The Fraud of "Substantial Equivalence"

US Government agencies entrusted with the mandate to safeguard the health and safety of the overall population were becoming dangerously biased.

Some years before, the first commercial GMO product hit the market in the US, the Reagan Administration had been moving quietly to open its doors wide to Monsanto and other private companies which were developing gene-manipulated products. The· key actor within the Reagan Administration on decisions pertaining to the new field of genetically modified products was former head of the CIA, Vice President George Herbert Walker Bushwho would himself soon be President, and father of the later President, George W. Bush.

By the early 1980's, numerous agribusiness corporations were in a gold rush frenzy to develop GMO plants, livestock and GMObased animal drugs. There was no regulatory system in place to control the development, risks and sale of the products. The agribusiness companies wanted to keep it that way.

The Reagan-Bush Administration was partly driven by an ideological agenda of imposing deregulation, reducing Government supervision in every facet of daily life. Food safety was no exception. Rather to the contrary, and even if that meant the general population could become guinea pigs for entirely untested new health risks.

The Fraud of "Substantial Equivalence" In 1986, Vice President Bush hosted a group of executives from a giant chemical company, Monsanto Corporation of St .. Louis, Missouri, for a special White House strategy meeting. The purpose . of the unpublicized meeting, according to former US Department of Agriculture official, Claire Hope Cummings, was to discuss the "deregulation" of the emerging biotech industry. Monsanto had had a long history of involvement with the US Government and even with Bush's CIA. It had developed the deadly herbicide, Agent Orange, for defoliation of jungle areas in Vietnam during the 1960's. It also had a long record of fraud, cover-up and bribery.

When he finally became President in 1988, Bush and his Vice President Dan Quayle moved swiftly to implement an agenda giving unregulated free-rein to Monsanto and other major GMO companies. Bush decided it was time to make public the regulatory framework which he had negotiated a few years earlier behind closed doors.

Vice President Quayle, as head of Bush's Council on Competitiveness, announced that "biotech products will receive the same oversight as other products:' and "not be hampered by unnecessary regulation."l On May 26, 1992, Vice President Dan Quayle proclaimed the Bush administration's new policy on bioengineered food. "The reforms we announce today will speed up and simplify the process of bringing better agricultural products, developed through biotech, to consumers, food processors and farmers," Mr. Quayle told executives and reporters. "We will ensure that biotech products will receive the same oversight as other products, instead of being hampered by unnecessary regulation:'2 Pandora's Box had been opened by the Bush-Quayle Administration.

Indeed, not one single new regulatory law governing biotech or GMO products was passed then or later, despite repeated efforts by concerned Congressmen that such laws were urgently needed to regulate unknown risks and possible health dangers from the genetic engineering of foods.

The framework that Bush put in place was simple. In line with the expressed wishes of the biotech industry, the US Government would regard genetic engineering of plants and foods or animals as merely a simple extension of traditional animal or plant breeding.

Further clearing the path for Monsanto and company, the Bush Administration decided that traditional agencies, such as the US Department of Agriculture, the EPA, the Food and Drug Administration (FDA) and the National Institutes of Health (NIH), were competent to evaluate the risks of GMO products.3 They determined that no special agency was needed to oversee the revolutionary new field. Furthermore, the responsibilities for the four different agencies were kept intentionally vague.

That vagueness ensured overlap and regulatory confusion, allowing Monsanto and the other GMO operators maximum leeway to introduce their new genetically engineered crops. Yet, to the outside world, it appeared that the new GMO products were being carefully screened. The general public naturally assumed that the Food and Drug Administration or the National Institutes of Health were concerned about their well-being.

Despite serious warnings from research scientists about the dangers of recombinant DNA research and biotechnology work with viruses, the US Government opted for a system in which the indus- . try and private scientific laboratories would "voluntarily" police themselves in the new field of genetically engineered plants and animals.

There were repeated warnings from senior US government scientists of the potential dangers to the Bush-Quayle "no regulation" decision. Dr. Louis J. Pribyl, of the Food & Drug Administration was one of 17 government scientists working on a policy for genetically engineered food at the time. Pribyl knew from studies that toxins could be unintentionally created when new genes were introduced into a plant's cells. Pribyl wrote a heated warning memo to the FDA Chief Scientist declaring, "This is the industry's pet idea, namely that there are no unintended effects .... But time and time again, there is no data to back up their contention:'

Other Government scientists concluded there was "cimple scientific justification" to require tests and a government Ireview of each genetically engineered food before it was sold. "The possibility of unexpected, accidental changes in genetically engineered plants justifies a limited traditional toxicological study:' they declared.4 Their voices went unheeded by the Bush Administration. They had cut their deal with Monsanto and the emerging biotech agribusiness industry.

At that early stage, few paid any attention to the enormous implications of genetic engineering on such a mass scale, outside a small circle of scientists being financed by the largesse of a handful of foundations. And no foundation was more important in the financing of this emerging sector of biotechnology than the Rockefeller Foundation in New York.

By 1992, President George H.W. Bush was ready to open the Pandora's Box of GMO. In an Executive Order, the President made the ruling that GMO plants and foods were "substantially equivalent" to ordinary plants of the same variety, such as ordinary corn, soybeans, rice or cotton.5

The doctrine of "substantial equivalence" was the lynchpin of the whole GMO revolution. It meant that a GMO crop could be considered to be the same as a conventional crop, merely because GMO corn looked like ordinary corn or GM rice or soybean, and even tasted more or less like conventional corn, and because in its chemkal composition and nutritional value, it was "substantially" the same as the natural plant.

That determination that GMO phints were to be treated as "substantially equivalent" ignored the qualitative internal alteration required to genetically engineer the particular crop. As serious scientists pointed out, the very concept of "substantial equivalence" was itself pseudo-scientific. The doctrine of "substantial equivalence" had been created primarily to provide an excuse for not requiring biochemical or toxological tests.

Because of the Bush Administration's "substantial equivalence" ruling, no special regulatory measures would be required for genetically engineered varieties.

Substantial equivalence was a phrase which delighted the agribusiness companies. That wasn't surprising, for Monsanto and the others had created it. Its premise was deceitful, as Bush's science advisers well knew.

Genetic modification of a plant or organism involved taking foreign genes and adding them to a plant such as cotton or soybeans to alter their genetic makeup in ways not possible through ordinary plant reproduction. Often the introduction was made by a gene "cannon" literally blasting a plant with a foreign bacteria or . DNA segment to alter its genetic character. In agricultural varieties, hybridization and selective breeding had resulted in crops adapted to specific production conditions and regional demands.

Genetic engineering differed from traditional methods of plant and animal breeding in very important respects. Genes from one