A harder look on risk assessment and risk management
The Petri Dish-October 2012- By: Behzad Ghareyazie and Mahaletchumy Arujunan-
Since 1996, billions of people worldwide have consumed foods derived from biotech crops with not a single health hazard recorded. To date a total of 16.7 million farmers in 29 countries grow biotech crops on a land area of 167 million hectares.
Since 1996, billions of people worldwide have consumed foods derived from biotech crops with not a single health hazard recorded. To date a total of 16.7 million farmers in 29 countries grow biotech crops on a land area of 167 million hectares.
However, this has not stopped regulators from devising guidelines to assess and manage the risks of growing biotech crops. At MOP4 in Bonn, Parties to Cartagena Protocol on Biosafety (CPB) agreed to establish an Ad Hoc Technical Expert Group (AHTEG) and an “Open-ended Online Forum (OeOF)” to assist in developing a Guidance on Risk Assessment of Living Modified Organisms (LMOs) in accordance to Annex III of the CPB.
Risk Assessment and Risk Management is Item 15 under CPB and the guidance prepared by the AHTEG is expected to provide streamlined guidelines to regulators on how to assess risk of LMOs.
At MOP5 in Nagoya, Parties to CPB evaluated the guidance prepared by AHTEG and OeOF, and decided to revise the Guidance Document by extending the term of AHTEG. This Guidance document and its associated training manual became one of the most contentious subject matters at MOP6 in Hyderabad.
The views on this issue was so fragmented that the differences of opinions were not resolved in working group II at MOP6 that led to a Contact Group Meeting (Contact Group is established when issues cannot be resolved at Working Group). Meetings dragged into late night as parties asked for a simpler and practical guidance that also takes into account the benefits of the modern biotechnology when conducting risk assessment and management.
Public Research and Regulation Initiative (PRRI), which represents public sector scientists and is the biggest delegation at MOPs in its intervention said, «Risk assessment and management should be proportionate to risk-benefit balance, based on verifiable, replicable and reliable science taking into consideration the experience and knowledge gained over the past decades of research and commercial scale use.”
PRRI believed that “the guidance on Risk Assessment and Management is confusing and that does not reflect the experience accumulated over the past decades. Moreover, there are still components in the Guidance that needs review”. PRRI added that, “The Guidance document should be tested in countries that have commercialized biotech crops by experienced risk assessors and followed by another testing by less experienced regulators.”
Finally Parties attending this meeting decided to assign another AHTEG (emphasizing that significant portion of the group will be recycled from the current group) to further revise and improve the guidance. The Parties wanted the Guidance to be tested in actual cases of risk assessments and an instrument that is not restrictive and does not impose any obligations on Parties.
The decisions made on Risk Assessment and Management at MOP are believed to have strong impact on the way biotech crops are regulated and hence, the heavy deliberations.
By: Behzad Ghareyazie and Mahaletchumy Arujunan
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Source: The Petri Dish-October 2012