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Information statement from the British Institute of Food Science & Technology on genetic modification and food

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London, United Kingdom
September 2, 2008

The Institute of Food Science & Technology has authorised the following Information Statement, dated September 2008, replacing the Statement of July 2004 and any previous version.

Source: http://www.ifst.org/uploadedfiles/cms/store/ATTACHMENTS/gm.pdf

SUMMARY

Over the past 11 years, and in many parts of the world, genetically modified (GM) crops grown by 12 million farmers (of which 11 million are resource-poor farmers) have already provided significant improvements in the quantity and quality of the food supply while reducing economic cost, energy usage, pesticide usage, fuel usage, soil erosion and carbon emissions, with no scientifically-documented evidence of harm to human health.

In addition to the foregoing benefits, the “second generation” of GM crops and those in the research pipeline have the potential to deliver crops to provide much needed nutritional benefits; crops with more effective utilisation of fertiliser; crops that will grow under drought and other adverse climate conditions; and crops that will grow on previously inhospitable land.

Food scientists and technologists can support the responsible introduction of GM techniques provided that issues of product safety, environmental concerns, information and ethics are satisfactorily addressed. IFST considers that they are being addressed, and need even more intensively to continue to be so addressed. Only in this way may the benefits that this technology can confer become available, not least to help feed the world's escalating population in the coming decades.

INTRODUCTION AND DEFINITIONS

Food biotechnology is the application of biological techniques to food crops, animals and micro-organisms to improve the quality, quantity, safety, ease of processing and production economics of food. It thus includes the traditional food manufacturing processes used for bread, beer, cheese and various fermented milk products.
A relatively more recent (i.e. starting about 30 years ago) application of biotechnology to food is genetic modification (GM), also known as genetic engineering, genetic manipulation, gene technology and/or recombinant DNA technology. The collective term "Genetically Modified Organisms" or GMOs is used frequently in regulatory documents and in the scientific literature to describe the deliberate introduction of DNA by human intervention into plants, animals and micro-organisms.

Random genetic variation occurs naturally in all living things and is the basis of evolution of new species through natural selection. Even before its scientific basis was understood, mankind took advantage of this natural variation by selectively breeding wild plants and animals and even micro-organisms such as yoghurt cultures and yeasts, to produce domesticated variants better suited to the needs of humans. Such selective breeding involves the transfer of unknown numbers and kinds of genes between individuals of the same species. Before the advent of GM technology, however, so-called "traditional" or "conventional" breeding technology involved far more than the foregoing. Over the past half-century it also included techniques involving polyploidisation and mutagenesis via x-rays, which are far more disruptive of the original plant genes than any GM modification. For example barley seeds (Golden Promise) were treated with x-rays in the Winfrith reactor in 1956 to yield the UK's favourite variety for brewing -- and this variety is also used in the production of organic beer. Many changes to food materials brought about by gene technology are no different in essence from those which can take place in nature or by selective breeding, except that the gene technologist transfers a carefully targeted selected few specific genes, thus drastically reducing both their random nature and the time taken to produce an improvement.

Thus, within-species GM involves few fundamentally new issues. However, gene technology also makes it possible to move genes between different species. When first used, this property made the technique revolutionary in terms of the potential benefits that it may bring, but it also caused concern regarding issues of safety, ethics, environmental impact and consumer choice.

TECHNIQUES OF GENETIC MODIFICATION

How is GM technology carried out? In simple terms, the gene technologist uses a "cutting-copying-pasting" approach to transfer genes from one organism to another. For this, bacterial enzymes are used that recognise, cut and join DNA at specific locations acting as molecular "scissors-and-tape". However, the selected gene is copied billions-fold, with the result that the amount of original genetic material in the modified organism is immeasurably small. Since DNA does not always readily move from one organism to another, "vehicles" such as plasmids (small rings of bacterial DNA) may be used; alternatively, some plant cells may be transformed by "shooting" small particles coated with the new DNA into the target cell using a special type of gun, the "Gene Gun". The modified cell can then be used to regenerate a new organism.
However, by currently available methods only small numbers of cells subjected to a genetic modification procedure are successfully modified. Furthermore, the regeneration of whole plants or animals from culture cells may take months or years. Consequently, it is necessary to identify the modified cells in a culture mix using "marker genes" closely linked to the genetic material to be transferred. Antibiotic resistance has often been used to "tag" genes so that they can be detected easily and rapidly at the cellular level in the laboratory, providing a basis for selection. The use of antibiotic resistance marker genes (ARMG) has, however, been a source of concern.

Although the transfer of antibiotic resistance from a marker gene contained in a GM plant to a microorganism normally present in the human gut has not been demonstrated
experimentally, it has been suggested that the potential risk, however small, of spreading resistance to therapeutic antibiotics could have serious health consequences and therefore should be avoided. In the absence of reliable data, the UK Advisory Committee on Novel Foods and Processes (ACNFP) erred on the side of caution and recommended some years ago against the use of antibiotic resistance marker genes.

However, on 4 February 2004 a Working Party of the British Society for Antimicrobial Chemotherapy http://www.bsac.org.uk/ stated: "There are no objective scientific grounds to believe that bacterial antibiotic resistance genes will migrate to bacteria to create new clinical problems." They looked at various routes "but are unable to identify a credible scenario whereby new drug-resistant bacteria would be created". However they point out that the theoretical possibility of transfer by novel mechanisms cannot be entirely ruled out, and so consider whether transfer of the three drug resistance genes that have been used would pose a threat to antibiotic use in medical treatment. These 3 genes are common in bacteria, and found on mobile elements that move between DNA molecules and bacterial cells, and this gene mobility has already compromised clinical use of the antibiotics.

"The argument that occasional transfer of these particular resistance genes from GM plants to bacteria would pose an unacceptable risk to human or animal health has little substance. We conclude that the risk of transfer of AR genes from GM plants to bacteria is remote, and that the hazard arising from any such gene transfer is, at worst, slight."

