“Inclusion of Socio-Economic Considerations in Biosafety Decision

Making: Governance and Implementation Issues”

José Falck Zepeda

Research Fellow
Leader Policy Team Program for Biosafety Systems (PBS)
IFPRI

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

 For biosafety regulatory purposes one needs to

understand the impact of the inclusion of socio-
economic considerations in decision making
 Consider technology flows, opportunities lost due to
additional regulatory hurdles and who is impacted
more
 Important distinction
An impact assessment
during the biosafety
regulatory stage needs
to be ex ante
For monitoring
purposes or for
standard technology
evaluation purposes this
is a conventional ex-
post assessment

 What is the goal and objectives for socio-

economic assessments as related to biosafety
or technology decision making?
 Socio-economic considerations and the
Cartagena Protocol on Biosafety (Article 26.1)
SOCIOECONOMIC CONSIDERATIONS • Relate to import
1. The Parties, in reaching a decisions
decision on import under this • Domestic laws
Protocol or under its domestic and regulations
measures implementing the
Protocol, Voluntary …it is
not
may take into account,
mandatory
consistent with their international
obligations,
Especially WTO
socio-economic considerations
arising from the impact of living
modified organisms on the Strictly a
conservation and sustainable narrow scope
use of biological diversity,

especially with regard to the value Impact

of biological diversity to parameter??
indigenous and local communities.
One list of potential socio-economic
considerations
 Distributions of benefits
 Public sector research
 Labor
 Global markets
 Competition
 Organic markets
 Intellectual Property Rights
 Public opinion
 Ethics, culture, religion

Source: Fransen, La Viña, Dayrit, Gatlabayan, Santosa, Adiwibowo,

WRI 2005
 Practical structural and governance decision for
socio-economic inclusion in biosafety processes
Issues Options
Type of inclusion • No inclusion
• Mandatory
• Voluntary

Scope • Narrow interpretation article 26.1

• Narrow set of socio-economic issues
• Broader set of assessments (SIA or SL)
• Socio-economics plus ethics-religious-philosophical considerations

Approach • Concurrent but separate

• Sequential
• Embedded
• Implementation entity
Assessment trigger • Each submission
• Event

When • Laboratory/greenhouse approvals

• Confined or multi-locational field trials
• Applications for commercialization
• For post release monitoring
• At all stages?

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

Contained Use Confined Deliberate Post

Deregulation
Experiments Field Trials Release Release
 Different approaches to inclusion
Issue \ Country Argentina European Union, United States and Brazil India China
Norway and Canada
Switzerland
Inclusion Mandatory Mandatory (?) Not required / not Only if a SEC issue 1989 guidelines does Not required
considered in the identified in the not include socio-
biosafety assessment biosafety assessment economic assessments
Implementation Sequential Sequential N/A Sequential Sequential (?) No guidance
approach
Scope Impacts on exports only Not clear – still None Not clear Not clear No guidance
negotiating
Implementing Agency within Ministry Proponent (?) N/A Separate bodies for Not clear – studies to 3rd No guidance – 3rd
agency of Trade biosafety (CTNBio) and parties by GEAC parties
for decision making
(National Biosafety
Council). Later
commissions studies to
external consultant
When Commercialization Post-release monitoring Deliberate release / de- Commercialization Commercialization Commercialization
(?) regulation
How Trade impact Not clear N/A Not clear Not clear – impact on Sophisticated impact
assessment farmers models
Comments Un-official policy De facto Thousands of Rationale for dual Bt cotton only Seems to have had
of only approving moratorium since confined field trials bodies was to approval to date an impact in terms
products accepted 1999 approved separate technical Does not seem to of supporting
elsewhere Events of cotton, At least 16 assessment from have been a factor approvals (Pray,
abandoned maize, oilseed products de- the “political” in the approvals 2010)
Example of a rape and soybeans regulated assessment” (Pray, 2010)
functional system are allowed for EU Two major cases
with a delimited import, while only take to court in
socio-economic two events, Bt USA and Canada
assessment maize MON810
approach and Starch
modified potato,
has approval for
planting

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

SEA Negative Socio –

Economic
Assessment

Require more
information

• What is the decision making rule and the standard by which to guide such
decision?

• Who is the best person to make this decision? Is it a regulator, decision

makers, or the persons who will endure the risk and the benefits of the
technology…farmers?
What can a decision maker do with the results
a socio-economic assessment?...continued
Not approve

SEA Negative Socio –

Economic
Assessment due
to institutional Require more
issues
BA information
Biosafety renders
“safe” outcome

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

 Need to reconcile with

 Other considerations beyond biosafety

 Democratic society’s right to know

 Freedom to operate and Freedom to Choose