Genetic Engineering: Too Good to go Wrong?

Government and corporations want genetic engineering to be big business². They want the public to believe it is safe, reliable and, above all, predictable. Officially this is the case. In reality it is not. This report concludes that the central assumption of predictability is invalid, and case studies demonstrate this.

This report documents a dozen incidents in which, far from going according to plan and producing better crops, farm animals or improved human health, these experiments have produced:

• genetically engineered bacteria which have unexpectedly killed beneficial soil fungi
• genetically engineered bacteria which have become toxic to plants or survived when they weren't expected to
• genetically engineered crops which bring new allergy problems
• farm animals with genetically engineered growth hormone which have lameness, heart disease, ulcers, arrested sexual development, kidney failure and other diseases
• genetically engineered bacteria which through human error and unanticipated pathways have escaped into sewers.

So what do these incidents mean? Aren't they the sort of minor teething problems that you'd expect from any new industry? Are they really significant?

If genetic engineering (GE) were just another manufacturing industry, this prospect of problems and errors might give little cause for concern. But it is not. Genetic engineering crosses a fundamental threshold in the human manipulation of the planet - changing the nature of life itself. Because genetic engineering deals with living organisms which can reproduce, these "mistakes" cannot be recalled. Agricultural and allied applications of genetic engineering are designed to be put into the environment. Farming takes place outdoors: GE crops therefore, cannot be "lab experiments". Once out, these organisms are uncontrollable. Often applications involve organisms like bacteria which cannot be swept up or recalled.

These incidents reveal genetic engineering to be no less flawed by routine error and ignorance than any other human activity. The examples point to the fact that things will inevitably go wrong against all the best predictions.

While substantial scientific resources are targeted on genetic engineering, and a large number of scientists are involved, "science" cannot make genetic engineering "safe". Politicians and businesses are expecting too much of "science". It is being asked to do the impossible.

What is an acceptable risk is a matter of opinion - a matter of judgement, not a technical question. If for no other reason than because we have no choice, people rely on government to control industry and "make things safe" by avoiding unnecessary risks altogether, looking for safer alternatives where they appear and minimising those necessary risks.

Yet the Government are so keen to develop genetic engineering that they are prepared to change definitions to "eliminate" risks by semantics (see later). But the scientific uncertainties are real. Government cannot make them vanish in order to please business or in the hope of new jobs.

The public finds it difficult to engage in this debate³, and that is not surprising as it is often couched in technical terms. Most people would rather not have to know, and that too is understandable. Yet the potential hazards are colossal and quite likely irreversible and uncontainable once released into the environment (Greenpeace does not oppose the principle of "contained use" of genetic engineering, as in the majority of the medical applications, so long as, of course, these applications are properly contained).

In these circumstances it is only right to ask questions, most importantly whether genetic engineering in the environment is really necessary. Greenpeace says "no" but whether one agrees with Greenpeace or not, public, scientists, politicians and all responsible business people should pause to question what risks are being taken in their name.

Genetic engineering, business and government

The European Commission identified⁴ genetic engineering and biotechnology⁵ as one of their hoped-for growth areas. Numerous developments and small company start-ups are taking place on the back of an explosion in knowledge and techniques at the disposal of molecular biologists. The European biotechnology sector in 1995 had a turnover of over a billion ECU, with venture capital of about 100 million ECU flowing into the sector in that year. Total market value of these companies is, of course, far higher⁶. This stock market enthusiasm was on the basis of a very few actual products on the market⁷. And so the apparent success is based on promises of goodies to come rather than existing product sales. There is, consequently, a pressure to maintain a stream of good news to keep the stock price high: a securities company recently marked down advice on buying shares in a biotechnology company on the basis that they did not expect there to be any upcoming good news⁸. There is also a level of interdependence of companies because a failure in one company product rubs off on the share prices of others⁹. Keeping the share price high is important in a sector where take-overs and mergers happen on an ongoing basis.

The commercial need for good news creates strong pressure on the source science. Markets need to be re-assured that genetic engineering techniques are a predictable science, and that results can always be anticipated and controlled.

Genetic engineering and science

The genetic engineering industry and its science base are closely linked and getting closer. This trend apparent throughout UK science funding may be good for business but fears have been expressed that the close alliance between academic science and industry may be compromising the independence of scientific investigations¹⁰. Science funding is becoming more biased towards genetic engineering ahead of other approaches. In the UK there is now the Biotechnology and Biological Sciences Research Council where once we had the Agriculture and Food Research Council. Whilst it may be argued that other funding for e.g. improvement in knowledge of organic farming, may come from other research councils, it speaks volumes that an institution has been created in which the promotion of genetic engineering is a key part. Given institutional biases it is unlikely that research into refining and improving low input agriculture will get the same support as it once might have.