The Working Party goes on to ask "Can a blanket ban on cultivation of GM plants carrying bacterial drug resistance genes be justified, even in part, because of extremely improbable, unquantifiable concerns?" They argue that a precautionary principle approach that argued that such a negligible risk must prevent the use of plants containing such genes, must be set against a pragmatic approach that takes account of the size of the risk and hazard and also the potential benefits of GM plants, such as reduced pesticide use. While the Working Party believes that the evidence means that most bacterial AR genes would be safe, they "consider it extremely undesirable and unnecessary to extend the list of AR genes approved for GM plant development. In particular, the use of any AR gene that if disseminated widely among bacteria would be likely to compromise use of a front-line or currently widely used antibiotic should be strongly discouraged, if not banned." They note that plant biotechnologists chose not to use AR genes in this category. And conclude, "The moratorium should continue, particularly as alternatives to AR genes are being developed".

On 16 April 2004 the European Food Safety Authority (EFSA) issued a scientific opinion http://www.efsa.eu.int/press_room/press_release/386_en.html on the subject, classifying those evaluated into 3 groups based on their biological distribution and taking into account the current importance of the antibiotics concerned to human and veterinary medicine. The EFSA GMO Panel has proposed the following classification for ARMGs:

• Group 1 ARMGs contains antibiotic resistance genes which (a) are widely distributed among soil and enteric bacteria and (b) confer resistance to antibiotics which have no or only minor therapeutic relevance in human medicine and have only restricted use in
defined areas of veterinary medicine. This refers to the antibiotic resistance genes nptII conferring resistance to the antibiotics kanamycin and neomycin with a 13-year history of safe use in food crops and the hph gene, which encodes for a protein that inactivates hygromycin, an antibiotic that is not utilised in human clinical medicine. No restrictions are required with this class of marker genes either for field experimentation or for placing on the market.

• Group 2 ARMGs contains antibiotic resistance genes which (a) are widely distributed in micro-organisms in the environment and (b) confer resistance to antibiotics which are used for therapy in defined areas of human and veterinary medicine. This group includes genes which confer resistance to chloramphenicol (cmR gene), ampicillin (ampR gene) and streptomycin and spectinomycyn (aadA gene). The use of these genes should be restricted to field trial purposes and not be present in GM plants placed on the market.

• Group 3 ARMGs contains antibiotic resistance genes, which confer resistance to antibiotics highly relevant for human therapy like the nptIII gene conferring resistance to amikacin and the tetA gene conferring resistance to tetracyclines. Irrespective of considerations about the realistic importance of the health threat, these genes should be avoided in the genome of transgenic plants to ensure the highest standard of preventive health care. Therefore these ARMGs should not be present in GM plants placed on the market or in plants used for experimental field trials.

However, other methods are becoming available. In a development, reported in Science in May 1999, researchers at University of Hawaii demonstrated the use of sperm to transport "foreign" DNA into an egg. It has a relatively high rate of success, is technically simple to carry out, has potential for transferring larger pieces of DNA and is applicable to animals.

ADVANTAGES AND POTENTIAL BENEFITS OF GENETIC MODIFICATION

For the development of improved food materials, GM has the following advantages over traditional selective breeding:

• Allows a much wider selection of traits for improvement: e.g. not only pest, disease and herbicide resistance (as achieved to date in plants) but also potentially drought resistance, halo tolerance, improved nutritional content (yield and quality of macro-nutrients, enhancement of micro-nutrients e.g. vitamin A, iron, enhancement of valuable phytochemical components, removal of allergens or toxic components) and improved sensory properties

• It is faster and lower in cost

• Desired change can be achieved in very few generations

• Allows greater precision in selecting characteristics

• Reduces risk of random occurrence of undesirable traits.
These advantages in turn lead to a number of potential benefits, especially in the longer-term, for the consumer, industry, agriculture and the environment:

• Improved agricultural performance (yields) with less labour and energy input and less cost input

• Benefits to the soil of “no-till” farming practice

• Reduced usage of pesticides and herbicides

• Benefits to the environment in reducing the cost, energy usage, fuel usage and carbon emissions associated with tractor diesel fuel usage and pesticide spraying

• More efficient use of land

• Ability to grow crops in previously inhospitable environments (e.g. via increased ability of plants to grow in conditions of drought, soil salinity, extremes of temperature, consequences of global warming, etc.) leading to improved ability to feed an increasing world population at a reduced environmental cost

• Improved sensory attributes of food (e.g. flavour, texture, etc.)

• Removal of allergens or toxic components, such as the research on a non-allergenic GM peanut (University of Arkansas and University of Georgia) and a non-allergenic GM prawn (Tulane University); and in Japan, to produce a GM non-allergenic rice.

• Development of crop plants that take up and assimilate nitrogen more efficiently to improve the efficiency of utilisation, and hence reduce the application, of nitrogen fertilisers, resulting in lower production costs.

• Improving nitrogen fertilisation by transfer of nodulation properties from legumes to non-legumes (research at the UK John Innes Institute).

• Research indicates that there are also improved nutritional attributes such as:

o increased Vitamin A content in rice, which will help to prevent blindness among children in Southeast Asia (Ingo Potrykus's EU research project jointly funded by the Rockefeller Foundation);

o the announcement in September 2003 by Edgar Cahoon and his team at the Donald Danforth Plant Science Center in Missouri that by inserting a gene extracted from barley into a common type of field corn, they have created a strain that grows with six times the usual amount of vitamin E, a powerful antioxidant.

o The BioCassava Plus Project by an international multi-centre research team led from Ohio State University, funded by a $12 million grant from the Bill and Melinda Gates Foundation, to produce GM cassava with enough vitamins, minerals and protein to provide the poor and malnourished with a day's worth of nutrition in a single meal while reducing the cyanogen content; successful in greenhouse trials and now extending to field trials.

o Research by Dow and Monsanto to develop a canola seed that produces omega-3 fatty acid, DHA (docosahexaenoic acid), thus minimising reliance on fish as source of omega-3.
Improved processing characteristics leading to reduced waste and lower food costs to the consumer.

• Prevention of loss of species to endemic disease (e.g. the Cavendish dessert banana which is subject to two fungal diseases that have struck Africa, South America and Asia, but could be reprieved by GM development of a disease-resistant version).

