The Natural Food Commission response
to
The safety assessment of novel foods and novel food ingredients
'Discussions and Options' paper
Australia New Zealand Food Authority

Standards Liaison Officer, ANZFA, P O Box 7186
Canberra Mail Centre ACT 2610, Australia

10th November 1996

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We are a consumer group organised as public service in New Zealand by the Natural Law Party. This paper has been prepared after:

Contents:

  1. Safety assessment of biotechnology
  2. The principle of 'substantial equivalence'
  3. Toxicology
  4. Health hazards of genetically modified foods
  5. Traceability and labelling of novel foods
  6. Consumer preferences and benefits
  7. Special consideration of enzymatic food processing agents, and byproducts of biotechnology and novel additives in foods
  8. The 'precautionary principle' and New Zealand law
  9. Regulatory recommendations and conclusions:


1) Safety assessment of biotechnology

Traditionally, safety assessment of foods has relied on the concept of 'long term usage'. If a food has been traditionally eaten over a very long period without any apparent ill effects then it is assumed to be safe. Given their novelty, foods produced through biotechnology pose some special challenges in deciding on safety. Firstly, viable whole foods will be able to reproduce themselves and therefore any deliberate release of such organisms will continue to affect the consumer and the environment for all time. Simply put, unlike nuclear or chemical pollution, genetic pollution can never be cleaned up, inevitable mistakes will be passed on to all subsequent members of a species.

This argument is challenged by some biotechnology advocates on the grounds that the risks posed by some new biotechnology products may be very small. However, by applying correct statistical rules of risk assessment we are forced to conclude that even a very small risk is magnified to certainty when a new food will be present in the environment and consumed for all time. Therefore risks in biotechnology need to be treated as requiring special safety procedures.

Informed comment:

Professor Richard Lacey, microbiologist, medical doctor, and Professor of Food Safety at Leeds University has become one of the best-known figures of food science since his prediction of the BSE crisis made more than seven years ago. In 1995, Professor Lacey spoke out strongly against the introduction of genetically engineered foods, because of 'the essentially unlimited health risks' - "The fact is, it is virtually impossible to even conceive of a testing procedure to assess the health effects of genetically engineered foods when introduced into the food chain, nor is there any valid nutritional or public interest reason for their introduction."


2) The principle of 'substantial equivalence'

Because it is very difficult and probably impossible to design a safe testing regime for a completely novel food produced through biotechnology, food safety experts have relied on two principles - 'substantial equivalence' and 'similarity to traditional breeding' - to scale down the task of assessing novel foods.

Establishing 'substantial equivalence' is suggested by ANZFA as a valid method to reduce pre-market testing requirements. However, a review of the scientific literature shows that the principle of 'substantial equivalence' relies on superficial similarities of nutritional value, food processing characteristics, and appearance; these are not recognised in biotechnology research as measures of equivalence as far as the key novel factor of enzymatic action is concerned. In fact, the reverse is the case. The 'position effect' is the standard statement of the effect of recombinant DNA technology on protein production and action. This states that there will be completely unpredictable effects when a new gene is inserted in any organism. The principle of 'substantial equivalence' misses the mark completely. Testing of novel products needs to focus on the areas where it is well known that there will be substantial differences between traditional varieties and novel foods, such as suppression and expression of genes, generation of novel protein products, disruption of preexisting molecular function, interference with RNA editing protocols, mobility of viral and other DNA inserts, and disruption of molecular shape. All of which pose novel health hazards.

There are now several examples where products initially presented as 'substantially equivalent' or even 'identical' to their naturally occurring counterparts have since proved to have unpredictable effects and/or health hazards. These can arise because of minute differences in genetic structure, which remain undetected by assessment procedures. The present state of DNA research is such that the complete genetic structure and function of even the simplest bacteria are not yet fully understood, what to say of complex organisms such as plants. It is already clear that minute imperfections in genetic coding can give rise to serious health hazards. Therefore caution is required.

