Agriculture Reference
In-Depth Information
Policy Challenges Posed to the EU
Pharm crop operations will be similar to production facilities and will
primarily be designed for maximum yield of intact proteins. Risk char-
acteristics are likely to differ from first-generation GM crops, and risk
mitigation requirements will become a focal issue. These specifics are
likely to pose a number of challenges to policy makers and regulators in
the EU.
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First, there is the need to thoroughly review and update current risk
assessment approaches and guidelines established for first-generation
GM crops. Possible challenges for risk assessment approaches include
the applicability of the concepts of substantial equivalence and familiar-
ity, discussed in Chapters 3 and 4, which play important roles for struc-
turing risk assessment of current GM crops. Familiarity, for instance,
also refers to environmental and agricultural experiences gathered with
the host crop in conventional agriculture.
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Familiarity might however
be less important if the crops have been subjected to multiple and
perhaps more substantial changes of genotype (see above) or if non-
food/nonfeed plants with which there is less experience are used, such
as safflower in Canada. Likewise, “substantial equivalence” understood
as referring to the degree of compositional, morphological, and agro-
nomic differences between the GM crop and its conventional counter-
part might no longer be considered appropriate to guide risk assessment.
Furthermore, with PMPs another step might be added to risk assess-
ment: to thoroughly assess and to advise on the appropriate level of
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A. Sauter & B. Husing, Gr une Gentechnik - Transgene Pflanzen der 2. und 3. Gen-
eration (2006), available at www.tab.fzk.de/de/projekt/zusammenfassung/ab104.pdf;
A. Sp ok & M. Klade, Molecular Farming. Novel Challenges for Risk Manage-
ment and Legislation (Office of Technology Assessment at the German Parliament
2005).
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K. Barret & E. Abergel, Genetically engineered crops. Breeding familiarity: environ-
mental risk assessment for genetically engineered crops in Canada. 27 (1)
Science and
Public Policy
2-12 (2000).