• Chinese scientists have developed a genetically modified (GM) corn that could help improve the nutritional value of livestock feed and reduce pollution. The research is carried out by the Chinese Academy of Agricultural Sciences (CAAS). The corn has now entered pre-production field trials. The GM corn produces seeds containing high levels of the phytase enzyme. This enzyme helps livestock to digest phosphorus which is enclosed in the indigestible form of phytate. Animals lack phytase in their system. As a result, farmers add the enzyme to animal feed to help livestock digest phosphorus. The CAAS scientists isolated the gene that produces phytase from a species of the fungus Aspergillus, and inserted it into corn. Preliminary test have shown that compared to regular varieties, the rate of seed germination, growth speed and yield of the GM corn were no different. The scientists said that, under current
industry criteria for feed additives, adding just a few grams of the GM corn seed per kilogram of animal feed would be enough to satisfy livestock's nutritional demand for phosphorus. If the technology is commercialised, Chinese farmers could save up to $60 million per year in buying industrial phytase. Phosphorus pollution caused by animal waste is a serious problem in China, resulting in widespread algal blooms in the Chinese lakes. Better phosphorous digestibility could add to improvement of the environment. China has not yet approved any GM corn for commercial sale.

• Perhaps a small benefit compared to the above-mentioned, but in January 2008, researchers at New Zealand Crop and Food Research announced the successful genetic modification of onion so that it does not make one cry! Normally when onions are cut or chopped, amino-acid sulphoxides and an enzyme are released to react and form the tear-causing volatile. The genetic modification blocks that enzyme action and redirects the reaction towards formation compounds responsible for flavour and health-giving properties. GM has huge potential for mankind in medicine, agriculture and food. In food, the real benefits provided by the early instances that have been appearing so far, are surpassed by its longer-term benefit to the world - and especially the developing countries - its potential for developing crops of improved nutritional quality, and crops that will grow under previously inhospitable conditions (see above), thereby contributing to alleviating hunger and malnutrition, while helping to prevent the otherwise inevitable future pressure to encroach on natural resources. Even today, there are 860 million people (800 million of them in the developing countries and 200 million of them children) who regularly do not receive enough food to alleviate hunger, still less provide adequate nutrition. 24,000 people die of malnutrition-related causes daily. That situation will be greatly worsened as a result of the world's escalating population over the coming decades.

There are those who allege that “scientists claim that GM will solve the problem of world hunger”. This is a familiar "straw man". It is frequently argued by some that there is more than enough food to feed the world and all that is needed is "fairer distribution" (which so far mankind has signally failed to achieve) – or a variant of that, "the real problem is not shortage of food, it is poverty". Whatever may be done by way of improved yields through conventional methods, attempted population control and more effective distribution would, however, be inadequate for the future. There are probably enough cereals to feed the present world population (if only they could be distributed to the right places at the right times and could be afforded). But there will be substantial shortfalls in cereals in the next two decades, especially if the present practice of diverting cereals from human food use to feedstock for ethanol biofuel production continues. Moreover, "world hunger" is a complex not only of inadequate quantity where it is needed but of inadequate quality i.e. for vast numbers of people the lack of foods with the necessary micronutrients and of clean water, for reasonable nutrition and health.

However, in decades to come, with the expected substantial increase in the world population, mostly in the poorest, least developed countries, the demand for increased agricultural land and for water will greatly increase. The important point is not only how to feed the world now but addressing and trying to solve the problem of "How shall mankind feed the world in a few decades from now?” Of course the problem that has huge political and economic dimensions will not be solved by GM alone, or even by science alone -- but will certainly not be solved without the contribution of science, including GM.

Food scientists and technologists can support the responsible introduction of GM techniques provided that issues of product safety, environmental concerns, ethics and information are satisfactorily addressed. so that the benefits that this technology can confer become available both to improve the quality of the food supply and to help feed the world's escalating population in the coming decades.

CURRENT GM FOODS AND FOOD INGREDIENTS

The "first generation" of GM food materials were those that were relatively easy to develop, chosen for their likelihood of rapid commercial success by providing traits that would commend themselves to farmers. Consequently, most of the 80+ crops that have been modified and the 25,000+ field trials that have taken place world-wide to date have involved crops engineered for agronomic traits. The first food plants to be grown successfully on a large commercial scale and put on the market were the GM maize resistant to the European corn-borer, a serious agricultural pest, and the soyabean genetically-modified to be tolerant of the herbicide glyphosate. The latter involves one or two applications of a less toxic, more rapidly broken down herbicide than the spraying regime that it replaces, that of several applications of different herbicides. Contrary to the widely held misconception, glyphosate is not a relatively new herbicide developed for GM crops. On the contrary it has been in use for over 30 years and has been a very popular broad-spectrum, safer and less soil-persistent herbicide, for many conventional crops. But it could not be used for soya because it killed the soya as well as the weeds. So soya farmers had to continue to use a "cocktail" of different herbicides at different stages of the growing season. The clever scientific trick was so to genetically modify soya that it was not killed by, but resistant to, glyphosate.

However, these GM products did not offer consumers a readily perceivable benefit “at the point of purchase”; and with intensified campaigns and media amplification in the early part of 1999 and thereafter highlighting problems and uncertainties (some real, some pure speculation, some spin-doctored and some urban myths), the UK public became turned against GM. Reacting to their customers' views, major retailers and manufacturers decided to exclude GM foods and ingredients.

An incidental victim was the canned tomato puree, prominently labelled "Produced from genetically modified tomatoes", on sale in stores of two major UK supermarket groups in competition with non-GM tomato puree. The GM tomato puree was of better flavour and consistency, cheaper, and consistently outsold the non-GM puree. It is now no longer available.

Chymosin, produced by GM micro-organisms, was developed to replace rennet, the milk-clotting enzyme used extensively in cheese-making, due to the severe shortage of the traditional source of the enzyme (i.e. calf stomachs). The GM enzyme, defined as a processing aid rather than a food additive in regulatory terms, has been in use since the late 1980s in the USA and in some European countries, including the UK

WHAT ARE THE CONCERNS ABOUT GM?

Increasingly at the heart of the "concerns" debate about GM, is the fundamental matter of the role of science and society in relation to "new" science-based developments such as GM.

