Social Interests
5.2 Principles of GM-crop Regulations
5.2.6 Summary of regulatory debates
Together, the seven debates associated with the regulatory framework and the five debates associated with the specific GM-crop regulatory principles reveal two distinct regulatory paradigms – a scientific- rationality paradigm and a social-rationality paradigm – where, essen- tially, these two paradigms establish the regulatory parameters of a jurisdiction (Table 5.10).
There are two crucial features of the GM-crop regulatory develop- ment process. First, and perhaps the most important feature, is the fact that the fundamental regulatory principles have not been established.
For instance, the definition of ‘risk’ for regulating new technologies and the applicability of the substantial-equivalence principle in regulations remain highly contentious debates. As a result, GM-crop regulations are unstable, as various economic and social interests lobby for either the scientific- or the social-rationality approach. Moreover, the regulatory instability associated with GM crops at national and international levels is a unique feature, distinct from other social regu- latory barrier issues. For instance, while the transatlantic trade of beef products has been controversial on health and safety grounds, at least the fundamental regulatory principles for regulating beef safety are very much universal (Spriggs and Isaac, 2001). Until the fundamental
principles for regulating GM crops are established, regulatory instabil- ity will remain and regulations will shift within the regulatory parame- ters according to the influence of the competing interests.
Another crucial feature of the GM-crop regulatory development process is the path dependency of the regulatory paradigms. Initially, the particular regulatory trajectory is determined by the independence Table 5.10. Comparison of scientific- and social-rationality regulatory approaches.
Scientific rationality Social rationality General or framework regulatory debates
Belief Technological progress Technological precaution Enhances growth and Technology cannot be separated development leading to from socio-economic factors – higher social regulations – must be socially responsive a regulatory race to the top
Type of risk Recognized Recognized
Hypothetical Hypothetical and speculative
Substantial equivalence Yes No
Science or other factors Safety All four regulatory hurdles
in risk assessment Health Safety
Health Quality
Other legitimate factors Burden of proof Innocent until proved guilty Guilty until proved innocent
Minimize Type I (rejected Minimize Type II (accepted when
when safe) unsafe)
Risk tolerance Minimum Zero tolerance
Science or other factors Safety or hazard-based Broader socio-economic concerns in risk management Risk management is for Risk management is for social
risk reduction and responsiveness prevention only
Specific regulatory debates
Precautionary principle Scientific interpretation Social interpretation Risk-assessment tool Risk-management tool Focus Product-based, novel Process- or technology-based
applications
Structure Vertical, existing structures Horizontal, new structures Participation Narrow, technical experts Wide, ‘social dimensions’
Judicial decision-making Consensual decision-making Mandatory labelling Two scenarios All GM crops are novel
Substantially equivalent Consumers’ right-to-know basis Safety or Hazard basis
Novel
Consumers’ right-to- know basis
and discretion of the regulators and the role of science in the regula- tory development process. If scientific rationality is the tradition, then subsequent regulatory principles tend to hold an important role for science in determining the appropriate level of regulatory oversight.
In fact, the position on the various regulatory debates cascades from the paradigm followed. For instance, the scientific-rationality para- digm leads to a focus on hypothetical risks and an acceptance of the substantial-equivalence principle for determining the novelty of prod- uct applications, which in turn lead to the use of the precautionary principle as a risk-assessment tool, a product-based, vertical regula- tory structure employing narrow and judicial decision-making and supporting mandatory labelling in the instance of hazard or safety only. Conversely, if social rationality is the main paradigm, then the underlying support for technological precaution encourages a process- or technology-based focus, which cascades into the use of the precau- tionary principle as a risk-management tool and into a process-based, horizontal regulatory structure with wide and consensual decision- making and mandatory labelling for the consumers’ right to know in order to be socially responsive.
Additionally, the path dependency is also influenced by the compet- itive position of the jurisdiction in the new technology. A commercial- ization lead affords a jurisdiction more time to become acquainted with the credence factors of a new technology and may even allow the unknown risks to become known. On the other hand, a commercializa- tion lag ill prepares the consumers within a jurisdiction for the sudden appearance of advanced technologies developed elsewhere.
The path dependency of the two regulatory paradigms makes integration very difficult. For instance, a regulatory trajectory focused on technology-based oversight is difficult to combine with a trajectory focused on application- or product-based legislation according to novelty. Similarly, substantial equivalence can be either accepted or rejected within a jurisdiction; there is really no middle ground with this regulatory principle. Further, a jurisdiction that follows the scientific- rationality paradigm would find it difficult, in the end, to implement a mandatory labelling strategy that is completely process-based for the consumers’ right to know. Indeed, like the labelling policy, many of the regulatory positions in the two paradigms are not stand-alone positions but are part of a logical flow of regulatory decisions that can be traced all the way back to the fundamental view on the approach to technology in society: progressive or precautionary.
The two distinct paradigms, along with the regulatory debates identified in Table 5.10, can be used to characterize the GM-crop regu- latory development process within a regulatory jurisdiction. In order to do so, the commercial position of the jurisdiction, the traditional regulatory role of the state and the influence of the various economic
and social interests must be identified. This will be done for the North American and the EU regulatory approaches in Chapters 6 and 7, respectively. However, prior to this, it is now vital to link the regula- tory approaches in Table 5.10 with various regulatory integration strategies. This is the objective of the next section.