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FIFRA Endangered Species
           Task Force

                   Current Status of Activities



12 December 2001            CPDA Registration 101   1
Endangered Species and
      Pesticide Regulation History
• 1973 - Endangered Species Act (ESA) enacted by
         Congress
• 1987 - EPA enhances regulatory approach using
         further label restrictions (county lists on labels)
• 1988 - Endangered Species Protection Program
         (ESPP) Action deferred, FIFRA amended
• 1989 - ESPP revised to a voluntary program
          - County bulletins continue to be developed
          - Conditional registrations based on ESA issues arise
12 December 2001          CPDA Registration 101                   2
Data Requests from EPA
 Dow Elanco        37 plants               1993
 ARP               19 plants               1994
                   19 fish
 Sandoz            49 plants               1994
 Monsanto          37 plants               1994
 DuPont            ~100 plants             1994
 Others            No List                 1995/1996

12 December 2001   CPDA Registration 101               3
EPA Requirement to Industry to
          Comply with ESA
• Requirement established as a condition of registration
  under FIFRA

• Registrants to provide
  - locations of endangered species
  - locations of crops in the vicinity of endangered
    species

• EPA to use information in the risk assessment process
   12 December 2001    CPDA Registration 101           4
FESTF Background
  • 1993 - First EPA data requirements for location data
  • 1994 - Endangered Species steering committee formalized
           under auspices of ACPA
  • 1995 - Pilot program initiated to evaluate “feasibility” of
           proximity analysis
  • 1996 - Pilot program indicated proximity analysis should be
           minimized, and that existing methods of protection
           and species biology should be used to make a “may
           effect” determination.
  • 1997 - FIFRA Endangered Species Task Force (FESTF)
           incorporated into an LLC

12 December 2001         CPDA Registration 101                    5
FESTF Member Companies
        Albaugh                  ISKBC
        Aventis                  Monsanto
        BASF                     NuFarm
        Bayer                    Rohm & Haas
        DowAgro                  Syngenta
        DuPont                   Uniroyal
        FMC                      Valent


12 December 2001   CPDA Registration 101       6
Response to Data Requirements

• Pre-FESTF
• FESTF responded to data requirements -- location
  and proximity analysis
• FESTF feasibility study revealed problems

• EPA concluded that methods of obtaining location
  data and proximity analyses were not practical


12 December 2001   CPDA Registration 101         7
Guiding Principles
• Need to minimize requiring registrants to provide
  proximity analyses
    –   Endangered species data are dynamic
    –   Precise location is often unknown or is secret
    –   Landowners may be affected by the release of data
    –   Using existing protections and species biology to help
        determine if “may affect” condition exists

• ESA requires use of best available existing data
• Ensure maximum protection for species
 12 December 2001          CPDA Registration 101                 8
PR Notice Components
• Development and submission by FESTF of an IMS that
  EPA can use to screen pesticide applications when their
  applications trigger potential endangered species issues
                       (Data Requirement #1)
• Funding to EPA by FESTF, through a Cooperative Research
  and Development Agreement (CRADA) of a state-by-state
  species access program that will enable EPA to access high
  quality species locality data to validate the IMS
                       (Data Requirement #2)
• Quality Test of IMS - in part based upon information
  collected by EPA pursuant to the CRADA

 12 December 2001        CPDA Registration 101               9
EPA/FESTF Interactions
• Recognized as a complex issue that needed in
  depth strategic analysis
     – Informational briefing sessions with growers, ACPA,
       state regulatory agencies and other stakeholders
     – Development meetings

     – Workshops to promote practical means of meeting data
       requirements



12 December 2001        CPDA Registration 101                10
Objectives of Joint Effort
• Regulatory compliance -- protection of
  endangered species and agriculture -- in expedient
  and useful manner

• Enhancement of interagency cooperation and state
  participation
• Utilization and refreshing of best available
  scientific data


12 December 2001     CPDA Registration 101         11
EPA Commitments
• No requirement for additional location data for
  FESTF members

