Problem Formulation and Option
Assessment (PFOA)
Linking Governance and Environmental
Risk Assessment for Technologies
Problem analysis for genetically
engineered organisms:
genetic biocontrol of invasive species.
Kristen C. Nelson
Department of Fisheries, Wildlife and Conservation Biology,
Department of Forest Resources
University of Minnesota
June 2010
GEO Challenges
•
•
•
•
GEOs may potentially have
widespread impacts.
They are alive and therefore able to
spread and evolve on their own
accord.
Every unique instance of proposed
GEO technology may need to be
considered individually.
Evaluating GEOs requires particular
scientific and institutional
capacities.
World-wide Interest
Biosecurity Frameworks
Enable a country to meet its international
treaty requirements related to the
movement of biological organisms
– Plants: International Plant Pest Convention (FAO)
– Animals: International Commission on Epizootics
(WHO)
– Foods: Codex Alimentarius (WHO)
– GMOs: Cartagena Protocol (UNEP)
» Convention on Biodiversity
Risk Analysis for New Technologies
Risk
Assessment
Risk
Management
Risk
Communication
Derived from
Codex
Alimentarius
(2005)
Adverse Environmental Effect
• Changes that are considered
undesirable because they alter
valued structural or functional
characteristics of ecosystems or
their components.
• Key Properties
– Change (effect)
– Undesirable (valued)
Problem Formulation
Exposure
Effects
Characterization Characterization
Risk
Assessment
Risk
Characterization
Risk
Management
Risk Management
Strategies
Monitoring
and Evaluation
EPA 1998
EU 2002
New GEO ERA Methodologies
1. Problem Formulation and Options
Assessment (PFOA)
2. Transgene expression and locus
structure (TELS)
3. Non-target and biodiversity risk
assessment
4. Gene flow and its consequences
5. Resistance risk assessment and
management
Major Products
Thinking about Fish
PFOA
Multi-country Transgenic Fish
Workshop
Chile Cuba China Thailand
PFOA Methodology
PFOA centers an ERA
around the people
potentially affected
by a technology to
assess the possible
benefits and harms
within a broad
societal contexts.
Kristen C. Nelson and Michael J. Banker
www.gmoera.umn.edu
Step 1:
Problem Formulation
Problem
Formulation
Phase
Step 2:
Prioritization & Scale
Is this a core
problem?
How extensive is
the problem?
Step 3:
Problem Statement
Step 4:
Move Forward?
Decision from Regulatory Body
Kristen C. Nelson and Michael J. Banker
www.gmoera.umn.edu
Step 5: Option
Identification
Option X
Option Y
Options
Assessmen
t Phase
Option Z
Step 6: Assess Options
in Relation to Problem
Step 7: Changes Required
& Anticipated
Step 8: Adverse Effects
Step 9: Recommendation
To
Decision
-Makers
Process
Science-based
Planning and assessment process
Process Characteristics
Multi-stakeholder dialogue
Key Concepts
underlying PFOA
ERA
• Science-based
• Deliberation
• Multi-criteria analysis
Governance
• Participation
• Transparency
• Accountability
PFOA Stages
PFOA Meeting #1 Informs Science
Why
1. Definition of the societal problem ‘solved’ by a new
technology
Who
Where 2. Discussion of boundaries and scope of concern
3. Creating of conceptual model of system
How
Values 4. Identification and prioritization of harms based on
multiple criteria analysis
PFOA Meeting #2 Informs Decision-makers
1. Respond to new information on risk and uncertainty
2. Discussion of ‘acceptable risk’
3. Discussion of risk management requirements
Indentifying Stakeholders
Stakeholder
Representatives
ERA Partners
Observers
Process Characteristics
Question driven process
???
Questions
!!!
not
Positions
Option Identification and
Assessment Analysis Chart
Step 5
Step 6
Step 7
Options
Attributes Changes
Anticipated
Identification
and
Benefits
Option A
Option B
Option C
etc
Step 8
Adverse Impact
to the System
Internal
External
Option Identification and
Assessment Analysis Chart
Step 5
Step 6
Step 7
Options
Attributes Changes
Anticipated
Identification
and
Benefits
Option A
Option B
Option C
etc
Step 8
Adverse Impact
to the System
Internal
External
Reflections on the
Problem Formulation and
Option Assessment (PFOA)?
Kenya Bt-maize Brazil Bt-cotton Vietnam Bt-cotton
Malaysia – World Fish/Aquatic Organisms
PFOA Reflection #1
PFOA is a ‘good idea for any agricultural or
aquatic technology but essential for GEOs.
“do it on a case by case,
use a precautionary approach.”
“should be considered and applied
in the whole process of making a
decision.”
PFOA Reflection #2
PFOA trial run suggests it:
* identifies important issues
* constructive dialogue
* possible consensus building points
* initiates discussion of options
PFOA Reflection #3
Essential PFOA characteristics include:
multi-stakeholder discussion
questions driven but needs improved
environmental questions
Ministry collects multi-stakeholder
views and considers these views.
PFOA Reflection # 4
PFOA requires an organized and integrated
data base so science informs discussion
and decision making.
Kenya needs studies to reduce
uncertainty in discussion.
Vietnam identified existing sources.
PFOA Reflection # 5
Needs assessment should be embedded in the
policy and regulatory review process!!!!
PFOA Reflection # 5
PFOA should be embedded in the policy
and regulatory review process!!!!
The government should be the organizer
of the PFOA.
Staged in minimum of two meetings
Added details about funding, criteria
development, and decision making.
Reflection #6
PFOA serves as a good foundation for future
monitoring of environmental and societal
impacts of the technology.
Reflection #7
Public education and training
on GEO risk assessment is necessary
to enhance awareness of GMOs and
options for influencing decision making.
PFOA in ERA
Problem
Formulation
Attributes
Option Assessment
System Changes
Adverse Effects
Multiple Stakeholder identification of common agreement on:
Problem:
Scale & priority
Understand
Technology
How likely hazard
will occur and potential
harm identification
Risk
Assessment
System changes
across scales
Risk
Management
PFOA in ERA
Problem
Formulation Attributes
Problem:
Scale & priority
Understand
Technology
Option Assessment
System Changes Adverse Effects
Risk
How likely hazard
Communication
will occur and potential
Harm identification
Risk
Assessment
System changes
across scales
Risk
Management
Risk Communication Opportunities through PFOA
1st Meeting
Transparent
Communication
of Problem and
Risk Assessment
Framing
2nd Meeting
Transparent
Communication of
Options Comparison
And Risk Management
Planning Needs
Identification
of Communication
Needs for
Public Education
And Participation
PFOA & Governance
1. Evaluate if a GEO would address
their problem
2. Inform decision making about and
oversight for new technologies
3. Assess the risks related to multiple
options for addressing the problem
4. Design technologies and policies to
reduce societal risks
Reflections
• What are the unique challenges in
using a PFOA methodology for
genetic biocontrol for invasive
species in the U.S.?
Other countries?