Risk assessment and risk management of transgenic pharmaplants

A limited number of pharmaplants have been grown in field trials under strict conditions to minimize their interactions with the environment. These trials have taken place for over 10 years in various locations within Canada, the USA, and the European Union (EU).  When reviewing applications for these field trials, regulators in these countries have focussed on the following general risk assessment criteria:
o the identity and origin of the pharmaplant;
o the properties of the novel gene and gene product(s);
o anticipated or known effects on the environment;
o description of the proposed trial site, particularly any presence of endangered species in the trial site area
o potential impacts on human and animal health resulting from the environmental release;
o the experimental protocol
o measures that will be taken to ensure reproductive isolation of the trial plants, trial site surveillance, and restrictions of post-harvest land use as well as proper record keeping, safe handling, storage and disposal of plant material;
o contingency plans, should the pharmaplant be released outside of its authorized area, or unintentionally enter the food or feed supply chains.
In Canada, the CFIA oversees confined field trials of plants with novel traits according to the general risk assessment criteria outlined in “Directive 2000-07:  Conducting Confined Research Field Trials of Plants With Novel Traits in Canada” . However, the CFIA has also adopted stricter risk mitigation measures for confined field trials of pharmaplants.  These are outlined in the “Interim Amendment to Directive 2000-07 for Confined Research Field Trials of PNTs for Plant Molecular Farming”  and include, among other things, increased reproductive isolation requirements.
In the USA, field testing research using pharmaplants requires a full APHIS permit. These permits require more detailed information than what is normally required for standard notifications. Decision summaries for all release permits are publicly available online .
Various member countries of the EU have also authorized confined field tests for pharmaplants.  In France, field trials of corn expressing a gastric lipase were authorized in 2000, with trials of corn expressing monoclonal antibodies following in 2005.  Applications for these trials and summaries of the risk assessments performed by the French authorities can be found online (French only) .  In Germany, field trials of potatoes expressing a de-toxified cholera toxin subunit and potatoes expressing viral coat proteins from rabbit haemorrhagic disease were authorized in 2006.  Notification reports for all confined field trials in the EU are available on the website of the Joint Research Centre of the European Commission .

While this technology is rapidly moving towards commercialization, there are currently no known authorizations for large-scale releases of pharmaplants into the environment.  However, it is anticipated that this will change in the near future as developers have expressed interest in submitting applications for non-research releases within 1 to 3 years.