• Acknowledgement of Task Force membership to
  fulfill data requirements

• No “responsibility” for completion of CRADA



12 December 2001       CPDA Registration 101        12
FESTF Commitments
• Pursue more efficient, effective, and uniform
  methods of protection: IMS

• Aid in equitable treatment among registrants: IMS
  and CRADA

• Provide consistency in data collection and
  communication: CRADA


12 December 2001    CPDA Registration 101         13
FESTF Structure
• 14 member companies
• Project Manager - Bernalyn McGaughey,
  Compliance Services International
• Information Management System - Tom
  Marr, Battelle Pacific Northwest Labs



12 December 2001       CPDA Registration 101   14
FESTF Proposal on Data
              Requirement #1
• IMS meets pesticide registration requirements
  using existing data

• System’s data are:
      - Ag statistics           - T&E Species data
      - County data             - Protections &
      - Expert data
                                exclusions

12 December 2001    CPDA Registration 101            15
The FESTF Information
             Management System
• An automated system providing data access and
  sorting
• A means of providing consistency
• An opportunity to concentrate on protections in
  place and build sound new protections where
  needed
• Allows FESTF members preliminary view of
  likely EPA assessment

12 December 2001    CPDA Registration 101           16
FESTF Approach to IMS
               Development
• Build system basics

• Develop the Information Management System
• System designed to be current in perpetuity

• Evaluate system and needs
• Plan for entire system to eventually be maintained
  by or for OPP

12 December 2001    CPDA Registration 101          17
IMS Features
• Will have different levels of access, essentially
  corresponding to EPA functions (reviewer, risk
  assessor, endangered species assessor, PM)

• Will be available only for use on FESTF member-
  company products

• CBI vs. data that can be shared

• Will be delivered populated with best available
  current data
12 December 2001     CPDA Registration 101            18
User Types
• Member User
• Member Superuser
• EPA Risk Assessor
• EPA Product Manager
• EPA Endangered Species Assessor
• EPA Superuser
• Data Administrator
12 December 2001    CPDA Registration 101   19
System Function
                                                                                       System Entry


                                                                 Yes



                                O P P IN F O R M A T IO N M A N A G E M E N T S Y S T E M

                                                   S ta n d a r d In p u t

                 In p u t E x a m p le :                   Q u e ry :
                                                                                   D o c u m e n ta tio n O u tp u t:
                   P ro d u c t n a m e            D is tr ib u tio n o f ta x a
                                                                                       ∙ M e c h a n is m o f
                  T a x a o f c o n c e rn        D is tr ib u tio n o f c r o p
                                                  P o te n tia l fo r u s e              p r o te c tio n
                  H a z a r d r a tio                                                 ∙ R e s p o n s ib le p a r t ie s
                  A p p lic a tio n m e th o d     P r o t e c t io n s a n d
                                                    E x c lu s io n s                 ∙ O u ts ta n d in g n e e d s
                  L a b e le d u s e s



                                                     FESTF
Data Feedback                                    W o rk P ro d u c t                                                       ESPP
                                                                                                                           Implementation

     12 December 2001                            CPDA Registration 101                                                           20
IMS Development Status
• Completed Summer 2001

• FESTF will continue interacting with EPA in the
  IMS process
• Currently running quality test, case studies, and
  protections initiative




12 December 2001   CPDA Registration 101 Task Force   41
FESTF Proposal on Data
              Requirement #2

• FESTF to protect sensitive species and agriculture
  by participating in a Cooperative Research and
  Development Agreement (CRADA) to give EPA
  access to comprehensive data.




