20011200 cpda festf update
TRANSCRIPT
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
ARP 19 plants
19 fish
Sandoz 49 plants
Monsanto 37 plants
DuPont ~100 plants
Others No List
1993
1994
1994
1994
1994
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
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FESTF Member Companies
Albaugh
Aventis
BASF
Bayer
DowAgro
DuPont
FMC
ISKBC
Monsanto
NuFarm
Rohm & Haas
Syngenta
Uniroyal
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
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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
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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
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FESTF Structure
• 14 member companies
• Project Manager - Bernalyn McGaughey, Compliance Services International
• Information Management System - Tom Marr, Battelle Pacific Northwest Labs
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FESTF Proposal on Data Requirement #1
• IMS meets pesticide registration requirements using existing data
• System’s data are:
- Protections & exclusions
- County data
- Expert data
- T&E Species data- Ag statistics
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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
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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
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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
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O P P I N F O R M A T I O N M A N A G E M E N T S Y S T E M
I n p u t E x a m p l e :P r o d u c t n a m e
T a x a o f c o n c e r n H a z a r d r a t i o A p p l i c a t i o n m e t h o d L a b e l e d u s e s
Q u e r y : D i s t r i b u t i o n o f t a x a
D i s t r i b u t i o n o f c r o p P o t e n t i a l f o r u s e
P r o t e c t i o n s a n dE x c l u s i o n s
D o c u m e n t a t i o n O u t p u t :∙ M e c h a n i s m o f
p r o t e c t i o n ∙ R e s p o n s i b l e p a r t i e s
∙ O u t s t a n d i n g n e e d s
S t a n d a r d I n p u t
F E S T FW o r k P r o d u c t
Y e s
System FunctionSystem Entry
Data Feedback ESPP Implementation
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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
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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
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Conclusions on the Process
• A model for industry - EPA joint development of solutions to complex problems
• Clear lines of responsibility
• A continuing process based on system “shake-down”
– Exploratory session
– Workshops
– Critical interaction
– Open review and comment
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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
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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
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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