EU Ratifies Biosafety Protocol

The European Union took yet another step away from the rational regulation of genetically modified crop plants and foods in late June, when it became the 22nd party to formally ratify the Cartagena Protocol on Biosafety.

Although heralded by the European Commission as providing a sound mechanism for the regulation of GM organisms, the Protocol will do no such thing. What it will do is establish a global regulatory apparatus that will stifle innovation, hinder trade, and focus on the wrong risks. Once the agreement is ratified by 50 signatories and becomes effective—expected to take place by early next year—it will make parties worse off, not better.

Two and a half years ago, when the agreement commonly known as the Biosafety Protocol was negotiated in Montreal, it was heralded as a landmark of global cooperation. The Protocol requires member nations to establish strict controls over nearly every aspect of research and development on GM crops, animals, and microorganisms.

“No clear purpose”

The Biosafety Protocol was the culmination of an effort begun in 1993, when few people had ever even heard of GMOs, and when the first GM crops had not yet been planted commercially. But it was doomed from the start. A scientific panel established by the United Nations’ Environment Program earlier that year to review the need for such an agreement advised that “a protocol would, for no clear purpose: (i) divert scientific and administrative resources from higher priority needs; and (ii) delay the diffusion of techniques beneficial to biological diversity, and essential to the progress of human health and sustainable agriculture.”

Nevertheless, politicians were intent on creating an agreement, whether or not one was needed. The Biosafety Protocol was never intended to be the scientifically driven regulatory apparatus its supporters so often claim. No scientific organization would have devised a Protocol that covers all GM plants, animals, and microorganisms, and only GM organisms, with a one-size-fits-all standard of regulatory oversight.

Ever since the methods of gene-splicing were invented in 1973, dozens of major scientific organizations—including the UK’s Royal Society, the World Health Organization, the American Medical Association, and the U.S. National Academy of Science—have investigated the potential risks of GM organisms and reached remarkably similar conclusions. The process of genetic modification is not inherently risky, they found, and genetically modified organisms do not pose new or unique risks compared to unmodified organisms or organisms modified in more conventional ways.

Risks neither new nor unique

For example, some critics have suggested GM crops could become invasive weeds or have other unintended environmental impacts, such as harming insects or other wildlife. But so, too, have numerous conventionally bred plants been shown to pose exactly the same kinds of environmental risks.

Others worry about GM foods introducing new toxins or allergens into the food supply. Here too, though, conventionally bred foods pose exactly the same risks. Food-grade potatoes and tomatoes, for example, are routinely mated with wild varieties toxic to human beings.

What explains the safety of our food supply? Over time, and relying upon vast experience with a wide array of techniques for the modification of plants and animals, scientists, breeders, and farmers have developed methods for keeping unsafe products off the market—methods that are more than adequate for ensuring the safety of GM crops and foods.

Still, supporters of the Biosafety Protocol have argued a layer of formal government regulation must exist to catch unanticipated problems. If this truly is the case, then why voluntarily blinder regulators so they miss the arguably greater risks of conventional plant breeding and the introduction of exotic species into new environments?

The total lack of interest by negotiators in these mundane, but more significant, sources of environmental and human health risk reveals the true motivation behind ratification of the Biosafety Protocol is merely politics.

It’s all about the politics

Politics also explains why, more than two years after the agreement was supposedly finalized, there remains a considerable amount of dispute about how it will be implemented.

GM pharmaceuticals were excluded from the document finalized in Montreal, because pharmaceuticals are already regulated by another multilateral agreement. Now, several less-developed nations want to bring them back into the Protocol’s regulatory framework so they will have financial leverage over European and North American drug manufacturers.

The Protocol’s section on GM labeling requires only that bulk shipments of commodity grains be labeled if they “may contain GMOs.” Now, the European Union is seeking to alter that provision so it correlates more closely with the EU’s proposed traceability regulation and gives the EU protection against a World Trade Organization challenge to its own dubious labeling rules.

Perhaps the most problematic issue is how the Protocol’s reference to a “Precautionary Approach” in regulatory standard-setting should be interpreted. Although the large agricultural exporting nations specifically opposed including the words “precautionary principle” in the final text, the European Union now argues for a strong reading of the precautionary language that would give it leeway to ban imports on the basis of little more than speculation about potential health or environmental risks.

Precaution stymies innovation

Although numerous critiques of the precautionary principle have been written, its shortcomings are no more evident than in the case of GMO regulation.

The principle has been invoked to support unwarranted restrictions on some of the safest, most well-studied food products in human history. It is simultaneously being applied inconsistently, as European cheeses, wines, and beers made with GM enzymes have escaped the EU’s regulatory maze. It has distracted regulators and the public from more significant sources of risk. And, by handicapping the development of GM crops intended for less-developed nations, it has kept researchers in those countries from trying innovative ways of combating hunger and poverty.

What is needed globally is a set of policies that make scientific sense and protect consumer choice. This is sorely lacking in the Biosafety Protocol. The only winners from its rules will be government regulators, who will enjoy additional power and resources, and anti-science extremists, who have succeeded in erecting yet another barrier to GM technology.

The losers will be consumers everywhere, who will once again be denied access to safer, more nutritious, and affordable products.