10
                d.   Carcinogenicity . . . . . . . . . . . .... ..... ; . . ...... „ 10
      .          e.   Developmental Toxicity  . ....	 . . . ip
                f-    Reproductive Toxicity   ... . .". ...  .....; . . . . ,  . . . . 12
              :, g.   Mutagenicify  : . . . ... . .... ..... k.. . .  .\. . . . .  ...... 13
                h.   Metabolism   . .... . . . . . . ... . .  ... ............ 15
                i.    Other Toxic Endpohits ... fi . . ............;   . . . 15
                j.    Dose Response Assessment  . .................... 16
                k-   Toxicplogical Endpoints for Risk Assessment ........ 16
           2.   Exposure Assessment .......................... ...17
               . a.   FoodSource  ............................. .^ 17
                b.   Drinking Water Source  . . .	 .  . ...... . . . 18
                Ci    Occupational Exposure Assessment/Characterization Assessment
 "-  ;.-.  '  *  V  ,.'..•  •  -'• \  '" .,' • .  •  ' '..'• ". ' V'. ..". '•'•' .  •'  .'•"  ••••: .:'. '..''^ ' ^'18 '
           3.   Mixer/Loader/Applicator Exposure Assessment . .  . . . ... . . . . 19
                a.   Occupational Risk Assessment/Characterization ...;... 20
                b.   Additional Occupational Exposure Studies .  . . . . . . .,. . . 23
           4.   Other Exposure and Risk Considerations ......... v ... .. 24
      C.   Environmental Assessment. ............................ .24
           1.   Ecological Toxicity Data  ,  ... .... 4 . .  , . . ...... ... .  . 25
        1        a.    Toxicity to Terrestrial Animals  . . '..: ..... . . ....   . 25
                b.   Toxicity to Aquatic Animals  ... ..... . .  . . . . . . . . . . 27
        . '       c-    Toxicity to Plants  ...... . ..;.................. 29

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            2.    Environmental Fate		29
                  a.    Environmental Fate Assessment		29
                  b.    Environmental Fate and Transport  ...............  31
                  c.    Water Resources	........	39
            3.    Exposure and Risk Characterization	, .  45
                  a.    Ecological Exposure and Risk Characterization  .......  45
                  b.    Water Resources Risk Implication for Human Health ...  50
                  c.    Environmental Risk Characterization	51

IV.   RISK MANAGEMENT AND REREGISTRATION DECISION ....   	53
      A.    Determination of Eligibility	  53
      B.    Determination of Eligibility Decision	54
            1.    Eligibility Decision 	. ...  54
            2.    Eligible and Ineligible Uses	54
      C.    Regulatory Position and Labeling Rationale	54
            1.    Tolerance Reassessment	55
            2.    Tolerance Revocations and Import Tolerances	 .  55
            3.    Potential Risks to Infante and Children/Aggregate Exposure
                  /Cumulative Effects	56
            <*.    Occupational Labeling Rationale/Risk Mitigation .	56
            5.    Endocrine Disrupter Effects	  58
            6.    Environmental Assessment ..,".	58
            7.    Restricted Use Classification	58
            8.    Endangered Species Statement	  58

V.    ACTIONS REQUIRED OF REGISTRANTS .....,,..	 59
      A-    Manufacturing-Use Products	59
            1.    Additional Generic Data Requirements	59
            2.    Labeling Requirements for Manufacturing-Use Products	59
      B.    End-Use Products	 .	60
            1.    Additional Product-Specific Data Requirements .	'..... 60
            2.    Labeling Requirements for End-Use Products . . .	 60
      C.    Existing Stocks		62

VI.   APPENDICES  . . . . .	 .  ..,..,,	  .....'..'		  63
      APPENDIX  A.    Table of Use Patterns  Subject to Reregistration   ...... 65
      APPENDIX  B.    Table of the Generic Data Requirements and Studies Used  to
                        Make the Reregistration Decision	68
      APPENDIX  C.    Citations Considered to be Part of the Data Base Supporting the
                        Reregistration of Butralin ..„	73
      APPENDIX  D.    Combined Generic and Product Specific Data Call-In ... 81
            Attachment   1.    Butralin Data Call-In Chemical Status Sheet  . . ... 103
            Attachment   2.    Combined Generic and Product Specific Data Call-In
                             Response Forms (Form A inserts) Plus Instructions
                              • ••:•......... —	;. 105

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      Attachment  3.


      Attachment  4.

      Attachment  5.
      Attachment  6.
      Generic and Product Specific Requirement Status and
      Registrant's Response Forms (Form  B inserts) and
      Instructions .......,.'......'.... . . ......  Ill
      EPA Batching of End-Use Products for Meeting Data
      Requirements for Reregistration . . . . .'. . .....  124
      List of All Registrants Sent this Data Call-In Notice
APPENDIX  E.
                      ,.
      Cost Share, Data Compensation Forms, Confidential
      Statement of Formula Form and Instructions .  . .126
List of Available Related Documents ......... .... .  133

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 BUTRALIN REREGISTRATION ELIGIBILITY DECISION TEAM

 Office of Pesticide Programs:

 Biological and Economic Analysis Assessment
 Steve Jarboe
 .Neil Anderson
"Ed Brandt
 Biological Analysis Branch
 Biological Analysis Branch
 Economic Analysis Branch
 Environmental Fate and Effects Risk Assessment
 Renee Costello
 Karen McCormack
 James Hetrick
 David Wells ,

 Health Effects Risk Assessment

 Paula Deschamp

 Stan Gross
 Thomas Campbell

 Registration Support Risk Assessment

 Daniel Kenney
 AlSmith
     '   -       ' '          '    '\ '

 Risk Management           •'•"-;

 Tom Luminello
 Margaret Rice
 Environmental Risk Branch II
 Environmental Risk Branch II
 Environmental Risk Branch II
 Environmental Risk Branch II
Reregistratibn Characterization  and Assessment
Branch   7
Toxicology Branch II    k
Occupational and Residential Exposure Branch
Fungicide-Herbicide Branch
Registration Support Branch
Reregistration Branch HI
Reregistration Branch III

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11

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 ADI
 AE
 a.i.
 ARC
 CAS
,CI
 CNS
 CSF
 DFR
 DRES
 DWEL
 EEC

 EP
 EPA
 FAO/WHO
 FDA
 FIFRA,
 FFDCA
 FQPA
 FOB
 GLC
 GM
 GRAS
 HA

 HOT
LD<,
LEL
LOG
LOD
LOEL
MATC
MGLG
mg/L
MOE
MP
MPI
MRID
 GLOSSARY OF TERMS AND  ABBREVIATIONS

   Acceptable Daily Intake. A now defunct term for reference dose (RfD).
   Acid Equivalent           ,        '             ,        '                      '    /
   Active Ingredient             ,r      v*           •                      '
   Anticipated Residue Contribution                                        .   -
   Chemical Abstracts Service         ,
   Cation-"   /'/".;   -   '       '.•',•;',       ''._.,•      .,   '   ' -   "•;-"'.-.
   Central Nervous System    ,   •                           ,                      '   '   •
   Confidential Statement of Formuk                                  •-               :..  !
   Dislodgeable Foliar Residue
   Dietary Risk Evaluation System   ..
   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. .;        ,•/"•.'       ,      '•'"'•     .'  '       '  ' •'•     ''•.-.''•
   Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
   such as a terrestrial ecosystem.       .   .                                             '
   End-Use Product            .
   U.S. Envkonmental Protection Agency,    ,
   Food and Agriculture Organization/World Health Organization              ^_   ,
   Food and Drug Administration       ,•'                                  .
   Federal Insecticide, Fungicide, and Rodenticide Act
   Federal Food, Drug, and Cosmetic Act                                                .
   Food Quality Protection Act
   Functional Observation Battery
   Gas Liquid Chromatography
   Geometric  Mean,  .  ,,,."';'              ,
   Generally Recognized as Safe as Designated by FDA    :  .
   Health Advisory  (HA). The HA values are used as informal guidance to municipalities and other
   organizations when emergency spills or contamination situations occur.              ,
'   Highest Dose Tested                                            -
   Median Lethal Concentration.  A statistically derived concentration of a substance that can be
   .expected to cause death in 50% of test animals.,, It is usually expressed as the weight of substance
   per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
   Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50%
   of the test animals when administered by the route indicated (oral,  dermal, inhalation).  It is
I   expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
   Lethal Dose-low. Lowest Dose at which lethality occurs.
   Lowest Effect Level                                   .             '       ; .. '
   Level of Concern
   Limit of Detection         ;               - ''  -  •    .         ,        -.-•.''..•
   Lowest Observed Effect Level              ,
   Maximum Acceptable Toxicant Concentration
   Maximum  Contaminant Level Goal (MCLG)  The MCLG is used by the Agency to regulate^
   contaminants in drinking water under the Safe Drinking Water Act.              •';•
   Micrograms Per Gram
   Micrpgrams per Liteir •      .                                   ;
   Milligrams  Per Liter
   Margin of Exposure      -                    -
   Manufacturing-Use Product
   Maximum Permissible Intake     "                   ,  ;
   Master Record Identification (number).  EPA's system of recording and tracking studies submitted.
                                               ill

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            GLOSSARY OF TERMS AND ABBREVIATIONS

N/A           Not Applicable
NOEC         No Observable Effect Concentration
NPDES        National Pollutant Discharge Elimination System
NOEL         No Observed Effect Level
NOAEL        No Observed Adverse Effect Level
OP            Organophosphate
OPP           Office of Pesticide Programs
Pa             pascal,  the pressure exerted by a force of one newton acting on an area of one square meter.
PADI          Provisional Acceptable Daily Intake
PAG           Pesticide Assessment Guideline
PAM           Pesticide Analytical Method
PHED         Pesticide Handler's Exposure Data
PHI           Preharvest Interval
ppb           Parts Per Billion
PPE           Personal Protective Equipment                                                 •
ppm           Parts Per Million
PRN           Pesticide Registration Notice
Q*i            The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC           RedBloodCell
RED           Reregistration Eligibility Decision
REI           Restricted Entry Interval
RfD           Reference Dose
RS             Registration Standard
RUP           Restricted Use Pesticide                     ,
SLN           Special Local Need (Registrations Under Section 24 (c) of FDRRA)
TC            Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD            Toxic Dose. The dose at which a substance produces a toxic effect.
TEP           Typical End-Use Product
TGAI          Technical Grade Active Ingredient
TLC           Thin Layer Chromatography
TMRC         Theoretical Maximum Residue Contribution
torr            A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
WP            Wettable Powder
WPS           Worker Protection Standard
                                              IV

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:  ABSTRACT  .  ' .     ;    ,      ••'-''' :/: ;    ','•'• •."    .-..• .  ••-   ..     . .  " . '  ' '   .' •

         The U. S. Environmental Protection Agency (referredto as "the Agency") has completed
 : its reregistration eligibility decision of the pesticide active ingredient 4-(l ,l7dmiethylethyl)-N-(l-
  methylpropyl)-2,6-dinitrobenzeneamine, also known as butralin.  This decision  includes  a
  comprehensive reassessment of the required data and the use patterns of currently registered
  products.  On August 3, 1996, the President signed the "Food Quality Protection Act of 1996"
  (FQPA) which amended the Federal Food Drug and Cosmetic Act and the Federal Insecticide,
  Fungicide and Rodenticide Act.  FQPA requires the Agency to consider the special sensitivity of
ปinfants and children to a pesticide, aggregate exposure to a pesticide from dietary^ drinking water
  and non-occupational exposures and cumulative effects from other compounds with a common
  mode of toxicity when establishing or reassessing tolerances. Butralin has no food uses.  It's only
  use  is a plant growth regulator on tobacco to control the growth of suckers on the stalk.  The
  Agency does not consider tobacco a "food" use and does not  establish tolerances on tobacco:
  However, notwithstanding the lack of a need for a tolerance, the Agency has evaluated potential
  butralin exposures from drinking water and non-occupational sources and determined that there
  would be no exposure of consequence.   Therefore, the only potential exposures of concern are
  for handlers and post-application workers. The Agency believes inhalation risks to handlers and
  post-application workers from butralin are very low, mat  dermal risks to handlers can be
  mitigated with chemical-resistant gloves, and that dermal risks to  post-application workers can be
 mitigated with a restrictedTentry interval and early-entry personal protective equipment. Based
 upon available data, the Agency has also concluded that risk to freshwater and terrestrial nontarget
 organisms and water resources will be minimal. Therefore, the tobacco use of butralin has been.
 determined to be eligible for reregistration. Certain confirmatory! data are being required of the
 registrant.                .                                       ,

        The Agency has not yet made a determination regarding the common mode/mechanism
 of toxicity of butralin and whether it is appropriate to consider exposure from butralin with other
 compounds in order to address potential cumulative effects. However, based on the lack of food
 uses, the unlikelihood of residues  in  drinking water, and the  absence of non-occupational
 exposure, the Agency believes that the contribution of butralin exposure to the exposure of other
 chemicals with a common mode/mechanism of toxicity is likely tobe minimal.
                  ' '  '    ' -   ' '    •. I-   '    '     -" <>-''•.--     " ' .         - '•-
        There are currently tolerances for food uses of butralin listed in 40 CFR ง 180.358 which
 have been removed from all butralin labels and will be proposed for revocation.  These food uses
 were cancelled several years  ago. The ornamental grass and turf use was cancelled in March
-1997.  There are no existing stocks of any butralin products other! than the currently registered
 product, Tamex 3 EC, which  is for tobacco use only.

       Beforereregisteringthe products containing butralin, the Agency is requiring that product
 specific data, confirmatory, ecological effects and environmental fate data, revised Confidential
 Statements of Formula (CSF) and revised labeling be submitted within eight months of the
 issuance of this document.  These data include product chemistry for each registration and acute
 toxicity  testing. After reviewing these data and, any revised labels and finding them acceptable
 in accordance with Section 3(c)(5) of FIFRA, the Agency will reregister a product
                                            v

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 I.     INTRODUCHQN

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

       FIFRA Section 4(g)(2)(A) states that in Phase 5  "the Administrator shall determine
 whether pesticides containing such active ingredient are eligible for reregistration" before calling
 in data on products  and either reregistering products or taking "other appropriate regulatory
 action."  Thus, reregistration involves a thorough review of the scientific data base underlying
 apesticide'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.                                        :

       The Food  Quality Protection Act of 1996 amends both the Federal Food, Drug, and,
 Cosmetic Act (FFDCA) and FIFRA. The F,QPA amendments went into effect immediately.
 Among other things, FQPA amended the FFDCA by establishing a new safety standard for the
 establishment of tolerances.  Although butralin has no food uses and specific determinations
 outlined in FQPA aire not required for reregistration, EPA believes that consideration of available
 data relating to special sensitivity of infants and children, as well as the potential for aggregate
 exposures and cumulative effects is prudent for butralin and all non-food use chemicals.

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

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H.     CASE OVERVIEW
                                     **               '''''•
       A.    Chemical Overview

             The active ingredient butralin is covered by this Reregistration Eligibility Decision.
       The product, CFPI Technical Butralin, is the technical grade active ingredient (TGAT) and
       contains the active ingredient chemical butralin. There is one end use product containing
       butralin.

             Butralin is used as a plant grow regulator on tobacco after the tobacco is topped.
       All tobacco is topped to stimulate desirable chemical and physical characteristics but also
       stimulates the growth of suckers.  Butralin is a contact-local systemic type of plant growth
       regulator that inhibits sucker growth.
             Common Name:

             Chemical Name:
Butralin

4-(l, l-dimethylethyl)-N-(l-methylpropyl)
-2,6-dinitrobenzeneamine
(CAS Name)

N-sec-butyl-4-tert-buryl-2,6-dinitroaniline
 (TUPAC Name)
             Chemical Structure:
                                      Butralin
             Chemical Family:  Dinitroaniline

             CAS Registry Number:    33629-47-9

             OPP Chemical Code:      106501

             Empirical Formula:       C14H21N3O4

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Molecular Weight:
                                  295.34
        Trade and Other Names:   Technical Butralin
                                  TamexSEC
       Basic Manufacturer:
                          CFPI (Compagnie Francaise de Produits Industriels)
                          Agro SA                           =
 B.    Use Profile
     •;••. The following is information on the currently registered tobacco use with an
 overview of use  sites and application methods.  A more detailed  table of the use
 parameters of butralin on tobaccb its found in Appendix Ai             >

       For Butralin;

       Type of Pesticide for Single Active Ingredient:
             Herbicide; Plant Regulator           ;          ^
.   •          "   -   •    -'  . • ••-' ".-     • • • '•  -'  -. •  ' ••'• '!  • .  •'   •'.'"  . '   - : ;"   '  .'
       Use Sites:    Terrestrial Non-Food Crop
                    Tobacco
  .  "'. .  ' • -•    V ' ''V '...  '.,-.. -   '  •    •"'''"'"''  ;-•'• ' •  •   '•;"••'';'''..••'.',...'
       Types/Formulations Registered:
      /      Manufacturing Product
       ;             Waxy Solid 98.8%

             End Use Product                                ,
                 ,   Emulsifiable Concentrate    36.5%
            - ' =:         i. .        . .   '   A         ;                  .    . '
 '-"'•    .  - <  •     '-.-''  '••:'  ^   '   . \  ' '        '     "        "•••-   •'-  '' --T.-' '   •
       Method and Rates of Application:

        .    Equipment-   iSprayers                '
- ,  "  '               -   ,'-'•.•    •     • •           .     ' '         —      f
             Method and Rate
             - Knapsack (pump) sprayer - 1.08 Ib/acre
             - Jug Application - 1.08 Ib/acre
             -> Handheld dripline - 3.00 Ib/acre   ,\
             - Motorized sprayers - 3.00 Ib/acre

             Timing - Bloom.  After  sprayMg with contact herbicides, such as fatty
             alcohols^for sucker control, butraHn is used with a systemic; herbicide such
             as maleic hydrazide for continuous sucker suppression.

      Use Practice Limitations:   One application per growing season.  There  is a
      twelve hour re-entry restriction following treatment. There is a preharvest interval

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       of 7 days for flue-cured tobacco and 30 days for air-cured (hurley or Maryland)
       tobacco.

             Butralin is a plant growth regulator that provides extended control of
       initiation and growth of unwanted vegetative buds in the axils of tobacco plants
       after topping.  If not controlled, these buds will rapidly develop Into "suckers"
       which compete with the leaves for sunlight and nutrients and interfere with curing
       of air-cured tobacco. The large suckers are expensive to remove by hand prior to
       harvest and if not removed will result in incomplete and inconsistent curing of
       marketable leaves causing reduced quality and marketability after curing.

             Butralin is applied through commercial equipment by using motorized field
       sprayers directing a coarse spray that runs down the stalk. It may also be applied
       to individual plants by using a hand-held dropline, knapsack sprayer, or jug
       application.

             Butralin can be used in a crop management regime that first applies "fatty
       alcohols" followed by maleic hydrazide.  The fatty alcohols kill buds present on
       the day of the treatment but have no effect on new buds which develop within days
       after treatment. Maleic hydrazide is a systemic compound which provides longer
       hormonal effects than fatty alcohols but often does not provide the season long
       control of buds and suckers which tobacco growers need. By using butralin in
       Sequence with fatty alcohols and/or in combination with maleic hydrazide growers
       will be able to obtain season long control of sucker growth without resorting to
       repeated treatments of maleic hydrazide which might result in excessive residues
       of maleic hydrazide in cured tobacco leaves. Tobacco is usually moved from field
       to field every year  and is grown in rotation with grasses  that are tilled back under
       prior to planting other crops.

C.     Data Requirements

             There was a December 19, 1984 Data Call-In for Chronic Toxicology
       studies. When the accelerated reregistration program started under the revisions
       of HFRA in 1988, the Phase 2 Data Call-In was issued in 1990.  In response, the
       registrant requested low volume minor use waivers and noted that the turf and
       ornamental grass use did not trigger most data requirements.

             Data  required in the Phase 3  Data Call-in of- 1991 included new or
       additional product chemistry,  a reduced set of ecological effects, environmental
       fate, toxicology and spray drift data.  During the reregistration process the tobacco
       use was registered in various states and a conditional Section 3 registration was
       approved in November 1996. Appendix B includes all data requirements identified
       by the Agency to support reregistration.

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  D.    Regulatory History
               Butralin was first registered in April 1973 for use on turf by Amchem
  •      Products, Inc.  Amchem Products had been issued an experimental use permit for
        tobacco field testing in 1971-1973.  In 1975 through 1976, preemergent uses of
        butralin were registered on lima beans, cottonseed, southern peas, soybeans,and
        watermelon.  Amchem, Products was acquired by Union Carbide Agricultural
        Products Company, Inc. in 1977 as a wholly owned subsidiary. In 1985, Union
•'..',- -1 ' Carbide sold their butralin registrations to CFPI.  They remain the sole registrant
        for products containing butralin.  An experimental use permit was* issued' October
        1986 to CFPI who intended to register butralin for use in the United States. At the
        time butralinhadbeen in use in tobacco production overseas.  In January 1991,
 .       Amex Preemergence Herbicide (33688-3), the registration for the use of butralin
        on lima beans,  cottonseed, southern peas,  soybeans, and watermelons was
-.•      cancelled.  Weedone No Crab (33688-1), registered for use on turf and ornamental
        grasses was voluntarily cancelled in March 1997, In November 1994, butralin was
        registered for use, on burley tobacco  in the States of North Carolina, Tennessee,
        and Virginia.  Use on burley tobacco in the Stateof Kentucky wasregistered in
        June 1996. The use on tobacco was amended in November 1996 to add use on.
        flue-cured tobacco and to allow use in any tobacco growing state.  At this time>
        Tamex 3-EC, is the only registered end use butralin product.

               Currently, there are two active products containing butralin which  are
        registered under Section 3  of the Federal Insecticide, Fungicide, and Rodenticide
    ." :• Act.  They consist of one technical (manufacturing use) product containing 98.8 %
        active ingredient and one emulsifiable concentrate end-use product containing
    :   , 36.5%  active ingredient.                           ,

 SCIENCE ASSESSMENT

 A.     Physical Chemistry Assessment

        Butralin, the active ingredient in reregistration Case 2075, is assigned CAS
 #33629-47-9and the isolated technical has the following physical and chemical properties:
 melting point 59-61ฐC; vapor pressure 5.79  x 10* mm Hg at 30 C.  The octanol/water
 partition coefficient is Log P = 4.93.  The dissociation constant and pH are not known
 due to very low water solubility at 0.3 ppm.  Other solubility values are:
 Solvent
 Methanol  ,   ' '• /
 Ethanol
 Isopropanol
 Benzene
 Ethylene.dichloride
 Acetone
 Water          ;
Solubility (grams/lOOg)
       9.8
       7.S  ,•"•-'
.       8.4
       270.0
       146.0    ,
       448.0
       0.3 ppm

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             The product identity and composition data requirements for the reregistration of
      the isolated technical ingredient for guideline series 61 were satisfied by MRIDs 40979802
      and 41225203. The analysis and certification of product ingredients data requirements for
      guideline series 62 were satisfied by MRIDs 40979801 and 41225202. The physical and
      chemical characteristics data requirements for guideline series 63-2 through 63-13 were
      satisfied by MRIDs 40979801, 41225201, 41225202, 41784101  and 42616401.  The
      additional data requirements 63-14, 63-15, 63-16, 63-17, 63-18, 63-19, 63-20 and 63-21
      will be satisfied by the submission of acceptable product specific data being called in as
      part of this RED.

      B.    Human Health Assessment

             1.     Toxicology Assessment

                    The toxicology studies reviewed in this human health risk assessment satisfy
             established guideline requirements for a non-food use pesticide.  The butralin
             toxicology database requirements are satisfied.

                    a.     Acute Toxicity

Table 1;  Acute Toxicity of Butralin TGAI
l-Stady
H 1,1 , t
GLN 81-1
MRID 42112701
GLN 81-2
MRID 42660701
GLN 81-3
MRID 42488201
GLN 81-4
MRID 42488201
GLN 81-5
MRID 42020702
GLN 81-6
MRID 42660601
KesปJte \ ;,'""""- - *\ ,'/„',, i '*""'*' -"'"' '
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  Sprague-Pawley rats (5/sex/dose) at dose levels of 0, 2, 10, 50, 250
  mg/kg/day for 4 weeks.  ;              ,  •_

       •No deaths occurred in any of the experimental groups studied.
  Butralin stained the urine and tissues in the 50 and 250 mg/kg/day dose
  group animals.  Body, weights of the high dose animals were reduced by
  22-26%, a difference which is not statistically significant from control
  animal data.  Clinical chemistries, hematology or urinalyses were not
  carried Out. At necropsy, the yellow staining by butralin was seen in the
  subcutaneous and fatty tissue of the 50 and 250 mg/kg/day dosage group
  animals. Centrilobular hypertrophy was seen in the high dose group males
  (3/5) and females (4/5). Based on these results in the range-finding study,
  a dosing level of 200 mg/kg/day was chosen for the top dose in  the 13
  week feeding study.

