1. Introduction
Food crops have been selectively bred by humans since the advent of the agricultural revolution. The crops in which desirable characteristics are more prominent have been selected for millennia in order to make these desirable characteristics within the crop’s DNA more prevalent. Although, these desirable traits manifesting themselves in the DNA of the new crop is largely based on chance, crops have changed dramatically through this process of domestication.
With the evolution of science, Genetic Modification (GM) became feasible. GM eliminates the element of chance that selective breeding will be successful. Instead of hoping for the desirable characteristics to manifest, they can be ‘programmed’ into the organism. This marked the commencement of widespread use of Genetically Modified Organisms (GMO). GMOs are used in a variety of sectors of production, with demonstrable advantageous effects to humankind. These positive effects are largely acknowledged, either implicitly or explicitly. However, the use of GM technology on foodstuffs, from the late 1980’s onwards, has been met with a significantly more negative public response, especially from European countries. This negative response was, and is still largely based, upon the perceived danger of GM crops to health and the environment. Although these concerns are warranted after a scientific breakthrough, the fear of GM has been exaggerated, creating an irrational public fear (bron).
Nonetheless, the negative response prompted the EU to initiate the creation of legislation regulating GM crops from the mid 1980s onwards. The system that was put in place by the EU developed over time under pressure of the public and the Member States. A continuous factor throughout the development of the regulatory system was the public’s negative image of GMOs. The fear of the public has been channeled by the Member States, resulting in a regulatory system that throughout its development persistently focuses on risks management of the process of genetic modification, rather than the potential benefits of GM foods.
This essay will study the way this regulatory system developed when contrasted against models concerning the role of the EU as a ‘regulatory state’ (Majone; 1998) and the usual path to the creation of new regulatory institutions (Krapohl; 2007). The first section will discuss the scope and extensiveness of the current regulatory system and the developments that led to it being created. The second section of the essay will be devoted to two models of regulatory development. These models explain the logic behind the ever increasing regulatory responsibility of the EU and the standard procedure for the creation of new regulatory institutions. The third section of the essay will analyse the extent to which the regulatory system for GMOs and its development fit the models discussed in the preceding section. Comparing features will be highlighted, but there will also be a critical observation as to which features of the regulatory system for GMOs do not fit the models. Finally, there will be a conclusion in which key aspects of the regulatory system regarding GMOs and its development will be summarised. The essay will end with some recommendations that could improve the current regulatory system.
2. The EU’s regulation of GMOs.
As stated, during the mid 1980s of the previous decennium, GM crops began to carry a negative connotation in the public sphere. However, this negative image can also be found within the EU’s political culture, with Skogstad describing it as: ‘A precautionary one whose epistemological underpinnings are scepticism about the capacity of science to know and assess the risks of this novel technology and, understandably therefore, less willingness to grant scientific experts exclusive authority in risk regulation (2011: 901).’ This unwillingness within certain Member States to let scientific evidence be the deciding factor in the adoption of GMOs continues until present day (Twardowski et al.: 1) This section of the essay will centre around the regulatory system that developed from this attitude. It will start by shortly summarising the evolution of the regulatory system. After this, there will be taken a look at the regulatory system that followed from this evolution and how it’s shaped around this attitude.
The development of the regulatory system regarding GMOs is marked by periods of distinct difference. Morris and Spillane distinguish five such periods in the creation of EU regulations regarding GMOs (2010: 359). The first period is a period in which polity was involved in the regulation of GMOs. Instead the scientific community was the primary institution regulating the risks associated with GMOs. However, as the potential of the new technology started to clarify, so did the economic opportunities and the moral debates. Member States responded to this explosion of interest by forming regulatory policies concerning GMOs. However, these regulatory systems differed between Member States, from strict to barely regulated (Johansson: 161-163). The creation of the Biotechnology Steering Committee (BSC) in 1984, the Biotechnology Regulation Inter-service Committee (BRIC) in 1985 and the passing of directive 90/220/EEC in 1990 marked the beginning of regulatory framework, aimed at levelling GMO regulatory policy throughout the EU (Morris et al: 361 & Johansson: 161). Already in this early framework is instilled a suspicion towards genetic modification. This is visible in the precautionary character of the framework. Additionally, from the outset the EU focussed their regulatory efforts on the process of GM, instead of the safety of the products that GM produced. This despite protests against this approach from scientists (Johansson: 190-192, Skogstad: 901 & Morris et al: 361). The framework proved weak and did not satisfyingly reflect the different opinions of Member States regarding GMOs. This eventually led to its discontinuation in 1997, when Member States started forcefully banned GMOs by invoking ‘safeguard clauses’. These clauses, triggered under severe public pressure, effectively banned EU approved GMOs and halted the acceptance of new GMOs (Skogstad: 901 & Morris et al: 361).
