The policy left gaping communication gaps between agencies, plenty of regulatory ground uncovered, and confusion over who would regulate what.[8,9] But most importantly, the regulations were founded on the false premise that bioengineered organisms used for food and agricultural products are no different from non-engineered, conventional products.10 In fact, to produce genetically engineered foods, researchers take genes from food or non-food organisms and add them to another organism to alter its genetic makeup in ways not possible through sexual reproduction. The process deletes essential proteins or adds entirely new ones, and can modify genetic characteristics in entirely unexpected ways. As long as the new genes come from an approved food source, the government treats new or altered genes in bioengineered foods as natural, not novel, additives. So in most cases regulators are not required to take a precautionary approach when evaluating new genetically engineered food products; products are considered safe until proven otherwise.
As late as 1994, it appeared that the federal government was still playing catch-up in establishing working biotechnology safety regulations. The Union of Concerned Scientists (UCS), which monitors the biotechnology industry and the federal regulatory system, was pointing out big holes in the so-called framework." "Fundamentally, it does not contain sufficient statutory authority to oversee all of the products and activities entailed in genetic engineering," wrote UCS in February 1994. "Where authority does exist, there are problems with implementing regulations and policies." For example, a 1992 FDA policy exempted corporations from having to test bioengineered food for safety and get FDA approval before the foods are put on the market.'2 Unless the corporation determined that "sufficient safety questions exist",'3 corporations could undergo voluntary, private "consultations" with the agency before marketing their product.'4