        GLN 82-la:  'in a 90-day ;subchronic feeding study (MRID
  43652701), butralin technical (99% a.i.) was administered to Sprague-
  Dawley rats (10/sex/dose) in the diet at dose levels of 0 (Gl), 10 (G2), 50
, (G3) and 200 (G4) mg/kg/day  for  13  weeks.    Ten  additional
  anirnals/sex/dose group from the control and high dose groups were carried
  for 4 weeks beyond the 13 week exposure period as recovery test groups.

      'Estimated actual dosages to 10.3 mg/kg/day for low-dose animus-'.
 51 mg/kg/day for mid-dose animals; and 202 mg/kg/day for the high-dose
 animals.  There were no mortalities or toxic signs in any of the test
 animals.  Animals in  all of the butralin treated groups displayed.yellow
 coloring in the urine and in fat and various tissues at necropsy.   The
 yellow  coloring was due to the  color of butralin  and decreased  in the
 recovery period, persisting only in the high-dose group by the end of the
 recovery period.  Body weight reductions were observed in high-dose
 males (-17%) and  females (-23%) and -14% in mid-dose males.  Food
 consumption was also reduced: -11 % for high-dose males* -7 %  for high-
 dpse females and -9% for.mid-dose males. During the recovery period, the
 high-dose animals  gained weight faster than the control animals  while
 consuming about the  same  amount of food during this 4 week period.
 There was no effect on water intake which was estimated visually         "

       There were statisticaUy significant alterations in several clinical
 chemistry values seen primarily in  high-dose males and females  as
 statistically significant changes and often as similar changes in mid-dose
 animals without achieving statistical significance. The following clinical
 chemistrychanges were  statistically  significant (with p ranging from
 <0.05 to 0.001):  Gamma glutamyrtransferase (GOT) was elevated by
 +100% in mid-dose females and +200% in high-dose females. The GGT

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elevations reverted to normal by the end of the 4 week recovery period.
Total protein and albumin was elevated in high-dose females (+12%) and
males (+8%) and also low-dose males (+3%) and males (+6%).  Urea
was  decreased in mid-dose males (-10%) and high-dose males (-13%).
Aspartate amino transaminase was decreased in the high dose males (-28%)
and  mid-dose  females (-24%)  and  males  (-24%).    Alanine  amino
transaminase was decreased in females of the low-dose group (-20%), in
mid-dose group females (-27%) and in females of the high-dose group (-
40%).  Total bilirubin was increased in the high-dose females (+66%) and
was also elevated after the recovery period. Calcium was increased hi the
high-dose females (+6%).  Glucose was decreased in the high-dose females
(-14%).
                                                 \
       liver weights were elevated in the mid-dose males (+40%), in the
mid-dose females (+11%) and m the high-dose females (+39%).  The
liver weight elevation persisted only in the high-dose females (+14%) at
the end of the 4 week recovery period.  Centrilobular hypertrophy of the
liver increased from 1/10 in the control males to 3/10, 6/10 and 9/10 in the
low-,  mid- to high-dose males,  respectively,  achieving  statistical
significance only  in the high-dose group.  Eight of 10  males and 9/10
females in the  high-dose group had normal thyroids by the end of the
recovery period. Control animals 2/10 males and 2/10 females exhibited
minimal hyperplasia (grade +\-) of the thyroid as did 1/10 high dose
females by the end of the recovery period (week 17). Other organ weight
changes were statistically significant in the adrenals, heart, kidney, and
spleen  but occurred  as  isolated  findings  without corresponding
morphological changes.

       Many of the toxic signs seen in the high dose animals at the end of
the 13 week treatment period were reversed or tended toward reversal by
the end of the 4 week recovery period. These included changes in body
weight, hematology,  clinical  chemistry,  organ weight  changes and
histopathology.                                  ,

       The NOEL for this study was 10 mg/kg/day. The LOEL was the
50 mg/kg/day based on body weight and food consumption reductions;
reduced RBCs, Ht and Hb;  and alterations  in liver and thyroid organ
weights.                                           .

       GLN 82-2. In a 21-day rabbit dermal toxicity study (MRID
40419601), butralin technical (95% a.i.) was administered topically to the
clipped dorsal trunk and flanks (intact skin) of New Zealand White rabbits
(5/sex/dose) as  granular material applied wet (distilled water) to the skin

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 at daily dose levels of 0 and 1000 mg/kg/day for 5 days/week for a 3-week
 period.

       The only clinical sign observed was yellow/orange staining of the
 treatment site. There were no signs of toxicity or effects on body weights'
 or food: consumption. Hematolpgy, urine analysis, macroscopic pathology
 and histology, and organ weights were considered to be unremarkable.
 Adrenal glands of treated  males  and females were somewhat enlarged,
 however there were no morphological changes noted.

       The.NOEL was considered to be greater than 1000 mg/kg/day, Ihe
 limit dose.  This 21-day dermal toxicity study is classified acceptable and
 does satisfy the guideline requirement for a 21-day dermal toxicity.study
 in the rabbit.

       GLN 82-4* A subehronic 13 Week inhalation toxiciiy study was
 conducted (MR1D 42633601,-03) using  butralin in Solvarex 90/18,0, a
 proprietary solvent,  the study data were submitted to fulfill the 90 day
 subehronic inhalation toxicity data  requirement. The use of "Solvarex" in
 the administered butralin dose,, when considered along with the strong
 presence of histopatiiolpgical changes in both the test and vehicle control
 test animals, resulted in the study being initially classified as "inadequate".
 The registrant submitted additional test data for the 90-day subehronic
 inhalation toxicity study which resolved  concerns related to the use of
 Solvarex to "aerosolize" butralin in the administered dose.  The study was
 upgraded to "acceptable".

       In the submitted study (MRID 42633601), butralin was administered
 by the hose-only inhalation route to male and female Fischer F-344 rats (10
 animals/sex/group) at concentrations of 0.3, 1.0 and 3.0 mg/L for 6
 hours/day, 5 days/week for 13 weeks.  Air and vehicle control groups were
 included.                  :

       The  animals were restrained in cylindrical tubes with their heads
 protruding through head ports into a 360 ml flat polycarbonate cylinder
 exposure chamber: A collision nebulizer was used to generate the test
 atmospheres which were directed  into the exposure chamber.  Technical
butralin  (99.6%  a.i.) was dissolved  in the Solvarex 90/180/' at a
 concentration of 363 grams butralin/liter of solvent.  Analytical exposure
concentrations in the chamber were derived from gravimetric filter samples
which  were analyzed for butralin.   The exposure particle sizes ranged
from 2.81 to 3.41 micrometers, slightly exceeding .the acceptable range of
1-3 micrometers for subehronic studies.
                       9

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       There were no deaths resulting from the administration of the test
 agent.  All animals treated with butralin developed yellow fur.  Body
 weight differences from air control groups were seen only in the high dose
 animals (male and female) and in the vehicle control animals  (male and
 female). Significant differences from air control animals were seen in all
 for animals in the vehicle controls and all of the butralin treated animals.
 These changes included:   hematology parameters (primarily  related  to
 RBCs (red blood cell counts)); several blood chemistry parameters (calcium
 (Ca), phosphorous (P), alkaline phosphatase (ALP) and glucose (GLU));
 organ weights changes (liver, kidney, adrenal and testes); and a variety  of
 histopathologic findings.  The lesions which appeared dose related included
 respiratory  epithelium hyperplasia, nasal  pharyngeal duct goblet cell
 hyperplasia, nasal submucosal edema; liver hepatocyte hypertrophy and
 cytoplasmic alteration; renal tubular epithelium cytoplasmic droplets; and
 trachea! hyperplasia. Much of the histopathological changes were seen
 strongly represented in the vehicle controls and dose related in the butralin
 treated groups.  The NOEL  = 0.3 mg/L and the LOEL =1.0 mg/L based
 on histopathological effects in the nasal passages, on hematological, clinical
 chemistry, and histopathology (much of which was based on the respiratory
 system, the liver and kidney).

 c.     Chronic Toxicity

       Based on the current use pattern of butralin, chronic toxicity data
 are not required. If in the future additional butralin uses are requested, the
 Agency may require additional studies.

 d.     Carcinogenicity

       The Agency determined that data were insufficient to evaluate the
 carcinogenic potential of butralin.  Because butralin is a non-food use
 chemical, chronic data to  determine its carcinogenic  potential  are not
 required.

 e.     Developmental Toxicity               /

       GLN 83-3a.  In  a rat  developmental toxicity study  (MRIDs
 40419603, 42156101, -02 and -03) butralin (96% a.i.) was administered by
gavage at 0, 500,  1250 or  2000  mg/kg/day.  Maternal toxicity was
demonstrated by a statistically significant decrease in body weight and body
weight gain at the mid-dose tested (MDT) and high dose tested (HDT).
Food consumption and relative efficiency of food utilization was depressed
at these same dose levels.  Mortality occurred in 2 dams at the HDT.
Maternal toxicity was also demonstrated by the 2 and 4 dams aborting  at
                       10

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 the MDf and HDT, respectively. In addition, vaginal bleeding occurred
 in 4 and 6 dams at me MDT and the HDT respectively. Maternal toxicity
 was less clear at the low dose tested (LDT) were statistically significant
 decreases  occurred in food consumption and  nominally, m relative
 efficiency of  food  utilization.  The maternal toxicity LOEL = 500
 mg/kg/day (LDT); a maternal toxicity NOEL was not established.

       Malformations were slightly elevated at the MDT and HDT, such
 as incomplete  ossification of the palate and presphenoidal bone, absent
 sacral vertebrae, and dilated brain ventricles. Statisticakanalyses03 and 41742003) was
 carried out at 0 and 50 mg/kg/day in order to establish a NOEL for the
 above study. The developmental ,and maternal NOEL was 50 mg/kg/day;
 the LOELs for these parameters were greater than 50 mg/kg/day, the only
 treatment level used.  Data from the two studies combined satisfy the
 guideline requirement for a rat developmental toxicity study.

       GLN 83-3b.  In a rabbit developmental study (MRIDs 40419601,
 41742002 and 42156104) rabbits were administered butralin (97% a.i.) at
 0, 8.2,2714, or 128 mg/kg/day. The study demonstrated maternal toxicity
 in the form of decreased body weight aiid decreased body weight gain^
 decreased food consumption and decreased deficiency of food utilization.
 The maternal toxicity  NOEL = 8-2 mg/kg/day;  the maternal toxicity
LOEL = 27.4 mg/kg/day.  Fetal toxicity was demonstrated at the MDT
 and HDT in the form of slight but probable dose  related increases! in 5
major defects:  enlarged fontanelles, one heart defect, a malrotated hind
limb, arthrogryppsis (major and minor) and scoliosis.  The major heart
defect was seen' in one pup in one litter at the highest dose group.  In
addition, a probable dose related and compound-related  increase was
observed in  1) atrium/atria increased size, 2) incomplete closure  of
abdominal muscular layer, 3) parietals incompletely ossified, 4) spatulate
ribs,  5)  kinked ribs, 6) fused  sternebrae,, 7) other anomalies in the
ossification of sternebrae, and 8) incompletely/not ossified metacarpals,
forelimb phalanges and hindlimbs phalanges.  The incidence of these eight
                      11

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(8) anomalies in fetuses of this  study were each higher than historical
control data submitted with the study.  When these major defects and minor
anomalies are  considered  together, a pattern  of increased effects and
toxicity appear at the MDT and HDT. The developmental NOEL = 8.2
mg/kg/day; the developmental LOEL = 27.4 mg/kg/day.  The study is
acceptable.

       In the prenatal developmental toxicity study in rats, developmental
toxicity  (delays or absence in  ossification of sternebrae, absence of
ossification in thoracic vertebral centra and caudal vertebral arches) was
observed in the presence of significant  maternal toxicity (increased
mortality, abortions, and vaginal bleeding; decreases in body weight gain
and food consumption). In contrast, in the rabbit prenatal developmental
toxicity study, developmental toxicity (enlarged heart, malrotated hindlimb,
and scoliosis) occurred in  the mid- and high-dose groups (27.4 and 128
mg/kg/day) in the absence of significant maternal toxicity (decreased body
weight and decreased body weight gain).

       Based on the results of these studies, the possibility of increased
prenatal sensitivity to.butralin cannot be ruled out. However, we have no
concerns regarding infants*  or children's risk to butralin for the following
reasons:  (1) the registration for turf use was canceled March 1997 so there
should be no exposure of infants or children to butralin; (2) MOEs for all
butralin use scenarios for which data are available are extremely high
indicating that exposures for children would not be of concern; (3) there is
no  toxicity endpoint for short-term (1-7 day)  exposure; further, there
would be no intermediate  term (one week to several months) exposure
scenario for children; since there is  no  infant's  or  children's exposure
scenario for which a toxicity endpoint has been identified, significant risk
to infants and children is unlikely; (4) there was no evidence of increased
prenatal or postnatal sensitivity in either the developmental toxicity or the
three-generation reproductive toxicity study hi  rats;  and, (5) exposures.,
should they occur,  would  be of  a dermal  nature,  whereas  in the
developmental toxicity study of concern, butralin was administered to the
maternal rabbits by gavage.                             ,.•    '

f.     Reproductive Toxicity

       Reproductive toxicity data have not been required to support the
reregistration of the non-food uses of butralin.  In a preliminary Agency
review of a three-generation reproduction study in rats (MRIDs 92014039
and d0154259), toxicity in the offspring (decreased pup survival during the
lactation period, in association with  decreased mean pup weights) was
observed in the presence of parental toxicity (decreased body weight) in all
three generations at the HDT (1000 ppm; 50 mg/kg/day).  The NOELs for
the parental rats and their offspring appear to be equivalent (6 mg/kg/day).
                       i             r ,' •  Jl             ' '       • ',
                   	  12' "     '   " .'         '         '•         ,    '

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 g.     Mutagenicity  ,                ,

        GLN 84-2.  The mutagenicity data evaluation  concluded .that
 butralin exhibits mutagenic activity in the in vitro studies conducted,
 Butralin is structurally related to trifluralin, a known carcinogen (see NTP
 Technical Report No.  34,  1977 ; EPA Peer Review, 1986, Doc. No.
 005578/007362). ,Trifluralin exhibits a mutagenic profile in the Ames test
 (pre-incubation modification) that is similar to butralin (i.e., positive in S.
 typhimurium strain TA 100 only in the presence of S9 activation and only
 at high precipitating doses).  With the exception of the positiveปresults for
 butralin in the mouse  lymphoma assay, the overall genetic toxicology
 profUe for the two compounds is similar.

        The following studies satisfy guideline requirements (GLN 84-2) for
 gene mutations:                  ฐ
                                            >'""'•'•''          ;
 Gene Mutations

 Salmonella typhimiirium reverse gene mutation assay (MRID 40121101):
 Eight concentrations of butralin (1.0 to 10,000 ^tig/plate) were evaluated in
 two independent Sahnonella typhimurium microsome mutagenicity assays.
 Results indicated that at highprecipitating concentrations (5000 and 10,000
 jug/plate), the test material induced reproducible and dose-related increases
 (1.8 to 2.0- and 2,2 to 2.4-fold, respectively), in revertant colonies of S.
 typhimurium TA100 in the presence of S9 activation;  It was  therefore
 concluded that butralin was mutagenic in thjs,test system. The study is
 acceptable.          -

 Mouse lymphoma L5178Y  TK*'" forward  gene mutation assay (MRID
 40121102):  Butralin was assayed over a concentration range of 7.5 to 50
 /ig/mL without S9 activation and at doses ranghtg from 7.5 to 60 /zg/mL
 with S9 activation in independent mouse lymphoma forward  mutation
 assays.  Without S9 activation,  increased mutant colonies and mutation
 frequencies (MFs) were seen at 40, 45 and 50 y^g/mL; cell survival at these
 levels was 23.2, 7.7, and 6.5%,  respectively.  In the presence  of S9
.activation, mutagenic activity was confined to the highest dose; however,
 less  than  10%  of  the cells  survived   treatment.    Based  on the
 reproduceability of  the results, the  increased  MFs,  which  were.
 accompanied by increased mutant colony counts, and the evidence of a
 dose-related effect under non-activated conditions, it was  concluded that
 butralin is mutagenic in this test system;  metabolic activation was not
 required. The study is acceptable.      '         \ •..

 Chinese hamster ovary (CHO) cell HGPRT gene mutation assay (MRID
 40551909):  Butralin was negative in the Chinese Hamster ovary (CHO)

••  '   •:•   -    . "       1-3      .   ' ,   •'••'-.  -.  "    •-'''.'•'•

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cell HGPLT gene mutation assay with and without S9 activation at up to
cytotoxic concentrations. The compound was insoluble at concentrations
to or greater than 100 /fg/mL without S9, and equal or greater near 70
/jg/mL with S9. The study is acceptable.                           v

Chromosome Aberrations

In vitro CHO cell chromosome aberration assay (MRID 40551910):  Under
the conditions of this assay, four doses of butralin ranging from 25 to 1000
/zg/mL with or without S9 activation did not induce a clastogenic response
in the chromosomes of Chinese hamster ovary (CHO) cells harvested 20
hours after nonactivated dosing or 10 hours after treatment in the presence
of metabolic activation,  The test material was assayed up to an acceptable
cytotoxic dose (100 jwg/mL), which approached the limit of solubility (100
/ig/mL/-S9; 75 /zg/mL/+S9), with no clastogenic effect.  The study is
acceptable   and satisfies  guideline  requirements  (GLN  84-2) for
chromosome aberrations.

GLN 84-4.  Other Mutagenic Mechanisms

In vitro  unscheduled DNA synthesis in primary rat hepatocytes (MRID
40350901): Primary rat hepatocytes from Fischer 344 males were exposed
for 18 hours to butralin in DMSO  (94.5% a.i.) at 10 concentrations
ranging  from 0.5 to  150 fj-g/noL.   The HDT proved to be  lethal;
precipitation was evident at 25 ^g/mL and above. There was no evidence
of induced DNA repair (as determined by net nuclear silver grain counts,
which measures unscheduled DNfA synthesis) at any dosage up to 75.1
/jg/mL,  a severely toxic (6.6% relative survival) dose.   The positive
control (2-AAF) responded appropriately. The study is acceptable.

In  vitro  CHO cell sister chromatid exchange assay  (SCE) (MRID
40121103):   Under conditions of two independent  sister chromatid
exchange (SCE) assays, butralin over a concentration range of 2.5 to 30
//g/mL without S9 activation and 5 to 80 /*g/mL with S9  activation did not
induce a  reproducible increase in the SCE frequency of Chinese hamster
ovary (CHO) cells.  The test material did, however, induce severe mitotic
suppression, and prolonged cell harvests were required for high test doses.
Although significant (p<0.05) increases in the SCE frequency were seen
in the initial assay (highest nonactivated and  S9-activated doses), the
response  occurred at severely cytotoxic doses, was not reproducible, and
did not show a dose-response relationship.  It was therefore concluded that
butralin  was assayed to levels inducing cytotoxicity with no genotoxic
effects.

       These studies satisfy the guideline requirements (GLN 84-4) for
other genotoxic effects.

                      14

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  Other Studies:   An unclassified mouse dominant lethal assay (MRID
  00078460) is listed in the one-liners as negative up to  1000 mg/kg/day
  (HDT); no further information was available,               i
  h.
Metabolism
       1 GLN 85-1. In a metabolism study (MRID 42743201), rats were
  dosed by gavage with butralin (ring labeled) in corn oil at 8 mg/kg/day
  (low dose levels) for single and multiple dosing and; biliary excretion
  studies and at 800 mg/kg/day (high dose single dosing) and the distribution
  and excretion of butralin followed over a 7 day period.  Low dose results
  indicate that about 100 percent of the dosed material was excreted in about
  2 days, with 55 to 60% excreted in the  feces and 35-45% in urine.  The
  feces contained about 10% unmetabolized butralin.  The excretory half life
  was about 12. hours.  Tissues retained only about 1% of the labeled
  butralin.  A  similar excretion pattern 'Was seen in the repeat low dose
           ' '          '       '   "        ''          '          '         '
        High dose administration of butralin took 5-7 days to achieve 100%
 excretion of butralin in the urine and feces.  The excretory half life was
 between 2 and 4 days.  Of the various tissues, fat and liver tended to retain
 more butralin residues.  Females excreted the butralin residues more slowly
 than males and retained more metabolite in the tissue (especially the liver
 and fat)..            '. -'•'•'•.-.-.'

   '     In abile excretion study using low dose levels (8 mg butralin/kg),
 enterohepatic circulation was  determined to be  a primary  pathway for
 butralin  excretion and metabolism.  Twelve butralin metabolites were
 identified in pooled urine, feces  and/or bile samples. Metabolites identified
 at concentrations of 5% to  10% of the administered dose were: 2-methyl-
/5(6)[l-(l-carboxy-l-methyl)ethyl3-7(4)-nitrobenzimidazole,    2-methyl-
 5(6)[2-(l-hydroxy-2-methyl)propyl]-7(4)-nitrobeiizimidazole, 2-methyl-2(4-
 amino-3,5-dinitrophenyl)propionic  acid  arid  2-methyl-2(4-amino-3,5-
 dinitrdphenyl)propanol-glucutonide.  Butralin, the parent chemical, was
 present at 10% of the administered dose. There were no metabolites at
 concentrations greater than 10% of the, administered dose identified in the
 study.  The Agency determined the stjidy satisfies the guideline requirement
 for a metabolism study in rats.
 . -   ' i                '         '             ''.','.
 L      Other Toxic Endpoints             ''.-,,
     •       . '  • '              '*,'•'  • • '    ' . .   •         '
 Neurotoxicity

        Neurotoxicity studies were not required or evaluated in this risk
 assessment.
                       15

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                    Incident Data
                           No information is available on incidents related to the use of
                    butralin from any of the available databases reviewed.

                    Potential Risks to Infants and Children

                           Butralin is not registered for food uses nor is it available for use in
                    the residential setting.

                    j.      Dose Response Assessment

                           Reference Dose                                          ,    '

                           A Reference Dose (RfD) for butralin is not warranted for the
                    current non-food use pattern of this pesticide. However, if the use pattern
                    and/or registrations change exposure to butralin an RfD determination may
                    be required (RfD Peer Review Committee, September 1996).

                           Carcinogenicity Classification

                           A  carcinogenicity classification  was not  determined  due to
                    insufficient data to evaluate the carcinogenic potential of butralin (RfD Peer
                    Review Committee, September 1996).

                    k. .   lexicological Endpoints for Risk Assessment
                                                f '
                           In July 1996 the Toxicological Endpqint Selection Committee met
                    and  established  endpoints for use in acute dietary  and worker risk
                    assessments.  The conclusions of the committee are summarized in Table
                    2 below.
Table 2; Toxicological Endpoints for Butralin
fypwd^itfatwaof , "w
Exposore'
Acute Dietary
Short Term Occupational
Exposure (1 to 7 days)
Intermediate Term
Occupational Exposure
(1 week to several months)
Any Exposure Duration
Tfe^^^B^^t^'^l^t-/'''''^/'5'^ „<<" "' ''*""'**]
None. An acute dietary risk assessment is not required since butralin is a
non-food-use chemical.
A short-term risk assessment is not required; no systemic toxicity was
observed at 1000 mg/kg/day in a 21-day dermal rat study.
10 mg/kg/day NOEL based on decreased body weight and food
consumption, alterations in hematology and clinical chemistry seen at 50
mg/kg/day LOEL in a 13-week rat feeding study. A dermal absorption
value of 5% should be used for route-to-route extrapolation.
0.3 mg/L NOEL (80.2 mg/kg/day) based on histopathological effects in
nasal passages seen at 1.0 mg/L LOEL in a 90-day rat inhalation study.
-HSoateftf .
J^OSBtfc'
Oral
Dermal
Dermal
Inhalation
                                          16

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2.
 Dermal Absorption

        A dermal absorption study was not available,  A dermal absorption
 value of 5% was calculated based on the route-to-route extrapolation using
 the maternal NOEL of 45 mg/kg/day from the developmental toxicity study
 in rabbits and the systemic NOEL of 1000 mg/kg/day from the 21-day
 dermal toxicity study in rabbits. The calculated value of 5% for butralin
 is comparable to the  1 % dermal absorption value estimated for trifluralin,
 a compound structurally similar to butralin.  This dermal absorption value
 will be used for intermediate-term risk assessment smceord studies were
 selected for this exposure scenario.                  _         '

       A short term (1-7 days) occupational dermal exposure endpoint of
 toxicological concern was not established. The intermediate term (1 week
 to several months) occupational dermal exposure endpoint is a NOEL of 10
 mg/kg/day observed in a 90-day subchronic rat feeding study.  A risk
 assessment of intermediate term dermal exposure is required.