Further, all the research councils now operate out of the Department of Trade and Industry rather than the Cabinet office or the former Department of Education and Science, strengthening the link between science and commercial considerations.

The unpredictable effects of genetic engineering

Genetic engineering is the use of recombinant DNA technology. This gives the power to move DNA from one organism to another, to identify the function of particular genes and to transfer the DNA coding for the characteristics from one species to another.

Uncertainties enter the frame at many stages.

At the very base of the technique, the insertion of introduced DNA into host organism's DNA is a random process; disruption can occur to existing genes within the host organism with unknown consequences.

The new genes may affect the expressioni of quite separate genes¹¹.

The expression of the inserted genes may affect the biochemistry of the cell in unexpected ways.

Gene flowii in the environment may be much more extensive than once thought¹².

Organisms transformed using genetic engineering can behave in unpredictable ways in the environment.

The problem is not simply one of predicting how DNA and cellular processes behave. As the example of the Flavr Savr tomato (see below) and the unexpected and undesirable results of the Green Revolution demonstrated¹³, new technologies always exist in a social, political and cultural context. The effects of their introduction are not predictable.

What is the justification?
Recent controversy over the introduction into the European food chain of genetically engineered commodity crops has focused attention on why so many agricultural applications, the so-called "ag-biotech" sector, are being produced.

Much of the justification advanced for genetically engineered food products is the widely aired claim that genetically engineered foods will "feed the world"¹⁴. Such justification is na‹ve. It supposes that major causes of hunger like poverty, social inequality, absence of land reform and displacement of peoples by war and conflict will be dealt with by higher yielding crop plants. One is reminded about similarly naive promises about nuclear energy being "too cheap to meter". In any case this justification hardly accounts for projects to create tomatoes that don't go soft or potatoes that don't go brown after being peeled.

The truth in a capitalist world is all too obvious. These products are being created because those who do are hoping to make money out of them. The "need" is to improve company bank balances. Whether this benefits society more broadly or not is virtually irrelevant to the decision making process and is not asked in any coherent way at any stage.

Whilst the media, pressure groups and the public question the real need for these new products, the regulatory process implicitly assumes that so long as a product is "safe" then it should be allowed. The absence of any coherent justification for the whole ag-biotech project is, no doubt, partly responsible for the low level of public support it commands¹⁵.

Case studies: Incidents where genetic engineering has gone wrong

1. Microbes that don't behave as predicted
In 1989, Biotechnica International wanted to test out a genetically engineered micro-organism (Bradyrhizobium japonica) which they hoped would show improved nitrogen fixation, thereby improving soil fertility. The microbe also contained some 'marker' genes. Biotechnica contracted the Louisiana Agricultural Experiment Station to conduct field tests for a year by planting soybeans coated with the GE rhizobia. At the end of the season the plants and seeds were incinerated, the field ploughed over and replanted. Biotechnica ceased to have anything to do with the experiment. However, subsequent monitoring revealed that the GE rhyzobia were out-competing the indigenous strain, something it was NOT supposed to do. Ploughing had also spread the GE version over a four acre area¹⁶. As a review of genetically engineered microbes put it "One of the major considerations about this case is that a microbe for which there existed an extensive historical database was used in a well-planned and thoroughly reviewed experiment, and an unpredictable result was still obtained"¹⁷.

2. Mix-ups of genes provokes costly seed recall
A large stock of canola seeds (oil seed rape) in Canada had to be withdrawn because they contained the wrong genes. Tests early in 1997 on two varieties of canola showed that the seeds contained genes that had not received Government clearance¹⁸. Monsanto had produced two lines of Roundup resistant genes (Roundup is a herbicide sold by Monsanto), type 73 and type 200. Only type 73 went through the full animal feed and human food review process. However, the type 200 gene appeared instead in two varieties of canola bred and sold by Limagrain, who were licenced to use Monsanto's genes. Seed that would be enough to plant 600,000 acres (an acreage equivalent to almost 7% of 1996 plantings¹⁹ in Western Canada) was recalled. Estimates of the cost of the recall reach $12 million²⁰ to farmers and $24 million in lost sales²¹. Reportedly ten farmers had already planted the canola²² and those fields were ploughed under. How it happened is uncertain but the problem is likely to have gone undetected for a substantial period because of the time required to produce enough seed for 600,000 acres. A researcher at the Plant Breeding Institute in Saskatoon is reported as saying "There is a lot of cross-breeding going on in literally hundreds of lines and monitoring it at all stages would be very costly and time consuming"²³. Whether it is as costly as $24 million in lost sales is not stated. Whilst Monsanto have downplayed the events and described the recall as "small quantities"²⁴ and "a very, very minor issue"²⁵ others have been less sanguine; it has been described as "possibly the largest and most expensive [seed recall] the industry has seen"²⁶. And referring to the regulatory agencies that took action against the Limagrain varieties, Mark Winfield, research director of the Canadian Institute of Environmental Law and Policy, said "I'm floored by this. These guys have been the biggest boosters of this stuff forever so for them to pull the plug on Monsanto, that's an indication to me that something is pretty wrong"²⁷.