12 December 2001    CPDA Registration 101          42
CRADA -- MJD
• Multi-jurisdictional database using Heritage data
     – Wider than OPP
     – Other business/federal agency sector interest (e.g.oil
       and pipeline)
• MJD will
     – Standardize data
     – Make data accessible
• FESTF support – a key factor for MJD
  development
12 December 2001         CPDA Registration 101                  43
Participants in CRADA
             • OEI
               – lead on project
             • ORD
             • Region 3
             • OPP
             • FESTF

12 December 2001          CPDA Registration 101   44
Industry’s Involvement in the
                CRADA
• Grant of funds to develop shared data on
  threatened and endangered species

• Opportunity to monitor process and utilize data
  produced

• Opportunity to be involved in data quality goals
  and interpretation

12 December 2001    CPDA Registration 101            45
CRADA Benefits
• FESTF’s contribution to the CRADA give OPP a
  much larger influence on the development of
  shared data than they would otherwise have had

• FEAD’s and FESTF’s involvement in the CRADA
  as it is developed gives a greater voice to
  agricultural issues



12 December 2001      CPDA Registration 101        46
Conclusions on the Process

• A model for industry - EPA joint development of
  solutions to complex problems

    – Exploratory session                   – Critical interaction
    – Workshops                             – Open review and comment


• Clear lines of responsibility

• A continuing process based on system “shake-down”

  12 December 2001          CPDA Registration 101                       47
Conclusions on the Process
                         (Continued)


• An integration of information technology with
  environmental problem solving
     – Simplifies the assessment process
     – Provides a transparent process for T&E Species
       assessment
     – Documents the decision-making process



12 December 2001        CPDA Registration 101           48
Why Join FESTF?
• EPA intends to continue requesting location
  information for registration actions where
  T&ES concerns are triggered
• Expedient way to meet registration
  requirements with respect to the assessment
  of T&ES
• Member companies can participate in
  development of IMS and other FESTF
  activities
12 December 2001       CPDA Registration 101   49
Why Join FESTF?
• To have the ability to preemptively self-
  assess impact (using “what-if” scenarios)
• Companies that join will have access to a
  higher, more accurate level of data on
  endangered species protections than are
  available under any other program
• Non-members will have the burden of their
  own data development
12 December 2001       CPDA Registration 101   50
Cost to join FESTF
• Cost to join is based on total assessments
  plus the interest as of the date of entry into
  the FESTF
• New members will be assessed a 50% risk
  fee.



12 December 2001        CPDA Registration 101      51
How to Join?
• Contact information:
     –   Harold Himmelman, Counsel
     –   Bernalyn McGaughey, Project Manager
     –   Mike McKee, Chair Administrative Committee
     –   Tilghman Hall, Acting Chair Technical Comm.
• Other information:
     – FESTF Website: www.festf.org

