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Substantial equivalence: Its uses and abuses

Nature Biotechnology volume 17, pages 1042–1043 (1999)Cite this article

These are trying times for biotechnology applied to agriculture and food production. Most recently, the accepted paradigms for genetically modified food risk assessment and management have come under attack from the fringes of the scientific community. These attacks have been based on the overinterpretation of experiments, flawed data, and false assumptions about risk and risk assessment. They have included the overinterpretation of a laboratory experiment that showed a modest effect on Monarch butterflies of larvae fed milkweed dusted with pollen from recombinant corn containing a Bacillus thuringiensis toxin1, and a gratuitous controversy about methodologically flawed experiments by Arpad Pusztai that purportedly showed toxicity in rats fed recombinant, lectin-enhanced potatoes2.

The latest attack comes in the form of a commentary by Erik Millstone et al. criticizing the application of a concept called "substantial equivalence" to the risk assessment of foods derived from recombinant DNA-manipulated organisms3. Deriding substantial equivalence as a "pseudo-scientific concept because it is a commercial and political judgment masquerading as if it were scientific," Millstone et al. appear to misunderstand the concept, its origins, and purpose. Their arguments are symptomatic of ideological opponents of the new biotechnology torturing logic and science in order to manipulate government regulation to obstruct the use of a technology that they dislike for any number of nonscientific reasons.

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Author notes

  1. Henry I.Miller: He was founding director of the US Food and Drug Administration's Office of Biotechnology, 1989-93 and a member of the OECD Group of Experts on Safety in Biotechnology, 1984-92.

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  1. senior research fellow at the Hoover Institution, Stanford University, Stanford, 94305-6010, CA

    Henry I. Miller

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  1. Henry I. Miller
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Miller, H. Substantial equivalence: Its uses and abuses. Nat Biotechnol 17, 1042–1043 (1999). https://doi.org/10.1038/14987

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