Substantial equivalence

GMO Bites by Emily Atkinson

Occupy Monsanto Genetic Biohazard

• Applying the concept of “substantial equivalence” to GMOs is problematic. Not only does it fail to capture the complexities that genetic modification introduces into a living organism, but it also deflects criticisms of GMOs and promotes the interests of biotech companies.

The idea of equivalence comes from conventional breeding, where two plants of similar species are crossed. But an expert group from the Organisation for Economic Co-operation and Development (OECD) actually borrowed the term “substantial equivalence” from another policy area entirely – the FDA’s classification of new medical devices – when they initially used it in a 1993 report. The term is inappropriate for living organisms with genes from very different species.

In fact, “substantial equivalence” deflects any scrutiny of GMOs. In Genetically Modified Diplomacy, author Peter Andrée explains that safety assessments based on “substantial equivalence” compare particular components of a GMO to those of its traditional counterpart, instead of studying the GMO as a living whole. They do not address the unintended consequences of a GMO’s “novel” gene or the serious harm that pesticide residue found on GM plants can have. Independent researchers motivated to study these dangers lack the funds while biotech companies spend massive resources to promote their products. As such, GMOs continue to be approved without proof of their safety.

The concept of “substantial equivalence” also discourages tracing the impacts of GMOs over time. Monitoring a GMO after approval would contradict the idea that it is “substantially equivalent” to its traditional counterpart. Would this explain governments’ resistance to mandatory labelling in North America? If so, it is an unconstitutional limit of consumers’ rights to choose when it comes to their food.

However, the logic of “substantial equivalence” does not limit the intellectual property rights of biotech companies even though patenting implies that a significant difference exists between GM and conventional seeds. A clear example is the infamous Supreme Court of Canada ruling that farmer Percy Schmeiser infringed on the intellectual property rights of Monsanto when he planted seeds contaminated with genes from its GM canola. The slim majority – 5 to 4 – compared the novel gene to “an invention in the domain of mechanical science.” Once again, a false analogy to a non-living entity was made, prioritizing the interests of Monsanto.

A focus on “substantial equivalence” also ignores the economic danger of GM crops for certain farmers. The strong resistance to GM products in the EU and the fact that GM crops cannot be sold as organic makes genetic pollution a serious threat. In Canada, a private member’s bill brought to the House of Commons in 2009 would have at least supplemented “substantial equivalence” by requiring that export markets be considered before a GM seed was approved for sale. But as it now stands, civil society organizations alone are responsible for pressuring the government to reconsider introducing GM products.

In a democracy, this is unacceptable. Governments must protect and engage citizens in issues that affect them. But the concept of “substantial equivalence” sidesteps so many of the far-reaching impacts of GMOs, to the detriment of the health of citizens and our food supply. It is up to us to convince policymakers that this must change – now – before it is too late.

Emily Atkinson is a recent M.A. graduate in political science involved with several non-profit organizations working towards environmental sustainability.

image by Daniel Lobo (Daquella manera) via Flickr

1 thought on “Substantial equivalence”

  1. For those interested in further information, references submitted with the article are as follows:
    – Andrée, Peter. Genetically Modified Diplomacy: The Global Politics of Agricultural Biotechnology and the Environment. Vancouver: UBC Press, 2007, pp.94-97. Andrée provides more detailed information about the link between equivalence and labelling of GMOs.
    Bill C-474: An Act respecting the Seeds Regulations (analysis of potential harm). 2nd sess., 40th Parliament, 2009. Retrieved from on 01/25/14.
    – Miller, Henry I. “Substantial equivalence: Its uses and abuses.” Nature Biotechnology 17, no.11 (1999): pp.1042-1043.
    – Monsanto Canada Inc. v. Schmeiser, [2004] 1 S.C.R. 902, 2004 SCC 34. Retrieved from on 01/25/14.
    – The Royal Society of Canada. Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada. January 2001, pp.177-178.

    In addition, the link to the photo is .


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