 Inhalation

       Based on the physical/chemical properties of butralin  (e.g.low
 volatility) and the formulation/application methods (e.g. no exceptionally
 high applicator exposure such as from air blast applications), the Agency
 would not anticipate any mixer/loader/applicator concerns. However, the
 Agency' s database does contain a 90-day rat inhalation study which was
 evaluated as part of the reregistration prpcess.  These data show, as one
 would expect, that margins of exposure are very high. Inhalation MOEs
 are in the tens of thousands for all mixer/loader/applicator scenarios.

      , Based on the tobacco use pattern chronic worker exposure (several
 months-lifetime) is not expected to occur. The Agency has determined that
 a risk assessment for chronic occupational exposure is not required at this
 time.-    •  -:'.'  •      '          :   .   .  ,      •;.•:.   ;' -'- ••"•

 Exposure Assessment

 a.     Food Source

       The currently registered tobacco use of butralin does not result in
 dietary exposure.  Tobacco is never fed to cattle, goats, pigs or iny known
rurninants  since the  tobacco is unpalatable and the nicotine in  tobacco
makes the animals sick.              ,
                             17

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b.     Drinking Water Source

Ground Water:  Butralin is persistent but relatively immobile in terrestrial
environments. Based upon qualitative leaching index and mobility studies,
butralin is not expected to leach into ground water.
Surface Water:  Butralin detections were not reported in STORET.  Based
on the Tier I GENEEC EEC, the peak EEC for butralin is 16.89 /zg/L-
A more reliable surface water characterization will be determined when
additional batch equilibrium data are received and evaluated. Neither a
maximum contamination level (MCL) nor Lifetime Health Advisory Level
(HAL) has been established for butralin.  The Agency believes foliar
interception  and subsequent foliar dissipation processes will affect the
magnitude of butralin residues available for surface water runoff.  Butralin
residues that are oversprayed or washed off from the treated plants are
likely to be the only butralin residues available for runoff into surface
waters.

       Considering the limited potential for butralin residues in ground and
surface water, butralin drinking water contamination is not expected to be
a dietary risk concern.

c.     Occupational Exposure Assessment/Characterization Assessment

       Handler Exposures & Assumptions

       The Agency has determined there are potential exposures to mixers,
loaders, applicators, and other handlers during usual use-patterns associated
with butralin.  Based on the current registered use patterns five (5) major
exposure scenarios were identified for butralin:

(1) mixing/loading liquids for groundboqm application.
(2) applying sprays with groundboom equipment.
(3) mixing/loading/applying liquids with a backpack sprayer.
(4) mixing/loading/applying liquids with a low-pressure handwand.
(5) jug application of liquids.
     ; "    "'  :,  ' I"  '     ' ''    '''',"','-
       Post Application Exposure & Assumptions

       Occupational:  The Agency has determined that there is an exposure
potential for persons entering treated sites after application is complete.
Workers may be entering treated tobacco areas to perform hand-suckering
(hand-labor task) as a supplement to the chemical-suckering treatment.
There are no chemical-specific data available upon which to assess  the risks
from post-application exposures.
                      18

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                3.     Mixer/Loader/Applicator Exposure Assessment

                       Potential daily exposure is calculated using the following formula:
Daily Exposure ( SSL#\ i Unit 'Exposure f
            {Day},,            \
                                            xMax. Appl. Rate ( 1ฑ*\ x Max. Area Treated {
                                                          (Acre)     '            \ Day
                                                                      '
                       The calculations  of daily exposure to butralin by handlers are used to
                calculate the daily dose'to those handlers. Intermediate4erm dermal and short- and
                intermediate-term inhalation  exposure assessments using  PHED Version  1.1
                surrogate data  are presented in  Table  3. '•> No chemical-specific data, were
 -               submitted.                  ,              ;   :                               V

 TakkSr fate^
                                      *,  t ''?•
                                                                    IM&
                                  Mixer/Loader Exposure Estimates
 Mixing/Loading Liquids for
 Groundboom Application (1)
                            2.9
 1.2
3.0
                                                                 80
    696
                                             0.29
                                   Applicator Exposure Estimates
 Groundboom Application (2)
                           0.015
0.7
3.0
                                                                 80
                                 3.6
                               0.17
                             Mixer/Loader/Applicator Exposure Estimates
 Bac]q)ack Sprayer(3)
                          No data  ,
                       (see additional
                           PPE)
30.2
3.0
No data (see
 additional
   PPE)
                                                                                          0.09
 Low Pressure Handwand (4)
                           103.8
31.2
                                                      3.0
                                .311
                                                                                     0.09
Scenario (4) also represents jug application method.
No data means no data are available for hand exposure..        -
1 Baseline dermal unit exposure represents long pants, long sleeve shirt, no gloves, open mixing/loading, open cockpit,
open cab tractor.    '                                          '   •  .       .    . ..'
*• Baseline inhalation exposure represents no respirator.
c Application rates are maximum values found on butralin label [EPA Reg. No.t 33688-4].
d Daily acres treated values are from EPA OREB estimates of acreage that could be treated in a single day for each
exposure scenario of concern.       •            ,, •  ,      ' /   .'••;'•        ;                .
e Daily dermal exposure (mg/day) = Exposure (mg/lb a.i.) * Appl. rate (lb a;i./A) * Acres Treated.,
f Daily inhalation exposure (mg/day) = Exposure 0/g/lb a.i.) * (lmg/1000 ^conversion * Appl. Rate (lb a.i./A)
* Acres Treated           -_,'.•'                                    '  ;               ',        •
                                                19

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               a.      Occupational Risk Assessment/Characterization

               Risk from Dermal and Inhalation Exposures

               Dermal: The daily dermal dose is calculated using a 70 kg body weight in
        the following formula:
Dotty Dermal Dose fCTgaiM = Daily Dermal Erasure (
                                  *
              (  Day }
{ Day J  \ Body Weight |
                      x 5% dermal absorption
              These calculations of daily dermal dose of butralin received by handlers are
        used to assess the dermal risk to those handlers. The  intermediate-term dermal
        MOEs were calculated using a NOEL of 10 mg/kg/day in the following formula:
                      MOE =
                                           day }
                             Daily Dermal Dose \ mg/kg}
                                              ( day }
            .  Inhalation:  The daily inhalation dose is calculated using a 70 kg body
        weight in the following formula:
      DaOy Inhalation Dose fmga//M = Daily Inhalation Exposure (ฃJLฃ\ x {
                     {  Day J                    ( Day )   \
                  Body Weight (kg))
              These calculations of daily inhalation dose of butralin received by handlers
        are used to assess the inhalation risk to those handlers.  The inhalation MOEs were
        calculated using a NOEL of 80.2 mg/kg/day in the following formula:
                                   •NOEL
                     MOE =
  (mglkg\
  (  day
                            Daily Inhalation Dose [
                                              \ day )
              Table 4 presents the risk assessment for intermediate-term dermal and
        short- and intermediate-term inhalation exposures.  The caveats and parameters
        specific to each  exposure  scenario and corresponding risk assessment  are
        summarized in Table 5.
                                    20

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                          ^}s-li?l|i


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                          3-2E3~^*  '^— ปH


                         o2;j| g W "Bb'^2-ซ2'- ™*

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                         Ifljiili!"
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-------
 Estimated Risk From Handler Exposures

 Dermal:  The calculations of intermediate-terni dermal risk indicate that the MOEs
 -ate more than 100 at baseline for the spray application with a groundboom sprayer
 scenario.  •  :  -;   ,     •     ,  '.'.",'"•'• ':. •    v. .   •• • •.•'    '•  •'

 The calculations of intermediate-term dermal risk indicate that the MOEs are more
 than 100 with the addition of chemical-resistant gloves to baseline attire for the
 following scenarios:
 *     (1)  mixing/loading liquids for groundboom application;

 •     (2)  mixing/loading/applying sprays with a backpack sprayer; and,

 •     (3)  mixing/loading/applying sprays with a low pressure handwand.

        Jug application is represented by scenario (3).

 Inhalation: The calculations of short-term and intermediate-term inhalation risk
 indicate that the MOEs are more than 100 at baseline for all scenarios.
                                    '' •' •       *       "    .   '     - •       \ •
 Risk From Post-Application Exposures             •             A

 Occupational: Based on relatively low dermal tpxicity, EPA concludes that risk
 due to post-application exposure^ fpllqwing applications of the liquid formulation
 to tobacco would be minimal, provided entry does not occur immediately following
 applications.  The Agency ttbtes that label directions indicate that hand-suekering
 of any suckers that escaped treatment  should occur two to three weeks after
 treatment and that this product should be applied at least 30 days before anticipated
 harvest dates.                   .

        b.     Additional Occupational Exposure Studies

 Handler Studies

        Based on  the  risk assessment of the current uses of butralin,  handler
 .exppsure studies are not required at this time.
i   .   .'     •   --'••-  ^ •••• .           .;'.''    -  . '  i. -• •  '-   . •   •
 Post-Application Studies

        Based on  the risk  assessment  of .the  current uses of butralin, post-
 application   exposure studies are not required at this time.
                              23

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       4.    'Other Exposure and Risk Considerations

       The Food Quality Protection Act of 1996 amends both FFDCA and FIFRA by
setting a new safely standard for the establishment of tolerances. In determining whether
or not a tolerance meets the new safely standard,  FQPA  directs EPA to consider
information concerning:  the susceptibility of infants and children to residues of the
pesticide in food; the potential for aggregate exposure from dietary as  well as non-
occupational sources, such as pesticides used in and around the home; and the potential
for cumulative effects from a pesticide and other substances  that have a common
mechanism of toxicity.

       Because the use of butralin on tobacco is not a food use and no tolerance has been
established, the specific determinations outlined in FQPA are not required for this
chemical.  However, EPA also believes that for non-food chemicals it should evaluate
available data relating to the special sensitivity of infants and children, as well as the
potential for aggregate exposures and cumulative effects if infants, children or the general
population may be exposed from drinking water or non-occupational uses.  The tobacco
use of butralin does not result in  any drinking  water or non-occupational exposure.
Therefore, there  is no need to consider an additional uncertainty (safety) factor nor
conduct an aggregate exposure/risk assessment.

       With  regard to cumulative  risk, butralin  is structurally similar to some
dinitroaniline compounds.  However, EPA has not made a determination regarding a
cumulative risk assessment. For the purposes of this Reregistration Eligibility Decision
document, the Agency has considered only risks from butralin. However, the contribution
of butralin exposure to the exposure from other chemicals with a common mode of toxicity
is likely to be minimal. If required, cumulative* risks will be assessed when methodologies
for determining common mode of toxicity and for performing cumulative risk assessment
are finalized.
C.     Environmental Assessment
                                   .,' ,,       ' 'l    :     ,''

       The environmental assessment consists of four sections: Ecological Toxicity,
Environmental Fate and Transport, Ecological Exposure and Risk Assessment, and
Environmental Risk Characterization. The first and third sections report the ecological
toxicity data from laboratory studies, estimates ecological exposure and assesses the effects
to nontarget  terrestrial  and aquatic  organisms.   The  second section  depicts the
environmental fate and transport data from field and laboratory studies, analyzes the
impact to water resources, and details the environmental fate assessment. The section on
environmental risk characterization integrates the exposure and effects assessments to
determine the extent and potential for risk to the environment.
                                   24

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              1.     Ecological Toxicity Data

                     Ecological toxicity studies indicate that butralin is practically nontbxic to
              terrestrial organisms on an acute oral and subacute dietary basis, but is highly toxic
              to aquatic organisms on an acute basis.  At this time, the Agency does not have
              sufficient data to adequately assess the ecological toxicity of butralin and is
              requesting the following studies:  chronic toxicity to invertebrates (GLN 72-4b);
              either a 48-hour embryo-larvae study or 96-hour shell deposition study with
              oysters (GLN 72-3 b); toxicity to terrestrial (GLN 123-1 a and b) and aquatic
              (GLN 123-2) plants;  aady avian reproduction (GLN ^1-4 a* and b> with both the
              mallard duck and bobwhite quail.

                     a.     Toxicity to Terrestrial Animals

                      ,      (1)     Birds, Acute and Subacute

                 ,                  In order to establish the toxicity of butralin to birds,  the
                            following tests are required using the technical grade material:  one
                            avian single-dose oral (LD5p) study on one species (preferably
                            mallard or tobwhite quail); two subacute dietary studies (LCSO) on
                            one species of waterfowl (preferably the mallard duck) and one
                      ,     species of upland game bird (preferably bobwhite quail).,
Table 6;  Avian Acute Oral Toxicity Findings
 Bobwhite Quail
96
• 2250
160643 Beavers/1986
                                     Practically nontoxic
                                                     Yes
Table 7; Avian Acute Dietaiy Toxicity
 Northern Bobwhite
   98
 > 10,000
   160644 Fink/1975
                                                        Practically nontoxic
                                                              Yes
 Mallard Duck
   98
 > 10,000
   160645 Fink/1975
                                                       Practically nontoxic
                                                              Yes
                        ,   These results indicate that butralin is practically nontoxid to avian
                     species  on an acute  oral  and subacute dietary basis.   The  guideline
                     requirements (71-2) are fulfilled.   .

                           (2)    Birds,'Chronic

                             "     Avian reproduction studies are required when birds may be
                           exposed  to a pesticide  repeatedly  or. continuously  through
                           persikerice,  bioaccumulation, or multiple  applications;  or  if
                                           25

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                            mammalian reproduction tests indicate reproductive hazard.  The
                            environmental fate data suggest that butralin should be moderately
                            persistent to persistent (t,/2=3'months to 3 years) and relatively
                            immobile in terrestrial environments. Based upon the persistence
                            of butralin in terrestrial environments, birds  are  expected to be
                            exposed repeatedly and for a long period of time.

                                  Two avian reproduction studies completed in 1972 were
                            reviewed and classified as supplemental, not-upgradeable.  That is,
                            they provided information to be used in the risk assessment, but did
                            not fulfill current guideline requirements.  There were numerous
                            guideline deviations in these studies, such as the lack of sufficient
                            treatment levels, inadequate description of testing facilities, and the
                            lack of raw data.

                                  Conclusions: Technical butralin (purity not identified) did
                            not impair the reproductive ability of mallard ducks, with the
                            exception  of  increased  eggshell cracks,  at  80  ppm  (MRID
                            44074105). Technical butralin, fed to bobwhite quail for a total of
                            15 weeks, did not impair the reproductive ability at either the 4 or
                            80 ppm levels (MRID 44074101).  However, these studies are
                           inadequate and the highest tested level (80 ppm) does not adequately
                           represent  avian  exposure  levels expected in the environment
                           according to Kenaga as modified by Fletcher (1994).  The guideline
                           requirements, 71-4(a & b), are not fulfilled.  The supplemental
                           studies indicate that butralin may adversely affect the reproduction
                           of mallard ducks, therefore a reproduction study with the mallard
                           duck is required. Based on the persistence of butralin,,the Agency
                           is also requiring a reproduction study  for the bobwhite quail
                           because of the high potential for exposure.

                           (3)    Mammals

                                  Wild mammal testing is required on a case-by-case basis,
                           depending on the results of the lower tier studies such as acute and
                           subacute testing, intended use pattern, and pertinent environmental
                           fate characteristics. Acute toxicity studies  show that butralin is not
                           acutely toxic to the animals tested to date.  Therefore, an acute oral
                           LD50 from the Agency's database is sufficient to assess toxicity to
                           mammals.  This LDSO is reported below.
Table 8; Mammalian Acute Oral Toxic
  Rat (small mammal surrogate)
1049
42112701
                             Slightly toxic
                                          26

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                    b.
                  The available mammalian data .indicate that butralin is
            slightly toxic to small mammals on an acute oral basis (MRID
            42112701).          '•'..'    :

                  Chronic                                 ;

                  Currently,  the  Agency  does  not  have  reproductive
            mammalian data because chronic data are not required for non-food
            uses.'Tobacco is a non-food use;

            (4)    Insects                  ,                   .

                  A honeybee acute contact LD^ study is required if new uses
            will result in honey bee exposure.  Based on the, use  pattern,
            tobacco, it is unlikely mat honeybees will be exposed to butralin,
            therefore, honeybee testing is not required.

            Toxicity to Aquatic Animals

            (1)    Freshwater Fish

                  In order to establish the toxicity of butralin to freshwater
            fish, the minimum data required on the technical grade of the active
            ingredient are two freshwater fish toxicity studies. One study used
            a cold-water species (preferably the rainbow trout), and the other
            used a warm-water species (preferably the bluegill sunfish).
Table 9;  Freshwater Fish Acute Toxicity
Rainbow trout'
         0.37
         160647, Swigert & Bowman/1986
                                                               Highly toxic
                                              Yes
Bluegill Sunfish
96
1.0
160647, Swigert & Bowman/1986
Highly toxic
Yes
                                  The results of the 96-hour acute toxicity studies indicate that
                           butralin is highly toxic to freshwater fish.  It should be noted that
                           the LC50 for bluegill sunfish is at the solubility limit for butralin.
                           The guideline requirements (72-1) are fulfilled.

                           (2)    Freshwater Invertebrates
                                 =•  •     • -j,    •   •.    •    •       • '*     -       • , •  ^
                                  The minimum  testing required to assess the hazard  of
                           butralin  to  freshwater  invertebrates is  a freshwater  aquatic
                           invertebrate  toxicity test, preferably using first iristar Daphnia
                           rnagia or early instar amphipods, stoneflies, mayflies, or midges.
                                           27

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Table 10; Freshwater Invertebrate Toxicity
          *'!,'#
DapJmia magna
98.77
    0.12
42636101, Evers/1992
                                             Highly toxic
                                                        Yes
Daphnia magna
 96
Not determined
159513, Forbis & Frazier/1986
                                             N/A
                                                  No - supplemental
                                 The results indicate butralin is highly toxic to freshwater
                           aquatic invertebrates.  The guideline requirement (GLN 72-2) is
                           fulfilled (MRID 42636101).                      ,

                                 Data from an aquatic invertebrate life-cycle test (GLN 72-4
                           b) is required for butralin because the following criteria have been
                           met:                ..'.'..  "'   '

                           o the product is expected to be transported to surface water from
                           the intended use site;
                           o the acute EC50 is less than 1 mg/L; and,
                         .0 the GENEEC estimated EEC in water is slightly greater than
                           0.01 of the acute ECSO value.

                                 Because aquatic invertebrates appear to be more sensitive to
                          butralin than freshwater fish, chronic testing with invertebrates is
                           required instead of chronic freshwater fish testing.  It should be
                          noted that the Agency does not have acceptable aquatic metabolism
                          data to confirm the persistence of butralin in aquatic environments,
                          and additional data may be required in the future depending on the
                          results of requested batch equilibrium and field dissipation studies.

                           (3)   Estuarine and Marine Animals

                                The  following  table  outlines  , the  acute  RQs  for
                          estuarine/marine organisms:             ,
            Table 11:  Risk Quotients (RQ) for Freshwater Invertebrates
            Tobacco/ 3.0 Ibs a.i./A
            Tobacco/ 3.0 Ibs a.i./A
                   Sheepshead minnow (LC50 > 0.18 mg/L)
                   Mysid (LC50 = 0.069 mg/L)
                                                                            0.09
                                                                             0.2
                                 The acute LOG (0.09) for endangered estuarine/marine fish
                          has been exceeded by a small margin. Also, the acute LOG (0.23)
                          for risk that may be mitigated through .restricted use has been
                          exceeded for estuarine/marine shrimp by a small margin.
                                         28

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                     c.     Toxicity to Plants                                      /

                           (1)    Terrestrial                     7

                                  Most herbicides, including plant growth regulators, require
                           a tier I or tier n data set for terrestrial plant testing, including a
                           seedling emergence and a vegetative vigor study (guideline 123-1
                           a and b).  The registrant has not fulfilled this data requirement and
                           needs to submit seedling emergence and vegetative vigor studies for
                           butralin.

                           (2)    Aquatic

                                  Aquatic plant testing (guideline 123-2) is required for any
                      ,     herbicide,  or plant growth regulator,  which has  outdoor non-
                           residential terrestrial uses that may move off-site of application by
                           runoff or by drift (aerial or irrigation).  The registrant has not
                           fulfilled this requirement  and needs to submit aquatic toxicity
                           testing for the following species:,  Selenastrum  capricdmutum,
                           Lemna gibba, Skeletonemacostatum, Anabaenaflos-toquae,
                           freshwater diatom.,
              2.     Environmental Fate                                            .

                    a.     Environmental Fate Assessment

                                 Laboratory studies1 suggest that the primary routes  of
                           dissipation for butralin are aqueous photolysis and to a lesser extent
                           microbial-mediated degradation and volatilization. Other potential
                           routes of dissipation are soil binding, surface water runoff, and
                           foliar interception/dissipation processes.  ,        '

                            ,     Based .upon available environmental fate data, butralin
                           appears  to be  moderately  persistent to persistent and relatively
                           immobile in terrestrial environments. The importance of the routes
   1 The environmental fate assessment for butralin is based on acceptable as well ^s
supplemental, upgradeable data  Environmental fate data which was found in Agency
reviews from the 1970's are regarded as supplemental, non-upgradeable data and are
referenced as 6PP File Symbol Nos. 2^4-ELNand -EAL and Pesticide Petition Nosf.4F1431
and 2G1285. Although these earlier 1970 studies and reviews contain useful information,
they do not meet current guideline requirements and can not be used in the butralih risk  '
assessment   .•   •- ;   '''-.    ;  '-'  '•      .•   :•  -  . •  ''.';••'• '  ''•-.''   ''.     '   '•

-------
 of dissipation of butralin is unclear at this time because there is a
 lack of consistent and comprehensive data on the contribution of
 individual dissipation routes to the total degradation pathway. The
 Agency  is  requesting that  the  registrant  submit  additional
 environmental fate data to confirm the extent of butralin binding to
 spil/sediment and to assess  rates and routes of dissipation for
 butralin and its degradates under typical use conditions.

       Butralin is stable to abiotic hydrolysis and photodegradation
 on soil (tj/2 = 99.6 days).  In sunlight irradiated water, butralin
 photodegrades with  a half-life  of 13.6 days.    The major
 transformation product (>10%  of applied) is  4-tert-butyl-2,6-
 dinitroaniline (DNTBA),  and  possibly  4-tert-butyl-2-nitro-6-
 nitrosoaniline (DBNNA).  The degradate,  DBNNA, was identified
 as a major photodegradate in an earlier aqueous photodegradation
 study.

       Laboratory  metabolism  studies  show that butralin is
 moderately persistent to persistent (ti/2 = 3 months to 3 years) in
 aerobic mineral soils.  The degradate DNTBA has been identified
 at a maximum of 2 % of the applied at i 2 months posttreatment.  In
 soil  metabolism studies,  volatile  ("Q  residues account  for
 approximately 15% of applied after 12 months.  These studies show
 that >95% of the volatiles are butralin. Earlier degradation studies
 in soil and  water also  show  evidence  of microbial mediated
 degradation of butralin.

       A  half life of 35 days has been observed in  an earlier
 anaerobic soil metabolism study where  the majority of the  14C
 residue was bound to the  soil.   Supplemental non-upgradeable
 aquatic metabolism data suggest that butralin degrades in non-sterile
 water  and binds to the sediment.   The, Agency does not have
 acceptable data to confirm routes and rates of dissipation of butralin
 in aquatic and anaerobic soil environments.