3. Gene changes create unanticipated allergies
A problem foreseen by critics of genetically engineered food is the transfer of allergenic potential along with the transfer of genes from one organism to another. In other words, people start getting allergies to things they never used to have problems with because of the genetic engineering. Dramatic evidence that this can occur came from a soya bean genetically engineered with genes from a brazil nut. Blood serum from people known to be allergic to brazil nuts was tested for the appropriate antibody response to the gene transferred to the soya bean. Seven out of nine volunteers did show such a response to the GE soybean and the researchers concluded that the allergenicity had been transferred with the transferred gene²⁸.

Pioneer Hi-bred developed this soya bean for use in animal feeds but from the outside one soya bean looks much the same as another, and fears that the product could end up in the human food chain meant that Pioneer stopped the commercialisation of the product.

The implication of this finding should not be lost. As was pointed out by a writer in the medical journal where the results were reported: "Most biotechnology companies use micro-organisms rather than food plants as gene donors, even though the allergenic potential of these newly introduced microbial proteins is uncertain, unpredictable, and untestable" and goes on to point out that "[in this case] the donor species was known to be allergenic, serum samples from people allergic to the donor species were available for testing,.....The next case could be less ideal, and the public less fortunate"²⁹.

4. Bacteria poison soil
A genetically engineered bacterium (Klebsiella) was found to produce dramatic changes in the soil food web and inhibit plant growth. The bacteria was engineered to produce ethanol from agricultural waste as a way of generating fuel³⁰. But when added to soil significant decreases in growth in both roots and shoots of wheat were found, as were a decrease in beneficial soil fungi, poisoning of plants, increases in parasitic nematodes and bacteria, and significant changes in the soil food web structure³¹. The effectiveness of survival of the GE Klebsiella to survive depended on soil type and other properties. Why the GE bacterium was so much better able to survive than expected is unknown but this case illustrates the damage that a single genetically engineered organism can cause. Inhibiting the spread and activity of a bacterium once released is likely to prove problematic.

5. Animal health problems from extra growth hormone
There have been numerous attempts to genetically engineer farm animals to grow faster by engineering genes coding for growth hormones. However, many of these have encountered problems because growth is a complex phenomenon involving more than just a single hormone and because the function of growth hormone may be wider than just promoting growth. In sheep, experimenters have had difficulty getting sheep to grow any more than normal - but they were more likely to have diabetes and all died early. A GE ram failed to mature sexually³². In pigs, although they didn't seem to die more quickly the transgenic animals suffered in other ways: "long-term elevation of [growth hormone] was generally detrimental to health: the pigs had a high incidence of gastric ulcers, arthritis, cardiomegaly, dermatitis and renal disease"³³. The same paper noted that the animals also showed lethargy, lameness and uncoordinated gait. Some suffered severe joint disease, inflammation and pneumonia. In general, many transgenic animals displaying excess growth hormone showed lowered fertility³⁴, a distinctly unproductive outcome for research aiming to create a viable line of farm animals. Note that all this flowed from just one genetic modification i.e. insertion of a single gene for enhanced growth hormone.

6. Toxic by-products kill beneficial soil life
A bacterium was engineered to degrade a persistent herbicide, 2,4-D, in contaminated soil. And so it did. But one of the by-products of the degradation, 2,4-DCP, built up in the soil and turned out to be toxic to soil fungi even in low concentrations. The soil fungi were completely wiped out in 10 days in one instance. This effect was not seen in non-genetically engineered varieties, nor in the soils that contained quite high concentrations of the original herbicide. Soil fungi are important in sustaining soil fertility and may protect plants from disease. The build up of the 2,4-DCP and the effects on the soil fungi were completely unanticipated³⁵.

7. Laboratory coats spread unpredicted contamination
Scientific endeavour is almost epitomised by the white coated scientist. Yet those same white coats bring their unexpected problems for laboratories dealing with genetically engineered bacteria as they provide a neat escape route for the bugs. It had been thought that genetically engineered bacteria, if they got splashed onto the lab coat, would die once it dried out. But Dutch researchers from the National Institute of Public Health and Environmental Protection³⁶ found that perfectly viable bacteria could be isolated from dried lab coats before they were sent to the local laundry. The first step of washing these coats is a soak at 35 degrees centigrade, just right for releasing the bacteria, which are then flushed into the sewerage system. The Dutch team went on to find that lab coats are regularly infected, that the bacteria can penetrate the lab coats and go onto clothing beneath (and then into the sewerage systems via home washing), and that the genetically engineered bacteria could survive just as well on lab coats as the wild types³⁷.

