Risk & Regulations
The U.N. offers “swimming lessons to people in the Sahara.”.

By Henry I. Miller, a physician and molecular biologist, is a fellow at the Hoover Institution and an adviser to the U.S. delegation to the Codex Alimentarius Commission’s task force on biotech foods. He was an official at the U.S. FDA from 1979 to 1994.
March 12, 2002 9:00 a.m.

he United Nations Environment Programme (UNEP) has announced a $38 million initiative to help developing countries set up infrastructure for the testing and commercialization of products made with recombinant-DNA technology. The three-year project will center on "building capacity for assessing risks, establishing adequate information systems and developing expert human resources in the field of biosafety."

But the proposal is problematic. Many of the countries for which it is intended have virtually no regulations in place for acknowledged high-risk activities (such as public transport and occupational hazards), and their expenditures on public health are woefully inadequate. In poor tropical countries, for example, it's not unusual to see preteens welding or using dangerous machinery with no protective gear and wearing only a loincloth; and enteric illnesses, malaria, schistosomiasis, and viral diseases that have been all but eradicated from industrialized countries are still epidemic in many underdeveloped countries.

Nonetheless, the U.N. reckons that what these countries really need is bureaucracies to "enable scientists to test for transgenic crops." This is "like offering swimming lessons to people in the Sahara," according to Calestous Juma, director of the Science, Technology and Innovation Program at Harvard University, which focuses on the role of R&D in developing countries.

The wrongheaded approach of the U.N. turns on its head a basic tenet of regulation — that the amount of oversight accorded a product or activity should be commensurate with risk. In fact, in UNEP's approach there is actually an inverse proportionality between risk and the amount of oversight. Only the more precisely crafted and more predictable recombinant DNA-modified organisms are subjected to extensive and expensive testing and monitoring (and perhaps, labeling) regimes; by contrast, plants crafted using less precise and predictable techniques, such as wide crosses (hybridizations in which genes are moved across wide phylogenetic distances) and intensive mutagenesis, are exempt.

Consider, for example, the relatively new manmade "species" Triticum agropyrotriticum, made by combining the genomes of bread wheat and a grass sometimes called quackgrass or couchgrass. Possessing all the chromosomes of the wheat plus one extra whole genome from the quackgrass, T. agropyrotriticum has been independently produced in the former Soviet Union, Canada, the United States, France, Germany, and China. It is grown for both animal feed and human food. At least in theory, several kinds of problems could result from such a genetic construction, which introduces tens of thousands of foreign genes into an established plant variety. These concerns include the potential for increased invasiveness of the plant in the field, and the possibility that quackgrass-derived proteins could be toxic or allergenic.

But U.N. regulators express no concern for these possibilities, and plant varieties like these — which are certainly "genetically modified" according to any reasonable definition — are subject to no review prior to being field tested or introduced into the food chain. If a single gene from couchgrass (or any other organism) were to be introduced into wheat by means of recombinant-DNA techniques, by contrast, the resulting variety would be subject to extraordinary and hugely expensive regulatory regimes.

How can one explain such an illogical, improvident proposal? Only as a cynical attempt by UNEP to "buy" recruits to the U.N.'s unscientific and flawed Cartagena biosafety protocol. This regulatory instrument is based on the so-called "precautionary principle," which dictates that every new technology must be proven safe before it can be used — or in the case of recombinant DNA, before it can even be tested! An ounce of prevention is certainly desirable, but because nothing can be proved totally safe — at least, not to the standard demanded by anti-technology extremists — the precautionary principle creates enormous obstacles to the development of new products. Precaution, in this sense, shifts the burden of proof from the regulator (who used to have to demonstrate that a new technology would cause harm) to the innovator (who now must demonstrate that it won't).

Thus, rather than creating a scientifically sound framework for effectively managing genuine risks, the biosafety protocol offers an ill-defined global regulatory process that permits overly risk-averse, incompetent, or corrupt regulators to hide behind the precautionary principle in delaying or deferring approvals. We have already seen many examples of this — for example, the German government's decision to block the commercial-scale cultivation of gene-spliced, insect-resistant corn by the biotechnology company Novartis. This action came one day before the product was expected to be approved by the Ministry of Agriculture for commercial use; regulators specifically cited the need to respect the precautionary principle, and called for more research into the crop plant's potential hazards. Italian regulators likewise have cited the precautionary principle as their rationale for blocking the testing or use of recombinant DNA-modified crops and food.

Under the biosafety protocol's standard of evidence, regulatory bodies are free to arbitrarily require any amount and kind of testing they may wish. Particularly in developing countries, this will be an invitation to caprice, intrigue, and corruption.

The UNEP's cynical attempts to bribe recruits — that is, countries that will ratify the Cartagena protocol — offer a Faustian bargain to developing countries. They would receive small grants up front; in the long term, however, unscientific, excessive regulation of this promising new technology — and companies' resulting uncertainty as to their ability to test and market products — will ensure that the biotechnology revolution passes them by.

Ironically, the U.N. is pressing developing countries to enact the same flawed, "precautionary" regulations that cause Europe to lag far behind the United States in the quest for world markets of biotechnology — markets that could exceed two trillion euros ($1.762 trillion) by the end of the decade, according to the European Commission's estimate.

It is as wrong for governments to create policies blocking the dissemination of crucial technologies as it would be for them to sanction the building of unsafe dams or the use of HIV-contaminated blood. Government officials should be held as accountable.