GM FISH AND THE RISK ASSESSMENT
PROCESS
Emma Issatt
AquAdvantage® salmon from Aqua Bounty
Technologies
Cartagena Protocol on Biosafety 2000
• scientifically sound
• taking into account recognized risk assessment
techniques
• to identify and evaluate the possible adverse
effects of living modified organisms on the
conservation and sustainable use of biological
diversity, taking also into account risks to
human health.
• Article 15 RISK ASSESSMENT
Cartagena Protocol on Biosafety 2000
• regulate, manage and control risks identified
in the risk assessment provisions of this
Protocol associated with the use, handling and
transboundary movement of living modified
organisms.
Article 16 RISK MANAGEMENT
Cartagena Protocol on Biosafety 2000
• Risk assessment should be carried out in a
scientifically sound and transparent manner, and can
take into account expert advice of, and guidelines
developed by, relevant international organizations.
• Lack of scientific knowledge or scientific consensus
should not necessarily be interpreted as indicating a
particular level of risk, an absence of risk, or an
acceptable risk.
Annex III RISK ASSESSMENT
General principles 3, 4.
Background to Risk Assessment
• 1962 “Silent Spring” by Rachel Carson
• 1969 US NEPA -> EIS
• 1970 US Occupational Health & Safety
Admin.
• 1972 “Limits to Growth”
• 1973 UK Ecology Party
• 1974 UK Health & Safety Commission ->
– COSHH (Control of Substances Hazardous to
Health)
Common Properties of Risk Assessment Process
IDENTIFICATION
ESTIMATION
EVALUATION
|
Risk Cost Benefit Analysis
Social Preferences I & II
Comparison
Limitations to Risk Assessment
Subjective
Error Deviations
Type I & Type II errors
Type of
Error
What is
it?
False premise
Who bears the burden of
the error?
Type I
False -ive
GM fish not safe in open
water
Industry
Type II
False +ive GM fish safe in open water
Society/Environment
Limitations to Risk Assessment
Subjective
Error Deviations
Type I & Type II errors
Human error
Bias values
Guesswork
Fraud
Risk Assessment and Uncertainty
•
•
•
•
Complex system
Linear thinking v diffuse effects
Beck on 3 ways that R A fails new technologies
Bayesian principles of risk evaluation
“The public are idiots”
Governmental faith in science
• DAD- ‘decide, announce, defend’
• The public need to be persuaded
• EC ‘Life Sciences & Biotechnology- a Strategy
for Europe’ 2002
• Arrogance
• Probabilistic Strategy
• Public’s rational fear
“Governments are idiots”
Public mistrust
• PABE- ‘Public Perceptions of Agricultural
Biotechnologies in Europe’
Wynne, Lancaster University, UK
“Governments are idiots”
Public mistrust
•
•
•
•
•
•
PABE
Stakeholder myths
Eurobarometer
Wynne- dictatorial nature of scientists
Collins & Pinch on the public understanders
C&P on those who venerate science
Only scientist in Commons 'alarmed' at MPs'
ignorance
By Nigel Morris, Deputy Political Editor
Tuesday, 3 August 2010
The only scientist in the House of Commons has called for all MPs to be required to take
a crash course in basic scientific techniques.
Julian Huppert, a research biochemist who became the Liberal Democrat MP for
Cambridge at the last election, said he was alarmed at the lack of scientific knowledge
among colleagues.
Related articles


Government ignored our advice on homeopathic remedies, say experts
David Colquhoun: These misleading beliefs are curing no one's ills
Risk Assessment and Judicial Review
• Jasanoff: Science Policy Paradigm
• Deference- Ethyl Corp v EPA at appeal:
[If legislation allows regulator the] flexibility to assess risks and make
essentially legislative policy judgments, as we believe it does,
preventive regulation based on conflicting and inconclusive
evidence may be sustained.”
“The Administrator may apply his expertise to draw conclusions from
suspected, but not completely substantiated, relationships between
facts, from trends among facts, from theoretical projections from
imperfect data, from probative preliminary data not yet certifiable as
"fact," and the like.”
Risk Assessment and Judicial Review
• Jasanoff: Science Policy Paradigm
• Deference
• ‘Hard look’ doctrine
Ethical Considerations in RA
• Transfer of risk
• Consent to risk
Risk Assessment of GM fish
• Life Cycle Assessment of GM Medaka fish
Risk Assessment of GM fish
• Environmental Risk Assessment of Genetically Modified
Organisms Volume 3 Methodologies for Transgenic Fish
ed. Kapuscinski et al
• “Risk assessment should involve all interested and affected
parties (the stakeholders), incorporating their perspectives
and knowledge, to ensure that the process produces a socially,
as well as scientifically acceptable, outcome.”
• “Stakeholder participation can enhance legitimacy and public
trust of the risk assessment conclusions and improve the
quality of the assessment. This is because people with diverse
experiences can provide information and insights that a
technically oriented team of scientists and risk analysts simply
cannot have.”
p.273 ‘Major messages from the book’
GMO ERA PROJECT
• “a pioneering initiative driven by public sector scientists to
develop tools to support environmental risk assessment (ERA) of
genetically modified organisms (GMOs).
• “The overarching goal of PFOA is to provide multi-stakeholder
deliberation about a GMO technology in relation to other future
alternatives. A PFOA interacts with traditional ERA processes
and builds upon them to make the overall consideration of the
GMO more inclusive and robust. Accordingly, a PFOA serves the
additional goals of informing the science of the ERA, assisting in
improving the science, and allowing the ERA science to
accurately inform multi-stakeholder deliberation.”
http://www.gmoera.umn.edu
Problem Formulation and Options Assessment
(PFOA)
•
•
•
•
•
•
1 Problem Formulation
2 Prioritization & Scale of Problem
3 Problem Statement
4 Recommendation to Move Forward
5 Option Identification
6 Assessment in Relation to the Technology and the
Problem
• 7 Changes Required and Anticipated
• 8 Adverse Effects
• 9 Recommendation
Malaysia PFOA Workshop on Transgenic Fish:
Representatives from Chile, China, Cuba, and Thailand
• “it provides a systematic way to integrate scientific
evidence and public interests…
• Participants often adapt their views as their
understanding of the issues deepens…
• Because information used in a PFOA needs to be
presented in terms that are broadly understood, it is
also relatively easy to link the PFOA to a broader
education effort to help the public understand the
significance of risk assessment and biosafety.”
PFOA Handbook www.gmoera.umn.edu
The End
Thank you!