       Soil mobility studies  indicate that butralin is relatively
immobile. In acceptable soil column leaching studies, butralin is
 relatively immobile (0.25% of applied butralin in leachate) in sand,
 sandy loam, loam, and clay soils.  Supplemental, non-upgradeable
 soil TLC/batch equilibrium  studies confirm these results and show
that butralin is relatively immobile.  The Agency estimates a K,,,. of
3,219 ml/g for butralin, using a first order linear regression model
based  on  the  K;W (Lyman, W.J.  1990).  Although there is
uncertainty with this estimate, the high value of the estimated
                30

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along with the soil column leaching studies suggest that butralin has
a  relatively  high binding affinity to  soil.   Additional  batch
equilibrium data are needed to  confirm the estimated K^. for
butralin  and to provide a more accurate quantitative mobility
assessment for risk characterization.           .                t

       Soil  metabolism, studies indicate that volatilization is  a
possible route of dissipation even though butralin has a low vapor
pressure (5.79 x W6 torr) and low Henry's Constant (7,50*10?
atmrrrVmol). As mentioned above, volatilization*of butralin from
soil has  been observed (approximately 15% of applied butralin
during a  12 month study) in a soil metabolism study.

       Several field dissipation studies conducted in Georgia,  North
Garblina, California, and Mississippi indicate that butralin, applied
at 1:5-4.0 lb/A, dissipated with half-lives ranging from 10 to 72
days.  .Only one of these studies is considered supplemental and can
be upgraded to meet current guideline requirements; In the Georgia
turf study, the registrant Calculates a half-life of approximately 73
days in bare ground plots of loamy sand soil and in sandy loam turf
plots. Residues of the butralin  metabolite DNTBA have been
detected only in the 0- to 6-inch soil depth in baregrpund and turf
plots.  Other metabolites have not been analyzed in this study.

       The  registrant  has  conducted  several laboratory fish
bioaccurnulation  studies in microcosms, aquariums, and ponds, all
of which show'that  butralin  bioconcentrates in bluegill sunfish,
channel  catfish,  and crayfish.   In a more recent acceptable
laboratory study, bluegill sunfish bioaccumulated butralin in 39
days of continuous exposure. Bioconcentration factors ranged from
765X, 3410X, and 1870X for edible, non-edible, and whole body
tissues, respectively at  a  nominal butralin concentration of 3.0
pg/L. At 30 /tg/L, butralin bioconcehtfation factors were 734X,
3590X, and 1950X for edible,  non-edible, and whole body tissues,
respectively. Elimination of butralin residues exceeded 50% by 7-
10 days,  and 95 % by 35 days of depuration.

Environmental Fate and Transport

(1)    Degradation

       Abiotic Hydrolysis
                31

-------
        Butralin was stable to abiotic hydrolysis in sterile buffered
 aqueous solutions at pH 4,7 and 9 at 25ฐC (MRID 43669401). The
 data requirement (GLN 161-1) is fulfilled.  No additional data are
 needed at this time.

        Photodegration in Water

        Radiolabeled butralin photodegraded in an aqueous solution
 buffered at pH 7 when irradiated with a filtered xenon sunlamp for
 15 days. The registrant calculated the  half-life of butralin to  be
 13.6 days, while the half-life  of the dark control samples was
 calculated to be 138.2 days.

       The major transformation product was 4-tert-butyl-2,6-
 dinitroaniline (DNTBA), which accounted for 31.8% of the applied
 radiocarbon on day 11 and  23.4% on day 15  in the irradiated
 samples.  In addition, a region of diffuse radioactivity (16%  of
 applied) was observed in the HPLC radiochromatogram which did
 not contain discernible  discrete peaks.  The author of the study
 reported that this diffuse region of radioactivity consisted of highly
 water soluble components displaying acidic and basic properties and
 probably resulted from the rupture of the aromatic ring of the major
 degradate DNTBA with subsequent formation of multiple products
 (MRID 44064901).

      .In   a   supplemental  non-upgradeable   study,  butralin
 photodegraded under natural sunlight and mercury arc vapor lamp
 to form 4^ert-bulyl-2-nitro-6-nitix)soaniline (76%) and several other
 minor photolabile transformation products (e.g., DNTBA) (Ace
 No. 24863).   In another  supplemental non-upgradeable  study,
•butralin degraded with a half-life of 7.7 days in irradiated buffer
 solution (pH 7).  This  study was unacceptable because the  dark
 cdntrol  also  showed  degradation (26%   in 30 days)  (MRID
 42620701).  In this study,  major degradates were identified as  4-
 tert-butyl-2,6-dinitroaniline (17.4% of applied at 30 days) and  3-
 nitro-l,2-phenylenediamine (19.3% of applied at 30 days).  These
 degradates  were detected in both irradiated and dark control
 treatments.  Additional open literature data indicate that nitroaniline
 compounds  may  be  intermediate  photoprodiicts  from the
 photodegradation of dinitroaniline compounds (Harris, J. 1990).

       The data  requirement  (GLN   161-2)  is  not fulfilled.
 However, the most recent  photolysis study (MRID 44064901) is
 considered supplemental and can be upgraded after the registrant
                32

-------
 provides a complete explanation of the differences in metabolites
 identified among the different aqueous photolysis studies.

 (2)    Mobility
   i    ,       7            ,      ...     •     ',.••      /  , .

       Pihotodegradation on Soil
- . " :      "   r      . -,   • • ""       '            ' *     ''.',,  '?•••••

       Radiolabeled butraliri, at 374 /ag/g, phbtodegraded slowly on
 sandy loam soil irradiated with natural sunlight for 30 days. Using
 linear regression, the registrant calculated the half-Jife-to be 99.6
 days. Butralin also degraded slowly (t1/2 =  112.7 days) in the daik
 control.  At 30 days posttreatment, butralin was 76.7-80.4% of the
 applied in the irradiated soil, and .78.2-81.4% of the applied !in the
 dark controls.   During the experiment, DNTBA and nine other
 unidentified transformation products were detected (all <2.3 of the
 applied) in the irradiated soil and dark controls (MRID 42496201).

       A supplemental non-upgradeable study, which assessed the
 photodecomposition of butralin applied to soil TLC plates  and
 irradiated with natural, sunlight,  showed that 91% of parent
 compound remained after  7 days (MRID 50500010).

       This data requirement (GLN 161-3) is not required for non-
 food terrestrial uses.

       Photolysis in Air

       The data requirement  (GLN 161-4) was waived because it
 is not requited to support terrestrial ^non-food uses.   Potential
 volatilization of butralin into air is expected to below because of
 butralin's low vapor pressure (5.79 x 10"6 Torr) and low Henry's
 Constant (7.50 * 10"6 arm. rrf/rnol) the Agency's Pesticide One-
 Liner Database (EFGWB).  The Agency notes, however, that
 volatilization of butralin from soil was observed (15% of applied
 butralin  during.a 12 month  study) in a  soil metabolism study
 (MRID 43201901):
      ' •    • ,           '..''••'>      .  '      "'        ' ' '  '
      ' Aerobic Soil Metabolism                             ;

       Radiolabeled  butralin,   at  3.9  |&g/g,  was persistent'
 (extrapolated half-life of 1126 days or approximately 3 years) in
 sandy loam soil incubated ,in the dark at 25 ฐC and 75% field!
moisture  capacity. Radiolabeled butralin was 95.9 - 96.4% of the
                33

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applied immediately ppsttreatment, and decreased to 71.6 - 73.1 %
at 12 months.

       The degradate,  4-tert-butyl-2,6-dinitroaniline (DNTBA),
was identified at a maximum of 1.9 - 2.2% of the applied at 12
months posttreatment.   Various other, degradates, which were
present at 
-------
 products of butralin were a dealkylated metabolite (1 % of applied)
 and unidentified polar metabolites (12% of applied).        ,    -

        The data requirement (GLN 162-2) is not fulfilled; however,
 it is not required for terrestrial non-food uses.

        Aquatic Metabolism

        Aquatic metabolism data were taken from supplemental non-
 upgrideable studies/on butralin degradation in non-sterile water,
 accumulation  in artificial aquatic  ecosystems,  and field runoff
 studies (MRID 42069703, OPP File Nos. 264-ELN and -EAL and
 PP#4F1431 and 2G1285).  The Agency reviewed revipus agency
 reviews for pertinent data relating to the fate of butralin in aquatic
 environments1. These aquatic metabolism studies provide limited
 information regarding the fate of butralin in aquatic environments
 and cannot be used as supporting data for a risk assessment.
   , j  , •    , \ '          " •       ' ' •      " - ':' ,   ' - , "   ••  ' • _ '
        In laboratory studies, butralin in non-sterile water degraded
 to form four polar metabolites:  2,3 diaminonitrobenzene, 4-tert-
 butyl-2,6-dinitroacetanilide,  N-isopropyi-2-amuio-4-tert-butyl-6-
 nitroaniline, and N-emyl-2-nitroso-4-tertiaiy-butyl-6-nitroanilirie
 (OPP File No; 264-ELN). ".-

        In  artificial  aquatic ecosystems;  radiolabeled  butralin,
 applied at 2 Ibs a.i/A in flooded sediment/test; water, was detected
 at maximum sediment concentration of 23 to 25.50 mg/kg at 7 and
 10 days posttreatment and then declined to 4.80 to 6.85 mg/kg at
 35 days posttreatment.  Butralin water concentrations ranged from
 0.14 mg/L to 0.81 mg/L (MRID 42069703).  In another artificial
 aquatic  ecosystem study, bluegill  sunfish, channel catfish and
 crayfish were  exposed to radiolabeled butralin, applied at 3 Ibs
 a.i./A for 35 days in a static pool.  The sediment in the pool was
 .treated with radiolabeled butralin and then aged aerobically for 27
 days before flooding. Butralin residues in the water ranged from
 0.02 (ftg/ml to a maximum of 0.06 /^g/ml  ppm  on day 35 of
. exposure.    In the soil, total  14C-residues  were 13.73  /tg/g
 immediately posttreatment, 10.25 /^g/g at 30 days ,and ranged from
 8.66 - 9.80 /ig/g during the animal exposure period (MRID
 42069704).

       Runoff studies in Pennsylvania and Mississippi on sites with
 3 to 6% slopes showed that butralin, at 3 Ibs a,i./A, was detected
 in adjoining  farm  pond  water and sediment  at  .maximum
                35

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concentrations  of  <2  /ng/ml  and  <30  /*g/g,  respectively
(PP#4F1431).

       Guidelines 162-3 and 162-4 are not required for terrestrial
non-food uses.                         ;

       Soil Column LeachingNBatch Equilibrium

     ,  Radiojabeled  butralin, at 0.197 ug/g,  was  relatively
immobile in 30-cm columns of sand, sandy loam, loam, and clay
soil eluted with 20 inches of 0.01 M calcium chloride  solution.
Trace quantities (0.14-0.25% of applied) of radiolabeled material
in the leachates were not  identified.  In  all soil columns, the
radiolabeled material was predominantly detected (>81.86% of
applied) in the 0-6 cm soil layer. The major compound detected in
the 0-6 cm soil layer was parent butralin.  The degradate 4-tert-
butyl-2,6-dinitroaniline, and two unidentified 14C compounds were
each j<3.8% of applied (MRID 42842301).

       Supplemental, non-upgradeable TLC studies  showed that
butralin and its metabolites (DNBTA and 2,6-dinitroaniline) were
immobile (Helling-Tumer mobility classification of 1)  on sand, silt
loam, and muck soil plates. (OPPFileNo. 264-EAL).
                                      i
       In a supplemental, non-upgradeable batch equilibrium study,
adsorption coefficients  (Kd's) of 2, 6.5, and 90 ml/g for butralin
were measured in  sand, sandy loam, and clay soil, respectively.
These values could not be used to calculate KO,. values because the
soil organic matter content was not reported (MRID 35622).

       The data requirement for an imaged mobility  study (GLN
163-1) is satisfied (MRID 42842301). At this time, the Agency is
not requiring an aged mobility study. The Agency is, however,
requesting  additional   batch  equilibrium data to  confirm the
estimated K^ for butralin.  The Agency estimated a  1^.  value of
3,219 ml/g using a Kow which was based upon an ^invalidated first
order regression analysis (Lyman, W.J. 1990).

       Volatility

       The data requirement (GLN 161-4) was waived because it
is not required for terrestrial non-food uses. Potential volatilization
of butralin into air  is expected to be low because of butralin1 s low
vapor pressure (5.79 x 10* Torr) and low Henry's Constant (7.50
               36

-------
 * 10* atm.m3/mol). The Agency notes, however, that volatilization
 of butralin from soil was observed (approximately 15%; of applied
 butralin during a  12 month study) in a soil metabolism study
 (MRID 43201901).
       i              '._%••"         _     •    '    ...  '

   1  ;  Bioaccumulation in Fish        .;  •....•

       Radiolabeled  butralin bioconcentrated in bluegill sunfish
 which were continuously exposed to nominal butralin concentrations
 of 3.0 and 30 jtig/Lfor 39 days. For bluegiE exposed to a nominal
 butralin concentration of 3.0 jtg/L, bioconcentration factors (BCF)
 of 765X, 3410X and 1870X were calculated for edible, non-edible,
 and whole body tissues, respectively.  Elimination of accumulated
 butralin residues exceeded 50% by day 10  and was greater than
 95%byday35.

       For bluegill exposed to a nominal butralin concentration of
 30 /tg/L, BCFs of 734X, 3590X, and 1950X were calculated for
 edible,  non-edible,   and   whole  body  tissues,  respectively.
 Elimination of 14C-residues exceeded 50% by day 7 and was greater
 than 95%  by day 35 of depuration. After 39 days of exposure to
 30 ptg/L, radiokbeled butralin was detected in both viscera (82.2%
 of TRR) and edible tissues (81.9% of TRR) of bluegill along with
 several minor metabolites.  The study authors concluded that the
 glutathione  pathway  was used in the metabolism of butralin by
 bluegm sunfish (MRID 4408.1601).

       Supplemental, non-upgradeable flow-through accumulation
 Studies at 0.01 and 0.75 mg/L of butralin showed that radiolabeled
 butralin bioaccumulated in edible  portions  of bluegill  (2200 to
 4260X) and in non-edible portions (32,000 to  33,OOOX).  Ninety to
 ninety-nine percent of the residues were eliminated after 7-35  days
 of depuration. Butralin was the only compound identified in the
 edible tissues. At the higher concentration of 0.75 mg/L of butralin,
 mortality  was  observed after 19 days. of exposure  (MRIDs
 42069702  and 42069705).

       Supplemental, non-upgradeable static accumulation studies,
 at application rates of 2-3 Ibs a.i./A in soil and water, showed that
 radiolabeled butralin bioaccumulated in edible portions of bluegill
 (123 to 473X), channel catfish (115 to 1250X), and crayfish (5 .to
 10X).  Biocdncentratioh factors found in non-edible portions'Of
bluegill ranged between 1561 to 7000X, and in channel catfish  they
ranged from 1000 to 2682X. Residues were eliminated to 
-------
of the highest level in bluegill and catfish  after 7-35 days of
depuration.   Butralin was the only compound identified in fish
tissues (MRIDs 42069703 and 42069704).
                                      ,>.

       Field  runoff-accumulation  studies in  Pennsylvania and
Mississippi showed that butralin, at 3 Ibs a.i./A, bioaccumulated to
150 - 1200X in edible portions of bluegill and catfish, respectively.
Bioconcentration  factors in  non-edible portions of bluegill was
1000X and in channel catfish was 75QOX. Maximum concentrations
in the .water and sediment were 2 /*g/L and 30 us/kg, respectively
(PP#4F1431).

       The  data  requirement (GLN 165-4)  is  fulfilled.   No
additional data are needed at this time.

(3)     Field Dissipation

       Terrestrial Field Dissipation

       Several field dissipation studies conducted in Georgia, North
Carolina, California, and Mississippi indicated that butralin, at 1.5-
4.0 Ib/A dissipated with half-lives ranging from 10-72 days.  None
of these studies met guideline requirements for the reasons  listed
below.  The most recent field studies were conducted in tobacco
and bare ground in North Carolina and in turf and bare ground in
Georgia.  The North Carolina study was not acceptable because of
low  and highly variable recoveries in the frozen storage stability
analysis.  In addition, the application rate of butralin could not be
confirmed, the pattern of decline of butralin in soils planted to
tobacco was not established, the concentration data on butralin and
the metabolite DNTBA in tobacco plants were not submitted, and
only one metabolite was identified.

       The  Georgia  study  with turf provided supplemental
information,  but could  not be used to  fulfill the  guideline
requirement.  If someone decides to register the turf use, then
additional data will need to be submitted concerning the application
rate of butralin, storage stability data for butralin beyond 651 days
and  for the  metabolite bNTTBA, and the identification  of all
metabolites at concentrations above 10% of applied.

       The Georgia turf study showed that butralin dissipated in
Norfolk loamy sand and sandy loam soils with registrant calculated
half-lives of  approximately 73 days in bare ground plots and in,
                38

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c.
 plots with previously established turf.  However, the actual half-
 lives may be much shorter than the calculated half-lives because
 butralin residues  decreased to less than half of the  nominal,
 concentrations by 15 days posttreatment (DPT).  Residues of the
 metabolite DNTBA were detected only in the 0- to 6-inch soil depth
, in bare ground and turf plots. Maximum DNTBAJevels were 0.04
 /ig/g in bare ground plots at 18 months post-treatment (MPT) and
 0.12 /ig/g in turf plots at 5 MPT.  The soil and turf were not
.analyzed   .for   other    metabolites,    such   as   3-nitro-l,2-
 phenylenediamine, 2,6-dinitroaniline,  3-(4-tert-bUtylanilin6-2i6-
 dinitro)-2-butanol (MRIDs 42069701, 43749801, 43764001).

        Supplemental, non-upgradeable field studies in California
 and Mississippi were conducted on soils'planted with crops  and
 treated with butralin at 1.5-4.0 lb/A.  In these studies, the reported
 half-lives of butralin ranged from 42 to 72 days.  Metabolites were
 not identified in thesb studies (PP#2G1285).

       The terrestrial field dissipation data requirement (164-1)/is
 not fulfilled at this time.

 (4)   Spray Drift

       The  Droptlet Size Spectrum  (201-1)  and Drift  Field
 Evaluation (202-1) data requirements do not apply for butralin
 because it is not applied aerially.

 Water Resources

 (1)   Ground Water      <:••

       The Agency evaluates the persistence and mobility of each
 pesticide for ground water concerns. If data indicate that the parent
 and/or degradates  are persistent and mobile, then a small-scale
 prospective ground water study  may  be required.   The basic.
 triggering criteria include:  weight of the evidence from laboratory
 and  field dissipation studies  indicating  that die pesticide has
 properties and characteristics similar to pesticides that are known to
 leach or have been detected in ground water; movement of the
 parent or degradates 75-90 centimeters through the soil profile or
 plow layer in  a field dissipation  study; reports of detections in
 ground water from other monitoring studies and information about
toxicity.   In addition, use patterns, application rates, timing of
 application, potential acreage treated, depth to ground water, soil
                      39

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                           types, hydraulic gradient, and climate are also evaluated as part of
                           the triggering criteria. Persistence, mobility, detections in ground
                           water and tpxicity are also used to evaluate a chemical to determine
                           whether its  use should be  restricted.    A compound may be
                           recommended for Restricted Use if it exceeds these criteria.

                           Persistence and Mobility

                                  Butralin  was evaluated for persistence and  mobility in
                           relation to its potential to leach to  ground water.  Below is a
                           summary of that evaluation.

 Table 12:  Physical and Chemical Characteristics of Butralin Relative to Mobility and
            Persistence Criteria
Crftcrloa
Persistence
Mobility
Xi €3ma6*&&ซ*'^ ' \ > , ,
Field dissipation half-life
Lab-derived aerobic soil metabolism half-
life
Hydrolysis half-life
Photolysis half-life (soil)
Soil adsorption: K^
Soil adsorption: K,,.
Depth of leaching in field dissipation study
ฎ)tmp&f W&tet (Mferia
> 3 weeks or
> 3 weeks or
< 10% in 30 days or
< 10% in 30 days and
^ 5 ml/g or
z 500 ml/g or
75 cm
" ซ^''?l&kta8a"'"
1 ,43 to 1&5 wfeifia- 72,6 ซ0
- ' ' ',\' '<. ~* ''? "'-ฃ„ / " - - <
- r -, ;;s wฃg;i& rj&aป ', ; '-.^ v
?'l " ;;stawf ; j^f^^/* ': j
19.6-23.3 % in 30 days
^7;?^^^^xrH,a:
3,219 ml/g** (est. by EPA)
15.2cm (6")
    Shaded ceils in cofoma indicates i
* (^lalitative data from soil column leaching studies show that butralin is relatively immobile.
** The K^. was estimated from a first order regression analysis using the K,,,, for butralin.

                           Ground Water Detections               •

                           EPA's "Pesticides in Ground Water Database"  (Hoheisel et al.,
                    1992) does not report any sampling for butralin in the U.S. A search of
                    the Agency records found no other sampling for butralin in ground water.
             •' . •  .    	•    ,    •  ."••    :    '•'" , '•'•     ' •' .;i ' '',".,,'./'
                           Butralin is currentiy not regulated under the Safe Drinking Water
                    Act  (SDWA).   The  Agency's Office of Water  has not established a
                    Maximum Contaminant Level (MCL) or Lifetime Health Advisory Level
                    (HAL) for butralin in drinking water.

                           Ground Water Leaching Index Evaluation.
                                          40

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                           A numerical scale or index was used tot assess the leaching potential
                    according, to environmental  fate properties, soil properties, and soil
                    hydrology.  It can be used to compare the relative mobility of different
                    pesticides under the same environmental conditions.  A Leaching Index
                    (LI) was developed by the Agency to divide the pesticide mobility index
                    into three discrete classes:  low (1), moderate (2), and high (3) potential to
                    leach to ground water.
              ,-   i .f ,  ', '  _   _       '  -\  '    • .' '  '  • , t. . ..     '     '.''-,•'"    '    •'•
                           The Agency used this method to calculate an attenuation factor (AF)
                    for butralin in five different Major, Land Resource Areas - (MLRA's). using
                    the soil metabolism half-life of 150 days and estimated K^. of 3,219 ml/g.
                    Below are the calculated retardation and .attenuation factors for butralin:

             Table  13;  Retardation and Attenuation Factor
I xv-kv,,.,', 'MLRA*^";/^'
108
129
133a
139 ,
142
l&taBMtm Pas&ar <&!# ':'„• "' " i
2053.09
. , • 1566.00 . I
.-••". 2140.19 •'•••
' 3248.25
.3184.45
j&feM&M re3erซ*ป' T -',"<•
0
0
'•" "•' T o
0
"• ':'•',• ' o •''-•' "• -
                          The Agency compared the calculated attenuation factors of butralih
                    to those calculated for a number:of well-known herbicides used inMLRA
             • •'•  ;  108.'     ;• .          .   "   •  /'- ;  ,   -v  .'   '   '.'.-.•:  .'  t  '  '.  :  •

Table 14: Comparison of Attenuation Factors (AF) for Various Pesticides
f*ซ^.?..jf'
chlorpyrifos
butralin
alachlor
bentazon •
atrazine
terbacil
tebutbiuron
;TV'**"-&;I
0.000000
"0"
0.000000
, 0.000110
0.002165
0.44222
0.93648
^*'/,
. -.1 ' ,
, 1
:2
'3
' 3,;-.
3
3
r^^i wf^^^&Ms^^^^.^rf^^^^ .'*si
Low Risk, may get to ground water in only a small number of wells
Moderate Risk, will probably get to ground water in a number of
wells '-•".' \ :'•'.-, !. •• - •
High Risk, will probably reach ground water in a high number of
wells - : . '\ ;.•-•' ' -'••..' ./' " . • -': - •
                          Compared to other pesticides, butralin has a rating of "1 "indicating
                    "low risk, butralin may get to ground water hi only a small number of
                    wells." From this evaluation, the Agency concluded that butralin ranks
                    very low in its potential to leach to ground water and can essentially be
                    considered a "non-leacher," This assessment is based on an estima.ted
                                         41

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                    value for butralin. Additional batch equilibrium data are needed to confirm
                    the leaching potential of butralin.

                    Tobacco Production                                         ,
                     " '  ,   ! '     '    '  " ',          ' '   !l .    .    . '
                           Tobacco production acreage is large, however unlike  the large
                    mono-culture crops, it is usually grown in small (less than 1-10 acres),
                    plots  widely dispersed  over large geographic areas (U.S.  Dept.  of
                    Commerce, 1992). Much of the use of butralin is expected to be on flue-
                    cured and air-cured tobacco which is grown in the Southeastern  U.S., the
                    Mid-Atlantic States, and the mid-southern States2.  There will be some use
                    on  Maryland dark type tobacco which is grown in parts of central  and
                    southern Maryland and southern Pennsylvania.

