Risk assessment and risk management of transgenic pharmaplants

Dear Forum Participant,

Welcome to the Discussion Group on “Risk assessment and risk management of transgenic pharmaplants”.

**The discussions within this group will take place during 10-23 November 2008.**

To assist in the discussions, a non-exhaustive list of suggested reading materials, as well as an introduction to the topic, have been made available.

A short tutorial to assist the participants in posting messages and navigating through the Forum has been made available at http://bch.cbd.int/forum/tutorial_discgroup.pdf.

As a participant to the Open-ended Online Expert Forum on Risk Assessment and Risk Management, your contribution is of extreme importance in making this Forum an unprecedented medium of discussion which is a forerunner to the intergovernmental negotiations on the development of guidance material on specific aspects of risk assessment of LMOs.

The CBD Secretariat thanks you for your active participation. Happy discussions!

Best regards,
The Biosafety Division

This is Kazuo Watanabe, working on LMO risk assessment, manangement and communication as was introduced in GM trees.

In the case of LMOs-pharmaplants, risk assessment context shall be  on the host plant biology as usual as others, and some of potential host species have been well examined in the consensus papers of OECD.  Those may be crop species already used in the presently commercialized LMOs-FFP, then, more attention shall be paid for confinement of the geneflow to avoid mixture of the LMOs with non-LMOs. 
However, individual nature of the host species well examined in terms of the geneflow.
Allelopathy may be the  aspect which shall be carefully observed as the plant produce novel subvstance which may not be exposed to the enviroment in the past. with that aspect, plant exudates to soil, interactions with herbivores could be carefully examined owing to the substance produced by the pharma plants.
However, more importantly, confinement of the LMOs, especially on the geneflow, such as various uses of biological confinement could be one specific aspects for management, besides the general risk assessment issues in order to avoid mis-intaking of the pharma products by the consequence of the geneflow.

Prof. Dr. Kazuo Watanabe

My name is Michael Schechtman and I work for the United States Department of Agriculture.   I have been following the conversations in this forum, and I would like to thank all of those who have contributed. I, along with the three other experts nominated to participate in this forum by the United States Government, consider this to be an important, lively and productive discussion.  The risk assessment and risk management of new and novel applications of technology is an important consideration and I thank the Parties and the Secretariat for providing this forum for the exchange of views and information.  These comments are a general response to all the discussion threads.

In the United States, we have more than twenty years of experience in the risk assessment and risk management of LMOs – for both experimental use and large scale release into the environment.  Based on this experience, we are in agreement with the conclusion of the Norway-Canada Risk Assessment Workshop (June 4-6, 2007).  Existing guidance should be adequate to provide risk assessment methodologies for analysis of the relatively new applications of biotechnology referenced in this forum. 

There are several internationally developed guidance documents related to risk assessments of LMOs that can be used to evaluate the potential impacts on conservation and sustainable use of biodiversity, including Annex III of the Protocol which provides an excellent outline of the general principles that are applicable to the risk assessment of LMOs.  Another prominent example is the OECD “Recombinant DNA Safety Considerations,” the so-called “Blue Book”.  These and other guidelines generally agree that LMO risk assessment should focus on a few basic considerations and their interactions: the organism that has been modified (its biology, lifecycle, level of domestication, and sexual compatibility with wild species, etc.); the trait that has been introduced (its effect on fitness, the nature of the gene/protein, the origin of the transgene etc.); and finally the receiving environment (is the environment managed or unmanaged, are there protected organisms that might be impacted, etc). 

Although risk assessment and risk management can be thought of as separate processes, it is usually acknowledged that risk assessment is iterative, and assessments should take into account risk management measures that may be applied to limit the potential impacts of an LMO on the environment.  Most guidance documents also agree that risk assessment should be done on a case-by-case basis and that the amount of information required to make a decision will vary depending on the nature of the LMO; its intended use and the receiving environment – familiar organisms with well-known traits intended for release into highly managed environments are likely to require less information for decision making than organisms that are less familiar that are intended to be used in new ways in highly unmanaged environments. 

It is important also to remember that risk assessment and decision making regarding LMOs should not be considered in a vacuum.  Other practices and the appropriate context for impacts on biodiversity (in agriculture, forestry, fisheries, etc.) should be factored into the assessment.  The impacts of LMOs on the conservation and sustainable use of biodiversity should be considered in comparison to their non-transgenic counterparts.

Finally, there is the issue of uncertainty, which is particularly relevant to this forum.  New or novel LMOs have more uncertainty regarding their environmental impacts than LMOs that have been in use and for which there is significant national or international experience.  This is one reason for allowing experimental releases, to collect data to address this uncertainty.  In scientific analyses, absolute certainty is impossible, but existing guidance also provides mechanisms for dealing with uncertainty.  From Annex III, “Where there is uncertainty regarding level of risk, it may be addressed by requesting further information… implementing appropriate risk management strategies… or monitoring the [LMO] in the receiving environment.” However, it is also important for regulatory officials to have a clear understanding of exactly how new data would be used in a risk assessment prior to requiring such data.

Below you will see links to U.S. regulatory websites and references that may be useful including some to policies and decisions dealing with some of the novel applications considered on this forum.  I can also provide contacts and information from U.S. regulatory agencies. U.S. regulatory decisions should be available through the Biosafety Clearing House or links on the U.S. regulatory website.  Once again, thanks to all of the participants for an informative discussion and to the Parties and the Secretariat for providing the forum and the opportunity to participate. 


OECD “Blue Book” – Recombinant DNA Safety Considerations
http://www.oecd.org/LongAbstract/0,3425,en_2649_34537_40986856_1_1_1_1,00.html

Other Relevant OECD Biosafety Documents (BioTrack):
http://www.oecd.org/findDocument/0,3354,en_2649_34385_1_1_1_1_1,00.html

U.S. Regulatory Agencies Unified Biotechnology Website
http://usbiotechreg.nbii.gov/

USDA Guidance for pharmaceutical plant field trials
http://www.aphis.usda.gov/brs/pdf/Pharma_Guidance.pdf

USDA Environmental Analysis and Decision documents for pharmaceutical crops
http://www.aphis.usda.gov/brs/ph_permits.html

USDA Environmental Assessments for non-pharmaceuticals (including trees)
http://www.aphis.usda.gov/brs/biotech_ea_permits.html

Canada -U.S. 2001 Bilateral Agreement on Agricultural Biotechnology Appendix II: Environmental Characterization Data for Transgenic Plants Intended for Unconfined Release
http://www.aphis.usda.gov/brs/canadian/appenannex2e.pdf