12 December 2001       CPDA Registration 101       52

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20011200 Cpda Festf Update

  • 1. FIFRA Endangered Species Task Force Current Status of Activities 12 December 2001 CPDA Registration 101 1
  • 2. Endangered Species and Pesticide Regulation History • 1973 - Endangered Species Act (ESA) enacted by Congress • 1987 - EPA enhances regulatory approach using further label restrictions (county lists on labels) • 1988 - Endangered Species Protection Program (ESPP) Action deferred, FIFRA amended • 1989 - ESPP revised to a voluntary program - County bulletins continue to be developed - Conditional registrations based on ESA issues arise 12 December 2001 CPDA Registration 101 2
  • 3. Data Requests from EPA Dow Elanco 37 plants 1993 ARP 19 plants 1994 19 fish Sandoz 49 plants 1994 Monsanto 37 plants 1994 DuPont ~100 plants 1994 Others No List 1995/1996 12 December 2001 CPDA Registration 101 3
  • 4. EPA Requirement to Industry to Comply with ESA • Requirement established as a condition of registration under FIFRA • Registrants to provide - locations of endangered species - locations of crops in the vicinity of endangered species • EPA to use information in the risk assessment process 12 December 2001 CPDA Registration 101 4
  • 5. FESTF Background • 1993 - First EPA data requirements for location data • 1994 - Endangered Species steering committee formalized under auspices of ACPA • 1995 - Pilot program initiated to evaluate “feasibility” of proximity analysis • 1996 - Pilot program indicated proximity analysis should be minimized, and that existing methods of protection and species biology should be used to make a “may effect” determination. • 1997 - FIFRA Endangered Species Task Force (FESTF) incorporated into an LLC 12 December 2001 CPDA Registration 101 5
  • 6. FESTF Member Companies Albaugh ISKBC Aventis Monsanto BASF NuFarm Bayer Rohm & Haas DowAgro Syngenta DuPont Uniroyal FMC Valent 12 December 2001 CPDA Registration 101 6
  • 7. Response to Data Requirements • Pre-FESTF • FESTF responded to data requirements -- location and proximity analysis • FESTF feasibility study revealed problems • EPA concluded that methods of obtaining location data and proximity analyses were not practical 12 December 2001 CPDA Registration 101 7
  • 8. Guiding Principles • Need to minimize requiring registrants to provide proximity analyses – Endangered species data are dynamic – Precise location is often unknown or is secret – Landowners may be affected by the release of data – Using existing protections and species biology to help determine if “may affect” condition exists • ESA requires use of best available existing data • Ensure maximum protection for species 12 December 2001 CPDA Registration 101 8
  • 9. PR Notice Components • Development and submission by FESTF of an IMS that EPA can use to screen pesticide applications when their applications trigger potential endangered species issues (Data Requirement #1) • Funding to EPA by FESTF, through a Cooperative Research and Development Agreement (CRADA) of a state-by-state species access program that will enable EPA to access high quality species locality data to validate the IMS (Data Requirement #2) • Quality Test of IMS - in part based upon information collected by EPA pursuant to the CRADA 12 December 2001 CPDA Registration 101 9
  • 10. EPA/FESTF Interactions • Recognized as a complex issue that needed in depth strategic analysis – Informational briefing sessions with growers, ACPA, state regulatory agencies and other stakeholders – Development meetings – Workshops to promote practical means of meeting data requirements 12 December 2001 CPDA Registration 101 10
  • 11. Objectives of Joint Effort • Regulatory compliance -- protection of endangered species and agriculture -- in expedient and useful manner • Enhancement of interagency cooperation and state participation • Utilization and refreshing of best available scientific data 12 December 2001 CPDA Registration 101 11
  • 12. EPA Commitments • No requirement for additional location data for FESTF members • Acknowledgement of Task Force membership to fulfill data requirements • No “responsibility” for completion of CRADA 12 December 2001 CPDA Registration 101 12
  • 13. FESTF Commitments • Pursue more efficient, effective, and uniform methods of protection: IMS • Aid in equitable treatment among registrants: IMS and CRADA • Provide consistency in data collection and communication: CRADA 12 December 2001 CPDA Registration 101 13
  • 14. FESTF Structure • 14 member companies • Project Manager - Bernalyn McGaughey, Compliance Services International • Information Management System - Tom Marr, Battelle Pacific Northwest Labs 12 December 2001 CPDA Registration 101 14
  • 15. FESTF Proposal on Data Requirement #1 • IMS meets pesticide registration requirements using existing data • System’s data are: - Ag statistics - T&E Species data - County data - Protections & - Expert data exclusions 12 December 2001 CPDA Registration 101 15
  • 16. The FESTF Information Management System • An automated system providing data access and sorting • A means of providing consistency • An opportunity to concentrate on protections in place and build sound new protections where needed • Allows FESTF members preliminary view of likely EPA assessment 12 December 2001 CPDA Registration 101 16
