4.4 Incorporating substantial equivalence into national and international law
The concept of substantial equivalence very quickly became important in international trade law. The WTO aims to harmonise national food standards to meet international norms. Under its rules, a country could be penalised if it imposed food standards more stringent than those agreed internationally. In this context, international food standards are set by the Codex Alimentarius Commission (Table 1). In 1996, a report was issued within the Codex framework, which endorsed the principle of substantial equivalence:
Establishment of substantial equivalence is not a safety assessment in itself, but a dynamic analytical exercise in the assessment of the safety of a new food relative to an existing food […] The comparison may be a simple task or be very lengthy, depending upon the amount of available knowledge and the nature of the food or food component under consideration. The reference characteristics for substantial equivalence comparisons need to be flexible and will change over time in accordance with the changing needs of processors and consumers and with experience.
Whilst the principle of substantial equivalence has played an important role in the regulation of GM food in both America and Europe, it has been used in different ways on the two sides of the Atlantic.
In the US, the regulation of biotechnology rested on the assumption that the products were not significantly different to their conventional counterparts and that therefore new legislation was not required. This meant that companies were self-regulating, and that there was no requirement to seek approval before marketing a GM food for public consumption. In practice, however, companies wishing to market GM foods voluntarily sought a safety review from the Food and Drug Administration (FDA). The companies provided the FDA with information on the physical composition of the GM food, citing this as evidence of substantial equivalence to existing products. In return, the FDA provided the companies with documentation noting the claim. There is some indication that companies saw this documentation as protection against legal liability. The prospect of huge payouts in lawsuits, meant that, whether it was a legislative requirement or not, in the US companies felt obliged to consult the FDA.
In the European Union, companies wishing to market GM products have always had to seek prior approval before release onto the market, or in the case of GM crops, before they were grown commercially. This arose from an underlying assumption that GM products are inherently different from their conventional counterparts. That is not to say that the EU did not approve GM products or crops. In 1997, the EU passed a regulation (the 1997 Novel Food Regulation) which allowed a simplified procedure for cases where the GM product was substantially equivalent to its conventional counterpart - in that case, companies had to provide scientific evidence to back up the claim of equivalence rather than carry out a full risk assessment.
Initially, it seemed that the fact that the principle of substantial equivalence played a significant part in the regulatory framework on both sides of the Atlantic, might lead to a straightforward 'harmonisation' of trading laws, as desired by the WTO. However, a combination of the very different starting assumptions and the negative public response in Europe led to two very different outcomes.
In the late 1990s, at the same time as international legislative bodies were developing policies based on the principal of substantial equivalence, it was becoming a key point of criticism from non-Governmental organisations (NGOs) and activists. The concept was attacked for downplaying the novelty of the transgenic products. Importantly, it was derided as vague and open to interpretation. We shall return to these points of criticism below.
In 1996-97 shipments containing American GM maize and soybeans were providing a focus of opposition to the opponents of GM food in Europe. By the year 2000, activists had successfully lobbied the major European supermarket chains into dropping GM products.
The widespread public opposition to GM in Europe provided the context for what became a much stricter interpretation of substantial equivalence. In early 1997, the UK Advisory Committee on Novel Foods and Processes (ACNFP) approved the use of a number of Bt maize products for use in processed food. The ACNFP had accepted that the products were only different from normal maize products in that they contained the Bt protein. The Bt protein was deemed safe, conventional maize was already accepted to be safe and therefore the new products were approved.
In focusing solely on the protein product produced by the transgene, the Bt protein, what assumptions were being made?
There was an implicit assumption that transferred genes/DNA sequences (the gene encoding the Bt protein; the selectable marker genes, like antibiotic resistance genes; and promoters, like the CaMV sequence) pose no threat. To be fair, the approval was for processed food, so it was unlikely that intact genes remained in the products.
By late 1997, and the passing of the EU Novel Food Regulation, the ACNFP was using a much tighter definition of substantial equivalence. A few months later, a member of the ACNFP described how the committee tightened its definition of substantial equivalence:
If we must use that criterion alone, then we will tighten its definition. In MAFF's [Ministry of Agriculture, Fisheries and Food] view, a food cannot be regarded as substantially equivalent if it contains any intact GM DNA, so the product must be highly refined to ensure that all the DNA has been denatured.
In the context of widespread public suspicion of GM throughout Europe, this change in interpretation rapidly became official EU policy. What had been designed as an accelerated way of approving new products that could be demonstrated to be substantially equivalent, had become a barrier to approval - the new foods had to demonstrably contain no modified DNA, or any of the protein products of that modified DNA.