Journal or Publishing Institution: Environmental & Nutritional Interactions
Study: https://web.archive.org/web/20101202164007/http://www.twnside.org.sg/title2/biosafety/pdf/bio01.pdf
Author(s): Ho, M.W., and Steinbrecher, R.A.
Article Type: Journal Publication
Record ID: 1054
Abstract: The Biotechnology and Food Safety Report issued jointly by the Food and Agriculture Organization (FAO) and World Health Organization (WHO), is the result of an Expert Consultation held in Rome, in October 1996. The Consultation was the latest, possibly the most significant, attempt to reach international agreement on the safety of genetically engineered (GE) food. If accept, it will set international safety standards to be adopted 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 ‘don’t 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 opposition.
The ‘principle of substantial equivalence’, on which all safety assessment is based, is completely unscientific and arbitrary. A GE product assessed to be substantially equivalent (SE) is regarded as safe and fit for human consumption. But the principle is not only vague and ill-defined, it is flexible, malleable and open to interpretation. ‘Substantial equivalence’ does not mean an equivalence of the unengineered 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 substantial equivalence. 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 assumed 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 pesticides residues in food crops engineered to be resistant to herbicides, hormone residues and veterinary drugs in BST (or bovine somatotropin) milk from cows fed with this GE bovine growth hormone, which have to be treated for subsequent stress and infections.
Much more serious is 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 baculoviruses. The 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, especially in the light of recent scientific findings. The FAO/WHO Report ignores these 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 socioeconomic 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 scientific evidence pointing to serious hazards, we 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 the following measures are implemented.
a. No food crops are to be engineered for producing pharmaceuticals and industrial chemicals, as the engineered crops could be mistaken for food, or cross-pollinate with non-engineered food crops. The onus must be on the producer to prove that any plant genetically engineered is not a food crop.
b. All projects involving genetic manipulation of baculovirus for insecticidal purposes should be discontinued, as this virus is being used in human gene therapy and invades human liver cells readily.
c. Complete characterization of inserted gene sequence(s) of the genetically engineered organism (GEO) must be provided in the application for market approval. This should include any antibiotic-resistance 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.
d. No GEOs with uncharacterized foreign gene inserts are to be considered for release. No parts of such GEOs, nor of animals from failed experiments in genetic engineering or xenotransplant animals are to be used as human food or animal feed.
e. No GEOs containing antibiotic-resistance genes are to be considered for release or to be used as human food or animal feed.
f. A detailed record of the stability of the GEO over at least five successive generations under field conditions (including drought and heat) is a precondition for market approval. (“Field conditions” does no mean open field conditions.) 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.
g. Data on the frequency of unintended gene transfers, including horizontal gene transfer from the GEO under field conditions, must be included int he application for market approval.
h. Data on the frequency of horizontal gene transfer from the GEO to gut bacteria must be included in applications for market approval.
i. Data on the ability of transgenes and marker genes in the GEO to invade mammalian cells must be include din applications for market approval.
j. A specific 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.
k. Safety assessment must include the GEO’s potential to generate pathogens through genetic recombination.
l. Safety assessment must include pesticide residues where they are integral components of the product, as in herbicide-resistant transgenic plants.
m. Product segregation, labelling and postmarket monitoring are non-negotiable conditions for market approval.
Keywords: GE foods, substantial equivalence, food safety, safety assessment, labelling, horizontal gene transfer, pollen-mediated gene transfer, stability, FAO/WHO Biotechnology and Food Safety Report, critique
Citation: Ho, M.W., and Steinbrecher, R.A., 1998. Fatal flaws in food safety assessment: critique of the joint FAO/WHO Biotechnology and Food Safety Report. Environmental & Nutritional Interactions, 2, 51-84.