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FESTF Update


    Karen Warkentien
  CPDA Registration 101
   November 6, 2003

                                      COMPLIANCE SERVICES INTERNATIONAL
FIFRA Endangered Species Task Force
Developments over Time

• Formative stage (1993-1996)
  – EPA wanted location data (crop and
    species)
  – Location data as implemented were an
    unequal conditional requirement
  – FESTF was formed to bring equity and a
    solution to providing “location data”
  – The conundrum, “Data, data everywhere
    but not a byte to be found . . .”

                                              COMPLIANCE SERVICES INTERNATIONAL
        FIFRA Endangered Species Task Force
Developments over Time

• Informative stage (1996-1997)
  – EPA got location data (feasibility study)
  – FESTF sought sources for providing data
    or expert opinion (state database)
  – EPA explored internal and stakeholder
    opinions
    • Phoenix workshop
    • TNC proposal
    • a CRADA proposed by EPA

                                              COMPLIANCE SERVICES INTERNATIONAL
        FIFRA Endangered Species Task Force
Developments over Time

• Conformative stage (1998-2002)
  – FESTF and EPA agreed in principle to
    • An IMS
    • A CRADA (species location data)
    • A quality test of the IMS
  – FESTF launched work on IMS
  – PR Notice 2000-2 published



                                              COMPLIANCE SERVICES INTERNATIONAL
        FIFRA Endangered Species Task Force
Developments over Time

• Reformative stage – phase 1
  (2002-2003)
  – Lawsuits filed sequentially; threats to
    registration and use status hit “home”
  – Endangered species reviews in REDs and
    registration actions are inconsistent
  – FESTF’s appreciation of the
    situation communicated to
     others
                                              COMPLIANCE SERVICES INTERNATIONAL
        FIFRA Endangered Species Task Force
Developments over Time

• Reformative stage – phase 2 (2003)
  – Consultations under consent decree
  – Defending products in litigation
  – FESTF need to abandon CRADA and
    directly deal with NatureServe
  – Federal Register Notice on ESPP
  – Federal Register Notice on ANPR
  – More lawsuits and threats of interim
    measures
                                              COMPLIANCE SERVICES INTERNATIONAL
        FIFRA Endangered Species Task Force
Bringing Focus

• Meetings with Adam Sharp and
  announcement of needs
  – Equity
  – Uniform and formal data requirements
  – Assurance that IMS will be a part of the
    ESPP and new rule process
• Positive but informal feedback from
  EPA
• Resumption of momentum
                                              COMPLIANCE SERVICES INTERNATIONAL
        FIFRA Endangered Species Task Force
FESTF Deliverables and the Overall Risk
        Assessment Process
• Overall RA process will be in new rule
  – Expected to include use of FESTF data
• FESTF deliverables must be fully
  functional to support ES assessments
  on an AI basis
  – FESTF case studies
  – Feedback from companies now performing
    ES assessments

                                              COMPLIANCE SERVICES INTERNATIONAL
        FIFRA Endangered Species Task Force
The Role and Importance of NatureServe
                Data
• NatureServe data are best available and
  therefore “trump” EPA/FWS data
   – Exclusions can be developed
   – Protections can be developed
• P/Es are critical for AI-specific ES
  assessments
   – Without P/Es, more AI-specific mitigation is
     necessary
   – With P/Es developed “now,” more consistency is
     likely

                                                COMPLIANCE SERVICES INTERNATIONAL
          FIFRA Endangered Species Task Force
Final Path toward Submission

• An IMS that functions within an AI-
  specific ES assessment
• A consistent set of protections and
  exclusions to make ES assessments
  less burdensome
  – Species location data (NatureServe)
  – Species/location-specific protections



                                              COMPLIANCE SERVICES INTERNATIONAL
        FIFRA Endangered Species Task Force
Summary of October PPDC Meeting

• Triggers for endangered species data
  requirements were discussed.
  – EPA explains the option of joining the FESTF or
    developing individual data.
• It is expected that a PR Notice or some
  modified version of a DCI will further outline
  data requirements.
• At some point in the future, 40 CFR Part 158
  test requirements are expected to include
  data requirements for endangered species.
                                               COMPLIANCE SERVICES INTERNATIONAL
         FIFRA Endangered Species Task Force
The Timeline and Tasks We Face

