Ongoing Debate Over Terminator Technology, The

Georgetown International Environmental Law Review, Summer 2007 by Caplan, Richard

B. THE INTRODUCTION OF GENETICALLY ENGINEERED CROPS AND FOODS BEGINS

Despite early calls for precaution, the first field experiments of genetically engineered plants began in the 1980s.37 In the United States, oversight of genetically engineered crops was largely in the hands of the National Institutes of Health through the first decade of development.38 As a result of a legal challenge from a public interest group,39 President Reagan's White House established an interagency task force in April 1984 to study and coordinate the government's regulatory policies for products of genetic engineering. The proposal for a Coordinated Framework for the Regulation of Biotechnology was published on New Year's Eve 1984 and outlined how government agencies overseeing genetic engineering should work together.40

Inadequacy regarding the regulation of agricultural biotechnology was demonstrated starting with the first product to be approved for human consumption. Recombinant Bovine Growth Hormone (rBGH) is a genetically engineered hormone injected into cows to make them produce more milk. In 1990, the U.S. Food and Drug Administration (FDA) declared rBGH poses no increased health risk to consumers.41 Part of the agency's findings were based on 90-day rat feeding studies reporting that rBGH produced no toxicologically significant changes in rats which were given rBGH orally.42 Based largely on this conclusion, FDA did not require the human toxicological tests that are usually required for a veterinary drug. However, in April 1999, researchers from Health Canada, the Canadian equivalent to FDA, issued a report contradicting FDA's findings.43 Canadian researchers explained that rats were absorbing rBGH after all. In fact, between twenty and thirty percent of the rats were developing distinct immunological reactions. Additionally, cysts formed in the thyroid of some male rats and infiltrated the prostate.44 According to a researcher with Consumer Policy Institute, a division of Consumers Union: "These are toxicologically significant changes in the rats and they should have triggered a full human health review, including assessment of potential carcinogenic and immunological effects."45 In addition to the unresolved health issues regarding rBGH, FDA also issued labeling guidelines regarding the hormone that did not require manufacturers to label their products as containing rBGH, despite many surveys that clearly indicated a consumer preference for such information.46 The agency also encouraged milk sellers not to label their products as free of rBGH.47 Monsanto, a St. Louis-based biotechnology company, sued two milk processors that labeled their milk as rBGH-free.48

Adding to the idea that biotechnology oversight requires nothing fundamentally new, Vice President Dan Quayle's Council on Competitiveness's 1991 report called for regulation of genetically engineered products based on their performance, not the processes by which they are produced.49 These directives resulted in a system in which the U.S. Department of Agriculture ("USDA"), Environmental Protection Agency ("EPA"), and FDA regulate genetically engineered crops and foods under existing laws. Generally, the division of responsibility for regulation results in USDA's oversight over plants, EPA's over pesticides, and FDA's over foods. This arrangement was established well before any real investigation into the human and environmental impact of genetically engineered crops and foods.50 An analysis by the former head of the National Academy of Sciences' Board on Agriculture concluded that "[l]ess than 10 percent of the total number of citations covering seven major areas of risk appeared before 1990."51 Because the regulatory framework was established before a comprehensive review of potential risks, criticism about the adequacy of regulation has been present from its inception, including from within the U.S. government itself.52