The researchers point out that "the potential for genetic exchange is great" when the bacteria enter the sewage system - in other words the genetic modifications could well find their way into the general population.

This shows how apparently great precautions in use of genetically engineered organisms can be totally undermined by the "oops, we didn't think of that!" factor.

8. Toxic products from engineered yeast
A yeast was engineered to produce high levels of enzymes that are important in the breakdown of sugar. The scientists were concerned to look at the effects of boosting enzyme activity on the different chemical pathways of the breakdown process. The researchers found that concentrations of a toxic and mutagenic product, methyl glyoxal (MG) was up to 30 times higher in the mixtures with the genetically engineered yeast compared to the original strains. The fact that boosting the concentration of an enzyme can affect build up of products several metabolic steps further downstream has serious repercussions for the credibility of the concept of "substantial equivalence"³⁸ which underpins the testing and labelling regimes applicable throughout Europe as a consequence of the Novel Foods Regulation³⁹. As the scientists put it in their conclusion

"in genetically engineered yeast cells, the metabolism is significantly disturbed by the introduced genes or their gene products and the disturbance brings about the accumulation of the unwanted toxic compound MG in cells. Such accumulation of highly reactive MG may cause damage in DNA, thus suggesting that the scientific concept of 'substantially equivalent' for the safety assessment of genetically engineered food is not always applied to genetically engineered microbes..... the results presented may raise some questions regarding the safety and acceptability of genetically engineered food, and give some credence to the many consumers who are not yet prepared to accept food produced using gene engineering techniques"⁴⁰.

9. Did genetic engineering produce deadly food supplement?
Tryptophan is an essential amino acid sold as an over-the-counter food supplement used for treating insomnia and depression. During 1989 in the USA a new disease appeared called EMS, whose main characteristics were raised numbers of a type of white blood cell and severe muscle pain. In November that year the US FDA issued a nation-wide warning, advising consumers to discontinue use of the tryptophan food supplements⁴¹. By then so many people had been affected by EMS that it caused over 36 deaths and thousands of disabilities, some estimates placing this as high as 10,000⁴². The problem was linked to a contaminated batch of tryptophan coming from the Japanese company Showa Denko, which had been using a newly modified strain of genetically engineered bacteria; the new modification being intended to boost the concentrations of an intermediate chemical, and ultimately the output, in tryptophan synthesis. It is unclear as to whether the genetic engineering or change to the post-production filtration process was responsible for the damaging contaminants getting into the marketed tryptophan⁴³. Although a causal agent (or agents) for the medical problems has not been identified, as one review commented: "all the analytical studies revealed the contaminants' low concentration in L-tryptophan and this means that the causal contaminant(s) must be very potent indeed"⁴⁴. Because there was such a low concentration of the contaminant, L-tryptophan could be said to have remained "substantially equivalent" after the production process was modified, yet it clearly was more deadly. The current EU Novel Food Regulation⁴⁵ bases its testing regime prior to marketing on the concept
of "substantial equivalence", and it is doubtful that this legislation would
prevent a reoccurrence of this kind of problem elsewhere.

10. Weather changes gene expression.
It is often thought that genes are constant and fixed attributes of a living thing, impossible to change whatever the weather, for example. This may not be so in the case of genetically engineered organisms. In an experiment to change the colouring of petunias, the engineered flowers were changed from the original white to an intended salmon pink. As the growing season went on the majority of the 11,000 plants started showing much paler colouring or areas of no colouring at all. The change of colour was observed both in the field and in greenhouses. The change in colour, indicating the loss of effect of the genetic modification, was put down to a three week period of high temperatures and high light intensity. A further important factor seems to have been when seeds were taken from the parent plants, or whereabouts on the parent plant the seeds were taken from, or (alternatively) the age of the parent plant⁴⁶.

11. Transplanting seedlings changes gene expression
In an experiment on tobacco, a genetically engineered alteration was found to disappear when the young tobacco plants were transplanted out into the field from the greenhouse. The gene was put into the tobacco seeds in order to give resistance to a common herbicide, chlorsulfuron. In field trials up to 59% of plants were found to have lost resistance. Only when field sown seeds were trialed did the reason become apparent. Tests showed that, strangely, mild trauma on transplantation was more likely to produce loss of resistance than severe trauma. Timing of transplantation during the plants' growth was also important. These results suggest that problems with vulnerability may not be picked up before commercialisation occurs. As the authors of the paper describing this effect put it "the stable expression of transgenic phenotypes is essential for the successful commercialisation of transgenic crops, however the expression of transgenes in plants can be unstable" (emphasis added) but points out elsewhere that in this case "[suppression] was triggered by the common agronomic practice of seedling transplantation and therefore could not be predicted from studies performed in growth rooms or greenhouses"⁴⁷.

