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

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

Article 26.1 of the Cartagena Protocol on Biosafety1 . 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

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?

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 ...

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

?

?

?

?

SEC and regulatory design issues – Process is important!!!

Issues Options

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

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

Comercialization

Risk Assessment Biological Aspects

Risk management

CTNBioMultidisciplinary

body with 54 members

Public consultation

Federal monitoring entities – Ministries Agriculture and Health

CIBiosResearch institutions,

universities, private and public companies

CNBS11 Ministries

ResearchProponent

Risk communication

Source: Paulo Paes de Andrade, 2012

Issue Brazil

Type of inclusion Only if an SEC identified during the scientific biosafety assessment

Scope / What Not clear / open

Who • Three separate bodies Institutional Biosafety Committee, CTNBio = biosafety assessments, CNBS (National Biosafety Council): decision making body.

• CNBS commissions a third party

When Commercialization

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

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

Issue Argentina

Type of inclusion Mandatory

Scope / What? Economic impacts on trade and/or competitiveness. Other impacts being considered.

Who? Minister of Agriculture – special unit DNMA

When? CommercializationComments For 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

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

Final comments…(2)• Therefore it is critical and prudent to:

o Judge technologies on their own meritso 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

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…

José Benjamin Falck-ZepedaSenior Research FellowIFPRI 2033 K Street NWWashington, DC 20006-1002USAj.falck-zepeda@cgiar.org