                           The effect of butralin to the environment would be limited to these
                    tobacco use areas.  In addition, this type of use on many small plots
                    distributed over many states, would reduce any potential impact to ground
                    water. The Agency does not anticipate any impact to ground water from
                    butralin use on turf since this use is no longer registered.

                    Ground Water Conclusions                 ป.

                           Butralin  is  persistent  but .relatively immobile  in terrestrial
                    environments. Based upon qualitative leaching index and mobility studies,
                    butralin is not  expected to leach into ground water. Additional batch
                    equilibrium data are needed to confirm the soil binding affinity of butralin.
                    The Agency concludes that use of butralin on tobacco should have minimal
                    impact on ground water.

                           (2)    Surface Water
                             /       "      ,   	  '',',,'     >,           .       ; '
                                 The current surface water assessment for butralin is  an
                           adequate qualitative characterization of the  runoff potential  for
                           butralin.  A more reliable surface water exposure characterization,
                           which is based on PRZM, cannot be adequately determined until the
                           Agency receives additional batch equilibrium data.
   2 The major tobacco growing regions correspond to the following major land resource
areas (MRLA): Southern Coastal Plains (MRLA 133), Southern Piedmont (MRLA 136),
Carolina/Georgia Sand Hills (MRLA 137), western edge of the Atlantic Coast Flat Woods
(MRLA 153); Kentucky and Indiana Sandstone and Shale Hills and Valley (MRLA 120);
Kentucky Bluegrass (MRLA 121), and Highland Rim and Pennroyal (MRLA 122) (Austin
1972).

                              '  . ' /      42

-------
       The potential for surface water runoff of butralin is expected
 to   be  dependent  on  the  cumulative  impacts  of  foliar
 interception/dissipation, binding  on soil/sediment;,  degradation
 processes, and site hydrology.  Since the current label for butralin
 (TAMEX-3EC) recommends foliar spray application onto the leaf
 axial, stalk, and crown of flue-cured and air-cured tobacco, the
 Agency believes foliar interception and subsequent foliar dissipation
 processes will affect the magnitude of butralin residues available for
 surface water runoff. The potential effect of foliar interception may
 be gauged from unacceptable field dissipation studies on tobacco in
 which 87% of applied butralin was intercepted by tobacco plants
 (MRID 43749801). Environmental fate data suggest that direct
 photolysis  will contribute to foliar dissipation of butralin.  The
 impact of foliar interception  and subsequent foliar,dissipation
 processes oh potential butralin loading into surface waters cannot be
 fully assessed without data on rates and routes of foliar interception
 and dissipation of butralin and its transformation products. Butralin
 residues that are over-sprayed or washed-off from the treated plants
 are expected to  be  the only butralin residues available for runoff
 into surface waters,

       Environmental fate studies indicate that butralin is relatively
 immobile and moderately persistent in mineral soils.  In terrestrial
 environments, the main routes of butralin dissipation appear to be
 dependent on microbiat-mediated degradation (tin— 3 months to 3
 years) and soil binding (1^=3219 ml/g). Acceptable soil column
 leaching studies and supplemental  batch  equilibrium/soil TLG
 studies indicate'butralin should be relatively immobile in terrestrial
 and aquatic environments (Accession No. 35622;  MRID 42842301;
 OPP File No. 264-EAL); These data indicate that butralin will be
 bound on entrained sediments in surface water runoff. However,
 the soil binding affinity of butralin cannot be adequately evaluated
 until the Agency receives confirmatory batch  equilibrium data.

       The major  tobacco growing regions  are, classified  as
 predominantly upland soils GJdalfs or Udults) and alluvial soils
 (Fluvents)2. These are somewhat freely-drained soils (Soil Survey
 Staff, 1975).  Soils with regional importance are the Psamments in
 MRLA 137 and poorly drained soils (Aquents, Aquepts, Aquults)
in MRLA  153.  Psamments (sandy soils)  are expected  be  of
minimal importance for surface water runoff because of their high
water permeability.  Although poorly drained  soils, as noted in
MRLA 153, would be expected to be tile drained for tobacco
production, they may serve as d groundwater  recharge areas from
                43

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 surface water. These soils are predominately limited to the Atlantic
 Coast Flat Woods region (MRLA 153).
                         1 •••        (        •    '

        Based on laboratory aerobic soil metabolism studies and the
 relatively high estimated K,,,., butralin is expected to be persistent
 and to bind on suspended and bottom sediments in surface waters.
 Dissolved butralin in the water column should be  susceptible to
 direct photolysis which is dependent on the clarity  and depth of the
 surface water body. Direct aqueous photolysis of butralin is more
 likely in shallow, clear water bodies with long hydrologic residence
 times (MRID 44064901).  Currently, there are no acceptable data
 to confirm the fate of butralin in aquatic environments.

        Butralin detections in surface water were not reported in
 STORET. Runoff studies in Pennsylvania and Mississippi on sites
 3 to  6%  slopes indicate butralin,  at 3 Ibs a.i./A,  was detected in
 adjoining farm  pond  water  and  sediment  at  a  maximum
 concentration of 2 /tg/L and 30 jtg/kg, respectively (PP#4F1431).
 Based on the Tier 1 GENEEC EEC, the peak EEC for butralin is
 16.89 jBg/L.  No maximum contaminant level (MCL) or Lifetime
 Health Advisory Level (HAL) has been established for butralin.

       Expected Aquatic Concentrations:  Butralin displays high
 toxicily to most aquatic organisms tested  to date.   The Agency
 calculated generic EECs for butralin application to tobacco (3.00
 Ibs a.i./A).  These EECs  are designed as a coarse screen and
 estimate  expected concentrations from a few  basic chemical
 parameters and pesticide label application information.  GENEEC
 is a tier one model which  uses a chemical's soil/water partition
, coefficient and degradation half-life values to estimate runoff from
 a ten hectare field into a one hectare by two meter deep pond.

       GENEEC calculates both acute and chronic generic expected
 environmental concentration (GEEC) values. It considers reduction
 in dissolved pesticide concentration due to  adsorption of pesticide
 to soil or sedjment, incorporation, degradation in soil before wash
 off to a water body, direct deposition of spray drift into the water
 body, and degradation of the pesticide within the water body. It is
 designed to mimic a PRZM-EXAMS simulation.

       The following environmental fate parameters were used to
 calculate the generic EECs:
                44

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  Table IS; Environmental Fate Parameters
>'&&&ฅ!<" ฃฃ'',:*?'„'ฃ*? ?~
Solubility in water
Aerobic soil half-life i
Aerobic aquatic half-life data2
Aqueous photolysis
Hydrolysis half-life ; ; ,
v ' ' • ' • '••'>
^H**; '
0.3 ppm
stable1^
stable
13.6 days
stable
3,219 mi/g
:*afa#s?f<*^*%, *,,',
EFGWB One-liner
MRID 432019-01
no data
MRID 440649-01
MRID 436694-01
Regression Equation:
*//jft*. ^"^^.rf, *;*ป^



"..'-'. • . ' . .

3 logK^^O.937 x log(Kow>0.006
 1 The aerobic soil half-life is >365 days.
 2 No data,are available to assess the degradation rate of butralin in aerobic aquatic environments. Therefore, butralin
 is assumed to be persistent (or stable) to aerobic aquatic metebolism.
 3LymanW.J.1990.                     :  ;                                  .        .       :

                            The following table outlines  the Generic  EEGs which were
                      calculated for butralin application to tobacco:
Table 16:  Generic Estimated Environmental Concentrations (GEEC) For Butralin
Tobacco
Broadcast - ground
3.00(1)
                                              16.89
15.69
11.15
                                                                             7.70
               3.     Exposure and Risk Characterization

                     a.     Ecological Exposure and Risk Characterization

                            Explanation of the Risk Quotient (RQ) and the Level of Concern
                     (LOC): The Levels of Concern are criteria used to indicate potential risk
                     to nontarget organisms.  The criteria indicate that a chemical, when used
                     as directed, has the potential  to  cause undesirable effects on nontarget
                     organisms.  There are two general categories of LOG (acute and chronic)
                     for each of the four nontarget fauna! groups and one category (acute) for
                     each of two nontarget floral groups.  In order to determine if an LOG has
                     been exceeded, a risk  quotient must be  derived and compared to the
               _,      LOC's. A  risk quotient  is calculated by dividing an appropriate exposure
                     estimate, e.g! tfie estimated environmental concentration (EEC), by an
                     appropriate toxicity test effect level, e.g. the LCS0.  The acute effect levels
                   ,  typically are:           ^
                                  (terrestrial plants),
                            -EC50 (aquatic .plants and invertebrates),
                            -LC50 (fish and birds), and
                            -LD50,(birds and mammals)
                                           45

-------
                   The chronic test results are the:

                         -NOEL (sometimes referred to as the NOEQ for avian  and
                         mammal reproduction studies, and either the NOEL for chronic
                         aquatic studies, or the Maximum Allowable Toxicant Concentration
                         (MATQ which is the geometric mean of the NOEL and the LOEL
                         (sometimes referred to as the LOEC) for chronic aquatic studies.

                   When the risk quotient exceeds the LOG for a particular category, risk to
            that particular category is presumed to exist.  Risk presumptions are presented
            along with the corresponding LOG' s.

Table 17; Levels of Concern (LOG) and Associated Risk Presumption
ss:::1 :? ',; ',,

acute RQ>
acute RQ>
acute RQ>
chronic RQ>

W*We 	 ""'' ' "
acute RQ>
acute RQ>
acute RQ>
chronic RQ>

Ifflto' "" 	 , "- ^
RQ>
RQ>
,;--UDC '

0.5
0.2
0.1
1

" LOC >
0.5
0.1
0.05
1

IQ&s*-
1
1
Pซs8ปtpซioa' - ',f/"/f' ' ' ' -',,;/^//M>
Mammals, Birds
High acute risk.
Risk that may be mitigated through restricted use.
Endangered species may be affected acutely.
Chronic risk, endangered species may be affected chronically.
Fish, Aquatic invertebrates
PfeSUltlptjCtt ^ s/Sf,ff' ;,'"', '; , ,„'''", '„'',''' f'
High acute risk.
Risk that may be mitigated through restricted use.
Endangered species may be affected acutely.
Chronic risk, endangered species may be affected chronically.
Plants
t^s&ftisj,< "*'* " * - ' ' , ซ* *> „,;, ,,ป~ '?-' "7" - " '- "i
High risk.
Endangered plants may be affected.
                         Currently, no separate criteria for restricted use or chronic effects
                  for plants exist.

                  Butralin use patterns addressed in this assessment: Butralin is registered
            on flue-cured and air-cured at a use rate of 3.0 Ibs a.i./A. For the purposes of this
            assessment, all types of tobacco will be referred to as "tobacco." This assessment
            is based primarily on the predominant method of application, boom application to
            foliage (one application per season). The label also includes individual manual
            application methods  using a  handheld dropline, knapsack sprayer or jug
            application.
                                        46

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                           (1)    Exposure and Risk to Nontarget Terrestrial Animals

                    V--         (a)    Birds

                                 Butralin residues foundon dietary food items following
                           application are compared to LCSO values to predict hazard.  The
                           maximum concentrations of butralin residues which may occur on
                           selected avian dietary food items following a. single application of
                           3.0 Ibs a.i./A, the maximum application rate for tobacco, and the
                           corresponding acute risk quotients are provided in the table below:

               Table IS: Estimated Environmental Concentrations on Avian  Dietary
               Food Items in PPM and Corresponding Risk Quotients
\^^^^^/^\''':^'^l''\
Short Grasses
Long Grasses
Broadleaf Plants and Insects , ,
Fruits and pods :

720
330
405
45
!, *?^" frfaXQ'*- -f~^
<0.07
<0.033
<0.041
<0.005
                                 The LOCs have not been exceeded for acute avian risk.
                           Therefor?, avian species are not likely to be acutely affected by the
                           use of butralin.  Data from supplemental studies, showing a NOEL
                           of 4 ppm, indicate the potential for high chronic risk.

                                 (b)   Mammals

                                 Small mammal exposure is addressed using acute oral LDSO
                           values converted to estimate an LC50 value for dietary exposure.
                           The estimated LC5Q is derived using the following formula:
                      ,           LCSO = LDso xbody weight (g)
                                 food cons, per day (g)

Table 19:  Small Mammal Food Consumption in PPMs  (Based on an LD^ = 1049
           mg/kg MRID 42112701)
Small Mammal
f *  . '''''', ••*  ;
Meadow vole
46 g
61 %
                                                                         1,717 ppm
Adult field mouse
13 g
16%
                                                       2.1 g
                                      6,493 ppm
Least shrew
 5g
                                  110%
                    5.5 g,
                                                                          953 ppm
The above table is based on information contained in Principles of Mammology by D. E, Davis and F. Golly, published
by Reinhold Corporation, 1963.
                                 The estimated LC56is tien compared to the EEC 'values
                          Hsted above to calculate a risk quotient. The table below indicates
                          the mammalian dietary risk quotients.                   ,
                                          47

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        Table 20:  Mammalian Dietary Acute Risk Quotients
feXK&MM'S * A, f $?•} '*'$ f s, . ,
xjySiซall Mairimai{ ^ ' ' „,, „
Meadow vole (short grasses)
Adult field mouse (seeds)
Least shrew (insects)
'/<ซ*",ป,,<;,,;,?,,„„„ ff ifeSj^ ซ,ฃbv^/^\
0.4
; 0.06
0.4
                        The acute LOG for endangered species has been exceeded
                 by four times the recommended LOG for the meadow vole and the
                 least shrew. Therefore, the use of butralin on tobacco at this use
                 rate may cause adverse effects to herbivorous and  insectivorous
                 endangered mammals.  Although the LOG for restricted use
                 mitigation  has  been slightly  exceeded, the  Agency is not
                 recommending restricted use classification at this time.  The actual
                 exposure to small mammals is expected to be reduced because of
                 the directed method of application to the tobacco plant.

                        Chronic risk to mammals cannot be assessed at this time
                 because chronic mammalian data are not available.

                        (c)    Insects

                        Honeybees are not likely to be exposed to butralin and are
                 not likely to be adversely affected by its use (Vaughan, A. 1983).

                 (2)     Exposure and Risk to Nontarget Aquatic Animals

                        (a)    Freshwater Fish

                        The following table outlines the acute RQs for freshwater
                 fish based on EECs calculated in the GENEEC model.
Table 21: Risk Quotients (RQ) for Freshwater Fish

Tobacco/3
catioa iste^ ^ , ,-
.0 Ibs a.i./A
Speaks ป ''. ' , ' '',"•'
*• t r f f t* f f
Rainbow trout LC^
Bluegill Sunfish LC.
= 0.37 mg/L
,0 = 1.0 mg/L

0.046
0.02
                              The acute LOCs for freshwater fish have not been
                       exceeded.
                                48

-------
                   (b)    Freshwater Invertebrates
                          The following  table outlines the  acute RQs  for
      •-,.          aquatic invertebrates.

Table 22:  Risk Quotients (RQ) for Freshwater Invertebrates
                                                                  •~''} s>
                                                                  "•<  f.
Tobacco/3.0 Ibs a.i./A    Deqthnia magna ECy, = 0.12 mg/L
                                   0,14
                          the acute LOG for restricted use (LOC?= 0.1) for
                   freshwater invertebrates has been slightly exceeded.

   .                       Chronic toxicily to freshwater invertebrates cannot
                   be assessed at this time.     '•'-'.'

                   (c)     Estuarine and Marine Animals

                    ;      The following  table outlines the acute RQs  for
                   estuarine/marine organisms:

 Table 23;   Risk Quotients (RQ) for Freshwater Invertebrates
Tobacco/ 3.^0 Ibs a.i./A
Sheepshead minnow (LC50 > 0.18 mg/L)
                                                               0.09
Tobacco/ 3.0 Ibs a.i./A
Mysid (LC50 = 0.069 mg/L)
                                                               0.2
                   The acute LOG (O.Qi?) for endangered estuarine/marine fish
            has been exceeded by a small margin.  Also, the acute LOG (0.23)
            for risk that may  be mitigated through restricted use has  been
            exceeded for estuarine/inarine shrimp by a small margin.

            (3)    Exposure and Risk to Nontarget Plants

                   The Agency does not have adequate data to assess the risk
            of butralin to npntargel plants.  The Agency is requiring that the
            registrant submit nontarget plant data.,

            (4)    Endangered Species

                  -The  following endangered species LOCs have  been
            exceeded:  herbivorous and insectivorous endangered mammals and
            freshwater aquatic invertebrates,  and estuarine/marine fish and
            shrimp. Also, there may be possible reproductive effects to birds.

            '  •  .   -^     •  49 ' '"'•'•'    ''' -'   , ,  :     ,:    :    •  :  ' •

-------
             Acute risk to endangered plant species cannot be determined
       due to insufficient data.

             The Endangered Species Protection Program is expected to
       be finalized in the near future.  Limitations in the use of butralin
       may be required to protect endangered and threatened species, but
       these limitations have not been defined yet, and they  may be
       formulation specific. EPA anticipates that a 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 will
       most likely consist of the generic lat>el statement referring pesticide
       users to use limitations contained in county bulletins.
                "''',ซ.               '.','"',        •      !
b.     Water Resources Risk Implication for Human Health

       The Agency has no data  indicating an undue risk to human health
from water resources as a result of butralin use on tobacco.

       (1)    Ground Water

             Butralin is persistent but relatively immobile  in terrestrial
       environments  Based upon qualitative leaching index  and mobility
       studies,  butralin is not expected to leach into ground water.
       Additional batch equilibrium data are needed to confirm the soil
       binding affinity of butralin. The Agency has concluded that use of
       butralin on tobacco will have minimal impact on ground water.

       (2)    Surface Water

             Butralin detections were not reported in STOKET. Based
       on the Tier 1 QENEEC EEC, the peak EEC for butralin is 16.89
       Aig/L. A more reliable  surface water exposure characterization
       based on GENEEC or PRZM cannot be adequately determined until
       the additional batch equilibrium data are received and evaluated.
       No  maximum contamination level  (MCL) or Lifetime Health
       Advisory Level (HAL) has been established for butralin.   The
       Agency believes foliar interception and subsequent foliar dissipation
       processes will affect the magnitude of butralin residues  available for
       surface water runoff.  Butralin residues that.are oversprayed or
       washed off from the treated plants are likely to be the only butralin
       residues available for runoff into surface water.
                      50

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 c.     Environmental Risk Characterization

       Background Information

    .'  Butralin is a post emergent plant  growth regulator which  is
 registered to control suckers on flue-cured and air-cured tobacco.  Butralin
 will be applied as an emulsifiable concentrate (36.5%) by direct spraying
 of the tobacco stalks, leaf axils, and crown using directed, coarse, low
 pressure spraying techniques. The maximum application rate is 3.0 Ibs
 a.i./A.  According to the registrant, the use of butralin is expected to be
 limited to-the southeastern U.S.,  the mid-Atlantic states and the mid-
 southern states. In these regions, most of the tobacco is grown  on small
 (less than  1-10 acre) plots which are widely dispersed  over  large
 geographic areas.                             ,

       Aquatic Organisms                          ,    ,

       Even though laboratory studies show that butralin is highly toxic to
 fish and invertebrates, the Agency expects that the overall acute risk to
 aquatic organisms in the environment will be low.  The risk quotients,
 which are based upon screening level exposure estimates, indicate that only
 three  LOCs  were   slightly   exceeded   (freshwater  invertebrates,
 estuarine\marine fish test\maririe shrimp)^   Furthermore, the estimated
 EEC values for butralin use on tobacco are conservative because the model
 does not account for foliar interception/dissipatipn.and aquatic metabolism
 of butralin. As previously mentioned, the exposure assessment is uncertain
 because the EECs are based on an estimated K^ value of 3,219 ml/g
 (Lyman, WJ. 1990).  Additional  batch equilibrium data are needed to
 confirm the GENEEC EECs for butralin.

  '••,.( The label for TAMEX-3EC.recommends foliar boom or manual
 spray application over the row, delivering a coarse spray that runs down
 the stalk  and wets suckers in the leaf axils.  Butralin may also be applied
 to individual plants using a handheld dropline, knapsack sprayer or jug
 application. Butralin residues from foliar over-spray or wash-off from the
 treated plants are expected to be the only residues available for runoff in
 surface waters.   Although the full magnitude of butralin loading into
 surface waters cannot be assessed  without additional data on rates and
 routes of foliar interception and dissipation, supplemental terrestrial field
 dissipation studies suggest that 87% of applied butralin is intercepted by
tobacco plants (MRID 43749801).  Therefore, the actual amount of butralin
 reaching surface water is expected to be considerably lower than predicted
by GENEEC.          ,      ,              '•       '   ,     :

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       Butralin also has the potential to move into surface waters on
entrained sediments and is expected to be bound on suspended and bottom
sediment in the aqueous environment.  Dissolved butralin in the water
column is expected to be degraded by  photolysis (t If2  '—  13.6 days)
(MRIDs 44064901 and 00024824).  Supplemental runoff studies in
Pennsylvania and Mississippi on sites with 3 to 6% slopes indicate butralin,
applied at 3 Ibs a.i./A, was detected in adjoining farm pond water and
sediment at maximum concentrations of <_ 2 pg/L, and <_ 30 jug/kg,
respectively (PP#4F1431).

       The  following study is required  for butralin:  either a 48-hour
embryo-larvae study or a 96-hour shell deposition study with oysters.

       The  Agency does not have data to assess the chronic effects of
butralin to freshwater invertebrates and is requesting an aquatic invertebrate
life-cycle test.
        .               '         *             ' '       '
       (1)    Nontarget Plants

             The  Agency cannot  determine the impact  of butralin
       application to nontarget terrestrial and aquatic plants at this time.
       It can be assumed that butralin, an herbicide, will adversely affect
       nontarget plants if they are exposed.  The Agency is requiring that
       the registrant submit Tier 2 testing for terrestrial and aquatic plants.

       (2)    Terrestrial Organisms

             Although, environmental fate characteristics indicate that
       butralin is persistent to moderately persistent (aerobic soil half-life
       is stable), the overall acute risk to terrestrial organisms is expected
       to be low.  No avian LOCs were exceeded; the only acute LOG
       which was exceeded was for endangered mammals, specifically the
       meadow vole and the least shrew, and those only by a small margin
       (RQ  - 0.4, LOG = 6.1 - 0.2). Although the LOG for restricted
       use  mitigation has  been slightly  exceeded,  the Agency is not
       recommending  restricted use classification.   The  method of
       application (coarse spray directed onto the plant) is  expected to
       reduce the amount of butralin which will reach potential food items
       eaten by small mammals in the field.

             Supplemental data suggests that butralin may impair the
       reproductive ability of mallard ducks at 80 ppm.  However, the
       Agency cannot fully assess the chronic affects of butralin to birds
       without valid data.  The supplemental studies only tested at two
                      52

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                            levels, the highest being 80  ppm.  , These test levels do  not
                            adequately represent  avian  exposure according  to  Kenaga as
                            modified by Fletcher  (1994).  A mallard reproduction study is
                            required based on an increase in eggshell' cracking.  A bobwhite
                            reproduction study is  also required based on the persistence of
                            butralin in terrestrial environments.

