ICTSD Outputs and Activities on Biotechnology, Trade and Sustainble Development

Biotechnology: Addressing Key Trade and Sustainability Issues

B.1 Environmental, health-related and socio-economic considerations

Q6 Should biotech products be subject to different rules than other technologies?

The approach to biotech products adopted by a government affects whether policy-makers decide to create a different set of rules for such products. There are broadly two types of approaches, namely a product-based approach guided by the 'substantial equivalence' principle and a process-based approach based on the precautionary principle. Each methodology, as described below, represents one end of a spectrum of possible approaches that a government can adopt; a combination of perspectives and practices is normal.

The product-based approach evaluates a novel product against an already approved counterpart by comparing the composition and characteristics of the two final products. This approach is based on the assumption that the process of genetic modification per se does not result in a different product. Countries adopting this principle often do not create a separate regulatory system for biotechnology, opting instead to regulate these products within the existing regulatory framework. The safety procedures tend to take the principle of 'substantial equivalence' as a starting point. Thus, the risk assessment begins by comparing the GMO to its conventional counterpart. If found to be substantially equivalent, the two products are subjected to the same safety considerations. If a food or food component is found to differ substantially from its counterpart, the safety evaluation focuses on the identified differences.

The concept of 'substantial equivalence' was developed by the OECD in 1993 as a guiding principle for safety assessment of genetically modified foods. Although there is no generally accepted definition of substantial equivalence, the concept is based on the assumption that the process of modern biotechnology "does not inherently lead to foods that are less safe than those developed by conventional techniques" (OECD, 1993:10). In other words, the substantial equivalence determination grants no significance to the fact that a product has been developed using modern biotechnology, but focuses solely on the compositional and other tangible characteristics of the GM product vis-à-vis its conventional counterpart (Kysar, 2004).

The substantial-equivalence approach, however, is controversial. It has been called "inherently anti-scientific" as it does not require biochemical and toxicological tests that would likely reflect critical differences (Millstone, 1999). It has also been criticised for not considering the unintended effects of genetic modification and the uncertainties regarding the effects of exposing humans, animals and other living organisms to the novel proteins generated by many GMOs that may not have physical manifestations in the GM product itself. Finally, it is considered inadequate for not taking into account significant, though non-scientific parameters such as consumer and ethical concerns (Stilwell, 1999).

The process-based approach, on the other hand, compares products by evaluating whether they were created using the same or different processes. Even if the final products are identical, a risk assessment is carried out if the production process was found to be different (such as genetic modification vis-à-vis traditional breeding), assuming that the process itself might impact on the final product. This approach is often based on the precautionary principle, which states that where there are threats of serious or irreversible damage to human health and the environment, lack of full scientific certainty should not be used as a reason for postponing measures to prevent possible harm. Thus, advocates of the principle argue that, given the lack of certainty regarding the long-term impacts of genetic modification, it is prudent to regulate GMOs in a way that presumes that they are different from conventional organisms.

The actual approach adopted by a government, and whether it decides to create a different set of rules, often reflects a mixture of the sentiments described above, motivated by the need to balance the risks and opportunities presented by biotech products. These risks and opportunities are discussed in Sections B.1 and B.5. In practice, many governments have chosen to develop separate rules to evaluate the safety and regulate the use of agricultural biotech products. Supporters of a distinct regulatory framework have also pointed to the Biosafety Protocol's existence as proof that the international community has recognised that biotech products require their own, distinct authorisation process.

Despite these differences in approaches, some forms of biotechnology have been widely recognised as posing unique regulatory challenges. For example, while medical biotechnology is largely regulated through existing legal frameworks for the pharmaceutical sector, some applications, such as human stem cell research or the cloning of animals, are generally seen as different from conventional animal and health research, not least due to the ethical concerns they have evoked. Similarly, most would agree that GM crops used to produce industrial or medical compounds should be grown under more restricted conditions than conventional crops (and GM food crops, some would argue) to avoid cross-pollination and intermingling with food crops.