For example, in the treatment of diabetes, human insulin factor produced in genetically engineered bacteria was initially thought to be superior to insulin extracted from porcine and equine tissues. At first it had fewer side effects, probably because it had less contaminants. It was also more economical to produce. However, recently and unexpectedly, some long term users of the genetically engineered product have developed a novel life threatening insulin deficiency syndrome which is not yet fully understood.

Informed comment:

Professor Mae Wan-Ho, of the Open University Department of Biology says, "Genetic engineering bypasses conventional breeding by using artificially constructed parasitic genetic elements, including viruses, as vectors to carry and smuggle genes into cells. Once inside cells, these vectors slot themselves into the host genome. The insertion of foreign genes into the host genome has long been known to have many harmful and fatal effects including cancer of the organism."

Biotechnology methods are not an extension of traditional breeding

Biotechnology advocates argue to the public that recombinant DNA methods are just an extension of traditional breeding and that therefore testing procedures for novel foods are unnecessary. This argument is widely recognised as spurious and artificial. Firstly cross-species transfers that are being made between diverse species such as between fish and tomatoes or between normally separate plant types could never happen in nature. Secondly, and more importantly, the actual methods themselves involve the introduction of foreign genes into plants and animals including viral vectors, antibiotic markers, and bacterial genes. The procedures involved, including 'gene gun' techniques, bear no resemblance to the cross pollination and grafting techniques of traditional breeding. The end result is that exotic genetic material is 'left' in the host where it has the potential to cause problems. Moreover, the forced integration of novel DNA sequences into a completely random position within the DNA of the target organism poses totally new health and environmental hazards. These go beyond the hazards already identified in traditional breeding methods.

The long shelf life FlavrSavr tomato was hailed in 1994 as a market winner for its developer, Calgene, but quickly problems surfaced. The tomato bruised easily like a peach and needed special handling equipment. In 1995, the entire crop failed. The plant itself wasn't hardy. In other examples, allergenic properties of one species have been transferred to another organism, herbicide resistant properties have been found to cross over into weeds within one growing season, and genetically engineered soil bacteria have unexpectedly caused catastrophic soil infertility when released.

References:


3) Toxicology

Hazards can also arise because of toxic byproducts of novel enzymatic function. Toxicological assessment techniques advocated by ANZFA are inadequate to detect some of these hazards. The present tests include 90 day tests for toxicity using rodents. This form of testing is inadequate to assess the effect of novel foods on humans. I

nformed comment:

Professor Dennis Parke of University of Surrey School of Biological Sciences, a former chief advisor on food safety to Unilever Corporation and British advisor to the US FDA on safety aspects of Biotechnology writes: "In 1983, hundreds of people in Spain died after consuming adulterated rapeseed oil. This adulterated rapeseed oil was not toxic to rats". Dr Parke warns that current testing procedures of genetically altered foods are not proving safety for humans. He has suggested a moratorium on the release of germ line genetically engineered organisms.

Completely new toxins, allergens, and carcinogens may be produced by novel foods, so testing for known toxins, etc will not be adequate to detect all possible harmful side effects.


4) Health hazards of genetically modified foods

It is important to assess the risks for health when novel foods are ingested by people and animals. The important principle here is that long term health risks will not be adequately assessed by the testing procedures and regulatory frameworks proposed by ANZFA. Recent research suggests that health risks are greater than previously thought. These risks arise in a number of ways.

Unpredictable mutation of the genetic blueprint of life

Given the huge complexity of genetic coding, even in very simple organisms such as bacteria, no one can possibly predict the effects of introducing new genes into any food. Therefore there is no way of knowing the overall, long-term effect on health. This is because:

Unnatural gene transfers from one species to another are dangerous

Cross-species transfers being made between unrelated species, such as the transfer of modified agrobacterium genes, viral genes, and antibiotic resistant genes, would not happen in nature and may create new toxins, diseases, and weaknesses. In this risky experiment, the general public will be the ultimate guinea-pig. Biotechnology industry advocates claim their methods are precise. In fact, there is a random element in all current gene insertion methods. Genetic research shows that many weaknesses in plants, animals and humans have their origin in tiny imperfections in the genetic code. Therefore, side-effects and accidents are inevitable, and some scientists have assessed the risks to be unlimited.

