FAO/WHO Report threatens strong biosafety protocol

While negotiations are underway for a biosafety protocol, a 1996 joint report by the FAO and WHO threatens to pre-empt comprehensive and necessary international safety standards for genetically engineered foods. A detailed critique by Drs Mae-Wan Ho and Ricarda A Steinbrecher draws attention to the scientific flaws in the Report.

A THREE-PAGE advertisement in the Financial Times (16 Sept.1997) launches food giant Monsanto's major offensive to reassure Europe that genetically engineered (GE) foods are safe. But, according to Drs Mae-Wan Ho and Ricarda A Steinbrecher, UK geneticists and scientific advisers to various public interest groups, consumers should not be taken in by this corporate campaign, particularly in the current regulatory regime. The scientists have done a detailed critique of the Food Safety Report issued jointly by the Food and Agricultural Organisation (FAO) and World Health Organisation (WHO) as the result of an Expert Consultation held in Rome last October. The Consultation was the latest, possibly the most significant attempt to reach international agreement on GE food safety. If unchallenged, it will set international safety standards by WHO's Codex Alimentarius Commission, which will determine, not only GE food safety, but also world trade of GE foods. It will be illegal for any country to ban GE food imports, so long as the Codex considers them safe.

The FAO/WHO Report shows up the glaring inadequacies in safety regulation of GE foods, designed to expedite product approval with little or no regard for biosafety. It is a case of 'no need - don't look - don't see', effectively giving producers carte blanche to do as they please, while serving to diffuse and allay legitimate public fears and oppositions.

The 'principle of substantial equivalence (SE)', on which all safety assessment is based, is completely unscientific and arbitrary, according to Ho and Steinbrecher. A GE product is assessed, on the principle of SE to be safe and fit for human consumption. But the principle is vague, ill-defined, flexible, malleable and open to interpretation. 'Substantially equivalence' does not mean equivalence to the unengineerd plant or animal variety. The GE food could be compared to any and all varieties within the species. 'It could have the worst characteristics of all the varieties and still be considered SE.' A GE product could even be compared to a product from a totally unrelated species. Worse still, there are no defined tests that products have to go through to establish SE. The tests are so undiscriminating that unintended changes, such as toxins and allergens, could easily escape detection. A GE potato, grossly altered, with deformed tubers, was nevertheless tested and passed as SE.

The Consultation explicitly failed to assume responsibility for major areas of GE food safety, such as labelling and monitoring; impacts on biodiversity; and the control of traditional food crops engineered to produce pharmaceuticals and industrial chemicals. The latter will readily cross-pollinate with unmodified food plants and contaminate global food supply for years to come. Also left out are pesticide residues in food crops engineered to be resistant to herbicides, hormone residues and veterinary drugs in milk from cows fed GE bovine growth hormone (BST milk) which have to be treated for stress and infections.

Much more serious are a list of gruesome products that will appear on our dinner table, if the Report goes unchallenged: a range of 'transgenic wastes' from GE plant residues after engineered industrial chemicals and pharmaceuticals have been extracted, meat from failed GE experimental animals or from animals engineered to produce drugs and human proteins in their milk (e.g. Tracy, the transgenic sheep), meat from pigs engineered with human genes for organ transplants, and crops sprayed with insecticidal GE baculovirus. Baculovirus is simultaneously engineered by medical geneticists to transfer genes into human liver cells because the virus is particularly good at invading those cells.

The possibility of new viruses being generated, and of genes jumping (horizontally) across species barriers, as the result of GE biotechnology itself, is real, according to Ho and Steinbrecher, especially in the light of recent scientific findings. The FAO/WHO Report ignores those findings, and sidesteps the whole issue by still maintaining that there is no difference between genetic engineering and conventional breeding methods. The Report is openly partisan to the technology, making unsubstantiated claims for its benefits while omitting to mention the socioenomic impacts on small farmers, and the viable alternatives to the technology in all forms of sustainable agriculture already practised worldwide.

Recommendations

In view of the gross inadequacies in food safety regulation and the existing scientific evidence pointing to serious hazards, Ho and Steinbrecher recommend a number of measures to safeguard the health of consumers and to protect biodiversity. The precautionary principle also demands that a moratorium on further releases should be imposed until those measures are implemented.

1. No traditional food crops are to be used for producing pharmaceuticals and industrial chemicals.

2. All projects involving manipulating baculovirus for insecticidal purposes should be discontinued.

3. Complete characterisation of inserted gene sequence(s) of the GE organism (GEO) must be included in the application for market approval. This should include any antibiotic marker gene(s), promoter(s) and enhancer(s) and their effects on the expression of neighbouring genes. The presence of mobile genetic elements and other proviral sequences in the host genome likely to contribute to secondary mobility of inserts must also be stated.

4. No GEOs with uncharacterised foreign gene inserts are to be considered for release. No parts of such GEOs, nor of animals from failed GE experiments or xenotransplant animals, are to be used as human food or animal feed.

5. No GEOs containing antibiotic-resistant genes are to be considered for release or to be used as human food or animal feed.

6. A detailed record of the stability of the GEO over at least five successive generations of field conditions (including drought and heat) is a precondition for market approval. This must be supported by appropriate data indicating the stability of the insert as well as the level of gene expression under different conditions in successive generations.

7. Data on the frequency of unintended gene transfers, including horizontal gene transfer from the GEO under field conditions, must be included in applications for market approval.

8. Data on the frequency of horizontal gene transfer from GEO to gut bacteria must be included in applications for market approval.

9. Data on the ability of transgenes and marker genes in the GEO to invade mammalian cells must be included in applications for market approval.

10. A specified set of tests must be carried out to establish 'substantial equivalence', which are sufficiently discerning to reveal unintended as well as intended effects. The comparator must be the unmodified recipient organism itself, and results of repeated tests must be provided to support the stability of the characteristics over at least five successive generations.

11. Safety assessment must include the GEO's potential to generate pathogens through genetic recombination.

12. Safety assessment must include pesticide residues where they are integral components of the product, as in herbicide-resistant transgenic plants.

13. Product segregation, labelling and post-market monitoring are non-negotiable conditions for market approval.

(Third World Resurgence No. 87/88, Nov/Dec 1997)

For the full critique entitled 'Fatal Flaws in Food Safety Assessment: A Critique of the Joint FAO/WHO Biotechnology and Food Safety Report (FAO Food and Nutrition Paper 61)', please click here.

Dr Mae-Wan Ho is the Director of Bioelectrodynamics Laboratory, Department of Biology, Open University, United Kingdom. Dr Ricarda Steinbrecher is a molecular geneticist and a scientific consultant for a number of NGOs including the Women's Environmental Network and the Genetic Engineering Network.