• Submission date, March 2005 with no
  options for further extensions
• NatureServe 36 month access period
  after submission
• Endangered species data requirements
  met



                                             COMPLIANCE SERVICES INTERNATIONAL
       FIFRA Endangered Species Task Force

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20031028 Cpda Festf Update

  • 1. FESTF Update Karen Warkentien CPDA Registration 101 November 6, 2003 COMPLIANCE SERVICES INTERNATIONAL FIFRA Endangered Species Task Force
  • 2. Developments over Time • Formative stage (1993-1996) – EPA wanted location data (crop and species) – Location data as implemented were an unequal conditional requirement – FESTF was formed to bring equity and a solution to providing “location data” – The conundrum, “Data, data everywhere but not a byte to be found . . .” COMPLIANCE SERVICES INTERNATIONAL FIFRA Endangered Species Task Force
  • 3. Developments over Time • Informative stage (1996-1997) – EPA got location data (feasibility study) – FESTF sought sources for providing data or expert opinion (state database) – EPA explored internal and stakeholder opinions • Phoenix workshop • TNC proposal • a CRADA proposed by EPA COMPLIANCE SERVICES INTERNATIONAL FIFRA Endangered Species Task Force
  • 4. Developments over Time • Conformative stage (1998-2002) – FESTF and EPA agreed in principle to • An IMS • A CRADA (species location data) • A quality test of the IMS – FESTF launched work on IMS – PR Notice 2000-2 published COMPLIANCE SERVICES INTERNATIONAL FIFRA Endangered Species Task Force
  • 5. Developments over Time • Reformative stage – phase 1 (2002-2003) – Lawsuits filed sequentially; threats to registration and use status hit “home” – Endangered species reviews in REDs and registration actions are inconsistent – FESTF’s appreciation of the situation communicated to others COMPLIANCE SERVICES INTERNATIONAL FIFRA Endangered Species Task Force
  • 6. Developments over Time • Reformative stage – phase 2 (2003) – Consultations under consent decree – Defending products in litigation – FESTF need to abandon CRADA and directly deal with NatureServe – Federal Register Notice on ESPP – Federal Register Notice on ANPR – More lawsuits and threats of interim measures COMPLIANCE SERVICES INTERNATIONAL FIFRA Endangered Species Task Force
  • 7. Bringing Focus • Meetings with Adam Sharp and announcement of needs – Equity – Uniform and formal data requirements – Assurance that IMS will be a part of the ESPP and new rule process • Positive but informal feedback from EPA • Resumption of momentum COMPLIANCE SERVICES INTERNATIONAL FIFRA Endangered Species Task Force
  • 8. FESTF Deliverables and the Overall Risk Assessment Process • Overall RA process will be in new rule – Expected to include use of FESTF data • FESTF deliverables must be fully functional to support ES assessments on an AI basis – FESTF case studies – Feedback from companies now performing ES assessments COMPLIANCE SERVICES INTERNATIONAL FIFRA Endangered Species Task Force
  • 9. The Role and Importance of NatureServe Data • NatureServe data are best available and therefore “trump” EPA/FWS data – Exclusions can be developed – Protections can be developed • P/Es are critical for AI-specific ES assessments – Without P/Es, more AI-specific mitigation is necessary – With P/Es developed “now,” more consistency is likely COMPLIANCE SERVICES INTERNATIONAL FIFRA Endangered Species Task Force
  • 10. Final Path toward Submission • An IMS that functions within an AI- specific ES assessment • A consistent set of protections and exclusions to make ES assessments less burdensome – Species location data (NatureServe) – Species/location-specific protections COMPLIANCE SERVICES INTERNATIONAL FIFRA Endangered Species Task Force
  • 11. Summary of October PPDC Meeting • Triggers for endangered species data requirements were discussed. – EPA explains the option of joining the FESTF or developing individual data. • It is expected that a PR Notice or some modified version of a DCI will further outline data requirements. • At some point in the future, 40 CFR Part 158 test requirements are expected to include data requirements for endangered species. COMPLIANCE SERVICES INTERNATIONAL FIFRA Endangered Species Task Force
  • 12. The Timeline and Tasks We Face • Submission date, March 2005 with no options for further extensions • NatureServe 36 month access period after submission • Endangered species data requirements met COMPLIANCE SERVICES INTERNATIONAL FIFRA Endangered Species Task Force