U.S. Regulation of GE Foods a Bad Model
By Sujatha Byravan,
The Hindu
August 31, 2006

India should learn from the mistakes other countries have made and not buckle under pressure from international and domestic agribusiness.

IT SHOULD surprise no one that the United States is applying pressure on India through the World Trade Organisation about its genetically engineered (GE) food labelling requirements, stating that these requirements are a trade barrier. India should, however, take advantage of provisions in the WTO for non-discrimination between trading partners. Other major trading partners of the U.S., Japan, Canada, the European Union, and Australia require GE labelling.

Currently, the U.S. has a lot on its hands with regard to GE foods, having recently announced that commercial supplies of long grain rice have been contaminated with LLRICE 601, a variety of GE rice not approved for human consumption. This has already had serious
ramifications: the European Commission now will test all U.S. rice imports and Japan has banned long grain rice imports from the U.S. altogether. The Commission also expressed unhappiness with the three week delay in being informed about the contamination and did not share the view of the U.S. that there was no risk from the event.

While people in agribusiness and in other circles within India often hold the U.S. up as a model of biotech regulation for India, many civil society groups and communities across the U.S. have criticised the federal regulatory process and oppose GE foods. They argue that at
the very least GE foods should be labelled so that consumers can make an informed choice. The U.S. has steadfastly refused to allow this to happen.

Three federal agencies in the U.S. regulate GE foods: the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA). Oversight by these departments is based on a hotchpotch of pre-existing statutes. No new federal laws have been passed to address the health or environmental safety of GE crops. Additionally, the USDA is charged with promoting GE crops as well as regulating them. This is not a model for India to follow.

The FDA allows companies to follow what is referred to as a "voluntary consultation" process that does not involve a comprehensive scientific review. The agency has, however, not used its authority under the Federal Food, Drug, and Cosmetic Act to require labelling of GE foods. In fact, according to Henry Miller, chief of biotechnology regulation at the FDA during 1979-1994: "In this area, the U.S. government agencies have done exactly what big agribusiness has asked them to do and told them to do."

The USDA "monitors" field trials of new GE varieties but applications for field-testing are never rejected. It deregulates crops based on information given to it by the seed companies.

Independent scientists often do not have access to proprietary materials, and researchers who have identified significant problems with GE foods or crops, either with regard to their adverse environmental effects or possible health risks, have had smear campaigns launched against them and have suffered loss of academic standing.

Concerns raised

In addition to studies by various public interest groups, two independent scientific assessments have been commissioned to evaluate the efficacy of the USDA oversight process: a 2002 report by the National Research Council of the National Academy of Sciences, and an internal USDA Audit Report published in 2005. A number of concerns
have been raised in these reports, the main ones being the limits of the USDA jurisdiction, the lack of transparency and scientific rigour in the review process, weaknesses in inspection and enforcement, and the failure to monitor crops beyond the initial pre-commercial phase. The last of these is especially troubling since many environmental
effects will only be detected after commercialisation.

The EPA has jurisdiction over plants that are engineered to produce pesticides, but not over any other aspects of the plants themselves. Further, this agency too relies almost entirely on company data, and does not require an approved set of laboratory tests.

In addition to the weak institutional mechanisms for GE food review and approval, revolving doors between agribusiness and regulators are commonplace. Individuals from agribusiness occupy key decision-making positions in regulatory agencies, and regulators are often rewarded with private sector jobs. As consumers, we need to be sure that regulatory agencies follow practices that ensure food safety and want to be confident that public interest is at the heart of public policy. What one sees in the U.S. is quite the contrary. In a review of the federal regulation of genetically modified organisms, Dr. David Schubert of the Salk Institute said: "One thing that surprised us is that U.S. regulators rely almost exclusively on information provided by the biotech crop developer, and those data are not published in journals or subjected to peer review ... The picture that emerges from
our study of U.S. regulation of GE foods is a rubber-stamp `approval process' designed to increase public confidence in, but not ensure the safety of, genetically engineered foods."

While India is still in the process of formulating policies for regulating GE foods we must learn from the mistakes other countries have made in their GE food regulations, not buckle under pressure from international and domestic agribusiness but stick to labelling
requirements and take advantage of the Cartagena Protocol on Biosafety. This protocol places the onus of segregating and testing GE before exports on the exporting country.

(The writer is president, Council for Responsible Genetics, Cambridge,
Massachusetts.)