Court In The Act

Court In The Act – Food and Drug Administration

Joseph Mendelson


IN SUPPORT OF the American public, the Centre for Food Safety has filed an action against the US Food and Drug Administration’s pre-market safety-testing and labelling policy on GM foods.

BEGINNING IN THE mid-1980s the United States Food and Drug Administration (FDA) began considering how it would review new varieties of foods developed through genetic engineering. Among the issues that needed review were the environmental, food safety and ethical issues surrounding these novel foods. On 29 May 1992, the FDA concluded its review and issued a policy for foods derived from new plant varieties. The policy determined that all transferred genetic material and the resulting food products derived from genetically engineered plant varieties were akin to traditionally bred plants and, bar a few, considered ‘generally recognised as safe’.

As a result of the 1992 Food Policy, and the subsequent federal action, genetically engineered foods and ingredients were allowed into the United States marketplace without labelling, without proper analysis of the potential safety risks associated with their genetic instability and without full study of their environmental impacts.

Recently, on 13 December 1999, the FDA held the last of three public hearings to reassure the public that it was being appropriately vigilant on the issue of genetically engineered foods. However, the hearings came over seven years after the US government deregulated genetically engineered foods from virtually any government oversight. For most, the FDA’s effort to assuage mounting opposition to GE foods held little validity.

Each day, tens of millions of US infants, children and adults eat genetically engineered foods without their knowledge. A significant percentage of processed foods purchased today contain some genetically engineered (GE) food products. Yet, US consumers have no way of knowing what foods are genetically engineered because the FDA does not require labelling of these products. What’s worse, the agency also does not require any pre-market safety testing of GE foods. Companies do not even have to inform the FDA that they are marketing GE foods.

Despite the attempts to put a friendly face on this government negligence, opinion polls consistently show that more than 90 per cent of Americans strongly support the labelling of genetically engineered foods. A 1999 Time magazine poll revealed that close to 60 per cent would avoid such foods if they were labelled.

The FDA’s inaction on this issue also compelled our organisation, the Centre for Food Safety, and numerous other plaintiffs, including leading scientists, religious leaders and consumers, to file a lawsuit to reform FDA policy on GE foods by seeking to obtain stronger safety testing and mandatory labelling. The action was filed in the US District Court for the District of Columbia on 27 May 1998. Consistent with the public’s comments, the legal case seeks to mandate that the FDA takes the following actions:

* The FDA treats all genetic changes to foods caused by genetic engineering techniques as food additives, thus triggering the FDA’s need for specific pre-market safety testing and approval of each genetically engineered food before it could be considered ‘generally recognised as safe’;

* The FDA performs a thorough environmental review of all genetically engineered foods made commercially available as established by a law known as the National Environmental Policy Act; and

* The FDA mandates the labelling of all genetically engineered foods because of the ‘material’ changes in such foods.


In response to a lawsuit, the FDA has admitted in court that it has made no regulations, ‘no binding norms’, and ‘no dispositive scientific findings’, whatsoever, about genetically engineered foods. In other words, the FDA has given the biotech industry carte blanche to produce and market any number of genetically engineered foods without any mandatory agency oversight or safety testing.

The FDA’s failure to require safety testing of GE foods is not only grossly negligent, but also poses a very real potential public health threat. A significant body of scientific evidence, including findings of the FDA’s own scientists, shows that the genetic engineering of foods can transform safe foods into dangerous products. Much of the scientific support for documenting these health hazards has come from the 44,000 pages of discovery provided to the Centre for Food Safety as part of the suit.

In 1992 the FDA ruled, without any scientific basis, that genetically engineered foods present no different risks than traditional foods. The FDA’s own scientists ridiculed the agency’s policy. ‘What happened to the scientific elements in [the] document?’ one asked. FDA scientists consistently stated that ‘[t]here is a profound difference between the types of unexpected effects from traditional breeding and genetic engineering[ldots] This difference should be and is not addressed’. The lawsuit seeks to require that the ‘unexpected effects’ and health risks posed by genetic engineering are addressed prior to any such food coming on to the market. These risks include increases in food toxicity, the presence of new allergens, the creation of antibiotic resistance, immuno-suppression, and the nutritional degradation of foods.

Genetically engineered foods are inherently unstable. Each insertion of a novel gene, and the accompanying ‘cassette’ of promoters, antibiotic marker systems, and vectors, is random. GE food producers simply do not know where their genetic ‘cassette’ is being inserted in the food, nor do they know enough about the genetic/chemical makeup of foods to establish a ‘safe’ place for such insertions. As a result, each gene insertion into a food amounts to playing food safety ‘roulette’, with the companies hoping that the new genetic material does not destabilise a safe food and make it hazardous. Each genetic insertion creates the added possibility that formerly non-toxic elements in the food could become toxic.

