Table 3.
General analysis of the advantages and disadvantages associated with product- and process-oriented regulatory triggers as well as the associated challenges concerning implementation of such systems [as particularly relevant for nGM applications (nGMs) or GM applications (GMO)].
| Advantages | Disadvantages | Challenges |
|---|---|---|
| PRODUCT-ORIENTED REGULATORY TRIGGERS | ||
| High flexibility to accommodate products of emerging technologies without need for legislation change (nGMs) | Some product-oriented triggers may result in inconsistent coverage of products with comparable traits (USA: nGMs and GMOs) | Different competent authorities may be involved, if a broad scope of use is intended (env. release and food/feed use)—split responsibilities, need for coordination |
| Existing regulatory structures can be used for comparable products | Individual applications may need to be reviewed for regulatory status | Criteria and guidance required for decision making on regulatory status |
| Similar regulatory approach for comparable products developed by different techniques | Process to determine regulatory status considered more complicated and less predictable compared with process-related triggers (GMOs) | Limited compatibility with regulatory systems based on process-oriented triggers regarding the scope of regulated articles |
| Consistent risk assessment perspective for products irrespective of the method of production | The typical remit of existing authorities may be ill-suited to address risk assessment challenges of emerging applications | |
| PROCESS-ORIENTED REGULATORY TRIGGERS | ||
| Typically new sectoral legislation is introduced and implemented by a specific authority | Limited flexibility to accommodate products of emerging technologies—possible need for legislation change in reaction to technological developments (nGMs) | Severe challenges of trigger interpretation regarding some nGMs if specific guidance is not available |
| Newly introduced sectoral regulations address all relevant risk assessment requirements | Regulation gaps until newly emerging technologies are addressed by trigger amendments (nGMs) | Ambiguous trigger definitions may lead to interpretation conflicts that have to be settled by administrative and/or court proceedings (nGMs in particular) |
| Process-oriented triggers considered easier to implement and more predictable (GMOs) | Trigger specifics (exemptions) may result in inconsistent coverage of products with comparable risk (nGMs) | Limited compatibility with regulatory systems based on product-oriented triggers regarding the scope of regulated articles |