12. Failed tomato shows "real world" uncertainties
The Flavr Savr tomato was developed to have a characteristic of delayed softening. The idea was that it could ripen on the vine, develop a fuller flavour, and still be firm on arrival at the retail outlet. The problem was that the "inventors", Calgene, appear to have been too busy with the finer points of gene manipulation to notice that handling ripe tomatoes off the vine and in transport was problematic - tomatoes are normally harvested green and hard, and allowed to ripen later. When the "Flavr Savr" tomato was being taken off the plants it got seriously bashed making the tomatoes unusable. Investment of $10 million in speciality equipment originally developed for peach handling⁴⁸ hugely increased the costs and delayed the product getting to market⁴⁹. This, together with consumer disinterest due to a combination of a "slightly mealy" texture and the high price⁵⁰ - left Calgene running up huge losses. Further, yields were reportedly disappointing and the Flavr Savr had insufficient disease resistance⁵¹. One analyst said of this venture "this tomato has brought them to their knees - the question is, can they get back up again?"⁵². In the end Calgene was saved by a take-over and the board substantially changed⁵³. Calgene, under new ownership, continues to modify the Flavr Savr so it will work commercially and agronomically. But as it says itself: "there can be no assurance that such efforts will be successful or will not be discontinued by Calgene. There can be no assurance that Calgene will be successful in developing genetically engineered tomatoes with the agronomic characteristics necessary for commercial production"⁵⁴.

Attitude of government

One example serves to illustrate the wilfully blind commitment of government to push ahead with genetic engineering. The European Union has chosen, through its regulatory framework, to solve many of the debates over minimising and measuring impacts by defining many environmental changes as not being anything to do with the environment, and so apparently beyond their remit.

A good example is the evolution of insect resistance to a natural toxin known as Bt.

Genes that code for this toxin (or actually a particular part of the naturally occurring form) have been inserted into a series of plants that are on their way to market. One genetically manipulated organism, Novartis Bt maize, has been given clearance to be marketed within Europe⁵⁵ although some member states are vigorously resisting it.

Many people would prefer, of course, that their food was not genetically engineered at all⁵⁶. But within the technocratic confines of EU decision-making this finds expression in scientific controversy, which, amongst other things, has been about how to manage and avoid the evolution of resistance among insect populations⁵⁷. Insect resistance is a major problem in modern agriculture.

Bt is used by farmers, including organic farmers, in its naturally occurring forms as a pest control agent. In the US, the Environment Protection Agency (EPA) offers only conditional and temporary registration to varieties producing Bt because of concern over evolution of resistance⁵⁸ which would also threaten the viability of naturally occurring Bt. Its conditions include that the company keeps databases on where the crop is grown, provides grower education, carries out research and development on resistance management, instructs farmers on reporting of unexpected levels of pest damage, notifies the EPA of such matters, and even stops selling seed in areas where resistance emerges⁵⁹. The EPA also currently requires 4% "refugia" with Bt cotton i.e. 4% of planted cotton does not express the Bt toxin but is conventional, and acts as a refuge for insects to survive and breed, thereby keeping the overall level of resistance in the insect population low.

Meanwhile for Bt maize, a major US seed company suggests that "sacrificial" refugia should be as large as 30%⁶⁰ (although how these crops are supposed to be commercially viable with that level of sacrificial planting which are "expected to sustain substantial damage"⁶¹ is unclear). At a 4% refugia level a recent paper has suggested that insect resistance will evolve in as little as 3-4 years⁶². Considerable technical uncertainties remain over the emergence of resistance including accurate "real world" data, the level of resistance genes in the insect population, pest behaviour, and how refuges should be arranged spatially and temporally⁶³.

The European Union has avoided this difficulty and complexity simply by redefining the problem as an agricultural one and not an environmental one. It states "Potential development of insect resistance to the Bt-toxin cannot be considered an adverse environmental effect, as existing agricultural means of controlling such resistant species will still be available"⁶⁴. Thus there is, in going through the regulatory process in the EU, no need to embark on research into resistance management or to look at ways to delay the emergence of resistance. Even the EU's own scientific committees have repeatedly pointed out that resistance management plans should be constructed⁶⁵.