There are two ways of dealing with new developments with associated problems and uncertainties. One is to reject or ban the developments. The other is to address and solve the problems, and to accept that there are no certainties in any aspect of life. Fortunately in the long run mankind has generally adopted the second course, otherwise we would still be living in the Stone Age. Looking at more recent times, there would be no electricity; the first passenger flight would not have taken place, so there would be no air travel; the first surgical operation would never have been carried out so there would be no surgery; the first anaesthesia would never have been used, so there would be no anaesthetics (it is worth recalling that the medical profession of the day prevented Queen Victoria from having anaesthesia with the difficult births of her first seven children ("not natural, not proven safe, not sufficiently tested, what about the long term effects?") -- the list could be endlessly extended. Exactly the same arguments were used in the early decades of the 20th century to try to prevent the legalisation of milk pasteurisation. Fortunately it was eventually legalised and over the last eight decades has saved untold numbers of lives that would otherwise have continued to be lost to milk-borne tuberculosis -- second only to clean water as the most important public health measure ever adopted.
Science depends on gaining knowledge, organising it into a coherent structure, hence improving understanding, and applying it. It is society's tool and method for doing so. However, we can never know everything there is to know about a topic. The one certain thing about life is that nothing in life is certain. Science cannot prove that anything is "safe" (i.e. absence of harm) because "absence of evidence" is not "evidence of absence". So any policy purportedly based on requiring science to prove safety is unrealistic.

In real life, decision and action by society to meet its needs has to be based, not on certainty but on using the best knowledge available at the time, and on skilful selection of areas for urgently needed research. In the absence of certainty it has to involve the combination of risk analysis and the precautionary principle, which are two inseparable sides of the same coin. These lie at the very crux of any discussion on the application of GM.

Risk analysis (RA) consists of:

• risk assessment, a task for scientists who are experts both in the topic and in the methodology of risk assessment. Risk assessment should take account of the likelihood of a risk occurring and its seriousness if it does occur, and should be applied not only to a potential course of action, but also to failure to take that action and to alternative courses of action;

• risk communication, a multi-directional interchange of information between legislators, the scientific community and the rest of society, which should be an ongoing process; and

• risk management, for legislators to carry out on behalf of society in the light of i and ii.

The relationship involving these three activities is not a linear one but one of dynamic and ongoing interplay.
A precautionary approach is a concept familiar to, and used by, food scientists and technologists. Taking precautions in advance to identify foreseeable hazards and adopting measures to prevent harm from occurring is at the heart of the Hazard Analysis Critical Control Point (HACCP) preventive food safety system.

On 2 February 2000, the EU Commission issued a "Communication on the Precautionary Principle". It is on-line at http://europa.eu.int/comm/dgs/health_consumer/library/pub/pub07_en.pdf

This includes
“The precautionary principle is not defined in the Treaty, which prescribes it only once - to protect the environment. But in practice, its scope is much wider, and specifically where preliminary objective scientific evaluation, indicates that there are reasonable grounds for concern that the potentially dangerous effects on the environment, human, animal or plant health may be inconsistent with the high level of protection chosen for the Community.”
and

“The precautionary principle should be considered within a structured approach to the analysis of risk which comprises three elements: risk assessment, risk management, risk communication. The precautionary principle is particularly relevant to the management of risk.

The precautionary principle, which is essentially used by decision-makers in the management of risk, should not be confused with the element of caution that scientists apply in their assessment of scientific data.
Recourse to the precautionary principle presupposes that potentially dangerous effects deriving from a phenomenon, product or process have been identified, and that scientific evaluation does not allow the risk to be determined with sufficient certainty.

The implementation of an approach based on the precautionary principle should start with a scientific evaluation, as complete as possible, and where possible, identifying at each stage the degree of scientific uncertainty.

Anti-GM activist groups have focused wholly on the phrases “….where preliminary objective scientific evaluation indicates that there are reasonable grounds for concern… and “and that scientific evaluation does not allow the risk to be determined with sufficient certainty” and have argued that these phrases justify opposing any and every GM activity.

This fails to recognise that science can never produce conclusive results and cannot deal in certainty. Moreover, experience teaches that the situation envisaged is most likely to arise in areas (such as biotechnology) where there are strong ideological agendas, in pursuit of which some individuals, including, unfortunately, some scientists, present unsubstantiated speculation, assumptions and guesswork as though they were "preliminary objective scientific evaluation". This sometimes takes the form of published purported "research papers" which on scrutiny turn out to be merely the authors' speculations and opinions, complete with references to similar papers by like-minded individuals.

If that sort of presentation is considered enough to bring a development to a halt, and, as we have seen, scientific evidence is always insufficient and science cannot prove anything to be safe, it can then be argued in perpetuity both by its ideological opponents and by scientists who see further research as a funding opportunity, that the development should not be implemented "until we know more".

Purported "preliminary objective scientific evaluation" should, therefore, always be very carefully and rigorously scrutinised to ensure that there is a broad scientific consensus that it is based on some hard scientific evidence.

Moreover, what is frequently overlooked ? and always overlooked by the opponents of a development ? is that PP should be applied not only to that development but to all alternative courses of action, including that of doing nothing. On 8 July 2008 the European Food Safety Authority issued a Question and Answer Document, titled "EFSA GMO Risk Assessment FAQs" which addresses the EFSA role in GMO risk assessment. Some of the questions answered are: How does EFSA carry out GMO risk assessments? Why does EFSA not carry out its own studies? Can the public access GMO applications? How does EFSA take account of long-term effects for human health and the environment and assess potential impact on biodiversity? What about the issue of coexistence with conventional crops and uncertainties, assumptions and the precautionary principle? Why does EFSA keep getting asked to look again at its risk assessments? Why does EFSA consider that antibiotic resistance genes in some of the GM plants are not dangerous?
http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_EFSAGMORiskFAQs.htm
It is an oft-repeated environmental truism that we hold the world in trust for future generations. It would be a betrayal of that trust and an abdication of responsibility by the present generation if science were to limit itself to collecting and providing information about current biotechnology applications, or if society were to limit itself to arriving at verdicts about them. We (society and scientists as part of society) must not behave as disinterested spectators standing on the sidelines and observing problems that may stand in the way of providing future generations with the potential benefits that GM can offer. We have a duty to address and solve such problems. Science is society’s tool for doing that.