References:

Informed comment:

Dr Peter Wills, theoretical biologist and senior lecturer in physics at Auckland University writes: "Genes encode proteins involved in the control of virtually all biological processes. By transferring genes across species barriers which have existed for aeons between species like humans and sheep we risk breaching natural thresholds against unexpected biological processes. For example, an incorrectly folded form of an ordinary cellular protein can under certain circumstances be replicative and give rise to infectious neurological disease".

Unpredictable health damaging effects and new diseases

When genetic engineers insert a new gene into any organism there is a "position effect" which entails an unpredictable pattern of genetic function. The protein product of the transposed gene may carry out unexpected reactions and produce toxic products. There is also serious concern about the dangers of using genetically engineered viruses as delivery vehicles (vectors) in the generation of transgenic plants and animals. This could destabilise the genome and lead to horizontal gene transfer to other species, including mammals. This risk arises because recent research suggests that disabled viral material used in recombinant DNA techniques can recombine with other viral material in the human or animal gut to produce new active forms of viral material. This may cause dangerous new diseases, resistance to antibiotics, and severe immune reactions. Genetic engineering also interferes with RNA editing and molecular folding which may cause the formation of prion-based diseases similar to BSE_mad cow disease.

References:

Informed comment:

Dr Joseph Cummins, Professor Emeritus of Genetics at the University of Western Ontario warns: "Probably the greatest threat from genetically altered crops is the insertion of modified virus and insect virus genes into crops. It has been shown in the laboratory that genetic recombination will create highly virulent new viruses from such constructions. Certainly the widely used cauliflower mosaic virus is a potentially dangerous gene. It is a pararetrovirus meaning that it multiplies by making DNA from RNA messages. It is very similar to the Hepatitis B virus and related to HIV. Modified viruses could cause famine by destroying crops or cause human and animal diseases of tremendous power."

Genetically engineered products carry more risks than traditional foods

The process of genetic engineering can introduce dangerous new allergens and fatal toxins into foods that were previously naturally safe. Already, one genetically engineered soybean was found to cause severe allergic reactions. References:


5) Traceability and labelling of novel foods

ANZFA appears to argue that identifying all foods produced through biotechnology by clear unambiguous labelling will be a sort of reverse discrimination against novel foods. Therefore, they conclude, labelling will not be necessary. There are many sound reasons why consumers and scientists reject this argument completely.

Firstly, consumers have a right to know what they are eating and decide for themselves. A recent NOP poll in the UK commissioned by the Consumers Association found that 93% of UK consumers want clear labelling of all novel foods. Polls in other countries have reached similar unambiguous conclusions.

Secondly, clear labelling of products, such as cheese and tomatoes, produced through biotechnology has not been an impediment to marketing in the UK. In fact it improves customer relations and confidence.

Thirdly, it is admitted by all that there are some health risks. Consumers have a right to avoid these risks. Therefore they should retain the ability to do so through clear labelling of all foods.

Finally, and most importantly, without clear labelling it will be impossible to trace any health effects of novel foods should they arise. This is a very salient point. To ignore this point is to abandon years of careful work by food regulators to uphold traceability in foods.

Informed comment:

Dr John Fagan, an award winning microbiologist and cancer researcher, Professor of Microbiology at Maharishi University of Management, has renounced $3 million in US government research grants to publicise the dangers of misuse of biotechnology. He advocates a science-based precautionary approach requiring the labelling of all novel foods. He says "without labelling it will be very difficult for scientists to trace the source of new illness caused by genetically engineered food".

In the most celebrated case, a food supplement was made by a Japanese Company, Showa Denko, which switched to a manufacturing process using genetic technology. L-tryptophan, a genetic 'copy' of an essential amino acid, was sold to the public without labelling to differentiate it from the original natural product. The public were unaware that they were consuming anything different and so did not suspect the tryptophan when there was an outbreak of a new illness with no apparent cause. In all, 37 people died, 1,500 people were permanently disabled, and 5,000 people were hospitalised. New cases of illness were reported for three months until minute quantities of a toxic contaminant in the unlabelled genetically engineered L-tryptophan were finally identified as the cause. The original testing and purification procedures used by Showa Denko had been inadequate to identify and remove the toxic contaminant which was very similar to tryptophan in its genetic structure. Showa Denkn has since paid out over $1 billion in damages.

