RA&RM of LMOs with Stacked Genes or Traits

Dear Forum participant,

The Discussion Group on “Risk Assessment and Risk Management of LMOs with Stacked Genes or Traits” is now open for discussions at http://bch.cbd.int/onlineconferences/stacked2_ra.shtml . The objective of this discussion is to provide input to the AHTEG Sub-working Group (SWG) for the preparation of a guidance document on this topic.

An initial outline of the guidance material being prepared by the SWG is attached to this message (the attachment is visible only in the Forum website on the link above). This document provides a basis for the discussions. An introduction to the work of the SWG as well as guiding questions and suggested reading materials are also available to assist in the discussions. The guiding questions are also copied below for ease of reference.

You may reply to this posting or create a new “thread” of discussion by email following the appropriate link below, or directly from the online Forum in the link above. In order to post your contribution through the online Forum, you must be signed-in to the BCH.

Your contribution is very important. We are looking forward to your views on this topic.

If you need any assistance, please do not hesitate to contact us at: riskassessment.forum@cbd.int .

Thank you and best regards,
Manoela

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** Guiding questions **

The following questions were prepared to assist in the discussions on this topic:

· Do you agree on the scope of the draft outline?

· Do you agree with the general structure and content?

· Are there aspects, points to consider which should be added or complemented?

In its apparent decision to move directly to develop guidance on the risk assessment and risk management of LMOs with stacked genes, the United States believes that the AHTEG has not adequately considered and analyzed the experience of countries.  The combining of traits with useful properties has been critical to farming for millennia and is part of traditional variety development and crop improvement.   Combining traits with LMOs should be no different.  With respect to the stacking of LMO traits, different countries have adopted different regulatory approaches related to the risk assessment and control of LMOs with stacked traits to address the conservation and sustainable use of biological diversity and other national priorities.  Nations may adopt particular risk assessment approaches or take particular measures for a variety of reasons, only one of which is the conservation and sustainable use of biological diversity. 

It would seem advisable for the AHTEG to gather information on these different national approaches and experiences, analyze them and consider them with respect to the conservation and sustainable use of biological diversity.  Further, this analysis should consider how any guidance on stacked traits will interact with the Roadmap.  There is a very real risk that this profusion of documents will lead to confusion and contradiction if not carefully coordinated.

The United States does not believe it is necessary to analyze stacked traits unless there is a reason to anticipate they may have an interaction.  For this reason, we are providing information relating to the U.S. approach based on the regulation of genetically engineered plants which express pesticidal compounds.  These compounds are referred to as “plant-incorporated protectants” (PIPs) under the pesticide law in the United States.  An example of the assessment of a PIP-containing stacked trait plant is included in the resource documents for the sub-working group, and it can also be found online at:
http://www.epa.gov/oppbppd1/biopesticides/ingredients/factsheets/factsheet_006430-006484.htm#science.

Regards,
Dave Heron