"As for the future, your task is not to foresee it, but to enable it."
[Antoine de Saint-Exupery, The Wisdom of the Sands (1948)]
Thus, the real questions to be answered are not "Is it safe? Is it environmentally friendly?" but "What do we have to do to make it safe? What do we have to do to make it environmentally friendly? " Recognition of these is the touchstone of sincerity and objectivity.

A joint report on "Transgenic Plants and World Agriculture" was published in July 2000 jointly by the Brazilian Academy of Sciences, the Chinese Academy of Sciences, The Indian National Science Academy, the Mexican Academy of Sciences, the National Academy of Sciences of the USA, The Royal Society (UK) and the Third World Academy of Sciences. It is available in printed form, published by The Royal Society, and it may be accessed on-line as a pdf file at http://royalsociety.org/document.asp?tip=0&id=1448
The US organization, the Center for Science in the Public Interest (CSPI), which is no friend of corporations or of US regulatory agencies, issued a report in November 2001, primarily from a US perspective, entitled "Genetically Engineered Foods: Are They Safe?" but which also included environmental considerations. It mainly took the form of Questions and Answers by the co-directors of the Biotechnology Project at CSPI. The full text can be accessed on-line at http://www.cspinet.org/nah/11_01/

However, their "bottom line" conclusions were as follows:

• The genetically engineered foods that are currently on the market are safe. By increasing yields and reducing the use of pesticides, they benefit farmers and the environment.

• To ensure that new genetically engineered plants and animals are safe for humans and the environment, Congress should institute a mandatory government approval process that is open to public participation and review.

• The Environmental Protection Agency (EPA) should monitor the environmental impact of genetically engineered crops. It should require more field testing, enforce insect refuges for Bt crops, and adopt other environmental safeguards.

• The U.S. government should fund more research on genetic engineering, especially on fruits, vegetables, and other crops that are not of great commercial interest to the biotechnology companies.

• To enable developing nations to benefit from biotechnology, the U.S. government should:

o fund research and the training of scientists,

o help countries develop regulations to ensure the safe use of genetic engineering to produce food, and

o press biotech companies to donate technologies and allow free access to patents that are used to produce genetically engineered seeds and animals.

On 21 February 2002, the US National Academy of Science (NAS) issued its report Environmental Effects of Transgenic Plants. The report, which was commissioned in January 2000 by USDA’s Animal and Plant Health Inspection Service (APHIS), reviewed the scope and adequacy of the APHIS component of the Federal regulatory framework for biotechnology. As requested, the report evaluates the evolution of APHIS’ regulatory program, assessed the effectiveness of changes that APHIS had made to improve the program over the years, and made recommendations for further refinements, particularly involving three processes: notification, permitting and petitioning for non-regulated status. On 2 August 2002, USDA's Animal and Plant Health Inspection Service (APHIS) announced the creation of the new "Biotechnology Regulatory Services" (BRS) Unit within APHIS "to focus on USDA's key role in regulating and facilitating biotechnology".

The full news release is at http://www.aphis.usda.gov/lpa/news/2002/08/bioreorg.html
The World Health Organization has issued "20 Questions on Genetically Modified (GM) Foods". These questions and answers have been prepared by WHO in response to questions and concerns by a number of WHO Member State Governments with regard to the nature and safety of genetically modified food.

SAFETY CONSIDERATIONS

When introducing any new technology, including gene technology, into the food chain, there is a need to adopt appropriate safeguards to protect human health. Most countries in the Western hemisphere started developing regulatory controls well before any GM foods reached the market. These controls were put in place not because safety problems had been identified but because of a lack of familiarity with GMOs. Although many of the early concerns regarding the safety of GM foods have not materialised, the precautionary approach has continued as it remains important to ensure that no new hazards are created.

When considering safety in relation to GM, generalisations cannot validly be made. Instances have to be considered and studied in a case-by-case approach, and each case should be assessed in relation to the food involved, as ready for consumption, whether by man or by animals. Regulations in most countries, including the UK, include the concept of substantial equivalence. This concept was developed in the late 1980s by several national regulators and refined and given international recognition by the Organisation for Economic Co-operation and Development (OECD) in 1993 and further developed by the FAO/WHO Consultation in 1996 with particular reference to foods produced by modern biotechnology (fully detailed on the Web sites of FAO and the UK Advisory Committee on Novel Foods and Processes (ACNFP)). The concept is based on the idea that existing organisms used as food or food sources can serve as a basis for comparison when assessing the safety for humans of modified foods or ingredients. If a new food or component is considered to be substantially equivalent to an existing food or component the theory is that it can be treated in the same manner with respect to its safety and nutritional assessments.
Acceptability or non-acceptability is established by determining whether a novel food is substantially equivalent to an analogous conventional food in terms of composition, nutritional properties, toxin and allergen content, the amount consumed, the type of processing (industrial or domestic) that the food might undergo and consumption by vulnerable groups of people (e.g. infants and the elderly). Foods are assigned to three categories:

• Products that are shown to be substantially equivalent to existing foods or food components

• Products that are substantially equivalent to existing foods or food components except for defined differences

• Products that are not substantially equivalent to existing foods or food components
Where differences are identified, extensive animal feeding and toxicological trials are required. The establishment of substantial equivalence is an analytical exercise which has to be approached carefully. The comparison may be a simple task, or very lengthy, depending upon the nature and experience with the foods or components being compared. It must also contain a dynamic element to take into account that the continuing modification of a food will require that the most recent novel food is compared with an appropriate former novel food and not necessarily with the original and traditional counterpart.

An understanding of substantial equivalence is key to understanding the basis of GM regulatory controls. This brief outline may be supplemented by studying the text of the Report of the Joint FAO/WHO Consultation on Biotechnology and Food Safety http://www.fao.org/ag/agn/food/pdf/biotechnology.pdf

The question of antibiotic resistance marker genes (ARMGs) has been addressed above. There are no inherent grounds for assuming that GM foods are more - or less - allergenic than traditional foods. However, when developing any novel foods, including GM foods, care must be taken that allergenicity is not inadvertently introduced into the diet. This requires assessment of the allergenicity of a new protein by predictive methods, experimental testing and a post-marketing surveillance based on traceability.
The testing of GM products for suspected allergens can be done by an IgE test with serum from sensitive individuals [e.g. Herian et al (1990)]. However, there is also a need to test products where genes have been inserted from sources not known to be allergenic. Astwood et al (1996) have developed a method. Stability of a protein or protein fragments to digestion in simulated gastric fluid (SGF) may be used to assess the potential allergenicity of a protein.

