Beyond Equal: From Same But Different to the Doctrine of Substantial Equivalence

A same-but-different dichotomy has recently been encapsulated within the US Food and Drug Administration’s ill-defined concept of “substantial equivalence” (USFDA, FDA). By invoking this concept the genetically modified organism (GMO) industry has escaped the rigors of safety testing that might otherwise apply. The curious concept of “substantial equivalence” grants a presumption of safety to GMO food. This presumption has yet to be earned, and has been used to constrain labelling of both GMO and non-GMO food. It is an idea that well serves corporatism. It enables the claim of difference to secure patent protection, while upholding the contrary claim of sameness to avoid labelling and safety scrutiny. It offers the best of both worlds for corporate food entrepreneurs, and delivers the worst of both worlds to consumers. The term “substantial equivalence” has established its currency within the GMO discourse. As the opportunities for patenting food technologies expand, the GMO recruitment of this concept will likely be a dress rehearsal for the developing debates on the labelling and testing of other techno-foods – including nano-foods and clone-foods. “Substantial Equivalence” “Are the Seven Commandments the same as they used to be, Benjamin?” asks Clover in George Orwell’s “Animal Farm”. By way of response, Benjamin “read out to her what was written on the wall. There was nothing there now except a single Commandment. It ran: ALL ANIMALS ARE EQUAL BUT SOME ANIMALS ARE MORE EQUAL THAN OTHERS”. After this reductionist revelation, further novel and curious events at Manor Farm, “did not seem strange” (Orwell, ch. X). Equality is a concept at the very core of mathematics, but beyond the domain of logic, equality becomes a hotly contested notion – and the domain of food is no exception. A novel food has a regulatory advantage if it can claim to be the same as an established food – a food that has proven its worth over centuries, perhaps even millennia – and thus does not trigger new, perhaps costly and onerous, testing, compliance, and even new and burdensome regulations. On the other hand, such a novel food has an intellectual property (IP) advantage only in terms of its difference. And thus there is an entrenched dissonance for newly technologised foods, between claiming sameness, and claiming difference. The same/different dilemma is erased, so some would have it, by appeal to the curious new dualist doctrine of “substantial equivalence” whereby sameness and difference are claimed simultaneously, thereby creating a win/win for corporatism, and a loss/loss for consumerism. This ground has been pioneered, and to some extent conquered, by the GMO industry. The conquest has ramifications for other cryptic food technologies, that is technologies that are invisible to the consumer and that are not evident to the consumer other than via labelling. Cryptic technologies pertaining to food include GMOs, pesticides, hormone treatments, irradiation and, most recently, manufactured nano-particles introduced into the food production and delivery stream. Genetic modification of plants was reported as early as 1984 by Horsch et al. The case of Diamond v. Chakrabarty resulted in a US Supreme Court decision that upheld the prior decision of the US Court of Customs and Patent Appeal that “the fact that micro-organisms are alive is without legal significance for purposes of the patent law”, and ruled that the “respondent’s micro-organism plainly qualifies as patentable subject matter”. This was a majority decision of nine judges, with four judges dissenting (Burger). It was this Chakrabarty judgement that has seriously opened the Pandora’s box of GMOs because patenting rights makes GMOs an attractive corporate proposition by offering potentially unique monopoly rights over food. The rear guard action against GMOs has most often focussed on health repercussions (Smith, Genetic), food security issues, and also the potential for corporate malfeasance to hide behind a cloak of secrecy citing commercial confidentiality (Smith, Seeds). Others have tilted at the foundational plank on which the economics of the GMO industry sits: “I suggest that the main concern is that we do not want a single molecule of anything we eat to contribute to, or be patented and owned by, a reckless, ruthless chemical organisation” (Grist 22). The GMO industry exhibits bipolar behaviour, invoking the concept of “substantial difference” to claim patent rights by way of “novelty”, and then claiming “substantial equivalence” when dealing with other regulatory authorities including food, drug and pesticide agencies; a case of “having their cake and eating it too” (Engdahl 8). This is a clever slight-of-rhetoric, laying claim to the best of both worlds for corporations, and the worst of both worlds for consumers. Corporations achieve patent protection and no concomitant specific regulatory oversight; while consumers pay the cost