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Development of the Roadmap for Risk Assessment

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Comments on the roadmap [#1246]
I would like to thank the SWG for their work.  I am attaching my comments on text, and responses the the discussion points.

Hector Quemada
posted on 2009-07-03 13:52 UTC by Dr. Hector Quemada, Program for Biosfety Systems/Calvin College
RE: Comments on the roadmap [#1256]
Thank you AHTEG for developing the Roadmap.  It is well-developed, readable, and a useful guide to many stakeholders in biotechnology particularly involving LMOs.

Regarding ‘Context of the risk assessment process-Points to consider:  Specific (e)’.  May I suggest the removal of parenthetic examples ‘e.g.field trials, commercial release’ in order to simplify and to avoid confusion by users of the Roadmap.  Information required on risk assessment of LMOs differ according to ‘stage of development.’  The Roadmap should not be interpreted as requiring the same level of information for approving field trials compared to commercial releases.  I am concern of this because many developing countries are already struggling with approving field trials-both from private and public sector-developed LMOs, and as written, the Roadmap could confuse users.

May I also thank everyone who shared their views, this forum is a valuable learning opportunity for me.

Sonny Tababa
CropLife Asia
posted on 2009-07-06 06:49 UTC by Sonny Tababa, CropLife Asia
RE: Comments on the roadmap [#1260]
In my opinion, the examples would greatly help users understand the text guideline and are very useful especially for those in countries who haven't got proper guideline to carry out risk asessment of LMOs. Researchers who are involved in LMO research generally understand common terms eg. field trial, commercial release etc. To ensure that confusion is avoided, some of the examples can be added into item 1 'glossary of terms'. Thank you.
posted on 2009-07-07 01:58 UTC by Maizura Ithnin, Malaysian Palm Oil Board
RE: Comments on the roadmap [#1273]
I would like to follow up on the comments submitted by Sonny Tababa and Hector Quemada about the application of the roadmap to ‘confined field trials’. 

While the steps for risk assessment in Annex III of the protocol could be applied to risk assessment for field trials, I don’t see how this can be the purpose of Annex III. 

Field trials are for research purposes to evaluate the performance of the plant, to compare it to the non-modified counterparts, and to generate information that will be used in the risk assessment for an unconfined release.  Plants evaluated in field trials may never be deployed in large-scale, unconfined plantings.  The risk from field trials is not the same as an unconfined release because the likelihood of adverse effects from field trials is not the same as those from unconfined release.  In field trials, the exposure is limited both by the small size of the field trials and by the additional confinement measures imposed on the trial. 

Under their domestic regulatory frameworks, most countries assess the risks associated with field trials with regard to the risk management practices proposed for the field trial.  They will consider the introduced trait, biology of the crop plant, and receiving environment in the context of those risk management practices to determine whether those practices are sufficient to conduct the field trial safely.  Most countries, under their domestic regulatory frameworks, will require a subsequent assessment of the risk for an ‘unconfined’ release.  At that time, the potential impacts of growing the plant in unconfined, large scale plantings will be considered.  This is when a detailed molecular characterization of the genetic material inserted into the plant and adverse effects such as impacts on nontarget organisms, consequences of gene flow, and changes in cultivation practices related to the use of the plant will be considered. 

This begs a question: Would it be consistent with the objective of the protocol if a risk assessment is only conducted for the first transboundary movement of an LMO when that first transboundary movement is intended for the purposes of a field trial?

Therefore, the roadmap being developed should have risk assessment of ‘unconfined’ releases as its focus.  I would suggest that reference to field trials be deleted from the roadmap, as suggested by Sonny.  But if it is not deleted, then I would strongly urge the addition of language in the roadmap, as suggested by Hector, that clearly distinguishes the application of the roadmap to risk assessment for confined release (field trials) from that for unconfined release (commercialization).  At the very least, the ‘points to consider’ for a confined release should be listed separately from the ‘points to consider’ for an unconfined release. 

In our work with developing countries on capacity building for the regulation of biotechnology, we find that it is extremely important to make this distinction.  If this distinction is not made, then the countries that will be using the roadmap will be likely to assume that the information required for an unconfined release is the same as that required for a confined release.  This is not reasonable, if not impossible, for the reasons described above.
posted on 2009-07-09 17:55 UTC by Dr. Karen Hokanson, University of Minnesota
RE: Comments on the roadmap [#1276]
I agree with the ideas here that risk assessment of LMOs for commercial release and field trial of the same LMO should be clearly separate. In the Philippines, we have developed risk assessment guidelines for field trials of LMOs different from risk assessment of LMOs for commercial release. The risks from field trials stem from an unknown quantity whose safety is yet to be assessed during field trials thus risks stem from unauthorized dispersal of seeds, gene flow and unauthorized use. These risks are manageable and thus field trials can be authorized with risk management measures given as condition for approval. On the other hand, risks from LMOs for commercial release stem from the very nature of the LMO itself, hence risk assessment is focused on this very nature and its effect on the environment. We do have separate risk assessment guidelines for LMOS imported for direct use.
posted on 2009-07-10 12:21 UTC by Saturnina Halos, Philippines
RE: Comments on the roadmap [#1279]
With regard to field trials: While inherently the risk assessment process for an engineered crop released as a field trial is the same, in practice the evaluation of field trials is mostly a risk management exercise.  Thus, since the hazards for the new engineered crops may not be known (without conducting the field trial and generating data) the goal is to minimize the exposure aspect through appropriate risk management.  Since the focus of the road map is risk assessment, it would achieve its greatest utility if the focus was confined to the risk assessment of large scale release of an engineered crop.
posted on 2009-07-10 17:06 UTC by Phil Macdonald, Canada
RE: Comments on the roadmap [#1284]
With regard to the question of a glossary, I feel that having terms clearly defined is helpful and necessary.  The following is an initial list of terms that should be defined to create more clarity for the Roadmap.

- comparative approach or manner
- endpoint
- recipient organism
- donor organism
(we use these last two terms perhaps not recognizing that many may not understand)
- risk
- exposure
- hazard
(many of these can be taken directly from OECD or other sources)

I believe that some terms will not lend themselves readily to defining in a glossary like transparency and adverse effect or harm.
posted on 2009-07-10 18:16 UTC by Thomas Nickson, Monsanto Company, USA

Update on 2009-07-10
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