The FDA was well aware of the ‘genetic instability’ problem prior to establishing their no-testing policy. FDA scientists warned that this problem could create dangerous toxins in food and was a significant health risk. The scientists specifically warned that the genetic engineering of foods could result in ‘increased levels of known naturally occurring toxicants, appearance of new, not previously identified toxicants, increased capability of concentrating toxic substances from the environment (eg pesticides or heavy metals).’ These same scientists recommended that long-term toxicological tests be required prior to the marketing of GE foods. FDA’s response to the potential toxicity problem with genetically engineered foods was to ignore it. The agency refused to require pre-market toxicological testing for GE foods or any toxicity monitoring, at all.


Additionally, in the United States, about a quarter of the population reports some adverse reaction to food. At least 8 per cent of children have physically identifiable allergic reactions to food. The genetic engineering of food creates two separate and serious health risks involving allergenicity. The first is that genetic engineering can transfer allergens from foods to which people know they are allergic, to foods that they think are safe. This risk is not simply hypothetical. A recent study by the New England Journal of Medicine showed that when a gene from a Brazil nut was engineered into soyabeans, people allergic to nuts had serious reactions to the engineered product. At least one food, a Pioneer Hi-Bred International soyabean, was abandoned because of this problem.

There is yet another allergy risk associated with GE foods. These foods could be creating thousands of different and new allergic responses. Each genetic ‘cassette’ being engineered into foods contains numbers of novel proteins (in the form of altered genes, bacteria, viruses, promoters, marker systems, and vectors) which have never been part of the human diet. Each of these numerous novel proteins could create an allergic response in some consumers. The FDA was also well aware of this new and potentially massive allergenicity problem. The agency’s scientists repeatedly warned that genetic engineering could ‘produce a new protein allergen.’ Once again the agency’s own scientists urged long-term testing. However, the FDA again ignored its own scientists.

Another hidden risk of GE foods that the lawsuit seeks to address is that they could make disease-causing bacteria resistant to current antibiotics, resulting in a significant increase in the spread of infections and diseases in the human population. Virtually all genetically engineered foods contain ‘antibiotic resistance markers’ which help the producers identify whether the new genetic material has actually been transferred into the host food. FDA’s large-scale introduction of these antibiotic marker genes into the food supply could render important antibiotics useless in fighting human diseases. For example, a genetically engineered maize plant from Novartis includes an ampicillin-resistance gene. Ampicillin is a valuable antibiotic used to treat a variety of infections in people and animals. A number of European countries, including Britain, have refused to permit the Novartis Bt corn to be grown, due to health concerns that the ampicillin resistance gene could move from the corn into bacteria in the fo od chain, making ampicillin far less effective in fighting a wide range of bacterial infections.

For the past seven years, FDA officials have ignored their own scientists’ concerns over the antibiotic resistance who warned, ‘IT WOULD BE A SERIOUS HEALTH HAZARD TO INTRODUCE A GENE THAT CODES FOR ANTIBIOTIC RESISTANCE INTO THE NORMAL FLORA OF THE GENERAL POPULATION.’ During the same time, medical professionals around the world have become increasingly alarmed at how GE foods are leading to a massive infusion of antibiotic genes into the human diet. Just this year, for example, the British Medical Association (BMA) addressed this problem in its study of GE foods. The BMA’s conclusion was unequivocal: ‘There should be a ban on the use of antibiotic resistance maker genes in GM food, as the risk to human health from antibiotic resistance developing in micro-organisms is one of the major public health threats that will be faced in the 21st century.’

Finally, genetic engineering can also alter the nutritional value of food. The genetic instability of these foods can be a major culprit in reducing their nutrients. In 1992, the FDA’s Divisions of Food Chemistry & Technology and Food Contaminants Chemistry examined the problem of nutrient loss in GE foods. The scientists involved specifically warned the agency that the genetic engineering of foods could result in ‘undesirable alteration in the level of nutrients’ of such foods. They further noted that these nutritional changes ‘may escape breeders’ attention unless genetically engineered plants are evaluated specifically for these changes’. Once again, the FDA ignored findings by their own scientists and never subjected the foods to mandatory government testing of any sort.

In sum, while much of the current controversy over genetically engineered food surrounds the important issue of labelling, the issue is only part of the lawsuit. The Centre for Food Safety’s legal action seeks to document the US government’s repeated failure to provide its citizens with the proper food safety oversight required by law and to force the FDA to remove all genetically engineered foods from the market until long-term tests have determined that such foods are safe for human consumption (including the risks enumerated above) and the environment. Only after proper testing is done, and the foods are found safe, should they be allowed to be sold. At that time we believe that US law requires that such foods be labelled so those who want to take a precautionary stance, those with allergies, and those with ethical or religious objections may choose to avoid GE foods.

While the US public awaits the ruling, the Centre for Food Safety has also acted to pre-empt rumoured steps by the FDA to make marginal and trivial changes to its 1992 Food Policy. In early March 2000, CFS coordinated the filing of a legal petition to the FDA, endorsed by over 50 other organisations seeking the withdrawal of GE foods from the market until the FDA establishes a pre-market safety testing and environmental framework and mandates labelling.

Joseph Mendelson is legal director at the Centre for Food Safety, Washington, US.

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