US pressing internationally for lax food safety testing for GM foods
Press Release
Contact: DR. SUMAN SAHAI
Phone: +91 11 26517248; 98-110-41332
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1 February 2005

Gene Campaign, The German Church Development Service and the Institute for Agriculture and Trade Policy from the US have protested to the US Food and Drug Administration (FDA) about the new guidelines that are being proposed to test for the safety of genetically engineered foods.

In a letter sent to the Commissioner of the FDA, Lester Crawford, Dr. Suman Sahai, Dr Rudolf Buntzel and Dr. Steve Suppan have called the proposed guidelines irresponsible and with the potential to jeopardise the health of people across the world. The guidelines which will be just voluntary (not mandatory), in the US, are proposed as an international model to be implemented by other countries. Given the aggressive track record of the US in influencing regulatory systems in developing countries, if these guidelines are not opposed in the US, there is a strong chance of their being implemented worldwide.

Dr. Sahai said this is a nightmare for developing countries where the regulatory system is weak and ineffective as it is. Further laxity with respect to food safety would enable companies to escape liability for their actions and not be accountable for contamination of the food supply. On the other hand, the regulatory and monitoring systems in developing countries would fail to protect the people because of the lack of technical competence and effective testing systems.

Dr. Suman Sahai
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To the FDA Commissioner,
Division of Dockets Management (HFA-305),
Food and Drug Administration,
5630 Fishers Lane, Room 1061,
Rockville, MD 20852, USA

Docket ID 2004D-0369

Dear Commissioner Crawford

We are writing to you as representatives of three civil society organisations, Gene Campaign from India ,the EED (Evangelischen Entwicklungsdienst -- the Church Development Service) from Germany and the Institute for Agriculture and Trade Policy (IATP) from the United States, to urge you to withdraw the proposals contained in the new FDA "Draft Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use".

This proposed Guidance is to set up a voluntary mechanism for "early food safety evaluation" of new proteins from experimental genetically engineered plants intended for food use, which are being field tested. This Guidance is supposed to address the likelihood that cross-pollination and mixture of seeds will occur, resulting in the presence of untested novel proteins in the food supply.

The US draft guidance that is being considered by the FDA is worrisome for several reasons.

* In an area as environmentally sensitive as GM crops, where novel proteins, such as drug and vaccine molecules, could escape from test plots and contaminate the food chain, the guidelines proposed by the FDA are only voluntary, so a company need not undertake appropriate and adequate testing.

* The guidelines on accidental presence of GM in non- GM foods have been kept so open ended that there is no upper limit to the amount of contamination that would be permissible. This permissiveness indicates that there is no rigorous regulatory mechanism to keep the food chain secure from contamination by potentially harmful molecules.

* The FDA has not required any tests to be conducted by the biotech industry to evaluate contamination from experimental fields. This laxity and lack of monitoring will ensure that early detection of contamination in the field will not be possible. Contamination problems could become irreversible by the time they are detected. This has special relevance to countries that are centres of origin for major crop plants, like India. Protecting native gene pools of crop plants from contamination is crucial for global food security.

* The new guidance does not pay much attention to monitoring health safety either. There are no clear provisions to test for allergenic or toxic response to novel proteins produced by GM organisms, making the proposed "early food safety evaluation" fully inadequate for genuine food safety evaluation.

* With respect to the general abuse of the Confidential Business Information clause in the Agbiotech sector, we propose that no information that may affect public or environmental health may be classified as Confidential Business Information under the Administrative Procedures Act.

* The Guidance fails to mention the need to test for unintended effects caused by genetic engineering. Such unintended effects are acknowledged as risk factors by the Codex Alimentarius Commission, the joint agency of the World Health Organization and the UN Food and Agriculture Organization.

* In the absence of mandatory test protocols that are specific and rigorous, companies will in all likelihood fail to provide the necessary scientific information required in the Codex risk analysis guidelines, much less to prove safety beyond reasonable doubt.

Such a permissive regulatory system as the draft Guidance proposes threatens to jeopardise human and animal safety as well as environmental integrity from the contamination that is likely to result from experimental plots of GM plants producing novel proteins.

One cannot escape the impression from the proposed Guidance, that US regulators have decided that their highest priority is not to protect public and environmental health, but to offer the Agbiotech industry the legal means to avoid liability for contamination caused by their products. We therefore urge the FDA to reflect on its proposed actions and withdraw the recommendations proposed in this Guidance.

As organisations that are closely involved with agriculture and food security in developing countries, Gene Campaign, EED, and IATP urge the FDA to elaborate strict rules and procedures to prevent contamination of the food supply with transgenic proteins. We also urge the FDA to replace its current lax and voluntary biotechnology consultation process with a mandatory, science-based and rigorous review process designed to ensure food safety.

All countries, particularly net food importing developing countries that are likely to import food from the United States have the right to require the FDA to introduce greater rigour in its testing procedure and its guidelines. In a globalised market with an integrated food chain, the lack of caution on the part of a major food exporting country could expose the public and environmental health of other countries to unacceptable risk. The FDA guidance as it stands would simply permit companies and developers to allow experimental genetically engineered crops to enter the food supply in the US and from there to other countries. This regulatory permissiveness violates the rights of those nations and communities who have chosen to exercise greater caution or remain GM free .

It is unclear how the FDA, with this Guidance, intends to comply with other countries' domestic regulations for unapproved or unauthorized genetically engineered organisms. Most developing countries lack the regulatory capacity and means to adequately enforce bio safety and the reality remains that unapproved genetically engineered organisms may slip through.

We are especially concerned at FDA's reported intention to use this Guidance as an international model to address the presence of low levels of genetically engineered plant material in non-genetically engineered crop fields. This would amount to forcing other countries to accept contamination of their food supplies by genetically engineered plants and denying them the right to exercise caution in the interest of the welfare of their people and their environment. The latter has special significance for those countries that are centres of origin and diversity for the major crop plants. Risking contamination of such unique gene pools is nothing short of irresponsible.

Given the seriousness and far-reaching impacts of the FDA's proposals, we will continue to raise this issue with our Governments. We also pledge to work towards ensuring zero tolerance for unapproved and experimental transgenic proteins in the food supply, and for our countries to remain GE-free.

Yours sincerely,

Dr. Suman Sahai
Gene Campaign, India

Dr. Rudolf Buntzel-Cano
Church Development Service, Germany

Dr. Steve Suppan
Institute for Agriculture and Trade Policy, USA