Dear Participants,
After taking a somewhat brief look at the proposed “Post-release Monitoring and Long-term Effects of LMOs Released into the Environment” draft, I am astounded by its internal logical inconsistencies, expansive recommendations and operational impracticality. (There are numerous annoying typos that I will address at the end.)

The primary logical issue is that of General Surveillance. It tacitly posits an incorrect view of biological systems that assumes some level of temporal stasis, any perturbations of which are indicators of possible harm from LMO release. This presumably requires follow-up in order to determine whether a causal relationship exists between LMO release and change in the indicator. So in contrast to the assertion put forth in the draft that…

“Futher [sic], GS  may begin as a hypothesis-free observation where detecting causation between the observed effects of the LMO may lead to testable hypotheses through further investigation.”

…there are clear tacit hypotheses. If these were explicitly developed in this draft and as part of the CSM plan, it would become much clearer what needs to be monitored and why, thus moving all of the GS into a science-based hypothesis driven CSM plan.

As long as the GS has no testable hypotheses, it cannot become what is asserted:

“…an important tool in decisionmaking [sic] with respect to the safeguarding of protection goals from any adverse effects of LMO release, particularly where the threats are considered serious or irreversible, but lack full scientific certainty of their occurance[sic].”

When hypotheses are abandoned, surveillance becomes a temporally and spatially indefinite un-scientific pursuit. While “long-term” is referred to repeatedly in the draft, in no place is any definition give to how long this is nor when it would no longer be required.

This expansive nature particularly impairs the usefulness of monitoring in the context of what the document is attempting to achieve. That is, it will be applied to…

“Parties without elaborated monitoring requirements within their domestic legislation, or little or no monitoring experience.”

The guidelines are being proposed as most helpful for Parties who have little experience or infrastructure, but then a monitoring approach is recommended that is open-ended and (supposedly) not hypothesis driven yet still claims to be science-based!

As a virtual footnote, the draft at least superficially acknowledges this limitation of the GS approach.

“Lastly, long-term effects monitoring may pose a number of practical challenges, e.g. in consistency or availability of test sites or subjects over long periods, and empirical limitations (e.g. establishing a causal relation with any change identified in the monitoring program).”

These are non-trivial issues which must not be dismissed with so few words and would merit a document at least as long as the one submitted! Even in the most developed countries, the likelihood of a GS leading to useful information is highly speculative. Developing countries will find this an insurmountable problem.

As a detail, I am puzzled by the statement that…

“…monitoring itself should not be considered a means for risk mitigation under decisionmaking[sic].”

Would not one’s ability to detect harm be essential to limit it and should be considered in risk mitigation?”

There also is little need to state the obvious:

“Unanticipated effects may be difficult to predict;”

Finally, this draft suffers from even basic editing for grammar and spelling. My apology if a writer who is not a native English speaker wrote it, but even a cursory examination with a spelling/grammar checker would have identified and easily remedied the obvious problems. It is hard to take the substance of a draft seriously when such a minor task as the latter has been neglected. I strongly suggest that in the future, drafts should be more closely vetted before distribution as style issues can compromise a fair consideration of the substance.

Mark Q. Benedict
Univ. Perugia, IT

POSTED ON BEHALF OF HIROSHI YOSHIKURA

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1. Reading through the proposed draft on “post-release monitoring”, I strongly concur the concerns expressed by Dr. Mark Benedict (posted on 2011-09-05) particularly on “expansive recommendations and operational impracticality” of the present draft.

2. I believe that the monitoring should maintain the principles of the “case-by-case” application and “comparative safety assessment”, which are outlined in Cartagena Protocol Annex III, paragraph 6, and paragraph 8(a), respectively, so that the guidelines remain practical and the requirements are proportionate to the risk compared with the conventional organisms.

3. I believe that the post-release monitoring should be proportionate to the risk. It is appropriate only in specific circumstances where risk assessment suggests the necessity. Its utility and practicability should be considered. Its purpose will be to verify conclusions obtained through risk assessment about the absence or the possible occurrence, impact and significance of potential environmental effect. This is in line with the risk analysis principles of codex alimentarius (Principles for the Risk Analysis of Foods Derived from Modern Biotechnology, Risk management, paragraphs 16-21).

4. To make monitoring decision and risk assessment more practical and usable, I propose that development and use of LMOs should be limited, for foreseeable future, to those, which have conventional counterpart(s) with long history of safe use. Attempting to have guidelines applicable to all the possible LMOs is too ambitious in my view. It may become too prescriptive particularly for LMOs derived from very familiar organisms, such as crop plants. No extensive scientific investigation can cope with the long history of use (there are so many phenomena that have not been explained by science, even for my potatoes in my back yard).  For organisms with no familiarity, LMOs should be developed only after extensive investigation relating to their biological and ecological behaviors. 

5. I strongly agree with Dr. Mark Benedict in saying that the drafter(s) assume “biological systems that assumes some level of temporal stasis, any perturbations of which are indicators of possible harm from LMO release”. It is rather reality that the biological diversity will continue to change, even without involvement of LMOs, through changes of climate, world population, expanding/changing agricultural practices, etc. In my limited experience of observation, change in precipitation, rather than microbes themselves, had the greatest impact on the microbial flora during the trial of bioremediation of underground water. The monitoring should always take into account changes that are produced by factors unrelated to LMOs.

6. Objective and Scope says “(the draft monitoring guidance) is mainly targeted towards Parties without elaborated monitoring requirements within their domestic legislation”. If so, I understand that the drafters from countries which have domestic legislation have already used this guideline in their own countries, for example, to monitor some exotic species. Attachment of such documents will be most useful for Members.

Hiroshi Yoshikura

I greatly appreciate the comments of Hiroshi Yoshikura.  However, with regard to the suggestion that "To make monitoring decision and risk assessment more practical and usable, I propose that development and use of LMOs should be limited, for foreseeable future, to those, which have conventional counterpart(s) with long history of safe use," I would like to point out that this could be interpreted as unduly restricting for new applications such as LM mosquitoes - which are being explored precisely because conventional mosquito control measures have been unable to meet public health needs for diseases such as malaria and dengue. It is important to remain open to the development of LMOs for use in ways that may not have obvious conventional counterparts, and have the potential to achieve benefits that are not currently available through other means.