  • 17. FESTF Approach to IMS Development • Build system basics • Develop the Information Management System • System designed to be current in perpetuity • Evaluate system and needs • Plan for entire system to eventually be maintained by or for OPP 12 December 2001 CPDA Registration 101 17
  • 18. IMS Features • Will have different levels of access, essentially corresponding to EPA functions (reviewer, risk assessor, endangered species assessor, PM) • Will be available only for use on FESTF member- company products • CBI vs. data that can be shared • Will be delivered populated with best available current data 12 December 2001 CPDA Registration 101 18
  • 19. User Types • Member User • Member Superuser • EPA Risk Assessor • EPA Product Manager • EPA Endangered Species Assessor • EPA Superuser • Data Administrator 12 December 2001 CPDA Registration 101 19
  • 20. System Function System Entry Yes O P P IN F O R M A T IO N M A N A G E M E N T S Y S T E M S ta n d a r d In p u t In p u t E x a m p le : Q u e ry : D o c u m e n ta tio n O u tp u t: P ro d u c t n a m e D is tr ib u tio n o f ta x a ∙ M e c h a n is m o f T a x a o f c o n c e rn D is tr ib u tio n o f c r o p P o te n tia l fo r u s e p r o te c tio n H a z a r d r a tio ∙ R e s p o n s ib le p a r t ie s A p p lic a tio n m e th o d P r o t e c t io n s a n d E x c lu s io n s ∙ O u ts ta n d in g n e e d s L a b e le d u s e s FESTF Data Feedback W o rk P ro d u c t ESPP Implementation 12 December 2001 CPDA Registration 101 20
  • 21.
  • 22.
  • 23.
  • 24.
  • 25.
  • 26.
  • 27.
  • 28.
  • 29.
  • 30.
  • 31.
  • 32.
  • 33.
  • 34.
  • 35.
  • 36.
  • 37.
  • 38.
  • 39.
  • 40.
  • 41. IMS Development Status • Completed Summer 2001 • FESTF will continue interacting with EPA in the IMS process • Currently running quality test, case studies, and protections initiative 12 December 2001 CPDA Registration 101 Task Force 41
  • 42. FESTF Proposal on Data Requirement #2 • FESTF to protect sensitive species and agriculture by participating in a Cooperative Research and Development Agreement (CRADA) to give EPA access to comprehensive data. 12 December 2001 CPDA Registration 101 42
  • 43. CRADA -- MJD • Multi-jurisdictional database using Heritage data – Wider than OPP – Other business/federal agency sector interest (e.g.oil and pipeline) • MJD will – Standardize data – Make data accessible • FESTF support – a key factor for MJD development 12 December 2001 CPDA Registration 101 43
  • 44. Participants in CRADA • OEI – lead on project • ORD • Region 3 • OPP • FESTF 12 December 2001 CPDA Registration 101 44
  • 45. Industry’s Involvement in the CRADA • Grant of funds to develop shared data on threatened and endangered species • Opportunity to monitor process and utilize data produced • Opportunity to be involved in data quality goals and interpretation 12 December 2001 CPDA Registration 101 45
  • 46. CRADA Benefits • FESTF’s contribution to the CRADA give OPP a much larger influence on the development of shared data than they would otherwise have had • FEAD’s and FESTF’s involvement in the CRADA as it is developed gives a greater voice to agricultural issues 12 December 2001 CPDA Registration 101 46
  • 47. Conclusions on the Process • A model for industry - EPA joint development of solutions to complex problems – Exploratory session – Critical interaction – Workshops – Open review and comment • Clear lines of responsibility • A continuing process based on system “shake-down” 12 December 2001 CPDA Registration 101 47
  • 48. Conclusions on the Process (Continued) • An integration of information technology with environmental problem solving – Simplifies the assessment process – Provides a transparent process for T&E Species assessment – Documents the decision-making process 12 December 2001 CPDA Registration 101 48
  • 49. Why Join FESTF? • EPA intends to continue requesting location information for registration actions where T&ES concerns are triggered • Expedient way to meet registration requirements with respect to the assessment of T&ES • Member companies can participate in development of IMS and other FESTF activities 12 December 2001 CPDA Registration 101 49
  • 50. Why Join FESTF? • To have the ability to preemptively self- assess impact (using “what-if” scenarios) • Companies that join will have access to a higher, more accurate level of data on endangered species protections than are available under any other program • Non-members will have the burden of their own data development 12 December 2001 CPDA Registration 101 50
  • 51. Cost to join FESTF • Cost to join is based on total assessments plus the interest as of the date of entry into the FESTF • New members will be assessed a 50% risk fee. 12 December 2001 CPDA Registration 101 51
  • 52. How to Join? • Contact information: – Harold Himmelman, Counsel – Bernalyn McGaughey, Project Manager – Mike McKee, Chair Administrative Committee – Tilghman Hall, Acting Chair Technical Comm. • Other information: – FESTF Website: www.festf.org 12 December 2001 CPDA Registration 101 52

