20011200 cpda festf update

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


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


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


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


FESTF Member Companies

Albaugh

Aventis

BASF

Bayer

DowAgro

DuPont

FMC

ISKBC

Monsanto

NuFarm

Rohm & Haas

Syngenta

Uniroyal

Valent


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


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


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


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


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


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


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


FESTF Structure

• 14 member companies

• Project Manager - Bernalyn McGaughey, Compliance Services International

• Information Management System - Tom Marr, Battelle Pacific Northwest Labs


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


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


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


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


User Types

• Member User

• Member Superuser

• EPA Risk Assessor

• EPA Product Manager

• EPA Endangered Species Assessor

• EPA Superuser

• Data Administrator


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


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.


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


Participants in CRADA

• OEI– lead on project

• ORD

• Region 3

• OPP

• FESTF


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


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


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


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


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


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


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.


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


20011200 cpda festf update

Documents

cpda registration

condition of registration

species biology

epa data requirements

state species access

epa requirement

data requests

release of data