The British Medical Association (BMA) in its earlier (1999) "interim statement" on GM had been hostile to GM and called for an open-ended moratorium on all commercial planting of GM crops until more was known about their effects on human health. Indeed that had been one of the factors influencing the visiting party of Zambian scientists to return to Zambia with recommendations against GM. "Doubts over the safety of genetically modified foods voiced by the British Medical Association were the main reason behind Zambia's decision to reject food aid in 2002, says a Zambian scientist who visited Europe this week. Famine still threatens 2.4 million people in Zambia today". New Scientist, 29 January 2003. http://www.newscientist.com/news/news.jsp?id=ns99993317

However in March 2004 the BMA issued a new statement

Announcing it they said "The BMA produced an interim report in 1999 on the health implications of GM food crops. In accordance with our intention to keep the public informed, we held a round table meeting of experts in June 2003 and have recently reviewed the emerging evidence. In producing an update of our 1999 report, the BMA seeks to support balanced debate. As an organisation of doctors, we are not experts in agricultural techniques and crop science, but we are concerned with all issues of public health. The environment in which we live, the air we breathe, the water we drink and the food we eat, all have an impact on our health as individuals. It is this context that the statement has been prepared. The BMA shares the view of the Royal Society that that there is no robust evidence to prove that GM foods are unsafe. However, we endorse the call for further research and surveillance to provide convincing evidence of safety and benefit."

Numerous perceived concerns regarding the safety of GM foods have been aired, many of them speculative and without any scientific evidence, but three substantial concerns which have been most widely discussed are in fact urban myths. These are the L-tryptophan story, the brazil nut allergen story and the events surrounding Arpad Pusztai and his potato experiment.

THE L-TRYPTOPHAN STORY

A frequently repeated account alleges GM as the cause of the disease that caused 1500 illnesses and 37 deaths in USA in 1989. The story refers to the so-called Eosinophilia-Myalgia Syndrome (EMS syndrome) associated with some dietary supplements containing the amino acid L-tryptophan.

The illnesses and death did occur, but the rest of the story is untrue. In reality, extensive investigation traced the cause to an impurity in L-tryptophan made by just one of its several chemical manufacturers, all in Japan. The culprit was Showa Denko KK of Tokyo (the fourth largest chemical manufacturer in Japan, but which had some 80% of the market for L-tryptophan). There has been successful litigation by three plaintiffs against SD KK. The GM issue was not raised seriously by the plaintiffs because there was such overwhelming evidence against it being a factor.

The manufacture of L-tryptophan is by a fermentation which also results in the formation of a number of secondary substances. To produce L-tryptophan of a purity necessary for human ingestion, the fermentation product mixture has to go through purification processes to remove the impurities, by-products and cellular debris, including treatment with activated carbon and reverse osmosis. Investigation of the records of Showa Denko KK showed that in the critical period (December 1988 to June 1989) they made a number of simultaneous changes to the manufacturing protocols. One of these was the use of the fermentation organism Bacillus amyloliquefaciens that had been genetically altered to increase the production of L-tryptophan. But this was accompanied by the partial bypassing of the reverse osmosis purification procedure, and a halving of the amount of activated carbon used (both stupid and irresponsible things to have done), thus failing to carry out the purification effectively. Subsequent research showed that in consequence the procedure left behind some sixty impurities; and also found significant correlation between the development of EMS and the reduction of the activated charcoal.

There have been several attempts to explain the precise mechanism by which the syndrome occurred. One involves a residual impurity 1,1 '- ethylidenebis-[tryptophan] (EBT), which then broke down to give 1-methyl-l,2,3,4-tetrahydro-beta-carboline-3-carboxylic acid (MTCA), a substance that was thought to have been involved in the EMS syndrome. Another suggests that it was the result of a reaction between two (or more) impurities. Like so many food poisoning outbreaks investigated after the event, the exact mechanism is unlikely now to be conclusively proved, but it was nothing to do with GM. Thus the "tryptophan" story was not a consequence of GM, nor of tryptophan itself, but an impurity or impurities left in as a result of irresponsible short-cutting by a particular chemical manufacturer.

THE BRAZIL NUT ALLERGEN STORY

With the currently much greater recognition of food allergens as a food safety issue, the possible introduction of allergenicity by genetic modification is a concern; and the apocryphal story of "people made sick by a brazil nut gene transferred into soya" has become a widely believed urban myth.

In fact, such a product never came on the market, and nobody ever ate any such product. Soya protein is deficient in methionine, and a seed company, Pioneer Hi-Bred, wanted to investigate the possibility of producing a soyabean with increased methionine content (thereby improving the nutritional quality of soya protein), by transferring a brazil nut gene to soya. With any research involving any gene transfer, it is routine standard procedure to investigate whether any allergenicity could be thereby transferred. In this instance, many people are allergic (some very seriously so) to soya itself; but it was important to investigate whether such a transfer would make the resulting soya allergenic also to people who are allergic to brazil nuts. The research was carried out at the University of Nebraska, the leading centre for allergenicity research. Perhaps not surprisingly, the researchers found that brazil nut allergenicity was transferred to the experimental material. Pioneer Hi-Bred announced that the research project was discontinued, and the results were published in a peer-reviewed journal [Nordlee et al, (1995)].

THE PUSZTAI POTATO EXPERIMENT

This has received considerable publicity. It relates to the purported adverse effects on rats of GM potatoes in which lectins had been inserted, and the associated TV programme and media interviews given by Dr Pusztai. Lectins, which are complex plant proteins, appear to act as pest deterrents in plants and lectin insertion into a crop plant by GM has been investigated as a means of enhancing pest resistance.
The story has been greatly confused by contradictory reports as to exactly what happened, and as to the supposed ill-treatment of the researcher concerned – mostly culled from the media and claims by Pusztai himself and activists keen to exploit the situation. Fortunately there is now a first-hand history available. In March/April 1999 the House of Commons Parliamentary Select Committee on Science and Technology investigated GM, and on Monday 8 March 1999 they held a Hearing at which Dr Pusztai and his friend Dr Stanley Ewen, and Professor Philip James, Director and Dr Andrew Chesson, Head of the Nutritional Chemistry Unit, both of the Rowett Research Institute (RRI), all appeared and were examined.

