The suit against the US Food and Drug Administration (FDA) was filed by consumer and environmental advocacy group Center for Food Safety (CFS), which claims the move comes after an "unreasonable delay" by the FDA in responding to a petition filed in 2000.
The CFS now calls for rigorous testing on genetically engineered (GE) foods before they are marketed in order to ensure that these do not carry certain risks as a result of their different breeding techniques. These risks could include triggering unexpected food allergies, creating toxins in food, or hastening the spread of antibiotic-resistant disease.
In March 2000, the CFS joined forces with over 50 consumer and environmental groups, including the Union of Concerned Scientists, Physicians for Social Responsibility and the Natural Resources Defense Council, to outline a "comprehensive approach" that the FDA should take to assess the health and safety issues from new GE foods.
But the FDA did not respond to the petition, said the CFS.
"Currently, there are no binding FDA regulations to protect the public from the risks of the genetically engineered foods that are found in thousands of products on supermarket shelves," it said
"FDA first adopted a hands-off policy on GE foods in 1992, and despite mounting evidence of health and environmental threats from GE crops, has never significantly changed its deregulatory stance."
In its Federal Register of May 1992, the FDA recommended that developers consult with the FDA about bioengineered foods under development. In June 1996, the agency provided additional guidance to industry on procedures for these consultations. These require that a developer who intends to commercialize a bioengineered food meets with the agency to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the bioengineered food and then submits a summary of its scientific and regulatory assessment of the food. The FDA then evaluates the submission.
But the CFS says the FDA's policy "assumes that gene altered foods are safe based solely on scant information that biotechnology companies voluntarily submit in consultations with FDA. Since these consultations are voluntary, industry determines what information they submit and in what form."
"For too long, the FDA has let biotech companies set the table for deregulation of GE food," said Joseph Mendelson, legal director for the CFS.
According to the advocacy group, strict pre-market testing is required in order to address any unexpected changes in food that the genetic engineering process can create. An example occurred last year, when Australian scientists found that genes from a bean engineered into pea plants created a potentially dangerous allergen in the GE peas.
CFS said the tests that exposed this potential hazard have not been conducted on any of the GE foods currently marketed in the US, even though these GE foods contain genes from non-food organisms that have never been in the human diet and have never been adequately assessed for allergencity.
Indeed, pre-market approval regulations and labeling systems for genetically modified (GM) foods are much more stringent in a number of other countries, including China, Japan, Russia and Brazil.
And in Europe, general opposition to GM crops led to a World Trade Organisation (WTO) ruling in February this year that the EU and six member states had broken free trade rules by imposing a moratorium on GM imports between June 1999 and August 2003.
The decision, in theory, opened up the EU market to GM food.
The issue, however, remains contentious and strong public opinion against GM food in Europe has forced major food companies and retailers to issue non-GM guarantees to customers in recent years.
According to the CFS' lawsuit, filed in district court in Washington DC, the US has a lot to learn from policies adopted in other countries.
"While the rest of the world is rejecting these risky, untested foods, FDA's unscientific approach is making American consumers the world's guinea pigs in this genetic food experiment," said Mendelson.
"Americans deserve the right to know what's in their food. FDA must stop playing politics and start developing a science-based policy to protect Americans from these risky foods."
The FDA was unavailable for immediate comment.