“Substantial Equivalence” and the Regulation of the Tobacco Industry: Part 1

Editors Note:  The term “substantial equivalence” is going to determine in large part the initial—and possibly— the ultimate regulatory regime for the tobacco industry.  The term has its genesis in non-tobacco regulatory programs which have  been the subject of CRE interventions for a number of years.

 CRE will be making periodic posts regarding this important subject notwithstanding the  longstanding  American disdain for  reviewing historical developments on pending topics.

 For starters, the term substantial equivalence goes back to the work of Food and Agriculture Organization, the World Health Organization and subsequently  OECD recommendations in 1991 dealing with genetically modified foods.  The Congressional Research Service offers the following definition of “substantial equivalence”

“Substantial equivalence — A concept, developed by OECD in 1991, that maintains that  a novel food, for example, one that derives from genetic modification or engineering, should  be considered the same as and as safe as a conventional food if it demonstrates the same characteristics and composition as the conventional food.

 Substantial equivalence is important from a regulatory point of view. If a novel food is substantially equivalent to its conventional counterpart, then it could be covered by the same regulatory framework as a conventional food.”

A  question that comes to mind is how much additional testing, if any, is required to demonstrate “substantially equivalent’?    In the  food  arena the issue of the level of required testing was a very controversial issue. A  think tank (AgBiWorld) which is supportive of genetically modified foods concluded:

“Myth 6.  Activists  say: “The principle of   ‘substantial equivalence’, on which risk assessment is based is intended to be vague and ill-defined; thereby giving companies complete license in claiming  transgenic products  ‘substantially equivalent’  to non-transgenic products, and hence ‘safe’.”

“Facts: The concept of “substantial equivalence” is misrepresented in the passage quoted above. Transgenic products are not assumed to be safe, allowing them to be exempt from safety testing. Substantial equivalence is a conclusion that can only be reached AFTER testing to ensure that the biotech improved crop is, in fact, equivalent to its conventional counterpart in nutritional and safety aspects.”

OECD statement on “substantially equivalent” :

“…. 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

                                       < More to follow

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