, ,

Policy and decision makers will have to clearly define what a requirement of conducting “long term” studies mean in terms of data collection, analysis and decision making. Does this mean, for example, that the regulatory/decision making entity will require long term data collection before authorizing deliberate and/or commercial) release?

Note that this requirement leads into an interesting conundrum. How can one collect “long term data” on an LMO release where none has been approved because there is no “long term data” AND How can one approve an LMO release without long term data if required? Obviously a careful definition of what is expected will be critical for designing a functional biosafety system.

The requirement of “long term assessments” also open a host of questions about how to implement such assessment. Will this “long term” data collection requirement be made mandatory for all submissions? Will it be required only for the first application of a specific event? Would this “long term” assessment be done for types of events?

Will this assessment be part of a mixed system, where there is a relatively standard period of confined field trials, multi-locational trials and advanced large trials (such as is required in China) before considering commercial approval followed by a renewable 3-5 year temporary permit – as is done in most countries anyhow- where there is a post-release monitoring assessment, ending in de-regulation if there are no issues raised?

As I have contributed in previous notes, the regulatory lags introduced by these requirements have consequences in terms of opportunities lost, information gained and technology flows which society will need to consider in its decision making processes.