“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 assessments
Technology approval within biosafety regulatory processes

 For biosafety regulatory purposes one needs to

understand the impact of the inclusion of socioeconomic 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 expost 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 1. The Parties, in reaching a decision on import under this Protocol or under its domestic measures implementing the Protocol, may take into account, consistent with their international obligations, socio-economic considerations arising from the impact of living modified organisms on the conservation and sustainable use of biological diversity, especially with regard to the value of biological diversity to indigenous and local communities. • Relate to import decisions • Domestic laws and regulations Voluntary …it is not mandatory Especially WTO

Strictly a narrow scope

Impact parameter??

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
Type of inclusion

Options
• No inclusion • Mandatory • Voluntary • 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 • Concurrent but separate • Sequential • Embedded • Implementation entity • Each submission • Event • Laboratory/greenhouse approvals • Confined or multi-locational field trials • Applications for commercialization • For post release monitoring • At all stages? •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

Scope

Approach

Assessment trigger When

How?

Biosafety as a process: When SEAs?
Socioeconomic assessments

?

Regulatory decision points

Contained Use Experiments

Confined Field Trials

Deliberate Release

Post Release

Deregulation

Different approaches to inclusion
Issue \ Country Argentina Inclusion Mandatory European Union, Norway and Switzerland Mandatory (?) United States and Canada Not required / not considered in the biosafety assessment N/A None N/A Brazil India China Only if a SEC issue identified in the biosafety assessment Sequential Not clear Separate bodies for biosafety (CTNBio) and for decision making (National Biosafety Council). Later commissions studies to external consultant Commercialization Not clear Rationale for dual bodies was to separate technical assessment from the “political” assessment” 1989 guidelines does not include socioeconomic assessments Sequential (?) Not clear Not clear – studies to 3rd parties by GEAC Not required

Implementation approach Scope Implementing agency

Sequential Impacts on exports only Agency within Ministry of Trade

Sequential Not clear – still negotiating Proponent (?)

No guidance No guidance No guidance – 3rd parties

When How Comments

Commercialization Trade impact assessment Un-official policy of only approving products accepted elsewhere abandoned Example of a functional system with a delimited socio-economic assessment approach

Post-release monitoring (?) Not clear De facto moratorium since 1999 Events of cotton, maize, oilseed rape and soybeans are allowed for EU import, while only two events, Bt maize MON810 and Starch modified potato, has approval for planting

Deliberate release / deregulation N/A Thousands of confined field trials approved At least 16 products deregulated Two major cases take to court in USA and Canada

Commercialization Not clear – impact on farmers Bt cotton only approval to date Does not seem to have been a factor in the approvals (Pray, 2010)

Commercialization Sophisticated impact models Seems to have had an impact in terms of supporting approvals (Pray, 2010)

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 BA

Negative Socio – Economic Assessment due to institutional issues Biosafety renders “safe” outcome

Require more information

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 knowledge to determine a product as “safe”  Food/feed safety  Environmental safety Other motivations
• Liability • Impact assessment • 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

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