The written statement submitted by the RRI, which, incidentally, is considerably sympathetic to Pusztai, gives a first-hand historical account (and, incidentally, disposes of the various myths that have been put around about Pusztai and his treatment). For a verbatim account of all the evidence submitted by RRI and by Pusztai himself, and for the Select Committee's conclusions, see UK House of Commons, Select Committee on Science and Technology, http://www.publications.parliament.uk/pa/cm199899/cmselect/cmsctech/286/9030801.htm and http://www.publications.parliament.uk/pa/cm199899/cmselect/cmsctech/286/28602.htm

The study which caused the controversy has since been reviewed twice by the Audit Committee, by the Royal Society; by ACNFP; by the Committee on Toxicity; and by the Nuffield Council on Bioethics. All have found the experiment flawed, poorly designed, and incapable of leading to meaningful conclusions. There is, however, agreement that adequate in vivo tests need to be developed before a new GM crop with a lectin insert is released for either human or animal consumption.

As the RRI Audit Committee stated "The research was preliminary and not part of the process of testing specifically genetically modified crops destined for commercial use." "However, the purpose of the research remains valid. It was part of a larger programme designed to identify possible candidate genes, and their implications, for possible future use in the genetic modification of crops to enhance the crops' resistance to pests."

Whilst investigations into this case have shown that the problems were not directly related to the genetic modification as originally claimed (and still perpetuated by some) they emphasise that a greater awareness of the possible areas of concern is needed when assessing the safety of GM foods.

ENVIRONMENTAL CONSIDERATIONS

Early regulatory controls over the release of GM crops had, of necessity, been developed on an ad hoc basis due to the virtual absence in the 1980s of quantitative data on the ability of GM organisms to survive in the environment. However, in recent years evidence has accumulated so that regulations and guidelines can now be developed on a more rational basis; but there is a continuing need for studies on the possible risks of GM crops to the agricultural environment In the last few years, the UK Government has responded to this need by funding over 20 projects in this area at a cost of over £6 million. Clearly, regulations will need continuous revision and updating as new data become available.

In the EU Member States, any release of GMOs into the environment was governed by national regulations implementing EU Directive 90/220/EEC (now superseded by Directive 2001/18/EC) (implemented in the UK as part of the Environment Protection Act). In the UK, at present there are no GM crops being commercially grown. An experimental release, such as a field trial of a food crop, requires consent from the Government. Applications for consent must include a considerable volume of data and a detailed assessment of the risk of harm to human health and the environment. If a risk is identified or there is some uncertainty about the level of risk, the applicant may propose measures to manage or eliminate the risk. The applications are scrutinised by the Advisory Committee on Releases into the Environment (ACRE), a group of independent experts who advise the Government on whether consent should be given and whether extra conditions should be imposed prior to giving consent. All releases are advertised locally and details are made available via a Public Register. Release sites are subject to inspection by the Health and Safety Inspectorate and those making the release are required to report any incidents that may occur during and after the completion of the trials. On the one hand this openness and transparency is admirable, but on the other hand the information made available has been seized on by organised extremists who invade and destroy the trials.

The EU objective has been to protect health and the environment when:

• carrying out the deliberate release into the environment of GMOs for any purposes other than placing on the market within the European Community

• placing on the market GMOs as, or in, products within the European Community
Data required other than for higher plants:

• Information relating to the GMO characteristics of donor, recipient (or where appropriate parental) organisms characteristics of vector characteristics of modified organism

• Information relating to the conditions of release and receiving environment information on the release information on the environment

• Information relating to the interactions between the GMO and the environment characteristics affecting survival, multiplication and dispersal interactions with the environment

• Information on monitoring, control, waste treatment and emergency response plans.

Data required for GM higher plants:

• Information relating to recipient and / or parental plant

• Information relating to the genetic modification

• Information relating to the GM plant

• Information relating to the site of release

• Information relating to the release

• Information on control, monitoring, post-release and waste treatment plans

Since 1987, more than 25,000 field trials of GM plants have been carried out in 45 countries without adverse environmental consequences. Furthermore, the rate of field-testing has increased rapidly especially in the USA where the number of trials has doubled each year since 1987. In terms of field releases, the European Union lags well behind North America. More than 70% of field trials were conducted in the USA and Canada followed in descending order by Europe, Latin America and Asia, with very few trials conducted in Africa. These trials represent considerable accumulated evidence in support of a favourable safety and environmental record for the new gene technology.

The relevance of environmental data obtained from small field trials to large-scale sowing on several million acres of land has been questioned. However, the present situation is reported in the International Service for the Acquisition of Agri-Biotech Information (ISAAA) Report issued 13 February 2008,"Biotech Crops Experience Remarkable Dozen Years of Double-Digit Growth” from which the following is extracted:
After a dozen years of commercialization, biotech crops are still gaining ground with another year of double-digit growth and new countries joining the list of supporters, according to a report released today by the International Service for the Acquisition of Agri-biotech Applications (ISAAA). In 2007, biotech crop area grew 12 percent or 12.3 million hectares to reach 114.3 million hectares, the second highest area increase in the past five years.

In addition to planting more biotech hectares, farmers are quickly adopting varieties with more than one biotech trait. These “trait hectares” grew at a swift 22 percent, or 26 million hectares, to reach 143.7 million hectares – more than double the area increase of 12.3 million hectares. New crops were also added to the list as China reported 250,000 biotech poplar trees planted. The insect-resistant trees can contribute to reforestation efforts.

Further, 2 million more farmers planted biotech crops last year to total 12 million farmers globally enjoying the advantages from the improved technology. Notably, 9 out of 10, or 11 million of the benefiting farmers, were resource-poor farmers, exceeding the 10-million milestone for the first time. In fact, the number of developing countries (12) planting biotech crops surpassed the number of industrialized countries (11), and the growth rate in the developing world was three times that of industrialized nations (21 percent compared to 6 percent.) “With increasing food prices globally, the benefits of biotech crops have never been more important,” said Clive James, chairman and founder of ISAAA and the report’s author. “Already those farmers who began adopting biotech crops a few years ago are beginning to see socio-economic advantages compared to their peers who haven’t adopted the crops. If we are to achieve the Millennium Development Goals (MDGs) of cutting hunger and poverty in half by 2015, biotech crops must play an even bigger role in the next decade.”