Imagine what would happen if the EU's 'creative' solution to this problem were exploited in other domains to avoid the need to act. Polluting companies could continue to pour toxins into rivers on the grounds that other rivers would still be available. Such an attitude ought to be as unthinkable as it is irresponsible.
Conclusion
The twelve case studies reported here should be enough to make anyone think twice about whether society really understands what it is now playing with. Some effects of genetic engineering are not merely difficult to test for, but, for all practical purposes untestable.

How can it be possible to know the impact of the genetic manipulation on an organism's cell chemistry when even minute quantities of contaminants pose huge risks?

How can regulators be sure of impacts and changes in the real world with its attendant complexity once genetically modified organisms get outside the laboratory, where the effects of genetic engineering can change because of a few hot days?

How is it possible to keep a track of where the genes are ending up in the environment when there seem to be problems keeping track of them whilst they are still being produced for seed?

What right do Government and industry have to release genetically engineered organisms when they can confound the best predictions as to how they should behave?

Beyond these purely technical questions, and scarcely addressed in this report, lie other, deeper questions about how our political institutions can respond to value-based doubts amongst the public. During the BSE crisis, for example, the UK Government was perceived to have covered up and allowed what the public clearly saw as "unnatural practices" in the production of feed for cattle. Genetic engineering also raises value-based doubts amongst the public, and by ignoring these values governments reduce their credibility. This in turn reduces their ability to handle problems as they arise; and with genetic engineering, on current behaviour, problems no doubt will arise.

These questions and others need unambiguous answers from the proponents of genetic engineering before irrevocable commitments are made for society as a whole. Already the Health and Safety Executive is planning to allow 'crippled' but still living genetically engineered bacteria to be flushed into the environment from laboratories. Above all, the possibility of "worst case" scenarios flowing from these possibilities must be addressed. The case studies show the potential for unforeseen, irreversible ecological damage or public health problems. After years of after-the-fact struggles with issues like nuclear waste and radiation, pesticides and BSE, the lesson must be that open-ended risks for society must be avoided rather than simply waiting for disasters to occur.

The only safe way to avoid such limitless difficulties and risks is to avoid the release of genetically modified organisms into the environment or the food chain altogether.

References
1 King, J., 1996. Could Transgenic Crops one day Breed Superweeds, Science, Vol. 274, 11 October 1996. Back to the text
2 See for example European Commission, 1994. Biotechnology and the White Paper on Growth Competitiveness and Employment, Preparing the Next Stage. Communication from the Commission to the Council, the European Parliament and the Economic and Social Committee. Back to the text
3 See for example, Grove-White, R., McNaughton, P., Mayer, S., and Wynne, B., 1997. Uncertain World, Genetically Modified Organisms, Food and Public Attitudes in Britain, CSEC, Lancaster University, March 1997. Back to the text
4 European Commission, 1994. op cit. Back to the text
5 Genetic engineering and biotechnology are not the same although in some contexts they appear to be used interchangably. Strictly, genetic engineering is the use of recombinant DNA technology (see text) whilst biotechnology is more broad and includes the use of living organisms for production processes - it would for example include the use of yeast in brewing ordinary wine or beer. However, some people have described genetic engineering as ãmodern biotechnologyà - then shortened to biotechnology, and some companies use both genetic engineering and some more conventional biotechnology in their process and describe themselves as a biotechnology company (see, for example, quote from Nestle ref. 29). In this report ãgenetic engineeringà will be used. ãBiotechnologyà will only be used if external sources have used the term. Back to the text
6 Lucas, P. et al., 1996. European Biotech 96 Volatility and Value, Ernst and Youngås third annual report in the biotechnology industry, pp.9, 10. Back to the text
7 Lucas et al. op cit pp.16-21. Back to the text
8 Reuter report, London, 10 June 1997. NatWest downgrades Brit Biotech to ãaddà. Back to the text
9 See, for example, Trial failure sends biotech shares plummenting, Nature, Vol. 387, p. 446, 29 May, 1997; and Flynn, J., 1996. Britainås bedazzling biotech stocks, BusinessWeek, 24 June 1996 Back to the text
10 See, for example, Pavitt, K., 1996. Road to ruin, New Scientist, 3 August 1996, p.32; Dickson, D., 1997. Little change in the politics of science - but closer links with industry, Nature, Vol. 386, 27 March 1997, p. 315.; Nigel Titchen quoted in Williams, N., 1996. K. Labs: A Year of Uncertainty, Science, Vol. 272, 31 May 1996, p. 1254. Back to the text
11 Senior, I.J., and Dale, P.J., 1996. Plant transgene silencing - gremlin or gift?, Chemistry and Industry, 19 August 1996, p. 604.
12 See, for example, Department of Environment, 1995. Gene Flow in natural populations of brassica and beta, published by Department of Environment; Yin, X., and Stotzky, G., 1997. Gene transfer in bacteria in the natural environment, Advances in Applied Microbiology, Vol. 45 to be published October 1997;Ho, M-W., 1997. Comments on HSE Health Directorate Executive Consultation Paper, ãDraft Guidance of Exemption No. 1à, submitted to UK Health and Safety Executive (HSE), June 1997. Back to the text

