Lurking behind the persistent reports that the U.S. is about to take the European Union to the World Trade Organization over the EU’s refusal to lift its moratorium on new biotech crop approvals is the specter of a recent ruling by the European Union’s Court of First Instance in Pfizer Animal Health SA v. Council. The Court focused its ruling on the Precautionary Principle, that instrument which suggests that governments take a "better safe than sorry" approach to regulation. The "principle" has been manifested in EU decisions regarding foods derived from biotechnology: numerous scientific bodies have agreed that biotech foods present no health or safety risks, but the EU restricts the planting, distribution, importation, and marketing of biotech foods. EU officials will tell you, without reservation, that there is no evidence to suggest that biotech foods cause adverse health consequences, but neither does there exist any guarantee that there will not be adverse consequences, someday. It is a philosophical divide, not between the EU and the US so much as between the risk-averse and those willing to take a chance at progress. Some of the most virulent critics of the "principle" are European scientists who have been muzzled by risk managers (read politicians).
The Pfizer case illustrates what can happen when regulators establish policy based on their finger-in-the-wind reading of public opinion, rather than on science. The Pfizer case was brought after the European Council banned several antibiotics used as additives in animal feed because they might lead to antibiotic resistance in humans who ate the treated animals. The Council lacked any proof that this could happen. Pfizer, the producer of one of the banned antibiotics, challenged the Council’s decision.
The court upheld the ban, signifying that political authority may craft public policy without regard for scientific facts. Thus, expediency will always trump science, and scientific inquiry will be a convenient fig leaf when its product happens to coincide with public policy. Pfizer decided not to appeal the court’s ruling, perhaps understanding that the "principle" is embedded into EU public policy.
Indeed, the new European Food Safety Authority has a regulatory philosophy based on the Precautionary Principle. This is a direct response to the food safety crises of the 80s and 90s, which did not arise because of risk managers failed to implement a precautionary principle: regulators knew problems existed and decided not to take action. Principles cannot make risk managers act if they have decided that it is not politically expedient to do so. Unfortunately, EU authorities have chosen to reclaim credibility on the back of non-issues with political and public relations currency, such as beef hormones and biotechnology. Real issues such as BSE and dioxins have yet to be truly addressed, and the "principle" can be of little or no help on that score.
To some degree, one can be sympathetic to the plight of the European regulators. While many deplore the inaccessibility of EU markets to American biotech products, it is, after all, their business, just as our regulatory regime is our business. However, with the Pfizer ruling, the EU has superimposed the "principle" onto the global trading system. Illusions of domestic gain from a trade war based on flimsy theory will be dashed as all concerned discover that trade restrictions cost jobs and profits.
More sobering, if the Commission ramrods the "principle" through WTO food trade agreements, it will be available to all comers. The idea of an American risk manager in the precautionary playground with BSE-ridden beef or dioxin-laden produce ought to be food for thought, if any of us can find any food anywhere after the merry-go-round spins a few more times. It may turn out that tariff barriers were easier to digest than non-tariff barriers. With tariffs, we knew it was about money. Money lurks in the shadows here as well, but now we have an extra layer of high-minded thinking to cut through before we reach real issues. Given the starving in Africa recently denied grain in part because the precautionary principle prevailed, we ought to spare the rest of the world the philosophical nuances of this sterile debate. None of those presently engaged in the debate can explain or even define the precautionary principle, so we shouldn’t expect the rest of the world to understand it, let alone pay the freight for its wholesale application to an already ponderous global regulatory system.
The content of this article does not constitute legal advice and should not be relied on in that way. Specific advice should be sought about your specific circumstances.