Reference:

Informed comment:

The British Retail Consortium which represents over 90% of food retailers in the UK has issued a policy statement on genetically engineered foods: "Retailers in the UK and Europe as a whole are clear that the preservation of consumer choice is paramount, and that substantial work over several years on product ingredient traceability should not be compromised". The Consortium has decided to boycott suppliers of raw materials who cannot guarantee that natural ingredients are kept separate from those produced by genetic engineering.

Discussions with leaders of major New Zealand food retailers and manufacturers have indicated that they already hold views similar to those expressed by members of the British Retail Consortium and EuroCommerce which uphold consumer preferences as paramount. Any attempt to bypass consumer preference for unambiguous labelling of all genetically modified products, even if only one ingredient is involved, will inevitably cause public distrust and product boycotts from environmental and consumer groups.


6) Consumer preferences and benefits

ANZFA is deliberating regulations primarily to benefit and protect the public. They have a duty to consumers to protect their right to choose what they are eating. Any move to limit clear labelling of genetically modified foods is essentially a form of chemical trespass. Consumers in most countries have clear preferences for labelling. Labelling should be fully supported by ANZFA who are publicly funded and therefore publicly accountable.

It has been estimated that more than 57% of biotechnology research on foods is to make plants resistant to herbicides and pests. Initially biotechnology companies promised that consumers would benefit overall from reduced use of herbicides and pesticides. However, first hand experience suggests the opposite. Monsanto Corporation in the USA has engineered a soybean by inserting DNA from soil bacteria and a plant virus into its genetic structure to make the plant resistant to Monsanto's best selling brand of herbicide Roundup. This means that the soybean plant can stand repeated dousing with Roundup, while weeds are killed off. Robert Shapiro, Monsanto chief executive, is reported in the 24 October 1996 New York Times as betting on Roundup sales to boost company profits to record levels. "I keep writing cheques for big bucks" to expand Roundup manufacturing capacity "as fast as we know how," says Shapiro. Consumer representatives are less than happy. They point out that the genetically engineered soybeans carry no nutritional benefits for consumers, moreover increased use of herbicides may cause more illness.

Biotechnology advocates claim that increased farm productivity will benefit consumers, but recent research has suggested that initial gains in yields for farmers will soon be lost as herbicide and pest resistant properties rapidly cross over into weedy relatives.

Informed comment:

Dr Norman Ellstrand, Professor of Genetics at the University of California, is one of the world's leading authorities in genetic engineering. He comments on the problem of gene exchange between crops and weedy relatives. "We see this as a multi-million dollar problem. In Europe, there is already a big problem with gene flow between wild beet and cultivated beet. Oil-seed rape also has close relatives and is going to cause problems in the future. One would expect that the kind of genes that are now being engineered are going to be the ones that have a higher potentiality for causing trouble".

More than anything else, ANZFA has a duty to protect the public from novel health hazards. In the case of genetically altered foods, these risks are sufficiently serious to warrant a moratorium on their introduction. In this regard plants that have been engineered to produce their own pesticides pose a special hazard for health. Novel foods that carry such genes pose a special category of health risk. The long term health effects of consuming such foods are serious and are very difficult to assess. It is not enough to argue that the enzymatic action of such foods will be destroyed when they are cooked. Everyone knows that all foods are eaten raw by some people and by animals. Foods are also often undercooked. Therefore it is irresponsible to approve such foods under the present inadequate regulations which are suited to testing for hygiene, but not for novel effects of genetically engineered foods.


