Countries have many choices in terms of how they can implement the inclusion of socio-economic considerations into decision-making. We can consider the following decision-making nodes for regulatory design. I will provide an expanded description of these in subsequent posts.

In  most countries, decisions related to the options presented here may be better and more flexibly addressed in implementing regulations rather than in laws or policies. This will ensure that changes can be made readily if the regulatory system considers potential alternatives to comply with inclusion of socio-economic considerations into decision-making.

1.  Type of inclusion?

  • No inclusion
  • Mandatory
  • Voluntary

2. Scope?

  • Narrow interpretation of  article 26.1
  • Narrow set of socio-economic issues
  • Broader set of assessments (Socio-Economic Impact Assessments or Sustainable Livelihoods)

3. Approach?

In contrast to the environmental and food/feed safety assessment, SEC assessment can be implemented:

  • Concurrently but separately
  • Sequentially
  • Embedded

Which implementation entity?

  • Independent (third party)
  • Proponent
  • Specialized full time unit within regulatory agency or government

Do you allow data from other countries with similar agro-ecological and/or social characteristics?

4. Assessment trigger?

  • Each submission
  • Event-by-event
  • First proponent within an event class (i.e. insect resistant cotton or drought tolerant maize)

5. When?

  • Laboratory/greenhouse
  • Confined Field Trials
  • Commercialization
  • Post release monitoring

Commercialization and for post-release monitoring?

At all stages?

6. How?

  • Choice of methods for ex ante assessments (before approval for deliberate release) is much more limited than for ex post
  • Decision-making rules and standards
  • Multi-disciplinary method integration, standards, and the decision-making process tolerance to errors



Falck-Zepeda, J.B. and P. Zambrano. 2011. Socio-economic Considerations in Biosafety and Biotechnology Decision Making: The Cartagena Protocol and National Biosafety Frameworks. Review of Policy Research. 28(2): 171-195.

Smyth, S.J., Falck-Zepeda, J.B., Gray, R.S., Nassem, A., Paarlberg, R., Phillips, P.W.B., et al. “Policy recommendations from the 13th ICABR conference on the emerging bioeconomy.” 2010. AgBioForum, 13(2), 98-103. Available on the World Wide Web:

Falck Zepeda, J. B. Socio-Economic Considerations, Article 26.1 of the Cartagena Protocol on Biosafety: What are the Issues and What is at Stake?” 2009. AgBioForum. 12(1):90-107.