of patent monopolization, and are not necessarily apprised, by way of labelling or otherwise, that they are purchasing and eating GMOs, and thereby financing the GMO industry. The lemma of “substantial equivalence” does not bear close scrutiny. It is a fuzzy concept that lacks a tight testable definition. It is exactly this fuzziness that allows lots of wriggle room to keep GMOs out of rigorous testing regimes. Millstone et al. argue that “substantial equivalence is a pseudo-scientific concept because it is a commercial and political judgement masquerading as if it is scientific. It is moreover, inherently anti-scientific because it was created primarily to provide an excuse for not requiring biochemical or toxicological tests. It therefore serves to discourage and inhibit informative scientific research” (526). “Substantial equivalence” grants GMOs the benefit of the doubt regarding safety, and thereby leaves unexamined the ramifications for human consumer health, for farm labourer and food-processor health, for the welfare of farm animals fed a diet of GMO grain, and for the well-being of the ecosystem, both in general and in its particularities. “Substantial equivalence” was introduced into the food discourse by an Organisation for Economic Co-operation and Development (OECD) report: “safety evaluation of foods derived by modern biotechnology: concepts and principles”. It is from this document that the ongoing mantra of assumed safety of GMOs derives: “modern biotechnology … does not inherently lead to foods that are less safe … . Therefore evaluation of foods and food components obtained from organisms developed by the application of the newer techniques does not necessitate a fundamental change in established principles, nor does it require a different standard of safety” (OECD, “Safety” 10). This was at the time, and remains, an act of faith, a pro-corporatist and a post-cautionary approach. The OECD motto reveals where their priorities lean: “for a better world economy” (OECD, “Better”). The term “substantial equivalence” was preceded by the 1992 USFDA concept of “substantial similarity” (Levidow, Murphy and Carr) and was adopted from a prior usage by the US Food and Drug Agency (USFDA) where it was used pertaining to medical devices (Miller). Even GMO proponents accept that “Substantial equivalence is not intended to be a scientific formulation; it is a conceptual tool for food producers and government regulators” (Miller 1043). And there’s the rub – there is no scientific definition of “substantial equivalence”, no scientific test of proof of concept, and nor is there likely to be, since this is a ‘spinmeister’ term. And yet this is the cornerstone on which rests the presumption of safety of GMOs. Absence of evidence is taken to be evidence of absence. History suggests that this is a fraught presumption. By way of contrast, the patenting of GMOs depends on the antithesis of assumed ‘sameness’. Patenting rests on proven, scrutinised, challengeable and robust tests of difference and novelty. Lightfoot et al. report that transgenic plants exhibit “unexpected changes [that] challenge the usual assumptions of GMO equivalence and suggest genomic, proteomic and metanomic characterization of transgenics is advisable” (1). GMO Milk and Contested Labelling Pesticide company Monsanto markets the genetically engineered hormone rBST (recombinant Bovine Somatotropin; also known as: rbST; rBGH, recombinant Bovine Growth Hormone; and the brand name Prosilac) to dairy farmers who inject it into their cows to increase milk production. This product is not approved for use in many jurisdictions, including Europe, Australia, New Zealand, Canada and Japan. Even Monsanto accepts that rBST leads to mastitis (inflammation and pus in the udder) and other “cow health problems”, however, it maintains that “these problems did not occur at rates that would prohibit the use of Prosilac” (Monsanto). A European Union study identified an extensive list of health concerns of rBST use (European Commission). The US Dairy Export Council however entertain no doubt. In their background document they ask “is milk from cows treated with rBST safe?” and answer “Absolutely” (USDEC). Meanwhile, Monsanto’s website raises and answers the question: “Is the milk from cows treated with rbST any different from milk from untreated cows? No” (Monsanto). Injecting cows with genetically modified hormones to boost their milk production remains a contested practice, banned in many countries. It is the claimed equivalence that has kept consumers of US dairy products in the dark, shielded rBST dairy farmers from having to declare that their milk production is GMO-enhanced, and has inhibited non-GMO producers from declaring their milk as non-GMO, non rBST, or not hormone enhanced. This is a battle that has simmered, and sometimes raged, for a decade in the US. Finally there is a modest victory for consumers: the Pennsylvania Department of Agricultu

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