                            (3)    Conclusions                                 ,

                                  Based upon limited data, the Agency concludes that  the
                            overall,  acute impact  on freshwater and  terrestrial nontarget
                            organisms and water resources, including ground and surface water,
                            from the use of butralin on tobacco will be minimal.  Available
                            ecological toxiciry data indicates that there is a "may effect"  for
                            endangered species of aquatic invertebrates, including mollusks and
                            crustaceans,  for acute  effects to estuarine marine fish, for acute
                            effects to mammals, and for ppssible reproductive effects to birds.
                            Compared to many other pesticides, the amount that the RQ exceeds
                            the LOG for endangered species is relatively low (Consultation
                            Request, 1991).  This data also shows that the LOG for restricted
                            use mitigation has been slightly exceeded. However, the Agency
                            is not recommending restricted use classification because of  the
                            directed method of application.  At this time, the Agency does not
                            have sufficient data to assess the chronic impact .of butralin on
                            aquatic and terrestrial nontarget organisms and the acute impact on
                            estuarine and marine invertebrates, and nontarget plants. A more
                            complete  characterization cannot   be  made  until  additional
                            environmental fate and  ecological  toxicity  data  are  submitted.
                            These include batch equilibrium data to confirm the estimated K^
                            value, clarification of different metabolites identified in aqueous
                            photolysis  studies'^ additional terrestrial field  dissipation  data,
                            chronic aquatic  invertebrate studies,  non-target plant studies,
                            marine/estuarine mollusk studies, and chronic reproduction studies
                            for mallard duck and bbbwliitequail.
TV.   RISK MANAGEMENT AND REREGISTRAUON 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

.'•••••  --  :"•   '.:  '-'-  •"• •  -  :.":•••.-'•'  '•  ••''53-"''   •'-'••   '- •'••     "'  ':' •''.  •'  ;       :••

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support reregistration of products containing butralin as an active ingredient. The Agency
has  completed its review of these generic data, and has determined that the data are
sufficient to support reregistration of all products containing butralin for use on tobacco.
Appendix B identifies the generic data requirements that the Agency reviewed as part of
its determination of reregistration eligibility of butralin, 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 butralin and to determine that butralin can be used without resulting in
unreasonable adverse effects to humans and the environment. The Agency therefore finds
that all products containing butralin as the active ingredient for the use on tobacco are
eligible for reregistration. The reregistration of particular products is addressed in Section
V of this document.                               .          •-.        ,',..'-

       The Agency made its reregistration eligibility decision based upon the target data
base required for reregistration, the current guidelines for  conducting acceptable studies
to generate such data,  published scientific  literature,  etc.  and the data identified in
Appendix B. Although the Agency has found that the use of butralin on tobacco is eligible
for reregistration, it should be understood that the Agency may take appropriate regulatory
action, and/or require the submission of additional data to support the registration of
products containing butralin, if new information comes to the Agency's attention or if the
data requirements for registration (or the guidelines for generating such data) change.

B.     Determination of Eligibility Decision

       1.     Eligibility Decision

              Based on the reviews of thegeneric datafor the active ingredient butralin,
       the Agency has sufficient information on the health effects of butralin and on its
       potential for causing adverse effects in fish and wildlife and the environment.  The
       Agency has determined that butralin products, labeled and used as specified in this
       Reregistration Eligibility Decision, will not pose unreasonable  risks or  adverse
       effects to humans or the environment.   Therefore, the Agency concludes that
       products containing butralin for tobacco use as a plant growth regulator are eligible
       for reregistration.

       2.     Eligible and Ineligible Uses

              The Agency has determined that all currently registered tobacco uses of
       butralin are eligible for reregistration.

C.     Regulatory Position and Labeling Rationale

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

       '•    •   '  •       '       '. ,  ,  54

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 1.     Tolerance Reassessment
  '-           .  ""      .      •       •     ••   '      '          "'  -     'f  '-  '
        Existing tolerances of 0.1 ppm are currently established for the herbicide
 butralin in or oh lima beans, cottonseed, southern peas, soybeans forage, soybeans
 and watermelon (40 CFR ง180.358).  Products beating these uses have not been
 marketed for sometime and the tolerances will be proposedfor revocation.

 2L.     Tolerance Revocations and Import Tolerances

        As part of  EPA's reregistration eligibility decision for butralin,  all
 tolerances cited will be proposed for revocation. Once a pesticide use is no longer
 registered in the  United States, the related pesticide residue tolerance and/or
 food/feed additive regulation generally is no longer needed It is  EPA's policy to
 propose revocation of a tolerance, and/or food/feed additive regulation, following
 the deletion of a related food use from a registration, or following the cancellation
 of a related food-use registration. ,EPA has the responsibility under the Federal
 Food, Drug, and Cosmetic Act (FFDCA) to revoke a tolerance/ regulation on the
 grounds that the Agency cannot conclude that the tolerance/ regulation is protective
 of the public health.

       The Agency recognizes, however, that interested parties may want to retain
 a  tolerance and/or  food/feed  additive regulation in the absence  of a  U.S.
 registration, to allow legal importation of food into the U.S.  To assure mat  all
 food marketed in the U.S. is safe^ under FFDCA, EPA requires the same technical
 chemistry  and toxicology data for  such import tolerances (tolerances without
 related U.S. registrations) as are required to support U.S. food use registrations
 and any resulting tolerances.  See 40 CFR Part 158 for EPA's data requirements
 to support domestic use of a pesticide and establishment and maintenance of a
 tolerance and/or  food/feed,  regulation.   In  addition, EPA requires residue
 chemistry data (crop field trials) that are representative of growing conditions in
 exporting countries in the same manner that EPA requires representative residue
 chemistry data from different U.S. regions to support domestic use of the pesticide
 and the tolerance and/or regulation. Additional guidance on the Agency's import
 tolerance policy will be published in an upcoming Federal RegisterNoti.ee.

       Parties interested insupporting an existing, butralin tolerance as an import
 tolerance shouldensure that all pf the data noted above are available to EPA during
 its further assessments of existing tolerances  and regulations, so that the Agency
 may determine whether maintenance of the tolerance and/or regulation would be
 protective of the public health.

 Codex, Harmonization                 '  >

       Codex harmonization is, not a concern in this reregistration case since
butralin food use registrations  have been canceled and no RfD is established.
Butralm is classified  as a non-food use pesticide.

 --..  •   .'••'.• "'   ,     "' '  ''..•- 55    '  •'•    .  .:    • ,    .    .  '    '•  " ' ••''.    '•

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3.     Potential Risks to Infants and Children/Aggregate Exposure
       /Cumulative Effects

       In determining whether infants and children are particularly susceptible to
the toxic effects of a pesticide, EPA considers the completeness and reliability of
the toxicity data base, the nature of the effects observed in toxicity studies, and
other information.  Based on current data requirements, only one developmental
study is usually required for non-food use chemicals.  However, because butralin
at one time had food uses, a developmental study in a non-rodent species and a two
generation reproduction study are also available for evaluation.  There was no
evidence of pre or post natal  sensitivity in  any of these three studies.  The
developmental effects and effects on offspring occurred at dose levels that were
equal to or greater than the maternal NOELs. Thus, the Agency has concluded
that there is no special sensitivity to infants and children from butralin exposure.
                            .  i         -    -    -   •       '          •  ,   .

       In addition, the Agency believes there is little likelihood of direct exposure
to infants and children since butralin has no  food uses and its only use, on tobacco,
will not result in drinking water exposure nor would the tobacco use result in any
non-occupational exposures.  The  Agency does not have concerns for prenatal
exposures based on the adequate MOEs for handlers and the lack of special
sensitivity seen in the developmental and reproduction studies.

       In examining aggregate exposure, EPA takes into account available
information concerning exposures from dietary sources, drinking water and non-
occupational  sources.  As noted in the preceding paragraph, the only source of
butralin exposure is occupationally related.

       The Agency has not yet made a  determination regarding the common
mode/mechanism of toxicity of butralin and whether it is appropriate to consider
exposure from butralin with other compounds in order to address cumulative
effects.  However,  based on the high MOEs for butralin and its lack of dietary
sources, drinking water  and non-occupational  exposures, the contribution of
butralin exposures  to  the  risks of, other  compounds  with  a common
mode/mechanism of toxicity is likely to be minimal.

4.     Occupational Labeling Rationale/Risk Mitigation
A     "                 r , '    ' '•  'i ,    i '    '''!""   .
;,    ,„'' ซ•           	i    /y1   •',''•'  ,''',' ',''"'    ,  '   ' .    '       ,'   ,'   " ' ,
       All butralin pesticide products are intended  for occupational use.   There are
currently no butralin products intended for homeowner use.

The Worker Protection Standard (WPS)

       On  August 21, 1992, the Agency issued worker protection regulations
affecting all  pesticide products whose labeling reasonably permits;use in  the
production of agricultural plants on any farm,  forest, nursery or greenhouse. In
general, products within the scope of the Worker Protection Standard (WPS) had

                            56

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 to bear complying labeling when sold or distributed by the registrant after April
 21, ,1994.                                                       ,

       The WPS labeling requirements pertaining to personal protective equipment
 (PPE), restricted entry intervals (REI); and notification are interim. The interim
 WPS handler PPE requirements are based solely on the acute dermal and inhalation
 toxicity and skin and eye irritation potential of the end-use product. The interim
 WPS  restricted-entry intervals for agricultural workers are based solely on the
 acute dermal toxicity and skin and eye irritation potential of the active ingredient.
 The interim WPS "double" notification requirement is imposed if the  active
 ingredient is classified as toxicity category I  for acute dermal toxicity or  skin
 irritation potential.  "Double" notification is the statement on the labels of some
 pesticide products requiring employers to notify workers about pesticide-treated
 areas  orally as Well as by posting of the treated areas. The WPS retained more
 stringent  PPE, REI, and notification requirements from existing labeling.  These
 requirements are to be reviewed; and revised, as appropriate, during reregistration
 and other Agency review processes. During reregistration, the Agency reviews
 risks  resulting from WPS  uses as well as  from  all  other occupational  and
 residential uses.                                   .

 Personal Protective Equipment for Handlers (Mixers, Loaders, Applicators)

       Occupational handler exposures and risks are evaluated jointly.  As a result
 of the reregistration evaluation of the acute and other adverse effects of butralin,
 the Agency has determined that risks to handlers do not Warrant the establishment
 of active-ingredient-based minimum personal protective equipment or engineering-
 control requirements that would apply to all butralin end-use products. The risks
 to handlers are adequately mitigated with the addition of chemical-resistant gloves
 for most handler scenarios. .Therefore, the Agency is requiring that all handlers
 wear chemical-resistant gloves.              '                   "        ''

 Entry Restrictions                             ,

       As a result of the reregistration evaluation of the acute and other adverse
 effects of butralin, the Agency has determined that the risks from post^application
 exposures to butralin by workers warrant the niinimum WPS REI of 12 hours
 following applications of the liquid formulation to tobacco. Furthermore, since
:EPA has determined that the risks from adverse effects following such applications
 are" minimal, EPA is establishing the minimum WPS early-entry PPE of coveralls,
 chemical-resistant gloves, shoes and socks.  At this time, butralin is not a candidate
 for a 4-hour REI, since there are no chemical-specific post-application exposure
 data and there is a dermal NOEL of 10 mg/kg/day.
                             57

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Worker Notification

       Butralin is not classified as toxicity category I for select acute dermal
toxicity or skin irritation potential and is not classified as a severe skin sensitizer.
EPA has no special concerns about butralin for adverse effects where a single
exposure can trigger the effect and EPA has not established an unusually long
restricted-entry interval.  Therefore, at this time, EPA is not requiring a WPS
"double" notification statement on the labeling of butralin end-use products.

Other Labeling Requirements
                       •,   ,     "      /     .•''',   •   ' -
       The Agency is requiring additional end use labeling statements addressing
application restrictions and user safety requirements.

5.     Endocrine Disrupter Effects

       EPA is required to develop a screening program to determine whether
certain substances (including all pesticides and inerts) "may have an effect in
humans that is similar to an effect produced by a naturally occurring estrogen, or
such other endocrine effect,.." The Agency is currently working with interested
stakeholders, including other government agencies, public interest groups, industry
and research scientists in developing a screening and testing program and a priority
setting scheme to implement this program. Congress has allowed 3 years from the
passage of FQPA (August 3,1999) to implement this program.  At that time, EPA
may require further testing of this active ingredient and end use products  for
endocrine disrupter effects.

6.     Environmental Assessment

       Based upon available data, the Agency concludes that risk to freshwater and
terrestrial organisms and water resources will be minimal.  No additional label
statements are required.  Certain additional confirmatory data are being required.

7.     Restricted Use Classification

       Butralin does not require and is not being considered for restricted use.

8.     Endangered Species Statement

       Currently, the Agency is developing a program ("The Endangered Species
Protection Program") to identify all pesticides whose use may cause adverse
impacts  on endangered and threatened species and to implement mitigation
measures that will eliminate the adverse impacts. The program would require use
restrictions to protect endangered  and threatened species at the county level.
                             58

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             Consultations with the Fish and Wildlife Service may be necessary to assess risks
             to newly listed species or from proposed new uses,  m the future, the Agency plans
             to publish a description of the Endangered Species Program in the Federal Register
             and have available voluntary county-specific bulletins. Because the Agency is
             taking this approach for protecting endangered and threatened species, it is not
             imposing label modifications  at  this time through the RED.   Rather,  any
             requirements for product use modifications will occur in the future under the
             Endangered Species Protection Program."    .
V.    ACTIONS REQUIRED OF REGISTRANTS

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

      A.    Manufacturing-Use Products

             1.     Additional Generic Data Requirements

            -   ^  The generic data base supporting the reregistration of butralin for the above
             eligible uses has been reviewed and determined to be substantially complete.
             However, additional confirmatory data are required to fulfill the requirements
             h'sted below.  Some of these requirements were levied in the Phase 2 and Phase 4
             Data Call-in Notices (DO).   Only the data requirements that have not been
             previously levied by the Agency will be included in the generic DGI -included as
             an attachment to this RED document:

              ;     Avian reproduction with quail data, GLN71-4(a)
           ,        Avian reproduction with duck data, GLN 71-4(b)v
                 •  Estuarine/Marine toxicity mollusk, GLN 72-3(b)
                   Life cycle with freshwater invertebrate, GLN72-4(bj
                   Seedling germination/seedling emergence, GLN 123-1 (a)
                   Vegetative vigor, GLN 123-l(b)
                   Aquatic Plant Growth, GLN 123-2
                   Leaching/adsorption/desorption, GLN 163-1

             2.     Labeling Requirements for Manufacturing-Use Products

                   To'remain in compliance with FIFRA, manufacturing use product (ME)
             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:     .
           '  '            •    ~       "    'I'"''".''      ' -   •'    ,   ' , • • ' Y     „        '
                   "Only for formulation into an herbicide for use on tobacco"   ,
                                        59

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             An MP registrant may, at his/her discretion, add one of the following
       statements to an MP label under:
       "Directions for Use" to permit the reformulation of the product for a specific use
       or all additional uses supported by a formulator or user group:
             (a)    "This product may be used to formulate products for
                    specific use(s) not listed on the MP label if the formulator,
                    user group, or  grower  has complied with U.S.  EPA
                    submission requirements regarding support of such use(s). "

             (b)    "This product may be used to formulate products for any
                    additional  use(s)  not  listed on  the MP  label if the
                    formulator, user group, or grower has complied with U.S.
                  ,  EPA submission requirements regarding support of  such
B.     End-Use Products
                                                     • i1                  '       ^
      • 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.  Registrants must review previous data submissions to ensure that they
       ineet current EPA acceptance criteria 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

             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. All end-use product labels [e.g. multiple active ingredient (MAI) labels,
       SLN's, and products subject to generic data exemption] must be amended such that
       they are consistent with the basic producer labels. See Appendix A for appropriate
       rates and restrictions for those supported uses,

             a.     Occupational Protection

       PPE/Engineering Control Requirements for Pesticide Handlers

             For  sole-active-ingredient end-use products that contain butralin, the
       handler personal protective equipment requirements set forth in this section must
       be incorporated on all butralin product labels.  Any conflicting PPE requirements
       on current labeling must be removed.  There are currently no multiple-active-
       ingredient end-use products that contain butralin.

                                   60

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 Products Intended Primarily for Occupational Use (WPS)
                 ,.- •      -. •   _      ป   .'.''-      /   ' F • ''        •• ~       " -
 Minimum (Baseline) PPE Reqmrements The minimum (baseline) PPE for all
 occupational uses of butralin end-use products is:

 "Applicators and other handlers must wear:
 —long-sleeve shirt and long pants,             :
 —chemical-resistant gloves*, and                                           ;
 —shoes phis socks."   _./    ; v                      ;        ;         ''•','
     -  "         _. .  -    '          , - ,'  '        i '        '•   ' .-  V    . '          "  ""'
 * For the glove statement, use the statement established for butralin through the
 instructions in Supplement Three of PR Notice 93-7.

 Actual end-use product PPE requirements:  The PPE, if any, that  would be
 established on the basis of Hie acute toxicity category of each end-use product must
 be compared to, the active-ingredient-based minimum (baseline) personal protective
 equipment specified above. The  more  protective PPE must be placed on the
 product labeling. For guidance on which PPE is considered more protective, see
 PR Notice 93-7.
       '         - •   '       •   '.     '    '     *      "        ' . ',   -•'.-'    t

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

 Entry Restrictions
     •  -'   '     '    •'.,..   •'.•..   ...•'••   •  -: -      • ' '•"'
        For sole-active-ingredierit end-use products that contain butralin, product
 labels must be revised to adopt the entry restrictions set forth in this section. Any
 conflicting entry restrictions on current labeling must be removed.

 Restricted-entry interval: A 12-hour restricted entry interval (REI) is required for
 uses within the scope of the WPS (see tests in PR Notices 93-7 and 93-1 i) on all
 end-use products.                                                    .  '

 Early-entry personal protective equipment (PPE):  The PPE required for early
 entry is:
'-•vcoveralls,  .'.."•'       -,^;   .. ...... .   '• .     '  ;/'• '  '  '.'' .''..'.'     _ -. ^   ;.
 — chemical-resistant gloves, and                        .
 — shoes plus socks.                         ;
             -,      '    -    '    >.•','•        '~    ' -.       S.              s'>
 Placement in. labeling:  The RE! and^^ early-entry PPE must be inserted  into the
 standardized REI arid early-entry PPE statements required by Supplement Three
 of PR Notice 93-7.
                              61

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              b.     Additional Labeling Requirements

              The Agency is requiring the following labeling statements to be located on
       all end use products containing butralin that are intended for occupational use.

       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."

       User Safely Requirements

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

       User Safety Recommendations

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

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

       "      "Users should remove PPE immediately after handling this product.
              Wash the outside of gloves before removing. As soon as possible,
              wash thoroughly and change into clean clothing."

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 Reregistratipn Eligibility Decision
(RJED). 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 butralin for
tobacco products bearing old labels/labeling for 26 months from the date of issuance of
this RED. Persons other than the registrant may distribute or sell such products for 50
months from the date of the issuance of this RED.  Registrants and persons other than
registrants remain obligated to meet pre-existing Agency imposed label changes and
existing stocks requirements applicable to products they sell or distribute.

                      ' '  '  .'        62

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VI. APPENDICES
      63

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64

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                               GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case ButraJin covered by this Reregistration Eligibility Decision Document.
It contains generic data requirements that apply to Butralin 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.  Dafa. 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 hi 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.
                                          68

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                  APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Butralin
REQUIREMENT .
USE
PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-1
61-2A
61-2B
62-1
"62-2
62-3
63-2

63-3

63-4

63-5
;'-
63-6
.. -' '-"" ,
63-7
. • • .
63-8

63-9

63-10

63-11

Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color

Physical State

Odor

Melting Point

Boiling Point .

Density
,• '- ' •" -•--
Solubility
/ - " i , ' ' ",•-'
Vapor Pressure

Dissociation Constant .

Octanoi/Water Partition
,''••' . . '•'••' ' ' ':
•'. .'.. c ;.',
. •' c ;•'
'; '-. C
c
'-./...'• c:"
c
- •\;:c'. /
. ./ '•,',,
"•'.."•.c •'.

- ••" "' ... -c, -:
.••'••'-
-•'".''•• c - '

'.-."•CV--

c '•'•••

c

c

: ' C ' -

•••' ' . c

40979802,41225203
40979802,41225203
40979802,41225203
40979801,41225202
40979801,41225202
40979801,41225202
40979801, 41225201, 41225202,
41784101,42616401
40979801, 41225201, 41225202,
41784101,42616401,
, 40979801 , 41225201 , 41225202,
41784101,42616401
40979801, 41225201, 41225202,
41784101, 42616401 .
40979801, 41225201, 41225202,
41784101,42616401
40979801, 41225201, 41225202,
41784101,42616401 :
40979801,41225201,41225202,
41784101,42616401
40979801,41225201,41225202,
41784101,42616401 ; ;
. 409798Q1, 41225201, 41225202,,
41784101^42616401
40979801, 41225201, 41225202,
41784101,42616401
                         69

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' ' • • ' '• .. " ' ' '-. ' ' . . , '. . • ' i.
Data Supporting Guideline Requirements for the Registration of Butralin
I^QIMEMENT
63-12 pH
63-13 Stability
ECOLOGICAL EFFECTS
71-1A Acute Avian Oral - Quail/Duck
71-2A Avian Dietary - Quail
71-2B Avian Dietary - Duck
71-3 Wild Mammal Toxicity
72-1A Fish Toxicity Bluegill
72-1C Fish Toxicity Rainbow Trout
72-2A Invertebrate Toxicity
TOXICOLOGY
81-1 Acute Oral Toxicity - Rat
81-2 Apute Dermal Toxicity -
Rabbit/Rat
81-3 Acute Inhalation Toxicity - Rat
8 1-4 Primary Eye Irritation - Rabbit
81-5 Primary Dermal Irritation -
Rabbit
81-6 Dermal Sensitization - Guinea
pig " '• ;
82-1 A 90-Day Feeding - Rodent
82-2 21-Day Dermal - Rabbit/Rat
82-4 90-Day Inhalation - Rat
USE
PATTERN
C
C
C
C
C
C
C
C
C
C
C
C
C
C
>< c
C
c
c
CITATION(S)
40979801, 41225201, 41225202,
41784101, 42616401
40979801, 41225201, 41225202,
41784101,42616401
1606^43
160644
160645
42112701
160647
160647
42636101
42112701
"42660701
42488201
42488201
42020702
42660601
,:,','' ' ~ • . • ' A ii
43626401,43652701
40419601
42633601
70

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 Pata Supporting Guideline Requirements for the Reresistration of Butralin
REQUIREMENT
  . USE
PATTERN
CITATION(S)
83-3A    Developmental Toxicity - Rat

83-3B    Developmental Toxicity - Rabbit
83^4     2-Generation Reproduction - Rat
84-2A    Gene Mutation (Ames test)
84-2B    Structural Chromosomal
         Aberration  •
84-4     Other Genotoxic Effects
85-1     General Metabolism
ENVIRONMENTAL FATE
160-5    Chemical Identity
161-1    Hydrolysis
162-1    Aerobic Soil Metabolism
163-1  '  Leaching/Adsorption/Desorption
165-4    Bioaccumulation in Fish
   C -•-..   40419601,40419602,40419603,
           41742003^42156101,42156102,
           ^2156103
   C      40419601,41742002,42156104
   C      92014039,00154259
   C      40121101, 40121102, 40551909
   C      40551910

   G      00078460, 40121103, 40350901
   C      42743201
    •••'  i'    • '  ,  '  •-'''''  ;  ' ; •.,  -:    •   '

   C      40979802,41225203
   C      43669401
   C      43201901,'          .  .,
   C       42842301
   C       42069702,42069703,42069704,
           42069705,'44081601
                                    71

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72

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3.
4.
                        GUIDE TO APPENDIX C

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

 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
 tinpublished 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,

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 precededby 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.

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 Rational, Standards Institute
(ANSI), expanded to provide forcertain special needs.

a     Author.  Whenever the author could confidently be identified, the, Agency has
      Chosen to show a personal author.   When ho 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. Thedateofthestudyis taken directly from the document.
      When the date is followed by a question mark, the bibliographer has deduced
      the date from the evidence contained in the document.  When the date appears

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

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.
                                  74

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    MRID
                    BIBLIOGRAPHY
                          • -. , •   • /-"  /

                    CITATION
    00078460
 ,   00154259


    00160643



    00160644
     i


    00160645



    00160647
•.ป


    40121101
   40121102
   40121103
 Baldwin, J.K. (1972) Evaluation of Compound A-820 on Spermatogenesis of
 Mice, Using the Dominant Lethal Test: Contract No. 120-666-12-70. Final rept.
 (Unpublished study received Oct 13, 1972 under 2G1285; prepared by Affiliated
 Medical Enterprises, Inc., submitted by Union Carbide Agricultural Products Co.,
 Inc., Ambler, Pa.; CDL:091821-K)
              -      ..''•.'    '     .'  '  '   •'•''.-  , ' "       ''•'./•'':''
 Litton  Bionetics,  Inc. (1978) Three-generation Reproduction Study in Rats:
 Technical Butraliri: Final Report: Project No. 20634. Unpublished study.  75 p

 Beavers, J. (1986) Technical Butralin: An Acute Oral Toxicity Study with the
 Bobwhite: Final Report: Project No. 215-101.  Unpublished study prepared by
 Wildlife International Ltd.  17 p.

