Agriculture Reference
In-Depth Information
the point: “PMEM is composed of case-specific monitoring and general
surveillance of GMplants. Case-specific monitoring is not obligatory 6 but
may be required to verify the environmental risk assessment, whereas
a general surveillance plan must be part of the application,” continu-
ing with “The GMO panel concludes that general surveillance cannot
be hypothesis-driven, but should when possible, 7 make use of existing
monitoring systems in addition to more focused monitoring systems (i.e.,
farm questionnaires).” The wording limits the impact of the first sen-
tence. One can conclude from these excerpts that Post-Market Environ-
mental Monitoring (PMEM) is not yet standard practice among growers
and farmers. Safety management has not yet come to GM production at
farm sites.
This original orientation, previously summarized, has been further
supported by the type of safety assessment, the “substantial equivalence
principle” that is currently accepted as state of the art for market autho-
rization of GM products. It certainly led to a rather restricted safety per-
spective on large-scale GM production.
TheImplicationsofthe“SubstantialEquivalence”Principle
foraSafetyApproach
The “substantial equivalence” concept explained in this topic by Mar-
ianne Shauzu is paramount. Essentially, for regulators to grant market
authorization, the required demonstration revolves around a systematic
comparison between the properties of the GMO-derived food with exist-
ing, “natural” products used as food or food sources. As stated by Mari-
anne Shauzu: “It is based on the idea that existing products used as foods
or food sources can serve as a basis for comparison when assessing the
safety and nutritional value of GMO-derived food. It implies that if the
modified food is found to be substantially equivalent to an existing food
6 Italics added.
7 Italics added.
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