7) Special consideration of enzymatic food processing agents and byproducts of biotechnology and novel additives in foods

In addition to genetically engineered organisms themselves, hundreds of biotechnology byproducts are beginning to be used as processing agents and additives in foods. These include rennets, baking aids, sweeteners, micronutrients and vitamins, and fat splitting and juicing enzymes. Most of these products have not been assessed adequately for their long term effect on health. Many are substituted for natural derivatives without precautionary labelling to inform the public of a change of process or ingredients. It is scientifically incorrect to assume, as ANZFA appears to do, that, because a product is present in small quantities, its effect on health will negligeable. It important that these novel products are also labelled clearly as derived from gene technology. For example, a six-fold increase in reported cases of asthma among German bakery workers following the introduction of enzymatic baking aids needs careful investigation and assessment.

Informed comment:

Dr Michael Antoniou, Senior Lecturer in Molecular Pathology at a London teaching hospital says, "the generation of genetically engineered plants and animals involves the random integration of artificial combinations of genetic material from unrelated species into the DNA of the host organism. This procedure results in disruption of the genetic blueprint of the organism with totally unpredictable consequences.The unexpected production of toxic substances has now been observed in genetically engineered bacteria, yeast, plants, and animals with the problem remaining undetected until a major health hazard has arisen. Moreover, genetically engineered foods or enzymatic food processing agents may produce an immediate effect or it could take years for full toxicity to come to light." Because genetically engineered foods reproduce themselves and can never be recalled from the environment, Dr Antoniou warns of an unprecedented health risk for humanity.


8) The 'precautionary principle' and New Zealand law

Here in New Zealand, the Hazardous Substances Act was designed to ensure adequate testing of genetically modified foods before they were introduced. However, its provisions will be breached by the ANZFA treaty which requires that New Zealand will accept foods approved by Australian regulators and vice versa. Current Australian regulations appear to favour the rapid introduction of genetically engineered foods. Therefore genetically modified foods approved in Australia are now automatically eligible to enter New Zealand. These include the Roundup Ready Soybean which has been rejected by European manufacturers, retailers and consumers because of health risks and consumer opposition. The New Zealand Department for the Environment Interim Assessment Group for GMOs is still assessing the potential impact of viable soybeans on the environment, but ANZFA rules seem set to permit their import before this process is complete. The location of ANZFA in remote Canberra is also a concern to New Zealanders who may have difficulty registering their views. The net result may be to bypass the 'precautionary principle' which was previously honoured under New Zealand law - in effect it will no longer be necessary for a producer to prove that a novel food is safe before selling it to the public.

World wide over 5,000 trials of genetically modified fruit and vegetables are currently taking place. Under current ANZFA arrangements, the New Zealand general public may become unwitting guinea pigs in a vast experiment, where almost all our fruit and vegetables will eventually be genetically altered by overseas companies, who will end up holding patents on our food supply.


9) Regulatory recommendations and conclusions

Moratorium on release of GMOs

There is already enough scientific evidence and consumer concern to warrant a moratorium on the introduction and sale of genetically engineered foods and crops. Once released, genetically engineered foods and crops will be in the environment and the food chain for all time. Our present foods have been evolved over millions of years. The human digestive system is finely attuned to derive nutrients from natural foods. To suddenly change almost all foods within a short space of time is highly dangerous and threatens the environment and human health. It could upset the delicate balance between our physiology and the foods that we eat, it could cause catastrophic environmental damage and food shortages, and it could create virulent new diseases and genetic defects with global impact. These are serious risks and we are being warned about them by renowned scientists. Therefore there is no need to rush approvals of biotechnology products. Just because biotechnology companies have short term commercial objectives, there is no need for regulators to ignore the risks to consumers and push ahead with deregulation. It could take years for health hazards to be properly assessed. We should take that time to be safe. Moreover, there are no obvious nutritional benefits of biotechnology for consumers. Traditional natural foods are more than adequate for our present needs. A moratorium on the release of genetically engineered foods will not stop research and progress, it will merely protect the public from risks that are known to exist but are not yet fully understood. Our present knowledge of biotechnology is in its infancy, everyone will benefit from caution. After all, if a product is going to affect the environment and human health for all time, caution is of the essence. Therefore a moratorium on the release of genetically engineered foods and crops is essential to protect human health and well being.

