Slowly but inevitably, the surge in understanding and precision tools that have illuminated the life sciences in recent years are transforming the two pivotal industries whose very essence is life: food and health. Downstream from the laboratory, agriculture and the health-care industries have seen their performances heightened and their competitiveness improved, often generating better value and quality for the consumer. The health and food sect-ors are both in ferment, as they try to absorb the flood of new knowledge and data that comes with the advances of biotechnology.
However, these advances have also underlined some key differences between the two. Health care is a highly regulated sector whose products address often life-threatening situations in a context where risks and benefits must be balanced; a context which imposes -ethical imperatives on the medical practitioner, the drug industry and the regulatory authority to be fully up-to-date with the latest knowledge. To fail to keep up with developments would be culpable negligence.
The food sector also deals with biological phenomena – the growth of plants and animals, their protection against infection and disease, the transformation and distribution of resulting products, safeguarding these against microbial or other contamination, fine tuning their taste, quality, and acceptability to the consumer, studying nutritional and other effects. The new knowledge and techniques are no less available to the food industry, and genome projects on the main agro-food plants and animals are ongoing.
But thereafter several differences start to emerge.
Food is familiar, and comforting in its familiarity: we need to eat every day, and because we are creatures of habit the latest innovations are not necessarily what we want. Furthermore, most of what we eat has never been the object of specific regulation. Innovation may raise suspicions, which regulation may intensify rather than placate. Thus in the public mind, novelty in food is a more sensitive issue than advances in health care.
For two decades the OECD has been addressing these problems and contradictions, clarifying the issues and encouraging the international sharing of experience and diffusion of best practices. And from its work, some regulatory developments have followed.
Expertise, ideas and familiarity
A basic conclusion of the early years is that the methods of assessment traditionally used in bio-safety matters remain relevant. Enormous experience has accumulated in sectors such as the production and testing of drugs and vaccines, worker safety, food safety, plant breeding, pesticides, agricultural quarantine. Safety assessment should build on existing knowledge of the organism to which changes have been made, providing clear information about the changes introduced and the intended use.
One significant criterion is familiarity with the organism – whether within the industrial fermentation tank, the farmer’s field or in food consumption habits, a long history of safe use is a reassuring and practical starting point. Thus the initial focus on the new technology of recombinant DNA and the genetic modification of organisms shifted by the end of the 1980s to focus on the organisms themselves, the specific changes, and the intended use. The responsibility for safety assessment lay with the various agencies concerned, dealing with such matters as live vaccines, gene therapy, environmental impacts of agricultural crop plants and food safety.
The regulatory trigger
Regulatory oversight, or safety assessment, in the food sector had long focused on such matters as residues, contaminants, processing aids, packaging materials, labelling – everything, in short, except the main elements of the food itself. The various plant, animal and other products by which we and our ancestors have met our needs for carbohydrate, fats, proteins and vitamins had generally been overlooked.
Only as modern or novel technologies, such as food irradiation or the use of explicitly identified enzyme additives, became available, did public interest and regulatory attention begin focusing on the main food elements themselves and the technological processes to which they have been subjected. This poses a fundamental and central question: given that we have not regulated the bulk of the foodstuffs we eat, raw or processed – many of which have entered human diet only in recent years – by what rationale should we start regulating the latest innovations in products or processing methods? What should be the trigger for new regulation?
This question has strong implications, not least for international trade, and for the provisions of international instruments such as the Agreement on Sanitary and Phytosanitary Measures under the World Trade Organization (see article by Wayne Jones et al., pp. 27–31).
To help solve these problems, the principle of substantial equivalence for assessing the safety of novel foods, including those derived through modern biotechnology, has become current practice in many countries. In the context of the European Union it has acquired legislative force, being incorporated into the text of the Novel Foods and Novel Food Ingredients Regulation (NF&NFIR), adopted in 1997. This Regulation, which is binding on all EU member states, is significant in several respects, and has been at the centre of some of the recent controversies over the applications of modern biotechnology in the food chain.
A term with its difficulties
Its implementation has raised criticism because, in focusing specifically on the characteristics and the safety of pro-ducts, it does not necessarily consider the technology through which the product has been derived. Nor does it oblige the producer or vendor to provide specific information to the consumer about the technologies used. Public concerns about genetically modified food and demands for inform-ation led the European Commission in 1997 to adopt a directive requiring specific labelling of products containing or produced from genetically modified organisms (GMOs) which are notified for -placing on the market. Foods or food ingredients containing or produced from GMOs fall under the NF&NFIR; they would not require specific labelling if found to be substantially equivalent to conventional foods. This has led to considerable dispute within Europe about the precise meaning of substantial equivalence.
Scientists and suppliers have argued that legislation should limit itself to the safety issues and question the rationale of including or omitting any particular technologies used in the production chain from such obligations.
On the other hand, where there is public anxiety there is policy priority, and this is evident in debates currently going on in some Euro-pean countries. Before the GMO question emerged, consumer trust in food safety had already been shaken by mad cow disease and there was widespread public dissatisfaction with how that crisis was handled by the regulatory authorities. Such delicate situations underline the absolute importance of international dialogue at expert level, to clarify matters and reduce the scope for misunderstandings and narrow, albeit crucial, differences. The OECD has become a valuable forum for that purpose.
Substantial equivalence cannot always be readily established. Several different perspectives on the operational problems with regard to new foods and processes emerged at a workshop held at Aussois, France, in March 1997. For example, it was stressed that comparisons should be made with closely related lines, ideally the parent, grown under the same conditions. The point was made that environmental factors can influence the plant phenotype – identical seeds grown in different circumstances producing differing plants, perhaps even in their nutritional characteristics – and that comparing data from several different locations would be useful (see next article).
Asking the right questions
From the political context come quest-ions which define the agenda – what shall we regulate, why, and how? It is vitally important to ask whether the aims of regulation are to protect public safety, to respond to public concerns, or to maintain public confidence in the safety of foods on sale. Although closely related, each of these formulations is quite different, a fact which has become as clear as it is -trouble-some in the context of regu-lating GM foods.
The regulatory issues associated with the diffusion of crop products and processed foods derived through -modern biotechnology have intensified. The OECD offers a well-struct-ured environment for building greater mutual understanding and pragmatic consensus, with its mixture of per-spect-ives and experiences in government, agriculture, environmental protection and consumer safety. Clear principles are needed now more than ever. Substantial equivalence is one useful tool which can help us to build those principles.
©OECD Observer No 216, March 1999