 Fink, R. (1975) Eight-day Dietary LC50-Bobwhite Quail: Technical Butralin:
 Final Report: Project No. 113-109.  Unpublished study prepared by Truslow
 Farms Incorporated.  9 p.

 Fink, R. (1975) Eight-day Dietary LC50-Mallard Duck: Technical Butralin: Final
 Report: Project No.  113-110. Unpublished study prepared by Truslow Farms
 Incorporated.  9 p.

 Swigert, J.; Bowman, J. (1986) Acute Toxicity ^f Technical Butralin to Bluegill
 Sunfish (Lepomis macrochirus):  Report No. 34102. Unpublished study prepared
 by Analytical Bio-Chemistry Laboratories, Inc. 43 p.

 Hoorn,  A-  (1986)  Muitagenic  Evaluation  of N-sec  butyl-4  tertbuty!2,6
 dinitroaniline in the Ames Salnionella/Microsome Plate Test: Laboratory Project
 ID: E9461-AM S/M.  Unpublished study prepared by Hazelton Biotechnologies.
 24p. .".-.-.;     .'.'•/•';•:••:  : '  .•'":.-"•    .''•'•  •  ''    '    ' ,.' '
     Boer, W. (1986) Mutagenicity Evaluation of N-sec butyl-4 tertbutyl-2,6
dinitroaniline in the L5178YTK +/Mouse Lymphoma Forward Mutation Assay:
Laboratory Project ID: E9469^1L FM. Unpublished .study prepared by Hazleton
.Biotechnologies. 19p.                 ,                '.-.
-'  -      -  ' ' '     '    '' . '         ,''"''-"'      ' '       •  '     'v  -
Taalman, R.  (1986) Clastogenic  Evaluation of N-sec  butyl -4 tertbutyl-2,6
dinitroaniline in an in vitro Sister Chromatid Exchange Assay Chinese Hamster
Ovary (CHO) CeUs: Laboratory Project ID: E9469-SCE.  UnpubHshed; study
prepared by Hazleton Biotechnologies.  18 p.
                                            75

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                                 BIBLIOGRAPHY
 MRID
CITATION
 40350901     Qfone, M. (1986) Evaluation of N-sec butyl-4 Tertbutyl-2,6 Dinitroaniline in the
              Rat Primary Hepatocyte Unscheduled DNA Synthesis Assay:  Laboratory Project
              ID 2099L  Unpublished study prepared by Hazleton Laboratories America, Inc.
              23 p.

 40419601     Leeming, N. (1986) N-sec Butyl-4 Tertbutyl-2,6 Dinitroaniline: Oral (Gavage)
              Teratology Study in the Rabbit: Laboratory Project ID: 80/104.  Unpublished
              study prepared by Hazelton Laboratories Europe Ltd.  143 p.

 40419602     Monnot, G. (1987) N-sec Buryl-4 Tertbutyl-2,6 Dinitroaniline: Teratology Study
              in ihe Rat by the Oral Rout: Part II:  Laboratory Project ID: 609488.  Unpublished
              study prepared by Hazeltonlnstitut Francais de Toxicologie. 130 p.
        '"      (•  ,        i   ,[' 	   "       |     ..!,  "',,'., v '''      ' ',

 40419603     Monnot, G. (1986) N-sec Buryl-4 Tertbutyl-2,6 Dinitroaniline: Teratology Study
              in the Rat by the Oral Route: Part I: Laboratory Project ID: 606217.  Unpublished
              study prepared by Hazeltonlnstitut Francais de Toxicologie. 209 p.

 40551909     Young, R. (1988) Mutagenicity Test on N-sec butyl-4 tertbutyl-2,6 dinitraniline
              in the CHO/HGPRT Forward Mutation Assay:  HLA Study No. 10067-0-435.
              Unpublished study prepared by Hazleton Laboratories America. 39 p.

 40551910     Murli, H. (1988) Mutagenicity Test on: N-sec butyl-4 tertbutyl-2,6 dinitroaniline
              in an in vitro Cytogenetic Assay Measuring Chromo somal Aberration Frquencies
              in  Chinese Hamster Ovary   (CHO)  Cells: HLA Study No.  10067-0-437.
              Unpublished study prepared by Hazleton Laboratories America, Inc.  35 p.

 40979801     Pertuisot, J. (1988) N-sec butyl-4 tertbutyl-2,6 dinitroaniline: Technical  Grade
              Active Ingredient (Manufacturing Product) Product Chemistry: Laboratory Project
              ID: LA/CLD/1291b. Unpublished compilation prepared by Compagnie Francaise
              de Produits Industrials. 39 p.

40979802     Pertuisot, J. (1988) N-sec butyl-4 tertbutyl-2,6 dinitroaniline: Technical  Grade
             Active Ingredient (Manufacturing-use Product): Product Chemistry: Laboratory
              Project ID: LA/CLD/1291.  Unpublished compilation prepared by Compagnie
             Francaise de Produits Industrials. 25 p.

41225201    jPertuisot, J. (1988)  N-sec butyl-4-tertburyl-2,6-dinitroaniline: Validation  of the
             N-Nitrosobutralin Assay  Method:  Product  Chemistry:  Preliminary Analysis.
            " Unpublished study.  61 p.

                                          76

-------
                                 BIBLIOGRAPHY
 MRID
                     CITATION
 41225202<


 41225203


 41742002



 41742003


 41784101



 42020702



 42069702



 42069703


 42069704


 42069705'



42112701  ,
 Pertuisbt, J. (1988) N-sec-butyl^tertbutyl-2,6-dinitroanaine: Product Chemistry.
 Unpublished study. 35 p.

 Pertuisot, J. (1988) N-sec-butyl-4-tertbutyl-2,6-dinitro;aniluie: Product Chemistry.
, Unpublished study .  25 p.
'f  .'.'':    *          '        -..'•.      -   , ^  ' _   '

 Leeming, N. (1987) Butralin: Oral (Gavage) Teratology  Study in the Rabbit:
 Amendment to Final Report: Lab Project No. 5284-80/104. Unpublished study
 prepared by Hazletpn UK.  15 p.       ,    \

 Monnot, G. (1986) Butralin: Teratology Study In The Rat By The Oral Route:
 Unpublished study prepared by Hazleton FR. 23 p
              >' .    ' •     • '          ...         ,         .  •      .
 Pertuisot, J. (1988) N-sec butyl-4 tertbutyl-2,6 dinitroaniline: Validation of the N.
. Nitrosobutralln  Assay  Method:  Product Chemistry:  Preuminary  Analysis.
 Unpublished study prepared by CFPI Analytical Laboratory.  52 p.

 David, R. (1991) Primary Dermal Irritation Test of Technical Butralin in Rabbits:
 Lab  Project  Number:  G-7346.242.    Unpublished  study  prepared  by
 Microbiological Associates, Inc. 21 p.

 Sleight, B.; Maceln, K. (1972) Exposure of a Fish to [carbon 14]Labeled A-820
Accumulation, Distribution  and Elimination of Residues: Butralin. Unpublished
 study prepared by Bionomics, Inc.  i9p.

Sleight, B.; Macek, K. (1973) Kinetics of [carbon 14]-A-82Q in Synthetic Aquatic
Ecosystems: Butralin.  Unpublished study preparedly Bionomics, Inc.  25 p.

Barrows, M.; Sleight, B. (1974) Kinetics of [carbon 14]-Butralin in a Model
Aquatic Ecosytems. Unpublished study prepared by Bionomics, Inc.  2Tp.

Parkhis, M. (1991) Identity  of Accumulated Radioactivity in Blue Gills Exposed ,
to [carbon 14>A-820:  Butralin.  , Unpublished study  prepared by Amchem
Products, Inc., Analytical Research Lab.  11 p.
      .       ."..","'     -. ',            - • ,  .     ,J,.       ' '      '"•".'''
David, R. (1991) Acute  Oral Toxicity Study of Technical Butralin in Rats: Lab
Project Number; G-7346.220.  Unpublished study prepared by Microbiological
Associates Inc. 58  p.
                                         77

-------
                                BIBLIOGRAPHY
MRID
CITATION
42156101    Monnot, G. (1991) Supplement to MRID No. 404196-2: Revised Pages from
             Hazleton France: Butralin—Teratology Study in the Rat by the Oral Route, Part I.
             Unpublished study prepared by Hazleton France. 7 p.

42156102    Monnot, G. (1991) Supplement to MRID No. 404196-3: Revised Pages from
           -  Hazleton France: Butralin—Teratology Study in the Rat by the Oral Route, Part EL
             Unpublished study prepared by Hazleton France. 7 p.

42156103    CFPI (1991) Supplement to MRID No. 404196-3: CFPI Worksheets: Assay of
             Butralin Solutions Used by Hazleton for Dosing Animals. Unpublished study. 6
           .'p.,            .    ,   ,''  ''' '  '  '   ,,''   ".",	, .   .  '..    ;,"   ;

42156104    CFPI (1991) Supplement to MRID No. 404196-1: Revised Pages from Hazleton
             UK: Butralin-Oral (Gavage) Teratology Study in the Rabbit (Unpublished study).
             HP-

42488201    Weir, R. (1992) Acute Inhalation Toxicity Study of Butralin in Solvarex 90/180.
             in the Rat: Lab Project Number: 1-7356.212. Unpublished study prepared by
             Microbiological Associates Inc. 65 p.

42616401    Morrissey, M.  (1992) Series 63 Product  Chemistry Determinations of Butralin
             (Density, Solubility, Vapor Pressure, Octanol/Water Partition Coefficient): Final
             Report: Lab Project Number: HWI  6461-100.  Unpublished study prepared by
             Hazleton Wisconsin, Inc. 71  p.

42633601    Weir, R. (1992) 13-week Subchronic Inhalation Toxicity Study of Butralin in
             Solvarex 90/180 in Rats: Lab Project No. 1-7356.142. Unpublished study prepared
             by Microbiological Associates. 708 p.

42636101    Evers, R, (1992) Butralin Technical-Acute Toxicity to Daphnids (Daphnia magna)
             iinder Static Renewal Conditions: Final Report: Lab Project Number: 92-11-0001:
             12874.0892.8101.110. Unpublished study prepared by Springborn Labs (Europe)
             AG. 78 p.

42660601    Wenk, M. (1993) Dermal Sensitization Test of Technical Butralin in Guinea Pigs:
             Final Report: Lab Project Number: G-7346.245. Unpublished study prepared by
             Microbioligical Associates, Inc.  42 p.
                                         78

-------
                                BIBLIOGRAPHY
MRH>
                    CITATION
42660701
42743201
42842301
43201901
43626401
43652701
43669401
44081601
92014039
 Wenk, M. (1993) Acute Dermal Toxicity Study of Technical Butralin in Rats:
 Final Report: Lab Project No.  G-7346.232.   Unpublished study prepared by
 Microbiological Associates Inc.  30 p.                            '

 Krautter, G. (1993) The Disposition and Metabolism of (carbon 14)Butralin in the
 Rat: Lab Project Number: 522:1429. Unpublished study prepared by PTRL East.
 522 p.   '•••     -•   '.•-•-' '••   V.   -,•--, V     •  '' ,,'   •.    .;./-.   .;•••'
            - • " -      : . "      ป          '     ,          •   • N ' •         "•
 Atkins, R? (1993) Column Leaching of (carbon 14) Butralin in Four Soil Types:
 Lab Project Number: 745: 1526. Unpublished study prepared by PTRL East, Inc
 9ip.     ...  -;;   ,    •  -.'•, '•   •, -  --   .    •:.....  • .. ..-   ;•-. ,-._;

 Atkins, R. (1994) Aerobic Metabolism of (carbon 14) Butralin in Sandy Loam
 Soil: Lab Project Number:  1567: 722.  Unpublished study prepared by PTRL
 East. 103p.                    .,

 Martin, T.; Heath, J.; Duffen, J. (1993) Butralin:  4 Week Dietary Dose Range
 Finding Study in Rats: Lab Project Number; 7875: 451031. Unpublished study
 prepared by Inveresk Research International.  103 p.

 Martin, T.; Heath,  J.; Hudson, P.; et al.  (1994) Butralin: 13 Week Dietary
 Toxicity Study in Rats With 4 Week Recovery Period: Reissued Report:  Lab
 Project Numbers: 451047: 7947: IRI 451047.  Unpublished study prepared by
 Inveresk Research Int'l. 366 p.

 Bonhoff, A.  (1994) (Carbon-14)-Butralin~Determination of Aqueous Hydrolysis
 Rate Constants and Half-Lives: Final Report; Lab Project Number:  93-004-1002- \
 1002.0593.18103.1715: 04JUN93/OECD 111.  Unpublished study prepared by
 Springborn Labs  (Europe) AG.  59 p.

Hartley, D. (1996) (Carbon-14)-Butralin-Bioconcentratioa and Metabolism Study
with Bluegill Sunfish (Lepomis macrochirus): Final Report: Lab Project Number
 12983.0895.6110.140: 052695:  96-2-6388.  Unpublished study prepared by
Springborn Labs., Inc.^ 215 p.             ;                   *

Johnston,  G. (1990) Scientific & Regulatory Assistance Phase 3 Reformat/of
MRID 00154259.  Three Generation Reproduction Study in Rats: Technical
Butralin: Final Report: Study No. 20634;  Project No. 2634.  Prepared by Litton
Bionetics, Inc. 75 p.
                                        79

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80

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                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                                     WASHINGTON, D.C. 20460
                                                                        OFFICE OF
                                                                  PREVENTION, PESTICIDES
                                                                  AND TOXIC SUBSTANCES
                       GENERIC AND PRODUCT SPECIFIC
                             DATA CALL-IN NOTICE
                                                                   MAY  27-1998
 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
produces) containing this active ingredient. Within 90 days after you receive this Notice you
must respond as. set forth in Section ffl below. Your response must state:
       1,
       2.
      3.
How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 6 or                        .

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

Why you believe EPA should not require your submission of data in the manner
specified by this Notice (see section m-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
ypur produces) 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 5).

      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 3-31-99).  ,                      -   '
                                        81

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       This Notice is divided into six sections and six attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I
Section n
Section m
Section IV
Section V
Section VI
       Why You are Receiving this Notice
       Data Required by this Notice
       Compliance with Requirements of this Notice
       Consequences of Failure to Comply with this Notice
       Registrants' Obligation to Report Possible Unreasonable Adverse Effects
       Inquiries and Responses to this Notice         ,      '
       The Attachments to this Notice are:
       1-
       2-

       3-

       4-

       5-
SECTION I.
Data Call-In Chemical Status Sheets
Generic Data Call-In and Product Specific Data Call-In Response Forms with
Instructions (Form A)                     ..-..,
Generic Data Call-In and Product Specific Data Call-In Requirements Status
&od Registrant's Response Forms with Instructions (Form B)
EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
List of Registrants Receiving This Notice
Confidential Statement of Fohnula, Cost'Share and Data Compensation Forms

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

n-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.

H-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.
                                        82

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 H-C.  TESTING PROTOCOL                                        '        .':'.
         ' f     "    '  •              -     '''/-'•',     ' '      - \        ' ':   - -      • •

       All studies required under this Notice mustbe Conducted in accordance with test
 standards outlined in the PesticideAssessment 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: 703-605-6000).          .••<••.        .

       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 ง 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 ง 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].       V

 H-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
 wifltthe 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 ffi.      COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE

       You must use the correct forms and instructions when completing your response to this
 Notice. The typeof^Data Call-In you must comply with^(Generic or Product Specific) is
 specified m item number 3 on me four Date CaU-In forms (Attachments 2 and 3).

m-A.  SCHEDULE  FOR RESPONDING TO THE  AGENCY

      The appropriate responses initially required by this^Notice for generic and product
specific date 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
                                        83

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 issuance of NOIS due to failure to comply with this Notice are presented in Section IV-A and
 IV-B.

 m-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).
                               "i! '.  „:   „  ^ ^  ^  .  * ^      ,,v  '','',"  ', '  ;  "•.,    • . ,
       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 DI-C. A discussion of options relating to requests for data waivers is
 contained in Section m-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
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       You may avoid the requirements of thisNotice by eliminating the uses of your product
 to which the requirements apply. If you wish to amend jtour 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 the1^
 Registration Support Branch, Registration Division, Office of Pesticide Programs EPA  bv
 calling (703) 308-8358.                                  ,              J      '

       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 yearfrom the due
 date of your 90 day response, is allowed only if the product bears an amended label.

       e.    Generic Data Exemption -

       Under section3(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 productwhich 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 ingredieiit 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;
     "a              '     " '       | - ' '              , "      - •    '"",','   '   ''' -     -  '
       (ii).  Every registrant who is the ultimate source ofthe 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 Gall-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.                                    '"•••,..              .

      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 registrants) who have committed to
generate and submit the required data fail to take appropriate steps to meet requirements or are
                                         85

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 no longer in compliance with this Data Call-In Notice, the Agency will consider that both .they
 and you are not compliance and will normally initiate proceedings to suspend the registrations
 of both your and their product(s), unless you commit to submit and do submit the required
 data within the specified time. In such cases the Agency generally will not grant a time
 extension for submitting the data.                                    .

       d.     Satisfying the Generic Data Requirements of this Notice

       There are various options available to satisfy the generic data requirements of this
 Notice. These options are discussed in Section HI-C.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

       tyaiveirs for generic data are discussed in Section HI-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
*             '         -  ';-" - 	 ^   "^    „  - --    ln    ,                   ,

       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 IQ-C.2: A discussion of
 options relating to requests for data waivers is contained in Section HI-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 tiie 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

                                          86

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 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 productฎ containuig the active ingredient that is the subject of this Notice. If you wish
 to voluntarily cancelyour product, you must submit a completed Data CaUL-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; fiuther 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 TV-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 fulfillinggeneric data requirements.
 Deletion of a use(s) and the low volume/minor use option are  not valid options for fulfilling
 product specific data requirements; It is important to ensure that you are using the correct
 forms and instructions when completing your response to the Reregistration Eligibility
 Decision document.                    '-.''•

        c.      Request for Product Specific Data Waivers

       Waivers for product specific data are discussed in Section IH-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.

 m-C  SATISFYING THE DATA REQUIREMENTS OF THIS  NOTICE

        1.      Qeneric Data                        '                            ,".  '  J

  '••     If you acknowledge on the Generic Data Call-In Response Form that you agree to  v
 satisfy the generic data requirements (i.e. you select item number 6b), then you must select

 •'-   ' : -.   '   ."•'•'   '  ••  -   •      '        87        ''   '     ' '.   '  .       '.:•••"   '

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

 Option 1. Developing Data
                          	  ;           •      -.                    .         '
      If you choose to develop the required data it must be hi conformance with Agency
 guidelines 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 n-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 withia 12 months of commitment, the name and
 address of the laboratory(ies) or individuals  who are or will be conducting the study.

      In addition, if the time frame for  submission of a final report is more than 1 year/
interim reports must be submitted at 12 month intervals from the date you are required to

                        ,  ,  .  '  ' ..'.-:'. 88  /   '        .-•  ''   '   '   '

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 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 ti 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 dpes
 not grant your request, the original deadline remains. Normally, extensions can be requested
 only incases ofextraordinary testing problems beyond the expectation or control of the
 registrant. Extensions will not be given in submitting lie 90-day responses,. Extensions will
 not be considered if the request for extension is not made in a timely fashion; in no event shall
 an extension request be considered if it is submitted at or after the lapse of the subject
 deadline;  • '    •-••;   /••'.'      ; •  : ;'.  -." ..'.'.  .  .'..-. .-  •;  '•'.• '-.  ;••  '"'  •  •'.  '•'.     • :-''.   •,/

 Option 2. Agreement to Share in Cost to Develop Data

       If you choose to enter into an agreement to share in the cost of producing the required
 data but will not be submitting the data yourself, you must provide the name of the registrant
 who will be  submitting the data. You must also provide EPA with documentary evidence that
 an agreement has been  formed. Such evidence may be your letter offering  to join in an
 agreement and the other registrant's  acceptance of your offer, or a written statement by the
parties that an agreement exists. The agreementto 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 did 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

 '•'•  '     .'••.'•-' ••'•'  '..-"•    '  , -  . '•" '    89  ''  ,.  ^     '    . •'•   -' . .;--       '••'.'.'•'

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 registrantฎ 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 6.  In addition, you must
 demonstrate that the other registrant to whom the offer was made has not accepted your offer
 to enter into a cost-sharing agreement by including a copy of your offer and proof of the other
 registrant's receipt of that offer (such as a certified mail receipt).  Your offer must, in. addition
 to anything else, offer to  share in the burden of producing the data upon terms to be agreed to
 or, failing agreement, to be bound by binding arbitration as provided by FIFRA section
 3(c)(2)(B)(iii) and must not qualify this offer. The other registrant must also inform EPA of its
 election of an option to develop and submit the data required by this Notice by submitting a
 Data Call-In Response Form and a Requirements Status and Registrant's Response Form
 committing to develop and submit the data required by this Notice.

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

 Option 4. Submitting an Existing Study

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

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

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

      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
             liie requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR
             Part 160. As stated in 40 CFR 160,3, "Raw data " means any laboratory
                                         90

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             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 mclude photographs, microrilm or microfiche copies, computer
             printouts, magnetic media, mcluding dictated observations, and recorded data
             from automated instruments." The term "specimens1', according to 40 CFR
             160.3, means "any material derived from a test system for examination or
         .'•  analysis."                   .                       ;

       b.     Health arid safety studies completed after May 1984 must also contain all
             GLP-required quality assurance and quality control information, pursuant to the
             requirements of 40 CFR Part  160. Registrants also must certify at the time of
             submission of the existing; study thatsuch 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 mat each study fulfills the acceptance criteria for the
             Guideline relevant to thestudy providedinthe FIFRA Accelerated
         '    Reregistration Phase 3 Technical Guidance and that the study has been
             conducted according to the Pesticide Assessment Guidelines (PAG) or meets
             the purpose of the PAG (both documents 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 to40 CFR 158.70 which states the
             Agency's policy regarding acceptable protocols. If you wish to submitthe
             study, you must, in addition to certifying that the purposes of the PAG are met
             by the study, qlearly 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 hot
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 a study is in the Agency's
 files, you need only cite it along with the notification. If not'in the Agency's files, you must
 submit a summary and copies as required by PR Notice 86-5.             ,   '

 Option 5. Upgrading a Study                                            .  .
                          >              • ,  n   '    , ' ,       "        ' ' '
       If a study has been classified as partially acceptable and upgradeable, you may submit
 data to upgrade mat 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 qonformance with PR Notice 86-5..

       Do nojt 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.
                                         .92

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       If you are citing a study of which you are not the original data submitter, you must
submit a completed copy of EPA Form 8570-31. Certification wife 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 dati
production are the first six options discussed under item 9 in the instructions for completing
the Requirements Status and Registrant'sResponse Form. These six options are listed
immediately below with information in parentheses to guide registrants to additional
instructions provided in this Section. The options are:                                 ,

       (1)    I will generate and submit data within the specified time-frame (Developing
 ,   '••;•'•  Data)  .-.   -;•"-•.   * '/ :" .".   .. :  /   ; ..     .'";•   •    '   .'.'."  ,"   •   • •
       (2)    I have entered into an agreement with one or more registrants to develop data
             jointly (Cost Sharing)
       (3)    I have made offers to cost-share (Offers to Cost Share) ,
       (4) •'f  I am submitting an existing studythathas riot been submitted previously to the
             Agency by, any one (Submitting ah Existing Study)     1
       (5)    I am submitting or citing data tp 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 IHC.1, 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 thatyour
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 productfor which data will be submitted must be noted in the
agreement to cost share by the registrant selecting tins option.

Option 3. Offer to Share in the Cost of Data Development —The same requirements for
generic data (Section IH.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.

