The spokesmen of the Biotechnology industry have been maintaining that there is no essential difference between conventional breeding and genetic engineering. They have been successful in making many national and key international regulatory bodies accept this opinion, including FDA in the US and many other national bodies, the European Union and the United Nations organization FAO.

The next step was then to assert that different treatment of various kinds of "essentially same" products is discrimination and against the law, at least in USA, which is the main producer and developer of such products.

But the Biotechnololgy industry has not denied that genetic engineering may give rise to products that are considerably different to the natural counterpart. For this reason a procedure has been established to decide if the engineered product is "substantially equivalent" to its natural counterpart or not. If it is found to be "equivalent", the product is considered as harmless as natural counterparts and can be treated as the latter from a regulatory standpoint.

The articles in this section explain why there is a fundamental difference between breeding and genetic engineeering (M. Antoniou, M. Antoniou et al, Ho and Steinbrecher). And the inadequacy of the principle of substantial equivalence is revealed ( "Inadequate safety assessment of GE foods" Ho and Steinbrecher, Fagan, PSRAST comment on EU regulations). The conclusion is that this principle is useless as a means for safety assessment of food as well as of release of geneticially manipulated organisms.

So the regulations do not ensure the safety of GE foods and therefor put the population of the world and the environment under peril.

It may seem surprising that experts and regulatory bodies can arrive at an insufficient and unreliable procedure for safety assessment. The articles " Dysfunctional science - Towards a "pseudoscientfic world order"?, and The Fallibility of Scientific Authorities" provide some explanations why this may occur. Against this background, a safety assessment procedure is suggested to minimize the risk of fallacious safety assessments.

It has been a tradition in most countries that governments do not require that the producer proves that a new product is harmless, be it a chemical, a food additive or a genetically engineered product. The products are allowed to be released into nature and to be used by humans as long as there appears no evidence of their harmfulness. This is a major reason for the serious global problems with various kinds of pollution damaging the health of people and the environment. The "Wingspread Statement on the Precautionary Principle", signed by several scientists, demands that the burden of proof of harmlessness has to be laid entirely on the producers. See also The Precautionary approach to the safety of new products. [EL]

In May 27 1998, a lawsuit was filed against FDA in the US. It alleges that current FDA policy, which permits such altered foods to be marketed without any testing and without labels, violates the agency's statutory mandate to protect public health and provide consumers with relevant information about the foods they eat. The suit also alleges that the policy is a violation of religious freedom. See  Landmark Lawsuit Challenges FDA Policy on Genetically Engineered Foods..

FDA records recently delivered to the court reveal the agency declared genetically engineered foods to be safe in the face of disagreement from its own experts--all the while claiming a broad scientific consensus supported its stance. Numerous agency experts protested that drafts of the FDA Statement of Policy were ignoring the recognized potential for bioengineering to produce unexpected toxins and allergens in a different manner and to a different degree than do conventional methods. See FDA records support the lawsuit challenging its policy (June 1999)   [EL]   .

Even if the regulations concerning GE foods are most liberal in the US, the safety regulations are more or less similarly insufficient in most countries in the world. However, under strong worldwide pressure from consumer protests, there seems now to be a tendency for improvement.

Published in May 1997. Last revision in April 6, 2000