Another Look at Biotech Regulation: Are Europe's Labeling Laws for Genetically Modified Foods Cost-Effective, or Even Necessary?
Kalaitzandonakes, Nicholas, Regulation
DISCUSSIONS OF APPROPRIATE REGUlatory norms for genetically modified foods date back to the early 1980s. Twenty years later, agreement among key trading countries on what such norms should be remains elusive. Some countries, including the United States, consider genetically modified foods substantially equivalent to conventional ones and regulate them similarly. Others, including the European Union, scrutinize and require mandatory labeling of genetically modified foods.
Mandatory labeling has added costs to the trade of agricultural commodities and food products and has restricted market access. Nevertheless, regulators in the EU have argued that mandatory labeling of genetically modified foods is necessary to safeguard consumers' right to an informed choice. But are, in fact, Europe's mandatory labeling laws necessary or cost effective? And how do the European standards compare with the standards of mandatory labeling laws implemented in other countries?
The global regulatory system for genetically modified foods is heavily fragmented--a patchwork of country-specific initiatives that continue to evolve. In 1986, the Organization of Economic Cooperation and Development recommended that risks associated with organisms derived through modern biotechnology were expected to be the same as those of conventional ones and could be assessed in similar ways. This notion of "substantial equivalence" was adopted in the United States and Canada where new food products derived through modern biotechnology are assessed for safety and nutritional fitness. Regulation in other countries, however, has zeroed in on the process of biotechnology rather than its products.
EUROPEAN UNION In the EU, a process-specific regulatory framework was adopted early on. Specifically, the EU government decided to regulate biotechnology by newly installed institutions, starting in 1990 with Directives 90/219 and 90/220 on the deliberate release of genetically modified organisms. Since that time, the regulatory framework in the EU has been a work in progress, frequently revised and reshaped by different legislative bodies. The 1997 revision of Directive 90/220 installed mandatory labeling for genetically modified organisms. In the same year, novel foods regulation 258/97 imposed mandatory labeling on food products derived from genetically modified organisms. It was not until a year later (regulation 1139/98), however, that the presence of novel DNA or protein resulting from genetic modification became the criterion for labeling. A standard was finally established in 1999 when the mandatory labeling threshold of the novel DNA or protein was set at one percent. Further revisions extending mandatory labeling to food additives and flavorings in processed foods went into effect in 2000 (regulations 49/2000 and 50/2000).
In 2001, the EU Commission adopted two new legislative proposals (2001/0180) that sought to extend mandatory labeling beyond foods and food ingredients. After almost two years of deliberations, the proposals were adopted by the EU Parliament and the Council of Ministers in July 2003 and have now gone into effect. The new regulation requires labeling of animal feeds and feed additives as well as highly refined oils, sugars, and starches. The regulation is far more onerous because a large share of genetically modified commodities is used for the production of animal feed. The new regulation also requires mandatory labeling of products that are derived from genetically modified organisms but do not contain detectable levels of novel DNA or protein (e.g., highly refined oils). Under those circumstances, enforcement of mandatory labels can no longer rely on laboratory testing. Instead, the new regulation mandates the implementation of a traceability system that requires chain of custody and accountability for all genetically modified commodities and food ingredients at each point of the $750 billion European agrifood marketing chain. …