Social Interests
5.1 Regulating Technology: the Risk-analysis Framework
5.1.3 Substantial equivalence in risk assessment
The equivalence of GM and non-GM crops is a very important debate associated with GM-crop regulations based on the RAF. Substantial equivalence is a ‘gateway’ regulatory principle used to determine the novelty, which is the key aspect in determining the regulatory path that a product must follow. The basis of this principle is the notion that it is products or the application of technology that should be the regulatory focus, not the use of the technology or the process per se.
Operationally, this implies that, regardless of the differences in the processing and production methods (PPMs), the risks from a product are substantially equivalent to the risks from another ‘like’ product. It is important to note that, as a gateway regulatory principle, substantial equivalence cannot be used to assess risk; it is simply used to assess whether the risk of a new product is equivalent to the risk of a conven- tional product or not. If substantial equivalence has been found between, say, GM crops and non-GM crops, then the only interpreta- tion to be made is that the risks from the GM crops are not greater than the risks from the non-GM crops. Consequently, the GM crops would be regulated according to the same standards as the non-GM crops.
The substantial-equivalence principle, in respect of GM crops, is applied in the following manner.4 The first step is to establish an equivalence baseline from a range of conventional varieties of the same crop. Conventional varieties are examined across four broad categories, each with its own subcategories: (i) nutritional and nat- ural composition; (ii) the level of macronutrients (e.g. protein, fat, carbohydrates, dietary fibre); (iii) level of vitamins (e.g. C, B6, thi- amine, niacin, folic acid, riboflavin); and (iv) the level of minerals (e.g. calcium, copper, iron, iodine, magnesium, phosphorus, potas- sium, sodium, zinc). The result is a baseline set of ranges for all the categories into which conventional crops fall. Then the GM variety is Table 5.2. Type of risk in the risk-analysis framework.
Scientific rationality Social rationality
Recognizable Recognizable
Data, accepted analytical models Data, accepted analytical models
Hypothetical Hypothetical
No data, but accepted analytical models No data, but accepted analytical models Speculative
No data, no accepted analytical models Logical possibilities
4Summarized from: Gasson (1999), Kearns and Mayers (1999), Millstone et al.(1999) and McHughen (2000).
assessed across the same categories and subcategories and a profile is assembled. This profile is then compared with the baseline ranges, and values outside the conventional range are sought. If no values are outside the conventional range, then the GM crop is considered sub- stantially equivalent and would be subject to the same regulations as the conventional crop. At the other extreme, if most values are out- side the conventional range, then the GM crop is considered to be novel – that is, it would have values never before characterized or approved for the market. Consequently, the GM crop would face nov- elty regulations more stringent and precautious than conventional regulations.
What if only some of the values were outside the conventional range, while the remaining values were well inside? In this case, each of the values outside the normal range would be individually assessed and for each it would be determined why is it outside the range and whether this creates a safety concern. It may be outside, say, because of a higher level of insect resistance, but, if this is the value that was actually the reason for the genetic modification in the first instance, then the only test that would be required is for the safety of this outly- ing value. Of course, if a value were outside the conventional range and there were no explanation why, then the default would be to a precautionary approach, probably resulting in a determination of nov- elty, not substantial equivalence.
Economic interests, supporting scientific rationality, are in favour of the substantial-equivalence principle, because they claim that the key issue is not the application of modern biotechnology per se, but the novelty of the resultant crop. In support of this view, the United Nation’s World Health Organization (WHO) published a report on the principle of substantial equivalence in safety evaluations of food products derived from GM crops (WHO/FAO, 1991). This report con- cluded that GM crops may be substantially equivalent to non-GM crops for risk-assessment purposes and that novelty was the justification for new regulatory oversight, not simply the use of genetic modification.
According to this perspective, most production-trait GM crops and some output-trait GM crops are substantially equivalent, but bioengi- neered products will not be substantially equivalent, because they are, by definition, all novel. Substantial equivalence is a well-estab- lished principle in international regulations, supported by institu- tions such as the WHO, the Food and Agricultural Organization, the Codex and the International Plant Protection Convention (IPPC), as well as the Organization for Economic Cooperation and Development.
