RA&RM of LMOs with Stacked Genes or Traits

This Discussion Group is now closed.

The objective of this Discussion Group is to provide input to the AHTEG Sub-working Group (SWG) for the development of a guidance document on risk assessment and risk management of LMOs with stacked genes or traits. For more information on the work of the AHTEG and its SWGs, please follow this link.

NOTE: To participate in this discussion, you must be registered in the Open-ended Online Forum (go to the Forum homepage for more information) AND signed-in to the BCH. To sign-in please use link in the top-right corner of the screen.

Contents

Please click on one of the following links:

• Ongoing discussions
• Introduction to the work of the SWG
• Draft outline of the guidance document
• Guiding questions
• Suggested readings

Ongoing discussions

Please choose among the links below to select a specific topic of discussion (so called "thread"). To start a new topic please click on the button 'Create a new thread' below. To reply, please click on the 'Reply' button at the bottom of the message you wish to reply.

Go to the top of the page

Introduction to the work of the SWG

At its meeting in Montreal end of April 2009 the AHTEG was tasked with taking into consideration the need for further guidance on specific aspects of risk assessment (see report). The ranking done resulted in three additional sub-working groups: (i) on living modified crops tolerant or resistant to abiotic stress; (ii) living modified mosquitoes; and (iii) LMOs with stacked genes or traits. These subworking groups shall produce an outline of a guidance document with a structure as follows (i) points to consider; (ii) rationales for the points to consider; and (iii) relevant bibliographies and supporting documents.

The subworking group on “Stacked Genes” started its work with a series of comments and submissions how to design an outline structured as decided and on the contents of the outline. In addition the members provided relevant publications. Based on these submissions the chair crafted a first draft outline. This first draft was submitted to the members of the group for a first round of comments.

With the comments on the first draft taken into account a second draft was compiled and is presented now to the discussion forum for further consideration and comment.

Main points considered by the SWG:

• Growing number of LMOs with multiple or stacked transgenes/traits
• The term "stacking" can refer to processes or situations where multiple, but not necessarily different transgenes are present in one plant genome as a result of conventional crossing of first-level transformation events or as a result of direct transformation.
• Transformation with a multigene cassette, retransformation with a second construct or simultaneous transformation with different transgene cassettes (cotransformation) are considered as new events and should be dealt with according the road map
• Some aspects addressed in this outline may be also relevant to these transgene events with multiple transgenes or traits
• Aim of this doc: to complement the road map on RA and RM and address special aspects of LMOs with stacked transgenes/traits resulting from conventional crossing of first-level transformation events
• Restriction to plants

Go to the top of the page

Draft outline of the guidance document

This draft outline was prepared by the SWG and provides the basis for the discussions on this topic.

• Draft outline - Stacked genes - 9 June 2009

Go to the top of the page

Guiding questions

The following questions were prepared by the Chair of the SWG to assist 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?

Go to the top of the page

Suggested readings

• Austrian Federal Environment Agency (2007) Risk assessment of "stacked events".
• Belgium Biosafety Advisory Council (2007) Guidelines for GM stacked events to be placed on the market.
• CropLife International (2005) Regulation of plant biotechnology products containing two or more traits combined by conventional plant breeding.
• De Schrijver A, Devosb Y, Van den Bulckea M, Cadotc P, De Loosed M, Reheulb D, Sneyersa M (2006) Risk assessment of GM stacked events obtained from crosses between GM events. Trends in Food Science & Technology 18: 101-109.
• EuropaBio. Evaluation of crops containing GM events combined by traditional breeding.
• European Food Safety Authority (2007) Guidance Document for the risk assessment of genetically modified plants containing stacked transformation events by the Scientific Panel on Genetically Modified Organisms (GMO). EFSA Journal 512: 1-5.
• European Food Safety Authority. Risk assessment of plants containing genetic modification events combined by crossing.
• Halpin C (2005) Gene stacking in transgenic plants – the challenge for 21st century plant biotechnology. Plant Biotechnology Journal 3: 141–155.
• Zhao J-Z, Cao, Collins HL, Bates SL, Roush RT, Earle ED, Shelton AM (2005) Concurrent use of transgenic plants expressing a single and two Bacillus thuringiensis genes speeds insect adaptation to pyramided plants. PNAS 102: 8426-8430.

Go to the top of the page