       '    •   ,-           •-.'•''.'•-•     93        "...    : • '•';.• ••'.'•  . ' •  ' .:'  ' .  ';.' . /'. '

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 Option 4. Submitting an Existing Study — The same requirements described for generic data
 (see Section HI.C.1., Option 4) apply to this option for product specific data,

 Option 5. Upgrading a Study ~ The same requirements described for generic data (see
 Section me.}., Option 5) apply to this option for product specific data,
  '  ,   '.',   ,:	I ,"  " , .    ,."•/,; •.•'.'i."1; '-." • r  .:,; ':•".' ,; :•'•;/'..:;  • ™.•:;''••,'   •.'.'-•'   ', ,
 Option 6. Citing Existing Studies — The same requirements described for generic data (see
 Section ni.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 (m.C.L), as appropriate.                   .

 m-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 requirements) 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 1he appropriateness of requiring data
for low volume, minor use pesticides. In implementing this provision, EPA considers low
volume pesticides to be only those active ingredients whose total production volume for all
pesticide registrants is small. In determining whether to grant a low volume/minor use waiver,
the Agency will consider the extent, pattern and volume of use, the economic incentive to
conduct the testing, the importance of the pesticide, and the exposure and risk from use of the
pesticide. If an active ingredient is used for both high volume and low volume uses, a low
volume exemption will not be approved. If all uses of an active ingredient are low volume and
the combined volumes for all uses are also low, then an exemption .may be granted, -
depending on review of other information outlined below. An exemption will not be granted
if any registrant of the active ingredient elects to conduct the testing. Any registrant receiving
a low volume/minor use waiver must remain within the sales figures in their forecast
supporting the waiver request in order to remain qualified for such waiver. If granted a
waiver, a registrant will be required, as a condition of the waiver, to submit annual  sales
reports. The Agency will respond to requests for waivers in writing.

      To apply for a low volume, minor use waiver, you must submit the following
information, as applicable to your product(s), as part of your 90-day response to this Notice:
                          x       . 	    .	  .  .           . i
                                        94

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        (i). Total company sales (pounds and dollars) of all registered produces)
 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 yeaf 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.              •"'.''                       ,  '. .  s: •• \

        (iii). Total directproduction 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. plairt overhead, amortized plant and
 equipment) charged to produces) 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 arid any data development.

        (v)  A list of each data requirement for which you seek awaiver. Indicate the
 type of waiver sought and the estimated cost to you (listed separately for ซach 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) ofconducting 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 produces) containing the active ingredient (following the
 parameters in item 3 above), and costs of data development pertaining to the active
 ingredient.       •

        (viii) A description of the importance and unique benefits of the active •
 ingredient to users. Discuss the use patterns and theeffectiveness of the active
 ingredient relative to registered alternative chemicals and non-chemical control
 strategies.  Fpciis 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 estirnates. 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 produces): (a) documentation of the usefulness of the active ingredient in
v     . . ,     " .     (        "-'/*''    ""•*•>-,'.   "      •-,*"'   -   V       '=,'."
'•..''     ;      - •  .   : '   •' ..    '95  '  .     -, :  -,.-':    '•'  •'' •- -. '• ' •;•••

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Integrated Pest Management, (b) description of the beneficial impacts on the
environment of use of the active jngredient, 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 produces) 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 hi writing. If the Agency
determines that the data requirements of this Notice are not appropriate to your
produces), 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(sV 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 FJFRA. 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 arid submit the Pption 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 mat submitting a waiver request will not automatically extend the

                                  96

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       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 fore
SECTION IV.     CONSEQUENCES OF FAILURE TO COMPLY WITH THIS
        ',      •    ' NOTICE           :':.,  V    ;       • -  - : .  ..-•   .  ,  . ... .

IV-A NOTICE OF INTENT TO SUSPEND

      The Agency mayissue a Notice of Intent'.to Suspend products subject to. tiii& 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 arenot limited to, the following:
       1.
      2.
      3.
      4.
      7.

      8.
 Failure to respond as required by this Notice within 90 days of your receipt of
 this Notice.          .;••'-,                                .

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

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

 Failure to submit on the required schedule acceptable data as required by this
Notice;  .". . .   .'.•'..   •  .-....';    ..-.''..•''   -•_.-  .     ; _  ,

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

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

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

Failure of the registrant to whom you have tendered an offer to share in the cost
of developmg data and provided proof of me registrant's receipt of such offer or
failure of a registrant on whom you rely for a generic data exemption either tor
a).  Inform EPA of intent tb develop and submit the data required by this
Notice on a Data Calkin Response Form and a Requirements Status and
Registrant's Response Form.
                                        97  ,

-------
       9.
   b). Fulfill the commitment to" develop and submit the data as required by this
   Notice; or                                            ,

   c). Otherwise take appropriate steps to meet the requirements stated in this
   Notice, unless you commit to submit and do submit the required data in the
   specified time frame.
  1 ' '           '   '       "'"',. Jf "   ...    '.''''   .    '    1
   Failure to take any required or appropriate steps, not mentioned above, at any
   time following the issuance of this Notice.
IV-B.  BASIS FOR DETERMlMATTON THAT SUBMITTED STUDY IS
       UNACCEPTABLE          ".'..'''...  		      :
     1  ,     VV1  ' ., •'  :', • 	 " ; '	' '!!    , , ; 	'.' : , . .', • i, ,   - ..,;,.	'  ; ..   • ;     .   ' '   ;  .   • \ . 1 •.
       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, DataReportihg 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
5TING STOCKS OF SUSPENDED OR CANCELED PRODUCTS
      EPAhas statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or canceled 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
                                        98

-------
 produces) 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 ifte quantity of existing stocks and your estimate ofIhe
 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 produces) 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 Agencywill allowpersons Other thanthe
 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 canceled products containing an active ingredient for which the Agency has
 particular risk concerns will be determined.on a case-by-casebasis.

       Requests for voluntary cancellation received after the 90 day response period required  :
 by Ibis Notice will notxesult in the agency granting any additional time to sell, distribute, or
 use existing slocks beyond ayear from Hie 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 mis Notice. For example, if you decide to voluntarily cancel
 your registration six months before a 3-year study is scheduled to be submitted, all progress
 reports and other information necessary to establish that you have been conducting the study
 in an acceptable and good faith manner must have been submitted to the Agency, before EPA
 will consider granting an existing stocks provision.
SECTION V.
REGISTRANTS* OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
 .      Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the
information to the Agency. Registrants must notify the Agency of any factual information
they have, from whatever source, including but not limited to interim or preliminary results of
studies, regarding unreasonable adverse effects on man or the environment. This requirement
continues as long as the products are registered by the Agency.


SECTION VI.     INQUIRIES AND RESPONSES TO THIS NOTICE

       If you have any questions regarding the requirements and procedures established by
this Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status
Sheet.'   ;     - .     • '     •• '  ' : ' - •.    .. •   ..-..•.-.•  '    ~~  , •  v  ,   :    ~  r~~
                                         99

-------
      All responses to this .Notice must include completed Data Call-fa 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,
                                    b  (2-
                               Lois A. Rossi, Director
                               Special Review and
                                Reregistration Division
Attachments
      The Attachments to this Notice are:                        -

      1-    Data Call-In Chemical Status Sheets
      2 -    Generic Data Call-in and Product Specific Data Call-in Response Forms with
     •,  '  '   '"instructions	,	  •	'	   (   ,..'.''       ,      •  :
            Generic Data Cali-In and Product Specific Data Call-In Requirements Status
            and Registrant's Response Forms with Instructions
            EPA Batching of End-Use Produces fior Meeting Acute Toxicology Data
3-

4-

5-
6-
            Requirements for Reregistration
            List of Registrants Receiving This Notice
            Confidential Statement of Formula. Cost Share and Data Compensation Forms
                                    .   100

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             BUTRALIN DATA CALL-IN CHEMICAL STATUS SHEET

 INTRODUCTION        ,
   '   '-'-''' t '         - •            • ' - '      '              .-.-•"' "'i -
      You have been sent this Product Specific Data Gall-In Notice because you have   '
 produces) containing Butralin.                               i

      This Product Specific Data Call-in Chemical Status Sheet, contains an nvftrviW ปf
 data required by this notice, and point of contact for inquiries pertaining to the reregistration
 of Butralin. 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) a list of
 registrants receiving this DCI (Attachment 5) and (7) the Cost Share and Data Compensation
 Forms in replying to this Butralin Product Specific Data Call-M (Attachment 6).  Instructions
 and guidance accompany each form.                     ,                          .,

 DATA REQUIRED BY THIS NOTICE

      The additional data requirements needed to complete Hie data base for Butralin are
 contained in the Requirements Status and Registrant's Response Attachment 3. The Agency
has concluded that additional data on Butralin are needed for specific products^ These data are
required to be submitted to the Agency within the time frame listed. These data are needed to
fully complete the reregistration of-all eligible Butralin products. .-V-

INOUIRIES AND RESPONSES TO THIS NOTICE

   ;  .If you have any questions regardingthis 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 date requirements should be
      submitted to:

            C.P. Moran, Chemical Review Manager  ,            ;
            Product Reregistration Branch
            Special Review and Reregistration Branch (7508W)
            Office of Pesticide Programs
            U.S. Environmental Protection Agency
        ;   Washington, D.C. 20460         -      -                    :

            RE:Butraliri                               ,         n
                                      101

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BUTRALIN DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION
                                            •,            •'  /
                         1 ',    ' '! '   '      ,",,',,.  i ', •,, ,,';    '       _          '
      You have been sent this Generic Data Call-In Notice because you have produces)
containing Butralin.

      This _(jeneric'Data Call-in Chemical Status Sheet contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of
Butralin.  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 3), (4) a list of registrants receiving this DCI
(Attachment 5), (5) the Cost Share and Data Compensation Forms in replying to this Butralin
Generic Data Call In (Attachment D). Instructions and guidance accompany each form.

DATA REQUIRED BY THIS NOTICE

      The additional data requirements needed to complete the generic database for Butralin
are contained in the Requirements Status and Registrant's Response. Attachment 3.  The
Agency has concluded that additional product chemistry data on Butralin are needed.  These
data are needed to fully complete the reregistration of all eligible Butralin products.

PTOUIRIES  AND RESPONSES TO THIS NOTICE                  ,

      If you have any  questions regarding the generic data requirements and procedures
established by mis Notice, please contact Tom Luminello at (703) 308-8075.

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

            Tom Luminello,  Chemical Review Manager
            Reregistration Branch III.
            Special Review and Reregistration Division (7508W)
            Office of Pesticide Programs
            U.S. Environmental Protection Agency
            Washington, D.C. 20460                              ,

            RE: Butralin
                                       102

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  Instructions For Completing The "Data Call-in Response Forms" For The Generic And
                             Product Specific Data Call-In


 INTRODUCTION
                       \   "•--'.;    ''••'•    , - v .      -J,       • •'.    "' '    ••',,'     '
       These instructions apply to the Genetic and Product Specific "Data Call-In Response
 forms" and are to be used by registrants to respond to generic and product specific Data Call-ins
 as .part  of EPA's Reregistration Program under the Federal Insecticide, Fungicide, and
 Rodenticide Act.   If you are an end-use product registrant only and have been sent this DCI letter
 as part of a RED document you have been sent just the product specific "Data Call-In Response
 Forms." Only registrants responsible for generic data have been sent the generic data response
 form.  The type of Data Call-In (generic or product specific) is indicated in item number 3
 ("Date and Type of DCI") on each form.

       Ahhough 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! through-4have been preprinted on thefbrm. Items 5 through7 must be mpleted
 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, Regulatory Information
 Division, Mail Code 2137, 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.      '                                    ,
                                        105

-------
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-In                           .

Item 1.       ON BOTH FORMS:  This item identifies your company name, number and
             address.

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

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

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

Item 5.       ON BOTH FORMS:  Check this item for each product registration you wish to
             cancel voluntarily. If a registration number is listed for a product for which you
           -  previously requested voluntary cancellation, indicate in Item 5 the date of that
             request. Since this Data Call-In requires both generic and product specific data,
             you must complete item 5 onboth Data Call-In response forms. Youdonotneed
             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 chemicallisted.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 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 /act  that some of  your sources are
             registered), you may not claim a Generic Data Exemption and you may not select
             this item.
                                       106

-------
INSTRUCTIONS FOR COMPLETING THE DATA GALL4N RESPONSE FORMS
Generic and Product Specific Data Call-In      ~~~'•  .-      .',-;"  .   . •.' '  .   T.,'

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

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

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

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

             FOR BOTH MUP and EUP products

             You should also respond "yes" to this item (7afor MUP's and 7b for EUP's) if
             yourproduct 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.
                                       107

-------
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 initialed and dated in the space
             provided for the certification.    '

Item 9.       QN 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.      0N BOTH FORMS: Enter the phone number of your company contact.
   Note
                                       th^
         wish to report flat yoOTproA*rthปiakMdybe P1"" "Wfr ซU relevant details so that EPA can emuwtiist its reeoids are comet
                                       108

-------
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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
Fungicide, and Rodenticide Act.  If you are an end-use product registrant only and have been
sent this DCI letter as part of a RED document you have been sent just the product specific
"Requirements Status and Registrant's Response Forms."  Only registrants responsible for generic
data have been sent the generic data response forms.  The type of Data Call-In (generic, or
product specific) is indicated in item number 3 ("Date and Type of DCI") on each form.

       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 deletion of uses or 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 oh 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.      ,   '

   i    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 mamtaiiing the data needed, and completing and reviewing the collection of
information. Send comments regarding the burden estimate or any other aspect of this collection
of information, including suggestions for reducing this burden, to Chief, Regulatory  Information
Division,  Mail Code  2137,  U.S.  Environmental Protection Agency, 401  M  St., S.W.,
Washington, D.C. 20460; and to the Office of Management and Budget, Paperwork Reduction
Project 2070-0107, Washington, D.C. 20503.                 -
                                        115

-------
    INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
                      REGISTRANT'S RESPONSE FORMS"
•           , ,	11 .    .•"   ,	•	', '. •• i1'  :' "'i	< . ."' >  "   	   •     	   •'•..,
Generic and Product Specific Data Call-In
 Item 1.


 Item 2.
ItemS.
Item 4.
ItemS.
 ON BOTH FORMS:
 address.
Thjs item identifies your company name, number and
 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.

 ON THE GENERIC DATA FORM:  This item identifies the type of Data
 Call-In. The date of issuance is date stamped.
    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 lie transmittal document for any data submissions in response to this Data Call-
in Notice.

ON BOTH FQRMS:  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, Subpartc.

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 in of the Data Call-In Notice, 90-day progress reports are required for all
studies.
•:i   . •   "  ' '• -,,; •. . ••• .). ' •••.'  •  •"  • ] ..... ,, •; ..... ""'.•  .-„•,.• ,     ••     •  .     -  , •
If an asterisk appears hi Item 5, EPA has attached information relevant to this
guideline reference number to the Requirements Status and Registrant's Response
Form.
                                      116

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    INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
                      REGISTRANT'S RESPONSE FORMS"

Generic and Product Specifip Data Call-In

Item 6.       ON BOTH FORMS:  This item identifies the code associated with the use patteni
             of the pesticide,  In the case of efficacy data (product specific requirement), the
             required study only pertains to products whichL  havethe use sites and/or pests
             indicated. A brief description of each code follows:
         • L       ,* - "  "       -•*  '     .'     •     •     •'     '      "
        ' '  '•  A     Terrestrial food
             B     Terrestrial feed   ;v       ;
             C     Terrestrial non-food
             P     Aquatic food         .
          x  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                              v     '    /
             L     Indqorfodd                                 ,
             M    Indoor non-food
             N     Indoor medical
             O     Indoor residential

Item?.       ON BOTH FORMS:  This itemIdentifies^e^^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
End-Use Product
Manufacturing-Use Product     !
Manufacturing-U-se Product and Technical Grade Active
Ingredient
Pure Active Ingredient
Pure Active Ingredient and Metabolites
Pure Active Ingredient or Pure 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
                                       117

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Item 8.
             tEP/PAI/M

             TGAI
             TGAI/PAI
             TGAI/TEP

             MET
             IMP
             DEGR
                   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 GFJSERIC DATA FORM:  The time frame runs from the date of your
receipt of the Data Call-In notice.
             ON THE PRODUCT SPECIFIC DATA FORM:  The due date for submission
             of product specific studies begins from the date stamped on the letter transmitting
             the Reregistration Eligibility Decision document, and not from the date of receipt.
             However, your response to the Data Call-In itself is due 90 days from the date of
             receipt.
             . lii > - ;'. • "•.,ป.:;""' 'I1  '•', •! f' • • '•.'..:' ::'.••;' • '•..,:";':; " / P .:•: • i't') -  ";; lf:\, •' '•,    ,,:'   ••           '.
Item 9.       ON BOTH FORMS: Enter the appropriate Response Code or Codes to show how
             y8u intend to comply with each data requirement. Brief descriptions of each code
             fallow. The Data Call-in Notice contains a fuller description of each of these
             options.

      Option L    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 mis option, I  certify that I will comply with all the
               J    requirements pertaining to the conditions for submittal of  this  study as
                   outlined in the Data^ Call-in Notice and that I will provide the prptocols and
                   progress reports required in item 5 above.

      Option 2.    ON BOTH FORMS:  (Agreement to Cost Share) I have entered into an
                   agreement with one  or more registrants  to  develop data jointly. By
                   indicating that I have chosen this option, I certify that I will comply with
                   all the requirements pertaining to sharing in the cost of developing data as
                   outlined in the Data Call-In Notice.
                                        118

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                    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 quality for this option. I certify that another party in
             the agreement is committing to submit or provide the required data; if the
             required study is, not submitted on time, my product may be subject to
             suspension.                                                     ,

Option 3.     ON BOTH FORMS: (Offer to Cost Share) I have made an offer to enter
        -     into an agreement with one or more registrants to develop data jointly.  I
             am also submitting a convicted "Certification of offer to Cost Share in the
             Development of Data" form.  I am submitting evidence that I have made
             ah offer to another registrant (who has an obligation to submit data) to
             share in the cost of that data. lam including a copyof my offer and proof
             of the other registrant's receipt of tiiat offer.  I am identifying the party
             which is committing to submit of 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 Cail-In Notice
             apply as well.

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

Option 4.     ON BOTH FORMS: (Submitting Existing Data) I wiU submit an existing
             study by the specified due date that has never before been submitted to ,
             EPA.  By indicating that I have chosen this option, I certify that this study
             meets all the requirements pertaining to the conditions for  submittal of
             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
             chosenthis option,I certify that I have met all the requirements pertaining
             to the conditions for'submitting or citing existing data to upgrade a study
             described  in the Data Call-in Notice.  I am indicating  on attached
             correspondence the Master Record Identification  Number (MRID) that
             EPA has assigned to the data that I am citing as well as the MRID of the
             study I am attempting to upgrade.           ,      .                „

Option 6.     ON BOTH FORMS: (Citing a Study) I am citing an existing study that
             has been previously classified by EPA as acceptable, core, core minimum,
                                  119

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             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
       f      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 low volume/minor use data waivers  in the Data Call-in
             Notice and I request a waiver of the data requirement. I am attaching a
             rationale explaining why I believe the data requirements do not apply. I am
             also submitting a copy of my current labels. (You must also submit a copy
             of your Confidential Statement of Formula if not  already on file with
             EPA). I understand that, unless modified by the-Agency in writing, the
             data requirement as stated in the Notice governs.

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

Option 7.    (Waiver  Request)  I  request a waiver  for this  study because  it is
             inappropriate for my product. I am attaching a complete justification for
             this request, including technical reasons, data and references to relevant
             EPA regulations, guidelines or policies. [Note: any supplemental data must
                                  120

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Item 10.



Item 11,

Item 12.
       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 J?e required to supply the  data pursuant to Section 3(C)(2)  (B)  of
     .  FIFRA. If the Agency denies my waiver request,! 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 thes
       Agency's written decision, submit a revised "Requirements Status" form
     -.: specifying the option  chosen. ,1 also understand that the  deadline for
       submission of data as specified by the original Data Call-in notice will not  .
       change.

ON BOTH FORMS: This item must be signed by an authorized representative  of
your company. The person signing must include his/her tide, and must initial and
date all other pages of this form.

ON BOTH FORMS: Enter the date of signature:
                               '.''•'               -              '
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 mat 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;keen transferred to another company or that youhave already voluntarily canceled '
                                          121

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EPA'S BATCHING OF BUTRAUN PRODUCTS FOR MEETING REREGISTRATION
ACUTE TOXICITY DATAREQUIREMENTS
      In. an. effort to reduce the time, resources and number of animals- needed to fulfill the acute
tpxicity data requirements for reregistration of products, the Agency has batched products which
can be considered similar for purposes of acute toxicity.  Batching was not done for Butralin
since there are only two products.
                                     122

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Cost Share, Data Compensation Forms,  Confidential Statement of Formula
Form and Instructions
      1      „ „     ,  „   , „",   „    ,„               	    ,   ,   ,     .             *

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:

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

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

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

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

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

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

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

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

            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.            , "  "  '"  .   •''...•   '

            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
            tlnits (i.e., pounds and kilograms).

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

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

            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.

            When new CSFs  are submitted and approved, all previously submitted CSFs
            become obsolete for that specific formulation.
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                                 124

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126

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                       United States Environmental Protection Agency
                                    Washington, D.C. 20460
                                Certification of Offer to Cost
                            Share in the  Development of Data
  Perm Approved
OMB No. 2070-0106,
    2070-0057
 Approval Expires "
     3-31-99
  PubBc reporting burden for this collection of information is estimated to average 15 minutes per response, including
  time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
  completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
  aspect of this collection of information, including suggestions for reducing this burden to. Chief Information Policy
  Branch, PM-233, U.S. Environmental Protection Agency, 401 M St.. S.W., Washington, DC 20460; and to the Office of
  Management and Budget, Paperwork Reduction Project (2070-O106), Washington, DC 20503.               '  .

  Please fill in blanks below:
  Company Nanw
 BnoactNanป
                                                                                   BPAIUC.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 developingdata.
    '  ' ' - "           ' '.       ' '   '  ' :   '          jf* '-•'.'   '   '  '    -          ....      .
  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)(2MB)(Hi) of FIFRA if final agreement on all terms
  could not be reached otherwise. This offer was made to the following firms on the following
  date(s):                                                  _
                                                                                   Dm of Offer
 Certification:
 Icertiry 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.
 Signatw of Company's Authorized nซnraaantaซiiป
                                                                                   Date
 Nam* and TMI* (PlMW Typ* or Flint)
EPA Form 8570-32(5/91} Replaces EPA torn 8580 which is obsolete
                                                127

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128.

-------
                         United States Environmental Protection Agency
                                     Washington, DC 20460
                               CERTIFICATION WITH RESPECT TO
                            DATA COMPENSATION REQUIREMENTS
Form Approved
OMB No. .2070-0107,
2070-0057  '
Approval Expires
3-31-99             ;
   Public reporting burden for this collection of information is estimated to average 15 minutes per response, including time for
   reviewing instructions, searching .existing data sources, gathering and maintaining the data needed,.and completing and reviewing the
   collection of information.  Send comments regarding the burden estimate or any other aspect of this collection of information,
   including suggestions for reducing this burden to, Chief, Regulatory Information Division, Mail Code 2137, U.S. Environmental Protection
   Agency, 401 M St., S.W., Washington, DC 20460; and to the Office of Management and Budget, Paperwork Reduction Project
   (2070-0106), Washington, DC 20503.        ,     '                                                          .,

   Please fill in blanks below.                              ,                                            N
Company Name ' • • '-'•'•.- .'•'".
Product Name ' ,/-.,.- "•'..''•".'•-.
=-. * t ' •
Company Number
EPA Reg. No.
  I Certify that:                                                                                          v

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

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

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

  3;   That I have previously complied with section 3(c)(1 )(F) of FIFRA for the studies I have cited in support of registration or
  reregistration under FIFRA.                                            ',
Signature • '.•'..
Date
  Name and Title (Please Type or Print)
  GENERAL OFFER TO, PAY: I hereby offer and agree to pay compensation to other persons, with regard to the registration or
  reregSstration of my products, to the. extent required by FIFRA section 3(c)(1)(F) and 3(c)(2)(D).
Signature ' ' , ,
•''.'.•''." • ' - • - ' •'. ' • . • - . , • . -".- !
Date
  Name and Title (Please Type or Print)
tHA l-orm 8570-31 (4-96)
                                                          129

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            APPENDIX E - LIST OF AVAILABLE RELATED DOCUMENTS

    The following is a list of available documents for Butralin that may further  assist you in
responding to this Reregistration Eligibility Decision document. These documents may be obtained
by the following methods:

Electronic                                                              .
File format:   Portable Document, Format (.PDF) Requires Adobeฎ Acrobat or compatible reader.
             Electronic copies can be downloaded from the Internet using World Wide Web on
             http://www.epa.gov/ElEDs/, or contact G.P. Moran at (703) 308-8590.

    1.       PR, Notice 86-5.

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

    3.       A full copy of this RED document.

    4.       A copy of the fact sheet for Butralin.


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

    1.       Health and Environmental Effects Science Chapters.

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

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

    1.       The Label Review Manual.

    2.       EPA Acceptance Criteria.
                                         130

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