Secondly, a risk assessment should be carried out in a manner that is as transparent as possible, for example via public notification.

Example – Risk assessment practices in various countries

In Argentina, once a LM plant has been sufficiently field-tested, the applicant may request that the crop be ‘flexibilized,’ that is, be approved for unconfined (usually large-scale) planting for certain specified uses. These are: (1) for regulatory purposes – to provide material for analytical, toxicological and other required tests; (2) for export; (3) for off-season seed increase – not to be sold in the country; (4) for tests to be later presented (after approval for commercialization is granted) in support of new variety registration; or (5) for pre-commercial multiplication pending variety registration.

In Canada the risk assessment audits for plants with novel traits (PNTs, which includes LMOs) are undertaken in offices of the Plant Biosafety Office of the Canadian Food Inspection Agency (CFIA).

In Mexico, a group of scientists, together with authorities from the Ministry of Agriculture, analyze the applicant’s risk assessment on the basis of national legislation. This group may request help from other experts to decide on an application. When the Ministry of Agriculture has become familiar with a LM crop, it may allow the applicant to increase the area planted for the crop, but the applicant will have to continue to present the risk assessment as was done for the first application. Any biosafety measures for a semi-commercial release would also have to be maintained.

In New Zealand, responsibility for risk assessment lies with the applicant based on the criteria in the legislation. Forms and guides assist applicants understand the intent of the legislative criteria. The Environmental Risk Management Authority (ERMA) evaluates the information provided and if required can seek further expert information or reports as appropriate. Low risk activities that conform to the requirements of the regulatory regime are not publicly notified. Some activities are discretionary for public notification while there are others for which there is a mandatory requirement for public notification (see ERMA’s website).