20031028 cpda festf update
TRANSCRIPT
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FIFRA Endangered Species Task Force
COMPLIANCE SERVICES INTERNATIONAL
FESTF Update
Karen WarkentienCPDA Registration 101
November 6, 2003
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FIFRA Endangered Species Task Force
COMPLIANCE SERVICES INTERNATIONAL
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 . . .”
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FIFRA Endangered Species Task Force
COMPLIANCE SERVICES INTERNATIONAL
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
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FIFRA Endangered Species Task Force
COMPLIANCE SERVICES INTERNATIONAL
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
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FIFRA Endangered Species Task Force
COMPLIANCE SERVICES INTERNATIONAL
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
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FIFRA Endangered Species Task Force
COMPLIANCE SERVICES INTERNATIONAL
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
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FIFRA Endangered Species Task Force
COMPLIANCE SERVICES INTERNATIONAL
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
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FIFRA Endangered Species Task Force
COMPLIANCE SERVICES INTERNATIONAL
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
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FIFRA Endangered Species Task Force
COMPLIANCE SERVICES INTERNATIONAL
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
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FIFRA Endangered Species Task Force
COMPLIANCE SERVICES INTERNATIONAL
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
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FIFRA Endangered Species Task Force
COMPLIANCE SERVICES INTERNATIONAL
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.
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FIFRA Endangered Species Task Force
COMPLIANCE SERVICES INTERNATIONAL
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