Agriculture Reference
In-Depth Information
That said, some PMPs (e.g., allergens for diagnostics or medical ther-
apy, vaccines, or hormones) might call for higher levels of containment
than others. EU member-states might also have different opinions about
what would constitute an appropriate level of containment for a partic-
ular substance. There might even be different ideas about the border-
line between contained production and deliberate release. For instance,
a commercial production using nethouses (saranhouse), as is envisaged
with potatoes in Denmark
65
might be considered by some EU member-
states as a rather unproblematic authorization under the contained use
EU Directive 2009/41/EC, whereas other member-states might classify
the same practice as deliberate release that would require an application
under Directive 2001/18/EC and a much more cumbersome EU proce-
dure. Such differences will need to be reviewed and perhaps harmonized
by EU regulators.
Possible Repercussionson Innovation
The United States and Canada are each developing a separate regula-
tory track for molecular farming with requirements for risk assessment,
risk mitigation, and monitoring that will be much more rigorous than
such requirements for first-generation GM crops. Under pressure by the
powerful food industry, the USDA is promising a highly precautionary
approach, a zero-tolerance policy, for both PMPs and PMIs with regard
to accidental contaminations, to prevent detectable traces of pharm or
industrial GM crops in human food and animal feed.
Europe can reasonably be expected to follow this approach. Hence,
much higher compliance costs can be expected for open field produc-
tion of PMPs compared to first-generation GM crops. Together with the
prospect of huge liabilities following contamination incidents, this may
drive innovation into nonfood crops or strictly confined or contained
65
United States Department of Agriculture, BRS Factsheet (2006), available at
www.aphis.usda.gov/publications/biotechnology/content/printable version/BRS FS
pharmaceutical 02-06.pdf.
