The document summarizes the activities of the FIFRA Endangered Species Task Force (FESTF) in responding to EPA's data requirements regarding pesticide use and endangered species. It describes the development of an Information Management System and a cooperative research agreement between FESTF and EPA to provide species location data to evaluate potential effects on endangered species. The goal is a joint effort between industry and EPA to develop efficient and practical solutions to further regulatory compliance and species protection.
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This presentation was delivered at the third Asia-Pacific Forestry Week 2016, in Clark Freeport Zone, Philippines.
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Our green future: green investment and growing our natural assets
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
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 IND -1 Industry Presents - Bernalyn McGaughey
IND -4 Industry Presents 1987 - Approach had problems 1988 - Approach was revised
Industry Presents Needing to revise county bulletins
Industry Presents - Jennifer
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
Industry presents
2 IND -6 EPA Presents FESTF feasibility study revealed problems (should be called the infeasibility study)
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
8 IND - 8 EPA Presents - Larry PR Notice Components (#2000-2)
4 IND - 9 EPA Presents - Arty
6 IND -10 EPA Presents - Arty
IND - 11 EPA Presents - Arty
3 IND- 12 Industry Presents - Jennifer
3 EPA - 10 Industry Presents
IND- 13 Industry Presents - Jennifer
8 IND- 14 Industry Presents - Jennifer
10 IND- 15 Industry Presents
IND- 17 Industry Presents CBI (Confidential Business Information)
IND- 16 Industry Presents
IND - 57 Industry Presents
IND- 21 Industry Presents
IND- 23x Industry Presents
IND- 25 Industry Presents
IND- 26 Industry Presents Send this slide and other slides that demonstrate the tiny window problems to Battelle
IND- 27 Industry Presents
IND- 33 Industry Presents Tilghman thought this many taxa with “yes” was unlikely.
IND- 31 Industry Presents
IND- 32 Industry Presents
IND- 34 Industry Presents All these XXXX together constitute an assessment of Endangered Species as required for a registration package
IND- 36 Industry Presents
IND- 34 Industry Presents
IND- 35 Industry Presents
IND- 38 Industry Presents
IND- 39 Industry Presents
IND- 40 Industry Presents
IND- 44 Industry Presents
IND- x45 Industry Presents
IND- 47 Industry Presents
IND- 48 Industry Presents
IND- 49 Industry Presents
Tilghman
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?
IND - 51 EPA Presents - Larry
IND - 52 EPA Presents
IND - 53 EPA Presents
IND - 54 EPA Presents
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
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.]
EPA presents - Mike McKee
EPA presents
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)