Professional Documents
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From left to rigth: a) Damage by Asia corn borer and b) Bt maize plot in Barangay Conel, Mindanao, The Philippines, c) Transgenic Garden,
UP-LB Los Banos, Luzon, Philippines
Observations on biosafety assessments
There is no technology or
activity with 100% safety
Proper biosafety
procedures have ensured
so far a remarkable safety
track record
No demonstrated (actual)
direct damage to date
Instances of purported regulatory
failures relate more to
deficiencies of standard
operating procedures for
biosafety management
Motivations for the assessment of
socio-economic considerations
Technology approval
Technology
within biosafety
assessments regulatory processes
How? •Choice of methods for ex ante assessments is much more limited than for ex post
•Decision making rules and standards
•Integration of methods, rues, standards, tolerance to errors
Biosafety as a process: When SEAs?
Socio- ? Regulatory decision points
economic
assessments
Source: based on Falck Zepeda, Wesseler and Smyth, 2010 and Pray, 2010.
Potential implications from the inclusion of
socio-economic considerations into
decision making
Regulatory cost of compliance increases
Potential regulatory delays
Reduction in the number of technologies
Reduction in the number of technologies released
by the public sector -> crops and traits of a public
good nature
Potential for a unworkable system if rules and
standards are not clear
Gain information about technology impacts for
decision making
What can a decision maker do with
the results a socio-economic
assessment?
Not approval
Require more
information
• What is the decision making rule and the standard by which to guide such
decision?
Approve after
resolving
institutional issues
Consider that….
• Socio-economic assessment include quite a bit of art in a process
that uses science and scientific tools
• Lots of uncertainties and subjectivities
Policy development and
implementation issues
Careful inclusion costs and benefits evaluation
Consider all potential outcomes from regulatory
actions
Not approving a technology is not riskless
Status quo is not riskless
Worst possible outcome is a process with a
mandate but with no implementation guidance
Do not stop at policy development need to think
carefully about implementation…at the same time
Transparency
Cost effectiveness
Protectiveness
Concluding comments
Does inclusion of socio-economic considerations improve society’s
welfare? Answer is not unequivocal
Need to examine reasons why include socio-economic consideration
Include all potential outcomes from regulatory decisions
Most economist probably agree with the policy of not including SEA
into a regulatory process unless done in well-defined approach. SEA
should not be the sole criteria for regulatory decision
If national decision is for the inclusion of SEA then need exist to
clearly define
Scope
Methods
Decision making rules and standards
Timing
Thanks
Beyond knowledge generation – decreasing
returns to biosafety research investments?
Necessary or sufficient Other motivations
knowledge to determine
a product as “safe”
• Liability
Food/feed safety • Impact assessment
Environmental safety • Marketing
• Science and curiosity
• “Excessive” precaution
Need to understand that generating knowledge beyond what is necessary and/or sufficient to
demonstrate safety can be a waste of resources