13 See, for example, Shiva, V., 1991. The Green Revolution in the Punjab, The Ecologist, vol. 21(2), p. 57, March/April 1991. Back to the text
14 See, for example, The Independent Education supplement, 19 June 1997, p. 17; comments by Prof. Derek Burke, chairman of the Governmentås Advisory Committee on Novel Foods and Processes, BBC Radio 4 Today programme, 18 June 1997. Back to the text
15 Biotechnology and the European Public Concerted Action group, 1997. Europe ambivalent on biotechnology, Nature, Vol. 387, 26 June 1997, p. 845. Back to the text
16 US National Biotechnology Impacts Assessment Programme Newsletter, March 1991. The Case of the Competitive Rhizobia. Back to the text
17 Cairns, J., Jr. and Orvos, D.R., 1992. Establishing Environmental Hazards of Genetically Engineered Microorganisms, in Reviews of Environmental Contamination and Toxicology, Volume 124, p. 19. Back to the text
18 Farmers Weekly, May 2 1997. Monsanto recalls GM seeds in regulation scare. Back to the text
19 Reuter report, Winnipeg, April 17 1997. Monsanto Canada recalls transgenic canola. Back to the text
20 MacArthur, M., April 24 1997. The Western Producer, Canola Seed recalled because of Genetic Contamination. Back to the text
21 Rance, L., April 24 1997. Manitoba Cooperator, Mix-up prompts recall. Back to the text
22 Reuter report, Winnipeg, April 17 1997. op cit. Back to the text
23 Quoted in Tjaders, T., April 24 1997. The Western Producer, Canola is First Gene Suspension Case for Government. Back to the text
24 St. Louis Post Dispatch, April 18 1997. Argosy names Perry new Chief Executive. Back to the text
25 Reuter report, Winnipeg, April 17 1997. op cit Back to the text
26 Rance, L., April 24 1997, op cit. Back to the text
27 Quoted in Tjaders, T., op cit. Back to the text
28 Nordlee, J.D., Taylor, S.L., Townsend, J.A., Thomas, L.A., and Bush R.K., 1996. Identification of a Brazil nut Allergen in Transgenic Soybeans, New England Journal of Medicine, Vol. 334(11), p. 688. Back to the text
29 Nestle, M., 1996. Allergies to transgenic foods - questions of policy, New England Journal of Medicine, Vol. 334(11), p. 726. Back to the text
30 Ho, M-W., and Tappeser, B., 1996. Transgenic transgression of Species Integrity and Species Boundaries Ñ Implications for Biosafety. Paper prepared for Workshop on Transboundary movement of living modified organisms resulting from modern biotechnology: issues and opportunities for policy-makers, Aarhus, Denmark, 19-20 July, 1996. Back to the text
31 Holmes, Michael T., and Ingram, Elaine R., 1994. Abstract for 79th Annual Ecological society of America published in Supplement to Bull. Ecol. Soc. Am. 75: 2 Back to the text
32 Rexroad, C.E., Mayo, K., Bolt, D.J., Elsasser, T.H., Miller, K.F., Behringer, R.R., Palmiter, R.D., and Brinster, R.L., 1991. Transferrin- and Albumin-Directed expression of Growth-related Peptides in Transgenic Sheep, Journal of Animal Science, Vol. 69, p. 2995. Back to the text
33 Pursel, V.G., Pinkert, C.A., Miller, K.F., Bolt, D.J., Campbell, R.G., Palmiter, R.D., Brinster, R.L., and Hammer, R.E., 1989. Genetic Engineering of Livestock, Science, Vol. 244, p. 1281. Back to the text
34 Pursel et al., op cit. Back to the text
35 Doyle, J.D., Stotzky, G., McClung, G., and Hendricks, C.W., 1995. Effects of Genetically Engineered Microorganisms on Microbial Populations and Processes in Natural Habitats, Advances in Applied Microbiology, Vol. 40. p.237. Back to the text
36 Cremers, H.C.J.C., and Groot, H.F., 1991. Survival of E.Coli K12 on laboratory coats made of 100% cotton, RIVM report no. 719102009, November 1991. Back to the text
37 MacKenzie, D., 1992. Clean White Coats spread Mutant Microbes, New Scientist, 21 March 1992, p. 11. Back to the text
38 substantial equivalence is described as ãthe idea that existing organisms used as foods or as food sources, can serve as a basis for comparison when assessing the safety of human consumption of a food or food component that has been modified or is new. If a food or food component is found to be substantially equivalent to an existing food or food component, it can be treated in the same manner with respect to safetyà. From Scientific Committee for Food, 1997, Opinion on the Assessment of Novel Foods, European Commission III/5915/97, January 1997. Back to the text
