To the editor:

In their recent articles in July issue (Nat. Biotechnol. 24, 753, 2006) and EMBO Reports1, Schouten et al. propose a rationale for a new subcategory of genetically modified (GM) plants. This new category should, in their view, be regulated not according to the rules applied to transgenics, but instead, no differently from the products of conventional breeding. This is a well-intended and clever proposal; but in my opinion, too clever by half. And although the last thing any reasonable person should discourage is anything that would get Europe out of the regulatory/political quagmire of a corner into which it has painted itself, this is a dog that won't hunt.

The crux of their argument is that “deliberate release and market introduction of cisgenic plants is as safe as the release and market introduction of traditionally bred plants.” They define a 'cisgenic' plant as “a crop plant...genetically modified with one or more genes...isolated from a crossable donor plant” and construe this to establish that the environmental and health consequences are no different from those associated with the products of traditional breeding. They conclude therefore that 'cisgenic' plants should be exempt from the regulations applied to transgenics. To indict them in their own words, “this is merely a semantic adaptation, rather than a means of controlling risk.”

No one familiar with the relevant facts and global experience with transgenic plants over the past two decades would disagree with the conclusion that the plant products generated thus far using recombinant technology are generally very safe indeed and that risks, although in theory perhaps not totally absent (though conspicuously missing to date), are in fact quite low, if not altogether infinitesimal. All of the arguments marshaled by Schouten et al. about the relative risk associated with 'cisgenic' plants seem reasonable, though exceptions can be found or conjured to each. But the logical flaws and factual errors in their rationale are numerous, and fatal. Critically, none of their arguments succeeds in drawing a sustainable distinction between 'cisgenic' and transgenic plants based on any defensible, risk associated criterion. What is proposed, in fact, is a regime no less indefensibly rooted in manufacturing process than other regimes that have been justifiably blistered for the same intellectually bankrupt foundation.

It has been a long time, but I think I remember witnesses testifying before hearings of the US Congress' House of Representatives Committee on Science, Space, and Technology, perhaps in 1983 or 1984 (chaired by Representative Al Gore), in which the proposition was explored as to whether or not the phylogenetic distance between DNA donor and recipient was necessarily an indicator of risk. It was not then, and it is not today. In fact, if there is any correlation between risk and phylogenetic distance, it may be inverse! But about the only rock solid universal truth on which one can rely in this arena is that the risk associated with a novel plant, whether it is genetically modified by in vitro recombinant DNA techniques, classical breeding or any other mechanism, is critically dependent on the encoded trait and the expression patterns of that trait (that is, the phenotype) in the recipient. Other details may be interesting, but are essentially irrelevant to the question of risk.

En route to their well-intended but ill-considered proposal, Schouten et al. misunderstand or mischaracterize a number of facts. Dismissing all regulatory regimes but Canada's as process based, they fairly damn the European regime they hope to ameliorate, while incidentally slandering those in Australia, New Zealand and the United States (“When it gives trouble, they profane even the beautiful and the good.”—Goethe, in Faust). They also misleadingly imply the existence of “current international GMO [genetically modified organism] regulations.” They offer no citation here, but surely they cannot be referring to the ill-conceived but purely hortatory language of the Biosafety Protocol to the Convention on Biological Diversity? There are excellent guidelines from the Organization for Economic Cooperation and Development (OECD; Geneva) and numerous national bodies, and any number of national regulatory regimes, but nothing that could fairly be described as “international GMO regulations” as invoked. But no matter—these are incidental errors; the take-home message here is clear.

Numerous authoritative bodies on both sides of the pond and around the world have concluded that the risks of transgenic plants are no different from the risks associated with the products of conventional breeding. This finding does indeed have implications for current regulatory regimes: they are all, even the best of them, disproportionate to the level of risk actually posed by the transgenic plants we have seen to date. Those regimes that are easily adapted need to be updated to take this juggernaut truth into account. Regimes that are not easily adapted should be junked and replaced with something (or nothing) that does less damage to reason, common sense and those billions who desperately need agricultural innovations around the world.