This moratorium lasted a period of almost five years, until the creation of an updated framework based on two pieces of legislature. First among these two was directive 2001/18/EC, focussed on requirements classifying GMOs as safe for use within the EU. This directive replaced and made stricter the framework introduced with directive 90/220/EEC. It kept the requirement for every GMO to be subject to risk assessment and approval of new GMOs to be done on a case-to-case basis, but expanded this with the introduction of the precautionary principle into the new framework. This broadened Member States’ capacity to ban a GMO without convincing scientific evidence (Skogstad: 901-902). Secondly, regulations 1829/2003/EC and 1830/2003/EC entrusted the newly created European Food Safety Authority (EFSA) with the responsibility to ensure the safety of GM foods. However, within this regulatory system GM foods have thus far continued to have a difficult time gaining approval. This can be blamed on divergent opinions within the Member States, preventing majority approval (Skogstad: 904-909).
3. Theory
In this section of the essay there will be an overview of models explaining the role of the EU as a regulatory polity and the development of regulatory institutions. The introductions of these models is necessary as they will provide a basis from which the development of system regulating GMOs will be analysed.
Explaining the EU’s modus operandi in response to the outcry over GM foodstuffs, there can be found a foundation in Majone’s description of the EU as a ‘regulatory state’. The primary role of a regulatory state is the ‘sustained and focused control exercised by a public agency over activities that are socially valued (1998: 196).’ Influenced by an increasing amount of economic sectors being subject to communitarisation and a privatization of national social sectors that went alongside this communitarisation, the amount of EU regulatory institution has increased greatly over the last two decades. A driving force behind this was the 1986 Single European Act, aimed at completing the Single Market (Idem: 213). It seems paradoxical that privatization causes new regulatory institutions to be created. However, Majone argues that ‘privatization [will] only mean the replacement of public by private monopolies unless the newly privatised companies were subjected to public regulation of profits, prices, and entry and service conditions (Idem: 199).’
Zooming from Majone’s broad theory to more specific conditions governing the creation of regulatory institutions, Krapohl describes the emergence of regulatory institutions being ‘path dependent’. This means that the order in which specific events called ‘critical junctures’ occur determine the time of emergence and the strength of the new supranational regulatory institution. This can create two distinctly different regulatory institutions. First, a public scandal can occur before the communitarisation of an economic branch. The occurrence of this scandal will initiate the creation of a national regulatory institution. In the subsequent communitarisation, these national regulatory institution will become stakeholders in the creation of the new supranational regulatory institution, attempting to uphold the national regulatory policies that they created. The result of merging these strong national regulatory institutions will be a supranational coalition of national regulatory institutions, upholding the high national standards (Krapohl: 32-35). Secondly, a regulatory body can emerge as a result of the communitarisation of an economic branch. This new branch of the Single Market will be weakly regulated as it lacks the influence of national regulatory agencies to become stakeholders in the creation of a supranational regulatory institution. It will take the occurrence of scandal to open a ‘window of opportunity’ which can be used to strengthen the regulatory powers of this supranational institution. Thus; ‘The smoothness of market integration has the negative effect that it leads to the likely occurrence of a regulatory deficit (Idem: 33).’
The paths described above are depicted in the graph below (Idem: 31).
It might be argued that to use Krapohl’s model to analyse the regulation of GMOs is stretching the employability of the model. This because Krapohl’s model requires a defined (regulatory) scandal to provide a path towards the creation of a regulatory institution. Nonetheless, I think Krapohl’s model can be used in the analysis of the development of the institution regulating GMOs. This because there has been huge public outcry influencing the. Additionally, national regulatory institutions were initially set up, becoming stakeholders in the resulting supranational regulatory system. Nonetheless, it must be pointed out that the original model was tested on the food and pharmaceutical industries, two landed sectors of industry which were present on the European continent before the creation of the Single Market.
4. Empirical analysis
The following section will shed light on different aspects of the regulatory system regarding GMOs fitting with the previously discussed theories. This will be done by placing the development of the GMO regulatory system over the theories, highlighting parts of the regulatory system that fit, as well as stroke with the mentioned theories.