39 Regulation (EC) No. 528/97 of the European Parliament and of the Council concerning Novel Foods and novel food ingredients. OJ No. L43, 14.2.97, p. 1. Back to the text
40 Inose, T., and Murata, K., 1995. Enhanced accumulation of toxic compound in yeast cells having high glycolytic activity: a case study on the safety of genetically engineered yeast, International Journal of Food Science and Technology, Vol. 30, p. 141. Back to the text
41 Mayeno, A.N., and Gleich, G.J., 1994. Eosinophilia-myalgia syndrome and tryptophan production: a cautionary tale, Trends in Biotechnology, Vol. 12, p. 346. Back to the text
42 DåArcy, P.F., 1995. L-tryptophan: eosinophilia-myalgia syndrome, Adverse drug reactions and Toxicological review, Vol. 14, p. 37. Back to the text
43 Mayeno and Gleich, op cit. 1994. Back to the text
44 DåArcy, op cit, 1995. Back to the text
45 Regulation (EC) No. 528/97 of the European Parliament and of the Council concerning Novel Foods and novel food ingredients. OJ No. L43, 14.2.97, p. 1. Back to the text
46 Meyer, P., Linn, F., Heidemann, I., Meyer, H., Neidenhof, I., and Saedler, H., 1992. Endogenous and Environmental factors influence 35S promoter methylation of a maize A1 gene construct in transgenic petunia and its colour phenotype, Mol. Gen . Genet., Vol. 231, p. 345. Back to the text
47 Brandle, J.E., McHugh, S.G., James, L., Labbe, H., and Miki, B.L., 1995. Instability of Transgene expression in Field Grown Tobacco Carrying the csr-1-1 Gene for Sulphonylurea Herbicide Resistance. Back to the text
48 The Splice of Life, April 1996, High-tech Tomato hits low tech problems Back to the text
49 US National Biotechnology Impacts Assessment Programme Newsletter, May 1995, Calgene Battling on Two Fronts. Back to the text
50 Anon. 1995. Improving on Mother nature?, Consumer Reports,US Consumers Union, July 1995. Back to the text
51 US National Biotechnology Impacts Assessment Programme Newsletter, March 1996, Whither the Flavr Savr? Back to the text
52 The Splice of Life, op cit Back to the text
53 Calgene press release, 31 July, 1996. Calgene announces planned $50 million Equity investment by Monsanto - Roger Salquist resigns as CEO; to Continue as Director. Back to the text
54 World Wide Web, http://www.calgene.com/freshpr.htm. Calgene Fresh Produce page, off Calgene home page. 13 June 1997. Back to the text
55 European Commission Press Release, Brussels, 18 December 1996. The European Commission has decided to authorize genetically modified maize in the light of scientific advice. Back to the text
56 Biotechnology and the European Public Concerted Action group, 1997. op cit. Back to the text
57 See, for example, submissions to the US Environment Protection Agency on plant pesticide resistance management, 1997 Back to the text
58 Letter by Janet Anderson of US EPA to Richard Lotstein, Director of Regulatory Affairs, Ciba Seeds, 9 August 1995. Back to the text
59 Letter by Janet Anderson of US EPA, 1995, op cit. Back to the text
60 World Wide Web, http://www.pioneer.com/customer/products/ecb/ncnp/section8.htm Back to the text
61 Andow, D.A. and Alstad, D.N., 1995. Letter to US EPA on Dockett no.OPP-30377 (Ciba Seeds petition for commercialization of transgenic corn, May 5, 1995.) Back to the text
62 Gould, F., Anderson, A., Jones, A., Summerford, D., Heckel, D.G., Lopez., J., Micinski, S., Leonard, R., and Laster, M., 1997. Initial frequency of alleles for resistance to Bacillus thuringiensis toxins in field populations of Heliothis virescens, Proc. Nat. Acad. Sci., Vol. 94, p. 3519. Back to the text
63 McGauchey, W.H., 1997. Comments to US EPA on Bt Resistance management Docket OPP-00470. Back to the text
64 European Commission Press Release, Brussels, 18 December 1996, op cit. Back to the text
65 Scientific Committee on Pesticides, 1996. Opinion of the scientific Committee for Pesticides on the genetically Modified Maize Lines notified by Ciba-Geigy, European Commission Directorate General VI, 9 December 1996; Scientific Committee on Pesticides, 1997. Further report of the Scientific Committee for Pesticides on the use of genetically modified maize lines, 12 May 1997. Back to the text

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