Deregulation is one term used for the process that eventually leads to the registration of a product and the granting of its unlimited commercial or noncommercial use. The national authorities of the respective countries in which the product is intended for use govern deregulation of GMO plants and the foods derived from these. The process is driven by a science-based risk assessment of the intended product and the environments into which it will be released. Current data requirements can be extensive and are comprehensive, and require the submission of publication quality data reports. The development of these materials can be time- consuming and costly. The studies required to compile a regulatory dossier fall into 2 categories: event-dependent and event-independent studies.
Event-independent studies can include biochemical analysis (function, specificity and mode of action), studies on toxicity and the allergenic potential of the newly expressed proteins. In addition, dietary exposure modeling and bioavailability studies can be conducted with the newly expressed proteins and, in the case of enzymes, with the products produced by catalysis.
Event-dependent studies vary by country and can encompass the characterization of the quality of integration, such as copy number, the determination of the site of integration in the host genome, demonstration of the absence of gene disruption, completeness of integrated DNA sequences, and the presence of the marker gene at the same locus and absence of vector DNA sequences. Phenotypic and biochemical evidence for trait stability, including the monitoring of gene expression levels at key growth stages and Mendelian inheritance over several generations, are usually components of these studies. Field performance of typical agronomic traits, such as yield, and pest and disease resistance, is an additional issue. The assessment is also based on the comparison of the compositional analyses from materials harvested at different locations with the equivalent nontransgenic crop (and food) comparator. Event-dependent regulatory data are usually not gathered until the developer is satisfied with the technical performance of the product and a few events (usually one) have been chosen. Assessment of the potential risks of GM crops is on a case-by-case basis within a scientific framework. A GMO crop producing -carotene must be viewed differently than a crop that produces an insecticide. Similarly, GR events expressing a phytoene synthase from maize, a widely consumed crop, might be viewed differently than one using the enzyme from a nonfood plant, such as daffodil.
From a scientific point of view it is often hard to understand why randomly mutagenized crop plants can enter into breeding lines easily, whereas GMOs, with considerably fewer genetic modifications, have a much more rigorous assessment. To have rational, science-based regulatory requirements it would be necessary to realize the benefits (not only potential risks) that GMO crops can provide (see lecture by Ingo Potrykus at http://www.syngentafoundation.com/golden_rice/index.htm). It is unhelpful to raise the regulatory requirements to the point where anything that appears technically feasible is being requested or is being offered to be applied (Kuiper and others 2001), with the only justification that the genetically modified organism involved is little understood. This strategy can raise costs to unaffordable levels. We do not understand bred varieties with their complex genomic changes much better at the molecular level, but we tend to consider the traditional way of producing new varieties safe in contrast to the novel way of producing GMOs even though this is not based on any rational evaluation. It is the final product and not the technology used to produce it that should be scrutinized.