1. Program for Biosafety Systems – http://pbs.ifpri.info/ Conceptual and Implementation Clarity of SECs and Biosafety Decision-Making Presented at the ICABR conference Ravello Italy June 2015. José Falck-Zepeda, Stuart Smyth and Karinne Ludlow

2. Socioeconomic Considerations (SECs) Socioeconomic assessments can include examination of a variety of – social factors – economic factors Objective is to better understand the potential impacts of relevant interventions on people and communities

3. Article 26.1 of the Cartagena Protocol on Biosafety 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 Applies to decision on import only, or National measures Voluntary – NOT mandatory Especially –not limited to - WTO Strictly a specific focus and line of causality Explicit impact indicator and emphasis on one target group

4. Article 26 is… a desire of a number of countries to understand the impacts of regulated technologies an alternative to contribute to the protection of producers and consumers... but, is this the best option?

5. Article 26 is not … an impossible regulatory barrier to overcome of mandatory implementation a "fuzzy" approach to slowing or preventing the flow of technology a platform to solve socio-economic problems in a country Who is best placed to decide whether a technology is beneficial or not?.... Producer, consumer or regulators...

6. What can a decision maker do with the results a socio-economic assessment? REVIEW / ASSESSMENT OUTCOME Negative socio- economic assessment due to institutional issues Biosafety renders product to be “safe” Not approve Require more information SEC assessment / review Approve after resolving institutional issues TECHNOLOGY DECISION Biosafety assessment / review Approve ? ? ? ?

7. SEC and regulatory design issues – Process is important!!! IssuesOptions Type of inclusion? No inclusion vs. Mandatory vs. Voluntary What? Issues for review Who? Developer vs. dedicated government unit vs. third party experts Scope? Narrow interpretation article 26.1 Narrow set of socio-economic issues Broader set of assessments (SIA or SL) Approach? Concurrent but separate vs. Sequential vs. Embedded Implementation entity Assessment trigger? Each submission vs. Event-by-event vs. class of events When? Laboratory/greenhouse vs. CFTs vs. Commercialization For post release monitoring How? Will the assessment require a de novo study? Choice of methods limited Decision making rules and standards Method integration, standards, tolerance to errors

8. Implementation issues Need to define burden of proof, rules for accepting evidence, decision making standards Focus on broad impacts of biotechnology and technology in society rather than on an event basis Need to consider the option of inclusion only for commercialization or post-commercialization Also consider doing by class of events (i.e. insect resistance or herbicide tolerance) while focusing on specific differences an event may have with respect to other events of the same class

9. Comercialization Risk Assessment Biological Aspects Risk management CTNBio Multidisciplinary body with 54 members Public consultation Federal monitoring entities – Ministries Agriculture and Health CIBios Research institutions, universities, private and public companies CNBS 11 Ministries Research Proponent Risk communication Source: Paulo Paes de Andrade, 2012

10. IssueBrazil Type of inclusionOnly if an SEC identified during the scientific biosafety assessment Scope / WhatNot clear / open Who Three separate bodies Institutional Biosafety Committee, CTNBio = biosafety assessments, CNBS (National Biosafety Council): decision making body. CNBS commissions a third party WhenCommercialization Comments Rationale for dual bodies was to separate technical assessment from the “political” decision making Mexico has a similar approach Source: based on Falck Zepeda, Wesseler and Smyth, 2010 and Pray, 2010

11. Argentina – Key regulatory steps CONABIA: Evaluates agricultural and environmental impacts through trials SENASA: Food safety evaluation DNMA: Evaluates potential commercial impact focussing on export markets CONABIA makes final report

12. IssueArgentina Type of inclusionMandatory Scope / What?Economic impacts on trade and/or competitiveness. Other impacts being considered. Who?Minister of Agriculture – special unit DNMA When?Commercialization CommentsFor a while..policy of only approving those already approved in trade sensitive markets Source: based on Falck Zepeda, Wesseler and Smyth, 2010 and Pray, 2010

13. Final comments (1) Critical need to use robust science-based approaches in decision making – evidence takes an important role Essential to achieve a systematic understanding of the possible implications of the issues that may affect the adoption and diffusion of GMOs Studies report beneficial social and economic impact of the adoption of GMOs, but it is necessary to judge whether or not to introduce socioeconomic assessment processes in decision making

14. Final comments…(2) Therefore it is critical and prudent to: o Judge technologies on their own merits o Think of crops and attributes of interest for developing countries There are significant advances in public and private sector R&D and innovation in developing countries

15. Final comments….(3) Countries like Brazil, Argentina, Mexico, Philippines, South Africa, Burkina Faso, Indonesia, China... will continue to take an important role in the development of these technologies Producers will have access to crops and traits of interest and public or private economic value if we solve regulatory and institutional issues constraining innovation….and this we know takes political will…

16. José Benjamin Falck-Zepeda Senior Research Fellow IFPRI 2033 K Street NW Washington, DC 20006-1002 USA j.falck-zepeda@cgiar.org j.falck-zepeda@cgiar.org