Agriculture Reference
In-Depth Information
confinement and containment measures. In response to this challenge
the European Food Safety Authority (EFSA) has recently published an
Opinion.
49
Second, and perhaps the most important goal of EU regulation, might
be to address the issue of “coexistence” between industrial crops and
food and feed crops, and the avoidance of any cross-contamination (con-
finement). In the case of open field production of food crops with PMPs
and perhaps with PMIs, there is a clear need for mandatory and harmo-
nized rules at the EU level. These rules need to include threshold limits
in case of accidental contamination that will have liability implications.
The present threshold limits of 0.9 percent for GM crops in non-GM agri-
cultural food products will clearly not be generally applicable to pharm
crops and only be envisaged for PMIs that do not have hazardous prop-
erties and have been authorized as GM food/feed under EU Regulation
1829/2003 (on GM food and feed). Conversely, it is difficult to envisage
a zero tolerance policy, which is being pursued by the USDA.
50
Even
thorough on-site risk mitigation measures and safety distances (e.g., 1
mile for maize-producing PMPs)
51
are not considered to be 100 percent
effective by many commentators and by Canadian regulators.
52
Given
the huge differences that can be assumed for the hazardous properties
49
EFSA, Scientific Opinion on Guidance for the risk assessment of genetically mod-
ified plants used for nonfood or nonfeed purposes (22 April 2009), available at
http://www.efsa.europa.eu/en/scdocs/doc/1164.pdf.
50
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; Howard, J. A., and Donnelly, K. C., 2004. A quantitative
safety assessment model for transgenic protein products produced in agricultural
crops.
Journal of Agricultural and Environmental Ethics
, 17, 545-558.
51
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.
52
Canadian Food Inspection Agency's Plant Biosafety Office, Developing a Reg-
ulatory Framework for the Environmental Release of Plants with Novel Traits
Intended for Commercial Plant Molecular Farming in Canada (2005), available at
www.inspection.gc.ca/english/plaveg/bio/mf/fracad/commere.pdf.