According to the report, biotech crops have delivered unprecedented benefits that contribute toward the MDGs, particularly in countries like China, India and South Africa. The potential in the second decade of biotech crop commercialization (2006-2015) is enormous.

Studies in India and China show Bt cotton has increased yields by up to 50 percent and 10 percent, respectively, and reduced insecticide use in both countries up to 50 percent or more. In India, growers increased income up to $250 or more per hectare, increasing farmer income nationally from $840 million to $1.7 billion last year. Chinese farmers saw similar gains with incomes growing an average of $220 per hectare, or more than $800 million nationally. Importantly, these studies showed strong farmer confidence in the crops with 9 out of 10 Indian farmers replanting biotech cotton year on year, and 100 percent of Chinese farmers choosing to continue utilizing the technology.

While these types of economic benefits are well substantiated, the socio-economic benefits associated with biotech crops are starting to emerge. A study of 9,300 Bt cotton and non-Bt cotton-growing households in India indicated that women and children in Bt cotton households have slightly more access to social benefits than non-Bt cotton growers. These include slight increases in pre-natal visits, assistance with at-home births, higher school enrollment for children and a higher proportion of children vaccinated.

Rosalie Ellasus, a widowed mother of 3 children, found similar benefits, choosing farming as a way to support her family. “With the extra income generated from biotech maize, investing in farming made sense and allowed me to earn more than the medical technology field I was trained in,” she said. “The biotech maze gave me peace of mind and meant less time monitoring for pests. With stack corn, I also incur savings on cultivation and weeding costs. With the added income, I have been able to send all my children to college.”

“It’s these types of benefits that will make crop biotechnology a vital tool in achieving the U.N. Millennium Development Goals of cutting hunger and poverty in half and ensuring a more sustainable agriculture in the future,” James said. “To reach these goals, a continued broadening and deepening of biotech crop use is crucial to meeting food, feed, fiber and fuel needs in the future.”

In 2007, the United States, Argentina, Brazil, Canada, India and China continued to be the principal adopters of biotech crops globally. While the United States continues to be the largest user of the technology, its biotech crop area represents a declining share of the global area due to a broadening adoption.

“With a dozen years of accumulated knowledge and significant economic, environmental and socio-economic benefits, biotech crops are poised for even greater growth in coming years, particularly in developing countries that have the greatest need for this technology,” James said. According to the report, Burkina Faso, Egypt and possibly Vietnam are the next mostly likely countries to approve biotech crops. Australia is field-testing drought-tolerant wheat and two states recently lifted a four-year ban on biotech canola. Finally, countries like India recognize the importance of using biotechnology to make the country self-sufficient in food grains, including rice, wheat and oil seed production with the first biotech food crop, biotech eggplant, expecting approval in the near-term.

“I predict the number of biotech countries, crops, traits, area and farmers will all grow substantially in the second decade of adoption,” James said. “More developing countries are likely to approve the technology as it’s now possible to design regulatory systems that are rigorous without being onerous given their limited resources. The current delay in timely approvals of biotech crops like golden rice with benefits for millions is a moral dilemma where the demands of regulatory systems have often become the end and not the means.”

The report is entirely funded by the Rockefeller Foundation, a U.S.-based philanthropic organization associated with the Green Revolution; Ibercaja, one of the largest Spanish banks headquartered in the maize growing region of Spain; and the Bussolera-Branca Foundation from Italy, which supports the open-sharing of knowledge on biotech crops to aid decision-making by global society.
http://www.isaaa.org/resources/publications/briefs/37/pressrelease/default.html See also related slides http://www.isaaa.org/resources/publications/briefs/37/pptslides/Brief37slides.pdf
ISAAA now has an excellent website, updated weekly, with a very large number of links grouped to cover Global, Africa, Americas, Asia and Pacific, Europe, Research, Energy Crops for Biofuels Production and Biofuels Processing. At the time of writing the current weekly issue is dated 5 June 2008, but there are previous and future issues can be accessed by changing the date at the end of the URL (note the US practice mm/dd/yyyy). http://www.isaaa.org/kc/cropbiotechupdate/online/default.asp?Date=6/05/2008

Past experience with introductions of new species to environments where they are not naturally present has shown that potential problems may take several generations to manifest themselves. Possible cross-pollination from GM crops to non-GM crops is of
concern to organic farmers, who fear that, if it occurs, their produce could no longer be said to be "organic", and to those who wish to have the right to choose non-GM foods.

Three reports of trials in USA, Germany and Spain respectively have demonstrated effective co-existence.

• Byrne, P. & Fromherz, S. (2003).
"Can GM and Non-GM Crops Coexist? Setting a Precedent in Boulder County, Colorado, USA."
 Journal of Food, Agriculture & Environment, 1, pp 258-261. http://www.botanischergarten.ch/Coexistence/Byrne-Fromherz-2003.pdf

• Anonymous (2004).
"Insights gained from the 2004 Test Crop Coexistence of Genetically Modified and Conventional Corn", InnoPlanta, pp 6 Nordharz/Börde. http://www.botanischergarten.ch/Coexistence/Innoplanta-Coexistence-2004.pdf

• Brookes, G. & Barfood, P. (2004).
"Co-existence of GM and non GM crops: case study of maize grown in Spain, PG Economics Ltd, pp 13 Dorchester, UK." http://www.botanischergarten.ch/Coexistence/Brookes-Coexistence-Casestudy-Spain-2004.pdf

In July 2006, Defra carried out a consultation on proposals for managing the coexistence of GM and non-GM crops in England.
http://www.defra.gov.uk/environment/gm/crops/pdf/gmcoexist-condoc.pdf
IFST responded that it agreed with Defra’s view of the governing principle of coexistence; to
“balance the interests of all farmers. Farmers have a legitimate interest in growing their preferred crops (conventional, organic or GM), and a coexistence regime

 

 

 

 

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