When fitting the EU’s dealing with GMOs into Majone’s model of the EU as a regulatory state, two things are noteworthy. Firstly, a continued line between adhering to the public’s demand and supporting GM technology has incited the EU to handle the rise of GM’s in a regulatory manner. Despite GMOs having had a negative public image from their entering the minds of the European public, the EU has continued this approach. Although banning GMOs’ altogether seem quite far fetched, a majority of Europeans would support this idea (bron). The EU’s regulatory handling of GMOs is therefore noteworthy. Secondly, there is the two-sided question of how the regulatory system for GMOs fits into Majone’s discussion about accountability. Majone’s ‘regulatory state’ is one of view concepts that does acknowledge the existence of a ‘difference’ in accountability between the EU institutions and the regulatory agencies. This difference is primarily caused by the fact that chosen officials primarily focus on short-term results with the aim of being re-elected, while regulatory agencies are shielded from the distorting effects of politics (Majone: 207-210). While Majone does not view this as necessarily bad for democracy, it has two sides. On the one hand the process regulating GMOs could be described as more democratic, since public outcry continues to result in a limited acceptance of GMOs in the EU. However, the downside of this has been ignoring the
Exemplary of this has been the process-based regulation of GMOs. While public suspicion against GM technology may warrant this approach from a democratic standpoint, the independent scientific committees have continuously advocated product-based regulation.
When fitting the development of the regulatory system for GMOs into Krapohl’s model there arise several problems. Firstly, the regulation of the market for GMOs is distinctly ‘negative’. While ‘positive’ market integration removes barriers for products entering the Single Market, ‘negative’ market integration creates rules to which products must abide to be allowed onto the Single Market (bron). Because there were relatively weak national institutions regulating GMOs, one might expect that the resulting supranational regulatory institution would be weak too. I would argue that the regulatory system for GMOs having a ‘negative’ character, despite the lack of a public scandal, can largely be largely attributed to continued public pressure. This pressure has forced the Member States to become stakeholders, demanding strong regulation for GMOs. Although the result is similar, there is a deviation from Krapohl’s model. Instead of national institutions being the primary stakeholders in the creation of a strong supranational regulatory institution, this role has been taken over by the Member States themselves, forced by their population. As can be deducted from the need to reform the regulatory system several times, this pressure was not equally strong throughout the EU. It was, however, strong enough to create a strongly regulated market for GMOs.
All in all, the development of the regulatory system for GMOs fits both models quite well. There are some reasons as to why the GMO regulatory system does not fit Krapohl’s model completely, however these have been explained. From this it can be concluded that, although GMOs are a contested topic, the regulatory procedures surrounding them follow the same path observed in other sectors of the Single Market.
5. Conclusion
In this conclusion there will be made a crude summary of the factors and developments shaping the system regulating GMOs. After this summarisation, there will follow some concluding remarks.
GM technology has had immensely advantageous effects for humanity. However, GM foods have been regarded with suspicion by the general public, giving GM foods a negative reputation. Since the introduction of these food-related GMOs to Europe the overall regulatory response has been struggle between this scientific evidence and political attempts to follow public opinion. Public pressure combined with political incomprehension have created an EU regulatory system that is partly rooted in scientifically disproven fears. This regulatory system has been reshaped several times but continues to because different from other regulatory systems in the EU because of its continued distrust of scientific. Examples this can foremost be seen in the process-based, instead of product-based approach. Additionally, the adoption of the precautionary principle (eliminates the decisive role of scientific certainty in the approval of a GMO.)
Because the regulatory system described above displays clearly visible flaws, it is not difficult to indicate places where improvements to its functioning could be made. Bartsch proposes to do away with the zero tolerance policy regarding GMOs. The standards that need to be maintained in order to conform to these standards are ‘set by perception and not by conditions of nature (2014: 58).’ Additionally, there should be put a stop on the use of the precautionary principle to ban GMOs without proper evidence to the dangers that they pose (Idem: 57). Ultimately, increasing the functioning of the regulatory system will have to go hand in hand with an increased public understanding of the advantages and disadvantages of the use of GMOs. Achieving this will require trust from the public and politician in the scientific committees to come up with reliable reports.
GMOs are already in wide use and will likely dominate agriculture in the future. GMOs can be modified to withstand the increasing heat and wetness which accompany climate change and be made resistant against new insect populations that migrate increasingly further north. Moreover, plants are the main converters of greenhouse gasses. Modified plants could potentially help solve the pressing climate issues. Therefore, to not have a regulatory system that promotes the optimal use of this developing technology, would be closing ourselves off from a potentially crucial technology contributing to the continued existence of humankind.