Full disclosure labelling

The Natural Food Commission advocates a policy of full disclosure labelling of all foods, so that all ingredients and processing methods are identified on the label. Present regulations in Australia and New Zealand allow some trace ingredients, and even major components, to remain unidentified on labels. Food industry representatives have argued that full disclosure labelling of foods will be burdensome and impede marketing. It is time to rationalise this situation. There is a growing need to trace the source of increased incidence of some illnesses among children and adults, such as asthma, behavioural and emotional imbalances, and allergies. The Natural Food Commission believes that full disclosure labelling is the only sensible and honest option. We do not feel that it is in any way a burden for any food manufacturer to list the full ingredients and processing methods on packets. Merely it is the only honest option. This applies to genetically engineered products par excellence. However, the Natural Food Commission believes that full disclosure labelling of genetically engineered foods or foods produced using genetic technology will be insufficient to protect the public from health hazards. Only a moratorium on their release will be sufficient to protect consumers.

Consumer safeguards in the composition of regulatory bodies

The present composition of ANZFA does not take proper account of consumer preferences. Mechanisms should be put in place to take proper account of consumer wishes. The present system, where small committees of scientists and civil servants decide what foods can be sold to the public, has not proved adequate to protect the public. Previous mistakes with thalidomide, tryptophan, DDT, etc are examples of novel products approved by scientists who lacked natural caution and then rushed to market for commercial reasons with tragic results. In many cases GMO approval committee members have close links to the biotechnology industry. They may derive their funds for research from biotechnology companies or act as paid consultants to food industries. The Natural Food Commission is recommending that ANZFA is made responsive to consumer wishes by mechanisms such as referenda on the acceptability of biotechnology and increased consumer representation on committees.

The present ANZFA discussion document shows that ANZFA is already committed to the introduction of genetically engineered foods. The question ANZFA asks is not 'whether?' or 'when?', but 'how?'. This is entirely out of step with public opinion. Any move to approve genetically engineered foods rapidly will inflame public opinion and cause lack of confidence among the public. The Natural Food Commission believes that the necessary first step is a genuine public debate on the risks and acceptability of genetically altered foods followed by public referenda in Australia and New Zealand.

Timing

Timing is of the essence. If the present plans of biotechnology companies come to fruition almost all the fruit and vegetables we eat will be genetically engineered within a few years. Every new growing season from now on will see a host of new genetically engineered varieties attempting to reach the market. Any delay in enacting a moratorium will mean that genetically engineered food will enter the food chain in Australia and New Zealand by default without adequate testing for health risks.

Commercial implications for New Zealand and Australia

Currently there are commercial reasons to steer clear of biotechnology in New Zealand and Australia. This year modified soybeans and maize in USA were the first genetically modified crops to reach the market in large quantities. Up to 2% of this year's crop was involved. Plans called for these crops to be mixed with their conventional counterparts in the grain elevators and sold without labelling or distinguishing the product. However, widespread consumer opposition in Europe and North America has caused a change of heart. In the last month, manufacturers such as Nestle and Unilever have responded to public pressure by announcing that they will not use US soybeans in their products. The EU itself has banned the genetically modified corn because of concerns in 13 member states over health hazards. Public opposition has featured persistently on the front pages of newspapers in Switzerland, Denmark, Norway, Sweden, Austria, and Germany. Massive new markets have opened up for products that can be guaranteed free of genetic engineering. Companies specialising in the testing and sale of such products have posted record order books as retailers and manufacturers start to take account of consumer preferences. Australia and New Zealand rely heavily on exports of primary produce. Any perception that we are introducing genetically engineered foods will affect overseas assessment of our products. Conversely, a moratorium on the introduction of genetically engineered foods will improve export opportunities to European markets.

Recent References on Biotechnology Developments and Consumer Reactions:


Natural Food Commission
PO Box 17-273, Greenlane, Auckland.
Tel: (09) 522-1043 , Fax: (09) 524-6003;
E-mail: natlaw@nlp.org.nz;

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Copyright © 1996 Natural Law Party of New Zealand.
Last updated November 16th, 1996.

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