Editor's Notes

  1. 1 IND -1 Industry Presents - Bernalyn McGaughey
  2. IND -4 Industry Presents 1987 - Approach had problems 1988 - Approach was revised
  3. Industry Presents Needing to revise county bulletins
  4. Industry Presents - Jennifer
  5. IND -5 Industry Presents - Jennifer 1994 - Endangered Species steering committee formalized under auspices of ACPA to start figuring out a way to get this information together
  6. Industry presents
  7. 2 IND -6 EPA Presents FESTF feasibility study revealed problems (should be called the infeasibility study)
  8. 7 IND -7 EPA Presents Precise location of often unknown or is secret (some species have a high black market value Landowners may be affected by the release of data if less than 3 growers, EPA can’t get the information for what they are growing from them Ensure maximum protection for species (usually complete protection but sometimes incidental take is allowed) USFWS and EPA consult on species
  9. 8 IND - 8 EPA Presents - Larry PR Notice Components (#2000-2)
  10. 4 IND - 9 EPA Presents - Arty
  11. 6 IND -10 EPA Presents - Arty
  12. IND - 11 EPA Presents - Arty
  13. 3 IND- 12 Industry Presents - Jennifer
  14. 3 EPA - 10 Industry Presents
  15. IND- 13 Industry Presents - Jennifer
  16. 8 IND- 14 Industry Presents - Jennifer
  17. 10 IND- 15 Industry Presents
  18. IND- 17 Industry Presents CBI (Confidential Business Information)
  19. IND- 16 Industry Presents
  20. IND - 57 Industry Presents
  21. IND- 21 Industry Presents
  22. IND- 23x Industry Presents
  23. IND- 25 Industry Presents
  24. IND- 26 Industry Presents Send this slide and other slides that demonstrate the tiny window problems to Battelle
  25. IND- 27 Industry Presents
  26. IND- 33 Industry Presents Tilghman thought this many taxa with “yes” was unlikely.
  27. IND- 31 Industry Presents
  28. IND- 32 Industry Presents
  29. IND- 34 Industry Presents All these XXXX together constitute an assessment of Endangered Species as required for a registration package
  30. IND- 36 Industry Presents
  31. IND- 34 Industry Presents
  32. IND- 35 Industry Presents
  33. IND- 38 Industry Presents
  34. IND- 39 Industry Presents
  35. IND- 40 Industry Presents
  36. IND- 44 Industry Presents
  37. IND- x45 Industry Presents
  38. IND- 47 Industry Presents
  39. IND- 48 Industry Presents
  40. IND- 49 Industry Presents
  41. Tilghman
  42. IND - 50 EPA Presents - Larry Bernalyn thinks Larry is overselling the CRADA and that it’s unlikely to do what he says it will - high resolution XXXXXX. CRADA gives XXXX to comprehensive data through state Heritage programs Situations of pipelines requires Endangered Species locations XXXXX as does road building. FOI = Freedom of Information XXXX means has to be released. XXXXX CRADA will/will not be foible?
  43. IND - 51 EPA Presents - Larry
  44. IND - 52 EPA Presents
  45. IND - 53 EPA Presents
  46. IND - 54 EPA Presents
  47. IND - 60 EPA Presents - Arty These things are what was important in getting this process to work: Exploratory session Workshops Critical interaction Open review and comment Clear lines of responsibility
  48. EPA presents [I think that if a company was the first to seek a registration on a product with a totally new risk pattern, then their competitor’s me-too products went through with this system, the competitor’s time disadvantage would be reduced.]
  49. EPA presents - Mike McKee
  50. EPA presents
  51. EPA presents Cost to join is based on total assessments plus the interes as of the date of entry into the FESTF ($360K) … After October 16 there will be a 50% risk fee assessed (to cover the work by the Task Force)
  52. EPA presents