ACTION! stop the US FDA from legalising contamination (21/12/2004)


stop the us food and drug administration from legalising contamination of the food supply with experimental gm crops. food imported to your country is at risk!

The closing date for comments is 24 January 2005

* Send in your comments to the FDA today - see below for a sample response
* Urge your Government to object to the proposals
Friends of the Earth International Action Alert: http://www.foei.org/cyberaction/fda.html


On November 19 the US Food and Drug Administration (FDA) announced new draft guidelines to deal with the growing problem of unapproved genetically modified plants contaminating food crops. But instead of tightening controls on GM crops, the FDA is proposing simply to legalise this contamination of the food chain. In addition, the FDA wants to promote these proposals as a model around the world.

Contaminated food imported into your country?

Experimental GM traits are being tested in a huge variety of food crops which are exported in large quantities from the US , for example maize, soy, rice and wheat. This means that not only would the guidelines allow contamination of the American food supply with experimental material that escapes from GM crop test sites, but contaminated food could then be exported to your country.

What's the risk?

Over 40,000 GM test plots have been authorised by the US government on over 500,000 acres since 1987. Many of the genes spliced into these experimental GM crops are hidden from the public as trade secrets, and it would be impossible to test for the presence of experimental GM material in foods imported from the US . Those experiments we know of include radically altered nutritional content for use as animal feed or anti-fungal compounds that resemble food allergens. Others include crops engineered to be resistant to chemical herbicides, produce their own insecticides or have sterile pollen or seeds. These proposals could see unapproved, untested GM material not intended for human consumption ending up in the food chain – with unknown consequences.

US proposals go against the Biosafety Protocol and its precautionary approach

The US proposals to legalize contamination from GM experimental crops are a clear breach of the precautionary approach anchored in the UN agreement dealing with GM crops, the Biosafety Protocol. Taking into account the potential threat of irreversible or serious damage derived from the unknown consequences of introducing untested GM material not intended for human consumption into the food chain, no Government in the world should allow the legalization of experimental GM crops in the food supply.

Protecting biotech companies over consumers

While presented as a food safety measure, both FDA Commissioner Lester Crawford and Michael Phillips, vice president of the Biotechnology Industry Organization, have acknowledged that these new rules would provide legal cover to companies whose novel crops contaminate the food supply, and avoid the need for expensive and inconvenient product recalls. But if US companies are protected from legal liability, who would then be liable if contamination was detected in food imported into your country? And who would be responsible if negative impacts on human health are discovered in the US or anywhere else in the world?

The proposed policy sets out loose 'safety assessment' guidelines under which companies may voluntarily consult with the FDA to have their experimental biotech traits deemed "acceptable" as contaminants in food. The 'safety assessment' is based on paperwork and two inadequate tests that FDA estimates will take companies just 20 hours to complete. It also sets no limits on the amount of GM contamination allowed in foods.

Tell the FDA that it needs to devise rules to stop contamination of the food supply with experimental GM traits, not find new ways to make it okay for companies to do so!

Submit your comments by 24 January 2005
Through the FDA website, (Docket ID "2004D-0369") at

Or send written comments, referencing Docket ID 2004D-0369 to: FDA Commissioner, Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane , Room 1061, Rockville , MD 20852

Urge your Government to object

Adapt the draft response to the FDA to ask what the position of your government is on these proposals and demand that it lodges a formal objection to them because of the impact it could have on consumers and food companies in your country.

For more information:
Press release: www.foei.org/media/2004/1123.html <http://www.foei.org/media/2004/1123.html>
Briefing paper: www.foei.org/publications/pdfs/contamination.pdf <http://wwwfoei.org/publications/pdfs/contamination.pdf>

Draft Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use:
www.cfsan.fda.gov/%7Edms/bioprgui.html <http://www.cfsan.fda.gov/%7Edms/bioprgui.html>

Sample response

Re: Docket No. 2004D-0369

Dear Commissioner Crawford,

I am writing to express my deep concern over the FDA's draft "Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use". I am also alarmed that the FDA is intending to use the FDA guidance as providing "an international model to address the presence of low levels of bioengineered plant material in non-bioengineered crop fields." For the reasons outlined below, I urge you to reject these proposals.

The implications of these proposals are far-reaching. Not only will they legalise contamination of the US food chain with unapproved, untested GM traits, but food exported to any country in the world will also be at risk. Public worldwide has made it clear that we want to be able to choose food free of GM contamination - even if the GMOs are approved. But this attempt to legalise contamination from unapproved GM traits, with unknown consequences is reckless and totally unacceptable.

The stated purpose of this guidance document is to set up a voluntary mechanism for evaluating the potential health risks from contamination of the food supply with material from genetically engineered (GE) plants being field tested out-of-doors. However, the true purpose of this initiative has nothing to do with food safety. As stated by FDA Commissioner Lester Crawford in a recent speech, the goals are to "enhance public confidence" and "avoid product recalls" when such contamination occurs. This is also why the Biotechnology Industry Organization regards the initiative as “enormously important.” It is unacceptable to protect biotechnology company interests at the expense of consumers.

In the event that these proposals were approved and US companies subsequently protected from legal liability, a significant questions over liability would emerge; who would be liable if contaminated food was exported into, and detected in other countries in the world? And who would be responsible if negative impacts on human health are discovered in the US or anywhere else in the world as a result of eating food contaminated with experimental traits?

The FDA presumes that any contamination that occurs will be at low levels, lessening concern. Yet "low level" is never defined. Permissible contaminant levels are in principle unlimited. Two considerations suggest that contamination may often be higher than anticipated. First, in some cases the transgenes responsible for novel proteins can cross over to related weed species or compatible cultivars, which can act as a genetic reservoir for the persistence and amplification of the transgene, which could be transferred back to food cultivars in the future. Secondly, by negating the existing de facto zero tolerance standard for experimental transgenic proteins in the food supply, GE crop field trial operators will have less incentive to strictly adhere to gene confinement protocols, resulting in more, not less, contamination.

Furthermore, the proposed 'safety evaluation' is totally inadequate. First, it applies only to experimental GE crop varieties that generate non-pesticidal proteins, by definition excluding the growing number of trials involving metabolic manipulations rather than novel proteins. Secondly, it excludes standard toxicological testing procedures and proposes absolutely no assay to detect unintended effects of the genetic engineering process. Third, experts agree that the digestive stability and amino acid homology tests proposed in the guidance cannot exclude a novel protein's toxicity or allergenicity, particularly since test conditions are not specified, giving applicants ample leeway to devise tests to get the results they desire.

I urge you to reject this misconceived policy. The FDA should be devising rules and procedures to prevent contamination of the food supply with experimental transgenic proteins, not give rubber stamp approval to such contamination when it occurs.

Finally, I urge the FDA to replace its current non-rigorous "voluntary consultation" process with a mandatory, science-based review process designed to ensure food safety rather than, as at present, "enhance public confidence" in inadequately tested and potentially hazardous GE foods.

Yours sincerely,

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