Social-rationality advocates do not accept substantial equivalence as a gateway regulatory principle, because they claim that it is the use of modern biotechnology that changes the fundamental nature of GM
crops and incurs special risks not evidenced in conventional plant breeding. This is a process or technology focus, where no GM crops would be considered substantially equivalent even if all of the values fell within the conventional range (Fig. 5.1).
Substantial equivalence may be assessed over both scientific factors (van den Daele et al., 1997) and normative factors (Nuffield Institute, 1999). Two popular arguments in support of the social-rationality asser- tion that GM crops are not substantially equivalent are that it is wrong to engineer living things and that it is wrong to transfer genes between species. Both of these arguments are biocentric ethical or moral argu- ments based on the idea that nature has boundaries and it is not right for humans to exceed those boundaries, regardless of the technological capabilities. With respect to the first argument, the notion of engineer- ing plants cannot be limited to GM crops only. To reject GM crops on the basis that they are engineered requires a rejection of all agricultural crops, including organic varieties, because, it is argued, it is impossible to disentangle the engineering of GM crops from the engineering of non-GM agricultural crops (Nuffield Institute, 1999). Consider that GM crops are modified varieties of conventional crops already engineered and made unnatural by generations of traditional plant breeding.
Similarly to all conventional crops, GM crops have been developed to fit within an ‘unnatural’ agricultural production system, not to grow in the wild, and to express desirable traits for human use, where these traits are not designed to confer any natural advantage on these crops relative to wild plants. It has been noted that ‘by itself genetic modifica- tion does not normally confer qualities that will make an organism more harmful to mankind or the environment’ (Fincham and Ravetz, 1991). In other words, to argue that it is wrong to engineer living things and reject GM crops on this basis requires a similar rejection of all agri- cultural crops, which have also been engineered to grow in an unnat- ural, human-made environment in order to meet human needs.
Risk-analysis framework
Scientific rationality Social rationality
Substantial equivalence No substantial equivalence GM Crop
All GM crops considered novel Substantially equivalent Not substantially equivalent and not substantially equivalent
Conventional regulatory Novel regulatory
oversight oversight
Fig. 5.1. Substantial equivalence in the risk-analysis framework.
Similarly, it is not a legitimate argument to reject GM crops because they are harmful to biodiversity (van den Daele et al., 1997).
By definition, all agricultural production is harmful to biodiversity. It must be accepted that production takes priority over biodiversity on agricultural land. The objective, given the priority of production, must be to minimize the impact of agricultural production upon biodiver- sity and there is no reason why GM crops cannot assist in minimizing the impact. For instance, an important example of the differing scien- tific- and social-rationality views on the substantial-equivalence prin- ciple concerns the relationship between GM crops and organic crop varieties. A common position is that organic produce provides con- sumers with a GM-free alternative. However, the debate arises because many seed developers reject the notion that GM seeds cannot be used in an organic production system. They argue that organic refers to a more labour-intensive production process, eliminating the use of arti- ficial fertilizers, chemicals and pesticide residues and replacing them with a more integrated crop-rotation and pest- and weed-management system. In this sense, organic is about the production method, and GM crops developed to be congruent with such a production method are substantially equivalent to conventional organic varieties. Critics of the substantial-equivalence principle argue that it is the use of GM techniques that fundamentally changes the nature of GM crops and makes them incompatible with organic systems.
With respect to the second argument, from a scientific perspective, gene transfer and modification even across the species barrier is a nat- urally occurring phenomenon, not specific to genetic-modification techniques.5 Indeed, genetic drift has always occurred between non- GM crops, wild relatives, other vegetation and soil microorganisms. In fact, it may be argued that GM crops involve more precise and specific modifications, which may be more carefully monitored, rather than the unmonitored random type that occur naturally, giving the plant breeder greater control than previously possible.
It would seem, given the above arguments, that from a regulatory perspective the key issue is not the genetic modification per se, but the ‘artificialness’ of the modification, such as the transfer of the antifreeze gene of arctic fish into crops to protect them from freezing.
This is an application-specific concern focused on novelty, not a process-based concern associated with the use of the technology. This implies that, for risk-assessment purposes, some GM crops may be considered as substantially equivalent and regulated accordingly, pro- vided they are not novel.
5Ho (1998) notes that viruses have the natural ability to transfer genes between
unrelated/sexually incompatible species; therefore, transgenic modification cannot be seen as unnatural.